DC Medical Malpractice & Patient Safety Blog

We’ve written about the wide range of state authority and competence in regulating medical practice, (for example, here and here.) Mostly, compromised patient safety occurs because of official acts of omission; rarely does a state appear to commit to compromising patient safety.

But as reported by the Milwaukee Journal Sentinel and analyzed by Pop Tort, the civil justice blog from the Center for Justice & Democracy, lobbyists are pushing legislation in Wisconsin to enable doctors to tell patients less than they’re obliged to communicate now.

Specifically, they want to rewrite the standard of “what a reasonable patient would want to know” to “what a reasonable physician would tell a patient.”

Such a regulatory change in informed consent—the idea that patients must be given the facts in order to make intelligent decisions about their medical treatment—pretty much renders the concept meaningless.

“The last thing you want to do is roll back the way we get information and how much information we get,” Martha “Meg” Gaines told The Journal Sentinel. She’s director of the Center for Patient Partnerships and an associate dean at the University of Wisconsin Law School.

Informed consent, as Pop Tort makes clear, should be what patients want to know, not what their doctors think they should be told. That’s the old, paternalistic model of patient relations that enlightened people reject.

The Journal-Sentinel recalled the story of how such a regressive idea gained legislative traction.

In 2003, Thomas Jandre, a heavy equipment operator, suddenly felt dizzy and weak. He was drooling and slurring his words. Co-workers took him to the hospital, where an emergency physician ordered a CT scan, and eventually diagnosed Bell's palsy, a viral nerve inflammation that causes facial paralysis.

She did not order an ultrasound of the carotid artery, which could have revealed that a blockage had cut off blood to Jandre's brain, and that he was having a mini-stroke.

Jandre had a massive stroke 11 days later that left him partially paralyzed and without use of his left hand.

An ultrasound subsequently showed that his carotid artery was 95% blocked. Had it been detected earlier, according to the lawsuit, surgery might have prevented the stroke.

A jury decided that the doctor was not negligent in her diagnosis, but was negligent in failing to tell Jandre that an ultrasound would determine whether he was having a mini-stroke. The jury awarded him $2 million in damages.

After appeal, the Wisconsin Supreme Court upheld the decisions of lower courts, an opinion, the Journal-Sentinel reports, that sharply divided the court and motivated medical professionals to propose the bill now before the Legislature to change the law on what doctors must tell their patients.

“Should patients be told about tests and procedures for medical conditions they might have, even if doctors don't believe they have them?” the newspaper asks. “Should a doctor explain why other diagnoses were ruled out? If not, can patients still make informed decisions about their care?”

Doctors and hospitals worry that the court decision is so broad that the list of options that must be disclosed to patients could be endless. The court’s lead opinion disagrees: What a patient must be told is not limitless, but is ruled by what a reasonable patient would want to know.

If you were in Jandre's shoes, wouldn’t you want to know if an inexpensive, noninvasive test could help determine if you were at risk of a major stroke, and if so, be given options about what to do?

The proposed law not only changes the standard to give physicians the keys to “reasonableness,” it requires them to tell patients only about alternative treatments for a diagnosis and their risks and benefits.

The court said the patient's condition—not the physician's diagnosis—should determine what the patient is told. And the current standard still offers physicians protection from the outlandish—they do not have to disclose information on highly unlikely possibilities.

Of course, “highly unlikely possibilities” is a definition open to individual interpretation, but given Jandre’s symptoms, no reasonable practitioner would have considered the possibility of a stroke “highly unlikely.”

See our firm's website for a detailed backgrounder on the vital concept of "informed consent," and the two dueling legal standards of what reasonable patients want to know, versus what reasonable doctors disclose.

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.

If you played a coin-flipping game where you could show all your winners and hide your losing tosses, you'd be way ahead. But nobody would let you get away with that, would they? If you're Big Pharma, you get away with hiding the evidence every day, as Dr. Ben Goldacre explains in an op-ed in the New York Times.

Drug companies developing new products get to run their own tests and publish only the results they like. Independent audits are few and far between.

This well known scandal was supposed to have been cured in 2007 when a new law required that the results of every clinical trial of a drug be published within one year of completion, or face a fine of $10,000 a day from the FDA. But as Goldacre reports, the first audit of this law was published in 2012 and found that four of every five trials had ignored the reporting requirements.

How many fines have been issued since the start of the new law?

Zero.

Goldacre also reports that a pledge of medical journal editors back in 2005 to never publish drug trial results unless the study had been publicly registered at its outset (to solve the same "bury the bad evidence" problem) has also failed to work. More than half of published research studies since then have not been properly registered, according to one audit.

Why is this bad for patients? Because we don't really know if the expensive drugs we take really work. And we'll never know unless each and every clinical trial that starts gets published when it ends.

In 2010, Johnson & Johnson recalled an all-metal hip implant device because of a high failure rate and because the grinding of its components released tiny bits of metal that damaged tissue and bone. The company conducted an internal review of the device in 2011 that showed the implant would fail within five years in about 4 in 10 patients.

Only now, as reported by the New York Times, is that information coming to light.

J&J’s report is among hundreds of internal company documents, says The Times, expected to become public as the first of more than 10,000 lawsuits by patients who got the implant, the Articular Surface Replacement (ASR), went to trial yesterday.

Hip implants made of metal and plastic instead of the metal-on-metal design of the ASR often last for 15 years before they wear out, according to The Times. They can fail prematurely for a variety of reasons, but not at the rate of the recalled device. A premature replacement rate would be about 1 in 100 after a year, and 5 in 100 after five years.

J&J never released the dismal five-year failure results for the ASR. “But at the same time that the medical products giant was performing that analysis,” says The Times, “it was publicly playing down similar findings from a British implant registry about the device’s early failure rate.”

We’ve written about the problematic history of metal-on-metal hip implants, and the new disclosure about hidden company documents once again puts Johnson & Johnson’s DePuy Orthopaedics division in the hot seat: What did company officials know about the device’s problem before its recall? What actions did they take or fail to take?

How many more failures of this shoddy device are about to occur? How many more patients who had the surgery are facing more painful and expensive surgeries to replace it?

As The Times reports, last year J&J took a $3 billion charge so that money could be reserved for patients and lawyers involved in the upcoming product liability lawsuits. DePuy, The Times says, has offered to cover the cost for patients to correct the problems.

That’s nice, but, really, if the company knew of the high potential for such problems and did nothing to address them before they harmed thousands of people, is that really much consolation?

The discovery last week of the internal report is only a tiny bit of what will become public knowledge if the company doesn’t settle, and the lawsuit proceeds to trial. Plaintiffs’ lawyers have been preparing for two years, and who knows what other ugly secrets J&J was protecting.

Approximately 93,000 people around the world have received an ASR; more than 31,000 of them live in the U.S. Some 7,000 separate ASR lawsuits have been consolidated in a federal court in Ohio, and another 2,000, says The Times, have been consolidated in a California state court.

The California case that brought the internal report to light involved a cancer patient who might not live much longer. The paper said DePuy has settled some ASR cases before trial, and it may do so in his.

Cold comfort, indeed. But a testimonial, at least, to the power of lawsuits to unlodge secrets of corporate wrongdoing.

Health journalist/watchdog Gary Schwitzer is among our heroes, and here’s another reason why. In a recent post on his HealthNewsReview.org, he championed the efforts of British physician/writer Margaret McCartney, who introduced a new resource for patients seeking information about their care.

“Private health screening tests are oversold and under-explained,” she wrote in a British newspaper that Schwitzer quoted. “Health screening can cause more harm than it prevents, so companies have a duty to provide full information to customers.”

With that, she described PrivateHealthScreening.org, explaining that frustration and anger led her and a few doctor colleagues to establish the website to share information about screening tests and help people direct their thinking in making decisions whether or not to have them.

McCartney reported that one of this group of doctors, a neurologist, went to his local church for something called a Life Line Screening. He paid $230 for the test. In a story he published later in BMJ (British Medical Journal), he asked: “Why is this nonsense tolerated or allowed?” (See our recent post about commercial come-ons for medical screenings.)

Although the “ask first, test later” sentiment and its productive result were forged in Britain, U.S. consumers can benefit from the online service. As the site explains, “We are a group of doctors who are concerned about the safety and the ethics of private screening tests. We are worried that the companies who charge you for these tests are not giving consumers full and fair information about them.”

