(Bruce Resnick is a trustee of Bard College.) Chronicle of Higher Education February 3, 2014 For UCLA, Pomegranate Research Is Sweet and Sour
By Ruth Hammond "Drink to Prostate Health." "The Antioxidant Superpill." "Take Out a Life Insurance Supplement." Pomegranates are a superfood, or at least that’s what ads told us for years in newspapers and magazines. Those ads have now vanished. They were banned as part of a lengthy battle between the couple behind Pom Wonderful, the company responsible for the ads and the federal government. Tangled up in that dispute, in more ways than one, is the University of California at Los Angeles. In an opinion issued last year, the Federal Trade Commission found that 36 ads and other promotional materials for Pom Wonderful products, many of which cited UCLA studies and quoted UCLA experts, were false or deceptive. An order now prohibits Lynda and Stewart Resnick, Pom’s owners, from making any disease-related claims about Pom or any product of their holding company, Roll Global, during the next 20 years unless they have substantiated those claims through at least two well-controlled, randomized clinical trials. The Resnicks appealed the case to the U.S. Court of Appeals for the District of Columbia Circuit last August. The continuing legal battle has highlighted the complications that can arise when people have multiple relationships with a university, as the Resnicks do with UCLA. The couple has given generously to various parts of the university. They’ve provided money to UCLA scientists to do research. They have engaged some of those same researchers to act as advisers. They paid the chief of the UCLA Health System more than $120,000 from 2010 to 2012. Two of the Resnicks’ expert witnesses at the FTC trial were from UCLA. Last summer the university created the Resnick Program for Food Law and Policy in the university’s School of Law, through a $4-million gift from the couple. The program’s founding executive director, Michael T. Roberts, worked as special counsel at Roll Law Group, part of Roll Global, for five years. It is not uncommon for industry donors and university researchers to have more than one connection. But, says Josephine Johnston, a research scholar at the Hastings Center, an independent institution that studies bioethics, she cannot recall hearing of a relationship as multilayered as the one between the Resnicks and UCLA. Such relationships "could actually create some kind of bias or impaired judgment" in researchers, she says, but even if they don’t, "they raise this question about how independent and trustworthy the institution is." Dale T. Tate, a spokeswoman for UCLA Health Sciences, said in an e-mail that the university has comprehensive policies regarding conflicts of interest, fund raising, and relationships with industry, and reviews those policies regularly. Senior managers have a "duty of loyalty" and "primary fiduciary responsibility" to the university, she said, and must obtain preapproval for all outside professional activities. "We understand our obligation to maintain the public's trust." A Giving Couple Forbes magazine estimated the Resnicks’ net worth at $3.5-billion last year. Besides owning companies like Teleflora and Fiji Water, they hold vast amounts of farmland in California, on which they grow tree crops like pistachios, citrus fruits, and pomegranates. The Resnicks are known for their philanthropy, and UCLA has been a principal beneficiary. The couple has donated more than $5.2-million to the law school and $15-million for the construction of the Ronald Reagan UCLA Medical Center. The university’s Stewart and Lynda Resnick Neuropsychiatric Hospital is named for them. The Resnicks were not available to be interviewed for this article, said Rob Six, a spokesman for Roll Global who answered questions by e-mail. In the mid-1990s, the Resnicks began financing experiments to discover the health benefits of pomegranates, a scientific research program whose scope, Mr. Six says, is "unmatched in the food and beverage industry." By 2012, the Resnicks said in a legal brief, they had invested more than $35-million in pomegranate-related research and had 70 studies published in peer-reviewed journals. They relied mainly on the results of a handful of those studies to support their assertions about Pom’s benefits for people with heart disease, prostate cancer, and erectile dysfunction. The FTC faulted studies on Pom products conducted at UCLA and other institutions for, among other things, lacking a placebo control group, not having statistically significant results, or not measuring a meaningful outcome for a disease. A 2004 ad for Pom said the company was working with top scientists, "including a Nobel laureate," on research with "heartening results." The laureate, Louis J. Ignarro, was a professor of pharmacology at UCLA from 1985 until his retirement last June. Like a number of the scientists who did research for the Resnicks at the university, Mr. Ignarro played another role with Pom or a sister company. In research papers on antioxidants in pomegranate products published in 2005 and 2006, he disclosed that he was a consultant for Pom Wonderful. That work, he said via e-mail, was unpaid. Another UCLA scientist who has played more than one role with the Resnicks’ companies is David Heber, an emeritus professor of medicine and public health, and founding director of the UCLA Center for Human Nutrition. He is on the Pistachio Health Scientific Advisory Board for Paramount Farms, a Roll Global company. He said in an