Glaxo Is Testing Paxil on 7-Year-Olds Despite Well Known Suicide Risks

The only word for this news is “Criminal!” I hope they are watching these children 24-7 to keep them from committingsuicide or homicide while in the study. I recall the seven year old boy on Paxil I worked with who wanted to cut the baby out of his mother’s belly and the 17 year old who impulsively jumped off an overpass in front of a semi-truck to end his life. Then there was the 10 year old brother and 15 year old sister, both on Paxil, who stabbed their 7 year old brother and buried him in the back yard. Sounds like a great drug for kids, doesn’t it?
I just finished a court report (I have been testifying as an expert in these cases for almost two decades) on a Paxil case and noted that 18 of the listed side effects were indicators of mania. If Glaxo had labeled those effects for what really are instead of the labels they gave those reactions then no one would be surprised to know that in children the rate of Bipolar Disorder increased 4000% from 1996-2004.
As for Paxil being beneficial apparently someone missed the news that came out just over two years ago where the original studies done on SSRI antidepressants finally surfaced – many the FDA had never seen – indicating that the drugs offer no more benefit than a placebo. So if even the worst drugs perform better than placebo, where does that leave the SSRI antidepressants?
Ann Blake-Tracy, Executive Director
International Coalition for Drug Awareness
www.drugawareness.orgwww.ssristories.drugawareness.org

Glaxo Is Testing Paxil on 7-Year-Olds Despite WellKnown Suicide Risks

By Jim Edwards | May 21, 2010

It was established years ago that Paxil carries a risk of suicide in children and teens, but GlaxoSmithKline (GSK) has for the last 18 months been conducting a study of the antidepressant in kids as young as seven — in Japan. It’s not clear why the company would want to draw more attention to its already controversial pill, but it appears as if GSK might be hoping to see a reduced suicide risk in a small population of users — a result the company could use to cast doubt on the Paxil-equals-teen-suicide meme that dominates discussion of the drug.

GSK didn’t immediately respond to a request for comment. A staffer on GSK’s trials hotline confirmed the study was ongoing, however. The drug carries a “black box” warning on its patient information sheet, warning doctors and consumers that the antidepressant is twice as likely to generate lethal thoughts than a placebo.

The trial criteria listed on ClinicalTrials.gov, however, provide an interesting lesson in how managers can carefully design drug trials designed to flatter their products — something good companies don’t do.

The primary aim of the study is not to find out why Paxil makes some children kill themselves. Rather, it’s yet another efficacy study, which the drug doesn’t need because it was approved years ago — we already know the drug works.

Paxil is being tested against a placebo, so the results won’t be very surprising — even terrible drugs work better than sugar pills.

To what degree Paxil triggers suicide is only a secondary aim of the study. If the results suggest a lower suicide risk, expect GSK to play them up. If they’re bad, expect the company to dismiss them in favor of the primary endpoint results.

About 130 children have been enrolled, according to ClinicalTrials.gov, which puts about 65 patients in each arm. That means the results won’t be too statistically robust — there only need to be two or three outlier results to skew the numbers by several percentage points.

The trial will wrap up in September.

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Ann Blake-Tracy

Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
(DrugAwareness.Org & SSRIstories.Net)
Author: ”Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

She has specialized since 1990 in adverse reactions to serotonergic medications (such as Prozac, Sarafem, Zoloft, Paxil, Luvox, Celexa, Lexapro, Effexor, Serzone, Remeron, Anafranil, Fen-Phen, Redux and Meridia as well as the new atypical antipsychotics Zyprexa, Geodon, Seroquel and Abilify), as well as pain killers, and has testified before the FDA and congressional subcommittee members on antidepressants.

WITHDRAWAL WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

WITHDRAWAL HELP: You can find the hour and a half long CD on safe and effective withdrawal helps here: store.drugawareness.org And if you need additional consultations with Ann Blake-Tracy, you can book one at www.drugawareness.org or sign up for one of the memberships for the International Coalition for Drug Awareness which includes free consultations as one of the benefits of that particular membership plan. You can even get a whole month of access to the withdrawal CD with tips on rebuilding after the meds, all six of my DVDs, hundreds of radio interviews, lectures, TV interviews I have done over the years PLUS my book on antidepressants with more information than you will find anywhere else for only $30 membership for a month (that is only $5 more than the book alone would cost) at www.drugawareness.org. (Definitely the best option to save outrageous postage charges for those out of the country!)

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