Smokescreen - Will Tobacco Company's New Research Program Create New Conflicts of Interest?

Writing in the Wall Street Journal, Anna Wilde Mathews and Vanessa O'Connell highlighted the increasing involvement of tobacco company Philip Morris (subsidiary of Altria Group Inc) in health and medical research. First, the company has been building a big research facility in a biotechnology research park.

At a research park that's home to several biotech companies, a $350 million facility under construction will soon house hundreds of researchers. But instead of testing lifesaving medicines, these scientists will be focused on a product that kills an estimated 438,000 Americans a year.

The facility, due to open in August, is owned by Philip Morris USA, the nation's biggest tobacco company. The Altria Group Inc. unit is preparing for a tectonic change -- regulation of tobacco by the Food and Drug Administration.

The bills also dangle a potentially lucrative opportunity. They say that if a new kind of cigarette can be scientifically proven to 'significantly reduce harm' to smokers -- and its availability would also benefit the health of 'the population as a whole' -- the cigarette's marketing claims may win approval from the FDA.

Philip Morris, which is working on a slew of new products it hopes might qualify for FDA-approved health claims, acknowledges it must transform itself into a credible player in the expected scientific debates at the FDA. So the company is trying to emulate an industry already under the agency's purview -- the drug companies.

The company has a number of highly engineered products in the works, all of which are designed to possibly reduce tobacco's dangers.

Analysts say the effort is consuming about half of the estimated $200 million Philip Morris spends on research and development each year. Philip Morris scientists are conducting human studies, presenting results at research conferences and publishing findings in scientific journals such as the Journal of Clinical Pharmacology.

To staff its 450,000-square-foot research center, its biggest investment in two decades, Philip Morris is trying to recruit dozens of physicians, biochemists, and other scientists.

Although the article did not identify the location of the new Philip Morris facility, the Richmond, VA dateline of the article suggests that it is in the Virginia Biotechnology Research Park, whose web-site boasts of hosting the new Philip Morris Research and Technology Center. The research park was "originally created as a partnership of Virginia Commonwealth University, the city of Richmond and the commonwealth of Virginia."

The WSJ article also suggested that Philip Morris is getting more involved with academic researchers, and that other tobacco companies are following its lead.

And in the same way that pharmaceutical companies pay top researchers to lead drug studies and speak about their findings to regulators and other scientists, the tobacco maker is trying to forge relationships with outside experts who might support Philip Morris's research efforts.

While they have been reaching out to outside scientists and medical researchers who can review their own reduced-harm product research, Philip Morris's rivals haven't done as much to ready themselves for regulation.

Also, Philip Morris is working more with outside research organizations.

One of the company's efforts -- hiring the Life Sciences Research Office in Bethesda, Md. -- has already sparked controversy. A nonprofit founded to conduct research for the Army, it has done work under contract for the FDA, as well as such projects as weighing the evidence of walnuts' health benefits for a group of walnut growers.

In 2004, Life Sciences began a Philip Morris project that focused on reviewing research from tobacco companies and others related to potential reduced-risk products, with the goal of figuring out what evidence was needed to prove reduced-risk claims. The nonprofit says it reached out to about 1,000 scientists and organizations, seeking recommendations on what questions to address and who might serve on panels that would conduct the review. It also invited scientists to submit research and participate in meetings.

Earlier this month, two University of California-San Francisco researchers published a paper in Tobacco Control, an antitobacco journal, accusing Life Sciences of downplaying or concealing its 'true level of involvement' with the tobacco giant. It warned that Life Sciences may not be fully independent, saying that some members of the nonprofit's outside panels have had financial relationships with tobacco companies.

The concern is that Philip Morris' research effort will generate a whole new set of possible conflicts of interest. The company already apparently has some sort of indirect relationship, through the Virginia Biotechnology Research Park, with Virginia Commonwealth University, which includes the VCU Medical Center. The Medical Center claims on a page on its web-site dedicated to the park that "the park works hand-in-hand with VCU, other academic institutions, businesses, and government and not-for-profit organizations to facilitate technology transfer and business development." It is hard to tell whether this relationship could be sufficient to constitute an institutional conflict of interest for VCU.

The company's efforts to build relationships with outside experts "who might support Philip Morris' research efforts" based on an attempt to "emulate" pharmaceutical companies suggest the possibility of new conflicts of interest affecting academic who consult for the tobacco company, and new institutional conflicts of interest affecting their parent instutions who receive grant money from the company. (We posted on Philip Morris' large grant to the University of Virginia, not to be confused with Virginia Commonwealth University, here.)

Finally, the company's relationship with at least one not-for-profit research organization also suggests the possibility of new conflicts of interest affecting other such organizations.

All these conflicts of interest are even more concerning than parallel conflicts of interest having to do with pharmaceutical, biotechnology, and device companies. At least all of those companies make products meant to ameliorate, control or cure disease. When physicians, academic researchers, or health care institutions take their money, doubts are raised whether their opinions and research are influenced by the commercial vested interests that fund them. Such doubts make it harder for patients and physicians to weigh the possible benefits and harms of medical interventions. That isn't good for health care.

Tobacco, of course, is cause of, not a treatment for disease. When physicians, academic researchers, or health care institutions take tobacco money, doubts will be raised whether their opinions and research are influenced by their tobacco company funding meant to obscure the risks of tobacco products. Since their are no benefits of tobacco that could counter-balance these risks, the result may be more people smoking more, thus more tobacco produced disease. For academics and health care professionals, and their organizations to thus promote disease would violate their core principles, and would be the opposite of the dictum "first, do no harm." Cloaking research meant to market more cigarettes in academic respectability could be very bad for health care.