By JEFF GOLDSMITH

On Christmas Eve 2014, I received a present of some profoundly unwelcome news: a 64 slice CT scan confirming not only the presence of a malignant tumor in my neck, but also a fluid filled mass the size of a man’s finger in my chest cavity outside the lungs. Two days earlier, my ENT surgeon in Charlottesville, Paige Powers, had performed a fine needle aspiration of a suspicious almond-shaped enlarged lymph node, and the lab returned a verdict of “metastatic squamous cell carcinoma of the head and neck with an occult primary tumor”. 

I had worked in healthcare for nearly forty years when cancer struck, and considered myself an “expert” in how the health system worked. My experience fundamentally changed my view of how health care is delivered, from the patient’s point of view. Many have compared their fight against cancer as a “battle”. Mine didn’t feel like a battle so much as a chess match where the deadly opponent had begun playing many months before I was aware that he was my adversary. The remarkable image from Ingmar Bergman’s Seventh Seal sums up how this felt to me.

The CT scan was the second step in determining how many moves he had made, and in narrowing the uncertainty about my possible counter moves. The scan’s results were the darkest moment: if the mysterious fluid filled mass was the primary tumor, my options had already dangerously narrowed. Owing to holiday imaging schedules, it was not until New Years’ Eve, seven interminable days later, that a PET/CT scan dismissed the chest mass as a benign fluid-filled cyst. I would require an endoscopy to locate the still hidden primary tumor somewhere in my throat.  

I decided to seek a second opinion at my alma mater, the University of Chicago, where I did my doctoral work and subsequently worked in medical center administration.

The University of Chicago had a superb head and neck cancer team headed by Dr. Everett Vokes, Chair of Medicine, whose aggressive chemotherapy saved the life and career of Chicago’s brilliant young chef, Grant Achatz of Alinea, in 2007.

If surgery was not possible, Chicago’s cancer team had a rich and powerful repertoire of non-surgical therapies. I was very impressed both with their young team, and how collaborative their approach was to my problem. Vokes’ initial instinct that mine was a surgical case proved accurate.

The young ENT surgeon I saw there in an initial consultation, Dr. Alex Langerman performed a quick endoscopy and thought he spotted a potential primary tumor nestled up against my larynx. Alex asked me to come back for a full-blown exploration under general anaesthesia, which I did a week later. The possible threat to my voice, which could have ended my career, convinced me to return to Chicago for therapy. Alex’s endoscopy found a tumor the size of a chickpea at the base of my tongue. Surgery was scheduled a week later in the U of Chicago’s beautiful new hospital, the Center for Care and Discovery.

This surgery was performed on Feb 2, 2015, by a team of clinicians none of whom was over the age of forty. It was not minor surgery, requiring nearly six hours:  resections of both sides of my neck, including the dark almond and a host of neighboring lymph nodes. And then, there was robotic surgery that removed a nearly golf ball-sized piece of the base of my tongue and throat. The closure of this wound remodeled my throat.

I arrived in my hospital room late that day with the remarkable ability to converse in my normal voice.

Thoughtfully, I was put in a quasi-isolation unit with two doors and negative air pressure. There was a consistent, very high level of focus on infection control throughout my stay. The next day, flushed with the news that no cancer had been found in any other lymph nodes, that there were clean, ample cuts around the tumors we knew about, and, best of all, that no follow-on chemo- or radiotherapy would be needed, I chatted away happily with two visitors for almost ninety minutes. I was repaid for this premature end-zone celebration with a siege of intense throat pain that lasted over a week. I was also repaid in a different way for the optimistic removal the next morning of the nasogastric tube installed during my surgery to feed and medicate me post-op. 

My surgeon, Alex Langerman, was generous with his time. We had four visits in the hospital that I could remember and one which I couldn’t. He responded thoughtfully and substantively to my questions and concerns but delegated the day-to-day management of my care to his senior and junior residents. The senior residents, who were present in the OR,  were as impressive as Alex was.

Some of the junior residents, however, literally phoned it in. On the second night, I woke up strangling on a large blood clot that had dislodged from the wound and blocked my airway. The anxious nurse in charge of my care paged the on-call resident who . . . didn’t answer the page in 90 minutes. Paged again, the resident scolded the nurse for bothering her and instructed the nurse to inform me that “breathing and swallowing problems were normal for this type of surgery” and refused to come in to the hospital to examine me.

At this point, I asked to speak to the resident on the phone, which prompted her to appear in my room thirty minutes later. She performed a perfunctory, fifteen-second examination, pressing down on my tongue with a depressor, but failing to examine my airway where a large piece of the clot was still lodged. Then she delivered a sour little lecture on how “breathing and swallowing problems were normal. etc.” and after documenting that she had showed up, ordered a swallowing study for the next day and vanished without taking any other action, not to be seen again. I eventually coughed up the rest of the clot myself and prayed it wouldn’t happen again. 

The failure of on-call residents to respond to pages from the nurses caring for me was repeated later in my stay. Despite this inconstant clinical back up, I received thoughtful and attentive nursing care throughout my stay. Sadly, the nurses seemed to spend twice as long typing into the numerous computers in the rooms and at the nursing station as they did actually caring for us.  

