Overview: Medtronic sits at the center of ethical and legal controversy over its bone growth product Infuse, following a U.S Senate report showing that clinical studies funded by the company failed to mention serious side effects associated with the product. Furthermore, the investigation revealed that Medtronic had helped edit and manipulate studies in order to portray Infuse in a positive light. Meanwhile, doctors who were listed at authors in these medical journals were paid millions, although this information was never disclosed in any of the Infuse studies. The scandal raises serious questions about the integrity of Medtronic-funded research and the subsequent risks that Infuse patients have been potentially exposed to.
- A report by the United States Senate shows that Medtronic edited medical studies to hide the side effects of Infuse while overstating its benefits; doctors listed at authors were paid millions by Medtronic but this information was kept private
- The Senate investigation was fueled by a Spine Journal expose, which criticized Medtronic researchers for omitting side effects such as male sterility, cancer, excess bone growth and infection
- FDA reports and other documents show that Infuse patients experience complications 10 to 50 times more often than reported in the studies paid for by Medtronic.
Product: Medtronic Infuse Bone Graft
Manufacturer: Medtronic, Inc.
Side Effects & Complications
- Difficulty breathing, swallowing
- Uncontrolled bone growth
- Nerve injury
- Male sterility
- Retrograde ejaculation
Senate Report Shows Medtronic Researchers Made Millions while Failing to Report Complications
A report by the United States Senate Finance Committee showed that Medtronic had helps write and edit 11 studies promoting the use of Infuse while downplaying the risks. While the so-called “ghostwriting” is not illegal, it is a breach of integrity and is condemned as being highly unethical; this is because patients and doctors rely on this research to make decisions about their health, unaware that the studies may contain biased or harmful information. According to the Senate report, a group of 13 doctors received $210 million over the course of 15 years. Medtronic claims that these payments were made as royalties; the financial ties were never disclosed in any of the studies.
Medtronic Infuse Side Effects Omitted from Studies
Medtronic Infuse was approved in 2002 to help stimulate bone growth. Currently, it is only approved for use in the lower spine in procedures performed through the front of the body (anterior lumbar fusion). Still, data shows that the majority of procedures involving Infuse are used for off-label or unapproved, procedures. The U.S. Food and Drug Administration (FDA) warned in 2008 that using Infuse off-label in the cervical spine is linked to life threatening complications, such as swelling of the neck and throat and difficulty breathing.
Infuse gained even more notoriety last summer when the Spine Journal dedicated an entire issue questioning the integrity of clinical studies funded by Medtronic. Researchers found that studies funded by Medtronic failed to mention a number of potential side effects, including:
- Male sterility
- Neck swelling, difficulty breathing
- Leg and back pain
- Uncontrolled bone growth
The spine experts found that, according to FDA reports and other documents, the side effects associated with Infuse are 10 to 50 times higher than those reported by Medtronic-funded studies.
Dr. Eugene Carragee, editor-in-chief of Spine Journal, found further evidence that Infuse is linked to cancer when researching Amplify, a high-dose version of Infuse. At the North American Spine Society meeting, Dr. Carragee presented data showing that high doses of rhBMP-2, the synthetic protein used in Infuse, was associated with a 5-fold increased risk of cancer after three years.
Doctors Question Validity of Infuse Studies
Yale University has been commissioned to conduct independent research investigating the side effects of Infuse. The project is being led by Dr. Harlan Krumholz, who Forbes has referred to as “the most powerful doctor you never heard of”. Dr. Krumholz’s fundamental goal is answer the questions: Does Infuse work? Is it safe? His ultimate goal is bring a new level of transparency to industry-sponsored studies.
“I think that for many people at Medtronic, these episodes are a great source of embarrassment,” said Dr. Krumholz. A well-known figure in the medical world, Krumholz has been cited by numerous news sources with regards to the Infuse issue, including the New York Times, MedPage Today, Star Tribune, Medscape and noted publications. In the past, Dr. Krumholz has helped testified on behalf of patients who suffered injuries from allegedly defective drugs, including Merck’s Vioxx heart attack risks.
In commenting on the findings of the Senate investigation, Krumholz told MedPage today that “This sounds eerily familiar to many of the transgressions we’ve read about from the pharmaceutical industry,” He went on to say that “It paints a picture of a company very heavily involved in the science; marketing contaminating the science; and the medical profession and researchers being complicit…It’s no wonder the public has lost confidence in the drug and device industries.”