How Did We Get Into This Situation, And How Can We Get Out: Two Recent Editorials
In December 2005 The New England Journal of Medicine (NEJM) announced that it had learned about "inaccuracies and deletions" in data contained in an article that it had published back in 2000 about the results of the VIGOR (Vioxx Gastrointestinal Outcomes Research) study by Bombardier et. al. In turn, later that same month, the NEJM published an "Expression of Concern" piece drawing attention to this disturbing discovery. That item concluded by asking the authors of the 2000 VIGOR article to "submit a correction" concerning the three myocardial infarctions, or heart attacks, in the Vioxx-user group arm of that clinical study which had been omitted from their original article. The VIGOR study was funded by Merck & Co., the manufacturer of Vioxx.
Two recent editorials have commented on the VIGOR / Vioxx study NEJM article controversy and other problems caused by clinical trials funded by drug companies.
On January 7, 2006 the Los Angeles Times published an editorial by John Abramson, the author of "Overdosed America", who is a clinical instructor at Harvard Medical School. Dr. Abramson's editorial is titled "Drug profits infect medical studies". In addition to referencing the Vioxx controversy, Dr. Abramson mentions how Scios, a Johnson & Johnson subsidiary, failed to include the deaths of two patients in a clinical study of Natrecor, its heart failure drug, in an article published in the Journal of Emergency Medicine. This editorial examines how we got into these situations:
"... over the last 25 years, clinical research has been largely privatized. Three-quarters of the clinical studies published in the three most respected medical journals (the New England Journal of Medicine, the Journal of the American Medical Assn. and the Lancet) are now commercially funded. As a result, our medical knowledge grows not in the direction that best improves our health but toward corporate profits, the way that plants grow toward sunlight.
This wasn't always so. Before 1980, most medical studies were publicly funded, and most academic researchers scorned industry support. Now, however, the vast majority of clinical trials are commercially funded, and with the financial stakes so high, there is mounting evidence of individual scientists and corporations manipulating their findings."
Earlier, on December 13, 2005, the Chicago Tribune published an editorial by Merrill Goozner, the author of "The $800 Million Pill," who directs the Integrity in Science project at the Center for Science in the Public Interest. Entitled "Trial and error: With some drug researchers hiding crucial data in clinical trials, there is a way to get better science on drug safety", the Goozner editorial provides a suggested remedy to our current predicament:
"The way to get better science in front of regulators and physicians (who rely on the medical literature) is to have an independent body take control of FDA registration trials. The drug and medical device industries already pay user fees to the FDA to hasten reviews of their new product applications. The user fee law is up for renewal next year. Why not expand those fees to include paying the government to conduct the final product registration trials?
It could be done through a new institute in the National Institutes of Health, which could contract with investigators at universities, independent research institutes, or the private firms that have sprung up in recent years to conduct clinical trials...."
Without a doubt, both of these editorials are worth a full reading by anyone truly concerned with the issue of drug safety.
(Posted by: Tom Lamb)