Drug Trials Turn Deadly

Back in the “good old days” of drug trials — before Vioxx — we usually didn’t learn about the deadly side effects of new drugs until after they hit the marketplace with a loud bang. An indication things may be changing: News of two drug trials that went horribly wrong.

Yesterday, Japanese drugmaker Eisal announced 11 patients died during a trial for Aricept, the near useless cholinesterase inhibitor prescribed for Alzheimer’s patients, that was being tested to treat vascular dementia. That’s no’insignificant number either, considering most patients had already suffered from a stroke or heart disease and the 326 patients who received a placebo, instead of Aricept, survived…

Earlier this week, six young men were hospitalized in intensive care in a London hospital after taking TBN1412, an experimental anti-inflammatory drug developed by TeGenero, being tested on humans for the first time. In the case of one critically ill patient, the face of the once healthy 28-year-old man is so swollen, he looks like the “Elephant Man,” according to a loved one. And, he may have jeopardized his health forever, just for a $3,500 check to pay the bills.

Does the news of fatalities during and after drug trials make a difference? Or, will the FDA slap on black box labels that few people read, and bring it to market? Or, as in the case of the lethal multiple sclerosis drug Tysabri, will regulators ignore the results and reapprove it for use anyway?

News accounts like these merely reinforce what we already know: Just how broken the conventional health care paradigm truly is.

BBC News March 16, 2006

Yahoo News March 15, 2006