NCHR’s Patient Advocacy Workshop: What I Learned

Hello Warriors;


A snapshot I took of a beautiful vigil held at the Rochambeau Statue in Lafayette Square in D.C. after the Paris attacks.

This past week/weekend, amidst the worldwide panic and sorrow over the terrorist attacks in Paris, I attended the National Center for Health Research’s second Patient Advocacy Workshop in Washington, D.C. It was strange to be there under such uncertain circumstances. I couldn’t help but worry about if one of our nation’s capitol cities, even D.C., could be next. Thankfully, that was not the case, and all of us returned to our homes safely, despite concerns at the three D.C. airports: Several People Removed from Spirit Airlines on flight departing BWI.




Fellow Patient Advocates at the NCHR Workshop

I felt at home, as I was surrounded by 30 or so patient advocates; individuals just like me, who advocate for a loved one, or by their own injuries, effort daily to raise the public’s awareness about the breadth and depth of medical harm. Many of these folks touched my heart. Like all of us, they each struggle to comprehend how so much harm has befallen so many and has come from the very institutions meant to promote good health and protect and preserve health as stakeholders in the health of our nation.



If you are mesh injured, and you don’t think this post is for you, keep reading.

Patients and advocates came from all corners of the nation for this conference: Hawaii, Pennsylvania, California to Tennessee; and everywhere in between, including Texas! Each attendee was invited for differing healthcare concerns, but we were all there for the same purpose: To unite as advocates who are committed to bringing real-world patient voices to industry and government.

After breakfast Friday morning, we began with a test to gauge our current knowledge base and understanding of the FDA and its regulatory practices. We took a follow-up test at the end of the program to gauge what we learned from our training sessions. I don’t have my results yet, but I promise to share them once I do!


Diana Zuckerman, Ph.D. and President of the National Center for Health Research AND the Cancer Prevention and Treatment Fund

Our training began in earnest as we learned the ins-and-outs of the FDA and its regulatory policies from our host and the founder of the National Center for Health Research and the Cancer Prevention and Treatment Fund, Diana Zuckerman, Ph.D. Dr. Zuckerman has a lengthy career as a scientist and researcher, as a faculty member at Vassar and Yale, and as a researcher at Harvard. Her work on Capitol Hill has ranged from Congressional staffer to AAAS Congressional Science Fellow and former senior policy advisor to First Lady Hillary Rodham Clinton. She has spoken dozens of times before Congress, federal agencies, state legislative committees, and even the Canadian Parliament! Formally trained in epidemiology and public health at the Yale College of Medicine, her work at NCHR now focuses on creating a stronger FDA. She serves on the federal Medicare Coverage Advisory Committee and on the board of directors at The Reagan-Udall Foundation and the Alliance for a Stronger FDA.

We then took time to introduce ourselves, our areas of interest, and what we hoped to gain from our attendance and training. Those moments were some of my favorites. That time gave me hope, because there are so many individuals who have made great strides in their advocacy. It reminded me that the possibilities for our mesh-injured community are endless. It renewed my hope in our shared cause. As is most often the case, it is the individual human being who has the capacity to make the most significant changes for good. I am reminded of the famed quote by author, seeker, academic, anthropologist and all-around troublemaker, Margaret Mead, who said,

“Never believe that a few caring people can’t change the world, for indeed, that’s all who ever have.”

I met more than a few caring people at the workshop.

I met a man who suffers from Ataxia; a congenital, degenerative neurological disorder that progressively affects coordination, speech, and swallowing. It must have required enormous effort each time he spoke, but I am forever changed by the confidence with which he uttered each word. Unafraid to ask for help, as he should be, he introduced himself and offered, “If you don’t understand what I say; ask me to repeat it.” What a powerful message, one from which we all can learn. Find out more about Ataxia from The National Ataxia Foundation, established in 1957, and dedicated to improving the lives of persons with Ataxia through support, education and research.

I met parents who have lost their young adult daughters to the often downplayed, lethal risks associated with hormone-based contraceptives. These parents have taken action; not because someone told them to, but because they want to honor their daughters’ legacies and raise awareness, with the hope that they will prevent others from experiencing the devastation of losing a child. Their heartbreak was so palpable that it was like another advocate in the room. Many people, from all walks of life, say that there is nothing in life so painful as the loss of one’s child.

Richard and Dianne Ammons honor the life and loss of their daughter, Annie, to YAZ, a drospirenone, hormonal contraceptive. They raise awareness through their Letters To Annie website. Other advocates Joe ( and Dru ( honor their daughters’ legacies and raise awareness about deadly blood clots associated with the Nuva Ring hormonal contraceptive device.

I met a charter member of Washington Advocates for Patient Safety, who though injured by a metal-on-metal hip implant herself, still advocates for others, even as she continues to suffer daily. In fact, The Center for Medicare and Medicaid Services,  just yesterday, announced their Comprehensive Care for Joint Replacement Model (CJR), saying,

Hip and knee replacements are the most common inpatient surgery for Medicare beneficiaries and can require lengthy recovery and rehabilitation periods. In 2014, there were more than 400,000 procedures, costing more than $7 billion for the hospitalizations alone.”

