I'm sure you all saw the headlines early this month related to the Department of Justice settlement with Pfizer over their past off-label promotions of Bextra and other drugs. The settlement will cost the company a record-breaking $2.3 billion ($1 billion in civil settlements and a $1.3 billion criminal penalty related to Bextra).

Bextra was approved for treatment of arthritis and menstrual pain, but Pfizer allegedly promoted it in doses and for uses not approved by the FDA, putting patients at risk of serious cardiovascular complications including heart attack and stroke. Pfizer voluntarily withdrew Bextra from the market in 2005.

Of course, Pfizer isn’t the only company that has been involved in off label promotions. And we physician are also involved in how off label uses occur, and in relationships with industry that are under increased scrutiny in these regards. Off label usage of pharmaceuticals is often how new therapeutic advances occur and it’s not evil. But, if we had more comparative effectiveness research and dollars (and we soon will) available to research off label use, we could more rapidly advance therapeutics of newer agents and protect patient safety as well.

Dr. Peggy Hamberg’s appointment at FDA has been well received in town (we had better ideas); no word yet on the all-important CMS job, given Medicare’s status as the means for much of the reform process; and hearings for Governor Sebelius have yet to be set up.

I still hope our own Past President Tim Garson is in the mix for Surgeon General or Assistant Secretary for Health after Gupta pulled out. Tim may not agree with me on promoting this, given his dedication to his wonderful current position as Health Provost at U of VA, but he’d be great there.

Also, last week HHS (Department of Health and Human Services) established an Office of Recovery Act Coordination, which will coordinate all ARRA (Stimulus) implementation efforts and serve as the primary liaison to the Office of Management and Budget. Dennis Williams, former Deputy Administrator of the Health Resources and Services Administration has been selected to oversee the new office as Deputy Assistant Secretary. Dennis is due to have lots of new friends, us included!

Still no real word on the Secretary of HHS. Governor Sebelius of Kansas is being background vetted, so may be #1 choice. Ted Kennedy has come out for her.  But no word really. The FDA job seems down to Margaret Hamburg, M.D., former NYC Commissioner of Health, and Baltimore Health Commissioner Scharfstein (Kennedy’s favorite), and former Henry Waxman (D-Calif.) staff person. Hamburg is a very effective person. Everything else seems on hold still.

*** Kathleen Sebelius. Image from Wikimedia Commons (Dayton Mitchell) ***

Beginning Tuesday, FDA Chief Scientist and Principal Deputy Commissioner Frank Torti became acting commissioner. There’s already an "acting" at NIH. Health and Human Services (HHS) announced the decision earlier this month, along with transition plans for the other key positions. Assistant HHS Secretary Charlie Johnson will take over when Michael Leavitt this week steps down. Johnson will serve as acting secretary until Secretary-designate Daschle takes office. CMS COO Charlene Frizzera will take over from Kerry Weems when he steps down this week.

In each case here, a civil servant is taking over as the acting director in place of the former Senate-confirmed appointee—because the appointees have been asked to resign by Bush, the Obama Transition, or both. Julie Gerberding at CDC wanted to stay, but was asked to go. Only one HHS key appointee did not get the resignation request: Carolyn Clancy, Director of AHRQ (Agency for Health Research and Quality). Why? Well, first, she’s one of few Dems appointed by the Bush Administration. But second, she’s great, and we work closely with her on many issues. Obama wants her to stay. This is good.

The Food and Drug Administration (FDA) has finalized guidelines for pharmaceutical companies to be further able promote off label uses for drugs to physicians, and particularly through peer-reviewed medical journals. The new guidelines are provoking criticism from some sectors that the FDA is allowing companies to promote products to doctors even if the uses have not been rigorously vetted.

It general this seems a practical thing for FDA to do to me, given the numbers of off-label uses in practice, but with discretion when adverse risks are not well known or documented. Maybe this could allow for more responsible educational venues around off-label uses, given that the funding to research these uses is in short supply now, and will likely be until Bank of America, Citibank, and average taxpayers like you and me are back on our collective feet. This will be an early challenge for the next FDA Commissioner -- haven’t heard anymore about where that decision is this week, except that there are three prominent cardiologists alleged to be close contenders now.