email message that he is paid an annual honorarium of $2,500 for that role. Dr. Heber also participated in studies on Pom products and pistachios, was quoted in promotional materials for Pom, and served as one of the Resnicks’ expert witnesses. No one at UCLA Health Sciences agreed to be interviewed for this article, although a few researchers and Ms. Tate responded to questions by email. Complex Relationships A student group, United Students Against Sweatshops, has criticized scientists like Dr. Heber on its website for their ties with Pom. It has also focused on the link between the Resnicks and David T. Feinberg, president of the UCLA Health System and chief executive of the UCLA Hospital System. Last May in Maryland, several students from the organization confronted Dr. Feinberg as he stood on stage to give a speech at the national conference of the Society of Hospital Medicine. One of them read a letter objecting to his and UCLA’s financial relationship with Pom. In state disclosure forms, Dr. Feinberg, a psychiatrist, indicated that he received between $10,001 and $100,000 from the Stewart & Lynda Resnick Revocable Trust in 2010 and again in 2012, and more than $100,000 in 2011, for his role as a "consultant/adviser." Dr. Feinberg did not initially answer a question from The Chronicle about the nature of his work for the trust, but Mr. Six said via e-mail that, while Dr. Feinberg attended a few meetings on Pom's research program, his primary consulting role "is to provide strategic advice" on Aspect Imaging, a division of Roll Global that designs and manufactures compact MRI systems. Ms. Tate confirmed that Dr. Feinberg had been involved in at least one discussion about possible medical uses for the product, and perhaps other discussions. Dr. Feinberg said in an email that he takes "great care" to comply with all university rules that permit faculty members to be involved in outside professional activities and "would never engage in any activities that would affect or influence my responsibility to our physicians, nurses, staff, and, most of all, our patients." A scholar who studies medical conflicts of interest, Eric G. Campbell, says that when a university leader has such a relationship, ethicists would consider it an institutional conflict of interest. Mr. Campbell says that matters in this example because doctors recruit patients for studies from the health and hospital systems Dr. Feinberg oversees. "When an institution like UCLA has all these relationships, I would be very skeptical about research coming out of UCLA on that company’s products," says Mr. Campbell, a professor of medicine at Massachusetts General Hospital and Harvard University. "And that’s why I would suggest those research projects be overseen by an independent third party." Though patients in the UCLA systems Dr. Feinberg oversees are eligible to be recruited for studies, Ms. Tate says, the recruitment is overseen by UCLA institutional review boards. Power in a Name Pom's ads said its products were backed by more than $30-million in medical research at leading universities. Ms. Tate said the university’s financial records indicate that the Resnicks and their related foundations provided about $2.5-million for research by the university’s medical school during the past decade. Whether Pom ever had permission to cite the university’s studies in its marketing campaign over several years is unclear. Mr. Six says it did. Ms. Tate wrote in an email that the university was unable to find any record that it had granted Pom permission to use UCLA’s name and studies in its advertising. She said later that while the institution's policies prohibit the use of UCLA's name in marketing in a manner "that implies endorsement of a product," identifying the location or the researcher’s affiliation is not prohibited. The university does "not use a formulaic approach" to such issues and would review each case, she said. In briefs filed in the FTC case, the Resnicks knocked the FTC lawyers’ "humorless interpretation" of their ads, which feature hyperbolic titles like "Cheat Death," and said they had promoted Pom products as food, not medicine. The Resnicks also stood up for the rigors of the science, saying that "notwithstanding the enthusiasm" of the researchers, the couple had third parties "independently verify the results" to ensure accuracy. Mr. Six said the FTC was using Pom as a test case to hold food companies to pharmaceutical-research standards. If the government prevails, he wrote, "it will stifle health research across the entire industry" and deny consumers access to "emerging science on the potential health benefits of fruits and vegetables." A lawyer who represents many food-industry clients says he expects the opposite to happen: Clinical trials on food and food supplements will multiply, predicts James R. Prochnow, a partner in the Denver office of Greenberg Traurig LLP, as companies seek the evidence they need "to support existing health-related claims and to develop a sound scientific basis for new health-related claims." The Resnicks argue in their appeal that the types of clinical trials the FTC is demanding are too expensive, but it continues to finance research on human subjects, at UCLA and elsewhere. One of the lessons from the FTC case, says Mr. Prochnow, is that when scientists do their clinical trials for food and food supplements, "they’d better be really good." _______________________________________________ pen-l mailing list [email protected] https://lists.csuchico.edu/mailman/listinfo/pen-l