However, the inadequate pain control regimen vital to my regaining my ability to swallow exacted a huge price. Originally, my pain meds were to be delivered through the nasogastric tube that bypassed my new throat. When the tube was removed the day after surgery, no thought was given to rethinking my pain control. Though I had a mild patient-controlled anaesthesia through IV, I was expected to swallow my primary pain medication delivered in liquid form roughly every four hours. 

As you might expect given the large wound in my throat, swallowing was a nightmare, particularly since the liquid pain medications seemed to be suspended in alcohol. I could not swallow them sitting up in bed, so I made a medication station out of my window sill. Even if I diluted them with water or a suspension of edible fiber, it took almost twenty minutes to down each dose of pain meds. Every tiny swallow brought a sharp stab, a hop and a yelp, followed by a spasm of painful coughing. Several days of protest brought a new idea:  bitter ground up pain pills mixed with apple sauce! Chunks of pain medication and apple hung up in my throat, lodging on the wound. 

Then the hospital entered the fugue state otherwise known as the weekend. A hospital stay expected to be seventy-two hours had stretched to six days, during which I was unable to eat and barely able to swallow even water, let alone therapeutic food. I made an angry circuit of the massive, aircraft carrier sized hospital floor every few hours, pushing my IV stand alongside of me, weakening each day from the cumulative deficit of protein. 

 I lost more than seventeen pounds during my stay in the hospital, mostly muscle, from my inability to eat. This muscle loss contributed directly to the collapse of my left hip joint later in the spring by depriving a badly eroded arthritic joint of its supporting musculature. Escalating pain in both hips required two joint replacements in the ensuing eighteen months.   

Finally, on Sunday evening, Alex called for a pain consult, which came on Monday morning, from a brilliant young anesthesiologist named David Dickerson. The result was a nearly complete victory: a combination of an anesthetic patch, local anesthetic mouthwash for the throat, a medication intended to numb the small nerves, and a strong liquid systemic painkiller to be used as needed. I was discharged within 36 hrs. able to swallow protein drinks for sustenance. 

Unfortunately, within twenty-four hours, I was back in the University of Chicago ER for bleeding. I was readmitted for minor surgery to cauterize the wound in my throat, and also to remove fluid from one side of the neck. Finally, after recovering from the anesthesia, I was sent back to my physician’s house, which was my base camp during my Chicago stay. I flew home to Virginia two days later, on February 13. 

The saga wasn’t over. Karen, my wife, stayed with me the first four days. Despite her constant presence, neither my wife nor my guardian angel hosts in Hyde Park were given discharge instructions. Karen was barely acknowledged by any member of the care team during her four days in the hospital, despite her impending role as my caregiver. I received my discharge instructions in a haze of elation and pain meds,  and immediately tucked them away in my bag. When I arrived home in Charlottesville, exhausted from my eleven-day visit to Chicago, I showered and collapsed into my welcoming bed.

I awakened fifteen hours later with no feeling in the fingers of both hands. I also found nearly two-inch blisters on my heels from lying on my back for fifteen hours. Karen, a florist, was preoccupied by Valentine’s Day, her busiest day of the year, and my son, Trevor, who came to stay, was reluctant to disturb me. Six months later, I still had no feeling in the two outer fingers of my right hand, needless collateral damage from my treatment. I basically lost my ability to type. This avoidable complication was eventually addressed with a six-hour nerve grafting surgery at Washington University in St. Louis in October, 2015.

I’d been warned by several of my policy colleagues about selecting Medicare Advantage when I turned sixty-five. “Wait ‘till you get sick”, they sagely warned me.

In fact, my carrier, Humana, did not delay my course of therapy by five minutes, and rapidly approved my personal decision based on medical advice to seek cancer care from an NCI designated Comprehensive Cancer Center five hundred miles from home and “out of network” for my Virginia-based plan. 

Unfortunately, the MA approval process placed a huge clerical/administrative burden on my Charlottesville-based primary care physician Jeff Davis, whose long-suffering office staff was required to initiate requests for authorization for every single stage of the diagnosis and treatment, a process which consumed nearly two person days of administrative time. I did get regular check-ins from a Humana nurse for several weeks after the procedure and a big shipment of frozen meals.  

But otherwise, my Medicare Advantage plan added no value to my cancer care, and grossly underpaid the University of Chicago for my surgery. The hospital was paid $15 thousand under their Humana MA contract for my total care, not counting Alex’s surgical fee, for a complex surgery, an eight day hospital stay and an emergency readmission.

The surgical care I received at the U of C was a triumph, both thorough and definitive. It saved my life.  However, the follow up pain management and the discharge process and post-surgical recovery were disasters, both from a patient experience standpoint (fed back with verve on my HCAHPS survey!) and a cost standpoint.  

The diffusion of responsibility throughout the complex care episode, and consequent lack of ownership of my recovery, was the root cause of much of this gap. An additional learning for me:  much of the risk of any clinical intervention is borne by the family after the intervention is over. The failure to prepare my family for its role had direct consequences for me in future surgical episodes that would have been unnecessary a better scripted episode. 