I met a man, now disabled for life, who was implanted with a spinal medical device used off-label by his surgeon. With access to the best care in the world and a powerful family to boot, not even he could escape the long arm of medical harm. His story speaks to how overwhelming the issue of medical device harm has become. It does not discriminate. 

I met a U.S. veteran from Austin, TX who was exposed to Agent Orange during his service to our country and has suffered and survived prostate cancer as a result. He now facilitates a Prostate Cancer Support Group, a group that I imagine my husband’s grandfather, a fighter pilot in the Vietnam and Korean Wars, would have benefited from greatly. 

I met mothers whose children suffer from rare diseases, and for which it is so difficult to raise awareness (not so different from mesh injury in that regard). I met many women who suffer from rare heart disease, yet are stigmatized. We agreed that no one deserves to be judged by any health condition, especially the number one killer in the U.S. for both men and women: heart disease.

I met a woman from Essure Problems who was involved with the recent FDA public hearing addressing Bayer HealthCare’s Essure System for permanent female sterilization and the adverse reactions associated with the permanent contraceptive device. Somewhat shy and reserved, it was hard to imagine that she recently spoke to the FDA. I point out this fact, because it is proof-positive that anyone can be an agent of change. All that is necessary to become an influential patient advocate is that you care deeply about others, and that you’re willing to push through any fear that could hold you back or keep you silent.

IMG_1167Two representatives from the FDA gave a brief presentation to explain how patient advocates can become involved in patient-centered policy at the FDA.

We also heard from PCORI, the Patient Centered Outcomes Research Institute  and how, in just three short years, the newly-formed organization has funded many research projects with the aim of measuring outcomes which relate to the patient’s perspective and well being. We learned that, far too often, research in healthcare is designed to test and measure factors that may impact the patient, but may not always be designed to assess the benefit of any given outcome to the quality or quantity of patients’ lives.

Susan Molchan, MD, a decorated physician and scientist provided an eye-opening perspective. Having worked in private practice, as a staff psychiatrist for the National Institute of Mental Health (NIMH), and as a medical officer at the FDA, she is a walking library of experiences! She has returned to clinical work and writing in her areas of interest: healthy aging, health literacy, and conflicts of interest in medicine. She now serves as attending psychiatrist at the Walter Reed National Military Medical Center in Washington, D.C. She spoke to us in her capacity as a member of the board of directors for the National Physician’s Alliance, an organization which champions “The Unbranded Doctor,” and the core values of the medical profession that many would say have been lost: Service, Integrity, and Advocacy. I’m glad to know the NPA exists, for surely there are many physicians who care deeply about the core values of their chosen profession and realize that so much trust between patients and physicians has been broken. It’s a great resource for us, as patients and advocates, too.

Screen Shot 2015-11-17 at 2.25.49 PM

Desirée Walker, two time Breast Cancer Victor

We heard inspiring talks by longtime patient advocates like Desirée Walker, who having survived breast cancer twice, refers to herself as a “Cancer Victor.” Desirée works with the U.S. DOD-funded breast cancer research program and has made such an impact for good towards the search for a cure.


Screen Shot 2015-11-17 at 2.27.40 PM

Tim Horn, 20+ year survivor of HIV and HIV/AIDS patient advocate

Tim Horn, HIV Project Director at the Treatment Action Group, reminded us that the long journies of HIV/AIDS patients and advocates, who came before us, can serve as an example for all of us. Though the road is long, significant change can be brought about by our long-term commitment and the continued courage to speak out, even through setbacks and progress that seems to come far too slowly for those who are suffering and dying.

The lives of these patients and advocates and the stories they tell are just like ours.

We are most certainly not alone in our fight against the epidemic of preventable medical harm and the diseases, common to all, which require the FDA to get involved in service of America’s public health. We even share the hurt that all patients suffer under the guidance of a public health system that can be much too bureaucratic to mobilize in the face of infectious disease. We’re experiencing that very problem now, as the irresponsible use and administration of antibiotics continues to hasten antibiotic resistance.

In sharing these insights, my hope is that no person in our community would feel abandoned or alone. We can connect to others through our shared suffering, but once connected, we can live our lives alongside one another to create a “new normal” which can draw us out of the isolation and loneliness of chronic illness. Suffering is suffering. We all experience the common feelings of anger, loss, regret, sorrow. . . and hope. As Desirée says,

“He who has health has hope. And he who has hope has everything.”

Though many of us have lost a great deal of our health, and we grieve that loss; we can also choose hope, for we still have health.

Thank you to the staff members at NCHR and PCORI for allowing us to learn from one another and together, as individuals working in concert, help us to gather our voices so that each of us may be heard louder still.

And for those of you who actually read this far, here’s a funny for you. If it’s one thing I think we all agree on, it’s that humor is often the best medicine, and sometimes the only medicine for our broken bodies and hearts.

