After Controversy Over Tobacco Money Funding Medical School, University President Steps Down

We have posted about the controversies arising from recently revealed research agreements between Richmond, Virginia based Virginia Commonwealth University (VCU) and tobacco company Philip Morris. These were first publicly discussed in May in a New York Times article. As we posted here, the main issues were that the research agreements themselves were secret; the agreements apparently gave Philip Morris control over all publications arising from the research, since they defined all products of the work as proprietary information belonging to Philip Morris; and that research for hire on behalf of a tobacco company, given that tobacco products have known severe health risks and no health benefits, seems to go against the mission of a medical school and academic medical center. We also noted that the university administration's apparent lack of qualms about its relationship with Philip Morris might have been related to its president's role as a leader of a tobacco company. (He sits on the board of Universal Corp, a tobacco buyer, processor, and distributor.) We later observed how little attention this subject has gotten in Richmond's major news outlet. Then, we noted that some university leaders were willing to open a public dialogue about the issue, thus exhibiting more transparency under criticism than has been shown by many other organizations. Most recently, we discussed how the Dean of the university's Medical School had allegedly actively sought grant support from Philip Morris for a center for research on women's health.

Today, the Richmond Times-Dispatch reported that VCU President Eugene Trani will step down next year. The article hailed Trani for his efforts to enlarge and expand the University. It also noted, however,

Trani was so intent on unifying the university in a shared mission that he forbid the mention of the Medical College of Virginia, renaming it the VCU Health System.

Furthermore, although the Times Dispatch has not published much about the controversy over the relationship between VCU and Philip Morris (see post here), it did acknowledge

But collaboration between VCU and Philip Morris also has stirred controversy because of the tobacco company's apparent level of control over research it sponsors through the university.

'The events of the summer are unfortunate,' [Professor of Political Science and Public Administration Blue] Wooldridge said, 'and would be a stain on [Trani's] legacy that didn't need to be there.'

A former president of the faculty senate, Wooldridge said he admires much of what Trani has done -- from building the engineering school to forging 15 alliances with universities in other countries -- especially while maintaining his own scholarship as a historian.

However, too often Trani hasn't considered the full costs to the university of his ambitions or listened to the informed opinions of others, Wooldridge said.

'I don't think the faculty has had their voices heard as much as they should.'

I hope that the impending retirement of President Trani will lead the VCU administration to rethink its apparent infatuation with cultivating tobacco as a source of funding for the medical school. The medical school's mission of promoting the health of individual patients, and the health of the public through teaching and research is ill served by financial arrangements with companies whose products only promote ill health.

Courting Tobacco Money

We have posted about the controversies arising from recently revealed research agreements between Richmond, Virginia based Virginia Commonwealth University (VCU) and tobacco company Philip Morris. These were first publicly discussed in May in a New York Times article. As we posted here, the main issues were that the research agreements themselves were secret; the agreements apparently gave Philip Morris control over all publications arising from the research, since they defined all products of the work as proprietary information belonging to Philip Morris; and that research for hire on behalf of a tobacco company, given that tobacco products have known severe health risks and no health benefits, seems to go against the mission of a medical school and academic medical center. We also noted that the university administration's apparent lack of qualms about its relationship with Philip Morris might have been related to its president's role as a leader of a tobacco company. (He sits on the board of Universal Corp, a tobacco buyer, processor, and distributor.) We later observed how little attention this subject has gotten in Richmond's major news outlet. Most recently, we noted that some university leaders were willing to open a public dialogue about the issue, thus exhibiting more transparency under criticism than has been shown by many other organizations.

This week's Richmond (VA) Style Weekly reported that there were plans for even greater ties between VCU and Philip Morris,

Virginia Commonwealth University officials have repeatedly denied the existence of a proposal to create a women’s health center funded by Philip Morris USA, but a draft copy of the proposal shows the idea did — and in some iteration still does — exist.

