Bad Blood, a story of the tell-tale start-up

Back in 2014 while studying for my master's degree, I remember touring Silicon Valley for the first time. It was a brand new world to me and I was, for lack of a better term, starry-eyed. Everything about the Bay Area told us to look for new ways to innovate and to make money out of technology or some big idea. It's what got me out of the idea that I wanted to do anything drug-related or something where the impact timeline would be 10+ years down the line.

Four years later, a Wall Street Journal investigative journalist publishes a book titled "Bad Blood: Secrets and Lies in a Silicon Valley Startup." All there is to be said about the book has already been said. In my opinion, it's worth the read if you're in biotech, basic sciences, or even just interested in a startup in the healthcare landscape.

There are so many facets to the story of Theranos. First, it's valuable to understand that the vision of Theranos was one of wanting to change the world and revolutionizing the healthcare industry. The mission was noble. The difference it could make to healthcare and medicine was profound (along the lines of preventative healthcare, drug reaction monitoring, etc.). There was a lot of money to be made. If the technology challenges had actually been overcome in the time that Ms. Holmes led Theranos (it called for advances and innovations in chemistry, microfluidics, scale-up, etc.), it would have truly been the next step to the tricorders of Star Trek. Combine this with the Silicon Valley hype train that the starry-eyed VCs rode in the 2000s and early 2010s. Combine that with Ms. Holmes' captivation with Steve Jobs and the idea of changing the world from a young age.

It's a very cautionary tale. Many profess that Ms. Holmes' was genuine in her desire to make a great technology that would help the world, but that she surrounded herself with the wrong people who encouraged her to cross too many lines, tell too many lies, and cut too many corners. It could have been her youth and the naivety that comes with it. It could have been she was a pathological liar.

In other industry spaces, (software, specifically), you might be able to get away with vaporware. But to continue on without conscience for the souls you affect when your technology affects medical decisions for patients -- it's naive to allow yourself to fall into a reality-distortion bubble. Whatever judgement you want to make on her, she's apparently paid her dues in a settlement (no shares for Theranos, 10 year ban on chairing or directing public companies, and $500,000 penalty) and it's interesting to note that she's now trying to start yet another company [Vanity Fair]. I'm not sure how she didn't get jail time for fraud and endangering the lives of patients...

Some interesting items explored in this book:

• Elizabeth Holmes surrounded herself with higher ups who championed her cause and gave her start-up credence in the eyes of the more naive.
• Elizabeth Holmes had a romantic relationship with her "second in command" Sunny Balwani (20 years her senior).
• The company lied to the military and several federal agencies, including the FDA, CLMS (Clinical Laboratory Management Systems).
• There is an interesting saga of how she suckered Walgreens into partnering with Theranos and spending millions of dollars on renovating their own stores to make wellness centers that accommodated the Theranos devices.
• An oppressive atmosphere was cultivated within Theranos, surrounded by secrecy, paranoia, and constant surveillance of employees.
• Theranos' persistence and bullying in silencing employees and former employees resulted in the SUICIDE of Ian Gibbons.
• John Carreyou (the journalist and author of the book) details his experiences in trying to gather sources for the story. Once news broke to Theranos that The Wall Street Journal was working on the story, Theranos began threatening and bullying those who they believed were Carreyou's sources, both public and confidential. Scary effing stuff.

A slew of other things but some food for thought:

"Hyping your product to get funding while concealing your true progress and hoping that realtiy will eventually catch up to the hype continues to be tolerated in the tech industry. But it's crucial to bear in mind that Theranos wasn't a tech company in the traditional sense. It was first and foremost a health-care company. Its product wasn't software but a medical device that analyzed peoples' blood. As Holms herself liked to point out in media interviews and public appearances at the height of her fame, doctors base 70 percent of their treatment decisions on lab results. They rely on lab equipment to work as advertised. Otherwise, patient health is jeapordized."

"This book, which flowed from my work exposing the Theranos scandal in the pages of the Wall Street Journal, would not have been possible without the help of the confidential sources who spoke to me at great personal peril throughout 2015 and 2016. [...] All were moved to talk to me, despite the legal and career risks they faced, by one overriding concern: protecting the patients who stood to suffer harm from Theranos' faulty blood tests. I will forever be grateful to them for their integrity and their courage. They are the true heroes of this story."

If you're in the healthcare industry and want to make a difference in the space, the industry, or your community, don't forget the reasons you are in it.

Another good read: http://nymag.com/selectall/2017/04/why-silicon-valley-keeps-getting-biotechnology-wrong.html

Currently Reading: The Three-Body Problem (Cixin Liu)

Playing Telephone

Work's been pretty busy. Progress since last blog entry? Have I become a machiiine? Have I become angry? Not quite yet but I have been getting more productive. That or there's just so much work that I have no choice to be....

Still getting mindsplit between the two jobs but it's very engaging and I'm never bored, so yay! Next to my original workload, helping with two grants, clinical data collection, document validation, and patient recruitment, I've been learning how to use SQL Server Integration Services, used for data integration and workflow applications and dabbing in MATLAB for data analysis.

From a high level, dealing with data at UCSF and Epic isn't easy. It's kind of like a game of telephone:

• Hospital staff collect and input the data into Epic as they observe them. If the data is not structured, they will enter free text.
• The data is cached in Epic. The software and data model is designed by software engineers.
• Cached data is sent to a relational database (SQL). Which can then be copied into separate databases. The SQL database and data structure is adapted to cached data by software engineers and data scientists.
• Clinicians request data reported in a way they can interpret and analyze.
• Analysts (programmers, computer scientists, data scientists etc) extract data from SQL or other database sources.
• Research assistants analyze the data extractions.
• Clinicians improve or change their practice based on data analysis.