A recent commenter on LinkedIn compared the “consumer” of healthcare to a person gorging on Baked Alaska in a restaurant where someone else picked up the bill. Given my own frightening experience with cancer, I found this characterization insulting and demeaning. I wasn’t “consuming” anything; I was drowning! My central challenge was finding someone I could trust to save my life. Would I have chosen someone I did not know or trust, but whose services were less costly, to rid me of my cancer? Not on your life. 

Economist Kenneth Arrow wrote sixty years ago that one thing that distinguishes medicine from other things our economy does is that illness is not only unpredictable, but also an “assault on one’s personal integrity”. Responding to that lethal uncertainty is the toughest job in our economy. I was and remain deeply grateful to my clinical team for saving my life.  

I am now nine years cancer free, and sobered by how fraught and complicated my care experience was. It is hard to describe how much fear and uncertainty I felt, even in my home institution, despite forty years of working experience in and around hospitals. When I hear marketing experts prattle on about the “consumer’s care journey”, it just makes me want to throw up.

Jeff Goldsmith is a veteran health care futurist, President of Health Futures Inc and regular THCB Contributor. This post comes from his personal substack

by MATTHEW HOLT

I met Sarah MacDonald in the early 2000s. She is the ultimate extrovert who sings, cooks, maintains a huge circle of friends, and lives life to the fullest–all at a pace & level most of us can’t imagine. In the early 2010s Sarah was flying high. Newly married, trying to get pregnant, all while being a Silicon valley business exec who had increasingly senior roles at eBay. Then in 2012 she was diagnosed with two completely separate types of cancer. And in her head “The Cancer Channel” started playing nonstop.

That became the title of her book. I just read it and I literally couldn’t stop. It’s practical, it’s heart-wrenching, it’s warm, it’s funny (yes, funny!). And it’s an amazing look at the exact experience of someone going through cancer. Or in this case cancer x 2. I was lucky enough to interview Sarah (so there is a very happy ending). So please watch this and buy & read the book

BY KIM BELLARD

Joe Biden hates cancer.  He led the Cancer Moonshot in the Obama Administration, and, as President, he reignited it, vowing to cut death rates in half over the next 25 years.  Last month, on the 60^th anniversary of President Kennedy’s historic call for an actual moonshot, he vowed “to end cancer as we know it. And even cure cancers once and for all.”

But, as several recent studies show, cancer is still surprising us.  

—————

Our body has its own defenses against cancer, such as T-cells, and great strides have been made in cancer therapies, including immunotherapies.  Still, though, as first author of a new study from Tel Aviv University, Amit Gutwillig, pointed out: “Despite its remarkable success, the majority of patients who receive immunotherapy will see their tumors only shrinking in size temporarily before returning, and these relapsed tumors will likely be resistant to immunotherapy treatment.”  

One reason, it turns out, is that some cancer cells have learned to hide – in other cancer cells.

The research found: “While the outer cells in this cell-in-cell formation are often killed by reactive T cells, the inner cells remain intact and disseminate into single tumor cells once T cells are no longer present.”  Sneaky little bastards.  Or, as Professor Yaron Carmi, who heads the lab, told The New York Times, “It was like seeing the devil.”

This is groundbreaking stuff.  The authors conclude: 

Overall, the ability of tumor cells to transiently enter and disseminate from each other in response to T-cell killing is a biological process that has never been described heretofore. It better explains how immunogenic tumors can survive in the host and provides a novel framework for immunotherapies

This may point to the need for new approaches.  Dr. Carmi believes:

This previously unknown mechanism of tumor resistance highlights a current limitation of immunotherapy.  Over the past decade, many clinical studies have used immunotherapy followed by chemotherapy – but our findings suggest that timed inhibition of relevant signaling pathways needs to occur alongside immunotherapy to prevent the tumor becoming resistant to subsequent treatments.

As interesting as the findings are, the NYT article suggests caution: “it remains to be seen whether it will lead to improvements in the treatment of cancer patients.”

————

The next set of studies are, if anything, even more startling.  It turns out that cancer has a microbiome.  And a mycobiome.  Cancer tumors are filled with microbes, particularly fungi.  

Two studies published in Cell last week document the presence of fungi in cancer tumors. The first study looked at 35 types of cancers – and found fungi, in varying degrees, in all of them.  In many cases, they were coexisting with bacterial colonies (the presence of bacteria in cancer tumors had already been uncovered in the past five years). 

First author Lian Narunsky Haziza, of the Weizmann Institute of Science in Israel, told the NYT: “I think this is an ecosystem.  It means the cancer cells are not alone.”

It’s not so much there are huge amounts of fungi present, but as STAT put it, “why are they there? And how did they get there?”  Amit Bhatt, a professor at Stanford who was not involved with either study, told STAT; “Or maybe there are immune cells that ate fungi and carried sequences to a tumor site.  Or maybe since you have a trillion microbes in and on you, it’s just not surprising that every now and then one makes its way into the body.”  

However they got there, Illana Livyatan, one of the researchers, notes: “Fungi can be food for bacteria and vice versa. They can even live within bacteria or bacteria can live within fungi. They can do a lot of biochemistry. Any of those avenues might have an effect.”  

