Whistleblower FDA Scientist Allowed to Publish Vioxx® Data
WASHINGTON, DC -- January 14, 2005 -- The Food and Drug Administration (FDA) has finally given Dr. David Graham the green light to publish data showing that 88,000 to 139,000 people who took the arthritis drug Vioxx® (rofecoxib) had heart attacks or strokes. The medical journal Lancet is expected to carry his article.
Dr. Graham, who is employed in the FDA's Office of Public Safety, says that the agency originally tried to block the article's publication, and to discredit him with Lancet. Instead, the Lancet editor, Richard Horton, wrote about the politics of Vioxx®. He blamed both Merck, the manufacturer of Vioxx®, and the FDA, for not making the public aware of the dangers of the drug. "...Too often, the FDA saw and continues to see the pharmaceutical industry as its customer--a vital source of funding for its activities--and not as a sector of society in need of strong regulation," Horton commented (Lancet, Vol. 364, No. 9446, 6 November 2004).
Vioxx® Was Recalled Last Fall
Vioxx® was removed from the market on September, 30, 2004, after a study involving colon cancer patients showed that it increased the risk of heart attacks and strokes. Over 2 million people took the drug to treat the symptoms of osteoarthritis and rheumatoid arthritis before its recall.
In November, Dr. Graham testified at a Senate hearing called to discuss the FDA's handling of the Vioxx® problem. He denounced the FDA for its lax safety standards and warned that the agency "is incapable of protecting America against another Vioxx®." He also stated that Bextra® and Celebrex®, two drugs closely related to Vioxx®, should be recalled. (See FDA Official Says Five Popular Drugs Are Unsafe).
Vioxx® and Other COX-2 Inhibitors
Vioxx®, Celebrex®, and Bextra® are nonsteroidal anti-inflammatory drugs (NSAIDs) that block cyclooxygenase, an enzyme needed for the production of prostaglandins. Prostaglandins may cause inflammation and pain. The drugs interfere with the form of cyclooxygenase known as COX-2, and are therefore referred to as COX-2 inhibitors.
The FDA will begin a review of all prevention studies involving Celebrex® and Bextra®. A prevention study is one in which healthy people are given medicine to prevent a disease or condition. The agency action comes after the National Institutes of Health halted a prevention study of 2,000 patients at risk for developing colon growths or polyps. Those patients who took Celebrex® had a much greater chance of having heart attacks or strokes than did those who took fake pills or placebos. A study involving heart bypass patients and Bextra® revealed similar problems. Patients who took Bextra® after their surgeries were more likely to develop further heart complications compared with those who took placebos.
In response to continuing criticism from medical experts, consumers, and consumer advocates, the FDA will hold hearings in February to evaluate the safety of all COX-2 drugs. It has issued an advisory telling doctors to consider the patient's risk for heart problems with every prescription written. Meanwhile, COX-2 drugs remain on the shelves, as doctors ponder how to best help their arthritis patients.
At Brayton Purcell, we are concerned about the health problems caused by unsafe medications, including the COX-2 inhibitors. We are currently reviewing cases involving arthritis drug users who have suffered from heart attacks, blood clots, and strokes. If you or a loved one has had these conditions while taking Bextra® or Celebrex® or after discontinuing either medication, please contact us.