Friday, May 23, 2008

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.'


'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.


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.


Anonymous said...

The May 22, 2008, WSJ highlights an AP story about Merck ending a study on a new cholesterol drug due to the less than expected results. "This was done three weeks after US regulators refused to allow sales of the drug."

Steve Nissen of the Cleveland Clinic had this to say: "I am concerned whether the reason for terminating this trial is commercial or scientific."

While it is certainly in a corporation's best interest to only fund those studies that put their products in the best light, we also have to question the discontinuation of studies that may give additional information about a group of products being sold. I found the comment section of the WSJ Health Blog article on John McCain to be very disturbing. We had doctors overtly selling Vytorin. Others felt qualified to offer health diagnosis based on a single LDL number. All of this after the much publicized results of the Enhanced trial.

Pharma certainly has done an excellent job of installing itself into the daily decision making process of the medical community.

Steve Lucas

Anonymous said...

Alan Finder is the NYT reporter for this story. The NYT Editorial Board has weighed in as well today (May 27). Separately, the Roanoke Times has an insightful editorial as well.

Extensive background on and discussion of this situation can be found in comments here.