A copy of a working paper titled 'Proposal to Create the VCU Center for Health Pregnancy and Neonatal Outcomes,' obtained by Style Weekly, shows plans for a center focused on treatment and research into preventing defects, early birth and mortality.

Furthermore, it appeared that VCU leadership, not Philip Morris, initiated these plans,

In part, the memo obtained by Style reveals a plan for how VCU could solicit money from Philip Morris.

The seven-page proposal includes various attachments and is detailed down to budget projections for such specifics as bus and cab fare for participants. It concludes with a subheading titled 'Why Philip Morris USA should support this initiative.' The rationale for the pitch? 'Philip Morris USA will be investing in the future of the Richmond community,' and 'giving new meaning to ‘being well-born’.'

Pam Lepley, a university spokeswoman, says she was unaware of the proposal until contacted about it last week. During a July 16 community forum held on the medical campus, Dr. Francis L. Macrina, the school’s vice president for research, repeatedly denied knowledge of the proposal, saying that no proposal has ever existed.

Lepley now says the proposal is a working paper developed by the dean of the medical school, Jerry Strauss, but adds that it was not specifically aimed at attracting the financial support of Philip Morris.

'This is a draft proposal that Jerry Strauss was working on for any number of potential philanthropic providers,' Lepley says, calling it a working proposal that remains internal to the school. 'This is an initiative of Jerry Strauss’.'

The Richmond-based tobacco company is the only private corporation mentioned in the proposal and the only entity mentioned that is not the university or one of various governmental service providers foreseen as partners.

The assertion that the proposal has yet to see the light may not be worth a pack of smokes, either.

'This was a proposal that the dean of medicine shopped with Philip Morris,' says a medical school faculty member, speaking on condition of anonymity. 'Since all this has broken, [Strauss] has said [in meetings] that Philip Morris did not accept it or they did not fund it.'

We have previously discussed how medical school and academic medical center leaders often seem to care more about financial goals than the fulfillment of their clinical and academic missions. This can lead to pressure on faculty to raise research money from commercial sponsors, such as drug, biotechnology and device companies who have vested interests in having the research results favor their products. Medical schools and academic medical centers often seem so eager to get such money that they let the research sponsors control many aspects of the research, making it easier for them to manipulate the research to favor their products (see post here). Faculty pushed to work with commercial sponsors may be prone to become "key opinion leaders" who help the sponsors market their products.

All that is bad enough, but at least drug, biotechnology and device companies make products designed to treat, prevent, and sometimes even cure disease. In my humble opinion, medical school leaders fundamentally violate their institution's mission when they solicit money from a company whose products cause disease without providing any clinical benefits.

A Town Meeting About Tobacco-Funded Research in Academic Medicine

We have posted about the controversies arising from recently revealed research agreements between Richmond, Virginia based Virginia Commonwealth University (VCU) and tobacco company Philip Morris. These were first publicly discussed in May in a New York Times article. As we posted here, the main issues were that the research agreements themselves were secret; the agreements apparently gave Philip Morris control over all publications arising from the research, since they defined all products of the work as proprietary information belonging to Philip Morris; and that research for hire on behalf of a tobacco company, given that tobacco products have known severe health risks and no health benefits, seems to go against the mission of a medical school and academic medical center. We also noted that the university administration's apparent lack of qualms about its relationship with Philip Morris might have been related to its president's role as a leader of a tobacco company. (He sits on the board of Universal Corp, a tobacco buyer, processor, and distributor.) Finally, we just observed how little attention this subject has gotten in Richmond's major news outlet.

VCU just held a "town meeting" that allowed faculty and students to comment on or question this recent unpleasantness. The meeting was covered by Richmond.com, the Associated Press, and, to its credit, the Richmond Times-Dispatch. According to the latter,

Francis Macrina, vice president of research at Virginia Commonwealth University and chairman of a task force on corporate-sponsored research, told a gathering tonight that the university made a mistake in its deal with cigarette giant Philip Morris.

