Pharma Promotion Dishonest - Slanted Reporting of Paxil, Prozac Studies

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Pharmaceutical manufacturers cannot promote the use of drugs for other uses than those approved for the label, however it has become normal practice to dishonestly slant the reporting of scientific studies to suggest such unapproved use of drugs or to hype the supposed benefits of certain medicines, while hiding their adverse effects.

GlaxoSmithKline, the manufacturer of the antidepressant Paxil, released on its company Web site the reports of clinical tests of that drug in children and adolescents suffering from psychological conditions including depression, reports the New York times in a recent article, but not before New York Attorney General sued the company charging it hid unfavourable research results. The situation is so bad that there are now calls for a register of all clinical drug trials that will allow more transparency for the results of such trials.

Another example of slanted reporting is a recent study on Prozac, commented on by Jenny Thompson of the Baltimore Health Sciences Institute. While trumpeting the positive conclusions of the first twelve weeks of a study that lasted three times as long, the report hid the fact of five times as many suicide attempts in the Prozac group as compared with the children that did not get the drug.

See also an earlier article on psychiatric drugs in schools, which in my humble opinion should be outright forbidden.

And here follows the succinct analysis of Jenny Thompson...

Talk To Me

Health Sciences Institute e-Alert

June 14, 2004

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Dear Reader,

When a clinical study is described by The New York Times as a "landmark government-financed" study, that's a pretty good tip off that we're all supposed to give a respectful bow and accept the results as gospel. After all, landmarks stand for the ages, and government financing, well, that's the gold standard of impartiality... right?

All of my skeptical alarm bells started clanging earlier this month when the Times and other mainstream media outlets reported that a National Institutes of Health (NIH) study showed that Prozac was more effective than counseling (or "talk therapy") in helping teens overcome depression.

And just as I suspected, there's a cow in the ointment, because: A) Drawing conclusions from the current results is ridiculously premature, and B) If you insist on jumping to conclusions, then the real headline is not about the effectiveness of the drug, its about the drug's danger.

There's your landmark right there.

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The kids are alright
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The new study won't be published until this summer. But drawing on reports from several news outlets we can piece together the basic nuts and bolts.

The NIH enlisted about 440 kids, aged 12 to 17, who were diagnosed with moderate to severe depression. The subjects were then assigned to four groups:

* Daily dose of Prozac
* Daily placebo
* Talk therapy with no medication
* Prozac and talk therapy combined

Treatments lasted for 36 weeks, but during the first 12 weeks, 61 subjects dropped out of the study for reasons unreported at this point. Using a common psychological measurement scale, the combined talk therapy and Prozac group had the best outcome, with 71 percent responding well to treatment. Among those who received only Prozac, 61 percent responded well, while 43 responded well to talk therapy alone. In the placebo group, 35 percent responded well.

"Case closed," was the general tone of the news reports. Combine Prozac with counseling, and well over two-thirds of the kids improve, they said. Don't want to bother with therapy? No problem - just back up the Prozac truck and plenty of kids will be chipper again in no time.

Unless they decide to harm themselves.

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High stakes
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As I mentioned above, these results are far too premature for the Times or anyone else to start throwing around a term like "landmark."

The subjects in the study were tested for 36 weeks, but the reported results are only based on an analysis of the first 12 weeks. So since we don't know what the analysis of the remaining 24 weeks might bring, maybe we should keep the corks in the champagne bottles for just awhile longer. Or at the very least, the NIH shouldn't deliver thumbs-up information that doctors and parents of young patients may act on.

But what received even less attention was the rate of attempted suicides among the subjects. Buried deep in the Times report is the information that among those who finished the study but didn't take Prozac, there was one suicide attempt. And among those who did take the drug: five attempts.

If I'm a parent with a depressed teen, I can't like those odds.

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Pass it on
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Most people never lay eyes on a drug company study - they get their information about studies from the mainstream media. And it's been obvious for a long time that some of the gritty and most revealing details of most of these studies never make the 6:00 o'clock news.

Of course, the media isn't completely to blame for this. When drug companies conduct studies that produce unwanted outcomes, the results may end up as part of the FDA's public record, but only the studies that deliver positive conclusions are promoted for high-profile publication and then given a big shove into the mainstream spotlight.

That's one of the reasons why New York State is suing GlaxoSmithKline (GSK), makers of the antidepressant Paxil. The NY suit charges that GSK suppressed four studies that concluded the drug was ineffective in treating adolescents. The suit also claims that the studies draw a possible link between Paxil use and suicidal thoughts among adolescent users.

Did you hear about those four studies on the news? Nope. Not a peep. Not until the NY attorney general decided to do something about them. And although the outcome of this lawsuit will be a long time coming, I'm hoping that the notoriety of it will be enough to create my favorite kind of regulation: Water Cooler Regulation. When people start talking about the dangers of antidepressants for kids around the water cooler, that will do more to inform the public than any number of government-mandated warning labels.

This article comes from the Baltimore Health Sciences Institute e-alert.

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See also:

Big Bucks, Big Pharma pulls back the curtain on the multi-billion dollar pharmaceutical industry to expose the insidious ways that illness is used, manipulated, and often created, for profit. Focusing on the industry's marketing practices, the video shows how direct-to-consumer pharmaceutical advertising glamorizes prescription drugs, and works to reinforce drug promotion to doctors. Pharmaceutical Research is seen as essentially uncontrolled and heavily skewed. Ultimately, Big Bucks, Big Pharma challenges us to ask important questions about the consequences of relying on a for-profit industry for our health and well-being.

Related articles:

You can see all of the letters the FDA has sent to pharmaceutical
companies for inappropriate advertising/labeling here:

Drugs companies are defrauding healthcare systems, conference hears - British Medical Journal - 23 October 2004

Makers 'ghost' drugs reviews
By Rosie Murray-West (Filed: 15/10/2004)
The pharmaceutical industry routinely bribes doctors and "ghostwrites" articles about drugs in major medical journals, MPs were told yesterday. Professor David Healy, of the University of Wales, told the Commons health select committee that as many as half the articles published in journals such as the British Medical Journal and The Lancet were written by members of the industry who had a vested interest in selling the drugs involved.

Glaxo settles New York drug suit
GlaxoSmithKline has agreed to publish results of clinical tests on its drugs, to settle a US lawsuit. The firm was sued by New York attorney-general Eliot Spitzer over allegations that it withheld negative information about its antidepressant pill, Paxil.

AUGUST 18, 2004 - BUSINESSWEEK ONLINE
Drugmakers "Blackmail the Public"

Doctors' body accuses drug firms of 'disease mongering'