CASAA’s FDA testimony re “3rd Party Governance”

In “response” to a report by the Institute of Medicine, the US FDA recently held hearings about whether to try to impose “third-party governance” of research.  (The scare quotes refer to the fact that the IOM report was conducted at the behest of FDA, so this is really a “response” to their own initiative.)  The concept is that certain parties cannot be trusted to do honest research, and therefore some more neutral third party should control the research.

This is not a bad idea at the simplistic level of political chatter, and there are efforts by independent parties to do genuine public-interest research (like recent initiatives by CASAA).  But the devil is in the details, and the details are indeed diabolical.  The neutral language is really a stalking horse for anti-tobacco extremists to try to control all of the research, furthering their efforts to censor consumer interests and all other voices in the discussion.  Of course, it is those ANTZ, not the modern tobacco and e-cigarettes industries, who consistently do extremely biased politicized junk science.

Thus, our comments, as presented at the FDA hearing by CASAA Legislative Director, Gregory Conley:

My name is Gregory Conley, and I am here on behalf of the Consumer Advocates for Smoke-free Alternatives Association, known as CASAA.  We are the leading US advocate that represents consumers of low-risk smoke-free alternatives to smoking, including electronic cigarettes and smokeless tobacco, and other consumers who might someday switch to such products.  We are an all-volunteer organization, funded entirely by donations.  Our organization does not take positions on the regulation of cigarettes or smoking, and therefore all of my remarks should be interpreted as referring to research and regulation of smoke-free products and research about tobacco harm reduction.

Research on tobacco harm reduction and smoke-free alternatives should focus on benefiting the primary stakeholder, the consumers.  Therefore, we support the principle of encouraging research that is controlled by third-parties who are primarily interested in informing and benefiting consumers.  However, we believe that the greatest concerns about research that is not done honestly, or is done in ways that do not support the public interest, do not relate to the tobacco or e-cigarette industries.  Recent research on these products – a significant body of which was conducted or directly funded by the tobacco and e-cigarette industries – has been in close alignment with the public interest.  Specifically, it has been honest research that pursued ways to improve the health and well-being of tobacco and nicotine consumers.

By contrast, there is serious concern about research that is conducted and sponsored by another special-interest group, the tobacco control industry, the coalition of organizations and individuals who are dedicated to the elimination of all tobacco and nicotine use.  Because honest consumer-oriented research tends to support tobacco harm reduction, and because tobacco harm reduction is a threat to the tobacco control industry’s business model, they have actively promoted scientific disinformation to mislead consumers about smoke-free alternatives.  This has been documented by researchers for over a decade and our own current research and publications document that this disinformation campaign continues.

Thus, redirecting some research away from manufacturers’ control and to the control of those who are specifically concerned about consumers’ choices and welfare might theoretically offer some modest benefits for the public interest.  To facilitate this, it is important to push back against the efforts to vilify any honest independent researcher who accepts industry funding.  But redirecting research away from the control of the tobacco control industry would be enormously beneficial for consumers and the public interest.  The worst possible scenario would be to use the principle of third-party governance of research to put more research under the control of anti-tobacco researchers who support an extremist anti-tobacco-harm-reduction agenda that threatens the health and welfare of consumers.

The claims that the tobacco industry engages in dishonest research are based on ancient history.  Recent research conducted and sponsored by the several tobacco companies who are actively pursuing tobacco harm reduction, as well as e-cigarette companies that have started to support research, appears to be objective and honest science.  When someone makes claims about dishonest research from the tobacco industry, they never identify any recent example of ethical misconduct, or even bad research.  Instead, their claims are based entirely on events that occurred many years before I was born, actions taken by people who have long-since retired or died.

The industry’s interests are not perfectly aligned with those of consumers.  But the public interest can and should be served by the FSPTCA’s already extensive FDA regulatory oversight.  A large portion of industry-funded research can be carried out by independent researchers who are primarily concerned about consumers, and about doing the best possible honest science.  In addition, the few in-house industry research operations appear to be very interested in doing the best possible honest science, and in considering the health of consumers even when it does not align perfectly with maximizing profits.

Thus, we believe that the public interest could be served by the creation of some consumer-oriented third-party institutions that conducted research that was funded by the manufacturers.  However, the status quo with respect to manufacturer-sponsored research is closely aligned with the public interest, and thus no major changes are demanded.

By contrast, anti-tobacco activists have a consistent record of publishing false and misleading claims meant to discourage would-be smokers from using low-risk alternatives instead.  This extends to the scientific research they conduct or control through their vast funding network.  Unlike the allegations about manufacturers’ supposed hidden manipulation of science, which are based on speculation and innuendo, it is easy to observe misleading research coming from anti-tobacco activists.

Common tactics include:

• suggesting that trivial risks and exposures from smoke-free products, which have no serious health consequences, are similar to the risks from smoking;
• denying the existence the overwhelming evidence about the efficacy and effectiveness of tobacco harm reduction products;
• starting with the premise that tobacco harm reduction is bad, and merely reporting that premise as if it were the result of a study.

Researchers have documented that these and other anti-harm-reduction lies from tobacco control were common a decade ago, and they have increased in volume since then.  Frequently they appear in journal articles and other research reports.  CASAA has a blog that is devoted to identifying this misleading research that runs contrary to the public interest.  We analyze several examples every week, and are forced to ignore many others due to the sheer volume.

The goal of third-party governance is to take control of research out of the hands of special interests who are likely to bias the science and otherwise act contrary to the public interest.  We understand that the FDA does not have any authority to redirect funds away from these misleading and harmful efforts by anti-harm-reduction activists, and we would not advocate for the violation of free-speech rights that such a government confiscation would entail.  However, the spirit of third-party governance says that FDA, and DHHS more generally, should avoid directing any additional research funding toward those activists and activist organizations.

If there is an opportunity to direct research funds, whether they come from manufacturers’ fees and contributions or some other source, to third parties who will do honest science in the interest of consumers and do not support an anti-harm-reduction or other anti-consumer prohibitionist agenda, this would probably have some benefit.  However, the current research practices of manufacturers are not actually very far from this scenario.  To reiterate, the worst possible scenario – in terms of public health, consumer well-being, and honest science – would be to transfer more research to the control of anti-tobacco activists.