~ For my mother, whom I love with audacious action. ~






“2 Doctors 2Day” – Dr. Kevin Benson of Sioux Falls/Dr. Vincent Lucente of Allentown, PA

Hello Warriors;

Coloplast Restorelle Direct Fix for POP; the device used in this FDA 522 study.

Coloplast Restorelle Direct Fix for POP; the device used in this FDA 522 study.

Below are two more physicians who are participating in the prospective cohort study, ordered by the FDA:

Restorelle® Mesh Versus Native Tissue Repair for Prolapse

If you live in or around Sioux Falls, SD or Allentown, PA, please be aware of these recruiting physicians, and please share this post with friends and family members who live in these areas.

Kevin Benson, MD, MS of Sioux Falls, SD

Kevin Benson, MD, MS of Sioux Falls, SD

Sanford Research

Sioux Falls, South Dakota, United States, 57104

Contact: Jessica Howard/605-328-1389  

Principal Investigator: Kevin Benson, MD, MS

Dr. Vincent Lucente, a Coloplast Proctor, recruiting new women for implant with Coloplast Restorelle Direct Fix.

Dr. Vincent Lucente, a Coloplast Proctor, recruiting new women for implant with Coloplast Restorelle Direct Fix

The Institute for Female Pelvic Medicine and Reconstructive Surgery 

Contact: Marcie Taff, RN/610-435-9575   

Principal Investigator: Vincent Lucente, MD, MBA  

It is no surprise that Dr. Lucente is recruiting for the Coloplast Restorelle study that would implant new women with a Coloplast product. The doctor touts his role as a “Proctor” for Coloplast. A proctor is usually a doctor, paid by a manufacturer, (in this case, Coloplast) to tour the U.S. or other parts of the world to teach other physicians how to use the manufacturer’s product(s). In this case, Dr. Lucente has been touring Australia, teaching physicians how to use Coloplast’s “Altis Single Incision Sling” for SUI. Many of Coloplast’s products under litigation, for SUI and POP, are still sold.

See below for a video describing the placement of the “Altis” device.

The important point here is that many doctors (and very obviously Dr. Lucente) have an incentive to recruit patients for these studies, because THESE DOCTORS ARE PAID BY THE MANUFACTURER TO DO SO. To me, that represents a clear conflict of interest for any FDA-ordered follow-up study (522 study) to render unbiased science.

Coloplast “Altis” Procedure Animation

I wouldn’t necessarily say I’m ending this post on a high note, but I am ending it on a note. . . from the great Billy Joel and his famous song, “Allentown.”

Dear Allentown, PA:

Don’t let the manufacturers of ANYTHING “take all the coal from the ground” again or return under a new name to take your mothers, grandfathers and fathers who “met at the USO” and fought and survived World War II at home and abroad. Mesh manufacturers, too, will “crawl away” leaving a generation of your families demolished by polypropylene mesh. 

I wouldn’t say it if I hadn’t seen it myself.

Generations of families are being wiped out by an enemy of a different name.

The rest of the country thinks of your community as the great, sturdy, American, Allentown.

Stand up to mesh in your community!

“Allentown” Lyrics/Billy Joel (1982)

Well, we’re living here in Allentown
And they’re closing all the factories down
Out in Bethlehem they’re killing time
Filling out forms
Standing in line

Well, our fathers fought the second World War
Spent their weekends on the Jersey shore
Met our mothers in the USO
Asked them to dance
Danced with them slow

And we’re living here in Allentown
But the restlessness was handed down
And it’s getting very hard to stay

Well we’re waiting here in Allentown
For the Pennsylvania we never found
For the promises our teachers gave
If we worked hard
If we behaved

So the graduations hang on the wall
But they never really helped us at all
No they never taught us what was real
Iron and coke
Chromium Steel

And we’re waiting here in Allentown
But they’ve taken all the coal from the ground
And the union people crawled away

Every child had a pretty good shot
To get at least as far as their old man got
But something happened on the way to that place
They threw an American flag in our face

Well, I’m living here in Allentown
And it’s hard to keep a good man down
But I won’t be getting up today

And it’s getting very hard to stay
And we’re living here in Allentown

“A Doctor A Day” – Dr. Steven Kleeman/Cincinnati, OH and “A Dose of Hope”

Hello Warriors!

Steven Kleeman, MD practices in Cincinnati, and West Chester, OH at Bethesda North Hospital, Good Samaritan Hospital & TriHealth Hospital, Evendale

Steven Kleeman, MD practices in Cincinnati, and West Chester, OH

Here’s your “Doctor a Day.”

READ ON FOR “A Dose of Hope!”

If you live in or around the Cincinnati area, please be aware that this doctor is recruiting new patients for a prospective cohort study which would include the implant of NEW WOMEN with Coloplast’s Restorelle Direct Fix for repair of POP. Here is the study: Restorelle® Mesh Versus Native Tissue Repair for Prolapse

Please share with any friends and/or family members who live in the area, and please take action, yourself, by calling or emailing the doctor to share with him why you think this study is dangerous, or whatever your personal thoughts may be. We may never know who we’ve helped with a single phone call or email.

