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.

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.”

“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?

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)

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

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)

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.