The Damage Done by the FDA, Symptom of the Deeper Problems - 0 views
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FDA is a scientific bureaucracy with police powers. Patients and physicians are free to choose only those drugs and medical devices that it has approved. When FDA approves a therapy that later turns out to be unexpectedly risky, the agency is the subject of front-page headlines and congressional hearings. On the other hand, when FDA delays a badly needed new therapy, patients will suffer but hardly anyone will blame FDA.
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Consider, for example, FDA's 10-year delay, in 1967-76, in approving beta-blockers to prevent death following heart attacks, because of the agency's fear that the drugs might be carcinogenic. During those years, the drugs saved lives in Europe and elsewhere, while an estimated 10,000 heart attack victims unnecessarily died in this country each year. When beta blockers were finally approved in the US, to wide acclaim, hardly anyone raised the lethal effects of FDA's slowness.
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As it turns out, however, that extra agency caution doesn't actually improve drug safety. Studies conducted by FDA itself show that the rate of drug withdrawals has remained essentially unchanged over the last 25 years, despite rising and falling approval times during that period.
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But FDA is only criticized for approving risky medicines - never for keeping beneficial ones off the market.
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Neither the Congress nor FDA (nor the IOM) is willing to admit that the agency's most significant problems are mismanagement and excessive risk-aversion.
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The motivation for most of these recent attacks on the FDA? That would be coming from the other squirming pigs wrestling in the pen, such as the large pharmaceutical and medical development companies, trying to make the most money they can from the suppression of competition and progress. They might be working on progress, but they're working just as hard at pushing new and better ideas below the waterline - so long as there's the threat that someone else will make money or threaten the bottom line for an aspect of their business model.
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In the worst cases, such as Germany and France, you see entire countries that contribute next to nothing to the advance of medical science. This is not for lack of will or desire, but their research and medical industries are hamstrung by decades of destructive government intervention.