Posts Tagged ‘Medtronic’

Reviews confirm that Medtronic’s spinal treatment “Infuse” provided little benefit

June 18, 2013

In 2011 The Spine Journal took on the morass of hyped scientific papers, multi-million dollar payments to researchers and adverse effects surrounding Medtronic’s Infuse product. As I posted in August 2011

Medtronic is the world’s largest medical device company and Minnesota’s seventh-largest public company based on revenue, which totaled $15.93 billion for the fiscal year that ended April 29. Medtronic’s Infuse product is a bioengineered bone-growth protein that has been used in spinal fusion procedures for the past nine years and is used in about half of the 80,000 anterior lumbar fusion procedures performed every year in the United States.

Now the NY Times reports that 

The controversy reached a climax in 2011, when a medical publication, The Spine Journal, devoted an issue to reports that repudiated the Medtronic-sponsored research, calling it misleading and biased. The journal’s move was significant because it is published by the nation’s biggest group of spine surgeons, the North American Spine Society.

Experts involved in research, like Dr. Zdeblick and Dr. Burkus, defended their work and insisted that their ties to Medtronic had not influenced them. But facing a firestorm, Medtronic agreed in 2011 to provide $2.5 million to Yale University to oversee an independent review of study data.

The resulting examinations, published Monday, involved reviews by two separate teams.

One of the teams, headed by scientists at Oregon Health and Science University in Portland, reported that Infuse appeared to have no advantages over a bone graft and might pose patient risks, including possibly a small added risk of cancer.

The other team, led by researchers at the University of York in England, found that Infuse fused spinal vertebrae more quickly than a bone graft but that the added speed appeared to lack clinical relevance.

Both the British and Oregon teams found no significant difference between Infuse and a bone graft in measures critical to patients, like reducing pain or improving physical function.

…… 

A professor at Yale who oversaw the review, Dr. Harlan M. Krumholz, said that while the two teams had slightly different findings, they pointed in the same direction.

“The general, overall picture is that they failed to find a big benefit,” for Infuse, Dr. Krumholz said. “And they found there might be some harms.”

Doctors and patients, he said, could use the review’s information to decide which treatment was best for them.

Some reviewers also concluded that the Medtronic-financed research had — unwittingly or not — presented a misleading picture.

“Selective reporting or underreporting of outcomes in journal publications may have misrepresented the benefits and harms,” of Infuse, the Oregon group wrote.

The selective reporting or under-reporting or non-reporting of scientific research to suit the commercial interests of the pharmaceutical and medical industries is not likely to disappear anytime soon. And Infuse is still in use and still generates significant revenues for Medtronic.

The review’s results, however, are likely to lead to further drops in Infuse sales. Annual sales of the product, which stood at about $900 million before The Spine Journal’s issue devoted to it, were $528 million in the company’s most recent fiscal year.”

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Medtronic pays 5 surgeons $7m kickbacks in just 9 months: The rape of Medicare

August 21, 2011

The Medtronic story is not just about ghost- writing and paying for favourable peer-reviewed scientific papers and supporting researchers to the tune of millions but it is also about all the surgeons in their pocket and how they exploit and “rape” Medicare.

Earl Stevens writes:

Norton Hospital in Louisville, Ky., may not be a household name nationally. But five senior spine surgeons have helped put it on the map in at least one category: From 2004 to 2008, Norton performed the third-most spinal fusions on Medicare patients in the country.

The five surgeons are also among the largest recipients nationwide of payments from medical-device giant Medtronic Inc. In the first nine months of this year alone, the surgeons — Steven Glassman, Mitchell Campbell, John Johnson, John Dimar and Rolando Puno — received more than $7 million from the Fridley, Minn., company. Medtronic and the surgeons say the payments are mostly royalties they earned for helping the company design one of its best-selling spine products.

Corporate whistleblowers and congressional critics contend such arrangements—which are common in orthopedic surgery—amount to kickbacks to stoke sales of medical devices. They argue that the overuse of surgical hardware ranging from heart stents to artificial hips is a big factor behind the soaring costs of Medicare, the government medical-insurance system for the elderly and disabled. ….

Using a Medicare database that tracks hospitals’ billing, The Wall Street Journal was able to ascertain that Norton is among the most aggressive practitioners of spinal fusion in the country.

Spinal fusion has become one of medicine’s most controversial procedures. It involves fusing together two or more vertebrae to alleviate back pain, usually with the help of metal plates, rods and screws implanted in the patient’s back. Tens of thousands of dollars of hardware can go into a single surgery. ….. Conservative spine surgeons argue that a spinal fusion is appropriate only for a small number of conditions, such as spinal instability, spinal fracture or a severe curvature of the spine known as scoliosis, and that financial incentives have caused the procedure to become overused. …

One health insurer, the nonprofit Blue Cross and Blue Shield of North Carolina, announced in September that it would stop paying for spine fusions performed on such patients beginning on Jan. 1. The insurer said that the procedures are “considered not medically necessary.” …

Some recent studies have suggested poor outcomes for spinal fusion.

