What do you do when you know something is wrong but you can’t find anyone to confirm your suspicions? Or when you finally identify the culprit but find out that other people are being kept in the dark? These days it’s likely that you go online and if you are lucky — or determined — you find or create online communities where people can share their health experiences.
I’ve written about how peer health advice has helped people prepare for brain surgery, deal with a one-in-a-million diagnosis, and manage tiny pills despite hand tremor. But how can peers help when it’s a company — or a government — that has failed to protect people from harm? That’s the story for today.
The International Consortium of Investigative Journalists dug into what they call the Implant Files to reveal a medical device industry that has been hiding its mistakes.
First some background:
I think we all can agree that regulating medical devices is a job for governments. But private citizens can play important roles as watchdogs and whistleblowers. In the U.S., our first line of defense against medical device harm is the U.S. Food and Drug Administration (and indeed, the U.S. government leads the world in many aspects of consumer protection). Another line of defense are clinicians who hopefully have first-hand experience with the implants and devices they use. Peer-to-peer health advice can be another layer to the safety net for patients. It’s a way to bring patients into the conversation, to organize their voices, and empower them to both report problems and ask questions.
Amanda Dykeman’s story is a parable for how medical device harm is concealed and how a single person can contribute to change.* When she had a contraceptive device called Essure implanted, the manufacturer had been under-reporting complaints for years (although they say they followed the letter of the law). Doctors didn’t know they were setting their patients up for searing pain and heavy bleeding. After Ms. Dykeman had the device removed, along with her uterus, her symptoms stopped and she could focus on organizing a patient response to the crisis. Through their online group, Ms. Dykeman and her colleagues loan their courage and expertise to anyone and everyone who has been failed by the systems meant to protect patients from harm. They fill in the gap left by clinicians, corporations, and government agencies.
We are not yet tapping into patient experience as effectively as we could be. When we do, clinicians won’t have to guess about how a device could affect a patient — they could point to a “someone like you” or even match people to a support group in advance so they have a ready-made network during recovery. Watchdogs could tap into patient networks and listen for early warnings of device malfunction and harm. In helping people to share their stories and learning the vocabulary they need to use to communicate with the medical professionals, patients are more likely to be heard by both clinicians and regulators.
When someone feels alone — or they just can’t take the pain anymore — they often look online for other people who can confirm the story they are trying to tell. I think peer health advice and connection are essential but invisible components of the health care system. Not everyone is tapping into this superpower. In 2012, the last time I had a chance to survey all U.S. adults, about two in ten said they had gone online to find someone who shared their same health condition. In 2018 I helped lead a study that found four in ten teens and young adults said they had gone online to find someone who shared their same health condition.
How might we increase people’s awareness of peer-to-peer health care? What other examples have you seen of patients and other people filling in the gaps left by regulators?
* Another parable of medical device harm and patient empowerment, this time featuring clinicians: Amy Reed, MD, and her husband, Hooman Noorchashm, MD, fought to ban the use of a medical device that spread the cancer that killed Dr. Reed. And indeed the fight continues. Watch a video about their lives and their campaign. This New York Times obituary of Dr. Reed captures the story, as well.
Featured image: “Go tell it on the mountain” a jacket for Marianne Vennitti by Regina Holliday
I always find it discouraging when at an event that has ‘patient’ in its title(conference, symposium,think tank) and has a tech aspect (portal, apps, bots etc) yet the peer-to-peer is glaringly missing. The most recent , where I was a PCORI (Patient Centered Outcomes Research Institute) Patient Stakeholder I spoke up, and included it in my ‘deliverable’: a summary of my take-aways. Happily, I’m on another PCORI initiative where we patients and caregivers are encouraged to talk to learn from one-another. While it’s not disease/illness related it is related to a similar learning curve: patients involved in research. Here’s hoping that peer-to-peer is evolving to become the norm. Thanks, as always, Susannah, for provoking thought and discourse.
Thanks, Kathy!
On days when I’m feeling optimistic, I think people don’t plan for or encourage peer-to-peer conversations because they are not aware of it — and certainly not aware of its power for the patients, caregivers OR for the organization hosting the meeting. That’s what I’ve seen most often — when they grok peer health advice, they say, “Aha! This could help us so much in our goal to [improve engagement/adherence; decrease errors/infection; insert your pet topic here]”
It’s rare to hear anyone say: I know what you mean by peer connection and we don’t want it.
If people have stories of either scenario, please share!
If you’re reading this and want to keep digging into how patients and caregivers can help close the gaps in the health care system, please check out:
Rethinking the “Patient Complaint” Process, by Julie Drury.
An excerpt:
“Complaints in healthcare don’t occur lightly. Patients and families are stressed and otherwise distracted with their own health and safety, or that of their loved one. Often they truly need to have an important conversation about the care they have experienced, but by the time they are well enough to have the energy, have navigated who they might raise their concerns with, and have returned home and to enough ‘normalcy’ to attend to the issues they faced, they decide to let the situation go unaddressed. It’s just too hard and they are too tired, or they’ve decided to just ‘let it go’.
In other instances, patients and families are fearful of raising a complaint. They feel they might suffer some form of repercussion from health care providers (doctors or nurses), or the healthcare setting (hospital administration, homecare, long term care).”
Hello Susannah and Happy New Year to you!
When you write “Doctors didn’t know they were setting their patients up for searing pain and heavy bleeding….” about the Essure device, it strikes me that this statement might have been true only in the very early days before patients like Amanda Dykeman began reporting horrific problems due to the device. Physicians continued to do these procedures for years. Clearly, the industry’s under-reporting of patient harm borders on criminal behaviour, but I’m wondering where the clinicians were all this time.
How is it possible that they were unaware as years went by that thousands of women were telling their doctors of debilitating symptoms like Amanda had suffered? Doctors talk to each other, they attend conferences together, they compare notes. How could they have been unaware of years worth of patient responses like Amanda’s?
The Implant Files paint a truly damning picture of Bayer and other device makers (noting that Bayer continues to “to stand behind the product’s safety and efficacy.”)
While patients banding together often represent a starting point, the “watchdogs” who tap into patient networks and listen for early warnings of device malfunction and harm” must include the physicians who implanted these devices in the first place.
Hi Carolyn and Happy New Year to you!
You are right — I’m assuming the best intentions among clinicians who continue to recommend, implant, or use devices that haven’t been recalled, but which may be the target of patient complaints. That could very well not be the case. But I hope that it is!
Thank you for this Susannah. Are you aware of any examples of health organizations creating/supporting a platform for families and caregivers to connect and support one another as peers?
We recently supported my mom to transition to a memory support community; so far, her experience and our family’s is going okay, but it feels like there could be a way to facilitate families meaningfully staying connected if we choose, with the ultimate common goal of improving the well-being for all our loved ones in the community.
It would seem there’s a lot of potential for something like what Seniorlink has developed with its Vela caregiver collaboration platform to evolve & create space for caregivers to support one another.
Thank you again for the thought-provoking post. It reminded me of my late friend Imogine Higbie, who after having a nursing home experience and moving out of an assisted living residence, got active in the “culture change” movement in aging and long-term services and supports over a decade ago. https://youtu.be/eEutSyL4gbs
PS. I don’t have any connection to Seniorlink, other than being a fan!
Joe, great question!
The answer is yes and no.
Yes, there are health care orgs actively creating and/or supporting peer networks. I maintain a collection of studies, articles, and examples of Peer to Peer Health Advice where you can see a wide range of both grassroots and (industry? organizationally? institutionally? what’s a good word for this?)-supported peer groups.
But I should also answer no because I don’t yet know of one like you describe — and it’s a great idea! Maybe someone else knows of one and can share it.
Thank you! There’s so much great info and resources on the page you maintain, the KHN “Support Circle” article from July was helpful.
Hmmm… I’m in a newly-forming grassroots *health* network for older women in my neighborhood. Quite a small group– four or five at this time.
Purpose– Learning about natural health, staying healthy, and minimizing our need for medical interventions in the first place. We share our science-based personal research. and our own experiences. And referrals to health resources.
Two members have health practitioner backgrounds. One is retired, and the other is still practicing. I worked as a nursing assistant in my earlier years— from nursing home to general hospital.
We don’t know if our group will continue, as we’re all so busy still working, leaving little time to organize and meet. We’ll see how it goes!
Many local younger women have expressed interest in starting a similar group. But some of the older ones in our group (not me) feel the younger ones can’t relate (to what the older ones are going through with their health. I believe we all have alot to learn from each other.
What a great idea! I’d love to hear more about why you decided to start the group and how it goes as you move forward. I share your belief that we all have a lot to learn from each other and so often people are too shy to ask questions or share what they know.
I happened to catch an interview yesterday with Hillary Frank, the creator of The Longest Shortest Time podcast. She talked about how she started the podcast because she wanted to feel less alone in her pain after a traumatic birth injury.
She talked about how women often talk openly about their bodies and health — but only up to a certain point. It’s socially acceptable to talk about some topics (menstrual cramps, hot flashes, peeing a little every time you sneeze — just to throw out a few) but not others (an unhealed episiotomy, apparently). She created a space where people could talk about whatever they wanted or needed to share.
How might we do that in our own lives?
Avoiding chronic conditions means staying highly-informed, and pro-active. About diet, exercise, and avoiding toxics. The more we learn, together, the better outcomes we may have.
If we’re as healthy as those we spend time with — we’re choosing wisely!
Personally, I basically follow the Functional Medicine approach to health– treating root causes. I listen to podcasts as I do my daily chores. Two of the other members are starting to hear about it too.
I just now invited a shop owner in her 80s. Hope the group likes her!
Thanks, Susannah, for this post. Getting peer support is more powerful than many think.
P.S. Great comment about some things seeming unacceptable to talk about. That has to change. I too hold back about some things– now I’ll reconsider!
P.P.S.
Thanks for the Hillary Frank link. I just now listened– she’s so courageous. Better we all learn what can happen in childbirth! My mom birthed many, and only told us the nice side of it all.
I’m so glad you were able to listen to the interview! Hillary Frank *is* courageous — perfect description. And yes, there is a taboo about a lot of topics that need airing. Plus we may not always have the words to describe things — the experience of pain, for example, whether in childbirth or from other situations, acute or chronic. Sally Okun of PatientsLikeMe has been leading some very interesting work among their members, asking for descriptions, in their own words, of how they feel. Then they translate that into clinical terms, empowering patients and caregivers to speak up in ways that are more likely to be heard by their clinicians.
Love the idea of PatientsLikeMe! My only hesitation to being in any symptom support group, especially online–
I assume insurance companies somehow get access to patients’ data. That’s an issue re pre-existing conditons. Who has time to read long, complex privacy policies?
That’s one of several reasons we’re forming our own in-person health network, for older women.
When I suffered a “progressive”, “irreversible” disabling condition, my research doctors— from the best university— just threw meds at me. And refused to take my med reactions seriously. They only cared about developing new drugs for symptoms. And I was their ideal case.
Btw, my condition, and related conditions, are entirely preventable. Functional Medicine is explaining exactly how.
Against doctors’ orders, I took myself off their program.
And pivoted to treating myself.
That meant treating root causes. First researching extensively. Then lifestyle change— diet (anti-inflammatory, gluten-free, organic whole foods), movement therapy, mindset, etc. Basically, the Functional Medicine approach. Yes— slow-going hard work.
My docs were super-pissed at me for pulling myself off their program. But later admitted my all tests came back great. And that I’m anonymously famous for that. Of course, they continue developing their drugs— for this entirely preventable condition.
The same approach has worked for all my conditions— focus on causes, not symptoms. Because the same few lifestyle factors are responsible for common chronic conditions. That’s what Functional Medicine is telling us.
I don’t need be told by an insurance company that I have a pre-existing condition. I’ve treated the causes, and my symptoms are virtually gone for years now. But I still fear that will happen, because this condition is officially progressive and irreversible.
Yes, I checked out online support groups for my symptoms. But it was all about managing symptoms and drugs. No one seemed to be interested in treating the causes, nor lifestyle change.
Yes I’ve tried helping others with related conditions. But they don’t believe me, since no doctor has told them about it. They only want their symptoms treated— treating root causes is not a popular concept yet.
Tell me if I’m hogging your post, and I’ll continue elsewhere. 🙂
Thank you! Not hogging at all — this is why I love to blog, to hear from people who have insights and experience to share.
Thanks for your important work, Susannah. Great discovering you!
Have you stumbled on peer-to-peer senior groups focusing on anti-inflammatory diets, microbiome, epigenetics, indoor air quality, toxics?
So far our group is talking inflammatory foods—thanks to our co-founder, a retired nurse. She and I have reversed our disease paths by ditching those foods. Literally saved our own lives, with no help from any medical practitioner.
Regina,
Because of the way comments are threaded I can’t reply to your last reply – sorry about that! And unfortunately no, I haven’t come across a group that fits that description. However, please do check out the Quantified Self movement, which has tested and used all sorts of tools to measure all sorts of things (including micro biome, air quality, etc.)
I posted this essay on LinkedIn and Brianna Wolin, founder of Find Your Ditto wrote:
“Another strong example of this is the hashtag #insulin4all movement fighting the rising price of insulin and peers sending each other vials to ensure everyone lives.”
It is a great example of how people can organize to fight for what they need. Here’s an excerpt of a CBS News story explaining part of what’s happening:
-begin quote-
The drug industry is starting the New Year by hiking the costs on hundreds of prescription medications despite pressure from President Trump. A group that tracks drug costs said about 60 companies increased the price on almost 300 medications.
The price of insulin, a life-saving drug for diabetics, tripled between 2002 and 2013. Since 2008 three of the top makers raised the list price of insulin at least 10 times. Now, the state of Minnesota is taking action by suing three of the world’s largest insulin manufacturers.
Lori Swanson is Minnesota’s attorney general. She’s now suing the top three insulin manufacturers for what she calls “deceptive, misleading, and misrepresentative list prices.”
“I think in America nobody should lose their life because they can’t afford the cost of insulin,” Swanson said. “They’ve raised the price of insulin by being in cahoots with the pharmacy benefit managers and having a secret price for them that the public doesn’t get.”
Drug manufacturers typically must negotiate with pharmacy benefit managers, or “PBMs”. Those PBMs are middlemen in the pharmaceutical supply chain. Swanson alleges to make money, manufacturers set “phony” list prices that are artificially high so they can offer greater rebates to PBMs and still maintain their profits.
“The drug companies can make the same amount of money. But by doing that, they’ve created this ever-cascading cycle of higher and higher drug prices,” Swanson said.
Because many aspects of the process are secret according to the drug companies, portions of the lawsuit are redacted.
“It’s incredibly frustrating and we’re gonna be fighting that. Because these companies claim that certain information is trade secret. That it’s confidential. And that they and only they can see it,” Swanson said.
That means they are not able to put those list prices in their lawsuit.
“Isn’t that ridiculous? It’s a public lawsuit filed in court, but we can’t put the numbers in because they’re claiming it’s a trade secret and that nobody’s entitled to know or see that information,” Swanson said.
CBS News reached out to the companies named in the lawsuit. Eli Lilly and Company told us the lawsuit’s “claims are without merit.” Novo Nordisk said the company is “committed to ethics and compliance” and Sanofi said it “provides significant rebates” but that “unfortunately, it seems these savings are not consistently passed through to patients in the form of lower co-pays or coinsurance.”
“PBMs certainly play a problem here in the system. No doubt about it … but we sued the pharmaceutical companies because ultimately it’s their product,” Swanson said.
-end quote-
Since this blog is my outboard memory: Here’s another example of people finding each other online when the system has failed them (read on for the happy conclusion!)
How One Woman Changed What Doctors Know About Heart Attacks: The story of SCAD underscores how much doctors still don’t understand, including about heart disease in women.
Learn more about Katherine Leon and Sharonne Hayes (two heroines of the story above). Check out how they and their colleagues devised a community-initiated research project.
Update: After injuries, FDA orders pelvic mesh off the market
The decision includes products sold by Minnesota’s Coloplast and Boston Scientific.
By Joe Carlson, Star Tribune, April 16, 2019
The story includes this quote:
“These mesh devices were on the market for over 20 years, leaving tens of thousands of women to live with permanent disabilities and disfigurement. We feel the announcement, while a step in the right direction, also does not go far enough; it does not address other mesh devices that are causing similar life-altering injuries,” wrote Amanda Dykeman, the Illinois-based founder of Medical Device Problems.
-end of quote-
I also want to highlight a comment on a different post since it is related to this watchdog conversation, written by Sandy Mau:
“I was in treatment for breast cancer when I had a hysterectomy. Since I was now post-menopausal (via surgery), my oncologist switched me from Tamoxifen to Femara as a long-term oral chemo treatment, which is the protocol for post-menopausal women.
The arthritis-like symptoms hit me hard and fast. By the first followup appointment, I had already taken four cortisone injections in my fingers and had to have surgery on a thumb joint. My doctor would only say that the drug didn’t “cause” arthritis (duh). As a health care writer, I accessed studies, but it took googling chat rooms to find out how common these symptoms are with Femara. Studies referred to the symptoms only marginally, so my doctor didn’t want to take me off it. She kept saying the Femara was “twice” as effective for patients like me than Tamoxifen. I finally asked her to show me the exact numbers, and it was the difference between a 2% chance of recurrence and a 4% chance. After she point-blank told me she (a) would not report my experience to the manufacturer and (b) didn’t believe in shared decision making, I walked out of there with a Tamoxifen script and found a new oncologist.”
How might we create a reporting system that does not rely on overworked (and see above: under-motivated) clinicians?
The New York Times Editorial Board published a strongly-worded opinion on Sunday, May 5, 2019:
“80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices. Patients suffer as the F.D.A. fails to adequately screen or monitor products.”
A few quotes:
“After searing investigations by journalists and patient advocates, the F.D.A. has promised to make “transformative” changes to medical device regulation. But so far, the agency’s suggestions have been meager at best. And in the meantime, regulators have accelerated the device approval process, not slowed it down.”
Recommendations include:
“Tighten approval standards. Regulatory loopholes — some of which date to the dawn of device regulation and were not meant to be permanent — enable companies to bring new or “updated” medical devices to market without testing them in human trials first…”
And:
“Fix post-market surveillance: Industry proponents say that medical devices can be brought to market quickly and safely by having companies conduct rigorous testing after products go to market instead of beforehand. But companies often fail to complete such studies, even when they’re ordered by regulators. What’s more, device makers frequently skirt rules requiring them to report publicly all incidents of malfunction, injury or illness — often through mechanisms that the F.D.A. itself created. And after years of wrangling, the industry and its regulators have still not fully put a system in place to better notify patients of product recalls and other safety issues.
The F.D.A. has vowed to fix some of these lapses. They’ve promised to abolish reporting exemptions that keep safety issues hidden from the public and to promote breast implant registries that monitor patient outcomes.
That’s a good start, but more can be done. An industry that prides itself on innovation, and earns some $400 billion in annual revenue, should be well equipped to build a global medical device registry where patient outcomes for all medical devices are openly monitored, and where doctors and patients can log concerns and obtain information.”
(And it goes on.)
My question: What role could peer to peer networks of patients and consumers play? How might we gather evidence to show the efficacy of grassroots efforts? (I have ideas but would love to hear from others.)
Adding to the list of related resources:
Kaiser Health News (KHN) has been pursuing medical device failure reports from the U.S. FDA since September 2018. In late June 2019, the FDA released the database publicly. KHN then wrote about Five Things We Found In The FDA’s Hidden Device Database (including the fact that “blood glucose meters for patients with diabetes had more unique incidents than any other device in the database, logging 2.4 million reports over the past 20 years.”)
When I asked community colleagues for more info, Joyce Lee shared:
Ekhlaspour L, Mondesir D, Lautsch N, et al. Comparative Accuracy of 17 Point-of-Care Glucose Meters. J Diabetes Sci Technol. ;11(3):558–566. doi:10.1177/1932296816672237
A Craftsman Blames His Tools: Blood Glucose Meter Accuracy & Long-Term Diabetes Control, by Chris Hannemann
Brianna Wolin tweeted: “Variability between glucometers is insane. Makes decision-making very tough, when the information isn’t reliable.” And shared:
Are Blood Glucose Meters Accurate? New Data on 18 Meters, by Jeemin Kwon and Adam Brown