Regulatory Science at NIH

June 21, 2013

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.

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11 Responses to “Regulatory Science at NIH”

  1. TwoYellowsMakeRed Says:

    CO and WA should fund the research with a special tax on pizzas ordered between 1 and 4 AM.

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  2. Isabel Says:

    “That brings me to cannabis. ”

    Oh god here we go again. Give it a rest already. Stop pushing your paranoid agenda on everyone else and get your grubby hands out of my pockets. You are already awash in funding and all we get is the corrupt NIDA.

    Here come more bogus studies for the purpose of controlling the population.

    I just saw the DSM-V diagnostic criteria changes to include “marijuana withdrawal”, based on a single study:
    1. surveys were filled out by people who answered an ad and were paid
    2. all they did was fill out a survey
    3. the survey asked about their most difficult attempt to quit
    4. they rated a series of symptoms by severity
    5. the average time since this most difficult attempt was 15 months
    6. the participants used all kinds of other drugs
    7. average use was NINE JOINTS A DAY

    Yes, these obvious sick, addictive personality types are totally going to remember the severity of each and every symptom months or years later. All their so-called symptoms (yeah these are the people whose hazy memories we should base important diagnostic criteria on) were totally caused by the demon weed! And we should now diagnose everyone based on this crap. That’s right- then the jerks who did the “study” announce how 40% of people who try to quit have at least three of these symptoms! Yeah right.

    200 million users and once again this is the best study the control freaks can come up with.

    Well, DM you’re going to have a lot more than two states to worry about soon. Or to grub money from I guess. 😡

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  3. drugmonkey Says:

    The diagnostic criteria are based on more than one study, Isabel. Why do you trot out such lies? Nothing in the DSM is based on a single study outcome, but for cannabis withdrawal I’m surprised you haven’t PubMedded the evidence for yourself. Since you have such firm convictions about cannabis, I would have assumed you actually read the relevant literature. You are a scientist of some sort, right?

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  4. Isabel Says:

    “of some sort” ha ha

    DM, I am happy you want to help those poor souls who smoke 9-20 joints a day along with their heavy drinking and prescription drug abuse. But you are really over the top demanding more money from cannabis users for your endless studies. The corrupt NIDA needs to be disbanded now.

    I just looked over Kennedy’s project SAM website. He’s on the NIDA board eh? Surprise surprise. He claims he has “learned the truth”. btw the “lowers IQ” study was debunked, and even if it wasn’t it is extremely dishonest to use those limited results in the first study to now go around saying it “lowers IQ”. I thought YOU were some kind of scientist-how can you support that kind of mis-use of research?

    It is terrifying. Bill Maher made mincemeat out of him thank god. Another prescription drug addict who goes after pot smokers! Here’s a challenge for you. Where on Kennedy’s site does he allow that some people who are arrested for pot may NOT have to be “re-educated” and “reintegrated into society”? He admits law enforcement will play a big part in this re-education campaign- this is what I have been warning people about right here.

    This is what your bosses are up to. You think I am exaggerating when I say this shit is fucking terrifying?

    http://www.alternet.org/news-amp-politics/life-sentence-growing-pot-legally

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  5. Isabel Says:

    Project SAM, the anti-marijuana legalization group started by former Obama administration advisor Kevin Sabet and chaired by former Congressman Patrick Kennedy (D-Rhode Island), has unveiled its website and policy goals.

    Topping the list is the recommendation “[t]hat possession or use of a small amount of marijuana be a civil offense subject to a mandatory health screening and marijuana-education program. Referrals to treatment and/or social-support services should be made if needed. The individual could even be monitored for 6-12 months in a probation program designed to prevent further drug use.”

    http://reason.com/blog/2013/01/11/patrick-kennedys-anti-pot-group-pushes-m

    Like I keep saying, the “third way” is even scarier than the old way. Seriously, DM I’m a casual user- do you really think I need mandatory intervention and rehab???

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  6. Isabel Says:

    Okay, I had some time yesterday to trace back where I heard that from (turned out to be a poorly written blog post), and I was wrong- the bogus study came after the bogus changes to the DMV.

