I have had reason to wonder about rosiglitazone, but also about the way in which advisory committees might approach matters of science. My concerns were stimulated by an unusual E-mail I received a few days ago from a pleasant and previously unknown (to me) lady called Barbara Quart. Quart is a leading American film critic. She has postmenopausal osteoporosis and attended a major osteoporosis congress. Roy Poses posted a few days back about an excellent newspaper article by Quart in which she discusses, with considerable insight that meeting, industry influences, and the perilous state of academia in medicine (alternative source for article).
Quart subsequently E-mailed me. She related her attempt to ask a question of Professor Watts who chaired a session she attended. She apparently felt humiliated by his response and entered into an E-mail exchange with him. I was surprised that this exchange pertained to me. With her permission I reproduce that exchange, and discuss its significance.
Barbara Quart to Nelson Watts 23 April 2007:
Dear Dr. Watts,
I was the person who asked the question at the evening satellite session over which you presided, about Proctor & Gamble’s apparent suppression of clinical trial research results in Sheffield England, according to a very persuasive article in an important on-line magazine called Slate.
It troubled me that you reacted a little indignantly to my written question so I have to tell you who I am. I was an academic at City University in New York for 35 years, PhD in American literature, published a book and many journal, magazine and newspaper articles. (You can “google” my name and see some of what I’ve done.) As a visiting humanities person, a bit shy, I found it hard to rise and speak in that ballroom as you challenged me to do.
I came to the Symposium to write about it for a newspaper, and to inform the community of women in my area, and I am in the process right now of writing that piece. But also I must say I was trying to understand my own diagnosis and the best way to deal with it. My doctor prescribed Actonel and I have hesitated (for a year!) to start it (because of the side effects) so I have a very personal stake in this issue. But certainly huge numbers of other women have much at stake as well. And the profession—especially a person like yourself, who is not only eminent within the profession but who consults with the FDA in overseeing this huge pharmaceutical operation among other things, would—I’d imagine—want to know why a senior lecturer and bone metabolism specialist (Dr. Aubrey Blumsohn) who was entrusted by Dr. Richard Eastell with completing the Sheffield study, would accuse the producer of one of THE major osteoporosis drugs of interfering with, and ultimately suppressing. clinical trial evidence about that drug.
And the presence of pharmaceutical money in all this is not reassuring.
I thought since one of the panel members that night had actually worked at Sheffield University, that he especially might have something solid to say about what seems to me a most serious charge, which I can find no response to on the Web. Why did he not speak?
Since the Sheffield study, according to the Slate article of December 22, 2005, was expected to “shed further light on how Actonel affects women’s bones and their susceptibility to fractures.” one has to be seriously concerned about what Proctor & Gamble found that they didn’t want the world to see.
Surely, given how many of the attending physicians have prescribed and will continue to prescribe Actonel in massive numbers--with NOF’s enthusiastic endorsement, so to speak--surely this accusation demands some attention in high places?
I will send the actual article to you in a second E mail, plus a thoughtful disturbing article that the researcher himself has put on the Web.
Hoping to hear from you, especially before I finish writing my own article,
Thank you for the explanation.
I don't know that "indignant" is the right word to describe my feelings, but your question was not directly related to the topic of the symposium and (without knowing where it came from), seemed designed to provoke controversy. Now I can understand your interest.
I know the parties involved but have no direct knowledge of the allegations. I do know that the research being questioned by Dr. Blumsohn has nothing to do with the efficacy or safety of Actonel or other osteoporosis medications.
I would be happy to talk with you by telephone or correspond by email if you have questions that I can answer. If you want more information about the Blumsohn story you should contact Procter & Gamble (Tom Millikin is the head of external relations and the right person to address all inquiries to, his phone number is 513-622-1522).
So what have we here:
In effect, Professor Watts, faced with a question about science and scientific malprocedure
1) brushed-off the questioner
2) referred her to the chief public relations officer and media contact of his commercial benefactor
3) with a reassurance that the research in question "has nothing to do with the efficacy or safety of Actonel"
Watts also seems to regard questioning in science (by a patient) as inappropriately "provoking controversy". But scientific questioning is precisely about controversy, and the honest resolution of that controversy.
