Speaking under the influence? - a note to Nelson Watts

Professor Nelson Watts chairs the FDA Endocrinologic and Metabolic Drugs Advisory Committee. Of current interest, this is the committee that recommended the 1999 approval of GSK's Avandia (rosiglitazone). He is also Professor and Director at the University of Cincinnati Osteoporosis Center, home of Procter and Gamble.

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.

Quart: I enclose the letter I wrote to Watts on April 23, and then his smoothie evasive answer back the next day.

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,

Sincerely,
Barbara Quart

Reply Nelson Watts to Barbara Quart - 24 April 2007:

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).

Nelson Watts

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."

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Root Strikers

"There are a thousand hacking at the branches of evil to one who is striking at the root"
Henry David Thoreau

This post is about our patients and their questions.
It is about the honesty of our profession.

Roy Poses at Health Care Renewal drew attention to an excellent article in an obscure media source, the Berkshire Eagle (located in the Bershire mountains of Massachusetts). The reporter, Barbara Quart, experienced something of a personal odyssey after attending a medical research convention. My interest in her story was enhanced by the fact that the meeting she attended was the 7th International Osteoporosis Symposium in Washington, D.C. This is exactly the sort of high-profile osteoporosis meeting I would previously have attended with some frequency. She writes well about my colleagues and the integrity of my clinical speciality. Her thought provoking article is reproduced following my comments.

As a profession we have a long and effective history of dealing with critics. We are of course scientists. We sell our services under the banner of science. We promote the wares of industry under the banner of science. So, when Prince Charles addressed the World Health Assembly in May 2006 to argue that homeopathy should be offered as part of "integrated healthcare" we could respond with ease. Anticipating his speech, we in "scientific" medicine struck back with an open letter expressing concern about the use of "unproven or disproved" treatments, and the need to reserve NHS funds for "treatments that are based on solid evidence". So much so good.

The problem we face is that the most important patient criticism of our profession is not about "alternative" medicine or homeopathy. Critics strike at the core of what we do. Their questions are about science. They question the quality, transparency and honesty of our science. And they do so with good reason. We ignore these patients and these questions at our peril.

Some of these individuals are patients. Others have lost family members only to discover that information about medicines had been hidden with the collusion of regulators. The questions they ask and the evasive dishonest answers they receive speak volumes. They have asked serious and pressing questions of doctors, companies, regulators and governments. I have watched with shame as they have received "answers" which have no scientific or linguistic meaning. The answering reveals a leadership of our profession that has lost its way. It reveals bullying appearance-based regulatory systems in which box-ticking and red tape trumps the need for scientific or personal integrity. It reveals that concerns raised about highly placed individuals are obscured by a network of powerful colleagues.

There are no open letters of concern about "solid evidence" this time.

It is worth reading the careful writings and correspondence of some of these root strikers. Why are we as doctors not asking those same questions, or teaching our students anything about real integrity? Perhaps we are fearful of speaking out for honest science. The questions that need answering are obvious ones. When patients lose trust in the integrity of the science upon which they depend, we may never be able to recover our status as a profession.

As Roy poses writes:

"if physicians don't give up the "nifty perks," and appearances in the "satellite sessions" that "subtly but unmistakably sell the drug,", an outraged public will and should take harsh measures to make sure we do give them up.

Here are a few root strikers. Just ordinary people asking ordinary questions:
Seroxat Secrets
Bob Fiddaman
Vera Sharav
Millie Kieve
Colin Downes-Grainger

And that excellent article by Barbara Quart about my bone colleagues is below:

Big Pharma is big dog at symposium
By Barbara Quart (Original Article)

May 28 2007 NEW YORK LATE LAST month I attended the 7th International Osteoporosis Symposium in Washington, D.C. I thought I'd learn a lot that I could then pass on to other older women in the Berkshires, many as little conscious of osteoporosis as I had been, and I hoped to get clearer what to do about my own diagnosis, and the urgently prescribed medication for it, which I have refused for a year now.

The event was basically a five-day non-stop education — some might call it a fancy sales job, or even indoctrination — by MDs for MDs (also physical therapists and other health professionals). From 8 a.m. to 9 p.m., talks and panels, lots of exciting information, in grand hotel ballrooms. All meals provided — dinners especially nice, supplied by the drug companies — plus nifty perks like a handsome tote bag emblazoned with "Lilly" (maker of Forteo, scariest of the drugs), and a beautiful pen inscribed "Fosamax," the blockbuster seller. A very different world from the pretzels and chips and cheap white wine of my own decades of university English literature meetings. I feel grateful now, thinking back, that one couldn't be for sale in my profession.

