BANANAS: The FDA Thinks Monkeys Are People

Discussion in 'Research, Health and Legal' started by The Vaper, Sep 29, 2017.

  1. The Vaper

    The Vaper I Vape ∴ I Am

    Jun 15, 2015
    Sydney 2016
    From BANANAS: The FDA Thinks Monkeys Are People by Carl V. Phillips on The Daily Vaper.

    The Washington Post reported that the FDA suspended its controversial research that administered nicotine to monkeys. This comes after a year of effort by White Coat Waste, a taxpayer watchdog group devoted to ending what they characterize as wasteful U.S. government funding of animal research.

    The action comes just weeks after WCW recruited renowned primatologist Jane Goodall to join their condemnation of the research.

    Coverage of this story has focused on Goodall and the controversies over animal experimentation. It has neglected the question why the FDA thought anything useful could be learned from this research. That question should be of interest to all American vapers, smokers and smokeless tobacco users, regardless of their feelings about animal experimentation.

    WCW reported this March that they discovered the FDA’s published abstract of research project they funded in March 2014. The abstract suggests that this is external research funded by the FDA, but it is actually an internal FDA project. The abstract cites as its motivation the FDA’s interest in lowering the nicotine content of tobacco products, a policy that was actually announced only this year. While the proposed policy of mandatory reductions in nicotine content applies only to cigarettes so far, the FDA seems unlikely to stop there if they are allowed to proceed.

    The abstract provides only vague descriptions of the study methods and what data is being collected. It is impossible to extract anything concrete beyond the plan to give a lot of nicotine to adult and juvenile monkeys. The claimed potential value of the research is unsurprisingly vague, given that it is difficult to imagine anticipating any useful outcomes from this research: “Study findings may improve methods for assessing the biological and behavioral effects of exposure to chemicals found in tobacco products and may provide data regarding the impact of nicotine reduction.”

    Unable to find any other public information about the experiment, WCW filed a Freedom of Information Act request and received 64 pages, apparently the detailed research proposal, which they described described as “heavily redacted.” WCW characterized the failure to provide more information as a violation of federal law and, after a failed FOIA appeal, announced a lawsuit. Unfortunately for those interested in the FDA’s nicotine policy, WCW never released the information they received and seem unlikely to do so now that they have won.

    However, it is possible to glean useful information from what they reported about the animal welfare issues. Devices were surgically implanted into the monkeys to deliver nicotine directly into their arteries. The monkeys were tightly restrained in isolation, presumably with little to do other than push a lever to deliver doses of nicotine. This apparently resulted in many nicotine overdoses, some of them fatal.

    It is difficult to fathom how the FDA thought that this experiment could provide any insight into human’s biological responses to nicotine under realistic conditions, let alone human behavior. Monkeys are not little humans, and pulling a lever out of boredom, frustration, and isolation-induced psychosis is not smoking or vaping. Drug self-administration studies of isolated captive animals have been discredited for decades, most spectacularly in Bruce K Alexander’s “Rat Park” experiments. He showed that rats lost interest in self-administering morphine when they were moved from isolation in empty cages, with no solace other than the drug, to a stimuli-enriched and social environment.

    The available information hints that the FDA was interested in observing the reaction to forced reductions in the monkey’s nicotine concentrations. While this is vaguely akin to forced reductions in the nicotine content of cigarettes, the differences render the comparison absurd.

    Following Goodall’s intervention, an open letter objecting to her and WCW’s position was signed by a group identifying themselves as “scientists and leaders in the addiction research community.” The signatories include anti-tobacco and anti-vaping researchers. The letter expresses general hostility toward efforts to reduce animal experimentation, and trying to head off threats to the signatories’ own experiments may be its primary motivation.

    The letter offers no argument why the research in question should be considered useful. Instead it contains hand-waving statements about needing more understanding of the “brain disorder” suffered by “the tobacco abuser.” It claims that other animals “self-administer drugs in a manner similar to humans” without seeming to recognizing the irony in suggesting this experiment in any way resembles how humans use nicotine.

    The letter objects to Goodall’s suggestion that studying actual smokers is more sensible, giving an unintentionally telling reply: “[the] two scenarios are entirely different.” So given that, what is the value of this experiment? The letter goes on to answer that with more unintentional insight: “[w]hat the monkey experiments allow them to do is isolate just nicotine” from the other constituents of tobacco smoke. In other words, the spirited defense of this research is about seeking ways to pursue the FDA’s war on nicotine; it is not about smoking.

    (In an additional interesting insight into the mindset of the signatories, who are taxpayer-funded researchers, the letter objects to the characterization of the monkey research as taxpayer-funded because the FDA’s Center for Tobacco Product’s research war chest comes from “user fees.” These are payments that regulated manufacturers are forced to pay to the government (i.e., taxes), and which are ultimately paid by consumers in the form of higher prices.)

    Vapers can find some consolation in the fact that this research was halted. But three years probably generated data that will be employed in the war on nicotine. The fact that the FDA ever conducted this experiment, to say nothing of other federally-funded researchers’ desperate defense against the public’s objections, suggest that the U.S. government’s war on nicotine runs much deeper than is generally recognized.
    margyb likes this.
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