The site links to pages explaining their concerns, as well as to a page offering examples of misleading advertising, doctor and patient commentary and stories about screening offers and their results. Its Evidence Bank link provides a host of authoritative, scientific analyses of a wide range of specific screening tests for head and toe and everything in between.

A Maryland-based medical staffing agency is at the center of allegations that it placed a rogue radiological technician into a number of hospitals in Maryland and other states. The technician is believed to have infected dozens of people with hepatitis C.

Maxim Staffing Solutions, a national firm with headquarters in Columbia, Maryland, placed technician David Kwiatkowski into three Baltimore hospitals: Baltimore Veterans Affairs Medical Center, Johns Hopkins Hospital and Maryland General Hospital, and also at Southern Maryland Hospital in Clinton, between 2008 and 2010.

Kwiatkowski was arrested in late July in New Hampshire after he was caught in a hospital stealing narcotic drugs that were intended for patients. He now faces federal charges.

The four Maryland hospitals are sending notices to several hundred patients to get testing for hepatitis C, a viral infection of the liver that, in bad cases, can lead to liver destruction and need for transplant.

Whether Maxim had reason to suspect the technician's danger to patients has yet to be determined. Lawsuits are likely against Maxim and another staffing agency that sent him to hospitals in as many as seven states in the last few years.

It's also unclear whether any of the Maryland hospitals had an inkling of problems with the technician. But at least two other hospitals, the prestigious UPMC Hospital in Pittsburgh and the Arizona Heart Hospital in Phoenix, fired Kwiatkowski after finding him with narcotic drugs.

A couple of months ago, we wrote about the sloppy, widespread clinical practices that put patients at risk of contracting hepatitis C, but this case, it appears, goes well beyond carelessness.

Maxim Staffing is alleged to have sent Kwiatkowski to UPMC in the spring of 2008. There, he was observed by another employee placing a syringe containing fentanyl, a Schedule II narcotic, in his pants. He replaced the missing syringe with another containing another liquid. Management confronted him, found three empty syringes with fentanyl labels on his person and an empty morphine syringe in his locker. His urine tested positive for fentanyl and opiates.

He was fired.

But UPMC did not report the theft, use or diversion of its controlled substances to any government agency or law enforcement authority. The technician was free to practice his alleged crimes elsewhere, and Maxim placed him in a matter of weeks into the first of four Maryland hospitals where he worked.

By the time he tested positive for hepatitis C in June 2010, dozens of patients who had undergone cardiac catheterizations at the hospitals that had employed him had been exposed to a common strain of hepatitis C. Most of them have learned only in recent months of their diagnosis. Based on this information, thousands of cardiac catheterization patients at hospitals where he worked are being tested for hepatitis C.

As noted in our backgrounder, hepatitis C can cause liver failure. The blood thins, and patients bleed easily. In the worst cases, called fulminant hepatic failure, the brain swells and the patient goes into a coma. About half of these patients die without an emergency liver transplant.

In July, a warrant was issued in New Hampshire for the technician’s arrest for acquiring a controlled substance by misrepresentation, fraud, forgery, deception or subterfuge, and for tampering with a consumer product with reckless disregard for the risk he posed to others of death or bodily injury, and for the serious bodily injury that has befallen others.

It’s shocking enough that a drug addict in a position to contaminate hospital equipment with a deadly virus not only would be hired and rehired and rehired without regard for his illness or the harm he created for others. But that the hospital and the staffing agencies that knew about the risk failed to report his crimes is unconscionable.

The tech was placed by Maxim into the four Maryland hospitals AFTER his firing from the Pittsburgh hospital. What excuse does Maxim have for failing to find out what had happened in Pittsburgh and for enabling his further crimes? We will find out in the coming lawsuits.

We do know this much. As a result of this infected technician being given access to patients in seven states across the country, dozens of people face a dire infection, and countless others are left to wonder if and when it will strike. With a hep C diagnosis comes significant costs for treatment and care, the possible loss of livelihood and maybe even life itself. And none of it had to happen.

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.

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.

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.



Posted by Patrick A. Malone | Permalink | Email This Post

Posted In: Conflicts of Interest , Disclosure

Approximately 40 million people undergo surgery every year. Writing on KevinMD.com, Dr. Paul Ruggieri asks: How many of those patients are informed of their surgeon’s track record? Not many, he surmises.

In a refreshing post of what’s-good-for-the-goose-is-good-for-the-gander, Ruggieri, a surgeon, argues that unless patients have access to the same information about doctors that hospitals and insurers have, “informed consent” is a hollow proposition.

“Today’s medical (and legal) system intentionally blocks patient access to pertinent performance information,” Ruggieri writes, ‘information readily available to hospitals, insurance companies and federal government agencies.

“…I believe in total transparency in the surgical profession and it is time to open up the hospital/insurance company books and take a look at information the public is craving….”

Read his full post by linking here.

For more reading on this important topic of patients' rights to get all the information they need to make intelligent choices about what happens to their bodies, check out the informed consent page on our firm's website.

Last week, the New York Times summed up pretty well what a lot of people have been thinking: “Poorly designed, hard-to-use computerized health records are a threat to patient safety, and an independent agency should be set up to investigate injuries and deaths linked to health information technology, according to a federal study…”

The paper was referring to “Health IT and Patient Safety: Building Safer Systems for Better Care," a report by the Institute of Medicine (IOM) calling for greater oversight of health-care technologies.

The U.S. Department of Health and Human Services (HHS) requested the IOM to evaluate electronic health records in the first place out of concern that some such products raised safety risks for patients. Practitioners were wondering if the boom in digital record-keeping is fostering a rash of medical errors thanks to balky, difficult or malfunctioning technology.

The report doesn’t decry the move – for reasons of both cost and care efficiency – from paper to electronic records, it just emphasizes that oversight must be part of the deal: “To achieve better health care, a robust infrastructure that supports learning and improving the safety of health IT is essential. Proactive steps must be taken to ensure that health IT is developed and implemented with safety as a primary focus. If appropriately implemented, health IT can help improve health care providers’ performance, better communication between patients and providers, and enhance patient safety, which ultimately may lead to better care for Americans.”

The IOM said an investigative agency -- like the National Transportation Safety Board, which investigates airline accidents and examines safety issues -- should be established for health-care technology. And that it should include tracking the safety performance of electronic health records.

So far, such efforts have yielded mixed results: There are tales of success, such as hospitals that use computerized, bar-coded prescription systems, but also tales of patient harm, such as delayed treatment due to lost data and/or problems with human-computer communication.

The IOM advised the Department of Health and Human Services (HHS) to devise a plan within 12 months to monitor patient safety risks associated with health IT, and to report on that progress every year. If, within a year, such progress is insufficient, the scientists’ group said the FDA should regulate these technologies, and that the agency should start planning for that now.

The IOM report is big on transparency. It is the government’s job to ensure that the private sector demonstrates concern for consumers by freely exchanging information about product use, “including details relating to patient safety.” You can’t establish a body of knowledge and develop a functioning market of safe products if you don’t share details of their risks.

This is thwarted today by the common practice of including nondisclosure clauses in contracts with vendors of IT health products. Such provisions impede efforts to improve safety by discouraging users from sharing information.

The report notes that clauses that limit liability (known as “hold harmless”) also undermine best-product practice by shifting liability “from the vendor to the users when an adverse event occurs.” As the story in The Times said, “Such language often limits the freedom of doctors and hospitals to publicly raise questions about software errors or defects.”

No one wants to stifle technological developments or the will to manage health care more efficiently. The key, as the IOM says, is to foster innovation without compromising safety.

A Kansas neurosurgeon who has been sued at least 16 times for malpractice has been able to enlist one important ally in protecting his privacy: the federal agency that runs the data bank that is supposed to keep track of dangerous doctors so they don't drift from hospital to hospital without their track record becoming known to hospitals who hire them.

The National Practitioner Data Bank (NPDB) is run by the U.S. Health Resources and Services Administration. It has both a public mission and a confidential one. The confidential mission is to allow hospitals to query the data base to obtain the track record of lawsuit payouts and disciplinary actions against doctors so they can make an intelligent decision about whether to bring a doctor onto their staff. The data bank also publishes aggregate data, without individual identifiers, about the doctors it keeps an eye on, so the public can see that it is doing its job.