Macrina said a confidentiality clause in the deal appeared to offer secrecy to the company.

'It won't happen again,' he said during the town-hall meeting at the Kontos Building on the university's MCV campus. 'We will not enter into any agreements that support secrecy.'

An estimated 75 attended the meeting, and about 20 spoke, many declining to give their names.

'Transparency at VCU is pathetic,' said one speaker who did not identify herself.

Another speaker, a faculty member in the pharmaceutical sciences, defended corporate research in general.

'I've never had a situation in which I felt my integrity was endangered,' he said.

Some wondered how a confidentiality agreement could be reached with a corporation without halting the publication of research information.

'That's a good question,' [Associate Dean of the School of Social Work Kia] Bentley said. The task force will address that, she said.

First, for what my opinions may be worth, I commend VCU for setting up this meeting, and setting up a task force to consider issues raised by the Philip Morris contracts. Second, I commend the Richmond Times-Dispatch and other media for covering it.

But I do wonder about how, at least according to the media reports, this meeting seemed to skirt some some of the issues involved. First, Vice President Macrina seemed not to be acknowledging just how comprehensive the secrecy provisions of the contract were. According to the original NY Times article,

The contract bars professors from publishing the results of their studies, or even talking about them, without Philip Morris’s permission. If 'a third party,' including news organizations, asks about the agreement, university officials have to decline to comment and tell the company.

Second, at least the Richmond Times-Dispatch coverage seemed to soft-pedal Philip Morris' control over publication of research results. Again, according to the NY Times,

Philip Morris alone decides whether the researchers can publish because the contract defines 'without limitation all work product or other material created by V.C.U.' as proprietary information belonging to the company.

Finally, it is not clear whether the issue of the VCU President's simultaneous responsibilities to the share-holders of a tobacco company was even mentioned.

Perhaps these are quibbles, given that this university was at least willing to have a public discussion of this problem. Many of the issues involving mismanagement by and conflicts of interest affecting leadership of academic medicine that we have mentioned on Health Care Renewal have never been discussed in anything like a town meeting at the relevant institutions.

So I hope that VCU is making some progress towards making its clinical and health related research transparent in all respects, its design, implementation, analysis, reporting, and who funds it and under what agreements. It would be nice if some other academic medical institutions also could show some progress.

VCU, Philip Morris, and the "Recent Unpleasantness"

While I lived in Richmond, Virginia from 1987 to 1994, one could still find some people who referred to the US Civil War as the "recent unpleasantness." Similarly, we have noted the "anechoic effect," how cases involving deficient ethics, poor leadership, and flawed governance in health care occurs produce few echoes. Many important cases and issues that have been discussed on Health Care Renewal have never appeared in medical or health care journals. Many specific cases have never been publicly discussed at the institutions in which they originated. Some specific cases have never appeared in the national news media. Some specific cases have not been covered even in the relevant local news media.

Here is a case in point, from Richmond, Virginia. The Richmond Times-Dispatch, the only major newspaper in that city, just reported that the President of Virginia Commonwealth University (VCU), Eugene P Trani, is recovering from coronary artery bypass grafting (CABG) surgery. We wish President Trani a speedy recovery. But buried in that article is the only mention that has ever appeared in the Richmond Times-Dispatch of the recent unpleasantness about research contracts between VCU and tobacco company Philip Morris. Here it is:

Trani was scheduled to be on a two-month sabbatical at Harvard University's Taubman Center for State and Local Government through mid-August. In his note to the university community, he said he returned to Richmond after his first month because the university was 'experiencing a number of recent challenges.'

Recent controversies have brought VCU some unwelcome attention.

There have been questions about whether a research agreement with Philip Morris USA was in accordance with traditional accepted research guidelines and policy.

A university Task Force on Corporate Sponsored Research will hold a town-hall meeting tomorrow to hear from faculty and students on the research issue.

