01 July 2011

Unhealthful News 182 - Did Serious people seriously think FDA regulation of tobacco would go any differently than it has? Really?


Yesterday Paul Krugman summarized someone else's comments as follows:
“Some people thought from the beginning that the stimulus should have been much bigger. Hahaha! Also, it turns out that the stimulus was too small, so we need some more.”

From this, he goes on to observe (a version of one of his points that may be as important has his economic theory):
This is actually a fairly familiar thing from my years as a pundit: the surest way to get branded as not Serious is to figure things out too soon. To be considered credible on politics you have to have considered Bush a great leader, and not realized until Katrina that he was a disaster; to be considered credible on national security you have to have supported the Iraq War, and not realized until 2005 that it was a terrible mistake; to be credible on economics you have to have regarded Greenspan as a great mind, and not become disillusioned until 2007 or maybe 2008.
Making the rounds lately is a piece from Tobacco Journal International by John Lauterbach, a nonvoting (industry) member of the US FDA's Tobacco Products Scientific Advisory Committee.  In it he observes:
Congress did not intend to forbid adult use of legally manufactured and marketed tobacco products. Indeed, Congress gave the FDA (Food and Drug Adminstration) the authority to make sure that tobacco products were made under good manufacturing practices using tobaccos and ingredients that were free from contamination, and that such products were not adulterated and/or misbranded.  …. Moreover, users of tobacco products would be given accurate information on which classes of tobacco products presented higher health risks to the user than did other classes of tobacco products. Furthermore, there would be active support by the FDA for reduced risk tobacco products.  Finally, the CTP staff would include scientists and engineers who were as knowledgeable in the design and production of tobacco products as were their counterparts in industry, and there would be joint research on test methods for the characterisation of tobacco products and tobacco smoke.
Um yeah.  It is not clear whether he really believes this, or if it is just a setup.  If he does believe it, he seems to join a lot of others in qualifying as Serious, in the Krugman sense.  He does take a tone of genuine surprise when he continues with:
So, why have the good outcomes that would lead to reduced tobacco-related disease not happened?  Apparently, Dr. Deyton and others at the CTP and the FDA do not want them to happen. It appears that they want to continue the scourge of tobacco-related disease in the hopes that the populace will demand the elimination of the tobacco industry and tobacco use.
Hmm.  Where have I heard that before?  Oh yeah, that is how I have been characterizing this political faction for about five years, having coined, defined, and characterized the term "anti-tobacco extremists" because I was sick of hearing them erroneously referred to as "public health".  It is what I predicted would be the outcome of FDA regulation when it was in the works.  This was at a time when many others who are interested in tobacco harm reduction, as well as the industry, were optimistic about how it would go.  It sounds a lot like what I was still pointing out a year and a half ago to anyone who would listen.  I never changed my position, by the way, I just got quieter after getting sick of being pretty sure I was right and yet watching all the focus (and money) flow away from the areas I work on.
Quite frankly, some with interests at the CTP and FDA seem to believe that when Congress approved the Family Smoking Prevention and Tobacco Control Act, the “TCA“ for short, it ratified the World Health Organisation's Framework Convention for Tobacco Control (FCTC) treaty. …. This is very important because the WHO does not want to reduce the health risks associated with tobacco use. The WHO wants to eliminate all tobacco use, even use of tobacco products whose health risks are indistinguishable from those of medicinal nicotine.
I am shocked to hear that.  Oh, except for the fact that my colleagues and I were among those who made exactly that point about WHO many years ago, and we have been following the FCTC follies with all of that treaty's implications for truly terrible public policy.

