Secret Smoke-Filled Agreements

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.

This would be unconscionable no matter who the corporate sponsor was, but the fact that the largest tobacco company in the US has secretly garnered such power over academic researchers (& that this agreement has been kept secret from VCU’s academic community itself no less) is almost beyond belief. And that such agreements have been secured with other universities as well is truly alarming.

An April 24 NEJM editorial notes “Given the enormous burden of smoking-related illness and the ongoing sale of cigarettes and other forms of tobacco, one might question the advisability of research entities accepting funding from tobacco companies except through the American Legacy Foundation, which distributes funds received through the Master Settlement Agreement with U.S. tobacco companies.”

So well said. What happens when you add the qualifiers that the tobacco company is given the IP, can block publication, and requires the University to deny even the existence of the contract and individual projects supported under it? I think we’re well beyond questioning advisability. However, this recently published history of the VCU-Philip Morris partnership sheds light on how and why VCU would have sought such an agreement with the tobacco industry.

This particular situation easily spills over into broader issues of research integrity, no matter the sponsor. The reporter correctly notes that the dire need for money fuels this sort of “turn a blind eye” reliance on any funding opportunity, no matter the source. (The reporter incorrectly suggests VCU takes in $227 million in research awards: as evidenced by the 2006 award listing, this total, inflated by contributors such as ~$25M from Qatar for their School of the Arts, is for sponsored programs of all types; the NSF ranks VCU 104th [wow, after Univ Alaska Fairbanks, at 102] with total R&D expenditures from all sources of $149M , $65M of which is from the NIH.) On the other hand, VCU seems to have sold its soul for not much money unless there is a significant “gift” under negotiation as a quid pro quo.

John Frangioni at Harvard recently noted in a Nature Biotechnology commentary about greed at academic medical centers (AMCs) that “US citizens and taxpayers expect that AMCs maintain their hard-earned status of independence from external forces and place the public good higher than any other motivation.”

I cannot imagine a situation in which the public good is abandoned more than in this agreement binding a public institution of higher learning and academic medical center to conduct secret research for the tobacco industry.

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9 Comments »

  1. BB said

    I think we’re all so speechless we can’t think what to write. Don’t they have to fill out conflict of interest form before accepting the funds? We do here in ethically-challenged NJ.

  2. writedit said

    No matter the sponsor, the University of Pennsylvania does not permit the sort of agreement described in the NYT between Philip Morris and VCU (which apparently has several of these agreements with other companies). Penn calls this work what it is: Fee-for-Service (Contract Research) and “Private Business Use of Facilities.” From the Penn Handbook for Sponsored Program Agreements:

    Some research programs will entail fee-for-service or “contract research”. This sort of work often involves analysis, evaluation, or diagnostics assessment that does not represent original research. The concern is that “contract research” is inappropriate as a sponsored research activity at the University. Generally speaking, the type of research conducted at Penn should be, given Penn’s status as a non-profit institution, beneficial to the general public and not solely for the commercial benefit of a Sponsor. Contract research subverts a non-profit research institution’s obligation to do research for the benefit of the public in general.

    The inappropriateness of “contract research” is based on two considerations, which can be generalized as “academic” and “economic”.

    Academic considerations. In the typical “contract research” agreement, the Sponsor controls the scope of the research project, has complete ownership of results and any Intellectual Property (IP), and imposes confidentiality on the University. In addition, publication may be forbidden. Such provisions are unacceptable at Penn for several reasons. Penn must control the research (conduct of the research rests with the investigator) and the results of such research should be made available to the public through publication and presentation.

    Economic considerations. One economic concern is that it is inappropriate for a non-profit institution such as Penn to compete with for-profit organizations; such competition violates Federal (NSF and NIH) policies. Unless Penn owns any IP that is generated, the work could be considered to be contract research. If research is determined to be primarily for the benefit of the Sponsor and not the public, it may be considered “private business use” under IRS Revenue Procedure 97-14, and the research funds received may be subject to the Unrelated Business Income Tax. The restrictions on “private business use” of facilities financed with tax-exempt bonds are part of a larger legal framework that ensures that non-profit institutions perform research for the benefit of the general public and do not unjustly benefit for-profit entities. Too much contract research could jeopardize an institution’s non-profit status. As contract research puts non-profits in direct competition with for-profit research organizations, it can lead to legal disputes with these entities.

