Medtronic Manipulated Bone Product Data, Senators Say

Medtronic Inc. (MDT) ghost-wrote sections of medical papers and paid physician authors hundreds of millions of dollars in “consulting fees” to promote its bone- growth product Infuse, a U.S. Senate investigation found.Medtronic, the world’s biggest maker of heart-rhythm devices, helped write, edit and shape at least 11 medical journal articles about the product, which is used to spur bone growth after spinal surgery, according to report released today by the Senate Finance Committee.The doctors and researchers who were the authors of the studies were part of a $210 million consulting and royalty payments program by Minneapolis-based Medtronic and never disclosed their ties or the company’s influence in their papers, the panel said in its report.
“Medtronic’s actions violate the trust patients have in their medical care,” Senator Max Baucus, a Montana Democrat and committee chairman, said in a statement. “Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has.”
Study ResultsSales of Infuse plunged after The Spine Journal published studies in May 2011 and June 2011 showing the genetically engineered protein raised the risk of infertility, infections and cancer. Revenue from the product was $195 million in the three months ended in January 2011 and fell to $141 million in the three months ended July 27, the company reported.The report is likely to be “a public relations nightmare” for Medtronic at the North American Spine Society meeting taking place now in Dallas, said Glenn Novarro, an analyst for RBC Capital Markets in New York, in a note to investors. While Infuse’s sales decline may be bottoming out, the report may push surgeons to further cut back their use, he said.Overall, Infuse represents 2 percent to 2.5 percent of Medtronic’s equity value, he estimated.Medtronic rose less than 1 percent to $41.88 at 4 p.m. New York time. The shares have gained 24 percent in the past 12 months.
“Medtronic was involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants who received significant amounts of money through royalties and consulting fees from Medtronic,” Baucus and Senator Charles Grassley, an Iowa Republican, said in a statement. Part of that influence was inserting language into on e study that emphasized  the pain caused by a competing technique to Infuse, the senators said.
2002 Approval
Infuse was approved in 2002 for use in fusing damaged vertebrae in the lower spine. It has never been approved for the upper, or cervical spine, where it is now widely used. The Food and Drug Administration warned surgeons not to use the product on the cervical spine in July 2008 after learning of complications in dozens of patients that included trouble breathing and eating.More than 140,000 spinal fusion surgeries were performed with Infuse in 2009, according to the Agency for Healthcare Research and Quality. Of those, only 21,240 were done using the product with a technique that’s approved by regulators, bolstering the contention that more than 85 percent of Infuse’s use is in patients who aren’t formally cleared to receive it, the senators said in the report.
Medtronic Rejects
Medtronic rejected many of the report’s findings.
“In particular, 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,” the company said in a statement. It also said the payments to doctors were part of a royalties program, not consulting fees.The Department of Justice and the Office of the U.S. Attorney in Boston conducted a four-year investigation of the company’s handling of Infuse marketing and closed the case in May without any finding, the company said.The Senate panel, as part of a 16-month probe, said it reviewed 5,000 documents collected from the company, including records that detailed payments to the doctors who conducted research on Infuse. The researchers were aware of the products risks and failed to disclose them, the committee, which has jurisdiction over the government health programs Medicare and Medicaid, said in its report.
Side Effects
Thirteen clinical trials funded by Medtronic reported no side effects from Infuse, while data provided to the FDA showed as many as half of patients had complications including infections, pain, cysts and cancer. The analysis, which sparked the Senate panel’s investigation, was published in The Spine Journal in June 2011.
The original reviewers believed there was a bias in the original studies that had favorable results for Infuse. After being assured that the data was correct and verified by three independent researchers, the journal published the work and didn’t elaborate on the potential financial conflicts, the report found.Two of the “independent reviewers” received compensation from Medtronic, with one getting $7.8 million and the other $722,000, the committee’s investigation found.
Possible Retraction
The spine journal may send out the studies it published to an independent reviewing group to help determine if a retraction is necessary, Eugene Carragee, chief of spinal surgery at Stanford School of Medicine in Palo Alto, California, and editor-in-chief of The Spine Journal, said in an interview before the report was published. “The devil is in the details,” he said.Harlan Krumholz, a Yale University professor of internal medicine, epidemiology and public health, is conducting an independent analysis of Medtronic’s Infuse data funded by a $2.5 million grant from the company. The grant also will pay to create a database of any patient risks.
“Sometimes what you are reading about in a study may not be everything,” Krumholz said in an interview before the Senate committee’s report was released. “We have to change the way this kind of science has been conducted.”
Source:Michelle Fay Cortez and Drew Armstrong.http://www.businessweek.com