We have discussed this "recent challenge" on Health Care Renewal. Briefly, the New York Times reported last month that VCU has been doing research under contract with Philip Morris USA. Contract provisions forbade the university from even revealing the existence of the contract itself. By classifying all products of the research as "proprietary," the contract seemed to bar university faculty from publishing or publicly discussing the research without permission from Philip Morris. Such provisions apparently violated not only the university's stated policies, but its fundamental mission. Furthermore, it appeared that the university's coziness with Philip Morris might relate to its President's leadership role for a company in the tobacco industry. President Trani, it turns out, is on the board of directors of Universal Corp, which buys, processes, and ships tobacco. For a university President who also leads a medical school and academic medical center simultaneously to be responsible to the stock-holders of a tobacco company seems quite a major conflict of interest, given that tobacco products clearly cause much disease, disability, and death in the absence of any health benefits.

But to the Richmond Times-Dispatch, all this seems just to be some recent unpleasantness.

The cone of silence that seems to confine much unethical behavior, poor leadership, and poor governance in health care has disabled medicine's and society's ability to address these problems.

For a Few Dollars More: Academic Ideals Go Up in Smoke

In the New York Times was a report on an unusual research program at Virginia Commonwealth University:

a contract with extremely restrictive terms that the university signed in 2006 to do research for Philip Morris USA, the nation’s largest tobacco company and a unit of Altria Group.

The contract bars professors from publishing the results of their studies, or even talking about them, without Philip Morris’s permission. If 'a third party,' including news organizations, asks about the agreement, university officials have to decline to comment and tell the company. Nearly all patent and other intellectual property rights go to the company, not the university or its professors.

The contract appeared to contradict the university's research policies:

Virginia Commonwealth’s guidelines for industry-sponsored research state, 'University faculty and students must be free to publish their results.' The guidelines also say the university must retain all patent and other intellectual property rights from sponsored research.

Under the agreement, though, Philip Morris alone decides whether the researchers can publish because the contract defines 'without limitation all work product or other material created by V.C.U.' as proprietary information belonging to the company.

Ms Saul asked Francis L Macrina, vice president for research at VCU, to explain the apparent discrepancies between the contract and the university's policies:

'There is restrictive language in here,' said Francis L. Macrina, Virginia Commonwealth’s vice president for research, who acknowledged that many of the provisions violated the university’s guidelines for industry-sponsored research. 'In the end, it was language we thought we could agree to. It’s a balancing act.'

Also,

'These restrictive clauses seek to protect the rights and interests of multiple parties in the agreement,' Dr. Macrina said, pointing out that Virginia Commonwealth scientists would be working with other researchers.

And,

Dr. Macrina also defended the requirement that the university decline comment and tell the company if asked about the agreement by news organizations and other third parties.

'Language like that occurs in agreements like this because the sponsor wants to be sure there are no slip-ups, that things will not be released inadvertently,' he said.

A Philip Morris executive, Rick Solana, "senior vice president for research and technology," rationalized the secrecy provisions thus,

Dr. Solana also said the contract represented a new focus on developing tobacco products with reduced risks, a shift in strategy in underwriting university research that requires more confidentiality to protect the corporation’s intellectual property rights. And he said Philip Morris had similar arrangements with other universities — although he declined to say how many or which ones.

And he noted that maybe under certain circumstances the company would allow university researchers to publish:

saying that once the company determined that its competitive interests were protected, it could permit researchers to publish.

'We have to start out with is anyone’s intellectual property going to be compromised?' Dr. Solana said. 'Once the intellectual property is protected, then it’s usually O.K. to publish.'

'Something being proprietary does not mean something cannot be published. We try to be very supportive in the health area of work being published.'

What's wrong with all this? Where do I start?

First of all, the fundamental mission of the university is to seek and disseminate the truth. Letting a research sponsor control whether research can be published, and making secret research agreements with research sponsors violate this fundamental mission. Perhaps under some special circumstances, such as when national security is involved, exceptions could be made. But obviously doing research for a tobacco company does not involve national security.