A second study, looked specifically at fungi in gastrointestinal, lung, and breast cancers, and its findings suggest that presence of certain kinds of fungi are correlated with lower survival rates.   It’s not clear why.  The NYT article notes: “It’s possible that some microbes don’t just take up residence in tumors but help them grow. They may cloak the tumor from the immune system, neutralize drugs or help tumors spread through the body.” 

Deepak Saxena, a microbial ecologist at New York University who was not involved in either study, told Nature that “more work is needed to understand whether fungi can contribute to cancer progression by causing inflammation, for example, or if advanced tumours create a habitable environment that encourages fungal cells to take hold.”

Dr. Saxena also told the NYT: “I was not expecting this amount of fungus in cancer.  This will change the way we think about it.”  Dr, Bhatt concurs, telling Stat: “We don’t have the experiments to present a causal link between tumor initiation or progression and fungi. But this really encourages future research to think about designing experiments with microbiome and mycobiome investigations in mind.”

Co-corresponding author Ravid Straussman, MD, PhD, from the Weizmann Institute of Science, added: “The finding that fungi are commonly present in human tumors should drive us to better explore their potential effects and re-examine almost everything we know about cancer through a ‘microbiome lens.”

Dr. Livyatan is optimistic about the potential applications, telling The Times of Israel: “This could offer a new avenue for diagnosis of cancers using a simple blood test that detects fungi in tumors.  And beyond diagnostics, this could really shake things up in tumor research. This is one of these eye-opening moments that makes us revisit our assumptions about cancer, as fungi now represent a whole new consideration in analyzing tumors.”

We’ve only been scratching the surface at understanding the presence of our microbiome/mycobiome, much less its effect on our health, so to just now realize that we need to look at cancer through that same “lens” just illustrates how far we most likely are from “ending cancer.”  

————-

Cancer cells hiding in other cancer cells, cancer cells cohabiting with fungi and bacteria; who knows what else there is left to surprise us about cancer (and other illnesses)? It’s an admirable goal that President Biden wants to end cancer “as we know it;” the problem is, we may not really know it all that well yet. 

Kim is a former emarketing exec at a major Blues plan, editor of the late & lamented Tincture.io, and now regular THCB contributor.

#THCBGang on May 5 was an extraordinary special on cancer & navigation. Everyone on this gang has been touched by cancer as a patient or caregiver.

Joining Matthew Holt (@boltyboy) will be fierce patient activist Casey Quinlan (@MightyCasey); Jennifer Benz (@Jenbenz); Suntra Modern Recovery CEO JL Neptune (@JeanLucNeptune); patient advocate Grace Cordovano (@GraceCordovano); policy consultant/author Rosemarie Day (@Rosemarie_Day1); Jeff Goldsmith; Jennifer Benz (@Jenbenz); PLUS Adam Pellegini (@adampellegrini) from cancer navigation company Jasper Health. It really was a great conversation about what to do (and what is being done) to make the experience better for people with cancer and those that love them.

You can see the video below & if you’d rather listen than watch, the audio is preserved as a weekly podcast available on our iTunes & Spotify channels.

Thyme Care is a cancer navigation platform that is looking to use technology to make the kind of high-touch care coordination usually only found at Centers of Excellence available to oncology practices across the country. The navigation we’re talking about is typically quarterbacked by experienced oncology nurse navigators, and is known to have a direct impact on a patient’s experience and their health outcomes. Thyme Care’s platform not only scale-ups this expertise, but also augments it with analysis of claims data and EMR data to help those navigators quickly detect which patients might be at higher risk for poor outcomes and which interventions might help mitigate those risks – whether that be addressing social determinants of health issues like transportation to appointments, or just more quickly spotting gaps in care.

Thyme Care’s President & Chief Medical Officer Bobby Green (an oncologist himself) introduces us to the tech platform and explains how, among a competitive field of tech-enabled care navigators, it’s managed to stand apart enough to win Medicare Advantage plan Clover Health as an early client and to gain a $22 million dollar Series A investment from platform-savvy investors like Andreessen Horowitz and AlleyCorp. (Frist Cressey Ventures, Casdin Capital and Bessemer also participated in the round, which was announced in October 2021.)

As the business looks to scale, what’s to make of all its connections to Flatiron Health, arguably health tech’s best-known cancer care platform? Lots of alumni on the cap table and in the biz, including Bobby himself! Find out more about expansion plans and points of differentiation in this quick get-to-know-you chat.

By ANDREA DOWNING

Seven years ago, I was utterly alone and seeking support as I navigated a scary health experience. I had a secret: I was struggling with the prospect of making life-changing decisions after testing positive for a BRCA mutation. I am a Previvor. This was an isolating and difficult experience, but it turned out that I wasn’t alone. I searched online for others like me, and was incredibly thankful that I found a caring community of women who could help me through the painful decisions that I faced.

As I found these women through a Closed Facebook Group, I began to understand that we had a shared identity. I began to find a voice, and understand how my own story fit into a bigger picture in health care and research. Over time, this incredible support group became an important part of my own healing process.

This group was founded by my friends Karen and Teri, and has a truly incredible story. With support from my friends in this group of other cancer previvors and survivors I have found ways to face the decisions and fear that I needed to work through.

Our Support Group is a Lifeline. And We’re Not Alone.

