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.