Weaning Us Off the Dope

Just as the hand-wringing PR exercise that has become the international AIDS conference was winding down halfway across the globe, this little item hit the newsstand in the states:

July 15, 2004 -- Members of a government panel, which earlier this week recommended more aggressive use of statin medications for people at the highest risk of dying from heart disease, failed to disclose financial links to the companies that make the drugs.

The revised consensus guidelines were issued by none less than the American Heart Association and were drawn up by a government panel of experts in the field, convened by the NIH's own National Heart, Lung and Blood Institute. The new rules, if sustained, would lower serum cholesterol targets to a point where 7 million more Americans would be encouraged to start taking the cholesterol lowering medications of Pfizer, Merck, BMS and AstraZeneca. (At $1,500 or so a year and 20-30% margins, we're talking an additional $2-3 billion a year in profits -- with little more than the stroke of a pen.)

New York Newsday first reported the story in its Thursday edition. Eight of the nine panel members had earned money specifically from cholesterol drug makers, including Pfizer, Merck, BMS and AstraZeneca. The NIH's Dr. James Cleeman and Dr. Rose Marie Robertson, of the AHA, both said they felt financial disclosure had been covered because all but two of the authors had also served on the 2001 consensus panel -- and that they had made their industry connections known then.

The summer imbroglio set familiar alarm bells sounding: foxes guarding the hen house, physicians and researchers as pharma shills. Of course, guidelines meddling is among the oldest tricks in the Big Pharma playbook. The wisest, perhaps privileged, clinicians routinely eschew such interference and hope nothing untoward will befall them for their brave and educated insolence. But the fact remains that guidelines of all guises in all specialties whack quite a wallop in establishing prescription patterns and the standard-of-care. And thus, not unlike the Swiftboat veterans' media blitz in swing electoral states, efforts to influence them suck in tens of millions of dollars a pop.

Perhaps due to an historic vigilance among AIDS activists and clinician advocates (or to its infectious nature), the field of HIV medicine has so far been spared the most egregious of these marketing-masquerading-as-medicine maneuvers. In fact, the two notable revisions to HIV's standard-of-care followed on the heels of therapeutic setbacks (results of the early vs. deferred AZT "Concorde" study, circa 1993; and the failure of the eradication hypothesis, around 1998) and resulted in retrenchment rather than new aggressivity -- albeit not without sustained intervention to limit the damage.

But might that portion of the Big Pharma enthralled research and treatment establishment still be clinging onto a model of overmedicatization in order to please its generous sponsors? After all, the NIH's hallowed Principles of Antiretroviral Therapy seem immune to re-evaluation -- even though the science and hypotheses on which they were based have largely been overtaken by events. "It's the virus, stupid" sprang from its en-coffined slumber on the wings of hope -- whipped to frenzied cries by the medical marketers -- and has since taken on a life of its own. But where the silver dagger to return it to its repose?

When otherwise patient friendly researchers and community docs self-satisfyingly state, with all the authority their years of furtive pharma hustling has bought them, before a conference crowd that "lifelong antiretroviral therapy is not really a problem (anymore) because easier to take, less toxic combos are now available or just over the horizon"; when Trizivir, Viread + Sustiva or Kaletra are considered treatment sparing "maintenance" regimens in virtually all the studies pretending to re-explore this approach; when patient advocates on federal panels sign off on (or instigate) sweeping prohibitions which diminish our treatment options and further bottleneck the progress of clinical care; we, my fellow HIVers, activists, clinicians, researchers, need to rediscover our activist rage and imagination.

The field of HIV/AIDS seems poised, once again, at a crossroads. This time, however, activism and advocacy are deafening only by their silence. While the black and white, demagogic issues such as Abbott's notorious price gouging rampage had even the bloated pharma front men crying foul, the more insidious issues -- an anachronistic treatment paradigm, a research and regulatory establishment high-jacked by industry -- go entirely unaddressed. It is within this context that an important voice may have serendipitously risen to stimulate our latent activist memory cells: former NEJM editor Marcia Angell via her gutsy deconstruction of (nearly) all that ails us.

Marcia Angell wasn't always a crusader. Some may remember her rather uncritical endorsement of the design and conduct of the seminal AZT study (at 1,500 mg a day; it's now dosed at 600 -- and 500 mg or less, outside the U.S.) when it appeared in the pages of her little journal, circa 1987. Others haven't forgiven her tough stance against alternative medicine. But with the release of her new book late last month, The Truth About the Drug Companies: How They Deceive Us and What We Can Do About It, Dr. Angell appears to have Goliath precariously centered within the cross hairs of a populist sling shot; her rousing philippic having transformed an otherwise mild-mannered Harvard lecturer into a present day Daniel J. Goldhagen of the medical profession.

She clearly doesn't buy the Nussbaumian "good intentions" defense; instead, she lays out the evidence like an expert prosecutor -- and goads us all to cease the charade. For those among us who, over the years, have come to rely on drug company beneficence for little luxuries here and there (and maybe even some extra pocket money), implementation of the Angell agenda will not be painless. Her clear and cogently articulated vision is of a reformed medical profession as much as it is a reformed pharmaceutical industry -- both of which need to return to their mission, she argues, of serving the public interest.

Angell's epiphanal moment is said to have occurred in the spring of 2000 when newly required conflict-of-interest disclosures for authors exceeded the available page space. The study in question was of an antidepressant drug, nefazodone, developed by Bristol-Myers Squibb. All but one of the study investigators reported consultancy arrangements, speaking honoraria and membership on pharma advisory boards -- in most cases, with pharma companies producing similar types of drugs. Visibly frustrated, Angell referred readers to the journal's Web site for the complete list of pharma financial entanglements. In disgust, she penned a now legendary accompanying editorial for the issue, "Is Academic Medicine for Sale?"

If we have become inured to apocryphal tales such as that of the section chief who supplemented his income to the tune of $500,000 a year through pharma consulting gigs or the clinical trials sites paid $12,000 per patient enrolled -- with a $30,000 bonus if the number reaches six, Angell's manifesto threatens to shake us from our stupor. And in a hodge-podge effort to depict the HIV KOLs and consensus makers in this regard, three extra pages of TAGline's back-to-school issue are dedicated to Dr. Angell, in support of her campaign to bring medicine back to the people and to save Big Pharma from its most egregious excesses.

Early reviewers of the names and numbers note that acceptance of financial goodies (not to mention the unquantifiable triumvirate of fame, friendship and flattery) is not in itself evidence of objectivity's loss. In fact, without exception, the half dozen or so New York City HIV docs informally queried about their advisory and lecture circuit relationships with Big Pharma were eager to point out that they moonlighted for "all the major drug companies" with HIV products expressly "to avoid any question of bias." Others note that Angell's scorched earth solution (barring anyone with pharma ties from key panel posts) would only be self-defeating. Were financial ties to drug companies an automatic disqualifier, the argument goes, there'd be only empty chairs at empty tables. (Angell disagrees.)