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May 29, 2007

Feedback on our 'Pharma Perks' story

Letters received about the POZ.com special report: "Do Pharma Perks Educate HIV Docs—or Bribe Them?"

Dear POZ,

It’s an incredibly complex business trying to tease out how AIDS folks’ reliance on pharmaceutical and diagnostic companies’ cash and coddling influences (or fails to influence) their thinking and actions. And since two of the three people you quote in your report (Harrington and Urbina) are former colleagues of mine, I would pause before casting aspersions on their good faith.

The simple truth is that 99% of AIDS activist and advocacy groups rely on the largesse of drug companies for a large share of their continuing funding. This has been the case since the late 1990s.

Where the Treatment Action Group is concerned, IRS filings show that these grassroots brainiacs took up to $99,000 a year from Hoffmann-La Roche (for the years 2000-2004) and up to $49,000 annually from the likes of GlaxoSmithKline, Bristol-Myers Squibb and Merck. Until a Gates tuberculosis grant (mission creep, anyone?) came to the rescue a few years ago, pharma support accounted for nearly half of the group’s $1 million annual operating income.

Is this the reason AIDS activists and educators have gone soft on the drug industry over the past half dozen years? Or is it that most of these folks have simply mellowed in their middle age—and often feel indebted to Big Pharma for enabling them to make it there?

In the case of AIDS docs, and in particular St. Vincent’s Hospital, I’ve had the opportunity to watch over the past ten years as continuing medical education at this fabled Greenwich Village institution morphed from a true academic undertaking into something more akin to a commercially tainted fast food enterprise. But even this tendency could stem from a broader intellectual laziness in our society at large, and not something specific to physicians who are loath to open a medical journal or critically apply their reasoning capacities. Or it might merely be an unfortunate by-product of physician training in the U.S., where interns and residents are taught to follow recipe books rather than think for themselves. It is truly the exceptional clinician who is strong enough, smart enough, or motivated enough not simply to lemming-like follow the prevailing zeitgeist—especially in the case of HIV/AIDS, where continuing medical education has come to more closely resemble an outing on an episode of Sex in The City than anything on Grey’s Anatomy or ER.

When trying to get one’s head around these issues, it is also probably useful to make a distinction between the low-level community physician (or even the much sought after “high prescriber”) and those docs that the pharmaceutical industry has identified as the field’s key opinion leaders (KOLs). While parasitic drug reps are paid to feed and befriend the former, it is the regional marketing directors and executives back at the home office—with enormous budgets at their disposal—who are in charge of making sure they have these accidental thought leaders in their pockets. Speakers bureaus, Scientific Advisory Boards and rich clinical trials contracts are all completely legal means to buy the loyalty of the hallowed KOLs—in many cases enabling them to double or triple the salary at their university or medical practice. A quick look at all they’ve got going on extracurricularly (www.shillfactor.net), makes one wonder how they could possibly have any time left to actually see patients—or even read a medical journal. In no other profession—law, government or journalism—would such corruption be tolerated.

With a bit of deft persuasion, states like New York and California may find it useful to follow Minnesota and Vermont in making information on many of these furtive financial exchanges publicly available. Project THAMES has been reaching out to key congressional representatives and Governor Spitzer’s office to see that this much-needed transparency happens sooner rather than later in the state of New York. And while it is understandable that HIV physicians and activists would scramble to defend the current system where money buys prominence, comfort and docility, were the public to learn of the enormous sums (of money—and TIME) involved, I cannot imagine that the status quo would continue.

Mike Barr
Project THAMES
Transparency in HIV Authorship, Medical Education, and Scientific Investigation


Mike,

Only one suggestion. You might add, when talking of the low-level community physician, that they, unlike the opinion leaders, have vast hands-on clinical experience—although maybe that’s obvious. And it is absurd that their opinions should be ignored, they are never sought, and even held in contempt. (I have personally experienced this—when one of these gurus at some meeting actually said he did not believe me when I commented on the fact that I had numbers of patients who had been stable for years, on treatment, with detectable viral loads—while the other experienced docs around the table were nodding their heads in agreement with me.) We were being instructed by those who are busy counting their money when not delivering the talks probably written for them by the companies that pay them. One should investigate how many patients these people actually have direct responsibility for, how their probably very few patients are doing, what is their actual practice and do all of them do what they preach. An article on key opinion leaders might be fun.