Dr. Steven Kleeman practices at at Bethesda North Hospital,
Good Samaritan Hospital, and TriHealth Hospital, Evendale.

Good Samaritan Hospital

Contact: Vivian Ghodsi, RN, CCRC    513-463-4308

Cincinnati, Ohio, United States, 45220 

Principal Investigator: Steven Kleeman, MD, FACOG 

A Dose of Hope

I am extraordinarily grateful and humbled to have been accepted and awarded a scholarship to participate in an important patient advocacy workshop next week in Washington, D.C.!

Diana Zuckerman, Ph.D. and President of the National Center for Health Research AND the Cancer Prevention and Treatment Fund

Diana Zuckerman, Ph.D. and President of the National Center for Health Research AND the Cancer Prevention and Treatment Fund

Diana Zuckerman, Ph.D., President of the National Center for Health Research and the Cancer Prevention and Treatment Fund is the workshop’s organizer. Not only does Ms. Zuckerman have a lengthy and impressive career in advocating for patient health and safety; she is also very knowledgeable about mesh and has been speaking out about its risks more than a decade! In fact, she participated in a briefing on Capitol Hill with Dr. Shlomo Raz/UCLA a few years ago.

I am BEYOND GRATEFUL for the scholarship and for this opportunity to learn from, not only Diana, but also her colleagues and the other, 30-or-so, attendees.

The workshop is a two-day learning seminar, and I’m preparing this weekend so I come with a fresh mind, ready to listen and learn. If you have any questions you’d like me to bring up at the workshop, please email me at: themeshwarrior[at]gmail[dot]com or comment on this post with your question.

Helping, Hoping for Healing . . . 

Aaron/The Mesh Warrior

“A Doctor A Day” – Costas Apostolis, MD/Akron Urogynecology Associates AND What Would You Say?

Hello Warriors;

Here is your “Doctor A Day,”  Costas Apostolis, MD at Akron General. You know what to do!

Costas Apostolis, MD is currently recruiting new patients for mesh implant in Akron, OH.

Costas Apostolis, MD is currently recruiting new patients for mesh implant in Akron, OH.

Akron Urogynecology Associates

Akron, Ohio, United States, 44333

Contact: Connie Cottrell    330-344-7681

Principal Investigator: Costas Apostolis, MD

Science with Hope

Many of you may have seen the recent video posted by Dr. Shlomo Raz and his team at UCLA. Associate Professor, Division of Pelvic Medicine and Reconstructive Surgery, Department of Urology, Ja-Hong Kim, MD, and a fellow of Dr. Raz, hosts a 20-minute video presentation titled, What You Need to Know About Vaginal Mesh for Female Pelvic Surgery.” Dr. Kim opens her talk by saying, she will provide a “clear, concise overview of mesh.” Finally, a well-respected surgeon is putting transvaginal mesh in plain English. This video will surely provide a much better education for women who are considering mesh as an option for repair of POP or SUI. Please watch the video below, and then read the rest of my post.

  • 1:25 – Dr. Kim defines Stress Urinary Incontinence (SUI) as a loss of urine during physical activity due to weaknesses of the pelvic floor. Dr. Kim notes that a woman’s lifetime risk for developing SUI is 20% – 40%. A 20% variability represents several standard deviations. I believe it is the most conservative approach to cite the highest level of known risk in treating SUI with mesh: 40% LIFETIME RISK.
  • 1:42 – Dr. Kim defines Pelvic Organ Prolapse (POP) as a vaginal bulge of pelvic organs resulting from weaknesses of the pelvic floor and cites that a woman’s a lifetime risk for POP is 30% – 50%. Again, with a 20% variability, I believe the most conservative approach, when contemplating repair with mesh, would be to use the highest incidence of lifetime risk: 50% LIFETIME RISK.

The Coloplast Restorelle® Mesh Versus Native Tissue Repair for Prolapse study for which I’ve been posting “A Doctor A Day,” has INCLUSION and EXCLUSION criteria.

I’m concerned about two of the INCLUSION criterion, specifically:

  • Subject has pelvic organ prolapse with leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥0 and C≥ -1/2 tvl or Bp ≥0 and C≥ -1/2 tvl
  • Subject reports a bothersome bulge they can see or feel per PFDI-20 question 3, response of 2 or higher (i.e. responses of “somewhat”, “moderately” or “quite a bit”)

These two criterion for INCLUSION are part of a longer list of criteria that defines a “good candidate” for the study. A woman who has early stage prolapse (Ba ≥0 and C≥ -1/2 tvl or Bp ≥0 and C≥ -1/2 tvl) and/or answers questions about how “bothersome” a “bulge” is with the answer of “somewhat” or “moderately” bothersome is considered a “good candidate” for the study.

In my many discussions with urogynecologists, some of them have been shocked, and even quite upset, that a mesh implant was used for a woman in early or moderate stage prolapse. These physicians said,

“Treatment of POP with surgical intervention and mesh implant should be a TREATMENT OF LAST RESORT.”

According to the University of Virginia, there are stages of POP, 0-4.

