VCU-Philip Morris Agreement Researched

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 and downloadable PDF 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.”

Well then. This restriction goes beyond protecting proprietary data and unapproved publicity/use of names to keep the agreement itself secret along with the relationship between VCU and Philip Morris. What other sponsors might they be protecting in this manner?

Indeed, given that we are talking about a public university, the most important omission from Trani’s discussion about all this is the level of secrecy, both documented in the agreement (and most certainly not a traditional component of any standard research services agreement) and on the VCU campus, as evidenced by the lack of awareness of not only this agreement but a high-level institutional partnership between VCU and Philip Morris.

Worse, consider the ominous reporting by the NYT of “A tenured scientist at Virginia Commonwealth, who would not be interviewed for attribution because he said he feared retribution …” Aren’t we talking about a public university in the US? And yet, tenured faculty are afraid to speak on record – and perhaps are also afraid to challenge this situation at VCU out of fear of retaliation?

One would hope that, given his concern for academic freedom, Trani will allow the faculty to debate this matter openly and abide by whatever decision they may reach with regard to continuing this partnership, begun without their knowledge or input. Such secrecy in relation to a partnership with the tobacco industry is especially egregious given this is an academic medical center with an “emerging” School of Public Health.

Moving back to the letter, Trani’s argument remains, weakly, that “everyone else does it” (like that worked when I tried to convince my mom to let me do something questionable). I refer him to the eloquent explanation by Penn as to why they adamantly do not accept research services agreements, nor should any institution of higher education with a research mission dedicated to advance the social good (versus that of industry). Trani further misleadingly suggests:

“Such agreements [research services agreements], in effect consulting contracts, are similar to those that universities enter into with the pharmaceutical industry and with state and federal agencies.”

Wrong. Here, he is mingling description of this corporate research service agreement with government contracts, which are only awarded through a competitive process [no snickering out there] in which the researcher submits a proposal as to how he or she will perform the required service in response to a request for proposals. There are no government-issued research services agreements of the type raised in the NYT story and being defended by Trani here. He is either unaware of this distinction or is himself intentionally confusing the issue using well-worn tobacco industry tactics. Neither is attractive for a university president.

On the other hand, I’m sure every major pharmaceutical company will be knocking on VCU’s door for these exact same terms in their next agreement. Let’s see, how about a research service such as, invent us a drug that prevents metastases!

Trani next suggests:

“This type of research usually involves gathering data …”

Um, not usually. The point is, work conducted under a research services agreement is not original research: it is a service clearly articulated by the sponsor using material and data provided by the sponsor. Do this, and exactly this. Gathering data? Not likely. If the university service provider needs more data, he or she should go back to the sponsor (client?) for these.

“These agreements [research services agreements] include language to protect the sponsor’s intellectual property, and most assign the intellectual property rights of the work produced to the sponsor.”

True – because, again, work conducted under a research services agreement is narrowly focused exactly because the IP is assigned to the company; no new intellectual property should be generated in the conduct of a genuine research service. The Oklahoma State University Research Services Agreement template serves as an excellent example, and other university research services agreements, such as that used by Auburn University, clearly differentiate between IP related to the sponsor’s product and IP generated incidentally in the course of conducting the service (which is assigned to the University).

In contrast, the VCU-Philip Morris research services agreement states:

“9.2 INVENTION shall mean any … or other intellectual property or know-how discovered, produced, conceived, or reduced to practice by VCU or its PERSONNEL in, or as a result of, the performance of RESEARCH SERVICES … 9.3 SPONSOR shall own all Intellectual Property Rights in Inventions and VCU shall promptly communicate full information regarding INVENTIONS to SPONSOR.”

So, if a VCU faculty member incidentally makes a discovery (say, a new and improved method or algorithm for analyzing the data) in the course of accomplishing a research service for Philip Morris, the IP automatically and preemptively is assigned to Philip Morris. No, I cannot imagine “most” universities signing up for this IP giveaway and placing their tax-exempt bond status at risk.

Trani continues:

“Disclosure sections in research services agreements are for the protection of intellectual property — not the suppression of data.”

