Tag Archives: US govt

Phillips testimony for FDA hearing on recognizing tobacco harm reduction

by Carl V Phillips

The title overstates a bit, but next week’s FDA hearings (official government announcement here) on whether to allow pharma nicotine products to be able to officially (“on label”) be used for long-term THR rather than just for the magical rapid weaning off of nicotine that they are supposed to accomplish.  Since they are approximately useless for the latter and are mostly used for the former anyway, this is not a huge stretch.  But recognizing the reality of THR would be a big step for the FDA, similar to what the UK’s MHRA has already done.

FDA is not really admitting that this opens the door to properly recognizing THR, but it does, and so several of us who are interested in THR are testifying on various points.  Annoyingly, the government wanted us to submit not just our slides, but an actual text of our statements a week in advance.  There are various conspiracy theories about the reason for that, but mostly I just find it a bother since I never write out the text of my talks, but usually put a lot of detail in the slides.  But since I had to do it, I might as well make use of it here, so….

Testimony for: FDA Actions Related to Nicotine Replacement Therapies and Smoking Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing

by Carl V Phillips PhD

17 December 2012; Silver Spring, Maryland

I am testifying as a private citizen and stakeholder, speaking for myself based on extensive professional experience and expertise.  I am a long-time advocate and researcher on tobacco harm reduction.  I have worked in this field for more than a decade as a researcher and educator, and have published roughly a million words on the topic.  I am also an informed, consciously-motivated, occasional user of low-risk tobacco products, which I find to be quite beneficial, and clearly worth the unmeasurably small risk that they pose.

In response to Question 4.4, which asks about identifying harm in this context and identifying which harms are of particular importance, I have the following observations:

[Note:  Full text is: 4.4. With regard to innovative products and treatments for ``reduction in the harm associated with continued tobacco use'': a. How should the ``harm'' be identified and measured? b. Is there a range of harms that might be addressed, and if so, which are the most important to address?]

Harm should refer to actual harmful effects.  This seems rather obviously, but there is a remarkable failure to follow this guideline in the discourse on this issue.  Life-threatening disease risk is an important harm.  Immediate problems of functioning are also an important harm.  “Addiction” is not a harm in itself (even setting aside that it is not even scientifically defined).  It might be a reason that people do something that actually causes harm, but it is only that actual harm that should be counted.

“Harm” must be considered in net term, as is done for treatment drugs or anything else the government properly regulates.  Nothing is harm-free, but harm may be low (or trivial) compared to benefits.  The common approach of naïve extremist activists approach, saying “this has a harm and therefore is bad” makes terrible public policy, but that is what you get if you do not consider full net costs and benefits.

To consider net effects, first requires considering the health benefits of using a tobacco harm reduction (THR) product as compared to abstinence.  There are psychological benefits and aids to basic functioning from nicotine use for a non-trivial minority of the population, and this is a highly important consideration.  Second, the net must consider health benefits that may not be considered “health”.  Acting as if nicotine is purely a treatment for disease, rather than recognizing it as a consumer good that serves other preferences, is simply out of touch with the obvious reality.  Many people use nicotine because they like the effects, and this is another highly important consideration.  If the “D” side of FDA are not accustomed to dealing with such goods, perhaps those on the “F” side could help (or anyone else in government who regulates any non-drug consumer goods).

Third, net health benefits need to based on the probability-weighted “but for” choices.  For example, if there is a 20% chance someone would be abstinent, but for the promotion of the THR option, and 80% they would continue smoke, then you need to compare any harms from the THR to .8 times the risk of smoking (a comparison that overwhelmingly favors the latter).  It is simply out-and-out wrong thinking to compare the harm from one option to some unrealistic world that some people consider a best-case.  This is not an odd concept: treatment drugs are evaluated based on their net effects, considering the harm from not getting the treatment.  Moreover, the calculation of the net harm needs to recognize that some of the methods for pursuing abstinence (e.g., Chantix) are quite hazardous in themselves.  And, most important, if someone tries to achieve abstinence but relapsing for a while, and as a result smokes for just a couple of more months, the resulting risk is (for the average smoker) greater than from than using a low-risk alternative for a lifetime, as I argued in my 2009 Harm Reduction Journal paper.  This means that pursuit of abstinence is often a higher risk alternative to THR.

