September 2, 2014

Court Nixes Litigation Standards Set by Pathologists

What if a truck drivers' union tried to set standards for when juries could conclude that a driver was negligent in causing a motor vehicle wreck? Or what if a trucking company could defend its driver falling asleep at the wheel by showing that its other drivers had impeccable driving records?

That's about the situation the courts face with litigation guidelines set by two pathologists' groups about when misreadings of Pap smears by members of these groups should be judged negligent.

A recent ruling by the 11th Circuit Court of Appeals, the federal appeals court for the southeastern-most states, found the pathologists were wrong in trying to enforce their litigation standards. And it reinstated a lawsuit brought by a patient which had been thrown out by a trial judge because the plaintiff's expert had not followed the litigation guidelines promulgated by the College of American Pathologists (CAP) and the American Society of Cytopathology (ASC).

Here's a quotation from the 11th Circuit's decision in Adams v. LabCorp that shows the judges saw the difference between clinical practice guidelines promulgated for better patient care versus these litigation guidelines:

As an initial matter, it is important to put these guidelines in context. Both sets of them focus not on how cytotechnologists should go about their duties in examining slides, but instead on how courts should go about their duty to adjudicate claims against cytotechnologists and similar professionals. In the words of the guidelines, they are to be used in assessing Pap smear slides “in conjunction with litigation or potential litigation.” They are not objective, scientific findings; they are not guidelines followed by laboratories to screen for pre-cancerous or cancerous cells; they are policy proposals to limit how the courts can find the members of the organizations liable for professional negligence when they are sued.

As far as we are aware, this is the first time that an industry group has promulgated a set of guidelines that attempts to define and limit the evidence courts should accept when the group’s members are sued. The members of the CAP and ASC have a substantial interest in making it more difficult for plaintiffs to sue based on alleged negligence in their Pap smear screening, and their guidelines do just that.

The guidelines, if enforced, would have made it not just difficult, but VERY difficult to impossible, to prove that a laboratory had been careless or negligent in reading a patient's Pap smear. Here's an excerpt from the ASC's guidelines:

A violation of a reasonable prudent practitioner standard of practice based on how specific Pap tests were screened and interpreted can only be established through an unbiased blinded rescreening review process that includes the contested case as one of a number of normal and abnormal GYN cytology samples representing a variety of disease states. Focused review or review with knowledge of subsequent development of carcinoma inevitably biases the objectivity of the review against the laboratory and does not reflect standard practice.

Hindsight bias is an issue, and every honest expert witness I've dealt with tries to make sure to keep that in mind and not let it unduly influence his or her view of a case. But these guidelines essentially use an elephant gun to go after a flea.

In practical terms, the ASC guidelines would require the plaintiff to hire an independent pathologist to go to the defendant laboratory, whereupon the pathologist would be put to a test devised by the defendant: the specimens at issue would be salted in with a group of other specimens, some normal, some not, and the pathologist would then study the specimens under the microscope as if they were specimens seen in the ordinary course of lab work.

(Except, of course, that most labs, LabCorp included, use "cytotechnologists," non-doctors, to first screen the specimens and point out potential abnormalities for the pathologists to then study more closely. And the issue in this case was that the cytotechnologists at LabCorp had not even flagged this patient's smears as possibly worrisome.)

And what if the independent pathologist passes the test devised by the defendant lab and correctly diagnoses the mix of normal and abnormal specimens? The test of the plaintiff's expert is still not over, because the ASC guidelines go on to say:

Courts and experts should recognize that a false‐negative result by itself is not sufficient proof of negligence. Rather, the courts should evaluate whether the overall Pap‐test practices of the laboratory meet the standard of care and whether unbiased blinded rescreening consistently detects significant abnormalities not initially identified by the laboratory.

I've italicized two key pieces. First, "overall practices of the laboratory" seems to mean that as long as the lab overall has a good track record, it shouldn't be found negligent for messing up on one patient's specimen, even if it was wrong that one time. This would be like a trucking company saying, "Never mind that our driver fell asleep at the wheel; we have a nearly spotless driving record other than this one time."

A fundamental aspect of American tort law is that the defendant's conduct is judged on the specific case, and it's not relevant to prosecute or defend a case based on what happened on some other occasions (with a few exceptions when the allegation of wrongful conduct is that the defendant had failed to detect a pattern in the prior events). This prevents plaintiffs from using prior bad events unfairly, and it prevents defendants from using prior good events unfairly.

The second italics is on the word "consistently." That means the pathology groups want their members to be found guilty ONLY if no experts can be found to defend their reading on a particular occasion. So only the most egregious cases could go forward, since it's child's play to find an expert who will give a pass to conduct that other experts will criticize.

In the Adams case, the plaintiff had hired an expert of sterling credentials, Dr. Dorothy Rosenthal of Johns Hopkins Hospital. She had not only spent 40 years training cytotechnologists how to read Pap smears, she also had worked on the pathologists' committee that set the medical standards for when cells on a Pap smear look cancerous, when they look borderline, and when they are benign.

The lab had criticized Dr. Rosenthal for doing a non-blinded review of Ms. Adams' Pap smears, but as the 11th Circuit pointed out, the lab's own expert witness did exactly the same non-blinded review. And the 11th Circuit was troubled by the one-sided nature of the litigation guidelines:

...the ASC's guidelines condemn non-blinded review because it “biases the objectivity of the review against the laboratory,” but express no concern about non-blinded review biasing the assessment of defense experts against plaintiffs. Clearly, the purpose of the guidelines is to raise the bar only on the plaintiffs' side of the courtroom.

The litigation guidelines go way too far on hindsight bias, as the court observed:

...both sets of guidelines treat the mere risk of review bias as intolerable. They do not specify the frequency or degree to which review bias actually affects reviewers’ judgments. Nor do they cite any empirical evidence supporting their assertion that knowing the outcome “inevitably biases” the reviewer. Yet they insist that a court should exclude expert testimony unless the expert has eliminated entirely the possibility of any review bias. That would be a radical reworking of [Federal Evidence] Rule 702, which requires courts to determine that the expert’s method is reliable, not that it is free of any possibility of bias.

The lab also claimed that Dr. Rosenthal's opinions were "Ipse Dixit" -- Latin for, "because I say so" -- but the Court said that was wrong too, since the expert had used the same atlas showing what abnormal cervical cells look like that the defendant's employees had used:

Dr. Rosenthal used a well-established classification system to assess the cells: the same Bethesda System that LabCorp's cytotechnologists use. In her deposition testimony she went picture-by-picture, pointing to specific places in each one where Ms. Adams's cells showed abnormalities and classifying those abnormalities using the same Bethesda classification system that is used by LabCorp's cytotechnologists and nearly every other professional in the field of cytopathology. And the Bethesda Atlas, which is maintained by the ASC, provides numerous examples of each abnormality that Dr. Rosenthal identified, including “classic examples” of abnormal cells as well as “borderline” cells. As Dr. Rosenthal explained in her deposition, the images in the Atlas could be used to assess whether her opinion was in step with the established standards in the field. The fact that Dr. Rosenthal applied an established diagnostic system in which she was well versed contributed to the reliability of her methodology.

One puzzle remains: these guidelines have been around since at least 2000, in the case of ASC, but only now in 2014 reached the attention of a federal appeals court. Maybe that's because trial courts before the one that was reversed here by the 11th Circuit could see so plainly that the "litigation guidelines" were an improper attempt by a self-interested professional group to stack the deck of lawsuits against its members.

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August 25, 2014

Feds Withhold Some Information From Doctor Dollars Database

Next month the federal government’s database of drug company and medical device manufacturer payments to doctors is supposed to launch. But it won’t be as we expected.

As reported by ProPublica.org, about one-third of the records will be withheld because of data inconsistencies. Keep in mind that although the Physician Payments Sunshine Act was passed in 2011 as part of the Obama administration’s health-care reform, and the database, Open Payments, was supposed to be available to the public last year, it has been delayed until now.

Withholding information seems to be trending: A few weeks ago, courtesy of USA Today, we blogged about the feds not reporting some serious hospital errors on its Hospital Compare website.

Open Payments is supposed to disclose payments industry makes to doctors for research, consulting, speaking, travel and entertainment as an effort to clear up — and, one hopes, clean up — conflicts of interest and the appearance of them. If your doctor chooses a certain kind of implant for your hip replacement, and he or she also has been paid to promote it at surgeon conventions, can you be sure that choice for you is completely for medical reasons? Or because the doctor likes getting two paychecks?

The first Open Payments release, scheduled for Sept. 30, covers payments made from Aug. 1 to Dec. 31, 2013.

The Centers for Medicare and Medicaid Services (CMS) has been investigating physician claims that payments were being attributed erroneously. The agency reported that, indeed, one physician’s payments were being recorded as being sent to another one with the same name. The feds said they found "intermingled data”— medical license numbers or national provider identification numbers linked to the wrong people — that had to be corrected before being made public.

These data won’t be included in the database until the next reporting cycle, which is June 2015.
CMS did not tell ProPublica how many records were involved, but it could be as many as tens of millions.

Certainly, it is in no one’s interest to publicize erroneous information. But it’s troubling that, like the rollout of the state and federal health insurance exchanges last year, a federal health-care initiative once again has proved to be balky, tardy and sloppy.

Before CMS makes the data public, it has allowed physicians 45 days to review and contest entries they believe are inaccurately attributed to them. When a physician in Louisville, Ky., found payments attributed to him that should have been attributed to a doctor with the same name in Florida, ProPublica reports, CMS suspended the verification system for 11 days to investigate. And now, physicians have until Sept. 8 to review their data, even though CMS has promised to stick with the Sept. 30 deadline for public access.

This vigilance is to be commended … except that when CMS promised not to post anything that hadn’t been validated, it didn’t mention that one-third of its records won’t appear on Sept. 30.

And, because some physicians told ProPublica that some of the data being withheld was accurate, you wonder about the quality of the whole program.

One physician said that only three entries for him currently show up, although several other legitimate ones from a device maker should be there. Another doctor reported that what he thought were legitimate payments attributed to him from three difference device makers or drug companies weren’t recorded under his name.

Supposedly, according to a follow-up by CMS, consumers will be given an explanation about the missing payments when the database launches. But doctors told ProPublica that they didn’t see such a notice on the verification site.

We’ve often blogged about websites that provide information about doctor behavior and pay, among them ProPublica’s Dollars for Docs. It lists approximately $2.5 billion in payments to doctors, other medical providers and health-care institutions that have been disclosed by 15 pharmaceutical companies since 2009. It can be searched by state and company, and filtered by category and year.

Dollars for Docs shows payments by companies that have made information public, typically under settlement agreements with the government to resolve allegations of improper marketing. ProPublica also has researched company websites for information.

“On each payment record in Dollars for Docs,” according to the site, “you can find details about the drugs each company makes, how it describes the service performed and questions you can ask your doctor about his or her relationship with the companies.”

It’s not as comprehensive as what the law requires CMS to do, but it’s a fine resource, especially in light of the fact that CMS is not really doing what it’s supposed to.

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July 6, 2014

Can Doctors Avoid Conflicts of Interest?

As editor-in-chief of JAMA for 11 years, Dr. Catherine DeAngelis was known for her outspoken views about the deficiencies of U.S. health care and the drug industry. Her recent commentary, “Conflicts of Interest in Medical Practice and Their Costs to the Nation's Health and Health Care System,” continues her campaign to expose what’s wrong with our medical care.

“Many, if not most physicians practicing today have, or have had, conflicts of interest that clearly do not result in their patients’ best interest,” she writes in the Milbank Quarterly, a health policy journal. She defines conflicts of interest as “a conflict between the private interests and the official responsibilities of an individual in a position of trust.”

That sorry situation, as summarized by MinnPost.com, has become widespread over the last couple of decades, largely driven by pharmaceutical companies whose marketing and scientific divisions seem to be one and the same.

We’ve blogged about the slimy intersection of these two forces, and their harmful effect on patient safety. DeAngelis traces their roots back to medical school, with “the free black bags, instruments or books given to medical students by a pharmaceutical company, or even the doughnuts, coffee, soft drinks and free lunches provided at teaching conferences.”

It’s not long before those … kindnesses … escalate to “the free food, tickets to sporting and other events, sponsored trips to resort locales and the shower of other gifts given to physicians by the pharmaceutical representatives assigned to them,” says DeAngelis.

Often, the recipients of this largess claim that their clinical and prescribing practices are not influenced by it, but if that were true, DeAngelis wonders, “[W]hy would pharmaceutical companies spend billions of dollars on these items, and why would they partially reimburse their marketing representatives according to the number of prescriptions written by the physicians to whom they are assigned?”

Sunlight is spreading over this smarmy practice of drug and device manufacturers showering practitioners with attention and treats — ProPublica’s Dollars for Docs is one site where you can track how the industry greases practitioners’ palms — but DeAngelis explains how much more disinfectant is required to clean up the mess.

“What about the free drug samples provided to physicians for their patients?” she asks. Some people say free samples help patients who otherwise can’t afford the drugs they need. If so, she asks, “[W]hy are the vast majority of these free samples for new (meaning those still under patent protection) and expensive drugs that are almost exclusively for illnesses that require the drug’s frequent or continued use?”

She’s concerned as well about academics who conduct research and/or write practice guidelines or review papers who are subsidized by Big Pharma. “Most Americans are surprised to learn that the clinical research funded by Big Pharma dwarfs the annual investment by the National Institutes of Health. Moreover, much of this industry-sponsored research is tainted by bias that is not always clearly stated.”

If you’re not happy to name the members of your team, doesn’t that suggest there’s something sordid about the game you’re playing?

DeAngelis decries the practice of physicians, biomedical and health-care researchers working for a pharmaceutical company’s marketing division instead of its scientific division. One example is “expert physicians” serving as industry-sponsored speakers using data provided by the pharmaceutical company. “Invariably” she writes, “such ‘chaperoned’ presentations accentuate the positive and downplay the negative (including price differentiation) aspects of the drug being promoted.”

Then there’s the common but illegal habit of promoting a drug for off-label use. DeAngelis describes how insidious drug companies and their willing medical partners operate in this arena:

Imagine the following and, unfortunately, common scenario: At a major clinical or health-related lecture, a physician paid by the pharmaceutical company is “planted” in the audience. The “plant” raises his or her hand and supposedly innocently asks the presenter if he or she has ever used the drug for an illness for which the drug has not been approved by the … FDA. The presenter then discusses off-label uses of the drug for this or that illness or symptom. Remember that physicians in the United States can write prescriptions for any drug, whether or not it has been approved by the FDA for that illness. So why not add a few more uses, which can translate into multiple sales and millions of dollars in unexpected revenue?

Later this year, as we’ve noted, the Physician Payment Sunshine Act, a provision of the Affordable Care Act, requires drug and medical device manufacturers to report what they pay individual physician on a website accessible to consumers.

Will that public disclosure persuade physicians to uphold their Hippocratic oath to do no harm, to always act in the best interest of their patients and reject the free meals and trips, the lucrative speaking and consulting fees Big Pharma offers?

Says DeAngelis, “We can only hope.”

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June 29, 2014

Senator Smacks Down Dr. Oz for Diet Supplement Nonsense

Dr. Mehmet Oz , a popular TV personality, is better known for his charisma than his medical expertise, and no wonder why — he’s constantly hawking dubious treatments, and recently the chair of the U.S. Senate's Consumer Protection panel called him out for it.

Oz's shilling for diet supplements now has the attention of comic John Oliver, to devastating effect, but readers will have to go all the way to the end of this piece to get the link.

Oz testified at a Senate hearing about deceptive advertising for over-the-counter diet supplements and products. According to CBS News, Sen. Claire McCaskill told him, "I get that you do a lot of good on your show [“The Dr. Oz Show”]. But I don't get why you need to say this stuff because you know it's not true."

The “stuff” is the outrageous, even false claims he routinely makes about “miracle” dietary and health supplements (See our blog, “Pulling Back the Curtain on Dr. Oz”).

Oz defended himself by claiming that if you can inspire someone to start a weight-loss regimen by using products readily available, you’re doing a good thing.

He isn’t concerned that these useless products have no scientific foundation and encourage people to believe in magic. He is concerned about getting “folks to realize there are different ways they can rethink their future."

But as McCaskill told CBS, he’s just fueling the sketchy diet industry with unscientific claims. That’s not how you “rethink” your future; that’s how you waste money on worthless products that serve only to set back a true effort at nutritional reform and weight loss.

A couple of years ago, Oz promoted a product on his show called green coffee bean extract. Half a million bottles of the pills were sold, and the Federal Trade Commission filed a lawsuit against the manufacturer for false advertising.

Oz defended his endorsement of it by citing a clinical study that McCaskill criticized because it was funded by the product's manufacturer.

"People want to believe you can take an itty-bitty pill to push fat out of your body," McCaskill said during the hearing. But "the scientific community is almost monolithically against you."

The civil justice blog PopTort.com also found fault with Oz’s latest performance. In addition to the coffee bean extract claim, it reported, McCaskill cited two others Dr. Oz has made on his program that stretch credulity:


  • "I've got the No. 1 miracle in a bottle to burn your fat. It's raspberry ketone."

  • "Garcinia cambogia: It may be the simple solution you've been looking for to bust your body fat for good."…


PopTort noted that Oz features alternative medicines on his show, and that Consumer Reports just published a study that found that 2 in 3 Americans think the word "natural" on the label of a packaged or processed food means it contains no artificial ingredients, pesticides or genetically engineered organisms. In fact, it means exactly nothing, as federal labeling rules do not exist for that term.

And Oz’s support of so-called “natural” treatments reinforces the lie that it does mean something.

According to CBS, Oz agreed to testify at the hearing because he supports lawmakers’ efforts to make companies accountable, require transparency about their products' claims and ensure safety.

Some members of Congress want to give the FDA the power to regulate supplements, which it does not have now. The Dietary Supplement Health and Education Act allows safety and efficacy testing of supplements to be done by the manufacturer. By law, companies selectively may provide information to the FDA and consumers. If a product is suspected to be unsafe, the FDA must investigate before it can remove the product from the market.

The proposed Dietary Supplement Labeling Act would require all companies and manufacturers to register their products with the FDA and disclose information about known risks and adverse effects. It also would require them to include more information on product labels.

As McCaskill told Oz, "I know you know how much power you have. … You can be part of the police here or you can be part of the problem."

Clearly, comedian John Oliver believes he’s the latter. Oliver did a hilarious and informative takedown of Oz on his HBO TV show, “Last Week Tonight with John Oliver.” In addition to portraying Oz as the huckster he is, Oliver indicted the lack of “regulatory zeal” by a Congress that succumbs to the lobbying of the supplement industry.

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June 1, 2014

Burn Surgeon’s Testimony Tainted by Conflict of Interest

Clothing and furniture containing flame retardants have come under scrutiny because their chemicals may not retard flame but do pose health risks. Recently, proposed legislation in Washington state brought the issue additional attention when a burn expert testified before lawmakers that flame retardants do prevent fire casualties, despite the fact that he had been paid nearly a quarter million dollars as part of an industry campaign to promote their use.

The story, recounted in a 2012 series by the Chicago Tribune, continued last month when the newspaper reported that Dr. David Heimbach, facing disciplinary charges in Washington, had surrendered his medical license. State officials had charged that he not only lied about his objectivity, but had fabricated testimony.

It was a sad end to an ostensibly brilliant career. Heimbach, a burn surgeon, was head of the burn center at Harborview Medical Center in Seattle for 25 years and had received an award from the Dalai Lama for his care of burn victims around the world.

In 2011, he testified before state lawmakers that babies had burned to death in fires fueled by furniture lacking flame retardants. The legislators were considering requiring furniture manufacturers to use flame retardants.

But Heimbach’s burned babies did not exist — he had made up their stories while serving as a consultant to a chemical-industry front that had paid him handsomely for his prominent name and voice in defending flame retardants, “despite research that shows they don’t provide any meaningful protection from home fires,” according to The Tribune.

The Tribune investigative series, “Playing with Fire,” reported how Heimbach’s testimony was only part of a campaign of deception by the industry to promote the use of flame retardants, which can migrate from furniture into human bodies, with numerous harmful effects.

Heimbach had told the paper that his testimony about babies dying in fires was meant to be only anecdotal. Later, through an attorney, he said he changed the facts to protect patient privacy.

Washington’s Medical Quality Assurance Commission brought the charges against Heimbach, citing his association with Citizens for Fire Safety. The Tribune showed that organization to be founded, funded and controlled by major manufacturers of flame retardants. “When states considered laws that would ban or limit the use of flame retardants,” said The Tribune’s latest story, “Citizens for Fire Safety stirred the public’s fear of fire and downplayed the health risks linked to the chemicals, such as cancer, neurological deficits, developmental problems and impaired fertility.”

Citizens for Fire Safety described itself as a “coalition of fire professionals, educators, community activists, burn centers, doctors, fire departments and industry leaders, united to ensure that our country is protected by the highest standards of fire safety.” Heimbach’s image, of course, imparted additional credibility, for which, according to commission records, it paid him $240,000 in 2010 and 2011. He never mentioned that during the legislative hearings at which he testified. He claimed to be unaware of the coalition’s industry ties until reading about them in the Chicago Tribune.

After the Tribune published its initial stories, California, which had established the standard, widespread use of flame retardants in American furniture, changed its regulations to allow furniture manufacture without them. And the chemical industry front group that paid Heimbach? It folded.

Heimbach, whose surrender of his license excuses him from paying any penalties, has retired to Hawaii. A true example of a career going down in flames.

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May 25, 2014

Harmful Spine Treatment Infuse Got an Assist from the FDA

The lawsuit-generating spinal treatment Infuse was approved by the FDA in 2002, and, according to a disturbing investigative report by the Milwaukee Sentinel and MedPage Today, the feds gave it the nod even though concerns about its safety were raised and it had been tested on so few patients as to make conclusions about its usefulness meaningless.

The problems caused by the spinal implant, which is supposed to encourage bone growth and fuse the gaps between vertebrae after fusion surgery, resulted in Medtronic, its manufacturer, recently agreeing to pay $22 million to settle about 950 lawsuits, and reserving another $140 million to settle an anticipated 3,800 additional claims.

"It appears the clinical trials, unfortunately, were not designed to adequately test for safety of the product," said one Sentinel/MedPage source, a chief of spinal surgery at a major metropolitan hospital.

The FDA approved Infuse not as a life-saving drug or an intervention that reduces disability significantly; it was approved as an alternative to traditional spinal fusion surgery.

As the story notes, testing new biologic agents usually requires clinical trials involving 1,000 to 3,000 people. But because the FDA invited Infuse on the market as a combination device, not a biologic agent, its trial involved a paltry 277 subjects. Medtronic’s website refers to Infuse as “biologic device.”

Biologic drugs, as the Sentinel/MedPage story explains, also are known as bio-pharmaceuticals. “They replicate natural substances in the body such as hormones, antibodies, or, in the case of Infuse, growing bone. Traditional drugs are made by combining chemicals. But biologics are manufactured in a living microorganism, such as plant or animal cells, and can pose special safety risks such as infections, immune system disorders and cancers.” One study found that about 1 in 4 of 174 biologic drugs had been the subject of safety-related regulatory actions after they got on the market.

Because Infuse was approved in a "noninferiority" trial, Medtronic did not have to prove it was any better than the traditional treatment.

"It should not have gone through the device approval process," a health researcher in orthopedic surgery told the Sentinel/MedPage "It should have gone through the biological testing process."

The story’s revelations won’t surprise readers of this blog (see our post, “Medtronic Spinal Treatment Is Riskier and No Better than Bone Graft ”); it showed that more than 6,500 reports of Infuse-related problems have been registered with the FDA's medical device reporting system since Infuse was approved.

The complications include cancer, sterility and pain.

Adding another “ick” layer to the approval of a product that harms people, according to the Sentinel/MedPage, is the group of spine surgeons who received millions of dollars in royalties from Medtronic and who had co-authored papers failing to acknowledge the link between Infuse and several serious complications. In some cases, the medical journals publishing the papers didn't fully disclose Medtronic's financial relationship with the authors.

Can you say “conflict of interest”?

So questionable was this product even among orthopedists that The Spine Journal, according to the Sentinel/MedPage, dedicated a whole issue to its deficiencies. It referred to research that found that Infuse had complication rates 10 to 50 times greater than the complication rates estimated in the papers written by the doctors whose priority wasn’t helping patients get well, but helping their own bottom lines.

The FDA, for its part, issued the usual “what, me?” response to Sentinel/MedPage inquiries. An email from its spokeswoman said Infuse was approved based on clinical and nonclinical data that "demonstrated a reasonable assurance of safety and effectiveness," and that an advisory panel of outside experts reviewed the evidence and voted unanimously to recommend approval.

She said the FDA has reviewed the thousands of adverse events reports about Infuse, post-approval studies and medical literature, and continues to believe there is a reasonable assurance of safety.

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May 7, 2014

Why Free Drug Samples Lead to Higher Drug Costs

A new study published in JAMA Dermatology gives yet more evidence that theres no free lunch in the medical industry. This study found that when doctors receive free samples from pharmaceutical companies, they’re more likely to prescribe the expensive, brand-name medicine even if other drugs, including generics, are available and equally effective.

As analyzed by a story on NPR, the JAMA study showed that dermatologists who accepted free brand-name acne drugs were likelier to prescribe the expensive medications than doctors who are forbidden from accepting samples. And the difference in cost is not marginal.

The average cost of medicines prescribed by docs who accept and distribute freebies is $465 per office visit. It’s about $200 for patients who see doctors who can't hand out samples.

One practitioner, who wasn’t involved in the study, told NPR, “When a doctor gives a sample to a patient, it's a very strong endorsement of a drug. Patients think the physician has chosen this sample because it's the best drug for them. They don't realize that the doctor might have chosen it because a drug rep gave him samples and it was what he had around the office.”

Once somebody gives a patient a free trial drug, it’s difficult for some docs to prescribe a different generic drug, because it looks inconsistent. So some physicians, not just dermatologists, end up prescribing an expensive branded drug when a less expensive option is available. And most physicians, according to the study, don’t even realize the influence free samples have on costs.

The researchers analyzed the prescribing habits of 3,500 dermatologists in private practices across the country. They compared that data with prescribing patterns at Stanford University clinics, where doctors aren't allowed to take samples from drug companies.

