Tag Archives: medtronic

Pushback against Medtronic’s Infuse hits boiling point

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

Medtronic’s ongoing woes with its blockbuster spine fusion product Infuse have been a staple of Covering Health for as long as we can remember, but things have reached a crescendo this week.

spine
Photo by attila acs via Flickr

The first blow came with the publication of John Fauber’s in-depth report (read it at the Journal Sentinel or in MedPage Today) on the conflicts of interest and regulatory weak points that kept Infuse going strong despite serious questions about medical outcomes.

The next day, The Spine Journal made the unprecedented move of dedicating an entire issue to repudiating the failures of science and medical journal publication that made Infuse what it is today. For the record, both those links point straight to journal press releases. If you’re looking for more context, you’ll find it in Fauber’s followup to The Spine Journal‘s Infuse issue. HealthNewsReview editor and publisher Gary Schwitzer also blogged his take on the releases.

Fauber’s Medtronic coverage is a joint project between the Milwaukee Journal Sentinel and MedPage Today.

Medtronic attracts attention from Baucus, Grassley

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

Readers of Covering Health are likely familiar with medical device manufacturer Medtronic and John Fauber’s coverage of conflicts of interest surrounding the company’s Infuse product.

It seems that U.S. Senators Max Baucus (D-Mont.) and senior member Chuck Grassley (R-Iowa) also are aware of the coverage.

The two, leaders of the Senate Finance Committee, have demanded “an extensive trail of documents, including financial records and communications between the company and doctors who have received millions in royalties and other payments.” [See the letter.]

Over the past year, Fauber, of the Milwaukee Journal Sentinel (see update), has reported that the company made payments to surgeons “involved in the clinical testing of Infuse or who wrote positive medical journal articles that failed to link the product to serious complications.” Those complications include unwanted bone growth outside the fusion site and sterility in men.

Infuse is a biological agent used in spinal fusion surgery that stimulates bone growth.

A professor of orthopedics at Dartmouth Medical School is pleased the Finance Committee is investigating, saying it is doing public health work because his profession and the FDA failed to prevent this circumstance.

It appears there is more news to come about Infuse:

Next week, independent researchers are expected to publish more papers revealing additional serious complications with Infuse that were not reported in numerous articles published over the last decade and co-authored by doctors with financial ties to Medtronic. The independent researchers said their research also was prompted in part by Journal Sentinel reports.

Update

This post should have mentioned that the Medtronic coverage is a joint project between the Milwaukee Journal-Sentinel and MedPage Today.

Medtronic, researchers failed to report known link to complication

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

Medtronic, a medical device maker, and researchers with financial ties to the company have known for years that a “biological agent used in back surgery was linked to sterility in men,” reports John Fauber of the Milwaukee Journal Sentinel.

The doctors, who have received millions in royalties from Medtronic, failed to include the information in journal articles and instead claimed the sterility was caused by surgical technique, not the product. Information linking the product to the complication was included in what the company sent to the FDA as part of the approval process in 2002. But the doctors linked to Medtronic claimed there was “no relationship” as recently as last year.

Several independent doctors contacted by the Journal Sentinel say that while the surgical technique may be a factor in the development of the complication, the Medtronic authors should have stated Infuse also was linked to the condition.

The Journal Sentinel uses Document Cloud to share the documents – journal articles, letters of concern and commentaries – that explain the history of the product, Infuse. The documents are annotated, with key points highlighted and comments explaining the conflicts.

A study done by independent researchers, published today, links Infuse to retrograde ejaculation, a condition that causes sterility in men. Fauber reports the study was prompted in part by the Journal Sentinel‘s earlier articles about Medtronic.

“To have such strong evidence that a life-changing complication of sterility exists and then cover it up in my opinion is obscene,” said Charles Rosen, an orthopedic surgeon and president of the Association for Medical Ethics who has read the Stanford study.

Update

Read about the little -known Croatian doctor who pursued concerns about Infuse. Medical journals dismissed his concerns, including one reviewer who told him “as a Croatian he did not have the standing to make comments about Infuse.”

Doctors tied to manufacturer report better outcomes, may influence spinal surgery

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

After using a FOIA request to obtain documents the Food and Drug Administration had labeled “confidential,” Milwaukee Journal Sentinel reporter John Fauber has found that conflicts of interest may have played a role in the outcomes of clinical trials for Medtronic’s much-debated spinal fusion product BMP-2.

In a review of the study’s summary data for the newspaper, researchers at Dartmouth-Hitchcock Medical Center found 91 of the 364 patients in the trial – 25% – were implanted by surgeons who had a financial connection with Medtronic. Those doctors reported an 80% overall success rate, compared with 63% for doctors with no ties to the company.

Fauber also notes Medtronic’s response, which was to simply point to comments the company had made for a previous Fauber story.

At the time, [Medtronic spokeswoman Marybeth Thorsgaard] said the company fully disclosed the success rates of the doctors with financial ties to the company to the FDA. She noted that those doctors also had better results with the patients in the trial who did not get BMP-2.

In a companion story Fauber writes that, much like in the clinical trials, the journal articles published to push BMP-2 (and its off-label use) were riddled with conflicts of interest. One of his sources even called one article “egregious” for “blowing off” complications.

Related

Bloomberg’s Peter Waldman and David Armstrong write about the “national boom in costly fusion surgeries” and how “surgeons have prospered from performing fusions, which studies have found to be no better for common back pain than physical therapy is – and a lot more dangerous.” The pair also look at Medtronic’s payments and other ties to doctors who perform the surgery, as well as some of the risks of the surgery.

WSJ details conflicts that drive spine fusion surgery

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

The Wall Street Journal‘s John Carreyou and Tom McGinty have taken advantage of their paper’s Medicare data stockpile to look at the conflicts of interest and piles of royalty money that drive the popularity of spine fusion treatments whose effectiveness has been disputed. Their work centers on Medtronic, which the Milwaukee Journal Sentinel‘s John Fauber also has written about.

spine

Photo by planetc1 via Flickr

For surgeons, the financial incentives to perform spine fusions can be strong. Though hospitals often lose money on the procedure when it’s performed on Medicare patients due to the high cost of the implants, the surgeons themselves can get paid as much as $12,000 per surgery.

Complex fusions … are reimbursed by Medicare at a sharply higher rate than decompressions, to account for the elaborate spinal devices used and the longer length of surgery. Complex fusions increased 15-fold among Medicare beneficiaries with spinal stenosis from 2002 to 2007, according to the JAMA study.

A big part of many surgeons’ income lies in their consulting and royalty arrangements with device makers, although disclosure of these arrangements remains piecemeal for now. Medtronic began releasing information about its payments to surgeons on its website in June, after coming under intense scrutiny from Sen. Charles Grassley (R., Iowa).

They’re required to keep some details under wraps, but the WSJ duo still manages to unleash anecdotes, including one about a surgeon who received “between $400,000 and $1.3 million in royalty, consulting and other payments from three spine-device makers.”

For reporters looking to understand the medical issues surrounding these procedures and why these conflicts can be detrimental to patients, see Janet Moore’s work in the Star Tribune.