26 August 2010

FDA regulation of tobacco as intentional sabotage

This morning I gave a presentation as part of a panel talking about U.S. FDA regulation of tobacco, specifically the upcoming discussion of possible regulation of quantities of chemical constituents (e.g., how many arsenic atoms per quantity).  Since that talk is posted behind a pay wall at TMA, and most of you cannot access it, I thought it would be useful to present my key points here.

1. There is no reason to believe that minor changes in concentrations of individual chemicals will have any appreciable health effect for users of cigarettes or smokeless tobacco.

This is a fairly simply point that I suspect most of my readers already know, but basically the harm from smoking comes from smoking, not what is being smoked.  Yes, there will inevitably be some reduction in risk to the user by limiting the concentration of known harmful chemicals.  Contrary to the usual rhetoric and Official Conventional Wisdom, some cigarettes are less harmful to smoke than others (it boggles the mind that anyone could actually believe otherwise).  But minor chemistry changes are not going to produce results that are big enough to ever be detected.

The story might be different for huge changes in the way that tobacco is processed, with wholesale removal of many harmful constituents.  When products with these changes come to market, it is quite possible that the effects will be big.  But big is still a matter of tens of percent reduction in risks, not an order of magnitude reduction.  Compare this to the two orders of magnitude (factor of 100) reduction from switching to smokeless tobacco (or, probably, e-cigarettes).

As for the effects of chemistry regulation on smokeless tobacco, to the extent that ST causes any health risks at all (and the evidence is not definitive about this), there is no reason to believe that there is any measurable risk from any chemical other than nicotine (which, as a mild stimulant, creates some cardiovascular risk).  If a few cases of cancer are caused by other chemicals and those chemicals are reduced or removed, that is certainly good.  But since we cannot even detect that any such cases are being caused, we certainly will never detect the reduction.

2. In spite of Point 1., consumers will learn about any chemical changes that are mandated and implemented, and interpret them as being major reductions in health risks.

The regulators have the idea (which would be rather comical if it were not illustrative of their belief that they can and should control people's fundamental freedoms) that they can keep secret the fact that such changes are made.  No doubt they can keep the manufacturers from making claims that the products are "now healthier!"; it is less clear they can stop them from simply reporting the changes without making health claims (at least not in societies where free speech is protected).  It is completely obvious that they cannot stop the press from finding the changes to be interesting and reporting on them, let alone having the information go viral on new media.  After all, the U.S. government cannot stop classified secret movies of it blowing up Iraqi civilians from becoming public, and for any product chemistry changes, the basic information will be open and public.

Once the information is out, we have ample research to show that consumers will almost certainly conclude that the changes represent major improvements in risk.  Our research (e.g., see ch.10) and others' shows that a large portion of smokers think that particular ingredients (often non-existent ingredients supposed added by manufacturers) account for the largest part of the risk from smoking.  This is due to a remarkable failure to understand just how bad breathing concentrated smoke (no matter what is burning) is, as well as the tendency (largely created by activists and the alarmist media) to attribute risks to particular chemicals (which when used in this context is intended to sound like it is a synonym for poisons).  The anti-tobacco activists have contributed mightily to this misperception (as our and others' research shows) by creating propaganda that talks about individual chemicals and vilifies the tobacco plant itself, rather than honestly communicating that smoking it is the only important risk.

I proposed some research that could be done to confirm these predictions more precisely and that perhaps that could help head-off harmful rule changes, or at least provide some useful "I told you so" ammunition later.  However, I was pessimistic that demonstrating that the possible regulation did far more harm that good would actually change anything because:

3. The FDA regulation of tobacco is not a normal regulatory regime; it is intended by all those in positions of influence over it as sabotage.

For quite a while, I avoided direct involvement with the FDA regulation, not jumping on the bandwagon of offering advice on the matter.  My reasoning was that I wanted to stick to science and communicating with the people, and leave inside-the-beltway bickering to others who knew more about it.  But I am starting to think that I have more critical insight than I gave myself credit for.  Other commentators/consultants/pundits seem to be treating this system as if it were a normal regulatory regime, where the regulators want compliance and recognize that imposing costs (mostly on consumers, and to a lesser extent absorbed by producers) is a necessary downside of ensuring better products.  Their advice naively follows the script that would be appropriate if this were really the case.

But it is not the case.  Rather than thinking that this is like FDA regulation of pharmaceuticals, a better model is that it is like border control laws in a corrupt country.  That is, the rules about chemical constituents, and others, are being made intentionally to make it difficult to comply.  Rules like that are great for border guards, because they can always collect bribes to look the other way.  Of course, there is no one to grease for the case of tobacco regulation.

As evidence of this view, observe how the combination of the congressional actors who made this happen, FDA itself, its science advisory committee, and others have created a crazy-quilt of stated goals and requirements.  People who influence the decisions are committed to a lot of different goals and theories, and it appears that the method for dealing with prioritization or even contradictions is to just do everything that anyone calls for.  Have you ever participated in a community group meeting where some political platform is being created and the organizers employ the strategy of just adding anything that anyone in the room says?  It's like that.  There is no indication that there is any consideration of the costs of compliance.

