August 27, 2014

FDA’s Expedited Drug Review Lets Sketchy New Drugs Slip into the Market

In the 22 years since the FDA implemented a program for pharmaceutical companies to pay a fee to expedite market approval for their drugs, recalls for drugs have increased significantly.

According to research published in the August issue of Health Affairs (subscription required), newer drugs have a 1 in 3 chance of either being withdrawn for safety reasons, or requiring a black box warning on their packaging. Such a warning denotes serious and/or life-threatening side effects of the medication.

As described on AboutLawsuits.com, the Prescription Drug User Fee Act (PDUFA) was enacted in 1992 after heavy lobbying by the pharmaceutical industry. The fast-track law has reduced the average drug approval time from 34 months to 16 months. But at what cost to patient safety? As AboutLawsuits said, the action “may be resulting in large numbers of patients being exposed to dangerous drugs before side effects are recognized.”

In the study, researchers from Harvard, Boston Medical Center/Boston University School of Medicine, City University of New York School of Public Health and Public Citizen analyzed drug approvals by the FDA over the last 35 years — before and after implementation of the PDUFA.

Between 1975 and 2009, the FDA approved 748 “new molecular entities” (NMEs) that were not
over-the-counter drugs. Researchers found that 114 of them subsequently received black box warnings, and 32 were recalled from the market.

According to Public Citizen’s review of the research, drugs that were released after the PDUFA passed were more likely to be withdrawn or have a black box warning; 26.7% percent of them receiving such a warning compared with 21.2% of the drugs that underwent the longer approval process pre-PDUFA. Half of all black box warnings appeared after a drug had been on the market for 12 years, and safety withdrawals have occurred as late as 30 years after a drug’s initial release.

So it appears that fast-tracking approvals might undermine the ability of overseers to detect serious drug side effects. That leaves patients who get these drugs exposed for months or years to danger before they are properly warned, or the drugs are withdrawn. The researchers also speculated that faster approval times could compromise the quality of clinical trial evidence.

One notable example of this rush to approval that had a bad outcome was Vioxx, Merck’s nonsteroidal anti-inflammatory drug (NSAID) that hit the market in 1999, was aggressively promoted directly to consumers as a pain reliever, gained widespread use and was recalled in 2004. According to AboutLawsuits, Vioxx was linked to between 88,000 and 140,000 cases of serious heart disease before it was recalled.

Public Citizen, a consumer advocacy organization, supports a grace period for new drugs. It issued a news release in conjunction with the new study, quoting its lead author, Dr. Cassie Frank: “The FDA is under constant pressure to rush new drugs through the pipeline to approval. In its hurry the FDA is apparently failing to distinguish useful drugs from toxic ones, and more dangerous drugs are slipping through. By the time many drugs receive serious safety warnings, millions of Americans have already been exposed to their side effects, which can sometimes be fatal. As a doctor, I try to keep my patients safe by avoiding new drugs, when there are similar, older ones available.”

The researchers suggested that patients and doctors wait until a drug has been on the market for a considerable amount of time before making it a go-to treatment. We’d go a step further, and suggest that the regulators reconsider the whole idea of pay-for-faster play. When it comes to drugs, faster is only better when it’s solving a problem, not creating larger ones.

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August 26, 2014

Suggested Reading-- What You Should Know About Long-Term Acute Care

Most patients who must stay in an acute care facility for an extended period do not have a rosy prognosis. And most people know very little about these specialized care centers. But thanks to an aging population, and the fact that medicine is very good at keeping people alive in the intensive care unit (ICU), the long-term acute care population will grow well beyond the current estimate of 380,000 patients.

These are highly dependent patients who survive the ICU, but aren’t well enough to go home or to a rehabilitation facility. According to a recent story in the New York Times called “At These Hospitals, Recovery Is Rare, but Comfort Is Not,” long-term acute care is “where you go when you survive but you don’t recover.”

In a profile of the Hospital for Special Care, one of 400 long-term acute care facilities in the U.S., The Times describes critically ill people who might live here for months or years, dependent on a respirator and, often, feeding tubes. Younger people sometimes recover, others won’t.

The cost is huge and the patient population has more than tripled in the last 10 years. We — practitioners, policymakers, consumers — are going to have to pay attention to this segment of the health-care industry, and grapple with how best we can deliver and accept this kind of end-of-life care.

Read the whole story here.

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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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August 24, 2014

Calculating the Risk of Medical Intervention

We always advise people to understand the risks as well as the benefits of any procedure or treatment they are considering, but getting your arms around the idea of “risk” — much less being able to quantify it — is a challenge all its own. Last month, “Risk and Reason,” a multipart series on NPR, looked at several ways people assess risk, with an eye toward helping medical consumers apply it to their own circumstances.

One part tells the story of Brian Zikmund-Fisher, a professor at the University of Michigan School of Public Health who teaches about risk and probability. As a graduate student, Zikmund-Fisher was studying behavioral decision theory when he was forced to become his own lab rat.

