Monday, January 02, 2006

"Superfluous Medical Studies Called Into Question"

Read the full article by David Brown in The Washington Post of January 2, 2006.

Professional medical practice is almost certainly the human endeavor most thoroughly based on strong scientific evidence. Case control studies showing safety, efficacy and effectiveness are required for licensing of new drugs and vaccines, and are common for medical practices. Peer review and replication of studies are common. Laws exist to further insure the quality of scientific practice, and meta-analyses are done in many cases to combine the results from studies and further increase certainty of the interpretation of their findings.

This article, however, cites two recent studies indicating that too much replication may be taking place. "One article examined 18 years of research on aprotinin, a drug used to reduce bleeding during heart surgery. The other looked at studies on the relationship between a baby's sleeping position and sudden infant death syndrome. Both concluded that research on these subjects went on long after the answers were known -- namely, that aprotinin worked and that babies sleeping on their backs were less likely to die of SIDS."
The odyssey of aprotinin, which is derived from the lung tissue of cows, was recounted in the journal Clinical Trials. Dean Fergusson and his colleagues at the Ottawa Health Research Institute found 64 randomized, controlled trials -- the most authoritative type of study -- on the use of aprotinin in heart surgery. They were done in half a dozen countries over 18 years, starting in 1987. Two-thirds were little more than variations on each other. And nearly all showed the same thing: Patients who received aprotinin during surgery bled less. They had only one-third the chance of needing a blood transfusion of patients who did not get the drug. What was surprising was that this advantage was clear by June 1992, after the 12th of the 64 studies.
In the International Journal of Epidemiology, Ruth Gilbert of the Institute of Child Health in London examined 40 studies of SIDS and sleep position going back to 1965. Gilbert found that if researchers had pooled the results of the oldest studies and analyzed them, they might have gotten a big hint by 1970 that putting babies to sleep on their stomachs raised the risk of SIDS. Instead, that observation did not become convincing until the late 1980s.

Delaying changes in medical practice awaiting unnecessary further replications of research seems likely to cause unnecessary suffering, and in some cases excess disability and death. Giving less than optimum treatment to controls in medical experiments raises ethical issues. Fortunately, the article suggests that medical journals are increasingly requiring better reviews of the state-of-the-art and meta-analyses for new publications, and fortunately there are efforts under way to make the results of medical research more widely available to other researchers (and to the medical profession and the general public).

Other professions could learn from the medical profession to use knowledge more effectively for their contributions to social and economic development, and perhaps take the lead in using timely meta-analysis of research results both to improve the quality of knowledge, and to avoid inappropriate delays in emboding research results in their practice.

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