If this sounds familiar it is because this is exactly what commentators who oppose all regulation often say about regulation in general.  Usually this assessment is very wrong; even if the regulation is not optimal, it almost always results in a better product than would exist in the absence of all regulation.  But for the case of FDA regulation of tobacco, we are not seeing a case of incompetent inefficient bureaucrats who cannot help but muck everything up (as the standard story goes), but one where the mucking up is welcomed by those who created the situation.

Perhaps even better than the border guard metaphor is the classic notion of Kafkaesque laws that are intended to just hurt those subject to them or impossible to comply with (as judged by those in power).  As I pointed out earlier this year, the FDA has the authority, and perhaps even the mandate, to do anything that lowers the quality of cigarettes (and they would likely extend this to smokeless tobacco, though they obviously should not).  Thus, taking out menthol can be justified simply because some people like it.  Why?  Because the total public health impact of smoking depends mainly on how many people smoke, and if menthol is banned then a few people who really liked it will quit smoking.  It would probably be very few, but that does not affect the mandate.  Jeff Stier from ACSH, who was on the panel, confirmed this from the lawyer's perspective.  He also confirmed another of my observations about the Kafkaesque nature of the situation, that the FDA gets to define the rules of decisions (i.e., the science), akin to a prosecutor getting to decide the rules of evidence.  That is, as I emphasized in a talk this spring, there can be no appeal to "science based policy" because a group of activists who already know what policy they want are the ones who get to decide what the science says.  It has also been pointed out that the regulations for introducing products and making claims in pursuit of low-risk alternatives to cigarettes basically require that the products already be widely used (to produce data) before they can be promoted (and thus will never be widely used).

As further evidence of the Kafkaesque situation, consider how FDA objected when manufacturers complied with their rule banning labeling cigarettes as "light" and the like.  As I explored from a different perspective a few weeks ago, FDA itself lashed out at companies who rebranded these products according to the rules.  This was not a case of outside activists who thought that the rule did not go far enough, but the government actors who created the rule themselves.  It is as if, upon enacting a speed limit, the police started pulling over people who were obeying it, fuming that they were getting away with something.  Recall our corrupt border guard:  When someone complies with the rules, he is much less happy than when they cannot.  He might even try to punish them for doing so.

This is not too surprising, of course.  Those with all the power over this process are committed to destroying the products and companies they are regulating.  It appears that no one in power is committed to the normal regulatory goal that is demanded by principles of good governance, to maximize the value of the product to society.  Unlike most regulatory systems, that are quickly captured by the industry they supposedly regulate, and thus favor it too much, this regime was pre-captured by a different interest group, the anti-tobacco industry.  What is worst about this for public health is that because they are the anti-tobacco extremists, they are even more committed to preventing harm reduction than they are to reducing smoking.  And what could be better for damaging the market (the legal market anyway) than to require expensive and foul-tasting alterations to products, pretending that this is intended to make them healthier.

In short, the seeming randomness and pointlessness of what FDA is doing and proposing is creating costs, but those costs are not just the price that has to be paid for the real goals of regulation.  Those costs are the real goals of this regulation.  This is not the case of regulation putting a bit of sand in the gears, as it inevitably does; it is not sand in the gears, but sabots.  So far, it looks like industry is treating this as a case of honest regulation rather than sabotage, but I do not see anything useful coming out of that.  As Stier pointed out this morning, the industry representatives were basically disinvited from the FDA science board meeting about constituents because no one was interested in what they had to say.  If Kafka were writing today, you could just imagine the defendant in The Trial being told that he could just listen to the proceedings over the webcast (as industry was advised) because nothing he had to say mattered.

Many years ago, I analyzed how in regulatory regimes like that presided over by the FDA, the industry has the role of speaking up for what people want.  That is, the normal part of FDA is concerned only with safety and health effects, and there is no government Agency for Promotion of the General Welfare so the only hope was that people wanted to buy something and so industry wanted to sell it, and so would make a case for that.  But I observed when FDA banned the very popular decongestant phenylpropanolamine (PPA), the industry did not resist at all because they really did not make much money from selling it (since anyone could produce and sell it, there were no monopoly profits), even though the loss to consumers was huge.  We can see something similar occurring now with the moves to ban BPA -- no one makes enough money from it to want to fight very hard, even though the costs to consumers are going to be substantial.  But since those of us promoting public health (and thus regulation that promotes the use of low-risk products), general welfare, and personal freedom have so little voice, and consumer advocates have been systematically driven away from defending tobacco products, the industry are the only ones who can push back against the anti-tobacco extremists.  

This could work out better than the PPA or BPA cases, since the industry clearly has an incentive to protect these product lines.  But so long as industry actors follow the script that has been handed to them, acting as if the FDA process is an honest effort at regulation, there will be no push-back.  In theory, sabotaging the legal market for tobacco products could be good for public health, and perhaps some of the FDA-backers actually believe it.  A more realistic prediction, I think, comes from looking at what a wonderful effect driving the market for other drugs underground has on public health and social functioning.  Clearly sabotaging the market is bad for overall welfare (unless you are regulating land mines or ground glass), and it obviously is bad for the regulated industry.  Perhaps it is not too late for the industry to act based on these impacts (or at least the last of them) and adopt a strategy that slows FDA's efforts to turn tobacco into Drug War II.

