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Psychiatrist crusades for antidepressant disclosure

Sunday, August 01, 2004
Star-Ledger Staff

NEW YORK -- David Healy may not be a household name, but his work has helped make the safety of antidepressants a familiar topic to millions of Americans.

The psychiatrist, who teaches at the University of Wales College of Medicine in the United Kingdom, is an outspoken critic of antidepressant research conducted by drug makers. Having spent nearly two decades reviewing clinical-trial data, Healy says these drugs are more than twice as likely as a placebo, or dummy pill, to cause a patient to attempt to commit suicide.

His work prompted U.K. authorities last year to warn doctors not to prescribe the drugs to children. Earlier this year, he distributed an internal GlaxoSmithKline memo that suggested the company suppressed negative results about its Paxil drug. This led the New York attorney general last month to file a lawsuit accusing the drug maker of consumer fraud.

Drug makers have said Healy either misinterprets or distorts data, and that he has done so for his own vested interests. Eli Lilly, which makes Prozac, noted Healy has frequently been paid as an expert witness in lawsuits brought against drug makers by families, whose relative attempted or committed suicide while taking an antidepressant. Officials at Pfizer and Glaxo, whose research Healy has criticized, declined to comment for this story.

Healy shrugs off such criticism. In his book, called "Let Them Eat Prozac," he takes the companies and the Food and Drug Administration to task. Yet, he says he believes antidepressants can be helpful for some patients, and he prescribes them. As he sees it, the issue is making sure doctors and patients have all the correct information.

In a recent interview in Bryant Park in Manhattan, Healy discussed his views.

There's a lot of confusion about antidepressants, because often the prescriptions are written for people who are genuinely depressed. But you say it's not that simple.

These pills are targeted at a big group of people, but there's a group who aren't suited to them and you need to know that, in the early phase of treatment, a person can get more worked up, more anxious. And the pills could make some of those people suicidal. And they could make a portion of the people become physically dependent, so when they stop treatment, they would go into withdrawal. This was recognized in the early to mid-1980s.

That's quite a long time ago.

One of the oddities about this controversy is that you can actually go into company archives and see a bunch of material from all of the companies 20 years ago. And it makes it clear there was no controversy back then -- they recognized it was a problem.

The evidence that these drugs actually work was awfully weak. And it's now clear that when you add up all the clinical trials done on these pills, you can barely show that the drugs beat placebos at all.

And this is why you advocate making the clinical-trial data available?

The antidepressant story brings out that we actually don't know anymore where the truth lies or what the evidence points to.

Once upon a time, we knew that industry didn't publish the trials that didn't suit them, but we had ways to work out how many trials were out that didn't suit industry. Now, though, it's clear there's an even bigger issue for trials they do publish -- they often show the drugs don't work. But somehow, you've got the biggest names in the field putting their names in the biggest journals and saying these drugs work wonderfully well and are safe to take.

Glaxo recently posted summaries of clinical trials for its Paxil antidepressant on its Web site. Isn't that sufficient?

Summaries may be fairly comprehensive, but they don't substitute for raw data.

Look at the material they posted. What's happened is a person working for the company hired to gather data for the trial may not be a physician or trained in mental health, and this person jots down a few notes, but may have missed information and how to classify it. And the experts back then might have looked at something where there were only hints.

The Glaxo summaries are less than complete -- they've missed a bunch of suicidal acts in children.

Would a clinical-trial registry solve this problem?

A registry won't do it. Simply knowing which trials were done, won't help. You need access to raw data underlying each trial. Now, if a registry contained that, it would be helpful.

You see, if there isn't anyone from outside a drug company who can get access to the data, what you've got is a situation where the industry can ensure that the data gets written up in a way that favors the product. The problem isn't that industry funds clinical trials. The problem is the data coming out these trials remains beyond the reach of people who aren't in the industry.

The FDA has asked Columbia University researchers to review clinical-trial data. What might they tell us?

It's hard to know. Faced with the material they've got, anybody who is reasonably serious would say they really can't come up with a clear view. If the FDA has gone to the trouble to engage in an exercise of this sort, it can only be to hide the problem.

Hasn't the FDA handled this properly?

When you get into seeing how the companies tried to work out whether they were going to let the FDA know about the hazards, I find I'm faced with a case of conspiracy involving the FDA, or incompetence. But it's hard to judge which one.

Until you get people on the witness stand and ask what happened and why, it's very hard to say.

Let's say the Columbia team reports that a link to suicide was found. Should the FDA withdraw one or more of these drugs?

I don't think the issue is that FDA should withdraw a drug from the market, even if there is a signal. The issue is much more to do with the kind of warnings put on the pills.

What FDA did a few months ago with a new round of warnings was fairly good, but they aren't going to change the behavior of physicians. You need the companies to informally tell the physicians that they need to take warnings seriously. And they have to say that since the warnings are out there, no one can sue us, but they can sue you.

Ed Silverman can be reached at (973) 392-1542 or

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