The private practice doctors recommended brand-name medications for almost 8 in 10 patients. The Stanford clinic doctors recommended name-brand medications only 1.7 in 10 times.

The experience of the Stanford clinicians is very telling, too, about patients’ perceptions and expectations. When they stopped accepting free dugs and giving them away, patients complained. NPR said one recent study, “Why Didn't Your Doctor Prescribe A Generic? Look In The Mirror,” found that more than 1 in 3 doctors surveyed sometimes prescribed a brand-name drug because a patient requested it, even when a generic version was available.

Sometimes, it is good medicine and good economics for practitioner to provide samples, especially when patients don’t have insurance coverage or are on tight budgets. Some brand-name drugs are available in different doses or in a time-release formula, which can be more convenient or better absorbed for some people.

But it’s largely the patient’s responsibility to ensure their drug bill isn't being inflated unnecessarily. That’s not expensive only for the individual, it raises everybody’s health-care costs.

As we’ve always advised, when your doctor prescribes a medicine, ask:


  • Why is this the best treatment?

  • What will happen if I don’t take it?

  • Are there alternatives and/or a generic version?

  • When can I expect to see results?

  • What are the side effects, and how likely am I to experience them?

  • What are the risks?

  • Are there foods or other medicines I should avoid when taking this medicine?

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May 1, 2014

UCLA Settles Whistleblower Lawsuit Over Conflict of Interest

Later this year, the Physician Payments Sunshine Act takes full effect. It’s part of the Affordable Care Act (ACA, or “Obamacare”), and requires public disclosure of financial relationships between health-care companies and physicians. (See our blog, “Which Doctors Line Their Pockets with Big Pharma Money?.”)

Clearly, it’s overdue. One example why is last week’s settlement by UCLA, whose orthopedic surgery department agreed to pay $10 million to its former chairman. Dr. Robert Pedowitz had sued the University of California system, alleging that its premier medical school allowed doctors to accept payments from the medical device industry that might have compromised patient care.

As explained in the Los Angeles Times, the settlement was reached just before closing arguments were set to begin.

Pedowitz, a surgeon, had been recruited in 2009 to run UCLA’s orthopedic surgery department. He sued in 2012, saying university officials, regents and fellow surgeons failed to act on his complaints about widespread conflicts of interest and later retaliated against him.

During the trial, Pedowitz testified that he was concerned about colleagues who had financial ties to medical device manufacturers and other companies, because such relationships could influence patient care and/or medical research. The best care, and the best research, is objective; it can’t be colored by what the practitioner gets out of it.

Pedowitz also claimed that UCLA allowed potential conflicts of interest because of the potential financial benefit from the medical products or drugs developed by its staff.

Commenting on the lawsuit’s outcome to the L.A. Times, Susan Chimonas, associate director of research at Columbia University's Center on Medicine as a Profession, said some medical schools “can be dependent on the money these big-earning specialties like orthopedic surgery bring in. They are the cash cows and they can set their terms. This is not the first time I've heard of medical schools having policies that are not well enforced."

The case brought to light one UCLA orthopedic surgeon who had received $250,000 in consulting fees from Medtronic, which makes products including Infuse. It supposedly promotes spinal bone growth but, as we wrote last year, involves a risky procedure that isn’t proved to be superior to other spinal treatments.

At trial, Pedowitz testified that he was concerned that the surgeon was trying to enroll patients in a research study involving Medtronic while he was accepting its money. "I saw this as an obvious problem," Pedowitz testified.

The surgeon, Dr. Nick Shamie, testified that he had followed university policy, and hadn’t pursued the study because finding patients had been too difficult.

His wasn’t the only doctor-manufacturer relationship highlighted in the case. And even before Pedowitz joined the university, it had been criticized by Congress after another top spine surgeon failed to report nearly $460,000 in payments he had received from Medtronic and other medical companies while researching their products' use in patients, according to government records.

Several patients, according to The Times, are suing that doctor, Jeffrey Wang, and UCLA for negligence, fraud and malpractice in connection with surgeries involving Medtronic's Infuse bone graft. Wang is no longer with UCLA.

The Pedowitz settlement terms include his departure from the UCLA faculty; in 2010, he had stepped down as department chairman after expressing his concerns to UCLA officials. He filed a whistleblower retaliation complaint in 2011.

Mark Quigley, the attorney who represented Pedowitz, said the lawsuit wouldn’t have been filed had the UC system enforced its own policies. "What good are all the policies if they protect the wrongdoers and fail to protect the actual whistleblower?" he asked.

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April 23, 2014

Making the Most of Medicare’s Doctor Pay Report

Last week, we introduced readers to the new, searchable federal database (“How Much Did Your Doctor Make From Medicare?”) showing what doctors were paid in 2012 by Medicare. It’s an important new tool showing your tax dollars at work, and how practitioners in your area might be using (and possibly abusing) this important health-care program.

But like every other informational resource, the database is most useful only when you put its data into context; when you understand how different practices and specialties demand different use of medical resources. Naked numbers aren’t very useful.

An insightful commentary by Charles Ornstein in the Los Angeles Times shows why the Medicare pay information is helpful, and why it’s limited. Ornstein is a Pulitzer Prize-winning journalist at ProPublica, the investigative news service that introduced Dollars for Docs, a data base of payments by a dozen pharmaceutical companies to health-care professionals for promotional activities, consulting and research.

Ornstein reminds readers that this autumn, as part of the Affordable Care Act, the federal government will release data on personal, promotional and research payments to doctors from all pharmaceutical and medical device companies, not just the ones represented on Dollars for Docs. “Armed with this information,” he writes, “patients will be able to at least ask whether their doctors have prescribed a drug because it is the best one for their patients — or because of a financial relationship.”

But data can be misleading. “There's a big difference between, say, a hospice doctor giving almost every patient a narcotic and a podiatrist doing the same thing,” Ornstein points out. There’s a big difference between doctors who treat the urban poor, who tend to be sicker when they seek treatment, and those who treat affluent folks with sufficient health insurance.

To get the most out of the Medicare information, you must know what is available, what's missing and how to interpret it. Raw numbers, Ornstein reminds, don’t tell you “whether one doctor's patients are sicker than another's and need different therapies. They won't tell you about a doctor's bedside manner or willingness to return a phone call at 3 a.m. They won't tell you about a doctor's surgical skill.”

Another story in the Los Angeles Times mentioned that one doctor, according to the Medicare information, received millions in Medicare payments that seemed off the charts in comparison to his peers. But it turned out that all eight of the doctors in his practice billed Medicare under his name, so it looked as though a single practitioner received payments that, in fact, went to eight people.

So Medicare’s database is a place to start, but for context, don’t overlook other avenues of information, such as review sites including Healthgrades and Yelp, where consumers offer opinions of their doctors — but be aware that your priority for a practitioner might not be the same as some other patient's.

Research practitioners on state medical board websites to see if someone has faced disciplinary action. (See our blog, “How to Find Out If Your Doctor Has Been in Trouble.”)

If you’re really ambitious, you can research lawsuits to unearth malpractice and other medical-legal histories.

It’s all an effort to help you get the best care for your needs. As Ornstein summarizes, “Access to information is crucial if patients are to have any hope of answering that most basic of questions: How does my doctor practice medicine?”

“We're still a ways off from having enough information to do an overall comparison of the quality of care from one physician to another,” he writes. “But Medicare should be applauded for its new release of data, and it should continue to do more. It should also encourage private insurers and other public programs to follow suit.”

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April 20, 2014

Choosing Wisely Campaign Protects Its Own

We’ve been champions of the Choosing Wisely campaign, an initiative by several medical specialties to call out procedures they advise doctors and patients to view with skepticism. But now it looks like there's a big "Not in My Back Yard" problem with the program.

Last year, for example, our blog “Orthopedic Treatments You Should Reject” outlined five treatments the American Academy of Orthopaedic Surgeons said appeared to have little worth.

So it’s disappointing to realize, as a story by KaiserHealthNews and the Chicago Tribune recounted last week, that some of the largest medical associations participating in Choosing Wisely tabbed rare treatments or those performed by practitioners in other fields instead of those that are lucrative for them. "They were willing to throw someone else’s services into the arena, but not their own," said Dr. Nancy Morden, whose research into the societies’ advice was published in the New England Journal of Medicine.

The campaign was a welcome change in a medical profession that historically had been reluctant to spurn unnecessary treatments, often because they are money-makers for the practitioners. Of course, that also means they add costs for patients and insurers, aren’t proved to improve health and sometimes can cause harm.

Since 2012, 54 specialty societies in Choosing Wisely have recommended procedures to avoid, and the lists have been distributed to more than half a million doctors. Hospitals that use them report diminishing use of unnecessary procedures.

And Morden’s study did find that some specialties pointed the finger at their own indulgences — gastroenterologists, radiologists and clinical pathologists among them. For example, as our blog reported, the Society of General Internal Medicine advised against getting an annual physical exam.

Other medical specialties said they hadn’t included their own procedures if the concerns about them were about overuse, because in some cases, for some patients, they are appropriate, such as stents for heart patients and spine surgery, two procedures we have advised patients to scrutinize very closely before undergoing.

Those societies tended to focus on limiting testing that others do. Morden, a researcher at the Dartmouth Institute for Health Policy & Clinical Practice in New Hampshire, examined everything named on the first 26 Choosing Wisely lists. More than 8 in 10 targeted radiology, medications and cardiac and lab tests — not physician services.

The American College of Cardiology included the use of cardiac testing in four circumstances, but didn’t address what scientific evidence indicates is the most frequent type of overtreatment in the field — implanting stents, which are small tubes used to prop open arteries of patients who are not suffering heart attacks. More measured, and often more successful treatments for potential heart problems, are prescribing certain medicines and making changes in lifestyle.

KHN/Tribune refers to a study showing that as many as 1 in 8 stent procedures should not have been performed, and at hospitals where stenting was most overused, about 6 in 10 stents were deemed inappropriate.

But, as one cardiologist told KHN/Tribune, "Let's face it, angioplasty and stenting is a big business, it's highly profitable for hospitals, and it's highly remunerative for physicians. There's a tremendous impetus to not rock the boat and not to call attention to the fact that we do too many procedures in stable patients for whom outcomes would be the same if not even better if treated medically."

Orthopedics is another specialty whose Choosing Wisely recommendations protected its members’ interests but not necessarily those of patients and insurers. The American Academy of Orthopaedic Surgeons discouraged patients with joint pain from taking certain dietary supplements, from using custom shoe inserts or overusing wrist splints after carpal tunnel surgery and from a procedure some doctors use to bathe an aching knee in a saline wash.

Although the advice to spare yourself the cost of glucosamine supplements is good, the loss of that commerce doesn’t affect doctors. And the knee saline injections are seldom done anyway. When Morden reviewed 2011 Medicare billing records for the procedure, she found "zero claims."

"That's how pathetic that item is," she told KHN/Tribune.

One orthopedic surgeon nominated other, more significant procedures he told the reporters were overused but were not on the Choosing Wisely lists, including replacing hips and knees when the patient’s pain is minimal and can be managed with medicine, and surgically inserting metal plates into broken collarbones, rather than letting the injury heal with the help of a sling.

"The abuse of surgery is due to the overwhelming control of the profession by the implant manufacturing companies," he told KHN/Tribune.

Being a spine surgeon is a lucrative profession: According to one survey, the median compensation is more than $730,000 per year, so it might seem upstanding that the North American Spine Society included a procedure using bone growth material for neck fusion on its “avoid” list. But it’s not clear how many spine surgeons even perform it anymore. The FDA issued a safety alert against the procedure it in 2008 because it could cause the neck to swell, compress airways and make breathing and speaking difficult.

This group’s members didn’t mention spinal fusion, which more than doubled in frequency between 1998 and 2008, according to one study. Patients with back pain are more likely to be referred to another physician, probably for things like injections and surgery, instead of physical therapy, which usually should be the first line of treatment.

As the KHN/Tribune story notes, “where the lists have been actively embraced, the rate of those services has dropped. Last year, the Cedars-Sinai Health System in Los Angeles added 120 Choosing Wisely recommendations into its computerized patient records so that they would pop up on a screen whenever a clinician tried to authorize one.”

The use of benzodiazepines and other sedative-hypnotics to treat the elderly have decreased at Cedar-Sinai as a result of Choosing Wisely recommendations by the American Geriatrics Society. That’s good, because these drugs can cause elderly patients to fall.

At Anne Arundel Medical Center in Annapolis, "Choosing Wisely" lists are broadcast on hospital television screens, posters decorate the walls of doctors' offices and the lists are included in communications mailed to county residents. The lists also are embedded as links in electronic patient records so physicians can easily review them.

Those are all excellent measures as far as they go, but as the NEJM study suggests, they just don’t go far enough.

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April 9, 2014

How Much Did Your Doctor Make from Medicare?

Now you can find out, by checking this huge database of names and dollars just released from Medicare. The New York Times made the data searchable by doctor's name, specialty and location.

The database shows total payouts by Medicare to individual doctors by name for 2012. It includes all Medicare "Part B" payments, which include not only the doctor's office visit fee, but charges for medicines and procedures administered in doctors' offices. Medicare payments to institutions like hospitals are not included.

Already news media have found some eyebrow-lifting numbers. One ophthalmologist in West Palm Beach, Florida, Salomon Melgen, received more than $20 million for 2012. His lawyer issued a statement cautioning that the vast bulk of the money went to pay drug companies for expensive drugs used in treatment.

Another high-dollar specialty is cardiology. By my count, in the one town of Ocala, Florida, seven of the 34 cardiologists in the database received seven-figure payments in 2012. One, Asad Qamar, got $18 million.

I checked my own internist's building in downtown Washington, D.C., and noticed that ten radiologists in the building all pulled down more than $300,000 in Medicare payments that year. (You can see for yourself by selecting "diagnostic radiology" and zip code 20036 in the database.)

The New York Times found that 2 percent of the 880,000 doctors paid by Medicare in 2012 received nearly a quarter of all the payments.

It will take a while to sort out the meaning of this vast trove of data, reportedly the largest ever released by Medicare.

Commenters on news sites are already drawing their own pre-fabbed conclusions, some arguing, for example, that this proves that all of government is vastly corrupt and inefficient, with others saying the data show the need for a single-payer medical system with doctors paid by salary.

Stay tuned for more on a story that is only starting to unfold.

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February 25, 2014

Hospital Promotion: Poor Judgment Looks Like Conflict of Interest

For all its techno-wonder, robotic technology is fraught with problems, including organ damage, that make it unsuitable for many surgical procedures. It also has a record of poorly trained surgeons, not to mention the under-reporting of adverse outcomes.

Then there’s conflict of interest, or what sure looks like it.

A story covered by ProPublica.org, the investigative news site, examined the role of a dozen members of the surgical team at the University of Illinois Hospital and Health Sciences System who were featured prominently in an advertisement for the da Vinci robot. The copy read, “We believe in da Vinci surgery because our patients benefit.”

Paul Levy, former chief executive of the prestigious Beth Israel Deaconess Medical Center in Boston, was among readers who had a problem with the ad. “While I have become accustomed to the many da Vinci ads,” he told ProPublica, “I was struck by the idea that a major university health system had apparently made a business judgment that it was worthwhile to advertise outside of its territory, in a national ad in the New York Times.

At the bottom of the ad for the robotic device, made by Intuitive Surgical Inc., was this notice: “Some surgeons who appear in this ad have received compensation from the company for providing educational services to other surgeons and patients.”

Ah.

When you are paid to promote a technology for which your patients also pay when they are subject to it, it looks as though cashing in is more important than ensuring that a procedure is the best possible treatment for the problem at hand. Is that what happened here?

Robotic surgery is a minimally invasive procedure in which the surgeon uses a computer to remotely control small instruments. The systems are expensive, and because they’re hot, new technology with marketing potential, surgical facilities that invest in them are highly motivated to use them, whether or not the robotic method is the best one for a given surgery.

As we’ve pointed out, in some cases such as hysterectomy and prostatectomy, they often aren’t.

For a long time medical professionals have been subsidized by pharmaceutical and medical device companies, and we’ve written about Dollars for Docs, a ProPublica database of who is getting paid by these commercial interests.

And although ads featuring physician testimonials for prescription drugs and medical devices are common, featuring a whole hospital department gave Levy pause.

“I was stunned that a public university would allow its name and reputation to be used in that way,” he said, and after reading the university’s website, concluded that the ad violated the university’s code of conduct and administrative procedures, and probably even state law.

Levy began a series in his blog, "Not Running a Hospital,” about the ad. One post read, “The University has allowed its reputation to be used in a nationally distributed advertisement produced and owned by a private party, in benefit to that party's commercial objectives. This is not consistent with ‘exercising custodial responsibility for University property and resources.’”

Later posts noted that some of the white-coated people featured in the ad weren’t doctors, or even medical professionals.

As it turned out, the ad was paid for by Intuitive, and neither the university nor the people depicted were paid for appearing. Still, it was questionable enough that the university asked Intuitive to suspend the ad, and announced it was using the incident as a teaching moment; it promised to assess its policies about these kinds of promotions.

Levy’s indictment didn’t exactly endear him to the university. A university official told ProPublica that the Boston Globe had called out Levy for lapses in judgment over a personal relationship with a female employee when he was with Beth Israel Deaconess. Levy was fined $50,000 by the hospital’s board of directors, copped to his errors and apologized.

ProPublica wanted to know how Levy’s past was relevant to the kerfuffle over the da Vinci ad. The university official said, essentially, consider the source.

As ProPublica makes clear, the cross-pollination of caregivers and device makers isn’t unusual. Hologic Inc. advertised in a trade journal last year using the staff of Methodist Hospitals in Indiana to promote its mammogram machine. Accuray, which makes the CyberKnife, a competitor of da Vinci, offers physician testimonials in its website videos, which don’t disclose if the doctors have been paid.

So although the Illinois University story is muddied with misinformation and drowning in bad blood, you have to get back to basics: When the medical establishment appears to engage in a conflict of interest, it isn’t thinking about patient safety; it’s thinking about its bottom line.

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February 21, 2014

Appeals Court Affirms Jury Verdict against Orthopedic Surgeons Society

An orthopedic surgeon who fought back and won a court case after the society of orthopedic surgeons slammed him for testifying that another surgeon had committed malpractice has now won an appeal of the legal case.

We reported last March on Dr. Steven Graboff's successful lawsuit against the American Academy of Orthopedic Surgeons (AAOS), when the trial judge rejected the AAOS's bid to overturn the jury verdict against it. We called our report: "When 'Peer Review' Has an Ulterior Motive."

The ulterior motive here is that the bone doctors set up their "peer review" program to go after doctors who testified in court that a surgeon had committed malpractice.

Now, eleven months later, the U.S. Court of Appeals says the trial judge was correct in refusing to throw out the jury verdict. The jury had found that the AAOS's report of its "peer review" of Dr. Graboff did not include "false statements" but did cast Dr. Graboff in a "false light," by failing to tell the full story of what had happened. The jury also found that the Academy acted knowing that its published report about Dr. Graboff was untrue or "in reckless disregard for the truth." The appeals court rejected the idea that there was anything inconsistent in the jury's finding that there were no false statements but that the AAOS report about Dr. Graboff did cast him in a false light. As the court noted, a report about someone can include literally true statements but by leaving out the rest of the story can create a false impression.

You can read the appeals court decision here.

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February 11, 2014

Apparent Conflict of Interest Sullies Panel of Patient Safety Experts

The National Quality Forum (NQF) reviews, endorses and recommends use of certain standards to improve the quality and delivery of health care. Its committee of patient safety experts, for example, is charged with defining guidelines for safe clinical practices that hospitals use to set protocols that minimize errors and promote good patient care. According to a recent investigation by ProPublica, the independent nonprofit news agency, one of the committee’s 12 members appears to have used his influence to benefit a company with which his own business had millions of dollars in contracts.

Although he was not a practicing physician, Dr. Charles Denham was a leading advocate for patient safety who, says ProPublica, invoked a study during discussions about preventing hospital infections endorsing ChloraPrep, an antiseptic skin cleanser made by CareFusion, the company in question. The panel’s 2010 guidelines ended up recommending the product.

Those guidelines remain in effect, although NQF officials say the endorsement did not corrupt them.

Denham did not disclose his relationship with CareFusion during the panel’s deliberations, despite rules requiring such disclosures. “The revelations,” says ProPublica, “call into question the inner workings of the Quality Forum, whose guidelines are regarded as the gold standard for best health care practices.”

In January, the U.S. Justice Department settled a $40 million whistleblower lawsuit with CareFusion. The suit called money paid to Denham's business a “kickback” for him to influence NQF standards and boost sales of ChloraPrep.

Denham said the allegations were false, but, as ProPublica says, “[T] he case has shaken the patient safety world, prompting speculation about a star figure’s motives and questions about the inner workings of the Quality Forum, …”

Last week, ProPublica reports, Sen. Charles Grassley demanded copies of contracts and conflict-of-interest policies from the NQF in response to the allegations of kickbacks paid to influence its patient safety guidelines. Grassley is the senior member of the Senate Committee on Finance, which has oversight responsibility for Medicaid, Medicare and other government health programs.

The NQF severed its relationship with Denham in 2010, and said it took steps to protect its guidelines from commercial influence. But committee members told ProPublica they believe the process was compromised.

They said they were surprised to see the ChloraPrep-specific formula in the 2010 guidelines. The transcript of the committee’s discussion in 2009 shows Denham suggesting its endorsement, but no final agreement among members to recommend it.

Last month, the NQF told the news organization that it would review all the recommendations listed in its 2010 “Safe Practices for Better Healthcare” report.

The NQF was created in 1999 by presidential commission. The nonprofit accepts private donations and collects fees from members, including consumer groups, health plans and medical providers.

Five years ago, ProPublica reports, the federal government hired the NQF to endorse measures to show whether health-care spending achieves value for patients and taxpayers. By 2012, that initiative represented nearly three-quarters of the organization’s $26 million in revenue.

A product given an NQF endorsement can mean riches.

Dr. Peter Pronovost, head of patient safety at Johns Hopkins Medicine, is a member of the clinical practices committee. He told ProPublica that no one on it was aware of Denham’s financial ties to CareFusion. Denham did not mention them during the 2009 meeting when members were asked to disclose their financial relationships.

“He clearly lied,” Dr. Christine Cassel, the Quality Forum’s president and CEO, told ProPublica. “He just didn’t say anything about any of his business relationships.”

Denham heads the Texas Medical Institute of Technology, a nonprofit that conducts patient safety research, and Health Care Concepts, a for-profit company involved in the whistleblower case. He’s renowned for his motivational speeches.

In 2007 and 2008, the NQF it received $485,000 in donations from a foundation affiliated with Cardinal Health, a company that spun off CareFusion in 2009. Between 2006 and 2009, Denham’s Institute donated $725,000 to the NQF.

The Justice Department lawsuit accused CareFusion of marketing ChloraPrep for off-label uses, and alleged that the money paid to Denham's company was part of an effort to boost sales and included financing a study published in the New England Journal of Medicine.

Published in 2010, the study’s authors all reported ties to Cardinal Health, and found that ChloraPrep reduced the risk of surgical site infection by 41% compared to a common alternative.

Pronovost told ProPublica that the Denham mess shouldn’t poison all of the NQF’s work. He said the lack of scientific rigor of the safe practices committee reflected Denham’s influence, but that the process behind the NQF’s other measures is stronger.

But, he said, it does raise significant concern about oversight of the burgeoning quality improvement industry.

“It’s an enormous business,” Pronovost said. “Hundreds of millions or billions of dollars are at stake, but our transparency procedures haven’t matured.”

Dr. Bob Wachter, a hospitalist at UC San Francisco and patient safety maven, has an interesting blog piece lamenting his own failure to realize that something didn't quite add up with Denham. The main clue was pretty basic: There was a lot more money washing around the guy and his institute than fit with the nonprofit safety image.

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December 24, 2013

Big Name in Big Pharma Ceases Its Unsavory Drug Payments

We’ve been among the many voices decrying the practice of pharmaceutical companies paying doctors to promote their drugs. Now, in a welcome announcement, GlaxoSmithKline says that it’s not going to grease those palms anymore.

As reported by the New York Times, in addition to not paying doctors to hawk their wares, the Big Pharma big player is not going to tie the compensation of its sales representatives to the number of prescriptions doctors write for its drugs. That can promote the inappropriate — and illegal — use of drugs for nonapproved purposes.

Both practices have been widely criticized as conflicts of interest with the real potential of causing patient harm.

Glaxo is among the largest drug companies in the world, according to The Times, with third-quarter sales of more than $10 billion.

The decision to clean up its act is refreshing in the pharmaceutical industry and comes, as The Times points out, at a “sensitive” time for the British company. It’s under investigation for bribery in China, where accusations have been made that Glaxo paid doctors and government officials to boost drug sales.

We’ve written about the billions of dollars in fines Glaxo has paid for paying kickbacks, illegally marketing drugs and withholding safety information. Now, one hopes, the company has developed a corporate conscience.

Glaxo said sales representatives would be paid based on their technical knowledge, the quality of service they provide to clients to improve patient care and the company’s business performance -- changes it made in the U.S. in 2011 and must continue according to a corporate integrity agreement with the Justice Department. Now it says it will extend those practices globally.

The company’s chief executive, Andrew Witty, told The Times that the proposed changes were not related to the China situation, but were part of a years-long effort “to try and make sure we stay in step with how the world is changing. We keep asking ourselves, are there different ways, more effective ways of operating than perhaps the ways we as an industry have been operating over the last 30, 40 years?”

Um … it took 40 years to know that? To know that paying doctors to speak on your company’s behalf at conferences and professional meetings might be exploiting the trust practitioners have for their peers? That such behavior might have unfair influence in doctors’ prescribing habits? That a drug might be prescribed inappropriately because someone got paid to pimp it?

And are we cynical to wonder if Glaxo’s change of heart has anything to do with the provision of the Affordable Care Act (ACA, or “Obamacare”) that all payments by pharmaceutical companies must be made public? (See our blog, “Dollars for Docs: Learn How the Big Bucks Flow From Manufacturers.”)

Many companies, including Glaxo, report many such payments now, but the new ACA requirements might seek more info than what’s already being provided, and will be searchable on a government website.

