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Attending a National Patient Training Workshop

Janet Holt in DC

Janet Holt in DC

Mesh Medical Device News Desk,  October 23, 2016~Two women who are part of the mesh-injured community pushed themselves to become involved in a national patient training workshop. Here’s what they found. 

The National Center for Health Research Conference

Introductory Patient Training Workshop

October 14-15 2016

Written by Janet Holt

Jane Pennington and I attended the conference together. We have learned through the years of suffering with mesh complications it is often better if we travel in pairs. One can always help the other.

Diana Zuckerman, the Founder and President of NCHR welcomed all of us patient advocates to the meeting. There were many different areas represented in this group of 31.

Kim Witczack

Kim Witczack

Kim Witczack www.Woody matters.com

janet-holt-at-pt-training-workshop

Patient Training Workshop, Washington DC National Center for Health Research

Kim spoke on the importance of being an advocate. Advocacy matters. She focused on Zoloft given “off label”. My take on her presentation was the importance of “just showing up” – Be part of the conversation for change – Be involved in the conversation.

Diana Zuckerman, NCHR

Diana Zuckerman,
NCHR

Diana Zuckerman Ph.D

Diana spoke after Kim on what we needed to know about FDA standards. How do they balance patients wanting new products and drugs with the harm that is caused to patients from devices and drugs? Did you know most hospitals are the buyers of implants not the surgeons? The surgeon normally uses the device the hospital buys. The surgeon may not have even looked at the warnings.  Most clinical trials, when used, are paid for by the manufacture. They in turn pay the doctors for the study. Did you know 98% of medical devices are not tested at all?

Miara Jeffress Ph.D

Miara Jeffress Ph.D

Miara Jeffress Ph.D.

She gave a quick break down on the different types of clinical trials. There is the “gold standard” double blinded clinical trial where neither the doctor nor the patient know what is being given.  The one with the least amount of information gathered would be an uncontrolled study. Here the doctor just follows the patients.

Susan Wood Ph.D

Susan Wood Ph.D

Susan Wood Ph.D

Ms. Wood’s topic was “How to get your voice heard at the FDA”. She reminded us the that the FDA is just made up of people. You also need to understand where they get their money from and what the FDA is allowed to do. They are only allowed to do what Congress allows them to. In order to make change, you must write comments, appear in person with comments and talk to your Congressional representative. After saying all of this you must have patience. Change is difficult. It takes years.

She then moved on to saying medical devices are the hardest to regulate. Much harder than drugs. The FDA almost never rescinds an approval of a medical device. The FDA just waits until the companies take action themselves.

Day Two

Stephanie Fox-Rawlings Ph. D

Stephanie Fox-Rawlings Ph. D

Saturday opened up with Stephanie Fox-Rawlings Ph.D

Her topic was the importance of clinic trials and the data within the clinical trial such as sex, race/ethnicity and age when treatments are studied. Your clinical trial may only consist of 10 people. Three women and seven men. Six of the men were white, and one was African American.  One man died during the trial. The treatment was not effective for three of the women, nor was it effective for the one African American. The drug was approved for all races, sex, and age. Is your head turning around yet?

Paul Brown, NCHR

Paul Brown, NCHR

Paul Brown, NCHR Government Relation Manager spoke on how patients can engage with the FDA and the NIM. On the FDA’s web site there is a link for patients. You can read on all the upcoming meetings. If you find one that interest you, such as medical devices, you can write or show up to speak.

Later that afternoon we did a mock FDA advisory committee meeting starring all of us.  It was not only fun but a great example of what to expect if you ever planned to attend one. They can be rather intimidating.

The NCHR is launching a new website for all patients to use and to learn from. You can go to this exciting new web site by typing in USA Patient Network. You can join

Jane and I both not only had a great time but we learned so much. We met women who had been harmed by different medical devices and drugs. There were women and men who represent other fields but all had an interest in patient safety. It was an awesome group of attendees.

After years of Jane and I traveling to DC for various FDA meetings, congressional hearings, a Capitol Hill Briefing, a town hall meetings and speaking before the advisory panel on mesh, we finally took a taxi to see the white house. Somehow we had never found the time to do so in the past. It was a very short walk from the taxi to the White House and back to the taxi.

Between Jane and myself we have needed 24 surgeries. It has been a very long and painful journey for both of us. Neither one of us dwells on what has past. There is nothing we can do about what happened. We can only move forward in hopes that our daughters and other women will have safer option for SUI and Prolapse treatment.

By showing up change can happen.

We were only two of a large group of injured patients and doctors speaking out on the dangers of mesh implants. It takes years to make change and a whole lot of patience. The only advice we could give other women is to JUST SHOW UP.

It does matter. ##

 

 

5 Comments

  1. Barbara says:

    This can not wait years as many will die from infections and pain!
    These mesh injured need help now not latter! This was done with out informed consent, nerve pain,septic,infections and extreamly pain with sex contracture! Plus auto immune caused by it.
    I have R.A. And lichens schlerosis and severe pelvic pain, many waiting for surgerys others trying to live with pain!
    If there is any humanity left!
    Please let us wait no more!
    The pain and torture must start to heal we need those responsible to be held accountable! And help these women now! Sincerely Barbara

  2. Kitty says:

    That is a very good thing that they are
    doing. I pray they will not be corrupted by money or fame or whatever.

  3. Traci says:

    I have had numerous surgeries and deal with chronic pain and infections. I can’t seek medical help because I have NO insurance and can’t work full time due to my numerous health problems caused by the pelvic mesh erosion. If anyone has any info to help me, please post…

  4. Cathy says:

    Thank you Janet Holt and Jane Pennington for sharing your experience with your mesh injured sisters. And thank you for “stepping up” to become a patient advocate. Our community needs more women like you two. Our community needs patient advocates that understand how difficult our journey really is. Change will come slowly, as we’ve seen in the past, but with women like you leading the charge, we may get there faster. Thanks again!

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