Diagnosed with myelodysplastic syndrome, a disorder that inhibits the production of blood cells and makes victims vulnerable to bleeding and infection, Zikmund-Fisher was told that if he didn’t have treatment he would have about 10 years to live. The treatment was a bone marrow transplant, which he was told would have a 70% chance of cure.

But bone marrow transplants involve chemotherapy, which leave patients susceptible to infection because it impairs immune function. Zikmund-Fisher was told the transplant/chemotherapy treatment had a 25% to 30% chance of killing him within six months to a year.

As NPR summarized his situation, “As it turns out, making decisions based on the odds can be an extremely difficult thing to do, even for people who study the science of how we make decisions.”

Ultimately, Zikmund-Fisher made his decision based on factors even he couldn't quantify. He chose the transplant, and had a positive outcome. But he observed that discussing probabilities with his medical team was useful, but limited in being able to predict what will happen to any one person.

But that’s not a productive way for doctors to think; Zikmund-Fisher says doctors should think about overall numbers, not individual cases.

"A doctor doesn't see one patient. They see hundreds of patients — thousands of patients — over their career,” he told NPR. “We want doctors to make choices that give all of their patients the best possible outcomes regardless of whether that particular choice turned out well in the last time they tried it, or turned out poorly," he says. "We want doctors to take the long view, to give us the best chances of success, knowing that sometimes it's going to work well, and sometimes it's not."

Another part grapples with how people understand risk through numbers versus text. A survey of primary care doctors about how they discuss risk with their patients showed that 1 in 5 were very comfortable using numbers and explaining probabilities to patients. Most prefer words or terms, such as “'very small risk,” “very unlikely,” “very rare,” “very likely” or “high risk.”

But such words can be unclear to a patient, or interpreted different from how the doctor would interpret them. “People may hear 'small risk,' and what they hear is very different from what I've got in my mind,” one doctor told NPR. “Or what's a very small risk to me, it's a very big deal to you if it's happened to a family member.”

Some patients better understand how taking a certain medicine to address their problem might affect them through a combination of charts, calculators and words. One patient considering taking a statin for his heart disease declined when he was shown a decision aid calculator developed by the Mayo Clinic using colored dots on a grid, each symbolizing a person.

When a patient's individual information is input, some of the green dots turn yellow, indicating in the next 10 years how many people with that profile are expected to have a heart attack. When this patient’s profile was entered, 12 dots turned yellow and 88 remained green, indicating that 12 in 100 men like him would have a heart attack within 10 years. "It looks like my chances are slim," he commented.

Others need a more experience-based discussion to visualize their risks.

One orthopedic patient was considering a hip replacement. He was 59, and physically very active. His doctor assessed his risk of infection from such a surgery to be less than 1 in 100. But that wasn’t his concern — his overarching calculation was how the procedure was likely to positively affect his quality of life, which, for him, depended on being able to pursue the activities that were starting to give him trouble.

He had read a booklet and watched a DVD about hip replacement, and had talked to people he knew who were very happy with their outcome after having one. That was more compelling information for him.

The FDA, the story notes, requests that drug companies use numerical values to indicate risk, and to avoid vague terms such as "rare,” “infrequent” and “frequent" to describe the chances of side effects. But the European Union’s Medicines Agency matches terms such as “very common,” “common,” “uncommon,” “rare” and very rare” with numerical values for each level of frequency. By that measure, a "very common" side effect occurs in more than 1 in 10 cases. A "very rare" side effect occurs in fewer than 1 in 10,000 cases.

Such explanations speak to both kinds of patients.

Another part looks at the work of Drs. Steven Woloshin and Lisa Schwartz, who are working on how best to communicate to doctors and patients the uncertainty of assessing benefits and risks of pharmaceuticals. They want the FDA’s drug information to be more useful and more readable.

That agency approves not only drugs, but the prescribing instructions that accompany them and the patient information material. We’ve all gotten drugs, both prescription and over the counter, with wads of paper stuffed into the packaging that is about as inviting to read as the fine print on a credit card application.

Woloshin and Schwartz have designed a drug facts box that simplifies all that fine-print stuff to, essentially, explain how a drug compares to a placebo, or sugar pill.

That's in contrast to what usually happens, Schwartz says. "The prescribing info is written by industry, and then negotiated with FDA, and then FDA ultimately approves it. And we have documented examples where important info — like how well the drug works — is not in the label."

They showed people ads for two competing heartburn drugs, one plainly more effective than the other. They also showed people two of their drug facts boxes, one for each of the heartburn drugs, showing how each fared against a placebo in testing.

"When the people are presented with the standard information they see — like a drug ad — about 30% percent of people chose the better drug," Woloshin told NPR. "But when we showed them information in the drug facts box form, 68% of people were able to choose the objectively better drug. So that's a really dramatic improvement. It just shows you that if you show people information in a way that's understandable, they can use it, and it can improve their decision."

