OR WAIT null SECS
A scandal-rocked Medical College of Georgia has announced tightened compliance controls for clinical studies in the wake of a 172-count indictment that charged two former professors with diverting more than $10 million in research funds. Richard L. Borison, M.D., the former chair of MCG's department of psychiatry and health behavior, and Bruce I. Diamond, Ph.D., once a professor in the department, were jailed in February.
A scandal-rocked Medical College of Georgia (MCG) has announced tightened compliance controls for clinical studies in the wake of a 172-count indictment that charged two former professors with diverting more than $10 million in research funds. Richard L. Borison, M.D., the former chair of MCG's department of psychiatry and health behavior, and Bruce I. Diamond, Ph.D., once a professor in the department, were jailed in February pending the posting of a $1 million bond each. Borison posted bond on March 5 after spending 10 days behind bars; Diamond remained incarcerated at the time this article was filed.
The charges stem from claims that the pair spent the last eight years conducting over 100 research projects for more than 20 pharmaceutical companies using MCG resources, but then pocketing the proceeds. The alleged scheme began to unravel during the last week of May 1996, according to MCG officials, after a whistleblower complained about irregularities in the medical management of research subjects. The study coordinator who raised the red flag, however, didn't even know they were working for research enterprises that weren't a part of MCG.
Within three days after MCG officials began asking questions about Borison and Diamond's operations, both researchers resigned their positions and refused to cooperate with an internal investigation, according to Malcolm Kling, Ph.D., a pharmacologist and MCG's interim vice-president of research. The Augusta-based medical school, one of the oldest in the country, then notified the attorney general's office, the U.S. Food and Drug Administration, other federal regulators and the pharmaceutical companies about the irregularities.
In a prepared statement, school officials said that they were initially "appalled by the conduct of these two former faculty members." But as the internal investigation proceeded "the initial reaction changed to frank anger as the extent of the allegations of misconduct became more apparent."
The 3-inch thick indictment chronicles a history of alleged misconduct dating back to 1988. The grand jurors charged that Borison and Diamond "developed and executed a scheme through which they systematically stole in excess of $10 million from the Medical College of Georgia," and that they "routinely lied to conceal their crimes and endangered the safety of the patients and study participants they were employed to serve, protect and heal."
Borison and Diamond conducted research into a broad spectrum of mental illnesses including Alzheimer's disease, schizophrenia, anxiety and depression, and they contracted with pharmaceutical companies throughout the United States and abroad. Their research included clinical trials for drugs such as olanzapine, Eli Lilly's new schizophrenia treatment, and Janssen Pharmaceutica's risperidone. A Medline search revealed that Borison and Diamond published more than 20 articles since 1988.
But the indictment, coming after months of painstaking investigation, charges that Borison and Diamond's national reputations were built upon a foundation of theft, false statements and representations, prescription forgeries, violations of controlled substances laws, income tax evasion, reckless conduct in the providing of medical care, bribery and racketeering. In addition to the criminal indictment, the Georgia attorney general has also brought a civil forfeiture suit against Borison and Diamond, claiming that millions of dollars in assets located in three states and London, England, are in actuality the fruits of their alleged illegal activities. A receiver appointed in the case has taken control of assets that include bank accounts, real estate, antiques and art work.
Michael Hobbs, counsel to Attorney General Michael Bowers, told Psychiatric Times that it could be a year before the criminal trial begins. Although he declined to comment on the merits of the case, other than to refer to allegations in the indictment, Hobbs said that the state will seek to prove that this is not just a case about financial misfeasance, but also one that involves patient safety.
"There are a number of allegations in the indictment concerning the use of untrained, undertrained, inadequately trained, or improperly trained clerical personnel to perform some of the procedures that were necessary in conducting the studies, such as drawing blood," Hobbs said. "There is some indication in the indictment of inattentiveness on the part of Dr. Borison and Dr. Diamond to subjects in the studies who had suffered from a serious, adverse event and were not seen or followed up with by Borison or Diamond."
