4 August 2008

Drug Testing, Approvals Process Fatally Flawed, Says New Study

by Kate Melville

More drug catastrophes like the Vioxx disaster are inevitable, says Donald Light, a professor of comparative health policy at the University of New Jersey, who contends that the current system of FDA administered testing and approval in the United States is increasingly inadequate.

"Drug disasters are literally built into the current system of drug testing and approvals in the United States," said Light, who presented his study at the annual meeting of the American Sociological Association. "Recent changes in the system have only increased the proportion of new drugs with serious risks."

Astonishingly, adverse drug reactions are the fourth leading cause of death in the United States. The two million serious reactions that take place every year occur for a variety of reasons, including improper prescribed dosage, drug abuse and drug interactions. Light's analysis identifies the organizational foundations of patient risk from prescription drugs and suggests institutional reforms to help avoid or reduce future drug disasters.

Rather than using current approved drugs as benchmarks of efficacy, the existing testing system evaluates the effectiveness of new drugs based on their effects compared to placebos, explains Light. Systematic reviews indicate that one in seven new drugs is superior to existing drugs, but two in every seven new drugs result in side effects serious enough for action by the FDA, including black box warnings, adverse reaction warnings, or even withdrawal of the drug. Based on this system, Light asserts that new drugs are twice as likely to harm patients as to provide them with benefits superior to existing drugs.

Light's analysis suggests another flaw lies within the design of clinical trials. He contends that pharmaceutical companies frequently design their trials to minimize evidence of toxic side effects. To do so, they sample from a healthier population atypical of patients who will actually take the drug, excluding people who are older, poorer or who have multiple health problems. Trials are run long enough to pick up main effects but not to detect some long term side effects. Approvals are based on these data; so drugs with harmful effects sometimes get through.

"Based on our current system, the designation of 'safe and effective' on today's new drugs could be replaced with, 'apparently safe based on incomplete information, and more effective than a placebo,'" Light said.

Light cites serious under-funding of the FDA, which creates a dependency on the pharmaceutical industry - the industry FDA regulates - to pay its staff. In return for drug company funding, Light says, the industry expects faster reviews, but faster reviews potentially fail to identify serious long-term side effects.

"Speed-up reviews for safety have more than tripled the number of 'black box warnings' of side effects or withdrawals after drugs are on the market," Light said. "Despite recent reforms to strengthen the FDA's role in protecting the public from harmful drugs, the harm-benefit ratio is worsening due to these reviews and relaxed rules that allow companies to promote drugs for unapproved uses."

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Source: American Sociological Association