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Drug Safety: What Studies Don't Report


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Drug Safety: What Studies Don't Report

Years of extensive testing are required by the Food & Drug Administration before a drug is approved. Yet several drugs, including Rezulin, for diabetes, Propulsid, for reflux, and the anti-angina drug Posicor have been pulled from pharmacy shelves in the past two years because of adverse reactions that showed up after approval. How could this happen?

A new study sponsored by the U.S. Agency for Healthcare Research & Quality suggests one reason: Large, randomized, controlled clinical trials--the gold standard for evaluating new drugs--may regularly underreport drug-safety problems. The study, in the Journal of the American Medical Assn.'s (JAMA) Jan. 24 issue, examined safety reporting in 192 drug trials, each involving a minimum of 100 patients. The trials ranged across seven medical areas. Say the researchers: "We found no instances where the safety reporting can be deemed satisfactory."

The study found that the severity of medical side effects was adequately reported in just 39% of drug-trial reports and drug toxicity in just 29%. Specific reasons why patients had to be withdrawn from a trial were given only 46% of the time. Also, none of this information was easy to find. The authors report that, on average, medical-journal articles on drug trials devote only a third of a page to such information.

A second JAMA article reported that Phase 2 clinical trials, which are meant to ferret out safety problems before a drug is tested on a larger group, may be adding to the problem. These studies, say the authors, are usually too small and their patients too carefully selected to produce the very data on potential adverse outcomes they are meant to uncover.Edited by Catherine ArnstReturn to top

Spider Spit Can Do a Shaky Heart Good

Proof that every cloud has a silver lining: Tarantula venom may hold the cure to atrial fibrillation, the erratic beating of the heart that is a major cause of death from heart attacks. Scientists report in the Jan. 4 issue of Nature that a protein isolated from the venom of the Chilean tarantula stopped irregular beating in rabbit hearts. As one of the researchers, Frederick Sachs of the State University of New York at Buffalo, aptly puts it: "No one in their right mind would have sought to block atrial fibrillation with spider spit."

Sachs and his team thought to use spider spit when they discovered that the GSMtx-4 protein, isolated last year, was able to block so-called stretch-activated ion channels in the cell membrane. These channels play a key role in a host of mechanical body functions, including heart-muscle contractions. When the heart muscle is damaged, the cells stretch and the channels open, allowing an influx of ions that overstimulate the heart. The researchers discovered that the spider protein blocks the ion channels from opening.

Sachs says the protein could be the first step toward a new class of drugs that would be directed at the causes of fibrillation rather than its symptoms. The research was funded in part by NPS Pharmaceuticals Inc. of Salt Lake City.Edited by Catherine ArnstReturn to top

Inventors Are, Like, Yucky and Stuff

Sadly, American teens do not aspire to be or even to meet the mothers of invention--unless they belonged to the late Frank Zappa's band. In the latest Lemelson-MIT Invention Index, an annual Massachusetts Institute of Technology survey of attitudes toward inventing, teens rank inventors lowest among five categories of people they would most like to meet. Musicians top the list at 30%, followed by athletes and actors. Only 8% of teens say they're dying to meet an inventor. And nobody wants to be one--only journalists and politicians rank lower on a list of careers that teens aspire to.

Still, the kids aren't fools. They picked an inventor, by 46%, as the best person to be stranded with on a desert island. Lester C. Thurow, chairman of the Lemelson-MIT program, says the overall findings bode ill for the future of innovation. "Being an inventor has to be seen as a normal activity," he says. "In the knowledge-based economy of the 21st century, nothing is going to be more important than being able to invent."Edited by Catherine ArnstReturn to top


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