Whatever. Glaxo has decided that by 2016, no longer will it pay health-care professionals to speak on its behalf about its products or the diseases they treat “to audiences who can prescribe or influence prescribing,” according to a statement. It will stop subsidizing doctors to attend medical conferences, which is prohibited in the U.S. by an industry-imposed ethics code but that still happens in other countries.

But Glaxo will continue to pay consulting fees to doctors for market research because it needs to know what practitioners think about its products. The company said that effort would be limited.

The Glaxo news was welcome in the medical community. One Times source, Dr. Raed Dweik, chairman of the innovation management and conflict of interest committee at the Cleveland Clinic, told the paper, “As a physician, I periodically meet with these sales reps and they usually come in armed with information about me that I don’t even know,” he said, like the number of prescriptions he writes for the drug company’s product. “I feel that’s not really a comfortable interaction to have.”

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November 10, 2013

Hospital Suspends Black Lung Program Under Black Cloud

A multipart story investigating how Johns Hopkins Medicine assessed coal miners’ claims of suffering from black lung disease has prompted suspension of its program. “Breathless and Burdened,” a yearlong effort by the Center for Public Integrity (Center), examined how doctors and lawyers, allegedly at the behest of the coal industry, helped to deny benefits claims of miners sick and dying of black lung, even as disease rates are on the rise and an increasing number of those workers turn to a system that is supposed to help alleviate their suffering.

As announced earlier this month by the Center and ABC News Johns Hopkins has suspended its black lung program while it reviews how medical opinions from its doctors helped coal companies deny disability benefits to sick miners.

“Following the news report we are initiating a review of the pneumoconiosis B-reader service [black lung X-ray reading],” read a statement by the medical facility. “Until the review is completed, we are suspending the program.”

“We take very seriously the questions raised in a recent ABC News report about our second opinions for pneumoconiosis including black lung disease, and we are carefully reviewing the news story and our pneumoconiosis service.”

Johns Hopkins said its diagnoses and reports have never been questioned by authorities, and that there are no financial incentives for the department or its personnel associated with the black lung program.

Caused by inhaling coal dust, pneumoconiosis, or black lung disease, compromises lung function and makes breathing increasingly difficult. There is no treatment or cure.

The decision to suspend the program, according to the Center/ABC story, was made as congressional representatives from coal states said they have begun working on new legislation to address “troubling concerns” raised in the report.

The focus is on Dr. Paul Wheeler, head of the Johns Hopkins unit that read X-rays of coal miners seeking black lung benefits. Since 2000, more than 1,500 cases have been decided in which his unit rendered an opinion. In how many of those cases did Wheeler find severe black lung?

Not one.

Wheeler testified in court that the last time he recalled finding a case of severe black lung, a diagnosis that qualifies a miner to receive federal benefits, was in “the 1970s or the early 80s.”

As reported last year by NPR and the Center for Public Integrity, “Incidence of the disease that steals the breath of coal miners doubled in the last decade, according to data analyzed by … the National Institute for Occupational Safety and Health (NIOSH).”

In some areas, cases of black lung disease have quadrupled since the 1980s.

That something is rotten in the state of Johns Hopkins’ department of radiology prompted outrage from miner advocates, including the United Mine Workers, the union that represents coal miners.

“You don’t have to be a doctor at Johns Hopkins to know black lung disease when you see it,” said Richard Trumka, president of the AFL-CIO, and a former president of the union’s affiliate, the United Mine Workers. Trumka noted that his father died from the disease.

“Whatever penalties or punitive actions that can be taken with respect to Dr. Wheeler should be,” Phil Smith, spokesman for the union, told the Center/ABC. “But whatever they are, they will pale in comparison to the pain and suffering he has caused thousands of afflicted miners. There is no penalty which will make up for that.”

For his part, Wheeler told the journalists that he stood by his opinions.

If you read the series of stories, you’ll wonder why.

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November 3, 2013

Urologists Who Own Radiation Equipment Use it More … and Probably Unnecessarily

A couple of weeks ago, we wrote about urologists who, according to clinical guidelines, use too much radiation to treat prostate cancer pain. Here’s some related have-you-no-shame prostate cancer news brought to you by your local urologist.

According to a study in the New England Journal of Medicine, (NEJM) an awful lot of urologists are making decisions about treatment for their prostate cancer patients based on whether or not they own intensity-modulated radiation therapy (IMRT) facilities. One-third of men whose doctors own such equipment get that therapy for about $35,000 per treatment course. But before they were financially invested in radiation equipment, the same doctors prescribed that therapy for only 13 of 100 of their patients.

As discussed in Bloomberg Businessweek.com, prostate cancer is the most common tumor diagnosed in the U.S.; nearly 240,000 men will get a diagnosis of prostate cancer this year. As we’ve blogged often (here and here), a diagnosis of prostate cancer presents a complicated scenario; the range of appropriate treatment moves from watchful waiting (no intervention unless and until the pathology changes in certain ways) to hormone therapy to surgery, chemotherapy and radiation. As Businessweek summarizes, “While only about 12%, or 29,270 men, will die from it this year, all will have to decide how, and whether, they want to treat the cancer.”

They shouldn’t have to do so through the filter of a physician who can line his or her pockets if one therapy is chosen over another.

The men treated with radiation in the NEJM study were newly diagnosed. They were at low risk of dire consequences because their cancer hadn’t spread. The 10-year survival rate for all prostate cancer is 98%, and for many people with the study subjects’ diagnosis, watchful waiting is appropriate—not radiation.

Jean Mitchell, the author of the report and a professor of public policy at Georgetown University in Washington, D.C., compared the use of the radiation therapy among urologists before and after they acquired the $2 million machines for their practices. She studied use of the technology among doctors who didn’t own it, and urologists at 11 National Comprehensive Cancer Network centers, the country’s gold standard of care.

Analyzing claims data from Medicare, Mitchell found that urologists who didn’t own the equipment prescribed use of it for more than 15 in 100 of their patients in 2010, compared with about 14 in 100 five years earlier. Among the NCCN, the ratio was the same for both years—about 8 in 100. But among docs who began to refer patients to treatment facilities in which they had a new ownership interest, it was 44 in 100.

In an interview with Businessweek, Mitchell said, “The patients are going to do what their physician tells them to do. The patient becomes almost like an ATM machine, with the doctor extracting as much revenue as they can.”

A urologists’ association spokesman said the doctors who own radiation oncology equipment use the technology appropriately. Would you expect anything different?

As Businessweek notes, physicians aren’t allowed to refer their patients for treatment in facilities they own because of the financial conflict of interest. But for patients’ convenience, radiation, as well as some other in-office “ancillary” services such as blood work and X-rays, are exempted from that law. Why radiation, which is a treatment and not an ancillary service, was exempted is not clear, Mitchell told the news outfit.

We’ve outlined the harms of overtreatment and those of radiation. The practitioner/owner scenario has great potential to harm patients from both.

Mitchell’s study found that doctors who owned the IMRT were treating men 80 and older just as aggressively as younger men with early stage prostate cancer. While prostate cancer usually grows slowly, the side effects of radiation (erection and urinary problems, for example) can be immediate. So using this treatment on older patients opens the door for them to experience harm and no benefit.

Medicine is not immune to greed: Mitchell’s study, Businessweek notes, supports similar findings with other forms of self-referral. Some urologists have pathology labs within their practices, giving themselves more business by biopsy. We’ve noted other medical specialties with physician-owners who line their pockets primarily because they can.

If you or a loved one is diagnosed with early-stage prostate cancer, and the urologist advises radiation treatment, ask why it is appropriate; what results are expected, and how soon; what the risks are; and … who owns the facility where the treatment is recommended to occur.

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October 13, 2013

How Big Pharma Peddles Influence in FDA Panel Meetings

When the federal government wants to set medical policy and testing standards, it assembles a panel of experts to analyze the state of that particular medical art and make recommendations to the FDA. You would hope—and expect—that the process would be strictly analytical and scientific, uncontaminated by outside commercial interests.

In at least one recent case, you would be wrong.

As reported by the Washington Post, a panel that shaped the government’s policy for testing the safety and effectiveness of painkillers was subsidized by pharmaceutical companies that paid hundreds of thousands of dollars for, essentially, access. They wanted to influence the thinking of the FDA, according to emails secured through a public records request.

The emails show that the companies paid as much as $25,000 to attend a meeting of academics intended to provide advice to the FDA on how to analyze evidence from clinical trials.

The communications suggest that the regulators had become too cozy with the companies who profit in the $9 billion U.S. painkiller market. FDA officials who regulate these meds also served on the steering committee of the panel, which met in private, and co-wrote papers with employees of pharmaceutical companies.

We’ve written in several posts about the questionable control of painkillers (here and here), and The Post’s story is yet more evidence that the FDA has been less than conscientious in addressing the epidemic of addiction to prescription drugs such as Oxycontin and other opioids.

“Instead of protecting the public health, the FDA has been allowing the drug companies to pay for a seat at a small table where all the rules were written.” Craig Mayton, the attorney who made the public records request, told The Post.

It’s not as if the FDA was unaware of this conflict of interest. “Even as the meetings were taking place,” according to The Post, “the idea of FDA officials meeting with firms that had paid big money for an invitation raised eyebrows for some. In an e-mail to organizers, an official from the National Institutes of Health worried whether the arrangements made it look as if the private meetings were a ‘pay to play' process.”

And although FDA officials did not benefit financially from participating in the meetings, two later worked as pharmaceutical consultants. The whole scenario portrays an agency that blurred the line between the regulators and the regulated.

FDA officials offered, in our estimation, a lame explanation, saying that strict rules of transparency and funding apply to the public-private partnerships that the agency engages in. But the group in this case was not initiated by the FDA, so it was a private partnership to which those rules did not apply.

The group was organized by two medical professors, one from the University of Rochester and one from the University of Washington, and the emails describe their efforts at financing and organizing the group’s meetings.

The professors got as much as $50,000 each for a meeting. The funds supported their academic research and expenses “or to cover a small percentage of faculty effort,” they said. In one email, they proposed receiving $5,000 each for a four-hour meeting near the FDA offices.

The meetings concerned the best methods for measuring the effectiveness of painkillers. One professor told The Post that their intent “was to help everybody develop better drug trials.” Both professors were responsive to The Post, but the Pharmaceutical Research and Manufacturers of America declined to comment.

The goal of the group was to publish “consensus” statements on scientific matters related to testing the drugs, and one of the professors said the scientific guidelines the group produced were of high quality.

The meetings included 30 or 40 people, including academics, FDA and National Institutes of Health (NIH) officials, and often as many as 14 representatives from pharmaceutical companies. Only the companies paid fees to attend.

Science might have been the subject of the meetings, but the subject of the emails was money.

When some drug companies balked at the $20,000 fee to attend the meeting, the organizers were firm. “20k is small change, and they can justify it easily if they want to be at the table,” one professor wrote to the other after an Eli Lilly representative objected to the price. “Everybody has been very happy with [the meetings] and they are getting a huge amount for very little money (impact on FDA thinking, exposure to FDA thinking, exposure to academic opinion leaders and their expertise, journal article authorship, etc.) and they know it,” according to The Post.

In his interview with the paper, the professor said that the costs of running such a meeting could run as high as $150,000, and they never knew how many sponsors they could attract. To make its gatherings more transparent, the group posted to its website copies of meeting presentations.

Still, some of the government officials seemed to find the whole thing fishy. One NIH staffer indicated that the fees paid by drug companies for private meetings could be criticized for influencing outcomes, and suggested holding the meetings at the NIH, and opening them to all interested parties to avoid the appearance of a “pay to play” process.

A lot of people thought this didn’t pass the smell test. None of them did anything about it.

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August 12, 2013

Conflicted Care: Physicians With a Financial Stake in the Medical Devices They Use

In reflecting on five years of “reading medical journals and writing to inform patients of the hazards of medical care,” patient safety advocate John James says he has “learned some difficult realities.”

Our blog posts frequently mirror his observations.

“Perhaps foremost is that when people want to believe that their health-care system is safe and just, their opinions are not going to be easily swayed by data and facts, regardless of how reliable the source may be. Secondly, people want to believe that physicians always have their interest at heart; this naïve supposition is not easily replaced by caution when seeking medical care. Thirdly, most people are less interested in preventing their own poor health than getting treatment when a preventable disease has gotten the best of them. Finally, most people cannot view the health-care industry in terms of how it affects less fortunate Americans – for them it is about me and my health care.”

In a poignant example of his second point, consider a recent fraud alert issued by the Department of Health and Human Services’ Office of the Inspector General. It addresses physician-owned businesses that market implantable medical devices “ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers (ASCs).”

We wrote about the alert when it was issued in the spring, and now, the Wall Street Journal probes the smelly entities knows as physician-owned distributorships (PODs).

“Surgeon in Probe Is Working in Detroit-Area Hospitals,” concerns the story of Dr. Aria Sabit. He had a decided preference for an obscure brand of spinal implants, but many of his surgeries had tragic outcomes. Dozens of medical malpractice lawsuits were filed. The California medical board, the FDA and the Department of Justice, the Journal reports, are investigating Sabit because he had “an ownership interest in the company that distributed, and profited from, the surgical devices he switched to, people familiar with the matter say.”

Federal prosecutors say Sabit is part of a broader civil investigation into a network of doctor-owned spinal-implant distributorships operated by two former medical-device company employees that earned millions of dollars for its investors over six years.

“Physician-owned distributorships … have proliferated in medicine,” the Journal writes. “Distributorships, whether owned by physicians or not, act as intermediaries between medical-device makers and hospitals: In exchange for marketing and stocking devices, the distributors get a cut of each sale. When surgeons own the distributorship, that commission goes into their pockets. And [because] surgeons often dictate to their hospitals which devices to buy, they can effectively steer business to themselves.”

Apparently, Sabit’s dicey doings didn’t dissuade other hospitals from seeking his “talents.” Sabit, the Journal reports, is a senior staff member at a Michigan hospital, and has privileges at several others in the region.

He continued to use spinal implants from Apex Medical Technologies, the distributorship in which he had an ownership, on patients in Michigan until last June.

In depositions for the malpractice cases filed against him in California, Sabit has been … inconsistent, sometimes saying he didn’t receive monetary benefit from Apex implants, sometimes saying he didn't know if he did.

“A Detroit Medical Center spokeswoman,” according to the Journal, “says it wasn't aware that Dr. Sabit owned part of a spinal-implant distributorship. ‘We are currently looking into this,’ she said.”

The spokeswoman told the paper that the medical center wasn't aware of any problems during Sabit's time in California when it recruited him to join its surgical staff in 2011, and only later learned about the malpractice suits when they were filed. He, of, course, has denied the allegations.

Another Wall Street Journal story, “Does My Surgeon Profit From My Implants?” delineates how the owner-and-provider role common among spine, hip and knee surgeons is spreading to cardiac surgeons, and how difficult it is for patients to know if their surgeon is involved in a POD, unless the doctor discloses the information.

Incorporation documents for PODs in the Reliance Medical Systems network, the Journal reports, name Adam Pike and Bret Berry or one of their business associates as officers. They say nothing about any surgeons or their ownership structure. “The only clue about the companies' business,” the story says, “is in their names, which all include the terms "Spine," "Spinal," "Medical," or "Surgical."

Pike is listed as a "registered agent," and Pike Industries Inc. and Berry Medical Enterprises Inc. are "managing members/managers." The company’s address is a post office box in Jacksonville, Fla.

This sounds more like a covert mail drop than a legitimate business.

The Journal says that Pike and Berry shared ownership of each POD with a different group of surgeons. Each investor got an equal stake and received an equal profit distribution based on the POD's overall sales.

The Reliance network grew to include at least 11 PODs in six states by last year, when Pike and Berry bought out all the surgeon investors when PODs starting drawing scrutiny from the Justice Department.

As we suggested earlier this year, if your doctor recommends a procedure, or if you are having surgery to implant a medical device, find out:


  • What is the purpose of this procedure/device, what results can I expect, and how soon?

  • Are there alternatives?

  • Why am I having the procedure at this particular facility?

  • What is your financial interest in the equipment used or the facility where it’s performed?


To report suspected fraud involving physician-owned entities, contact the Office of the Inspector General’s hotline at (800) 447-8477, or online here.

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July 25, 2013

Suggested Reading—Medical Price Fixing

The Washington Monthly recently published a fascinating story—fascinating in the way of horror movies. Called “The shadowy cartel of doctors that controls Medicare,” it's about how medical provider fees are determined.

Author Haley Sweetland Edwards traces the secretive process to reach the inevitable conclusion that, essentially, the value of an MRI, a heart stent, surgical anesthesia, is a matter of price-fixing that in any other context would be illegal.

There are 31 medical members of the Specialty Society Relative Value Scale Update Committee (RUC) convened by the American Medical Association. One was an anonymous source for Edwards. That doctor described the process: "No one ever says the word 'price.’ But yeah, everyone knows we're talking about money."

Their work is so secret most medical professionals have no idea what the RUC does.

RUC members send their list of “recommended values” to the Centers for Medicare and Medicaid Services, which almost never denies them. Edwards writes:

The RUC … enjoys basically de facto control over how roughly $85 billion in U.S. taxpayer money is divvied up every year. And that's just the start of it. Because of the way the system is set up, the values the RUC comes up with wind up shaping the very structure of the U.S. health care sector, creating the perverse financial incentives that dictate how our doctors behave, and affecting the annual expenditure of nearly one-fifth of our GDP.

This screwy system means that although the prices Medicare and private insurers pay for certain procedures have increased, fees for other services have declined or stagnated. The RUC, which is dominated by specialists, spends most of its time reviewing specialty procedures, which change quickly as technology advances, rather than common treatments such as office visits, which is how primary care doctors and other generalists make a living.

This system incentivizes lucrative overtesting while basic care gets the shaft. No wonder medical specialists are proliferating as we suffer from a serious shortage of primary care practitioners.

If you have the nerve, read her full report by linking here.

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June 25, 2013

Rooting Out Conflicts of Interest from Clinical Treatment Guidelines

Although people skills are critical to good doctoring, at heart physicians are (or are supposed to be) scientists. They are obliged to remain current with the science in their field. Because the body of knowledge never stops growing, that’s a big job. And conflicts of interest make it tougher, when the writers of practice guidelines are in the pocket of Big Pharma.

Writing in the New York Times earlier this month, Dr. Jerry Avorn, professor of medicine at Harvard and author of “Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs,” has captured the difficulty of digesting the big, endless meal that turns continuing education into clinical practice.

Docs get help, he says, from medical groups that issue clinical-practice guidelines derived from experts sorting through reams of clinical research and drug studies, and publishing summaries about what treatments work best.

But their advice can be imperfect. Avorn cites recent recommendations from the American Association of Clinical Endocrinologists for diabetes treatment. It placed many drugs higher in the prescribing hierarchy than some familiar, popular and generic drugs like metformin. The organization also emphasized that established treatments like insulin and glipizide are risky.

But several of new, promoted drugs are expensive and lack the proven records of clinical effectiveness and safety that the older drugs have. It’s one thing to have new treatment choices, and another to have them because their manufacturers might have had a role in the development of the guidelines because some their authors were paid consultants of the manufacturers.

We’ve covered this conflict of interest before.

Avorn recalls practice guidelines for treating anemia in patients with kidney disease that recommended high doses of the drug erythropoietin. But such doses substantially increased the risk of heart attack, stroke and death, “with little countervailing benefit,” he writes. “Here, too, the professional society that issued the guidelines, as well as many of the doctors who formulated them, received funding from companies marketing the drug.”

Pharmaceutical companies love to flog their new, expensive drugs, never mind, says Avorn, that “there is much less muscle behind efforts to encourage the use of established, off-patent drugs, even when the weight of evidence and experience recommends them.”

And when the medical literature reports solidly conducted trials resulting in thoughtful, balanced clinical guidelines, doctors need help harvesting the crop, then sorting the wheat from the chaff.

Enter several groups — including the Institute of Medicine, the American College of Physicians and the Cochrane Collaboration, a network of experts who evaluate clinical research — that sift through medical information to synthesize and present the honest science.

Docs also get help from the Independent Drug Information Service, a nonprofit service funded by the state of Pennsylvania and the District of Columbia. It assesses medical literature absent of any product-driven bias. Then it dispatches pharmacists and nurses to doctors’ offices to guide them through the treatment recommendations the analysis yields.

It’s a front-line defense against the pharmaceutical industry, which deploys armies of sales representatives to promote their products directly to doctors. Such practices, as we’ve noted, can be rife with exploitation.

“A few large health systems,” Avorn writes, “ including Kaiser Permanente and the nation of Australia, have adopted this curator-docent approach, which has been shown to improve doctors’ clinical decision making. The programs can also control costs over time, as they counter the influence of drug companies promoting the most expensive new drugs, whether or not they’re an improvement. But to make a significant difference, many more health-care systems, both private and public, must adopt them.”

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May 20, 2013

Treatment Risks Climb When Drug Companies Plant Stories in Research Journals

Medical providers, insurance companies and well-informed medical consumers know that drugs, devices and treatments aren’t considered best-practice—or even credible—unless and until research has been conducted, the results reviewed by scientific peers and the results published in a reputable journal.

So how was it, health reporter Martha Rosenberg asks on KevinMd.com, that blockbuster drugs such as Vioxx (an arthritis drug withdrawn from the market in 2004 because of heart risks) and Baycol (a cholesterol drug withdrawn in 2001 because of muscle degeneration) were deemed safe, and that their benefits outweighed their risks?

These, and many others, Rosenberg writes, passed peer muster after journal reports were published that were written by drug companies or their hired writing hands. Gee, if you’ve spent millions developing a drug and you’re given license to appraise its effectiveness and safety, wouldn’t you make sure the story had a happy ending?

We regularly write about drug company conflicts of interest, and Rosenberg’s post adds to this stinky body of “knowledge.”

“Scratch the surface of many blockbuster drugs that went on to be discredited, or even withdrawn as risks emerged,” she writes, “and an elaborate ‘publication plan’ emerges, developed by the drug company’s marketing firm. For example, at least 50 articles promoting hormone replacement drugs like Prempro were planted in medical journals by Pfizer’s (then Wyeth) marketing firm DesignWrite…” You can read that document, courtesy of the University of California, San Francisco’s Drug Industry Document Archive.

One of DesignWrite’s articles published in the Journal of Women’s Health was called “Is There an Association Between Hormone Replacement Therapy and Breast Cancer?” The answer was “no.” Another DesignWrite offering appeared in the Archives of Internal Medicine, “The Role of Hormone Replacement Therapy in the Prevention of Postmenopausal Heart Disease.”A third, also from DesignWrite, in the Archives of Internal Medicine, championed “The Role of Hormone Therapy in the Prevention of Alzheimer’s disease.”

Rosenberg calls the marketing firm’s so-called science “egregiously flawed.” Hormone therapy has a demonstrable association with breast cancer, heart disease and Alzheimer’s. Still, the papers have not been retracted from the journals, two of which are published by the American Medical Association.

Parke-Davis/Pfizer also engaged in planned research plants with regard to its anti-seizure drug Neurontin. It wanted to expand the drug’s use to people suffering from migraines, bipolar disorder and other problems for which it had not been given FDA approval. Such “off-label” uses are the prerogative of practitioners, but manufacturers are not allowed to promote them for any use not approved by the FDA.

We wrote about the unethical use of fake Neurontin trials a couple of years ago in our blog, “The Difference Between Pharmaceutical Research and Marketing Blurs Yet Again.” Rosenberg notes that within a three-year period, Parke-Davis planted 13 ghostwritten articles in medical journals promoting off-label uses for Neurontin, and made 43,000 reprints from one for dissemination by its sales representatives.

“Researching, writing and submitting papers to medical journals — and reworking and finessing them if accepted — is a demanding, time consuming job which drug companies have made into pay dirt. … ‘publication plans’ for their products —elaborate grids with the names of journals where papers have run, are slated to run, have been submitted and have been resubmitted, the marketing firms apparently not taking ‘no’ for answer. Do the journals know they are part of such machinations?” Rosenberg asks.

Not only is iffy science given cred by these journals, the stench of conflict grows stronger when you realize that journals make money off such dreck when they license reprint rights for drug company promotion.

Several years ago, when it came to light that some researchers were subsidized by companies whose products they were testing, journals loudly announced they were raising their standards, scrutinizing submissions and adding disclaimers to address even the appearance of conflicts of interest. But, says Rosenberg, “Often the disclosures are relegated to a barely readable paragraph linking authors identified by initials, not names, to 60 or more drug companies. Worse, the disclosures don’t appear in abstract databases like PubMed but are hidden behind a financial firewall available only to paid subscribers who have access to the full articles.”

So if John Q. Public wants to read a full study, he must shell out a meaningful amount. And that’s for only one journal.

Rosenberg is not optimistic that this status quo can be changed any time soon. The problem, of course, is that it’s just too lucrative for both journals and drug companies to stop scratching each others’ backs at the cost of patient safety.

She highlights a well-established class of drugs called TNF blockers that includes Humira, Remicide, Enbrel and Cimzia. They treat various forms of arthritis formerly considered fairly rare, but promoted to “under-diagnosed” by their manufacturers in the hope of enlarging their market to people with a tenuous, at best, connection to them.

She warns consumers about taking their planted “quizzes” to encourage self-diagnosis, and practitioners about ghostwritten journal stories that minimize the drugs’ dangerous side effects, including suppression of the immune system.

As Rosenberg writes, “Recently, research by drug industry-funded authors has appeared in medical journals to dispel data linking TNF blockers to increasing incidences of hospitalizations, malignancies, cardiovascular events and Herpes zoster. Looks like another publication plan.”

And another strike against patient safety.

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May 5, 2013

Pharmaceutical Company Sued—Again—for Paying Kickbacks

Manufacturing an excellent product and marketing it well should ensure commercial success. A new lawsuit suggests that it wasn't for Big Pharma player Novartis AG—the company was charged last month with fraud, allegedly for paying kickbacks to pharmacies that switched transplant patients from a less expensive generic drug to to its brand name med, Myfortic.

Paying kickbacks, it seems, seems to be part of the Novartis business plan: In the same week, the U.S. intervened in a private suit from 2011 that claims the company allegedly crossing the palms of physicians with the intent of increasing sales two drugs that treat hypertension, Lotrel and Valturna, and its diabetes drug Starlix.

