U.S. Alters Test Policy on Psychiatric Drugs

[MountainLaurel]

A six-month study is considered TOO LONG?! Am I misreading that? So, basically, we'll have no idea of the long-term implications of taking these drugs? Whether users will have to keep taking larger doses to get the same effect, whether toxicity will occur?

:wtf:

The 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.

http://www.washingtonpost.com/wp-dyn/content/article/2005/10/25/AR2005102501576.html?nav=rss_health

[depakid]

1. This story not only doesn't ring true the way it's written

it's so hopelessly muddled that it's impossible to figure out exactly what's going on.

Until someone sees an objective review of the policy making process here- and what was actually presented to the panel, I'd urge people to pretty well ignore the Post. They have an incredibly poor track record on science matters- and aside from that, the industry bias in this copy is obvious.