Wednesday, May 28, 2008

A Worse Variant of a New Species of Conflict of Interest

We recently commented on a New York Times article that revealed that Virginia Commonwealth University got a research grant from the tobacco company Philip Morris, a grant which gave proprietary control of any research results to the company, not the academic researcher, and required the grant itself to be secret.

It turns out that VCU has more extensive ties to the tobacco industry. In particular, first the Medical Writing, Editing and Grantsmanship blog, then the Richmond, VA publication Style Weekly reported that the president of VCU, Eugene Trani, is on the board of directors of a tobacco company (not Philip Morris). From Style Weekly,

As a member of the board of directors of Universal Corp., Trani receives an annual retainer of $40,000, including stock options. He also receives a fee of $2,000 for each board of directors’ meeting he attends and another $1,500 for attending committee meetings.

Based in Richmond, Universal Corp. is a leaf tobacco merchant and processor. The company’s Web site describes its operations as 'selecting, buying, shipping, processing, packing, storing, and financing of leaf tobacco in tobacco growing countries for sale … throughout the world.'

Though it does not manufacture cigarettes, the Web site says 'the Company’s revenues are derived from sales of processed tobacco and from fees and commissions for specific services.'

Actually, Style Weekly understated Trani's financial ties to Universal Tobacco. In fact, according to the company's 2007 proxy statement, in May, 2007, Mr Trani held 12,642 shares of company stock (including shares which he had the right to acquire via options within 60 days of May 25, 2007). His total director's compensation in 2007, including fees and stock options, was valued at $117,575. He held 6000 stock options valued at $41.88 per share (thus worth $251,280). Finally, his aggregate balance of his director's retirement plan was $321,740.

Style Weekly quoted a VCU spokesperson who thought that Trani's board service was irrelevant:
'I don’t see any connection between these two,' university spokeswoman Pam Lepley says. 'And his being on the board doesn’t really pertain to the university.'

Similarly, an editorialist for the Richmond Times Dispatch shrugged off this new development. However, in my humble opinion, it really is important.

We have previously discussed conflicts of interest incurred when the leaders of health care organizations also serve on the board of pharmaceutical, biotechnology, medical device companies and the like. The issue goes beyond just the often generous payments board service entails. The important consideration is that directors of public for-profit corporations have a duty to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.] It would seem that the conflict created when the president of a university to whom a medical school and academic medical center report also is the director of, for example, a pharmaceutical company is obvious.

I have not previously heard of case in which the leader to whom a medical school or academic medical center report who also leads a tobacco company. That of Mr Trani appears to be the first case reported of this worse variant of what we once called "a new species of conflicts of interest."

It seems to me that the conflict created by this situation is much worse than that of, for example, a university president who also is on the board of a pharmaceutical corporation. At least pharmaceutical, biotechnology, and medical device companies make products that are intended to provide more benefit than harm to patients. Tobacco companies make products that increase the risk of severe medical problems, but provide no medical benefits. It does not seem ethical for a medical school or academic medical center to report to someone with a fiduciary duty to increase the profits of a company that facilitates the making of such products.

Thus, Dr Trani's "being on the board" of Universal Corporation pertains most seriously to Virginia Commonwealth University, particularly to the VCU School of Medicine and VCU Medical Center. They ought not to be lead by someone with "unyielding loyalty" to the shareholders of a tobacco company.

(Note, for the purposes of full disclosure, that I am an unpaid, adjunct faculty member in the Department of Internal Medicine of the VCU School of Medicine of Virginia Commonwealth University.)


Anonymous said...

Actually, the opinionated blog entries noted above are not part of the Richmond Times-Dispatch, though I can understand the confusion given that they too display an extreme bias in defending Trani.

Anonymous said...

Even worse, Trani serves not only as President of VCU, he also serves as President of the VCU Health System, as Chair of the VCUHS Authority Board (not sure how he oversees himself), and as Chair of both the Authority Board of Directors and the Corporation Board of Directors for Virginia BioTech Park ... where Philip Morris recently opened their $350 million Center for Research and Technology (and where the VCU Office of the Vice President Research [Macrina] is housed).

