Monday, June 25, 2007

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.

5 comments:

Michael J. McFadden said...

June 25th's "Health Care Renewal" article notes that, "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."

It is beyond my understanding how someone can write something like this without seeming to even think about the other side of the coin.

Antismoking earmarked funds have resulted in at least as much one-sided and biased research in the last 20 years as Big Tobacco's grants produced in the 1950s and 60s and 70s.

I would strongly suggest reading my Edmonton Journal letter at:

http://www.canada.com/edmontonjournal/news/letters/story.html?id=4a64c2d9-4da5-4420-b50b-9e19a8229912

and Dr. Michael Siegel's analysis of it (and blog comments) at:

http://tobaccoanalysis.blogspot.com/2007/04/prominent-anti-smoking-advocate-accuses.html

before forming an opinion on this issue.

Michael J. McFadden
Author of "Dissecting Antismokers' Brains"
http://pasan.TheTruthIsALie.com
Active and unpaid member of The Smokers Club and many other smokers' rights groups.

Anonymous said...

"It is beyond my understanding how someone can write something like this without seeming to even think about the other side of the coin."

You must be joking.

Anonymous said...

VCU invites Philip Morris employees to secure affiliate faculty appointments (see http://www.vcu.edu/graduate/pdfs/Graduate_Faculty.pdf or for example see http://www.egr.vcu.edu/FacultyDetail.aspx?facid=24 or http://www.pubinfo.vcu.edu/pharmacy/Faculty/FacDetail.asp?ID=114), trains postdoctoral fellows paid by Philip Morris, and has a long history of accepting donations, research awards, and other largess. VCU and VCU upper administration are mentioned repeated in Philip Morris documents, with the current VCU Vice President for Research having served on the Philip Morris Research Advisory Committee in the 1980s and meets with tobacco company personnel regularly in his current position. One wonders what IP arrangement has been made in the University's Master Agreement with Philip Morris USA.

Anonymous said...

VCU provides Philip Morris employees with affiliate faculty appointments (see http://www.vcu.edu/graduate/pdfs/Graduate_Faculty.pdf or see for example http://www.egr.vcu.edu/FacultyDetail.aspx?facid=24 or http://www.pubinfo.vcu.edu/pharmacy/Faculty/FacDetail.asp?ID=114), trains postdocs paid by Philip Morris, and accepts millions of dollars in "research" grants, donations, and other largess. VCU and VCU personnel appear repeatedly in Philip Morris tobacco documents. The current VCU Vice President for Research served on the Philip Morris Research Advisory Committee in the 1980s and meets regularly with Philip Morris leadership on shared research resources, projects, and funding. Philip Morris has sponsored a class at VCU, and one wonders what IP arrangement has been made in the University's Master Agreement with the company.

Anonymous said...

Following are excerpts from an article published in the Richmond Times-Dispatch discussing "secret negotiations" to build the Philip Morris research facility and the enthusiastic partnership with VCU. Of additional note is the fact that Francis Macrina, the VP for Research teaches an annual course on Scientific Integrity at VCU and is regularly invited to conduct workshops on ethical aspects of research, including - ironically - issues related to authorship and publication policies (with no mention of the decades of unethical publication practices employed by Philip Morris with his apparent blessing as a Research Advisory Committee member).

Philip Morris shot in the arm for park
New center is giving biotechnology facility boost it had needed

BY GARY ROBERTSON
TIMES-DISPATCH STAFF WRITER
May 23, 2005

The construction trailers are up. A trackhoe is digging up a parking lot, biting off metal fence posts as it goes.

And in this slice of Richmond, on downtown's northern edge behind the Coliseum, expectations are soaring.

In April, Philip Morris USA ended months of secret negotiations to announce that it was going to build a $300 million research and technology center in the Virginia BioTechnology Research Park in Richmond.

On a fast track, the center is projected to open in 2007, creating up to 700 of what are expected to be some of the highest-paying scientific and technical jobs in the region.

Local and state leaders have hailed the Philip Morris technology center as an economic coup for the Richmond area and a huge step forward for Virginia's aspirations to become an East Coast hot spot for biotech.

...

The Philip Morris research center will nearly double the size of the 575,000-square-foot park and increase employment there by nearly 40 percent, to 1,800.

VCU has had a relationship with Philip Morris for years. The company has endowed a chair of international business in the university's School of Business, and Philip Morris, the world's largest cigarette maker, is backing 12 studies accounting for $4.4 million in various parts of VCU.

One objective of the research at Philip Morris' research center in the biotech park will be the development of products and technologies to lessen the harm caused by smoking, company officials have said.

Robert T. Skunda, president and chief executive officer of the biotechnology park, has emphasized that the kind of research that Philip Morris might explore could lead to advancements and products far beyond tobacco.

And one local official has told The Times-Dispatch the research would include basic genetic and molecular science, although Philip Morris has not divulged its plans.

Whatever those plans are, VCU is poised to become a partner in key areas of compatible research with Philip Morris.

"We're in a full discovery mode," said Francis Macrina, the university's newly appointed vice president of research, a microbiologist by training.

Thomas Huff, VCU's vice provost for life sciences, is bullish on the possible opportunities for collaboration between scientists and researchers at Philip Morris and those at VCU.

Last August, seven months before Philip Morris made the announcement for the research center, Huff said he and Skunda received a call to come to Philip Morris' research center on Bells Road.

"More or less the first thing we heard from Philip Morris," Huff said, "is that they were looking to be an industry that reinvented itself."

He said basic scientific research is driving the $300 million investment in Richmond, and what he said was a nearly equivalent research investment in Europe.

Fifteen years after the idea for the biotechnology park began bubbling, Trani said that now even persistent doubters can see its value.

And with the park's success, he said, VCU has reinforced its role as an economic engine for the region.

Contact Gary Robertson at (804) 649-6346 or grobertson@timesdispatch.com