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Better Arthritis Drug Studies Needed
Friday, December 24, 2004
By Steven Milloy
Amid the snowballing arthritis medication controversy, federal researchers published a study this week reporting that acupuncture (search) was a safe, alternative treatment for arthritis.

The treatment may be safe, but it doesn’t appear to be terribly effective.

Researchers reported that, in a study of 570 elderly patients, arthritis sufferers receiving acupuncture for 26 weeks experienced a 40 percent improvement in pain and mobility symptoms, while those receiving the placebo treatment, reportedly experienced only a 30 percent improvement.

But since there is no calibrated instrument for objectively measuring improvement in arthritis symptoms, the results were determined somewhat subjectively. So I’m not quite sure that the researchers reported any real or significant difference between acupuncture and placebo treatment.

Vioxx, Celebrex, Aleve and other anti-inflammatory medications, in contrast, provide much clearer benefits, at less cost and inconvenience, to arthritis sufferers — that’s why they’re so popular.

Nevertheless, the questions recently raised about whether the medications pose some small heart attack or stroke risk to certain individuals should be answered as soon as possible.

In the meantime, however, it would seem that the great weight of data — gathered over years and even decades — evidencing the undisputed benefits and general safety of these drugs should have prevented any panic caused by the relative novelty, paucity and inconclusive nature of the data underlying the ongoing scare.


The clinical trials triggering the controversy are contradicted by many other studies which haven’t reported any increased risk of heart attack and stroke; nor are the trials particularly impressive from a statistical viewpoint. The reported correlations are small and may, in fact, be artifacts caused by inappropriate study design.

None of the clinical trials giving rise to the questions about Vioxx, Celebrex and Aleve were, after all, specifically designed to test whether the drugs posed a heart attack or stroke risk. The data on Vioxx came from a study of gastrointestinal effects; the Celebrex data came from a cancer prevention study; and the Alleve data came from an Alzheimer’s prevention study.

If weak statistical correlations are to raise legitimate concerns about drugs that have been widely used for years without noticeable problems, those correlations should at least be produced by studies specifically designed to examine the precise health endpoints of concern. Results from well-designed studies would allow physicians and arthritis sufferers to choose whether to manage any clearly identified risks of effective drugs, rather than be told to be happy with “safe”, but ineffective treatments.

FDA Orders Review of Pain Drug Studies

Saturday, December 25, 2004



The Food and Drug Administration on Thursday ordered a review of all prevention studies involving drugs such as Celebrex (search) and Bextra (search), which have been associated with increased risk of heart problems. The agency also urged the public to limit use of over-the-counter pain medications.

"Consumers are advised that all over-the-counter pain medications ... should be used in strict accordance with the label directions," said Dr. John K. Jenkins, FDA director of new drugs.

That means the drugs — including such popular products as Aleve (search), ibuprofen (search) and even aspirin (search) — should not be used longer than 10 days without consulting a doctor, Jenkins said.

Jenkins said the agency will review dozens of studies now under way in which the so-called Cox-2 inhibitors (search) are being tested as possible ways to prevent various illnesses.

These drugs, sold by prescription, have been implicated in higher rates of heart problems and stroke. One of them, Vioxx (search), was pulled from the market by its manufacturer, and the FDA has advised caution in using the others, Celebrex and Bextra.

In addition, naproxen (search), a popular pain killer sold as Aleve and Naprosyn, has also been implicated in heart problems in a National Institutes of Health study.

"This is a rapidly evolving area," Jenkins said in a telephone briefing, adding that the public health advisory to limit use of these pain killers is an interim measure pending a full review of data on the drugs.

Jenkins said the FDA will convene an advisory panel in February to thoroughly study the available information on the drugs.

Pain killers such as aspirin car carry a serious risk of stomach and intestinal bleeding, Jenkins noted, and doctors must balance this with the potential heart risk of some of the other drugs.

"Physicians prescribing Celebrex or Bextra should consider this emerging information when weighing the benefits against risks for individual patients. Patients who are at a high risk of gastrointestinal bleeding, have a history of intolerance" to drugs like aspirin or ibuprofen may be appropriate candidates for Cox-2 drugs, he said.

The agency is "advising physicians to be very thoughtful as they are prescribing" painkillers, Jenkins said. "We are clearly suggesting that doctors take into account the new information that's become available."
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