Doctors eventually solved the mystery of why Brenda Kitrosser suffered from unrelenting pain after her back surgery at a University of California hospital in San Diego.
A UCSD surgeon had implanted experimental screws and other hardware into her back, promising this would relieve her pain. Instead the devices pressed on her nerves endlessly, according to a lawsuit she filed later.
It took longer to uncover some critical details that Dr. William Taylor, the surgeon, had not told the retired special education teacher or the university: He owned stock options worth hundreds of thousands of dollars in the company selling the spinal devices and had also collected six-figure annual fees from the same firm, the lawsuit said. Disclosure of such corporate payments is required by state law and university policy.
A lawyer for UCSD said Taylor did nothing wrong and denied that any patients were harmed. But the university last year paid Kitrosser $1.75 million to settle the case.
The controversy over Taylor’s undisclosed compensation is not an isolated case. The University of California has repeatedly failed to discipline medical professors who did not disclose payments from drugmakers and medical companies.
Last month, after UCLA paid $10 million to settle a lawsuit that centered on undisclosed corporate compensation, the non-profit group Consumer Watchdog called on state Attorney General Kamala Harris to investigate how widespread the unreported payments have become.
In a letter to Harris, the Santa Monica-based consumer group said that evidence presented in the case had shown that the university’s policies were “either inadequate or unenforced.”
“Patients in UC hospitals deserve the most reliable surgical devices and medication,” the group wrote, “and they shouldn’t be treated as subjects in expensive experiments.”
Officials at UCLA and UCI said they have recently increased efforts to make sure professors comply with the rules. UCLA doubled its compliance staff and hired a chief compliance officer. UCI’s chancellor directed all medical faculty to certify they were in compliance with reporting requirements and not engaging in unauthorized outside activities.
Those changes came after a series of undisclosed compensation cases involving professors from across the UC system. In each case, the professors who received the payments were involved in promoting or encouraging the use of a company’s product at the same time they were treating patients. In all the cases except one, it was people from outside the university who discovered the undisclosed payments.
• In a Los Angeles courtroom last month, Dr. Robert Pedowitz, the former chair of UCLA’s orthopedic surgery department, testified that administrators retaliated against him after he tried to get surgeons to report their corporate payments – including one doctor who said he had received $250,000 from a device maker for just 20 days of work. Just before closing arguments, UCLA agreed to pay Pedowitz $10 million to settle the case. The university said administrators did nothing wrong.
• At UC Irvine, Dr. Thomas Ahlering received more than $100,000 since 2002 from a company selling a surgical robot, but put most of that money in his nonprofit foundation without disclosing it, the Register reported last year. University officials say they have since required Ahlering to turn over $4,000 of that money to the school.
• An investigation by U.S. Sen. Charles Grassley in 2009 found that UCLA spinal surgeon Dr. Jeffrey Wang had failed to report almost a half million dollars in compensation he had received from several companies. UCLA officials say Wang was required to turn over an undisclosed portion of that to the university.
Although some of the professors were required to return a portion of their undisclosed pay to the university, it’s not clear whether the universities disciplined them in any other way.
In Oakland, UC administrators said they have an obligation to encourage faculty to work with companies to develop new medicines and medical devices that can help the public. And they pointed to the policies that the university has long had in place to require faculty to disclose payments.
“We also recognize that more can be done to increase transparency and oversight,” said Steve Montiel, a spokesperson at UC’s Office of the President, “and we are reviewing our policies to determine how best to achieve these goals.”
Consumer Watchdog has asked the state to consider having an independent agency, rather than the university, police the professors’ corporate work.
SURGEONS DECLARE MUTINY
The court case at UCLA involved claims that the orthopedic surgery department flouted the rules.
Pedowitz filed the lawsuit against UCLA in 2012, charging that administrators and faculty had tried to drive him out of the university after he blew the whistle on the unreported payments.
In court, Pedowitz recalled how professors in orthopedic surgery had mutinied after he told them they needed to report their corporate incomes. Two dozen surgeons signed a petition demanding he be let go.
