The FDA states it’s happy to sanction unproven drugs

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Debate continues to swirl about the cholesterol management guidelines issued by the American Heart Association and the American College of Cardiology recently. The new recommendations shift the emphasis away from treating those on the basis of their cholesterol levels to based on overall risk of cardiovascular disease.

How is risk determined? With ‘calculators’ that use data such as cholesterol, blood pressure, smoking history and body weight. What a shame, then, that these tools used to calculate risk have been found to be quite flawed, and generally appear to overestimate risk. This, coupled with the fact that the recommendation is to treat people at lower risk than previously, means that many more people stand to be treated with cholesterol-reducing drugs such as statins.

However, the new guidelines also recommend that drug treatment should essentially be confined to medications that have actually been proven to reduce the risk of cardiovascular events such as heart attacks and strokes. Overall, this does appear to be true for statins, though the reality is the evidence shows that, in individuals without a prior history of cardiovascular disease, many people need to be treated with one person to benefit in terms of protection from a heart attack or stroke (and no-one will have their life saved).

Nevertheless, I welcome the recommendation to base treatment on drugs that have been proven to have clinical benefit.

However, if doctors were to actually act on this advice today, then the bottom might fall out of the market for some drugs. One example is the cholesterol-reducer ezetimibe, which has never been shown to prevent a single heart attack or stroke. It might also apply to a new class of drugs known as the PCSK9 inhibitors. While these reduce cholesterol, there is no evidence that they have clinical benefit. You can read more about this issue on the Reuters website here.

The very next day, Reuters carried this story. Here, we are informed that the Food and Drug Administration (FDA) in the US has issued a statement informing us it may grant licences to drugs without them having been proved beneficial to health. Yes, in other words, the FDA continues to be happy to let drugs onto the market with no proven benefits whatsoever.

The timing of this statement is extraordinary, and it seems to me to have been released to sooth the nerves of pharmaceutical company executives who are perhaps worried they are not going to be able to peddle unproven medicines in the future. Makes me wonder who the FDA exists to protect.

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