Law under the Microscope

FDA, WHO Create More Web Sites to Help Decipher Drug and Vaccine Safety Information

More than one political pundit has deemed our current time as the Information Age. We're constantly inundated with data - some mundane, some crucial, much of it not-quite-so-accurate.

In the medical arena, omitting information or disseminating partial or inaccurate info can be annoying at best, fatal at worst.  In an effort to try to keep the public better informed about drug safety issues, the FDA is preparing to launch a new Drug Watch webpage. Likewise, to combat the myriad of websites that contain false or misleading information about vaccine safety, the World Health Organization (WHO) has created a list of 23 websites that it considers "reliable."

San Francisco to be Home for California's Stem Cell Research Institute

California made a big splash last year when it passed Prop. 71, which called for distributing $3,000,000,000 in bond-backed funds for stem cell research over the next 10 years. One of the first tasks the board that was chosen to run the California Institute for Regenerative Medicine had to face was picking a home. On Friday, San Francisco was officially announced as the future home for the Institute.

What I love about the NY Times article about the announcement is that it's incredibly brief, and notes that "[w]ith its international standing and spectacular views, San Francisco had been the early front-runner in an initial field of 10 cities that last week was narrowed to the four finalists."  As if the most urgent consideration in the process was which city was the most picturesque (having lived and traveled all over California, if that really was the criteria, they'd likely have chosen Santa Barbara, Napa or Tahoe instead).

FDA Still in Need of Leadership

The FDA has been without a permanent commissioner for about a year. It was exciting when, just a couple months ago, it looked like Dr. Lester Crawford would move up from being the Acting Commissioner to being the permanent Commissioner. Alas, his confirmation was blocked by two Senators and the FDA is still in limbo.

The reason for the blockage is rather substantial - Senators Patty Murray (D-WA) and Hillary Clinton (D-NY) are concerned about the FDA's dragging its feet in making a decision about approval of OTC Plan B contraceptive. The contraceptive is strongly opposed by conservatives, but all scientific evidence states that it is safe and effective, so its prohibition from being on retail shelves appears to be entirely political.  As the FDA is supposed to be making decisions based on science rather than political winds, this is rather alarming.

NIH Still in Ethical Quandary

I have to imagine that there are some days where the director of NIH, Dr. Elias Zerhouni, just wants to run down the hallway with his fingers in his ears yelling "LA LA LA LA LA!"  In the last year, one of the stickiest issues the NIH has faced and that has gained huge public attention is the dilemma regarding outside compensation to NIH scientists by corporations.

To sum up the issue - until last year, NIH scientists were able to receive a certain amount of compensation  from outside corporations, so long as they disclosed that work. Then it came out that maybe two dozen of the thousands of NIH employees (researchers and non-researchers) had received rather hefty sums of money and it wasn't clear in each case whether those amounts were disclosed.  Following Congressional hearings on the issue, Dr. Zerhouni placed a moratorium on any scientists receiving outside compensation for their work.  In February, a new interim final rule was put in place that allows non-researchers to have up to $15,000 in stock holdings of pharmaceutical companies, and no NIH employee may perform any compensated speaking, editing or writing for a regulated entity or any uncompensated outside employment. In addition, no senior employee may receive any gift or award because of their NIH position that is more than $200 in value.

Oh, who knew how many problems this would bring to NIH ...