So much for the Hippocratc Oath which requires “prescribing regimens for the good of my patients according to my ability and my judgment and never doing harm to anyone“.

Related: Medtronics and others – “supporting doctors with multi – million dollar payments”  

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The Spine Journal takes on Medtronic and publication of questionable research

August 12, 2011

When medical researchers have financial ties – running into millions of dollars – with pharmaceutical or medical equipment companies, and then publish scientific, peer-reviewed papers which are to the financial benefit of these companies,  questions of scientific misconduct escalate to become questions of scientific fraud.

Medtronic is the world’s largest medical device company and Minnesota’s seventh-largest public company based on revenue, which totaled $15.93 billion for the fiscal year that ended April 29. Medtronic’s Infuse product is a bioengineered bone-growth protein that has been used in spinal fusion procedures for the past nine years and is used in about half of the 80,000 anterior lumbar fusion procedures performed every year in the United States.

According to Twin Cities Business, The Spine Journal recently published two articles about the product, one that claims the product may increase the risk of sterility in men, and another that claims that the product’s adverse effects were not reported in clinical research. Those effects reportedly include inflammation, back pain, infections, and potentially life-threatening complications. The Journal pointed out that researchers for 12 of the product’s 13 industry-sponsored studies had multimillion-dollar “financial associations” with Medtronic.

The Spine Journal seems to be on a crusade:

From the Nature News Blog:

The Spine Journal devoted its entire June issue – two clinical studies, two reviews, two commentaries and a scathing editorial – to picking apart Medtronic’s controversial bone growth treatment, Infuse. The drug, which is a recombinant form of the protein BMP-2, is used in some kinds of spinal fusion surgeries and racked up $900 million in sales last fiscal year, according to the New York Times.

Company-sponsored clinical trials for Infuse found no side effects directly linked to the drug. But a review and reanalysis of these studies published in Spine Journal found that the incidence of adverse events ranged from 10 to 50 percent, depending on the use. What’s more, the same review study, led by Eugene Carragee, of Stanford University School of Medicine in California, reports that the authors of the supporting studies had financial ties to Medtronic ranging from $560,000 to $23,500,000, with a median of $12 million to $16 million. In some cases, the authors of these studies did not disclose the full extent of their financial relationships with Medtronic.

“A consistent number of people involved with these studies got extraordinary sums,” Carragee told the Times.

Side effects of the drug include cancer, fertility problems, infections, dissolving bone, and leg and back pain. According to the Times, Medtronic reported the side effects to the US Food and Drug Administration, as required.

In response to the Spine Journal articles, Medtronic CEO Omar Ishrak issued a  statement  that said: “While the Spine Journal articles raise questions about researchers’ conclusions in their published peer-reviewed literature, the articles do not raise questions about the data Medtronic submitted to the FDA in the approval process or the information available to physicians today through the instructions for use brochure attached to each product sold.”

The US Justice Department is conducting a criminal investigation into whether Medtronic illegally promoted Infuse for “off-label” applications not approved by the FDA, the Times reports.

 

The American Society of Business Publication Editors have acknowledged the efforts of the Spine Journal and awarded them the 2011 “Journalism That Matters” award. From the New York Times Media Decoder blog:

In June, the publication, The Spine Journal, devoted an entire issue to editorials and reports that challenged previous medical studies supporting the safety and effectiveness of Infuse, a bone-growth product sold by Medtronic. The product, a bioengineered material, is used mainly in spinal fusions.

The Spine Journal charged that academic experts paid by Medtronic to conduct earlier research about Infuse had issued biased and misleading results that overstated the product’s benefits and claimed that it did not pose risks.

On Friday, the American Society of Business Publication Editors celebrated the journal’s effort by presenting it with its 2011 “Journalism That Matters” award, an honor given in recognition of coverage that causes change by government or industry.

It is highly unusual for one group of researchers to publicly repudiate the work of professional colleagues. And by throwing down its challenge, the special issue of The Spine Journal, which is the official journal of the North American Spine Society, was something of a turning point in the debate over conflicts of interest in research paid for by makers of medical products.

Medtronic is on the defensive and is conducting a damage limitation exercise:

But there is little doubt that The Spine Journal’s coverage has had an effect. Last week, Medtronic took the unusual step of announcing that it was giving a $2.5 million grant to Yale so that independent researchers could conduct a broad review of all Infuse studies in order to determine the facts. 

Related:

http://www.courier-journal.com/article/20110731/BUSINESS/307310070/Norton-pair-accused-hiding-risks-spine-drug?odyssey=tab|topnews|text|Local%20News

http://beckersorthopedicandspine.com/spine/item/8901-two-more-spine-surgeons-cited-for-underreporting-infuse-complications

http://www.theglobeandmail.com/life/health/new-health/paul-taylor/medtronic-pledges-independent-review-of-bone-graft-product/article2119735/

 

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Posted in Corruption, Ethics, Media, Medicine, Scientific Fraud, scientific misconduct | 3 Comments »