Senate Investigation Reveals That Millions Were Paid
for Positive Spin on Spine Fusion Product
SOURCE: MedPage Today ~ October 25, 2012
By John Fauber
Milwaukee Journal Sentinel and MedPage Today
Highly positive studies, published in peer-reviewed medical journals, depicted Medtronic’s spine fusion product as a major breakthrough in back surgery, but those studies were drafted and edited with direct input from Medtronic employees, while the doctors listed as authors were paid millions, according to a U.S. Senate investigation.
The company’s heavy, undisclosed manipulation of information about its bone morphogenetic protein-2 product called Infuse included removing and downplaying concerns about serious complications linked to the product and overstating its benefits.
The Money Trail
Over the course of 15 years, Medtronic paid $210 million to a group of 13 doctors who co-authored the series of now-repudiated papers about the product. The payments also included two corporate entities associated with some of the doctors.
The investigation by Senate Committee on Finance was prompted in part by Journal Sentinel/MedPage Today investigations that showed how the practice of medicine has been corrupted by conflicts of interest involving doctors, drug and device companies and medical journals.
The Senate report, to be released Thursday, details how Medtronic employees, including some working in the company’s marketing department, covertly collaborated with the academic physician authors in producing 11 different papers between 2002 and 2009.
Such “ghostwriting,” though not illegal, has been condemned as a breach of integrity and transparency because doctors and patients rely on information in those articles to make medical decisions, not knowing that the papers may contain biased, inaccurate or potentially harmful information.
The Senate’s findings highlight problems that should have been reported as at least a decade ago, said Ray Baker, MD, a Kirkland, Wash., pain specialist who served on an advisory panel to Medicare and Medicaid on Infuse.
“I am just sad this happened,” he said. “At every level when we thought, ‘that wouldn’t happen,’ it happened. The integrity of our scientific literature is our foundation. It’s what predicates our treatments.”
Medtronic disputed many of the findings in the Senate’s report.
“Medtronic vigorously disagrees with any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events,” a statement emailed by the company said.
The company said it reported the adverse events to the Food and Drug Administration and those risks also are listed the product label for Infuse. Medtronic also called the report’s characterization of the payments to the doctors misleading and unfair.
“The vast majority of such payments were royalty payments made to compensate physicians for their intellectual property rights and contributions, not consulting payments,” the company said.
In 2011, after the Spine Journal devoted an entire issue to repudiating Infuse research, the company, under its new CEO, Omar Ishrak, hired Yale University to oversee an independent review of the safety and effectiveness of Infuse.
“This sounds eerily familiar to many of the transgressions we’ve read about from the pharmaceutical industry,” said Harlan Krumholz, MD, a professor of medicine at Yale University, when told of the Senate report. “It paints a picture of a company very heavily involved in the science; marketing contaminating the science; and the medical profession and researchers being complicit.
The Public Trust
“It’s no wonder the public has lost confidence in the drug and device industries.”
Krumholz is overseeing Yale’s review of Infuse. Those results are expected in January.
Medtronic’s behavior also drew sharp criticism from two key senators on the committee.
“Medtronic’s actions violate the trust patients have in their medical care,” Sen. Max Baucus, (D-Mont.), chairman of the committee, said in a statement. “Patients everywhere will be better served by a more open, honest system without this kind of collusion.”
Senior member Chuck Grassley (R-Iowa) said the findings support the Physician Payments Sunshine Act that he and Sen. Herb Kohl (D-Wis.) authored. That legislation will require drug and device companies to disclose such payments beginning next year.
“The findings also should prompt medical journals to take a very proactive approach…,” Grassley said in a statement. “…The public will benefit from more transparency and accountability on their part.”
In response to the Senate investigation, Medtronic turned over more than 5,000 documents, including emails involving the doctors and Medtronic employees as well as 14 years of payments from Medtronic to the doctors.
The Infuse Story
In January 2002, Hal Mathews, MD, spoke glowingly about Infuse to a FDA advisory panel that was considering whether to recommend approval of the product.
Mathews, then a Richmond, Va., spine surgeon who had taken part in the pivotal Infuse clinical trial, told the panel he had no direct financial interest in the product and that he was not being paid to appear at the meeting.
However, a 2001 email shows that Medtronic worked with the New York-based public relations firm, Ketchum, to prepare Mathews’ speech to the panel, which went on to recommend approval of the product.
In addition, though Medtronic told the committee that Mathews was not paid for any activity undertaken in January 2002, Mathews was paid under consulting arrangements with the company in 2001.
In 2007, Mathews was hired by Medtronic as its vice president of medical and clinical affairs.