Americas media seemed startled recently by a published study implicating prescription drugs in causing serious harm to more than two and a quarter million patients hospitalized during a one-year period (JAMA, 15 April 1998). The most surprising finding, according to the studys authors, was the large number of fatalities, 106,000, which would make adverse drug reactions (ADRs) the fourth leading cause of death in the U.S.

After completing their meta-analysis of 39 prospective U.S. studies of adverse drug reactions covering a 32-year span,University of Toronto researchers Jason Lazarou, MSc., Bruce C. Pomerantz, M.D., Ph.D., and Paul Corey, Ph.D., concluded that patients admitted to a hospital because of a drug reaction had a 4.7% risk of serious injury and a 0.13% risk of death. For patients hospitalized for reasons other than an ADR, the risk of serious injury caused by a drug prescribed during their hospital stay was 2.1% and the risk of death was 0.19%. Although the risk of fatal drug reactionsmay seem very small, the actual number of deaths that occur are significant given that more than 30 million people are discharged from U.S. hospitals each year.

In an accompanying editorial, David W. Bates, MD., MSc., Brigham and Womens Hospitals, Boston, points out that the studys methodology has been criticized by some experts as overestimating hospital ADRs. But, he also concedes that the number is much higher than is generally recognized. One reason for this, Bates suggests, is that hospitals have strong incentives not to identify too many of these events. Reporting large numbers of adverse events...brings intense scrutiny from regulators and the public. Thus, most hospitals have relied on spontaneous reporting which identifies only about one in 20 adverse reactions and leads to the perception that injuries from ADRs are less common than they really are.

The FDA devotes very limited resources to monitoring drug safety. (See HealthFacts, April 1998). In addition, the agency relies on spontaneous reporting by doctors, hospitals, patients and others, which critics claim captures only about 1% of ADRs. The agency has announced very modest plans to reorganize the monitoring effort to make it more effective. However, getting new drugs and other products to market quickly is where the political rubber meets the road and the drug industry, doctors, researchers, patients and their families, and their respective lobbyists all work hard to bring political pressure to bear. As a result, the speedy approval of new products is likely to continue to be the FDAs main focus, rather than monitoring those drugs already in use.

So what is there to do? In their recently published commentary, Thomas J. Moore, Bruce M. Psaty, MD, Ph.D., and Curt D. Furberg, MD, Ph.D., of George Washington University Medical Center, University of Washington and Wake Forest University School of Medicine, respectively, call for the establishment of an office of drug safety with sufficient authority, independence, industry funding, and a clear legal mandate to do whatever is necessary to protect the public health. (JAMA, 20 May 1998) The proposed office would have four specific tasks: (1) estimating the number and cause of serious injuries and deaths due to ADRs; (2) Identifying new serious reactions; (3) monitoring the effectiveness of FDA safety alerts; (4) operating an early-warning system featuring active surveillance rather relying solely on spontaneous reporting.

RXNews agrees that an independent office of drug safety would benefit the public health. The need for such oversight is all the more critical in light of the rapid development and diffusion of new drugs (for example, one million U.S. prescriptions written for Viagra in six weekssix deaths reported to date). Making matters even more worrisome are the new, less stringent requirements for new drug approval and the easing of restrictions on off-label drug promotion now in effect due to the 1997 FDA Modernization Act (see HealthFacts, December 1997).

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