The fast-track drug approval process puts consumers in danger
The fast-track drug approval process puts consumers in danger
“Aggressive Drug Marketing May Endanger People”
When I saw that Reuters Health headline recently, my sarcasm meter lit up like a Christmas tree…
No! Really? Do tell!
The Reuters article features an interview with Dr. David Kao who published an analysis of drug marketing in the British Medical Journal late last year. Dr. Kao “reveals” what many e-Alert readers already know: Drug companies actually pay special fees to put drug approval applications on a fast track. He doesn’t address the obvious conflict of interest in having major drug companies underwrite the cost of the approval process. But he does highlight the safety problem.
According to Dr. Kao, a typical drug review between 1979 and 1986 took more than 33 months. More recently, a review takes about 16 months. The good doctor told Reuters Health: “It’s probably not helping drug safety.”
Right. And gasoline probably doesn’t help put out a fire.
This is how it’s been over the past decade or longer – the review process gets short shrift, and the next safety net (if you can call it that) is post-approval surveillance. In other words, the first few thousand consumers who use a new drug are guinea pigs in a safety trial. And when a drug is truly bad – such as Vioxx – many people die in the process.
Dr. Kao rightly points out: “We just have very poor post-approval surveillance now.” But then he completely goes off the rails with this bon mot: “People are going to want new drugs and it is going to be impossible to guarantee their safety before a lot of people get them.”
People are going to want new drugs? No. Drug company executives want new drugs to expand their markets. People just want drugs that work and are safe. Period. And that’s clearly going to be a hit-or-miss proposition as long as drug company money is deeply entwined in the approval process.
Source:
“Aggressive Drug Marketing May Endanger People” Reuters Health, 12/3/08, reutershealth.com