It is painful to see a university vice president for research verbally squirming to try to justify signing a contract that so fundamentally violates the university's mission.

Second of all, the research was being done on behalf of the interests of a tobacco company. There is no doubt that smoking cigarettes leads to severe health risks, and has never been shown to provide any important health benefits. It has been shown by others that tobacco companies seek to have academic institutions do research on their behalf to give their selling of hazardous products a cloak of respectability. For a university that includes a proud and venerable medical school (formerly the Medical College of Virginia, and, for the purposes of full disclosure, a medical school on whose faculty I served for seven years), to help a tobacco company gain such a cloak violates the fundamental health care mission of the school, in my humble opinion.

Thus, it is obvious why this story provoked some outrage among academics:

'When universities sign contracts with these covenants, they are basically giving up their ethos, compromising their values as a university,' said Sheldon Krimsky, a professor at Tufts University who is an expert on corporate influence on medical research. 'There should be no debate about having a sponsor with control over the publishing of results.'

Stanton A. Glantz, a professor at the University of California, San Francisco, School of Medicine who has lobbied for banning tobacco money on campuses, said, 'University administrators who are desperate for money will basically do anything they have to for money.'

At Virginia Commonwealth, few professors appeared to know about the contract; when told about it, a number of them said they were concerned about its secretiveness.

'It’s a controversial area, and I personally prefer transparency,' said Richard P. Wenzel, chairman of the department of internal medicine at the university’s medical school, who had not heard of the contract before a reporter’s call.

A tenured scientist at Virginia Commonwealth, who would not be interviewed for attribution because he said he feared retribution against his junior colleagues, called the contract’s restrictions, especially the limitations on publication, 'completely unacceptable in the research world.'

As we have noted before, often the leaders of academic medical institutions seem to make the pursuit of money, prettied up as "external funding," their highest priority. Thus do the high ideals of academia go up in smoke.

ADDENDUM (26 May, 2008) - See also comments on the Clinical Psychology and Psychiatry blog.

Smoke Alarm: Tobacco Funding of Medical Research at Reputable Medical Schools May be Prevalent

We recently posted about a controversial study of using CT scans to screen for lung cancer that turned out to have been partially sponsored by a tobacco company. Even though we have written quite a bit about conflicts of interest, this surprised even me, since the conflicts of interest presented by financial relationships with tobacco companies seem so blatantly risky that I would have thought few physicians or medical researchers would dare contemplate them. It looks like even having blogged on Health Care Renewal for several years, I am still too naive.

For example, the Boston Globe just reported on funding of medical research in the Boston area just by tobacco company Philip Morris USA, just spun off from Altria Group Inc.

The nation's largest cigarette maker has paid for scientific research at four Massachusetts universities since 2000....

Philip Morris USA, which makes Marlboro and other top-selling cigarette lines, gave grants to scientists at Boston University, Harvard University, the Massachusetts Institute of Technology, and the University of Massachusetts, company spokesman David M. Sylvia said Friday.

The research supported by the company touched on conditions such as heart disease and cancer that are linked to smoking.

Funding went to Boston University.

BU's acceptance of research grants from Philip Morris was first disclosed Thursday in The Daily Free Press, a student newspaper at the university.

At BU, one recipient, Dr. Douglas Faller, is a longtime professor and director of the BU Cancer Center. According to a document detailing work at the university's Women's Health Interdisciplinary Research Center, Faller received $268,759 from Philip Morris to investigate a cancer drug.

Reached at his home late Friday, Faller deferred to university officials for comment.

Funding went to Harvard, although it has decreased since Harvard banned new tobacco funding of research in 2004.

At Harvard Medical School, researchers were ordered to stop pursuing tobacco-industry grants in July 2004. 'The policy did, however, allow those few researchers who had ongoing projects funded by those entities to complete them,' Margaret Dale, dean for faculty and research integrity at Harvard Medical School, said in a statement released Friday by a university spokesman.

