14 March 2012

Unhealthful News 206 - Does journalism school un-teach people how to count, "Shisha Clampdown" edition

H/t to @cjsnowdon for pointing out the BBC article reporting the oh-so-shocking turn of events, that bans on shisha cafes (hookah bars) have resulted in them going underground.  I mean, who would have ever thought that banning the social component of a popular legal activity might cause people to gather clandestinely instead?  Or that by banning something, the ability to properly regulate it -- e.g., to minimize fire risk -- would vanish?

But what struck me about the article was the claim,
The World Health Organization has advised that a 40-minute session on a waterpipe is the equivalent to the volume of smoke inhaled from at least 100 cigarettes.
Yet 84% of those surveyed thought it was fewer than 10.
Now maybe Sarah Sturdey (the author of the article, who deserves to be shamed by name for this) could have just transcribed that first bit from somewhere without engaging her brain at all -- basic reporter behavior.  But you would think that immediately following it by a radically different belief would cause her to think "wait, do I believe that?"

The WHO claim is pure fiction.  It is an n-th generation telephone game miscopy of some claims that were basically made up from whole cloth, tied to a tiny bit of reality.  Snowdon wrote an extensive report about the apparent provenance of the disinformation, I have written a couple of brief comments about it, and there are plenty of other analyses out there too.  But let's set aside the crazy option of Ms. Sturdey doing some research before writing her article, and just consider what would happen if she had a third-grader's command of math and had thought about what she was writing during a quick trip to the restroom (or rather, I suppose, it would be the loo):
Hmm -- "volume of smoke inhaled".  To smoke 100 cigarettes in 40 minutes would be more than two per minute.  That is much faster than anyone smokes, and indeed would require more total inhaling then someone normally does in that much time, and for every breath to be smoke.  That is close to physically impossible.
She would then have time during her inevitable hand washing -- she is a health reporter after all -- to think:
Smoking even 10 cigarettes in 40 minutes would require about 1/5th of all breaths to be a solid drag.  Smoking that much that fast would be an extreme intense session, whatever was being smoked.    Gee, maybe "those surveyed" are not morons after all.
Notice that this requires no subject matter knowledge about the relative harm of a lung-full from a cigarette as compared to a hookah.  Someone could believe the common claim that hookah smoke is much worse for you (an absurd claim, given what we know about heat-not-burn smoking, and one not supported by any evidence), but still be able to do the simple "volume of smoke inhaled" arithmetic.

Frankly, I am a bit concerned about the 16% who thought that it was typical to smoke a greater volume than 10 cigarettes' worth in 40 minutes.  But I guess that is why society has a place for people who are just really bad with numbers and are willing to make claims about matters they are clueless about, like taking a job as....

[You know, just forget it.  It is too easy a parting shot.  I will just let readers finish the sentence themselves if they want.]

09 March 2012

Unhealthful News 205 - Mother abuse as a solution to child abuse (yes, its about Wisconsin again)

The health science aspect of the story has hardly been mentioned, but it should be.  And besides, how can anyone resist writing about this story, even if in the form of a few disjointed snippets.

The story in question is that Republican Wisconsin state senator Glenn Grothman has proposed a bill that would define being a single mother as a "contributing factor" in child abuse.  As far as I can tell, the main implication of this would be that state anti-child-abuse messaging and such would start delivering this declaration.  There might also be some implications for court cases where "contributing factors" are being considered.  The proposal would fortunately not declare that single motherhood is child abuse, in spite the inevitable misinterpretations to that extent (example).

Given that inevitability, though, you have to wonder what Grothman was thinking.  One might think that this is a publicity ploy.  But he is already notorious in his home state, because of his prominent role on attacks on collective bargaining and the other issues that have turned that state's government into such a mess, so there is not much notoriety to be gained at home.  Maybe he is going for national-level loonyness, angling to be Santorum's VP pick or something.  (This was before Tuesday's primaries that pretty much assured Romney of the nomination.  Of course, simple biology means that Santorum still has a chance:  If I could be a major party's nominee for president if and only if my 64-year-old opponent died in the next few months, I would stick around and take that shot.  Well, I would if I wanted to be president anyway -- what a bad idea that would be, huh?)

As you might guess, the outcry against this is coming from the American political left.  Yet once you get past the naive outcry that misinterprets the proposal, it actually looks remarkably similar to the wars on drugs/tobacco that are pushed by the Democrats and increasingly opposed by the right-wingers

Note: in pointing out that most of the outcry is naive, I am not implying that the outcry against the proposal that was actually made is not justified -- I certainly think it is.  But just because someone is attacking a bad idea does not mean they are right.  Also, I sympathize with those who cannot figure out what is actually being proposed and claims, given what an utter muddle the press coverage has been.  I had to read a half dozen different reports before I started to figure out what was really going on.  On the other hand, without that, I might have missed such gems as "single mothers far outnumber single fathers in the state and in the rest of the country".  (Yes, I realize that the "outnumber", though not the "far", is probably true, since some unsavory men make a disproportionate contribution; also I realize that they almost certainly failed to notice they had meant to say "custodial" but left it out.  Still, it is pretty funny.)


One of the underlying claims used to justify the proposal is certainly true, and has been known for quite a while (despite implications in some of the coverage that this is a new discovery):  A child is an order of magnitude more likely to be physically abused by a male partner that is living with him and his mother (regardless of marital status) as compared to the risk of abuse from the biological father.  No doubt that biological instinct, the socio-demographics of the women in that situation, the types of men that are more willing to enter into that situation, and other factors all contribute to that.

So, by the standards of modern "public health" making a choice that has negative health effects -- no matter how strong the motivations or how difficult the alternative would be -- deserves to be condemned, aggressively "educated" against, stigmatized, and when circumstances are just right, to be actively punished.   If good, honest, healthy, hard working, moral Americans are going to be subsidizing these no-good smokers/unwed mothers/fatties/junkies, then it is only right that we make it clear that they should shape up. 