    Sponsored Research Agreements should avoid features that could lead to characterization of the arrangement as “contract research.” If a Sponsor defines the nature and scope of a given research project, or if an SRA grants the Sponsor the right to restrict publication of the research, or assigns to the Sponsor intellectual property created in the research, or requires deliverables that will be owned by the Sponsor, such research could be considered “contract research”. In order for research that is funded by for-profit entities to be considered part of Penn’s non-profit activities, Penn must control the research and the results of such research must be freely available to the public. Sponsors may receive certain limited rights, such as an option to negotiate to obtain a license to inventions created in sponsored research.

    For those Universities that do perform contract research via research services agreements, a tremendous burden is placed on the researcher and sponsor before the agreement can be signed to ensure the work truly is narrowly focused, product-testing types of activities. This is to ensure the University is not in violation of state and federal laws (as noted by Penn above). For example, Oklahoma State University requires the following certification before any research services agreement will be considered:

    CERTIFICATION: We the following undersigned University employees, proposed Project Leader(s), Department Head, and Associate Dean of Research of the College (Division) wherein the Project is to be conducted, verify each of the following statements:

    1. The proposed Project involves only the analysis, evaluation, classification, diagnostics, or interpretation of Sponsor’s data, samples, mechanisms, procedures, products or processes.

    2. The analysis, evaluation, classification, diagnostic, or interpretation services involved in the Project will be done in accordance with the specifications or protocols which have been prepared or supplied by the Sponsor or Sponsor’s duly authorized agent(s). Neither I, nor any other University employee involved in the Project or under my direction, have prepared or provided scientific input into the Project specifications or protocol or if the specification or protocols have been prepared by me, or other University employees involved in the Project or under my direction, said specifications or protocols have been prepared using only Sponsor provided information, specifications, or protocols.

    3. I have not provided, nor will I provide, any basic or applied research in the preparation of or for the proposed Project and I will not provide any basic or applied research in the conduct of the Project. It is not likely that there will be any new knowledge, technologies, or intellectual property that will be developed by University employees in the performance of the scope of the proposed Project.

    4. The conduct of the proposed Project will not involve or employ the use of any inventions or technologies learned, created, or developed under federally-sponsored or privately-sponsored research projects or grants in which I have been involved. A check has been made of my past and current grants and/or research projects and there do not exist any conflicting or inconsistent contractual arrangements that would prevent the University from entering into this proposed Research Services Agreement or burden or otherwise impede past and/or current grants or contractual arrangements with other parties.

    5. I have read, am knowledgeable of, and will honor the confidentiality obligations of the Project and will inform and ensure compliance with said obligations by all University employees, including students, working on or with the Project under my direction. If there are students that will be working on the Project, I have advised them of the limitations on publication(s).

  3. BB said

    My ethically-challenged university in ethically-challenged NJ doesn’t accept tobacco funding.

    Maybe VCU will be last-U standing with regard to tobacco funding; when outside-VCU scientists can no longer collaborate with VCU scientists because of PM’s hold on data, we may see some changes.

  4. ram fan said

    According to Style Weekly, Trani has received more than $1 million from big tobacco. Wow!