In response to Question 4.6, which asks about how FDA and other HHS agencies can help promote public health in this context,…

[Full text: 4.6 In regulating the innovative products and treatments referenced in section 918(b), how can FDA and other HHS Agencies act to ensure that the three effects mentioned in section 918(b)--total abstinence from tobacco use, reductions in consumption of tobacco, and reductions in the harm associated with continued tobacco use--are achieved as broader outcomes, in a manner that best protects and promotes the public health?]

…far and away the most important thing to do is:

Stop lying!

Units of HHS are the world’s biggest anti-THR liars, and have been since I started documenting anti-THR disinformation campaigns about a decade ago.  The pervasive message to smokers about low risk tobacco and nicotine alternatives coming out of HHS has been and still is “you might as well smoke” (a phrase that was the title of my 2005 BMC Public Health paper that reports some of my research on this disinformation).  FDA has now joined other agencies in publishing disinformation designed to discourage smokers from switching to low-risk alternatives by grossly exaggerating the risks of those alternatives using false and intentionally misleading claims.

These anti-THR messages encourage people to smoke when they would otherwise use a smoke-free alternative that poses risks that are two orders of magnitude lower.  No conceivable amount of low-risk product usage could cause as much health harm as the smoking this causes.  Following the phrases from Question 4.6, respectively “total abstinence from tobacco use” and “reductions in the harm associated with continued tobacco use”, the current practice of promoting the former at the expense of encouraging the latter is guaranteed to be bad for public health.  Obvious and simple arithmetic makes that clear.

Regarding Question 4.7, about what to consider in FDA’s premarket evaluation of new product candidates,…

[Full text: 4.7. How can these broader outcomes be taken into account in FDA's premarket evaluation of new product candidates?]

…I reiterate that focusing on the net on smoking is most important.  Indeed, from a population health perspective, it is the only thing that matters.  Everything else is a rounding error.

In addition, premarket evaluation depends on having a correct basic model for what motivates consumers to choose particular products.  People act based on incentives which include health risks, of course, but also include many other factors.  Consumers making choices are not mere patients – sick people seeking treatment for a disease and nothing more.  If they are treated as such when predicting what they will do, the predictions will inevitably be wrong.  Even worse, if they are just treated as black boxes who are assumed to just make choices at particular rates because that is sort of what other consumers did in the past under difference circumstances, then you will have garbage in yielding garbage out.

I have a lot more to say about this, but only seven minutes total, so that is where I will end.

Aside

Just a quick aside today.  I only just noticed the hilarious “warning” message on the shopping page SnusCentral.com: US Government Mandated Warnings for Americans:  Depending on the month, this product can cause mouth cancer, can cause gum disease and tooth … Continue reading

US Department of Health and Human Services are liars (and kinda stoopid)

by Carl V Phillips

I hope my readers in the US had a good holiday, those in the UK are recovering from being intensively aware of alcohol during #alcoholaware2012, and everyone else was productive for the last few days.  In honor of the US holiday, I present another little chapter on the past and current champion anti-THR liar on the planet, the US government.

The Department of Health and Human Services (HHS), at apparently the central-administration level (no operating division is mentioned), recently released this document that trashes e-cigarettes, and so joints its FDA, CDC, and NIH operating divisions in the anti-THR lies business.  There is really not much here that is not already pushed by the departments, but for completeness, a few words about this additional abuse of our tax dollars being used to keep people smoking.

The short document contains the usual lies that these products appeal to children (despite the lack of evidence about that, and the clear evidence that they appeal less than does smoking) and that they lead to smoking (despite the fact that this is utterly ludicrous).  Interestingly, they felt constrained enough by the evidence to not make risk claims, but instead use this to sneak in a reference that gives the casual reader the impression that they are making risk claims:

Using e-cigarettes may lead kids to try other tobacco products—including conventional cigarettes—which are known to cause disease and lead to premature death.

Yes, that’s right:  Because the product they replace is known to cause disease, e-cigarettes are bad.

They also tell us that in addition to sometimes looking like cigarettes and cigars, e-cigarettes sometimes look like pens.  While I am sure that there is some product on the market that does look like a pen, I have never seen one that could be mistaken for a pen from five feet away.  I think all they are suggesting is that they are often roughly cylindrical objects that fit in your hand, in which case they apparently also look like… well, you get the idea.

