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Antidepressant Makers Withhold Data on Children
The Washington Post ^ | January 29, 2004 | Shankar Vedantam

Posted on 01/29/2004 9:43:31 AM PST by neverdem

Makers of popular antidepressants such as Paxil, Zoloft and Effexor have refused to disclose the details of most clinical trials involving depressed children, denying doctors and parents crucial evidence as they weigh fresh fears that such medicines may cause some children to become suicidal.

The companies say the studies are trade secrets. Researchers familiar with the unpublished data said the majority of secret trials show that children taking the medicines did not get any better than children taking dummy pills.

Although the drug industry's practice of suppressing data unfavorable to its products is legal, doctors and advocates say such secrecy distorts the scientific record.

"Conflicts of interest and the company control of the data have thrown out the scientific method," said Vera Hassner Sharav, a critic of the drugs and a patients' rights advocate. "If hundreds of trials don't work out, they don't publish them, they don't talk about them."

(Excerpt) Read more at washingtonpost.com ...


TOPICS: Business/Economy; Constitution/Conservatism; Culture/Society; Front Page News; Government; News/Current Events; US: District of Columbia; US: New York; US: Texas; United Kingdom
KEYWORDS: antidepressants; apa; children; effexor; fda; nimh; paxil; pediatricpsychiatry; placebo; prozac; ssri; zoloft
"If you start publishing negative data, will it be concluded by practitioners and others that the drug is ineffective?" he asked, saying that genuinely effective medicines sometimes do no better than placebos, or dummy pills, in trials -- at least half of all children seem to get better on placebos.

That's nice to know.

1 posted on 01/29/2004 9:43:34 AM PST by neverdem
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To: neverdem
The drug scam!! Buyer beware!!
2 posted on 01/29/2004 9:56:51 AM PST by Sacajaweau (God Bless Our Troops!!)
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To: neverdem
They also don't published reports where people die in other countries when they test these drugs prior to doing US human trials. Prozac killed 14 people purportedly in the UK during initial trials but only US studies were submitted to the FDA. Lots of other countries have much less stringent requirements and the companies start from there.

Personally, I think people should be given the option to take something that is going to make them kill themselves. As long as they have a clear waiver of the risk. Its the secrecy that harms consumers and makes this an arguably criminal practice.

I know research physicians who work for drug manufacturers and they all have stories about drugs that don't appear to be working in the trials but they are still promoted to the medical community and they use glowing anecdotal stories from patients about the success of the treatment. The guys doing the studies themselves don't believe the anecdotes but they can't go out publicly and say so because they are under contract to the manufacturer. This is not always a dangerous situation but in the case of psychoactive drugs, it certainly could lead to your Columbine situations where its not just the patient him/herself who is getting harmed.

3 posted on 01/29/2004 9:57:10 AM PST by bpjam
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To: bpjam
What about Ritalin?
4 posted on 01/29/2004 10:03:35 AM PST by steve8714
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To: neverdem
The Dumbming Down Of America's Youth by these Corporate Drug companies (many foreign owned), seem to be afraid of being caught in a huge scam that the Psyciatric doctors and other doctors have been bought off to prescribe rather than allowing for the treatment of children to take a more holistic approach. Judeo-Christian values seem to be missing as part of the remedy.

The more kids that are on prescribed dope, the more control they will have over them. Clouded minds, propped up by excuses for bad behavior leads to the downfall of America's future. Who's agenda? I wonder?

Ops4 God BLess America!
5 posted on 01/29/2004 10:03:44 AM PST by OPS4
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To: fourdeuce82d; Travis McGee; El Gato; JudyB1938; Ernest_at_the_Beach; Robert A. Cook, PE; lepton; ...
I goofed when I posted this the first time. I failed to click on Front Page News. Despite the appearance of a function "Click to Add Topic" to amend the category under which an article is listed, it doesn't work.

The "Extended News" sidebar no longer exists also. Therefore, because of personal experience with adverse drug reactions, I pinged you again on the same article in case you are interested in the additional comments of more Freepers on the subject, as the original post is off the screen in the cyberworld.
6 posted on 01/29/2004 10:58:59 AM PST by neverdem (Xin loi min oi)
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To: neverdem
thank you for posting this article. it is outrageous what the drug companies are doing, and the feds are enabling them. the congress should pass a law that requires all data on medications to be posted on a federal web site.
this isn't science--it's fraud disguised as science. if you run enough studies on any drug, eventually one will turn out positive just because of chance.
7 posted on 01/29/2004 11:25:30 AM PST by drhogan
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To: drhogan; Sacajaweau; bpjam; steve8714; OPS4
Here's the link that I failed to post under Front Page News:

http://www.freerepublic.com/focus/f-news/1067321/posts
8 posted on 01/29/2004 11:50:17 AM PST by neverdem (Xin loi min oi)
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To: neverdem
Bump!
9 posted on 01/29/2004 12:05:58 PM PST by AuntB (Do away with all entitlements (except the military!))
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To: neverdem
I just checked drugdex. Neither paxil. zoloft or effexor is approved by the FDA for use in children.

Md's may be using these off list applications but they do it at their own risk.

Drugs are usually not tested on children except in special situations. Children cannot legally consent to be part of medical experimentation.

They only test on children when the risk of the drug significantly outweighs the risk of the illness that a child has. Usually this means life threatening illness something on the order of leukemia or hodgekins disease.

Kids have to be sick enough so that the alternative to a drug trial is death .

10 posted on 01/29/2004 1:43:30 PM PST by TASMANIANRED (black dogs are my life)
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