Pharma Promotion Dishonest - Slanted Reporting of Paxil, Prozac Studies
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-AlertJune 14, 2004
**********************************
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
------------------------------------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 combinedTreatments 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
----------------------------------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
-----------------------------------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.If you would like to get their regular health comments, you can subscribe here
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'
Scandals have eroded US public's confidence in drug industry
Pharmaceutical Study Fraud: Group Weighs Plan for Full Drug-Trial Disclosure
Consumer organisations criticise influence of drug companies - British Medical Journal
Drug Advertising Not Based on Facts
Medical system is leading cause of death and injury in US
The Truth About the Drug Companies
The Once-Solid Foundations Of The Big Pharma Colossus Are Shaking says Marcia Angell, a former editor of the New England Journal Of Medicine in her upcoming book...Pfizer Finds Two Failed Trials Equal One Coup for Zoloft
Aug 15, 2004 - Mosholder Report - M E M O R A N D U M
DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH PID# D040495 (Download PDF version from FDA's site)
Hired Education
A hidden culprit in the drug scandals: the increasingly corporatized university.Marketing of Vioxx: How Merck Played Game of Catch-Up
"Show me the money," appeared on an internal Merck document near Dr. Altman's name. He said those were neither his words nor his intent. He also said his involvement in the trial did not affect his prescribing. Merck's dinner with Dr. Altman, internal company documents show, was a brief stop in a long-running campaign by Merck to enlist the support of doctors for Vioxx or, at the least, to defuse their support for Celebrex - to "neutralize" them as the documents put it.Ads for drugs under fire
By RACHEL ROSS
Bringing a drug to market is an expensive endeavour. Building a market for a drug can be pricey too. Pharmaceutical companies contend drug prices must be high to fund research and development. Yet these same companies typically spend twice as much on marketing and administration as they do on drug discovery.THE WASHINGTON POST - Doctors Influenced By Mention Of Drug Ads
Actors pretending to be patients with symptoms of stress and fatigue were five times as likely to walk out of doctors' offices with a prescription when they mentioned seeing an ad for the heavily promoted antidepressant Paxil, according an unusual study being published today. The study employed an elaborate ruse -- sending actors with fake symptoms into 152 doctors' offices to see whether they would get prescriptions. Most who did not report symptoms of depression were not given medications, but when they asked for Paxil, 55 percent were given prescriptions, and 50 percent received diagnoses of depression. The study adds fuel to the growing controversy over the estimated $4 billion a year the drug industry spends on such advertising. Many public health advocates have long complained about ads showing happy people whose lives were changed by a drug, and now voices in Congress, the Food and Drug Administration and even the pharmaceutical industry are asking whether things have gone too far.Was Traci Johnson driven to suicide by anti-depressants? That's a trade secret, say US officials
Researchers trying to establish the truth about a new drug - now on sale in the UK - are being thwarted by a government agency whose job is to protect the publicUK: Crackdown on drug firm promotion
Drug firms will no longer be able to court doctors with prizes and lavish venues, following an overhaul of the industry's code of practice. Companies must only offer economy air travel to delegates sponsored to attend meetings, the Association of the British Pharmaceutical Industry adds.PROZAC BACKLASH - Trouble in Prozac Nation
"Woody's death was the most out-of-the-blue, out-of-character death," she told FORTUNE recently. "He had no history of mental illness." Kim Witczak, who lives in Minneapolis, has sued Pfizer, alleging that Zoloft induced the suicide and that the company failed to warn about the drug's potential to cause perilous side effects.Pregnant women warned to avoid antidepressant Paxil
Pregnant women and those who plan to become pregnant should avoid taking the antidepressant Paxil if possible because of the risk of birth defects, a group of obstetricians said Thursday. Two studies of pregnant women who were taking Paxil during their first trimester have shown that their babies have heart defects at a rate that is as much as twice the norm...Video: Fox News Big Story with Doug Kennedy on Big Pharma's Lie
Fox News Big Story with Douglas Kennedy on how Big Pharma leaves out the bad studies and downplays the nasty side effects of their highly addictive drugs.
Glaxo Hid Suicide Data In Paxil Studies
That's the angle the New Scientist takes on recently released court documents from a lawsuit against Paxil's maker, GSK."An analysis of internal GSK memos and reports, which were released to US lawyers seeking damages, suggests that the company had trial data demonstrating an eightfold increase in suicide risk as early as 1989. Harvard University psychiatrist Joseph Glenmullen, who studied the papers for the lawyers, says it's 'virtually impossible' that GSK simply misunderstood the data - a claim the company describes as 'absolutely false.'..."
posted by Sepp Hasslberger on Tuesday June 15 2004
updated on Wednesday December 8 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2004/06/15/pharma_promotion_dishonest_slanted_reporting_of_paxil_prozac_studies.htm
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October 16, 2004 - Sepp Hasslberger
