18 November 2010

FDA exercises its muscles but not brains, bans caffeine

Ok, they did not really ban caffeine, of course.  What they did was notify the makers of Four Loko and similar high-alcohol + stimulant drinks that the caffeine was an "unsafe food additive".  As I predicted, following all the press that only talked about the caffeine, and not the other less-studied and possibly more dangerous stimulants in "energy drinks", the ban is only on the caffeine.   There was no mention by FDA of any other stimulant.  The government's chief drug warrior also weighed in, repeating the caffeine-only view of the problem.  My nonsystematic review of the news found only one mention of "other stimulants", by CNN.  Everyone else continued to get this wrong.

It is utterly implausible that a small coffee's worth of caffeine, when mixed with what is roughly five shots of liquor and two cans of soda, has any substantial effect.  The same cannot be said for other stimulants (taurine, guarana, etc.), which we know much less about and have some reasons to be suspicious about.

The maker of Four Loko moved ahead of the ban, saying they would reformulate their product to leave out all the stimulants, not just the harmless one.  Assuming they make good on that promise the resulting product will be the equivalent of store-brand soda with cheap vodka, which I suspect is cheaper and easier to acquire in most jurisdictions, and can be mixed to taste.  Perhaps Four Loko has enough brand equity to keep selling in spite of this.  If that is really the case, perhaps the authorities should be investigating marketing practices rather than ingredients.

But it is inevitable that someone -- one of the other four market incumbents or someone else -- will fill the void with a product that dutifully leaves out the caffeine but ups the other stimulants (which are harder to find in, say, the cooler of soda that is sitting right next to the cooler of booze at a party).  This might turn out to be relatively low-risk, like we know the caffeine is, but we do not know that.  It seems plausible that the much talked-about case of a heart attack that was attributed to one of the existing drinks was caused by the taurine, which relatively few people are used to consuming and which stimulates the heart in particular; it was almost certainly not caused by the one cup of coffee worth of caffeine.

So, we shall see if FDA succeeded in killing anyone by banning something that is very low risk while doing nothing important to discourage the high-risk alternative.  (See also: electronic cigarettes.)

It is really quite remarkable that news reporters have let FDA pretend that they can keep people from mixing alcohol and caffeine by banning four products that put them in the same can.  If anyone needs a recipe for making caffeinated alcohol using common household products, I would be glad to provide it for them.

But that was not really what this was about for FDA -- it was pure muscle flexing, trying to see what they can get away with and pushing the boundaries of how much they can meddle in people's personal choices.

This is quite a bad sign.  My personal bias is that the world is probably made a better place through the removal of these products (for an extra few dollars the kids can drink good beer and Starbucks).  But, first they came for the Four Loko and I did not object because I did not like Four Loko..., and so on.

The press release suggests that this was the proudly implemented pet project of FDA's Nanny in Chief (I don't remember his exact title, but I think it is something like that), Josh Sharfstein, who may be the greatest threat to the well being of Americans that almost no one has ever heard of.  It seems unlikely that any of the targeted manufacturers will have the resources to fight this (notice that FDA arbitrarily avoided sending notice to the much more influential makers of such caffeinated alcoholic beverages as Kahlua and Starbuck Liqueur -- an interesting point that would almost certainly be grounds for challenging the action if anyone involved had the resources to stand up to the FDA).  The feeling of unmitigated power that this will create will inevitably lead to further nanny attacks.

No doubt also that the unchallenged perversions of the science will encourage more such behavior.  Those who were gunning for these beverages made repeated pseudo-scientific claims (let's be frank:  lies) about the supposedly known effects of mixing caffeine and alcohol which defied common sense and were not supported by evidence.  But they got away with it, so they know that they can do it again.

So when does the caffeine in Coke get declared an "unsafe food additive"?  If the new trend becomes mixing Mountain Dew and vodka into homemade Four Loko (minus the possibly actually bad ingredients), will Sharfstein and company ban Mountain Dew?  Probably not because its manufacturer has enough lawyers and lobbyists to fight back and perhaps even consumers would stand up for themselves.  So instead, they will keep chipping away around the edges, attacking targets that are too weak to stand up for their legal rights or for good science, banning things just because they can, regardless of whether the ban will help or is even rather likely to cause harm, as in the caffeine targeting (or, of course, attacks on low-risk alternatives to smoking).  If things go their way, they will eliminate low-risk nicotine products, Mountain Dew, and Coke, and eventually come for our Peet's Coffee, but by then there will be no one left to stand up to them, because we will all be too groggy to fight back.

