New FDA drug safety announcement. Cue the lawsuits.
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The FDA announced this week that it is adding new safety information and warnings to the labels of all statin drugs. In a nutshell, the FDA is adding new warnings that suggest that statin may slightly increase the risk of developing diabetes, and (also very rare) may lead to some transient memory problems or confusion in some patients.

Here's what the FDA says:

We want health care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol.

The irony here is that obesity is a risk for both heart disease and diabetes, and obese patients may now wonder whether or not the drug they are taking to prevent a heart attack will give them diabetes.

Still, (as the FDA says) the risk is small. And patients and doctors can now take additional steps to watch for changes in blood sugar in otherwise healthy patients after they begin statin therapy.

This is all to the good. Knowledge, after all is power.

So why is it that the FDA is so much more forthcoming about the details of potential drug risks than benefits?

The FDA's announcement underscores a fundamental imbalance between how it conveys (and allows companies to convey) risk and benefit information to the public.

If, as in this case, a meta-analysis of studies shows a likely safety problem, the FDA will add it to the label and make an announcement that (through no fault of the FDA) may lead to a rash of lawsuits against companies.

On the other hand if companies do a meta-analysis of studies on their own products and discover a benefit, they can't talk about it. In fact, they will be fined and prosecuted if they promote these "off-label" uses to physicians, even if they are true or very likely to be true.

Instead, they will have to invest many millions of dollars in new clinical trials to prove to the FDA that the "signal' from their initial studies turns out to be correct. This may take a decade or more and in the meantime patients who would have benefitted from the new use of drug that is already FDA approved will suffer - and perhaps die - because the company's hands are tied from promoting off-label use.

Of course, allowing off label promotion might encourage companies to peddle snake oil using misleading statistics or poorly designed trials. A sensible compromise would be to allow the companies to distribute non-industry sponsored, peer reviewed research on off-label use to physicians with the expectation that physicians have the knowledge and expertise to use the information appropriately.

The benefits wouldn't be certain, of course, and physicians would have to use their judgment in a case by case basis that the drugs' benefits outweighed its risks.

Isn't this exactly the situation that the FDA is offering us today, by informing us about rare statin risks?

So why not create a parallel safe harbor for describing a drug's benefits?

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