True. But what Trani is leaving out is that the final decision to permit publication in this particular research services agreement (not of those used at most other universities) lies with the company. This restriction comes up not in the discussion of publication (where the longer than typical review period arises) but in the definition of Sponsor Proprietary Information, which was clearly articulated in the original NYT story (so the claim of being unfairly portrayed does not hold muster):

“10.1 SPONSOR PROPRIETARY INFORMATION shall mean … including without limitation all work product or other material created by VCU and/or its PERSONNEL in connection with this AGREEMENT and all SPONSOR MATERIALS. … All information provided by SPONSOR or its representatives shall be presumed to be SPONSOR PROPRIETARY INFORMATION …”

And what does this mean for publishing or presenting (or even talking about) any results from research services performed?:

“8.2 VCU shall remove from the proposed publication that material which SPONSOR identifies as SPONSOR PROPRIETARY INFORMATION …”

Which would leave the articles and prepositions and punctuation marks, I think.

So VCU can’t publish any data conducted under this master research services agreement unless Philip Morris rules it isn’t proprietary. Yet apparently, overnight:

“V.C.U. investigators already are at work preparing manuscripts connected with a project on pulmonary disease financed under the Philip Morris research services agreement. These manuscripts will be submitted for publication in peer-reviewed medical journals in the near future.”

First, why didn’t Solana or Macrina mention these in the NYT article or Macrina in the RTD “article” or even Trani last week in his open letter to the VCU community? Seems like the sort of evidence of freedom to publish the University would have trumpeted from the very start. What a coincidence that these manuscripts seem to have just been started this weekend. Remarkable. I’m sure they’ve at least created empty Word documents entitled PM MS #1 and PM MS #2, just to make an honest man out of Trani.

And so, eventually, when these manuscripts are ready, they’ll have the “discussions” with Philip Morris noted by Macrina in the NYT story, and the company might agree to maybe permit submission … of something, but who knows what (& what will be pulled out as “proprietary”). What if Philip Morris flags some unflattering data as proprietary and dictates that they need to come out of the manuscript? What if the removal of these data alters the conclusions drawn? We cannot possibly know, nor could the reviewers at these journals. Thus, the integrity of the research record is at risk. Nothing should be published from work conducted under the restrictions of this agreement.

(whole ‘nuther blog entry … especially considering VCU has multiple research services agreements – could other manuscripts generated under one of these restrictive agreements be [have been?] submitted for review with selective undesirable results potentially – and invisibly to reviewers – withheld at company request due to their proprietary nature?)

Further, considering again this example, what proprietary data on pulmonary disease would Philip Morris own – and be at liberty to give to VCU researchers to analyze? Shouldn’t the mere fact of a tobacco company owning intellectual property related to the early signs of lung disease raise some alarm bells, particularly at a university with an academic medical center?

And who are these unknown, unnamed “multiple parties”? Why do they have rights above those of the university researchers? The agreement is between VCU and Philip Morris but apparently extends to … whom? Again, the secrecy at play here does not belong on the campus of a public university.

“the V.C.U. scientists involved do have the final say in choosing their work — including the design of their studies, interpretation of results and the publication of findings.”

Except under a research services agreement, both the one of concern here and the other unnamed agreements also in effect at VCU. No research service work confers such freedom to the faculty or students, most especially in study design (sponsor defines the service), yet again Trani either doesn’t understand this distinction or purposely obfuscates it in his closing comment.

What he omits throughout his rationalization for this abomination of university ethos is the fact that this is a Master Research Services Agreement. This agreement covers every project – every “task order” – conducted. Most research services agreements are linked to a specific project, again to ensure that the terms apply to narrowly defined and appropriate product-testing type services. Here we have blanket coverage of all future (& secret) work with these outrageous restrictions. Perhaps the individual task orders are even more restrictive – who knows, because no documented details (& possibly, see below, no accurate information) are being released on these.

If Trani would like to be able to accurately claim that VCU ‘s research is “consistently conducted under the highest ethical standards”, I would urge him to emulate outstanding role models such as the University of Pennsylvania than settle for the lowest common denominator, “everyone else does it” approach.