But these pale compared to the lead-off moronic lie, one I have previously covered before in other forms:

Because clinical studies about the safety of e-cigarettes have not been submitted to the U.S. Food and Drug Administration (FDA), you have no way of knowing:

  • If they are safe
  • Which chemicals they contain
  • How much nicotine you are inhaling

Seriously?  How can someone believe such a thing and still understand how to dress himself in the morning?  Did you know that since clinical studies about taking a stroll in the park (or reading this blog!)  have never been submitted to FDA, you have no way to know if it is safe?  Did you know that since clinical studies of foods have never been submitted to the FDA, you have no way of knowing what chemicals they contain and how much?  It turns out that no one in the world knows anything until something is submitted to FDA.  That is going to seriously slow down science.

(Ironically, no one has submitted studies of any type to anyone that suggest e-cigarettes appeal to children or lead to smoking.  But they have no hesitation to make those claims.)

I am sure what they must have been trying to say is that you have no way of knowing unless you have a bit of common sense and knowledge about how the world works, and know how to read.  So if you are an infant or just arrived from another planet, you definitely have no way of knowing, and therefore should probably not be vaping.

But it gets worse than that if you think about it a moment.  How, exactly, would a submission of a clinical trial of safety tell you what chemicals they contain?  And how would it tell you how much nicotine you are getting?  (I would recommend looking at chemistry studies and statements by reputable manufacturers to assess the former, and assessing your own reaction for the latter.)

I realize that people at HHS central administration are politicos and lawyers, not scientists, but geez.  Can our science education really be failing so badly that not one of what was probably a couple of dozen people who reviewed the document noticed how absurd this was?

Less absurd, but similarly wrong, is the closer:

Although e-cigarettes may be marketed as a tool to help smokers quit, they have not been submitted for FDA evaluation or approval and there is no evidence to support those claims.

The first bit is not true, except to the extent that marketers are violating US law.  The latter bit is, of course, another version of the “I am going to pretend the evidence I do not like does not exist” lie.  That statement is followed with:

There are, however, a number of FDA-approved quit-aids available to smokers, including: Nicotine gum, Nicotine skin patches, Nicotine lozenges, Nicotine oral inhaled products, Nicotine nasal spray, Zyban, Chantix

To their credit, they did not lie about this.  Those products do indeed exist and they are FDA-approved.  They never actually claimed those products work, that using them is a good idea, or that people are better off using them rather than pursuing THR.

There are no “neutral” views on THR (but there are clues about who is honest)

posted by Carl V Phillips

I run into quite a few people who want there to be some authoritative honest broker who can provide a “neutral” opinion about THR.  (Actually, we see this all the time regarding most controversial subjects, and it fails for basically the same reasons.  But I will stick to talking about THR and you can extrapolate to other topics.)  Everyone defers to authority or conventional wisdom for the overwhelming majority of what they do and think — that is the only practical way to exist.  But when there is political controversy and the issue is important to your own health (or public health, for those making public health pronouncements), it is time to stop deferring and recognize that there often (perhaps usually) are no neutrals.

This is clearly the case when it comes to THR.  While these observations are probably obvious to anyone who is invested in this topic, it might provide some useful information for those trying to begin to understand it.

A favorite target to defer to on matters of health (even by many non-Americans) is the US government.  Deferring to them in this cases consists of thinking: “They say e-cigarettes and smokeless tobacco are very very bad for you, so it must be true.  After all and they would not mislead me.”

Really?  Does anyone really believe that the government would not be biased or try to sell you on a particular belief system?  Almost no one would ever make such a claim, and yet many people act as if they believe it.

I hope it is obvious that our government is not an unbiased neutral broker of information when it comes to, say, the Department of Defense opining on the usefulness and ethics of assassination-by-drone-aircraft, or the Drug Enforcement Agency offering its assessment of the Drug War.  The retort I might expect to that is that, FDA and CDC are supposed to be looking out for our best interests, not pushing an agenda.  But I would expect that the people at DoD and DEA also think that they are looking out for our best interests.

The government, of course, is not a unitary actor, but consists of a lot of operations that each have their own mission.  When officials create a particular unit or a particular assignment, they have a goal in mind, and it is seldom to create a neutral arbiter.  But even when that is the goal, the well-known phenomenon of “agency capture” means that the people who join the agency or exert the most effort to influence it will be those who are highly focused on the issue, which is basically synonymous with “interested in a particular outcome”.

