Reporting Chris Simon
WASHINGTON (WCCO) – A Senate report out Thursday concludes Minneapolis-based Medtronic helped write and edit medical journal articles attributed to outside physicians which downplayed the risks of InFuse, the company’s best-selling bone graft, responsible for $800 million in annual sales.
Medtronic vigorously denies it improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events. However Steven Miles, professor for bioethics at the University of Minnesota, says such practices are endemic in an industry with very little oversight.
“At some point, what we are going to have to do is as a country is require that all raw data from every study to be public data so that re-analysis of every claim that is made can be fairly evaluated,” Miles said.
Such ghostwriting has been condemned as a breach of integrity and transparency because doctors and patients rely on information in those articles to make medical decisions. Miles says it is not unusual nor is it wrong under current practice for universities to accept grants from companies in exchange for studying the effects of medicines and medical devices, but Medtronic is accused of going a step further by co-authoring the critiques, and using the universities as mere “rubber stamps.”
“The universities should be giving the companies a fair and balanced science, because that is what the companies are paying for. But what they are doing is using the universities to obtain a Good Housekeeping seal of approval, while in fact we are not getting the correct data out,” Miles said.
The Senate Finance Committee says Medtronic did not disclose its role in shaping the articles, which helped turn the InFuse bone graft into an $800 million per year product.
Senate investigators also say Medtronic did not disclose $210 million paid to the authors for unrelated consulting work over 15 years.