Remember back when "public health" identified people at high risk of disease and tried to fix the problem rather than fixing the people?  Actually, I don't either.

What makes this worth writing about in this series  is that it is such a perfect case of identifying a problem (child abuse), identifying a condition that is strongly associated and almost certainly does cause some of it (single motherhood), and then trying to address the problem by trying to punish the condition.  Keep in mind that a government banning, discouraging, and condemning are fundamentally the same thing, differing only in the quantity of punishment imposed for not conforming.

Note to politicians/FDA/DEA/police/etc.:  You need to punish people who do things that hurt others but enrich themselves, like armed robbery, banking, or factory farming.  You do not need to punish people for things that hurt themselves (and their immediate families) far more than they affect anyone else -- they are already suffering plenty of incentives to not be in that condition.  Since, in spite of those incentives, they are choosing that condition as the best of their alternatives, perhaps you might want to try to help by creating better alternatives or by improving that condition.  Of course, some people argue that you have no business at all involving yourself in those personal/family matters.  But even if you do not buy that, how the hell do you justify actively trying to make someone's personal situation worse, so that a previously inferior alternative starts to look better for them?

By saying that, though, I risk being as bad as the press coverage of this matter, just looking at some extreme or our-team-vs.-their-team aspect and not delving into the interesting legitimate issues.  There is a scientific literature that suggests that a highly-imperfect (though not disastrous) two-parent family is better for kids than the alternative, which means that its positives incentives can be created for staying together in spite of the imperfections, action might be warranted.  It is also worth working to try to reduce the abuse from (obviously a small minority of) non-biological father figures.  Some serious exploration of where to draw the line to maximize welfare would also be interesting (and I am sure it has been done -- this is just way outside of my areas of great expertise).  Leave it to the press (at least the 20+ reports and blogs I read) to fail to grapple with any of this.

I was also a little disappointed that no one thought to characterize the proposal as the Santorum approach to single motherhood (condemning and punishing it without offering a solution) and suggested that an alternative would be the Romney solution: allowing polygamy to make up for the shortage of available father figures.  So I guess that is up to me.  (And before my oh so many Mormon readers write to me about that, yes I know, the official LDS church no longer supports polygamy etc. etc.)

Finally, in case what I have written about the issues made the political action seem balanced and thereby suggested that Grothman is not toxic, misogynistic, evil, or loony (and that is not an exclusive or), I should mention that looking at his full agenda makes it clear he is trying to punish single parents and their kids.  He all but says that women become single parents to cash in on the sweet deal offered to them by the state (he apparently thinks he is living in Sweden, or at least Massachusetts -- dude, you live in fracking Wisconsin, and what you offer is a sweet deal only in comparison to central Africa and Afghanistan).  He calls for making public-supported housing more cramped, forbidding those on housing assistance from accumulating more than than a trivial amount of material goods (a limit set so low that someone would have a hard time owning a laptop and mobile phone to try earn a living), and denying those on assistance the right to school choice (it really says something when a government official basically says that forcing someone to attend the public schools is a good way to punish them or at least incentivize them to get off of assistance).  He also has apparently fought the notion that the logic of his position calls for making contraception more available, and takes a Limbaugh-esque position on the matter.

I notice that most every article on the topic notes, without further comment, that Grothman, who appears to be about 55, has never been married or had kids.  This is in spite of his clear commitment to family values (*cough*).  Hmmmmm?  It is too bad that beating up on single mothers is not an "outable" offense.  (For those who do not know, some gay advocacy groups keep files on which politicians and officials are in the closet, and makes clear that such choice will be respected -- so long as they do not take official actions that are actively harmful to GLBT community.)

Oh, wait:  This would apply to all lesbian mothers.  Oh, this could be fun.




07 March 2012

PBHL647 Occupational and Environ Epi (Drexel Univ), CVP Guest Lecture, 13mar2012

[As is probably clear from the title, the primary purpose of this post is as a pre-read for a class.  However, I have composed it so that my regular readers might also find it interesting/useful/entertaining to read.]

Overview:  Epidemiology exists almost entirely to aid in decision making.  Other sciences seek timeless knowledge or to fulfill deep curiosity, but almost every result in epidemiology varies wildly across popular and circumstances, and is frankly not all that inherently interesting.  Yet epidemiologic analysis and education typically ignore most of what should be considered when making a decision.  This is a very (very! -- I would normally spend 30 class hours on this, not 2) brief skate through the considerations that need to be part of any policy recommendation or decision that is informed by epidemiology.  The two breakout session and debriefings will be about half an hour each, and the other points will divide the remaining time.

1. If you only come away from this with one lesson, it should be:  Any statement in a research paper (or a press release, or anywhere else) that paraphrases to,
This study demonstrates that E causes D, and therefore we should....
is wrong.   No example reading for this; you have seen it hundreds of times.

Perhaps even worse is the phrase "unintended consequences", as it is typically used with "might exist" phrasing.  Together, such statements call into question the intellectual integrity of not just those who write them, but any field in which they are common in the journals.

2. Every policy, proposed or existing, has costs (aka "unintended consequences").  Almost every policy has benefits (ideally that would also be "every", but there are some really stupid policies out there).  "Should" statements require a consideration of all of those costs and benefits, as well as the ethical standards and quantification needed to trade them off.  Generally, about 95% of that is missing from epidemiology papers that conclude with "...should...".

3. First group exercise breakout:  List the important costs and benefits that should be considered when making policies related to the background readings: installing IWTs; promoting THR; giving the nicotine "vaccine" to teenagers (optional if you have time: other anti-smoking measures touted to the press by Gartner et al., at the end of the popular press article).   Just list them -- do not attempt to compare or quantify.  Hint: costs and benefits are just words that both mean "resulting changes in the world that people care about", and differ only in sign; figuring out the sign for a particular change is useful, but identifying what changes is the first step.

