Several FDA TPSAC members flaunt their drug industry conflicts of interest

[Bill Godshall]

http://www.eurekalert.org/pub_releases/2010-10/uom-eum100110.php
http://tobaccocontrol.bmj.com/content/19/5/e1.abstract

Citing a lack of scientific evidence, drug industry funded consultants (including three members of FDA's TPSAC: Hatsukami, Henningfield, Benowitz) wrote a recently published article advocating additional and urgent research to prompt the FDA to vastly increase the drug industry's share of the nicotine market by taking it away from cigarettes (via mandatory reductions in nicotine in cigarettes), which also would create a huge untaxed and unregulated cigarette black market, and would cause many smokers to inhale more smoke and increase cigarette consumption (due to nicotine compensation).

While the FDA has rejected/ignored previous requests to dismiss these (and another) TPSAC member due to financial conflicts of interest, I think it will be difficult for the FDA to continue ignoring this blatant financial conflict of interest whereby TPSAC members who receive funding from drug companies then urge the FDA to financially benefit drug companies at the expense of tobacco companies.

Attached is the full text of the article.View attachment 20042

 

[kristin]

What studies show that smokers do not compensate by increasing the number of cigarettes smoked with low-nicotine cigarettes? I'm going to have to look up those studies they cite.

And if nicotine is more addictive than ....... and ......, how can there be a "non-addictive level?"

Additionally, the popularity of e-cigarettes over gums, patches and lozenges for those who have tried them has shown that smokers don't smoke ONLY for nicotine. Low-nicotine may "cure" the nicotine addiction and remove the appeal for some, but people who smoke for other reasons - such as MAOIs and the hand-to-mouth habit - would have no motivation to quit. so they will continue to expose themselves to the toxins and carcinogens in spite of the lack of nicotine.

I suspect low-nicotine cigarette users will simply suppliment their smoking with smokeless tobacco or even pharmaceutical nicotine products (which is probably the true goal.) Would the next goal be nicotine-free or non-addictive smokeless tobacco?

These groups don't really want people to quit smoking or stop the creation of new nicotine addicts - it would make their NRT products obsolete.

 

[kristin]

Here's an interesting one:

Smoking in the absence of nicotine: behavioral, subjective and physiological effects over 11 days.
FINDINGS: Daily de-nicotinized cigarette use declined immediately by 1.7 cigarettes/day compared to the preferred brand baseline and declined by another 3.5 cigarettes over time; participants smoking de-nicotinized cigarettes also demonstrated a 31% decline in the number of puffs earned on a progressive ratio, a measure of the motivation to smoke, during the study. Subjective ratings of smoking were largely negative throughout the study in the de-nicotinized group, while the nicotine-containing condition reported increasingly positive subjective effects with repeated exposure. Acute craving suppression following smoking remained evident throughout the study regardless of nicotine content.

CONCLUSIONS: These effects highlight the importance of non-nicotine sensorimotor stimuli as determinants of the maintenance of smoking behavior and suggests that extinction of conditioned reinforcement in the absence of nicotine progresses slowly.

So, even in the absence of nicotine, the craving was suppressed by smoking. The de-nicotinized smokers may have reduced their intake during the study, but who knows what a smoker would do in a real-world scenario, where the cigarettes would not be de-nicotinized, but LOW nicotine?

 

[BCB]

After skimming the article, what jumps up at me is the idea of lowering the nicotine in cigarettes as a way to curb smoking. What? The people using this new product are still ingesting the products of combustion, so they are still being harmed by the thing that's harmful--the smoke! This makes no sense whatsoever to me. I'd have to agree that the only possible reason to entertain this idea would be to drive smokers to pharmaceutical products. This wouldn't seem so crazy if we didn't already know there's a way to get what we want/need in a safe manner with e-cigs and Swedish snus. But we know what we know. So the ideas promoted in this article are absurd. Scheesch.

 

[kristin]

The theory is that they will no longer keep smoking because there is no nicotine addiction. Np nicotine= no motivation to smoke and eventually quitting. The study I posted above showed that smokers of de-nicotinized cigarettes did reduce their intake over time. I'm not sure if de-nicotinized cigarettes are actually 100% nicotine-free or low nicotine, though. Since the FDA can't make cigarettes 0 nicotine, using completely de-nicotinized cigarettes in a study doesn't reflect real-world scenarios.