23 August 2010

Just what do the anti-tobacco extremists think they are regulating?

For the last few months, a lot of my contemplation about the logic and sociology of anti-tobacco has focused on the question, “what exactly do they think they are regulating or trying to create appropriate public policy about?”  My working thought was landmines, but I recently refined that because I think that they have directly answered my question with their current advertising campaign.

To explain:  Landmines are a scourge that kill and maim thousands of innocent victims in many parts of the world.  There is an effort to ban them supported by most countries in the world (with the holdouts being, not surprisingly, the most militarized countries that largely fight their wars on someone else’s land, a few that really have no interest, and, sadly, a few whose people are often victims).  Here were some observations that led me to the comparison:

-The call for an outright international ban of landmines is explicit and is widely supported.  Anti-tobacco activists are aware that there is very little support for prohibition, so almost never admit they support it, but they act as if there were as much support for a ban as there is for mines.  They act as if current regulation of tobacco products were really prohibition.  For example, when someone obeys the regulations that are in place, such as by changing the packaging of former “light” brands or continuing to sell in ways or places that are allowed, the extremists characterize it as a “loophole”.  By that standard, all those people who drive just below the speed limit are taking advantage of a loophole that needs to be closed.  If there were a consensus to ban driving and the speed limit were actually intended to prohibit driving, then thus merely obeying the letter of the law would perhaps constitute a “loophole”, as it would for a variant on landmines that skirted the treaty.  The anti-tobacco extremists seem to not understand that there is not a prohibition nor general support for one.

-Almost all victims of landmines are innocents, involuntarily exposed because they had no choice but to work on mined land or because they had no idea that there were mines where they were walking.  Thus, “consumers” of mines received no benefits from them and did not consent to or benefit from their deployment.  (Perhaps the case differs for the rare victims who are intentional combatants and encounter mines used in set-piece combat situations, like to guard a military base against approaching invaders.)  This fits the extremists’ bizarre interpretation of cigarette/tobacco/nicotine consumption as some complicated involuntary spasm, rather than as a consumption choice that has benefits and costs, and thus might represent rational decision making (and undoubtedly does in some, but not all, cases).  Their model is that, unlike every other consumer good – iPhones, Starbucks, Hoegaarden, Priuses – the distribution of the product only benefits those distributing it, not those receiving it.  Never mind the volition involved in purchasing and consumption, as well as the the many known benefits; their theory is that tobacco users (even those using low-risk tobacco) are unwilling targets, as if they were victims of landmines.

(Some readers might argue that smokers are often the target of the extremists’ attacks despite the claim that they are the intended beneficiaries of anti-tobacco policies and propaganda, which is a rather sharp contrast with anti-mine activists.  But in some ways this still fits the model:  If one denies that the users are getting any benefit, then torturing users until they change their inexplicable behavior could actually benefit them.  This contrasts with all normal consumption decisions, where the benefits of consumption to the consumer must exceed the costs, and thus increasing the costs necessarily hurts the consumer, either by driving him away from the good (in which case all net benefits are lost) or raising the cost without changing the behavior.)

-Those distributing landmines are trying to injure and kill people.  While it is certainly the case that many people in power in tobacco companies for several decades demonstrated a callous disregard for known health effects, and undoubtedly some of those currently in power still have that attitude, suppliers do not actively want to kill anyone.  Moreover, many of those steering the industry now are basically riding the tiger, trying to reverse the damage done by cigarettes in the only way possible, by turning low-risk products into a viable alternative for producers and consumers.  One of the silly demands by some activists is that if a company really cares about harm reduction, it should just stop selling tobacco products.  (Gee, I wonder if anyone would step in to supply the demand if that happened – let me go find a high school economics textbook or a well-read eleven-year-old to help me figure out that tough question.)  But that demand would make sense for landmines; if a particular actor stopped deploying mines, it is not like someone else would step in and make the same ground deadly, because it is genuinely all supply driven (there is no demand).  There is no reason to ask the distributors of landmines to do anything other than cease.

But despite the parallels between the reality of landmines and the confused attitude toward tobacco (and I think the one about the difference between a demand-side and a supply-side phenomenon is particularly useful), there are a few things fundamentally wrong with the comparison.  Landmines are obviously not intended to provide any benefit to those on the receiving end, and are not a consumer product.  They are intended as weapons and their proponents argue that they serve a worthy purpose by killing some intended targets.  Banning them, like banning any weapon, necessarily interferes with the plans of those who want to use force, not the choices of consumers.  While I still think it is fair to say anti-tobacco extremists act as if they are trying to regulate the distribution of landmines to consumers, it seems safe to assume that even most of them recognize that tobacco/nicotine does not represent an intentional assault by one group on enemies that they are trying to kill, and who obviously would prefer that the product did not exist at all.

