Wednesday, December 20, 2006

Conflicts of Interest: All in the Family

In the last week two stories surfaced about conflicts of interest within health care organizations that involved family ties.

The St Jude Sales Representative and the Jackson Memorial Chief Cardiologist

The first one was in the Miami Herald. The basic elements were as follows. Monica Rodriguez was a representative first for Medtronic, specializing in implantable cardiac devices. She had been a patient of Dr Alberto Interian Jr, who was interim chief of cardiology at Jackson Memorial Hospital, a major teaching hospital for the University of Miami. Rodriguez had listed Interian "as a recommendation on her application to Medtronic." Rodriguez quit Medtronic in May, 2004. " That summer, Interian and Rodriguez say, they began seeing each other socially." Interian first urged Medtronic to re-hire Rodriguez, then urged Guidant to hire her. Finally, she took a job with St. Jude Medical. Then, suddenly, sales of St. Jude devices to Jackson Memorial increased. "In the final four months of 2004, Jackson paid $499,145 to Medtronic, $405,750 to Guidant and $166,000 to St. Jude. That changed. Starting in February 2005, St. Jude sales led the other two for the next six months. In 2005, investigators say, St. Jude's sales at Jackson increased about $2 million. Medtronic's fell about $2 million at Jackson and about $1.8 million at the VA hospital. Guidant didn't offer figures but said sales fell."

Soon, Rodriguez and Interian's ongoing relationship was revealed. A Medtronic manager "received a call from a sales rep who handled Medtronics accounts at Jackson: 'She was incensed. She . . . said they were dating. She said, `We are going to lose our shirt.' . . . She started losing business right away.'' Then, "In June 2005, anonymous letters faxed to UM President Donna Shalala and Jackson chief executive Marvin O'Quinn revealed the romance and the shift of sales to St. Jude."

Then, "On Aug. 16, UM's internal audit department decided there was ''at the very least, a possible perception of conflict of interest.' The UM report indicated Interian said 'it's a coincidence that he's come to view [St. Jude] as better since he started dating her.'" Apparently, Interian and Rodriguez decided she should stop working at Jackson Memorial. However, her departure was delayed. "On Nov. 17, Interian's boss, Laurence B. Gardner, fired off a heated e-mail to Interian: 'Al, the board of trustees has told me your 'friend' still has Jackson. I would remind you that is exactly the opposite [of what] you told me.''' Then Interian was fired as interim chief of cardiology. "Eventually, Rodriguez left Jackson but kept working at Mercy Hospital, where Interian operates under a contract as medical director of the Arrythmia/Syncope Center. In April, ethics investigators Karl Ross and Kennedy Rosario submitted a report noting that taxpayer dollars had been spent at Jackson and that the county code states no person 'shall use or attempt to use his official position to secure special privileges or exemptions for himself or others.' The report concluded that the 'primary beneficiary' of St. Jude's rise in sales was Rodriguez, who earned more than $100,000 from sales to Interian's department at Jackson alone, along with tens of thousands at other hospitals where he worked."

The FDA Manager and the Platinum Solutions Advisory Board Member

The second story comes from the Los Angeles Times. Margaret "Margo" Burnette was a senior manager at the US Food and Drug Administration (FDA). She was in charge of developing a new data system to handle industry applications for medical products. She was working with a contractor called ProObject Inc. to develop the system. In April, 2004, Burnette married Mark A Boster. "That same month Burnette was promoted to information-technology director. A top FDA official praised her as a 'very successful leader.' Boster, who was working full-time with another technology contractor, joined Platinum Solutions [Inc.] ' advisory board about then. He was paid a retainer and fees for attending meetings, he said." At about the same time, "Burnette was making no secret within the FDA of her displeasure with ProObject." The agency did not obtain a satisfactory replacement through the competitive bidding process. "At that point Burnette conferred with her husband and steered her deputy, James Shugars, to contact Platinum Solutions." Then, "Once Platinum Solutions was aboard, Burnette said, she assigned Shugars to handle 'contract issues' directly with the company. Shugars briefed her regularly, she said. [Burnette's supervisor James J] Rinaldi said that Shugars voiced concerns to him and was 'very, very nervous' about managing the data project while reporting to Burnette. I think he was concerned about just the overall conflict of interest,' said Rinaldi, now chief information officer at the federal Jet Propulsion Laboratory in La Cañada Flintridge. 'Obviously that was because of the spouse.' Rinaldi confirmed that the FDA awarded the initial contract to Platinum Solutions without competition, a move that hinged on the company's special status as a disadvantaged business."

"In June 2005, Burnette said she relinquished any role with the data project because about two months earlier her husband had become a full-time executive with Platinum Solutions. In addition to salary, Boster's new position placed him in line for extra pay when the company's revenue increased, he said. 'Since he was actually working there as the chief operating officer, the perception would have been just too bad,' Burnette said. 'It would have appeared that I would have had some influence.' This year, the FDA sought competitive proposals for the completion of its data system. On Nov. 27, Platinum Solutions said that it won the contract. Although Burnette said she no longer oversees the project, she helps shape technology priorities from the FDA commissioner's office. Her husband said that he was in charge of Platinum Solutions' performance on all ongoing contracts, including with the FDA."

There is no report yet of any official response by the FDA to all this.

Comments

It seems that if we search, we may find every possible species of conflict of interest affecting large health care organizations. It also appears that organizations that have issues with any one type of conflict are likely to have issues with other types. For example, we previously posted about apparently major conflicts of interest affecting the President of the University of Miami, Jackson Memorial's parent university. And we very recently posted about conflicts of interest affecting members of FDA scientific advisory panels.

One wonders how practicing physicians and other health professionals in the trenches, much less the public at large would react if all such conflicts were fully disclosed.

The pervasive web of conflicts that spans many of the large organizations that now dominate health care suggest that much of the health care system may operate more for the private benefit of its insiders than to actually improve the health of the public.

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