New study finds corrosive influence of industry money on cardiology practice guidelines

In a finding that may stun heart patients but surprise few others, researchers have found that more than half of the doctors who wrote key clinical practice guidelines in cardiology had financial ties to medical device and drug companies that stood to benefit from those guidelines. The study, published today in the Archives of Internal Medicine, raises serious questions about the reliability of such clinical guidelines in treating heart disease.

In recent years, much of the attention on conflicts of interest in medicine has focused on how lucrative financial ties can influence doctors' ability to carry out unbiased research or give patients sound medical advice. But as the researchers who did the study note, "improper bias in the production of clinical practice guidelines can have a potentially more widespread adverse effect on patient care than individual practitioners' conflicts of interest." That's because such guidelines, which range from how to treat patients with various types of heart disease and stroke to how to do coronary bypass surgery, are often adopted as the standard of care throughout the field and taught in medical training programs at all levels.

As Dr. Steven Nissen, a noted cardiologist at the Cleveland Clinic who commented on the study in an accompanying editorial, put it: To allow individuals with financial conflicts of interest to write clinical practice guidelines "defies logic."

The authors of the study, physicians and bioethicists at the University of Pennsylvania, Thomas Jefferson Hospital and Massachusetts General Hospital, found that more than half of the doctors who wrote clinical practice guidelines in cardiology between 2004 and 2008 served as promotional speakers on behalf of industry, and a substantial number actually held stock in companies affected by the guidelines they wrote. Again to quote Nissen:

"No conceivable logic can defend the practice of including promotional speakers and stockholders on CPG writing committees. Participants in speaker's bureaus essentially become temporary employees of industry, whose duty is the promotion of the company's products."

Even more worrisome, the study found that the chairs of these guideline writing committees are significantly more likely (81 percent) than committee members (55 percent) to have a potential conflict of interest. As Nissen says, "Such findings are disturbing and suggest that the decision-making process for selecting chairs for cardiovascular [clinical practice guidelines] is seriously flawed."

Proponents of the status quo often argue that such guidelines are merely a synthesis of scientific evidence derived from randomized clinical trials. But as Nissen notes, research shows that nearly half of these recommended guidelines are based on expert opinion. "The subjective nature of the [guidelines] makes it even more essential that these documents be free of commercial influence," he says.

Nissen then poses the question as to why professional societies have allowed "such extraordinary levels of commercial influence to infiltrate CPG committees?" His answer:

"Professional societies and their leadership are often plagued by the same commercial relationships as the [guideline] committees. Pharmaceutical and medical device companies provide large amounts of financial support for the education and advocacy efforts of professional societies. Such relationships have created a dependency that is difficult to terminate because the leadership of professional societies is reluctant to antagonize their financial benefactors."

I'm glad to see Nissen, who has consulted for drug companies and received research funding from some of them in recent years, lay it on the line like this. Hopefully, his plainspokenness is a sign that change is coming. It's past time for doctors in all fields, not just cardiology, to recognize the corrosive influence of industry money on the practice of medicine and stop taking the dough. Only then can patients truly trust their doctors' medical judgments.

NESW posts video of informative blogging panel

Here is a link to the newly posted video of a blogging panel sponsored earlier this winter by the New England Science Writers, a local chapter of NASW. I moderated the panel, which featured a stellar group of health and science bloggers: Gary Schwitzer, who writes the Healthnewsreview blog, Daniel Carlat, of the Carlat Psychiatry Blog, Rachel Zimmerman, who curates WBUR's Commonhealth blog, and Ivan Oransky, who writes Embargo Watch and Retraction Watch. About 60 local health and science writers turned out for the event at the Harvard Faculty Club, and as you can see for yourself, it was an informative and entertaining evening.

Drug companies and psychiatry profession still singing the same old duet

The same drug giants paying millions of dollars to settle claims that they engaged in illegal and improper marketing of anti-psychotic drugs in the U.S. are even now looking for new worlds to conquer. Consider the study published today in the Archives of General Psychiatry. It surveyed more than 60,000 adults in 11 countries in Eastern Europe, Asia and South America and concludes that the treatment needs for people with bipolar disorder are "often unmet, particularly in low-income countries."

That may indeed be true. But I'd find this result a lot more believable if the study were not funded in large part by the same pharmaceutical companies who make the atypical anti-psychotics used to treat bipolar disorder: Eli Lilly (which makes Zyprexa), Janssen (the unit of Johndon & Johnson that brought us Risperdal), Pfizer (Geodon), Bristol Myers Squibb (Abilify), GlaxoSmithKline (Lamictal), and Novartis (Fanapt).

The fact that one of the study's primary authors is a long-time paid consultant for the drug industry also gives me pause, particularly since this researcher has been carrying water for the industry for years. I am referring to Ronald Kessler, an epidemiologist at Harvard Medical School, whose specialty is publishing alarmist studies about the increasing problem of mental illness among various populations -- a problem, of course, that can only be solved with drug treatment.

In 1999, for example, Kessler co-authored a widely publicized study showing that depression was afflicting more children than ever before; you may recall this was right around the time that Eli Lilly, Pfizer, GlaxoSmithKline and Forest Labs were ramping up their highly successful efforts to market antidepressants like Prozac, Zoloft, Paxil and Celexa to children and adolescents (and hiding the dangerous side effects of these drugs while doing so).

In 2001, Kessler (and coauthor Martin Keller of Brown University) struck again with a study purporting to show that a significant number of the world's population is plagued by chronic and excessive anxiety -- severe enough to require drugs. Like Keller, whose myriad conflicts I exposed in Side Effects, Kessler was a paid consultant at the time for GlaxoSmithKline and other companies who were also marketing their antidepressants as anti-anxiety agents. In 2007, he co-authored yet another finding declaring that one in four adults have symptoms of mental illness but only a third of them are receiving effective treatments (read drugs).

Then in 2008, in perhaps his most bizarre contribution, Kessler was among the authors of a controversial commentary in Nature that heralded a new era of "cognitive enhancement" -- the use of brain-stimulating drugs in healthy people. Kessler and his co-authors argued that competent adults should be able to freely indulge in such drugs and noted that this was already happening among undergraduate and graduate students trying to boost their academic performance with drugs like Adderall and Ritalin, which contain amphetamines. As one pediatrician who criticized the commentary told the San Francisco Chronicle, their arguments will only "fuel the fire of what we call prescribing pressure" even though the drugs in question have "very significant side effects." To its credit, the Chronicle article noted that Kessler and another co-author of the commentary were consultants to the same drug companies that stood to gain handsomely from their rhetoric.

Kessler currently serves on the board of an advocacy group for child mental disorders with none other than Joseph Biederman, the Mass General Hospital psychiatrist who was a major proponent of expanding the definition of childhood bipolar disorder so that more and more children could be diagnosed with it and treated with powerful anti-psychotic drugs. As I've blogged about here, Biederman came under fire from the Senate Finance Committee for failing to disclose his extensive financial ties to companies that make these anti-psychotics. (Biederman's failures to disclose have been under investigation for the past two years by Harvard Medical School, in what must be the longest investigation in that school's history).

But getting back to Kessler, if you read the fine print at the end of the latest Archives bipolar study, you can see for yourself the long list of drug companies whose generous payments have been padding his salary at Harvard over the years.

That list may help explain why I find the latest pronouncements about the unmet treatment needs of bipolar patients around the world so hard to swallow. What this study mainly indicates to me is that the psychiatry profession and its journal handmaidens are still singing the same tired old tune at the behest of drug companies.

To borrow a better tune (from Joan Baez), when will they ever learn, when will they ever learn?