$802M/d and Clinical Trials

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By unbroken3106
December 4, 2001

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Everyone would like shorter clinical trials, but it does not seem like that is going to happen anytime soon. The push for blockbuster status means that drugs will be introduced to people with conditions not included in a narrowly designed clinical trial. I'm not sure if this is the cause of the change in FDA approval criteria, but these changes will keep the clinical burden high. In a nutshell, which is the extent of my knowledge of the situation, the FDA has said that to get approval for a new drug, it needs to be 10% more effective than current therapies, up from 5%. That puts a lot of burden on the trials, because it adds to the number of patients required to meet that new standard. Patient care during clinical trials is the key factor in their expense.

It is not a surprise that PHARMA likes the study, and that the Health Research Group (HRG) hates it, because the figures add the cost of all the failures to the cost of the one winner. PHARMA (a lobbying group) says that the cost of failures is part of the cost of business, while the HRG says that padding costs forces the consumer to pay for more than they are getting. This has been argued on an international level with Brazil and South Africa saying that they can knockoff anti-AIDS drugs for pennies on BMS's and others dollars.

Efforts to weed out losers early, particularly on safety issues, is certainly the way to go, but the industries are just getting started. As discussed well in previous posts, data from animal and cell models are not going to convince anyone that human trials are not required. The question is what properties of drugs cause toxic effects, and how do you flag them early? Major pharmas and CRO's are just getting set up now to look into this, and it will be a couple of years before there is enough data for the FDA to sign off. CRO's and biotechs that specialize in this are still developing their databases with known compounds that can be used as references (GeneLogic's ToxExpress is the only one that springs to mind, but there are many others). The deeper problem is that it will be a while before we know enough about how drugs behave in average, healthy people, and that this doesn't get to where the serious, blockbuster-killing toxicity problems occur, which is with people with complications and genetic predispositions to unusual drug metabolism.


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