Originally published October 28 2005
FDA will not require six-month trials for new psychiatric drugs
by Mike Adams, the Health Ranger, NaturalNews Editor
An advisory panel's rejection of a proposed six-month testing duration for psychiatric drugs has convinced the FDA to not implement the new policies.
All the critics predicted that the policy would lead to delays in bringing new drugs to market while providing little new information that may not apply to most patients.
Like many other medications, psychiatric drugs are typically approved on the basis of positive results from two short-term studies, each of which may last only eight weeks.
Because physicians routinely prescribe psychiatric drugs for much longer periods, the FDA had started demanding longer-term data, as do regulators in the European Union, said Thomas P. Laughren, director of FDA's Division of Psychiatry Products.
Criticism of the plan was voiced in all 15 presentations made at the panel meeting yesterday, prompting the chairman of the advisory panel, University of Florida psychiatrist Wayne Goodman, to implore his fellow scientists to mount an argument in favor of the requirement, if only to play "devil's advocate."
But all the panelists agreed with the academic researchers, patient advocates and industry executives from Merck and Co., Wyeth Pharmaceuticals, Eli Lilly & Co. and other companies in stressing that the new federal requirement would have adverse consequences.
In the real world, as many as half of all psychiatric patients switch medications after three months of treatment, and as many as 70 percent switch after six months, said David Michelson, executive director for neuroscience medical research at Eli Lilly, which makes Prozac and other psychiatric drugs.
Asking companies to conduct trials that show that medications work for six months or longer will lead to trials that focus on the small subset of patients who do well for such long periods, rather than on the majority that do not, Michelson and others said.
As a result, added Gary Sachs, a Harvard University researcher who testified at the meeting, such data will be of little help to clinicians in the real world who usually have to deal with less predictable cases.
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