15 Comments »

  1. BB said

    Nothing short of Trani stepping down should be the result. Anything else is a whitewash.

  2. BB said

    In our ethically-challenged state, ourt ethically-challenged university was put under a deferred prosecution agreement by the Feds; the FBI came swarming in to seize records, and a Federal judge (retired) had oversight of the darn place for 2 years. For lesser crimes, I might state. Methinks a whistle-blower from inside VCU ought to tip the Feds off anonymously. Or get the Gov involved. There usually are strict rules about who can serve on Boards and what Boards the Pres of the U can serve on. I would bet real $$ that bylaws forbid the Pres of VCU to serve on a board that’s donating money, or even serve in a way that suggests impropriety on the part of the pres. Public U’s are under so much more scrutiny than private U’s.

    Well, I have no idea if VCU is getting any $ from Universal Corp (tobacco leaf dealer), but they could well be, in which case you are absolutely correct. More importantly, it shouldn’t take a lot of deep thinking to decide whether it is appropriate for the president of an academic health system to also have fiduciary responsibility to the financial success of the tobacco industry. – writedit

  3. ram fan said

    New communication from Trani:

    Dear Colleagues,

    I am pleased to report that the University Task Force on
    Corporate-Sponsored Research, formed in response to the recent media
    interest in certain research agreements between the University and Philip
    Morris, held its first meeting today. Chaired by Vice President for
    Research, Dr. Frank Macrina, this Task Force will be meeting in the days
    and weeks ahead to continue the dialogue on the nature of the relationships
    that the University should have with corporate sponsors of research going
    forward. The members of the Task Force are identified below.

    I have asked Dr. Macrina to create a website for the Task Force so members of the University and Health System Communities will be able to follow its progress. I also have asked the Task Force to schedule a town-hall-type meeting on each campus of the University at which any member of the faculty or staff of the University or the Health System will have an opportunity to express his or her respective personal and professional views on this topic. I encourage all who are interested in this issue to communicate with Dr. Macrina or any member of the Task Force.

    I am grateful for the service of each member of the Task Force as the
    University continues the dialogue on this very important issue.

    Best regards.

    Sincerely,

    Eugene P. Trani
    President, Virginia Commonwealth University
    and
    President and Chair, VCU Health System

    copies:
    Mr. John M. Bennett
    Mr. Don Gehring
    Dr. Stephen D. Gottfredson
    Dr. Frank L. Macrina
    Ms. Sue Ann Messmer
    Dr. Sheldon M. Retchin
    Mr. Peter L. Wyeth

    Members of the University Task Force on Corporate-Sponsored Research

    Dr. Francis Macrina, Chair
    Dr. Gordon Archer
    Dr. Faye Belgrave
    Dr. Kia Bentley
    Dr. PonJola Coney
    Dr. Linda Corey
    Dr. Carolyn Funk
    Dr. Marie Gardner
    Dr. Fred Hawkridge
    Dr. Thomas Huff
    Dr. Russell Jamison
    Dr. Shiv Khanna
    Dr. Shelly Lane
    Dr. Allen S. Lee
    Dr. Gary Matzke
    Dr. Cindy Munro
    Dr. Ann Nichols-Casebolt
    Dr. Laura Razzolini
    Mr. Daniel Ream
    Dr. Susan Roth
    Dr. Harvey Schenkein
    Dr. Sarah Spiegel
    Dr. Beverly Warren
    Dr. Jeffrey Williamson

    [note absence from this list of Dr. Macrina’s secretary Jane Lalich, whose name unexpectedly appeared, without a publicly documented explanation or process for appointment, among the Task Force membership after this initial roster was announced by Trani]

  4. writedit said

    Related articles, editorials, and commentaries …

    Secret Smoke-Filled Agreements

    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)

    Commonwealth Times: Tobacco money debate continues in VCU community (Sept 15) (Macrina makes an erroneous statement in this story by claiming that no University bans tobacco funding entirely. The University of Pittsburgh has a university-wide ban against tobacco funding for research.)

