Will President Elect Obama give the FDA a fresh start?
A new president brings a new head of the FDA. There are rumors as to who the new FDA director will be, however the real question is, will the FDA continue on the same path or will change come to the Food and Drug Administration.
Bloomberg.com reports that Janet Woodcock – “a 22 year insider at the Food and Drug Administration is the top choice of drugmakers who are lobbying for her to be named the agency’s chief by President-elect Barack Obama, according to people associated with the industry.” The article continues “Representatives of drugmakers are advocating to lawmakers that Woodcock, 60, be chosen to serve as commissioner on either an acting or permanent basis, according to two people associated with the industry who spoke on condition of anonymity. The Pharmaceutical Research and Manufacturers of America, a drugmakers’ trade association in Washington, declined to discuss individual candidates.”
The Bloomberg article shares that consumer advocacy groups are supporting cardiologist Steven Nissen and BaltimoreCity’s health commissioner, Joshua Sharfstein. “Both doctors have pressed the FDA for changes on drug safety.”
A Google Search for cardiologist Steven Nissen reveals a history of Dr. Nissen standing up to the FDA when science has proven them neglectful. A 2005 article on CNN.com (http://www.cnn.com/2005/HEALTH/11/01/profile.cardiologist.nissen/index.html) refers to Dr. Nissen as a ‘whistle blower’. “In 2001 he was the first physician to link Vioxx (rofecoxib) to an increased risk of heart attacks and strokes. Three years later Merck pulled Vioxx from the market when additional studies confirmed that daily, long-term use of the drug could increase the risk of heart attacks and strokes.” CNN.com also reports that in 2005, after the FDA approved the diabetes drug Pargluva, Dr. Nissen’s research proved the drug was risky and “Bristol-Myers Squibb announced that it would terminate its Pargluva development agreement with Merck. Bristol-Myers Squibb”.
MedPageToday.com in a May 2007 articles states “But the dustup created this week by his meta-analysis of published data from 42 randomized controlled trials of rosiglitazone has placed him squarely in the glare of critics who charge that Dr. Nissen is an anti-pharmaceutical crusader.” http://www.medpagetoday.com/Cardiology/CoronaryArteryDisease/5776
The Wall Street Journal also has a list of potential Obama FDA candidates; http://blogs.wsj.com/health/2008/11/05/horse-race-begins-for-new-leaders-at-fda-and-hhs/.
The existing FDA has more than proven it cannot properly protect citizens (nor their pets). The new commissioner of the FDA must be confirmed by the Senate; every concerned U.S. citizens should pay close attention to who is appointed, let your Senator know if you approve or disapprove of the new appointment.