Red Flag On Anti-Arthritis Drug
A study financed by the federal government has found that Vioxx, a popular anti-arthritis medicine, may cause serious heart problems, the Wall Street Journal reports.
As a result, a large HMO, Kaiser Permanente, is reconsidering its use of the drug. According to the Journal, physician committees from the HMO will decide in the next few weeks how it will deal with the latest findings on Vioxx.
Vioxx is manufactured by Merck. The Journal quoted Mary Elizabeth Blake, a Merck spokeswoman, as saying the company "disagrees with the conclusion" of the study.
The study adds to the mounting safety questions surrounding Vioxx, and is expected to boost its biggest rival, Pfizer's Celebrex.
CBS News Correspondent Sharyl Attkisson reports experts flagged a heart issue as far back as 1999, when Merck's own pre-trial study of Vioxx revealed significantly more heart attacks and strokes than a competitor.
"If I were sitting on the FDA what I think I would do is really urge physicians not to use higher doses of this agent Vioxx. And really reconsider even using the lower doses,'' said Dr. Deepak L Bhatt, a Cleveland Clinic cardiologist.
Dr. David Graham, the lead FDA scientist on the new study, is so concerned, he told reporters: "I don't think doctors should prescribe high dose Vioxx, and patients shouldn't take it."
But FDA leaders sometimes reject their own scientists' advice and side with the drug companies. Today, the FDA told CBS News it plans no immediate action on Vioxx, and that heart risks are already mentioned on the drug's label.
Merck, which makes Vioxx, stands by its safety pointing to other studies that show no increased heart risk.
"There have been six or seven observational studies and I would say half of them have shown Vioxx doesn't have an increased risk of heart attack,'' said Alise Reicin, vice president of clinical research for Merck.
Citing data from health-care information company NDCHealth, Atlanta, the Journal reports that Vioxx had U.S. sales last year of about $2 billion, compared with about $2.8 billion for Celebrex.