According to the stories on Bloomberg.com, Novartis, was sued in federal court last month for violating the False Claims Act. That’s the same law Lance Armstrong is accused of violating for defrauding the U.S. by using banned substances when he was sponsored by the U.S. Postal Service.

For seven years, the U.S. says, the Myfortic payments were disguised as rebates and discounts to at least 20 pharmacies that switched patients to Myfortic from drugs sold by other companies. The cost to Medicare and Medicaid was tens of millions of dollars in false claims, the complaint says.

The damage isn’t just financial—patient safety is at issue. “Hundreds, possibly thousands, of transplant patients have undergone switches in their medication as a result of recommendations from pharmacies that were based on undisclosed financial, rather than independent clinical, considerations,” according to the complaint.

Myfortic is an immunosuppressant that helps prevent organ rejection for kidney transplant patients. The drug competes with another manufacturer’s drug, CellCept, which has been available as a generic since 2009. In 2011, Bloomberg reports, Medicare reimbursed Myfortic at more than twice what it did for generic CellCept.
In the older lawsuit, Novartis supposedly treated physicians to luxe dinners, fishing trips, outings at Hooters (class acts!) and provided speaker fees to juice sales; that is, they’re accused of buying physician prescribing loyalty. That commitment should be borne only of science and patient communication. The U.S. says Medicare, Medicaid and other federal health-care programs paid millions for these kickback-inspired claims as well.

In the Myfortic complaint, the U.S. called Novartis a “repeat offender. So, are the penalties for this skanky behavior insufficient, or is Big Pharma just too big to notice them? It wasn’t even three years ago, according to Bloomberg, that Novartis agreed to pay $422.5 million to settle charges that it paid kickbacks and illegally promoted drugs for off-label uses (that is, to treat problems for which the FDA had not given approval; doctors are allowed to prescribe drugs for off-label use, but manufacturers are not allowed to market them for such uses).

We’ve examined the idea that for pharmaceutical companies, paying penalties for illegal drug promotion is just a cost of doing business, and that some doctors are expert practitioners of going to the pharma well.

As part of the 2010 deal, Novartis signed a five-year corporate integrity agreement with the U.S. Department of Health and Human Services requiring promotional activity reforms. The document said that Novartis could be excluded from federal health-care programs for a “material breach.”

We’re waiting.

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April 21, 2013

Psychiatric Guidelines Are Riddled With Conflicts of Interest

The Practice Guideline for the Treatment of Patients with Major Depressive Disorder is the primary resource for clinicians who treat patients with depression, which often involves prescribing drugs. Researchers from the University of Massachusetts, Boston, examined financial and intellectual conflicts of interest involved in the process of defining the guidelines to see if outside influences affect patient care.

Their conclusion isn’t pretty: “The prevalence of conflicts of interest among panel members was high. The quality of the evidence cited raises questions about the validity of the recommendations.”

The study, published in the Journal of Evaluation in Clinical Practice, showed that all of the people who devised the guidelines, published by the American Psychiatric Association (APA), had numerous financial ties to drug companies that manufacture antidepressants.

That’s like compiling a buying guide for safe automobiles when all of the authors work for Ford.

A lot of attention has been paid lately to psychotropic drugs (those that affect brain function, emotions and behavior) because of widespread concern that they are overprescribed and misprescribed. (See our recent blog posts, “Misuse of Antipsychotic Drugs Is Off the Charts,” and “Atypical Antipsychotic Use High in Children.”)

We’re all familiar with the suspect marketing behavior of drug manufacturers, but this study is an indictment of the behavior of the people we personally must trust with our lives.

The researchers evaluated the quality of the evidence the committee used to advise prescribing antidepressant medication. The APA recommends drugs as a first-line treatment for all levels of depression, but the study found that more than one-third of the research panelists cited in support of drugs for depression did not examine outpatients with major depressive disorder; 17 percent of their references didn’t measure clinically relevant results.

“The recommendation for antidepressants for mild depression is not congruent with the evidence,” the researchers said, noting that guidelines produced by the National Institute for Clinical Excellence say that antidepressants should not be first-line intervention for mild depression, and that Dutch guidelines recommend them as first-line treatment only in cases of severe depression because people may be exposed to unnecessary harm.

In order not to put patients at risk, the researchers said, it’s critical for groups developing clinical practice guidelines to pay attention to the quality of the studies they cite as well as to any bias resulting from conflicts of interest.

Every member of the APA guideline committee disclosed financial ties to the pharmaceutical industry. Some members had nine such relationships; some had 33.

None of them should have any.

Most of the committee members participated in pharmaceutical companies’ speakers’ bureaus. According to a UMass news release about the study, doctors serving on a speakers bureau are known as “Key Opinion Leaders” or “KoLs” because they are so important to the marketing of a drug. And some members of a separate independent panel charged with mitigating any effect of committee conflicts had undeclared financial relationships with drug manufactures.

Do these sound like people who should be treating your disorder, much less advising other professionals how to do it? Or do they sound like people who should be kept as far away from a clinical setting as the moon is from the Earth?

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April 14, 2013

Your Doctor’s Financial Interest Shouldn't Determine Your Medical Care

Now there's a headline we should never have to write. But consider this: If you think kickbacks are the sleazy kind of financial reward more commonly associated with organized crime than medicine, you’re probably not aware of PODs—physician-owned distributors. Last month, the Department of Health and Human Services’ Office of the Inspector General (OIG) issued a fraud alert about this worrisome commerce.

Doctor-owned medical devices or services—such as scanning equipment, laboratories or the sale/manufacture of implantable devices, which is the particular focus of this alert—are ripe for abuse and conflicts of interest. As described on AboutLawsuits.com, the alert focused on PODs that sell medical devices that were ordered by the practitioners themselves for use in procedures they perform on their own patients at hospitals.

“We are particularly concerned about the presence of such financial incentives in the implantable medical device context,” the alert reads, “because such devices typically are ‘physician preference items,’ meaning that both the choice of brand and the type of device may be made or strongly influenced by the physician, rather than being controlled by the [facility] where the procedure is performed.”

According to the OIG, PODs are “inherently suspect under the anti-kickback statute.” That’s because you can’t be certain that the decision to refer a patient for testing was made with complete medical objectivity if part of the cost paid for it is returned to the person who made the referral.

Violation of the statute, by the way, is a felony punishable by a maximum fine of $25,000, imprisonment for as long as five years, or both. Conviction gets you excluded from Federal health-care programs. That’s serious, but it pales in comparison to the damage a patient can suffer because someone’s priority was self-enrichment instead of patient safety.

As AboutLawsuits explains, the additional profits for the doctors often are shared with the hospitals or ambulatory surgical centers where the procedures are performed.

In addition to corrupting medical judgment, the PODs can contribute to the overuse of medical devices. The harm of that, as we’ve noted, is a higher incidence of false positives, leading to unnecessary worry and additional tests that might be invasive, painful and pose risks of their own, such as radiation or infections. Overuse also increases costs for patients, insurers and public health-care programs. The OIG also says it promotes unfair competition.

The OIG says a disclosure statement of financial interest, which often occurs in doctor testimonials that a patient should choose a certain facility, is not sufficient to overcome the whiff of conflict of interest. The only interest a doctor should have in referring a patient for a particular test at a particular facility is the best, most appropriate medical care. That usually doesn’t come with a side order of line-my-pocket.

As AboutLawsuits points out, kickback warnings have concerned the OIG in the past. In 1989, a special Fraud Alert on Joint Venture Arrangements was issued that discourages hospitals from using PODs and doctors from joining them.

According to an OIG letter in 2006 about doctors’ financial interests in PODs, “The strong potential for improper inducements between and among the physician investors, the entities, device vendors and device purchasers should be closely scrutinized under the fraud and abuse laws.”

Whenever your doctor recommends a procedure, or if you are having surgery to implant a medical device, not only are you well within your rights to ask the following questions, as a matter of self-protection, you should.


  • What is the purpose of this procedure/device, what results can I expect, and how soon?

  • Are there alternatives?

  • Why am I having the procedure at this particular facility?

  • What is your financial interest in the equipment used or the facility where it’s performed?


If you are having a device implanted, find out the name, model and manufacturer. Then check the FDA’s MedWatch site to find out if there are adverse event reports about it.

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April 11, 2013

Study of Premature Babies Failed to Inform Parents of Risks

Several prestigious universities, including Stanford, Duke and Yale, conducted a research study on behalf of the federal government to examine which of two levels of oxygen given to extremely premature babies was better at preventing blindness without increasing the risk of brain damage or death. The purpose and execution of the study were solid; the ethics weren’t.

As widely reported, including by the New York Times, the universities failed to inform the parents of the 1,300 hundred babies that the risks of being in either group included blindness and death. The federal Office for Human Research Protections, whose job is to protect people participating in government-financed studies, detailed the ethical breach last month in a letter to the University of Alabama, Birmingham, the study’s lead site of the 23 universities involved. The babies’ families, says The Times, have yet to be notified of what the government learned.

The consumer advocacy organization Public Citizen found out about the letter, and informed the media of it on Wednesday. Public Citizen wrote a letter to HHS Secretary Sebelius asking her to step up the discipline of the universities involved, and to personally and publicly apologize to the families of the 1,300 babies.

The study, published in the New England Journal of Medicine, occurred from 2004 to 2009, and involved babies born from 24 to 27 weeks of gestation—full term babies gestate for 39 to 40 weeks. Such premature infants are extremely fragile and at high risk of death and eye disease.

Babies in the study who received the higher level of oxygen were more likely to develop the eye disease, called retinopathy of prematurity, and blindness; those who got less were more likely to die. Of the 654 low-oxygen babies, 130 died; 91 of 509 high-oxygen babies developed the eye ailment.

“The researchers,” according to the letter, “had sufficient available information to know, before conducting the study, that participation might lead to differences in whether an infant survived, or developed blindness, in comparison to what might have happened to a child had that child not been enrolled in the study.”

The consent form the parents were given to sign so their babies could participate in the study noted only the risk of abrasion of the infants’ skin by an oxygen monitoring device, and that the possible benefit to participating was a decreased need for eye surgery, depending on the group the infant was assigned to. (To learn more about informed consent, see our backgrounder.)

The vice president for research at the University of Alabama, Birmingham, told The Times that the study kept the infants within the standard band of treatment for oxygen levels. But the letter from the Office for Human Research Protections, which is an agency of the Department of Health and Human Services, found the consent form wanting, and that the risks of participating in the trial “were not the same as those receiving standard care.”

The consent form, it said, should have explained that “there is significant evidence from past research indicating that the oxygen provided to an infant can have an important effect on many outcomes including whether the infant becomes blind, develops a serious brain injury or even possibly whether the infant dies.”

The consent form, said The Times, had been approved by all of the participating universities.

Consent forms generally cover every possible adverse event because the institutions conducting research are careful not to expose themselves to legal liability. But as Dr. Arthur Caplan told The Times, parents often rely more on what doctors say in deciding whether to participate than on the fine print of a consent form. Caplan is the medical ethicist at New York University Langone Medical Center.

Treating extremely premature infants has always been challenging. Administering oxygen is indicated because preemies’ lungs are underdeveloped and they struggle for air. But the higher oxygen levels that were thought to improve their odds of survival led to many cases of blindness. So doctors usually make treatment decisions based on each individual, often in consultation with parents, and nothing having to do with such tiny babies is without risk.

The researchers said their approach also was flexible and that the infants in the study weren’t necessarily confined to rigid bands of oxygen levels. But because they wanted to determine the effects of two different levels, they tried to keep half the subjects in the low zone and half in the high zone. Also, they said a similar group of infants born around the same time in the same hospitals who did not participate in the study, but were eligible, died at higher rates than those in the low-oxygen group..

Still, assuming risk is not a unilateral decision to be made by practitioners. It’s unconscionable that parents were deprived of knowing all the concerns in their childrens’ participation in this study.

Some readers of The Times’ story, however, had a more nuanced appreciation of the ethical breach.

“Death or blindness is a terrible choice,” said one. “The retrospective finding that similar patients (in the same hospital at the same time) who did not participate in the study suffered more deaths and blindness illustrates the dire nature of the patients' condition and the extra care bestowed on them by the researchers. Also that oxygen delivery to the infants was appropriately adjusted by the researchers—evidence that their clinical care was not adversely affected in any way by the research. Nevertheless, the federal agency is right that the parents should have been given all the available information before they signed the consent.”

Another, who identified herself as a health researcher who has written consent forms, said “This is an explanation of how research ethics works, I am not making a judgment about whether the concept of this study was right or wrong.

“Many readers are expressing anger that parents were not informed in the consent form about the risk of death and blindness with oxygen treatment. These are extremely preterm babies, who without treatment would likely die and even with treatment, may die or face a lifetime of complications. If oxygen treatment is standard of care, then any competent physician treating this baby would tell the parents about the risk of death and blindness before starting the treatment. The key question here is whether participating in the study increased these risks. If the risk of blindness and death with oxygen treatment for babies in the study is the same as babies receiving oxygen treatment and not in the study, then there would be no requirement to mention those risks again in the consent form. If there was increased risk of these outcomes due to participating in the study, then the consent form would be required to mention it. Researchers are not obligated to mention the risks of a procedure that the person has already made a decision to participate in. It is the responsibility of the consulting physician and the hospital to make sure the parents are informed of the risks of that procedure before agreeing to undergo it.”

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April 11, 2013

Suggested Reading: Several New Takes on the Dangers of Prescription Drugs

Sometimes, we read an article or book about health, medicine and/or patient safety that’s fascinating but too long to summarize fairly in a blog post. So here’s a shout-out to a few recent stories you might want to look up, on a common theme.

According to the Centers for Disease Control and Prevention (CDC), drug overdose death rates in the U.S. have more than tripled since 1990 and have never been higher. Most of these deaths, says the CDC were caused by prescription drugs. In the last several months, the Los Angeles Times has published a series of investigative articles about the epidemic of prescription deaths. The four-part series explains how legal drugs have deadly outcomes, how reckless doctors and rogue pharmacists contribute to the problem, how regulatory authorities allow problems to fester and what they can do to address it. Link here.

Also, see our blog, “Doctors Don’t Know Dangers of Narcotics, and FDA Leaves Drug Makers in the Driver’s Seat.”

“NPR’s Akathisia Blind Spot,” was posted on Paul John Scott’s website devoted to “groupthink in science medicine and fitness—popular culture and the madness of crowds.” In the eloquent essay, he indicts the media for continuing to ignore a major side effect of a class of anti-depressant drugs known as SSRIs—selective serotonin reuptake inhibitors--including Celaxa and Lexapro. “[T] he problems with SSRIs and suicide seems no closer to being articulated in the culture at large, let alone resolved, beyond a few ardent voices and the small print on some drug labels that, thanks to the silent skepticism of so many, no one really knows what to think of.” Link here.

“Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients,” Dr. Ben Goldacre’s new book, addresses our culture’s willingness to believe that drug treatment is based on evidence, that doctors are familiar with the latest drug studies, that drug research is pure science unpolluted by conflicts of interest and that when it comes to drug safety, regulators have our back.

As readers of this blog know, that’s fiction. Goldacre shows how the manipulation of the prescription drug market has been protected from public scrutiny because it’s too complex to capture in a sound bite. Goldacre untangles the tale in the hope that all patients and medical professionals can understand the tricks and distortions inherent in Big Pharma. Link here.

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March 29, 2013

When "Peer Review" Has Ulterior Motives

A federal judge this week upheld a jury verdict against the American Academy of Orthopedic Surgeons, finding sufficient evidence for the jury's decision that the AAOS acted with "reckless disregard for the truth" in publicizing its discipline of an orthopedic surgeon who had testified that another surgeon had committed malpractice.

The decision was written by U.S. District Judge Joel Slomsky, who was nominated to the federal bench by George W. Bush and sits in Philadelphia. Read the judge's decision against the orthopedic surgeons' society here.

The surgeon who successfully sued the AAOS is Steven Graboff, MD, whom the AAOS suspended for two years after he testified against an AAOS member. The jury found that the AAOS report about its disciplinary action cast Dr. Graboff in a "false light" because of various errors. The AAOS report remains on its publicly accessible website.

The AAOS is one of a number of doctor organizations with "peer review" programs for reviewing expert testimony against members. The programs exercise vast economic power over the members' testifying activities, as the court found. Responding to an argument from the orthopedic surgeon group that the expert witness had not shown enough economic harm from its slam of him, the judge wrote:

The AAOS is well aware of its clout in the profession of orthopaedic surgeons and created its compliance program and standards to control the occupation of its members as experts.16 It is also aware that its enforcement program and standards would affect the income of doctors because the loss of AAOS accreditation has a substantial impact on the ability of an expert to work in that industry. Further, the presence of the standards alone, however noble they are as a mission statement, can have a chilling effect on orthopaedic surgeons who serve as expert witnesses against other orthopaedic surgeons.

The ostensible goal of these expert witness "review" programs is "truth" in testifying, but the judge's decision summarizes the evidence at trial supporting the jury's verdict that AAOS did not run an unbiased review system.

The bias started with the doctor the orthopedic surgeons picked to set up and run its testimony review program: Dr. Peter Mandell, an orthopedic surgeon who had stopped treating patients and focused his practice on testifying for insurance companies in workers' compensation cases (i.e., testifying against patients).

Dr. Mandell, as Judge Slomsky found, is the head of the AAOS Committee on Professionalism, the first body to hear charges that an orthopedic surgeon has testified in violation of the AAOS expert witness standards.

(By the way, only members of the AAOS are eligible to start complaint proceedings against an orthopedic witness; that means that any patient who feels aggrieved by a surgeon's testimony against the patient -- like Dr. Mandell's testimony against a worker's comp claimant -- has no recourse.)

Dr. Mandell is also head of the AAOS Council on Advocacy, which lobbies in Washington for "tort reform" to curb malpractice lawsuits.

Hmm. Coincidence?

The expert witness review program, Dr. Mandell testified (with admirable candor) in the Graboff lawsuit, came about because orthopedic surgeons were upset about high jury verdicts against orthopedists in malpractice cases.

Any scientist knows that biased decision makers produce biased outcomes. That's why medical research usually requires "double blinded" studies so that doctors studying a new drug or device don't subconsciously tilt the results one way or the other from knowing which way something should come out.

But in this case, the old doctors' joke may hold true. Q: What's the definition of a double-blind study? A: Two orthopedic surgeons examining the same patient.

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February 20, 2013

Obesity Analysis Is Larded with Potential Conflict of Interest

An article published last month in the New England Journal of Medicine (NEJM) about obesity research prompted a lot of health journalists to respond, but their interest wasn’t about this growing (sorry) health problem—it was about the possible conflict of interest that the otherwise prestigious journal might have sidestepped.

Both Gary Schwitzer, editor of HealthNewsReview.org and Kevin Lomangino, a contributor to that site as well as editor-in-chief of Clinical Nutrition Insight, were moved to comment. As Lomangino wrote, the NEJM article “was a ‘mythbusting’ paper designed to separate fact from fiction and expose nonsense masquerading as truth. … as the authors point out, … clinging to unsupported beliefs can ‘yield poorly informed policy decisions, inaccurate clinical and public health recommendations, and an unproductive allocation of research resources and may divert attention away from useful, evidence-based information.’

“But can we trust this particular team of mythbusters?” Lomangino asked after reviewing the disclosure at the end of the article listing all of the companies that paid the authors for a variety of things, including board membership, consulting and lecture fees, licensing agreements and to conduct research. It’s such a hefty catalog—Lomangino calls it “epic"—that you want to laugh at the way it concludes: “No other potential conflict of interest relevant to this article was reported.”

Among the various interests listed with, as Lomangino said, “considerable skin in the obesity game,” are Coca Cola, Pepsi, Kraft, National Cattlemen’s Association, World Sugar Research Organisation, Jenny Craig and drug companies that make weight-loss medications.

“I don’t think there is much doubt,” Lomangino said, “that these relationships influenced the content of the paper, and not for the better. How else to explain the choice of ‘facts’ that the authors chose to highlight in the paper, and those they inexplicably left out?”

Yeah, that’s pretty telling—good science doesn’t pick and choose the data it reports.

Lomangino discussed three interventions the authors say are “suited to clinical settings” in the “facts” section of the paper. Two of them — meal replacements such as low-calorie drinks and bars and weight-loss drugs—are well represented in the list of disclosures. But not represented on the list nor in the article is another intervention—counseling and behavioral therapy. It’s curious, Lomangino wrote, that the authors didn’t think it worthwhile to discuss the benefits of that approach.

Especially when you consider that such an intervention can be successful. The U.S. Preventive Services Task Force (see our blog about this agency) reviewed nearly 40 trials using counseling/therapy for weight loss and deemed it of sufficient value to warrant reimbursing qualified counselors. “But,” wrote Lomangino, “the disclosure list doesn’t indicate any obvious financial stake in this approach for the authors. Could that have had anything to do with their decision not to mention it?”

Everyone knows that a huge contributor to this country’s obesity problem is our fondness for soda and other sugary drinks. Then you realize that the authors say nothing in the paper about soft drinks or sugar and obesity, you look at the inclusion of Coke, Pepsi and the sugar research organization in the disclosure club and you say ‘what’s wrong with this picture?’

“I’m not saying it’s an undisputed fact that cutting out soda reduces obesity (although the evidence from clinical trials seems to be close to erasing any doubts…),” Lomangino wrote. “But considering the huge implications and obvious widespread confusion related to this issue, I think it’s strange that the authors didn’t include some kind of evidence-based discussion.”

“Strange”? He’s being kind. We’re thinking it’s more like “deficient,” or maybe “disingenuous.” “Deceitful,” even. The authors believed that the myth of sex as a big calorie burner deserved their analysis more than the effects of consuming Coke. They believed sex-as-exercise deserved their analysis more than examining whether you can lose weight with the help of dietary supplements, on which Americans spend billions of dollars each year; more than a discussion of the “myth” that eating dairy products can help you lose weight.

“I’m a little surprised,” Lomangino wrote, “that the article didn’t have more to say on these topics, and I can’t help but wonder if their decision-making had anything to do with ties to Basic Research, which according to WikiPedia makes the Zantrex-3 weight loss supplement, or multiple relationships with global dairy interests.”

Lomangino didn’t suggest that these relationships directly compromised the information the authors included, or that they consciously tailored the content to benefit their funders. He acknowledged that they provided a lot of useful, evidence-based information, and, like he, want to see better research in nutrition.

But no thinking person can ignore the possibility that their business relationships have the potential to influence the data and information they choose to present, and how they present it. And when you tiptoe down that path, you add to what the article authors describe as “poorly informed policy decisions, inaccurate clinical and public health recommendations, and an unproductive allocation of research resources.”
Conflicts of interests abound in medicine and medical research. But it’s pretty unusual when those on its front lines make its potential harms so easy to see.

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February 11, 2013

Which Doctors Line Their Pockets with Big Pharma Money?

As we reported last year, part of the Obama administration’s health-care reform includes the Physician Payments Sunshine Act. It requires drug companies to disclose payments they make to doctors for research, consulting, speaking, travel and entertainment. Sometimes, such compensation influences treatment decisions and encourages overuse of drugs and devices. And these relationships are ripe for conflicts of interest.

So where are we in this process of finding out who’s getting what from whom?

According to the public interest news site ProPublica.org, things are moving slowly, but they’re moving. Final regulations were announced last month, but the release of payment data won’t happen until September 2014. The information was supposed to become public beginning this year, but since federal officials released the proposed regulations in December 2011, they’ve been collecting and analyzing comments about them.

Either there was a tsunami of comments, or the government is a bit tardy.

The first group of data to be released reflects payments made from August to December of this year. The reporting companies must turn the data over to the government by March 2014, then doctors have 45 days to review it for accuracy before it becomes public. Companies must report every year.

The information helps patients find out if their doctors receive money from any companies whose products they prescribe. If they do, these docs might be influenced to treat their patients in a way that might not be in the patients' best interests.

Until now the only similar resource has been a ProPublica initiative, Dollars for Docs. It has tracked payments since 2009 from a dozen drug companies, most of which were required to post the information on their websites as part of lawsuit settlements with the federal government. Mostly, the companies allegedly engaged in illegal marketing practices, such as off-label promotion. That’s when they promote a drug or device for a treatment purpose for which it hasn’t been approved by the FDA. Such settlements total billions of dollars.

Soon, Dollars for Docs will be updated through 2012 and include payment info from 15 companies.

Everyone—drug companies, lawmakers and consumer advocates—has been frustrated with how long it has taken the Centers for Medicare and Medicaid Services (CMS) to release the final rules for collecting and publishing the data. But at least it’s happening.

Any payment larger than $10 made to a U.S. physician or teaching hospital must be reported by date of payment and include a description of the service provided, the amount paid and which company products the payment involved. Speaking fees, consulting payments, research, gifts, food, entertainment, honoraria, research grants, royalties and license fees are included.

Fines for failure to report range from $1,000 to $10,000 for each incidence. A deliberate failure to report can cost $1 million.

According to ProPublica, some practitioners are rolling in the payment (graft?) green.

One Los Angeles-area doctor got more than $300,000 in speaking fees in 2009 and 2010 alone just from the companies in its database. Those businesses account for less than half of all U.S. pharmaceutical sales, so who knows how much more dough is in promotional play?

It’s interesting—dismaying?—to note that more than 250 physicians who were drug company speakers and consultants had been disciplined by their state medical boards or other regulatory agencies.

Find out if your physician is one of them at the Dollars for Docs link.

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November 1, 2012

Surgery Decisions Shouldn’t Be Larded With Conflicts of Interest

The health and medicine watchdog HealthNewsReview.org recently laid bare how regulatory absence can poison what’s supposed to be an objective, scientific analysis of the suitability of a surgical procedure.

In excerpting an article that has been accepted for future publication in Arthritis Care & Research, HealthNewsReview shows the wide cracks in how the FDA approves some medical devices. Known as the 510(k) expedited review process, the exercise allows certain devices to be approved for sale “without formal testing in clinical trials as long as they confer low or moderate risk to patients and are structurally similar to a previously approved device.”

We’ve examined how devices are approved by the FDA, and how nonsensical the 510(k) process can be. On its face, an expedited process has merit. Many people otherwise without treatment for their medical problems can receive relief faster when bureaucracy gets out of the way. But speed doesn’t always result in good medicine.

As the journal article points out, a “previously approved” device might have been approved under 510(k), “leading to daisy chains of approved devices going back for decades, most of which have not undergone rigorous premarket assessment in human subjects.”

