Journal: Drug Sales Based on 'Seriously Biased' Data

In implementing "step programs," in which doctors are counseled to start arthritis and pain patients on NSAIDs before moving on to COX-2 drugs, Cox said managed care plans are free to be as aggressive as they want to be. Some HMOs, Cox said, may handle the issue through "profiling" -- using software to track what a doctor prescribes. If he or she doles out too much Vioxx or Celebrex, a talking-to may follow.

Merck & Co., the maker of Vioxx, takes issue with Express Scripts' findings, especially the assertion that almost three-quarters of new COX-2 users are not at risk for stomach problems. Spokesman Gregory Reaves called the report "unfair" and said the company's findings have shown that one in five people who develop serious upper gastrointestinal reactions to aspirin or ibuprofen are unaware of it and were never deemed "at risk." These reactions may take the form of undetected bleeding or ulcers in the stomach. Vioxx, Reaves said, has been proven to reduce the incidence of such reactions.

When Celebrex and Vioxx entered the market in 1999, the U.S. Food and Drug Administration (FDA) required that both drugs carry the same warning as ibuprofen and naproxen, one that alerts consumers to possible stomach upset and bleeding. Following a recent study funded by Merck, the FDA allowed Merck to alter Vioxx's labeling to indicate that, although a risk of stomach problems still exists, it is significantly lower for Vioxx than for NSAIDs.

In responding to Express Scripts' findings, Pharmacia also pointed to the stomach issue. John Fort, the company's vice president of global medical affairs, said Celebrex is just as effective as ibuprofen and aspirin, with "an improved safety profile, especially on the gastrointestinal side."

According to the pharmaceutical consulting firm Scott-Levin, 24.5 million Celebrex prescriptions were filled in the United States in 2001, making it the 10th best-selling drug on the market. Vioxx ranked 13th, with 23.7 million prescriptions filled. Celebrex (jointly marketed by Pharmacia and Pfizer) generated worldwide sales of $3.1 billion last year; Vioxx raked in $2.6 billion.

The two drugs were introduced in 1999 with splashy, expensive TV ad campaigns. But over the last year the buzz has turned sour. Last year, research indicated that Vioxx patients ran four times more risk of heart attack than patients taking aspirin or ibuprofen. Last summer, a study published in the British journal The Lancet associated Vioxx with kidney failure. In March of this year, the FDA reported that five people taking Vioxx had been hospitalized with aseptic meningitis, an inflammation of the membranes covering the brain and spinal cord. And just last week came a report showing that Vioxx and Celebrex slowed the healing of bone fractures in lab animals.

Larry D. Sasich, a pharmacist and research associate with the Wasington-based consumer advocacy organization Public Citizen, recommends traditional anti-inflammatory drugs for arthritis and other pain. His group included COX-2's on its "worst pills" list in its monthly publication Worst Pills, Best Pills News.

"There's no evidence that they are any safer on the gastrointestinal tract than drugs that were already on the market," said Sasich, adding that research performed by drug makers consisted only of visual inspection of the stomach and duodenum, ignoring other parts of the digestive system. Besides, says Sasich, the drugs are overpriced.

Mike DeAngelis, spokesman for CVS drugstores, says the pharmacy at Dupont Circle charges $134.99 for 30 50-mg Vioxx capsules, and $96.99 for 30 200-mg Celebrex pills. The prescription anti-inflammatory generic drug naproxen costs $16.69 for 30 500-mg pills, while 24 pills of over-the-counter 200-mg ibuprofen (Advil) cost $3.99.

Given the pills' costs, Sasich agrees with Express Scripts' recent findings. "Individuals and the health care system can save billions of dollars a year just by being informed shoppers," said Sasich. "So far, they're not doing it."

Suz Redfearn is a regular contributor to the Health section.