After struggling for a better comparison for a while, I found it.  Actually, it was given to me.  I did not have to make up an analogy, because the extremists actually volunteered it.  The American Legacy Foundation (the huge anti-tobacco organization paid for by a de facto sales tax on U.S. cigarettes) recently re-released its “shards o' glass” campaign (note that this webpage does not seem to work with all browser configurations; with billions of dollars and a primary mission of delivering propaganda, and they cannot even create a fully functional website – or perhaps my security software just recognized it as malicious).  For those who have not seen the campaign, which debuted in a Superbowl ad a few years ago (talk about dollars!), they liken tobacco products to popsicles that contain pieces of broken glass, creating fake television ads for the latter that are supposed to parody ads for cigarettes (which, of course, have not existed for decades -- in addition to thinking they are dealing with the wrong product, the extremists are definitely stuck in a bygone era).

The new version of this advertisement, which they recently started hyping, features new fake products that are clearly intended to mimic the Camel Orbs style of products (though perhaps, since they are not in a childproof container, maybe it is really supposed to be Nicorette lozenges).  With its emphasis on dissolvable oral products and presumably intentional invocation of the fiberglass myth(*), Legacy’s propaganda is clearly aimed at discouraging the use of low-risk nicotine products, making it the worst kind of anti-harm-reduction (and thus anti-public-health) extremist propaganda.

[(*)There is a zombie myth (one that will not die despite having absolutely no support in reality) that smokeless tobacco products have fiberglass added to them.  This actually seems to not have been engineered as propaganda.  It appears to originate from people not understanding that intact mucosa can absorb all manner of chemicals, and thus thinking that some method of making holes was necessary for nicotine delivery, and the appearance of salt crystals that could be mistaken for glass in some products when subject to certain conditions.  Of course, the anti-THR propagandists have been happy to perpetuate the myth.]

Presumably Legacy intended the broken glass silliness to be a bumper sticker for their naive foot soldiers (“using smokeless tobacco is just like sucking broken glass”) and a “nyah nyah” point for children who are inclined to believe propaganda to deploy when criticizing their tobacco-using elders or more rebellious peers.  I am sure that American Legacy Foundation President Cheryl Healton and most of her top lieutenants are not so stupid as to think that dissolvable tobacco products – which have no proven risks and are clearly very low risk – are similar to a product that would likely cause rapid death from internal trauma, and they are far too political to actually make such a claim.  But they clearly would like their foot soldiers and target audience of impressionable children to believe and repeat exactly that message.

But this analysis is about their view of the product they are fighting, not their lack of ethics, and a closer analysis of the content of the ads reveals more about that.  Yes, they try to ridicule consumers who are joyously popping the acutely deadly products into their mouths.  But they also show a mock industry spokesman giving a version of the standard message that these products are intended for adults only and are intended to meet demand from legal consumers in legal situations.  The message is not merely that low-risk products are an absurdly deadly travesty, but that efforts to obey the law and sell such products only to adults are also somehow a travesty.  By trying to turn this message into a joke, Legacy makes clear that they really think they are fighting the marketing and consumption of something just like broken glass in food.  If that really were the case, then they would be justified in attacking products that reduce the risk by a factor of one-hundred (why merely almost eliminate the risk of a product that is utterly valueless) and ridiculing the notion that it could be a rational choice by adults.

Like landmines, no one would want to be on the receiving end of the glass product.  Deployment of both products is rapidly deadly without question.  Any attempt to distribute any version of either product would be a homicidal act.  If the glass product somehow actually existed, everyone would support the complete ban that the extremists seem to mistakenly think is widely supported for tobacco.  But unlike landmines, which are openly intended to kill enemies (though they usually kill innocent bystanders), the glassed food is portrayed as being a voluntary decision by the consumer.  So it is not so much something analogous to landmine use by military forces that the extremists think they are trying to eliminate, but something that absolutely no one would benefit from or ever consider doing, but that is inexplicably extremely popular.

Yes, I know that the ad campaign is intended as parody, but the fact that they think this parody is anything other than random farce tells us a lot about their fantasy worldview.  It is clear from hundreds of statements they make that they think they are dealing with something other than a popular consumer product, albeit one that is quite dangerous in one of its several forms.  With that background, the glassed food parody is really an aha moment.  The behavior of the anti-tobacco extremists is frequently unethical and seems ludicrously out of touch with reality when we assume that they actually understand the role of tobacco in society and people's lives; but if we model them as thinking they are actually on a campaign against glass-filled food, everything they do makes more sense.

22 August 2010

Enstrom-vs-UCLA SPH, rules, politics, and my own experience

I have been asked by quite a few people to offer further comments about the Enstrom situation from the perspective of the professor who was in the most similar situation recently.   I decided this analysis calls for a new post rather than an update to my previous news-oriented post.

There has been a bit of debate about what the rules say and allow.  Mike Siegel argued that firing Enstrom as they did violated the rules, citing AAUP guidelines (which are non-binding recommendations/demands by the professors' advocacy organization, which may or may not influence university rules) and guessing that university rules were violated, particularly regarding the very limited warning time and Enstrom not having the opportunity to present his case.  On the other hand, via private communication with a friend at UCLA public health (someone whose name has not appeared in the posts about the matter, btw), I have learned that it appears that Enstrom's appointment was such that the proceedings actually did follow the letter of the rules.  I would argue from experience and observation that it does not really matter which of those is true.

