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Why Is the Pipeline of New Meds So Slow?
Feb 11, 2005

Many people are running out of options while the HIV drug pipeline slows down. Now that each of the major drug companies has anti-HIV products the monopolists are not eager to speed new drugs through the system that might compete, even though patients need options.

Why does it take ten years to get a new drug approved? It's be okay if we got ten years of safety data. However most drugs that are approved after that length of time have much shorter periods of actual testing, with lots unnecessary delays from Phase I, II and III.

If the approval process was based on science and not on politics couldn't we get new drugs in two to three years with the same amount of safety and efficacy data we get now?

Response from Dr. Henry

Several of the PIs were approved quite rapidly (time cut in half) so it is possible. However, with the current legitimate concern about long term safety of drugs (i.e. Vioxx) there is a need to accumulate 6-12 month data in at least moderate sized studies to feel somewhat comfortable about a drugs safety. Given that first animal safety studies have to be conducted, then in humans initial dose ranging and safety studies followed by efficacy and safety trials it is frustrating but understandable why the process is a long one. Also, the market for HIV drugs in wealthy countries is finite so financial/stock considerations play a role too which is unfortunate. It is very frustrating to care for patients with resistant virus and hear about drugs in the pipeline that we can't obtain. Pressure from activists and patients is crucial to speeding up the process. KH



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