After I came home I thought for a while that things seemed clearer. Just about everyone who spoke or whom I spoke to seemed of one mind: this is a really bad disease, undertreated, it desperately needs to be publicized, diagnosed (give a DEXA scan to every woman over 65), and medicated, or it will wreak devastation. And I heard about several memorable instances of osteoporosis-caused spinal collapse, hip collapse, chronic horrible pain, hideous operations.

So my first draft of this article read like the NIH ad in the recent Sunday Times Magazine devoted to older women. I crammed it full of data, carefully defining the disease (bone thinning, especially after menopause), listed risk factors (like family history and smoking), noted how men get it too but later and to a lesser degree, urged kale and yogurt, heavy vitamin D3, exercise overseen by a really skilled physical therapist (working with amazing Jill Esterson of Great Barrington was the best thing I did this last year).

I couldn't however share the leadership MDs' enthusiasm for the drugs as good, safe, effective; nor their repeated deploring of "non-compliance" (naughty patients who drop their meds). The scolding of the "non-compliant" seemed to have priority at the symposium over the exciting talks by research scientists, and no speaker dealt with why so many people go off these drugs or are reluctant, like me, to take them in the first place.

There was a giant image of jaw necrosis: the white patch of exposed bone in the mouth from taking a bisphosphonate (Fosamax or Actonel) — though no mention of the horrific pain, or how some cases heal but others don't, and for those there is no help. And little or no mention of esophageal problems, from heartburn to severe terrifying esophagitis. Nor leg pain, eye pain, other "adverse events."

The tone was always upbeat, a kind of beating the drum, and the line between the drug companies and the MDs uncomfortably unclear. True, the dinner panels are called "industry sponsored satellite sessions" — but the same leadership MDs who are major speakers during the day, and whose names keep appearing on the important research in the major medical journals, are the same ones on the evening "satellite" sessions that subtly but unmistakably sell the drug — Forteo, Actonel, Fosamax — sponsoring the session.

Health professionals I respect argue that osteoporosis is being hyped to create a massive new market to take over where the disastrous Hormone Replacement Therapy left off, all the money it generated vanishing. True or not, money weaves through all of this in disconcerting ways.

Before I left for Washington, I stumbled upon an on-line story in Slate about two Sheffield University (England) researchers conducting clinical trials of Actonel (second in sales to Fosamax) for Proctor & Gamble for $250,000. But P&G took away the final data, denied them access, wanted to ghostwrite the conclusions for publication under their signatures.

One of the scientists, Aubrey Blumsohn, refused and insisted on seeing the data first, only to find that 40 percent had been removed. This a year after medical journal editors "warned that growing industry interference with academic research (from study design to data analysis and publication) was threatening the objectivity and trustworthiness of medical research."

As former New England Journal of Medicine Editor Marcia Angell, MD of Harvard Medical School and author of a book on the subject, states that drug companies are "involved intimately in every detail of the research" for new drugs, and "they design the research so that their drugs look better than they really are." How could one ever again trust any scientific study, in however reputable a journal? What won't I know about?

So in my own looking for some truth I could rest my decision on, I discovered that even the truths I thought I already had are probably not trustworthy. Compromised doctors. Compromised data. Flying blind indeed.

So perhaps it's not surprising that what stays with me most from the symposium is the only critical voice I heard in five days, a gray-bearded man who spoke with quiet grace after the final session. An orthopedic surgeon from a small town near Pittsburgh, he said he feared we are walking into yet another medical disaster of huge proportions and the people treated will be the ones who will pay the price. He himself prescribes these drugs because he feels something must be done to intervene with continual bone loss in his elderly patients. But it will be another 15 years before we know what we're doing. When you take this medication, he said to me later, you should see yourself as being in yet another clinical trial.

Finally, I contacted the medical consumer advocate whose sanity in print I've long valued. BMD numbers are critical, she says, and you must assess what exactly the drug will do for you. How effectively does it prevent fractures? Percentages can be made to look large but may actually be very small, barely more than the placebo effect, perhaps the same as the chance of an esophageal ulcer. Is that worth the risk? The whole industry is trying to terrify you, she says.

My own conclusions? I feel I must take that pill, but I will do so angrily.

I am angry that this richest of American industries uses its vast wealth far less for research to make better, less dangerous drugs, than to buy off doctors; to plaster misleading ads everywhere; to dispatch armies of salesmen and lobbyists; and to manipulate and thus destroy the meaning of scientific research results. Still, as I write this, stories and editorials are suddenly erupting in the Times about MD/drug company collusion; and Vermont's Bernie Sanders eloquently attacked Big Pharma in the Senate itself as the very worst of a long list of the most powerful, greediest special interests in America.

So maybe there's hope.

But for now, dear reader, sorry, but you're entirely on your own.

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