    American Lung Association (national report, see p 13 for VCU coverage): 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)

    Style Weekly: Smoke and Mirrors (July 30)

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

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

    Bacon’s Rebellion: Vindicated! VCU Comes Clean (July 17)

    Health Care Renewal: Town Meeting About Tobacco-Funded Research in Academic Medicine (July 17)

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

    Richmond Times-Dispatch: Task force leader: VCU erred in deal with Philip Morris (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)

    No Sucker Left Behind: Ethics Go Up in Smoke at VCU (May 26)

    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)

    Improper degree scandal that unfolded in parallel with Philip Morris controversy: VCU Monroe Scandal

    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

    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

  5. writedit said

    VCU-Philip Morris Master Research Services Agreement (PDF file)

    I received the above agreement from Jeanne Lenzer, who filed the FOIA request on behalf of BMJ (British Medical Journal), who paid VCU over $200 for the privilege of receiving this information. Please note the titles of the task orders given by VCU’s Pam Lepley in the cover e-mail below, neither of which seems to describe any work remotely related to removing nitrogen or phosphorus from wastewater:

    From: Pamela D Lepley/AC/VCU [mailto:pdlepley@vcu.edu]
    Sent: Wednesday, May 07, 2008 5:40 PM
    Subject: FOIA Request Response

    Dear Jeanne,

    This e-mail is in response to your Virginia Freedom of Information Act Request of April 24, 2008. I have attached the documents you requested, and also have mailed the hard copies to you. In some instances, you have been provided with documents that precede 2003 because they serve as the base agreements for research conducted from 2003 to the present.

    Redactions in most cases involve the removal of electronic banking information. However, in the case of the Master Research Services Agreement dated September 22, 2006, two items have been redacted from the agreement because of their proprietary nature. (This is the document requested by the New York Times.) The first is bank account information and the second is exhibit C, which is Philip Morris’ information security policy. There are two task orders from this agreement, “Anatomic Pathology Research Services” and “Analysis of COPD Data” which I have been advised are exempt from public disclosure under Section 2.2-3705.4.4 of the Virginia Freedom of Information Act because they contain or constitute records of a proprietary nature produced or collected by VCU faculty, whether sponsored by the institution alone or in conjunction with a government body or private concern, in the conduct of or as a result of study or research on medical, scientific, technical or scholarly issues which have not been publicly released, published, copyrighted or patented.

    I also have attached the invoice for producing the requested records.

    I hope that this response fulfills your request.

    Sincerely,

    Pam

    Pam DiSalvo Lepley, APR
    Director, Communications and Public Relations
    Virginia Commonwealth University
    Harrison House, 816 West Franklin Street
    P.O. Box 842036
    Richmond, VA 23284-2036
    Ph: 804.828.6057
    Mobile: 804.868-9274
    Fax: 804.828-2018
    pdlepley@vcu.edu

    So, were Drs. Solano (in NYT) and Macrina (in RTD) mistaken about the wastewater treatment research? Ms. Lepley was given her information from the VCU Office of Research (which Dr. Macrina oversees), so one wonders which version is correct.

    The investigator responsible for the “COPD disease progression and biomarker discovery” (his title) lists this Philip Morris task order award along with a possibly linked gift. {perhaps not surprisingly, this section of his Website has since been removed … what a coincidence}

    Similarly, an award from Philip Morris to a faculty member in the Department of Pathology entitled “Anatomic Pathology Research Services” is published on page 17 of this April 2007 VCU School of Medicine Newsletter (PDF, Newsline, April 2007, Vol 10, No 3).

    On the other hand, searches of the VCU Website for candidates of the research to identify ways of removing nitrogen and phosphorus from tobacco processing wastewater come up empty.

  6. 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.

    See also the detailed history on the decades-long relationship between VCU and Philip Morris, summarized separately by the author as follows:

    VCU’s medical school and predecessor schools had such tight ties with the American Tobacco Company in the 1930s and 1940s that it funded just about the entire pharmacology staffs. So dramatic were the ties that a Stanford University professor is titling an entire chapter on VCU “Sold, American” in his upcoming book on tobacco research. The less-than-flattering title suggest that the Medical College of Virginia had been bought completely by tobacco interests.

