The Seven Million Dollar Man

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You could call Dr. James Kahn the research world's "Seven Million Dollar Man." That's how much he's being sued for, not because he did anything wrong in his research, but simply because he published it, reports CBS News Correspondent Sharyl Attkisson.

His research was on a drug called Remune. Its maker, Immune Response Corporation, hopes it will be the next big advance in AIDS-related therapies — the first vaccine that can be given to patients after they're infected with HIV, to boost their immune systems and prevent them from getting AIDS.

A Five Year Plan
The Centers for Disease Control and Prevention (CDC) has a 5 year plan for HIV prevention and control.
The main national goal of the CDC's plan is to reduce the number of new HIV infections in the United States
from an estimated 40,000 to 20,000 per year by 2005.
Click here to read the CDC's 5-year HIV Prevention Strategic Plan.
Source: CDC
Everyone had high hopes. But when a board overseeing the study looked at results comparing patients who got Remune with those who didn't, Kahn said after 16 months it found, "There's no difference between the two groups and in fact there is no chance that there will ever be a difference between the two groups and, as a result, our recommendation is that you stop the trial."

Remune's maker agreed with the board's recommendation. But when Kahn tried to publish the results he claims the company, which paid for the study, turned from advocate into adversary, withholding data he needed to write the article, then trying to insert disputed data to make Remune look better.

"We were really flabbergasted by this kind of response and I've never seen anything like this! This was the first case where I felt there was a company that was putting profits before patients," said Kahn.

Kahn, who is an AIDS researcher, with the Positive Health Program at the University of California, San Francisco, says publishing was critical because patients still taking Remune in other studies needed to know about his findings. But Remune's maker says it took legal action because Kahn shouldn't have published until the company approved of the article, that he broke his confidentiality agreement, and excluded positive information about Remune it says was revealed by the study.

The Study
Click here to read Dr. Kahn's study as it appeared in the November 1, 2000 issue of JAMA.
The Journal of the American Medical Association agreed with Kahn, and printed his study last November along with a supportive editorial on the importance of research independence.

Such disputes are becoming more common, especially with less federal money available and universities relying heavily on drug industry grants to fund their studies. Dr. Allen Arieff, Professor of Medicine at the University of California at San Francisco, says when his study showed a drug was dangerous, the drug maker didn't want him to publish, either — even though a half million people were taking it.

"It could kill a large number of them and I didn't think that was right, so I published it anyway," said Arieff.

The FDA soon pulled the drug from the market. But not before the drug maker yanked its ongoing grant from Arieff, he says, in retaliation.

Soon after, another pharmaceutical company did the same thing, pulling Arieff's grant when his research showed its treatment wasn't as effective as a competitor's product.

"The doctors are usually in a very delicate situation — basically their funding will be cut off if the data does not come out the way they want it to; it's a tough situation to find yourself in. Our research money used to come from places like the National Institutes of Health, but there's much less federal money available now so it has to come from private sources and these are the pharmaceutical industry. And they don't want the research done to reflect, I shouldn't even say badly, not the way the want their drug to be reflected. So they do a lot of things to try to influence the outcome and if something is bad they do their best not to have it publishd," said Arieff.

The pharmaceutical industry calls such examples "rare" adding "No company wants to risk patient health or its own reputation by relying on inaccurate or biased research data."

But scientists say they're under growing pressure to make drugs sound better or safer. And they worry they'll be entangled in lawsuits if they bite the hand that feeds them.

"An individual like myself or my colleagues can't contend with a pharmaceutical company with massive resources in a lawsuit. We don't have hundreds of thousands of dollars for this purpose. So even the threat of a lawsuit is enough to put a damper on research," admitted Arieff.

Despite his ordeal, Kahn believes most companies still want honest research.

"Much to my delight, companies want to still work with me and my colleagues, and still value the integrity and value that we bring to the projects."

It's some comfort, but with that $7million case still hanging over his head, the question is: can Kahn and other researchers can afford the high cost of independence?



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  • CBSNews.com staff CBSNews.com staff

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