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.
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?
 
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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.
