In the latest installment of the Milwaukee Journal Sentinel’s excellent “Side Effects” series, reporter John Fauber raises serious questions about how data was presented in a 2009 study of a Medtronic spine-surgery product — one the company hopes to bring on the market soon — called Amplify.
The article also underscores why there is a growing public outcry about medical papers written by physician-researchers with financial conflicts of interest.
And it illustrates why political efforts to speed up the Food and Drug Administration’s approval process for medical devices may be misguided.
“Doctors paid millions of dollars by Medtronic failed to identify a significant cancer risk with the company’s spine surgery product [Amplify] in a 2009 paper about results of a large clinical trial.
“The surgeons left out important data and claimed there was no significant link between the product and cancer.
“The company and doctors had become aware of information on an additional cancer case, which pushed the concern to a critical level, at least two months before the paper was published, a Journal Sentinel/MedPage Today investigation found. Independent researchers say they had an ethical duty to report the cancer risk.
“The breach is the latest conflict-of-interest controversy facing Medtronic, which is under investigation by a U.S. Senate committee and the U.S. Justice Department for its marketing of the spine surgery product known as bone morphogenetic protein-2, or BMP-2.”
Amplify is the second BMP-2 product developed by Medtronic. The company hopes Amplify will soon win Food and Drug Administration (FDA) approval for use in spinal fusion surgery. But FDA reviewers have expressed serious concerns about the product’s cancer risk.
Medtronic’s other BMP-2 product, Infuse, has been used in spinal fusion surgeries since 2002. Recently, however, serious questions have been raised about the research that brought it to market. As I reported in Second Opinion last June, the editors of one medical journal took the remarkable step of devoting an entire issue to a series of scathing reports of how 13 Medtronic-funded studies (and their physician authors) misled the medical community — and the public — about Infuse’s side effects.
A matter of timing
In its defense of the Amplify study, Medtronic told Fauber that the additional cancer case that occurred — the one that would have forced the authors of the paper to report that the study had found a statistically significant increase in cancers among the product’s users — wasn’t discovered until after the paper had been accepted for publication in the Journal of Bone & Joint Surgery.
Medtronic refused to provide Fauber with the date at which the additional case was discovered. But the Medtronic spokesperson did tell him that the company reported the case to the FDA in April 2009.
That was two months before the Amplify study was published, a date that should have allowed the study’s authors time to revise their conclusions.
A spokesperson for the Journal of Bone & Joint Surgery wouldn’t comment specifically to Fauber about the Amplify study, but she told the reporter that authors have an ethical obligation to report the complete facts of any research.
The pressure to be positive
“How can two such starkly different pictures of a medical product be presented — one in the published medical literature that doctors read, the other in FDA records that many doctors never see?” asks Fauber.
‘Papers about company-funded research are more likely to present positive results and gloss over a potential complication, said George Lundberg, the former editor-in-chief of JAMA, the Journal of the American Medical Association.
“’The authors by virtue of how little attention they paid to it, … they didn’t want it to be there,’ he said. ‘And the company especially didn’t want it to be there — out where everybody would see it. They also knew that nobody much reads the FDA reports.’”
You can read the Journal-Sentinel’s entire investigative piece on the Amplify study on the newspaper’s website.