But if they are satisfied by just the act of smoking, this won't do any good. It completely ignores the fact that many smokers are just as dependent upon the act (and other ingredients in cigarettes) as they are on the nicotine. If people smoked only for the nicotine, NRTs would have a much higher success rate than 7%.

 

[kristin]

From a 2007 study cited in the article (#35):

New lower nicotine cigarettes can produce compensatory smoking and increased carbon monoxide exposure.
Strasser AA, Lerman C, Sanborn PM, Pickworth WB, Feldman EA.

Transdisciplinary Tobacco Use Research Center, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA 19104, United States. strasse3@mail.med.upenn.edu

Abstract
Potential reduced exposure products (PREPs) are marketed as a means to reduce exposure to tobacco toxicants. Quest cigarettes, a new type of PREP, use genetically modified tobacco to provide a nicotine step-down approach, and are available as 0.6, 0.3 and 0.05 mg nicotine cigarettes. However, these cigarettes deliver equivalent levels of tar (10 mg). Prior research on low nicotine cigarettes suggests smokers will compensate for lower nicotine delivery by increasing their puffing behavior to extract more nicotine. This study tested the hypothesis that compensatory smoking will occur with this PREP as nicotine levels decrease, increasing exposure to tobacco toxins. Fifty smokers completed a within-subject human laboratory study investigating the effect of cigarette nicotine level on smoking behavior. Cigarette nicotine level was double-blinded and order of presentation counter-balanced. Breath carbon monoxide (CO) boost was used as a biomarker of smoke exposure; total puff volume to assess smoking behavior. Total puff volume was greatest for the 0.05 mg nicotine cigarette and CO boost was moderately greater after smoking the 0.3 and 0.05 mg cigarettes compared to the 0.6 mg nicotine cigarette. These data provide novel behavioral and biochemical evidence of compensatory smoking when smoking lower nicotine cigarettes. Although marketed as a PREP, increases in CO boost suggest this product can potentially be a harm-increasing product.

New lower nicotine cigarettes can produce compensa... [Drug Alcohol Depend. 2007] - PubMed result

This seems to directly contradict their assertion that smokers will quit rather than smoke more of the low-nicotine cigarettes!

 

[BCB]

Exactly! They are considering a product that promotes more smoking by consumers unless consumers supplement with patches, lozenges, etc. It makes no sense as a way to improve the public's health.

 

[kristin]

A 2010 study this article cited (#40)

Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation

Findings:
Unlike the 0.3 mg cigarettes, 0.05 mg cigarettes were not associated with compensatory smoking behaviors. Furthermore, the 0.05 mg cigarettes and nicotine lozenge were associated with reduced carcinogen exposure, nicotine dependence and product withdrawal scores. The 0.05 mg cigarette was associated with greater relief of withdrawal from usual brand cigarettes than the nicotine lozenge. The 0.05 mg cigarette led to a significantly higher rate of cessation than the 0.3 mg cigarette and a similar rate as nicotine lozenge.

Conclusion:
The 0.05 mg nicotine yield cigarettes may be a tobacco product that can facilitate cessation; however, future research is clearly needed to support these preliminary findings.

http://onlinelibrary.wiley.com/doi/10.1111/j.1360-0443.2009.02780.x/abstract

So, the cessation rate was similar to that of a nicotine lozenge ie. 7% success rate. That's progress. Not.

 

[markmcs]

In my experience, smoking 'ultra light' cigarettes caused me to smoke more, and take bigger drags to compensate for the lack of taste. Making cigarettes nicotine free may very well prevent "NEW" smokers from starting, but it wouldn't help smokers like me who are just as addicted...if not more addicted....to the whole smoking ritual and the hand-to-mouth thing than to nicotine. This is why, before I started vaping, I smoked while wearing the patch and I smoked while using the lozenges. Nicotine is only a part of the addiction.

 

[GregH]

In my experience, smoking 'ultra light' cigarettes caused me to smoke more, and take bigger drags to compensate for the lack of taste. Making cigarettes nicotine free may very well prevent "NEW" smokers from starting, but it wouldn't help smokers like me who are just as addicted...if not more addicted....to the whole smoking ritual and the hand-to-mouth thing than to nicotine. This is why, before I started vaping, I smoked while wearing the patch and I smoked while using the lozenges. Nicotine is only a part of the addiction.

