Who Will Lead the FDA?

Drug scandals. Recalled drugs. Vested interests that color drug approval, post-market surveillance, published studies, and practice guidelines. These, apparently, are only the tip of the FDA iceberg.
In matters relating to drug safety, MedWatch, the FDA’s safety information and adverse event reporting program, has announced that black box warnings will be required for the prescription drugs (oral sodium phosphate products) used to cleanse the bowels before a colonoscopy procedure. These drugs have been linked to a form of kidney damage called acute phosphate nephropathy, which may seriously and permanently damage kidney function. In the same breath, an FDA panel of experts voted to ban the use of the drugs Servent and Foradil in the treatment of asthma. While Servent and Foradil expand lung airways, they also increase the risk of death unless paired with a steroid, and at least half the patients taking these medications do not receive a steroid. Use of Advair and Symbicort continue to be allowed.
Reps. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), Chairman of the Subcommittee on Oversight and Investigations, launched an investigation in November into whether managers within the FDA’s Center for Devices and Radiological Health (CDRH) knowingly corrupted the scientific review process and approved or cleared medical device applications, in gross violation of laws and regulations designed to assure the safety and effectiveness of medical devices. Dingell and Stupak believe such activity could allow potentially unsafe and ineffective medical devices into the U.S. market. Medtronic, one of this country’s largest medical device manufacturers, has now reported the death of a patient who underwent spinal surgery with one of its medical devices. The family has filed suit, alleging the surgery involved an off-label use of Medtronic’s Infuse Bone Graft product. The FDA’s oversight of medical devices has come under increasing scrutiny with the revelation in the media that physicians were unaware of medical device problems, though they were known by the FDA and the medical device maker, who kept the information hidden as a “trade secret” protection.
In related news, the FDA has announced it is re-evaluating its research on the chemical Bisphenol A (BPA), which is found in plastics. An independent review of the FDA’s conclusion that BPA is safe found deep flaws in the FDA’s work. Canada and Europe have already taken action to ban BPA because of its link to reproductive and developmental problems.
All of this comes as president-elect Barack Obama has named Dr. Joshua Sharfstein, head of the Baltimore Health Department, to lead a team to formally assess the FDA. Many believe this action boosts Dr. Sharfstein’s chance to become the next FDA commissioner. Dr. Sharfstein has tangled with the pharmaceutical industry on several occasions. The other contender for the FDA commissioner position is Dr. Steven Nissen, head of cardiovascular medicine at the Cleveland Clinic. He and his former colleague, Dr. Eric Topol, raised questions about the safety of drugs like the cox-2 inhibitors, Avandia, and Vytorin.
All of this is further evidence that the FDA is a broken agency that needs a complete reform and restructuring. Visit www.ReformFDA.org to sign the petition and learn more.