    VCU started to improve its research situation in 2000 after a debacle in which federal regulators shut down all human research at all of its schools. The academic research ringer hired to help boosted R&D at VCU but she left in 2005 critical of new ties between the school and Philip Morris USA.

    Dr. Eugene Trani, president of VCU, and his staff were greatly involved in “Operation Peat Moss,” a secret and ultimately successful plan to convince Philip Morris USA to locate a major research facility at the faltering Virginia Biotechnology Research Park instead of the Research Triangle in North Carolina in 2004 and 2005.

    While Philip Morris claims that much of the research it does in Richmond is limited to smokeless products such as snuff, evidence shows it is involved in a major effort to use respiration devices used in cigarette research as vehicles for dispensing drugs through the lungs to fight such diseases as diabetes.

    Both the University of Virginia and Duke have accepted far more research money from Philip Morris than VCU has. But unlike VCU, they insisted on controlling the research and make their relations public.

    Some VCU faculty say there are fearful of Trani’s wrath if they speak out against the Philip Morris contracts. Yet, there appears to be great confusion on campus about what is going on. Trani’s absence at Havard this summer isn’t helping.

    Trani has appointed a task force to explore his school’s corporate contracts. But the very administrator who oversaw negotiations with Philip Morris is heading the task force, which has decided he is not a conflict of interest. It remains to be seen if the task force will force change or sweep the controversy under the rug. The first public meeting is slated for July 16.

  7. writedit said

    VCU Task Force on Corporate-Sponsored Research

    Task Force Membership
    (missing title for Ms. Lalich is Executive Assistant to Vice President for Research [and Task Force chair] Francis Macrina; no publicly available details on the authority or process for her formal appointment, which was President Trani did not acknowledge)

    June 10, 2008 Task Force meeting minutes

    June 24, 2008 Task Force meeting minutes

    July 8, 2008 Task Force meeting minutes

    Faculty/Staff/Student Comments Submitted to Task Force – July (PDF)

    July 16 Town Hall Meeting Summary (Task Force Word document)

    July 29 Task Force meeting minutes

    Aug 19 Task Force meeting minutes

    Task Force written comment form

    Faculty/Staff/Student Comments Submitted to Task Force – Sept (PDF)

    Town Hall Meeting Summary – Sept (Task Force Word document)

    September 3 Task Force meeting minutes (seems to repeat the Town Hall Meeting summary)

    September 10 Task Force meeting minutes (oddly, approved by the Task Force on a day they did not meet)

    September 24 Task Force meeting minutes (3 external consultants attended from the top 3 industry-funded universities, which seems an unusual choice if the goal was to seek input from highly ethical versus opportunistic institutions)

    Revised Wood-Bromley statement (Sept 30 – call to break all ties with Philip Morris)

    Comments on Draft of Task Force Report

    Final Report of the Task Force October 1, 2008 (of most importance is the decision to stop entering research services agreements, which are not appropriate funding mechanisms for any institution of higher learning … missing is an indication as to whether existing research services agreements, including the one in effect with Philip Morris through 2010, will be terminated or at least renegotiated to comply with the other Task Force recommendations)

  8. ram fan said

    Dear Colleagues:

    I am writing to invite you to attend a Town Meeting organized by the VCU Task Force on Corporate Sponsored Research. This group has been charged by President Trani to review the process of how VCU conducts business with corporate sponsors of research. The Town Meeting is going to be held on Wednesday, July 16, 2008 in the auditorium of the Kontos Building on the MCV Campus. The meeting is scheduled from 4 to 6 pm. The Task Force maintains a web site where you can review its charge, connect to a variety of resources, and read the Task Force meeting summaries. The URL for this site is: http://www.research.vcu.edu/vpr/corporate_sponsor.htm.

    In an effort to ensure that each person who wishes to speak will have an opportunity to do so, we will use some simple ground rules. Each speaker will have a maximum of 3 minutes to present their ideas, comments, or to ask questions. If speakers do not finish their comments at 3 minutes, they may rotate to the end of the line and continue their comments in turn. Further, we will provide an opportunity to comment anonymously in writing for those who do not wish to speak publicly.

