Biased Studies Draw Further Criticism of Medtronic Infuse® as Device is Associated with New Injuries

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Biased Studies Draw Further Criticism of Medtronic Infuse® as Device is Associated with New InjuriesOverview: Infuse, a synthetic bone graft product manufactured by Medtronic, continues to be the subject of controversy following reports suggesting that the company acted unethically to promote their product while putting patients at risk for serious side effects. Among other things, a government report showed that Medtronic employees helped write and edit a number of studies promoting Infuse. Meanwhile, new evidence suggests that the product may be linked to Cauda Equina Syndrome, an emergency medical condition that can lead to paralysis and other devastating consequences.

  • Medtronic Infuse is comprised of a synthetic recombinant human Bone Morphogenetic Protein (rhBMP-2) that is supposed to help stimulate bone growth in the spine; the device became the subject of controversy when reports suggested that Medtronic paid doctors to hide side effects
  • A report by the U.S. Senate Finance Committee showed that Medtronic employees helped ghostwrite 11 studies promoting Infuse; none of the 13 company-funded studies mentioned serious side effects
  • Evidence suggests that Medtronic Infuse may be associated with Cauda Equina Syndrome

Product: Medtronic Infuse Bone Graft

Manufacturer: Medtronic, Inc.

Side Effects & Complications

  • Cancer
  • Difficulty breathing, swallowing
  • Uncontrolled bone growth
  • Nerve injury
  • Male sterility
  • Retrograde ejaculation

 

Senate Report Shows Medtronic Employees Helped “Ghostwrite” Positive Infuse Studies

Medtronic Infuse came under intense scrutiny in June 2011, when a group of spine experts published research showing that Infuse was associated with a number of serious complications, including male sterility and cancer. The research was published in The Spine Journal; in fact, the journal dedicated an entire issue to the data. What was truly disconcerting, the publication said, was that none of the 13 Medtronic-funded studies mentioned these side effects, suggesting that Medtronic paid doctors to omit these complications. The report helped prompt an investigation by the U.S. Senate Finance Committee, who released a report late last year on the issue.

The Senate report highlighted the fact that none of Medtronic’s studies mentioned the side effects, and showed that millions of dollars were paid to doctors listed as authors in the research. The report also showed that Medtronic marketing employees helped write and edit 11 studies between 2002 and 2009. This so-called “ghostwriting” is not illegal, but is considered a breach of integrity in the scientific community because biased opinions are being used to influence decisions about patient health.

“This sounds eerily familiar to many of the transgressions we’ve read about from the pharmaceutical industry,” Dr. Harlan Krumholz, a renowned professor of medicine at Yale University, said to MedPage Today when told of the Senate findings. “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,” Krumholz is leading the Yale review of Infuse to further investigate side effects.

Medtronic Infuse Linked to Cauda Equina Syndrome

In addition to the complications revealed by earlier research, new evidence suggests that Infuse may also lead to Cauda Equina Syndrome when doctors mix the wrong amount of water or BMP-2 powder during surgery. Cauda Equina Syndrome occurs when the nerves at the base of the spine become compressed. This condition is considered a medical emergency; if left untreated it can lead to leg paralysis and permanent loss of bowel and bladder control. Nerve injuries associated with Cauda Equina Syndrome following surgery with Infuse include pain, altered reflexes and decreased strength or sensation.