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| The right decision on antidepressants
OUR OPINION: FDA SHOULD MANDATE COMPANIES TO DISCLOSE THE RISKS
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The Food and Drug Administration should follow a panel's recommendation to
warn doctors and patients in strong terms that some children and teens who
take antidepressants might try to commit suicide.
The panel made the right call. Potential antidepressant users must be
informed not only of the potential benefits of such drugs, but of the
dangers, too. That hasn't been the case.
Drugs' risks
This week, the FDA panel heard testimony from dozens of grieving parents
whose children had killed themselves and frightened parents whose kids had
tried, but survived. Most said that they were unaware of the drugs' risks
and that many doctors prescribed antidepressants without much thought.
The panel voted 15-8 that the FDA should require ''black box'' warnings on
the information sheets that doctors use when prescribing the drugs.
The alerts would be published in bold-face type and surrounded by an
eye-catching black border. Clearly, alerting physicians to the drugs'
negatives will allow them and their patients to make better-informed
decisions.
The recommendation comes amid questions about antidepressants' overall
effectiveness in children and adolescents. Several studies indicate that the
drugs have questionable benefits in young people. This makes the risks,
though low, even more intolerable.
The black-box decision is another significant step toward forcing
pharmaceutical companies to disclose fully their products' effects. As
outlined in The Herald's Sept. 12 story Truth, lies and Paxil, patients and
physicians accuse manufacturers of withholding crucial information about
some drugs' potential dangers. Indeed, the negative results of many clinical
studies never are revealed to the people who need them most: doctors and
patients. If doctors knew a drug's downside, the reasoning goes, they would
better weigh the risk before prescribing it. Companies have a financial
incentive to keep mum.
Post results online
This is a dangerous practice that puts people at risk. Advocates wisely are
taking action. The American Medical Association backs the creation of a
government-monitored public registry on which all the results of clinical
trials would be available. This idea should be implemented. Last week,
editors announced that pharmaceuticals that want to tout their products in
medical journals must post all clinical-trial results online.
We commend these efforts toward greater transparency and accessibility to
crucial information.
Now the FDA should follow suit. Most over-the-counter drugs include long
lists of potential side effects. The FDA should require no less from drug
companies that produce antidepressants. Anything less than full disclosure
is a threat to public health.
--
'All policymakers must be vigilant to the possibility of research data being
manipulated
by corporate bodies and of scientific colleagues being seduced by the
material charms of
industry.
Trust is no defence against an aggressively deceptive corporate sector.'
Editorial (2000). Resisting smoke and spin. Lancet 355, 1197.
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