And lax regulation invites conflicts of interest. Using a hypothetical example, the writers demonstrate how, because surgeons have few constraints on their choice of medical device, “many are able to decide for themselves when they wish to begin using newer models.”

In the authors’ scenario, a surgeon, Dr. Jones, reviews a total hip replacement procedure with the patient, a man in his 50s. Dr. Jones makes sure he understands his options, and the patient signs the surgical consent form. Everything seems kosher but, although the risks and benefits of total hip replacement were detailed, shouldn’t the patient have participated in the decision about which implant device to use?

The authors say that without regulatory demand, not all the evidence must be presented that would fully inform the patient about technical considerations and the surgeon’s personal beliefs and possible conflicts of interest.

What if Dr. Jones has received consulting fees from the manufacturer of one of the devices under consideration? As the authors note, “Orthopedists who receive industry support express, on average, a greater sense of shared goals and priorities with their vendors and sales representatives than surgeons who don’t.”

Doesn’t the patient deserve to know that?

Doctors with financial interests in medical devices aren’t limited to orthopedics—the industry is rife with cross-pollination of science and commerce in all manner of devices and drugs. Among the most active players are pharmaceutical manufacturers and the doctors they pay for research, consulting, speaking, travel and entertainment to (see our post).

Patients can’t make a fully informed decision about surgery unless they’re offered a clear, complete picture of all aspects of the procedure. To that end, the article authors suggest that for their hypothetical hip-replacement, “the informed consent process … be enriched with a greater focus on shared decision-making. This would include discussing the choice of implant and other technical decisions that may affect the outcome of the procedure, in addition to disclosing any relevant financial relationships. We note the challenge of providing patients with easily digestible information that helps them make decisions consistent with their own values.”

Yes, it’s challenging. But it’s necessary and only fair, for this and any surgical procedure.

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August 9, 2012

The Torturous Tale of Anemia Drugs: How Many People Did They Harm?

Three anemia drugs--Epogen, Procrit and Aranesp--have generated more than $8 billion in U.S. sales. Epogen became the single costliest medicine under Medicare, and taxpayers shell out as much as $3 billion a year for these drugs.

A growing body of research has shown that the drugs’ benefits, including quality-of-life issues such as “happiness,” are seriously overstated. Worse, according to a long story in The Washington Post, their potentially lethal side effects, including cancer and strokes, were long overlooked.

Anemia occurs when the body produces too few red blood cells, which carry oxygen from the lungs to the rest of the body. The drugs are artificial versions of a natural hormone called erythropoietin, which stimulates the body to produce red blood cells. Before the drugs’ advent, patients were given transfusions of red blood cells, a cumbersome process that can take hours.

Epogen and Procrit were approved by the FDA in 1989 for patients with kidney disease. Amgen manufactured both; Procrit was licensed by Johnson & Johnson. Amgen’s Aranesp was approved in 2001.

Last year, an 84-page Medicare research study determined that among most kidney dialysis patients, who compose the drugs’ largest market -- the kidneys are where the natural hormone is made -- there was no solid evidence that they made people feel better, improved their survival or had any “clinical benefit” except a higher red blood cell count. As The Post said, “It was a remarkable finding of futility: While drugmakers had seen billions in profits over 22 years, much of it from taxpayers, millions of patients had been subjected to dangerous doses that might have had little advantage.”

One of those patients was Jim Lenox. On the day the frail cancer patient received his last injection in 2008, he was awaiting discharge from the Baltimore Washington Medical Center. Then a nurse said he needed another dose of anemia drugs.

His wife, Sherry, wondered why, because his blood readings had been close to normal. But the Lenoxes deferred to the professionals and accepted an injection of Procrit, which his cancer clinic normally billed for $2,500 each.

Hours later, Lenox was dead.

The story behind the anemia drugs is long and complicated, and illustrates how the financial incentives that are integral to the U.S. health-care system contribute to its inefficiency and lethal potential. We wrote about this smarmy situation last year.

Drug trials conducted by both Amgen and Johnson & Johnson missed the dangers and promoted the benefits that years later would be deemed unproven. The companies took more than a decade to fulfill their research commitments. And when bureaucrats tried to curb the largest doses, Congressional lobbyists were successful, and regulators opened the spigot.

The fault of dangerous drugs being promoted on the open market is shared by doctors, clinics and hospitals, whose budgetary pressures contribute to a “more is more” philosophy. The more they treat, the more they earn, the bigger the dose, the bigger the payoff.

Unlike medications you fill at a pharmacy, drugs administered by physicians, such as the anemia group, can be profitable for them.

Big Pharma offered doctors incentives to give large doses and they offered volume discounts. Most critical, The Post says, was the lobbying pressure, under which Congress and Medicare administrators forged a system in which doctors and hospitals were reimbursed more for the drug than they paid—as much as 30 percent, according to the Medicare Payment Advisory Commission, a group that advises Congress. The markup on patients covered by private insurance was even larger.

At the peak of the drugs’ use in 2007, more than 8 in 10 Medicare dialysis patients were receiving the drug at levels higher than the FDA now considers safe, according to federal statistics. (Other patients got the drugs, but records kept on dialysis patients are better.)

“An oncologist could make anywhere from $100,000 to $300,000 a year from this alone. And all the while they were told that it was good for the patient,” Charles Bennett, from the Medication Safety and Efficacy Center of Economic Excellence at the University of South Carolina, told The Post.

During his cancer treatment, Jim Lenox was given Aranesp several times at a clinic. The insurance company reimbursed it about $900 for each, although the clinic would have paid about $600.

The profit margin for Amgen was far higher than the industry average. Much of it came from the pockets of taxpayers. A Washington University professor of medicine who had been paid by Amgen to promote the drug, called its success “a paradigm for the pharmaceutical industry.” He later turned critic after Aranesp’s dangers became known while Amgen continued to promote higher doses.

Both companies declined the paper’s requests for interviews and claimed that their primary interests were serving patient needs and providing consumer information.

The market expanded to nearly all dialysis patients, not just the estimated 16 in 100 who require blood transfusions, and the size of the average dose more than tripled. The FDA approved the drugs to treat anemia in cancer and AIDS patients, as well as those getting hip and knee surgery.

The drugmakers agreed to conduct safety studies, but the full results were never published. Amgen filed a “clinical study report” with the FDA in 1995, claiming its research commitment was fulfilled. The FDA did not deem the study completed until March 2004, almost 15 years after the company agreed to conduct it.

Another study in conjunction with the drugs’ approval was supposed to have 400 patients. Eleven years after initiating it, Johnson & Johnson said it was having difficulty recruiting enough, so statistically significant conclusions were elusive. And the FDA said significant amounts of data were missing.

With FDA approval, Johnson & Johnson halted the study in 2004. Medicare researchers later noted that patients in the trial who took the drugs appeared more likely to die than those who took a placebo, or fake, inert drug.

The drugmakers committed to doing another study, which was supposed to be completed by 2008. It still isn’t finished and Amgen doesn’t expect to finish until 2017 — nearly 25 years after the drug was approved for use in cancer patients.

Still another study funded by Amgen involved dialysis patients with a history of heart trouble. It was supposed to study the effect of the drugs in boosting certain blood levels close to normal, instead of simply higher than the anemic levels, which had been medically acceptable. That trial was stopped three years after it began because patients in the “normal” higher-dose group were dying or having heart attacks at a higher rate than those in the lower-dose, lower-level group.

What should have been a clear warning wasn’t: The FDA didn’t limit the recommended dosing levels, and the reason for the “increased mortality” at the higher doses, according to the label, “is unknown.”

In 2006, a study published in the New England Journal of Medicine reported that kidney patients taking higher doses were linked to higher risks of hospitalization, strokes and death. Some Danish researchers stopped a trial of Aranesp in cancer patients because of an increase in deaths and tumor growths.

Finally, the FDA ruled out the drugs’ use for cancer patients considered curable and for patients considered only slightly anemic. Maximum recommended doses were lowered, and the agency told doctors to use the smallest amount possible to avoid a blood transfusion. The agency removed the quality-of-life claims from the label.

Last year, nearly two decades after the Office of the Inspector General first suggested it, economic incentives to use more of the drugs on patients in dialysis were withdrawn. Medicare implemented a system under which health-care providers are allowed a certain amount of money per dialysis patient, rather than more money for each dose.

“The effects were immediate,” The Post reports, “suggesting again that health is not the only factor that doctors weigh in treating patients. After a quarterly sales plunge in April, Amgen chief operating officer and President Robert Bradway blamed the drop on the new payment scheme.”

Still, no major class-action lawsuits have been mounted, presumably at least in part because the patients taking the drugs were already ill. Amgen has been hit with whistleblower lawsuits alleging that the company engaged in illegal sales tactics.

But for people like Sherry Lenox, questions remain: Although her husband’s death certificate says he died of cancer, did he? Or was he he killed by the drugs he took to treat it?

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August 6, 2012

Overeager Surgeon Does His Melanoma Patient No Favor

For many people, the word “melanoma” often prompts the same response as the word “snake”— fear and, if announced as a personal warning, panic.

Indeed, the worst form of skin cancer can be deadly if ignored or treated improperly. Several years ago we sued a dermatologist whose dereliction in treating a patient with moles led to his death. But like so many other kinds of cancer, many people are harmed because their symptoms or their disease is overtreated by fear-mongering surgeons. This was the case in a story published in the Archives of Internal Medicine called “What the Surgeon Should Have Said to My Patient with Thin Malignant Melanoma.”
The writers, two medical doctors, explained how the patient presented with a colored lesion on his shoulder. A simple biopsy revealed a stage 1A malignant melanoma which, on a relative scale, is a small, early-stage cancer. This one was 0.5 mm deep. It had no ulceration nor evidence of palpable lymph nodes, either of which should have raised more questions. The surgeon, who specialized in oncology, played the fear card in encouraging the patient to have a procedure known as a sentinel node biopsy.

According to the authors, he said, “It is up to you, but you have a risk that there is spread into your lymph nodes. It has been shown that patients with nodal disease operated on at an early stage do better than those having total lymph node resection at a later stage when an enlarged lymph node is palpable. By doing this procedure, I could save your life.”

A sentinel node biopsy involves injecting a radioactive substance, dye or both near the tumor. Then the surgeon uses a probe to locate the lymph node(s) containing the injected marker—that’s the “sentinel.” The affected nodes are removed and analyzed for the presence of cancer cells. The point is to see where cancer cells are likely to spread from the primary tumor.

As noted in a companion story in the same publication, performing sentinel node biopsy on patients with early-stage melanomas is not considered best practice. But nearly 1 in 10 such melanomas are overtreated with such invasive procedures. About 30,000 of these melanomas are diagnosed every year, so thousands are overtreated in this way.

The risks of sentinel node biopsy include:


  • infection;

  • hematoma (swelling of clotted blood caused by a break in a blood vessel wall);

  • nerve damage.

In addition, the procedure can cost about $15,000.

Patients in the only scientifically sound study on sentinel lymph node biopsy had lesions that measured at least 1.2 mm. The death rate from malignant melanoma was nearly identical in the group with sentinel lymph node biopsies compared with those whose lymph nodes were biopsied only if enlarged. But patients with microscopic disease did better than those with lymph nodes that were enlarged and palpable.

The journal writers note that it’s wrong to compare outcomes of patients with palpable nodes with those who have normal-sized lymph nodes, because the latter group’s disease is at an earlier stage, and when it’s discovered incidentally is usually less aggressive. In short, it’s possible that their positive sentinel nodes might not progress because of the body's natural immunity. “The unambiguous finding of this trial,” the writers reported, “is that there was no advantage of sentinel node biopsy over observation.”

The surgeon in this case not only was too eager to practice his skills, he was malfeasant; he neglected to discuss treatment options with his patient and their possible side effects weighed against their benefits.

According to the journal authors, the surgeon should have said, “A wide excision alone [cutting around the lesion] gives you an excellent chance of cure. No studies have shown that sentinel node biopsy will improve your chances, and we do not know if you would benefit from the discovery of microscopic lymph node disease.”

If you want to more about melanoma and how to assess the value of treatment options, link to the website LifeMath.net, which tries to make sense of “the enormous number of fundamentally discrete events that occur among the many molecules, genes, and cells of which we are comprised.” Click on the cancer and melanoma tabs.

Here's a discussion on our firm's web site about the vital issue of "informed consent" in medicine.

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July 22, 2012

TV Doctors: Good Entertainment, Bad Medicine

We couldn’t have said it better than the Los Angeles Times: “ Television is great for sports, reality shows and reruns of ‘The Big Bang Theory,’ but if you're getting your health information from TV, you might not be as well-informed — or as healthy — as you could be.”

We would add that you also might be courting harm. See our newsletter, “Those TV News Doctors: Good Advisors or Fear Mongers?”

Whether it’s “Celebrity Rehab with Dr. Drew” or “The Doctors,” America can’t seem to get enough of practitioners giving medical advice, especially if they’re dishing dirt on famous people or strutting hunkily in their scrubs. They have medical degrees, they’re confident and articulate, and it’s a whole lot easier to flick on the TV than schedule a doctor’s appointment, and sit in the waiting room 30 minutes beyond the time you were supposed to be seen about your upset tummy.

There’s a problem with seeing doctor TV as an authority rather than entertainment, Dr. Steven Woloshin, professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice, told The Times. Sometimes, TV doctors who are accomplished in one field might be discussing topics beyond their areas of expertise or certification.

Dr. Mehmet Oz is a practicing cardiothoracic surgeon and a professor of surgery at Columbia University who gained media fame appearing on the Oprah Winfrey show. Photogenic and warm, he inspires responses from his audiences to his advice on how to keep a great head of hair as much as on ability to repair somebody’s heart.

Americans are desperate to lose weight, so nutrition is a frequent topic on these shows. But, "Just because someone's on TV, just because they're wearing scrubs, doesn't mean they're an expert on nutrition," Woloshin, a specialist in internal medicine, said.

Oz recently told his TV viewers that coconut oil is a "super food" that "helps you lose weight.” He got all science-y, demonstrating that the fatty acids in coconut oil dissolve easier than the saturated fat in meat. But Christine Tenekjian, a dietitian at the Duke University Diet and Fitness Center, pointed out that the considerable caloric load of coconut oil would override the modest benefits it might have on metabolism. “We have people who come in with all sorts of misconceptions that they heard on TV,” she told The Times. “They cling to it as gospel.”

In the spring, “The View” aired an episode with Dr. Steven Lamm, who, not coincidentally, was promoting his book, “No Guts, No Glory.” The professor of medicine at New York University championed several probiotic and nutritional supplements from a company called Enzymedica Inc., guaranteeing that "… in three to five years, everyone is going to be on a probiotic, everyone is going to be on a digestive enzyme."

He said these products are crucial to overall gut health. He must know something nutritional scientists don’t. "There's no evidence that probiotics improve your health if you take them every day," Lynne McFarland, a probiotic researcher at the VA Puget Sound Health Care System in Seattle, told The Times.

Some people, such as those with pancreatic disease, are prescribed digestive enzymes. But to pop them like cough drops is simply a fad.

We reported last week how Pinsky was paid by pharmaceutical company GlaxoSmith Kline to promote its antidepressant Wellbutrin. Guess who paid Lamm for his consulting services? Enzymedica. Although he told The Times that he has no financial stake in the company's products, don’t you think TV viewers deserve to know that his advice might have been less than objective?

As publisher of Health News Review, Gary Schwitzer is a frequent critic of shallow health journalism and how it engenders the gullibility of consumers. He said “The View” illustrated another problem with health-as-entertainment – the show's hosts constantly interrupted Lamm, so even if he had a helpful, coherent message he was given little opportunity to share it. "It's like getting your health information by listening to people talk on the train," he told The Times.

Sometimes, nutrition advice purveyed on TV isn’t just questionable, it’s dead wrong. “The Talk” is another daytime talk show directed toward a female audience. Early this year, it fed viewers’ celeb-and-weight-loss lust a segment featuring so-called “celebrity nutritionist” Cynthia Pasquella. She touted apple cider vinegar as “very alkalizing for the body, which promotes weight loss.”

Woloshin begs to differ, noting that all vinegars are acidic, which is the opposite of alkaline. And that even if you could “alkalize” yourself via salad dressing, there’s no evidence that it confers a benefit. Tenekjian agrees, saying no studies suggest that vinegar helps with weight loss.

Then there’s advice to boost your sex life. TV land found the perfect doctor to deliver this information in Travis Stork, the hunky ER doc on “The Doctors.” Last winter he told viewers about a “love potion” called Oxytocin Factor , an over-the-counter version of the hormone oxytocin. The ob-gyn doc on the show, Dr. Lisa Masterson, described oxytocin as the hormone that promotes the bonding of babies to their mothers and of women to their men. She put a few drops of Oxytocin Factor on pediatrician Dr. Jim Sears, who joked, “I feel like bonding right now.”

This isn’t medicine, this is sophomoric posturing. Commented Dr. David Feifel, a professor of psychiatry at UC San Diego, “[The segment] was pretty ridiculous and irresponsible, in my opinion." He told The Times that real oxytocin can promote bonding when delivered directly to the brains of people or animals, but had "no idea" where anyone got the notion that a few drops on the back of the neck would do anything at all.

A spokeswoman for Nutriceuticals Inc., manufacturer of Oxytocin Factor, said the doctors on the show didn't use the product as directed; it’s delivered via either nasal spray or oral drops.

Oh, that makes it better.

If you enjoy watching doctors on TV, stick to reruns of “ER,” where you know the stories and most of the medicine is fiction. If you want to see real doctors wearing their scrubs on a TV set rather than in an OR theater, fine—just don’t confuse what they say as medical advice to live by.

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July 18, 2012

Big Pharma Bust: Unsavory Details Behind the GlaxcoSmithKline Lawsuit

Last week we reported about the widely publicized criminal behavior of pharmaceutical giant GlaxoSmithKline, and the $3 billion fine it will pay for its crimes. Thanks to Kaiser Health News (KHN), consumers can get the gory details of just how Big Pharma inflates drug sales and the cost of health care.

It’s about doctors who leverage their medical celebrity into roles as drug shills. It’s about doctors who accept fancy trips and recreational pursuits from the companies who supply their wares It’s about spinning research results into fictional scenarios that make a great story and really bad patient care.

Courtesy of KHN, here are some of the players and their playgrounds with which Glaxo promoted the depression drugs Paxil and Wellbutrin and the diabetes drug Avandia.


  • Glaxo paid Dr. Drew Pinsky (radio call-in show “Loveline,” reality TV show “Celebrity Rehab with Dr. Drew”) $275,000 to promote Wellbutrin “in settings where it did not appear that Dr. Pinsky was speaking for” Glaxo.

  • On a radio show Pinsky said the active substance in Wellbutrin “could explain a woman suddenly having 60 orgasms in one night” even though Wellbutrin was approved to treat only major depression.

  • Glaxo promoted Wellbutrin “knowing that much of the cost of the unapproved, nonmedically accepted and/or inappropriate uses would be borne by federal health care programs.”

  • In 2000 and 2001, Glaxo flew psychiatrists to resorts (El Conquistador in Puerto Rico and Renaissance Esmeralda in Palm Springs, Calif.) to promote Paxil for children, even though it was unapproved for that use. “Results suggest that the Paxil Forum had a significant impact on Paxil market share in the months after attendance,” according to a Glaxo memo.

  • Glaxo paid what prosecutors described as kickbacks to doctors in the form of consulting fees, entertainment, travel and “sham advisory boards.” It tracked their prescribing habits. A Glaxo memo emphasized that only “KEY Customers” (high-prescribing doctors) should get free tickets to Boston Bruins and Celtics games.

  • “When I asked for the business he laughed,” one Glaxo sales rep said of a doctor whom he had treated to a St. Louis Cardinals baseball game. “I didn’t really see the humor in it. How could he think I wouldn’t ask for the business when I’ve treated his family to a day at the ball park.”


Most doctors who accept this graft would say that they wouldn’t prescribe a drug they didn’t believe in, so as long as they do anyway, what’s the harm in being treated well by its makers? We think it’s the patient’s decision, not the provider’s, as to what is and isn’t a conflict of interest.

So if you’re going to accept gifts, people should know about it. The 2010 health-care reform legislation supports that notion, and as of next year, the Physician Payment Sunshine Act will require doctors to disclose such activity.

In the meantime, you can look up any number of palm-crossing transactions between doctors/researchers and the medical drug and device industry on the “Dollars for Doctors” page of ProPublica, a nonprofit investigative news operation.

Should anyone doubt that these professional courtesies have the potential to affect someone’s health adversely, consider this comment posted at the end of the KHN story earlier this month:

“I’m on a brand medicine that has a generic. The brand drug is at least ten times the cost of the generic. I have asked my doctor to switch me to the generic and he refuses. He always says to me, ‘I’m the doctor. If you don’t like how I do things, there’s the door.’ The trouble with making my exit is that I’m not sure I can find another doctor that takes Medicare and I’m sure my current doctor will put me on the black list. He’s done to his other patients and I’m sure he’ll do it to me.”

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May 20, 2012

Conflict of Interest Kills Pain Control Advocacy Group

Here's another tale of Big Pharma insinuating itself into places it doesn't belong, to the detriment of quality care and patient safety.

Established to support patients with chronic pain, their families and the health-care professionals who serve them, the American Pain Foundation claimed to be the pain community’s largest advocacy group. Early this month, it abruptly shuttered its operation, attributing its demise to economic circumstances.

As several news organizations reported, that’s hardly the whole story.

Given the boom in prescription pain medicine—according to Marketplace.org, prescriptions for painkillers such as Oxycontin and Vicodin have quadrupled in the last decade—Americans clearly are hurting. You’d think there would be plenty of support for an organization that salved the pain.

But as explained in an investigative report by ProPublica, the foundation shutdown had to do with a U.S. Senate committee investigation into makers of narcotic painkillers and groups that champion them. According to ProPublica, 9 of every 10 dollars of the foundation’s funding in 2010 came from the drug and medical-device industry.

And—surprise!—its guidelines for patients, journalists and policymakers had minimized the risks associated with opioid painkillers and had exaggerated their benefits.

Senators Max Baucus, D-Mont., and Charles Grassley, R-Iowa, sent letters to the foundation and drug companies citing an "an epidemic of accidental deaths and addiction resulting from the increased sale and use of powerful narcotic painkillers."

Drug companies, they wrote, "may be responsible, at least in part, for this epidemic by promoting misleading information about the drugs' safety and effectiveness."

The senators are looking into the whole pain-control industry and medical oversight agencies to expose the financial connections among them. In addition to the American Pain Foundation and drug makers, recipients of the letters included the American Academy of Pain Medicine, American Pain Society, the Federation of State Medical Boards (the trade group for agencies that license doctors) and The Joint Commission (an independent nonprofit that accredits hospitals).

The U.S. Government Accountability Office (GAO) reported in 2003 that the Joint Commission had partnered with Purdue Pharma, the maker of Oxycontin, to distribute pain educational materials. In 2007, Purdue had pleaded guilty to federal criminal charges that it misled regulators, physicians and consumers about Oxycontin's risk of addiction.

No one denies that opioids might be appropriate for people in serious pain. But like any other drug, their benefits must be measured against their potential harm, and you can’t do that when manufacturers and so-called “advocates” supply inaccurate or incomplete information.

As quoted in the ProPublica story, Dr. Andrew Kolodny, chairman of psychiatry at Maimonides Medical Center in Brooklyn, N.Y., and president of Physicians for Responsible Opioid Prescribing, said, "These groups, these pain organizations … helped usher in an epidemic that's killed 100,000 people by promoting aggressive use of opioids. What makes this especially disturbing is that despite overwhelming evidence that their effort created a public health crisis, they're continuing to minimize the risk of addiction."

Sales of these potent drugs have risen 300 percent since 1999. And opioids were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined. In 2009, the use and misuse of the drugs were cited in more than 475,000 emergency department visits, nearly doubling the 2004 number. The figures come from the Centers for Disease Control and Prevention (CDC).

One in 8 high school seniors surveyed for a research paper in the Archives of Pediatrics & Adolescent Medicine said they had used prescription opioids for nonmedical reasons.

Another report in the Journal of the American Medical Association found that the rate of newborns diagnosed with drug withdrawal jumped threefold from 2000 to 2009. The rate of mothers using opioids at the time of delivery was five times higher in 2009.

Typically, medical professionals and patient advocacy groups acknowledge that drug overdoses are a legitimate concern, but say that most deaths involve illegally obtained drugs. They also say that patients' risk is low if they do not have addictive personalities, and people who suffer from serious pain should not be deprived of relief.

No, they shouldn’t. But narcotic manufacturers also shouldn’t be bankrolling advocacy groups whose job is to provide objective and complete information about drugs.

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May 13, 2012

Sunshine Dims with Delay on Big Pharma Payment Reports to Docs

Here’s another arrow for the quiver of people exasperated with government.

As part of its health-care reform, the Obama Administration proposed that drug companies be made to disclose payments they make to doctors for research, consulting, speaking, travel and entertainment. The rationale, as reported by The New York Times, was evidence that such payments can influence treatment decisions and boost costs by encouraging the use of more expensive drugs and medical devices.

Disclosure, the thinking goes, would make doctors more disposed toward making decisions in the best interests of patients instead of their bottom lines. As we’ve reported, drug and device company largess can be ripe for conflicts of interest.

According to The Times, about 1 in 4 doctors takes cash payments from drug or device makers; nearly 2 in 3 accept routine gifts of meals for themselves and their staff. The Times also concluded that doctors who take money from drug makers often practice medicine differently from those who do not—they’re more willing to prescribe drugs in risky and unapproved ways, such as prescribing powerful antipsychotic medicines for children.

Some companies have begun posting some payment information on their web sites, sometimes as the result of legal settlements with the federal government. Under the new proposal, if a company has even one product covered by Medicare or Medicaid, it must disclose all payments to doctors other than its own employees. The federal government will post the information on a public Web site.

The penalty for noncompliance could be $10,000 for failure to report. A company that knowingly fails to report payments could be subject to a $100,000 penalty for each violation, to a maximum of $1 million a year.

Comments about the proposal were accepted until Feb. 17, then Medicare officials were to issue final rules with the force of law.

