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Junk Science Report

Better arthritis Drug Studies Needed

By Steven Milloy

December 27, 2004

amid the snowballing arthritis medication controversy, federal researchers published a study this week reporting that acupuncture 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.

Fat But Not Fit?

p>“Fat but fit” is a faulty concept, according to a new study published this week in the New England Journal of Medicine.

“There has been some suggestion that if you are particularly active, you don’t have to worry about your body weight, about your diet. That’s very misleading,” study author Frank Hu of the Harvard School of Public Health told the aP.

What’s more likely to be misleading, though, is Hu’s study.

Hu claims his data show that physically active-obese women had a 100 percent greater rate of premature death than physically active-lean women; sedentary-lean women supposedly had a 50 percent greater rate of premature death than active-lean women.

“Being physically active did not cancel out the increased mortality of overweight. Being lean did not counterbalance the risk effect of being sedentary,” Hu told the aP.

I don’t know whether fat-but-fit is a myth, but I do know that Hu’s study is extraordinarily dubious.

Data on the women’s level of physical activity were collected at numerous points during the study (in 1980, 1982, 1988, 1992, 1996 and 1998). In contrast, the data on the women’s bodyweight were collected only once — by self-report in 1976.

So Hu’s results are based on analyses of the women’s bodyweights in 1976 and their subsequent physical activity levels as much as 22 years later. Hu's myth-busting effort might have been on firmer ground had he showed, for example, that women who were consistently overweight but active throughout 1976-1998 had greater mortality than women who were consistently lean-and-fit throughout that time frame.

Hu claims that the 1976 bodyweight data alone were used “to reduce the effects of underlying disease on weight” — whatever that means. He, therefore, admits possession of the bodyweight data for the period 1976-1998.

I can only conclude that Hu chose to use the 1976 data alone because they gave him the myth-busting, headline-making answer he wanted.

If you think I’ve been too rough on Hu’s fat-but-fit hooey, please recall his recent dastardly effort to link soft drink consumption with diabetes. Hu and crew are notorious purveyors of junk science.