By Jeff Stier, Esq.
Posted: Monday, September 14, 2009

LETTER
Publication Date: September 14, 2009

This letter first appeared in TheHill.com on September 14, 2009:

A major policy shift is underway, and it is bound to have a dangerous unintended consequence. The new team at the FDA has slapped a black box warning on an important class of drugs that treat inflammatory diseases such as rheumatoid arthritis, Crohn’s disease, and colitis.

The cancer risk highlighted by this new bold warning has been known for years — and hasn’t gotten worse. We already knew of the cancer risk in children and adolescents, and responsible doctors were cautious in using them. The new warning signals only a change in perception of risk, not any change in actual risk.

Physicians should still give due consideration to the benefits of the drugs, especially in light of the paucity of other treatments for debilitating and often dangerous inflammatory diseases. Consider the benefit versus risk analysis for inflammatory diseases with secondary risks.

For example, by not using these drugs out of possibly inflated concerns due to the new additional cancer warning, might inflammatory bowel disease patients face a higher risk of colon cancer as a result of years of inflammation? You won’t see that risk in bold print. But it is just as real. And this is precisely the problem with the FDA’s new policy, which is based on the assumption that erring on the side of more warnings is the safest way to go.

Similarly, this summer, the FDA warned about the safety of e-cigarettes, a product many smokers are using to quit smoking real cigarettes. E-cigarettes are devices that supply users with vaporized nicotine and look like cigarettes, many even having an LED light at the tip. These products, which contain no tobacco and are non-combustible, eliminate virtually all the risks of smoking. For the vast majority of smokers unable to quit even with the help of drugs and counseling, e-cigarettes could be a lifesaver.

Yet the FDA found tiny levels of carcinogens in the product and warned smokers to stay away, essentially telling them to go back to deadly cigarettes.

Unfortunately, it is no surprise that the new leadership at the FDA is taking a more aggressive stance with regard to warnings.

These warnings are a harbinger of how the agency will weigh benefits versus risks: with a thumb weighing down the risk side. This distorted approach has numerous downsides:

• Fewer patients will get the treatment they need, out of an “abundance of caution” and physicians’ fear of litigation.

• Black box warnings, originally meant for only the most dangerous drugs, will become more widespread but less meaningful.

• The FDA, newly armed with regulatory power over tobacco, will make it harder for people to quit smoking cigarettes by warning them away from disfavored alternatives.

• Investors and researchers (innovative drug companies) will have less incentive to pursue new medications that may attract scary warnings.

The old adage “better safe than sorry” is too simplistic in today’s world to be the guiding principle at the FDA.


Jeff Stier

New York City

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