Thursday, December 21, 2006

Making Us Sick

The Government Accountability Office (GAO) has released a study, New Drug Development: Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts, an analysis of the problems with the drug industry in the past decade. For example, only 12% of new drug patents are for truly innovative drugs that might help people; the rest are primarily for "me-too" drugs or insignificant modifications to existing drugs with the primary purpose of extending the patent and profits. Although half of their conclusions shouldn't be taken even with a grain of salt, the data is interesting. The best part, of course, is that this is the government, so the data has the veneer of neutrality.

Despite the numerous claims by the drug industry to what is hindering their progress, the statistics show that drug approval times are actually diminishing and the chances of getting approved have not varied. The report effectively lays out the flaws in a for-profit drug research model, where the vast majority of truly significant advances are still coming from government and charity-funded research. The path of least resistance for capitalism is the me-too drugs and sexy drugs, not necessarily something that will help people who are suffering from serious problems. Industry complains about FDA guidelines getting in the way, but the report does not offer any clear demonstration that this is something that has change significantly in the past ten years.

The reality is that we need more restrictive drug approval, instead of the system that has gotten things like Vioxx into the marketplace. Drug news over the past several years has shown how linked the FDA and the pharmaceutical industry are.

The proposals out of this report will do little to aid the rest of us. Shorter patents for non-innovative drugs isn't an answer: no patents is. And putting longer patents on innovative drugs isn't the problem, since the drug that might help (or even cure, a notion contrary to profit motives?) isn't likely to be profitable. Furthermore, such drugs should be quickly and cheaply available on a widespread basis, not restricted to only the wealthiest patients for years to come.

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