  • Stage 0 means that there is no prolapse. The pelvic organs like the vagina, bladder and rectum are perfectly supported by the ligaments in the pelvis.
  • Stage 1 means that there is virtually no prolapse. The pelvic organs are very well-supported by the ligaments in the pelvis.
  • Stage 2 prolapse means that the pelvic organs are not as well supported by the ligaments and have begun to fall down. In Stage 2 prolapse, the organs are still inside the vagina.
  • Stage 3 prolapse means the pelvic organs are beginning to bulge to or beyond the opening of the vagina.
  • Stage 4 prolapse means the pelvic organs are completely outside of the vagina.

Do you know which stage of prolapse you have/had at the time of mesh implant?

Do you think it is ethical for a study to recruit NEW patients who are in early-stage prolapse?

If you could talk to a woman who is considering participation in this study, what would you tell her?


“A Doctor A Day” Keeps This Study Away/Novant Health Urology Partners, Winston-Salem, NC

Hello Warriors!

Dr. John J. Smith, III of Novant Urology Partners in Winston-Salem, NC

Dr. John J. Smith, III of Novant Urology Partners in Winston-Salem, NC

Please be aware if you live in the Winston-Salem area. Dr. John J Smith, III of Novant Health Urology Partners is recruiting for implant of new women in a study sponsored by Coloplast and ordered by the FDA.

Restorelle® Mesh Versus Native Tissue Repair for Prolapse

Novant Health Clinical Research

Winston-Salem, North Carolina, United States, 27103

Contact: Kim Robinson

Principal Investigator: John J Smith, III, MD

A Crazy Little Thing Called Hope

In the midst of working our way through the crazy-making maze of our healthcare system as it is now, how do we stay HEALTHY? How do we avoid danger?

I am not suggesting that you follow this physician’s advice, but I find it very telling. The last time I was in the ER with my mom, her admitting ER physician came to speak with me about some of her test results. Completely unsolicited, the FIRST thing he said to me was,

“The best way to keep your mom healthy is to keep her away from doctors.”

WOW! This unsolicited advice from a doctor I had NEVER met, who knew very little about my mother’s medical history! Honestly, I was not surprised he said it. I was just surprised it was the FIRST THING OUT OF HIS MOUTH!

While we still have the ability to CHOOSE which doctor we believe will best provide care for our speciality care needs and our total health, we can continue to educate ourselves – about our personal medical history, medical terminology, and the benefits and risks of any medications or treatments that may be recommended to us by our healthcare professionals.

Pause-iconLately, I’ve been learning to “push the pause button.” Stop and think. If my doctor recommends a treatment, it’s responsible for me to research the risks and benefits and then ask for a second consultation once I have more education about any treatment that will affect my body and my life.

So today, as you think about your own life, your own body, your own health; think about pressing the pause button. Stop. Think. Research. Consult. Decide. All of those actions do not have to be done in one consultation with your doctor.

YOU are the most important person in the room when you’re with any doctor. After all, it’s your life. With “pressing pause” comes hope and a renewed sense of control over your own health destiny. I hope this little, seemingly obvious, technique helps you regain a sense of your options and a sense that YOU are the MVP in your healthcare decisions.

“A Doctor A Day” William Porter, MD of Charlotte, NC . . . and An Apology

Hello Warriors;

Here is your “Doctor a Day.” You know what to do. Call, email, question. Always question.

William Porter, MD of Novant Health Urogynecology, Charlotte, NC is actively recruiting for the FDA’s 522 prospective cohort study: Restorelle® Mesh Versus Native Tissue Repair for Prolapse

William Porter, MD of Novant Health Urogynecology in Charlotte, NC

William Porter, MD of Novant Health Urogynecology in Charlotte, NC

Novant Health Urogynecology

Charlotte, North Carolina, United States, 28210

Contact: Christine Mackey    704-574-5157

Principal Investigator: William Porter, MD

An Apology . . . .

As I was thinking this weekend, I realized that in sharing each doctor who is actively recruiting for this study that would implant NEW patients with Coloplast’s Restorelle for the repair of POP, I have been remiss in my “Doctor A Day” postings. I have not been doing what is core to my cause. I vowed to provide you with information, but I also promised to PROVIDE YOU WITH HOPE.

In these posts, I have not provided HOPE. For this failure, I ask, “Will you forgive me?”

hope changes everythingI hope you will. This blog is about providing you with helpful information, but it’s also about providing hope, for if we lose hope, then we have surely lost everything.

Science should be a celebration of human endeavor, the indomitable human spirit, and the ability of science, when used for GOOD, to overcome the barriers and burdens of Mother Nature that lead to human suffering and pain.

So, how does our mesh-injured community celebrate science when everywhere we turn, we seem to find another doctor who has minimized our suffering; another researcher with a clear conflict of interest; another underhanded tactic used by a lawyer; another failure of the FDA to protect us; and yet another layer of the onion, peeled back to reveal something even more horrendous?

We celebrate the true scientists among us. They are still out there.

