Loophole Blocks Prosecution of U.K. Firm for Allegedly Marketing Dangerous Drug
Mar 10th, 2008 • Posted in: News“I think there is a tension between marketing considerations and the ethical dimension of making health products,” says head of Britain’s drug regulatory agency
LONDON
U.K. regulators have decided not to prosecute pharmaceutical firm GlaxoSmithKline for allegedly downplaying hazards of the antidepressant Paxil, but the officials say they are unhappy with the firm’s behavior and plan changes in the law.
The Wall Street Journal reports that a four-year probe by Britain’s Medicines and Healthcare Regulatory Authority (MHRA) determined that Glaxo withheld evidence that suggested the drug increased the risk of suicidal behavior in people under 18.
According to the Guardian, the issue boils down to the wording of the law, which requires companies to hand over safety data from trials when a drug is licensed. Paxil, sold in Britain under the name Seroxat, was never licensed for use in children, but the law allowed physicians to prescribe it for them anyway for so-called off-label use.
Kent Woods, head of the MHRA, told the Guardian that the loophole should be closed. He also said he could not rule out the possibility that other companies were withholding data that could cause them monetary damage.
“I think there is a tension between marketing considerations and the ethical dimension of making health products,” Woods said. “We have to look again at that. The pharmaceutical industry has to look again at that. You could even say there is a positive disincentive to explore the data as fully as it could be explored.”
Legislation to be introduced later this year would require drug companies to inform regulators of potential safety problems regardless of licensing status.
The BBC claims that secret emails showed that the company distorted trial results, covering up the suicide link, and documents indicated that Glaxo knew there was a problem with the use of the drug by children for five years before such use was banned.
A similar issue was raised in the United States in 2004 when New York State settled with Glaxo for $2.5 million and an agreement that Glaxo would make public data about the apparent link between Paxil and suicide.
In related news, the Toronto Globe & Mail reports that the recall of a blood-thinning drug linked to a Chinese factory is raising new questions about the ability of government and industry to keep a handle on the safety of drugs made with ingredients from China.
While China has become one of the world’s largest suppliers of pharmaceutical ingredients, a series of incidents highlighting safety problems has led many experts to call for North American governments to take a more aggressive attitude toward overseas inspections and safety checks, according to the Globe & Mail.
Sources: Globe & Mail, Mar. 6 — Guardian, Mar. 6 — Wall Street Journal, Mar. 6 — BBC, Mar. 6.
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