Daily Vaper

Shut-Down Monkey Study With Shoddy Methods Will Likely STILL Drive FDA Policy

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Carl V. Phillips Contributor
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As previously reported here, the FDA agreed to shut down controversial research in which monkeys were injected with intravenous nicotine. This came following pressure by White Coat Waste, a taxpayer watchdog group devoted to ending wasteful U.S. government animal research, as well as the intervention of primatologist Jane Goodall.

White Coat Waste obtained a copy of the 64-page research protocol via the Freedom of Information Act. They made a copy of that available to The Daily Vaper, which helps clarify the political goals of the research. No reports on outcomes of the research are currently available.

The protocol’s stated timeframe for the research was February 2014 through February 2017. Since the project was shut down in September, one of three possibilities must therefore be the case: (1) The research was already complete by the time the FDA agreed to “end” it, and they kept that fact quiet for public relations reasons. (2) There was a secret extension to the research. Or (3) the research was running substantially overtime, but must still have been at least close to complete. Whichever is the case, we can expect to see the results used by the FDA soon.

The protocol claims that the research would provide insights into both biological and behavioral aspects of real nicotine use. It is difficult to imagine this being true, however, given that the protocol consists of having unhappy (isolated and restrained) monkeys choose whether to pull a lever that injects nicotine into their artery. Perhaps some simple basic physiological results might be relevant to real human nicotine consumption (albeit of the sort determined from from previous monkey research). But any behavioral observations simply would not be relevant.

The primary goal stated in the protocol is to “[c]ompare the acquisition and maintenance of nicotine self-administration across decreasing doses in adolescent and adult squirrel monkeys.” This suggests the FDA plans to spin the data from the experiment in support of their twin mission: Forcing manufacturers to reduce nicotine concentrations in their products and justifying draconian enforcement measures because adolescents react strongly to nicotine.

The stated hypotheses are that the one-year-old monkeys would self-administer more nicotine compared to the adults, and that they would be “more resistant to extinction” of the nicotine. The latter appears to be a tortured way of saying that they will be less inclined to just give up on injecting themselves when the dose of nicotine becomes very low.

The protocol explicitly described reducing nicotine levels as “a primary regulatory strategy.” It cites this assertion to various opinion pieces, but obviously to no actual experience since this “primary strategy” had never been tried. It goes on to say that the researchers intended “to determine the threshold nicotine dose that maintains self-administration.”

So, the researchers set out to find how low the concentration of nicotine has to be for one to stop taking it. Of course, that’s not what they measured. Instead, they researched how low the concentration of nicotine (in an injected solution) has to be before a caged monkey (which has spent weeks injecting higher concentrations of nicotine) will stop bothering to push a lever injecting the solution (choosing instead to stare at the wall until the end of the experiment).

It is difficult to imagine why or how anyone would think this experiment translates into a measure of how low the nicotine in cigarettes or e-liquid would have to be before everyone would just quit. And yet it is safe to predict that we will see some pseudo-scientific conversion from this to real products, with a declaration that the optimal low level of nicotine has been discovered.

The biological absurdity of such a conversion is only the beginning; there’s also policy implications to consider. The monkeys who were locked up with their depleted nicotine injection had no black market sources to get the good stuff. They could not enhance the nicotine concentration with the addition of (easily purchased) bottles of 100 mg/ml e-liquid base or even almost pure nicotine. They did not have decades of nicotine use behind them. Yet we are probably going to be told that their experience represents the behavior of human nicotine consumers.

The protocol goes on to make a series of assertions about nicotine having particular effects during adolescence. Despite this being ostensibly a scientific document, the period of adolescence – variously delineated as ending at age 17 or 21 or even later – is never defined. Some of the assertions in the protocol are only true if a cutoff as low as 17 is used, while others are only true if it is substantially older. This is hardly the biggest flaw in this experiment, but it makes clear that the whole ordeal is sloppy political posturing rather than proper science.

The bigger problem is equating human adolescence, a largely social phenomenon, with monkey adolescence, which is almost entirely biological. The premise of the experiment is that people’s complex relationship with nicotine is no different from that of monkeys who are just trying to relieve boredom and reduce withdrawal symptoms. Plus, the one-year-old monkeys are roughly equivalent to twelve-year-old humans in terms of development. However, the results of the study will inevitably be spun as if they were representative of the high-school-aged humans.

The study protocol also describes a series of secondary experiments and hypotheses that look at the effect of myosmine and anatabine, other psychoactive alkaloids that are produced by tobacco. These are present in cigarette smoke and smokeless tobacco, though only are found in trace amounts in normal e-liquid. The same monkeys were switched to injecting these, with and without nicotine.

The analysis of the non-nicotine exposures might appear to be of little interest to vapers. But vapers may actually have more to fear from the resulting claims than smokers. By separating the measures of nicotine alone from what will probably be spun as all the relevant constituents of tobacco smoke (though there are really others), the FDA is anticipating the response that smoking is not just about nicotine. They are positioning themselves to assert that higher nicotine levels alone are a threat to fragile adolescents. Combine this with their repeated breathless statements  that e-cigarettes “are the most commonly-used tobacco product among youth,” and the nearly completed database of all vaping products on the market, and the FDA has an easy path to imposing a cap on e-liquid nicotine concentrations.

It is notable that in the animal experimentation form, the researchers checked “no” for the question, “May any animals experience more than momentary pain or distress?” The form goes on to clarify that if something would cause pain for humans, it should be assumed to cause pain for other animals. The main protocol is all about getting the monkeys habituated to a large dose of nicotine and then taking it away from them. The FDA, along with many others, frequently describes nicotine as addictive and cessation as difficult and distressing. Either FDA is suggesting that quitting nicotine products is really no big deal, or they allowed their researcher to lie about what the monkeys would endure.

FDA will undoubtedly keep the results of this research secret until they publish it in a journal, with great fanfare and a press release claiming the results demand whatever policies they currently favor. When that happens, it is likely that 24 monkeys will not be the only ones to suffer as a result of this junk science.