A bribery count in the indictment alleges that Borison and Diamond paid an undisclosed sum to an MCG employee in exchange for her not filing a complaint regarding a patient suicide that occurred during a clinical study of olanzapine. A spokesperson for Eli Lilly and Co., the drug's manufacturer, said that despite the allegations of financial misfeasance against Borison and Diamond, they are confident that none of the data provided was compromised in any way. Following the pair's resignation from MCG, Lilly arranged for new principal investigators to take over ongoing trials.
According to Hobbs, he has no evidence, "one way or the other," that data provided to any of the pharmaceutical firms was falsified, fabricated or plagiarized, although an FDA investigation is underway. A spokesperson for the agency refused to comment on the status of their inquiry while it is pending.
Meanwhile, Jay Sawilowsky, an Augusta attorney representing Borison and Diamond in connection with the civil forfeiture suit and the FDA audit, and who is consulting with respect to their criminal defense, denies that his clients were involved in any improper conduct. Rather he says the case is a dispute over money and who is entitled to the wealth generated by Borison and Diamond's research. He lashed out at MCG's leadership, calling it "maladministration," and charged that school officials will have some explaining of their own to do when the business arrangements involving the research are "finally hashed out in court."
"They are not accused of any plagiarism; they're not accused of faking data...," Sawilowsky said. "When you get down to what is the dispute between them, the doctors and the medical college, it is about a dispute over money, money, money. That's what it's about."
Sawilowsky accused the attorney general's office of turning the situation into a media circus, and filed a motion in the civil suit to prevent further disclosures of the identities of psychiatric patients involved in research programs. The indictment named the psychiatric patients in conjunction with forged prescription allegations, individuals who were then deluged by media requests for interviews after the charges became public. The motion to restrain further disclosures was denied, though Sawilowsky claimed that the attorney general's office promised the judge there would be no further disclosures unless absolutely necessary.
"The torment to these psychiatric patients who have been publicly exposed is terrible," Sawilowsky said. "I accuse the staff of the attorney general's office of being completely indifferent to the welfare of the patients. Of being completely unconcerned about harm to the patients."
Jill P. Hauenstein, M.D., president of the Georgia Psychiatric Physicians Association (GPPA), and an associate clinical professor at MCG, agreed that the disclosure of confidential patient identities by the attorney general's office was inappropriate and could have been handled more sensitively. "Confidentiality is the cornerstone of the psychiatric doctor-patient relationship, and to violate that is [to violate] one of the most basic trusts that a patient has. This was not done by Dr. Borison or Dr. Diamond or their attorneys, it was done by the attorney general's office."
Efforts by the GPPA's legislative consultant to sensitize the attorney general's office to confidentiality issues has thus far not resulted in any assurances that any changes will take place. In a letter from Attorney General Michael Bowers, the GPPA was told that while he is concerned about confidentiality, the disclosures were necessary in order to ensure the indictment passed legal muster.
Meanwhile, MCG's Kling said that the school is instituting changes to assure better controls over research contracts and the investigators who enter into them. "We will be doing things after the barn door was left open and the horse is long gone, but we'll keep the next horse from getting out," he said.
Already, a new Office of Clinical Trials Compliance will monitor all research contracts, and manage their compliance with "federal, state and local regulations and policies to protect the research subjects and the interests of the university," according to an MCG announcement.
In addition Kling said that audit controls would be tightened so that issues like the ones that arose in connection with Borison and Diamond's research project would be discovered sooner. For instance, no one noticed when research projects by the two former faculty members dropped off precipitously. Some of the research was performed literally across the street from MCG's campus using the medical school's employees, but no one caught on for years, Kling said.
"The way we manage our studies and we manage the flow of money and we manage contracts, they're handled through different offices," Kling said. "...We didn't know where they were working. Why didn't we know where they were working? We're going to take a look at that process. Why didn't someone hold up some red flags, and say 'look at this?'"
Finding answers to these questions will occupy the medical school for some time, Kling added. Thus far, there are no indications that irregularities in the management of research contracts will surface in other departments, though efforts are underway to ascertain whether problems exist elsewhere in the medical school.