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StarTribune’s #ForcedAccountability of FDA: Medtronic’s Lost Study

StarTribune’s #ForcedAccountability of FDA: Medtronic’s Lost Study

#ForcedAccountability StarTribune to FDA

UPDATED:  Senator Al Franken pushes for Medtronic Study details with FDA 

StarTribune Question of Risk Medtronic I’ve been critical (yes, shocking I know) of media who often cut and paste DOJ press releases and Joe Carlson of StarTribune,  is among those whose journalistic integrity I’ve questioned.  However, Joe Carlson, Jim Spencer and MaryJo Webster of the StarTribune may be doing their jobs as journalists after all with the long-format Special Report Question of Risk: Medtronic’s Lost Study. Now we must do our jobs as employees, consumers, patients, shareholders, and taxpayers and read pieces like this to show support and engaging in the comments sections of their piece, while sharing on social media, so journalists will be green-lit to do more in-depth reporting, like this, in the future.

Although I do still question the timing of this piece, centered around Boston DOJ. Minnesota’s StarTribune’s Carlson’s previously reported on medical device executives manipulating the First Amendment without shame, remorse guilt or accountability regarding William (Bill) Facteau (resides in Silicon Valley) and Patrick (Pat) Fabian (resides in Minnesota) who are awaiting their criminal trial in Boston; and, it appears Carlson does to not fully grasp the complexity of the case.    I sure hope this isn’t a journalist trying to help indicted executives place blame without taking accountability because that’s just as criminal as what FDA tries to pull!

On the success of Huffington Post & Steven Brill’s American’s Most Admired Lawbreaker: Johnson & Johnson and now StarTribune’s Report Question Of Risk: Medtronic’s Lost Study both of whom have read Killing My Career regularly, maybe this is the start of the positive change those injured by the corrupt system from medical device makers and FDA are looking for.

Case Study Breakdown:

Federal law requires medical device companies to report possible product-related injuries to the Food and Drug Administration within 30 days of learning about them. Instead, Medtronic employees shut down the study in spring 2008 without telling the government anything.

These reports are called MAUDE reports or as this site views them FRAUD reports.

MAUDE-Reports are Fraud Reports #TheSociopathicBusinessModel

MAUDE data is mandatory from the FDA  and represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.191.

How can a MAUDE Report be both mandatory and voluntaryGive the corrupt medical device industry an inch and they’ll take a yard to try and avoid accountability.

Medtronic, which reincorporated in Ireland last year but maintains its operational headquarters in the Twin Cities, said Infuse has been used in more than 1 million patients and has a “well-established” safety profile. The company says the number of complications that turned up among the 3,600 patients with surgeries between 2002 to 2006 wasn’t surprising given experiences in earlier clinical trials. And it said reporting doctors concluded that Infuse was not connected to the deaths.

“There was no analysis to suggest there was a problem … or [that] there was an unusual set of complications and we better keep this quiet,” said Richard Kuntz, Medtronic’s chief scientific, regulatory and medical officer.

Well, as long as the paid company figurehead from Medtronic Richard Kuntz, says there weren’t problems, guess there weren’t problems. Except…

Medtronic would eventually tell the FDA about more than 1,000 adverse events discovered through the study, more than five years after they were due.

The FDA raised no issues about the late reporting and blacked out the total number of events from the three-sentence summary that became public. That number was revealed just months ago, after the Star Tribune challenged an FDA decision to keep it secret.

FDA busted protecting both Medtronic and their own asses. Again, why this site maintains that allowing two known corrupt entities (FDA + Medical Device Company) to negotiate on behalf of the American people behind closed doors is for their best interest and not ours as employees, consumers, patients, shareholders, and  taxpayers.

The commercial potential was clear to Medtronic executives, who were looking to diversify the company’s product line beyond its traditional heart devices. In 1999, they (Medtronic) paid $3 billion to buy a Memphis company that had exclusive rights to make a specific bone-growth protein, called rhBMP-2.

What? This looks a lot like venture capital funded startup medical device fraud, expect StarTribune forgot to name the startup and the venture capitalists: potential RED FLAG 

Fixed that for you StarTribune:

MEMPHIS, Tenn.–(BUSINESS WIRE)–Aug. 27, 2003–Medtronic, Inc. (NYSE:MDT) announced today that its spinal business, Medtronic Sofamor Danek, has reached agreements with Wyeth (NYSE:WYE) and Yamanouchi Pharmaceutical Co., Ltd., to acquire the remaining worldwide exclusive rights to promote recombinant human bone morphogenetic protein (rhBMP-2), a genetically engineered version of a naturally occurring human protein that forms new bone. In the new agreement with Wyeth, Medtronic expanded its rights for rhBMP-2 to include the United States, Canada, Australia, Latin America and other countries, for spine, orthopaedic and trauma indications. Financial terms were not disclosed.

These new agreements provide Medtronic with worldwide commercial license rights for rhBMP-2 for all spine, orthopaedic and trauma indications. Medtronic recently announced that Yamanouchi had agreed to grant to Medtronic the exclusive license for rhBMP-2 for orthopaedic surgery in Japan and Asia.

So, this wasn’t an outright acquisition but rather an exclusive license agreement, which should also potentially make Yamanouchi on the hook as well.

At least 85 percent of the 340,000 BMP surgeries in the United States between 2003 and 2007 were for uses the FDA had not reviewed for safety or effectiveness, according to a study in the journal Spine. BMP use grew fourfold during those years.

Yep, you read that correctly 85% off-label use, and this is why Judges like Judge Lamberth in the VSI First Amendment case against CEO Howard Root, should pay attention and not make fraud easier for companies by allowing them to hide behind the First Amendment but hold them accountable.

Medtronic executives had promised shareholders that Infuse could become the “standard of care in spinal fusion therapy.” They wanted more FDA-approved uses. To gather evidence for those new uses, a team reviewed medical records from patients who had received Infuse between 2002 and 2006.

RED FLAG: Where oh where have we seen companies claiming they’re the “gold standard” or “standard of care” which is used only to deflect from fraud allowing profits to come before consumers or patients?  This is very common in venture capital funded startup medical devices that once acquired underperform due to fraud, like with NEA venture funded Gynecare acquire by  Johnson & Johnson’s Ethicon’s where JNJ’s minion of Satan, Sheri Woodruff called the transvaginal mesh the “gold standard of treatment.”

Johnson-Johnson-spokeswoman-Sheri-Woodruff-says that some thing mesh is the gold standard

Pretty sure these women would disagree with JNJ’s Woodruff’s opinion regarding the “gold standard.”

Need further proof there are patterns in venture capital funded startup fraud? Just look to the recent headlines of venture capital funded startup Uber who claimed their hiring process was the “gold standard” in the industry as they cut a check (or wire transfer) for $25 million for misleading in an advertising suit.

Please check back for Case Study update.

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