The US government will back down from a plan to
require long-term studies of new psychiatric drugs before
allowing them on the market, regulators said yesterday.
The reversal of the recently adopted policy came
after a panel of experts unanimously recommended against
requiring such studies as a condition of approval. While
such studies are needed, the experts said, delaying decisions
on new medications would hurt patients.
The panel's vote came after it heard a barrage
of complaints from industry executives, academic researchers
and patient advocates. 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. They also warned that
the policy would cause drug companies to scale back on
developing new drugs because of the potential increase
in expense and risk.
The new plan, which the Food and Drug Administration
had begun to implement over the past six months, called
for companies to conduct studies for as long as half a
year before seeking approval of new drugs. 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. After the emphatic rejection by the
panel yesterday, Laughren said regulators will "back
off."
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.
"I believe the public interest is not served
by this requirement, and it could cause a lot more harm
and confusion than benefit," Sachs told the panel.
"It would be telling someone with a heart attack
that we have a drug that we know works, but we can't give
it because we don't yet know whether it would prevent
further heart attacks."
Sachs and other experts said "effectiveness
studies" that can guide clinicians about which drug
to try first, and when patients should stop taking a medication,
are very valuable -- but their complex design and requirements
mean they are best conducted at public expense by research
institutions such as the National Institute of Mental
Health.
While that institute does fund such studies, Sachs
said, "their commitment to do that is substantially
less than we would wish."