Actually, this is something that I'm going to talk about—I think I might have already told you. It  concerns a conflict between a theoretical basis for treatment and empiric information. (In this case, an inappropriate use of sound Darwinian theory). The HIV educators go to great lengths to say their recommendations are "evidence-based." But a look at the early writings on evidence-based medicine would put that claim to rest. In its original meaning, evidence based medicine was an attempt to replace authoritarian dictates with something more rational in clinical decision making. It stressed that a combination of clinical expertise and the best external evidence (controlled trials, meta-analysis, etc.) was necessary. Where the best external evidence was not available, one should obtain it. The value of individual clinical expertise was stressed. The question of when to start ARVs could have been answered—even if not with great precision—by now, if the appropriate randomized trials had been done. So could the issue of undetectability under every circumstance. So these opinion leaders are making a mockery of evidence-based medicine, and sending us back to the dark ages of the oracular authority of the clinician. Somewhat in their defense, I should say that there is a common misconception of evidence-based medicine. I just read Richard Horton's review of Jerome Groopman's book. It is a silly opinionated review revealing both his and Groopman’s ignorance of the meaning of evidence-based medicine. Horton, who may well have never had any clinical responsibilities (I don't know his history), has the chutzpah to take doctors to task without considering the obstacles placed in their way by managers, administrators, insurance companies, economics etc. He actually says something like: doctors must change their way of thinking. He should try working at my old HIV clinic, and get a taste of the real world. I wrote a letter in response but have no belief that it will be published.

Joe Sonnabend


Dear Joe,

I couldn't agree more with your suggestion and your analysis of what amounts to the censorship of real discussion and debate about the meaning of evidenced-based medicine. The lack of vibrant scholarship and inquiry into the knowledge acquisition process (clinical research) and the clinical decision making process (clinical practice) has handicapped progress in our field enormously.

I am continually astounded that our profession conducts itself devoid of any awareness of the history of science or medicine, the nature of a scientific paradigm, or the contexts that shape clinical research and clinical practice. It seems that most in our field and the media covering our field act as if the clinical research process is an objective process that is not analyzable or appropriate to report on or to subject to criticism. The DHHS panel that decides on treatment guidelines consists largely of people who have no clinical experience and amazingly, like some medieval or modern ecclesiastical authority, have lifetime appointments.

In fact, my own efforts to chronicle the history of HAART over its first ten years, with a focus on possible mistakes made and lessons learned, was censored by the president of IAPAC, who had asked me to write it and had agreed to publish it. He told me he was uncomfortable with mentioning specific examples such as Roche's promoting its defective protease inhibitor saquinavir and with stories about pharma-sponsored KOLs potentially misshaping clinical practice and research in HIV medicine. He told me he feared the IAPAC organization could be subject to lawsuits if it published an article critical of specific drug companies or specific KOLs.

According to Mark Harrington's opinion cited in the POZ article, things like pharma misshaping clinical practice and research don't happen in the field of HIV medicine because the activists would bring it to the community's attention. In his mind I guess there are no examples. Ironically, in fact it was Mark's activism that alerted me to the potential dangers saquanivir posed to my pts when protease inhibitors first became available in ’95/’96.

Ironically again and sadly, Mark’s firing of Mike Barr as the editor of Tagline at a time when Mike was doing groundbreaking reporting on the unholy alliance between KOLs and pharma symbolized the end of a vibrant activist interest in the way in which clinical practice and research operates.  Mark fired Mike Barr and stopped the presses on Tagline’s monthly reports on treatment issues. Why?

Here's a sad but potentially instructive example, in my opinion, of the points Joe and Mike are making. At the Toronto International AIDS Conference, the Editor in Chief of the Lancet, Richard Horton, chaired a panel of illustrious people like activist Gregg Gonsalvez and Dr. Tony Fauci urging us all to do more and better. He exhorted the panel and the audience to challenge conventions and press for progress including maximizing the impact of financial resources in both the developed and developing worlds.

The Lancet in conjunction with the conference published a special red issue devoted to HIV/AIDS.  Unfortunately, the lead clinical article in the RED issue was a report on the GSK-sponsored KLEAN trial that showed GSK's Lexiva was "noninferior" to Abbott’s Kaletra. The lead author, Dr. Joe Eron is also the Chairman of the NIH Optimization of AntiRetroviral Therapy Committee (OP ART) that decides how government research money and clinical trial resources are spent.