As group of cancer previvors and survivors we’re not alone. Millions of people go online every day to connect with others who share the same health challenges and to receive and provide information and support. Most of this happens on Facebook. This act of sharing stories and information with others who have the same health condition is called peer support. For many years there has been a growing body of evidence that peers seeking information from each other can and do improve the way they care for themselves and others. Today many of these peer support groups exist on Facebook.

Our Support Group Is Trapped. We Cannot Leave.

I know what anyone reading this might be thinking if you have experienced a peer support group. After all the terrible news about Facebook and privacy, why would ANYONE share sensitive or private health information on Facebook?!

The truth is: we really have no choice. We’re trapped. Many of these health communities formed back before we understood the deeper privacy problems inherent in digital platforms like Facebook. Our own group formed back in 2009 when Facebook was the “privacy aware” alternative to MySpace. And because they grew so big the network effect becomes very strong; patients must go where the network of their peers live. We started out as a small collection that organically grew over time to become bigger and more organized. This dilemma of the network effect is illustrated beautifully in an Op-Ed by Kathleen O’Brian, the mother of a child with autism who relies on her own peer support group and who wishes that she could jump ship but cannot leave.

People turn towards peer support groups when we fall through the medical cracks of the healthcare system. When facing the trauma of a new cancer diagnosis and/or genetic test results, the last thing on your mind is whether you should be reading 30 page privacy policies that tech platforms require. Rather, patients need access to information. Patients need it fast. We need it from people who have been down the same path and who can speak from personal experience. And that information exists within these peer support groups on Facebook. We need to be protected when we are vulnerable to those who can use information about out health against us.

Our awakening to deep cybersecurity problems.

My own experience with peer support groups took a terrifying turn last April. After the news of Cambridge Analytica broke in headlines, I asked myself a simple question: what are the privacy implications of having our cancer support group on Facebook?

As a geek with a professional background in tech, I thought it might be fun to do some research after looking at the technical details of what happened with Cambridge Analytica. As I looked at the developer tools on Facebook’s platform, I began to get concerned. Not long after this initial research, I was lucky enough to meet Fred Trotter, a leading expert in health data and cybersecurity. I shared this research with Fred. What followed next for me was a crash course in cybersecurity, threat modeling, coordinated disclosure, and learning about the laws that affected our group. Fred and I soon realized that we had found a dangerous security flaw that scaled to all closed groups on Facebook.

Since discovering these problems and navigating submission of this vulnerability to Facebook’s security team, our group has been desperately seeking a feasible path forward to find a safer space. We have awakened to the deeper issues that created breach after breach of data on Facebook. It seems like every day we hear about a new data breach and a new apology from Facebook.

Our trust is gone. But we’re still trapped.

The lasting impact of peer support group privacy breaches

When health data breaches occur, members of vulnerable support groups like ours are at risk of discrimination and harm. Women in our own support group can lose jobs and healthcare when health information generated on social media is used to make decisions about us without our knowledge or consent. For example, health insurers are buying information about my health — and potentially can use this to raise my rates or deny coverage. And 70% of employers are using social media to screen job candidates.

For me, these security problems raise questions about the lasting impact on our group when data is shared without our knowledge or consent. Without transparency and accountability from these tech companies on their data-sharing practices, how will we ever know what decisions are being made about us? If the data generated in the very support groups these patients need to navigate the trauma of a health condition is used against group members who is being held accountable?

There is a stark contrast between Facebook’s rhetoric about “meaningful groups” and our current reality. We are trapped. Who is protecting these vulnerable groups? Who is being held accountable if and when the privacy and data generated by these groups are breached and used against their members? What are the solutions that give us the ability to trust again?

Does Our Support Group Have Any Rights?

Over this past year we have done a lot to try and understand what are rights are. Digital rights for groups like my own really do not exist. I have been reflecting on how when someone is arrested a police officer will read someone their Miranda rights.

“You have the right to remain silent. Anything you say can and will be used against you.”

This is really our only right at the moment. These words keep repeating in my mind as I think about our group’s current predicament of what to say and not to say about health on social media. From the perspective of a cancer support group, it seems we’ve reached a point where anything we share on Facebook can be used against us… by third parties without our knowledge or consent. As we lose our trust, we stop engaging. We stop trusting that it is safe to share things with each other in our group. We become silent. Moreover, our group cannot simply pick up and leave. Where would we go? What happens to the 10 years of work and resources that we created on Facebook, which we would lose? How do we keep the same cycle from repeating on a new platform?

At the root of this problem there are gaping holes in consumer privacy rights that might protect our group. While there are rules about health data breaches from the FTC there has been no enforcement to date. We are watching and waiting to see what the FTC might do. And while health information shared in hospitals, clinics, and doctors’ offices is protected by HIPAA, no such protection applies to the enormous amount of personal health information provided to social networks every day. The millions of people who convene through support groups are in a highly vulnerable position, and are currently powerless to change the dynamic to one in which they have protections and rights.

Congress and the FTC have held numerous hearings about a path forward to protect consumer data privacy, and a central theme for these dialogues is what to do about Facebook. There have been hearings upon hearings held by the FTC on consumer privacy in the 21st century. Recent hearings in Congress include those at the Senate Commerce Committee. While these hearings show a generalized desire to enact meaningful change, and some recognition of the urgency of the problem, I cannot help but notice the lack of representation in these dialogues from actual consumers who are affected by these privacy problems. I have held onto hope that there would be meaningful policy discussion about how to protect these vital peer support communities, but realize that we must help ourselves.

