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Venture Capitalists & FDA Hold Prized Contest to Kill Your Kids!

Venture Capitalists & FDA Hold Prized Contest to Kill Your Kids!

August 23, 2017


Venture capitalists falsely hide behind innovation as a manipulation to evade the law. That’s the phrase I repeated often to the Department of Justice’s Attorney Generals, FBI, FDA, DOD, and CMS agents as a federal whistleblower who helped them recover $18 million for taxpayers, remove a fraudulently cleared medical device from the market; and, helped convict two Silicon Valley venture capital-funded startup executives.

“Make Your Medical Device Pitch for Kids!” 

 The National Capital Consortium for Pediatric Device Innovation (NCC-PDI), I thought surely this must be a joke. Why would anyone actively want children to have surgery-sooner? If you are a parent, rest uneasily, this is not a joke. Venture capital-funded medical device startups need to demonstrate hypergrowth quickly in order to get their investment back (10 times their investment in 3-5 years is the goal).  Sales quotas aren’t based on what the surgical market can bear, but rather the venture capital firm’s return on investment (ROI).

What this means to you as a potential patient is that medical device companies push for surgical intervention sooner.  Not because it’s what’s best for the patient–it’s because it’s what’s best for the company. As a former medical device rep, I can tell you that our bonuses were dependent upon getting new surgeons trained each quarter; and, surgeons had to have surgeries with the new device already on the books before they could go to training. If we didn’t hit our surgeon trained quota each quarter we ran the risk of getting fired.   The medical community will falsely tell you that surgeons decide when patients have surgery, not reps-sure-grab a snack and I’ll tell you another fairy tale. Venture capital-funded startup medical device companies need patients to skip lifestyle modification and medication and jump right to surgery in order to be profitable for an acquisition or IPO.  Simply put their putting their profits ahead of patients and the FDA has done a horrific job of protecting patients, especially women like the Essure (15,437 adverse events/3,700+ lawsuits) & Gynecare (50,000 cases in federal court) victims.

Venture capital-funded startup medical device companies often underreport adverse events to protect their investment-putting profits before patients.  Reps are also threatened with termination from sales and marketing if they report adverse events which is usually inconsistent & contradictory to what they hear from regulatory & compliance.  That’s why we see so many adverse events (surgical complications) post IPO or acquisition.

I remember sitting in a Regional meeting with the Area Director who later became the VP of Sales and Marketing at Acclarent, when he  demanded that we increase medical device sales in the pediatric market.  I pointed out, in front of everyone, that it was not indicated for children in that particular sinus.  He argued with me, and he was later proven incorrect but, those numbers were unethically added into our quotas regardless. Medical device companies need to hit growth numbers and will do anything to achieve those goals, including targeting your kids.   Just ask my two former executives from Acclarent that are awaiting federal sentencing just how far a company will go for venture capitalists at your expense.

To add insult to injury, your federal tax dollars via a FDA P50 grant helped fund NCC-PDI to target your kids for surgery. What the public doesn’t often known is that most of these innovation and healthcare advocacy groups are nothing more than shell companies funded by the industry. The advocacy groups are designed to deceive the public and use innovation as a manipulation to evade the law. (Have we heard that somewhere before?)

Killing with Prizes!

Up to six prizes totaling $250,000 will be awarded to the winning presentations at the Fifth Annual Pediatric Device Innovation Symposiumon Sunday, Sept. 24, 2017 in San Jose, Calif., hosted by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System.

NCC-PDI, led by the Sheikh Zayed Institute and the A. James Clark School of Engineering at the University of Maryland, invites proposals from innovators – researchers, entrepreneurs, and clinicians – with a pediatric medical device concept that has potential for commercialization. Competition finalists will pitch their medical device to a distinguished panel of judges at the symposium. (Oh boy, this is where it gets really good!)In addition to the prize money, winners will receive consultation services from the FDA-funded consortium. For competition details and to apply, visit innovate4kids.org/funding-opportunities.

Oops! Looks like NCC-PDI left out of their press release that some of the distinguished panel of judges have a pathological history of funding medical device startup fraud-that’s you know-also killing people…wait for it…Essure, Gynecare and Acclarent (the venture capital-funded startup medical device company where I was a federal whistleblower).

Judges for this year’s pitch competition include Susan Alpert, M.D., of SFA Consulting, a former director of the FDA Office of Device Evaluationand former senior vice president and chief regulatory officer of MedtronicCharles Berul, M.D., of Children’s National; Andrew Elbardissi, M.D., of Deerfield ManagementRick Greenwald, Ph.D., of the New England Pediatric Device Consortium (NEPDC); Josh Makower, M.D., of NEAJennifer McCaney, Ph.D., of MedTech Innovator; and Jackie Phillips, M.D., of Johnson & Johnson.

Hey, wait? You don’t think that the distinguished panel of judges and the companies they represent put up the prize money, do you? Well at least one of the judges got more creative. Josh Makower’s involvement in this prized contest, would certainly prevent him from getting sued for patent infringement…again.

NEA is the world’s largest venture capital firm and boasts Josh Makower, M.D. as one of the firm’s general partners.  Makower is also co-founder of Acclarent (hey-isn’t that the company where I was a federal whistleblower?) and a patent holder on the medical device that fraudulently obtained FDA clearance; and, was at the center the Department of Justice civil and criminal investigation. NEA along with Johnson & Johnson’s venture capital arm, Johnson & Johnson Development Corporation (JJDC) funded in-part Acclarent which sold to Johnson & Johnson (the parent company) for $785 million in 2010. Confused yet?  That’s certainly the goal of venture capital.

NEA also funded in-part, Conceptus which is now Bayer’s Essure and Gynecare which is now a Johnson & Johnson company. All of these companies are now plagued with lawsuits and Department of Justice investigations stemming from injured or on behalf of deceased patients but, you know hasn’t been held accountable? Venture capital, they made their money & don’t care about the wake of destruction they’ve left behind-because now they’re on to targeting your kids for surgery!  Logic (as well as fact-based evidence over time) indicates that any time Johnson & Johnson and NEA get together it’s not good for the public.   think Johnson & Johnson shareholders would break up this unholy alliance that costs them billions, but nope they’re still funding a federally convicted former Acclarent CEO (William Facteau currently CEO of EarLens).

Look the Commissioner of FDA Scott Gottlieb also has a pretty NEA picture too, just like his buddy Josh Makower.

Now that these two axis of evil, NEA & JJDC, are judging a medical device contest targeted towards pediatric patients, let’s hope the media starts to pay attention.  I spoke with Tom Burton of the Wall Street Journal last year regarding the Johnson & Johnson, NEA, Acclarent, and FDA and he just couldn’t really see the link.  Oddly, I have seen a rather unique link to Johnson & Johnson and The Wall Street Journal.  The FDA and media have both failed hundreds of thousands of injured medical device adult patients. I don’t hold out much hope for the FDA fixing this problem anytime soon because:

  1. FDA does not make money in preventing fraud
  2. FDA is funding the problem
  3. NEA also boasts another general partner by the name of Dr. Scott Gottlieb, you may also know him as the Commissioner of FDA. Hello? Conflict of interest anyone???

Please reach out to any and all media contacts to make sure that we stop allowing venture capital firms to use innovation as a manipulation to evade the law at our expense and soon the expense of children. That includes the venture capital-funded medical innovation bills.

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