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.
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.
May 4, 2011
It is officially time to get a grip.
Over at writedit’s voluminous comment thread discussing NIH scores and paylines I ran across this gem:
rumor has it that NCI is limiting funding of new projects there, to prevent losing Institute dollars when that part of the portfolio moves to the new addiction institute
So if you’ve been following along, the NIH is planning to disband NIDA and NIAAA and launch a new Institute on Substance Abuse / Substance Use Disorders. Name is yet to be determined.
Also yet to be determined is the portfolio of such a new institute. It did not escape the attention of the sharp-eyed that there are substantial amounts of addictive-disorders related funding being handled by the NCI, a comparatively much larger Institute. So the present state of affairs appears to be an effort to take an accounting of various existing grant portfolios that are related to substance use and therefore might be best placed in the new Institute for all addiction-related science. This taskforce/working group accounting and proposing effort appears to be the latest kicking-the-ball-down-the-road strategy* for Francis Collins, Director of the NIH.
November 8, 2010
This is Drug Facts Week, an effort of NIDA to promote understanding of the effects of recreational drugs. I have a little bit of interest in such things. Unfortunately, I’ve been a bit busy and will continue to be so this week. So I thought I would get at least partially in the game with a series of re-posts. This post originally went up at Scienceblogs.com on April 29, 2008.
For some reason many people are in denial about cannabis dependence and wish to assert that there is no such thing, or if there is, it is somehow of lesser importance than is dependence on other substances of abuse. There are many ways to assess importance of course. What gets me going, however, are the assertions about cannabis abuse and dependence that are informed by anecdote and personal experience with a handful of users instead of an understanding of the available evidence.
To provide a little context for todays’ post, I took MarkH of denialism blog to task for his expression of what I viewed as standard cannabis science denialism a fair while ago. In a comment following his post, MarkH specifically identified nicotine withdrawal as being worse than cannabis withdrawal. This is the perfect setup since there are two recent papers which set out explicitly to test this hypothesis. Let us see what they found, shall we?
October 19, 2010
October 18, 2010
…and this is a story about political attitudes and behavior.
First, the bottom line from PalMD:
While many may cringe at the paternalistic nature of public health laws, few complain about the availability of clean water and the notable absence of open sewers.
I lived through the smoking ban enacted in bars and restaurants and I couldn’t be more delighted. Although I was never particularly bothered by the smoke, no more than most that is, I certainly noticed the lack after the bans went through. No more smelly hair and clothes. No more changing the pillowcases after a night out because the smoke smell went from hair to the pillow like clockwork.
Since I’m not a smoker there was no problem.
But oh, you should have heard the caterwauling. Personal liberty was being infringed! (Never mind the liberty of others to be free from annoyance of smoke, eh? Why do the libertarians always forget that?) Business will be AffEcTed! Bars will close. Nobody will buy alcohol anymore! Nobody will go out to dine.
Naturally this never came to pass in my region of the world. Nor did it in a myriad of other jurisdictions that passed smoking bans.
And here is a tale from a bartender who was practically on the ramparts to oppose the smoking ban. Changing. His. Mind. Based on the results of the policy as he personally experienced it.
And it was at that moment, silently of course, that I grudgingly had to thank old Mayor Bloomberg. For regardless of what his motivation was and regardless of the fact that he did it with an iron fist, the son-of-a-gun when it’s all said and done was right. The good, as it all turns out, outweighs the bad. And not just because of the major things, of which we are all aware, but the minor things of which you’re about to read…
Test out a policy change, evaluate the outcome. If you are originally opposed to the policy….what do you do? Do you leave your ego at the door and really look at the data? Or do you stick to your guns no matter what the evidence?
Scribbler is a standup guy for admitting he was wrong. May we all be able to do the same when public policies have results that are demonstrably better than our initial preferences.
April 14, 2010
As a bit of a followup to the poll we ran on whether or not cigarettes make you high, I offer context and my thoughts. As of this writing, btw, the votes are running 44% “Yes”, 47% “No”, the balance “other” with a fair bit of commentary to the effect that “high” is not exactly the right description for nicotine.
For the background, we might as well start with the comment from SurgPA:
This started with an email from PalMD asking why doctors react much more negatively to narcotics abusers than alcohol or nicotine abusers. I hypothesized that most people view acute use of the various drugs differently. Specifically I suspected that most doctors’ gut reactions when seeing someone light a cigarette are qualitatively (and vastly) different from seeing someone shoot heroin (or snort crushed oxycontin). In short that we don’t see the act of smoking as an acute intoxication by a neuroactive substance, even if we understand it intellectually.
April 13, 2010
Today’s question comes from a reader and occasional commenter.
I have the sneaking suspicion there will be a lot of people wanting to add caveats and modifications to these simple choices….have at it in the comments here because for some reason the polldaddy doesn’t seem to make the ‘other’ comments easily viewable.