Competition Acquaints a University with Strange Bedfellows - CROs

Universities, particularly tax-payer supported institutions, exist to serve the public good through academic research, teaching, and service. Corporations are focused upon providing products and services to consumers, with the objective of creating a profit. While the two may have competing interests, universities and corporations frequently enter into agreements with one another. This often leads to potential conflicts of interest, as suggested by Jeanne Lenzer, a medical investigative journalist and the author of an article published today in the British Medical Journal.

The article calls attention to issues associated with research performed by academic and corporate contract research organizations (CROs). She cites examples of ethical concerns such as pitting commercial interests against those of individuals recruited to participate in clinical trials. Lenzer describes how in the PRECISION trial patients with cardiovascular disease are being given the drug celecoxib, a medication known to increase the risk of heart attack, stroke, and cardiovascular death, despite their already increased risk. In order to meet the criteria of clinical equipoise, one would have to believe that the potential benefit of reducing arthritis pain outweighs the known increased risk of death.

Another concern noted by Lenzer is that of exploitation of research subjects.

"CROs reduce costs partly by… recruiting participants from impoverished regions of the world."

Jean-Paul Garnie, former CEO of GlaxoSmithKline, was interviewed for the article and confirmed that CROs save money by taking trials overseas. Quintiles Transnational, a large CRO based in Durham, is guilty of recruiting participants in foreign countries for clinical trials as well. According to sources, including Reuters, Duke University's Center on Globalization, and Quintiles, the company has acquired status as the "global leader in pharmaceutical services" in part by expanding operations into Czech Republic, Romania, Thailand, the Phillipines, China, and India.

At a time when many Americans have difficulty affording medications, it is difficult to believe that the residents of these nations will have widespread access to these drugs beyond the trials.

"…even though public funds for research may often flow in the same directions as public funds for health care, it seems unfair that populations dependent on public health care constitute a pool of preferred research subjects if more advantaged populations are likely to be the recipients of the benefits."
-- The Belmont Report, National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

According to the principle of justice, individuals participating in trials, and the populations from which they are selected, should stand to benefit from the results.

Although not mentioned in the article, Quintiles has continued to grow in part by offering contract sales and information services, such as physician detailing and direct-to-consumer advertising. They have also invested capital into drug development in partnership with firms, including Solvay Pharmaceuticals and Eli Lilly, where their financial returns are tied to the success (or failure) of drugs, Cymbalta being one example.

In the final paragraphs of the BMJ article, Lenzer mentions the desire for CROs to form relationships with academic institutions, citing the example of Quintiles and UNC-Chapel Hill. The University’s affiliation with Quintiles and alignment with its founder and CEO, Dennis Gillings, are based upon sponsorship of forums, scholarships, internships, and corporate donations, as well as a $50 million pledge, that the School has accepted over the last decade.

In return for their apparent generosity, Quintiles and Gillings have been given the opportunity to participate in the planning of academic events held on the UNC campus (i.e. Driving the Future of Clinical Trials: Safer Drugs and Faster Approvals), to meet with officials such as Dr. Richard Temple, a director at the FDA’s Center for Drug Evaluation and Research who spoke at the School, to solicit information regarding the health care system in China from faculty for the purpose of developing a business strategy, and to influence the training of students at the School of Public Health.

The $50 million gift appears to be contingent upon renaming the School after Gillings, as well as basketball tickets to see the Tarheels play at home for the lifetimes of the Gillingses and their children. At least $750,000 of the pledge will be directed to the new Center for Innovative Clinical Trials. Gillings was given the opportunity to align his interests and those of Quintiles with the School by becoming involved in the planning of the Center. According to a letter from former Chancelor James Moeser to Gillings dated February 20, 2007, priorities of the "Gillings School of Global Health" will include "new methodologies to speed clinical trials…"

At least three current executives of Quintiles, including Dennis Gillings, and two of their spouses hold leadership positions at the School. While Dean Rimer has argued that they do not have the capacity to make decisions and are unbiased, it is apparent that they bear influence on the School by the nature of their appointments on the School of Public Health Advisory Council and the Acceleration Advisory Committee (AAC). Members of the AAC have no fiduciary responsibility to the School and thus are free to remain loyal to their personal interests and to those of their employer. Paula Brown Stafford, an executive vice president at Quintiles, serves as a member of the Public Health Foundation Board of Directors and is therefore involved in managing the School’s endowments and charitable gifts. Former Quintiles executive and current School of Public Health faculty member Lisa LaVange appears to have been recently relieved of her duty as a director for the Public Health Foundation. Julie MacMillan, a former Quintiles executive who has worked closely with Gillings in the past, currently serves as the Managing Director of Carolina Public Health Solutions, which Rimer describes as "the office we created to managed the [Gillings] gift."

Quintiles is not the only CRO with ties to UNC. Fred Eshelman, CEO of PPD, Inc. of Wilmington, has given over $30 million to the School of Pharmacy which has since been renamed.

Given the inherent conflicts of interest between universities and CROs, the relationship between UNC and Quintiles should be restricted from its current state, if not completely severed. Provisions should be made to ensure transparency and oversight by students, faculty, and alumni. Measures must be taken to guard against undue influence of current and former employees of Quintiles, including limiting the number of leadership positions to which they are appointed. Furthermore, the Gillingses should be removed from any and all positions at the School in which they might further influence how their gift is spent in an effort to preserve academic freedom and integrity as described by the American Association of University Professors.

Failure to implement these steps, as may become evident through a lack of leadership and moral courage within the School, will lead to an erosion of the core values of public health, including trust, respect, and social justice. If Carolina is to continue as a leading institution of public health, we must band together and speak out against the corporate corruption of our School.