Science Lesson: Anti-Vaping Research Studies Include Blatant Violations Of Ethics Rules

Carl V. Phillips | Contributor

Tobacco controllers are astonishingly unethical. Some of their unethical behavior is obvious to any politically aware vaper. Unfortunately the obvious behavior violates no laws or professional norms. However, their treatment of human research subjects includes blatant violations of ethics rules, and it deserves more attention despite being more subtle.

Tobacco controllers constantly out-and-out lie about there being substantial risks from vaping, smokeless tobacco and environmental tobacco smoke. They even exaggerate the risks from smoking, as if the truth were not enough, because making claims that cannot be supported by legitimate science simply comes naturally to them. Unfortunately, it is necessary to fight a painful war of attrition against this disinformation while trying to empower people to recognize that it is happening. There is no law against lying in support of a political position (it would be a disaster for free societies if there were), and no neutral arbiter except in the rare cases of lawsuits.

Similarly, tobacco controllers unethically pervert scientific methods, cooking up results that further their political aims. They assert conclusions that are in no way supported by the study data. This not only creates disinformation, but spills over into other subfields of health research. Other “public health” political campaigners have happily adopted their methods. However, this is normal and accepted in their world. Again, the only response is a war of attrition combined with empowering people to understand that public health journals and researchers mostly publish junk science. I have written extensively about the failure of peer review and scientific methodology in the field, both to educate non-experts and as technical scientific analysis.

Moreover, tobacco control’s underlying political philosophy (i.e., ethics at the level of society’s decisions) is ethically dubious, at best, and they never attempt to justify it. Using the state’s police powers, let alone disinformation, to discourage or prevent adults from making decisions about their own bodies is an extreme position that violates many ethical principles. Such a position could be defended by its supporters, but it never is. Instead they act as if it is self-evidently acceptable (which is clearly false) and if pressed offer only some hand-waving narrative about consumers being victimized by external forces (which is even more clearly false). Their political philosophy is effectively equivalent to suggesting they are on a mission from God to protect us from witchcraft or from Emmanuel Goldstein. But once again, this can only be confronted. Acting in accordance with an extremist political philosophy does not violate any rules.

What does violate rules, however, is tobacco controllers’ disregard of the principles of human subjects ethics. There is a codified set of rules, which trace back to the Nuremberg Trials and have been adopted by governments and universities, stating what is not allowed when conducting research on people. Almost every tobacco control researcher is obligated to adhere to these, usually due to explicit contract terms and always due to professional ethics.

The details vary, but these codes generally require fully informing subjects about the research and requiring affirmative consent to proceed based on that. They forbid doing research that is intended to harm the research subjects, as well as forbidding deceiving the subjects (with rare exceptions when an experiment depends on some technical deceit, such as not telling subjects that someone in a focus group is actually an undercover member of the research team, which is then revealed to the subjects at the end). Tobacco control researchers routinely violate these rules.

Some of these violations are incredibly blatant. I have written about several of these, including a case in which subjects were presented with false information which they were never told was false, and were promised a sample of a product but were instead given a lecture on why the product is evil, and another case where the researchers snuck into a vaping convention to collect data. Both of those were conducted by university-based FDA-funded researchers who were therefore in violation of both government and university ethics rules.

Other violations are more subtle, particularly the practice of including vapers in research whose purpose is to generate negative messaging about vaping. While the study activities themselves might pose no threat to the participants, this is not sufficient. The overall research agenda is intended to harm all vapers, including those who participated in the study, by facilitating efforts to forbid or otherwise burden vaping. This is a violation of the requirement that research not harm the study subjects, as well as the requirement that subjects be fully informed about the research when the agenda is not disclosed to them. This ethics violation is close to ubiquitous in US-government-funded research and most other research that is not conducted by industry or by independent researchers who support consumers.

