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  EMAIL=20 ARTICLE   LINK TO=20 ARTICLE   PRINT=20 ARTICLE

Article Last=20 Updated: Sunday, June 20, 2004 - 3:40:23 AM PST

OTHER ARTICLES = IN THIS=20 SECTION
6/21/2004

It's time to focus on information = bias about=20 drugs

HEARING about an exciting new = drug study=20 can make a pill sound so fantastic that we can hardly wait = to take=20 it. We rush to our doctor's office to show her the newspaper = clippings, and for extra measure we bring along a few = supporting=20 documents that we have downloaded from the Internet.=20

But suppose that one glorious study we heard about was = just that=20 -- the one glorious study about that drug. Suppose that = there=20 existed three or four additional studies that made that drug = seem=20 undesirable or, at least, inglorious, and we had no way of = knowing=20 about them. Suppose those hidden studies contained = information about=20 side effects or contradictory data that suggested the drug = really=20 didn't work.

It's unsettling to consider these possibilities, but it's = important to remain vigilant about them. Clinically = important -- and=20 generally unfavorable -- information about drugs is often = buried in=20 publicly inaccessible archives. Our medical journals tend = not to=20 publish studies about drugs that were found to be duds in = clinical=20 trials.=20

Hidden drug data poses a serious and pervasive problem. = For=20 example, a recent study in the Journal of the American = Medical=20 Association analyzed 102 drug trials and found that 50 = percent of=20 efficacy data and 65 percent of harm outcomes were only = partially=20 reported.=20

In certain circumstances, the suppression of drug = information can=20 be heavy-handed. Researchers conducting trials funded by = drug=20 companies have been required to sign contracts that grant = the=20 companies the right to control which results get submitted = for=20 publication. A few years ago, a vaccine manufacturer even = filed a=20 multimillion-dollar lawsuit against a team of AIDS = researchers who=20 insisted on publishing results from a clinical trial that = found the=20 company's HIV vaccine to be worthless.=20

Furthermore, because there is no one place where all data = about=20 drug trials and their results are stored, it becomes a bit = of a=20 scavenger hunt to find all knowable information about a drug = that=20 might interest you.=20

This is not a healthy system when you don't know where to = look=20 for drug information, and you can't telepathically access = what's=20 been kept out of publication.=20

A lawsuit filed this month in New York promises to = challenge the=20 formidable power of the pharmaceutical companies to pick and = choose=20 the information that gets disseminated and promoted in the = public=20 domain. New York Attorney General Eliot Spitzer has decided = to sue=20 drug manufacturer GlaxoSmith-=20

Kline PLC, claiming that it committed consumer fraud by=20 misrepresenting and withholding data about the use of its=20 antidepressant paroxetine (Paxil) in children.=20

The human stakes in this case are considerable, because=20 researchers elsewhere have raised serious concerns that some = antidepressants might actually increase the risk of suicide = in=20 children. Moreover, about 2.1 million paroxetine = prescriptions were=20 written for children in 2002.=20

Mr. Spitzer alleges that the drug manufacturer skewed = information=20 about paroxetine by widely disseminating the single study = that was=20 able to showcase the drug in a positive light. He charges = Glaxo with=20 suppressing four other studies conducted on children and = adolescents=20 in the late 1990s that found paroxetine to be either = ineffective or=20 suspect for increasing the potential risk of suicide.=20

According to the Associated Press, the lawsuit also = exposes an=20 internal Glaxo document indicating that the company intended = to=20 "manage the dissemination of data in order to minimize any = potential=20 negative commercial impact."=20

In summing up his mission, Mr. Spitzer succinctly stated = his=20 case: "Having doctors prescribe drugs without full knowledge = of=20 safety and efficacy is wrong."=20

Iapplaud Mr. Spitzer's efforts to drive out the forces = that=20 wittingly and unwittingly obscure or manipulate the = information we=20 need to evaluate the safety and efficacy of drugs. But he = will need=20 a good many deputies to help him.=20

Because the vast majority of drug trials are currently = funded by=20 the pharmaceutical companies, he will have to persuade that = industry=20 of the merits of his mission. If he's lucky, federal = regulators like=20 the FDA will be armed with reporting requirements and riding = at his=20 side. Perhaps he can commandeer the public wagons to circle = tight=20 around the research industry, closing in with demands that = it=20 consistently reveal and disseminate all drug trial = information --=20 whether it is good, neutral, or bad.=20

Hopefully, the medical community will posse up en masse. = So far,=20 the American Medical Association and the publishers of a = dozen major=20 medical journals have called for proposals that require drug = companies to register their studies in a central database at = the=20 outset of their trials. We could go further and decline = arrangements=20 with drug companies that allow them to own or silence the = results of=20 the research trials they fund.=20

Meanwhile, Mr. Spitzer's move is bold and courageous. It = gives me=20 hope that we may be nearing high noon in New York, about to = witness=20 an overdue showdown between the commercial interests of the = drug=20 marketplace and the health interests of humanity that drug = science=20 should serve.

Kate Scannell is a physician with Kaiser Permanente and = the=20 author of "Death of the Good Doctor."=20

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