15 November 2010

Playing Hearst for the War on Tobacco

After the New York Times played the Hearst role in convincing the public there was actually a reason for the Iraq war, we have no capacity for for further shooting wars, so the NYT now seems to restrict its warmongering to the wars on drugs, tobacco, fast food, "chemicals", salt, and other targets of scaremongering and public health fascism.  When they report on tobacco policy they are basically transcribing the drug warrior position, much like they did with the Iraq war.  Like their Bush Administration reporting from the White House, this serve no one other than those who are using them as stenographers.

In the paper's top story Sunday, reporter Duff Wilson transcribe the tobacco warrior's party line in the lead up to the FCTC meetings in Uruguay.  In fairness, the article includes a tiny bit of "balance" down the page, with quotes from a few who disagree.  But the contrary views are reported as one person's opinion, while the party line is stated as facts, even the bits that are empirically false (that smoking rates in the West have "fallen precipitously" recently; display bans are a "proven method" of reducing smoking) and the completely unsupported assertions (like that the industry as "ramped up its efforts" because of the upcoming FCTC meetings).

The theme of the story (and another highlighted tobacco story by the same author published the same day that focused on Indonesia) was the usual fiction that tobacco use is caused entirely by the legal supply (i.e., the "big tobacco" companies), having nothing to do with demand.  Sadly, there is a lot of room for honest reporting to call the industry to task for not aggressively marketing low-risk alternatives to smoking – and calling the governments to task for not letting them.  But by just parroting the anti-tobacco extremist party line, reporters do nothing for public health or the dying profession of journalism.

The hook is the claim (sort of attributed, to unidentified WHO officials, making it slightly different from just stating it as fact) is that Philip Morris International was trying to "intimidate" the government of Uruguay by challenging some of their anti-tobacco rules as violating trade treaties.  The story claims that PMI filled a lawsuit, somehow not fact checking enough to learn that though this is the political spin, it is an appeal to arbitration under the terms  of a commercial treaty between Uruguay and Switzerland (where PMI is based).  It focuses on labeling requirements that basically make it impossible for PMI (or others) to communicate their brand.  The report failed to explain it is not actually a lawsuit (how could it be, unless it was a challenge under Uruguay's own constitution? it is rather difficult to sue a government for its policy choices -- on the other hand, the reporter originally referred to Uruguay's "gross domestic profit" until it was later corrected to "product", so perhaps he did not actually understand much about political economy).  Nor did it mention that the claim focuses on attempts at brand destruction, not actual anti-smoking measures.  And, besides, how exactly does an entity without an army or even any desperately needed IP or local assets (like Microsoft, Google, Chiquita, Goldman, IMF, etc.) intimidate a sovereign state?  Don't know – it was not explained in the story, only asserted.

In short, the company was asking that the provisions of a commercial treaty be enforced in a situation where they believe they are suffering the confiscation of their equity and intellectual property.  Gee, a company would have to be totally evil to try to enforce their legal rights like that.  If Uruguay wanted to ban smoking and PMI fought that, it might be a different story, one that was about how people should live rather than brand equity, but this is a simply case of commercial property rights.  Of course, the FCTC crowd want to make it appear to be something more, and to make it appear that PMI somehow has the upper hand when they and their competitors are the only ones who either lose or merely break even in this fight.  Somehow any critical analysis of their spin was missing from the story.

Also missing from both stories is even the vaguest awareness that people smoke because they want to and, indeed, that consumers are far and away the most important stakeholder.  Interestingly, the final word in the main story is given to a tobacco growers spokesman: “We all know the real objective here is to eliminate tobacco consumption".  But that is left unexplored.

That's were the story should begin.  Whatever happened to reporting?

It would be so great to see an honest hard-hitting piece of journalism about tobacco policy and the tobacco industry.  The reporter would need to learn a bit more than health reporters seem to understand about tobacco harm reduction, about the benefits of tobacco use and why people like to smoke, as well as delving into the politics of hatred and the bizarre bug in some people's brains that causes them to want to prevent others from indulging in certain life-improving activities that some people like and others do not (i.e., being anti toward nicotine, pornography, marijuana, homosexuality, alcohol, inter-racial coupling, etc.  – the targets changes but the "I don't like that so you shouldn't be allowed to do it" attitudes are the same).  With that education, the reporter could effectively challenge the industry for what it genuinely does wrong rather than just reciting anything it does an implying that whatever it does must be wrong, as the antis who control the discourse do.  This would call for no small dose of criticizing what the antis do wrong also. 

