FDA Incapable of Protecting Americans

The aforementioned headline derives from numerous publications including the November 18, 2004 edition of the LA Times. This feature article strongly points too the FDA as currently configured and run cannot protect the American public from bad medications.The content notes how the Food and Drug Administration knew ahead of the agency approved Merck & Company's, Vioxx painkiller in 1999 that the drug might have serious negative effects to the heart. Regardless of knowing of problems ahead of time the content stated 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, declared that consequently, as many as 139,000 Americans who took the drug for arthritis, back pain and other ailments might have suffered serious unwanted effects. He also noted that from 26,000 to 55,000 people could have died because of this. 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 debate that the FDA, as currently configured, is not capable of protecting America against another Vioxx. We are virtually defenseless."

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