Arthritis after Vioxx®
The Media’s Focus on Prescription Pain Killers Ignores
Natural Remedies for Preventing and Treating Arthritis
By Richard P. Huemer, MD – LE Magazine February 2005
Last fall, doctors and patients were stunned by Merck’s voluntary worldwide withdrawal of its arthritis drug Vioxx® (rofecoxib) from the market, the largest prescription drug withdrawal in history. Vioxx® and other COX-2 (cyclooxygenase-2) inhibitors had been promoted as “wonder drugs” because of their ability to relieve arthritis pain without causing the stomach problems associated with other pain medications.
This startling decision to abandon Vioxx® followed the report of a significant increase in heart attacks and strokes among long-term users of the drug. An estimated 80 million people had taken Vioxx® by the time it was withdrawn, and annual sales of the drug exceeded $2.5 billion. The news media speculated on which drugs might fill the gap left by Vioxx®, while devoting curiously little attention to natural arthritis remedies.
Although Merck’s announcement came as a surprise to many, doubts about the drug had surfaced years earlier. In early 2001—less two years after the FDA approved Vioxx®—the FDA’s Advisory Committee on Arthritis met to discuss potential cardiovascular risks associated with Vioxx®.
Critics Blast FDA, Merck
Commenting on the 2001 FDA Advisory Committee meeting, Eric J. Topol, MD, wrote a stinging editorial in the October 21, 2004, issue of the New England Journal of Medicine, titled “Failing the Public Health—Rofecoxib, Merck, and the FDA.” Dr. Topol charged that the FDA never exercised its initiative to mandate a trial of rofecoxib (Vioxx®) and a similar drug, celecoxib (Celebrex®), in relation to their cardiovascular risks or benefits, despite evidence suggesting a correlation. Nor did Merck embrace the idea of conducting a trial to assess cardiovascular risk or benefit associated with Vioxx®. Instead, Merck sponsored educational symposia and commissioned medical articles to debunk the cardiovascular concerns associated with Vioxx®, while spending more than $100 million a year to promote the drug with direct-to-consumer advertising.
In November 2004, Dr. David Graham, associate director for science at the FDA’s Office of Drug Safety and a 20-year FDA scientist, testified before Congress about the FDA’s failure to protect the public health, calling the agency’s oversight of the drug “a profound regulatory failure.” Although concerns about the safety of Vioxx® had been building for several years, the FDA maintained that the drug’s benefits of providing pain relief with minimal gastrointestinal side effects warranted keeping it on the market, albeit with a warning about heart risks. Vioxx® was finally taken off the market on September 30, 2004, following the release of a study showing that the drug doubled the risk of heart attack and stroke in long-term users.
By this time, millions of Americans had used the drug, and Dr. Graham estimated that Vioxx® had caused 88,000-139,000 excess cases of heart attack and stroke. “I would argue the FDA as currently configured is incapable of protecting America against another Vioxx®. We are virtually defenseless,” said Dr. Graham. During his testimony, Dr. Graham noted that he felt pressured by supervisors to water down his findings from a study of patient insurance records indicating that Vioxx® increased heart attack risk. US Senate Finance Committee Chairman Charles Grassley, an Iowa Republican, said he worried that the FDA was “far too cozy” with drug companies, noting that an independent drug safety office might be needed.