Most of the time, the capture is by an industry that stands to make or lose profit based on agency actions.  Sometimes not.  Theoretically, the government units that deal with tobacco could have been captured by the tobacco industry, but instead they were captured by the tobacco control industry.  Why that happened is no mystery, but it is sufficient to just observe that it happened.  So, there are revolving doors (people moving between the tobacco control industry and government agencies that support them) and iron triangles (a generalization of Eisenhower’s “military industrial complex” concept, which is basically the epitome of capture) everywhere you look.  No agency employee would dare contradict the government anti-THR lies, let alone say that perhaps people can rationally choose to use tobacco rather than not.

Trusting government agencies to be neutral — on most anything — is simply absurd.  It is generally safer to assume the opposite.  In this case, it is easy to see who controls the agencies.  But it should be equally clear that for an issue like this, these observations about government generalize to any supposedly neutral committee (made of people with an interest in the issue, chosen by someone who has an opinion) or organization (which generally exist to advocate a particular position).

Moreover, for the case of THR, being neutral makes about as much sense as being neutral about the shape of the Earth.  Someone who claims the Earth it is flat is an outlier who apparently is unfamiliar with evidence, or is just lying for some purpose.  But someone who “sees that both sides have merit” is also a nutcase (or worse, an irresponsible journalist trying to provide “balance”).  It would certainly be possible for someone to present the arguments from the flat-earther alongside the rest of the evidence.  But anyone who did not then arrive solidly at “spherical” should not be considered a trusted source of information.

People who learn and understand the truth about THR — and tell the truth about it — invariably come down on the pro-THR side, or at least admit that it offers clear benefits for public health, overall welfare, and individual rights.  The honest brokers might recognize nuances and caveats that are absent from extreme pro-THR positions, but frankly there are not very many people who exhibit extreme pro-THR positions.

It is theoretically possible for someone to take an honest neutral position on THR or even an honest anti-THR position, but I am aware of nobody who does.  It is possible to argue “there is overwhelming evidence that the risk from smoke-free tobacco/nicotine products is very low, and there is no reason to believe that encouraging their substitution for cigarettes will have negative effects on health, but I oppose [or, am on the fence about] providing accurate information and legal access to these products because….”  The “….” would have to be a statement like “I do not really care about health outcomes, but only care about hurting the tobacco industry” or “I am more worried about whether other people sully their bodies by using a drug then their happiness or health”.

You never hear such honestly, but it is theoretically possible.  The one version of the “….” that you almost see sometimes is “I care more about whether people are ‘addicted’ than the effects of that behavior”, but even this it is never stated so honestly, and is never coupled with the honest presentation of the health benefits.

The truth has an overwhelming pro-THR bias, and those who would attack THR implicitly acknowledge that fact by avoiding the truth.  Everyone who is anti-THR, or even claims to be neutral, whatever their real motivations might be, lies about the health science and bases their stated oppositions on those lies.  So they clearly fail the “honest broker” test.

But there is still a useful guide to finding the truth in this, but (like any other useful guide) it is not as simple as “just trust the government”:  When you observe:

  • everyone of any visibility on the anti side repeatedly makes claims that those on the pro side point out are lies, often based on easily verifiable information
  • those on the pro side consistently acknowledge and respond to the claims made by the antis
  • while those on the anti side never engage in dialog, not even so much as to dispute the substantive statements made on the pro side, but instead just keep repeating the zombie lies
  • some of those on the pro side try to police their side’s information, while those on the anti side virtually never criticize anyone on “their team”,
  • and those on the pro side can explain and document the motives of the antis to lie, while the antis can only resort to (unsubstantiated, and indeed easily refuted) sputtering protests about the other side consisting entirely of some secret industry cabal (for a non-existent THR industry, no less!),

well, then, I really think that it is not too difficult to figure out where to find the honesty.

 

 

CDC on cigars – a great example of liar’s citations

posted by Carl V Phillips

I will come back to FDA in a few days, but we want to cover a few other things first.  One is to point out that the behavior of the FDA — in terms of both being anti-THR and junk science about tobacco/nicotine — does not represent either new or exceptional action by the US government.  The CASAA leadership just happened to be discussing this document from the US Centers for Disease Control and Prevention (CDC).  It is about cigars, which is related to THR, though not a core part of THR efforts.

