Database ignites COI discussion

For some modern doctors and researchers, work for outside pharmaceutical companies supplements traditional pay.

Companies invest significantly in hiring medical professionals for services ranging from speaking engagements to consulting.

ProPublica—a non-profit organization that conducts investigative journalism aimed at public interest—recently created a comprehensive database containing information about $282 million in payouts from seven pharmaceutical companies to doctors and researchers since 2009, including well-known companies like Eli Lilly, GlaxoSmithKline and Cephalon. North Carolina alone accounts for 3.41 percent of all industry payouts nationwide at $10,385,554.

But these relationships between medical staff and drug companies compel institutions like Duke University Health System to monitor the outside engagements of its faculty to ensure that their primary duties as Duke employees—treating patients and conducting research—come first.

The University requires faculty to disclose the existence of outside partnerships but does not prohibit employees from working for outside medical companies, said Dr. Ross McKinney, director of the Trent Center for Bioethics, Humanities and History of Medicine.

According to the Duke University School of Medicine Conflict of Interest Policy, faculty and staff have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure their activities do not interfere with their University obligations. The policy also states that those who may feel they have a conflict of interest must file a disclosure form with a dean or his designate.

“Industry relationships are very complicated,” McKinney said. “The intrinsic problem is that the relationship with industries could lead to bias. You want to be careful about what relationships people have if they engage in research or prescribe medications.”

McKinney added that too close of a relationship with a certain outside institution could lead to the overuse of a prescription drug or device by physicians. To monitor this tendency, Duke requires all medical faculty and staff to report each February any outside contracts, which are then reviewed.

Not necessarily “bad or wrong”

Conflicts of interest are not inherently bad, provided that doctors are transparent about their existence, said Wesley Byerly, associate dean for research services. For example, faculty who discover ground-breaking research or invent a new drug have a stake in the success of their own work. Similarly, a doctor can work for an outside company without letting it compromise patient care. Issues arise when there is a lack of “transparency” by physicians or researchers, he said.

“Conflict of interest is not bad or wrong,” Byerly said. “What we’re concerned about is when there is a conflict that is not known or that can’t be evaluated or managed in a way to ensure that it doesn’t appear to or actually influence their study [or practice].”

Byerly noted, though, that Duke is a leader in upholding its conflict of interest policy.

“We essentially have 100 percent reporting, which is almost unheard of,” he said. “Our faculty and staff are very good at letting us know what their relationships [with outside institutions] are.”

The annual review of conflict of interest reports is a multi-tiered process that begins with staff from the Conflict of Interest Office checking to make sure all of the appropriate information is present, Byerly said. The reports are then reviewed by McKinney, who decides if a certain case needs to be further reviewed by faculty on conflict of interest committees.

Striking a balance

For some doctors, successfully managing their primary responsibilities and outside work can be lucrative.

Dr. David Rizzieri, a doctor and associate professor for the medical school’s Cellular Therapy division, was reported by ProPublica as one of North Carolina’s top earners from outside institutions. From 2009 to 2010, Rizzieri received a total of $237,150 from Cephalon and $36,000 from GlaxoSmithKline—both outside pharmaceutical companies.

Rizzieri wrote in an e-mail that, at the request of a physician or nursing group, he gives educational presentations and promotional lectures relevant to his field of study, and he conducts research studies for treating leukemia or lymphomas with new agents in part developed by the companies themselves.

“My relationships with various companies have allowed me to reach out and meet with practitioners and health care providers all over our region,” Rizzieri said. “I benefit by gaining a better understanding of what their experiences are in treating these diseases and using these agents in community cancer centers. We are able to compare and contrast our experiences and see how treatment at a large medical center with a selected patient population may or may not reflect what happens in the community.”

Rizzieri said he discloses all of his outside partnerships with the University. Additionally, he limits the amount of activity and time away from Duke’s campus and avoids enrolling patients in or serving as a principal investigator for a study of a drug owned by companies he works for.

Rizzieri added that he thinks his patients are not negatively affected. In fact, properly managed relationships with pharmaceutical companies can benefit patients, he said.

Obstacles for medical companies

Medical companies must carefully choose doctors and researchers who will best represent them.

ProPublica recently alleged that a number of hired physicians and researchers have either been accused of professional misconduct or are not qualified to be consultants or specialists. The organization also claims that the seven companies within the database have paid $7.1 million to doctors or researchers who have previously faced disciplinary action or were guilty of other misconduct.

“When you look at the backgrounds [of physicians and researchers], in many cases, they don’t have research credentials, academic appointments or leadership positions in their field,” said Charles Ornstein, senior reporter for ProPublica.

Hiring the wrong researcher or doctor can expose medical companies to potential embarrassment. GlaxoSmithKline and Eli Lilly paid Dr. Anil Potti $6,000 and $92,644, respectively, in the previous two years, even after his genomics research began to be called into question in 2007. The cancer researcher has also since been accused of exaggerating his credentials on his resume and on grants for government funding. Potti resigned from Duke Nov. 19 and the process to retract two papers he co-authored began recently.

The publication of ProPublica’s comprehensive database has raised awareness among several health and pharmaceutical companies. Mary Anne Rhyne, director of U.S. Media Relations for GlaxoSmithKline, wrote in an e-mail that ProPublica’s series has raised issues that the company is currently investigating further.

Since the publication of the database, several physicians have questioned the relevancy of the gathered information to the public or their patients, Ornstein said, but he added that there has been support from other medical experts and consumers.

“I do expect companies will be taking additional steps to review the qualification of their consultants,” he said. “I think patients will be having conversations with their physicians that they didn’t have before.”


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