Funding previously went to University of Massachusetts Medical Center, but the institution does not currently get tobacco funding.

A UMass Medical School spokeswoman said that the school does not currently have any research supported by tobacco companies and that it had accepted 'no more than' $2 million from the industry over the past decade.

No Philip Morris funding went to Tufts University School of Medicine, but the school did admit to receiving money from another tobacco company.

The Tufts University School of Medicine received no Philip Morris grants, but a school spokeswoman said that one laboratory there had received a grant in 2006 from a tobacco company.

The argument against funding of clinical research by pharmaceutical, biotechnology and medical device companies has been that such companies often try to exert influence, subtle or overt, that might bias the research to favor their products, or even suppress research that shows their products in a bad light. Such influence could adversely affect the advancement of science, and decision making by physicians and patients who accept the published research as unbiased. Such influence also breaks the trust of research subjects who were told that they were volunteering to advance science and health care.

But at least pharmaceutical, biotechnology, and device companies make products intended to help patients more than they harm them.

Tobacco products obviously pose serious health risks, and have no health benefits to counterbalance them. So the bias that could result from tobacco companies' sponsorship of research could be much worse for science, for medical decision making, and for research subjects than bias resulting from pharma, biotech, or device companies' research sponsorship.

Yet some medical schools seem to push their faculty so hard to get "external research support" that they do not mind if such support comes from tobacco companies.

Kudos to Harvard, though, for trying to cut back.

No medical school administrator nor researcher willing to be quoted by the Boston Globe reporter dealt directly with why tobacco company research support might not be a good idea. For example,

In a statement issued Friday evening, the provost of BU's medical campus, Dr. Karen Antman, said the school had received $3.99 million from Philip Morris during the past decade and devoted it to the study of tobacco-related diseases.

'We adhere to the highest ethical conduct in research and pursue funding from a variety of sources for unrestricted medical research,' Antman said in the statement. 'Our research is conducted and the results are assessed against the standard benchmarks that apply to any research.'

Again, the issue is that a researcher getting "unrestricted" research funding, funding that might be keeping his or her academic career alive, might naturally feel some gratitude for the funding, and consequently might unconsciously be less likely to criticize his or her funding source or its products than otherwise. Of course, the more the researcher might need future funding from this sponsor, the more likely would be a conscious sense of obligation to be nice to that sponsor. Furthermore, even "unrestricted" funding may open up some lines of communication between the sponsor and the researcher which the sponsor could use to further increase its influence.

Also, the tobacco companies surely are not spending money to support research out of pure altruism,

'Their interest now is to try to convince the public that they are truly concerned companies and that they care enough to fund important research at reputable institutions,' said Dr. Michael Siegel, a Boston University School of Public Health researcher who has extensively studied the tobacco industry. 'And, they're using the good name of these institutions to try to bolster their own scientific and public credibility.'

That seemed to be working, as demonstrated by this seemingly self-contradictory quote from a Massachusetts Institute of Technology researcher:

'As there were no strings attached in the application process I had no qualms in applying for this funding,' Rami Tzafriri, of MIT, said in an e-mail. 'In retrospect I can say that the whole process was very professional and friendly and that under similar circumstances I would apply for such funding again. Funding for research is essential, but unfortunately scarce. So any source that does not compromise my independence is welcome.'

On the other hand,

'Taking money from the tobacco industry to conduct scientific research is like the DA taking money from the Mafia to conduct investigations of crime,' said Gregory Connolly, a Harvard School of Public Health professor and former director of the Massachusetts Tobacco Control Program.

Indeed. It would strongly be in society's interest to find a way to wean academic medical institutions from their addiction to research dollars proffered by those with something to sell other than science and improving health care.

ADDENDUM (2 April, 2008) - See also comments on the Effect Measure blog.