    So I stand corrected. See DM, that’s not so hard is it? You ought to try it sometime.

    Anyway, it doesn’t matter in the end as it’s ALL bogus. We’ve been over this a hundred times. Every study you refer to has at least one of the following three drawbacks (and frequently all three):

    1. small N

    2. largely based on participants’ hazy recollections

    3. participants who are addicted to multiple substances

    The last should give you a clue as to where your research should be focused instead of on the demon weed. All these people who smoke 9-20 joints a day* have addictive personalities. It has little to do with the weed.

    Look, I realize you’ve led a sheltered life. Still, I don’t know why I have to explain to you that cannabis is not like alcohol or other popular drugs. Your level of “highness” is reached pretty quickly, and after that you just start getting more tired- or in the popular parlance, baked. This may be a phase some people go through if they do at all (getting baked/stoned/wasted) but the vast majority of cannabis users do not find this pleasant or interesting. And it’s not like the difference between a few drinks and half a bottle of gin. It’s a really different thing.

    As experienced users will tell you, with pot less is more. A couple of tokes of decent bud is all anybody really needs, so over the course of a day maybe a joint or two max, and even most regular users would not do that every day. So all these heavy users who get sick and need to throw up all day, or smoke 10-20 joints a day with all their other drugs have a much more serious and deep seated problem than the fact that they happened to have the opportunity to smoke some weed one time.

    * What’s the deal with all these studies that talk about joints? All this concern for precise doses (in the fight against medical pot) and we have to try and figure out how much is in a joint? And who smokes joints these days? Anyway 10-20 joints is an absurd amount even if you are talking about ditchweed.

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  7. Isabel Says:

    Sorry I mean the DSM 🙂 🙂

    Okay I am going to have a glass of wine now (and a toke or two). I want to make one more point about the Patrick Kennedy/Nora Volkow alliance and then I am thinking of permanently withdrawing from discussion of the topic, and I’ll explain why.

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  8. DrugMonkey Says:

    Right Isabel. No alcohol drinkers find more than a couple of drinks to be unpleasant, eh?

    Do you even listen to yourself?

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  9. Isabel Says:

    I don’t think I said that. In fact, I know I didn’t.

    But I did imply that they keep getting more intoxicated.

    Holy shit Nora is the great-granddaughter of Leon Trotsky. The plot thickens! 😉

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  10. drugmonkey Says:

    Your level of “highness” is reached pretty quickly, and after that you just start getting more tired- or in the popular parlance, baked. This may be a phase some people go through if they do at all (getting baked/stoned/wasted) but the vast majority of cannabis users do not find this pleasant or interesting. And it’s not like the difference between a few drinks and half a bottle of gin. It’s a really different thing.

    Please do explain how this is “not what you said”. You seem to be implying that pot is unique in that the “vast majority” of users seek a pleasant or interesting moderate level of intoxication in a way that is totally different for alcohol drinkers (or just gin drinkers?).

    This is patently untrue, of course.

    Still, I don’t know why I have to explain to you that cannabis is not like alcohol or other popular drugs.

    Because you are wrong about this. Beyond, of course, the trivial factors. In terms of the fact that most recreational drugs pose a risk for dependence and compulsive use, for interfering with other life demands and goals and for increasing harm to self and others during acute intoxication….yeah, just like other drugs, including alcohol.

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  11. Isabel Says:

    “Beyond, of course, the trivial factors.”

    “trivial” factors?

    wow you are scaring me DM.

    This whole business is getting too scary for me. This is the reason for my retirement from the topic, with this comment.

    Who would have ever imagined that one day Joe Kennedy’s grandson and Leon Trotsky’s great-granddaughter would join forces to rid the world of the demon weed through the merger of the criminal justice system and private health care?

    When I declared victory six months ago I knew it wouldn’t be a smooth transition, but I just imagined a few remaining squabbles. But I realize now that I was naive; I think it’s going to get ugly. 😦

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