Then they used a real drug, the insomnia medicine Lunesta, and made a drug facts box with FDA data. Two columns compare people with insomnia who took Lunesta with people who, unknowingly, took a sugar pill.

The people who used Lunesta took 30 minutes to fall asleep. The sugar-pill users took 45 minutes. The Lunesta users stayed asleep 37 minutes longer than the others.

Insomnia drugs have very real risks, such as mental fuzziness. (See our blog, “FDA Cuts Lunesta Dose in Half.") So seeing those comparisons would be enormously helpful for deciding whether to take one or not.

"That's the whole point of the drugs facts box," Woloshin said, "to let people look at the evidence and come to their own judgments. But you can't make those judgments without the facts.”

He and Schwartz believe that patients can handle numbers, including percents, but that too often the information supplied is incomplete or misleading. And when you see the small difference between Lunesta and a fake pill, you see why drug companies use information to confound instead or explain.

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August 21, 2014

More Muscle for Medical Sleuths

This summer, the National Institutes of Health (NIH) began a campaign to define, explain and find support for disorders whose origins and treatments are unknown. The Undiagnosed Disease Network is composed of six medical centers around the country focused on the most difficult-to-solve medical cases.

They will conduct clinical evaluation and scientific investigation in cases that involve patients with prolonged undiagnosed conditions.

As described in the Los Angeles Times, it is hoped that the “whodunnit” initiative will clear a backlog of medical cold cases with “dazzling” new tools yielded by medical sleuths. In addition to helping patients who shuffle from doctor to doctor in search of answers to a disorder no one can pin down, it’s also an opportunity for scientists to glean new insights into the human genome and how it causes — and maybe cures — disease.

By the summer of 2017, the Undiagnosed Disease Network is expected to have enrolled at least 300 new patients per year, nationwide, with mysterious and intractable conditions. All of these disorders have stumped the pros. Many practitioners fail to recognize some of the conditions under study because they see them so seldom, if ever. Many have not been described in the medical literature or are rare forms of more common diseases.

Some might have origins in infection or environmental exposure, some in a patient's genes, but have been unexpressed or escaped detection in the patient’s forebears.

The new infusion of cash ($43 million) and renewed commitment to solving medical mysteries builds on a 6-year-old pilot program at the NIH's Bethesda, Maryland, clinical center, where about 600 patients whose symptoms have eluded diagnosis and treatment receive extensive diagnostic work-ups in a bid to identify and treat them.

So far, using genomic analysis and tons of standard diagnostic tests, the clinical/research team has diagnosed about 100 patients. Two unknown diseases have been identified as well as 15 genes not previously associated with any other human disease.

New members of the network are:


  • Baylor College of Medicine in Houston

  • Boston Children's Hospital, Brigham and Women's Hospital and Massachusetts General Hospital in Boston

  • Duke University in Durham, N.C.

  • Stanford University in Palo Alto, Calif.

  • UCLA

  • Vanderbilt University Medical Center in Nashville, Tenn.


Key to successful sleuthing is our rapidly developing understanding of the human genome. Since the Human Genome Project was launched in 1990, genomic analysis has become faster, less expensive, more comprehensive and more reliable. And the results are significant.

For example, the genetic analysis of solid tumors often drives the choice of targeted treatments for cancer — before, all patients with a certain kind of cancer generally received a common treatment, whether it was drugs, radiation, chemotherapy, surgery or a combination. Now, each patient’s genetic profile helps doctors customize the treatment just for them.

The same gee-whizzery, it is hoped, provides the clues to mysterious health threats. A simple blood sample from a patient and both parents might enable researchers to search the exome; that is, the 37 million base pairs in 20,000 genes where most known genetic disorders are thought to arise. The point is to spot the genetic variation responsible for causing the patient’s disease, and suggest existing therapies or treatments to manage it or clarify the prognosis.

It can help the extended family plan for other problems. One family had a very sick child whose brain suffered constant seizures. There was no family history of the disorder. Clinicians at UCLA were able not only to identify the infant's seizure disorder as a genetic condition, but found the exact location of the genetic mutation responsible for it. Unfortunately, it was fatal.

But if the parents choose to have another child, they can undergo in vitro fertilization so that their genetic information can be searched for the mutation in the embryos created, allowing them to implant only those without it.

Common practices across the network are being developed so that member institutions select, evaluate and diagnose patients in similar ways. Network members will collect and share their data. No patient will be denied participation in the Undiagnosed Diseases Network solely because he or she lacks health insurance coverage.

To find out more about the Undiagnosed Diseases Network, link here.

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August 20, 2014

Californians to Vote on Revising Caps on Medical Malpractice Judgments

It has been 39 years since California passed the Medical Injury Compensation Reform Act (MICRA), and, finally, its chilling effect on the rightful redress for the victims of medical error is being exposed to prospective voters as the unjust law that it is.

Voters will decide in November whether to adjust the caps on medical malpractice judgments for people who have been harmed by medical errors. But the argument in favor of correcting a gross injustice is complicated by tangential medical oversight measures that have been included in the ballot proposition.