Background readings:
Note: you are reading this to gain a familiarity with the issues (i.e., proposals, costs, benefits, ethical concerns, etc.) involved in these topics.  You are not trying to fully understand the details (of the two research papers -- the rest are pretty casual reading anyway); for purposes of the class, you can ignore the model details in the nicotine paper and epistemic arguments in the IWT paper.

(a) Industrial Wind Turbines
(b) Anti-smoking methods
  • FAQ re concept of Tobacco Harm Reduction (a bit outdated and simple, but useful if you have never even heard of the concept)
  • Gartner et al. (2012) Would vaccination against nicotine be a cost-effective way to prevent smoking uptake in adolescents?
  • What Gartner said to the popular press (aside: it is always an interesting exercise to observe how this differs from what the paper actually looked at)
(c) A bit of each

4. A ridiculously brief discussion of public health policy ethical considerations (but probably more than you will get in your public health ethics class):  What costs and benefits should be considered when making a policy recommendation?  What other ethical concerns should also be considered (hint: think about the non-childish bit of the American "pledge of allegiance", the last few words).

5. How can we deal with difficult-to-compare and completely incommensurate considerations:  money spent vs. lives saved; present vs. future; rights vs. consequences; the needs of the many vs. the needs of the few?

6. Second group exercise breakout:  Pick one of the policy decisions that is addressed in the readings and sketch out (very brief and abbreviated, of course) what you would want to consider in making a decision or recommendation.  Identify quantifiable factors you would want to quantify (using epidemiology or other methods).  Identify tradeoffs that are not merely matters of adding-up that need to be considered (extra if you have time: Discuss how you might try to deal with one or more of the tough tradeoffs).

29 February 2012

The latest in "tobacco candy" research


under review at Tobacco Command
(29 Feb 2012)

Demonstrating that children believe that deadly tobacco products are harmless candy, an experimental study

C.V. Phillips, P.S. Heavner-Phillips, I.Q. Burstyn, P.L. Bergen
Populi Health Institute, Wayne, Pennsylvania USA
UASPH, Edmonton, Alberta Canada


Abbreviations
FDA = United States Food and Drug Administration
NRT = Nicotine Replacement Therapy
OR = Odds Ratio
OTC = Over the Counter
QUANGO = Quasi-non governmental organization
SES = Socioeconomic Status
TCACS = Tobacco Control Alarm-Call System
UASPH = Unaffiliated Alberta Scientific Public Health researcher

Figures and Tables
Table 1
Figure 1
Figure 2


Abstract
Background: There has been concern expressed about children mistaking smoke-free tobacco products for candy.  There is evidence that anyone doing a study on the topic will have a inappropriately great influence on policy, and meta-regression suggests an inverse association between study quality and impact on public health discourse.
Methods: Children of aged 15 months to 15 years were presented with a tableau of smokeless tobacco products, along with benign alternatives like candy, breath mints, dietary supplements, and medicine.  A second experiment presented the younger children with sippy cups that contained water, nicotine solution (e-cigarette refill liquid), and other liquids.  A third experiment presented the older children with selected products in de-branded original packaging.
Results:  The children could not distinguish between tobacco products and candy (p=0.86).  The younger children were more likely to reach for a cup of nicotine solution than a cup of water (OR=2.2645, p<.0314).  When products were presented in their original packaging, subjects successfully identified medicine, but half the tobacco products were still most often identified as candy.
Conclusions: Smokeless tobacco products should be stored with the same care recommended for other somewhat hazardous items found in the household, rather than displayed on plates or stored with candy.  Children should not be presented with toxic substances in contexts that send the message they should eat them, and should not be told to think of them as candy. 


Introduction
Dissolvable tobacco products consist of finely ground or powdered tobacco in a confectionary base that are held in the mouth while they dissolve, thereby delivering nicotine and perhaps other psychoactive alkoloids in a similar manner as other low-risk oral smokeless tobacco products.  These include products that have been available in the United States for about a decade (Stonewall and Ariva lozenges), as well as several new products that have entered the market or are expected to do so soon (new lozenge and toothpick-shaped products from the tobacco companies RJ Reynolds and Altria).  None of those products have sold widely to date.  However, trend analysis by TCACS indicates that the major-brand products will gain in popularity.  Moreover, one popular form of dissolvable tobacco product that is known by the street name "NRT" or "nert", which are the same as the others except that the nicotine is extracted from the tobacco and then put in the confectionary base, are already widely consumed.

There has recently been an explosion of organized concern about the risk of accidental poisoning of children who mistake dissolvable smokeless tobacco products for candy.  It is already known that that young children may be at risk of ingesting small objects that come within their grasp.  However, since tobacco is completely unlike any other consumer product, previous research on other products cannot be considered informative.  The nicotine lozenge variants of dissolvable tobacco products have already been implicated in a significant number of toxicant exposure events, which suggests that there is risk that one of the tobacco company products might someday poison someone also. 

Several previous studies demonstrate that there is a view that the public health community should encourage worry about the poisoning risk:

An anti-tobacco QUANGO of the Virginia state government calling itself "Virginia Foundation for Healthy Youth" issued a press release [1] reporting that when teens were presented with dissolvable tobacco products without any context, they often thought they were mints or candies.  While it might be considered a minor limitation of the study that the methods and actual results of the study were never reported or that the research was designed and conducted by high school students without any apparent supervision by scientists, the subsequent wide coverage in the popular press confirms that it was credible, important, high-quality research.

The Indiana Department of Health has mined social networking comments and otherwise gathered comments from teens about dissolvable smokeless tobacco products.  Some commentators have expressed concern that they have never reported their methods and their results appear to be unrepresentative cherry-picked out-of-context quotes.  However, these concerns can be ignored because the importance of this research is demonstrated by the production of high aesthetic quality slideshows that have generated repeated invitations to report to government agencies and public health gatherings [e.g., 2]. 

