Phil Kerpen, 3/18/2018 [Archive]

FDA Tobacco Policy Faces Key Test

FDA Tobacco Policy Faces Key Test

By Phil Kerpen


Shortly after Scott Gottlieb took over as the Commissioner of Food and Drugs, he announced a paradigmatic shift in the agency's approach to regulating tobacco products centered on harm reduction - the idea that smokers who can't quit outright can get nicotine from products other than cigarettes and dramatically improve their health outcomes as a result.The first test of the extent to which things have really changed at the FDA comes with the application of a product called IQOS from Philip Morris, an electronic device that heats tobacco enough to release nicotine - but without combustion and all of the health harms associated with the products of combustion.

"The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes," Gottlieb correctly observed in a landmark speech last year."Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts."

In its press release surrounding the Gottlieb announcement, the agency added: "A key piece of the FDA's approach is demonstrating a greater awareness that nicotine - while highly addictive - is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes."

So a product like IQOS that heats tobacco to release nicotine without combustion should be a slam dunk for FDA approval - especially because IQOS is attractive primarily to smokers who want to quit, but are challenged by the taste and tactile difference between cigarettes and vapor products.

But culture change comes slowly at a large bureaucratic institution like the FDA, and a recent hearing of its Tobacco Product Scientific Advisory Committee (TPSAC) showed that the absolutism that has driven hostility to the harm reduction approach remains strong.

Committee member Michael Weitzman was the most bizarrely hostile, at one point criticizing Philip Morris for not exposing pregnant women to the product for testing purposes. He asked: "Do you have any information on prenatal effects or secondhand exposure to the aerosol? And if you don't, why don't you?"He also attacked them for adopting a policy "not to involve children under the age of 18 in these studies."You can only imagine the reaction if they had, in fact, tested the product on children and pregnant women.

Vaughan Rees repeatedly asked about the temperature of combustion and the process of combustion - despite the fact the product is non-combustible, which is the entire point of the application.

Deborah Ossip asserted - despite literally millions of pages of evidence - that the expected decline in mortality rates was "not clinically meaningful."

Ultimately, the advisory committee voted 5-4 against the claim that switching to IQOS presents less risk of health harms than continuing to smoke cigarettes - flying directly in the face of Gottlieb's vaunted new direction - despite the fact they also voted 8-1 in favor of the claim that IQOS significantly reduces exposure to harmful chemicals.A confused outcome.

The advisory committee is just that - advisory - and the final decisions rest with Gottlieb, who will decide whether IQOS can be sold in the United States and separately whether it can be marketed as less harmful than cigarettes.Allowing it on the market without any health claim should be a no brainer, could be done immediately, and would create real-world experience that could help validate the research on who would use the product and how it reduces harm.But the real test for Gottlieb is whether he will follow through with action on his words in support of harm reduction and approve the comparative health claims.

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Copyright 2018 Phil Kerpen, distributed by Cagle Cartoons newspaper syndicate.

Mr. Kerpen is the president of American Commitment and the author of "Democracy Denied." Kerpen can be reached at phil@americancommitment.org.

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