What I want to focus on now is the TPSAC and the forces who want to take the word, "science" out of the Tobacco Products Scientific Advisory Committee. …. The three industry representatives on TPSAC have been a troublesome team for the FDA. We have been very professional in asking all the questions the FDA did not want asked.  ….unlike the other scientific advisory committees that help the agency deal with difficult scientific issues, the real expertise on the TPSAC lies with the non-voting industry representatives, not with the voting members of the committee.  Indeed, the difference in expertise between the industry members and the voting members is so great; the FDA has to hide our expertise. Our expertise is listed as "Industry Representative."  If the FDA listed our expertise, it would make the voting members of the committee look weak.
I should make clear that I am not writing this to criticize Dr. Lauterbach's presentation.  It is just a good example, and he certainly deserves credit for bits like that.  My frustration is that he has to tell anyone most of this information at this late date.  However, I do have specific disagreements.  In particular, I take issue with the implications of this question:

So why doesn't the TPSAC have academics who are experts in tobacco science, tobacco chemistry, and tobacco toxicology?
Setting aside the answer, the question implies that those are the most relevant fields.  But the matters being addressed by the Committee and the FDA are almost entirely about epidemiology, welfare economics (consumer preferences and such), and other social sciences.  No doubt chemistry will have its role, but it is pretty minor so far.  Indeed, where there has been focus on chemistry, that ignores much more important health and social science points.
….if we had such faculty members available to serve on TPSAC, the FDA would not want them on TPSAC, as they would ask the wrong questions. Tobacco and tobacco smoke are difficult materials, and those doing serious research soon learn to assume nothing and insist on proof before deciding the validity of a scientific proposition.
Right prediction about their opposition to experts, of course.  They did not want, and carefully avoided including committee members who might ask tough questions about the relevant sciences.  But the rest of that, ouch!  It seems to play right into their hands, sounding remarkably like 1960s-70s style industry obstructionism.  I am not saying that was what was intended, but the tough questions that are being ignored are along the lines of "how can low-risk smokeless products possible cause any measurable harm based on existing epidemiology and economics?"  Questions like "how can we know what to do until we do more research about smoke?" are not only the wrong question but sound a bit contrived.  I suspect the Serious people will come around on that too, eventually.

Those who write anti-tobacco materials generally stay away from the mainstream journals that cover the sciences associated with product regulation even though scientists from other parts of the FDA publish in such journals. Why? They know that the reviewers and editors of such journals have little tolerance for pseudoscience. So, those opposed to tobacco publish in journals such as Tobacco Control, Nicotine & Tobacco Research and other journals that welcome less than accurate science as long as it is anti-tobacco.
A nice point.  Of course, it is one that those of us who have been doing academic and academic-style research in the social sciences have been pointed out all along.

However, when such pseudoscience has made it to print, the industry, for the most part, has not challenged the bad science. ….  Fortunately, some of us who are not part of big tobacco, did the science, and got it published. I can assure you that you do not win friends when you write to a journal editor and show him that he let research into his journal that stated, if one took the experimental as it was written, the cigarettes were smoked well into the filter sections and that cigarettes were smoked under such variable conditions as to render the results useless.
How many times have I (and Rodu, and Enstrom, etc.) fought with publishers?  A lot more than we have written about, and we have written about quite a few cases.  I would contend that the social science side is far worse than the chemistry side, both in terms of publishing junk and censoring real science.
Action is required
.  Big Tobacco needs to step in and do its share to correct the errors in the literature and respond promptly to new ones.  ….  Unless someone acts, [an article he cites] is going to be used against dissolvable tobacco when TPSAC considers those products later this year.
Sounds right.  Also sounds a big familiar.

While we can hope that the FDA will learn from its mistakes and start using good science for tobacco product regulation, we have no guarantees that will happen.
Um, you might want to consider whether they believe they have made mistakes.  I think agreeing to the premise that there were mistakes is a prerequisite for learning from them.
We know that our legislators do not look favourably on regulatory agencies that do not use good science as the basis for their regulations. We are fast approaching the point when we will need to solicit their help in getting the FDA's tobacco regulatory function back on the path that Congress intended. If we do not do it now, we may not have another opportunity.
So Congress is the best hope for defending good science?  Oh that is good news.  And it is because the regulators have acted the way some of us predicted that they would, and because no one is doing the science to push back against them because everyone decided to just trust the process.  On top of everything else, Congress's role is predicated on their intent being enough different from what is happening that they are willing to micromanage it, as opposed to, say, exactly what those who were pulling the strings wanted and expected.

Some of us were un-"Serious" enough to have seen and discussed the impending problems from the start.  All it took was a bit of science (economics, polisci, historiography, epidemiology -- chemistry was not so helpful). 