Additionally, there is even one study where a vague description of the methods and results was published, though unfortunately it has still never appeared in a scientific journal [3].  The study, from a research group calling itself "Harvard School of Public Health", was widely cited in the popular press.  (Note that while this organization does not seem to be related to the prestigious research institution called "Harvard University", the allegations in the literature that it is actually a lobbying front group for shadowy government agencies and industry have not been proven, and so cannot be considered a reason to doubt their research.  Thus, we consider their work to be just as credible as the other studies cited herein.) 

News reports, based on the highly touted press release from the "Harvard" study authors, indicated there was a dire risk of accidental poisoning from "tobacco candy".  One possible limitation of this work is the almost complete lack of correlation between the study results and the claims touted to the press (p=.984).  For example, popular media reports based on what was communicated to the press by the research team leader include the claim that "600 children a year" are poisoned by "tobacco candy" [e.g., 4], though this differs (p<0.001) from the actual study results by 600/yr.  This lack of correlation should be interpreted as further evidence of the seriousness of the public health worries.  Creating fear as a substitute for evidence is a standard invocation of the Precautionary Principle, which should be applied in situations where it appears there will never be enough evidence to support the necessary warnings.

Related research from several government and activist organization has looked at children's perceptions of flavored (though not necessarily dissolvable) tobacco products.  For example, work conducted by the Utah Health Department used an innovative method in juvenile research, in which a researcher disguised as Santa Claus first tricks the children into thinking they are in a benign situation, and then warns them about the dire risk the researchers just exposed them to [5].

There is evidence that these results are being taken very seriously.  For example, a spokesperson associated with the Indiana studies was invited to present for half an hour at recent FDA hearings on dissolvable tobacco products, while the experts on the public health benefits of introducing new low-risk tobacco products were restricted to three minutes each.  The lead author of the "Harvard" study is frequently invited to participate in policy discussions, including in some forums that normally restrict participation to people who draw only those conclusions that are related to their research results.

A group of US Senators recently wrote a letter to the FDA urging removal of a "dangerous loophole" about dissolvable tobacco products [6].  Once again, concern was so great that the fact that the "loophole" was irrelevant to the concern (it was a legalistic trick by FDA to delay acting on a statutory requirement that they recognize certain products as less harmful than smoking) and the "solution" did not address the "danger" (the matter had no relevance to whether young children could be given access to the products) posed no obstacle to decisive action by respected politicians. 

Given that concern about this matter is so intense even in the absence of supporting evidence, it is clear that this is an important public health issue.  It is established practice in modern public health that the assessment of a risk is most reliably determined by those who express the most concern.  This is especially true in cases where, if action is not taken immediately, the concern might be proven unfounded.  Thus, a public health activist Code Gamma Alert has already been issued, including the monthly television news stories and invoking of the mandatory opinion-alignment rules for professors at public health schools and employees of public health advocacy organizations. 
[CARL, WE ARE NOT SUPPOSED TO TALK ABOUT THE ACTIVIST ALERT SYSTEM. YOU SHOULD PROBABLY TAKE THIS OUT BEFORE WE PUBLISH.]

While further evidence may be unimportant now that policy action is underway, we were curious about whether the results about children confusing dissolvable tobacco products with candy could generalize.  In particular, we were interested in whether they could be replicated in a scientific paper authored by real researchers with scientific skills.

Methods
A convenience sample of 42 children, aged 15 months to 15 years was recruited.  They were divided into the "younger" (n=25) and "older" (n=17) subsamples based on a cutpoint of age 7 years, as measured by a validated birthday frequency questionnaire.

In the first experiment, a tableau was created that included a collection of the candy and candy-like items listed in Table 1.

-------------------------------

Table 1. Product list

Dissolvable Tobacco Products
Ariva (Star Scientific)*
Camel Orbs (RJ Reynolds)
Nicorette Lozenges (GlaxoSmithKline)*
Nicorette Mini-Lozenges (GlaxoSmithKline)*
Stonewall (Star Scientific)

Medicines and Supplements
Pepcid AC 10mg*
Tums Extra-Strength tablets
Vicodin*
Zicam Cold Remedy "homeopathic"*

Candies
Junior Mints
M&Ms dark chocolate mint
Mentos mint*
Skittles*
SweeTarts giant chewy
Tic Tac mint*

All listed products were used in the first experiment.  Those noted with * were also used in the third experiment.
Brand names are given for identification purposes only and do not represent an endorsement of any listed product.

-------------------------------

Each subject viewed tableaus of 10 items.  The first that was presented included positive and negative controls.  The positive control consisted of a marshmallow Peep candy, chosen because of its history as a model species in research [e.g., 7].  The negative control was a rubber ducky.  The other items were chosen at random in each trial, thus eliminating any bias that might have been created by the grouping of particular products.  An example of one of the the tableaus, as presented to the subjects, appears in Figure 1.  The objects were always arranged in an attractive pattern (e.g., the circle in Figure 1); this served no scientific purpose, but it amused us. 

Figure 1.  Example of one random tableau from first experiment

Note: Pictured items are, clockwise from bottom center (numbers correspond to order of list in Table 1): 14, 12, 11, 3, positive control, 9, 4, 7, negative control, 6, 13.
Older subjects were individually presented with a tableaus and asked "what are these items"; if answers were not provided for each item, they were prompted to respond about the remaining items.  A second tableau was then presented, for a total of 20 observations (which generally included some duplicate items) per subject.  Results were recorded as open-ended answers and coded as "candy" if the the word "candy", "mint", "breath freshener", "sweet", "sugar", or the product name of a specific candy was offered as part of the answer.

The younger subjects, for whom the former methodology would not be age-appropriate, were grouped into pairs and presented with a tableau.  The were asked "candy! who wants candy? pick out a piece of candy!"  Results were recorded for which items were reached for or picked up.  After grabbing ceased, another tableau was presented and this was repeated until a total of 20 grabs were recorded.  When some pairs of the younger children demonstrated hesitation about reaching for any of the objects, the protocol was quietly rewritten to require that the researcher reach for and pretend to eat a random (non-ducky) item until the children complied.