What really matters more in a case like this is the optics -- how it looks to interested influential constituencies.  Because the optics are so completely on Enstrom's side on this case, I think it is a good bet (I will offer 5-to-1 odds) that, assuming he does not choose to retire or take a position at a think-tank that allows free inquiry, he will do no worse than keeping something equivalent to his current position, though the university will likely move him to another unit to save face for those who instigated this.  There is some possibility that the university will make him an offer that is better than sticking around just to be done with it.

As background, it is useful to realize that most professors and department-level academic administrators are terrible at politics.  The former are too busy being scientists/philosophers/etc. (there is something to the stereotype about the nerd/party-kids divide, after all), while the latter tend to be barely competent middle-manager-types (the conventional wisdom is that anyone who actually wants to be department chair should absolutely never be allowed to have the position, and an implication of that is to never join a department where the chair job does not rotate often).  This is why in academic departments unscrupulous people who are good at politics can get away with most anything so long as they do not cross top administrators.  University administrators, by contrast, are generally excellent politicians, rising in the hierarchy with the same skills that would have worked in a big company, the bureaucracy, the military, or electoral politics.

As a result, most professors and low-level academic administrators are clueless about political maneuvers, like how to fire of someone.  That characterizes Enstrom's situation and my own (I will tell the full story of before too long; before going on, I feel the urge to note that I was not so stupid as to walk into the situation: there was a disastrous administrative shake-up and the chair who hired me and almost all of the quality people left the department, leaving me isolated among political hacks).  The problem is that the players are generally a combination of a petty tyrant administrator who thinks he can get his way just by issuing orders and professors who think that if you follow certain formalized rules then certain things must eventually happen.  And typically they start by doing something really dumb that puts them in such a hole that they cannot dig themselves out.

In my case, the people who tried several times to fire me from the University of Alberta School of Public Health because they did not like my research did quite a few dumb things.  To name just a few of many, they tried to give me the lowest score in the department in my annual performance review even though I was one of the best performers by any measure (this was overturned on appeal); the Dean subjected me to an arbitrary financial audit and finding nothing else tried to accuse me of impropriety because of books I had bought, insisting on having the authority to tell me I could not read certain material as part of my research (saying this in front of my union rep, no less -- note that such utter tone deafness is exceptional -- itwas because the Dean parachuted in from outside academia); and the department chair (not the one who hired me, obviously, but her successor) explicitly said, in front of witnesses, that the reason they were trying to get rid of me was because of the content of my research.  With all that on the table, I was pretty much bullet-proof.  Even if they had a case against me for something, after all that they would have a very difficult time getting their accusations taken seriously by any outside observer, like the university administration.

In Jim's case, the attacks regarding his ETS paper years ago left him in pretty good shape.  It is clear that there are people out to get him because his legitimate science revealed a result that they do not like.  But the justification for the decision to terminate him, that his research focus did not align with the department, finished off any hope they had of not being buried politically.  As Siegel explains nicely, his research fits the department perfectly, unless of course you define fit in terms of always manipulating your analyses to get the results that the political actors in the department prefer.  At this point, then, it does not really matter whether the vote to oust him was legal or not.  It is now clear that people are out to censor his research -- without apparently having any legitimate basis for criticizing the research -- and so that no rationalization they come up with now, even if it is actually legitimate, will play well.  For example, my aforementioned source say some people believe that Enstrom was identifying himself using an incorrect title, though it is not clear that this is not just another trumped-up inaccurate claim.  While things like this are not the sort of thing you can fire someone over (unless he had ignored explicit instructions to stop doing it, perhaps), but accurate trumped-up complaints could have been piled on to construct adequate rationalization, had they not blown it by making a claim that was incredibly embarrassing to the accusers.

Oh, and it helps that he has published controversial but scientifically unchallenged claims of substantial worldly import (as was the case with me) and is a successful whistle-blower.  It is probably fairly easy to fire someone in critical literary studies whose research is not liked without generating much fuss in the newspaper.  But now it is like a company trying to fire its one black employee who recently came out of the closet:  It does not matter if he is legitimately performing at a level that justifies termination -- no one in their right mind would try it.

So it really does not matter if the department faculty are legally authorized to vote him off the island just the way they did.  It no longer matters if they can come up with a legitimate justification for firing him.  They screwed up and made this a major political issue, and the people who do understand politics realize that the cost is far too high to have Enstrom out in the world telling talk radio hosts how the University of California fired him for daring question the liberal orthodoxy.  The game is already over, even though the naive among Enstrom's attackers may not understand it.

There are ways to drive away a professor.  With a bit of patience, you can force someone into bad office space, horrible committee assignments, advising the poorest master's students, etc. until they just want to leave.  I cannot imagine the Jim wants to stick around in the environment they have created.  (In my case, I had the best offices in the department, in trying to isolate me they ended all my committee assignments, and since the department was falling apart there were many new students to assign.  As I said, they were not very good at this.  Being stuck in what had become such a low quality department -- during the last round of student admissions I participated in, I argued that it would be completely unethical to admit students until the curriculum improved --  eventually was sufficient to drive me away, but I don't think they did that on purpose.)  Smart operators can make sure that any overt administrative acts follow due process and are sufficiently arcane that they are not patently absurd, as was the case with Ward Churchill.  University of Colorado officials said some improper things about him early on, but avoided acting until there was an investigation that accused him of the rather arcane academic crime of passing some of his work off as other people's (yes you read that right).  Even then, a jury found that he was wrongfully terminated, though he did not have the political juice to do anything with that.

