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.

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