When You Must Report Misconduct

Image: Anne MacNamara Cherlynn Mathias agonized over whether to report her allegations of scientific misconduct to the government and sought help from her parish priest. She still recalls the image of the church's art deco rectory, where she told the priest what she had learned about the ethics of research during her year at the University of Oklahoma (OU) in Tulsa and about her fear of retribution should she report the wrongdoing. At the end of the day, the priest asked, "What's the worst they could do to you?" She replied, "I could lose my job, lose my license, become bankrupt, lose my home." "And if you don't turn them in?" "I can't live with myself," she said. A week later, Mathias sent documents titled "Allegations of Misconduct" to the US Department of Health and Human Service's Office for Human Research Protections (OHRP). She had linked alleged wrongdoing by Michael McGee, the primary investigator of a melanoma vaccine trial based at OU's Health Science Center in Tulsa, to the Institutional Review Board (IRB), and to the institution itself. She also sent documentation of improper production and safety testing of the vaccine, improper monitoring of patients, and overstatement of the treatment benefits. The subsequent fallout brought national attention as the university's federally funded medical research trials were temporarily shut down. McGee was fired, the head of the IRB retired, and both the dean and director of research at the Tulsa campus were forced to resign. Mathias, who testified before the US Senate this past April, would never again work at OU. Nevertheless, how she blew the whistle and survived provides insight into the perils and potential benefits of reporting on wrongdoing. RISKING REPORTS Last month, research institutions reported the highest incidence of misconduct activity since 1997, according to the Office of Research Integrity (ORI).1 In 2001, sixty-one institutions opened 72 new cases to investigate 127 allegations. The previous high mark had been 60 institutions reporting 103 allegations. Chris B. Pascal, director of the ORI, attributes the rise to institutions' growing sophistication, and to the heightened awareness of scientific misconduct, rather than to an actual increase in incidences of wrongdoing. The government relies a great deal on whistleblowers in identifying and stopping such misconduct, according to Peter Poon, who is responsible for overseeing potential research misconduct at the Veterans Administration. "The whistleblower occupies a vital role in ensuring the ethical conduct of research," Poon says. "However, the scientific community maintains an ambivalent attitude toward the whistleblower." Whistleblowing is a risky activity. Thomas Devine, legal director for the Government Accountability Project, says whistleblowers should expect some reprisal. The ORI, part of the US Department of Health and Human Services, found in a 1995 survey that more than two-thirds of whistleblowers to scientific misconduct experienced some sort of negative consequences for their actions. Retaliation can include marginalization, firings, loss of promotions, and even death threats. Those at the greatest risk for retaliation were academics with PhDs conducting research in the basic sciences as opposed to clinically oriented physician researchers. "Before sticking their necks out, whistleblowers should carefully plan a survival strategy," cautions Devine, "so that they are not reacting to bureaucratic harassment, but rather that the system is reacting to their charges." Mathias made no spur-of-the-moment decision, though she suspected research protocol violations from June 1999 when she began working in OU's surgery department. She observed improper enrollment of patients in clinical trials and inconsistent storage of the vaccine, which was manufactured by an assistant to McGee. "My knowledge was incremental," Matthias relates. "Not only my knowledge of what was wrong with the study, but also what the regulations were." Mathias immersed herself in the Food and Drug Administration's regulations concerning laboratory, manufacturing, and clinical practices. She educated herself on informed consent and protection of human subjects. As her knowledge increased, so did her certainty about the research misconduct. But still, she did not blow the whistle. In October 1999, Matthias contacted the OU's IRB, which oversees research on human subjects. Determined to work through the chain of command, Mathias met frequently with university officials over the next eight months, before she decided to take her allegations to the government. A STRATEGY OF CALM Composure and self-education can aid a would-be whistleblower, according to Pascal. "[My] advice for the whistleblower is stay calm and keep your head about you," Pascal says. But few whistleblowers carefully plan their actions. "Most of the people don't think about it because they only view it as telling the truth," says Don Soeken, a Maryland-based therapist who consults with whistleblowers. "Telling the truth, you don't need a book to do that, so they don't think about it." Additionally, few whistleblowers have any education about the process. Even when whistleblowers have knowledge, they may not avoid retaliation. Mathias was aware of the risks, she had extensive documentation, she had educated herself about the regulations, she had support from her priest, and she had attempted working within the system. But a year after she blew the whistle, Mathias found herself unemployed, depressed, and overwhelmed with legal fees. Mathias had not obtained legal advice before she contacted the OHRP, nor had she anticipated the swiftness of OU's disapproval. Mathias says that access to her building was denied, and she was placed on immediate administrative leave. "I had this fantasy that once the government got involved and Oklahoma City found out, they would realize I had done the right thing," Mathias relates. Obtaining early legal counsel can help whistleblowers avoid some problems with administrations and can acquaint them with federal and state statutes for the protection of whistleblowers, says Ann Lugbill, an Ohio attorney who specializes in such cases. A person can also face suits for defamation and contract violations. "One of the reasons ... to get a lawyer early on is because there are some things that you could do that would preclude [you] from bringing a law suit later," Lugbill says. "There are some things ... that might seem to be legal but aren't, such as violating trade-secret rules." Although federal regulations aim to prevent retaliation against whistleblowers, they do not allow a whistleblower to sue for reinstatement, damages, or back pay. "In those instances, the whistleblower's primary rights would be under the False Claims Act," said Devine, adding that false-claims cases are time consuming and laborious. "Scientific misconduct is in the statute." Mathias eventually reached a settlement with her employers. She decided not to pursue a more significant suit because she wanted to maintain the focus on the patients and not on herself as the wronged whistleblower. "I didn't see myself as a victim," she said. "I approached it as I knew what I was doing, took the consequences and made the best of it." Eventually Mathias was hired as the manager of clinical trials for Harris Methodist Hospital in Fort Worth. The job required her to move away from her two sons, who are finishing high school, and she now maintains two mortgages. But she does not regret her decision. "If [whistleblowers] look at it a little more as a third party, that this is the right thing to do for the scientific community," Pascal says, "then you make the allegation, you cooperate and provide the information that you can, but it is somebody else's responsibility to make the decision, not the whistleblower's." Mathias has counseled several potential whistleblowers. "You have to be willing to risk, and if you aren't willing to take the risk, then don't do it," she advises. She encourages potential whistleblowers to "document, document, document," and to exhaust their institution's procedures on reporting of misconduct. "Only go to the government as the last resort, and be willing to accept the consequences of your actions," she cautions. Soeken, who says he usually sees whistleblowers only after they have suffered consequences, advises others to maintain their anonymity for self-protection. "Truth and honesty cost too much," he says. "They should tell the truth, but they should do it in such a way that it gets done without endangering themselves. Saying all that, it does me no good to tell a whistleblower to not do it," he relates. "I go to bed at night and sleep nicely because I know that there are these people out there that are going to find all kinds of corruption and graft, and I've always said that they might save the world." Katherine Uraneck (kuraneck1@nyc.rr.com) is a physician and freelance writer in New York. 1. "Institutions Report Increased Misconduct Activity in 2001 Annual Reports," Office of Research Integrity Newsletter, 10:3, June 2002.

When You Must Report Misconduct

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