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Rant, rant, rant
"106,000 deaths" by drug reaction? Maybe, maybe not -- but this is no way to report on a study!

This is the standard caveat that I am going to post in response to any further references to the claim of "106,000 deaths by drug reaction each year." I object to "sound-bite science" and want to make sure that anyone who reads this claim will have the necessary background by which to evaluate it. If you don't want to see this and any other caveats I may post, you can set your filters to exclude any posting that contains the character string [CAVEAT] in its subject. Be sure to include the brackets, so as not to filter out other postings that may contain the word caveat in their subject.
It's time to drive a stake through the heart of the myth that a study reported in the Journal of the American Medical Association has demonstrated drugs to be the country's fourth-largest cause of death.

Here is the actual conclusion of the study report in the April 15, 1998 issue. Please note the continued use of the word *estimate.* Please also note the line about using viewing the results with circumspection because of the heterogeneity among the studies -- meaning, in other words, they weren't at all sure they were comparing apples to apples. The study is a meta-analysis of 39 prospective studies of adverse drug reactions conducted over a forty-year period.

The results were challenged by several correspondents, as demonstrated by the November 25, 1998 issue. Some wrote in with data from their own institutions indicating a much lower rate of ADR; some had significant issues with the methodology. The physician who originally reviewed and commented on the study himself supplied a revised estimate of 25,000 ADRs.

This does not negate the fact that adverse drug reactions continue to be an issue of concern. As the original reviewer noted in his accompanying editorial, even if some of these reactions are neither preventable nor forseeable now, they may be in the future, and the data collected today could help save lives tomorrow. But the continued misreporting of the study and the follow-on information in JAMA is, in my opinion, a disservice to readers.

Sadly, this is an example of how some folks with an agenda will take a highly tentative conclusion, suggesting that further research is necessary, and use it as the basis for a polemic.

*Study conclusions and author credentials follow*

Incidence of Adverse Drug Reactions in Hospitalized Patients: A Meta-analysis of Prospective Studies. Lazarou, Jason MsC; Pomeranz, Bruce H. MD, PhD; Corey, Paul N. PhD. Journal of the American Medical Association, 297(15), 15 April, 1998, pp 1200-1205.

"Perhaps, our most surprising result was the large number of fatal ADRs. We estimated that in 1994 in the United States 106.000 (95% CI, 76,000-137,000) hospital patients died from an ADR. Thus, we deduced that ADRs may rank from the fourth to sixth leading cause of death. Even if the lower confidence limit of 76,000 fatalities was used to be conservative, we estimated that ADRs could still constitute the sixth leading cause of death in the United States, after heart disease (743,460), cancer (529,904), stroke (150,108), pulmonary disease (101,077), and accidents (90,523); this would rank ADRs ahead of pneumonia (75,719) and diabetes (53,894). [18] Moreover, when we used the mean value of 106,000 fatalities, we estimated that ADRs could rank fourth, after heart disease, cancer, and stroke as a leading cause of death. While our results must be viewed with some circumspection because of the heterogeneity among the studies and small biases in the sample, these data suggest that ADRs represent an important clinical issue.

"This work was supported by a grant (Dr Pomeranz) and a scholarship (Mr Lazarou) from the National Science Engineering Research Council, Ottawa, Ontario.

"J. L. Lazarou did this work in partial fulfillment of his MSc degree at the University of Toronto, Ontario; B. H. Pomeranz, MD, PhD, was the principal investigator; and P. N. Corey, PhD, was the statistician who contributed to the conception, design, analysis and interpretation of the data, and also particpated in writing the manuscript.

"A complete list of the 104 papers excluded from our meta-analysis is available on request from the authors.

"Reprints: Bruce H. Pomeranz, MD, PhD, Departments of Physiology and Zoology, University of Toronto, 25 Harbord St, Toronto, Ontario, Canada M5S 3G5 (e-mail:"