A reporter for the Kansas City Star used the public data on the NPDB, among other resources, to figure out the lawsuit record of neurosurgeon Robert Tenny.

As shown by newly released documents, Dr. Tenny responded with a flurry of letters to the federal agency, which responded with:

* A threat against the newspaper reporter to punish him with fines for misusing the data bank. (This was later withdrawn.)

* Stern letters to all the 28 hospitals who had queried the data bank about Dr. Tenny to warn them that the information they had obtained on him was confidential and not to be disclosed.

* Shutting down the public access portion of the data bank.

The shutdown of all public data from the data bank has caused the most outcry, with a bunch of journalist organizations demanding that it be reinstated.

Senator Charles Grassley of Iowa released documents this week showing the cozy relationship between Dr. Tenny and the federal agency. You can read the documents by clicking here.

Article first published as Federal Health Agency Takes Side of Multi-Sued Surgeon on Technorati.

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.

In theory, people support the presence of trainees for medical procedures. But when it comes to personal practice … not so much.

So says a study in the Archives of Surgery, which examined patient perceptions and willingness to participate in resident education. More than 8 in 10 patients consented to having an intern participate in their surgical procedure, and more than 9 in 10 consented to the presence of a resident. But when presented with a real situation of trainee participation, not even 1 in 5 said OK.

More than half of the survey respondents said that knowing that their operation was a trainee’s first would affect their consent negatively.

As explained on MedPage Today, in the 1980s surgeons thwarted proposed legislation to mandate “informed consent” when trainees were involved in a patient’s procedure. The docs had argued that such patient consent referred only to the “responsible” surgeon who provides supervision and oversight. Today, the study’s researchers noted, it’s still common practice not to inform patients of trainee participation.

In an accompanying commentary to the study, Ali Salim, M.D., wrote “"As part of [the informed consent] discussion, it seems obvious that patients would want the extent of involvement of surgical trainees during a surgical procedure to be disclosed, but current ethical and legal requirements for informed consent for care by trainees have not been well elucidated."

"To my knowledge,” Salim wrote, “no specific requirement or guidance exists regarding disclosure of the extent of participation of surgical trainees."

If that just seems wrong, the writers concur that full disclosure of trainee participation would affect their education negatively, because patients might refuse permission for them to participate in their care. More than 8 in 10 survey respondents indicated they wanted to be informed about trainee participation.

So here’s the quandary: Medical students can’t learn how to be good doctors without hands-on training, and although patients understand that, they don’t want to be the individual guinea pigs. The authors suggested that patients should be better educated about the nature of a teaching hospital and the benefits for patients to have trainees participating in procedures. But they remain wary about full, mandatory informed consent.

"We believe that broad calls for routine mandated disclosure should be carefully planned and analyzed prior to implementation to avoid any adverse effects on surgical training," they concluded.

Anyone who watches TV has been bewildered/amused/confused/annoyed by pharmaceutical ads that begin by explaining how your life can be perfect if you take this drug, and end with a rushed recitation of all the things that can go wrong if in fact you do take the drug.

Drug companies, of course, are obliged by the FDA to include potential side effects when they’re trying to sell you their products. But as proved by a recent study in PLoS ONE (a journal for peer-reviewed scientific and medical research), Big Pharma pretty much thumbs its nose at the FDA when it advertises in medical journals, where it's trying to sell its wares to doctors.

Among the nine publications reviewed by researchers were such mainstream journals as Annals of Internal Medicine, New England Journal of Medicine and Journal of the American Medical Association. About half of the ads reviewed violated at least one FDA rule, and about one-third were “possibly” out of compliance because of missing information. More than half of the drug ads failed to quantify serious risks. Fewer than 1 in 5 adhered to all FDA guidelines.

As explained by MedPage Today, the pharmaceutical industry spends $58 billion on marketing; the FDA’s division of marketing and advertising has $9 million. So what are the chances a miscreant marketer will get caught?

To help bridge the budget gap, the FDA recently implemented the “Bad Ad” program, asking physicians to report nonadherent or misleading ads. But that’s like asking the playground monitor to report bad behavior – what’s bad to one monitor is just kids being kids to another. As the researchers noted, the guidelines are difficult to enforce, don't emphasize transparency and ignore basic information relevant to prescribing.

The most common breaches or possible breaches of rules were:

• misused references to the scientific literature;


• misleading use of graphics;


• failure to cite references;


• overrepresentation of the experience with the drug.

By medical specialty, at least one FDA rule was broken by ads for:

• 6 in 10 hematology/oncology products;


• 5 in 10 cardiovascular and diabetes products;


• more than 4 in 10 psychiatric products.

As the researchers wrote, “Advertisements do a poor job of conveying basic information necessary for safe prescribing, with the majority failing to quantify serious risks.”

Despite their concerns, they said that “most advertisements we reviewed satisfied the majority of FDA guidelines.” It makes you wonder, though, about the squishy nature of the guidelines – the researchers also noted that an ad that makes no specific claim about efficacy and does not quantify drug safety is still in compliance.

The study recommends that the FDA update and simplify ad regulations, and require ads to explain risks clearly, offer information on absolute benefits and verifiable references and identify the appropriate population for the drug’s use.

All of that seems like a no-brainer. And another reason why, when your doctor prescribes a drug, you should ask what are the potential side effects and risks, and why he or she has chosen it over others. Read the patient information that’s included in the drug packaging.

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.

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.

MarylandReporter.com reports that the state will request an exemption from a new requirement by Medicare that hospitals demonstrate their quality of care. Taking effect Oct. 1, the requirement financially rewards hospitals that meet the new standard and penalizes those that don’t.

Robert Murray, executive director of the Health Services Cost Review Commission, said the state will document for the feds that “Maryland already has those programs in our system.” The commission has tracked the quality of hospital care for three years.

“The health reform act says you can be exempt from this regulation if you show you already meet or exceed [the national requirement]," Murray said.

Maryland is the only state in the country with a waiver from the Medicare payment methodology, which was negotiated in 1977 when Medicare agreed to pay hospitals in Maryland on the basis of commission-set rates. Other states since have been granted waivers but only Maryland has maintained its waiver.

Every patient and every doctor know that delivering bad news is something that physicians sometimes have to do. But too many doctors don't realize that the way they communicate can cause terrible and needless emotional injury.

A flat, heartless delivery of bad news can make patients feel abandoned and devastated. A touch of compassion, on the other hand, may not extend a patient's life by a single day, but does make them feel that they are still part of the community of the living.

Patient advocates say that Compassion is one of the four C's that patients have a right to expect. (The others are: Competence, Communication and Convenience.)

William Branch, an internist and professor at Emory University School of Medicine in Atlanta, has conducted studies for two decades to determine if physicians can be taught to be more compassionate.

Dr. Branch maintains that “our healthcare system does not lack compassion,” and that compassion can be taught, though not in a single training session.

In research conducted at five medical schools in 2009, Branch studied two sets of faculty members on their compassion skills as evaluated by their medical students and residents. The students watched the faculty members interact with patients, and they scored those interactions plus the quality of their direct teaching of caring skills.

One faculty group underwent a two-year program that combined experiential learning of skills such as role modeling along with reflective exploration of values through writing narratives and other activities. The other group had no intervention. The study found that the compassion-training group rated significantly more compassionate with their patients.

However, just as it can be taught, compassion also can be lost. A 2008 study of 419 medical students showed that women had twice the empathy scores of men and that scores declined at the end of the third year, when students had begun regular exposure to patients during clinical rotations — exactly at the point where they needed more, not less, empathy. But this trend can be prevented; another study of 209 students at the Robert Wood Johnson Medical School found that empathy was maintained among third-year students who received specialized training.

Source: Washington Post

You can read Dr. Branch’s research paper in Academic Medicine here.

Research shows that a surgeon who has been working for 24 hours is impaired as much as a drunk person in thinking and motor function. So should patients have a right to know if their doctor has been up all night?

Yes, say a group of sleep researchers, who argued for full disclosure of sleep deprivation in a recent article in the prestigious New England Journal of Medicine.

No, responded the American College of Surgeons, whose leaders say it should be up to the individual surgeon to decide if he or she is too tired to operate -- or if the surgeon needs to tell the patient before heading to the OR.

