Fauber finds ‘failed back surgery syndrome’ after off-label use of Medtronic’s Infuse
Filed under: Conflicts of interest, Hot Health Headline
John Fauber follows up his previous investigations into the myriad problems and conflicts of interest surrounding Medtronic’s Infuse product with a story on the emerging national epidemic of what pain specialists are calling “failed back surgery syndrome.” One local pain specialist Fauber contacted said that a full 10 percent to 15 percent of his patients suffered from the condition.
To bring the whole thing full circle, Fauber spends much of the body of this latest installment explaining how conflicts of interest and other questionable ethical situations, including off-label use, propelled the early and sustained success of Medtronic’s spine-fusion blockbuster and set the stage for the emerging pain epidemic.
Fauber’s Medtronic coverage is a joint project between the Milwaukee Journal Sentinel and MedPage Today.
Medtronic hires Yale researchers to review Infuse data
Medtronic, the manufacturer of spine fusion product Infuse, has hired Yale University researchers to review patient data and adverse event reports for the product.
Photo by planetc1 via Flickr
The review follows months of reporting by John Fauber for the Milwaukee Journal Sentinel and Medpage Today that have raised questions about the independence of doctors involved in clinical trials for the product.
The Wall Street Journal’s John Carreyou and Tom McGinty also used their paper’s Medicare data stockpile to look at the conflicts of interest and royalty money that drive the popularity of spine fusion treatments whose effectiveness has been disputed.
Serious complications involving Infuse have gone unreported in medical journal articles that were written by doctors who have financial ties to Medtronic.
The June issue of The Spine Journal was devoted to unreported complications related to Infuse, revealing that “complication rates … were 10 to 50 times greater than the estimated complication rates revealed” papers co-authored by doctors with financial ties to the company.
In a statement about the review by Yale researchers, Eugene J. Carragee, M.D., editor in chief of The Spine Journal, says “this appears to be a big first step in the right direction” but points out three challenges that lay ahead for the reviewers.
Top docs spar over Medtronic research, Iraq service
Filed under: Conflicts of interest, Hot Health Headline, Pharmaceuticals
Following up on his work on the dangers of Medtronic’s Infuse spine fusion product and the conflicts of interest that appear to have facilitated its approval and adoption, the Milwaukee Journal Sentinel’s John Fauber has the latest on high-profile sniping between two top orthopedic surgeons over the Spine Journal’s recent Infuse issue devoted to the many complications and conflicts of Infuse.
The combatants in this case are frequent Fauber target and University of Wisconsin-Madison orthopedic surgeon Thomas Zdeblick, who has received $23 million from Medtronic since 2002, and Stanford orthopedic surgery professor and Spine Journal editor-in-chief Eugene Carragee, the Iraq veteran whose research helped spark the recent push against Infuse.
The showdown began with Zdeblick’s defiant response to the Spine Journal’s Infuse research, a letter which included an apparent attempt to discredit Carragee’s review because the surgeon wasn’t performing the elective spine fusion surgeries while he was serving with the American military in Iraq. In response, Carragee says he took no extended leaves of absence during the period covered in his study. For the record, Carragee’s second tour of duty in Iraq was cut short in 2008 after he was injured in an attempted suicide attack.
The full text of Zdeblick’s initial letter and the response of Carragee and his co-authors has been published online, and the medical community has rallied around the decorated veteran.
In an email to the Journal Sentinel, Charles Rosen, president of the Association for Medical Ethics, was sharply critical of Zdeblick’s letter.
“Zdeblick’s assertions are so nonsensical that the whole letter strikes me more like the ravings of a guilty man who’s been cornered,” said Rosen, a clinical professor of orthopedic surgery at the University of California, Irvine.
Fauber’s review included a particularly tidy summary of the overall Medronic fracas, and I have included his wrapup below the fold in case anyone still needs to get up to speed on the issue.
Pushback against Medtronic’s Infuse hits boiling point
Filed under: Conflicts of interest, Health journalism, Hot Health Headline, Pharmaceuticals, Public records, Studies
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.
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
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
Filed under: Conflicts of interest, Hot Health Headline, Pharmaceuticals
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
Filed under: Conflicts of interest, Health data, Health journalism, Hot Health Headline
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
- Conflicts of interest + off-label use = Blockbuster
- Article looks at evidence behind back surgery
- Journal editor linked to spinal implant royalties
- Kuklo scandal spotlights DoD/Medtronic ties
WSJ details conflicts that drive spine fusion surgery
Filed under: Conflicts of interest, Health data, Hot Health Headline, Public records
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.
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.
Journal editor linked to spinal implant royalties
Filed under: Conflicts of interest, Hot Health Headline
John Fauber of the Milwaukee Journal Sentinel continues his coverage of conflicts of interest in medical research and journals with a look at journal editors. First, Fauber lays out the case in question:
- For seven years, a University of Wisconsin orthopedic surgeon (university bio | hospital bio) has been editor-in-chief of the Journal of Spinal Disorders & Techniques.
- During that time, he’s received more than $20 million in patent royalties thanks to spinal implants sold by Medtronic.
- Also during that time, an average of more than one Medtronic-related article appeared in each issue of the journal, most of them positive. Some were even co-authored by the editor/surgeon himself and related to the implant for which he gets royalties.
- Despite these coincidences, the journal never disclosed the potential conflict of interest.
Fauber then goes on to explore why journal editors aren’t mentioned more often in conflict-of-interest scandals, and then to explain exactly why those editors hold the sort of power that makes these conflicts particularly distressing. As Fauber explains, editors of medical journals can accept or reject manuscripts of studies involving drugs or devices - something that can make or break the product.
They can send a study out to peer reviewers who may be sympathetic to a particular drug or device by virtue of their own financial relationships with the companies that make those products. They can give authors more leeway to say positive things about a drug. They can turn down studies that say bad things about the product of a company they get money from.
The author of “On The Take: How Medicine’s Complicity with Big Business Can Endanger Your Health
Earlier coverage:
- Wis. researchers didn’t disclose conflicts to journals
- U. of Wisconsin conflict of interest policy gutted
- Wyeth paid university for ghostwritten articles
- University’s ties to testosterone therapy questioned
- Drug companies aim to sway docs through classes
- Wyeth-funded course promoted hormone therapy
- Academic docs collect money from manufacturers
Kuklo scandal spotlights DoD/Medtronic ties
Filed under: Conflicts of interest, Europe, Health journalism
In the wake of news of a falsified study published in a British bone and joint medicine journal by former Walter Reed Medical Center surgeon Timothy Kuklo, reported by The New York Times‘ Duff Wilson and Barry Meier, the Center for Public Integrity’s M.B. Pell, Aaron Mehta and Nick Schwellenbach have help paint a broader picture of Medtronic-funded travel at the Department of Defense. First, some background from Wilson and Meier:
The former Army surgeon, Dr. Timothy R. Kuklo, reported that a bone-growth product sold by Medtronic Inc. had much higher success in healing the shattered legs of wounded soldiers at Walter Reed than other doctors there had experienced, according to Colonel Coots and a summary of an Army investigation of the matter.
The two reporters mentioned that Kuklo indulged in privately funded travel, and the Center for Public Integrity helped put some numbers to the relationship, finding that “Between 2001 and 2006, Medtronic paid for at least 15 trips taken by Dr. Kuklo, worth more than $13,000.”
Kuklo isn’t the only one at DoD who benefited from being cozy with the folks at Medtronic, which “paid more than $90,000 for about 80 Defense Department trips from 1998 through 2007, according to the Office of Government Ethics data.”
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