As I’ve been sharing “A Doctor A Day,” a question occurred to me:

“What does it mean to be a ‘TRUE SCIENTIST,’ and when did the twin disciples of science and medicine begin to drift apart in such seemingly different directions?”

I immediately recalled the answer of a new friend, whom I met just recently. A chemist himself, I was truly curious and so asked him, “So, what is the difference between a true chemist and someone who uses chemistry?” I found his answer to be simple yet profound.

“A true chemist does chemistry for the sake of doing chemistry,” he said.

My friend’s answer provoked in me another question that I did not explore at the time.

“Where are our generation’s heroes of science, those men and women who, in their various hyper-intellectual specialities, are currently making history by ‘doing science for the sake of doing science?'”

And why do we now refer to scientists as “researchers?” I don’t think I like that term. At least for me, the word “researcher” carries with it a connotation that an appropriately educated person works for someone or something other than the cause of science itself, maybe even for a company who seeks to pay any given researcher to find the answer that company wants, not the answer that is scientifically valid. That is not “science for the sake of science.” That is “science for the sake of profit.”

Clearly, everyone must earn a living, but somehow the scientists of history did make a living, many times before they were employed at all. They were scientists because they wanted to be.

Maybe scientists became researchers with the advent of today’s modern Corporation, an entity whose highest value is profit.

The Corporation (Click link to view the informative documentary.)Screen Shot 2015-10-27 at 3.55.54 PM

In contrast to “researcher,” the term “scientist” conveys a sense of the noble pursuit of truth, as revealed by science. For me, this word offers more meaning. The imagery I get is one of anticipation, hope and a fidelity to the purity of the scientific method.

Dr. Neil deGrasse Tyson, astrophysicist, cosmologist, author, and science communicator. In 2015 for his "extraordinary role in exciting the public about the wonders of science."

Dr. Neil deGrasse Tyson, astrophysicist, cosmologist, author, and science communicator. In 2015 for his “extraordinary role in exciting the public about the wonders of science.”

I’m thinking we need to borrow from Justin Timberlake’s lyrics here and “bring sexy back” to science and scientists.

Why should our society revere doctors as if they were gods, and not think about from where their earthly powers come, the steady long-suffering pursuit of scientific knowledge by SCIENTISTS?

The lucrative “practice of medicine,” is rooted in the dreams of scientists, the discoverers, the curious among us, those with a deep-seated need to find and find out, those with a “keen sensing search,” as Nikola Tesla has been quoted to say. By this method, we uncover the highest calling to the scientist.

Sir Alexander Fleming in his lab at London University

Sir Alexander Fleming in his lab at London University

History-making scientists of the past brought us life-saving discoveries. Many of you may know the story of Sir Alexander Fleming, who in 1928, discovered the enzyme lysozyme and the antibiotic substance penicillin from the fungus Penicillium notatum. Sir Fleming is quoted as saying,

“One sometimes finds what one is looking for.”

I love that quote. It acknowledges that Sir Fleming had the fortitude of character to know his endeavors might not reveal what he’d hoped, but, alas, that is the nature of science. Science reveals truth – not convenient truth, not truth meant for manipulation, not truth meant be to harm those whom it may benefit. Sir Fleming worked at London University.

Below are two living scientists, studying polypropylene and its effects on humans. They are to be celebrated! With many hundreds of articles published as first author, these men have C.V.s that echo what my chemist-friend said.

These men “do science for the sake of doing science.”

Thank you for chasing protons, mixing potions, and failing to find a convenient truth, but succeeding to find a scientific truth in service of humanity. 

Claudio Birolini MD, PhD, Abdominal Wall and Hernia Repair at the University of São Paulo, School of Medicine

Claudio Birolini
MD, PhD, Abdominal Wall and Hernia Repair at the University of São Paulo, School of Medicine

Dr. Claudio Birolini works for the University of São Paulo, School of Medicine.

Mesh Squamous Cell Carcinoma:

Authors: Birolini Claudio, Minossi JG, Lima CF, Utiyama EM, Rasslan S.

Dr. Vladimir Iakovlev St. Michael's Hospital, Toronto Implantology, Oncology, Pathology

Dr. Vladimir Iakovlev
St. Michael’s Hospital, Toronto
Implantology, Oncology, Pathology

Dr. Vladimir V. Iakovlev works for St. Michael’s Hospital, Toronto.

Long-term effects from the degradation of polypropylene in vivo:

Authors: Vladimir V. Iakovlev, Scott A. Guelcher, and Robert Bendavid

A “Doctor a Day” Keeps This Study Away/Karolynn Echols/Cooper University Hospital, Camden, NJ

Hello Warriors;

Here is your doctor-a-day to call regarding the Coloplast Restorelle vs. Native Tissue Repair study, currently recruiting new patients for implant.

