Another Hired Gun Repents, This Time a Cardiologist

When it comes to conflicts of interest, cardiology is the new psychiatry.

Psychiatry is cleaning up its act through a combination of external forces and the profession’s own commitment to ethical rehab. But cardiology, a field awash in drug company cash, is only now taking baby steps in the right direction. The pace of change is about quicken, in part because of a remarkable cardiologist named James Stein, who was profiled yesterday in this article by John Fauber in the Milwaukee Journal Sentinel. Also, watch this video of his talk at a recent ethics conference.

James Stein is not your everyday cardiologist. He a full professor at the University of Wisconsin, and is one of the top researchers in the country, having invented techniques to use echocardiograms to take more precise measurements of atherosclerosis. He was named one of the top 20 cardiologists in the country by Men’s Magazine.

Dr. Stein, like me, used to be a hired gun for the pharmaceutical industry. Unlike me, he was in the game at the highest levels, having been on speakers' bureaus, advisory boards, and research steering committees for many different companies. It all started when he was a 29 year old cardiology fellow. His academic mentor could not make it for a scheduled promotional talk and invited Stein to pinch hit for him. Stein gave the talk, and was handed a sealed envelope containing a $500 check. According to the Journal Sentinel article:

"I got a pat on the back and he said, 'There's more where that came from, son.' I had no idea what that meant, but I went home and paid off part of my student loans," Stein said in a presentation at UW this month.

One thing led to another. From the article:

Over the years, many of the big names in the drug industry would hire Stein to give speeches or serve as a consultant, eventually leading to fees of $2,000 to $3,000 per talk....For instance, in 2005 Stein did work for six drug makers, according to a disclosure form filed with UW. That year, Pfizer paid him between $10,000 and $20,000 for four days of work as a speaker and advisory board member. LipoScience, a firm that markets a cholesterol test, paid him $10,000 to $20,000 for four days of similar work. Another firm, Schering-Plough, paid him about $12,000 for two days as a lecturer.

Like all hired guns who hop onto gravy train with the best of intentions, Stein thought he was providing added value for everyone concerned. In his videotaped talk at UW, Stein characterized this as an apparent “win-win-win-win situation” in which he benefitted financially and professionally, patients benefitted from the education he provided to their doctors, his university reaped benefits in prestige and the drug companies sold more of their products.

When journalists started publishing the amounts of money he and other opinion leaders made from their talks, he went on the offensive, arguing that such relationships were fine:

“I defended my relationships with industry by saying that conflicts were inevitable for successful researchers, that my relationships with industry helped build bridges, that my talks always were educational, that this was part of the UW mission, and that at the end of the day I saved lives by educating people about the medications and diseases states I spoke about.” (This and most of the quotes that follow are from my transcription of his recent talk).

Inside, however, he said he felt embarrassed about the public disclosures of his income and noted that many of his patients made a pittance in comparison, and sometimes could not even afford their medications. He decided to make some changes. He pushed for better disclosure policies at the university, he sent letters to his patients disclosing his industry relationships, and he decided to donate all his promotional money to charity.

Even with all his growing misgivings, he continued to give the talks because, as he put it:
“I was sure I could avoid bias because I controlled the content and I had these strong personal convictions.” But then, things changed: “Well, unfortunately, over the past several months, I’ve learned that I was wrong. I’ve learned that I could not stay unbiased, that I could not control all the content of my talks, and that my personal convictions were not good enough.”

In fact, he said he realized that everybody is a little biased, even physicians, and not because they are evil, but because they are human. He noted that bias is inevitable in research, and that no one is insulted when they are told that certain research designs are off limits because they would lead to bias.

“So I ask myself, why are physicians so insulted when similar influences might be influencing us in our patient care?”

He realized that he was wrong in supposing that simply disclosing his relationships with industry was enough:

“I really felt that if I stood up in front of a crowd and said that these are my disclosures, look how honest I am, that I was really managing conflict of interest. But actually the medical literature and the social science literature tells me that it is actually the opposite effect. Although it is laudable to disclose your relationships, actually thinking that disclosure manages relationships is harmful. It has the perverse effect that when you disclose your relationship, the recipient of your information becomes more trusting, and the social scientists also have shown us that professionals who disclose actually become more biased…. I would argue … that the solution is not disclosure, because if you are doing something that is wrong or unethical, don’t disclose, just don’t do it!”

He also realized that every drug company he had worked with over the past 15 years had been fined or convicted for ethical or legal violations involving activities like off-label marketing or suppression of data.

Finally, he was particularly disturbed to realize that accredited CME had been adopted as a marketing technique by drug companies.

“I trusted continuing medical education but what I found was that many times it was a sanitized way of presenting a marketing message….My personal conclusion is that the medical device and pharmaceutical industries are no longer trustworthy partners in medical education.”

As of Dec 31 of 2008, Dr. Stein ended all of his industry interactions that were not related to bona fide research activities.

Congratulations, Dr. Stein. Welcome to the small but growing “I’ve Had It” club of former hired guns!

Devastating Indictment of Industry-Funded CME Published

Occasionally, a piece of investigative journalism sets into motion processes that strike corrupt business practices at their core. Such an article was published yesterday in the Milwaukee Journal Sentinel, written by John Fauber and Suzanne Rust.

The article is entitled “Drug firms' cash skews doctor classes: Company-funded UW courses often favor medicine, leave out side effects.” It is such a devastating indictment of the corruption inherent in drug company funding of CME that it will become required reading for all those involved in health care policy.

The University of Wisconsin has a huge program of industry funded CME. Why? This is fueled largely by George Mejicano , UW’s associate dean for continuing education. Mejicano, who was profiled by Medical Meetings magazine in 2008, was the driving force behind winning $12.3 million from Pfizer for a CME program on smoking cessation, $3.5 million of which went to UW. Pfizer, of course, markets Chantix, the new smoking cessation drug which is effective but laden with side effects, such as nausea and insomnia, and, potentially, suicidal ideation. These side effects should not necessarily dissuade doctors from prescribing a drug which may ultimately save many lives, but they should be made aware of these risks.

Unfortunately, Fauber and Rust found that the smoking cessation course produced by UW does not even mention Chantix’s side effects. The reporters asked Dr. Mejicano to comment on this and on the fact that the course did not disclose that clinical trials of Chantix excluded patients with common comorbid conditions, such as mental illness and heart disease. Here’s how he responded: “UW's Mejicano said he did not think the side effects or the people excluded from the clinical trials should have been included in the course. He said such courses are rarely comprehensive and are designed to meet selected learning objectives.”

Indeed—and this is precisely the problem with industry funding of CME. The drug companies, via the proxy of various third parties, set the agenda for medical education. That agenda does not include saying bad things about the funder's product. I commend Mejicano’s honesty for essentially admitting this, thought it was apparently an unwitting confession.

The article goes on to profile other UW CME courses, in each case showing how the content is biased in favor of the supporter’s drug. This rogues' gallery includes a course pushing Boehringer Ingelheim's Mirapex for restless leg syndrome and one hawking Bayer’s Yaz and Pfizer’s Xanax XR for premenstrual dysphoric disorder.

I wonder if the American Medical Association, that great defender of industry sponsorship of CME, will respond to this article. Perhaps they can reference it in their new and embarrassing “fact sheets” on CME, which I reviewed here.