A second study expanded the target of the study to include e-cigarettes.  The failure to ban these new devices, so far, demonstrates that more research is needed about them and their components.  The younger subgroup were presented with six sippy cups, that contained (pictured from left to right in Figure 2) e-cigarette refill liquid (a 6mg/ml nicotine solution), water, vodka, antifreeze, fruit juice (white grape), and e-cigarette refill liquid (a 20 mg/ml nicotine solution).  Inclusion of milk and soy-based formula were considered, but concerns about the allergies mandated their removal.  Coke and Sunny Delight were also eliminated from the experiment because of the recent discovery that sugary drinks are the world's most dangerous public health threat.  The cup(s) that each child reached for or picked up were recorded.  Picked-up cups were immediately removed from the children's hands and returned to the tableau.  Children that started crying at that point were removed removed and thanked for their contribution.

Figure 2.  Sippy cup arrangement

Note: Contents ordered as listed in text.
For the third study, the older subgroup were presented with some of the products (noted in Table 1) in their original packaging, with the branding and labeling information obscured with olive-green paint or tape.  A disposable e-cigarette that closely mimics the appearance of a real cigarette was added as a positive control.  Subjects were then asked to classify each into the categories candy/mint; medicine/vitamin; tobacco product.

No incentives were offered to the study participants, no matter how much they begged (though the Junior Mints and vodka mysteriously disappeared).  All of the recovered study materials were disposed of following appropriate biohazard protocols.  The liquids were returned to their bottles; most of the solid objects were consumed by the research team; the drooled-on products from the young children tableaus were autoclaved and put in the municipal trash (there was no budget for analyzing biological samples); the NRT products, considered too unpalatable to consume but too expensive to throw away, were saved for future research.  A count of the tobacco and medicine products revealed that approximately all of them had been recovered from the children (the measurement error was at a level that does not affect the study results).

Statistical analyses were conducted using SAS (vers. 9.1.3, SAS Institute, Cary NC), the preferred choice for researchers who want to show off that they are real scientists, but do not understand the statistics they are using well enough to just do the calculations in the spreadsheet where they recorded the data.

Results
During the first experiment, five of the youngest children had to be dropped (from the experiment).  Two refused to participate, wandering away and/or crying.  Two others were apparently unfamiliar with candy, and thus did not produce reliable results.  Another seemed to be claiming that every object in the tableau was a cat. 

The remaining 37 subjects completed the first experiment, and all members of the younger and older subgroups completed their other experiment.

Subjects in the older subgroup all correctly identified the negative control (rubber ducky) as something other than candy/food, and 16 (94.1176%) correctly identified the positive control as either "candy", "a Peep", or "those things are so gross".  The younger children were more likely to pick up the Peep than the rubber ducky at a rate that was borderline statistically significant after correcting for latent confounding by race, gender, and SES (p<0.1).  Older children were more likely to volunteer an observation that the experiment seemed to be designed to intentionally trick them (p-value for trend = 0.03 after correcting for mutations in the data).

In the first experiment, the rate at which the tobacco (82%) and other non-candy products (78%) were identified as candy was the same as the rate for candy products (86%).  The faster grabbing younger children demonstrated a preference for the larger items, but the trend did not achieve statistical significance.  However, at a statistically significant rate, the older children identified the Vicodin (which had a distinctive pill shape, including scoring for breaking in half) as non-candy.  The older children also identified the Stonewall (which has a color and shape that are unusual for candy) and Pepcid (smaller than most candies) as non-candy more often, but the difference was not statistically significant.

In the second experiment, the younger children were significantly more likely to reach for a nicotine solution cup than any of the other liquids.  Compared to water, the odds ratio for reaching for the nicotine was 2.2645 (p<0.0314).  The other liquids were chosen at rates that were statistically identical to the water.

In the third experiment, all of the older children recognized the positive control as a tobacco product and the Vicodin (in a prescription bottle) as medicine.  For other non-candy products, most identified them as something other than candy: 94% for the Ariva and for the Pepcid (both are in a distinctly medicinal blister pack and do not look like typical candy).  65% identified the Zicam (in a distinctive supplement pill style OTC bottle) as non-candy and 35% as candy; given that it is a fruity sugary tablet, sold as homeopathic remedy, it is not clear who is correct, and in retrospect we realize that its inclusion in the study introduces unnecessary ambiguity.

Most important, for several tobacco products with the labels hidden many subjects still thought they might be candy, including 53% for Orbs (in a unique package, clearly meant to be childproof, but not similar to packages normally used for medicines) and 94% for the Nicorette products (non child-proof packages that are quite similar to mint or candy packages).  One subject appeared to subconsciously mimic the Nicorette television ad where a consumer jauntily pops open the plastic tube with his thumb and smoothly pours a lozenge into his mouth one-handed.  (Note: fearing this possibility, we replaced the content of the Nicorette packages with Tic Tacs and Mentos; since this part of the experiment was focused on the packages and those candies are almost visually identical to the tobacco products, we believe this precaution did not bias the results.)

Discussion
The accurate identification of the positive and negative control items proved that our methodology was scientifically valid.  Both older and younger children can differentiate candy from other objects, and older children can clearly identify tobacco products that are not shaped like candy.  Given the reliability with which products can be made to not look like candy, even to young children, the persistent refusal of tobacco companies to employ non-candy shapes (e.g., plastic water fowl morphology) is evidence that they are marketing to children.

Our results replicate the previous research that showed that children can be convinced that non-candy tablets/lozenges are candy when they are presented in a context that suggests candy and lacks any clues that some products are not candy.  This is the first study to demonstrate that children apparently cannot distinguish dangerous nicotine solutions from water or other liquids when they are presented in translucent vessels.  It follows immediately from these findings that all smoke-free tobacco products that could lead to accidental poisoning should be banned, unless they have been approved by the FDA as a smoking cessation aid.  In particular, those who use e-cigarette refill liquid -- "modders", as they are called in gang patois -- should not be allowed to continue to exploit a loophole that allows adults to legally possess poisonous liquids so long as they are not explicitly marketed as children's beverages.

