FDA Incapable of Protecting Americans

The above headline comes from numerous publications including the November 18, 2004 edition of the LA Times. This feature article strongly suggests that the FDA as currently configured and run cannot protect the American public from bad medications.

The article notes that the Food and Drug Administration knew before the agency approved Merck & Company's, Vioxx painkiller in 1999 that the drug could have serious adverse effects on the heart. In spite of knowing of problems in advance the article said that the FDA gave its approval without resolving the concerns.

David Graham, a doctor with the FDA's Office of Drug Safety, which monitors drugs already approved for patient use, said that as a result, as many as 139,000 Americans who took the drug for arthritis, back pain and other ailments may have suffered serious side effects. He also noted that from 26,000 to 55,000 people may have died as a result.

In his testimony, Dr. Graham told the US Senate Finance Committee, “Vioxx is a terrible tragedy and a profound regulatory failure." He continued, “I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless."