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February 2020 Patient Network Digest
Visit our website to see what we've added!

www.USAPatientNetwork.org

Here it is, the end of February, Spring is around the corner and we are all listening to the news reports about the coronavirus.  As advocates we are all aware that we have to separate fact from fiction, truth from misinformation, so that we share helpful information with those we know and care about.  

Here is information from the CDC 
https://www.cdc.gov/coronavirus/2019-ncov/index.html?fbclid=IwAR0adZUuq0955hglFuARvUFPNon-rPhryjwF2R2EKUc0Bi1gDddY4pPF8pw

A friend shared this photo on her FaceBook page with the heading "I really need to quit watching the news."
OUR MEMBERS IN ACTION
Angie Firmalino, advocate and USA Patient Network board member, recently participated as a panel speaker about Medical Devices and Patient Advocacy at the Arizona Women's Health Conference.
 
Medical Device Safety 2020 - Call for advocates!
We want to empower YOU! 

 Medical Device Safety 2020
Call for advocates!

Medical Device Problems is looking for advocates to help pass the Medical Device Safety Act
https://www.congress.gov/bill/116th-congress/house-bill/2669

and the Medical Device Guardians Act https://www.congress.gov/bill/116th-congress/house-bill/2915 

MDP, Medical Device Problems, is looking for individuals to help advocate for these bills in their local area by reaching out to their Members of Congress to co-sign the bills. The more Members of Congress that sign on to the bills will compel Congress to act. How will we do this? We will coach you starting with a Q & A Webinar, provide a simple, consistent plan of action and provide all the tools you need.

Interested in helping? 

1. Fill out the Call for US Advocates Form at: https://docs.google.com/forms/d/e/1FAIpQLSeJu_gf_-QuzLGiN5PHrHPiw4LAiYLn9AVBErMLu0i0Q9nxlQ/viewform

2. Look for the email invite to join the Group. 

3. Join the MDSA/MGA Congressional Group.

4. Participate in our webinars.

5. Follow a simple guide of tasks with the support of fellow advocates.

Medical Device Problems contact info is medicaldeviceproblems@gmail.com

. RESOURCE LINKS to websites and FaceBook groups
on the USA Patient Network 
website

 
We're adding a list of websites and FaceBook group to our resources tab for people who want information, support, or to connect to an advocacy group.  

If you know of a group that you want to make sure we include, please send us an email with the group's name and website or FaceBook information.  
 
REPORT ON METALS IN MEDICAL DEVICES 

By Linda J L Radach

In November 2019, the FDA held two days of hearings on metals in medical device implants and mercury use in dental amalgam. There were 50 members of the public signed up to speak during open public comment.  Breaking with past practices, the FDA allowed every speaker a minimum of 4.5 minutes.  Some speakers, such as Madris Tomes of Device Events, and Dr. Steve Tower, were given 8.5 minutes. Public Comment provided overwhelming evidence of reactions to metals in a wide variety of devices.   Still the FDA and the panel continued to put forth the narrative that these events are rare, happening to a small subset of patients. We consider this narrative to be false.

First, whenever the statement is made that adverse reactions to metal in implants are rare, no science is offered in support of that statement.  Where would that science come from?  No entity routinely documents how many devices are implanted into patients.  It is mathematically impossible to determine rarity without such a denominator. MAUDE data are both limited by gross under-reporting, the use of summary reports, exclusion of patient outcome information, redaction of implant specific identifiers, and an assumption of acceptable collateral damage. The rate of reporting is estimated to be as low as 0.5%-2% of all occurrences. (1) The continued use of summary reports allows manufacturers to lump together thousands of negative outcomes as one report, masking the true size of the problems. Patient Problem codes are redacted by the FDA, making it impossible to establish cause and effect by connecting devices to their health consequences. Even more problematic, adverse health outcomes are seldom properly categorized or understood to be related to the implant. If diligence is not given at point of care to establish the etiology of symptoms, then outcomes such as cardiomyopathy or kidney failure will never be associated with the metals in implanted medical devices.  FDA MAUDE data is also fraught with inaccurate, or at the least unclear, information. One analysis found that the most severe outcome, death, was shown to be miscategorized as malfunction or injury 17.5% – 24.7% in the sampled device reports. (2)   

“It is estimated that up to 17% of women and 3% of men are allergic to nickel and that 1% to 3% of people are allergic to cobalt and chromium. These types of reactions can be localized reactions that are limited to one area, but they can also be more generalized and affect other more distant parts of the body. ” (3) Another analysis cited the combined results of approximately 50 studies showing the incidence of metal sensitivity: 

• Among the general population is about 10-15%, with Nickel sensitivity being the highest at approximately 14%. 

• Among patients with implants, regardless of whether their implants are well-functioning or poorly functioning, is about 25%, almost twice as high as that of the general population.

 • Among patients with a failed implant is 50-60% (compiled from five investigations), five times that of the general population and two to three times higher than all patients with metal implants. (4) 

How rare is something that effects 10-15% of the general population? With a U.S. population of 328 million, (5) metal hypersensitivity easily exceeds the “rare” definition of 200,000 people. If over one million hip and knee replacements are done every year,16 and if 25% of those people have adverse immunological reactions to the metals, within 4 years a million people would experience these adverse events due to implants that are intended to be used for a much longer period of time. And, that is not rare.  

To read the complete comments and recommendations submitted to the FDA Public Docket go to: https://www.regulations.gov/document?D=FDA-2019-N-3767-0448

References

1 Craig, Amanda, Patrick O’Meley, Pamela Carter, “The Need for Greater Reporting of Medical Device Incidents,” Medical Devices Branch, Health Products Regulation Group, Department of Health, Canberra, Australia; Citation: EMJ Innov. 2019;3[1]:56-63; https://www.emjreviews.com/innovations/article/the-need-for-greater-reporting-of-medical-device-incidents/ (Accessed 2/26/2020). 

2 Meier, Lily, Elizabeth Y Wang, BA, Madris Tomes, MBA, Rita F. Redberg, MD, MSc, “Miscategorization of Deaths in the US Food and Drug Administration Adverse Events;” 2019 American Medical Association, Research Letter, JAMA Intern Med. Published online October 7, 2019. doi: https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2752362 (Accessed 2/26/2020).

https://medbroadcast.com/condition/getcondition/metal-hypersensitivity (Accessed 2/26/2020). 

4 Jacobs, Joshua J., MD; Hallab, Nadim J., PhD; Skipor, Anastasia K., MS; Urban, Robert M., AS; “Metal Degradation Products, A Cause for Concern in Metal-Metal Bearings,” Clinical Orthopaedics and Related Research, 2003; doi: 10.1097/01.blo.0000096810.78689.62; https://journals.lww.com/clinorthop/Fulltext/2003/12000/Metal_Degradation_Products__A_Cause_for_Concern_in.16.aspx(Accessed 2-26-20).

5  Census Bureau; https://www.census.gov/newsroom/press-releases/2019/new-years-population.html (accessed 2/26/2020).

Watch Dr. Tower’s public testimony at the FDA hearing on cobalt-chromium alloys in implantable medical devices, which was held in November 2019.

YouTube video of Dr. Tower's public testimony at the FDA hearing on cobalt-chromium. https://youtu.be/sNnvjgajiRQ

Today Dr. Steve Tower, who was featured in The Bleeding Edge documentary, made a public release of his research into neurologic cobaltism resulting from some medical devices like hip implants, knee implants, etc. Many patients with implants which contain cobalt-chromium alloys are misdiagnosed with dementia, Parkinson’s Disease, or other disorders due to the similar symptoms caused by cobalt toxicity, like:

  • Extreme Fatigue
  • Forgetfulness
  • Mood Disorders
  • Sleep Disorders
  • Imbalance & Muscle Weakness
  • Numbness in Extremeties
  • Tinnitus or Deafness
  • Tremors
  • Generalized Pain

You may download his research at the following link and share it with your healthcare providers if you think you are experiencing neurological symptoms from a cobalt-chromium (Co-Cr) implant.

Arthroprosthetic Metallosis Poses Risk of Neurologic Cobaltism to Millions Implanted with Cobalt-Chromium Implants

 

FEATURED USA PATIENT NETWORK MEMBER 
Tess Schulman - ASHES Nonprofit
Medical Device Problems Co-Chair
Tess answered a few of our questions
for this newsletter.

Could you tell us a little about yourself?

I  was a relatively healthy person who became very ill after being implanted with Essure, primarily with new onset-allergies and autoimmune-like symptoms. I spent 6 years visiting various specialists trying to get a diagnosis. Eventually, doctors dismissed me because my test results were normal despite being visibly ill, and no one even considered the possibility that it might be due to my new implants, probably because none of them had any idea what materials were in the device (like nickel and polyethylene terephthalate fibers) or that people can have immune reactions to devices, which are supposed to be inert and bio-compatible. The general theme was, "We don't know, so go home and take these pills for your symptoms."  

At that point, I knew if I was going to have any hope of getting an answer, I had to be the one looking for it. So, that's what I did. I started doing my own research on my symptoms, and I quickly found Essure Problems on Facebook. That was the first time I considered my implants might be the root of all my new health issues. The wealth of knowledge from other patients inspired me to advocate for others in the same boat as me, and the rest is history!

I'm now a board member of ASHES Nonprofit, which has several patient-focused initiatives. Since I have a degree in Chemistry & Physics, I'm the science communications officer, and I also chair our Medical Device Problems committee, which focuses on better regulation and post-market surveillance of all medical devices.

Why did you become an advocate? 

I became an advocate because shared patient experience is vital. It can help other patients who are struggling as well as help the FDA make better informed regulatory decisions. If it weren't for others sharing their experiences, I would not have made the connection and been able to find doctors who were willing to help me remove Essure. I have a moral imperative to continue that and give back to others. When we share and advocate, we all benefit.

What are your goals as an advocate?

My primary goal is to change how the FDA approves and labels medical devices and to educate patients (and doctors!) on how devices are approved and monitored. I was stunned to learn they aren't as rigorously tested as drugs, and most doctors have no idea. Why on earth is something that is supposed to be permanently implanted in my body studied less than a drug, which I can cease taking should it cause a bad reaction? I don't think the average patient realizes this, which puts all of us at a very distinct disadvantage when it comes to taking an active role in weighing risks v. benefits and deciding which treatments to accept. That has to change, and I think it's going to require patients demanding these changes and fighting the overwhelming resistance to these needed changes from industry.

What is your advice to others that are just starting their advocacy?

I would tell any new advocates that the two keys to success are collaboration and persistence! Team up with experienced advocacy groups and other non-profits like NCHR, even if they are tangentially relevant to your specific advocacy goals. We have strength in numbers, and that's how we get things done! You must be willing to go the distance, too, and realize it will be slow going, which is why you have to be persistent. It does get tiring, but that's why we collaborate, to share the load when some of us become overwhelmed. If I'm not knocking on the FDA's door or attending a public hearing like the one on immune reactions to metals in implants, I have a whole network of other advocates who can. We are the constant water, slowly wearing away the rock.

What challenges did you face becoming an advocate?

The biggest challenge for me was accepting that you will often get a lot of push-back from the medical community and regulatory authorities like the FDA. Most of us, as patients, suffer from white-coat syndrome and have a tough time challenging authority and asking for what we need or expect from those we perceive as "in charge" of our treatments, especially if they keep telling us our experience is merely anecdotal. I had to shift my perspective. I am in charge of my health, and my clinicians are part of my team. Teamwork is the theme with advocacy, and my experience is a data point that needs to be recorded and analyzed, along with other patients' outcomes. So, not only do I have to shift my perspective, I have to work to shift my healthcare providers' perspectives, too, and that can be very difficult.

What is your greatest accomplishment as an advocate? 

My greatest accomplishment is getting the FDA to place sales restrictions on Essure and make disclosure of the black box warning a requirement. The warning started as voluntary guidance, but I kept statistics on the women in our Essure Problems group who were implanted after it went into effect. Most of them did not get that warning or any type of disclosure of potential risks of the device. The Essure Problems committee had a meeting with Dr. Scott Gottlieb in 2018, and I gave him that information. 

I also presented some data on the occurrence of new-onset or worsening allergies & immune reactions in women with Essure, which was also mentioned in a French retrospective study comparing women with Essure against those who had tubals. We like to think that meeting also prompted him to schedule an FDA immunology panel hearing on metals in devices & immune reactions before he left the FDA. I attended that hearing as a public speaker, which was held in November 2019, to urge the FDA to require labels on devices of ALL materials in them, much like the ingredients label we have on food products, and to send "Dear Doctor" letters to physicians to alert them to be on the lookout for a constellation of symptoms as a potential immune reaction in their patients with implants. I also asked them to require studies to look at the genome of patients receiving implants. I'm eagerly awaiting the recommendations from the FDA as a result of that hearing.

What can be done to prevent this from happening to others?

The FDA has to do better. We need them to require clear, plain-English labeling of risks of and materials in medical devices, and it has to be mandatory for this to be given to patients and recorded prominently in their medical records. We need better insight into what is in the FDA's adverse event reporting systems, and it also needs to be easily consumable and usable to the average patient and doctor. This could help address the under-reporting of adverse events and misdiagnosis of adverse reactions. We also need more rigorous clinical trials for devices: no more single-armed, limited trials or 510k approvals for IMPLANTABLE devices, at least!

How should we (patients, their families, and advocacy groups, such as USA Patient Network) move forward dealing with this issue?

We have been greatly successful in harnessing social networks and the media to organize and propel patients to action. It allows us to collaborate more effectively and have greater educational reach. Establishing these communication channels is vital, I think, to our success in affecting patient-focused changes. We can mobilize patients to comment on the dockets for upcoming FDA hearings and guidance through these channels. We can use these to organize grassroots lobbying efforts around important legislation, like the Medical Device Safety Act and Medical Device Guardians Act.

INFORMATIVE ARTICLES and INFO ON DRUGS & DEVICES
Dr. Sudeep Taksali tells “CBS This Morning” about his efforts to get a cheaper version of a drug commonly known as a hormone blocker for his daughter, who has central precocious puberty.

The report is the latest collaboration between CBS, NPR and Kaiser Health News on the “Bill of the Month” crowdsourced investigative series. 
https://khn.org/news/watch-one-fathers-fight-against-predatory-drug-price/
As the Coronavirus Spreads, Americans Lose Ground Against Other Health Threats
https://khn.org/news/as-the-coronavirus-spreads-americans-lose-ground-against-other-health-threats/view/republish/
 

WHO’s malaria vaccine study represents a “serious breach of international ethical standards”

Experts are troubled by the apparent lack of informed consent in a large, cluster randomised study of the malaria vaccine. Peter Doshi reports 

A large scale malaria vaccine study led by the World Health Organization has been criticised by a leading bioethicist for committing a “serious breach” of international ethical standards. The cluster randomised study in Africa is already under way in Malawi, Ghana, and Kenya, where 720 000 children will receive the RTS,S vaccine, known as Mosquirix, over the next two years.123

https://www.bmj.com/content/368/bmj.m734



Reminder:
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