To appreciate the significance of this interchange, and its relevance to other aspects of drug approval, we need to know a little more about Professor Nelson Watts.
Watts chairs the FDA Endocrinologic and Metabolic Drugs Advisory Committee. He is Professor and Director at the University of Cincinnati Osteoporosis Center, home of Procter and Gamble. Unsurprisingly he is extensively associated with Procter and Gamble, has "authored" a lot of P&G funded studies about Risedronate, some with Professor Richard Eastell (or here). He was involved with Eastell in helping P&G to produce educational material to rebut the implication from Merck's FACT trial that Alendronate may be more efficacious (using in part the very data we generated in Sheffield). He does plenty of speaking for P&G. He also gets honoraria from Aventis (who co-market risedronate), P&G, and Merck. He serves as a consultant for Aventis, Eli Lilly and Company, GlaxoSmithKline, Merck, Novartis, NPS, P&G, Roche, Servier, and Wyeth. He receives other funding through his university from Amgen, Aventis, Eli Lilly, Merck, Novartis, and P&G. Sadly Watts had to get special dispensation to be allowed to attend one FDA meeting involving a Pfizer insulin inhaler because he earned too much money each year for serving on Pfizer's speaking bureau (around $10,000).
When Watts gets a question about science and scientific mal-procedure his natural instinct as a scientist is to refer it to the public relations department of P&G.
So what of Avandia? Watts should have made some comment about the FDA's approval of Avandia by the advisory committee he now chairs. Perhaps he saw the 2000 letter from Dr. Buse about Avandia to the FDA where Buse stated that GSK employed "blatant selective manipulation of data" and had attempted to silence him. He may even have seen actual raw data from GSK instead of GSK's own interpretation of those data. He may have some thoughts about the FDA staffer who was recently abused for trying to raise the problems with Avandia. Perhaps Watts agrees with the view that those within the FDA who bully ethical FDA scientists should be fired. He might however agree with the view of FDA Commissioner Andrew von Eschenbach who feels that those within the FDA who try to discuss science should not be tolerated. Perhaps Watts has a view about the survey showing that almost one-fifth of the FDA scientists surveyed said they had been pressured to manipulate findings. Does any of this matter?
Perhaps all these things too should be referred to some Public Relations technocrat at GSK or P&G for a little smoothing-over? That seems to be the way of science. What do you think Professor Watts?
By the way Professor Watts - I note your paper
Watts et al., J. Clin. Densitometry, 7: 255-61, 2004.
May I ask who wrote it?
I know that the medical writer (ghostwriter) for that paper was Mary G Royer. I also know that the paper contained assertions and text about bone density that have striking similarity to those in the two draft papers about bone turnover (in those same studies) that P&G attempted to publish in my name.
Perhaps we need to consider the role of a scientist Professor Watts. One role of a scientist is to admit when a question is too hard to answer. Another is to respect evidence, logic and honesty, and to refer questions to someone who will supply a truthful answer. Some feel that the most important single attribute of a scientist is a curiosity intense enough to make them keep questioning their beliefs to see whether they fit with actual observations. Sending questions about science to a public relations officer does not seem to be a good approach, particularly for someone in your position. Perhaps scientists who fail to recognize that should not be sitting at the table where decisions are made that impact on public health.
I apologize if I am lacking in decorum Professor Watts. I don't care about decorum when it trumps integrity and when it involves academic bullying that damages our patients. Perhaps you will join the tiny collection of your bone colleagues who have cared enough about the integrity of our profession and our clinical speciality to have discussed the matter with me before passing callers onto the public relations arm of a commercial benefactor. That might have been a kind gesture towards a beleaguered colleague - and a colleague who was also in the right. But you wouldn't really know that, would you?
For starters you might like to read about the way in which P&G attempted to interfere with the first attempt to correct the scientific record. You might also ask why P&G persists in their refusal to allow us to make the raw data they eventually provided that formed the basis of the Eastell 2003 paper and the two further draft papers available for public scrutiny. Any views about these things and their likely intent Professor Watts? A scientists who is truly confident of the integrity of their work, should have nothing to hide.
In the words of Upton Sinclair:
"It is difficult to get a man to understand something when his salary depends upon his not understanding it."