    Faculty, staff, and students are encouraged to share opinions, recommendations, and to ask questions in an effort to assist the Task Force in formulating its report to the President.

    I hope you will be able to attend and provide your voice to the deliberations of the Task Force. If you are unable to attend, please note that we will hold a second Town Meeting on the Monroe Park Campus in late August.

    Best regards,

    Francis L. Macrina, Ph.D.
    Edward Myers Professor of Dentistry and
    Vice President for Research

  9. writedit said

    Town Hall Meeting Coverage

    July 16

    Town Hall Meeting Summary (Task Force document)
    (clearly the Task Force is in serious need of an editor, but more importantly, two discrepancies with regard to Macrina’s quoted statements: no mention in this summary that he admitted the secrecy clause was a mistake that will not be repeated in future contracts, and a statement not reported elsewhere he heard of “conversations with Philip Morris and the VCU Foundation” with regard to a proposal being developed by Dean Strauss

    Faculty/Staff/Student Comments Submitted to Task Force – July (PDF)

    Additional Task Force-perspective on Town Hall Meeting in July 29 Task Force meeting minutes

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

    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.

    AP Summary (posted at several television and newspaper outlets)

    Style Weekly: Smoke and Mirrors (focus on faculty fear at meeting)

    Although refreshing to see an acknowledgment that the secrecy clause was wrong, Macrina has not rescinded the agreement and continues to suggest the University can freely publish under the agreement (see following comment as to why this is also in error).

    September 3
    (curiously, for a public forum allegedly soliciting comment from the VCU community, this town hall forum was never listed on either the University calendar nor the Office of Research Calendar – and the July 16 meeting was only put on the calendars the day prior)

    Faculty/Staff/Student Comments Submitted to Task Force – Sept (PDF)

    Town Hall Meeting Summary – Sept (Task Force document)

    Forbes: VCU panel holds final corporate research hearing (Sept 3)

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

  10. writedit said

    Despite his recent denials, in talking with the NYT, Macrina himself has already confirmed that Philip Morris has ultimate control over all dissemination of data obtained through this agreement:

    “Under the agreement, though, Philip Morris alone decides whether the researchers can publish … “We would have discussions, and there could well be agreements that could ultimately result in the publication of proprietary information,” Dr. Macrina said.”

    “Discussions” possibly resulting in “agreements” that “could” (not ‘would’) result in publication. But, Philip Morris is the one providing permission – the right is not guaranteed to VCU faculty.

    This is outrageous and unacceptable and unethical for any type of agreement or contract with industry, no matter who the sponsor is. The fact that this is a “research services agreement” does not excuse such behavior, especially if the work being conducted (such as discovery of early markers of lung disease) could benefit society.

    Article 10 of the agreement gives Philip Morris power to decide what can and cannot be published via the definition of “sponsor proprietary information”, which includes, essentially, everything (well beyond what ethical industry contracts would reasonably define as proprietary):

    10. “SPONSOR PROPRIETARY INFORMATION” shall mean all material or information relating to SPONSOR’s research, development, trade secrets or business operations and affairs that SPONSOR treats as confidential, including without limitation all work product or other material created by VCU and/or its PERSONNEL in connection with this AGREEMENT and all SPONSOR MATERIALS.

    Article 8 in turn explains that

    8.2 SPONSOR further acknowledges that VCU or its PROJECT DIRECTOR engaged in each RESEARCH PROJECT shall be free to publish such findings subject to the following conditions: … in the event SPONSOR has notified VCU in writing that SPONSOR reasonably believes that such publication contains SPONSOR PROPRIETARY INFORMATION … VCU shall remove from the proposed publication that material which SPONSOR identifies as SPONSOR PROPRIETARY INFORMATION …

    The unusually long review period (main focus of discussion to date) pales in comparison with giving the company authority to remove study results generated by this research, all of which are “proprietary” by Article 10’s definition; if the company demands that most or all of the data be removed, the researchers will not have a manuscript left to publish. Further, publication refers to any public mention of the data, not just manuscripts to be submitted to journals:

    8.2 For purposes of this Article 8, the term “publication” shall be deemed to include any making public of the results of any RESEARCH SERVICES, whether in print, by presentation or by some other means.

