Does holding back data embellish the published results of clinical trials? You decide.
From the Winnipeg Free Press:
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Doctors, patients 'deceived,' Journal says Tue Feb 17 2004 TORONTO -- Pharmaceutical companies
"deceive" doctors and their patients -- and perhaps their shareholders -- when they withhold
unfavourable data on prescription medicines, the Canadian Medical Association Journal argues in an
editorial today. The editorial was part of a package of articles looking at the suppression of trial
data, with a particular focus on testing of antidepressant drugs in children and teenagers. Concern
has been rising for some time about how safe antidepressants called selective serotonin re-uptake
inhibitors are when used by children. There is evidence that SSRIs, as the drugs are called, can
induce suicidal thoughts or actions in a small proportion of people who take them. Several
countries, including Canada, have recently urged renewed caution over the use of SSRIs in children.
Health Canada is striking an expert panel to study worldwide safety data on the question. In
addition to safety concerns, there are questions about whether the drugs actually work in children.
Last week the journal revealed that GlaxoSmithKline deliberately withheld trial results that showed
paroxetine (sold as Paxil) was no more effective than sugar pills in children. The journal called it
the "file drawer phenomenon" -- when clinical trials which don't reflect favourably on a drug get
buried by the company that paid for them. The editorial called these types of trials a "commercial
liability." In their defence the drug companies insist they have a responsibility to their
shareholders not to reveal information that might give a competitor a leg up. -- Canadian Press
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What proportion of meager beneficial results reported for clinical trials can be attributed to
withheld data? Can withholding data elevate nonsignificant results to significant results?
Once admissions of withholding data are made, surely everything Pharma has done must come into
question. They, by their reported admission, have a responsibility to their shareholders to withhold
information. They do not have a responsibility to the public to be honest and above reproach.
A.L.