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This is distressing.
Two members of Congress want to adopt legislation that would require pharmaceutical companies to publish all their clinical studies.
This is distressing because one would hope that drug companies would do this anyway, for all their tests, no matter the result. To not do so gives the impression of moral bankruptcy.
U.S. Reps. Edward Markey, D-Mass., and Henry Waxman, D-Calif., intend to introduce legislation to establish a mandatory registry of clinical trials. Their written statement said the legislation “responds to failures to provide information voluntarily by including strong enforcement mechanisms.” They also seek audit authority for the “completeness and accuracy of the information in the registry.”
Essentially, they want the feds to have some teeth.
Yet no matter how reasonable the legislation, there's a battalion of drug company lobbyists - more than 600 of them, according to Public Citizen - poised to outflank any attempt at transparency and fairness.
The drug industry's compromise is a voluntary Internet repository of studies. Voluntary reporting - how dismally desperate. Full disclosure only when it's most convenient.
Drug companies chose to champion inadequate oversight as a shield for their failures. Is a consumer's life so meaningless in the rush for profits that sanity is bypassed by greed?
And greed isn't always good. Earlier this year, Eliot Spitzer, the New York attorney general, filed a civil suit against GlaxoSmithKline for withholding studies that raised doubts about the effectiveness of Paxil in treating childhood depression. The lawsuit states the company conducted five studies. Only one showed promise. One study concluded Paxil didn't help at all. Another showed the anti-depressant increased the risk of suicide in teens.
The lawsuit states more than 2 million prescriptions for Paxil were written to treat children and adolescents in 2002. U.S. sales alone accounted for $55 million for the company that year. To the company, that's 55 million reasons against full disclosure.
Yes, drug companies should be spanked. Conversely, the New England Journal of Medicine and 10 other medical journals should be praised for entering the fray.
The journals, which provide the sort of non-biased peer review needed to protect the public, will not publish any study that wasn't registered in a trial registry database when it began. Maybe this will be the right pressure for drug companies to be more open about test results.
Maybe not.
It's all very distressing.
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