UCLA had hired Pedowitz as the department’s new chair in 2009 – about the same time Sen. Grassley uncovered $460,000 in hidden corporate payments to one of its faculty members, Dr. Wang. Most of that money came from Medtronic, a device maker with a growing spinal hardware business.
Pedowitz said he soon discovered that other surgeons had also failed to report their payments, going back as far a decade. One of the professors, Dr. Arya Shamie, had received $250,000 from Medtronic.
“I was very concerned,” Pedowitz said. “If faculty members are getting money from companies, it can affect their choices when it comes to patient care.”
He said he had discussed his concerns with Dr. A. Eugene Washington, the dean of UCLA’s medical school.
“I thought I had the dean’s support,” he said. “But I came to learn that they actually didn’t want me to enforce the rules.”
Shamie testified in court that he didn’t report the money from Medtronic because the previous department chair had advised him and other surgeons not to disclose it.
One reason faculty members avoided reporting their corporate pay is that the university keeps part of the payments. The professors are paid as full-time employees and time spent working for companies takes away from their university hours.
Shamie testified that he received the money from Medtronic for consulting about a spinal device called the X-Stop, which he was using in patients. He had frequently spoken to doctors and the public about the device, detailing its benefits.
Shamie referred questions from the Register to the campus’ spokesman.
Steve Ritea, UCLA’s associate director of communications, said that Medtronic paid Shamie to train physicians. “Dr. Shamie has a unique teaching expertise which was highly sought after in 2008 when he was paid for his time,” Ritea said. “Neither patient care nor research were implicated or compromised.”
Ritea said UCLA officials decided that Shamie had properly handled the Medtronic money.
Wang now works at USC. He said in a court deposition in 2011 that UCLA officials had not disciplined him for failing to report the Medtronic payments, but had instead promoted him.
He declined to discuss the case further. “We’re not interested in commenting at this time,” his assistant told the Register.
Several patients have sued Wang and the university. They say they were injured after Wang used a Medtronic product called Infuse in a way that was not approved by federal regulators.
Infuse, a genetically-engineered bone graft substitute, has been found, in rare cases, to cause uncontrolled bone growth that leads to severe pain.
A Medtronic spokesperson said the company does not pay doctors to use its products. Instead the company pays certain physicians for their expertise, including for consulting on the development of products, to conduct clinical trials and to educate and train other doctors about its products.
UCLA officials say Pedowitz’s claims had been repeatedly investigated. Those probes found that neither the professors nor the administrators had broken any laws, they said, and that no patients were harmed.
“UCLA adheres to stringent ethical and procedural guidelines and will continue to do so,” Ritea said.
He said that UCLA had settled the case with Dr. Pedowitz “to end a prolonged conflict and permit UCLA Health Sciences to refocus on its primary missions of teaching, research, patient care and community engagement.”
CONCERNS ABOUT BIAS
The public looks to academics to provide a clear-eyed, independent view. But studies have found they can be influenced by corporate pay.
“We know accepting gifts and money from drug companies changes doctors’ behaviors,” said Eric Campbell, a professor at Harvard Medical School who has studied financial conflicts of interest. “That’s why the companies spend the money.”
Campbell offered a baseball analogy. Imagine a game between the Yankees and the Red Sox, he said, where in the preceding weeks, the Yankees had treated the umpires to lunch every day, where they talked about how to call strikes.
“No reasonable person would assume that scenario would not change what umpires do,” Campbell said.
The corporate money becomes an even greater concern, Campbell said, when the academics are leading clinical trials where they can make decisions that significantly change published results.
Both Shamie and Wang led research involving Medtronic products and published the results in scientific journals – work that Pedowitz said factored into his push to get the UCLA surgeons to disclose the payments.
“If the research is somehow tainted,” Pedowitz said, “it affects the behavior of physicians all over the world.”
Ritea said other professors had reviewed the two professors’ research and found no problems.
“Research is overseen by independent committees to ensure that activities meet the high standards patients should expect,” he added.
Some other universities have gone further to ensure professors disclose their corporate ties. For example, Stanford requires professors to list the companies they consult for on the university’s website.
