The Rise and Fall of Vioxx: An American Tragedy
The Rise and Fall of Vioxx: An American Tragedy
Pharmaceutical companies don’t always have your best interests at heart. An illustrative case is that of Merck, who produced a nonsteroidal anti-inflammatory drug (NSAID) called Vioxx to treat patients with arthritis. Vioxx is a class of anti-inflammatories called cox-2 inhibitors, which were heavily touted as having fewer side effects than older NSAIDs. They released Vioxx to the public in May 1999 and gained widespread use among healthcare providers treating arthritis and other chronic diseases.
The New England Journal of Medicine (NEJM) published an article on November 23rd, 2000, in which the authors concluded Vioxx had a safety advantage over an older drug, Naproxen because it caused fewer serious stomach complications. However, four years later, on September 30th, 2004, Merck voluntarily pulled Vioxx off the market after completing a study showing that it doubled the risk of heart attacks and strokes. Three weeks later, the FDA finally pulled Vioxx off the market after a 17-year-old girl died of a stroke days after taking Vioxx. It was the largest drug recall in history. Eighty million people worldwide had taken the drug over the previous five years. Patients were taking Vioxx to relieve their aches and pains from arthritis while unknowingly doubling their risk of heart attacks and strokes.
Merck knew Vioxx caused heart attacks and strokes years before withdrawing the drug. The malfeasance doesn’t end there. In his book, Sickening, How Big Pharma Broke American Health Care and How We Can Repair It, John Abramson MD states that Merck scientists distributed an email in March 2000 about the cardiovascular dangers of Vioxx. Merck researchers falsified the statistics by omitting heart attacks to avoid a statistical threshold. In addition, Dr. Scott Reuben, a professor of anesthesiology at the Tufts University of Boston, published several studies on cox-2 inhibitors and was considered an authority on the subject. Later, he admitted that he never conducted the clinical trials he published in 21 journal articles about cox-2 inhibitors. Dr. Reuben had fabricated the data and overstated the analgesic effects of the drugs. Scientific American labeled Reuben the medical equivalent of Bernie Madoff.
Merck knew as early as 1996 that humans taking Vioxx were at greater risk of cardiovascular problems. Merck covered the effects of cardiovascular problems in the studies by giving patients daily aspirin. Merck failed the world by not being forthright about the risk of heart attack and stroke associated with Vioxx. The NEJM failed the world by not setting the record straight about the November 2000 Vioxx article. Even worse, the NEJM remained silent for over four years and never attempted to correct the Vioxx article. They only wrote “a letter of concern” a year after they took the drug off the market. The FDA failed the world by not informing healthcare providers about the cardiovascular risks of Vioxx. Furthermore, the FDA didn’t stop Merck from buying nearly a million reprints of the incomplete and falsely reassuring NEJM article handed out to millions of healthcare providers. Merck had put more into its advertising campaign for Vioxx than any other drug in its history.
In the end, Vioxx was responsible for between 88,000 and 140,000 heart attacks from 1999 to 2004, killing 40,000 to 60,000 Americans. Merck paid over $5 billion to settle civil litigation and illegal marketing. Only a fraction of what they ultimately earned from the drug; Merck made over $11 billion from Vioxx during its four years on the market. The very sources healthcare providers rely on to inform their clinical decision have become profit-driven rather than science-driven. Sources: Abramson, 2002; Prakash, 2007).
This is an excerpt from my book, Stopping Pain. Please go to www.johnathanedwardsmd.com for more information.