As Krugman went on to comment today,
you might think that hippies like me were basing their views on some wild and crazy, unorthodox version of economics, while the wise, judicious people who thought that [what was actually done] was just right were using standard analysis.  But actually it was the other way around. .... The hippies read the textbooks; the Very Serious People apparently rely on close analysis of entrails, or something.
It is an interesting question whether Krugman's observations about how the Serious People come around to our hippie reality (and then get more credit because took the Serious position in the first place) will soon come true, as Lauterbach is campaigning for.  Or will it be that by the time they do, the whole matter will be buried far too deeply in the contents of those entrails.


  1. Carl, I have a question on tobacco harm reduction.

    Non-Smokers’ Rights Association/Smoking and Health Action Foundation Harm Reduction in Tobacco Control: What is it? Why should you care?
    "Needle exchange programs, safe injection sites, and methadone clinics are examples of harm reduction initiatives that accept that not everyone is ready, willing, or able to overcome a drug addiction. Rather than exhorting abstinence, these initiatives focus instead on reducing the related harms, such as HIV transmission from dirty needle"

    I agree 100% with the above quote and have to ask why are the methods used in "tobacco harm reduction" not following this principle.

    People who smoke are forced outside day or night and in any type of weather. They are forced to place themselves at "risk" by being exposed and made vulnerable to situations that most people would not be in.

    A great deal of those that speak of "tobacco harm reduction" are under the mistaken impression that people only smoke for nicotine and therefore are really looking at abstinence.

    "If nicotine could be delivered to addicted smokers in a purer form, without the deadly particles and gases formed by combustion, the disease and death now caused by cigarettes would drop dramatically. In Canada and many other countries, the perverse situation exists whereby the product that causes the most harm—cigarettes—is the most widely used and the least regulated, whereas the safest products—nicotine replacement therapies—are the least used and subject to the most regulatory control."

    There appears to be very little interest in the actual product safety. We give the drug user clean needles but we don't consider giving the smoker clean cigarettes?

    I have talked to tobacco farmers and they told me that back in the 50's the tobacco industry only used the very best leaf but now they add the stems and other impurities of the plant. (reconstituted and or expanded leaf)

    "Manufacturers are using more reconstituted tobacco, which makes it easier to add chemicals
    and to include leaf stems and dust which had previously been discarded."

    Why is this additional waste material that is being added to cigarettes not been looked as an area for "tobacco harm reduction".

    And has anyone looked at the long term use of reduced ignition propensity (RIP) cigarettes.

    "Some cigarette manufacturers claim that RIP cigarettes are even more poisonous than their regular products. They use this excuse as part of their campaign to oppose change even though the tobacco industries own tests suggest it is untrue.

    There is some evidence that levels of some toxins are slightly higher arising with some methods used to meet the RIP standard.

    On the other hand there is no evidence that small increases in one or more toxins affect the already highly toxic nature of cigarette smoke."

    Any insight to why the tobacco harm reduction methods are so different.

  2. I will interpret the subtext of this to include "why are you so down on the potential contributions of chemists, given that making smoke safer is the most natural form of harm reduction imaginable?" I will grant the point and clarify that I was not saying that chemistry has no good role, just that most of what FDA has done and has planned is more about epidemiology and economics, so those are the (absent) skills needed.

    As for why THR is different from other areas of harm reduction (apart from the nutcase politics that cause a lot of nasty people to oppose it), the short answer is, I think, the potential to reduce risks to almost zero while keeping the aspect of the behavior that is most appealing to most users. Nicotine is not everything, but it is dominant, and perhaps some of the rest of the experience could be built around low-risk alternatives. Given that option, it is difficult for HR supporters to get so excited about in-between options that offer some reduction in risk, and that is true even if "some" might mean, say, 80%.

    That said, those of us who are genuinely devoted to the principle of harm reduction to support lowering the harm from the smoke as one of the legitimate public health strategies available. Many people will definitely still choose to smoke in the short run, and some even in the long run, so safer is better. So that side of THR is real and there are those pursuing it. It is just difficult to get fully excited about it when the very low risk alternative already exists.


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