There is good evidence that cigar smoking in traditional cigar style — puffing into the mouth with minimal inhalation into the lungs — is much less harmful than cigarette smoking.  Of course, the same method can be used with cigarettes too.  However, the interest in such substitution is limited and switching to smoke-free alternatives is far healthier, so there has been little interest in pursuing this.  (In addition, a lot of cigar consumption lately has been for products that are basically cigarettes and are smoked like cigarettes, as a way to avoid the punishing cigarette taxes.  That is understandable motivation, but it is not meaningful harm reduction.)

Still, that document says a lot about CDC’s approach to tobacco.  About half of the content is cited to three sources (links appear in the original if you really want to see them):

1. Campaign for Tobacco-Free Kids. The Rise of Cigars and Cigar-Smoking Harms . Washington: Campaign for Tobacco-Free Kids, 2009.

2. National Cancer Institute. Cigars: Health Effects and Trends. Smoking and Tobacco Control Monograph No. 9 . Smoking and Tobacco Control Monograph No. 9. Bethesda (MD): National Institutes of Health, National Cancer Institute, 1998.

3. American Cancer Society. Cigar Smoking . Atlanta: American Cancer Society, 2010.

This is a great example of lying with citations — putting in little footnotes that imply that the information presented is based on the best possible evidence, when actually the sources are rather useless.

You probably noticed that the first is to an anti-tobacco extremist organization, which, among other things, opposes harm reduction.  Moreover, it is not research by that organization, or even a review paper, but is just a two-page broadside.  The third reference is similar:  While ACS is thought of as a scientific organization, when it comes to this topic, they are also an extremist activist organization with little regard for honest science.  The cited webpages have a bit more content than the CTFK broadside, but not much, and do not even cite evidence for their claims.

So basically, we have an agency of the US government sourcing its scientific claims and consumer advice about a tobacco product to activist organizations whose mission is to say anything they can think of that is negative about tobacco products.  Their job description is to be biased, and that often means dishonest.  There is no possibility that CDC does not know this.  Could you imagine the State Department citing information in its travel advisories to the Middle East to anti-Islamic activists or the Department of Agriculture citing nutrition advice to anti-GMO activists?  This is similar in terms of credibility.

[You probably could, however, imagine agencies of the government deferring to other, more powerful, players for information in their areas of interest.  That observation -- and its relation to the present topic -- will be the subject of this week's Background post in a couple of days.]

At least source #2 is a real scientific review.  The problem is that it is from 1998 — very old history in a field like this.  But, funny thing: the CTFK document cites that 1998 report extensively.  So what CDC is really doing, by citing CTFK, is trying to hide the fact that all their information traces to 1998 by citing a more recent document that cites the original.  A common sneaky trick used in undergraduate term papers, brought to you by an authoritative voice of our government.

It gets worse.  The first statements that are cited to those three sources are:

A cigar is defined as a roll of tobacco wrapped in leaf tobacco or in a substance that contains tobacco….[1][2]

The three major types of cigars sold in the United States are large cigars, cigarillos, and little cigars.[1][2][3]

There is nothing wrong with the information, of course.  What is baffling is why CDC felt a need to provide a citation for it.  What is even more baffling is that citation #1 does not even provide a definition for cigar; citation #2 probably does, but I am not going to hunt for it.  Interesting, #3 does provide a clear definition — based on tax law — but is not even cited for the first sentence.  There is also clearly no need to cite that second sentence, but if you are going to, it should be to something relevant (like the official tax or regulatory definitions).  Here is a hint for those of you who want to cite a definition:  try a dictionary.

That is mostly just amusing, but it shows a general lack of seriousness.  More serious, and equally lacking in seriousness, are the series of health and other claims that are also cited to these three sources.  And lest you think I am cherry-picking, there are no other cited sources that provide any health information.  I am not going to go into detail about the claims because, for the reasons noted above, their role in THR is limited.  Suffice it to say that there is a lot of doubt now about the conventional wisdom about the risks that existed in 1998 (that probably sounds a bit familiar for those who know the science about smokeless tobacco).

So, basically, the official word of our government is: “(a) as far as we know, nothing has been learned since 1998; (b) just go read these activists’ position statements because we just defer to them anyway.”

FDA does not understand how science and knowing work

posted by Carl V Phillips

Epistemology (roughly, how we know what we know) is at the core of scientific inquiry.  Some of the most profoundly anti-scientific claims that you will ever see — certainly among the most frustrating — are attempts to replace the complicated epistemic processes in science with simplistic rules of evidence.  Typically these are so oversimplified as to be suitable only for a stylized game like high school debate contests.  The rules are too simplified even for a courtroom, the context for which they are often designed.