No one should ever again trust the NYT when it reports there are good reasons for starting a war.  They have demonstrated that they will blindly parrot the false claims of the warmongers.  Similarly, there is no information content in them reporting that the tobacco industry has done something bad, since they have demonstrated that they cannot tell the difference between "the industry acted" and "the industry sinned".  If someone really wants to report what is wrong in this arena, they need to understand what is reasonable expected human and corporate behavior.  Only then can they challenge what (on both sides) is not reasonable, ethical, or acceptable in a free world.

12 November 2010

Reefer madness 2010

I thought that perhaps the closest thing to reefer madness this year would be Greg Connolly and his ilk lying to the people about the hazards of dissolvable smokeless tobacco products.  But I am not aware of them actually claiming that these products caused madness and destructive behavior, so we had to wait until fraternity party season and the American Public Health Association (APHA) meetings.

Part 1 - Loko about caffeine

If you follow American news (not sure if this was reported anywhere else) you probably saw the stories of canned party drinks that are roughly a combination of Red Bull and alcohol, particularly Four Loko brand.  The scare stories were not limited to the age-60 demographic television news; they were widely reported in the new media with the same tone.  I think every news clipping email I got the day the story broke had something about it, including the ones that are just devoted to politics or tobacco.  And it was not as if it was a slow news week, coming just before the American elections.  

It seems that health beat reporters cannot resist an opportunity to blame something new and commercial for all of our ills.  I will admit I too am inclined to condemn these products:  in an era of so much brilliant craft brewing in America, I think it is a crime against culture to forgo beer in favor of what is basically ethanol (and other drug) infused Kool Aid.  Sadly, the tirades are not that the kids should be drinking good beer, but that selling a drink that contains both caffeine and alcohol presents a unique problem, a reefer-madness-worthy horror story of people drinking themselves to oblivion without realizing it.  There are several things so desperately wrong with this analysis that you think that at least one health reporter would have figured it out (I did not find any):

First, there is nothing particularly unique about parties where young people drink to dangerous levels.  Sadly, it happens all the time, but when it is chugging at a kegger or doing shots it does not trigger the same desire to blame the product rather than the consumption culture.  Rather than blame the product, perhaps we should either deal with the question of why young people in our society prefer to spend their time pursuing low-cost oblivion or concede that it is not surprising that they do. 

Second, the amount of caffeine in these drinks, though not always reported, seems to be consistently modest.  Someone alternating between Coke and beer will probably have a higher caffeine:alcohol ratio than consumers of these new vile concoctions, as will consumers of the considerably less vile old concoctions, bourbon or rum and Coke (so long as the liquor is diluted down to college party levels).  Moreover, as anyone experienced with these two drugs should know, modest amounts of caffeine does not mask the effects of being drunk other than drowsiness, and certainly will not keep someone who is close to overdose from realizing this.  In other words, something is not good about this behavior, but banning the inclusion of caffeine in alcoholic prepared beverages as has been proposed does nothing to address it.

Third, if there is a reason to worry about these drinks, it is not the widely consumed, tested, and understood caffeine, but the other stimulants that are in them.  The above link refers to alcoholic "energy drinks" being banned, but it is really just the caffeine.  But these "energy" drinks have a couple of other ingredients that have stimulant effects and which may indeed be bad for you.  I know from personal experience that Red Bull is a great study/work/concentration aid, but after combining it with strenuous exercise once, and getting heart palpitations as a result, I gave it up and now stick with a regular diet of caffeine with the occasional nicotine.  Do these other ingredients effectively mask the warning signs of alcohol overdose or otherwise create an unusually dangerous combination?  I do not know, and apparently no one else does either, but it is plausible.  What will happen when the proposed bans are carried out?  The manufacturers will reformulate to include the other stimulants but not caffeine, possibly making any actual problems worse and avoiding figuring out whether there really is a problem.

Finally, there is a bit of a class issue here, since the club set has been drinking $15 Red Bull cocktails for a decade, and you can make your own at home – it just costs twice as much as an equivalent amount of the new drinks.  In other words, it is another ban that only affects the people who do not have extra money in their pocket.

