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Johnson & Johnson’s Ethicon’s Gynecare’s “Withdrawing” Decision on Morecellators

Johnson & Johnson’s Ethicon’s Gynecare’s “Withdrawing” Decision on Morecellators

UPDATED:

#Native Press Releases

July 31, 2014

Today according to WSJ:   Johnson & Johnson’s Ethicon’s Gynecare is withdrawing a surgical tool that can spread cancer in women, effectively removing the device’s largest manufacturer from the market amid a contentious debate over its use. Wow that’s really generous of the company who views their products as the “Gold Standard,”  that they’d willingly pull a product, rather out of character for the company.  Or did the FDA force accountability on Johnson & Johnson’s Ethicon’s Gynecare only after the WSJ put pressure on the FDA?  Now if the FDA would just do the same with Mesh.

“The bottom line is that it looks like the sarcoma risk is much higher than we originally thought,” said Steven McCarus, a paid Ethicon consultant and the chief of gynecological surgery at Florida Hospital Celebration Health, which was one of the chief J&J training sites for the morcellator device. The hospital is part of a larger Orlando-area system that, like many health systems, suspended use of power morcellators after the April FDA advisory.

I guess Dr. Brill, paid Ethicon consultant and FDA panel member wasn’t available for comment.  You’d think getting paid almost $213,000 from Johnson & Johnson’s Ethicon’s Gynecare he’d be able to provide the media an update.  Good thing Johnson & Johnson has so many paid consultants around the country.

Johnson & Johnson’s Ethicon’s Gynecare Business Spreading Like Cancer While Holding Hands with The FDA

July 11, 2014

Johnson & Johnson holding hands with The FDA

WSJ Pharmalot reports:

A San Francisco gynecologist named Andrew Brill received nearly $213,000 in consulting fees last year from the Johnson & Johnson’s Ethicon unit, which makes a device known as a laparoscopic power morcellator used in thousands of hysterectomies each year. 

Read more about Johnson & Johnson’s Ethicon’s Gynecare’s Gynecare Morcellex, Morcellex Sigma, Gynecare X-Tract, tools the FDA has estimated are used about 50,000 times yearly to perform fibroid-removal procedures. Overall, fibroids account for about 40% of the roughly 500,000 hysterectomies performed annually in the U.S., by some estimates and potentially spreading a rare and dangerous cancer.  

It appears that Dr. Brill was a consultant for another “company” the FDA Panel looking into and investigating Johnson & Johnson’s Ehticon’s Gynecare’s morcellators.  That certainly wouldn’t be a conflict of interest, would it?  Not any more than Johnson & Johnson hiring a ex-FDA Comissionioner the same year they’re ordered to pay $2.2 billion for kickbacks and off label marketing, would it?  Is this a “if you can’t beat ’em buy ’em” business model?

The-Sociopathic-Business-Model™

Now for the worst part.  Dr. Andrew Brill quit the 16 person committee on the evening before the FDA committee was to meet and review the saftey of the Johnson & Johnson/Ethicon/Gynecare products.  That sounds like good news-except the FDA didn’t know Dr. Brill was also a consultant for Johnson & Johnson/Ethicon/Gynecare until the Wall St. Journal inquired into his relationship with the company.  

A spokesman for Brill referred the Journal to the FDA. And an agency spokeswoman conveyed this message: The FDA “has a rigorous conflict of interest process in place designed to ensure the integrity of our meetings. During the course of the agency’s review and in consultation with Dr. Andrew Brill, it was determined that the financial information he disclosed was just above the threshold established for panel members to participate in one of our meetings.”

Wait is that inconsistent & contradictory language to actions from the FDA?  I know, I know yes that’s what’s needed to run the FDA through The Sociopathic Business Model™.

Beating-a-dead-horse

Why wasn’t Dr. Andrew Brill arrested for lying to The FDA or Johnson & Johnson fined for not reporting this?