The message here is not pure optimism.  I think that politicized semi-academic programs, like most public health schools are quite good at censoring science that they disagree with in many different little ways.  But when they are so clueless as to do something that can be easily described in a newspaper lead sentence to someone who has some prominence, then they are out of their element, and the rules they think they are playing by no longer apply.

16 August 2010

UCLA School of Public Health votes to fire Jim Enstrom

The faculty at UCLA School of Public Health apparently voted to fire Prof. James Enstrom.  I am not quite sure what the full story is yet, but those writing about it seem to think it is enforceable (however, I can tell you from experience that there are people who think they can subvert academic freedom and fire a faculty member because they do not like what he writes, but discover they actually cannot).

The claim is that Enstrom's work was unsound, which I can assure you is not the case.  Besides, anyone who pays attention can see that doing the worst imaginable junk science will not get you fired from a school of public health.  This was obviously political.  Enstrom’s recent foray into controversy had to do with outdoor air pollution, mostly associated with diesel engines (read the above link – it is quite a story).  It seems unlikely, however, that anti-diesel people have the combination of firepower, egocentrism, and lack of ethics to bring about the firing of a senior academic researcher.  While they undoubtedly played a part, I have to assume that this was substantially the long-sought revenge of the anti-tobacco extremists for him daring to publish good research that suggests that any health effects of second-hand smoke are trivial.  He and I have both written about how his story epitomizes the anti-scientific attitude of the anti-tobacco movement and of public health researchers more generally.  Universities and real academic departments consistently stand up for academic freedom and free scientific inquiry, and favor good research over bad, but public health programs have generally descended – in scientific quality and ethics – to the point where they might as well be the “health promotion” people at county health departments, or Mad Men.

One result of this action, I predict, is that it will become impossible to keep up the narrative that Republicans or the right in America are the ones at war with good science.  Whatever you might believe about that generalization’s accuracy (it certainly never applied to public health where the junk science tends to come from the left), it is likely to be replaced by the story that, “under Obama, professors who dare challenge the liberal propaganda get fired”.  I assume that enough Chamber of Commerce types follow Enstrom’s work that they will not overlook this event or its symbolic importance.  It would be quite interesting to see UCLA or schools of public health in general get the full Fox News treatment.

I will follow the story, try to talk to Jim, and update this post.

Update (17 Aug - morning):  The original ACSH email that broke this news (i.e., that went international the Bakersfield newspaper article linked above) now has a URL.  Ben linked to it in his comment, but here it is again.  Also, Chris Snowdon goes into more detail about why the information reported in the Bakersfield article is rather a smoking gun about this being more about the tobacco research than Enstrom's current controversies.  I will be talking to Enstrom as soon as it is morning in California.  I will report more if I learn anything I can repeat.

Update (17 Aug - afternoon) A new article appeared in the Sacramento newspaper which does not even mention Enstrom's previous work on tobacco.  It attributes the vendetta against him entirely to him having a non-politically-correct position on diesel exhaust alone.  This does not mean that is necessarily right, of course -- note that Beate Ritz, the only one involved in the proceedings against Enstrom who did not refuse to offer any explanation, cited only the tobacco research.  But it still might mean that I am wrong and California is so far gone down the anti-science road that scientific opinions that in multiple areas (not just tobacco and the usual hot-buttons), including the relative arcane study of particulate matter pollution, disagreeing with the political power will arouse censorship attacks.

Regarding Prof. Ritz, Enstrom mentioned that she is the one person involved with the purge who has the skills and potential for objectivity to weigh in on the research.  I am attempting to reach her for comment through my own connections.  She refused to respond to Enstrom directly and he asked me what I could find out.  Unfortunately, as Geoffrey Kabat forcefully noted (scroll down)  in a comment on the Bakersfield article, she apparently did not attempt to play that role.  I will report her comments or her refusal to talk.

As for my conversation with Jim, he was not ready to go on the record with much information yet.  But given the questions he asked me about my experience, it is pretty clear that this was every bit the blindside that some of the comments about it portrayed.  He did not know this was coming and has literally a matter of days to figure out how to appeal it.  He mentioned the connections to the usual suspects in tobacco (Glantz, ACS), but was more interested in discussing the context of his recent work, which seems to have a similar collection of dishonest actors.  He offered the phrase "total hypocrites and just plain bad scientists" (this was generic about the type of people he is dealing with -- he was not referring to anyone specifically).

He noted, in particular, the experience of the small and medium businesses (in transport, construction, etc.), getting slammed with these new health regulations -- based on debatable science -- and having no idea what to do.  There are reports of the guys who run these firms just despairing and confused, trying to deal with the situation.  My take on this is that even if the science were indisputable, this is clearly a horrible regulatory process, that disregards all the basic principles of ethics, transparency, due process, and incrementalism.  The targets of the diesel regulations are not big pharma companies or some other entities that are used to dealing with arbitrary regulatory decisions and adjusting to them (and fighting them effectively if so desired).  If there were a viable transition strategy in place, one that did not just heap the costs onto existing businesses and drive business to other jurisdictions, and the costs of transition were thus fully recognized, I have a feeling that genuine doubts about the science would be taken much more seriously.  This seems to be a classic case of deciding that the way people have been doing things for decades is wrong, and thus any suffering they experience as a result of changing the rules should be counted as just dessert, a benefit of holy vengeance, not the real cost that it is.

