Sunday, September 22, 2013

Conflict of Interest


In another one of my naive moments about the 'system', I thought those who approved the devices were independent of the manufacturer, and those who oversaw the studies were independent, and those who had oversight at the FDA were also independent. On paper, it seems like it would work, except is doesn't exist on paper. It doesn't exist at all. I was completely wrong and so are countless others.

I've spent several months in my battle against Essure, and the FDA. During this time, I've looked at countless documents, many of them found by Krystal Donahue, who is one of the administrators of the Essure Problems Facebook Group. We've seen the names of so many doctors, hospitals, clinics - they are starting to look the same and for a while, I began to think I was reading the same documents. Then the light clicked - it’s not the same documents, it’s the same people or different people from the same hospital over and over. What I thought was independent isn't even close.

Let's start with the members of the FDA's OB/GYN Devices Panel. These are the current members:

Dr. Thommaso Falcone
Professor and Chairman of Obstetrics & Gynecology
Cleveland Clinic Foundation
Cleveland, OH

Dr. Ann J. Davis
Dartmouth Medical School
Hanover, NH

Dr. Frank W. Ling
Obstetrics and Gynecology
Women’s Health Specialists, PLLC
Germantown, TN

Dr. Paula J. Hillard
Professor and Chief Gynecologic Specialties
Stanford Univ. School of Medicine
Dept. of Obstetrics and Gynecology
Stanford, CA

Lisa M. Maldonado, MPH
Expertise: Reproductive Health Care
Executive Director
Reproductive Health Access Project
New York, NY

Dr. Lisa E. Moore
Associate Professor
University of New Mexico
Dept of OB/GYN; Div. of Maternal Fetal Medicine
Albuquerque, NM

Conceptus has its own Advisory Board. Members of the Conceptus advisory committee are paid consulting fees for their services and those with the title of Director, are REALLY paid. The list of these physicians is below:

Dr. Linda Bradley
Cleveland Clinic Foundation
Cleveland, OH

Andrew Brill MD
Conceptus Director
Sutter Health / Sutter Pacific Medical Foundation
San Francisco, CA

Mark Levie MD
Conceptus Director
Montefiore Centennial Wmns Ctr
New York, NY

Viviane Connor MD
Cleveland Clinic Foundation
Weston and West Palm Beach, Florida

Malcolm Munro
Director of Gynecologic Services,
Served at Study Chair for Stop - precursor to Essure
Los Angeles Medical Center at Kaiser Permanente,
Los Angeles, CA

Robert Zurawin
Baylor College of Medicine
Obstetrics & Gynecology
Houston, Texas

I hope you noticed what jumps out at me - Cleveland Clinic. It’s really interesting that doctors from Cleveland Clinic sit on the OB/GYN Advisory Board of the FDA and are also members of the Conceptus advisory panel. I smell a RAT. In my FOIA request to the FDA, I've asked for all emails between Conceptus, their advisory board, and members of the FDA advisory board. My FOIA was submitted in March of 2013, and I'm still waiting...Wonder why?

Dear Dr. Linda Bradley, your boss at Cleveland Clinic sits on the same FDA panel that provides "oversight" to medical devices, including Essure. You are member of the Conceptus advisory board. Interesting, very interesting. There is more to why I'm calling out Dr. Bradly. She was one of the doctors who participated in the clinic trials. She was PAID by Conceptus to perform the trials, and these patients were implanted at Cleveland Clinic's hospital, which means the hospital got paid also. Did I mention I smell a rat? We have a young lady in our Facebook group who was a study patient. She was implanted by Dr. Bradley herself and she started having issues during the study. Instead of being helped, she was dismissed from the study. Dr. Bradley will not communicate at any level with her formal patient. She won't return phone calls, emails and is even making it difficult to get medical records.

Now, let’s talk about dear Dr. Mark Levie, who is also a Director at Conceptus and a member of their advisory board. He is a practicing physician in New York City who continues to implant patients with the device. Upon being appointed as Director, he was compensated with the equivalent of $300,000.00 in Conceptus stock. The total numbers of shares is determined by the fair market value at the time of his appointment. After 6 months of service, he received an additional $112,000.00 in stock. Following each annual shareholders meeting, he receives an additional $28,000.00 in stock. There are additional payouts awarded for serving as chair to audit committees or compensation oversight committees. These payouts are $17,500 and $10,500 respectively and all paid in stock. These compensation guidelines apply to any person who is named as an independent director as of January, 2008.

Being paid in stock gives those in this position personal motivation to ensure the stock performs well so they will make more money when they sell. In January, 2008, the stock was selling for approx. $15.00 per share. For a $300,000 award, the person received approximately 20,000 shares. The final price of the stock when Bayer bought Conceptus was $31.02 - the value had doubled. That $300,000.00 award is now worth of $600,000. And you think I'm still going to believe the doctors are neutral or independent? ABSOLUTELY NOT... They are motivated by dollar signs, and in the case of Dr. Mark Levie, we've caught you red handed and I hope to be a fly on the wall when you are thrown under the bus. Forget that, I want to drive the bus, and my e-sisters will be my passengers.

Now, let’s talk studies - there have been seven formal studies on Essure, only 7. Each and every one has been paid for by Conceptus and oversight is provided by a medical board member. There has never been a study which is independent. The numbers from these studies are what the FDA continues to site when responding to us about the safety of the device. These numbers are ALWAYS going to say the device its safe. The doctors have a vested financial interest in making the device look safe. They dismissed one person from a study, and it you've done it once, you've done it before and you'll do it again.

Did I mention I smell a rat?

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