Copyright 2001 Chicago Sun-Times, Inc.
Chicago Sun-Times

May 27, 2001, SUNDAY, Late Sports Final Edition

You take a medication for high cholesterol or depression. You have a heart bypass, or radiation therapy for cancer. Receiving any treatment is an act of faith: faith in the integrity of the researchers who say it works.

Now it appears that faith is often misplaced. Consider these recent headlines:

This month a National Cancer Institute scientist admitted making up data to show a hepatitis vaccine was effective.

Last month the prestigious Journal of Clinical Oncology retracted a landmark breast cancer study. The study has been used to justify giving thousands of women bone marrow transplants. Faced with exposure, the lead researcher admitted faking much of his data. Many of his "patients" didn't even exist.

Such retractions are becoming more and more common. Why? Because these days most studies aren't paid for by the government, but by the drug industry.

Here's the problem: drug companies pay researchers to determine whether their drug works. That's a conflict-of-interest.

I recently talked to one exasperated researcher who said this is how most studies work:

The principal investigator -- the one who goes to Hawaii twice a year at drug company expense -- sees each study patient for their first interview. Then he never sees them again. His assistants do all the follow-up, they collect all the data.

"When the study's over the principal investigator doesn't even write it up. He just sends the raw data back to the drug company. Ghost-writers there write it up. They spin the data to make the drug look as effective as possible.

"Then they send the article back to the researcher, he puts his name over it, a journal publishes it, and everybody's happy."

Amazingly, drug companies admit this is true. In a recent court case, a former drug executive, Jo Alene Dolan, testified that all drug companies "ghostwrite" their researchers' studies. They claim the studies are still accurate because the author has the "final editing authority."

But recently a University of California researcher exercised his "final editing authority." And it may cost him $ 7 million. Dr. James Kahn had the temerity to publish a study that found an AIDS vaccine, Remune, didn't work. The drug's maker, Immune Response Corp., sued Kahn and his university for not allowing the company to rewrite his manuscript to make it "more balanced."

Immune Response says Kahn and the University of California caused it financial harm. But wait a second; lots of treatments don't work. Are researchers likely to tell us which ones if they know doing that might cost them millions of dollars? Just how independent are they? And just how much can we trust their results?

The editors at the Chicago-based Journal of the American Medical Association are asking those same questions. They published Kahn's study partly because "the integrity of the research process must be protected and preserved."

A 1998 JAMA study found about one in five papers in major journals was ghostwritten. Now the editors ask every author some tough questions: Who crunched the data? Who wrote the paper? Who signed off on it? Who received the funding?

Dr. Phil Fontanarosa, JAMA's executive deputy editor, says some researchers are offended, and that's OK. "These are tests and procedures and drugs that are being carried out on you and me and our families. They have to be accurate."

Very noble. But JAMA has a conflict-of-interest of its own. Who pays for the advertising that keeps medical journals alive? Drug companies. Even the watchdogs have become tainted.

So what can you do? Put more trust in the larger journals. They have more sources of funding and are less likely to be influenced by drug companies.

Dr. Michael Breen is the medical editor at WBBM-Channel 2