Part 2 - Stamp out social interaction now!

In a study that was presented at APHA this week and aggressively press released (do not get too excited about that – it is not as if the peer review process actually makes junk public health science any better), Scott Frank et al. of Case Western Reserve Medical School found an association between extremely high rates of text messaging (and social network site use) by teens and various risky behaviors.  They could have concluded that teens who devote more of their time and attention than average to peer socializing are more likely to text, drink, use other drugs, have sex, fight, and smoke.  Perhaps they might have even said that parents could monitor the rate of texting as a clue about propensity toward social activities, though I am not sure anyone would need a study to conclude that.

But this was APHA and declaring conclusions that are not supported by the data is practically mandatory so, of course, the authors claimed that the texting was causing sex, drugs, etc.  It is not that sending 120 texts per day is an indicator that you are probably not spending 14 hours per day studying or engaged in organized college-admissions-friendly activities.  Or that it means you are not playing World of Warcraft or working part time jobs to support your family.  It probably means that you are a comfortable popular/jock/cheerleader type.  And these researchers are telling us that those kids are more likely to have sex and try drugs?  Shocking!

(They also seem to claim, as a footnote that the texting is associated with obesity, suicide, and some other decidedly non-popular-kid behaviors, but it is kind of hard to make sense of what they are actually claiming when they publish via press release.  This may be a different subpopulation or could be most anything.)

The reason that this crap makes the news while 99.9% of the other crap at APHA does not is because of the reefer madness aspect:  Beware the scary new technology!  It is causing teens to interact and do what comes (perhaps a bit too) naturally.  I am talking about email and online chat programs, of course (no, wait, it is not 2000).  I mean the private phone line telephone (no, wait, it is not 1950, 1960, 1970,…).  I mean the Rock and/or Roll music (no, wait, it is not 1965, 1975,…).  I mean the erotic cave paintings (no, wait, it is not 100,000 BCE).  You get the idea.

Moreover, I think they may be getting this one just as wrong as the anti-caffeine people are, though for a rather different reason.  I suspect that among those who were teens in the 1980s or 1990s, controlling for native intelligence, the same kids who today would be the text masters are now more likely to be doing better based on their socializing and networking skills than their downwardly-mobile technically competent peers who have to compete with a few millions Indians and Chinese in their cohort who also studied 14 hours per day.  Not that I am advocating we encourage text, drugs, and rock-and-roll, but let's try to remember the fogies who worried about excessive use of socializing aids in past decades -- weren't they embarrassingly clueless.  Perhaps we can just try to encourage a taste for sipping good beer and listening to real music, rather that that crap that kids are pounding down and listening to today.

11 November 2010

Apparently MSNBC does not understand conflict of interest either

If you ask someone in my fields who has just used the term "conflict of interest" what it means, I would estimate that you would get a meaningful answer less than 5% of the time.  Most answers that were other than a blank stare would be some mechanistic and legalistic statement along the lines of "you are supposed to declare who has funded your work when you publish in a journal", which is not actually a response to the question.

This is especially sad since the definition is built into the term:  all you need to do is figure out what interest someone has and what other interest it conflicts with.  Even with that hint, though, my experience is that those who are fond of exclaiming that someone is guilty of COI has no idea what it means. 

Here's what it means in the presently relevant context:  The interest that may be threatened is the mythical scientific or journalistic "objectivity" – roughly the idea that someone is completely indifferent about how their analysis turns out and are just following the data.  This is  pretty much never the case in the health sciences (and probably most areas of inquiry) – very seldom does someone start an analysis without some notion of how it will come out, and some preference about whether that outcome is realized.  This is why a huge portion of the epidemiology literature suffers from publication bias in situ.

That said, most of the time most analysts working on most subjects do the best they can to analyze and report in a way that is close to the theoretical ideal.  The interests that conflict fiercely with that goal are strong preferences about the world that would be aided by a particular result of the analysis.  The most important of these are preferences about how the world should be that might be supported by the results of the research.  Thus, someone who believes that all tobacco products should be eliminated and who reports research on harms from tobacco products has an obvious enormous conflict of interest:  They are looking for evidence that might encourage consumers or regulators to conform to their wishes.  An equally compelling conflict of interest is when someone is employed by an organization that has a similar worldly preference.  Of course, if the employee already shares that preference (as they likely would, having taken that job) the employment relationship probably adds little to the motivation. 