“We Take Your Group’s Privacy Very Seriously.”

Last year, we started a dialogue with Facebook’s teams after submitting our security vulnerability via the white hat portal. I heard over and over again from people at Facebook: “we take your privacy very seriously.” But Facebook never publicly acknowledged or fully fixed the security problems created within their group product. In fact, Facebook directly denied that there was ever a privacy and security problem for our groups.

Given this experience, you can imagine my surprise this week when Mark Zuckerberg announced his big new plans for Facebook. After a heartwarming commercial of a twenty-something finding her people in meaningful groups, Zuck walks onto the stage and declares: “The future is private.”

Our support group had reasonably expected the present and past to be private too.

Watching the F8 Summit my heart sank. It seems we must all submit to this future that Facebook imagines for us. A future where problems and abuse in Silicon Valley are swept under the carpet. Where no one is accountable. A future where exploitation of our data lurks just underneath the surface of all the heart-warming rhetoric and beautiful design for meaningful groups. Currently Facebook Groups have one billion users per month. Our trapped group is just one example of so many that are at the heart of Facebook’s future as a company.

These groups go beyond health to others seeking support for a shared identity. Active duty military. Survivors who have lost a loved one. Moms needing support from other moms. Cybersecurity professionals. In extreme cases the information in vulnerable groups can be weaponized. For example there were groups for the Rohingya in Myanmar and groups to support sexual assault survivors that are now quiet or have been deleted.

It seems that the data that has made this company so wealthy is still a priority over our security and safety. I quietly watch the reactions to the latest Facebook event, and the lack of any responsibility to the people in groups like my cancer support group.

We Cannot Remain Silent

When I think about my support group of cancer previvors and survivors, I feel strong and brave. I fear retaliation writing this because we are truly vulnerable on the platform where we reside. Yet, we can’t remain silent. We don’t want any more empty promises from the technology platforms where we reside. We would rather not be appeased with shiny new features and rhetoric about privacy.

Rather, we seek autonomy. We seek a way to take our own power back as a group. We seek to protect our shared identity as a group and make decisions collectively. We seek to protect any data that is shared. There is something truly unique about the shared identity of our support group: we have always done things on our own terms. We are ten thousand women who have faced really hard realities about our future.

Facebook did not create our incredible groups. We did. We’ve worked hard for ten years cultivating this online group for a simple reason: we wanted our group to feel less afraid and alone than we felt in the beginning. Facebook does not have a monopoly on any vision for our future. The data generated within these groups is not an abstraction to us. It represents generations of suffering. Our own suffering. Our families’ suffering. We have an urgent need to develop a new way forward that protects our identity, and the future of our groups. We will create the future we choose for this community. That future exists with or without Facebook.

If you are in the same boat, please reach out to us here.

Andrea Downing. Previvor | Community Data Organizer | Accidental Security Researcher. This post originally appeared on Tincture here.

By LEILA ALI-AKBARIAN MD, MPH

As news of Tom Brokaw’s cancer diagnosis spreads, so does his revelation that his cancer treatments cost nearly $10,000 per day. In spite of this devastating diagnosis, Mr. Brokaw is not taking his financial privilege for granted.  He is using his voice to bring attention to the millions of Americans who are unable to afford their cancer treatments.

My patient Phil is among them. At a recent appointment, Phil mentioned that his wife has asked for divorce. When I inquired, he revealed a situation so common in oncology, we have a name for it: Financial Toxicity.  This occurs when the burden of medical costs becomes so high, it worsens health and increases distress.  

Phil, at the age of 53, suffers with the same type of bone cancer as Mr. Brokaw.  Phil had to stop working because of treatments and increasing pain. His wife’s full time job was barely enough to support them. Even with health insurance, the medical bills were mounting. Many plans require co-pays of 20 percent or more of total costs, leading to insurmountable patient debt.  Phil’s wife began to panic about their future and her debt inheritance. In spite of loving her husband, divorce has felt like the only solution to avoiding financial devastation. 

Sadly, as healthcare costs rise, more Americans find themselves in similar situations. The United States spends more on healthcare than any other nation, without better results. Uncontrolled costs waste money and may be worsening the health of cancer patients. An astounding 30 percent of advanced cancer patients reported financial distress higher than physical or emotional distress. In these cases, the cost of care was literally more toxic than the effects of cancer or cancer treatment. 

Yet, oncology care can be delivered for far less money. The American Society of Clinical Oncology found that the costs of treating metastatic colon cancer in Washington State vs. British Columbia was double in the US compared to Canada, with similar outcomes. American doctors provide some of the highest quality medicine in the world, but the associated costs are neither affordable nor sustainable.

Much of this financial toxicity could be eliminated with a single payer system. Such a system would reduce the administrative costs associated with the ‘business of medicine’ — costs accounting for 25 percent of American healthcare charges.  Additionally, small companies would not be responsible for expensive healthcare benefits, and citizens could endure job change more safely.  A single payer system would also allow medical providers to get paid appropriately for services, but industry CEOs could no longer inflate costs in a market that profits from the sickest and most vulnerable Americans. 

