Healthy Skepticism Library item: 450

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Dr. Kate
It's time to focus on information bias about drugs
Times Star 2004 Jun 20

Full text:

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

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

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

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

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

Furthermore, because there is no one place where all data about drug trials and their results are stored, it becomes a bit of a scavenger hunt to find all knowable information about a drug that might interest you. This is not a healthy system when you don’t know where to look for drug information, and you can’t telepathically access what’s been kept out of publication.

A lawsuit filed this month in New York promises to challenge the formidable power of the pharmaceutical companies to pick and choose the information that gets disseminated and promoted in the public domain. New York Attorney General Eliot Spitzer has decided to sue drug manufacturer GlaxoSmith-Kline PLC, claiming that it committed consumer fraud by misrepresenting and withholding data about the use of its antidepressant paroxetine (Paxil) in children.

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

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

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

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

I applaud Mr. Spitzer’s efforts to drive out the forces that wittingly and unwittingly obscure or manipulate the information we need to evaluate the safety and efficacy of drugs. But he will need a good many deputies to help him.
Because the vast majority of drug trials are currently funded by the pharmaceutical companies, he will have to persuade that industry of the merits of his mission. If he’s lucky, federal regulators like the FDA will be armed with reporting requirements and riding at his side. Perhaps he can commandeer the public wagons to circle tight around the research industry, closing in with demands that it consistently reveal and disseminate all drug trial information — whether it is good, neutral, or bad.
Hopefully, the medical community will posse up en masse. So far, the American Medical Association and the publishers of a dozen major medical journals have called for proposals that require drug companies to register their studies in a central database at the outset of their trials. We could go further and decline arrangements with drug companies that allow them to own or silence the results of the research trials they fund.

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