As I noted in the first of this series of posts on the US FDA, FDA’s epistemic toolbox pretty much contains only one tool: their standard recipe for doing clinical trials of new pharmaceuticals.  That works pretty well for what it does, but it obviously represents only one little tiny corner of scientific methodology, let alone scientific knowledge.  The FDA document that I started discussing yesterday makes clear how unsuitable FDA’s limited understanding of science is when it comes to studying THR.  It includes:

Because clinical studies about the safety and efficacy of these products [e-cigarettes] have not been submitted to FDA, consumers currently have no way of knowing

This is followed by some bullet points, which I will address shortly.  But for now, just consider that sentence fragment.  No way of knowing?  Are they kidding? There is no way to complete that sentence truthfully, other than with something circular like “…no way of knowing what clinical studies submitted to FDA do say.”

The mind boggles at the arrogance.  The typical epistemic error is to claim that there is no evidence in the absence of studies that follow a particular clinical study recipe.  That is also completely wrong.  But there is something extra special about a unit of the government claiming that knowledge does not exist until it is formally submitted to them.  That is downright Soviet, or maybe even more l’état, c’est moi.

Since I cannot think of much to say about that other than shaking my head in disbelief, I am just going to pretend they said, “Because clinical studies have not been done….” and explain why this — the all-too common misconception that clinical trials are the best way to answer every single scientific question — is a lie.

The bullet points that complete the sentence are:

  • whether e-cigarettes are safe for their intended use,
  • what types or concentrations of potentially harmful chemicals are found in these products, or
  • how much nicotine they are inhaling when they use these products.

For some questions it takes a bit of work to explain why clinical studies are not the most useful method for finding an answer.  For example, clinical trials are not very good at answering the most important questions about whether smokers will switch to a THR alternative.  But that takes a bit of explaining (which I am sure I will eventually cover in this series).  But for now, FDA has provided examples that are so obviously wrong that there is no such challenge.

How do we know how much of what chemicals (nicotine and others) are in the vapor?  A clinical study is not well suited to answering this at all.  Instead, we need a method for drawing out and analyzing vapor that avoids the complication of the user absorbing some unknown portion of the chemicals (i.e., which does not include a clinical component).  And that has, of course, been done.  FDA even did it themselves (though they lied about the results).

We could replace the last point with something that actually does involve the user, like how much nicotine users are taking up?  That is possible to answer using clinical research methods.  Possible, but not necessary.  One way to measure nicotine uptake is blood chemistry.  But another is to just be the person taking up the nicotine and feeling the effects.  That will not answer some questions very well, but it is clearly a way of knowing.

How about whether e-cigarettes are safe (I am not sure what the “for their intended use” clause even means)?  Well, in that case some clinical studies would have been useful and would still be useful.  Indeed, we would have those if those in government “public health” thought of themselves as public servants (who would observe that the public wants this information and then try to provide it in order to possibly improve health) rather than public masters.  Nevertheless, clinical studies are obviously not the only way of knowing.

We have learned an enormous amount — in spite of governments’ uselessness in this matter — about the health effects of e-cigarettes.  We have ample data to rule out important negative acute effects, to be confident there are no non-rare major short-term health risks, to be optimistic about the lack of long-run effects, and to be quite sure that they are better than smoking by a lot.  This evidence comes from the experience of users as well as extensive data about other smoke-free nicotine sources and our knowledge from various sources about exposure to the other chemicals.

The general lesson here is that when someone claims “we know nothing” or “we have no evidence” about some scientific question, they either have no idea how scientific inquiry really works or they are lying.  Or both.

FDA is trying to manipulate people while avoiding an honest policy process

posted by Carl V Phillips

Continuing the series started yesterday, we are responding to disinformation from the FDA at the behest of one of our members whose employer (an agency of the US government) is trying to keep her from vaping based on FDA claims.  In particular, her boss justified his action based on this FDA document.

The first thing to observe is that this note from the FDA, identified as “news & events”, should be seen more as a blog post than a policy statement.  This may sound like a one-off observation, relevant for the one person to whom this note was presented as if it were government policy.  But it actually introduces an important point about the pattern of FDA’s (and some others’) lies:  FDA and some other actors often put out throw-away junk claims in forums where they are not subject to review or oversight, but can still give the impression that they are making official statements.  This is possibly against the law (I will leave it to others to judge that) but is certainly sleazy and bad behavior by a government agency.

