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Concerns with prescribed drugs
By: Elizabeth Cohen, CNN

Candace Downing's parents said the first hint they had that their daughter might be suicidal was when they found her hanging from her bedroom ceiling.

Andy Downing said, "We called the paramedics, and they tried feverishly to revive her, and I was trying to give her mouth to mouth resuscitation but I knew something was wrong because her body was cold."

Mathy and Andy Downing blame the drug Zoloft. The Downings' said Candace wasn't suicidal -- wasn't even depressed -- before she began the medication.

Mathy said, "She was very into sports. A ton of friends, probably the most social child I've ever met."

Whether or not drugs like Zoloft, used to treat anxiety and depression, really do cause suicides is a matter of medical debate. But now another debate has emerged. The Downings, and other families, charge drug makers knew from pre-marketing studies that these drugs made some children and teens suicidal, but hid the study results.
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Pfizer
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Take a look at the Pfizer website.


Pfizer, which makes Zoloft, wouldn't comment on the Downing case because the family has filed a lawsuit. The company referred us to the corporate policy on their web site which states, "Pfizer commits to timely communication of meaningful results of controlled clinical trials -- regardless of outcome."

By law, drug companies have to tell the Food and Drug Administration about all their studies when they apply for permission to put their drug on the market. But the FDA -- by law -- is not allowed to release those studies to the public.

Dr. Bob Temple of the FDA said, "We are not allowed to by law release confidential commercial information. It's illegal, it's a crime."

Patients aren't the only ones feeling kept in the dark. Doctors also said they are deprived of information and are now pushing for a change in the rules.

The American Medical Association said drug companies should be required to submit their study results -- negative as well as positive to a central registry -- accessible to anyone via the Internet.

Dr. David Fassler , an expert on childhood depression, wrote the AMA proposal. He said he was shocked by what happened when he was reviewed data from antidepressants that he was given at an FDA meeting six months ago.
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Drug concerns

There are certain leaps of faith we take where our health is concerned. You might assume for instance that your doctor has carefully weighed the pros and cons of whatever drugs she prescribes for you. But, what if the cons are hidden from view?




Dr. Fassler of the Univ. of Vermont College of Medicine said, "I was given access to data from 25 clinical studies, most of which I had never seen before or I hadn't heard about. But there were maybe three or four major studies that were in the literature that we all knew about. But we didn't realize there were these many studies involving 4,000 children and adolescents."

The pharmaceutical industry hasn't taken an official position on the AMA's registry idea but has some official concerns.

Dr. Temple said, "We don't think that practicing physicians are going to have the time spent pouring through tens of thousands of pages of clinical studies."

Dr. Fassler disagrees. "This is clearly something which is going to help people. It's going to improve the quality of health care. It's going to improve it. It's going to improve our ability as physicians to take care of people," he said.

Two months after Candace's death, the FDA urged doctors to closely monitor patients on drugs like Zoloft for suicidal behavior. The Downings said that is not enough, and they are lobbying congress to make all research public.





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