The debate shows that surgeons and hospital administrators are just beginning to consider some basic issues of fatigue and patient safety that in other contexts -- piloting airliners and driving large trucks on interstate highways -- have long been settled.

Surgeons understandably don't want to be subject to the welter of bureaucratic rules that truck drivers and pilots deal with. And patients might not like it either if a surgeon was required to announce that he would be starting their surgery but another doctor would come into finish it because the time would stretch beyond the first doctor's hour limit.

But some sensible limits could easily be put in place. For one, the opportunity for a surgeon to work inhuman hours is created by hospitals who let a surgeon sign up for overnight call, which often results in working all night in the OR, and let the same surgeon schedule elective non-urgent cases for the next day.

Why would a surgeon do this in the first place? The lure of money, as a number of commenters on the New England Journal of Medicine website candidly admitted. Which raises a problem with the American College of Surgeons' idea that surgeons should be left to their good judgment on when and when not to operate. Anyone who schedules back-to-back call nights with elective cases is not showing good judgment in the first place.

Another issue for patient safety is the surgeon who is well rested but inexperienced, for not having gone through sleepless nights filled with surgical cases. Residency training programs are now starting to limit young surgeons to 16-hour days, which many surgeons say is going to result in a generation of rested but green doctors.

The right of informed consent gives at least one answer to the conundrum. Every patient has a right to know what any reasonable patient would want to know going into a surgery. And since we would all pause before submitting to the knife with a surgeon smelling of alcohol, the same right should apply to the less obvious danger of the sleep-deprived surgeon. If a doctor wouldn't want a family member to undergo surgery with that glassy-eyed doctor, then the same right should apply to all patients.

This means patients should be told, and should be given the option of rescheduling or bringing in a fresh replacement to operate. This will be inconvenient for hospital schedulers and may cause some surgeons to lose income. But patients will ultimately be safer for it.

And if hospitals want to minimize patients getting upset for having their plans upended at the last minute, all they have to do is adjust their call schedules to make these up-all-night dilemmas a rare event.

Article first published as Should Patients Have a Right to Know When Their Surgeon Has Been Up All Night? on Technorati.

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.

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.

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.

State medical boards are important agencies that can take away a license from a doctor who is dangerous to patients because of drug addiction, ethical lapses or incompetence. Routinely, however, the boards turn out to be focused more on protecting wayward doctors than protecting the public from malpracticing doctors.

Here is how a new article in the Dallas Morning News opens:

Seven years ago, after a scathing series of stories in The Dallas Morning News, the Texas Medical Board promised to crack down on bad doctors. Patient endangerment would be dealt with severely. And sexual misconduct, one official said, would become "intolerable."

It hasn't turned out that way.

After its last meeting, in late August, the board announced decisions on four sex-related cases. Two involved doctors whom judges had already sentenced for crimes against children. Two involved psychiatrists found to have had affairs with adult patients – potentially sexual assault under Texas law, but they've not been charged.

The child abusers were allowed to go on practicing medicine, though not with kids. The other two are working without restrictions.

It's all part of a broader pattern of tolerance for misconduct, a News analysis shows. Others who kept their licenses after the August meeting include two doctors convicted of lucrative federal crimes that put patients in harm's way; a neurosurgeon who operated on the wrong body part four times; a cardiologist found to have performed dozens of invasive procedures with little or no cause; and at least seven physicians linked to a death.

In all, 131 doctors were disciplined at the meeting. Only two had their licenses revoked, and then only because they quit contesting the cases against them. A handful of others were suspended or surrendered their licenses rather than fight.

Readers are urged to look at the entire story.

This is depressingly familiar to patient safety advocates. Thirty years ago, I participated with a team of investigative reporters at the Miami Herald where we uncovered similar attitudes. (See discussion on my bio page.)

One key part of the pattern is that medical boards are dominated by physician members. There is no reason why this needs to be. Any intelligent public-minded citizen can understand issues like sex abuse of patients, drug addiction, wrong-site surgery and the other serious transgressions that the boards deal with.

Yet another problem is that even when boards act, their actions are so shrouded in secrecy that patients often never find out that their doctor has any issues. That is why in my book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, I counsel patients looking for a doctor not to rely heavily on a "clean slate" when they search for medical disciplinary actions. That can often be meaningless. Even an empty listing on medical malpractice lawsuits can be meaningless, when those are settled quietly and the records sealed.

The CEO of Beth Israel Deaconess Medical Center in Boston is speaking out about his hospital's efforts to prevent deadly infections. The question is: How come few other hospital executives are talking about their efforts? Are they not making vigorous efforts? Or are they obsessed with secrecy, as so many in the medical industry are?

Paul Levy posted his hospital's numbers on reducing "central line" infections -- the infections that patients in ICUs get in the large-bore tubes that have to be inserted to monitor activity in the heart and deliver medicines to really sick people. When these infections occur, the already sick patient often dies. Pioneering work by Dr. Peter Pronovost proved that rigorous hand washing and other sanitation practices can reduce these infections to close to zero.

Mr. Levy is justifiably proud of Beth Israel's hard work at getting its infection rate down. But he wrote a blog entry that talked about his disappointment that others have not joined in. Here's an excerpt:

The response to my public and private entreaties in this realm has been silence -- from hospital professionals, from insurance executives who care about a transformation of this industry, and, indeed, from public advocacy groups who care about access to care and the quality of care delivered. Some observers attribute the medical profession's lack of engagement to an underlying fear of transparency. And yesterday, a world expert in this field, whose wisdom and advice I treasure, told me that he has come to accept gradual progress in quality and safety improvement, citing the kind of training doctors get, which does not emphasize these areas. That such a person has become content with gradual changes in the status quo is an indication of what it must be like to beat your head against this wall of recalcitrance for several decades.

My advantage, being without medical training and having had but a short tenure in this field, is that I retain a sense of outrage. Our collective failure to approach this problem using well established methods of process improvement -- including publication of current performance results -- represents a moral and ethical lapse by the clinical and administrative leadership of the medical establishment in this city. Why? Simply put, a profession that takes an oath to do no harm is, by inaction or incomplete action, doing harm. We are causing people to die who should not die. What would we call that if we saw it happening in other sectors of society?

Here's the full blog entry, which has comments below it.

I learned about Mr. Levy's blog from Consumer Union's excellent blog at their Safe Patient Project website.

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."

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.

One hundred thousand preventable deaths from medical errors in hospitals each year: That is the usual statistic cited by patient safety advocates. It comes from a 10-year-old report issued by the Institute of Medicine of the National Academy of Sciences. The fact is, though, that the death and injury rate could be substantially higher. No one is sure, because no one is counting "adverse events" in a rigorous, systematic way, and evidence keeps piling up that hospitals under-report these events to health authorities and worse, cover them up.

An investigation by the New York Daily News of the city's municipal hospital system -- with eleven hospitals and 1.1 million patients treated last year, the nation's busiest city-run system -- found dozens of examples of failures to report egregious errors, and subsequent cover-ups including alteration of medical records to make it look like nothing had gone wrong.

The Daily News reported:

The coverups hid a trail of human suffering among patients who were maimed and relatives who were never told the truth about how their loved ones died or were injured unnecessarily.

The newspaper found a pattern of failures by state health authorities to act on evidence of fraudulent behavior in covering up the injuries. Moreover, it found that the state reporting agency itself was dysfuctional. According to the article:

The state is supposed to track and analyze all medical incidents and implement improvements. The problem is this oversight system — the New York Patient Occurrence Reporting and Tracking System (NYPORTS) — is a disaster.

Since 1999, all New York hospitals have been required to self-report a long list of medical incidents to NYPORTS, which in turn analyzes the incidents and implements patient safety reform.

Sunday NYPORTS barely functions. The Statewide Council that oversees it hasn't met in more than two years. Though NYPORTS is supposed to release "annual" reports, the last one filed is dated 2004.

To avoid needless injury, patients have to be vigilant about their own health care. That is why I wrote my book, "The Life You Save," which lays out a system of nine simple steps for patients to follow to get the best medical care and avoid the too-frequent disasters that happen in our fragmented care system.

Web sites are proliferating that offer candid -- sometimes brutally so -- reviews by patients of doctors. The sites include Angie's List, RateMDs, Yelp, DrScore and Vitals.com.