I am not talking about things like the @FDAtobacco twitter feed which, as I have noted before, is embarrassingly amateurish and a serious embarrassment to the US government.  That is a different problem, but at least no one with any clue would take it seriously.  I refer to documents which look like official statements but are not — and thus lead to (presumably intentional) confusion like that of our member’s boss.

As noted yesterday, FDA is a police agency that often gets mistaken for a science agency.  It is perfectly legitimate for scientists to float their half-baked ideas in public to see what feedback they might get — indeed, public health science would be so much better if this were done like it is in “real” sciences.  But actors with police powers are obligated to avoid such behavior.  Imagine the legitimate objections if a police agency published a newsletter in which they wrote things like, “the district attorney refused to try to take action against Acme Novelties for selling faulty road runner traps despite the evidence we collected, but we still think they are guilty and intend to make arrests as soon as we find some evidence.”  Needless to say, this would provoke justified outrage; they are free to continue their efforts, of course, but effectively pre-declaring what police actions they are going to take is unacceptable and probably illegal.

Yet consider from the FDA document:

FDA [lost] the decision by the U.S. Court of Appeals … holding that e-cigarettes and other nicotine-containing products are not drugs or devices unless they are marketed for therapeutic purposes, but that other nicotine-containing products can be regulated as “tobacco products” under the Federal Food, Drug, and Cosmetic Act.  Therefore, FDA intends to develop regulations for electronic cigarettes.

This would be fine as a technical statement of agency plans, in an appropriate forum.  But consider what else appears in the document:

…contain ingredients that are known to be toxic …. may be attractive to young people and may lead kids to try other tobacco products …. no way of knowing whether e-cigarettes are safe …. Please report adverse events with e-cigarettes …. warning letters to electronic cigarette distributors for various violations of the Federal Food, Drug, and Cosmetic Act …. Public Health Experts Announce Potential Health Risk Posed by e-Cigarettes …. More Information on Safely Quitting Tobacco

You see the pattern.  I will address the various specific lies in subsequent posts.  My current point is that when “intend to develop regulations” is presented in that context, it is pretty clearly an accusation and threat that avoids proper procedure — procedure that exists for very good reasons.  A police agency can make a flat statement that they are investigating the public claims made by Mr. W.E. Coyote against the company.  But they cannot also publish every speculative claim and bit of unexamined evidence they can come up with.

FDA can propose or take action that they believe is within their policing authority.  When they do, they can then be subject to lawsuits, legislative action, and popular uprising.  Having done that once regarding e-cigarettes, and having lost, they have resorted instead to playing games of making unofficial statements that sound like official policy, but are not subject to any oversight or review.  This is a violation of the public trust and the authority granted to them as police (the spirit of it, if not their legal authority per se), just as much as their scientific lies, but it has largely been overlooked.  They are playing the role of cop in the worst way — making intimidating statements and exercising power via implicit threat (“you are not under arrest — we just want you to come in voluntarily and answer a few questions”) while avoiding the official action that would subject them to scrutiny.

In some ways, that is more disturbing than the lies themselves.

US FDA lies about THR. And lies. And lies. And lies.

posted by Carl V Phillips

As I mentioned to some of you, I am going to write about the leaked EU document that shows their plans to ban e-cigarettes, but I will come back to that (perhaps it will be disavowed as a horrible bit of anti-public-health anti-democracy by then, and I will not have to — we can dream, can’t we).  But today, at the request of one of our members who needs to respond to an employer’s claims about the US Food and Drug Administration’s position on e-cigarettes, I thought I would start a series about the FDA claims.  FDA is probably the single biggest anti-THR liar of the last couple of years, so this is probably overdue.

I am going to partially outsource the content of this post to Brad Rodu, who posted on FDA lying about THR a few months ago (it is a quick read, so pop on over to it).  The post is about a page on the FDA website that claims, in boldface, no less:

To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products.

So the FDA, continuing the tradition of the US government for more than a decade, is telling people, “if you are considering using any tobacco product at all, then you might as well smoke.”

FDA’s only possible partial defense for the claims on this page (and I stress “possible”, “partial”, and “this page”) is that the primary purpose of the page is not to communicate to consumers or to provide scientific information, but to inform merchants and busybodies who might want to report on them that any comparative risk claim is “fraudulent”:

Claiming less harm or reduced risk of disease from using tobacco products misleads consumers to think that these products are safe to use.  FDA considers these kinds of claims to be health fraud.

