At first glance, that headline gives the impression that 65% of studies are in existence. That seems pretty pitiful. But if you read it closely, you see the word "pending", and realize that only 35% of said studies are given life.
Drug companies have launched barely a third of the follow-up studies they agreed to undertake once their new medications were on the market, the government said yesterday.
Often the drugs received expedited approval from federal regulators on the condition that the studies be carried out.
The FDA said it relies on the so-called Phase 4 studies to gather additional information about a drug's safety, efficacy or use. The outcome of those studies can lead to changes in how a drug is made, prescribed and used. The FDA also can require the studies after it has approved a drug.
The pharmaceutical industry does this because we let them. The extent to which they've been able to game the FDA is almost laughable. Laughable that the FDA is still able to claim independence and authority at all.
These behaviors won't change without tough rule shifts at the FDA. The most effective way to do that may be to start a new organization from scratch, with a new crop of officials, ethics rules, and procedures.