Our findings suggest that package design might reduce the risk of mistaken identity and accidental toxification events.  In other areas of consumer product regulation, there is a belief that in such circumstances, clear labeling and distinctive packaging should be required for potentially toxic products, with shapes and markings that make clear they are not food.  For example, minimalist plain labels that would be similar to the obscured labels that we used to trick the children are generally forbidden.  However, because tobacco is unlike any other consumer product, different standards should apply.

Nicotine lozenge manufacturers should not be required to change their packaging:  If smokers were not able to flip the attractively-shaped bottle open with one hand and stylishly pour one (or all) of the lozenges into their mouths, then these products might no longer be considered "cool".  That could, in turn, interfere with their proven ability to increase users' chance of quitting smoking by 0.0027%.

Packaging-based regulation is also an inappropriate approach for tobacco industry products, since reducing risk is never acceptable for health-affecting choices when prohibition is an option.  Moreover, there is no evidence that younger children understand the cues from packaging.  While it is possible that children might be less likely to try to drink nicotine solution if it is not in a sippy cup, there is no scientific proof of this claim.  The only proven method of reducing the risk from these products is eliminating them entirely.

Strengths of this study compared to previous research on the subject include the fact that the authors understand irony and are not lying fanatics.  Moreover, only one of them is functionally illiterate, and even he apparently understands scientific inference better than many of the authors of previous studies.  Additionally, we have introduced to this field, for the first time, the methodologic innovation of not sending out a press release containing conclusions that are in no way supported by the content of the study.  We consider this to be an important scientific breakthrough in itself, and suggest that future tobacco product researchers attempt to replicate the methodology.

This study has a few possible limitations.  The older children proved surprisingly adept at detecting that they were being manipulated for some political purpose.  This may have resulted from selection bias, since this work was carried out in a community of educated professionals with high-quality schools.  The same demographic selection bias may explain why some young children were not practiced consumers of candy.  If the experiment were repeated in a community where most of the teens were poorly educated, raised by public health officials, or otherwise never taught to think critically, we expect the results would be different.  This would further strengthen our conclusions.

An additional factor that might be considered a limitation of the study, though it provides several important advantages in the context of tobacco research, is that we did not actually do it.  That is, the methods narrative is pure fiction and we just made up the data (however -- and we realize it is difficult to believe, given that even one of the authors of this paper was sure we were making it up -- the literature review in the introduction is all true, down to the name of the author of reference #2).  There were multiple reasons for not actually doing the study.  First, we do not have access to a Romanian orphanage or a sample of foster children, and no halfway decent parent would ever allow their children to participate in such research.  Second, we did not want to ruin perfectly good sippy cups and the Russian member of the research team would not allow us to waste vodka. 

Third, we would never conduct experimental research on children without getting human subjects ethics approval, and no legitimate ethicist would ever consent to an experiment like this.  Human subjects ethics requires a balancing of possible costs to the subjects against the potential benefit of the knowledge gained.  Since it is obvious to any casual observer that it is possible to trick children into thinking that small pill-like items are candy, and to generally concoct situations that create confusion about objects that look, are scented, or are flavored like comestibles (be they medicine, cosmetics, tobacco products, air fresheners, industrial chemicals, etc.), there is no knowledge to be gained by these studies.  While the risks of such a study would be reasonably low (assuming the children were carefully monitored and restrained from consuming any of the products), the mere act of including children in research, as well as taking actions that might convince a group of children that a collection of non-food objects are candy, creates a cost.  Thus, such research could never be ethically justified.

Fortunately, such concerns did not create fatal limitations.  Even though we did not recruit subjects or make observations, we carefully predicted what imaginary subjects would have said and done.  While this may have created some confounding and measurement error bias in the results, it is well known in epidemiology that when a result is really strong, like most of ours are, it cannot be explained by study errors.  Additionally, we conducted a sensitivity analysis that proved that our results are would have been similar had we actually gathered data (details omitted). 

Moreover, in social science research related to tobacco, the drawing of conclusions based on how the researchers think subjects should act, rather than actual observations, is an established and accepted practice.  For example, it is well documented that discussion and conclusions sections are frequently written before any data is collected.  Furthermore, even patently false statements are so common in this field's research reports that it appears that they are mandatory.  Thus, neither our methodology nor the fictional statements in this paper are outside the bounds of anti-tobacco research.  Indeed, had we actually carried out the field study and adhered to legitimate scientific standards in our analysis and conclusions, our results would have been less useful, as such methodology would render our work incommensurate with the existing public health and tobacco research literature.

Conclusions
This study provides clear evidence that children can be persuaded to consume dissolvable tobacco products.  The risk is clear even though -- in contrast with nearly every other toxic or small object in the world -- it does not appear that, so far, any children have suffered serious harm from these products (other than the NRT versions), or that they have frequently mistaken them for candy when encountering them in natural situations.  Because they pose a risk, these products should be banned, as is appropriate for any product that causes risk but serves no necessary medical purpose.

Smokeless tobacco and e-cigarettes are not a safe alternative to smoking, and smokers should use only clinically proven cessation methods like NRT, social stigmatization, and lung cancer.  Giving adults legal access to low-risk, affordable, appealing, satisfying nicotine products creates the risk that they might decide they are better off using nicotine rather than being abstinent, but without offering any profits to the pharmaceutical industry.  Such a risk is not considered acceptable by public health authorities, even if the availability of the products might cause thousands of smokers to quit smoking.  Tobacco harm reduction is a serious threat to public health officials and other career activists, and the tobacco industry must be stopped from making misleading claims such as "some nicotine products are much lower risk than cigarettes" and "citizens in our society have free choice".

Additionally, we conclude that it is unethical and dangerous, and should be criminal, for anyone to try to create confusion between dissolvable tobacco products and candy.  This would include such actions as a parent putting the tobacco products in a candy jar, or activists constantly referring to the products as candy and encouraging the popular media to do the same.