WOW-the FDA doesn’t do a quick background check (HELLO NSA?) to see if their review board panelists have a conflict of interest? It’s not like Dr. Brill just remembered the night before this could be a “conflict of interest.” It wasn’t until the FORCED ACCOUNTABILITY from the Wall St. Journal did Dr. Brill step down from the FDA panel that was to review Johnson & Johnson/Ethicon/Gynecare products.  So does this suggest that Johnson & Johnson’s Ethicon’s Gyencare is actually in bed with the FDA?  It sure looks like it, doesn’t it?

Oh and a little thing called the Sunshine Act that requires physicians to report all monies, lunches, dinners, etc, received by the pharmaceutical and medical device companies should have alerted the FDA that Dr. Brill was being a paid Johnson & Johnson/Ethicon/Gynecare as a consultant.  If he didn’t report it or Johnson &  Johnson didn’t-there’s a problem!

Sunshine Act and Dr. Brill Johnson & Johnson Ethicon Gynecare and the FDA

This might put the Wall St. Journal on Johnson & Johnson’s Naughty Advertising List next year but I’m happy to see some real reporting and fact finding from a news outlet and not just reading a press release at face value.  Or is the “journal” referring to itself that way in the article to stay in the good graces of Johnson & Johnson? And again, not shocked this information was released right before the weekend and the WSJ Pharmalot or Wall St. Journal appears to be the only source for this information regarding Dr. Andrew Brill the FDA panel and Johnson & Johnson/Ehticon/Gynecare.

 

Here is the link to the full 16 panelists for the Obstetrics and Gynecology Devices Panel  July 10-11 FDA Meeting 

Dr. Michael P. Diamond, M.D.

Dr. Cheryl Igelia, M.D., F.A.C.O.G

Dr. Lisa E. Moore, M.D., M.S.

Dr. Paula J. Hillard, M.D.

Dr. Craig. D. Shriver, M.D., FACS COLS, MC

Dr. Keith Isaacson, M.D.

Dr. Abdelmonem A. Afifi, Ph.D.

Dr. Carol Brown, M.D.

Dr. Daniel Simon, M.D.

Dr. Robert F. Mattrey, M.D.

Dr. Michael R. Neuman, M.D., Ph.D.

Dr. Colleen M. Gallager, Ph.D, M.A.

Dr. Mark A. Talamini, M.D.

Dr. Russell R. Snyder, M.D.

M.D.’s and Ph.D.’s but noticeably absent from the list are D.O’s, attorneys or actual sales reps (who are in the field ever day). And to that point:

Here’s an interesting link to FDA Advisory Committee vs. FDA Approval from Innovation Breakdown

FDA Stacking the Deck

 

2 Comments
  • Hi, Great article. Just sharing this, which includes the morcellation and FDA issue, because I think you might be interested: http://www.gynreform.com

    Thanks!

    October 21, 2015 at 7:08 am
  • The global gynecology devices market was valued at US$ 15.2 Billion in 2014 and is estimated to reach US$ 21 Billion by 2021, at a CAGR of 4.4% from 2017 to 2021. Market by device type (surgical devices: endoscopy devices – hysteroscopes, colposcopes, resectoscopes, laparoscopes, endoscopic imaging systems; endometrial ablation devices – hydrothermal, radiofrequency, balloon-based; fluid management systems – female sterilization and contraceptive devices, permanent birth control devices, temporary birth control devices; handheld instruments: vaginal speculum, tenaculum, curettes, trocars, biopsy forceps; diagnostic imaging system – ultrasound, mammography; gynecological chairs – fixed-height and adjustable-height chairs). Major players include Boston Scientific Corporation, Hologic, Inc., CooperSurgical, Inc., Ethicon, Inc., Karl Storz GmbH, Medtronic, Inc., Olympus Corporation, Richard Wolf GmbH, and Stryker Corporation.

    https://www.ihealthcareanalyst.com/report/gynecology-devices-market/

    December 27, 2017 at 3:43 am

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