The writer, Maran Wolston, also happens to be a professor of medical ethics, so she renders her personal story in a particularly thoughtful way. When she first met her neurologist 5 years ago, she found out that he was being paid to do clinical trials of MS drugs, which gave her some pause--but she chose to stick with him because she thought his involvement in research might lead to better care. He invited her to participate in a trial he was doing, but after learning about the possible side effects, she declined. Six months later, he told her that her disease had worsened, and recommended Copaxone, a drug that required self-injections daily or every other day. While it caused fewer side effects than some generic alternatives, she found the injections very painful, and after several months she stopped it--and her neurologist agreed this is was a good idea.
But a year later, he found she had worsened again, and recommended the drug Tysabri. She researched it and learned about a checkered FDA approval history, and more alarmingly a rare but potentially deadly side effect. It was then that a friend told her about the Minnesota database of drug company payments to doctors. She learned that her neurologist had been paid $300,000 over 3 years by the makers of both Copaxone and Tysabri.
I like how thoughtfully she responded to this information:
"In fact, I have no idea whether my neurologist’s advice and judgment were affected by his relationships with the drug industry. But because I was his patient, the effect of those relationships was not a theoretical question—an issue to be bantered about over coffee or in the seminar room. It would have been foolish of me not to consider the possibility that the relationships were affecting my care. Having MS is difficult enough. The last thing I needed was to worry about whether my neurologist was acting in the best interest of the drug companies or in the best interest of me, his patient."
To find out what happens next, go read the article at the source in Health Affairs. The bottom line is that transparency, once it is implemented as part of the Physicans Payment Sunshine Act, will mean different things to different people. But ultimately, it will improve our health care system, because it will help to clarify when incentives are appropriately based on patient welfare, and when they are based more on money.
(Thanks to WBUR's Commonhealth blog for alerting me to this article).
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9 comments:
I am in complete support of a total ban on promotional/marketing for physicians. However, I am somewhat concerned by the implication (implicit in the patient's search for a neurologist who didn't take any pharmaceutical industry money) in the article that research funding is just as bad as promotional money. If reputable physicians do not conduct research studies, who will? If the trials are not funded by the government (which does not have the means nor the will to fund such studies) and pharmaceutical industry funding is so tainted, how do we make progress? To suggest that this is all "me-too" drug marketing research is to miss that there are real advances made every year and that happens mostly through pharmaceutical industry funded research.
I don't know what would be worse: learning that my doctor was paid $300K by the maker of a drug he prescribed me, or learning that he was paid $300K by a company whose drug he did not prescribe.
In the first case, I'd have serious concerns about the credibility of the doctor; in the second, I'd have serious concerns about the drug.
Wow, as a medical professional, this makes my heart sink. I applaud the efforts of ethicisists to bring these issues to light.
I generally support the ban on pharm reps at academic institutions. I am proud to be at a training program that supports the ban of reps in our clinics.
Hmm, I read from a link by a commenter at a recent post from 1boringoldman.com that the APA stands to make $10 million or so from sales of DSM5 related products. Isn't that a conflict of interest too?
In relation to clinicians being paid by pharmaceutical company sponsors to enroll subjects to participate in clinical trials, the New York Times had a two-article series, “Research for Hire”, with the first article, “Drug Trials Hide Conflicts for Doctors” (Sunday, May 16, 1999; pages 1, 34-35), and the second, “A Doctor's Drug Studies Turn Into Fraud" (Monday, May 17, 1999; pages A1, A16-A17). The articles were written by Kurt Eichenwald and Gina Kolata.
Not only are doctors paid to do research studies, but patients are, too. There's a great chapter on this phenomenon in Carl Elliott's book "White Coat, Black Hat."
And just this morning, David M. Allen's blog featured this link to an ABC News story about stay-at-home moms who make extra cash as subjects for drug trials.
There's enough conflict of interest for everyone to enjoy!
Here in Arizona the drug sales people have clamped down so hard on the freebies they won't even offer us pens and scratch pads! I think if I were paid to speak at the drug company dinners; I would have a policy of full disclosure and have my patients sign a form acknowledging that I have disclosed this relationship to them; and they see no conflict of interest. This would also be accompanied by an explanation as to why I represent xyz drugs and why I prescribe their drugs. When in doubt - disclose!
Great post, Dan.
@ Dr. Gronley, while I applaud you for your beliefs on transparency in disclosure, the problems with conflicts of interest don't just evaporate with disclosure. If the neurologist in question is being paid 300 large to effectively endorse products, how do you reasonably sort out whether he or she is making the appropriate medical decisions and not being influenced by the good vibes from being on a company's speaker's bureau? Drug companies are smart enough to understand that quid-pro-quo is unethical and illegal, but there are subtler forms of gaming the system that can affect a doctor's prescription habits. A good explanation of this can be found in a story by NPR and Pro Publica (http://www.npr.org/2011/09/13/140438636/doctors-often-receive-payments-from-drug-companies).
Indeed, the very fact of the doctor's acceptance of such a large sum is potentially indicative that the doc is being unconsciously biased (http://www.npr.org/templates/story/story.php?storyId=130730104) or, much more troubling, that he or she has a history of substandard or even unprofessional conduct (http://www.propublica.org/article/dollars-to-doctors-physician-disciplinary-records).
I'm not a neurologist (internist, ID), and haven't read the link article yet, but for what it's worth based on Dan's description, the meds the doc was prescribing seemed to me to make sense. Tysabri in particular seemed logical, and the FDA troubles Tysabri had are not, to the best of my knowledge, related to company shenanigans, but is a legitimate risk/benefit issue in terms of the potential harms (a fatal neurologic infection known as PML) versus the relentless progression of MS. It's a high-reward drug, the question is how high is the risk, and several years ago the FDA thought it was too high, but they've since reversed and it's back in play.
I agree with Anonymous #1 in that there's a qualitative difference between being on a speaker's bureau and accepting money from Pharm companies to run trials. In the latter case, the devil is in the details. As Carl Elliott documents in his great book, there are some appalling abuses of the system with respect to setting up clinical trials...but it's hard to know how many legit trials sponsored by drug companies occur since they don't make headlines. (My academic division has accepted money from companies to do studies, and while I've never been directly involved in the studies, I have seen the research protocols, and they seem to be on the up-and-up.)
Best, Billy
Well, once upon a time I was on multiple Speaker's bureaus, and they funded the adoption of my kids. (In the early 2000s)
That being said, what irritates me are academics who forbid their residents getting food or pens from drug companies, but accept speaker money to the tune of over 10 K a year.
Research funding is a completely different story, however. Drug company funds are used to make breakthroughs. Incidentally, very little drug research that is significant goes on without access to the US market, you know.
Personally, I think this is a touch overblown when Defense companies skate by, don't you?
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