I can think of no better way to spend 15 minutes than to check out this amazing video of a recent talk given by University of Wisconsin cardiologist Jim Stein.
In the talk, Stein outlines his own long road to conversion from a full-fledged, industry-supported KOL (key opinion leader) to his recent decision to refuse all industry support for all activities not related to legitimate research. Stein’s journey began while he was still a cardiology fellow in the mid-1990s when he filled in for a faculty mentor at a speaking engagement. He remembers his pleasant shock at receiving a first class airplane ticket and limousine ride to the hotel. “As I walked off the stage I was shocked to get an envelope— it was almost like being in a movie— that had $500 in it. I got a pat on the back and someone said, ‘there’s more where that came from.'”
Soon after Stein was asked to give another talk at a local community hospital in Chicago. He received a $750 honorarium “and I was hooked.” Stein says he “wasn’t completely naive” and realized that this lecture “was actually an audition.”
Stein started to give frequent talks sponsored by industry and joined the speaker’s bureaus of many different pharmaceutical companies. “Over and over again I was told that I was a future thought leader.”
When he joined the faculty at the University of Wisconsin he fully disclosed his involvement with industry, and discovered that it was “more than acceptable.” From the chief of medicine down, “everyone said it was encouraged, it enhances our institutional notoriety, it increases referrals to your clinic, it enhances your personal reputation, and it creates industry contacts that can be used for funding research and education.”
As Stein notes, his involvement with industry “really paid off for me in the 1990s. I developed a local and national reputation predominantly by lecturing.” In addition to his speaking duties, Stein served on many scientific advisory boards for most of the leading pharmaceutical companies and sat on the steering committees and data and safety monitoring boards for many clinical trials.
For all of these activities Stein was well paid. “At the end of the day every time I gave a lecture I got paid, and I typically got paid between 2 and 3 thousand dollars per lecture.”
Stein admits that he “had concerns” about his activities “but I had a lot of justifications.” Stein told himself: “I’m an educator and a researcher, and not a sales person. I had a self imposed management plan.” Stein always disclosed his funding and he always “demanded complete control of my content” and would “never use a prepared slide set.” Further, he always gave his talks on his own personal time.
“So from 1996 until 2004 I considered this a win-win-win situation: it was good for me, it was good for the patients, it was good for UW, it was good for industry.”
Starting in 2004 things began to change for Stein. His lectures went from being educational to promotional, and the companies insisted he use their slides. But of course, “what really got my intention was the scrutiny this issue received” in the media. Stein was the focus of local news coverage. Although he defended his interactions with industry, ” I have to be honest with you, inside I was mostly embarrassed” by the coverage, which included publication of his salary and the extra money he received on top of his salary.
Stein talked with UW officials and ended up sending a letter to all his patients “disclosing all my industry interactions.” Then he started to donate all the industry money he received. He resisted the idea of going cold turkey: “I thought [the talks] were a public service. I also loved teaching. I loved feeling important.” He believed that he had saved more lives by giving talks than by treating patients. “Finally if I give the money to charity… how could anyone really object?”
But it wasn’t enough, he now acknowledges. “I’ve learned over the last several months that I was wrong. I’ve learned that I could not stay unbiased, that I could not control the content of my talks, and that my personal convictions were not good enough.”
Research about bias has demonstrated the complexity of the bias problem: “I’m not biased because there’s something evil about me, I’m not biased because I’m doing something unethical, I’m biased because I’m human, and all of us are biased. Most of our biases are unintentional and unavoidable.”
Stein notes the unintended consequences of disclosures: although it’s “laudable to disclose your relationships it’s harmful because it has the perverse effect” of instilling trust in the person listening to the disclosure. Research shows that “professionals who disclose become more biased.”
Here’s Stein’s simple conclusion: “The solution isn’t disclosure. If you’re doing something that’s wrong or unethical, don’t disclose it, just don’t do it. So if you don’t do it you don’t have anything to disclose and there’s no more conflict of interest.”
“The solution isn’t disclosure. If you’re doing something that’s wrong or unethical, don’t disclose it, just don’t do it. So if you don’t do it you don’t have anything to disclose and there’s no more conflict of interest.”
Regarding CME, Stein says it is often simply 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 December 31 2008, Stein has “stopped all activities not related to bona fide research.” He reports that “personally I’ve lost friends and collaborators” due to his new position.
Stein admits he doesn’t “know how to correct the problem but it begins in recognizing that there is a severe imbalance of power between the players here. You have doctors, patients, academia, and industry. Patients have the least power. Industry has the most power. Some of us are right in the middle.”
Stein echoes an idea expressed in the recent IOM report on Conflict of Interest that if the medical profession doesn’t resolve this problem itself it will have the problem resolved for it through legislation.
Thanks to PharmaGossip for pointing out this video.
Kind of “horse gone, lock the door” mentality, isn’t it?
What did you do with all the tens of, if not hundreds of thousands of dollars prior to your conversion?
I see nothing wrong with promoting a product that is successful and, in the clinical setting, you personally see the results.
Dr Stein summarizes arguments which discourage interaction between industry and academia. While there are clear problems that develop in this relationship in areas of research, speaking, advisory services and other, it is a shame to point to an envelope handout as evidence of a seedy method of payment, something that occurred likely decades ago and is not nor has been the norm. Academic medicine is the focal point for education and research in medicine, producing the physicians that care for us and much discovery and research that produce improvements in medical care.
Industry, while it has exhibited flaws at times – as has academia – has produced a myriad of innovative and worthy treatments and cures for diseases, vaccines that have prevented disease, and a huge number of well-paying jobs in our economy. It has long been a hobby of some to point a finger at the drug makers and device companies and find blame in the less savory aspects of things. Many of these have improved immensely and not all companies behave the way some Dr Stein seems to have worked with. A more worthy approach may exist for the two entities – medicine and industry – where both parties work together in what many see as a very natural partnership where the many and varied resources are melded together to maximize outcomes for all, most importantly and ultimately patient care.
If Dr Stein needs to cleanse his mind for past activities that is one thing, but for him and CardioBrief to assail all advisory boards, all research, and all lecture/speaking engagements as conflicted is simply erroneous. As someone who has participated at many such events for a number of different companies, it has been apparent that advise received at boards has bettered clinical trial work, research activity has been improved b levels of participation by physicians in academia, and many physicians who speak do teach busy community physicians who do not have time to delve into all new drugs as much as is needed.
As a previous respondent pointed out, now that Dr Stein has collected all the money that must have come from participation in a variety of programs for several companies he now has banked this windfall, he apparently has come upon a epiphany and will no longer participate. I struggle to understand why someone there suggests listening to this person speaking about something he admits to having no expertise in is a good fifteen minute exercise.
Good for Dr Stein. It is about time that the ugly underbelly of the pharmaceutical industry that spends more on advertising than research is exposed. It is easy, as Dr Stein found out, to rationalize away all the conflicts that these activities create. It takes courage to admit that you have been wrong. The incestuous relationship with “big pharma” and the medical profession go back to the Flexner Report and does not belong today in a so called “patient centered profession.” Learning diseases for four days and having a drug rep come in and tell you what drugs to use is not education, it is selling of product.