Finally, we conclude that anyone who would actually carry out an experiment on children like the one described herein is in violation of basic rules of human research ethics, and may be guilty of criminal offenses.  There is no evidence that previous researchers who carried out and published similar experiments sought human subjects ethics approval; indeed, it seems impossible that they would have gotten such approval.  We recommend that national and local authorities consider whether sanctions are appropriate against the authors and sponsoring organizations.


Acknowledgments and author contributions: Support for this study was provided by Blue Cross (paid for the pharmaceuticals), Populi Health Institute (paid for the candy), and random donations of products from companies and advocates received over the years.  CVP conceived of the study and wrote the manuscript.  PSHP watched the process with fascination, contributing random strings of characters to the manuscript; he is responsible for any typos that appear in the text.  IQB contributed statistics and words; he offered some amusing suggestions for embellishing the stories about the previous research, and was utterly floored to learn that we could not make those changes because the reported background was actually an accurate description of reality.  PLB contributed content to the manuscript.  The following bears repeating:  None of the authors every seriously considered carrying out the human subjects research described herein; to do so would have been criminally unethical.


References

1. Virginia Foundation for Health Youth (2010). Press Release: More than 1/3 of Teens Surveyed ID Flavored Tobacco as Candy.

2. M Spitznagle (2012). Indiana’s Experience: Marketing of Dissolvable Tobacco Products.  Invited slideshow, FDA Tobacco Products Scientific Activism Committee (TPSAC), available at http://1.usa.gov/yuB1MO

3. GN Connolly, P Richter, A Alequas, TF Pechacek, et al. (2010). Unintentional Child Poisonings Through Ingestion of Conventional and Novel Tobacco Products. Pediatrics 125:896-899.

4. The Week (2010). Fact Sheet: What is 'tobacco candy'? Available at theweek.com/article/index/202095/what-is-tobacco-candy

5. M Cortez (2010). Santa demonstrates danger of 'sweetened' tobacco products. Deseret News, available at http://www.deseretnews.com/article/705362953/Santa-demonstrates-danger-of-sweetened-tobacco-products.html

6. J Merkley, S Brown, T Harkin, B Mikulski, et al. (2011). Senators to FDA: It's Time to Close the Door on Tobacco Candy.  Available at http://www.merkley.senate.gov/newsroom/press/release/?id=ea7b14e4-c4aa-490f-bc98-19713218acaf

7. www.peepresearch.org








17 February 2012

Unhealthful News 204 - Governments openly conspire to lie

Today I will defer to my clever colleagues, and link to two very brief and insightful posts.  (I am just too much the philosopher to do brief, so I have to delegate that :-)

First, check out Chris Snowdon's expose of UK government plans to lie to the public as they try to implement minimum alcoholic beverage pricing and an anti-alcohol social engineering plan.  (Further explanation and analysis can be found in some of his previous posts.)  What is interesting about it is that it is not just the usual catching the government in a lie, but watching de facto government actors overtly present their plan for lying, almost like they figure they can so easily get away with it that they do not have to cover it up.

Second, read Kristin Noll-Marsh's empirical economic analysis of the effects of smoking bans on bars.  Those fancy words, by the way, mean that unlike the government and those who control it in this area, who assert that the bans benefit the bars, she went out and made a couple of observations to figure out cui bono, or rather cui malo (note: I depended on a translate bot to figure out how to say "who loses", so corrections are welcome) [Update: corrected per comment].

It is just such a shame that we do not have some major institution whose job includes monitoring government (and its allies) and reporting when it is lying to us.  Oh, wait.

Well, at least we have bloggers and a few good reporters.  On the latter note, and off topic, check out Jeremy Scahill's reporting on Yemen, about the Obama administration's stupid little war that you may have never even heard of.

Anyway, how did they get these scoops?  Snowdon looked at materials posted on the web from a 2010 meeting.  Noll-Marsh apparently thought about the implications of one news report, unlike those reporting it, and drove down the road with a camera.  No wonder health reporters have so much trouble seeing through governments' lies -- who has time to do complicated research like that when there is so much transcribing to be done?

14 February 2012

Unhealthful News 203 - Malaria: how many killed? Decent science reporting: what killed it?

Last week I was struck by one line from a news story about a new study that claims that the death toll from malaria may be underestimated by half.  The claim is based on revising the current conventional wisdom that basically only young children die and everyone who survives childhood in malaria zones has immunity that keeps all but a very few from dying.  I will admit to a soft spot for any study that that seems to claim "it has generally be believed that X, but that was not really based on evidence, and now we show Y" -- perhaps it is because I have contributed a tiny bit of that in my own work and found it to be a real high point. 

The new study depends on the controversial method of "verbal autopsies", which is just a silly medical-speak way of saying that when a cause of death cannot otherwise be determined, it is based on interviews with those who were around the decedent toward the end and can describe his symptoms.  The authors obviously believed that this works; others (such as in this very well-reasoned and balanced news story about it in Nature) have argued that there is a huge amount of measurement error.  (On the other hand, official death certificates have a lot of measurement error too, but that is another story.)  At the WHO, which kind of owns the malaria issue, the head of the malaria unit responded to the article with a memo that said the agency stood with its estimate and believes the study is importantly flawed.

The subject matter is very important and the question of that methodology interesting, but I have to concede that I am unlikely to learn enough to judge either -- certainly not this month.  So I am one of those educated non-experts who I try to empower to judge.

What I can judge for sure is that this remark by an advisor to the UN envoy for malaria about the scientific disagreement, reported in the NYT article, is really really dumb:
Some experts were dismayed. The dispute “is a little like Gingrich and Romney going at each other — it’s only going to hurt the whole field,”
Huh?  The act of scientists seriously debating scientific beliefs and offering divergent positions about the merits of a key research method is like two exceptionally dishonest politicians talking past the issues, misrepresenting the state of the world and their opponents' beliefs, and launching attacks on each others' character with a level of sophistication reminiscent of a grade-school brawl?  Really?

