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Patch Job

Warning: VCU's proposal for a tobacco-funded pregnancy center could cause irreparable harm to its reputation and research efforts.

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I's buried in a funding proposal floated by Virginia Commonwealth University to create a new health center for pregnant women: Research shows that nicotine entering the bloodstream of pregnant women enrolled in smoking-cessation programs improves the health of their unborn children.

Indeed, in the annals of tobacco-related research there isn't a consensus on the effects of nicotine patches and cessation therapy during pregnancy. The lack of consensus, though, isn't what goads critics. It's that the nicotine replacement claim is part of a funding proposal that VCU recently shopped to Altria, parent company of Philip Morris USA.

The proposal is at the heart of the uproar over VCU's research partnership with Philip Morris. At a minimum, critics say the proposal's claim regarding the benefits of smoking cessation illustrates how far VCU is willing to go in its courtship with Big Tobacco. At its worst, a tobacco-funded health center could damage the university's academic reputation and ability to obtain federal funding for research.

University officials initially denied such a proposal existed or was ever presented to Philip Morris. But after confronted with a copy of the proposal obtained by Style Weekly, last week VCU confirmed the proposal was indeed floated in May or June to Altria, which decided against funding the new VCU Center for Healthy Pregnancy and Neonatal Outcomes.

The proposal's originator and its key proponent, VCU Medical School Dean Jerome Strauss, says that regardless of debate over particulars of the proposal, its goals are noble and unimpeachable.

"The goal of the center is outcomes — in getting the prematurity rate and the neonatal mortality rate down to acceptable levels," he says, citing Richmond's mortality of 17 deaths per 1,000 live births, among the most in the country.

"You have to balance out the risks of taking a medication during pregnancy with the consequences of continued smoking," Strauss says. "This is a program, not a research project."

But while Strauss's proposal cites numerous sources for its claim that nicotine replacement therapy is safe — indeed good — for improving healthy births among pregnant smokers, judging what is healthy is another issue.

"Basically we found that nicotine during development is not a good thing," says Duke University researcher Dr. Fred Seidler, whose own research into the topic relied in part on Philip Morris money.

Research like Seidler's is just that — research, Strauss says. His goal with the pregnancy center is not to study the effects of nicotine replacement therapy on pregnant women and publish the results, he says, but rather to provide an urgent public health service.

Should the university's solicitation of tobacco funds for the project prove successful — Strauss says he's still committed to seeking tobacco funds — the debate could well be heard in the offices of the Centers for Disease Control and Prevention or the National Institutes for Health, both of which provide public money for research at the university.

A CDC grant is paying for a study under way by university researcher Dace Svikis, which bears striking resemblance to some of Strauss' stated provisions.

"Earlier this year, Dr. Strauss called me to discuss the Philip Morris monies, and funding for a project to improve perinatal outcomes," says an associate professor in the medical school who specializes in women's health, via e-mail.

"I did indeed mention to Dr. Strauss at the time, that the proposed process for improving outcomes was very similar to the grant that I was already working on with Dr. Svikis, funded through the CDC," says the professor, who spoke on the condition of anonymity.

During a recent meeting with local news media, Strauss denied his proposal's similarities to the Svikis study. Contacted last week, Svikis says she worries about the negative effects Strauss' proposal would have on her funding.

"I'm very concerned about the impact of the [potential] Philip Morris funding on us being able to keep that grant," she says. "And on our ability to test the interventions — and that the CDC … could pull the grant if they felt this was in conflict to [my] work."

Svikis studies disparities in minority prenatal care, based on data showing women with less prenatal care are more likely to have babies that require longer post-birth care.

Even if Svikis' research were to continue to receive federal funding while cigarette dollars paid for the health center, she would face an uphill climb in getting her peers to take her work seriously, according to a research administrator at another university.

"Faculty conducting work that benefits from both federal and Philip Morris funding would need to list all sponsors when submitting manuscripts for peer review and when presenting these findings to their scientific peers," says a former VCU faculty member now at a major research university. While not in violation of federal policy, the seemingly contradictory interests listed among sponsors would "raise eyebrows among public-health professionals in particular and could impact acceptanceA├┐of the results being presented."

Strauss decries the concern. "That's bogus, absolutely bogus," he says. "There's no regulation that I'm aware of that restricts use of any industry support." Strauss, who denounces criticism coming from anonymous sources, insists that there's no dissent within university ranks.

The proposed center, however, is fanning an already heated controversy that began after a front-page New York Times report on a research-for-funding exchange agreement between VCU and Philip Morris. It would give Philip Morris unprecedented control over that research and its publication.

"No reputable organization will accept money from the tobacco industry in the public-health sector, and none will solicit it," says John F. Banzhaf III, a professor of public interest law at George Washington University, and a tobacco industry opponent for more than 40 years. Banzhaf is particularly concerned that Strauss's proposal went looking for the money: "Solicitation is very unusual."

On Aug. 5, Strauss denied the university had approached Philip Morris to fund the women's health center, though he acknowledged the initial proposal was seeking $30 million from an outside partner. A day later, VCU spokeswoman Pamela Lepley acknowledged the university's advancement office had approached Altria, Philip Morris's parent company, seeking funding for the new center. The current proposal is budgeted at less than $4 million.

On Aug. 7, Strauss amended his earlier statements: "What I said is I never went personally to talk to anyone at Philip Morris or Altria and to the best of my knowledge, the proposal — that was stolen and was given to [Style] — never saw anybody's eyes at Philip Morris."

Strauss insists that the debate over the long-term effects of nicotine replacement therapy during pregnancy is immaterial to the university's proposed health center because its stated goal isn't to conduct research.

"There is no evidence in humans that nicotine replacement adversely affects babies," says Dr. Hank Kranzler, a researcher at the University of Connecticut, who recently co-wrote a study on nicotine replacement.

He says the study shows "that nicotine replacement results in substantially larger babies than placebo. Larger babies do better. It could have an important implication for baby's health."

Duke researcher Seidler and his colleague there, Dr. Ed Levin, disagree. Their studies have looked at nicotine exposure, both in unborn fetuses and on young subjects. Their research has been on animals, never on humans.

"Certainly if you give nicotine in the animal models, you do see long-term effects on brain development," Levin says. "There are neural and behavioral effects. Nicotine in prenatal development is really something that should be avoided."

"I don't think there's enough research into the [nicotine replacement] patch," Seidler says. "It could in fact be worse than the … cigarette."

Part of this controversy erupts from the fact that no thorough studies have been done on nicotine replacement therapy's direct effects on the fetus or newborn or on its later development. Such thorough studies run into a number of issues, including ethics, because testing would require knowingly risking health for the purpose of a study.

Indeed, according to one top-level VCU researcher familiar with Strauss' pregnancy-center proposal, another researcher at the university recently approached the National Institutes of Health "about doing research on this as a harm-reduction model."

"We asked would that be a fruitful direction for her to go," says the researcher, who says the reply from the NIH was "absolutely not."

Strauss says he's sympathetic to the opposing views on cessation through nicotine replacement. But in a clinical application, he says, such theoretical debates are out of place.

"Does the end justify the means?" he asks. "Am I willing to take tobacco money to do good? Yeah. I think it's immoral not to."

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