  5. writedit said

    Related articles, editorials, and commentaries …

    VCU-Philip Morris Agreement Researched

    Inside Higher Ed: New Research Rules Urged at VCU (Oct 2)

    Chronicle of Higher Education: After Tobacco Flap, Panel Urges Virginia Commonwealth U. to Change Research Rules (Oct 1)

    Daily Press (AP story): VCU panel urges updating corporate research rules (Oct 1)

    Richmond.com: VCU Panel Says No More “Work for Hire” with Philip Morris (Oct 1)

    Richmond Times-Dispatch: VCU task force recommends new research guidelines (Oct 1)

    American Lung Association (national report, see p 13 for VCU-Philip Morris discussion): Big Tobacco on Campus: Ending the Addiction (Sept 8 )

    Herald-Dispatch: VCU Worried about Research for Big Tobacco (Sept 3)

    Style Weekly: Lung Association Chastises VCU For Tobacco Ties (Sept 3)

    Richmond.com: Lung Association Blasts VCU-Philip Morris Ties (Sept 3)

    Richmond Times-Dispatch: VCU research contract with Philip Morris draws questions (Sept 3)

    Wall Street Journal: We’re Not All Friedmanites Now (Aug 27)

    Health Care Renewal: After Controversy Over Tobacco Money Funding Medical School, University President Steps Down (Aug 15)

    Style Weekly: Patch Job (VCU proposal for a tobacco-funded pregnancy center) (Aug 13)

    Health Care Renewal (VCU adjunct faculty): Courting Tobacco Money (Aug 6)

    Style Weekly: Calling Philip Morris? VCU Courted Tobacco Money (Aug 6)

    Bacon’s Rebellion: Scandal Reaches Critical Mass at VCU (July 24)

    Boston Globe: VCU panel questioned about Philip Morris deals (July 18 )

    Richmond Times-Dispatch: VCU holds forum on its research ties: Task force chairman says school made mistake in deal with Philip Morris (July 17)

    Richmond.com: Academic Freedom in the Spotlight: VCU erred in signing off on secrecy agreements in Philip Morris research contracts, research VP Frank Macrina conceded in a public forum this afternoon. (July 16)

    AP Summary of Town Hall meeting posted at several media outlets (July 16)

    Richmond Times Dispatch: VCU Is Harmed By Ties to Philip Morris (letter to the editor from 2 VCU faculty, July 16)

    Health Care Renewal (VCU adjunct facutly member): VCU, Philip Morris, and the “Recent Unpleasantness” (July 15)

    Roanoke Times: VCU-Philip Morris Agreement compared with Virginia Tech-Philip Morris Agreement (July 14)

    Richmond.com:
    In Pursuit of the Golden Leaf
    (July 8 )

    Bacon’s Rebellion: VCU and Tobacco: A Long and Profitable History (July 8 )

    Richmond Times-Dispatch: VCU, Trani are a lot like school mascot (July 1)

    Richmond Times-Dispatch: VCU chief orders review of policies (June 30)

    Inside Higher Ed: VCU Allows Improperly Awarded Degree (June 30, also discusses PM agreement, including quotes from VCU faculty on the matter)

    Style Weekly: Trani’s Tobacco Ties Hurt MCV’s Reputation (June 25)

    Richmond.com: VCU Faculty Question Research Contracts (June 21)

    Richmond Times-Dispatch: VCU will review research pacts (June 5)

    Style Weekly: Faculty Fumes, Condemns VCU’s Philip Morris Deal (June 4)

    Style Weekly Commentary: Tobacco U. (June 4)

    Health Care Renewal (VCU adjunct faculty): Linking the Anechoic Effect and Suppression of Research to Conflicts of Interest and Mission-Hostile Management: the VCU Case (June 4)

    Trani Letter to the Editor (NYT): Tobacco Research: Virginia Commonwealth Responds (June 1)

    CDC Public Health Law News: Virginia: At one university, tobacco money is a secret (May 28 )

    Health Care Renewal (by VCU adjunct faculty member): A Worse Variant of a New Species of Conflict of Interest (May 28 )

    The Courier-Journal (Ky) Op-Ed: Two examples of shutting out a public that needs to know (May 28 )

    NYT Editorial: Virginia Commonwealth’s Secret Deal (May 27)

    Las Vegas Sun Editorial: Joe Camel meets academia (May 27)

