Tag Archives: dual use

FDA almost kinda sorta following MHRA, almost recognizing THR

by Carl V Phillips

Yesterday, in what was not nearly funny enough that it could be an April Fool’s joke, the US Food and Drug Administration issued a statement that they “may” allow changes to pharmaceutical nicotine product (NRT) labels to reflect a bit of reality.  In particular, the label would not be so restrictive about the period the products can be used and there would not be warnings about simultaneously using multiple tobacco/nicotine products.  Those warnings had many smokers and others convinced, for decades, that violating those protocols put them at dire risk.  Many were convinced that they might as well smoke rather than dare defy the label.

This comes following hearings a few months ago where several of us from CASAA found ourselves in the odd position of testifying on the same side as the pharmaceutical companies.  We were arguing in favor of explicitly allowing long-term use of low-risk nicotine products like their UK equivalent, the Medicines and Healthcare products Regulatory Agency (MHRA), already does, with the recognition that this would also tend to open the door for recognition of other THR options.

First, the bad news:  The unit of FDA that oversees NRT and made this move is the Center for Drug Evaluation and Research.  They are not the unit with the authority to regulate all other tobacco products, the Center for Tobacco Products, and so nothing about this extends beyond NRT except in spirit.  Additionally, the very weak move does not go nearly as far as the MHRA.  The language will still insist that the products should be used only in pursuit of nicotine abstinence.

By contrast, MHRA has approved one NRT product for use as a long-term substitute for smoking, perhaps with no intention of pursuing abstinence (i.e., THR).  This same approval is expected to be granted to other products, including particular e-cigarette products.  (However, though the application process for that is far easier than for a typical drug approval, it is still out of the reach of all but the larger manufacturers.)

Second, the lies:  I will not bother with the boilerplate lies about tobacco use that always show up in writings like this, focusing only on the substance of the statement itself.  FDA states that these particular products do not have “significant potential for abuse or dependence”.  Not only does this indicate their commitment to the bad old model of NRT (“if you use this to become abstinent, you have our blessing and sacred permission, but if you use it, say, just because the effects of nicotine improve your life, then you are abusing it, you evil degenerate”) but it also presents a backhanded indictment of other products by suggesting a contrast.  Since long-term NRT use seems to resemble use of any other tobacco product, particularly e-cigarettes, this implicit distinction is a lie.

The statement also nerfs the recognition that long-term use of these products poses no major health problem by stating, “Consumers are advised to consult their health care professional if they feel the need to use an [over the counter] NRT for longer than the time period recommended in the label.”  But if health care professionals generally had half a clue about this, the move by FDA would be moot.  Those that know the truth have been offering accurate advice about THR (using NRT and other low-risk alternatives) all along.  The others are not going to suddenly acquire any understanding that they currently lack.

Third, the good news.  This opens the door a crack toward the US government to recognizing THR.  It is an embarrassingly small crack, given the accumulated evidence and the move by the British, and is not nearly enough to end the US government’s reign as the worst anti-THR liar in the world, but it is something.

More interestingly, there is an official recognition that the favorite ANTZ bogeyman, “dual use”, poses no harm in itself.  The FDA admits the obvious, that there is “no significant concern” about using multiple products at once.  Of course, the ANTZ will cling to the specific wording:  Since this is a statement about just NRTs, the statement about using multiple products at the same time is phrased in terms of one of them being a pharmaceutical industry product.  Thus, the ANTZ will claim, if someone is using more than one product, and none are made by the pharma industry, then that is somehow still bad.

Yeah, right.

Of course they are going to try that.  It does not mean that the rest of us cannot keep hammering away at the message that the FDA has stated that the evidence does not suggest there is anything harmful about dual use.  (That is, of course, that there is no harm above and beyond any harm from the use of each product in itself, in whatever quantity is being used.  Smoking even a little bit is still far more harmful than just using smoke-free alternatives, though any reduction smoking due to use of the alternatives provides a health benefit.)

So, please recite it with me now, and repeat it often:

The FDA has stated that there is nothing harmful about dual use.

Of course, everyone who is not a liar or one of their useful idiots already knew that.  It is obvious, and there has never been any reason whatsoever to believe there was any harm generated by mixing products from two categories, any more than there was about mixing cigarettes from different packs.  Still, it is fun to say that this knowledge is now “FDA approved”.