Karolynn Echols, MD

Karolynn Echols, MD

Karolynn Echols, MD

Cooper University Hospital
Camden, New Jersey, United States, 08103
Contact: Gunda Simpkins, RN    856-968-7547
Principal Investigator: Karolynn Echols, MD, FACOG

“A Doctor A Day” – Douglas Van Drie of Grand Rapids, MI

Dr. Douglas Van Drie of The Institute of Michigan Female Pelvic Medicine & Urogynecology is actively recruiting for the FDA 522 Study:

Restorelle® Mesh Versus Native Tissue Repair for Prolapse

Dr. Douglas Van Drie of Grand Rapids, MI is participating in the study: Restorelle® Mesh Versus Native Tissue Repair for Prolapse

Dr. Douglas Van Drie of Grand Rapids, MI

Female Pelvic Medicine & Urogynecology Institute of MI
Grand Rapids, Michigan, United States, 49503
Contact: Beth Rogers, RN    616-588-1800
Principal Investigator: Douglas Van Drie, MD

You know what to do MESH WARRIORS!

Previous “Doctor A Day” Blogs:

Dr. Arturo Menchaca/Paris Community Hospital, Illinois

Dr. Sherry Thomas/Angoura Hills, CA

Dr. Ty Erickson of Rosemark Women Care Specialists in Idaho

Dr. Babak Vakili of Delaware’s Christiana Care Health System

Dr. Oz Harmanli of Baystate Health System, Springfield, MA

A Doctor A Day Keeps This Study Away/Oz Harmanli, MD & Pam Behrens, NP of Baystate Health System/Springfield, MA

Hello Warriors,

Dr. Oz Harmanli, actively recruiting NEW patients for implant with Coloplast's Restorelle.

Dr. Oz Harmanli, actively recruiting NEW patients for implant with Coloplast’s Restorelle.

Among the 45 or so physician/practices and hospitals participating in a prospective cohort study to test mesh against native tissue repair is Dr. Oz Harmanli.

I have to admit, he looks like a nice guy. Maybe that means he’ll listen when we call to tell him how dangerous we believe this study is:

Restorelle® Mesh Versus Native Tissue Repair for Prolapse

Baystate Health System
Springfield, Massachusetts, United States, 01199
Contact: Pam Behrens, NP    413-794-7045
Principal Investigator: Oz Harmanli, MD, FACOG

For ideas/suggestions for making your call, please see my previous posts:

Dr. Arturo Menchaca/Paris Community Hospital in Illionois

Dr. Sherry Thomas/Agoura Hills, CA

Dr. Babak Vakili and Jennifer Mann, RN BSN of Rosemark Women Care Specialists in Idaho

And I found this quote by Nikola Tesla to be very inspiring. Tesla is known for being a scientist at heart, a scientist for science’s sake. I am inspired by his words because they summon a time when man’s pursuit of science was much less adulterated by a motive to profit, a time when science and humanity served in concert to produce a better quality of life for all. Also regarded as a futurist, even in 1905, Tesla knew that through “the strife of commercial existence . . . what is ridiculed, condemned, combatted, suppressed,” will emerge triumphant.

My hope is that his words will prove true, and that by science in service of humanity, “so [will] we get our light.”

Mesh Squamous Cell Carcinoma:

Thank you scientists and authors: Birolini C, Minossi JG, Lima CF, Utiyama EM, Rasslan S.

Long-term effects from the degradation of polypropylene in vivo:

Thank you scientists and authors: Vladimir V. Iakovlev, Scott A. Guelcherand Robert Bendavid

Tesla, aged 34 Born: 10 July 1856 Smiljan, Austrian Empire (modern-day Croatia) Died: 7 January 1943 (aged 86) New York City, New York

Tesla, aged 34
Born: 10 July 1856
Smiljan, Austrian Empire (modern-day Croatia)
Died: 7 January 1943 (aged 86)
New York City, New York

“It is not a dream, it is a simple feat of scientific electrical engineering, only expensive – blind, faint-hearted, doubting world! […] Humanity is not yet sufficiently advanced to be willingly led by the discoverer’s keen searching sense. But who knows? Perhaps it is better in this present world of ours that a revolutionary idea or invention instead of being helped and patted, be hampered and ill-treated in its adolescence – by want of means, by selfish interest, pedantry, stupidity and ignorance; that it be attacked and stifled; that it pass through bitter trials and tribulations, through the strife of commercial existence. So do we get our light. So all that was great in the past was ridiculed, condemned, combatted, suppressed – only to emerge all the more powerfully, all the more triumphantly from the struggle.” – Nikola Tesla “The Transmission of Electrical Energy Without Wires as a Means for Furthering Peace,” Electrical World and Engineer, January 7, 1905″

Taking a Break from “A Doctor A Day” to report some GOOD NEWS!

Hello Warriors;


Ms. Esperanza Worley, Deputy District Director for U.S. Congresswoman Eddie Bernice Johnson (left) and Joleen Chambers of FIDA speak passionately about preventable harm by med devices.

This morning was a great morning. Fellow patient advocate, Joleen Chambers of FIDA (Failed Implant Device Alliance), and I met with Ms. Esperanza Worley, Deputy District Director for U.S. Congresswoman Eddie Bernice Johnson of Texas’ 30th District. We met with Ms. Worley for more than an hour, and we covered quite a bit of ground.