Exactly how does science advance, except for someone making a new claim based on their best analysis, criticizing the old beliefs, and (a minority of the time) turning out to be right?  And what do we expect from those who believe the current view and that the evidence supports it when confronted with a radical new claim?  We should hope that they respond by acknowledging the new analysis and pointing out why it is inferior to the basis for the existing belief.  In totally political realms, they would just ignore the new result; we should praise them for identifying points of disagreement.  And we should hope that their beliefs are based on enough information that they are inclined to defend them.  There are, in science, rare "head smack" moments when someone points out a previous error in such a definitive way that any honest expert has to say "yup, they're right; we were wrong all this time", but rare is the key word there.

Part of the problem was created by the editor of the journal that published the new paper, The Lancet, who in advance of the article tweeted "a revolution is about to strike" about malaria.  A tendency of big name journals to traffic junk science (and that kind of hype about a single inherently uncertain paper is junk science, even if the analysis in the new paper is spot on) is a lot of the problem.

How about the contribution to the bad science by the politicians, like the UN envoy.  Nothing to see there, it turns out.   It sounds like the envoy offered the sensible observation that the optimal intervention tactics are not affected, so it does not matter much which claim is right.  Similar sentiments were expressed by other officials in anti-malaria, as reported in the various news stories.

Anyway, whatever the stupid hype by the Lancet editor, that quote by the advisor is still the worst bit.  It really exemplifies the difficulties in getting non-scientist people to understand scientific debate.  It is hard enough to get lay people to realize that genuine scientific debate is...

(a) ...not like elections, and especially not like how they are reported.  Election coverage should really be more scientific -- there is analysis about what promised policies would really cause and the truth about someone's past policies.  But the press likes to report on football matches, so they turn election coverage into that, and convince everyone that it is just a silly bickering match between scientifically and ethically symmetrical opponents even when it is not.  Then they cover science as if it were just like such an election. 

(b) ...not all whiny and weepy.  Scientists say "you got that wrong; that method has been shown to produce bad data" not "I understand that this claim is important to you, and since everyone is entitled to their own belief, we might have to agree to disagree, but I feel that your new method -- which is creative and clever, and represents a really good effort that I have the utmost respect for -- does not cause me to change my own feelings about this, which should be seen as valid also."  It is so damn frustrating to try to talk through a scientific disagreement in the company of people who are clueless about how science works, who think that things are just "discovered" and everyone agrees.  The worst is when they freak out about typical patterns of disagreement, clutching their pearls and fanning themselves to try not to faint.  It is like a voter getting mad at a candidate for "going negative" because he points out that his opponent's economic plan is based on making up numbers -- it's just arrogant and mean to say something like that in polite company!

So, anyway, who was the advisor who offered up the quote that played so well into all the reasons people do not understand science?  You are probably figuring it is some political hack or public relations guy who himself does not understand science.  You may well be right, but it is attributed to Jay A. Winsten; no affiliation or any other information attached to the name, but the "Jay A. Winsten" who dominates a web search is Associate Dean for Health Communication and Director for the Center for Health Communication at the Harvard School of Public Health.  Not that this disproves your original hypothesis (though shame on you for saying such disparaging things about a presumably respected professor from a unit that is often considered by some to kinda sorta be part of Harvard University).

I wish it was harder to figure out why the reporting of public health science is as bad as it is, and I wish we could just blame the reporters.

They just cannot believe their opponents have more honest motives than they

A random observation for the day.  The NYT reported that an American of Chinese birth recently traveled to China and was detained and tortured by state security officials (fortunately, just in an ad hoc street cop kind of a way, not sent-to-Guantanamo style) because he engages in the mildest of human rights activism, particularly posting to Twitter.  Apparently they mostly wanted his Twitter password, which could only serve to let them hijack his account and mimic him, since public broadcast of all the info that is there is kind of the point of Twitter.

What struck me about the story, beyond the always useful reminder about the behavior of governments and our "important partners" in China, was the following:
In a phone interview on Monday from his home in Fremont, Calif., Mr. Ge described how the agents, infuriated by his assertion that bloggers in the United States were volunteers and not government-sponsored agitators, demanded that he turn over his Twitter password.
That seemed vaguely familiar.  Kind of like the cries from members of the anti-tobacco extremist industry when confronted with human rights or good-science activists who challenge their bullshit, accusing people of doing it under the secret employ of industry.  Low-lifes like Chinese government thugs or paid astroturf activists simply cannot understand that someone might take a principled position and devote their time because they simply care about the world.  Since said thugs personally would never do something they were not getting paid for, they reason (to the extent they are able), no one else would either.

Of course, I realize that this is not the story for everyone.  Some pro-government thugs in China etc. might be decent people who simply have no access to honest information and have been brainwashed -- it is not that difficult to persuade idealistic young men to become monsters.  Western "public health" activists have no such excuse, though in fairness to them, presumably many of them are just lying as part of their jobs and do not genuinely believe that everyone who calls them out is as dishonest as they are.

As a side note of warning from that story:
In the end, Mr. Ge and his captors came up with a compromise: he did not reveal his password but logged on to Twitter and allowed them to peek inside his account. “The truth is I have nothing to hide,” he said.
Unfortunately, he might as well have just given them his password, because he undoubtedly did so, as the reporter should have known if he read his own newspaper's article about how Chinese and Russian officials are adept at installing password stealing software and otherwise breaking into computers.  Companies with security concerns have taken to not allowing employees to take their computers or phones to these countries or log in from there, bringing only temporary burner devices that they sometimes then forbid from ever plugging into the company network based on the assumption that the spyware is so good that it cannot be removed.  A good lesson for all of us.  And don't forget that the border guards even from "free" countries sometimes seize and search computers, your email, etc. when you come through customs, even entering your own country -- Canada did it to me once.