The reason I start the discussion of FDA with this material is that it provides some useful insight about the organization that might not be generally understood.  FDA is a basically a law enforcement agency that does a little science, but many people mistake it for a scientific agency.  As with any branch of government that makes rules and focuses on enforcement, the mindset is not that of a scientist — seeking truth — but of a cop or legislator.  They declare how things are rather than seeking to learn about the world.

Consider the second quote, above.  Obviously not every claim of reduced risk would mislead consumers into thinking the products were safe.  For example, someone could say about a smokeless tobacco or e-cigarette product, “this product poses a health hazard to the user, however, that hazard is less than that from smoking.”  Frankly such a claim is such an understatement of the science that it could be used as an anti-THR lie, but it obviously would not be overstating the risk difference, and even more obviously would not lead to the conclusion the product is safe to use.  But the FDA “considers” even that fraud.

Considers.

Most people who think that FDA is a scientific agency would assume that “considers” implies a scientific conclusion based on scientific study.  The natural assumption would be that FDA has done that study and, taking the normal meaning of the word “fraud”, someone would assume that scientific study leads to the conclusion that it is false to say that smoke-free tobacco products are lower risk than cigarettes.  But once you recognize that FDA are cops and not scientists, it becomes clear:  FDA declares that any such claim is fraud — whether the claim is true or not.  They can define “fraud” to be anything they want, and in this case they have defined it to include true statements.

To further understand FDA, it is useful to explore why it is easy to mistake them for a scientific organization.  Much of what they do is to run and oversee a lot of studies, and those are a kind of science.  But despite the huge volume of work, there is not much scientific thinking going on.  The studies consist of carrying out the same couple of recipes, over and over again.  They are scientists in the sense that McDonalds employees are chefs.  More directly, it is like cops doing investigations, which generally follow the same routine — not unskilled and not thoughtless, for sure, but also not Sherlock Holmes.

Police follow fairly systematized procedures that mostly get the job done and mostly avoid the various obvious things that can go wrong if people are allowed to exercise more discretion.  The same observation applies to things like FDA’s pharmaceutical approval process.  But once we move beyond flipping burgers and interviewing the usual suspects, to trying to answer complicated questions based on complicated bodies of information, FDA is out of their expertise and — the evidence shows — out of their depth.

Just as it would not be wise to assign an average city police detective — however good he might be at his job — to, say, figure out who might be planning to attack an airliner somewhere in the world, it is not a good idea to trust FDA to do science that does not follow one of their recipes.  Unfortunately, the US government does not have an equivalent of the NSA for health science, so we are stuck with the FDA and their recipes.

Evidence for why this is such a problem can be found in the first quote, above.  Any scientist knows that there is no such thing as “scientifically proven”.  Proof naturally exists in math and logic and it is defined and created in law, but is absent in empirical science (it is often used as shorthand for “there is very very strong evidence supporting the claim” but that is not technically accurate).  Since FDA as a legal agency, it is used to dealing with “proof” in the legal sense.  What this means is when FDA declares that “if you follow our recipe for drug trials and particular results come out the other end, then particular things are proven“.  Again, it is them declaring something to be true, rather than discovering it; it is “proving” in a legalistic sense because the law declares that what matters is following the recipe, not true scientific inquiry.

Do not mistake any of this as excusing their lies.  They write in the language of science.  They portray themselves as having scientific expertise.  They explicitly offer scientific advice.  So they are subject to scientific standards and scientific criticism.  They could have chosen to just be honest cops, but they have chosen to be liars.

Even their legal declarations read as if they are making scientific claims.  In the second quote, they make the obviously false statement that consumers would over-interpret any possible comparative risk claim.  But it is they who are engaging in marketing tricks to mislead consumers.  If they said “we currently declare this to be fraud, regardless of what the science shows”, that would be honest.  If they said “no tobacco products have been subject to one of the two or three scientific recipes that we do, and we refuse to accept the scientific evidence”, that would be honest.

But when they suggest that the science supports their absurd claim that all tobacco and nicotine products pose exactly the same risk as smoking, they are lying.  It is not quite true to say that all of their statements about THR are lies, but remarkably close to all of their substantive claims are.  I will start addressing some of them.  I will quit when I run out of energy to do so — I suspect long before I run out of their lies.