Blockbuster revelations made to a U.S. Senate investigation committee paints a bleak picture of the integrity of the medical devices industry. This is an industry that appears to be motivated by greed and success at the ultimate expense of patient safety. Specifically, it was said 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 was also alleged that serious risks were downplayed and benefits overstated by Medtronic. The company has disputed 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 U.S. Food and Drug Administration 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 the testimony heard by U.S. 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 appeared before an FDA advisory panel in January 2002 and spoke glowingly about Infuse. 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. But it was revealed that Dr. Matthews had been paid by Medtronic a year prior, under a consulting arrangement. It was also alleged the speech Dr. Matthews made to the advisory panel was crafted with the help of a New York public relations firm paid by Medtronic for the work. Dr. Matthews was eventually hired in 2007 by Medtronic as the manufacturer’s president of medical and clinical affairs.
There were other allegations that, if true, are most serious and damaging to Medtronic. 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 of 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. One reviewer noted: “This manuscript is full of biased statements that are a reflection of the data evaluators–the company that markets the product.”
In another 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 gotten the company in deep trouble. Several patients have suffered as a result.
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 clearly illegal for manufacturers to promote such uses. It may be an understatement to say that Medtronic didn’t fare well at the Senate hearing. Dr. Harlan Krumholz, a professor of medicine at Yale University, had this to say:
It’s no wonder the public has lost confidence in the drug and device industries. 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.
Hopefully, Congress will take action on this issue. Based on our experience in litigation with the drug and medical device industries, I believe Dr. Krumholz is absolutely correct. The public should be outraged to learn how these industries operate. Clearly folks are losing confidence in the FDA when it comes to its regulation of the drug and medical device industries. There must be some changes at the FDA, and Congress must make sure the agency does its job. But that will require breaking loose from the powerful lobbyists who represent these industries.
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