Why the FDA's criteria for approving drugs and the current system of drug evaluation are contributing to questionable pharmaceuticals.
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Dr.Jerry Avorn, author of "Powerful Medicines, the Benefits, Costs and Risks of Prescription Drugs," says one conern is the criteria the FDA uses to approve most drugs:
"Well, the bottom line really is that our way of testing drugs is really pretty limited in that if you can show, if you're a drug company, and you can show that your drug makes a lab test look better after a brief period of time in comparison to what a sugar pill does then you can get the drug approved in many instances. And we certainly have seen that with cholesterol drugs and diabetes drugs. And the problem with that way that the FDA evaluates drugs is that what most patients and doctors want to know is not is it better than a placebo over a couple of month period on a lab test but will it make me healthier. Will it prevent a heart attack or a stroke or kidney failure? And amazingly enough the federal government does not actually require that that be demonstrated for an awful lot of drugs on the market, which is why we get these surprise headlines that we've seen."
In other words, our Food and Drug Administration does not require that drug companies demonstrate that the drugs won't make us sick in some fashion.
"What the drug companies who want to sell the drug have to convince the FDA is that it will make let's say your cholesterol level look better if you take it for a couple of months compared to taking a dummy pill. And at the moment, unfortunately, at the moment that is the standard that the FDA applies for approving drugs and it does not make the companies go beyond that and say, 'yeah, but will it prevent heart attacks?'
"So, we've got this first problem of really pretty lax standards for approval. And then we've got the other issue of do we even know about the results when they don't meet that low standard. The poster child for that problem was the Vitoren story of several weeks ago in which it turns out that the companies that was doing the testing of their drugs did not find that even the standards of making your arteries look healthier was being met. And somehow it took two years for that result to make its way into the public consciousness because the companies were sitting on the data. So even with low standards we often don't even get those results in a timely manner."
Dr. Avorn explains that our current system of drug evaluation is to blame:
"We've evolved into a system of drug evaluation that is very heavily influenced by the industry that makes the drugs. Just as we have an energy policy that's influenced by the petroleum industry and environmental and finance and other policies that are heavily influenced by those industries and not by what Joe Citizen would expect the government is doing. We just need to have more of the voice of the patient and the voice of the doctor at the table when we're considering how the FDA is ruling on these drugs and not primarily the voice of the manufacturers."
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