Now some doctors burned by reviews are striking back. A growing number of them are asking new patients to sign up-front agreements promising not to post anything about them on-line, or in any other media, "without prior written consent," according to an article by Sandra Boodman in the Washington Post.

The ethics and legality of such "gag orders" are questionable. But to my lights, they serve a useful purpose: Any doctor who would be so sensitive to criticism that he or she would ask me to sign such an agreement is not a doctor whom I would want to trust with my life. Period.

As for the web sites themselves, they have varying amounts of useful information. RateMDs, for example, one of the biggest, covers some 200,000 physicians across the country, but most of the doctors have only one or two reviews. It's not fair to make a judgment about a doctor based on such a limited survey. I would want to see at least ten or more reviews of a doctor, and see how consistent the ratings were among the responders, before thinking this was useful information.

The popularity of these web sites is a sign of how hungry patients are for reliable information in making the important choice of a doctor. And the fact is that there is very little reliable objective information on which patients can make informed decisions. I devoted a chapter of my book, "The Life You Save," to finding a top primary care doctor, and another to finding a top surgeon. I believe there is no easy shortcut for the hard work of:

* Checking credentials to make sure the doctor is board-certified by one of the officially recognized boards (Michael Jackson's live-in doctor, for example, was not certified in anything).

* Experiencing the doctor's care, at least once, to gauge his or her listening skills and empathy. These are important not just for making patients feel good, but for making accurate diagnoses and giving patients confidence in the care plan the doctor develops.

* Making sure the doctor has adequate backup for when the doctor is out of town.

* Learning that the doctor is on staff at a good nearby hospital.

A detailed discussion of how to find top doctors and surgeons can be found in Chapter 5, Chapter 6 and Chapter 10 of "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst."

A column in the New York Times by Pauline Chen, M.D., relates how a colleague of hers named "Ed" crashed and burned on his way to becoming a general surgeon, seemingly because of his difficulty in learning from his own mistakes.

The blog comments by both doctors and patients are revealing. Many make the point that physicians can deal with the stresses of medical practice, and become better at their craft, by being less obsessed with perfection and more open to working with others in a supportive, teamwork environment. I particularly enjoyed a comment (No. 121) from "Susan," that linked the issue to the recent story by Jane Gross in the Times about the Sisters of St. Joseph near Rochester, New York, who have figured out that putting the patient's wishes at the heart of the enterprise makes for more humane and better health care.

Here is the comment I posted on the Times' site:

Susan’s comment is right on target. A team ethic, and the recognition that “we’re all in this together” — patients included, goes a long way toward making the inevitable small mistakes a teaching moment rather than one step toward a disaster for the patient. And when disaster does happen, honesty is always the best policy. I represent patients in lawsuits against hospitals and doctors, and can say emphatically that the medical industry could greatly reduce its exposure to legal actions if hospitals and doctors would just respond with maturity and complete candor when mistakes happen.

One more change in philosophy could help reduce the toll of medical error. If patients were more involved at every step of the process, we could help nip a lot of disasters in the bud and get better care for ourselves and loved ones. There is much that we can do, starting with reading our own medical records. I just wrote a book about this called “The Life You Save: Nine Steps to Finding the Best Medical Care — and Avoiding the Worst.” Chapter One can be read at http://www.lifeyousave.com.

Several letters to the editor in the New York Times have good thoughts on the critical topic of reducing hospital-acquired infections. It's important not just to exhort hospital administrators to try harder, but to set up incentives that reward safety and punish harm. One incentive not discussed in these letters is a national mandatory disclosure system. That would require hospitals to measure and publicly report all their infections. Consumers would then be able to make intelligent decisions about which hospitals to seek care at.

As previously discussed in this blog, Consumers Union has been advocating such a disclosure system for several years and has made headway in various states, but a national system is needed.

Chapter 13 in my new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, talks about, as the chapter title says: "The Scandal of Infections in Hospitals and Other Health-Care Facilities, and What You Can Do." Patients and family members can do a lot to enforce hygiene rules and avoid infection.

Many elderly patients suffer protracted, and expensive, deaths as health care providers pummel them with technological fixes for bodies that have already worn out. The dilemma is that while no doctor wants to give futile care that tortures more than it heals, no one also wants to be guilty of euthanasia or abandoning their patient.

A group of Roman Catholic nuns at a convent near Rochester, New York, has a new/old answer to this dilemma: Involve the patient in a warm and loving community where the patient's wishes are always paramount, but death is faced with realism, and care goals are clarified long before any final crisis. As Jane Gross reported in a beautiful article in the New York Times:

A convent is a world apart, unduplicable. But the Sisters of St. Joseph, a congregation in this Rochester suburb, animate many factors that studies say contribute to successful aging and a gentle death — none of which require this special setting. These include a large social network, intellectual stimulation, continued engagement in life and spiritual beliefs, as well as health care guided by the less-is-more principles of palliative and hospice care — trends that are moving from the fringes to the mainstream.

For the elderly and infirm Roman Catholic sisters here, all of this takes place in a Mother House designed like a secular retirement community for a congregation that is literally dying off, like so many religious orders. On average, one sister dies each month, right here, not in the hospital, because few choose aggressive medical intervention at the end of life, although they are welcome to it if they want.

“We approach our living and our dying in the same way, with discernment,” said Sister Mary Lou Mitchell, the congregation president. “Maybe this is one of the messages we can send to society, by modeling it.”

I recommend reading the entire article, which is one more example of a spirit that I have tried to imbue in my book, “The Life You Save: Nine Steps to Finding the Best Medical Care — and Avoiding the Worst.” When patients become actively involved in understanding their own health care, they can make decisions that best fit their own values.

Having an ally to help you negotiate the health care maze can be absolutely critical to obtaining the best medical care, especially if you are sick enough that you're not thinking as clearly as usual. A patient advocate does not need any special training in medicine or nursing -- just an inquisitive mind and persistence in asking questions and getting answers.

As this blog has previously reported, patients in some parts of the country now can find professional patient advocates to help them. People who have tried it say these advocates are lifesavers who are worth every penny of their fee.

A group that does this for free with volunteers is called Bedside Advocates in the Boston area, founded by retired physician Jonathan Fine. The group was featured in a recent story by NPR health reporter Richard Knox. The problem is that volunteers working part-time can only help a limited number of patients, and the need is vast.

Nurse Dianne Savastano has set up a professional patient advocacy service, also in the Boston area. The NPR story quotes one of her clients, Barbara Porter, who hired Ms. Savastano to help manage the complex care needs of her elderly father, for which she pays Ms. Savastano $15,000 a year. Says Ms. Porter: "I tell him, 'Dad, you got resurrected.' He literally did get resurrected. He would either be dead or in a nursing home right now if it wasn't for Dianne."

Patrick Malone's new book, "The Life You Save," gives a list of pointers for how family members can become effective advocates for their elderly relatives who cannot manage their own care. If you live in an area with professional patient advocates, that should be an option you should consider. None of us can go it alone in this complex health care system.

A new report from Consumers Union says too many patients are still dying every year from needless errors. The report makes a number of proposals for how reforms could be instituted to improve patient safety. A starting point will be to change the health reform debate in Washington from one of just access and money to one focusing on quality and safety.

Nearly 10 years ago, the Institute of Medicine estimated that nearly 100,000 people died each year from preventable medical error. Has there been any substantial improvement in the last decade? The Consumers Union report says the frustrating answer is "We don't know" -- because systems to methodically measure and report harm are still not widely in place.

What should consumers push for?

* A national system with mandatory reporting of all infections acquired in health care facilities and other harms from preventable errors.

* More widespread adoption by hospitals of computerized systems for ordering and dispensing drugs to cut medication errors.

Those are the key steps called for by the Consumers Union report. Here's one more that I advocate in my new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst -- a "single payer" system. How would having a government-paid health care system help with safety? For starters, it would allow much easier monitoring of quality and errors. Instead of cobbling together data from dozens of insurance companies about how patients did at a particular hospital, all the data would be centralized and could be easily analyzed and compared. That way, problems with care could be more easily identified before tragedies occur.

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.

One day after the FDA approved a new antiwrinkle drug (Dysport) in April 2009, the agency issued a new requirement that these drugs must carry a “black-box” warning label, the strongest safety warning typically reserved for drugs with very serious risks, Natasha Singer reports in a New York Times story. A popular antiwrinkle drug in the U.S. is Botox.

