Friday, October 24, 2008



Even higher than the number of people who die from medication errors is the number of people who die from medication, period. Even when a prescription drug is dispensed properly, there's no guarantee it won't end up killing you. A remarkable study in the Journal of the American Medical Association revealed that

prescription drugs kill around 106,000 people in the US every year, which ranks prescription drugs as the fourth leading cause of death. Furthermore, each years sees 2,216,000 serious adverse drug reactions (defined as "those that required hospitalization, were permanently disabling, or resulted in death").

The authors of this 1998 study performed a meta-analysis on 39 previous studies covering 32 years. They factored out such things as medication errors, abuse of prescription drugs, and adverse reactions not considered serious. Plus, the study

involved only people who had either been hospitalized due to drug reactions or who experienced reactions while in the hospital. People who died immediately (and, thus, never went to the hospital) and those whose deaths weren't realized to be due to prescription drugs were not included, so the true figure is probably higher. Four years later, another study in the JAMA warned:

Patient exposure to new drugs with unknown toxic effects may be extensive. Nearly 20 million patients in the United States took at least 1 of the 5 drugs withdrawn from the market between September 1997 and September 1998. Three of these 5 drugs were new, having been on the market for less than 2 years. Seven drugs approved since 1993 and subsequently withdrawn from the market have been reported as possibly contributing to 1002 deaths.

Examining warnings added to drug labels through the years, the study's authors found that of the new chemical entities approved from 1975 to 1999, 10 percent "acquired a new black box warning or were withdrawn from the market" by 2000. Using some kind of high-falutin' statistical process, they estimate that the "probability of a new drug acquiring black box warnings or being withdrawn from the market over 25 years was 20%." A statement released by one of the study's coauthors — Sidney Wolfe, MD, Director of Public Citizen's Health Studies Group — warned:

In 1997, 39 new drugs were approved by the FDA. As of now [May 2002], five of them (Rezulin, Posicor, Duract, Raxar and Baycol) have been taken off the market and an additional two (Trovan, an antibiotic and Orgaran, an anticoagulant) have had new box warnings. Thus, seven drugs approved that year (18% of the 39 drugs approved) have already been withdrawn or had a black box warning in just four years after approval. Based on our study, 20% of drugs will be withdrawn or have a black box warning within 25 years of coming on the market. The drugs approved in 1997 have already almost "achieved" this in only four years — with 21 years to go.

How does this happen? Before the FDA approves a new drug, it must undergo clinical trials. These trials aren't performed by the FDA, though — they're done by the drug companies themselves. These trials often use relatively few patients, and they usually select patients most likely to react well to the drug. On top of that, the trials are often for a short period of time (weeks), even though real-world users may be on a drug for months or years at a time. Dr. Wolfe points out that even when adverse effects show up during clinical trials, the drugs are sometimes

released anyway, and they end up being taken off the market because of those same adverse effects. Postmarketing reporting of adverse effects isn't much better. The FDA runs a program to collect reports of problems with drugs, but compliance is voluntary. The generally accepted estimate in the medical community is that a scant 10 percent of individual instances of adverse effects are

reported to the FDA, which would mean that the problem is ten times worse than we currently believe. Drugs aren't released when they've been proven safe; they're released when enough FDA bureaucrats — many of whom have worked for the pharmaceutical companies or will work for them in the future — can be convinced that it's kinda safe. Basically, the use of prescription drugs by the general public can be seen as widespread, long-term clinical trials to determine their

true safety. We are all guinea pigs.

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