ADMINISTRATORS’ CORPORATE JOBS
It’s not just UC professors who receive money from companies. Some university administrators – including those in charge of enforcing policies – also have lucrative side jobs with industry. That corporate work is allowed as long as it does not affect their ability to do their university jobs. But critics say that outside work may serve as a disincentive for administrators to enforce the rules.
Last month, University of Pittsburgh researchers questioned cases where a medical school’s dean sits on the board of a drug company in a report in the Journal of the American Medical Association.
The researchers mentioned drug and device maker Johnson & Johnson’s relationship with UCLA’s dean as well as 18 other companies that have appointed university leaders to corporate positions. The deans’ responsibilities to the companies could easily conflict with their university duties, the researchers said.
Washington, the dean of UCLA’s medical school, received $261,000 last year to sit on Johnson & Johnson’s board, according to the company’s public filings.
The practice of top university administrators accepting large stipends for sitting on a corporate board or as a corporate consultant is widespread, and is not limited to drug companies.
Marye Anne Fox, who was UCSD’s chancellor from 2004 to 2012, sat on several corporate boards, including that of W.R. Grace. The chemical giant has been repeatedly involved in high-profile environmental incidents, including toxic asbestos contamination that polluted the town of Libby, Montana.
At UCI, Chancellor Michael Drake received $24,000 in 2012 for sitting on the health policy advisory board of Gilead Sciences, a drug company. He received another $114,000 as a director of Bank of the West, his university disclosures show.
John Murray, a UCI spokesperson, said Drake’s outside compensation had no effect on his enforcement of the rules or on university operations. He noted that Drake, in August, had required all medical faculty to attest that they were following the rules on outside compensation.
University officials say such work by administrators can benefit both the school and the company. For example, Ritea said, Washington’s work for Johnson & Johnson provides the company with a perspective on the needs of physicians who treat patients, while giving him experience with top business leaders so he can better manage UCLA’s medical operations.
“Outside income should not in and of itself be a concern for patients or the general public,” Ritea said.
Campbell, the Harvard expert on medical ethics, said it would be OK for academic leaders to serve on corporate boards if they weren’t paid.
“I think they should do it free of charge,” he said. “That removes the conflict of interest.”
JURY VERDICT
The unsuccessful back surgery on Brenda Kitrosser, the retired teacher, ended up costing both the university where the doctor worked and the medical device maker he worked with.
Last year, a civil jury in San Diego Superior Court issued a verdict against NuVasive, finding that the company and UCSD’s Taylor had conspired to intentionally mislead patients considering spine surgery.
The jury ordered the company to pay $3.1 million to Kitrosser. A judge later ruled that the $1.75 million that UCSD had agreed to pay could offset the verdict against NuVasive. The company was also ordered to pay court costs. NuVasive has appealed the verdict.
Neither Taylor nor a NuVasive spokesperson responded to phone calls or emails seeking comment. Thomas Lotz, a lawyer who represents UCSD, said Taylor never got the chance to fully tell his story in court. Taylor has not exercised the stock options that were revealed by the lawsuits, he said.
UCSD settled the case, Lotz said, to avoid a lengthy legal fight.
Robert Vaage, Kitrosser’s lawyer, said he had repeatedly informed UCSD about Taylor’s failure to report the payments from NuVasive. “They haven’t punished him at all,” he said. “In fact, they’ve promoted him.”
Carr, the UCSD spokesperson, disputed that, but said she could not explain further because personnel matters must be kept private.
After the state Fair Political Practices Commission fined Taylor $12,000 in 2011 for failing to report his compensation from NuVasive as required by state law, UCSD officials called it “an administrative error.” They said then that they planned no further action against him, according to a report in The Guardian, the campus newspaper.
Dr. James Doty, a clinical professor at Stanford, testified that Kitrosser should not have had the surgery that Taylor performed in 2008 because she suffered from a high-degree of scoliosis, an abnormal curvature of the spine. Doty said that Taylor had an ethical duty to tell her about his financial relationship with NuVasive.
“It’s a big problem,” Vaage said of the large payments received by Taylor and other surgeons. “It’s something the public needs to know about.”
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