Originally, as we blogged last year, MICRA was promoted as a way to address what some people perceived as a malpractice insurance “crisis” that was boosting insurance premiums and driving doctors out of the state. It capped the amount plaintiffs could recover in damages at $250,000, and it wasn’t indexed to inflation. In 1975 dollars, $250,000 is worth less than $58,000 today. If it had been inflation-indexed, that current cap would be $1.1 million.

Last month, the advocacy organization Consumer Watchdog reported that the medical malpractice insurance industry and hospitals are subsidizing the campaign against what it supports as a patient safety measure. Consumer Watchdog said those interests have spent more than $27 million to oppose Proposition 46.

No wonder. Denying people their rights has been good for the medical and insurance industries. They like to repeat the old, demonstrably wrong line that malpractice caps like MICRA prevent frivolous lawsuits and curb the practice of defensive medicine, in which doctors overtreat for fear of being sued for not doing their job.

As Los Angeles Times columnist Michael Hiltzik was quoted in our blog last year, “… the most frequent injustice in malpractice cases involved not undeserving patients collecting payments, but the opposite, deserving patients getting nothing.”

“Malpractice litigation,” he said, “has indeed failed to serve patients and their doctors. The cost of a lawsuit, which includes extensive expert witness fees, has become exorbitant for both sides, and the typical case takes five years to resolve.”

“… Simply padlocking the courthouse to whole categories of plaintiffs doesn't meet the fairness test. ... It's time to bring this … law into the 21st century, and fix the malpractice system so that it actually works.”

The ballot initiative, known as the Troy and Alana Pack Patient Safety Act, would raise the malpractice cap to at least $500,000, and to index it to inflation. Bob Pack is the father of Troy and Alana. As young children, they were killed by a drunk and drugged driver who had gamed the system by “doctor-shopping” to get physicians to overprescribe him thousands of pills.

“Even as America experiences an epidemic of up to 440,000 deaths a year due to preventable medical errors,” Pack said in the Consumer Watchdog report, “those who hold our lives in their hands are more interested in protecting dollars and bad doctors rather than taking reasonable steps to save lives.”

As explained by Consumer Watchdog, the medical malpractice insurance industry is “incredibly” profitable, and has paid out in malpractice claims as little as 10 cents of every dollar collected in insurance premiums. According to its report, “Malpractice insurers’ net income is roughly double what is collected by most other lines of insurance, including auto and home policies.”

Some supporters of malpractice reform are troubled that the proposed initiative deals with more than just caps on judgments that are indexed to inflation. The proposition includes a physician oversight measure that, although intended to protect patients, could dissuade voters opposed to what they see as over-regulation but who otherwise would vote to correct decades of legal malpractice injustice.

Proposition 46 would:


  • Adjust the state’s cap on malpractice damages, giving the cap the same value it had when it took effect in 1975, while maintaining the existing cap on attorneys’ fees.

  • Require physicians to check the state’s existing prescription drug database before prescribing certain addictive drugs to first-time patients, in order to curb doctor-shopping drug abusers.

  • Require random drug and alcohol testing of doctors with admitting privileges at California hospitals, to protect patients from being treated by impaired physicians.


Like other regions, California patients are vulnerable to impaired doctors. According to Consumer Watchdog, the state’s medical board says that nearly 1 in 5 five doctors will abuse drugs or alcohol during their lifetimes.

But whether this reality undermines or assists the effort to revise the state’s deficient medical malpractice laws remains to be seen.

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August 19, 2014

Pelvic Exam Debate Continues to Rage

Early this summer, the American College of Physicians (ACP) said that for many women, there is no need for a routine, annual pelvic examination. Like many such sweeping conclusions about a longstanding clinical practice, it caused confusion among patients and disagreement in some medical corners.

An article called “You don’t need that annual pelvic exam. So why is your doctor giving you one?” by Dr. Deepthiman Gowda on Reuters.com, reviewed the situation earlier this month.

The revised guidelines for pelvic examinations were published in the Annals of Internal Medicine and were based on reviews of nearly 70 years’ worth of studies about the benefits and harms of the standard gynecological practice. The meta-analysis (review of a whole body of studies over an extended period) showed no benefits to performing this exam as part of routine care for most women.

Doctors who were surveyed said that they perform it to screen for ovarian cancer, but the analysis found that the pelvic exam did not effectively detect ovarian cancer, nor reduce deaths from it. Also, the exams did not reduce deaths from nonovarian and noncervical cancers.

The ACP — a national organization of internists whose mission is to apply scientific knowledge and clinical expertise to the diagnosis, treatment and care of people both healthy and seriously ill — recommended against performing pelvic exams for women who aren’t pregnant and who don’t have pelvic pain or other symptoms that suggest a gynecologic problem.

So the group was very clear that women still require the standard scrutiny of Pap smears to screen for cervical cancer, as experts remain united in the belief that there is strong evidence for their continued use for this purpose. The revised guidelines are specifically for the aspect of the pelvic exam in which the doctor uses a speculum to perform an internal exam, then uses his or her hands to palpate the pelvic organs.