Healthcare as a private enterprise is hurting people like Phil and his wife. It is increasing the suffering of cancer patients. The Canadians have proven that the same care can be delivered at half the cost. It’s time to put politics aside and move forward with a similarly designed system, with the goal of improving the health of Americans without the toxic burden of medical debt.

Dr. Leila Ali-Akbarian is a Public Voices Fellow and a primary care physician who practices Cancer Survivorship and Palliative Care at the Banner-University of Arizona Cancer Center.

By BISHAL GYAWALI MD

Me-too deja vu

I read the report of a phase 3 RCT of a “new” breast cancer drug but I had the feeling that I had already read this before. Later I realized that this was indeed a new trial of a new drug, but that I had read a very similar report of a very similar drug with very similar results and conclusions. This new drug is a PARP inhibitor called talazoparib and the deja vu was related to another PARP inhibitor drug called olaparib tested in the same patient population of advanced breast cancer patients with a BRCA mutation. The control arms were the same: physician choice of drug, except that physicians couldn’t choose the one drug that is probably most effective in this patient population (carboplatin). The results were nearly the same: these drugs improved progression-free survival, but didn’t improve overall survival. In another commentary, I had raised some questions on the choice of control arm, endpoint and quality of data about the olaparib trial when it was published last year. This current talazoparib trial is so similar to the olaparib trial that you can literally replace the word “olaparib” with “talazoparib” in that commentary and all statements will stay valid.

The oncology version of half-full, half-empty glass

The PARP inhibitors olaparib and niraparib are also approved in ovarian cancer based on improvement in progression-free survival (PFS), without improving overall survival (OS). If a drug doesn’t improve OS but improves only PFS, it should also improve quality of life to justify its use. According to two new reports, these drugs do not appear to improve quality of life. The niraparibtrial reported that the patients were able to “maintain” their quality of life during treatment while the olaparib trial reported that olaparib did not have a “significant detrimental effect” on quality of life. I find it remarkable that a drug that isn’t proven to improve survival is lauded for not significantly worsening quality of life … at $10,000 a month!

It is also important to recognize that these drugs were tested as maintenance therapy against placebos. For “maintenance therapies,” as explained in this paper, improving PFS alone is not an important endpoint. That’s why I am also not excited about this new trial of sorafenib maintenance in ovarian cancer. A drug has to be very ineffective to fail to improve even PFS as a maintenance therapy against placebo.

Off TRAC

What if I told you that there is a drug that doesn’t improve overall survival or disease-free survival, and also worsens quality of life, but is FDA approved? This is the story of adjuvant sunitinib in renal-cell cancer (which I have written about multiple times, for example here and here). In the latest report from the S-TRAC trial, adjuvant sunitinib significantly worsened quality of life versus placebo. However, the conclusion reads: “Patients on sunitinib did report increased symptoms and reduced HRQoL, but these changes were generally not clinically meaningful, apart from appetite loss and diarrhoea, and were expected in the context of known sunitinib effects.” If reporting lack of improvement in quality of life as “no detrimental effect” is the “glass is half-full” view then this assertion that the reduced quality of life doesn’t matter because it was expected has to be “an empty glass is not empty; it’s actually full of air” view towards cancer drugs .

Brain mets: checkmate?

Checkmate 204 was a phase 2 study that tested nivolumab plus ipilimumab for melanoma patients with brain metastases and found an intracranial clinical benefit rate of 57%. Although whole brain radiation therapy or stereotactic radiosurgery would achieve higher response rates, a justification for using immunotherapy instead could be that, unlike radiotherapy, these drugs will also treat extracranial lesions and have shown improved survival in melanoma patients in general. They would also avoid the side effects of radiotherapy to the brain. However, there are important caveats to consider: first, the fact that only 57% patients had intracranial benefit means that the other patients still needed radiotherapy; second, the patients included in this trial were asymptomatic; third, this drug combination has its own risks including death; and fourth, we don’t know that combining nivolumab plus ipilimumab is better than nivolumab alone.

Making Precision Oncology Precise Again

Much of what is being sold as precision oncology is actually imprecise in that drug and target combinations are being prescribed based on preclinical data, bioplausibility, retrospective data, and single arm studies showing a few responses…in short, everything but survival outcomes in RCTs. There are two main harms with this approach: the over-expectation but under-deliverance with precision approach and the pessimism surrounding the whole precision approach despite some remarkable success like trastuzumab and in HER2 positive breast cancer patients. The ESMO Scale for Clinical Actionability of molecular Targets (ESCAT) is a welcome step in the right direction because it will at least help to bring uniformity in reporting these targets. Kudos to ESMO for trying to systematize the targets in oncology.

