Former FDA Führer von Eschenbach Favors Approving Drugs for General Use Without Proof of Efficacy!

Former FDA Führer von Eschenbach Favors Approving Drugs for General Use Without Proof of Efficacy!

Andrew von Eschenbach, famous for resigning as FDA commissioner and leaving the agency leaderless on the very day that Obama was inaugurated (see Eschenbach Announces Resignation, FDA Staffer Throws Shoes in "Farewell Kiss"), is now employed as chairman of conservative think tank Manhattan Institute's Project FDA initiative.

If von Eschenbach has his way, FDA will be out of the business of approving new drugs based on efficacy, but will merely rubberstamp any drug that won't kill humans outright! In essence, the entire U.S. population will become non-volunteer experimental subjects. A drug's efficacy will be proven (or not) in the marketplace.

Instead of the FDA asking pharma companies to complete "laborious clinical trials proving efficacy," says von Eschenbach in a WSJ Op-Ed piece (see here), "after proof of concept and safety testing, the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies."

This is free market economics gone wild!

Currently, "post-market studies" are a undertaken to test the SAFETY of drugs as they are used in the real world. Such studies are not required of all drugs. What von Eschenbach proposes is to use post-market studies to test if drugs work as advertised, not if they are safe.

The problem is that post-market studies are NOT scientific because there are no controls to determine a baseline against which to measure efficacy. It's easy to find safety problems because that does not require controls.

I am amazed that von Eschenbach headed up the FDA and before that the National Cancer Institute! The fact that he is advocating tossing the scientific method aside takes my breath away considering that he is now well-positioned in the conservative political arena and no doubt has hopes that a future Romney or Gingrich administration will appoint him FDA commissioner or worse, Secretary of the Department of Health and Human Services!

December 7, 2011: A Date Which Will Live in Infamy for Women's Health!

December 7, 2011: A Date Which Will Live in Infamy for Women's Health!

"If I close my eyes...I might think I was in the Bush era,” said Michelle Goldberg (@michelleinbklyn), Senior writer for Newsweek/The Daily Beast, and author of Kingdom Coming and The Means of Reproduction. Her remark -- made via Twitter, of course -- was in reference to "Obama's terrible decision to override the FDA on Plan B."

She expressed my feelings precisely!

By now you've all probably heard the news as reported in the NY Times (here): "For the first time ever, the Health and Human Services secretary publicly overruled the Food and Drug Administration, refusing Wednesday to allow emergency contraceptives to be sold over the counter, including to young teenagers. The decision avoided what could have been a bruising political battle over parental control and contraception during a presidential election season."

The action was taken by U.S. Department of Health and Human Services Secretary Kathleen Sebelius in a letter addressed to FDA Commissioner Margaret Hamburg, M.D. Find that letter plus statements by both Sebelius and Hamburg here, where you can also vote on who you think is right.

Sebelius blocked the FDA from allowing the contraceptive pill, called Plan B One-Step, to be made available without a prescription (over-the-counter) to women and girls 16 and younger who now need a prescription to get Plan B. "If taken soon after unprotected sex, the pill halves the chances of a pregnancy," according to the NY Times (op cit).

Who's right? Hambug or Sebelius? Vote here.