Enstrom noted to me that he has been forced to sacrifice doing new epidemiologic research in order to be a watchdog for good government.  Since good epidemiology gets ignored when it gets the "wrong" result, this is probably an efficient choice, and an impressively altruistic one, though the repercussions are pretty awful.

Update (18 Aug - very early a.m.)  I exchanged messages with Beate Ritz through a mutual friend.  She declined my invitation to correct or clarify anything she was quoted as saying, or to explain to the world or to Enstrom what she knows of what happened.  I get the impression that she did not actually play any substantive role in this matter and wants her association with it to just go away.  She is not in the same department (i.e., was not part of the vote) and does not play any role in the decision making.  However, if it is really the case that she was not asked to weigh in it would mean that members of the faculty who (like her and just a few others) were best qualified to assess the substance of Enstrom's work that was supposedly the basis for the attack were not asked to do so.

Chris Snowdon put a face to the irony of the claim that the basis for censoring Enstrom was that he drew conclusions beyond the results of his research.  I notice that he, like I, could not really find words to follow that claim.  Sometimes actually adding a punchline to a joke simply cannot be as funny as leaving the set-up hanging.

On a more serious note, I wonder if U.S. whistle-blower protection laws cover this matter.  Enstrom clearly blew the whistle on some serious ethics violations by one arm of the state of California, and his employer is another arm of the state.  And then, there is that whole free speech thing.  I cannot begin to guess what the law actually says about such matters, but it would be interesting to find out what federal authority over the states (laws created to try to protect black people from oppression by racist local governments) might apply here.

Update (18 Aug - afternoon) To fully understand the ironic (to put it kindly) ramifications of how the firing was justified, and some of the politics of the California air pollution authorities, be sure to read Mike Siegel's analysis.

A new newspaper article reports that 22 members of California's legislature have written a letter demanding an accounting by UCLA officials.

There is a rumor (I cannot confirm) that the story has been picked up on national talk radio.  Perhaps Fox News is indeed right around the corner.

(22 Aug) I have now continued this analysis here.

02 August 2010

FDA is behaving normally (unfortunately)

There has been much discussion about whether FDA's regulation of tobacco will go down a reasonable and sensible path, and whether decisions will be based on whether they improve the human condition.  Little to none of this discussion has paid any attention to the political science issues of institutional culture that strongly suggest an answer.

This probably passed below most everyone's notice (because FDA are not yet very good at being activists), but the FDA tobacco regulators recently tried to launch an activist campaign against no-longer-called-light cigarettes.  This is significant not because it had any impact, but because it is non-science-based activism of the sort that we and others predicted would occur if FDA took on lifestyle nicotine products, leading them beyond their competence and lowering the credibility of the entire organization to that of political activists rather than trusted scientists.  (Our comments about this during the FDA comment period were reprinted here and in Tobacco Harm Reduction 2010.)  FDA's activist campaign dovetails with overtly activist organizations who attacked the cigarette companies for rebranding their formerly "light", "mild", etc. brands with new recognizable packaging that removed the banned words (just what else were they supposed to do???).

If I wanted to write a two paragraph post, I could just notice that FDA seems to be at risk of smoking their credibility as scientists to pursue an activist agenda.  But there is more to it.

The problem is not that this particular activist message is a bad one.  "There is no safe cigarette" is clearly literally true and, moreover, unlike "smokeless tobacco is not a safe alternative to smoking", it is actually honest.  (The latter quote is a clear case of substituting truth for honesty, a lie by any realistic measure, as I have written about extensively.)  But the message is clearly a departure from regulation into social engineering.  FDA cannot be so out of touch as to think that anyone still believes there is such thing as a safe cigarette, so this is not the type of factual warning that is FDA's institutional competence and designated role.  The epitome of activism behavior was FDA's junk-science attack on e-cigarettes, but the latest foray into activism -- clearly institutionalized and planned -- shows that the former was not an isolated fit of pique.

FDA's history of pharma regulation shows that they (a combination of government employees and the outside consultants/advisors they choose and then yield most decisions to) is already quite bad at appropriately assessing tradeoffs between medically-defined risks and other human preferences.  They do fairly well with questions of whether a life-saving disease treatment does more harm than good, but tend to fall down when the benefit is something other than saving lives.  To illustrate with just the most recent failure to understand that there is life beyond mere longevity, FDA recently prohibited the introduction of a drug to combat low female sex drive, based on the evidence that it sometimes caused dizziness and other passing minor ailments, and does not provide much benefit to many users.  Their panel said that the benefits did not justify the costs.  For whom?  This was not a question of hidden health costs or a ticking bomb -- the benefits and the costs were both immediately evident to the consumer, who could thus make her own choice.  If she is one of the ones with unpleasant side effects or for whom it does not work, she does not need to take it twice -- no serious harm done; if it works for her, she can figure that out too.  But, no.  FDA decision makers decided, in effect, that they personally would not choose to take the drug and so therefore no one should be allowed to see if it works out for them.  FDA's institutional culture does not really approve of letting people choose tradeoffs for themselves.

