Is Your Doctor a "Return on Investment"?

Ever since ProPublica published its disturbing database called Dollars for Docs, there have been many local news stories written about hired gun physicians who take money from drug companies to promote drugs to other doctors. A particularly good one was published yesterday in the SentinelSource by the Chicago Tribune's Judith Graham.

The Tribune interviewed about a dozen physicians who make thousands per year from drug company talks, and, according to Graham, "all said they believe such ties have no effect on their medical practices."

But Graham also interviewed a former drug rep, who provided the unvarnished and rather ugly truth about how these apparently well-meaning doctors are actually being manipulated by their handlers:

"Angie Maher, a former Michigan drug sales representative turned whistle-blower, described training sessions where psychologists and coaches would brief her on how to play on doctors’ vulnerabilities — their desire to feel important, their eagerness to be on the cutting edge — while working to boost sales. Each time a physician would give a talk, Maher would fill out a “return on investment” spreadsheet tracking prescription trends for all the doctors who attended the event. If sales went up, the speaker was asked to give another presentation, she said. If not, further invitations to speak would not be extended."

That says it all. Time for these doctors to wake up and realize that have transformed themselves into ROIs for their sponsoring companies.

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!

Psychiatrist Recounts a Wyeth Snow Job

In 2004, Dr. Steven Reidbord, who was at that time the medical director of the mental health clinic at California Pacific Medical Center, had a Wyeth coming-of-age experience (read about my own adventures here). As he details in his interesting new blog, Dr. Reidbord was approached by his own hospital's Community Health Resource Center to give a talk to the public about depression. This was part of an event called "GOAL" (Go on and Live!), and would feature Delta Burke, an actress best known for a role on the TV show "Designing Women."

Dr. Reidbord, assuming that this was a community initiative and not a drug company-sponsored event, initially agreed to give the talk, but when he received the flyer advertising the program, he noticed a phrase that sounded suspiciously Wyeth-crafted: "... it is possible to virtually eliminate the emotional and physical symptoms of depression and go on and live." Recall that the Effexor XR campaign emphasized remission as the goal of treatment, because their studies found that the drug slightly outperformed SSRIs only when remission was used as the outcome statistic.

Dr. Reidbord investigated the event further, and found that it had been organized by a public relations firm, Porter Novelli, and that the website created to promote the event was copyrighted (surpise, surprise) by Wyeth.

I won't steal anymore of Dr. Reidbord's thunder, but I will give you the sneak preview that this story also involves that Zelig of industry-funded research, Charles Nemeroff.

Congratulations on a great new blog, Dr. Reidbord, and welcome to the Wyeth Refugee Club!

Hired Gun, M.D.: The Three Million Dollar Man

Recently, I spoke with a physician who speaks for various pharmaceutical companies on a scale that puts my brief 2002 foray to shame. "Hired Gun, M.D." gave over 500 talks in 2006, netting close to $1 million. Many of these talks were teleconferences done from the comfort of his office, which allowed him to average nearly two talks a day.

On a more hopeful note, however, Hired Gun (H.G.) has noted a "massive reorganization based on changing appearances" among drug companies. Most dramatically, companies have lowered the maximum salary caps that speakers can receive per year. Wyeth, for example, recently decreased its cap to $25,000 per year; Lilly, not quite so stingy, decreased it to $75,000.

This has done damage to H.G.'s bottom line. In 2007, he was able to do only about 200 talks, and he estimates that 2008 will be even more meager--perhaps only 100 talks. "The climate is changing," he said. "We've seen the signs for years, but now it's really happening. Most of us are just rolling with it."

Over his career, H.G. estimates that he has delivered 2500 lectures and has made $3 million. What makes him do it? "Different things," he said. "Obviously I like the money, but I also like being in the spotlight, and I enjoy providing education. I think you'll find a variety of motivations in most speakers you'd talk to." While H.G. doesn't deny a marketing component to some of his talks, he feels he does a good job being accurate and unbiased. But some of his colleagues are less scrupulous. He singled out one extremely well-known physician-speaker as being "incredibly biased, pro-[company X] and anti-[company Y]. He's not one of the good guys."

I've encouraged H.G. to go public. I know several senate and congressional offices that would love to hear his testimony. But he's reticent, for obvious reasons. In the meantime, I hope to post his observations from time to time.