    In addition to not being able to publish “sponsor proprietary information” without Philip Morris’s permission, VCU also cannot turn it over in response to a court or Congressional subpoena:

    10.2 Notwithstanding the foregoing, VCU may disclose SPONSOR PROPRIETARY INFORMATION to the extent required by a court or other government authority to be disclosed, provided that VCU notifies SPONSOR prior to any such disclosure and cooperates with SPONSOR, at SPONSOR’s expense, in SPONSOR’s attempt to use legally available means to resist or limit the scope of such disclosure or to obtain a protective order for such SPONSOR PROPRIETARY INFORMATION.

    Wow. This is a taxpayer-subsidized public university in the US agreeing to these terms? I’m not a lawyer, but it seems as all the sponsor could rightfully ask is that the university provide notification when a subpoena has been received — not demand that the university stonewall until Philip Morris can “resist or limit the scope of” VCU’s disclosure to a court or Congress. I’d love to know if this is standard industry contract language.

    Beyond the master agreement, we have the exceedingly secretive task orders themselves, which could be even more restrictive in their terms:

    Article 1.7 A TASK ORDER may contain terms which expressly supersede specified terms of this AGREEMENT.

    A serious unexplored problem in this agreement is whether the rationale used to justify the restrictions in the agreement is valid. The question remains, is the work being done truly just product testing/analysis services of interest only to the sponsoring company (the definition of a research services agreement)? The brief discriptions given by Macrina and Solana suggest this work is indeed research rather than research services, in which case a research services agreement should never have been signed to fund and control these projects.

    The sponsor’s product line is irrelevant to this investigation, but the agreement could represent an unethical case of VCU looking the other way to accommodate a local and long-standing corporate partner. The Task Force must review and disclose the terms of the two task orders, including the nature of the work being conducted, to prove they truly are a research services (product testing) rather than traditional discovery-oriented research (discovery of early markers of lung disease).

    Further, one or both task orders might explicitly in plain language (versus the convoluted legal work-around explained above) block publication of data. The task orders themselves must be openly disclosed to demonstrate that they are not even more restrictive than the master research services agreement itself.

    Speaking of plain language (versus legalese), here is the actual text of the article that Macrina feels only “appears to offer secrecy”:

    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.

    So Macrina promises not to do it again, but why not terminate this inappropriate agreement immediately?

    Well, actually, it is too late. The terms of the agreement itself prevent Macrina from canceling it until July 2009:

    15. The term of this AGREEMENT shall commence as of the EFFECTIVE DATE [Sept 22, 2006] and shall continue thereafter for three (3) years. Thereafter, the term of this AGREEMENT automatically shall renew for up to two successive one (1) year terms unless either party gives notice of the termination of this AGREEMENT to the other party at least sixty (60) days prior to the date on which this AGREEMENT otherwise would be renewed.

    That would have been July 23, 2008 (assuming it’s 60 calendar vs business days).

    So, if he hasn’t already sent word to Philip Morris that he wants to terminate the agreement, he can’t do so until next year, and the agreement will now automatically renew. Philip Morris, on the other hand, can terminate the agreement at will:

    15.3 SPONSOR may terminate this AGREEMENT at any time upon thirty (30) days’ written notice to VCU.

    [no similar clause permits VCU to terminate the agreement]

    This is an unconscionable imbalance of power. Who on earth agreed to such terms giving so much control to Philip Morris – and more importantly, why?

    And, incredibly, the restrictions imposed could continue on indefinitely:

    23. The provisions of this AGREEMENT and any TASK ORDER concerning, representations, liability, proprietary rights, confidentiality, publicity, and the interpretation of this AGREEMENT or such TASK ORDER and any other provisions of this AGREEMENT or any TASK ORDER that by their terms or their nature should survive the expiration or termination of this AGREEMENT or such TASK ORDER shall survive and continue after any expiration or termination of this AGREEMENT or any applicable TASK ORDER and shall bind the parties and their legal representatives and permitted successors and assigns.

