The following is a guest blog post from one of our contributors, Susan Molchan, MD, a psychiatrist in the Washington, DC, area.
In the first of a series of pieces, New England of Journal of Medicine national correspondent Dr. Lisa Rosenbaum wrote, “Reconnecting the Dots – Reinterpreting Industry-Physician Relations.” (You really should read this piece to get its full impact.) The piece was supported by a plug from NEJM editor Dr. Jeffrey Drazen.
Dr. Rosenbaum makes a nice try at reinterpreting financial conflicts between physicians and pharma, but however one twists and turns it, the dots still reconnect into dollar signs. She asks, “Have stories about industry greed so permeated our collective consciousness that we have forgotten that industry and physicians often share a mission — to fight disease?” Is Dr. Rosenbaum’s consciousness so clouded as to think that pharmaceutical companies don’t exist first and foremost to make money? That their primary responsibility is not to their shareholders? It’s true that a means to this end is fighting disease, (including new “diseases,” tailored to one’s drug), but this should not be confused or conflated with the primary mission of (hopefully most) physicians.
I and many others suggest that the “stories about industry greed” have not permeated enough, and that this problem has polluted much of medical research and medical practice, to the point where trust of the medical research enterprise has been eroded (Greenhalgh 2014; Every-Palmer 2014; Stamatakis 2013). Dozens of books detail examples, including two by former editors of the New England Journal of Medicine (NEJM): On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health, by Jerome Kassirer, and The Truth About the Drug Companies: How They Deceive Us and What to Do About It by Marcia Angell. Two more recent books on the subject include Deadly Medicines and Organized Crime, by Peter Gotzsche, and Bad Pharma, by Ben Goldacre.
Dr. Rosenbaum’s example of our perception/emotional reaction to industry as an ugly house, was strained. For anyone who truly understands this pharma business, I thought her implication that we shouldn’t trust the “cognitive lessons,” our own thinking, a bit condescending. This led me to think of fish, the ones from David Foster Wallace’s famous commencement address. An older fish had swum by and asked a couple of younger ones, “How’s the water boys?” After a few minutes, one asked the other, “What the hell is water?” Drug companies and their allies existing in “the so-called real world of men and money and power…” might ask the same thing.
The example Rosenbaum used in her NEJM article of the Jesse Gelsinger story is one thing, a tragedy stemming from signals missed in a small trial of a small biotech. The example of Vioxx quite another, and goes beyond clarifying the need for better post-marketing surveillance (which, by the way, has not come to pass in the 11 years since). It involved the mega-company Merck and an estimated 55,000 deaths, along with thousands of heart attacks and strokes. As detailed in the Wall Street Journal and other places, data concerning the number of heart attacks while on Vioxx in a pivotal study had been withheld by Merck, and the NEJM were aware that these data were missing from the submitted manuscript. Editors had also rejected letters pointing out the problem (Dr. Drazen was editor at the time).
As Richard Lehman pointed out in his BMJ blog post this week, journals have industry conflicts of their own in the form of reprints, and the NEJM sold at least $697,000 worth, mostly to Merck, of the Vioxx article. It helped that NEJM reviewers and editors also let slide the idea that naproxen (the comparison drug in the Vioxx trial) decreased the number of heart attacks, for which there was no evidence, making it seem as though the increase on Vioxx was all relative and really not so bad.
Lesson learned: Don’t trust what comes out of a drug company (or medical journals?) and verify, verify, verify.
This is not to say that physicians and academic medical centers should never work with drug companies. While at the National Institutes of Health, one of my major projects was to help launch a major public-private partnership—some of the “private” included about a dozen drug and biotech companies—to establish neuroimaging and biomarker standards for Alzheimer’s disease. Neither the NIH, nor any one company could afford to do this $80 million-plus project on its own. A key provision, on which there was push-back initially from some companies, was that the data and tissue specimens collected would be open and available to any investigator who applied to use them. The project was replicated in a number of other countries and has been a stellar success.
During the years I was working on the partnership, LA Times reporter David Willman uncovered the worst conflict-of-interest scandal the NIH had ever seen, showing that hundreds of undisclosed consulting fees and stock options had gone to top scientists. Dr. Elias Zerhouni, the NIH Director at the time, said these payments threatened the integrity of the NIH. Ironically, the only one of the duplicitous consultants to be convicted in federal court and to lose his medical license was my former supervisor at the NIMH, where I’d lost my job years before, perhaps, I realized later, because some of the research I was doing wasn’t in line with industry interests. (That’s my disclosure, or chip, on the issue.)
The Institute of Medicine and others have made recommendations of ways to manage conflicts of interest between physicians and industry. There are ways to work collaboratively and constructively for all concerned. Allowing open access to clinical trial data (and not just summary data) would go a long way towards pharmaceutical companies showing that they want to work collaboratively and constructively with the medical community.
Publisher’s note: Dr. Rosenbaum’s second part to her series, “Understanding Bias — The Case for Careful Study,” was published in the NEJM today. Dr. Molchan’s post (above) was written before Dr. Rosenbaum’s second part was published. The fact that both reference the Kassirer and Goldacre books and the IOM report is coincidental, but somewhat understandable.
Addendum on May 18:
Note that in that second part of her series, Rosenbaum writes, “Physicians know that ‘pharmascolds,’ as physician-scientists David Shaywitz and Tom Stossel have dubbed them, will ‘vilify the medical products industry and portray academics working with it as traitors and sellouts.’ ”
We won’t participate in the name-calling, although we’ve heard from readers who were ready to suggest some. On Twitter, Yale’s Dr. Harlan Krumholz wrote:
On a related topic, see Jeanne Lenzer’s piece in The BMJ, “Centers for Disease Control and Prevention: protecting the private good?” Subhead from The BMJ: “After revelations that the CDC is receiving some funding from industry, Jeanne Lenzer investigates how it might have affected the organisation’s decisions.”
Addendum on May 19:
In his May 18 journal review blog for The BMJ, Richard Lehman wrote about part two of Dr. Rosenbaum’s series: “It’s a stream of consciousness narrative in which she struggles to persuade us that all this talk of bias harming patients is a naughty lie and that we should demand more evidence. It’s quite sweet but I’m not sure what it is doing in a leading medical journal.”
Addenda on May 21:
On his Forbes blog, Larry Husten writes, “No, Pharmascolds Are Not Worse Than The Pervasive Conflicts Of Interest They Criticize.”
Later in the day, Susan Molchan reacted to parts 2-3 of Dr. Rosenbaum’s series. Her synopsis: “But for all (the series author’s) more than 9,000 words, I think she missed the big picture.”