In Dr. Eron’s presentation at Toronto and in all the website and media coverage of the trial (which is touted in theBody.com and TheBodypro.com report by Dr. Dave Wohl as the third of the ten most important developments in HIV medicine in 2006), no mention is made of the fact that boosted Lexiva is in one way non-inferior. It costs at least five thousand dollars more per year. Simply put, what’s the most important government official in HIV clinical research doing on a project showing a treatment is non-inferior when so many HIV patients need treatments that are better not just non-inferior. Why are KOLs touting this predictable finding as so important?

Dr. Eron, who receives an unspecified amount of money from GSK, defends his involvement in KLEAN and the NIH because he disclosed in the Lancet article that he is a paid consultant of GSK. (As if disclosing a potential conflict of interest makes that conflict of interest okay.) Dr. Eron defends the importance of KLEAN by saying it led immediately to its elevation as a first line treatment in the IAS-USA guidelines. The pharma subsidized IAS panel similarly did not mention its excessive cost. Why not?

A predictable and huge marketing effort by GSK is successfully increasing Lexiva’s market penetration led by KOLs like Dr. Eron who report on these results at CME events such as the Clinical Care Options conferences that he chairs. My letter to the Lancet that was published has not been reported on nor the issues raised in it discussed in any HIV website/magazine/journal. Why for example did theBody.com not report to its readership my published letter on this topic even as it reports stories of patients dying on waiting lists for ADAPs. Those same ADAPs pay for the extra costs associated with boosted Lexiva, no questions asked, without evidence that it is preferable to the standard cheaper treatment.

What are the opportunity costs of having the head of the OPART working on KLEAN instead of on developing research protocols that could answer important questions like the natural history and treatment of the patients that Joe refers to who have the viral disconnect response to ARV treatment? What is the cost to clinical progress and patient care when it is taboo to talk about such things here and in the developing world?

In my opinion it is vital that we doctors, scientists, government officials, drug company employees, scholars, activists, patients and all interested parties talk much more about what is evidenced-based medicine. We need to recognize that our understanding or lack of understanding of what it is powerfully shapes and can misshape clinical practice and research with real impact on the lives and health of patients.

Best regards,
Dr. Paul Bellman


Dear POZ,

A few points about your POZ article on Pharma Perks are worthy of further consideration and in my opinion further discussion and debate given my contention that pharma has seriously misshaped the course of HIV research and practice in HIV medicine. It has done so through a core group of key opinion leaders who sit on the important government panels that determine treatment guidelines on the DHHS guidelines panel and at the NIH OPART committee that decide on how government money and resources are spent on research.

Most of the KOLs on these committees receive extensive support from many drug companies involved in HIV medicine and perks would not be an accurate way to describe the compensation involved. There are many examples of how this plays out including one involving the OP ART Chairman and PI for GSK of the KLEAN study that was the subject of a letter of mine published in the Lancet. Another example is the chair of the Anemia in HIV Working Group, who as a paid consultant for J&J advocated for more of the world's most profitable drug EPO to be given to more HIV patients possibly in hazardous ways, also a subject of a published letter of mine to JAIDS.  Please see Mike Barr's website shillfactor.net, which chronicles the pharma KOL story in detail.

I believe Dr. Urbina statements that reps "are part of the health care team" and that he "looks at them not as salespeople but as people who can supply me with scientific data" as really quite astonishing.  I would ask why Tony isn't already getting that scientific data from medical journals, conferences, continuing medical education and medical and scientific colleagues that he needs to get scientific data from sales reps.

In fact, when Tony turns to those more traditional sources of scientific data he may not realize that these traditional sources are already influenced and some would say tainted by pharma's influence. Pharma heavily subsidizes and is involved in most HIV conferences, conference chairs, medical journals, working groups, panels and HIV websites designed to educate physicians. Pharma also subsidizes community groups such as TAGLINE and Project Inform that started out as activist oriented groups.

To me, the most important assertion in the article that I believe needs discussion and debate is "In the sometimes unique field of HIV, that may not be necessary. Harrington, for one, has confidence that the HIV community would nip major unethical practices in the bud. ‘I don't think the industry could get away with some of the more outrageous things [that go on] with other diseases.’” I guess with the one of the world's most important and recognized activists thinking that way, it is "case closed.” Or is it?

Regards,
Dr. Paul Bellman





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