Antidepressant approval system criticized
By Carey Goldberg, Globe Staff | April 23, 2004
A top British medical journal reported yesterday that studies funded by drug companies -- but never published -- suggest that several popular antidepressants like Paxil and Zoloft are not safe or effective enough to warrant their use by children.
The report in The Lancet marks the third time this year that a major medical journal has issued a broadside against the widespread prescription of such drugs for children and teens, and against the drug approval system.
Six British academic psychiatrists and researchers wrote that while published studies made several Prozac-generation antidepressants look appealing to doctors, five studies that were not made public made the benefits no longer seem worth the risks. Only Prozac made the cut.
In a separate editorial, the journal also criticized the Food and Drug Administration for failing to "act appropriately on information . . . that these drugs were both ineffective and harmful in children."
"The story of research into selective serotonin reuptake inhibitor [SSRI] use in childhood depression is one of confusion, manipulation, and institutional failure," The Lancet's editors wrote. "In a global medical culture where evidence-based practice is seen as the gold standard for care, these failings are a disaster."
British medical authorities have responded much more aggressively than their US counterparts to accumulating evidence that the antidepressants have problems. Last December they banned use of all the newer antidepressants, except Prozac, by children, saying the dangers outweighed benefits.
In March, the FDA issued a warning that patients taking the newer antidepressants should be carefully monitored for signs that they may become suicidal. But the agency is still reviewing data on the risks and benefits of the drugs, and has said the link between suicide and antidepressants has not been conclusively shown.
Earlier this month the BMJ, formerly the British Medical Journal, published a paper concluding that even the published studies on SSRI antidepressants, paid for by drug companies, exaggerated the effectiveness of the drugs and played down the risks to patients, including increased thoughts of self-injury. "Biased reporting and overconfident recommendations in treatment guidelines may mislead doctors, patients, and families," the authors wrote.
And in February, Dr. E. Jane Garland, a psychiatrist and clinical head of the clinic for mood and anxiety disorders at British Columbia's Children's Hospital, wrote in the Canadian Medical Association Journal, "The disappointing reality is that antidepressant medications have minimal to no effectiveness in childhood depression."
In an editorial, the journal wrote that Garland had worked on industry-sponsored trials of antidepressant drugs and seen unpublished data indicating that a drug on the market was ineffective, but she had been silenced by a nondisclosure agreement she had signed.
Drug companies are under no obligation to make results of their clinical trials publicly available.
Garland has pledged "never to do an industry-funded trial again unless the whole structure and management of these is drastically changed," the journal reported.
Journals such as The Lancet carry great weight as opinion leaders in the medical research establishment, and the recent spate of articles, seems to reflect a shift in thinking among many researchers that the system for testing drugs should become more transparent.
But the approach of the US medical establishment seems to be less critical of the drugs. A New England Journal of Medicine article earlier this month noted that Prozac is the only one of the newer antidepressants shown to be effective in depressed children. It did not criticize the system, but suggested that to improve the risk-benefit balance, perhaps antidepressants should be reserved for children unlikely to be helped by nondrug methods.
Carey Goldberg can be reached at email@example.com.
© Copyright 2004 Globe Newspaper Company.