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Tech dean heard of problems at seminar

By GEORGE SCHWARZ
george.schwarz@amarillo.com
Amarillo Globe-News - December 23, 2004 - Pharmaceutical researchers knew years ago that certain arthritis pain drugs could cause heart problems. Naproxen, marketed as Aleve, is the latest drug that researchers have questioned. In the past three months, Vioxx, Bextra and Celebrex have come under scrutiny for raising the risk of heart attacks and strokes. The drugs are known as COX-2 inhibitors. Merck & Co.'s Vioxx was pulled from the market in September amid much national publicity.

Dr. Arthur Nelson, dean of the Texas Tech University School of Pharmacy, said he was at a seminar six years ago when participants saw that the structure of Vioxx pointed to a potential for cardiovascular problems. "But once it got in the market and they showed a lot of success with it, physicians prescribed it, patients demanded it, and so we saw multi-millions, hundreds of millions of dollars, of sales of drugs, which I think we knew all along were not 100 percent safe," Nelson said. "They finally had enough patients and collected enough data to show it had significant cardiovascular effects and needed to be removed from the market."

"We thought Celebrex was safe and the problem was just with Vioxx," said Dr. Richard Hayes, a New York cardiologist who is recommending his patients switch from Celebrex to nonprescription medicines such as Advil to treat pain. "The problem is more complex than we thought," Hayes told The Associated Press.

According to USA Today, pain drugs were a $2.4 billion market for the past year ending in October, excluding information from Wal-Mart, which doesn't report sales by category. Arthritis drugs accounted for $80 million in sales. Because a drug is on the market doesn't mean it's safe, Nelson said. "There is no such thing as a safe drug. Period," Nelson said.

Rebecca Young, a pharmacy technician at Village Pharmacy, said Merck & Co. will refund the cost of the drugs. Patients should contact their pharmacy, and the drug company will reimburse the cost of the drug and the shipping.

According to THEHEART. ORG, a Web site for medical professionals, the cardiovascular risk with Celebrex arose in a long-term, cancer-prevention study in which subjects took either 400 or 800 milligrams daily. The findings prompted the National Cancer Institute and Pfizer, the drug's manufacturer, to stop the study. Those findings, and some others, are preliminary and should be viewed with caution, said Eric J. Mac-Laughlin, an associate professor at Texas Tech School of Pharmacy.

The cancer study used much higher doses than normally prescribed. The results are clearer about the risks with Vioxx. Until now, there were no studies showing cardiovascular risk for Celebrex, he said. "Right now, I would say it's conflicting information," MacLaughlin said. "With the other COX-2 inhibitors, it's much, much less clear and very preliminary." MacLaughlin said the COX-2 inhibitors are no more effective for pain than non-steroidal anti-inflammatory drugs - NSAIDs - such as ibuprofen. They have fewer gastric side effects. He recommended people look at their options on the recently launched Consumer Reports drug Web site.

He also said the studies about naproxen are too preliminary for comment. "I think people might be jumping the gun a little bit," he said.

Dr. William D. Ratnoff, an associate professor and rheumatologist at Tech's health sciences center in Lubbock, agreed. "Above all, the advice now is to get with your own physician," he added, "because the decisions are individual."

Statement About treatments

Late Wednesday, American College of Rheumatology president Elizabeth Tindall, M.D., issued a statement, part of which said:

"For patients with arthritis and the physicians who treat them, it remains critical to consider factors that affect the risk/benefit ratio when determining whether to continue or discontinue any pharmaceutical product, including those NSAIDs (non-steroidal anti-inflammatory drugs) that are under scrutiny for potential increased health risks. Treatment guidelines exist to help physicians choose the best treatment options for their patients based on current scientific studies.

"It is unfortunate that physicians and patients have limited preliminary data, some of it in direct conflict with existing conclusions, causing anxiety that, at this time, cannot be definitively confirmed nor refuted."

Because peer-reviewed data and analysis are not available to substantiate the studies' preliminary results, the validity of elevated health risk conclusions are unknown. To address these concerns, the college advises physicians to follow the current treatment guidelines and manufacturers' dosage recommendations.

The ACR is the professional organization for rheumatologists and health professionals who heal people with arthritis and related rheumatic and musculoskeletal diseases.

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