The dual use lie

by Carl V Phillips

I’m back, after some holidays and then trying to catch up on research work.  I cleverly avoided the need to do some kind of new year’s deep reflection or retrospective, though I will mention that the your-year-in-review WordPress bot congratulated this blog for having so much content and readership for its short tenure.  I will start with a few easy ones for a few days, mostly taking advantage of what others have written about THR over the last few weeks.

But today I will start with an often unchallenged bit of THR lying that is related to my current work, the claim that dual use (a term which usually refers to someone who both smokes and uses a low-risk alternative product) is somehow more harmful than merely reducing smoking.  Today’s example comes from serial liar Stanton Glantz(*) who publicized his comments opposing honest labeling about the low risks of smokeless tobacco.  As you might know, RJR has petitioned the US FDA to change the health warning labels on smokeless tobacco so that they accurately point out that ST it is much less harmful than smoking, rather than implying that it is just as bad, as the current labels do.  Of course, the anti-harm-reduction forces, who prefer that people keep smoking if they are not going to obey and become abstinent, vehemently oppose this.

[*In keeping with an ongoing meta-theme of this blog, I will repeat my observation about Glanz that many of his claims appear so earnest and yet are so incredibly out of touch with the obvious reality, one might debate whether “liar” is the right term for him.  This contrasts with the many obviously cynical liars in the tobacco control industry who clearly know what they are communicating is false.  Arguably someone is not precisely a liar if they are so deluded that they actually believe what they are saying despite being well-read on a topic (the latter contrasting with many of the “public health” useful idiots who just repeat what they are told and are lying in claiming expertise).  Of course, “grossly incompetent and out of touch with reality” is not exactly better than “liar”.]

Glantz’s testimony includes this statement:

Altering the text of the warning label to unequivocally state that smokeless tobacco presents substantially lower risks to health than cigarettes neglects the effects of dual tobacco use and the effects of smokeless tobacco use on smoking cessation, and so is fundamentally misleading consumers to underestimate the true risks associated with smokeless tobacco use.

The last bit is the usual obvious lie, since it is almost impossible for someone to underestimate the true risks of ST, as low as they are, and any correction away from the current overestimates will clearly reduce how much consumers are “fundamentally misled”.  The first part is more interesting.

Those of you who have followed anti-THR over time will know the pattern of the anti-tobacco extremists drawing the same conclusion, year after year, but altering their claimed justification for the conclusion when last year’s rationalization falls apart.  The current vogue is to claim that the existence of dual use means that THR is not so low risk after all.  Of course, a major reason for the persistence of dual use is that the extremists have prevented consumers from getting the message “now that you are using a low-risk product some of the time, you will lower your risks a lot by switching completely.”  But setting that aside, is there any basis for claiming that dual use is bad?

Someone who replaces some of their smoking with a low-risk alternative is smoking less.  Smoking less reduces risk (though obviously not as much as smoking none at all).  The big implicit lie — never stated, because then they would have to try to defend it, which they cannot — is that reducing smoking due to dual use is not as beneficial as reducing smoking without substitution.  There is simply no evidence to support this claim and no reason to believe it is true (beyond a level that is so small as to be a rounding error).

Put simply, dual use is reduced smoking, and reduced smoking reduces risk.

Even the worst-case scenario, in which someone uses a low-risk product while still smoking just as much, any additional risk is so trivial as to be inconsequential.  But someone who is doing that is in a great position to start substituting, and thereby reduce their risk (if only they learned about the option), so they are still on average better off in the long run.

Of course, that worst case (as defined in terms of actually caring about health and people) is not really the worst case in the eyes of the extremists.  They are bothered by the possibility that dual users do not have to suffer the pain that anti-smoking restrictions inflict on people who exclusively smoke, and they want tobacco/nicotine users to suffer.

Besides, if they really cared about discouraging dual use — rather than just using it as their anti-THR rationalization du jour, they would be supportive of a new label on ST that said something like “Exclusive use of this product is far less risky than smoking”  (h/t to Gregory Conley for that observation).  But, of course, they do not really want to encourage dual users to shift entirely to low-risk product use, because that would ruin their entire business model.  Rather, they are just saying whatever they think will accomplish their cynical goals, without regard to whether they really believe it.