Thursday, February 09, 2006

Tobacco Control Researcher Proposes Tobacco Industry Funding of "Independent" Tobacco Control Research

For the first time that I am aware, it has been proposed from within the tobacco control community that tobacco control researchers seek funding from the tobacco companies for their research.

Specifically, a researcher writing in the current issue of Tobacco Control promotes seeking tobacco industry funding to research the health effects of potential reduced exposure products (PREPs) (see: Eisenberg T. The time for tobacco industry sponsored PREP evaluation has arrived. Tobacco Control 2006; 15:1-2).

"Tobacco industry support for objective work completed by independent researchers may seem challenging, but the expertise exists and the need is real. ... The time for industry sponsored evaluation of the exposure reduction associated with specific PREPs has arrived. ..."

The article calls for industry funding of independent scientists to evaluate PREPs "in an environment where industry support for PREP evaluation is accepted only under specific, clearly articulated conditions; by qualified, objective researchers using state of the art techniques; with oversight that maintains the integrity of the research enterprise, from study design to data analysis, to timely publication."

The reason provided for the need for industry funding of independent research is that "failure to act in this manner will, at best, leave evaluation in the hands of an industry with a poor track record for objectivity. At worst, failure to act will doom us to repeat the very history that we remember too well: a history where uninformed consumers and many public health advocates embraced untested products that enriched the tobacco industry but did not reduce smokers' exposure to lethal smoke toxicants."

Of note, the article was written by a researcher who is conducting evaluation of PREPs with funding from NIH.

The Rest of the Story

I don't buy this at all.

I don't think it is appropriate for tobacco control researchers to seek funding from the tobacco industry to conduct their research. I think the bias inherent in doing so is so great that it is impossible to generate objective research, no matter how many controls are built in to the system to try to protect the integrity of the research.

By the arguments in this article, much of the research conducted by tobacco industry-funded scientists over the past 50 or so years would have been acceptable. After all, a fair amount of this research was conducted in a manner in which the industry had no control over the process. But that very same research contributed to a systematic process by which the public's appreciation of the health effects of tobacco use was undermined.

By the arguments in this article, we should be actively encouraging universities to seek tobacco industry funding for research, and we should be opposing the decisions of academic units, such as the Harvard School of Public Health, UC Berkeley School of Public Health, UCSF Comprehensive Cancer Center, and many others, to not accept tobacco industry funding of academic research at those institutions.

I think this proposal goes against the grain of what the tobacco control movement has been trying to achieve over the past few decades, and it greatly undermines the progress that has been made. In addition, it greatly undermines the basic premise for much of the Department of Justice's claims of fraudulent tobacco industry conduct in its litigation against cigarette companies.

What this proposal says is that it is acceptable to promote tobacco industry funding of research to improve human health and that there is no inherent conflict in doing so. I disagree.

Don't get me wrong. I am not criticizing any individual scientists who have made the decision to accept tobacco industry funding. That's their decision. But I don't agree with a systematic and institutionalized policy of promoting and seeking tobacco industry funding of research at private and public academic institutions.

I'm sorry, but if research is being funded by the tobacco industry, there is a huge incentive on the part of the researchers to produce findings that are beneficial to the funder. That is not a slam on the integrity of researchers, it's just a simple fact of academic life.

And another simple fact of life is that the tobacco industry has used supposedly "independent" academic research as a public relations and marketing tool for decades, and continues to do so. Why would we want to make public and private universities pawns of the tobacco industry, and agents in the industry's public relations and marketing schemes?

To me, that's not tobacco control nor is it public health, although it does sound like a good way to open up funding streams for researchers who are interested in doing work in this area.

There are really only two ways I can think of that a system of industry-sponsored research could work. First, the industry could voluntarily fund such a system. But if that were to be the case, then the bias would be intolerable, because the very fact that the industry could then voluntarily withdraw the funding would create a huge incentive to produce results favorable to the industry.

Second, the industry could be forced to fund such research. But I don't see any legal basis for requiring that.

In addition, I think it would present ethical problems under either scenario. Should universities really be arms of the tobacco companies, serving to help them conduct research and development for deadly products? After all, that's essentially what this amounts to. Evaluation of PREPs is a part of the research and development process that goes into the eventual marketing of these products. I don't see that as an appropriate role for academic institutions.

The last thing in the world that I think we want to do is to take the requirements for documenting health claims of PREPs off of the shoulders of the tobacco industry and onto independent researchers at academic institutions. It is the tobacco companies' responsibility to document their health claims, not "ours." And I don't see any role for "us" in the process of helping the companies to do that in any kind of partnership or collaboration, which is what this article is essentially calling for.

I'm not arguing that public health research on the effects of PREPs is unwarranted. It's quite important and valuable. But it should be done as completely independent public health research with the aim of producing information of interest, not as a collaborative endeavor with tobacco industry that forms a substantive part of the companies' research and development in the potential marketing of a deadly product.

Do we really want it on our conscience and on our record as academic institutions that we conducted research that formed a substantive part of the research and development of a deadly product, and that we sought to do so in collaboration with the tobacco industry? In some ways, I think we would become, in part, accomplices.

I'm sorry, but partnering with the tobacco industry is not the way to go. In addition to the ethical problems, it would give the industry a tremendous public relations boost and provide the industry with much-desired legitimacy. That would do more damage to public health then any possible research that I can imagine being funded.

The bottom line is that the research and development of tobacco products and the documentation of the health claims being made in tobacco marketing is the responsibility of the tobacco companies. If we are concerned about misleading health claims, then the way to deal with that is two-fold: (1) to enforce laws that make misleading claims illegal (such as pressuring the FTC to enforce the current law which makes misleading advertising claims illegal); and (2) to work to retain cigarette company liability for misleading health claims by making sure that the proposed FDA legislation is killed.

The most important thing protecting the public from potentially misleading health claims associated with PREPs is the threat of litigation. And that is precisely why Philip Morris so badly desires enactment of the proposed FDA legislation, which would completely remove the liability threat regarding misleading health claims of its new PREPs. It is removing that liability that would actually open up the door to the worldwide marketing of these products and to the ability of companies to get away with making misleading health claims of reduced exposure products.

Industry sponsored research on PREPs would only serve to reduce the liability associated with marketing PREPs and increase the chances that companies would make misleading health claims. After all, what better documentation could there be then "independent" confirmation of the reduced exposure from PREPs (exposure reductions that could well turn out not to be related to improved health outcomes)? But the industry could use such data in arguing, successfully I believe, that it should not be held responsible for any damages from misleading health claims. Academic institutions would become accomplices in the marketing of PREPs and in the damage done by any misleading health claims.

I think we are deceiving ourselves if we think anything good is going to come out of seeking tobacco industry funding so that we can become a part of the research, development, and marketing process for tobacco products.

Be warned now. This is a disaster waiting to happen.

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