Botox and Dysport are injectable drugs developed from botulinum toxins, which temporarily paralyze the muscle into which they are injected. When administered for approved uses at approved doses, the botulinum toxins cause no harm. However, if used improperly, the toxins can travel from the injection site to other parts of the body, causing difficulty with swallowing or breathing.

Approved uses of injectable botulinum toxins include treatments for crossed eyes, eyelid spasms, severe underarm sweating, frown lines, and cervical dystonia, a neck problem that can cause severe pain and abnormal head position.

According to the new FDA requirement, the drug manufacturers not only have to add the black-box warning labels, they also have to inform doctors of the risk information in writing, and make available a medication guide to patients at the time of injection.

Patients are well advised to read all handouts on drugs they take, especially something used for cosmetic purposes. Every drug has risks and must be taken with caution.

Ten rules for safer drug use can be found at Public Citizen's Health Research Group website. These rules and more tips for safe drug use are discussed by Patrick Malone in his book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

An Institute of Medicine report released on April 28, 2009, denounces the adverse effects that the health care system suffers from the free gifts regularly pumped into hospitals, medical schools, and doctors’ offices, writes New York Times’ Gardiner Harris. The report strongly advises doctors to stop accepting the gifts. The report says that accepting gifts would “create conflicts of interest, threaten the integrity of their missions and their reputations, and put public trust in jeopardy.”

When doctors accept gifts from drug companies – which may be money, drug samples, office supplies or food – they change their prescribing habits. This change may or may not be conscious, but the “reciprocity instinct” that prompts people to return a favor is part of human nature that has been recognized by psychologists and anthropologists. And when this happens, the patients are the real victims: their doctors may prescribe new drugs that are yet to be tested for their safety or effectiveness, or drugs that patients can easily replace with diet or lifestyle changes.

In his new book, The Life You Save: Nine Steps to Finding the Best Medical Care – and Avoiding the Worst, Patrick Malone discusses steps patients can take to avoid being victims of such conflicts of interest. He also explains how an average patient can dissect statistics on drug performance to determine if a particular drug is really as effective as it’s marketed to be.

In its letters sent to 14 pharmaceutical companies in March 2009, FDA required risk information to be included in the Internet search advertisements of drugs – a move welcomed by consumer advocates, reports Stephanie Clifford in a New York Times story.

The short text ads that appear to the right of Google search results are limited to 95 characters, in which space pharmaceutical companies are now required to include not only the drug’s name but also its risk information. Although the drug companies had made risk information available just one click away from the search ads, which linked to a webpage containing detailed information of the drugs including side effects, the FDA issued this new requirement to ensure consumers are not misled.

Rita Chappelle of the FDA said in an NYT interview that it’s “vital and critical” that consumers do not mistakenly believe the drugs to be safer or more effective than they really are. This precaution is especially important in drugs that have frequently occurring or serious side effects, such as depression, liver damage, infections or severe allergic reactions.

Widely hailed for saving lives through early detection of breast cancer, mammography may in fact “do more harm than good,” writes Roni Rabin of the New York Times. Rabin reports that British health care advocates and experts complained in a letter to The Times of London that candidates for mammography receive informational fliers that exaggerate the exam’s benefits and neglect to advise patients of potential harms.

Mammography detects cancers indiscriminatingly, picking up aggressive tumors as well as those so slow-growing that they present no health risks for women who have them. As a result, for every woman saved from deadly breast cancer by routine mammography, at least one other woman would have her life unnecessarily disrupted by overtreatment of a slow-growing cancer that’s not life-threatening.

Mammograms also often result in "false positive" reports which scare women who think the test has shown they have a deadly cancer when further testing shows they have no disease. This is particularly a problem when mammograms are used in low-risk groups like women under age 50.

Further, early detection of the deadly form of breast cancer may not necessarily be life-saving, says Dr. Ned Calonge, chairman of the United States Preventive Services Task Force, which writes consensus reports on all sorts of screening tests, because the cancers are too aggressive to treat even when found early.

In addition to unnecessary emotional distress and extraneous treatment and related costs, other potential harms of mammography include exposure to radiation during the exam.

On the other hand, many doctors, including the director of cancer screening for the American Cancer Society, still believe mammography should be recommended to women of normal risks for breast cancer (e.g. over 50 years of age, family history of the cancer), preferring overdiagnosis to delayed diagnosis.

Before a more definite conclusion is reached within the scientific community, patients should educate themselves about the benefits and harms of mammography, because the ultimate decision of whether to be screened is in their own hands.

It's always intimidating to undergo an MRI scan or CT scan. The machines are loud and enormous and seem to swallow your body. For all the trouble and expense, patients deserve the very latest scanning equipment and should have their images read by only the most highly qualified doctors. Alas, there is a quiet scandal in the $100 billion/year medical imaging industry. Patients cannot count on the best unless they insist on it.

As quoted by Gina Kolata in the New York Times, radiology leaders say, in the words of one: "The system is just totally, totally broken." That from Dr. Vijay Rao, chair of radiology at Thomas Jefferson University Hospital in Philadelphia. One big problem is that insurers pay standard rates for scans, even if a scan on a 10-year-old machine produces a blurry image and results in patients undergoing unnecessary surgery or missing a diagnosis. There is also no financial incentive for scanning facilities to have the images interpreted by sub-specialists with more expertise in the body part being studied. But there is a big financial incentive for doctors to own their own scanning equipment, and that results in many unnecessary referrals for scans when the doctor's judgment about the patient's needs is clouded by financial conflicts of interest.

Wise patients should ask pointed questions before submitting to any imaging scan. Here is a list, adapted from Patrick Malone's new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, available at Amazon.

1. Is the scanning machine the latest generational available? If not, is there another facility nearby that has the latest generation? (In MRI scans for example, the stronger magnets on newer machines make for crisper images.)

2. Does the doctor who wants me to have this scan own the scanning equipment or the scanning facility? (If so, get an opinion from another doctor with no financial interest about whether you need the scan at this facility.)

3. Who will interpret the images? Is that doctor a sub-specialist in what's being studied? (Examples of radiology sub-specialties include musculo-skeletal, neuroradiology (brain and spine), abdominal and chest.) If not, can we get a second reading from a sub-specialist?

4. Is the scanning facility accredited by the American College of Radiology? (This ensures that basic standards are met, such as the technologist who runs the scanning machine being certified and the machine being regularly inspected for proper functioning.)

Involved patients will also want to sit down with the doctor and look at the images together. You will notice how much more detail comes out when the scan has been done on an up-to-date machine by well-trained personnel. In the New York Times article, you can see in a knee scan how the ligament is blurry on the left-side image but comes out clearly in the image on the right -- a slanting striated structure that connects the middle of the top of the tibia to the back of the femur.

When a doctor knows that his patient would receive better care elsewhere, should he inform the patient and send him to another provider? While this question is yet to be settled among bioethicists and physicians themselves, authors of an article published recently in the journal, Public Library of Science Medicine, think doctors have an ethical obligation to tell patients that better care is available to them, according to the New York Times’ Denise Grady.

Research has shown that facilities that perform high volumes of a certain procedure do it better than those that perform the procedure less frequently. The difference is substantial, especially in surgeries of pancreatic and esophageal cancer, although “the experience of the surgeon and the whole medical team [is] important in any major cancer surgery.”

Only a few courts around the country have decided whether doctors have a legal duty to inform patients that another doctor might have more skill and experience performing a planned surgery. One of them is Maryland's highest court, the Court of Appeals, thanks to a client of Patrick Malone named Billy Boone who suffered brain damage after an ear surgeon punched a hole into Mr. Boone's brain.

Mr. Boone's case shows that surgeons' skills make a difference in much more than cancer surgeries. The Maryland Court of Appeals decided that Boone had a legal right to know that his surgeon did not have extensive experience doing the ear surgery that Mr. Boone underwent.

Mr. Boone had an outpatient surgery in January 2000, to remove a benign growth from the mastoid cavity behind his left ear. Dr. Seth Goldberg, an ear nose throat surgeon, performed this surgery, called a mastoidectomy. Seventeen years before, Mr. Boone underwent the same procedure, in which another surgeon drilled out the same mastoid to remove a cheesy growth of skin debris called a cholesteatoma. Unknown to Boone, the surgeon had become lost at one point during the procedure and drilled a hole in the skull just above the mastoid, near the bottom of the brain's temporal lobe. But nothing happened to his brain, which was protected by the tough fibrous shell below the skull called the dura. Years later, when Dr. Goldberg prepared for the new surgery, he took some CT scan pictures of the bone anatomy and saw the pencil-sized hole in the side of the skull.