    Democratic Central (Va.): VCU jumps into bed with Philip Morris (May 27)

    501(c)(3) Files: Missing the Mission | A University Sells Out to Big Tobacco (May 27)

    Really Magazine: Sic semper (May 27)

    Roanoke Times Editorial: VCU’s deal with the devil (May 25)

    The Trickledown: The Ethics of Non-Disclosure Agreements vis-a-vis the Public Interest (May 24)

    Richmond Times-Dispatch: VCU, Philip Morris partners in Research (researched, written, and posted online within 12 hours of publication of the NYT article)

    The Chronicle of Higher Education: Secrecy Shields Industry-Financed Tobacco Research at Virginia Commonwealth U. (May 22)

    The Scientist: Virginia U in secretive tobacco deal (May 22)

    UPI: Tobacco research money secret at VCU (May 22)

    The Situationist (Harvard Law School): The Situation of University Research (May 22)

    Genome Technology Online: On Sale Now: Ethics (May 22)

    Bit of Humor … Tobacco Avenue (“The Onion” of Richmond): VCU’s Trani linked to Philip Morris and blah, blah, blah whatever


    Older postings/commentaries prior to the NYT article:

    VCU News Release (Feb 2006): VCU vice president for Health Sciences testifies before Virginia legislative panel together with the Philip Morris VP for R&D

    Center for Media and Democracy: It’s a Tobacco Thing, You Wouldn’t Understand: Virginia Commonwealth University and the Tobacco Industry

    Health Care Renewal (VCU adjunct faculty): Smokescreen – Will Tobacco Company’s New Research Program Create New Conflicts of Interest?

    Health Care Renewal: Smoked Out: Funding Lung Cancer Screening Research with Tobacco Money

    Health Care Renewal: CT Scans to Screen for Lung Cancer, Tobacco Companies, CT Scan Manufacturers, and the NIH

    Later On: Universities and tobacco

    The Situationist (Harvard Law School): The company “had no control or influence over the research” …

    The Situationist (Harvard Law School): (tobacco) Industry-Funded Research

    The Situationist (Harvard Law School): (tobacco) Industry-Funded Research – Part II

    WomenHealth

    Pittsburgh Post-Gazette shows how to cover a university controversy in which the institution’s reputation is at stake:

    West Virginia University MBA controversy – On Dec. 21, 2007, the Pittsburgh Post-Gazette reported that West Virginia University awarded an MBA degree to Heather Bresch, a politically well-connected top executive at drug giant Mylan Inc., rewriting university records that originally showed she had completed only about half the credits needed to earn the degree. The Provost, Dean of the School of Business, and University President resigned in the wake of the findings. Coverage has continued through the July 9 Board of Governors’ approval of the new interim WVU president.

  6. writedit said

    I need to correct Macrina’s relationship with the Tobacco Institute, about which a query last year to the Legacy Tobacco Documents Library was not resolved but for which I have since tracked down more complete information. A Legacy Library document from the Tobacco Institute files suggests he was on their Scientific Advisory Board, a fact that would not be surprising given the very active testimony by other VCU faculty on behalf of the Tobacco Institute refuting peer-reviewed reports of harm caused by second-hand smoke (e.g., Raphael Witorsch, in many depositions and formal communications such as this).

    However, the grouping of scientists on aforementioned Scientific Advisory Board is odd, and Macrina is the very odd man out – especially since it turns out, as shown in a different repository of tobacco documents, that this listing is part of a larger document describing the subcommittee of an EPA panel examining indoor air quality that focused on total human exposure to environmental tobacco smoke. (and a bench science microbiologist would be included here because …?) I have sent a comment to the Legacy Library suggesting they include this Board’s affiliation with EPA in the document heading or title in the database (document itself cannot be modified of course).