For concreteness, consider the example presented by Jim McDonald in two recent Vaping360 articles. Researchers at Johns Hopkins University were recruiting vapers via a Reddit discussion group to participate in a health status study that was presented as if it were genuinely truth-seeking. Discussion participants pushed the researcher who made the post to report a summary of the research’s hypotheses and the underlying goals of the research, but these were ignored. McDonald found the missing information about the study elsewhere, and noted that the health of vapers was only going to be compared to that of never-smokers. This comparison nearly guarantees that the study would “show” that vapers (basically all ex-smokers, often quite recent, with residual health effects) have poorer average health.

McDonald also observed that the study protocol included irrelevant anti-vaping political rhetoric and the lead researcher had a history of anti-vaping research. (In this case, that history was limited. In some cases the researchers have an extensive history of aggressive anti-vaping activism.) The project is funded by an anti-vaping US government agency. It seems safe to assume the disclosure to the participants will not mention that a goal of the researchers and funder is to find bad things to say about vaping. There is similarly little chance participants will be informed they will be compared to never-smokers, rather than to the obviously better and perfectly practical comparison group of non-vaping recent ex-smokers, and that this almost guarantees misleading results.

Additionally, the subjects were offered substantial material compensation for their participation. This introduces other ethical concerns about pressuring participants. Even someone who understood that the research was unethically designed to harm vapers might be persuaded that she personally comes out ahead if she sells out the community. It is not a big leap from that to the many ways that powerful authoritarians bribe or extort people to sell out their own communities. Research ethics codes were designed to prevent researchers from acting like government agents.

This is just a single example, but it is the rule rather than the exception. Most researchers in the field conducting studies on people do so with the intention of using the results to harm their subjects, and without adequate disclosure. This is not just a case of junk science methods or political propaganda. It is a bright-line violation of clear rules of conduct. It could be legally challenged as a violation of university rules and US law.

For readers who might not see just how appalling this is, it is worth considering an analogy. Imagine a researcher whose agenda was to deny the liberties of Muslim-Americans by suggesting their faith threatens themselves and “innocent bystanders.” Most of those who are happy to do exactly that to vapers and smokers would object to this, and probably try to run him out of the university. But in a free society, the researcher is perfectly free to present that message, and others are free to condemn him for it. Now imagine that he frequented mosques to gather inflammatory observations without disclosing his presence. He also recruited individuals to participate in biased studies without disclosing his intent, offering them a payoff to cooperate.

Some people, of course, would support his agenda and suggest that the ends justify any means. But apart from whether such a position is ever defensible, professional university and government researchers are not at liberty to declare a class of people “enemy combatants” and suspend the rules when dealing with them.

It seems appropriate for vaping advocates to call for a general boycott of participating in human subjects research, unless it is explicitly endorsed by respected vaping advocates. There are some devilish details in that exception, but they could be worked out. It might even be appropriate to encourage efforts to volunteer for studies and then subvert the research.

McDonald’s article and other analyses offer the suggestion that vapers should investigate a study and the researchers before volunteering, or ask experts to assess it if they are not able to do so themselves. That is a good advice. Unfortunately, about 99 percent of vapers have never read such a piece of advice, or even discussed the matter with someone who has. As with all political activism, most people have too much else to attend to. A few informed vapers balking at participating after looking into the details will do nothing to slow recruitment for unethical research.

By contrast, a campaign to tell vapers to simply boycott vaping research would reach a much larger portion of vapers. It is much simpler than trying to dive into nuance, and it is the type of bold message that can gain momentum. Moreover, learning that there is a reason to boycott the research would itself be useful for educating vapers and others about what is being done to them. Meanwhile more informed vapers who identify unethical research could actively seek to jam it, doing anything from volunteering and then not showing up to providing junk data.

Researchers conducting ethical research that is designed to create legitimate information, which thus might benefit the participants, would be given the option of approaching trusted vaping authorities to validate it. They could then get active assistance in recruiting participants from those who vet the research.

This proposal might sound rather radical, especially coming from a researcher. It might seem like it is based on mere political antagonism and that it is calling for unethical behavior. But keep in mind that the objection here is that these researchers are blatantly violating research ethics that are based on codes of fundamental human rights. If a boycott campaign focused on that, it could avoid coming across as a mere political tactic and help expose the habitual disregard of ethics by tobacco controllers. Radical action in defense of codified human rights is no vice.

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