When low-risk patients are examined, according to the report, the vast majority of abnormal exams turn out to be false alarms. That invariably invites additional tests that can be uncomfortable, expensive and present complications of their own — ultrasound, CT scans, specialty referrals, biopsy or even surgery. One study, Gowda reported, showed that pelvic exams resulted in a 1.5% increase in unnecessary surgeries.

But even normal results from a pelvic exam might not be an accurate picture of a woman’s health status. These exams aren’t very good at detecting ovarian cancer, so a normal result could invite false reassurance.

None of this is news, but thousands of physicians continue to conduct annual pelvic exams anyway. That’s largely because the American Congress of Obstetricians and Gynecologists (ACOG) says they should. After the ACP review was published, ACOG said that it “firmly believes in the clinical value” of the annual pelvic exam, despite the remarkable admission that its recommendations were “not evidence based.”

“So why does the gynecologist group still promote the annual pelvic exam?” Gowda, an internist, asked. One reason is because ACOG says that annual pelvic exams can help gynecologists recognize problems including urinary incontinence and sexual dysfunction. “In reality,” he said, “… clinicians learn about these conditions primarily through a medical interview; rarely would they first discover them through an exam.”

ACOG also said that annual pelvic exams are warranted because patients expect them. As readers of this blog know, overtreatment is a huge problem in U.S. health care, because it wastes resources and money, and because it can cause additional harms, like complications and needless worry from unnecessary tests. Part of a doctor’s obligation to his or her patient is to know this, and advise the patient about appropriate care, not to cave in to ill-informed pressure. As Gowda noted, “… doctors routinely advise against unnecessary treatments or procedures even when doing so bucks patient expectations. I don’t prescribe antibiotics, for example, if I suspect a nonbacterial cause of an illness, even when a patient asks for them.”

ACOG believes that the annual pelvic exam is an important part of the “well-woman visit”; that it helps to establish “open communication” between patient and doctor because it’s an opportunity for the professional to explain anatomy, reassure a patient of her of normalcy and answer her questions. But any good clinician does that every day; you don’t need a certain procedure to enable it; a procedure that is unnecessarily invasive and expensive. “If the clinician’s and patient’s time is freed up from the unnecessary examinations,” wrote Gowda, “the clinician can spend more time and attention counseling the patient on nutrition, exercise and sexual health.”

Last month, a commentary in the New York Times addressed the situation of the two medical societies at opposite ends of the pelvic exam debate. Its conclusion? “Women will need to make their own judgments about procedures that many of them, and their doctors, may have used for years as a matter of standard practice.”

Maybe. But how do women know if their practitioner is offering objective, evidence-based advice, or only adhering to what he or she has always done? Absent a history of gynecological/sexual problems or pregnancy, we think doctors should take the lead in curbing overtreatment that benefits no one except those who collect the checks.

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August 18, 2014

The Wrong Thing to Say About Robin Williams’ Suicide

Can words kill? Maybe not literally, but what happened on NPR in the aftermath of Robin Williams' suicide is a fresh reminder that certain choices of words, well meaning but still very wrong, can perpetuate a myth about suicide that can be deadly for vulnerable listeners.

One NPR commentator referred to Williams’ role as the voice of the genie in the Disney movie “Aladdin.” When Aladdin frees the genie from his lamp, he pronounces him “free.” The NPR reporter ended his appreciation of Williams by saying, “[Williams] is, as his genie character in ‘Aladdin’ would have it, finally free.”

The next day, NPR aired a response from Elizabeth Minne, a licensed psychologist who counsels people with illnesses including depression and bipolar disorder. She said comments like the NPR commentator’s make her job more difficult because they can be interpreted as a sign that people struggling with depression and suicidal thoughts can attain something positive — freedom — by taking their lives.

Some people, she said, might see such suicide “as a positive way to find — or an appropriate way to find — some sense of relief.”

“[W]hen people are in a dark mindset,” she said in the NPR follow-up, “I have found that they may interpret things that are said out in the media and in the environment as signs or invitations to take some action that has irreversible effects.”

Such comments might prompt some people suffering from depression to believe they will be memorialized or viewed more positively if they “free” themselves.

“My main message,” Minne said, “is that suicide is never an option for working through distress — that there is always a way for us to get to a better place.”

Minne is also concerned about how quickly and efficiently social media communicate these messages. “[W]hen you combine emotional problems with impulsive tendencies you get very concerned about the safety of that individual.”

So we hope the media take a more measured and informed approach when reporting on prominent people who have taken their lives. For the loved ones of people suffering such devastating illness, or who have experienced the suicide of a loved, see our newsletter, “The Shock of Suicide.”