Dr. Goldberg's surgery seemed uneventful, but after Boone went home, he developed a short-term memory problem that ruined his ability to do carpentry; worse, he developed a problem controlling his temper that unleashed itself at stressful moments on whoever happened to be nearby. Later, his neurologist explained to the jury that Boone's outbursts could be traced to injury in the limbic system that modulates emotional response.

A CT scan showed that a hole had been poked from the pre-existing skull defect into Boone's brain. A small pocket of air could be seen in the temporal lobe, surrounded by a pool of blood. But it wasn't just air in the brain – it was something slightly denser than air, likely surgical gelfoam which could have made its way there only if Dr. Goldberg had pushed it in to try to stop bleeding after he punched the first hole.

The key moment for Mr. Boone came not in the surgery but a month before, when he sat down with Dr. Goldberg to go over the planned operation. Goldberg never volunteered the key information: that with the hole in the skull from the prior surgery, his surgery would be that much more difficult, could even result in an injury to the brain, and Mr. Boone might benefit from consulting with someone who regularly did "revision mastoidectomies," the technical term for this second go-round. A general ENT doctor who advertised his specialty in facial cosmetic work like nose jobs – he named his professional corporation the "Aesthetic Facial Surgery Center of Rockville" – Goldberg only had done occasional revision mastoid surgeries. His operation on Boone proved he wasn't up to the job. On the witness stand, Goldberg admitted he hadn't discussed with Boone the hole in the skull, the chance of brain damage, or the availability of sub-specialists called neurotologists. For Billy Boone, the jury's vote in his favor, and the Court of Appeals' affirmance of the award, gave him some vindication. For other patients, his win makes it easier to demand the information you need to make a sensible selection among surgeons. Of course, if you asked Billy Boone, he would trade in legal vindication for a healthy brain any day. It's too late for him, but not for the rest of us.

(Click here for more information on the Boone case, and follow this link to Mr. Patrick Malone's closing argument.)

Nearly every week, we hear more evidence that American children are over-medicated, especially with drugs that affect mood and behavior. Most recently, a panel of experts has denounced the overuse of Risperdal, a powerful antipsychotic drug, for attention deficit disorder. The drug has too many side effects, including potential development of permanent muscle twitching, to justify its use in mild conditions like ADD for which other options exist, according to the expert panel convened by the Food & Drug Administration to advise it on labeling changes.

What is behind the explosion in use of antipsychotic drugs in children (besides Risperdal, they include Zyprexa, Seroquel, Abilify and Geodon) is a drumbeat of support from leaders in child psychiatry. But that leadership is tainted by their ties to the drug industry -- ties that frequently don't get mentioned in public when these same doctors are lecturing their colleagues and advising worried parents. One leader, Dr. Joseph Biederman, a child psychiatrist at Harvard, was revealed by a Congressional investigation to have accepted $1.4 million from manufacturers of antipsychotic drugs that he did not disclose to his university. Another psychiatrist leader, Dr. Charles B. Nemeroff of Emory, had to step down as chair of psychiatry after it was revealed that much of his consulting pay from drug makers, which totaled over $2.8 million in seven years, had been hidden from his university.

Now another influential psychiatrist has been exposed for his secret ties to the drug industry. He is Dr. Frederick Goodwin, former chief of the National Institute of Mental Health, who hosted a popular show on National Public Radio, "The Infinite Mind." Senator Charles Grassley of Iowa released data to the New York Times showing that Dr. Goodwin received $1.3 million from drug manufacturers from 2000 to 2007 for giving marketing lectures to other doctors. The money was never mentioned on his radio show, and NPR now says the show has been canceled and all reruns will stop soon.

According to the Times' Gardiner Harris, on one day in 2005, Dr. Goodwin received $2,500 from GlaxoSmithKline to give a talk about its mood stabilizer drug Lamictal at a Ritz Carlton resort in Florida. On his radio show broadcast the same day, Dr. Goodwin said that children with bipolar disorder who did not get treatment could suffer brain damage (a controversial prognosis) but he reassured his listeners that mood stabilizer drugs were a safe and effective way to treat the problem.

Senator Grassley has sponsored legislation to require drug makers to post publicly all the payments they make to doctor consultants. That would help the public to know whether the recommendations they see from doctors for medicating their children are truly unbiased or should be taken with a grain of salt.

Millions of people with normal cholesterol levels in their blood could be started on cholesterol-lowering statin drugs based on a new research study, but if patients understood the numbers behind the study, they might not move so fast to put statins in their medicine cabinet. Every patient can benefit from a closer understanding of how statistics work in medicine to push people toward treatments that they may or may not really benefit from.

The latest study involves people who were put on cholesterol-lowering statins because they had a high result on a blood test called C-Reactive Protein, even though the same people did not have high cholesterol.

As reported by Tara Parker-Pope in the New York Times' "Well" blog, here are the key numbers:

* The researchers reported an impressive sounding 50 percent reduction in heart attacks in the group treated with statins, as compared to patients in the same study who got a sugar pill (placebo) instead.

* But the real numbers of actual patients helped by the statins were only around nine in every 1,000 people treated -- less than one percent.

How do those numbers fit together? In the placebo group, 18 of every 1,000 patients suffered a heart attack or some other serious heart event during the study. In the group taking the statin drug, nine of every 1,000 patients had a serious heart event. That's how the researchers could report that the risk had been cut in half -- from eighteen to nine -- although the actual numbers of patients were few. Comparing eighteen to nine is called a relative risk ratio. Comparing 18/1,000 to 9/1,000 is called comparing the absolute risk. The absolute risk number is usually more meaningful.

Another important number for patients to understand in figuring out if a new medicine is for them is called the "number needed to treat." How many patients need to be treated with the new drug for one patient to benefit?

According to a New England Journal of Medicine editorial which analyzed the new study, 120 patients would need to be treated with statins over two years for just one of those patients to benefit.

That number might be enough to persuade some patients to take the drug. But it's a lot different than fifty percent. Bottom line: to make intelligent choices about treatments, patients need to understand how many patients like them are really expected to benefit from the treatment.

An online service called inSPOT allows patients who test positive for STDs to use a website to notify sexual partners, anonymously if they so choose, of the possibility that the partners were infected. A report done by the San Francisco Department of Public Health finds that since 2004, 30,000 people have used the service to send 50,000 notifications of all sorts of diseases contracted through sexual activity.

This project has enormous potential health benefits because embarrassment and a desire to remain anonymous are factors that can prevent people from notifying past sexual partners of their risk of contracting the disease. Of course, as Dr. Richard Rothenberg of Georgia State University notes in the article, it is difficult to track the effects of the project because of confidentiality issues. Nevertheless, the project is valuable:

However, it may be difficult, if not impossible, to study the impact on health because the service is confidential, Rothenberg said. "I think we, and the authors, must be content with the idea that this appears to be an acceptable method to fulfill the moral imperative of notification, and it has a chance to be a better approach than what we currently do," he said.

It is instructive and interesting to read about Senator Edward Kennedy's treatment for his brain tumor.

The linked article describes the change in direction between May 20th of this year, when Kennedy's brain cancer was first disclosed and surgery was not discussed as a possible treatment, and two weeks later, when neurosurgeons performed a "successful" surgery on his brain.

Why the change? From the article:

Precisely why Mr. Kennedy’s treatment course changed is not known; he and his doctors are not talking to reporters.

What is known is that a few days after Mr. Kennedy learned he had a malignant brain tumor in the left parietal lobe, he invited a group of national experts to discuss his case.

The meeting on May 30 was extraordinary in at least two ways.

One was the ability of a powerful patient — in this case, a scion of a legendary political family and the chairman of the Senate’s health committee — to summon noted consultants to learn about the latest therapy and research findings.

The second was his efficiency in quickly convening more than a dozen experts from at least six academic centers. Some flew to Boston. Others participated by telephone after receiving pertinent test results and other medical records.