Exactly!

And it's not going to stop people (namely teens) from starting a smoking habit. Teens don't wake up one day and think "maybe today I'll try out that nicotine everyone keeps going on about." No. Instead, they think "maybe today, I'll smoke a cigarette so I'll look cool in front of my friends." When I started, I couldn't have cared less about nicotine. Didn't even think about it. I wanted to smoke so I would fit in with the crowd I was hanging around with.

I agree that having no nicotine in the cigarettes might help some keep from making it a life long habit. But for many, I think the other addictive aspects of smoking will keep them hooked.

 

[Panini]

In my experience, smoking 'ultra light' cigarettes caused me to smoke more, and take bigger drags to compensate for the lack of taste. Making cigarettes nicotine free may very well prevent "NEW" smokers from starting, but it wouldn't help smokers like me who are just as addicted...if not more addicted....to the whole smoking ritual and the hand-to-mouth thing than to nicotine. This is why, before I started vaping, I smoked while wearing the patch and I smoked while using the lozenges. Nicotine is only a part of the addiction.

Not to mention...when I switched to a "lighter" cigarette, it was to reduce my exposure to the tar, not the nicotine. What a pointless idea. Kind of like helping someone lose weight by offering a rice cake that contains the same amount of fat as a Big Mac.

 

[Stephaniems]

I went from full flavored to lights and from 1 pack to 2 or more a day. I know its just me but well lights made me smoke more and I wasnt even aware half the time how much I was smoking till my pack was empty.

 

[Our House]

Kind of like helping someone lose weight by offering a rice cake that contains the same amount of fat as a Big Mac.

Off topic, but I learned a trick about Big Macs two weeks ago and tried it last week. It worked! Here it is...

Instead of ordering a Big Mac, ask for a McDouble with lettuce and Big Mac sauce instead of ketchup. It's a "diet" Big Mac (~80 less calories without the middle bun) and costs $1.25 ($1.00 for the McDouble and $0.25 for the lettuce) instead of 3 or 4 dollars. Tastes great too...just like a real Big Mac. Pure genius!

 

[Bovinia]

Forgive me for not reading the linked studies, it's almost 5am so I just skimmed...but don't these studies bring to light (altho this was not the point of the studies) that we need that hand to mouth ritual and the vapor that simulates smoking in our efforts to quit? It's not stated, but seems obvious to me that the test subjects got those benefits with their next to no nicotine cigs.

I just can't wrap my head around the fact that nicotine is still treated as the deadly aspect of smoking.

OT; Darn it House...now I'm hungry!

 

[Vocalek]

I created this poll: http://www.e-cigarette-forum.com/forum/polls/100527-light-cigs-smoke-more-less-same.html

 

[Bill Godshall]

Please note that Jack Henningfield and Neil Benowitz (both of whom have received enormous amounts of funding from drug companies) first advocated this policy (to sharply reduce nicotine in all cigarettes) back in 1994/95. If it wasn't for their drug industry funded work, it is doubtful that Henningfield or Benowitz would have been selected to be on the FDA's Tobacco Products Scientific Advisory Committee. Both have irreconcilable conflicts of interest, and should not be on the TPSAC. Unfortunately, the FDA remains in denial that drug companies (and e-cigarette companies) compete against tobacco companies in the nicotine market.

Those who advocate mandatory reductions in nicotine in cigarettes aren't interested in reducing smoking attributable diseases (as their proposal would increase smoking attributable diseases in many/most smokers, and would create a huge black market for unregulated and untaxed cigarettes), but rather they primarily want to deprive smokers of obtaining nicotine from cigarettes, and they want to the FDA to give a huge chunk of the nicotine market to their drug company funders.

Their evidence (which is not at all convincing) is based solely upon several clinical studies that were conducted in academic health care facilities with just several dozen participants (who were biased by their desire to quit smoking, by the ads that recruited them and offered them money to participate, by their desire to promote science, and by the academic medical environment where the studies take place).

In the real world market place, Quest 3 (the cigarette brand that is virtually nicotine free) has failed miserably, as I cannot even find the brand at any stores in PA anymore. I've been trying to obtain sales data on Quest 3 ever since it was test marketed in several states (including here in PA) about 5 or 6 years ago. The test market went so badly, that the brand wasn't even introduced in 45 other states.