Here’s where the archers among us start to take aim. As reported on FDA Law Blog, earlier this month the Centers for Medicare & Medicaid Services (CMS) announced “that manufacturers will not be required to collect data under the physician payment sunshine provisions of the Patient Protection and Affordable Care Act before Jan. 1, 2013.”

The regulation requires the first report to be submitted by March 31, 2013 for payments made in this calendar year, but CMS already has exceeded one deadline--under the Patient Protection and Affordable Care Act (ACA), payment-reporting procedures were supposed to be established by of Oct. 1, 2011.

The postponement gives CMS time to review more than 300 comments about the proposed rule, and also affords manufacturers additional time to prepare for the disclosure reports. Although the CMS didn’t expressly say the March deadline was extended, it’s implicit in the delay.

On news of the extension, Sen. Charles Grassley, R-Iowa, one of the sponsors of the Physician Payments Sunshine Act, said, “It’s disappointing that CMS won’t even collect data at all this year. The process has dragged on long past the statutory deadline for implementation. Consumers need to know more about the financial relationships between their doctors and drug companies sooner rather than later. It’s important that CMS get this right in every way, including the usefulness and accuracy of the information. Given all of the extra time, CMS will have no further excuses for not accomplishing these goals.”

We’d like to believe him. But when it comes to excuses in Washington, supply always
seems to exceed demand.

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March 21, 2012

FDA Workers Say Outsiders Influence Medical Device Decisions

Lots of people are unhappy with the process by which the FDA approves medical devices, including patients who’ve suffered harm from deficient products and manufacturers who claim burdensome bureaucracy stands between them and profit.

Congress has acknowledged that the process is less than ideal, and supposedly is trying to establish fair access to safe new technology. Pending legislation includes efforts to speed up device approval, many of which we recently suggested were tainted with lobbying dollars. Patient advocates want the FDA to spend more time reviewing implantable and life-sustaining devices.

Now, a survey by the Union of Concerned Scientists (UCS) captures the conflicted feelings of some FDA employees. Many believe that political and corporate interests wield too much influence when the agency is considering the value and marketability of medical devices.

According to a story in the Minneapolis Star Tribune, some employees feel pressured to approve devices despite misgivings they might have about their safety.

Survey participants were asked, “Have you ever been pressured to approve or recommend approval for a device or product despite reservations about the safety, efficacy or quality of the product?” One in 4 said yes.

The results were decidedly more cynical than a similar poll in 2006. At that time, most employees of the FDA’s Center for Devices and Radiological Health trusted agency leadership and felt it was headed in the right direction.

This time around, as the Star Tribune reported, “dozens of employees reported experiences in the past year where they believe the medical device industry hurt public health by withholding information or by forcing changes in FDA policy.”

Dr. Jesse Goodman, chief scientist and deputy commissioner for science and public health, applauded the growing worker confidence to be candid, then undercut the survey’s message by saying that the survey’s response rate was low enough to make “definitive conclusions difficult.”

But maybe he did get the message. He also told the Star Tribune that some things in the survey "should still concern us. … some scientists still fear retribution for sharing concerns about the FDA. Some believe that business interests frequently influence science-based regulatory decisions."

UCS got responses from 997 employees across the agency—17 percent of those asked. Of the respondents, 158 worked in the center for devices.

Some respondents reported experiences within the last year in which they lacked complete scientific data to make conclusions about outcomes for devices seeking approval.

In addition to expressing concern about undue influence for approvals, some survey participants called into question the FDA’s ability to monitor the performance of medical devices once they were on the market. Again, 1 in 4 said they lacked confidence that the FDA had enough authority to assure patient safety for available devices. Many members of the medical profession share this concern.

"When inappropriate influence clouds scientific judgment at the FDA, public health and safety suffer," said Francesca Grifo, director of the Scientific Integrity Program for UCS.

To voice concern about malfunctioning medical devices and for guidance where to register your beliefs about the process, visit the website of the Consumer Union’s Safe Patient Project.

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March 15, 2012

Drug Company Payments to Doctors—To Whom, How Much and for What?

ProPublica, a nonprofit enterprise that conducts investigative journalism in the public interest, continues to build its database of medical industry payments to medical professionals and health-care institutions. It’s a fine resource for anyone seeking to know the extent of the medical back-scratching that used to occur only outside the bright glare of transparency.

As we explained a few months ago,“Dollars for Docs” tracks payments from drug companies to care providers for things like speaking fees and drug promotions. As explained on the ProPublica website, thanks in part to a legal settlement, these sweet deals now must be posted on company websites. As of this writing, 12 companies are participating. By federal law, all companies must make these reports by 2013, and the information will appear on a government website.

ProPublica’s database is updated regularly. Consumers can mine information about their physicians, their state or other topics that can signal science-advancing research or potential conflicts of interest.

Here are a few things we found recently about company payments to doctors in Maryland:


  • From the first to second quarters of 2011, Cepahlon paid Dr. Mohamed Al-Ibrahim of the SNBL Clinical Pharmacology Center of Baltimore $1,498,675 for clinical research.

  • From the second to fourth quarters of 2009, GlaxoSmithKline paid Dr. Ralph V. Boccia of Bethesda $129,400 for speaking fees.

  • From the first to second quarters of 2011, Cephalon paid Dr. Bruce Cheson of Rockville $11,133 for travel expenses.

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February 10, 2012

Honesty with Patients Is Optional with Some Doctors

A large survey of doctors published in the prestigious journal Health Affairs finds that while physicians generally subscribe to the idea that honesty is the best policy, they don't always practice honesty with patients, especially when it conflicts with their self-interest.

The article by Lisa Iezzoni, MD, of Harvard Medical School and others, says:

[A]pproximately one-third of physicians did not completely agree with disclosing serious medical errors to patients, almost one-fifth did not completely agree that physicians should never tell a patient something untrue, and nearly two-fifths did not completely agree that they should disclose their financial relationships with drug and device companies to patients. Just over one-tenth said they had told patients something untrue in the previous year.

The authors conclude:

Our findings raise concerns that some patients might not receive complete and accurate information from their physicians, and doubts about whether patient-centered care is broadly possible without more widespread physician endorsement of the core communication principles of openness and honesty with patients.

In 2013, patients will be able to look up data on their doctors' financial ties with drug and device manufacturers, thanks to the new Affordable Care Act. Tentative regulations setting up the reporting system were published in December by the Food and Drug Administration.

As the New York Times' Robert Pear reported recently, researchers have found that payments can influence doctors’ treatment decisions because they steer patients to more expensive drugs and medical devices.

First published on Technorati.

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January 24, 2012

Conflict of Interest Strikes Again at the FDA

On his GoozNews website, journalist Merrill Goozner recently tackled the decision by Health and Human Services Secretary Kathleen Sebelius to overrule FDA scientists and ban the sale to minors of the over-the-counter morning-after contraception pill. He noted that opponents called it a blatant political move by the White House to woo social conservatives.

It’s part of a pattern, Goozner suggests, that Capitol Hill pols might be influencing other FDA decisions. To wit: the agency’s appointment last month of at least three scientists to a drug safety advisory committee charged with reviewing birth control products made by Bayer. The scientists, it seems, had financial ties to Bayer. The FDA did not disclose their connections, as reported in an investigation by BMJ and the Washington Monthly.

The committee recommended that Bayer’s problematic birth control pills (sold as Yaz and Yasmin) remain the market despite the FDA’s own reports of dozens of deaths from blood clots. (We recently wrote about Bayer’s questionable marketing efforts for the troubled drug.) The tsunami of lawsuits filed against the company weren’t compelling to the committee, which, Goozner reported, said the benefits of having another birth control option on the market outweighed the risks.

The committee vote was controversial from the start; we’d go as far as to call it hypocritical.

Before the meeting, Goozner noted, the FDA ruled that the committee’s usual consumer representative, Dr. Sidney Wolfe from Public Citizen, couldn’t participate because he had publicly called for banning the drugs. The agency also refused to distribute a legal/scientific brief prepared for plaintiffs’ attorneys by Dr. David Kessler, who once headed the agency, because it said he submitted it too late. Apparently, punctuality is more important than patient safety.

Goozner draws the smelly political connection in referring to U.S. senators who introduced legislation last year relaxing the FDA’s conflict of interest policies. “The ostensible goal?” Goozner asks. “To speed up the review of medical products. That legislation followed statements by the FDA Commission[er] Margaret Hamburg that the agency was having difficulties finding people without conflicts of interest to serve on its 55 committees.”

Conflict of interest laws can be suspended if the agency needs a particular person’s expertise; it grants a waiver provided the conflict is disclosed to the public or if it is deemed too minor to affect someone’s judgment. But the price of compromised judgment is not quantified.

Goozner says that U.S. universities, research institutes and private practices yield a large resource of nonconflicted experts who are “just as knowledgeable as people who sign consulting deals with industry. Moreover, eliminating the whiff of impropriety that appointing scientists with conflicts of interest brings would maintain the public’s faith in the integrity of the process, even if the appointee swears up and down that is or she isn’t biased by the relationship.”

When political expedience compromises patient safety, it’s no longer grist simply for Beltway chatter. As one practicing cardiologist quoted by Goozner said, “Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process.”

Goozner isn’t the only prominent critic of the FDA’s shady process. As noted on AboutLawsuits.com, the Project on Government Oversight wrote a letter requesting that a new meeting about Yaz/Yasmin be held.

We join this chorus of voices for competence and transparency in government -- especially when it concerns the public's health.

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January 2, 2012

Unnecessary Testing Happens When Doctors Own Medical Equipment

When a diagnostic test result is negative, usually it’s cause for relief. But when the preliminary results of a study showed that nearly 9 in 10 MRI scans were negative, eyebrows were raised.

Not because the test results were questionable, but because of who owned the equipment used to conduct them. As described in a story on MedPage Today, the study, presented at a meeting of the Radiological Society of North America, involved patients who were sent for testing by physicians who had a financial interest in the MRI equipment.

It also showed that doctors with a financial stake in the device referred much younger patients for the test than those referred by practitioners who did not benefit financially from use of the imaging equipment.

It’s a pretty straight line from that set of data to conclude that docs with a financial interest in the medical device might be ordering unnecessary scans. So said the researchers. We have written about such conflicts of interest as well.

Increased spending on diagnostic imaging, one researcher noted, is due to several factors: imaging technology has improved, patients demand its use and clinicians are practicing defensive medicine (that is, ordering tests that might be of questionable need or usefulness in an effort to suppress lawsuits if somebody experiences an unwelcome outcome -- a concept that many of us challenge as more myth than reality). Two-thirds of the cost of imaging tests goes to the physician-owners, of whom only 1 in 3 is a radiologist. Hospitals and other providers get the rest.

That’s why the researchers decided to study whether nonradiologist clinicians who owned scanning devices were more likely to order imaging tests for, in this case, lumbar spine scans.

They reviewed charts for 500 such cases. Some of these patients were seen at a medical practice with a financial stake in the MRI and some were seen at one that did not. All scans were read by radiologists with no financial interest in the equipment.

They found no difference in the average number of lesions among scans that were positive (meaning that the severity of the problem was the same in both groups). The difference in the number of negative scans order by doctor-owners, however, was astounding. And the age difference in patients for that group was notable as well—they were more than seven years younger on average.

"We're not saying these studies are necessarily unnecessary, but when there's a clear difference between the scans ordered for these two groups, and the only difference is whether the [clinician] owns the scanner, that makes you think there's a tie," said one physician who served as an adviser on the research. "We're not sure if it's conscious or unconscious."
"Still," he said, "if the positives are the same, but one group has more negative scans, then at a minimum you have to wonder what the reason for ordering that scan is."

Yes, you do. You need, he said, stricter and more transparent information about scanner ownership. You need to re-examine federal Stark laws, which regulate physician self-referral of Medicare and Medicaid patients. Stark allows these programs to pay physicians for tests if the devices used are in their offices. You need, he said, to figure out ways to slow the growth of medical costs.

One way is to know whose pockets are lined when tests are prescribed that might not be necessary to solve a problem someone might not even have.

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November 9, 2011

Dining with Drug Reps Proves Unappetizing

As the saying goes, keep your friends close and your enemies closer.

Not that we know for sure that behavioral economist Dan Ariely considers pharmaceutical manufacturers “enemies,” but we know he’s onto their practices that are not exactly in the best interest of patients. He and a colleague recently had dinner with a few pharmaceutical sales representatives to find out the tricks of their trade, which is getting doctors to prescribe their companies’ drugs.

Trick No. 1: “One of [the reps] told us a story about how he was once trying to persuade a reluctant female physician to attend a seminar about a medication he was promoting. After a bit of schmoozing, she finally decided to attend – but only after he agreed to escort her to a ballroom dancing class.” A fine example of, Ariely says, if-you-scratch-my-back-I’ll-scratch-yours.

Trick No. 2: “[B]ring meals to the doctor’s office. … [O]ne office even required alternating days of steak or lobster for lunch in exchange for access to the well-fed doctors.”

Trick No. 3: “When the reps were in the physician’s office, they were sometimes called into the examination room (as ‘experts’) to inform the patients about the drug directly. And the device reps experienced a surprisingly intimate level of involvement in patient care, often selling medical devices in the operating room, while the surgery was going on.” (Comment by Patrick Malone: What's really shocking is that these sales reps have at most a bachelor's degree and a few weeks of training from their employers.)

So, Ariely asks, what should be done about this shocking insinuation of commerce into medicine? “[R]ealize that doctors have conflicts of interest. …[P]lace barriers that will prevent this kind of schmoozing, and keep reps from accessing doctors or patients.”

And have dinner with somebody else.

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November 7, 2011

Doctor's Conviction Goes Far Beyond Mere Malpractice

Propofol is a surgical anesthetic safely used only in a hospital operating room or a comparably equipped medical facility with continuous monitoring of the patient's heart rate and breathing. The idea of using propofol as a sleep aid in a private home, with a doctor occasionally looking in? Unthinkable, before Michael Jackson's death.

Now Dr. Conrad Murray has been convicted of manslaughter for his role in Jackson's death. Murray was supposed to be Jackson's personal doctor, a unique physician with only one patient, who was paid $150,000 a month by Jackson's concert agency to keep the singer healthy.

Medical malpractice occurs when a doctor violates basic patient safety rules and causes harm to a patient. But this was much worse. Dr. Murray was guilty not just of breaking rules, but of a fundamental conflict of interest. Apparently seduced by his large monthly salary, he threw his medical judgment out the window and let Michael Jackson wheedle him into dangerous and ultimately fatal behavior with powerful prescription drugs. If he had "just said no," like any ethical, responsible physician would have done, Jackson presumably would have shopped for some other doctor to supply him drugs. But then Jackson's death would have been on some other hands, and Murray would not be facing prison and loss of his medical license.

While this is a particularly egregious example, conflicts of interest are common in medicine, from unnecessary surgery to advocating drugs, surgical devices and other treatments based on the doctor's relationship with the drug or device manufacturer.

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October 24, 2011

Under Scrutiny, Orthopedic Device Manufacturers Cut Dough Flow to Surgeons

A review of money paid over three years from orthopedic device manufacturers to orthopedic surgeons is an eye-opening manual of influence-peddling at best and conflict of interest at worst.

A study published in Archives of Internal Medicine concluded that once surgeons were required to disclose these payments, they declined in both total number and amount. Also notable was the increase in the proportion of consultants with academic affiliations.

The study was prompted by the U.S. Department of Justice (DOJ), which in 2005 investigated payments to orthopedic surgeons by the five largest manufacturers of artificial hips and knees.

“There is ongoing discussion of physician relationships with the pharmaceutical industry and medical device manufacturers,” the study authors wrote. “Our objective was to use data made available by [the DOJ] lawsuit to describe the extent of orthopedic surgeons’ financial relationships with implant manufacturers.”

The study defined the number of surgeons receiving payments and the amounts paid, comparing that data in the years before, right after and a couple of years after the DOJ settlement with the manufacturers in 2007.

In 2007, the manufacturers paid 939 orthopedic surgeons more than $198 million. In 2008, they paid 526 surgeons more than $228 million, but this figure includes $109 million in royalty buyouts from one company.

When limiting analysis to only the three companies that reported data for all four years, the authors found that the average payment by device makers per surgeon was $212,740 in 2007, $193,943 in 2008, $246,867 in 2009 and $233,108 in 2010.

But the proportion of surgeons receiving payments who had academic affiliations increased from fewer than 4 in 10 in 2007 to more than 4 in 10 in 2008. A similar pattern was seen in 2009 and 2010 for the three companies that continued disclosing payments by choice.

Of course, without mandatory disclosure, who knows how much was paid to whom. The authors concluded, “There is a need for clearer specific requirements for disclosure to allow for meaningful long-term analyses to be performed.”

In an accompanying commentary titled "Industry Payments to Physicians," Dr. Robert Steinbrook of the Yale School of Medicine analyzed the study findings. “Unfortunately, the public data provide no information about how the payments relate to research and device development, the choice of hip or knee implant or other aspects of patient care,” he said.
“The disclosure of industry payments should not divert attention from the real issues with regard to conflict of interest. These are the minimization or elimination of financial ties between physicians and industry in areas other than research support, bona fide consulting related to basic and clinical research, and legitimate payments related to intellectual property.”

“In the United States, the rules regarding the disclosure of industry payments are about to change,” Steinbrook notes. “With mandatory disclosure of payments and amounts imminent, there should be many new opportunities to better control conflicts of interest in medicine.”

Here, here.

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October 9, 2011

The Award for Most Fear-Mongering Health Care Statement of the Year ...


... goes to Skip Lockwood, head of a prostate cancer advocacy group called Zero. When the US Preventive Services Task Force recommended against routine screening of men with the PSA blood test, Lockwood said the PSTF's advice "condemns tens of thousands of men to die this year and every year going forward..."

Prostate cancer kills about 30,000 American men a year, so if Lockwood is right, that means the PSA test would have prevented MOST of those deaths. If it was that obviously beneficial, why would so many doctors and health care leaders have such doubts? Last year, in a less publicized statement based on the same research studies, the American Cancer Society also pulled the plug on its advice for screening with the PSA test.

The fact is that fears of just this kind of over-the-top reaction caused the PSTF to delay its advice for two and a half years after definitive studies came out from Europe and the US showing that PSA testing just doesn't do the job of putting any measurable dent in the death rate from prostate cancer. The PSTF was cowed by the blowback to its last big recommendation: that the numbers don't justify routine mammograms for women in their 40s.

PSA testing has generated a billion dollar industry of urologists doing surgery on men, with high rates of impotence and incontinence in their wake. At the risk of making a bold statement in the opposite direction of Mr. Lockwood's, it's almost malpractice now to put men into routine prostate cancer screening when the odds are much greater for harm than help.

Even the inventor of PSA testing came out last year against its routine use in low-risk men. The test is best reserved for high-risk men who need monitoring after they've already had prostate cancer and need to know if it's coming back.

But don't try to confuse the advocates with scientific facts. They'd rather play on emotions.

Article first published as The Award for Most Fear-Mongering Health Care Statement of the Year ... on Technorati.

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September 18, 2011

Dollars for Docs: Learn How the Big Bucks Flow from Drug Manufacturers

In 2013, by law all drug and medical-device companies will be required to report to the federal government how much they spent promoting their products. It’s a long-overdue effort to shine a cleansing light into the murky closets of Big Pharma.

The figures will reflect not only expenses for advertising but fees for doctors who are paid to speak about their wares in what are often described as "educational" seminars.

Until 2009, such pharmaceutical company payments were not disclosed. But the enormous sums came to light under pressure from lawmakers or as a condition for settling federal whistle-blower lawsuits. Some companies have reported the first full year’s payments, and thanks to the stark comparisons of how much they paid, some appear to be tightening their purse strings.

As described in a series of articles by the investigative service Pro Publica, this world of conflicting interests is wide and deep and soon to be accessible to any patient who wants to check up on the professionals who treat them.

In its recent gob-smacking dish, Pro Publica reports that eight pharmaceutical companies, including the nation's three largest, doled out more than $220 million last year to promotional speakers for their products. Industry leader Pfizer, with drug sales of $26.2 billion last year, spent $34.4 million on speakers, ranking third among the eight companies. Eli Lilly and Co. spent the most on speakers, $61.5 million, and had about half the sales of Pfizer.

The data about payments to health professionals in 2010 published by Pro Publica also includes information about expenditures for travel, meals and other perks that encourage people to think nice things about the companies that make their lives so comfortable.

Some companies have reduced their doctor-payment budgets since disclosure has become common. Cephalon paid physicians nearly $9.3 million in 2009 for speaking and consulting, and $5 million last year. AstraZeneca cut speaker spending from about $22.8 million in the first half of 2010 to about $9.2 million in the second half.

And, no surprise, some physicians have reduced their shill-for-pills work in the bright light of public disclosure. One pulmonologist was paid at least $88,000 for promotional talks on behalf of GlaxoSmithKline in 2009, but last year she declined the work out of concern that patients would think her advice was tainted.

And that’s the bottom line for patients: Can you trust the advice or treatment of someone who is paid by companies whose products are vying for a role in your care?

Like the hematologist who was paid $49,250 from Cephalon in 2009, and $177,800 (plus $35,500 for travel) in 2010? Is it any wonder that he didn’t return calls from Pro Publica’s reporters?

One pain specialist who spoke and consulted for four companies has earned $522,113 since 2009. In a companion commentary published in the Los Angeles Times, the Pro Publica reporters noted that this anesthesiologist’s slides identified him as the director of pain management at a well-known urban hospital. But that hospital’s spokesman said the physician has never held that title and that his pain clinic is not part of the hospital, even though he does have admitting and treating privileges.

He didn’t return calls either.

Maybe the poster girl for questionable behavior courtesy Big Pharma is Dr. Christiana Goh Bardon, who, as Pro Publica reports, “runs a hedge fund in Boston that bets on the rise and fall of health-care companies. She was paid nearly $308,000 to ‘provide input on our BioTherapeutics business development plan,’ Pfizer spokeswoman Kristen Neese wrote in an email.

“Bardon, who started her hedge fund after her Pfizer contract ended, was required to sign a confidentiality agreement and not allowed to invest in Pfizer or any of the biotech companies that Pfizer was looking at acquiring or partnering with for projects, Neese said.

“Bardon said in a voice-mail message that she does not currently practice as a physician and her work was based on her business acumen.”

From a patient safety point of view, business and medicine do not make a happy marriage. It’s in patients’ best interest to know who and what are influencing their doctors’ decisions. Until 2013 when all companies post their payments for your review, ask your doctor if he or she is being paid by pharmaceutical or device manufacturers. If you’re prescribed a drug, ask if there’s a generic or older version available, and if it has more side effects than a competitor’s drugs.

You can also review your state’s medical licensing board website for disciplinary or criminal issues your physician might have had.

To see if your physician has been on the Big Pharma payroll, search the Pro Publica database called Dollars for Docs at http://projects.propublica.org/docdollars/.


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July 25, 2011

Beware Drug Companies that Pretend to Be Your Social Media Friend

Technology is a wonderful thing. Most of us rely on it to do our jobs, remain informed, communicate and plan and participate in recreational activities.

But like a wonder drug that can render a dread disease a manageable irritant, technology has side effects and some of them are dark, indeed. Writing on his health news blog, Gary Schwitzer recounts the ominous tale of a pharmaceutical company's sly efforts to pretend to be a Facebook friend but whose motives were clearly mercenary.

Marilyn Mann is a well-informed medical consumer; she has to be, she's a breast cancer survivor whose daughter has heterozygous familial hypercholesterolemia (FH), a genetic disease that elevates LDL cholesterol to dangerous levels. She is an administrator of a Facebook group--Familial Hypercholesterolemia (FH) Discussion Group--that enables networking for people with FH and their family members.

Schwitzer reports that recently, Mann got a message from a public relations woman who had joined the Facebook page: "A few months ago, I had emailed you about some research I was doing about a new treatment for FH. I am now working with a pharmaceutical company, and the company currently has a drug in development to help treat people with severe FH that may not be responding to current therapies."

The PR woman continued: "I am trying to do exactly what you are doing--to educate patients and physicians about this disease and to raise awareness so that undiagnosed patients can get the help they need. ... I thought it might be good for us to connect so that I can explain to you a little about what the company is doing and to see how we can work together to reach a larger audience. Through my work in FH, I am regularly in touch with many of the world's leading researchers and the people who work at the company to discuss ways we might be able to collaborate...."

On its face, the approach was friendly and compassionate. Mann spoke with the PR woman, who disclosed that she was working for Genzyme, the company developing the drug to treat FH. The woman wanted Mann to recruit journalists to generate stories about people with FH.

Mann politely declined, saying, "Genzyme's purpose is to sell their products. My purpose is to help patients. Those two goals are not the same."

Not only was the PR person actively trying to manipulate the news--there's a difference between raising awareness about a disorder most people never heard of and working to ensure your employer has skin in the game--but her behavior could be seen as a form of electronic stalking. "I think it was creepy for this PR woman to join the Facebook page,"Mann told Schwitzer, "lurking there and observing on behalf of her drug company client. The idea of having a drug company planting human interest stories in the press is yucky ...a big corporation pulling string behind the scenes. I'm not interested in being used in that way."

As the informed person she is, Mann knew about the Genzyme drug, believed it had limitations based on trials and so informed the PR person.

The PR rep had clearly identified herself, her employer and the nature of her interest in the Facebook community. So why was her attempt to exploit it so unseemly?

As Schwitzer noted, it wasn't just the attempt to join a discussion group because of its potential usefulness for a certain company, it was the attempt to influence news coverage that that was so offensive. Whether you're voting for your local school board, signing a legal contract or making a determination about treatment for a medical condition, you need objective, complete information. Such decisions aren't made by listening to feel-good human interest stories.

Genzyme intended its FH drug not as first-line therapy, but as an additional treatment for people whose cholesterol is not controlled with a statin. Typically, those patients have the most severe forms of FH. It is their stories Genzyme wants the media to tell, not those of people who can control their cholesterol with a statin--they don't need another drug.

Schwitzer says tactics like those of Genzyme might fall under the category of "disease mongering," an effort to "sell" sickness by profit-driven interests beyond the boundaries of what science and medicine accept. The subject is well covered in PloS Medicine by writers Ray Moynihan and David Henry. The point, they say, is to sell products, not to inform, educate or otherwise help medical consumers understand and maintain their health.

