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Pharma Attacks Drug Warnings as Sales Fall

Pharma Attacks Drug Warnings as Antidepressant Sales Fall


by Martha Rosenberg

In April, Dr. Catherine DeAngelis, editor of the Journal of the American Medical Association (JAMA), wrote that pharma's influence on medicine "is so blatant now you'd have to be deaf, blind and dumb not to see it," adding, "We should all get together and say, 'Enough!'"

But an article in the September 3 JAMA finds her not taking her own medicine.

Ever since the FDA mandated black boxes on selective serotonin reuptake inhibitor (SSRI) antidepressants like Prozac and Paxil in 2004 that warned of suicidal behavior in children and teens--causing sales to drop 25 percent--pharma has been on the war path.

In a research letter in JAMA titled Suicide Trends Among Youths Aged 10 to 19 Years in the United States, 1995-2005, Jeffrey A. Bridge, PhD of Nationwide Children's Hospital in Columbus, OH, Joel B. Greenhouse, PhD of
Carnegie Mellon University in Pittsburgh, PA and three other authors continue pharma's campaign against black boxes.

The warnings they say have actually increased suicide by scaring doctors and parents away from perfectly good drugs. Kind of like how the withdrawal of diet drug Phen-fen is causing our national obesity.

Nor is Bridge, who spoke at a Lilly sponsored conference on youth suicide in Switzerland in May, a stranger to JAMA's pages with his pro-antidepressant message.

A study he headed in last April's JAMA (Clinical Response and Risk for Reported Suicidal Ideation and Suicide Attempts in Pediatric Antidepressant Treatment) found "a much lower overall risk" of suicide than the FDA reports when "the potential benefit of these medications" was added. In fact the drugs should be "a first-line treatment option" says Bridge for the childhood scourges of major depressive disorder (MDD) and obsessive-compulsive disorder (OCD)--which somehow didn't exist before pharma had money-making drugs to treat them.

Do you know where your children are?

Joel Greenhouse also has a pro-antidepressant trail.

He lent statistical support for a Lilly funded article in the August 18, 2004 JAMA (Fluoxetine, Cognitive-Behavioral Therapy, and Their Combination for Adolescents With Depression) which vindicated Lilly's beleaguered Prozac for depressed adolescents when used in conjunction with cognitive-behavioral therapy.

And in April 2006 Greenhouse coauthored a study posted on ClinicalTrials.gov (Do Antidepressants Cause Suicidality In Children?) that, while agreeing "an association between antidepressant use and an increased risk of suicidality" exists concluded "that the evidence… is weak," when analyzed with Bayesian hierarchical models.

Got that?

But in reporting the Bridge/Greenhouse research, news organizations were as vigilant in their vetting as JAMA.

Especially The Wall Street Journal.

It quotes Kelly Posner, PhD, a Columbia University researcher "who says she doesn't have any financial ties to drug companies"--she would know, right?--in an article about the JAMA research, corroborating that the suicide rise was seen "as soon as these warnings started," and, "If you look at the whole evidence puzzle, it points in one direction--antidepressants save lives."

Unfortunately, Posner's "evidence puzzle" according to a June 2007 paper in the Journal of the American Academy of Child & Adolescent Psychiatry (Texas Children's Medication Algorithm Project) is a little fuzzier with financial ties to fourteen drug companies.

"Dr. Posner has received research support from GSK, Forest, Eisai, Z Pharmaceuticals, Johnson & Johnson, Abbott Laboratories, Wyeth-Ayerst Research, Organon USA, BMS, Sanofi-Aventis, Cephalon, Novartis, Shire Pharmaceuticals and UCB Pharma," says the paper.

Who can say conflict of interest?

Nor did the New York Times disclose Posner's web of pharma funding when it used her for a source in a 2006 article about new suicide warnings for young people taking the GSK drug Paxil. The pro-drug "expert" termed the incriminating data "the first analysis to show a relationship between suicide attempts and one of the antidepressants" and added, "It's not clear that the drug caused the behavior."

But not everyone buys the cause of suicide being black box warnings.

The new data is likely manipulated by "stepping-up suicides on placebo by inclusion of the wash-out period" and "rigid interpretation of confidence intervals for each trial" says Mayer Brezis, MD of Hadassah Medical Center & School of Public Health in Jerusalem, Israel. Especially since "antidepressants have become society's main response to distress expectations."

Sam Dunbar, opinion editor of the Saint Mary's College of California newspaper The Collegian is also skeptical. "I would love to hear a doctor explain to me and my parents that yes, you have depression and that the answer to the problem is a prescription that could heighten or worsen the problems. This means, potentially, a patient who suffers from acute depression could suffer from suicidal tendencies after treatment begins."

Meanwhile pharma's aggressive Center for Medicine in the Public Interest (CMPI), created to combat bad press stands with the black box theory and awaits the next move from the "anti-SSRI mafia."

"You can bet it'll be vitriolic pharma-bashing with a heaping measure of junk science," warns CMPI president Peter Pitts.

*************

Martha Rosenberg, Staff Cartoonist, Evanston Roundtable.

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