Medtronic Slammed by Infuse Testimony to US Senate Investigators

October 31, 2012, 2:00PM. By Gordon Gibb

Washington, DCBlockbuster revelations made to a US Senate investigation committee paints a bleak picture of the integrity of the medical devices industry, which appears motivated by greed and success at the ultimate expense of patient safety. Specifically, it is alleged that Medtronic helped control the content of published papers trumpeting the company's Infuse product, and paid doctors millions of dollars in fees in exchange for their co-authorship of papers. It is also alleged that serious risks were downplayed and benefits were overstated.

According to the Milwaukee Journal Sentinel (10/25/12) Medtronic disputes several findings in the report.

Infuse is a breakthrough product that was touted as revolutionizing spinal surgery. Rather than grafting bone from elsewhere in the human body, Infuse is a natural enzyme that fosters natural bone growth at the site. Infuse was granted approval by the US Food and Drug Administration (FDA) for certain procedures, but was not approved for others due to various concerns.

But even the very approval of Infuse is clouded in controversy, if testimony heard by US Senate investigators can be believed.

It was revealed at hearings conducted by the Senate Committee on Finance that even before Infuse was approved, a medical doctor presented to an FDA advisory panel and spoke glowingly about Infuse in January 2002. Dr. Hal Matthews, according to the report, spoke in the present tense that he had no financial interest in Infuse and was not being paid to attend the meeting.

However, it was revealed that Matthews had been paid by Medtronic a year prior, under a consulting arrangement. It was also alleged the speech Matthews made to the advisory panel was crafted with the help of a New York public relations firm paid by Medtronic for the work.

The Journal Sentinel reveals that Matthews was eventually hired by Medtronic as the manufacturer's president of medical and clinical affairs, in 2007.

There are other damning allegations. Senate investigators heard that no fewer than 13 doctors were paid a total of $210 million over a span of 15 years to help craft papers in support if Infuse—papers that have since been repudiated. One professional journal devoted an entire issue to the repudiation of papers that appeared to contain bias and marketing slants.

"This manuscript is full of biased statements that are a reflection of the data evaluators—the company that markets the product," one reviewer noted. In one case, the co-author of a paper that appeared in the Spine Journal in 2004 also served as a deputy editor and received $3.1 million in payments from Medtronic from 1998 through to 2010. It was revealed those payments were evenly split with the university that employed the doctor as chairman of the neurosurgery department.

While Infuse was approved for lumbar spine fusions "from the front" in 2002, various alleged attempts to promote, and use Infuse for unapproved uses has also not only landed the company in hot water, several patients have allegedly suffered as a result.

One of those patients is Patricia Caplinger, an emergency room nurse who has suffered from excess bone growth after Infuse was employed in her case for an allegedly unapproved use.

While doctors have always had the legal, moral, professional and ethical authority to supersede FDA recommendations and employ drugs and medical devices for unapproved uses, it is illegal for manufacturers to promote such uses. Caplinger's neck injury lawsuit claims that a Medtronic representative was present during her surgery and provided ongoing information about Infuse to the surgeon.

Caplinger is now incapacitated due to excessive bone growth. She has undergone several surgeries and will require additional procedures. "I live with pain every minute of every day," she told the Journal Sentinel. "I have forgotten what not being in pain feels like."

Medtronic is seeking to have her case dismissed.

"It's no wonder the public has lost confidence in the drug and device industries," said Harlan Krumholz, MD, a professor of medicine at Yale University, when told of the Senate report by the newspaper. "It paints a picture of a company very heavily involved in the science; marketing [and] contaminating the science; and the medical profession and researchers being complicit."