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August 14, 2014

Suggested Reading — Dishing More Dirt About the Medicare Drug Program

An investigative story by ProPublica and the New York Times is a troubling narrative about how Medicare spends shocking amounts of money on drugs to treat rare conditions that have not been shown to be superior than older, less expensive options. To add insult to injury, several of the doctors who most often prescribe these drugs have ties to the companies that make them.

H.P. Acthar Gel is an obscure injectable medication made from pigs' pituitary glands that cost Medicare less than $7 million in 2008. By 2012, that tab had surpassed $141 million, and the cost for 2013 probably will exceed $220 million. But experts question its effectiveness, so why does Medicare keep paying?

Until about a decade ago, the drug was prescribed primarily for a rare infant seizure disorder, and it wasn’t expensive. Then Questcor bought the drug, raised its price precipitously and began to market it controversially for a much wider group of disorders.

Read the whole story here, and its companion piece about the association between the doctors who prescribe it and the company that makes it here.

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August 13, 2014

The Escalating — and Useless — Diagnosis of "Pre-Diabetes"

Like most chronic illnesses, diabetes is treated most successfully when diagnosed early. But too many people are being given a diagnosis of “pre-diabetes,” which not only subjects them to unnecessary treatment, but places unsustainable burdens on the health-care infrastructure.

The title of a commentary published last month in the journal BMJ pretty much summed up the problem: “Too Much Medicine,” by Dr. Victor Montori, an endocrinologist who specializes in diabetes at the Mayo Clinic, and Dr. John Yudkin, an emeritus professor of medicine at University College London, calls a diagnosis of pre-diabetes dubious. It’s an important assessment, because a dubious diagnosis is an unreliable predictor of who will actually develop the disease.

“Pre-diabetes is an artificial category with virtually zero clinical relevance,” the Minnesota Post reported in a news statement Yudkin released when the commentary appeared. “There is no proven benefit of giving diabetes treatment drugs to people in this category before they develop diabetes, particularly since many of them would not go on to develop diabetes anyway.”

As we regularly write, overtreatment, which is what the writers are dealing with here, is not just inefficient and wasteful, but leads to unnecessary worry and the possibility of complications from procedures that stem from this unacceptably aggressive use of medical care.

Rather than turning people who are at risk of developing diabetes into patients who are given inappropriate care, the writers argue that those resources should be directed toward educating this population on how to prevent the disorder. That means helping them understand the role of diet and exercise in developing diabetes. It also means expending energy on public policies that address the obesity epidemic that promotes diabetes.

The artificial problem is the result of one segment of the medical industrial complex — the American Diabetes Association — lowering the threshold for what is defined as disease, and it’s disgraceful.

Diabetes is diagnosed when levels of blood glucose, or blood sugar, are too high. It’s a hormonal disorder — the hormone insulin helps deliver necessary amounts of energy (glucose) to cells, but sometimes the body does not make enough. That’s type 1 diabetes, a condition that usually develops when you’re young.

Type 2 diabetes is more common, and develops later in life, when the body doesn’t make enough insulin or doesn’t use what it makes properly. It’s often promoted — and controlled — by lifestyle habits

A deficiency of insulin means that glucose stays in the blood, and if the condition persists too long, can cause a host of problems including:


  • heart disease;

  • stroke;

  • compromised kidney function;


  • blindness; and

  • skin and gastrointestinal problems.


Because glucose comes from food, weight control, and exercise, are critical to managing diabetes.

“Pre-diabetes” often is diagnosed when your blood sugar is higher than normal but not high enough, or high enough for a long enough period of time, to be called diabetes. The BMJ writers claim that 1 in 3 U.S. adults have been deemed to have pre-diabetes, and that the loose use of the term makes it more confusing than helpful.

The American Diabetes Association (ADA) coined the term, and although it is used globally, the World Health Organization, among other professional groups, discourages its use.

It’s a new descriptor for what, until the late 1990s, was known as “impaired glucose tolerance.” Its evolution to a category that invites excessive treatment reflects the fact that testing for impaired glucose tolerance was a long and complicated process that didn’t always render reliable results. According to the Minnesota Post story, about 3 in 10 people diagnosed with impaired glucose tolerance had normal results when they were re-tested.

In 1999, WHO officials revised the diagnostic criterion for diabetes and called it “impaired fasting glucose.” That replaced the earlier, balky glucose challenge test. But, in 2003, the ADA lowered those blood glucose levels, raising concern among many public health officials when that threshold doubled the number of people who would be diagnosed with impaired fasting glucose.

So in 2009, a third test was developed to measure how much of a certain blood protein is coated with sugar. By WHO standards, people with certain levels of it could be diagnosed with diabetes, and could be diagnosed at an intermediate category at somewhat lower levels.

Even that wasn’t good enough for the ADA, which reduced that threshold further. In their commentary, Montori and Yudkin called it “a decision not endorsed by any other group.”

Those lower thresholds means that as many as three times more people are told they have impaired blood sugar metabolism — or pre-diabetes. That would include half of all adults in China, or half a billion people in that country alone.