If you're a member of a medical-topic social media group, be aware that sometimes a fox gains entry to the henhouse with very little commotion. If you're asked to tell your story, or to find other people who will, make sure it's for the greater good, and not just somebody's bottom line.


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July 18, 2011

The Difference between Pharmaceutical Research and Marketing Blurs Yet Again

The road from conception to useful application for a new drug therapy, when properly navigated, is fully mapped, carefully followed, scientfically rigorous and honestly appraised. Not so with a big study of the lucrative drug Neurontin, according to Yale researchers.

In the case of Neurontin, a drug to treat epilepsy, critical parts of that journey took a few unauthorized detours, according to a report in the Archives of Internal Medicine.

Researchers at the Yale School of Medicine reviewed documents relating to the epilepsy drug gabapentin, a drug patented as Neurontin by Pfizer in 1994, that they concluded were misrepresented by the pharmaceutical company as a clinical trial.

Instead, they said, it was a “seeding trial,” which they described as “An important and expensive form of marketing, … a study of an approved drug or device in which the primary objective may not be to answer an important scientific question but rather to introduce a new product and induce clinicians to use it.”

In other words, seeding trials juice the market by enticing practitioners to sample and prescribe a drug that’s already FDA-approved.

Joseph Ross, M.D., said that Study of Neurotonin: Tritrate to Effect, Profile of Safety (STEPS) “was a seeding trial posing as a legitimate scientific study. The trial itself, not trial results, was part of a marketing strategy used to promote gabapentin and increase prescribing among investigators without informing trial patients or investigators."

As noted in the Los Angeles Times, the STEPS study also was intended to fend off efforts by a competitor to introduce a rival drug.

The breach wasn’t against the law, but it wasn’t ethical because the purpose was primarily to promote, not to discover, and because trial participants and physicians might be unaware of the studies’ true purpose.

The Yale team said STEPS’ stated purpose was to examine doses of gabapentin within a patient population of 2,759. Two articles about its results were published in scientific journals, but, the team noted, outside sources had questioned the study’s design as uncontrolled (that is, it didn’t include a separate, or "control," group of participants who didn’t receive the drug). In addition, it was not a blind study. Scientific rigor demands that study participants remain unaware—blind—about whether they are receiving a drug or a placebo (fake drug).

There's more. The Yale team said, "Data quality during the study was often compromised," and some documents appeared to suggest that marketing personnel helped to collect data and witnessed the trial, not just the results.

Article first published as Neurontin Research Was So Flawed It Deserved to Be Called Marketing, Not Science on Technorati.

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June 30, 2011

The Going Rate for Compromising A Surgeon's Principles and Patient Safety: $16 Million

That's the sellout price for a spine surgeon. Give or take a few million.

Like police officers, whose thin blue line separates them from “the other,” medical researchers and doctors are loath to diss their fellow professionals. But this week, the code of omerta was breached with a series of critical reports in The Spine Journal about industry-sponsored research in general and the use of a bone growth product in particular.

As noted in the New York Times, “It is extremely rare for researchers to publicly chastise colleagues, and editors of leading medical journals said they could not recall an instance in which a publication had dedicated an entire issue for such a singular purpose.”

At the center of attention is Infuse, a product manufactured by Medtronic that’s used in more than 100,000 spinal fusion surgeries in the U.S. each year to encourage growth of new bone so the spine fusion "takes." The Spine Journal articles claimed that researchers subsidized by Medtronic exaggerated the benefits of Infuse and minimized the risks.

All surgical procedures and all medical products carry some element of risk, large or small. Dumbfoundingly, some of Infuse’s defenders claimed it had no risk. None. Zip. Nil. Uh-huh, and I’m vacationing next month on Jupiter.

In a joint editorial, five doctors wrote, “It harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research.”

Objective research and the “do no harm” vow apparently have their price, and for some of the so-called “scientists” championing Infuse, it is $12 million to $16 million—the median amount collected by researchers from Medtronic. Median. That means half got more. Clearly, for Medtronic, corrupting science is a good investment: In the most recent fiscal year, Medtronic earned an estimated $900 million from Infuse.

Infuse was approved by the FDA in 2002 for one type of spinal fusion, and as required, Medtronic reported complications in its use that the agency considered sufficiently significant to require the company to list them on the product label. But, as the New York Times explained, “in reporting on such studies in 13 medical journal articles published during the last decade, researchers whose studies were paid for by Medtronic maintained that Infuse’s use was not tied to any complications.”

In addition to its approved use, Infuse is used for other spinal procedures. The Justice Department, however, has been conducting a criminal investigation to determine whether Medtronic illegally promoted such off-label uses, which the company denies.

At this point, Medtronic's credibility, and that of the people who speak for its scientific authority, is thin.

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June 23, 2011

What doctors are paid and how it affects your care

Chances are, you or a family member has been the beneficiary of a freebie from the doctor’s office, and we don’t mean a cherry lollipop when the kids got their tetanus booster. We’re talking drugs, often of the prescription variety, that a pharmaceutical representative has left after a marketing visit to the doctor’s office. "Samples," they're called.

We've covered the dangers and the hidden costs of "samples" for both doctor and patient previously in this blog, Today's topic is a little broader: the many tentacles of the pharmaceutical industry that reach into the doctor's office and that can affect the care you and your loved ones get. More specifically, there is a possible pay-for-play attitude that’s harder for doctors to resist as medical costs continue their upward thrust and doctors say they feel increasingly marginalized.

In “Doctor Compensation and Industry Influence,” writer Ed Silverman notes that “The ongoing controversy over financial ties between physicians and the pharmaceutical industry centers, of course, on concerns that medical practice may be unduly influenced,” and that doctors are indignant that people could believe their medical judgment would be influenced by swag. But many doctors are unhappy with their compensation, citing costly and lengthy education and training, stressful and protracted relations with insurance companies, rising malpractice insurance premiums and patients armed with an Internet medical degree and questions about diagnoses and treatment.

There’s a lot going on here, and although much of doctors’ dissatisfaction is righteous, it’s unfair for them to expect patients to:

be sympathetic about the costs of an education they chose to pursue;
suffer their ill will in the face of greedy or incompetent insurance companies; and
simply accept that mistakes will be made and that retaining legal counsel is disloyal and unfair.

And it’s just flat-out arrogant and dismissive for physicians to prefer patients who never ask questions, who aren’t invested in their own health care and whose default is to defer to the guy in the white coat because he’s over-educated and underpaid. That’s not good for the patient or, ultimately, the practice of medicine.

A recent survey by Medscape, “Do doctors earn enough?”, generated a robust response within the medical community, and not necessarily for the numbers report (orthopedic surgeons and radiologists earn the most--$350,000 median income—and pediatricians the least-- $148,000 median), but for the ancillary issues.

Responding to the survey in “Mo money mo problems,” physician Sean Pannick drew a line of clarity for parties on both sides of the worth issue: “Doctors should look at their income and ask themselves--and their patients--whether it fairly reflects the quality of their work. Patients, on the other hand, also need to be mindful of the financial component to the doctor-patient relationship. They may not know (or want to know) that money matters when it comes to doctors, who often profit more from a series of tests and procedures than a simple clinical assessment. Conversations in the consulting room already mask a number of hidden agendas, and the issue of renumeration (sic) is another one that lurks beneath the surface.”

Absent a truly malfeasant practitioner, the quality of care a patient receives from his or her doctor probably isn’t influenced markedly by occasional, reasonable attention from members of the medical industrial complex with something to sell. But it might be affected by the efficiency of ordering a test over the harder work of having a conversation.

It is your duty to yourself and your loved ones to get the best possible care, and that means asking questions. If you wonder if your doctor has gotten paid to represent a medical product or service, ask. If you have read something on the Internet that might relate to the problem you’re presenting in the exam room, broach the subject. If your doctor is too busy, distracted or feeling too undercompensated to engage, it’s time to go doctor shopping.

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March 11, 2011

"When you're a hammer, everything looks like a nail"

Yet more evidence that expensive technology drives treatment decisions in medicine: A new survey of prostate cancer treatment shows that once a hospital invests the $1 million to $2.5 million it takes to get a surgical robot, men in the area start to get a lot more prostate removal surgery than they otherwise would.

Although heavily marketed, robotic surgery has never been proven to reduce the two big risks of prostate removal: incontinence and impotence. And each surgery with a robot is about $2,000 more expensive than those done the traditional way.

An excerpt from a New York Times piece on the new study:

One reason for the increase in operations in hospitals that own a surgical robot may be that the technology helps a hospital lure potential surgical patients away from the competition. But the data also suggest that once a hospital obtains a robot, patients who might be candidates for nonsurgical options are more likely to be steered toward robotic surgery instead.

“This may be the medical embodiment of the phrase, ‘If you’re a hammer, everything looks like a nail,’”said the lead study author, Dr. Danil V. Makarov, assistant professor of urology at New York University’s Langone Medical Center. “If you have the technology, it will get used.’’

...

“If you’re a hospital and you get a robot, clearly you want to use it,’’ said Dr. David Penson, a study co-author and director of the Center for Surgical Quality and Outcomes Research at Vanderbilt University. “There are some real pressures here that have nothing to do with science,” he said. “We have this interplay of patients’ fascination with technology coupled with business interests on the part of the hospital and device makers, pushing people to try a new technology perhaps before it’s been fully tested.’’

And here's a good bottom line point for patients, also from the Times article:

“For patients, there are a lot of choices in prostate cancer,’’ said Dr. Makarov. “Knowing that technology can influence both what they want and what their physician may advise them should make them a little more skeptical and maybe make them ask a few more questions.’’

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February 19, 2011

Medical Malpractice in Breast Biopsies

Most breast lumps found in women need to be looked at under the microscope to make sure they're not cancer. But new research says too many women are getting unnecessarily aggressive open biopsies, which produce a scar, when most of them could get enough tissue for sampling with a simple needle stick.

About 1.6 million breast biopsies are done every year in the United States, with about 200,000 of those resulting in a diagnosis of invasive cancer, which requires more treatment. That means that about seven in eight women who undergo biopsy receive the good news of no cancer (or the pre-invasive diagnosis of ductal carcinoma in situ).

Needle biopsy is the gold standard for the initial investigation of most suspicious breast lumps, except for those that a needle cannot reach. It can be done with numbing local anesthetic and a quick needle stick, which sometimes needs to be guided by x-ray imaging when the lump cannot be felt. In that case the needle biopsy is done by a radiologist, not a surgeon.

An open biopsy requires a one-inch incision, which leaves a scar, and must be done with either general anesthesia or sedation. It costs about twice as much as a needle biopsy, both for the surgeon's fee and the hospital's fee. And that could be the economic motivator for the persistently high rates of open biopsies still done in the U.S., according to researchers.

The new study of breast biopsies in Florida found that three in ten were done by the more expensive and scarring open technique, when the rate should be less than one in ten.

A New York Times piece on the new study quoted Dr. Melvin J. Silverstein, a breast cancer surgeon at Hoag Memorial Hospital Presbyterian in Newport Beach, Calif., as saying it was “outrageous” that 30 percent of breast biopsies were done by surgery. The article went on:

He said some of the unnecessary procedures were being performed by surgeons who did not want to lose biopsy fees by sending patients to a radiologist.

“I hate to even say that,” Dr. Silverstein said. “But I don’t know how else to explain these numbers.”

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January 20, 2011

Hype Busters: Helping You Get Better Health Care

An overdose of news media hype has long been a problem for consumers who want high quality health care but don't want to bounce from health fad to health fad. Naive and uncritical journalists who write about health care issues are a huge source of the hype overdose. So it's great to learn about a Web resource that systematically and thoroughly reviews health news and rates the quality of the stories.

The site is the somewhat stodgily named HealthNewsReview.org. With a foundation grant, it employs a team of medical journalists and physicians to critically review health news in major publications. The stories get rated on a scale of one to five stars, based on how well the following issues were addressed:

* What's the total cost?
* How often do benefits occur?
* How often do harms occur?
* How strong is the evidence?
* Is this condition exaggerated?
* Are there alternative options?
* Is this really a new approach?
* Is it available to me?
* Who's promoting this?
* Do they have a conflict of interest?

The site says its goal is: Holding Health and Medical Journalism Accountable. And it lives up to that by naming names and taking no prisoners on current health news.

A recent Wall Street Journal piece that suggested Vitamin B12 as a potential cure-all got a low two-star rating for putting out a series of unsubstantiated claims with loose anecdotes and little evidence.

A Denver Post article on an "anti-gravity treadmill" scored a lowly one star for glorifying an unproven product.

NPR and CNN Health scored highly for their well done columns on the recent research about antibiotics for kids with middle ear infection.

I give the site five stars for being a very useful resource. It asks the right questions about medical news and gives straight answers. I'm particularly keen on conflicts of interest and other things that tend to get underplayed in much coverage: for example, the hidden harms of touted new medical devices.

Article first published as Hype Busters: Helping Patients Get Better Health Care With a Dose of Skepticism on Technorati.

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November 10, 2010

Maryland Hospital Pays Feds in Cardiac Malpractice Scandal

St. Joseph Medical Center in Towson, Maryland will pay $22 million to the federal government to settle claims that it engaged in a decade-long, illegal kickback scheme with the cardiology group MidAtlantic Cardiovascular Associates, which was co-founded by Mark G. Midei - the cardiologist accused of performing hundreds of unnecessary heart procedures.

More than 100 patients have filed malpractice lawsuits against the hospital and Midei. He was taken off duty in May 2009 under suspicion that he had falsified patient records to justify unneeded stent procedures.

Dr. Midei filed a suit against St. Joseph last month in which he said that officials there ruined his reputation by warning nearly 600 patients about his work. He denies all allegations against him.

Read more in the Washington Post article here.

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October 11, 2010

"The Mammography Wars" and Doctors' Conflicts of Interest

It was nearly a year ago that the U.S. Preventive Services Task Force caused a huge uproar with the mildest imaginable recommendation about mammograms, and now two physician researchers say it might be time to point out that certain emperors are wearing no clothes.

In their Sounding Board article in the New England Journal of Medicine, Drs. Kerianne Quanstrum and Rodney Hayward note that some of the harshest cries against the Preventive Services Task Force came from those doctors with the highest vested self-interest in maintaining the importance of mammograms: radiologists with the Society for Breast Imaging. Yet nobody seemed to notice the obvious conflict of interest.

As the authors note:

When a given service is successfully extended to more people with more intensity, the profession providing that service tends to grow in importance and profitability. In the United States, where medical specialists often enjoy an exalted status in the minds of the public, if experts shout loudly that every woman 40 years of age or older must be screened annually for breast cancer, then breast cancer must be important, screening must be a basic human right, and doctors who provide this service must have great value and authority.

But what if those experts are basing their recommendations on more than the interest of patients alone? In any other industry, we accept the idea as natural that those providing a service or product hold their own and their shareholders' interests as a primary objective. Why have we failed to acknowledge that the same phenomenon occurs in health care? Although it is true that individual medical providers care deeply about their patients, the guild of health care professionals — including their specialty societies — has a primary responsibility to promote its members' interests. Now, self-interest is not in itself a bad thing; indeed, it is a force for productivity and efficiency in a well-functioning market. But it is a fool's dream to expect the guild of any service industry to harness its self-interest and to act according to beneficence alone — to compete on true value when the opportunity to inflate perceived value is readily available.

The objective facts, as Quanstrum and Hayward point out, are that the well known economics law of diminishing marginal returns applies in health care as much as anywhere. In mammograms, as the rareness of the tested condition increases, the hidden costs of the test goes up and the value goes down.

So for women between ages 60 and 69, you can save one life by subjecting only 400 women to mammogram screening (in the process of 5,000 screening visits and 400 false alarms in the same group over 13 years of follow-up). That's enough of a benefit to encourage everybody in the age group to get annual screening.

But in women between ages 40 and 49, the data show that to save a single life, you need to subject 1,900 women to screening and endure 20,000 screening exams with 2,000 false alarm tests during eleven years of follow-up. That puts the risk-benefit equation in more of a gray area where you cannot say definitely that no one should have it, or that no one should not have the screening.

And that was exactly the point of the Preventive Services' recommendation: To put the issue into the hands of individual doctors and patients and let them decide if family history or individual anxiety are enough to make the patient want to have the test. That's not a cop-out, it's a prudent bow to individual self-determination.

Here's another quote from Drs. Quanstrum and Hayward:

We must acknowledge that just as in any other profession or industry, self-interest is unavoidably at work in health care. Rather than even acknowledging practice guidelines offered by vested experts, we ought to borrow from the wisdom of sound governance and implement a system of checks and balances when it comes to the interpretation and application of medical evidence. At the same time, we need to recognize that these two tasks are distinct. Although the interpretation of medical evidence is (or ought to be) a scientific exercise, the application of that evidence, as in guideline formation, is ultimately a social exercise.

Decisions regarding practice guidelines can, and certainly should, be informed by evidence. But they will always require value judgments regarding how much evidence is sufficient to dictate care, for example, or whether and to what degree costs should be considered. By separating the processes of evidence review and guideline formation, fair disagreements about the quality or substance of the evidence can occur separately from, and before, disagreements about the implications for clinical care.


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June 10, 2010

Malpractice Suit Exposes "Ghost Surgery" at the Cleveland Clinic

Sometimes patients sign up for surgery with an experienced surgeon who then allows a doctor in training, with far less experience, to do the actual surgery. If this hasn't been disclosed up front by the surgeon and agreed to by the patient, the switcheroo is called "ghost surgery," and it's not acceptable. But exactly that has now occurred at the prestigious Cleveland Clinic, according to allegations in a new malpractice lawsuit reported by Diane Suchetka in the Cleveland Plain Dealer.

Retired Air Force Colonel David Antoon says in his legal complaint filed in court that he, his wife, and the surgeon, Dr. Jihad Kaouk, signed a consent form in advance agreeing that only Dr. Kaouk would do the surgery to remove Mr. Antoon's prostate gland. He alleges in the suit that he has been left incontinent of urine and sexually impotent as a result of Dr. Kaouk allowing junior doctors to do the surgery.

The patient also contends that the hospital ombudsman who investigated his informal complaints told him there was no such consent form in his records at the hospital.

Surgical volume is critically important to a good outcome for prostate surgery, as previously reported on this patient safety blog. The author of one study in the Journal of the American Medical Association said he didn't feel comfortable about his own competence with the "robot" device now widely used for prostate removal until he had had several hundred cases under his belt. So it's understandable why Mr. Antoon would feel outraged that his wishes weren't followed.

I discussed "ghost surgery" in my book, "The Life You Save." Here is my advice for how you can avoid having this happen to you:

First, have a good discussion with the surgeon about who is going to do the critical parts of your surgery. If you don't feel comfortable turning over those aspects of the surgery to a doctor in training, then say so.

Second, follow up by putting it in writing. One simple way to do so is on the consent form. It usually says something like "I authorize Dr. Jones and/or his designee to perform _____ [type of surgery filled in here] on me." All you have to do is cross out the phrase "and/or his designee" and initial your cross-out.

Third, if you're in a teaching hospital, you might want to consider some compromise that lets trainee doctors do the non-critical parts of the procedure. But you have every right to insist that only the experienced doctor do the delicate, critical work. If the surgeon resists your wishes, you may have to go to another surgeon.

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June 7, 2010

Why Is U.S. Health Care So Expensive?

A new report comparing the United States to other industrialized countries has a depressing list of all the ways that America outstrips other countries in money spent but lags behind in health quality results. For example:

* Per person, the U.S. spends twice as much on health care as on food, and much more than the average Chinese person spends on EVERYTHING. (See slide #1 of the interactive graphic of the McKinsey Global Institute report here.)

* "Branded" prescription drugs are 77 percent more expensive in the U.S., and because we use a more expensive mix of drugs than other countries (being quicker to adopt new and expensive drugs), the average spending on drugs per person is more than double other industrialized countries. (Slide #8.)

* We lag behind 22 other advanced countries in life expectancy but spend around $650 billion more per year than our population's mix of health conditions would predict. (Slide #4)

* Administration costs -- paperwork, claims processing, etc. -- are on average five times more expensive in the United States. (Slide #9.)

* The care in the U.S. is much more intense than elsewhere -- more expensive surgical procedures, more diagnostic tests, but we spend less on prevention than elsewhere.

* We also are shifting more to outpatient care instead of care with overnight stays in hospitals, but that has not cut costs. The outpatient care is much more profitable for providers than inpatient care, and it tends to be more intense.

The New York Times did some arresting graphics on the McKinsey report. Click here to see them. Note that the U.S. appears as a red dot, "peer" European economies like Germany and the UK are yellow dots, and other industrialized countries are gray dots.

The red dot never wins on these graphs -- except on expense.

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June 1, 2010

Conflicts of Interest: Not Bad People, Just Human

Recent news on this blog about unnecessary heart stents in Baltimore and overly complex back surgeries across America may give some readers the wrong idea. This malpractice and patient safety blog is not about good versus evil and picking a doctor to trust because you decide he or she is a "good" trustworthy person. Instead, it's about recognizing that doctors are human too and are subject to the same self-interest as the rest of us -- and this can subtly tilt them to make recommendations for treatments that may not really help us.

I was struck by this when reading a letter to "The Ethicist" column in the New York Times Magazine. The writer was a husband whose wife had been told she needed a CT scan, and the doctor sent her to a radiology lab that he owned. The husband said: "I'm OK with this lab -- I say you either trust the specialist or you don't -- but my wife is not so sure."

Columnist Randy Cohen responded by quoting bioethics professor Katie Watson of Northwestern University:

"I trust my physicians not to be criminals who intentionally order unnecessary tests to feed their yacht habits. I also trust them to be human beings, which means they're vulnerable to subconscious influences and incentives just like the rest of us."

That's exactly right.

This is not to excuse those doctors who create conflicts of interest for themselves that they could easily avoid. There's no reason to buy a CT scanner for your office when there are plenty of others available.

Nor is it to excuse the doctor for failing to disclose up front to the patient that he has an ownership interest in the imaging machine. Patients shouldn't have to cross-examine their doctors to get this basic information.

But it is to say that patients need to learn how to be sophisticated consumers of the medical industry. This is not a question of "do I trust or don't I?" And it's not a matter of trading naive trust for paranoid suspicion. It's just to recognize that we're all human, and that the medical industry unfortunately has many built-in conflicts of interest for doctors that require patients to look out for themselves when it comes to getting sound medical advice.

So ask lots of questions, do your own research, and get second and third opinions. You'll be healthier for it.


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May 28, 2010

Surgery for Back Pain: Less Is More

Nearly every week, I hear about a patient who had surgery to relieve terrible chronic back pain and ended up far worse off than before. One of the biggest problems is that money motivates surgeons to talk patients into much bigger and more complex operations than they really need -- and then those surgeries result in predictable complications.

The greed allegation sounds a bit harsh, but it comes straight from the top: The Journal of the American Medical Association, in an editorial by a leading Stanford orthopedic surgeon, Eugene Carragee, and in a study carried out by a group of doctors at Oregon Health and Science University led by Dr. Richard Deyo.

The Oregon study found that the rate of complex surgeries for back pain in Medicare patients jumped by 15-fold over a recent five-year period, but there was nothing in the patient population -- like increasingly complicated back deformities -- to justify the increase.

Joanne Silberner of NPR reported:

Deyo says there's no reason to think people suddenly started developing the spinal deformities that justify the complex surgeries. He offers several possibilities for the upswing. "Many surgeons genuinely believe that the more invasive procedures offer some benefits," he says. "But certainly there are important financial incentives at play as well." Surgical fees for simple decompressions are about $600 to $1,000. The complex surgeries earn surgeons as much as 10 times more. He says another possible factor is the tendency for both doctors and patients to go for a new, more expensive approach just because it sounds better.

The problem is that the more complex surgeries carry at least double the risk of a bad outcome, according to the Deyo study.

Most back pain that isn't relieved effectively with medicines or other non-surgical therapies is caused by disk herniation or spinal stenosis. Spinal stenosis is growth of bone near a nerve coming out of the spinal cord which presses on the nerve root and causes pain to radiate down a leg. The vast majority of patients who need back surgery because of spinal stenosis can be benefited from a fairly simple lumbar decompression. This involves removing bone, ligament and facet joint material which is compressing the nerve root. This operation has a high degree of success as it's been developed over the last 20 years.

According to Dr. Carragee's editorial, if the patient also has some deformity of the spine -- front to back or side to side -- the simple lumbar decompression can result in spine instability with increased deformity, so those patients might need a fusion where adjacent vertebrae are fixed together with bone grafts. But even here, simpler techniques get just as good results than more complex procedures that add metal or other instrumentation into the back.

A very small minority of patients, says Dr. Carragee, have spines that are so collapsed and twisted that the spine is unbalanced and tilted forward and the patient has severe pain and poor quality of life. These are the patients who might qualify for the complex surgeries now being done so commonly. Techniques have improved in the last ten years, but the surgeries in these patients still carry a very high complication rate -- 30 to 40 percent. And a lot more patients are getting the complex, multi-level surgeries than is warranted by the medical evidence, according to Dr. Carragee and other researchers.

Consumer Reports has rated spinal surgery as No. 1 on a list of overused tests and treatments.

As quoted by NPR, Dr. Deyo said he would like his study to alter the practice of medicine. "The effect I would hope it would have is to have surgeons and patients choose the least invasive procedure that would accomplish the surgical aim," he says. But he's pessimistic about it, unless there's a change in the financial incentives.

This is yet another area of medicine where it pays for patients to be skeptical and to get multiple opinions. It fits our natural instincts to think that bigger and more elaborate surgeries have a higher likelihood of success, but the human body proves over and over that it prefers minimal interventions.

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May 23, 2010

Update on Baltimore Cardiac Malpractice: Victims of One Doctor Could Exceed One Thousand

The scandal of Dr. Mark Midei, the cardiologist at St. Joseph's Medical Center in the Baltimore suburb of Towson, Maryland, is scaling new heights in the number of victims counted. The hospital mailed letters to 585 Midei patients informing them that an independent review shows they may have received heart stents unnecessarily for artery narrowing that Midei grossly exaggerated. But now, according to the Baltimore Sun, many more patients are coming forward whose procedures were done outside the two-year arbitrary time limit the hospital set for its own review. It appears now that the total number of cases of unnecessary heart stents could easily exceed one thousand.

Read more here.