    But, the story does not end there. Macrina did interact regularly with a charming character at Philip Morris named Thomas Osdene, PhD, as documented in Osdene’s personal notebooks: e.g., in 1983, see #6 about three-quarters down the page, under RAC meeting at MCV (Medical College of Virginia or the VCU medical school), and 1984, see 2nd-3rd lines, which include Macrina’s office number confirming he is the person Osdene called (to answer the question, was PM hiring?). Macrina admits in Task Force minutes to serving on the VCU Research Advisory Committee (RAC) with a Philip Morris employee in the 1980s, which could only have been Osdene. Further, Philip Morris was clearly monitoring Macrina’s career with interest given the number of deposited files documenting his participation at scientific meetings hosted by Philip Morris, awards, publications, presentations, appointments, and news items of interest.

    Osdene became involved with the company’s Environmental Tobacco Smoke Advisory Group and the Center for Indoor Air Research (CIAR). Thus, he may have had a hand in placing Macrina’s name on the above-mentioned EPA indoor air quality Scientific Advisory Board given that Macrina was a microbiologist studying oral bacteria (not the sort of expertise the EPA would have sought out for this panel). In addition, two members of this EPA Scientific Advisory Board are identified as members of Osdene’s CIAR. One wonders if Macrina even knew about this, actually. So, still something not quite right here in a tobacco sort of way, but not directly involving the Tobacco Institute other than their monitoring of this Board’s activities.

  7. writedit said

    For every $40,000 Philip Morris gives, someone dies. That is the grim math of a product that, used exactly as intended, kills customers, and at a now highly predictable rate. About 20 billion packs are sold every year in the U.S. resulting in about 500,000 deaths. That comes to about 40,000 packs per death; those 40,000 packs don’t cause that death in that same year, but over time, it is accurate to say that for every 40,000 packs sold, someone dies. It turns out that Philip Morris makes about a dollar a pack profit, so the math works out simply and neatly: for every $40,000 Philip Morris gives for science funding, someone dies. It’s that simple. There is no other place Philip Morris gets the money from. There is no way the product can be consumed less lethally. The fact is, if Philip Morris gives $1 million of science funding to the University, 25 people had to die for that. That’s where the money came from.

    — Jonathan Krueger

  8. writedit said

    As the RTD so aptly declared, VCU, Philip Morris Partners in Research, with the partnership enthusiastically led in 2004 and 2005 by Task Force members Macrina and Huff:

    In April, Philip Morris 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. …

    Whatever those plans are [for the PM center], VCU is poised to become a partner in key areas of compatible research with Philip Morris.

    “We’re in 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 [president of Biotech Park] received a call to come to Philip Morris’ research center on Bells Road. …

    – Richmond Times-Dispatch, May 23, 2005

    with the Huff-Skunda leadership in negotiations with Philip Morris confirmed by Virginia Business Magazine (August 2007):

    “In Richmond, recruitment efforts to cement Philip Morris’ position in the city are about to pay off. The company is scheduled to open its 450,000-square-foot, $350 million research center in the Virginia BioTechnology Research Park. Virginia Commonwealth University was a founding partner of the park.

    Officials from the biotech park and VCU initiated the first meetings with Philip Morris in August 2004 and were soon joined by city and state representatives.”

    In February 2006, the importance of VCU to Philip Morris’ success was confirmed during testimony by Sheldon Retchin, M.D., vice president for Health Sciences at VCU and CEO of the VCU Health System, before the Virginia state senate finance sub-committee for education. Included in the VCU news release covering Retchin’s testimony is the enthusiastic support of Philip Morris:

    Dr. Rick Solana, senior vice president of research and technology for Philip Morris USA, told sub-committee members state support of higher education and research play an important role in the future of his company. “Further, interaction with a vibrant VCU can have a significant impact on our success,” Solana said.

    “Our company values the higher education research initiative because to us it represents an opportunity to increase the critical mass of creative minds in this state, and through VCU in this region,” Solana added.

    Philip Morris employs more than 300 VCU alumni and is one of the top two employers of VCU engineering graduates.

  9. [...] only academic medical centers would be so enlightened with regard to banning tobacco industry sponsorship of research and of [...]

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