This post has been modified in recognition of reports that this center proposal is no longer under consideration for funding by Philip Morris; discussion of the questionable request has been removed, though issues related to research on the safety of nicotine use during pregnancy have been left for reference purposes. In August 2008, a Richmond paper reported on a proposal by the dean of the VCU School of Medicine (Jerome F. Strauss, III, MD, PhD) for a Center for Healthy Pregnancy and Neonatal Outcomes submitted to Philip Morris for up to $30M in funding. Although the proposal was turned down, of lingering concern is Strauss’s statement that
“Research shows that nicotine entering the bloodstream of pregnant women enrolled in smoking-cessation programs improves the health of their unborn children.”
This remarkable claim aside, there remains the dilemma of what to do with moms-to-be who can’t or won’t go cold turkey on smoking cessation. The most recent published data available are from an open-label randomized clinical trial showing that while nicotine replacement products help maintain smoking cessation during pregnancy, they do not promote permanent cessation, and the long-term effects of nicotine exposure on the fetus remain unknown. Unfortunately, this trial was stopped early by its DSMB when too many negative birth outcomes occurred among the group of women using nicotine replacement therapy. Three prior clinical trials conducted in Denmark (two studies) and Canada were inconclusive at best (Canadian study was stopped early as well), and a randomized, double-blind, controlled clinical trial is underway in the UK. [oddly, Kranzler, cited in the Richmond story, has not yet published the claims he makes to Dovi and only has one review article on the topic from 2003]
The NICHD is funding a cooperative clinical research program (U10HD036104) in minority women specifically addressing “the risk of nicotine exposure to the fetus and during infancy, … [along] a continuum impacting both health and development in later life.” Perfect. The U10 award is in its tenth year, so stay tuned for results from the George Washington University Medical Center.
Although he adamently told the media that the center at the heart of the Philip Morris request would not involve any research nor publish any findings, Strauss appears to be too overcommitted to rework his proposal for a research-oriented sponsor given that he serves as as Dean of the VCU School of Medicine; as Executive Vice President for Medical Affairs for the VCU Health System; and as PI for:
- one P60 Comprehensive Center Grant (P60MD002256-02),
- four R01/R01-equivalents (R01HD034612-11A2; R01HD037416-08; U54HD034449-12A16018; P60MD002256-020001),
- one K12 Research Career Program (K12HD055881-01), and
- one P30 Center Grant Core (P30ES013508-039002).