To counteract this narrowness of vision, getting Viagra approved required a junk science study that "showed" that the average man would accept a 1/3 chance of dying immediately rather than suffer from complete erectile disfunction.  This allowed the message to be not just "lots of people really want this a lot" (which FDA is not good at understanding) but "there is a big loss in quality adjusted life years", just like there is with premature death.  And all it took to do this was an utterly absurd quantitative claim.  As I always told my classes when I used that study as a teaching example, if that is really true then most men's lives are either far less interesting than mine (because they would so easily give them up) or far more interesting than mine (because, well....).

Another example that I used for teaching was the ban of the decongestant phenylpropanolamine (PPA) based on some sketchy evidence that maybe it caused an occasional stroke.  FDA's position was that millions of people getting relief from cold symptoms was of no consequence and since there was suspicion (little more) that a few users might die from it, this trumped all of the benefits.  Never mind that it was easy to show that even if the strokes were occurring at the rate claimed (which seemed very unlikely), the benefits of PPA were enormously greater than the costs.  If FDA had the authority and followed their script, caffeine, rock climbing, and compact cars would be banned, and non-procreative sex would be at serious risk; alcohol might be allowed, but only because it protects against heart attack.

Of course, you might respond that FDA would not follow the usual script when it came to rock climbing.  But therein lies the problem.  Scripts matter.  Habits matter.  Put the police in charge of enforcing drug laws and they arrest and jail a lot of people because that is what they know how to do.  Put the military in charge of nation building and they end up killing a lot of people and creating more rebels than they actually get rid of; it is not that there is something wrong with the military, it is just that they are very good at some things, but nurturing institutions is not one of them.

So, the FDA follows their script.  People's preferences for anything other than longevity are ignored, and utterly absurd science carries the day so long as it conforms to a set of stylized rules.  If the latter makes it sound like a sporting competition to you, then you understand.  This is the game the FDA plays.

But as odd as it may seem, this is not usually such a bad system.  FDA makes policy decisions in a way that violates any accepted ethical standard (note that a lot of what gets called "ethics" in the discussion of health has little to do with real ethics, but that is another story).  But FDA has evolved in a way, to particular narrow purpose and narrow-minded action, that means that this is not as wasteful of human welfare as it might be.  It would be crazy to design an agency that plays by FDA's rules, but it is actually pretty much impossible to create a well-functioning large institution by design.  The beauty of institutional evolution is that incremental changes yield something good that never could have been designed from scratch.  If FDA's methods were bad at regulating new medicines and their other charges, they would have been changed due to pressure, but such evolutionary pressure does not exist to create methods that would be good for regulating other products.  This nice evolution only works, however, when changes are kept incremental, which is why political science advice tends to favor incremental changes over utopian plans.  Massive top-down changes are likely to create havoc, such as putting this narrow way of doing things in charge of something that does not fit the mold.

In the case of tobacco regulation, it is easy to see how that can play out.  FDA's institutional failure to recognize human wants beyond longevity is a very bad sign for FDA's ability to regulate tobacco.  Tobacco/nicotine is a product whose costs include life-threatening disease but whose benefits are psychological and lifestyle.  But it gets worse:  FDA is used to having police powers and being obeyed, and it is easy to predict the same frustration that leads cops and armies to lash out at people who will not do what they are told.  When FDA called for the removal of PPA, pharmacies locked their doors and started pulling the many popular products containing it off the shelves as if they were poisoned.  So when people did not just do what The Authorities wanted them to do -- to magically forget which new brands were their old preferred "light" cigarettes and stop buying them -- FDA launched an astroturf campaign to fight people's choice.  The e-cigarette junk science study was clearly a case of lashing out:  FDA is used to unquestioned police powers, and when someone dared challenge them, FDA lashed back with a blatant propaganda campaign (for those who do not know, the two brands of e-cigarettes FDA tested and attacked were made by the companies that were suing FDA for overstepping its authority, and while the study results showed nothing relevant to health risk, they were touted as showing that e-cigarettes are as unhealthy as smoking).  You can see where this is going.

And it gets one step worse than that.  You might argue that since the FDA tobacco unit was created from scratch, the FDA culture would be weakened by new hires.  The problem is that not only is this unlikely to eliminate an institutional culture, but also that most people interested in working there are part of the anti-tobacco industry which has many of those same ethical failings of the FDA script (when it is applied to anything other than disease treatment), only more so.  The dominant attitude among those activists is to ignore all ethical concerns, causing whatever harm is necessary to support the anti-tobacco extremist goal of eliminating all self-administration of nicotine regardless of other concerns.  (No, that is not hyperbole -- they basically say that themselves, with pride.)

So where does that leave us?  An institution that is used to being obeyed, and that does not function well in a realm where that does not happen, and that primarily measures life years saved and dollars spent and ignores most other human desires.  Merge in a political movement that has been itching for more police powers and tends toward utopian (i.e., overly optimistic fascism) extremism.  I am not sure whether the better metaphor is The Drug War or Afghanistan.  Either way, I fear that even most of the pessimists have not predicted just where this is going to end up.