Normal Limits

"Chance is the very guide of life"

"In practical medicine the facts are far too few for them to enter into the calculus of probabilities... in applied medicine we are always concerned with the individual" -- S. D. Poisson

November 05, 2005

Nature Biotech - Pessimistic response to FDA leadership change

Dr. Kaitin, Director of the Tufts Center for the Study of Drug Development:
I think the agency has left a period of uncertainty, and has now entered an era of instability.

In September, Dr. Lester Crawford resigned from his post as the commissioner of the FDA. He was replaced by acting commissioner Andrew von Eschenbach, who was the 12th Director of the National Cancer Institute, and continues to be affiliated with it. Given his most recent initiative at NCI--unveiled with great fanfare--of making cancer a managable disease by 2015, some in the biomedical industry have expressed concerns that Dr. Eschenbach may steer the FDA according to his agenda as a cancer scientist.

The image of the FDA has already been severely tarnished: SSRIs have been linked with suicide in children, COX2 inhibitors with cardiovascular complications, and the non-approval of the post-coital contraceptive Plan B with frank political intervention. The FDA has already shown a tendency to be overly conservative in the drug approval process.

What these all add up to, I think, is a re-newed focus of drug research on cancer therapeutics. Cancer drug research is a relatively straightforward area of pharm research. Cancer patients, out of options and desparate, self-refer to clinical trials. Risk-to-benefit calculus is easily dominated by the patients' imminent deathes. These medications are given only briefly, and long-term adverse effects are not technically considerations unless the medication in fact works. But in my opinion, some of the most exciting drug developments in recent years have been things like SSRI, statins, ARBs, etc. The focus on oncology merely will give the agency a chance to lay low and play it safe for a few years--hampering advancement in other areas of applied biomedical research in the process.

Kaitin predicts much more codevelopment and many more licensing agreements between small biotechs and big pharmas. In the uncertain environment of the next couple of years, he believes that few biotechs will be able to transform themselves into large companies that market their own products, the way companies like Genentech and Amgen did.

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