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主题:辉瑞的药物化学新战略 -- 风的笑容

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家园 interesting WSJ blog comment

I found this WSJ comment on Pfizer is noteworthy:

The problem of pharmaceutical companies is not related to its inadequate R&D spending, it is related to the way the science is finding a drug.

Clinical trials are very expensive and they tend to be short (6 months or 12 months). In such as short period of time, it is unlike to find a drug to cure a chronic condition. To gain FDA's approval, companies take the route of reducing biomarkers instead of curing disease. In the end, drugs that only reduce biomarkers get on the market. There is a big gap between biomarkers and disease although in some cases they are correlated, but not very cases.

Another example is cancer drugs. Although saying that no-treating cancer patients in clinical trials is non-ethical, in reality, other studies showed that most cancer treatments actually kill patients sooner comparing with non treatment at all. Afraid of having a no-treatment arm in clinical trials, pharmaceutical companies are saying that not-treating cancer patients in a trial is non-ethical.

The failure of pharmaceutical companies also roots at its business model. Today a company produce a good brand drug. 10 years later, it becomes generic. To produce the next brand drug becomes harder because it has to compete with existing generics. In addition, the development cost is always increasing. In the end, there will be a point that there is no financial gain of producing new drugs.

Finally, FDA's requirement of clinical trials is out-off-date. In the old time, clinical trials can find good drugs for curing acute diseases. Now, when many disease are chronic, 6-month or 12-month long clinical trials are not capable of discovering good drugs of curing conditions. There why today, when you start to take pills, you have to take for the rest of your life. Clinical trials are extremely expensive and add the burden to companies. So, the question to FDA is since clinical trials is not a good way of finding drugs treating chronic conditions, why requiring it? FDA should go back to its original mission to ensure safety; let the market play out the efficacy.

Finally, single chemical is not capable of treating or curing a complex disease. Sometime, US has to learn from Europe and Asia about traditional medicine

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