MSNBC suspended the anchor/commentator who is the only apparent reason for watching MSNBC (or, I am informed by Maddow fans, one of two), Keith Olbermann, because he donated money to some Democratic candidates in the last election, violating company rules about how their journalists must avoid COI or remain objective.  (Those are my characterizations of the motivation for the policy; I have not noticed them being explicitly stated in what has been written about the matter.)  Of course, they quickly reinstated him after the public outcry about his absence and the legality of the rule, and the publicity was so valuable that the truly cynical can suggest it was all planned.  But there was nothing in the retreat that suggested that anyone realized how naive the action was in the first place.

For those who do not know, Olbermann is probably the most interesting and insightful American liberal television commentator (sorry, Jon Stewart – that used to be you).  As such, there is no question that his role is to advocate for a particular worldview.  If you interpret his job as being that of "objective journalist" (whatever that mythical concept means), then his strong beliefs present a COI (as do most "objective" journalist's worldly beliefs).  If, however, you consider his job to be the spokesman for his causes (and, even more so, brilliant critic of the dishonest and/or nutcase opponents of those causes) then there is no conflict.  But in either case, his donations to the cause cannot possibly create a COI.  He makes the donations because he has particular beliefs, and those beliefs matter.  But to anyone who thinks that the changing hands of money matters in this case apparently has some difficulty with the ordering of cause and effect.

To draw an analogy back to the tobacco researcher, if that researcher were doing a study of whether a particular intervention were effective at discouraging tobacco product use, there would be no COI with her worldly preference for eliminating use.  Indeed, the motivation to figure out exactly what works would tend to favor doing the best possible analysis.  (So why does it seem that researchers evaluating anti-tobacco interventions always seem to twist their results to make the intervention appear more effective than it really was?  Perhaps they are not very good at what they do.  Also, it is often because  they are employed by the organization that implemented the intervention, which creates an obvious COI that might overwhelm the motivation to get the right answer.)  Just as Olbermann's personal beliefs, and even ties to the Democratic party, do not conflict with him being a good spokesman for his causes, a tobacco researcher's goal of eliminating use would not create a conflict with research designed to figure out how to eliminate use.

So if Olbermann pretended he was not doing what he does – trying to make the best possible arguments for a particular viewpoint – then his beliefs would represent a COI (even still, the exchange of money that caused the trouble would still be irrelevant, serving only as evidence of the real COI).  Similarly, if the anti-tobacco researcher reported study results that tended to support the anti-tobacco cause while pretending to be an objective researcher, then there would be a COI.  So, naturally, we would expect her to declare her COI when publishing the results.  (Bazinga!)

Contrast this with the recent hand wringing by the NYT over analysis by their excellent business reporter/columnist Joe Nocera, who condemned an executive's ethics in an article only to find out (after it was published, unless someone is lying) that the law firm where his fiancee works is representing a company that is suing over that executive's actions.  Nocera reported this when he learned it and the NYT published what was basically a COI disclosure which appears with the original column (ok, it could not be added to the print version, but does anyone actually read printed periodicals anymore?).  As it played out, there was actually no COI because the author did not know his family had an interest, via employment, in making the arguments he made.  But if he had known, this would have been a clear COI that should be reported since the appearance of disinterested journalism would have been misleading.  (As and aside, the NYT never once flagged either the original column or their subsequent discussion with the topic label "ethics", a label they usually inappropriately reserve for sex scandals and insider activities that are clearly criminal rather than interesting ethical questions.)

Nocera declared that he would not have written the story if he had known about the chain of relationships.  This is a reasonable strategy in this case.  No matter how heartfelt, it is difficult to make worldly declarations while forgetting that they could affect the success of an employer (of oneself or an immediate family member).  And the downside of not doing it is not so great since for newspaper reporting, anyone else on the beat could pick up the story, or for that matter the world would not notice if no one did.  The latter contrasts with scientific situations where the people most invested in a topic are likely to have worldly preferences, but are also the only ones who are expert enough to do the analysis, so simply avoiding it is not possible.  So long as someone is well-known to be or discloses that they are an advocate for a particular worldly goal (and similarly makes clear the preferences of their employer), there is no reason to avoid making the best case for that goal with the Olbermann approach: choosing particular topics to analyze, disputing opposing claims, and making opinionated declarations.  This does not extend to making factually misleading statements or analyzing data in ways to skew the result, but that is a topic for another time.