As the article notes, Senator Kennedy called similar conferences of experts when one of his children was diagnosed with bone cancer and the other with lung cancer. He has been known to advise his colleagues in the Senate to use this method when dealing with an illness in the family.

Obviously, powerful senators can do things the rest of us cannot. Again, from the article:

Mr. Kennedy can tap leading doctors for answers in a way few patients could. His celebrity status aside, he has spent a career promoting insurance and other ways to improve the health of Americans. And he has had a track record of being thorough and diligent in researching medical options when relatives or friends have fallen ill.

Nevertheless, despite Kennedy's power and influence, there are ways in which the average person can imitate his example and seek second and third opinions on their medical care:

Several doctors not connected with Mr. Kennedy’s case said in interviews that they admired his resourcefulness in getting more opinions simultaneously. At the same time, these doctors said many average patients gained competent advice, without a command performance, by sending pertinent records to experts for their opinions.

Many patients search the Internet for medical information and ask that their scans and other data be sent electronically or by overnight services.

Then such patients visit, call or write the consultant.

The potential negative consequence of all this opinion-shopping is that people may focus on what they want to hear and disregard everything else. This is partly why the doctors quoted in the article strongly recommend actually meeting physicians whose advise you intend to take (rather than just sending records and receiving written responses). That way the physician can make sure your expectations are realistic and address your specific concerns.

Tara Parker-Pope recently had an article on how fewer and fewer patients trust their doctors.

About one in four patients feel that their physicians sometimes expose them to unnecessary risk, according to data from a Johns Hopkins study published this year in the journal Medicine. And two recent studies show that whether patients trust a doctor strongly influences whether they take their medication.

The distrust and animosity between doctors and patients has shown up in a variety of places. In bookstores, there is now a genre of “what your doctor won’t tell you” books promising previously withheld information on everything from weight loss to heart disease.

What are the reasons for this new distrust? Several factors appear to be involved:

(1) Patients often don't understand what is going on with their health care because doctors and nurses are too rushed to explain things to them. Dr. Sandeep Jauhar, cardiologist and author of Intern: A Doctor's Initiation, is quoted in the article with a story of a patient who was transferred from one hospital to another with no explanation for why. He blamed a "broken system" for such failures to communicate.

(2) There has been greater coverage in the news of medical error, the power of the drug industry and the flaws in health care administration.

(3) The Internet makes information much more available, so patients can be informed skeptics. Drug companies also market directly to patients, so they come into the doctor's office with their own desires and opinions on what medications they should take. The upside to this is that patients have the information to challenge a doctor's errors. The downside is that many end up taking a drug commercial, for instance, at face value and will not listen to a doctor's reservations about the efficacy of a drug.

Again, from the article:

“Doctors used to be the only source for information on medical problems and what to do, but now our knowledge is demystified,” said Dr. Robert Lamberts, an internal medicine physician and medical blogger in Augusta, Ga. “When patients come in with preconceived ideas about what we should do, they do get perturbed at us for not listening. I do my best to explain why I do what I do, but some people are not satisfied until we do what they want.”

The whole article is worth reading. In addition, the article's page also has an embedded video clip of interviews with people discussing their attitudes to their doctors.

Senior citizens who bring company to their doctor or hospital visits receive better medical care, according to a new study published in the Archives of Internal Medicine. Of the 38.6% of elderly patients who brought a companion along on their medical visits, the most common person to bring along was a spouse or an adult child, followed by other relatives and friends and neighbors.

The effects of bringing along a companion are clear and beneficial:

The parts that these companions played varied. Primarily, they aided communication in the visit, with 63.8% of companions filling this role. Of these, 44.1% reported recording physician comments and instructions, 41.5% communicating information related to the patient's medical conditions to a health professional, 41% asking questions, 29.7% explaining the instructions given by the physician, and 3.3% who translated the English language. Companions filled other roles as well, with 28.4% of all companions present for moral support and to provide company, 16.6% to help schedule appointments, and 8.4% to provide physical assistance.

Additionally, the elderly patients who regularly brought companions were more satisfied with their physicians' services, including technical skills, information dissemination, and interpersonal skills. If their companions actively assisted with communications, the patients rated their physicians' informational and interpersonal skills more highly. This trend became stronger in patients who reported themselves to be in worse health.

Not only is an elderly person more likely to feel better during the visit if he or she brings along a supportive person, but it will also lead to better communication with the doctor.

A new project, conceived of by Google and the Cleveland Clinic, will try to give patients the ability to access and control their health information.

This project would hopefully enable patients to give their information quickly and easily to multiple physicians and pharmacies. Such a thing would be beneficial because, as we have discussed often on this blog, lack of communication between physicians is a frequent cause of medical error. Patients might assume that doctors would automatically share relevant facts with each other in their medical histories, and this is indeed what is supposed to happen, but too often it does not. This new project would give the patient some control over making sure that doctors know important details.

The New York Times also has some comments on this, quoting Dr. John Halamka on the importance of "consumer-oriented health care."

Most scientists are extremely unwilling to part with the raw data of the studies they perform on cancer and other life-threatening illnesses.

The author of the article speculates that this reluctance is due to convenience and careerism, specifically the fear of having others (especially layfolk) analyze their work and possibly find flaws in it. This may be an uncharitable speculation but it is difficult to disagree with, especially when one considers the pathetic reasons scientists cite for hiding their data. From the article:

Dr John Kirwan, a rheumatologist from the University of Bristol in England, has studied researchers’ attitudes on sharing data from clinical trials. He found that three-quarters of researchers he surveyed, as well as a major industry group, opposed making original trial data available. It is worth restating this finding: most scientists doing research on how best to help those in pain, or at risk of death, want to keep their data a secret.

Dr. Kirwan went on to ask his subjects why. Their reasons were entirely trivial: one cited the difficult of putting together a data set (wouldn’t this have to be done anyway in order to publish a paper?); another was concerned that the data might be analyzed using invalid methods (surely a judgment for the scientific community as a whole). This is something of a clue that the real issue here has more to do with status and career than with any loftier considerations. Scientists don’t want to be scooped by their own data, or have someone else challenge their conclusions with a new analysis.

As the author points out, however, new analyses are exactly what cancer patients (and patients in general) need. We all need all the information available that pertains to our health, so we can look at it and think about it and use it to safeguard ourselves. This reluctance to part with information is contrary to the spirit of scientific openness and inquiry. It is also unsafe and unfair to patients.

The overwhelming majority of hospitals will not admit mistakes to patients if there is little chance of patients finding out, and may not even discuss the mistakes after the patients do find out. Of course, hospitals do this to fend off the threat of lawsuits.

Yet Dr. Steven Kramm, former chief of staff at the VA hospital in Lexington, Kentucky, argues that the opposite approach might be best from everybody's perspective. A PowerPoint file of Dr. Kramm's report entitled "Victim Compensation Without Litigation--the Lexington Experience" can be found on the SorryWorks website. To find it, scroll down and click on the link that says "Download."

Some of the key points of Dr. Kramm's assessment:

-As mentioned above, most hospitals say nothing to patients if something has gone wrong. If the patient does know and wants compensation, the hospital takes the same action regardless of whether it is at fault or not. That action often involves cutting off all contact with the patient; even where this is not the case, the patient is usually kept at a distance and given little information. (Slides 3-4)

-From 1987 onwards, the Lexington VA took the opposite approach and offered full disclosure even when the patient did not know anything had gone wrong.

-The process involved practitioners and administrators identifying cases where compensation might be justified, discussing the possibility of disclosure in those cases together, and finally making the disclosure to the patient with a presentation of compensation options. The hospital would also suggest that the patient might retain an attorney, as this would prevent the patient from having "buyer's remorse" or feeling cheated. (Slides 9-11)

-The result was that, from 1987 to 2003, the single largest payment made by the Lexington VA was $341, 000 for a wrongful death case and the average settlement was $16,000. They negotiated over 170 settlements and took only three cases to trial, out of which they lost two and won one. (Slide 15)

-By contrast, the mean malpractice judgment for VAs across the nation in 2000 was $413,000, the mean pre-trial settlement was $98,000 and the mean at-trial settlement $248,165.

-The overall mean payment for Lexington (regardless of whether the case was settled or went to trial) was $36,000 as of 2000.

Clearly, Lexington comes out as the financial winner, in addition to having a policy that gives more consideration to accountability and sympathy.