Let me take a selfie

A recent RCT that showed that H. pylori eradication therapy lowered the rates of metachronous gastric cancer also showed a non‐significant increased risk of all‐cause mortality among patients randomized to eradication therapy (Hazard Ratio 1.95; 95% CI, 0.72 to 5.27; P = 0.19). The possibility that there could also be an association with an increased risk of all‐cause mortality is an important public health concern. To address this possibility, we performed a meta‐analysis of RCTs evaluating H. pylori eradication therapy focusing on the risk of all‐cause mortality. Reassuringly, we did not find a statistically significant increase in the risk of all‐cause mortality associated with H. pylori eradication therapy. However, continued real‐world surveillance of patients treated with eradication therapy as well as longer‐term follow up of these RCTs remains necessary.

Dr. Gyawali is a research fellow at the Program On Regulation, Therapeutics And Law (PORTAL) at Brigham and Women’s Hospital/Harvard Medical School. The opinions expressed herein are his own. This piece was originally published in ecancer here.

By ASHLEY ANDREOU

In 2014, the majority of international health aid was dedicated to HIV. So, one might reasonably assume that this is the largest health problem facing the world. Yet, HIV only constitutes 4% of the global burden of disease. In 2014, noncommunicable diseases (NCDs) made up 50% of the entire disease burden, but only received 2% of all global health funds.

The disease burden of NCDs is fast outpacing that of infectious diseases. Despite this, the proportion of global health financing dedicated to combatting NCDs has remained constant over the past 15 years at 1 to 2%.

Currently, 32.6 million individuals are living with cancer (diagnosed in the last five years). In 1970, 15% of new cases were in low- and middle-income countries. In 2008, 56% were in low- and middle-income countries. By 2030, this proportion is expected to be 70%. So, not only is the burden of NCDs rising globally, but it is also beginning to disproportionately affect countries with the least resources to deal with them.

But, if NCDs have been steadily increasing in low- and middle-income countries, why has global action not followed suit? The HIV epidemic reversed the reduction of infectious disease deaths in children and young adults and, as a result, stunted the epidemiological and demographic transition, particularly in sub-Saharan Africa. Consequently, preventing HIV and other major infectious diseases became the focus of the Millennium Development Goals (MDGs) set in 2000. Likewise, in 2001, the United Nations General Assembly committed all governments to prioritizing the HIV epidemic, shelving the issue of NCDs for the next decade. Accordingly, the World Health Organization (WHO) and UNAIDS updated their “Strategies for the Prevention and Control of Diseases” to reflect this HIV and infectious-disease focused agenda; within this document, NCDs were not mentioned.

This concerted advocacy and mobilization around HIV/ AIDS gave way to an international surge of funding that gave millions of people in low-resource settings access to antiretroviral therapy (ART). Although this global movement to fight AIDS came too late for many, today HIV/AIDS is largely seen as a manageable condition rather than a death sentence.

Analyzing how HIV was internationally addressed offers important lessons on the barriers, and potential points of intervention, for NCD treatment, such as cancer.  Although a similar end point needs to be reached in the fight for cancer care—high quality, affordable, accessible, sustainable treatment—there are different pharmaceutical barriers to addressing cancer in low- and middle-resource settings.

Once adequate health systems are in place, medicine is indispensable for treating and managing NCDs. However, the pricing, development, and administration for cancer drugs are markedly different than that of HIV. An important point of divergence between HIV treatment and cancer treatment is the level of generic competition: generics were integral in making ART internationally affordable.

Many cancer treatments are biologics (i.e. a virus, therapeutic serum, toxin, antitoxin, hormone or protein, including monoclonal antibodies or similar products used to diagnose, prevent, treat or cure a disease) rather than small molecules (i.e. small, chemically manufactured active-substance molecules). New cancer medications are increasingly biotechnology products, meaning they are produced using living systems such as plant or animal cells, bacteria, viruses, and yeast. In contrast, the treatment for HIV/AIDS, antiretroviral therapy (ART), is a small molecule drug. This means that the research and development (R&D) process as well as regulatory landscape is different. This has a significant impact on how generic versions of cancer treatment are made and regulated.

For a manufacturer to obtain marketing authorization and WHO prequalification of generic versions of a drug, they must simply demonstrate interchangeability. For small-molecule products, relatively simple bioequivalence studies establish interchangeability, such as testing a compound’s melting point. Approving generics does not require fully repeating  efficacy and safety clinical trials. However, the regulatory requirements for biologics are different.

Due to their biological nature, biosimilars are never the exact same molecule. As a result, the repeat tests to demonstrate interchangeability with the originator are much more extensive. For FDA approval, biosimilar companies must repeat clinical trials that may have taken the originator company upwards of five years and hundreds of millions in investment to complete. As a result, biosimilars cost much more to produce than traditional small-molecule generics and require significant investment by the generic producer. The immense cost for biosimilar R&D is a large part of why there is a lack of generic competition and, thus, the high, monopolized prices of cancer therapy.

Reduction of cancer mortality will be suboptimal without treatment. Like HIV drugs, cancer treatment must be affordable and reliable. However, given the biologic nature of many cutting-edge cancer therapies, the current approval process for generic cancer drugs is inadequate. As such, regulatory agencies need to acknowledge that the current approval process is effectively acting as a barrier for generic competition in the cancer drug market. If we envision a future where cancer treatment is as widely accessible as ART, health organizations need to start prioritizing NCDs as much as they do infectious ones—streamlining the biosimilar drug approval process is a necessary first step.

Ashley Andreou is graduate student in the MPH program at Yale University