Merck’s Promotion Of Its Arthritis Drug Rofecoxib (VIOXX) Crosses Legal Lines And Poses Public Danger

The Food and Drug Administration (FDA) on September 17, 2001 made public a Warning Letter it had issued to Merck & Co. about a false and misleading promotional campaign that the pharmaceutical giant had been conducting on behalf of its blockbuster arthritis drug rofecoxib (VIOXX). A Warning Letter—a sort of administrative slap on the wrist—is the strongest option available to the FDA when a company repeatedly violates the Federal Food, Drug, and Cosmetic Act and its implementing regulations, because the agency lacks power to impose civil fines and rarely brings criminal actions against drug companies for advertising violations.

More than 19 million prescriptions for rofecoxib were dispensed in the U.S. during 2000 at a retail cost exceeding $1.5 billion.

The FDA found in the eight-page Warning Letter addressed to Merck President and CEO Raymond V. Gilmartin that:

You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for Vioxx. Specifically, your promotional campaign discounts the fact that in the VIGOR study, patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator nonsteroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen).

Following the February 7, 2001 meeting of the FDA’s Arthritis Drugs Advisory Committee at which the VIGOR study was reviewed along with a study of the gastrointestinal safety of celecoxib (CELEBREX) known as the Celecoxib Long-term Arthritis Safety Study (CLASS) we listed both drugs as Do Not Use (see the April 2001 issue of Worst Pills, Best Pills News).

In the VIGOR study comparing rofecoxib to naproxen, there was a statistically significant five-fold increase in heart attacks in the overall rofecoxib group (0.5 percent) compared to the naproxen group (0.1 percent). This amounted to 20 heart attacks with rofecoxib (out of 4,047 patients) compared with four with naproxen (out of 4,029 patients). This increased number of heart attacks was also accompanied by an increase in other thrombotic (blood-clotting) adverse effects such as strokes and clots in the legs as well as problems with hypertension in the rofecoxib group compared with the naproxen group.

Rofecoxib was approved on May 20, 1999, for the treatment of primary dysmenorrhea (painful menses), for the management of acute pain in adults, and for relief of the signs and symptoms of osteoarthritis (rofecoxib has not been shown to be safe and effective for rheumatoid arthritis and thus is only FDA-approved for osteoarthritis). Shortly after the drug’s approval Merck began its campaign of Vioxx misinformation. The table below highlights the offenses cited in two Notice of Violation Letters and the Warning Letter issued to Merck over the illegal advertising of this drug.

Merck has demonstrated a corporate culture of deception in the promotion of its other products, not only rofecoxib. A June 16, 1998 Warning Letter regarding false and misleading advertising of five of its drugs, famotidine (PEPCID), indomethacin (INDOCIN), losartan (COZAAR), losartan hydrochlorothiazide (HYZAAR), and imipenem cilastatin (PRIMAXIN) concluded by saying that the FDA:

…is seriously concerned that the dissemination of the above-listed promotional materials demonstrate a continuing pattern and practice of widespread corporate behavior to avoid compliance with the regulations concerning the disclosure of risk information.

The false and misleading advertising of rofecoxib, or any prescription drug for that matter, has the potential of causing patients both physical and economic harm. Such a strategy of deception when used in conjunction with direct-to-consumer advertising is irresponsible because patients do not have reliable access to objective information about the risks of prescription drugs.

The fact that Merck has continued to violate legal and ethical advertising standards underscores how little authority Congress has chosen to permit the FDA to exercise over prescription drug advertising. Now, incorrigibles such as Merck expect no more than an occasional Notice of Violation or at most a Warning Letter as a result of their illegal activities, and to remedy a bad situation the FDA may at most require a corrective ad that in effect amounts to only a single letter to health professionals that the public never sees. Merck will be required to send a corrective letter about its rofecoxib advertising.

The FDA already has authority to bring criminal charges against companies such as Merck that repeatedly flout existing laws and regulations, and should start using it. It would be nice if Congress would also rise to the obvious occasion and give the agency pocketbook authority as well, but the power of the drug company lobby’s purse is too well recognized to provide much hope that this will happen any time soon.

What You Can Do

Always be very skeptical about safety claims made by prescription drug manufacturers about their products.