Regulatory Science at NIH

One of the more fascinating things I attended at the recent meeting of the College on Problems of Drug Dependence was a Workshop on “Novel Tobacco and Nicotine Products and Regulatory Science”, chaired by Dorothy Hatsukami and Stacey Sigmon. The focus on tobacco is of interest, of course, but what was really fascinating for my audience was the “Regulatory Science” part.

As background the Family Smoking Prevention and Tobacco Control Act became law on June 22, 2009 (sidebar, um…four years later and..ahhh. sigh.) This Act gave “the Food and Drug Administration (FDA) the authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health.”

As the Discussant, David Shurtleff (up until recently Acting Deputy Director at NIDA and now Deputy Director at NCCAM), noted this is the first foray for the NIH into “Regulatory Science”. I.e., the usual suspect ICs of the NIH will be overseeing conduct of scientific projects designed directly to inform regulation. I repeat, SCIENCE conducted EXPLICITLY to inform regulation! This is great. [R01 RFA; R21 RFA]

Don’t get me wrong, regulatory science has existed in the past. The FDA has whole research installments of its very own to do toxicity testing of various kinds. And we on the investigator-initiated side of the world interact with such folks. I certainly do. But this brings all of us together, brings all of the diverse expert laboratory talents together on a common problem. Getting the best people involved doing the most specific study has to be for the better.

In terms of specifics of tobacco control, there were many on this topic that you would find interesting. The Act doesn’t permit the actual banning of all tobacco products and it doesn’t permit reducing the nicotine in cigarettes to zero. However, it can address questions of nicotine content, the inclusion of adulterants (say menthol flavor) to tobacco and what comes out of a cigarette (Monoamine Oxidase Inhibiting compounds that increase the nicotine effect, minor constituents, etc). It can do something about a proliferation of nicotine-containing consumer products which range from explicit smoking replacements to alleged dietary supplements.

Replacing cigarette smoking with some sort of nicotine inhaler would be a net plus, right? Well…..unless it lured in more consumers or maintained dependence in those who might otherwise have quit. Nicotine “dietary supplements” that function as agonist therapy are coolio….again, unless they perpetuate and expand cigarette use. Or nicotine exposure…while the drug itself is a boatload less harmful than is the smoking of cigarettes it is not benign.

There are already some grants funded for this purpose.

NIH administers several and there was a suggestion that this is new money coming into the NIH from the FDA. Also a comment that this was non-appropriated money, it was being taken from some tobacco-tax fund. So don’t think of this as competing with the rest of us for funding.

I was enthused. One of the younger guns of my fields of interest has received a LARGE mechanism to captain. The rest of the people who seem to be involved are excellent. The science is going to be very solid.

I really, really (REALLY) like this expansion of the notion that we need to back regulatory policy with good data. And that we are willing as a society to pay to get it. Sure, in this case we all know that it is because the forces *opposing* regulation are very powerful and well funded. And so it will take a LOT of data to overcome their objections. Nevertheless, it sets a good tone. We should have good reason for every regulatory act even if the opposition is nonexistent or powerless.

That brings me to cannabis.

I’m really hoping to see some efforts along these lines [hint, hmmmm] to address both the medical marijuana and the recreational marijuana policy moves that are under experimentation by the States. In the past some US States have used state cigarette tax money (or settlement money) to fund research, so this doesn’t have to be at the Federal level. Looking at you, Colorado and Washington.

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As always, see Disclaimer. I’m an interested party in this stuff as I could very easily see myself competing for “regulation science” money on certain relevant topics.