Star Ledger: Psychiatrist David Healy crusades for antidepressant disclosure

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> Tue, 3 Aug 2004 21:50:54 -0400

> [sSRI-Research] Star Ledger: Psychiatrist

> David Healy crusades for antidepressant disclosure

>

http://www.nj.com/printer/printer.ssf?/base/business-0/1091337099184670.xml

>

> Psychiatrist [David Healy] crusades for

> antidepressant disclosure

>

>

> Sunday, August 01, 2004BY ED SILVERMAN

> 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

> esilverman.

>

> Copyright 2004 NJ.com. .

 

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