In the U.S., those levels mean that 35 in 100 people older than 20, and half of everyone older than 65, have pre-diabetes. That's about 86 million people, and although this country has a problem with obesity and diabetes, that’s outrageous. Unless you’re with the ADA.

The larger point made by Montori and Yudkin is that a pre-diabetes diagnosis is of little value. They say research shows that half of people identified with “impaired glucose tolerance” and about 2 in 3 people identified with “impaired fasting glucose” will not have diabetes 10 years later. They say there’s no evidence that borderline levels of sugar-coated blood protein are a good predictor of who will and who won’t develop diabetes.

But treating people with pre-diabetes with either lifestyle interventions or drugs also has been shown to have a modest effect. It doesn’t prevent the onset of type 2 diabetes, but delays it by only a few years.

Still, lifestyle interventions are not risky or, generally, expensive; they’re healthful habits everyone should adopt. Drugs, of course, are a different matter.

As Yudkin said in the news release, “The ADA recommends treating pre-diabetes with metformin, but the majority of people would receive absolutely no benefit. There are significant financial, social and emotional costs involved with labeling and treating people in this way.”

Using new and expensive drugs as treatments for pre-diabetes, he said, would benefit primarily the drug manufacturers. And, we would add, the practitioners who write those prescriptions.

“Healthy diet and physical activity remain the best ways to prevent and to tackle diabetes,” Montori added. “…We need to keep making efforts to increase the overall health of the population, by measures involving public policy rather than by labeling large sub-sections of the population as having an illness. This is not a problem to be solved at the bedside or in the doctor’s surgery, but rather by communities committed to the health of their citizens.”

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August 11, 2014

Feds Quietly Stop Reporting Some Hospital Errors

We’ve long advised medical consumers to research hospitals they’re considering using for the kind and frequency of errors they make. But according to a story on USAToday.com, suddenly that’s more difficult than it used to be.

“The federal government this month quietly stopped publicly reporting when hospitals leave foreign objects in patients' bodies or make a host of other life-threatening mistakes,” the paper reports. That’s contrary to what the Centers for Medicare and Medicaid Services (CMS) is supposed to do, which is making available to the public data on hospital-acquired conditions (HACs).

Last year, according to USA Today, the CMS denied changing its data-reporting practice. But as of this month, the data for eight of these avoidable “conditions” no longer are being supplied.

So where is current information about hospitals with high rates of serious errors, including embolisms (obstruction of a blood vessel by blood clot or air bubble) and transfusions with the wrong blood type?

Hospital Compare is the CMS’ website for consumers to research hospital performance — you determine the nature of the search, either by location or hospital name. The site used to list how often many HACs occurred at thousands of hospitals that accepted patients with severe injuries or illnesses and/or while recovering from surgery. Now, says USA Today, CMS still reports the rate of occurrence for 13 conditions, including infections such as MRSA and sepsis after surgery, but has dropped others.

CMS told the paper that the changes are an effort to make reports "more comprehensive and most relevant to consumers," and that new measures using data from the Centers for Disease Control and Prevention (CDC) received "strong support" from a partnership of the National Quality Forum (NQF).

That’s a public-private enterprise that reviews performance measures that might be used in federal or private reporting and payment programs. Earlier this year, our blog, “Apparent Conflict of Interest Sullies Panel of Patient Safety Experts,” highlighted problems with a prominent physician in that organization.

Helen Haskell, a member of its Patient Safety Advisory Committee, told USA Today that some members of the hospital working group thought they were voting to strengthen, not drop, the measures.

"When we voted, I certainly didn't think it would result in the (hospital acquired conditions) being removed from Hospital Compare," she said. Founder of Mothers Against Medical Error, her son died in 2000 of a reaction to medication after surgery.

According to a spokeswoman for the NQF, it decided to drop the data because it wasn't "appropriate for comparing one hospital to another."

Um … isn’t that the definition of “compare”? Contrasting one thing with another of a similar type?

No reporting system is perfect, and the CMS and the American Hospital Association have questioned the reliability of the error data for things like foreign objects left inside the patient after surgery. But we wonder if the disappearance of important data has a political component — the Affordable Care Act (“Obamacare”) requires that the 25% of hospitals with the highest rates of certain HACs, including hip fractures or sepsis (severe blood infection) after surgery, receive less money from Medicare. And Medicare or Medicaid reimbursement also is withheld if treatment is related to one of the eight HACs.

According to USA Today, “CMS said it's working on new ways of measuring HACs that would represent some of the most common adverse events in hospitals; the HACs that are no longer publicly available are considered rare events that should never happen in hospitals. That makes them both harder to track — and, patient-safety experts say, more important for consumers to know about.”

The fact that they should never happen, but do, is exactly why the public should be able to find out if such events have happened.

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August 10, 2014

Sovaldi — Pay Now or Later

The $84,000 cost of Sovaldi, a drug recently developed to treat hepatitis C, has horrified patients and insurers and again invited people to see Big Pharma as an industry that gouges helpless people with life-threatening illness. But a recent analysis sheds new light on the issue.

