Troubling questions on what the U.S. media didn't say about the warning on anti-depressant drugs

By Merrill Goozner

Parents of children on anti-depressants received disturbing news last week. The Food and Drug Administration asked manufacturers of popular drugs such as Zoloft and Paxil to warn physicians and parents to watch out for hostility, agitation and suicidal tendencies among their young patients, especially when they are first put on the drugs.

The warning, which comes after a similar action by British regulators last fall, followed an FDA advisory committee meeting in which the issue of anti-depressants and suicides in kids received its first full airing in more than a decade.

At that meeting, the FDA reported that tests done on kids for five of seven anti-depressants showed "a potential signal" for increased risk of suicide attempts.

Unfortunately, these tests were never published in the academic literature.

Nor did they appear in the popular press.

Rather, if one goes back over the previous decade's steady stream of published reports on so-called SSRIs -- selective serotonin reuptake inhibitors -- one finds almost universal praise for the drugs, including praise for their use in kids.

Indeed, even after the FDA issued its warning last week, most news accounts included statements from prominent physicians and researchers cautioning parents against taking their depressed kids off the drugs. Some physicians questioned the wisdom of the FDA action.

But a closer look at those press accounts raises a troubling question. Are consumers getting all the information they need when reading about the latest medical news over their morning coffee?

For instance, the day after the FDA warning, most of the nation's prominent papers included quotes from psychiatrists expressing fears that the new label might scare off doctors who want to prescribe antidepressants for their patients.

"The consequences for not treating depression are very high," Dr. Madhukar Trivedi, director of the mood disorders program at the University of Texas Southwestern Medical School at Dallas, told The New York Times.

"I worry that patients, family members or physicians might turn away from antidepressants that might be lifesaving," Eric Hollander, a professor of psychiatry at Mount Sinai School of Medicine, told the Wall Street Journal.

What the Times didn't tell its readers was that Trivedi is also a major contributor to the Texas Medication Algorithm Project, which was developed and funded by companies that make antidepressants and mood-modification drugs and is now being used around the country to persuade state Medicaid authorities to step up their use of the drugs in poor children and prison populations.

What the Journal didn't tell its readers was that Hollander receives numerous grants from anti-depressant manufacturers to conduct his research.

USA Today quoted University of California at Los Angeles psychiatrist James McGough, who expressed the hope that "this doesn't scare doctors away from prescribing antidepressants."

What this 2 million-plus circulation paper didn't tell its readers was that McGough's research in using drugs for treating hyperactivity was funded by Shire Pharmaceuticals.

Unlike the press, medical journals in recent years have instituted mandatory conflict-of-interest disclosure policies. Guardians of the integrity of the medical evidence, especially when it came to the use of drugs, became increasingly concerned about the pharmaceutical industry takeover of what was once a purely academic exercise.

To combat industry's undue influence, the New England Journal of Medicine a few years ago began requiring authors of articles that appeared in its pages to disclose who funded their studies.

The Journal of the American Medical Association, the Lancet and the British Medical Journal adopted similar policies.

Their reasoning was scientifically based. Study after study has shown that clinical trials funded by the drug manufacturer are much more likely to report positive outcomes than comparable trials funded either by the government or non-profit foundations.

No one should be surprised by those results. Who do you pick to include in the clinical trial? How do you interpret the data? What conclusions do you report?

The answers to all those questions can be subtly or overtly influenced by whoever funds the study. In science, as in life, he who pays the piper calls the tune.

And with drug companies increasingly dominating medical research, the published record on many drugs had begun to look like a press release written by the corporations that manufactured them.

This was certainly the case for the limited amount of published research on SSRI use in children. When industry funded the studies, their conclusion was nearly unanimous that these drugs are safe, and they work. When independent researchers looked at SSRI use in children, nearly half questioned their efficacy.

And how about the FDA reviewer who looked at the mostly unpublished studies (which were submitted to the agency to win patent extensions)? Twelve out of 15 studies, or 80 per cent, showed they were no better than placebo. No wonder the companies never published them. Why would anyone want to give their kid a drug that had even a remote risk of suicide if there was no proven benefit?

Unfortunately, average readers never got that information. Instead, what poured into the U.S. daily newspapers, weekly magazines and ubiquitous television segments was a steady stream of praise for SSRIs and their use in kids, mostly drawn from the published academic record without regard to its funding source.

It's time for the news industry to follow the lead of the medical literature. When reporters interview the experts, they should always ask: "Oh, and by the way, who funded your study?"

Medical journals think doctors should be informed about conflicts of interest so they can properly evaluate the information.

Consumers deserve this from the media.

Merrill Goozner, author of The $800-Million Pill: The True Cost of New Drugs, is director of the Integrity in Science Project at the Centre for Science in the Public Interest in Washington, D.C.