    Who is responsible for this agreement at VCU? Now that the Office of Industry Partnerships (and its director) has been eliminated, that would be Macrina:

    24. Each of the Director of the Office of lndustry Partnerships and the Vice President for Research (or other individual identified in writing to VCU as having such actual authority) shall be among those who shall be among those who have actual authority on behalf of VCU …

    Only Philip Morris can decide who else at VCU has authority over this agreement? (notice individuals are identified in writing to VCU – not by VCU)

    Thus, Macrina alone is responsible for this agreement, and he bears full responsibility. He must take action to terminate this agreement and its task orders, leaving open the possibility of renegotiating them after the Task Force identifies the appropriate procedures for doing so. Will the Task Force that Macrina himself chairs come to the same conclusion?

  11. writedit said

    Out of the mouth of women, as told to the NYT (excellent article):

    Marketing campaigns have greatly influenced consumers. Menthol cigarettes have been heavily promoted to African-Americans since the 1960s, numerous studies have documented. A study released this year by the Harvard School of Public Health found that menthol cigarettes are increasingly popular with adolescents, partly because tobacco companies have new milder brands that facilitate “initiation.”

    Of course, some smokers had their eyes wide open when they succumbed to the habit.

    Katherine Dozier, 24, a wedding planner in Los Angeles who is white, said she started smoking regularly about a year ago, when a Hollywood club passed out Camel No. 9 menthols as a promotion. She was struck by the “cute” black-and-turquoise box with a pink camel, and said the cigarettes were obviously aimed at young women. “You just don’t see men smoking them because they wouldn’t be caught dead with these pink and green boxes,” she said.

    Ms. Dozier liked the cigarettes, finding them “really smooth and minty and very light,” she said. “They didn’t make me cough.”

    And yet, as reported in the Style Weekly, VCU School of Medicine Dean Jerry Strauss is (was?) seeking Philip Morris sponsorship for a “Center for Healthy Pregnancy and Neonatal Outcomes.” Cough-cough.

    In fact, Strauss notes in a follow-up article, “Am I willing to take tobacco money to do good? Yeah. I think it’s immoral not to.”

  12. writedit said

    How fitting … while recovering from quintuple bypass surgery and amidst continuing Philip Morris controversy, VCU and VCU Health System President Eugene Trani acquires another 1,450 shares of Universal Corp (international tobacco leaf merchant), on whose Board of Directors he sits, bringing his total to an even 7,700 shares.

  13. […] conducted under their previously secret agreement uncovered by the NYT last May. (see also this explanation of how Philip Morris finagled this and the IP giveaway plus a downloadable copy of the actual […]

  14. writedit said

    Please sign the The petition protesting the relationship between Virginia Commonwealth University (VCU) AND Philip Morris USA

  15. writedit said

    In an interview with the VCU student newpaper, Macrina conveyed an incorrect statement as fact:

    Macrina said no American universities ban tobacco money entirely.

    In fact, the University of Pittsburgh does just that:

    Provost and Senior Vice Chancellor James V. Maher later noted that the University refuses to accept research grants that restrict researchers’ ability to publish and also refuses material transfer agreements that restrict a faculty member’s right to pursue research based on using the material. In addition, Arthur S. Levine, senior vice chancellor for Health Sciences and dean of the School of Medicine, noted that Pitt has a University-wide policy of refusing tobacco company sponsorship of research.

    One wonders how many other “American universities” he might have missed. He likewise neglected to clearly acknowledge to the reporter his awareness of university-wide bans in other countries, such as Australia (more than a dozen have such bans). Hiding behind the qualifier of “American” is rather unbecoming of someone so deeply involved in the field of scientific integrity given the intent of the message he sought to convey.

    Perhaps the VCU Vice President for Research would care to do a little more research before presenting additional unsubstantiated statements as fact and/or take a little more care in choosing his words. It would certainly be befitting of his position at the University and his ongoing activity in the field of the responsible conduct (& dissemination) of research.

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