Writing in the New York Times, Margot Sanger-Katz acknowledges that although the drug is a legitimate breakthrough in the treatment for the liver disease caused by hep C, many people accuse its manufacturer, Gilead Sciences, of setting an unreasonable and unsustainable price for it, at $1,000 per pill.

“But maybe we are looking at the costs of Sovaldi in the wrong way,” suggests Sanger-Katz. “One reason it is causing such angst among insurers and state Medicaid officials is that treatment costs are coming all at once.”

The average course of treatment is one pill per day for nearly three months. The problem is that so many people have been infected with the hep C virus that the pent-up demand results in a huge total cost.

As Sanger-Katz notes, about 3.2 million people in the U.S. are infected. Many have no symptoms for years, and remain undiagnosed, but those who have been diagnosed, have been waiting for a good treatment. Unlike drugs for other chronic diseases, including diabetes or AIDS, that require years-long treatment, Sovaldi can cure most patients’ hepatitis in weeks.

The bill comes due, and with it, sticker shock. But as Sanger-Katz points out, it’s a matter of pay now, or pay forever. “The lifetime cost of treating someone with an HIV infection,” she writes, “is around $380,000, according to estimates from the federal Centers for Disease Control and Prevention, but the annual bill is much smaller.

“Think about AIDS treatment as paying a mortgage. Sovaldi is like buying a house with cash.”

In this country, we’re used to health-care costs that are spread out and predictable because that’s how the insurance system works. An insurer doesn’t want a huge initial outlay for someone who might change plans later — it has paid to deliver a healthier person to a competitor.

Before its advent, treatment for hepatitis C was mostly about addressing symptoms — there was no “cure.” Some drugs attacked the virus itself, but they weren’t very good at it, and they came with significant side effects (fever, depression, anemia), so about half its patients weren’t healthy enough to tolerate them.

Those drugs weren’t really affordable, either — about $70,000. But few patients took them, so the cost didn’t generate the attention or reaction that Sovaldi has. Because it works fast and with fewer side effects, patients want it now, and, as Sanger-Katz says, “That means a big financial shock to the health care system all at once.”

Hep C is expensive because infected people can end up with liver damage and its complications, including joint pain, kidney disease, cirrhosis and even cancer. You can catch the virus from blood transfusions (rarely), but the people most at risk are intravenous drug users who share needles. In terms of demographics, it’s most common among the baby-boomer generation, whose members, as we’ve blogged, are all recommended to be tested.

Because so many people might be candidates for Sovaldi, some estimates say the cost could raise employer insurance premiums by half a percentage point next year, and that it could increase premiums for Medicare’s drug benefit program as much as 8% next year. One drug benefit manager for major insurance companies said that states alone could shell out $55 billion if every Medicaid patient or state prisoner with the disease was treated.

The law requires state Medicaid programs, which insure poor and disabled residents, to cover any drugs that are approved by the FDA. But even with a significant Medicaid discount, many states are concerned about the budgetary impact of Sovaldi.

So no wonder that so many interests, from the health insurance industry to patient advocates to members of Congress, are scrutinizing Gilead’s pricing strategy. The drug reached $3.48 billion in sales in the last quarter alone. The challenge gained steam when a Congressional investigation, according to Sanger-Katz, found documents showing that the pharmaceutical company Pharmasset, which developed the drug and was acquired by Gilead in 2011, had planned to sell it for $36,000 per course of treatment.

But what we should be focusing on, suggests Sanger-Katz, is the fact that Sovaldi appears to have the potential to save money over the long run. CDC data show that more than 6 in 10 people with hepatitis C will contract chronic liver disease, and as many as 2 in 10 will get cirrhosis. Both can result in the need for a liver transplant, the cost for which can approach $600,000.

Sovaldi cures about 9 in 10 patients, and researchers believe it has the potential to limit the spread of disease and, obviously, the costs of treating it.

In this light, the penny-wise, pound-foolish approach seems especially misguided, but logic is a weak opponent to industrial momentum. Under U.S. health-care financing, people change insurance coverage when they change jobs, lose Medicaid coverage when financial circumstances change and become eligible for Medicare at age 65. So one company pays the big Sovaldi bill, leaving another to enjoy covering a person with a healthy liver 20 years later.

“If it is cost-effective from a societal standpoint, it is not necessarily going to be cost-effective from a health plan standpoint,” Dan Mendelson, chief executive of a health-care consulting company, told Sanger-Katz. “I think some of the friction here results because the societal value is not reflected in the health plan operations.”

As we’ve seen over the tumultuous years of Obamacare, the way we subsidize health care is not likely to change any time soon. But as Sanger-Katz notes, the hep C crisis may soon wane. New, effective drugs are being developed to compete with Sovaldi, and competition generally drives down a drug’s price.

And demand for Sovaldi and its competitors also should diminish as the untreated population dwindles.

For this issue, it seems, time might be one of the best healers. If only people could afford the luxury of time.

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