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May 22, 2010

Baltimore Medical Malpractice Scandal Shows Systemic Problems of Hospital Peer Review

Hundreds of patients appear to have received cardiac stents that they didn't need from Dr. Mark Midei, a cardiologist at St. Joseph's Hospital in Towson, Maryland. So why did no one at the hospital blow the whistle? And why did the patients not realize that Midei was rushing them into unwise and risky surgery?

Heart surgery is highly profitable, and there are no incentives for doctors or hospital administrators to rock the boat by raising questions when one cardiologist is putting stents into far more patients than his colleagues.

As for the patients, we Americans have a bias toward dramatic action. If one doctor tells us we need a stent to prop open the coronary arteries in the heart, and another doctor says all we need to do is take a pill every day, most of us will tilt toward the big intervention. Which can be a big mistake, because we then get a piece of metal permanently implanted in a blood vessel, and we have to take medicines anyway for the rest of our life to avoid getting blood clots from the metal that could cause a devastating stroke or more heart damage.

Recently in this blog, I pointed readers toward an excellent review by the Harvard Medical School of the scientific evidence on who should -- and shouldn't -- get the balloon and stent treatment for opening their heart arteries. Many studies have found that unless a patient is having repeated symptoms, the stent treatment does nothing to extend his or her life, even if an artery looks dramatically narrowed.

In the case of Dr. Midei, it appears that outright fraud might have been involved. You have to have a significant narrowing of the artery, 70 percent or more, to even start to qualify for stent treatment, and Midei aggressively over-read his own X-ray studies of the heart's blood vessels to make it seem that patients had much worse narrowing than they really did, according to the published allegations about his practice.

This raises a Fox/Henhouse issue: How is it that a cardiologist can do his own testing to see if someone needs treatment, and then be the one to profit mightily if the decision is yes, they need it? Should second opinions be mandatory on any patient with blood vessel narrowing?

Dr. Bob Wachter, a patient safety pioneer at UCSF medical school in San Francisco, wrote a thoughtful blog on this topic. I'm reprinting part of it below, and urge readers to read the whole article here.

Dr. Wachter writes:

Obviously, the Mideis of the world could be caught by requiring that every cath [blood vessel X-ray] undergo an independent second reading. Some insurers in New Jersey now require such readings before they authorize a stent, and at least one SoCal Kaiser hospital mandates that each cath be presented at a conference before a treatment decision is rendered, analogous to what many tumor boards do for cancers.

Such required peer review might have benefits beyond simply preventing the rare case of fraud. If done well, it might also ensure that other conflicts of interest and non-evidence-based decisions are avoided to the degree possible. For example, a meta-analysis in last month’s Annals of Internal Medicine illustrates the limited value of percutaneous coronary interventions – whereas older studies found that PCI was more effective than medical therapy in treating angina, more recent studies show that these differences have narrowed or even vanished. I’d guess that, when recommending a treatment for a patient with mild angina and a 60% LAD lesion, a peer review group is more likely to pay attention to this kind of evidence than the average cath jock – who may not only be staring at his kid’s private school tuition bill but also at a patient whose bias is to see a stent as a more intuitively satisfying solution than “just medications.”

Some will argue that mandating second opinions for every cath is the equivalent of hitting a nail with a sledgehammer, and they might well be right. However, I do favor at least random over-reads of a sample of catheterization studies. Something like this already happens in a few specialties. In many teaching hospitals, a random sample of pathology studies is reviewed by a second provider. In a few forward-thinking practices, radiologists re-read a sample of x-rays, looking for discrepancies. In response to this case, in fact, St. Joseph’s now requires that 5% of its cath cases undergo a random and blinded re-review. Random audits won’t catch every case of fraud, any more than IRS audits catch every tax scofflaw. But they do help keep people honest, particularly if the audits are coupled with a culture in which the docs welcome feedback and strive for continuous improvement.

Speaking of which, the Midei case made me wonder about the institutional culture at St. Joseph’s. Was Midei a rogue interventionalist working in isolation? Perhaps so – it's common for no other doc to be looking over the shoulder of a cardiologist and his cath readings. But cardiologists don’t perform caths on desert islands – they are assisted by cath techs and nurses. In my experience, these folks become as adept at reading cath films as any physician. If the allegations against Midei are true, it strains credibility to think that no one in the lab knew that inconsequential lesions were being read as tight stenoses and treated with stents.

And what about the hospital administrators? Stents are big business. When Johnson & Johnson first launched their drug coated Cypher stent in 2003, Dr. Midei told the Baltimore Sun, “This is the hottest thing in cardiology in years.” And it was: Maryland hospitals chalked up nearly $250 million in stent business in 2009, and St. Joseph’s stent revenues were $38 million, up more than 50% in 5 years. Before the case broke, St. Joseph’s advertised itself as the busiest cath hospital in Maryland, averaging nearly 20 interventional cases daily. While it is possible that no St. Joe’s leader knew precisely what was happening, I'm guessing that some did but chose to look the other way: the pressure to steer clear of the golden-egg-laying goose must have been intense. Perhaps the fact that the hospital’s CEO and two other senior executives resigned after the case broke provides a clue as to who knew what when.

Cases like this one are terribly troubling, not just because they harm individual patients but because they do violence to the trust that is so fundamental to the physician-patient relationship. Part of the solution must be more robust oversight procedures, such as mandatory second readings of randomly selected cath films.

But these cases also force us to consider the kind of culture that could allow such a fraud to take root and go on for years – a culture that likely prized the hospitals’ and physicians’ financial health over the clinical health of their patients. If the allegations are true, the penalties should be severe, not only for Dr. Midei but also for leaders who knew – or should have known – what was going on, yet remained silent.

Patients need to know that this is not just an issue of a few rogue bad apples. Medicine's fee-for-service payment system pushes doctors toward advocating for more aggressive and profitable interventions. The only way to find out what your body really needs is to shop for second and third opinions, every time. I have more on this subject in chapter 9 of my book, "The Life You Save."

The chapter title says it all: "The Second Opinion: Always Your First Choice."

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March 29, 2010

New Health Care Law Will Expose Drug Manufacturers' Gifts to Doctors

The free meals, trinkets and other goodies now lavished on doctors by the prescription drug industry will soon be a matter of public record for each doctor in the United States, under a provision of the new health care reform law. A searchable database goes into effect in 2013 that will let anyone plug in a doctor's name and find out how much largesse that doctor received in the past year. This is a positive development for patient safety in the United States.

Readers of this blog know from past reports that even small "gifts" from manufacturers are highly effective in influencing doctors' prescription writing habits. The industry spends about $1 billion a year in free meals for doctors and many more dollars in countless free pens, scratch pads, textbooks and other trinkets branded with the names of various drugs being promoted. (As we reported in another post, deep-sea fishing trips and golf junkets are also part of the blandishments.)

Do small gifts matter? Yes, as the Pew Prescription Project points out in an excellent fact sheet that summarizes the studies on how doctors' decisions about drugs are influenced by manufacturers. As the Pew researchers write:

[T]he evidence is clear: gifts, even small ones, change behavior. Such marketing drives up drug costs and sometimes puts patients at risk. Social science research ... shows that a gift of any size imposes on the recipient a sense of indebtedness. This need for reciprocity is a deep-seated human reaction. It creates in the recipient, whether consciously or not, a sense of obligation to repay favors, gifts, invitations, etc. Research shows that it takes extraordinarily little to bias an individual’s interpretation and processing of information. Such bias is both subtle and unintentional.

Now, that's "subtle and unintentional" bias on the part of the doctor receiving the gift. Most doctors will deny heatedly -- and honestly -- that drug freebies have any role in how they prescribe medicines. The manufacturers, who study this closely, know otherwise. There is nothing "unintentional" about the way they spend money on seemingly innocuous trinkets like pens.

The new reporting law requires the drug manufacturers to report to the government everything of value given to any doctor or teaching hospital, starting January 1, 2012 (and the government web site has to be up by September 30, 2013).

Manufacturers do not have to report gifts worth less than $10, but if the total of those gifts in one year to any doctor reaches $100, then all gifts have to be reported. There are a few other exemptions and other details worth reading in this "Sunshine" fact sheet from Pew.

Free samples of drugs also will be covered by another part of the law. As I have reported before, thoughtful doctors don't even accept free samples because that can bias their prescriptions away from "tried-and-true" medicines toward newer drugs with uncertain safety records.

I have a chapter in my book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, educating consumers on how to use prescription drugs safely. One of my key points is that people need to realize that the first few years a new drug is on the market -- during the time of its heaviest promotion by the manufacturer -- is also the most dangerous time for the patient to try the drug, because early users are basically guinea pigs.

This new law infringes no doctor's freedom to accept gifts from industry, and doesn't impact any patient's freedom to patronize such doctors. But with education and "sunshine" about how these gifts create conflicts of interest for the doctor, we can hope that the torrent of freebies will start to slow. All patients will be better off if the education doctors get about new drugs is not influenced by industry gifts.

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February 11, 2010

Big Profits in Cutting Corners on Quality for Owners of Long-Term Care Hospitals

The handsome silver-haired doctor in the long white coat, standing at the nurse's station in a photograph accompanying a New York Times story, is the national medical director for a chain of for-profit long-term care hospitals. But he puts in barely ten hours a week for Select Medical Corporation, which has no physicians in its top management. Or nurses for that matter.

The founders of the publicly traded company, a father and son team, have made about $200 million since they started Select in late 1996, according to the Times. They also own stock worth many millions more.

From barely a handful in the entire country in the 1980s, the number of long-term care hospitals now exceeds 400, with growth fueled by Medicare payment rules that penalize hospitals when patients languish too long with a particular condition but reward those same hospitals if they can transfer the patient to a long-term care facility. Many of the long-term care hospitals -- and nearly all in the Select chain -- actually consist of a wing or floor within another hospital, so patients can be transferred just a floor or two and for reimbursement purposes be tagged as located in a wholly different facility.

According to the Times report, many of the long-term care hospitals have no doctors in the building overnight as routine practice. They have heart monitors watched by untrained clerks, or not watched at all. Patients have died from lack of appropriate attention.

Here are government inspection reports obtained by the Times from a Freedom of Information request. Statistics show that bed for bed, Select hospitals have four times as many official findings of poor quality than the average hospital.

Medicare rules pay long-term care hospitals more if the patient is hospitalized at least 25 days, but then reimbursement declines drastically for patients who need longer treatment. It's no surprise that the average length of stay at Select hovers at 25 days.

What is the appropriate role of profit making in American health care? Money can certainly drive improvements in technology and medications, but we have to question the role of profits in routine medical care.

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February 2, 2010

A Doctor Chooses Paid Speeches for Drug Makers Over Academic Prestige

New ethics rules that bar Harvard doctors from giving speeches paid by drug manufacturers have prompted one doctor to give up his prestigious academic position in favor of keeping the income from the speeches. The physician is Dr. Lawrence M. DuBuske, an allergy and asthma specialist who is quitting his positions at Boston's Brigham and Women’s Hospital and Harvard Medical School. According to the Boston Globe, Dr. DuBuske made about $100,000 in three months last year giving some 40 speeches for six drug makers, including GlaxoSmithKline.

The ethics rules were put in place by Partners HealthCare, the physicians' group that employs most Harvard-connected doctors.

One Globe reader put this in a good perspective:

It's a good thing that he resigned. Now, when he speaks, the information he presents will be judged by the standards of a paid speaker employed by an entity with interests, rather than a disinterested academic. Meanwhile, he remains an expert allergist, and will likely find a place to practice.

The contacts between drug companies and academic medicine are extensive. They should be. You want the best, smartest, most creative docs involved in drug (and device) production. But the money involved is huge, and some will get seduced by the Green Side of the Force. Full disclosure of interests is a step, but only a step.

For patients, it helps to know if the prescription the doctor is writing for you has even a hint of a special interest from the drug maker. The many blandishments that drug makers lavish on doctors -- even small things like pens and scratch pads, plus free meals and "fees" for speaking at seminars -- are known to do their job of creating subtle influence on the prescription writer.

That's why I recommend that patients look for doctors who have the "no free lunch" philosophy: they accept nothing whatsoever, including samples, from the drug makers. That leaves their judgment completely independent.

You can read more about the "no free lunch" movement in medicine at this website.

I have a whole chapter in my book, "The Life You Save," on how to become a smart consumer of medicines.

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December 29, 2009

More on Those Glossy Ads for Cancer Treatment

Several thought-provoking letters appear in the New York Times responding to the recent piece about the cancer treatment industry's advertisements. One letter was from Dr. James Rickert, of Bloomington, Ind., president of the Society for Patient Centered Orthopedics:

To the Editor:

As a cancer survivor who has faced recurrent bouts of disease, I agree that the intense marketing campaigns used by cancer centers only heighten the stress and anxiety of the difficult treatment decisions that all cancer patients face. It becomes nearly impossible, at a time when one feels that any poor decision could be fatal, to wade through all the non-science-based claims for success.

As a physician who treats many patients with terminal metastatic disease, I have seen that this marketing often leads to heart-wrenching guilt and second-guessing by patient and family alike when treatments fail. Rather than being allowed to accept that their disease was incurable despite the best medical care, patients often feel that they are somehow to blame for choosing the wrong institution in which to receive treatment.

This is a distressing example by our nation’s finest medical centers of the shameful practice of placing financial concerns before the needs of the patients that they claim to serve.

If our academic medical centers cannot offer better patient-centered, evidence-based care than this, where in the world shall the medical community look for leadership?

Dr. Rickert makes an even better case than I could about the dangers of relying on advertising to make important decisions.

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December 19, 2009

Cancer Treatment Industry Markets Hope to Desperate Patients:

The ads are striking: Handsome, smiling people, very much alive, victors over cancer -- thanks to their choice of a prestigious cancer center for their treatment. But are they true?

The cancer centers -- with brand names like Sloan-Kettering and Massachusetts General -- cannot prove that the patients are alive because of something unique about their institutions. But they don't have to prove anything, under the law. If a drug manufacturer wanted to make a similar claim, it would have to line up statistical evidence, and the ads would have to have a lot of disclaimers. The ads from the cancer centers have no such disclaimers, and little to no backup from statistics.

Natasha Singer has a thoughtful article in the New York Times exploring these ads and what patients who are looking for cancer treatment should do.

The marketing executives who craft these ads say they're not even aimed at current patients -- but are more "reputation advertising," as one told the Times.

The article has a good sidebar that gives tips for how patients should shop for cancer treatment.

A regular community hospital can be fine for common cancers like colon, but for anything unusual, it's best to look for a center that sees a lot of that condition.

The National Cancer Institute designates Comprehensive Cancer Centers for their scientific excellence and comprehensive approach. Here is a list from the NCI. Ironically, these are some of the same centers with the heavy advertising budgets.

In my book, "The Life You Save: Nine Steps for Finding the Best Medical Care -- and Avoiding the Worst," I discuss the importance of a multi-disciplinary approach where doctors from different specialties collaborate together on figuring the best line of attack to a particular patient's cancer. Most advanced centers have "tumor boards," where these collaborative discussions occur, usually at no extra charge to the patient.

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October 22, 2009

A Small Step Forward in Curbing Drug Industry Influence on Doctor Education

Most doctors have to take regular continuing education courses to maintain their medical licenses. But what if the courses have a hidden agenda -- promoting the drugs of a sponsoring manufacturer?

That hidden influence has occurred far too often for the comfort of patient safety advocates, who want prescribing doctors to receive fair, balanced and neutral advice in the important subject of what prescriptions to write for sick patients.

Now the group that gives the official seal of approval for continuing education courses is taking tentative steps to curb the drug industry's influence on these courses. The group is called the Accreditation Council for Continuing Medical Education (ACCME). Its approval is necessary for a doctor to get official credit for any course taken. The head of the ACCME, Dr. Murray Kopelow, told the New York Times he will:

First, make public in the next few weeks a list of the classes and educational companies that have already been found to have broken the rules against commercial bias. This list was previously secret. Apparently there are less than a dozen names on the list as of now.

Second, consider further steps such as requiring the sponsor of a course found to be biased to send out corrective material to the doctors who took the course.

A doctor who is pushing for these and stronger reforms is Dr. Bernard Carroll, who filed a lengthy complaint about an online course on treatment of major depression, which he said was strongly biased by hiding bad information about the drugs of the sponsor, AstraZeneca.

The Times reported:

Dr. Carroll faulted the accrediting council for taking nine months to resolve the complaint, allowing the program to rerun and failing to notify doctors who had taken it. “They’re more interested in protecting the providers than watching what gets put out there as education,” Dr. Carroll said in an interview.

Here is Dr. Carroll's own blog posting on the subject.

The steps taken so far by the accrediting body are modest, but go in the right direction. Let's keep watching. As another industry critic, Dr. Bernard Lo, said, it's okay for the drug industry to support medical education. What's not okay is to create commercial bias in favor of one or another company's products.

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September 22, 2009

"Ghostbusters" Are Weeding Out Fake Authors at Medical Journals

A few brave medical journal editors are cracking down on the common practice of drug companies ghost-writing articles for authors who are willing to lend their names to drug industry propaganda. But at other journals, editors seem to have a "don't ask, don't tell" policy. For patients, it is vital that the truth come out.

The problem with ghost-written medical articles is that they purport to be something that -- once the disclosure of who wrote them is made -- they clearly are not: independent, objective evaluations of which medications work best for a particular disease. Instead, the ghosted articles turn out to be elaborate infomercials, disguised by the author's prestigious name and studded with multiple footnotes and the other signs of scholarly elbow grease. Yet because they are published under false pretenses, these articles can be very effective at selling their sponsors' products.

What first broke open this scandal was lawsuits against Wyeth for breast cancer and other injuries caused by its hormone drugs Prempro and Premarin. Attorneys for the patients found multiple examples in the manufacturer's records of prominent medical researchers putting their names on articles written by someone hired by the drug company.

Some of the medical school professors who were caught tried to brazen their way out of it by saying that of course, they wouldn't put their name on something they didn't agree with, and they just happened to agree with every single word that was written for them. For example:

Dr. Gloria Bachmann of the Robert Wood Johnson School of Medicine said in a published report: “This is my work, this is what I believe, this is reflective of my view.”

With shameless attitudes like that rife in the medical academic world, it's important for the editors who control what goes into the journals to step up and enforce some accountability. The first steps down that road have been cautious at best. As the New York Times reported:

Dr. Cynthia E. Dunbar, the editor in chief of Blood, said that, in the future, the journal would consider a ban of several years for authors caught lying about ghostwriting, in addition to retracting their ghosted articles.

But, said Dr. Dunbar, who is a hematologist at the National Institutes of Health in Bethesda, “I hope we don’t have to do that.”

The Times reported on another journal that took a stand:

In an editorial last week calling for a zero tolerance policy, the editors of the medical journal PLoS Medicine, from the Public Library of Science, called for journals to identify and retract ghostwritten articles and banish their authors.

“Any papers where this breach is substantiated should be immediately retracted,” the editors wrote. “Authors found to have not declared such interest should be banned from any subsequent publication in the journal and their misconduct reported to their institutions.”

Click here to read the full editorial.

Other journal editors told the Times that because they banned ghostwriting, they didn't really have to have a specific policy enforcing the ban. Huh???

For an amusingly arch, tell-it-like-it-is take about medical ghostwriting from someone outside the medical industry, I recommend English professor Margaret Soltan's blog, University Diaries.

The ghostwriting scandal, and the cautious, tepid response from many in the medical journal world, are the latest proof of why I advocate that patients be skeptical about prescription drugs, especially those with expensive marketing campaigns behind them. Read more in Chapter 7 of my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst." The chapter is titled: "Drugs: A Dose of Reality About the Prescription Drug Industry and How You Can Safely Use Medicines."

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August 6, 2009

Does My Doctor Have a Conflict of Interest? Why You Should Care

Whether or not a patient should get an expensive imaging scan or some other elaborate and expensive test is not always clearcut. But what should be clearcut is that doctors should not have a thumb on the scale when they're balancing harms versus benefits. The balancing ought to be focused entirely on what's in the patient's best interest. The news story about what happened when a group of urologists in Iowa ordered a new CT scanner for their office sheds light on this conflict of interest issue.

According to the article by Shankar Vedantam in the Washington Post, the doctors at Urological Associates in Iowa were ordering fewer than one dozen CT scans per month for their insured patients in the months before their office bought its own CT scanning machine. That number jumped to 55 scans per month soon after the doctors got their own machine and started getting direct insurance payments for its use.

Defenders of the doctor-owned machines say it's more convenient for patients not to have to go to some other building for their scan. That's no doubt true -- if the scan is really needed in the first place. The problem is that self-interest colors the doctor's calculation, whether subtly or blatantly.

You might say "so what," but no test is without its downside, and excessive radiation from unnecessary CT scans can ultimately cause cancer in some patients -- as many as one in one hundred cancers are traced to radiation exposure. Not to mention bankrupting our health care system in the meantime.

Congress is considering outlawing the practice of what is called "self-referral," referring the patient to a test on a machine that the doctor owns. At the least, Congress should make it mandatory that doctors disclose any self-interest they have in testing, so that patients can take it into account in deciding whether they want the test.

I discuss doctor conflicts of interest in Chapter 9 of my new book, "The Life You Save." Chapter 9 is called "The Second Opinion: Always Your First Choice." It explains why you the patient need to understand if your doctor may have some ulterior influence on his or her thinking, and how it's always a good idea to get a second opinion before undergoing any major procedure.


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August 5, 2009

The Medical Industry's Own "Steroids in Baseball" Scandal

Another reason for careful patients to be skeptical about overly hyped prescription drugs came this week with news about the extent to which articles in important medical journals are "ghost-written" by drug manufacturers.

According to an article in the New York Times by Natasha Singer, newly released papers from lawsuits involving Wyeth's hormone replacement drugs Premarin and Prempro show that over several years, Wyeth repeatedly hired ghost writers who placed 26 articles in 18 prestigious medical journals, all promoting the drugs in the guise of objective analysis by medical experts:

The court documents provide a detailed paper trail showing how Wyeth contracted with a medical communications company to outline articles, draft them and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing. The documents suggest the practice went well beyond the case of Wyeth and hormone therapy, involving numerous drugs from other pharmaceutical companies.

The Times article made an interesting comparison to professional baseball's steroids scandal.

“It’s almost like steroids and baseball,” said Dr. Joseph S. Ross, an assistant professor of geriatrics at Mount Sinai School of Medicine in New York, who has conducted research on ghostwriting. “You don’t know who was using and who wasn’t; you don’t know which articles are tainted and which aren’t.”

Because physicians rely on medical literature, the concern about ghostwriting is that doctors might change their prescribing habits after reading certain articles, unaware they were commissioned by a drug company.

“The filter is missing when the reader does not know that the germ of an article came from the manufacturer,” said James Szaller, a lawyer in Cleveland who has spent four years going through the ghostwriting documents on behalf of hormone therapy plaintiffs.

The same concern about ghostwriting applies to patients who read literature on the Internet. People can be easily misled if they think an article is truly objective.

My advice, as I write in my book, "The Life You Save," is to rely on truly independent groups like the Medical Letter and Public Citizen's Health Research Group for objective information about drugs.

Some top medical journals like the Journal of the AMA now require authors to fill out detailed forms describing exactly how much input they had into the writing of an article. But many do not have such requirements. Consumer, beware.

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June 9, 2009

Too Much Medical Care Is Dangerous and Expensive

A New Yorker article by Dr. Atul Gawande, a surgeon, focused on why McAllen, Texas has higher medical costs than just about anywhere in the country. Dr. Gawande concluded that much of the problem could be traced to the very aggressive, intervention-oriented style of medicine practiced there -- all stemming from the fee-for-service payment system that rewards the doctors who practice intensive, high-cost care. His article achieved new prominence this week when President Obama told White House aides and members of Congress that after reading the article, he decided "This is what we've got to fix."

The President was quoted on that by Senator Ron Wyden in an article in the New York Times by Robert Pear.

Aggressive, high-cost medicine has never been proven to make anyone healthier or live longer. Why do the McAllen doctors order so many tests and procedures? Because they make more money from our fee-for-service system. The answer is to reorganize care so that doctor don't have a built-in conflict of interest where they prosper economically the more stuff they order. But that reorganization is easier said than done. Dr. Gawande rightly looks to models like the Mayo Clinic, where doctors are on salary. Read more about this on Dr. Bob Wachter's health care blog.

One interesting sidelight to Dr. Gawande's article is that he nails the old bug-a-boo of the medical industry: so-called "defensive medicine" in which doctors supposedly order lots and lots of tests not out of any perceived medical necessity but out of fear of being sued for malpractice. A group of McAllen surgeons tried this explanation out on Gawande, but he rightly pointed out to them that Texas has some of the strongest tort reform in the country, so he was skeptical.

He didn't mention, but might have, that other states like California, which in the 1970s made it almost impossible to sue for malpractice except for the most egregious cases, have enjoyed no medical cost savings that anyone has been able to count. Health care economists have proven that what explains disparities in medical costs is high numbers of specialists in a community and correspondingly low numbers of primary care doctors.

That Congress is just now discovering the realities of medical economics, which have been published in study after study over the last three decades, is itself pretty scary.

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May 20, 2009

Vermont Pioneers Crackdown on Drug Industry Freebies to Doctors

Starting July 1, Vermont residents will be able to learn exactly how much money any doctor in that state is receiving from the drug and medical device industry. The state is also banning most gifts like free meals to doctors, nurses, pharmacists and other health care providers.

This is an important step forward in eliminating the conflicts of interest that plague use of prescription drugs in the United States.

Vermont already has publicized non-doctor-specific data on drug industry payments intended to influence doctors. Even in a small state like Vermont, the total spent last year was $2.9 million, with most of the money targeted to doctors thought to be influential with their peers. The biggest single payment was $112,000 to a psychiatrist. And the drugs which topped the list for money paid were Strattera, a drug for attention deficit disorder, and Cymbalta, for depression and anxiety.

The new legislation was reported in an article by Natasha Singer in the New York Times.

Doctors and drug companies often deny that free meals and payments of consulting fees have any influence on doctors' prescribing habits. The mere fact that the industry spends hundreds of millions of dollars each year on such marketing suggests otherwise. Commendably, the Vermont Medical Society supported the new disclosure law.

Patrick Malone discusses conflicts of interest and how patients can use drugs -- sensibly, skeptically and safely -- in his new book: The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

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