Anonymous said...

Even worse, Trani serves not only as President of VCU, he also serves as President of the VCU Health System, as Chair of the VCUHS Authority Board (not sure how he oversees himself), and as Chair of both the Authority Board of Directors and the Corporation Board of Directors for Virginia BioTech Park ... where Philip Morris recently opened their $350 million Center for Research and Technology (and where the VCU Office of the Vice President Research [Macrina] is housed).

Anonymous said...

I wish you'd respond to the egregious statements written at on this topic. Basically, the author is caliming that VCU's agreement with PM is just like every university's contract with pharma and that the NY Times is bad for picking on VCU and Trani.

Anonymous said...

This is vile. Trani should not only be forced to resign he should be tarred and feathered.

Maybe he should be credited with a new health system paradigm: "We caused your disease so we sure as heck know how to treat it!"

Anonymous said...

Published on

The Human Injury of Lost Objectivity

If I were to rate the corruptive tactics performed by big pharmaceutical companies, the intentional corruption of implementing fabricated and unreliable results of clinical trials by pharmaceutical companies by hired third parties who manipulate these trials they sponsor because of their power to control others involved in such trials that is largely absent of regulation would be at the top of the list, and likely the most damaging to the requirement of authenticity and, more importantly, assuring the safety of the public health, as I understand that this does in fact occur.
Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of meds. Then, in 1980, the Bayh-Dole Act was created, which allowed for such places to profit off of their discoveries that were performed for pharmaceutical companies in the past. This resulted in the creation of for-profit research trial sites, called Contract Research Organizations, which is often composed of community research sites with questionable investigators possibly void of necessary research experience or quality regarding their research purpose and ability. Since they are for- profit, with some CROs making billions of dollars a year. The trials conducted at such places are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their med being studied in the trial. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner has been transformed into a method of marketing, which includes altered results of the trial to favor the sponsor’s med. Their activities are absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit what may be a collusive relationship between the site and the sponsor.
Further disturbing is that once the creation of the trials is completed, they are then written by ghostwriters often, although no one seems to know how often. These people are not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers, as one does not need research training or certification in order to perform this function. Rarely do trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the sponsor. Also, these hired mystery writers are known to make about 100 grand a year. This activity removes accountability and authenticity of the possibly fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring an author to be placed on the trial that likely had no involvement with the trial, and, along with others, was paid by the sponsor for doing this deceptive act.
To have the trial published, the sponsor pays a journal to do this in various ways, I understand, such as purchasing thousands of reprints of their study from the journal. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers and research sites to support the pharmaceutical industry. So benefits of meds studied in such a malicious way potentially can harm patients and their treatment options and safety risks. The purchased reprints are distributed to the sponsor’s sales force to share the content with prescribers which may lack validity.
Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns, if in fact true based on reports by others. If so, our health care treatment with meds is now undetermined in large part with such corruptive situations, as well as the possible absence of objectivity that has been intentionally eliminated. Trust in the scientific method in this type of activity illustrated in this article is absent. More now than ever, meds are removed from the market are given black box warnings. Now I understand why this may be occurring.
Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method. More importantly, research should not be conducted in a way that the sponsor can interfere in such ways described in this article, requiring independent sites with no involvement with the drug maker. And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters. Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course. We can no longer be dependent on others for our optimal health. Knowledge is power, and is also possibly a lifesaver.

“Ethics and Science need to shake hands.” ……. Richard Cabot

Dan Abshear

Anonymous said...

Ironically, Macrina is lecturing at an OHRP-sponsored workshop on the importance of managing conflict of interest as part of the responsible conduct of research so as to maintain public trust. Trani will be welcoming attendees to this workshop no less.

In addition, a Richmond publication has two items this week, one addressing faculty fears to speak out against the Philip Morris partnership as well as a PM funding request by the SOM Dean Jerry Strauss and the other by Anne Landman tracking even more ties between VCU and Philip Morris (& the rest of the tobacco industry).