Jeff Stier

When it comes to regulating pharmaceuticals, it is important to remember that there are no "safe" drugs. All medicines have benefits and risks and they must be weighed against each other for each particular patient's unique circumstances.

This is a nuance that Public Citizen, a Naderite activist group doesn't seem to comprehend. Last week they, for the second time, called on the FDA to remove from the market the weight-loss drug Orlistat, marketed as the prescription drug Xenical, and the lower dose over-the-counter, Alli.

After drugs are approved by the FDA, the agency and the manufacturer continue to monitor reports of adverse events. This post-marketing surveillance allows regulators to identify a risk that did not show up during pre-approval trials, a key part of drug safety. But just because an adverse event is reported does not mean there is a causal relationship between the effect and the medicine, only that the report was made. Further, mere reporting of events does not necessarily change the overall benefit/risk ratio. Reports of effects are independent of benefits the drug provide patients.

In the case of Orlistat, where some 40 million doses have been sold world-wide over a decade, some adverse effects are likely to be picked up. Public Citizen cited 47 U.S. post marketing surveillance reports of acute pancreatitis and 73 cases of kidney stones associated with the drug. They also point to known effects related to how the drug works; it blocks the breakdown of fat, so there may be oily stool and related issues, especially after the consumption of foods higher in fat.

But does that justify removal from market for all patients?

Not at all. The number of incidents of each type of effect reported compared to the overall number of doses taken over many years is extremely low. Then consider the benefits of weight-loss from the drug. Public Citizen argues that the benefits are “meager” and therefore don’t justify even the very low risk. They ignore the fact that some drugs work well for some people than for others. They point to the average weight loss of “only” about 5-7 pounds. But some patients may lose almost no weight, while some may lose closer to 10 or more pounds, which can be significant, and may give patients the psychological boost they need to stick with the diet and exercise regiment necessary for the drug to be beneficial. Public Citizen’s cookie-cutter approach just does not reflect the scientific realities.

Public Citizen’s argument is further weakened by the fact that there are so few other FDA approved weight loss drugs. Specifically, Orlistat is the only drug in its class, a weight loss-loss drug which does not suppress the appetite. So critics cannot even argue that there are safer drugs like it which have the same benefit.

It is important to note that Xenical is not a magic bullet against obesity. Proper diet and exercise are critical. But the drug did show increased weight-loss in those who maintained a proper regimen, over and above those on the same regimen but who did not take the drug. And the science is clear, even losing a few extra pounds (and keeping them off) provides significant health benefits over the long term.

The already hyper-cautious FDA should ignore Public Citizen's latest effort to reduce our access to medicines, which, with risk taken into account, still benefit many patients.


Jeff Stier

Jeff Stier is a Senior Fellow at the National Center for Public Policy Research and directs its Risk Analysis Division. You can follow him on Twitter at @JeffAStier.