Vioxx® Risks Were Downplayed by Merck Sales Force
WASHINGTON, D.C. -- May 16, 2005 -- Merck heavily promoted the arthritis drug Vioxx® to physicians at a time when there were serious questions about its safety, according to documents presented at a Congressional hearing this month. As early as the year 2,000, sales representatives were told to avoid discussing Vioxx®'s history of cardiovascular problems, whenever possible. If the issue did arise, they were instructed to downplay heart risks and provided with set "obstacle responses" (Bulletin for Vioxx, May 1, 2000).
The company knew the results of the VIGOR study, which showed that patients taking Vioxx® had an increased risk of developing strokes and heart attacks compared to those who took the traditional painkiller, naproxen (see Vioxx, a History of Deception). Nevertheless, the company told its sales force to focus on the gastrointestinal benefits of using Vioxx® as opposed to other prescription painkillers. They were required to present doctors with data from a "cardiovascular card" only if necessary. This was a brochure, based on outdated studies, that minimized the heart problems caused by Vioxx®.
A 2001 memo was more strident. "DO NOT INITIATE DISCUSSION ON ...THE RESULTS OF THE VIOXX GI OUTCOME (VIGOR) STUDY," it warned (Bulletin for Vioxx, February 9, 2001). Instead, salespeople would tell physicians to put their questions about the study in writing and submit them to Merck to receive pre-written answers. Another document makes the allowed response even more general, " ... I cannot discuss the details with you. However, I would be happy to direct you to our Medical Services Department."
Merck sales campaigns for Vioxx® had colorful names such as "Project Offense" and "XXceleration." These aggressive promotions gave salespeople tips on everything from dress to manners, as well as canned responses to problem customers. They helped propel the drug to first place among related painkillers.
"This sales force is given extraordinary training so that it can capitalize on virtually every interaction with doctors," commented Rep. Henry A. Waxman (D-Los Angeles) (Los Angeles Times, May 6, 2005). "Yet when it comes to the one thing doctors most needed to know about Vioxx®--its health risks--Merck's answer seems to be disinformation and censorship."
Will Vioxx® Be Marketed Once Again?
Merck finally withdrew Vioxx® from the market in September, 2004. This was in response to the APPROVe clinical trial, which treated colon cancer patients with the drug. Those who took Vioxx had a much greater chance of developing serious heart conditions compared with those taking a sugar pill or placebo. Merck ended the study before its completion, citing safety issues. However, the company has suggested that it may return Vioxx® to the marketplace, coupled with a list of warnings.
Biology of Vioxx® and Other COX-2 Inhibitors
Also known as rofecoxib, Vioxx® is a nonsteroidal anti-inflammatory drug (NSAID) that blocks cyclooxygenase, an enzyme needed for the production of prostaglandins. Prostaglandins may cause inflammation and pain. Vioxx interferes with the form of cyclooxygenase known as COX-2, and is therefore referred to as a COX-2 inhibitor. Before its recall, Vioxx was approved to reduce the pain of osteoarthritis, rheumatoid arthritis, and migraine headaches. It was also used to relieve short-term pain and the discomfort of severe menstrual cramps.
Celebrex® (celecoxib) (and Bextra® (valdecoxib) are two other COX-2 inhibitors, both manufactured by Pfizer. The company withdrew Bextra® from the market at the request of the Food and Drug Administration (FDA) in April of this year. Bextra® may increase the risk of heart attacks and strokes, especially among patients who have undergone coronary bypass surgery. It also has been linked to skin allergies and Stevens-Johnson syndrome, a painful blistering of the skin and mucous membranes that sometimes proves fatal. Although Celebrex® is still available, it has also been associated with heart problems.
Evaluating Your COX-2 Case
Brayton Purcell is evaluating cases of heart attacks, strokes, and blood clots that are linked to COX-2 arthritis drugs. If you or a loved one has had these conditions while taking Bextra® or Celebrex® or after discontinuing either medication, please feel free to contact us.