NOT YOUR FATHER'S FDA

Sweeping Changes in Store

It happens in small steps, but every day we learn another bit about the changes the Hamburg/Sharfstein team are bringing to an FDA saddled in dysfunction, corruption, and incapacity. Most recently, they have announced a program that would bring much more transparency to decisons on NDAs and applications for new indications that could unearth material on drugs and devices that are normally not surfaced except in litigation. Read about it in the New York Times:

http://www.nytimes.com/2009/06/02/health/policy/02fda.html?emc=tnt&tntemail1=y

After years of having to put up with an FDA leadership that wanted mostly to hide under rocks or their jockey shorts of their benefactors, it is almost difficult to believe we are seeing this much change. I still wonder how many dead-enders there are who will offer pockets of resistance--and maybe more--as reform goes on. Old and corrupt regimes die hard, as the last eight years have taught us, even at their most grotesque.

One interesting tidbit I didn't know. After the scam around the CLASS study was uncovered, and JAMA learned that it had been given the only part of the data set, the journal explicitly disowned the article. Neverthless, detailers continued to use it to sell Celebrex. I never get tired of quoting what Bob Temple said at the time: That the hype from the JAMA article will always have greater impact than our labeling does.

The Good Guys

Kate Rawson of THE RPM REPORT gives us a window into the character of Joshua Sharfstein.

After completing his undergraduate degree, Joshua worked a short while for Sidney Wolfe at Public Citizen. While there, he helped write a report that found, “…states without adequate inpatient mental health facilities jailed mentally ill patients rather than providing appropriate treatment.”

During his first year of med school, Sharfstein urged his classmates to return books donated by Sandoz pharmaceutical company. Above the drop box was a letter to the president, Timothy Rothwell:

"We recognize that while the books are gifts, they are not free," the letter states.

"They--and similar gifts and incentives offered to other medical students and physicians--are paid for by consumers in the form of higher drug prices. Accepting gifts from companies violates an ethical obligation to our future patients."
- The Harvard Crimson :: News :: Students Return Free Books

Through the years, Sharfstein and Wolfe have collaborated on issues such as Pfizer’s marketing practices and children’s cough medicine.

It’s a new day at the FDA. I feel better already.

See: THE RPM REPORT - Following Up With Sid Wolfe (Part 2)