Medical Writing, Editing & Grantsmanship

Although the NYT has not printed a correction, clarification, editor’s note, retraction, or any other indication that the veracity of Mr. Finder’s reporting has been called into question, they did offer, rightly, the opportunity for VCU to respond in the form of a letter to the editor from President Trani. This letter, although more thoughtfully articulated than his prior memo, continues to downplay the real problems of any university engaging in research service agreements and the even greater ethical problems with this particular research service agreement, setting aside the sponsor for now.

As part of my commentary on this, I disclose that I have been sent a copy of the agreement obtained by a third party through a Va FOIA request (details below) and will quote verbatim a few critical points omitted by Trani in his letter and overall response to this story.

For example, secrecy (from the agreement itself):

”19. Neither party shall, without the prior written approval of the other party, (i) advertise or otherwise publicize in a written manner the existence or terms of this AGREEMENT or any TASK ORDER or any other aspect of the relationship between SPONSOR and VCU … If at any time a third party, including without limitation any news organization, contacts VCU concerning SPONSOR, VCU shall make no comment and shall notify promptly SPONSOR of the third party.”

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Update: I’ve discussed President Trani’s letter to the NYT above. And perhaps this NYT article explains how this all could have happened.

Update: Outstanding Blog Entry by an VCU Adjunct Professor summarizing the many (& snowballing) unethical activities going on in Richmond (and a great follow-up commentary here as well).

The NYT today reports on an astoundingly unethical and outrageous research agreement between VCU (Virginia Commonwealth University) and Philip Morris USA. The need to deny existence of this agreement if asked by the press … the ability of Philip Morris to remove everything but prepositions from journal manuscripts and any other form of dissemination … the pre-assignment to the company of intellectual property generated. Jiminy Crickets.
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JAMA also reports the shocking (or not) news that Philip Morris, RJR, et al. continue to deceive the public with false advertising about tar and nicotine levels in their cigarettes. “At the November 13 hearing, Sen Frank R. Lautenberg (D, NJ), who chaired the session, said he had uncovered a lengthy history of false and deceptive cigarette ratings and marketing practices. “It is now clear that the tobacco industry has been aware of the inaccuracy of these ratings for more than 3 decades,” said Lautenberg. … Cigarette manufacturers Altria Group Inc (Philip Morris International) and R. J. Reynolds Tobacco Co were called to the hearing but refused to attend.” The Supremes will take a listen next.

Update: The reason for these meetings can be better understood in light of the VCU-PM master research services agreement.

Not events I would want or expect to come across on a local calendar …

Nov 7 Philip Morris senior leadership summit (provost and vice presidents only) 3-5 p.m.
Nov 7 Philip Morris reception for deans, PM-funded faculty and DoDs 5-7 p.m.

Aside from their outlandishly inethical practices with regard to manipulating research, publications, and policy, Philip Morris et al. have one product line, and that product line is known to be highly addictive, toxic, and lethal. Profits used to fund tobacco industry grants are earned at the cost of millions of lives and billions of dollars worldwide. Why would any academic health center solicit and accept grants and gifts funded solely and directly through the sale of a product they themselves must counsel each and every patient, employee, faculty, student, and community member to avoid or stop using … an industry in direct conflict with their mission to protect and advance public and personal health.

Instead, an academic legitimacy dream come true: the newly constructed $350+ million Philip Morris USA Center for Research & Technology is the flagship member of Virginia BioTechnology Park, “a joint initiative of Virginia Commonwealth University [which gives PM employees affiliate faculty appointments] and the city of Richmond, situated on 34-acres adjacent to the VCU Medical Center [including the NCI-designated Massey Cancer Center, which lists Philip Morris and Altria among its corporate partners]” and home to the VCU Office of Vice President for Research (with the presidentially appointed VPR on comfortable terms with Philip Morris … also a recipient of NIH funding from ORI’s research on research integrity program).

Update: Science and The Chronicle of Higher Education (which includes a thread of comments) note that Philip Morris ended its PM External Research Program. However, this is not the end of PM funding at Universities.
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Last week’s issue of Circulation includes a report that further fuels my tirade against the tobacco industry as a funder of “scientific” research. Tong & Glanz describe “how the tobacco industry initiated and funded scientific work to counter epidemiological and biological conclusions that secondhand smoke causes cardiovascular disease. The industry pursued this work initially to fight smoke-free regulations; later, the work also was done to promote allegedly “reduced-harm” products.”

The scientific consensus is that frequent exposure to secondhand smoke increases the risk of cardiovascular disease by 30%. The industry has gone so far as to attribute the effects on blood and vascular function to “an unproven epinephrine-related stress response from odor” … not the toxic smoke itself. After detailing the subtle and not so subtle shortcomings of tobacco-funded study designs, Tong & Glanz conclude that “industry interest in preserving corporate viability has affected the design and interpretation of their cardiovascular studies”.