When Quest was introduced, it came in three subbrands (Quest 1, Quest 2, Quest 3), whereby Quest 1 is similar to other light cigarettes, Quest 2 has less nicotine, and Quest 3 has virtually no nicotine. It was marketed as a step down nicotine reduction strategy, in which users were encouraged to start with Quest 1, then switch to Quest 2 and finally to Quest 3.
But it appears that Quest 1 accounts for virtually all Quest sales, as almost nobody repurchased the Quest 2 or Quest 3 after trying them. It has long appeared to me that the entire marketing strategy was to encourage health conscious smokers (who inaccurately believed that nicotine was the harmful component in cigarettes) to switch to Quest, knowing that very few if any of the Quest smokers would actually use the Quest 2 or Quest 3 products, but would continue using the Quest 1 product (while deceiving themselves to believe it was less hazardous than other cigarettes).

I bought several packs of each of these brands five years ago, but haven't seen any Quest 2 or Quest 3 brands in any stores in the past 3-4 years. Most stores don't even sell the Quest 1 anymore because it never gained enough market share.

 

[Vocalek]

Hmm... I did not find this study listed in Hatsukami's footnotes: Reduced-nicotine cigarettes increase platelet acti... [Nicotine Tob Res. 2008] - PubMed result

The research compared the effects of medium-nicotine (0.6 mg nicotine) and low/zero-nicotine cigarettes (0.05 mg nicotine) on platelet activation state (PAS), one of the processes involved in blood clotting.

The increase in PAS caused by nicotine withdrawal in the second group is very significant (p<.02). We conclude that in smokers, nicotine modulates platelet activation, and it may significantly moderate the risk of cardiovascular disease caused by non-nicotine smoke components. Conversely, reduced-nicotine cigarettes may increase harm.

Hatsukami, et al appear to be functioning as an entity with borderline personality disorder. They want to mandate denicotinized cigarettes, therefore to avoid feelings of guilt they pretend that no harm will result.

 

[kristin]

The irony is that most of the studies they cite actually counter their argument that low-nicotine cigarettes will make people quit. It may help people who want to quit (with a 7% success rate of lozanges) but the real problem is with people who don't want to quit and smoke for the hand/mouth habit more than the nicotine. Those who need the nicotine will switch to smokeless (which is a good thing) or smoke and use smokeless (bad), but the rest will just keep smoking, seeing no difference and exposing themselves to toxins.

Even though the research they cite is limited and much of it contradicts their argument, most people will read their conclusions and never follow up to see if the evidence they cite actually supports their claims. (It looks impressive that they cite all of those studies though, huh?) The media & public health groups will get ahold of it, claim low-nicotine cigarettes are scientifically proven to get smokers to quit and the FDa will require all cigarettes to be low-nicotine. same thing that happened to smokeless tobacco - sound bites will trump science.

 

[rothenbj]

From a 2007 study cited in the article (#35):



This seems to directly contradict their assertion that smokers will quit rather than smoke more of the low-nicotine cigarettes!

Kristin, what you fail to recognize is this study was on a product produced out of the tobacco industry. When the tobacco industry produces low nicotine cigarettes it causes smokers to smoke more. If the pharma industry would provide the same low nicotine products, it will enable the percentage of smokers to decrease to single digits.

I can't even believe that they would consider decreasing the amount of nicotine from smokes. As you say, nicotine is not the ONLY reason people smoke, TC just doesn't get it. They've listened to their lies for so long that they actually believe it. In my humble opinion, the only result of lowering nicotine levels in cigarettes will be increased consumption, dual use, or increased black market activity. Unless people become aware of viable alternatives like E Cigs and snus.

 

[kristin]

LOL! Yeah, Jim, but they aren't going to make their own product - only require the tobacco companies to comply with low-nicotine cigarettes. It'll be interesting to see how BT responds to this - they have a big lobby of their own. I'm surprised they don't seem to use it so much anymore. Maybe since BT has been moving toward building it's smokeless lines (seeing the writing on the wall) they don't care anymore if people quit smoking. But now GlaxoSmithKline is attacking the smokeless products, too. BT has to be up to SOMETHING to protect it's revenues!