We asked that the Congresswoman, a former RN herself, take immediate action regarding the serious, life-altering and PREVENTABLE injuries affecting mesh-injured patients and patients of Bayer’s Essure device for permanent female sterilization.

Jeffrey_ShurenWe emphasized the FDA’s lax, highly-negligent oversight of the medical device industry in general, even calling for the resignation of, Jeffrey Shuren, Director, Center for Devices and Radiological Health since 2010, who has come under scrutiny regarding clear conflicts of interest, which render him unfit for such a position with the FDA. Read more from Joleen’s FIDA blog, here: Injured Device Patients Blitz CDRH’s Shuren.

Allison W. Shuren, Partner and Co-Chair of the FDA/Healthcare Practice Group at D.C.-based Arnold & Porter, LLC.

Allison W. Shuren, Partner and Co-Chair of the FDA/Healthcare Practice Group at D.C.-based Arnold & Porter, LLC.

Also of great concern, Shuren’s wife, Allison W. Shuren, is a partner at Washington-based law firm Arnold & Porter, LLP and is co-chair of the firm’s FDA/Healthcare Practice Group. As her bio states, she “advises a broad group of clients, including pharmaceutical, medical device, and biotechnology companies, physician practice management companies and physician practices, hospital and academic medical centers, ambulatory surgery centers, healthcare professional societies, diagnostic imaging centers, and Internet-based healthcare companies.”

Notice Arnold & Porter makes the list of Large Public Policy Practices in Law Firms. *Source: National Law Journal

Arnold & Porter – In “The Influence 50” as one of the number of law firms that counted almost $100 million or more in revenue from work intended to influence federal policy.

One can easily conclude that the couple’s entire household income is dependent upon the success of a failing and harmful tax-payer-funded regulatory agency – maybe the most important regulatory agency responsible for the domestic safety and protection of the American people. Read the National Law Journal’s article in its entirety here: How Large are the Public-Policy Practices Within Law Firms?

Ms. Worley and I discuss important patient safety issues and the failure of the FDA to serve the American people.

Ms. Worley and I discuss important patient safety issues and the failure of the FDA to serve the American people.

We found in Ms. Worley a sympathetic ear, and as a woman herself, she took great interest in our shared causes. She was emphatic that she would share the information we provided her with EBJ and Washington TODAY! We spoke at length about the preventable harm that is befalling so many patients under a regime of stakeholders who stand to benefit from rushing devices to market and keeping them on the market.

I shared my family’s story of the horrors of mesh, and I shared about the recent and tragic death of my mesh-injured friend, Linda Batiste. Other topics we covered:

  • The FDA’s MedWatch Program for reporting adverse events: Passive and reactionary, MedWatch is a convoluted interface that’s difficult to navigate and not well-publicized to patients who would seek to report complications. MedWatch doesn’t serve those who have no internet access and/or are not technophiles, and thus, contributes to the under-reporting of serious adverse events.
  • Issues with Informed Consent: How is a patient enabled to provide true, informed consent when the medical device company, who stands to benefit from the patient’s consent, is responsible for educating that patient’s doctor and thus, the patient (conflict of interest, perhaps)? And how were doctors or patients to know of PERMANENT adverse events when vaginal polypropylene mesh was not studied long term before coming to market?
  • The FDA’s antiquated and deeply-flawed 510(k) process for clearance of medical devices: The current legislation for regulation of medical devices was put into effect in 1976! The FDA’s website states, “The Medical Device Amendments of 1976 followed a U.S. Senate finding that faulty medical devices had caused 10,000 injuries, including 731 deaths. The law applied safety and effectiveness safeguards to new devices.” What has legislation done to protect the millions of harmed patients since then? Clearly, it’s time to modernize this legislation, as the healthcare climate was SUBSTANTIALLY different in 1976 than it is now, almost 40 years later.
  • The FDA’s 522 post-market surveillance program often churns out faulty science. A current 522 study seeks NEW participants to compare Coloplast Restorelle vs. Native Tissue Repair.
    •  This 3-year study cannot possibly accurately reflect outcomes and complications from the implant of a PERMANENT DEVICE.
    • The study is recruiting patients as young as 18!
    • The study seeks to “exclude” patients with “a known sensitivity to polypropylene.” How are doctors going to measure that? To my knowledge, there is no test for “sensitivity to polypropylene,” and if there is, WHY wasn’t this metric used BEFORE millions of people were implanted?
    • Why is the FDA 522 study a prospective study, rather than a retrospective study? The latter would measure outcomes from a patient population already available, which seems a MUCH safer approach and the study could be longer than three years, giving more comprehensive and longitudinal data.

I am ENCOURAGED today, for this is another step towards exposing the dangers of our country’s Healthcare System AND its primary regulatory agency, the FDA. Thank you Esperanza for giving voice to our community, and for opening your heart and mind to our pleas for help.

Thank you Ms. Worley and Congresswoman, Eddie Bernice Johnson!

Thank you Ms. Worley and Congresswoman, Eddie Bernice Johnson!