Specifically, they caution: “The question of whether cardiovascular disease effects, not just carcinogens, can be eliminated with the large number of chemicals in tobacco smoke must be on the forefront in the ongoing “reduced-harm” product debate, a debate that will intensify if the federal Food and Drug Association is granted authority to regulate tobacco products. The industry’s past and recent cardiovascular scientific activities indicate the need for great caution in current debates about future tobacco industry regulation and development of “reduced-harm” tobacco products.”

In commenting on this report, a spokesperson for Philip Morris USA stressed that the company continues to research ways to reduce the health risks from smoking, creating a $350 million center for research and technology in Richmond, Va. Oh joy.

From the NYT today:

“The extent to which depictions of smoking actually spur the young to smoke remains a subject of debate. Widely cited research by Dr. James A. Sargent of the Dartmouth Medical School showed a connection between adolescent exposure to smoking in movies and addiction to tobacco. But Dr. Deborah Glik, director of the Health and Media Research Group at the University of California, Los Angeles, said the connection appeared strongest among those who were already predisposed by other factors to smoke.”

Let’s see … Dartmouth, no tobacco industry funding. UCLA, currently receives $6 million from Philip Morris to fund the UCLA Adolescent Smoking Cessation Center (plus additional grants for other projects). Hmmm.

Update: Science and The Chronicle of Higher Education (which includes a thread of comments) note that Philip Morris ended its PM External Research Program. However, this is not the end of PM funding at Universities.

The University of California Regents adopted a new policy that establishes special review and approval procedures for research proposals involving funds from tobacco companies or affiliated agencies (ie, a front organization such as the now defunct Tobacco Institute). Specific components of this policy, derived from a thoughtful examination of the issues involved, include:

• Establishing scientific peer review by committee and approval from UC chancellors for any research proposals seeking funds from tobacco-affiliated companies. The scientific review committee will be drawn from a community of scholars, which will work with campus chancellors in helping to determine whether to approve a proposal. [one hopes the vice chancellors for research will also ensure adherence to the 30-day sponsor review of manuscripts, presentations, etc. and maintain full control over IP in the award contracts themselves] Additionally, regents will be provided with timely notice of the relevant grants and a description of the research to be undertaken.
• Requiring an annual report to regents on proposals and research involving or seeking funds from tobacco-affiliated companies. The report will summarize the number of proposals submitted to the scientific review committee, the number approved and the number funded, along with a description or abstract of each proposal.
• Developing a regental statement to UC researchers that among other things, upholds academic freedom, expresses concern about the tobacco industry and asks researchers to exercise professional and ethical care.

A brief lab report in today’s JAMA refers to an e-pub ahead of print in the Am Journal of Public Health on the Pharmacological and Chemical Effects of Cigarette Additives, including activity to camouflage the odor of cigarette smoke, enhance or maintain nicotine delivery, make it easier for cigarette smoke to penetrate the lungs, and reduce coughing.

Documents discussed in the article related to industry research of these additives suggest a motive geared toward product enhancement rather than harm reduction: “Philip Morris’s research into EEG, PREP, and CSERP shows that the tobacco company attempted to quantify “impact” and to monitor the neurological effects of specific additives to maximize “cigarette acceptance” (which encompasses factors such as cigarette “satisfaction” and is influenced by a number of elements, including primary reinforcement [e.g., nicotine addiction] and secondary reinforcement[115]).”

Can we ever trust this industry to conduct true harm-reduction research purely for harm reduction sake? Can an academic health center - whose mission is to protect and promote the health of the public - ethically accept research funding knowing the data could potentially (even if the link is not obvious to or intended by the investigator) be used to enhance the addictive potential and/or lethality of this industry’s product?

Harm reduction research touted by Philip Morris, already a stretch, could run into more hurdles with a report in BMC Genomics that gene expression changes brought on by smoking persist years - decades - after quitting. Nature gives the sound bite version.

From the WSJ today: “Altria Group Inc. is likely to announce a spinoff of its Philip Morris International tobacco arm after a board meeting Wednesday. That would create a new company, unfettered by legal and public relations problems in the U.S., to blanket overseas markets aggressively.”

“Overseas growth [+15.9% in Asia, for example] contrasts with Philip Morris USA’s volume, which shrank 3.3% in the latest quarter from a year earlier. For all of 2006, Philip Morris International had revenue of $48.26 billion, compared with $18.47 billion at Philip Morris USA.”

This is $66.73 BILLION earned entirely and unambiguously from the sale of a known addictive and lethal product. Compare this with the fact that those of us who choose not to smoke - in the US alone - pay a $172 BILLION economic penalty each year ($75 billion in direct medical costs, $92 billion in lost productivity). Yet some academic medical centers feel no conflict of interest in accepting research awards and enthusiastic partnerships (also see page 8 or RTD excerpt) funded by the sale of said addictive and lethal and economically draining products. Roy Poses sums it up well: “Cloaking research meant to market more cigarettes in academic respectability could be very bad for health care.”

Indeed, as so clearly illustrated by the secret and unethical research services agreement between Virginia Commonwealth University and Philip Morris.