For this to work smoothly, a good understanding of what happens at every part of this pathway is necessary. It is important for everyone to understand data flow and how things get captured clinically and electronically. But providers in a busy large research hospital do not always have the bandwidth to be mindful of data methods. In the moment of service, patients should always come first.

How do we put everybody on the same page?

The easiest way is to change the way hospital staff interfaces with data input and output methods in the first step. Increasing the intuitiveness of graphical user interfaces (GUI) and the data feedback loop will:

• Increase staff awareness on the importance of meaningful data input
• Increase staff appreciation for data output
• Increase the need for standardizing methods of other types of data. (For example, images need to be stored and interpreted.)

What other solutions are there?

What Are You Angry About? (Fixing Healthcare)

OKAY.

I've been reading this book, recently "Where Does It Hurt?: An Entrepreneur's Guide to Fixing Healthcare" and came across an interesting passage:

I reached the conclusion not long ago that anger, either white hot or smoldering, is a fundamental fuel for entrepreneurs. They don't have to be angry all of the time, of course; that would be no fun for anyone. But it helps if deep down they nurse some wound, grievance, or perhaps a sense of injustice. The anger gets them stoked. I think Steve Jobs was often angry. I often see myself as friendly and humorous. Sometimes I am, but in thinking through phases of my life for this book, I realized that during many of my most productive stretches, I was seething, and also terrified of impending failure. This combination of fear and anger, along with a good bit of luck, served me well during those difficult months.(p.54)

In lieu of this, I wondered what my great motivators were and what it would take for me to become successful. What would it take to be the productive machine that can accomplish all the wonderful, noble things I'd like to accomplish in life?

All my life, I believed it to be passion. (defined: "strong and barely controllable emotion")

I also believed that there are two forces at tension driving human behaviors: a pulling force, akin to love, that forces us to fight and a pushing force, akin to fear, that forces us in flight. We need both a pulling force and a pushing force to keep us moving forward.

Now, I am generally a very agreeable woman. Anger and strong opinions are just not part of my interpersonal repertoire. I like to believe I'm guided primarily by love and compassion.

Maybe I've been conditioned to dismiss anger as a negative fruitless emotion so I've never allowed myself to be angry. I was afraid of feeling angry and aggressively defending my ideals. I've been angry before, at people, and it was uncontrolled and untapped and sometimes hurtful. I can be scathing and cruel (hard to believe, I know, but just ask my ex). I would always feel guilt and shame, like a classic Mr. Hyde, and maybe that's why I'm so afraid of the emotion. 

However, the running theme in the past few months of my life has been the dissipation of fear--facing my personal demons head on. If demons are fallen angels, then anger is a corrupted emotion spun out of love and the need for preservation. Anger can be a force that helps us to fight for that which we seek to love and protect. Unbridled, however, it is as harmful as Cyclops' optic blasts.

Don't be afraid to admit you nurse your own wounds, grievances, or sense of injustice.

What am I angry about?

The broken and archaic healthcare system? The limitations of human movement? My friends and family getting hurt? Growing up less "privileged" than most of my colleagues in the Bay Area?

Will I ever own a rehabilitation clinic focused on new research/technologies? Write that sci-fi novel? Write those short stories? Will I ever go on that volunteer trip abroad? Will I ever be able to give back to my parents? So many smoldering ambitions and so many energy resource options...

I don't agree fully with Bush's statement on entrepreneurs and anger. But perhaps anger is an emotion I should let myself explore.

Also, a good video between Malcolm Gladwell and David Goldhill:

The Big Story: Fixing Healthcare

Currently Reading: Where Does It Hurt?: An Entrepreneur's Guide to Fixing Health Care (Jonathan Bush, 2014); Jailbird (Kurt Vonnegut, 1979)

Currently Listening: Bad Girl (Usher)


Brainstorming thoughts
Energy resources / Analogous motivators:
Solar energy = love
Wind power = fear
Fossil fuel = anger?
Hydroelectric = physical

Digital Health Commons

Are larger health institutions and hospitals capable of supporting a digital health commons?

Last Thursday, I attended a Stanford Medicine X meetup with Teresa "On Peer-to-Peer Healthcare and Human Centered Design." The speaker, Sean Ahrens, a down-to-earth guy that spoke to the audience on a beanbag chair, beer in hand, spoke on how public good can be created with the advent of an online community that allows truly shared health data (a digital health commons).

Sean talked about his website, Crohnology, which serves patients diagnosed with Crohn's disease, a chronic condition with no cure. Inflammation can occur anywhere within the digestive system, taking a huge toll on a patient's quality of life. Sean developed a website in many ways reminiscent of sites like Livestrong and Weight Watchers because it builds a community where people can talk about their health progress, share information, and motivate each other. However, the site also serves a broader public good: it accumulates health data that contributes to research for, at the very least, quality of life management. If you want to think with a little more grandeur, it may one day help researchers find a cure for Crohn's. I was most impressed with the intuitiveness of patient journals - they report on how they are feeling in their journal on a scale of 0 to 100. This perceived health would then be charted against the diet, medications, supplements, and lifestyle changes they report to manage their disease. Patients can look at their own data over time and see how that compares with other people who have Crohn's.

Ultimately, the goal is to build a "Patient-Powered Research Network." Sean shared his struggles with creating Crohnology - he journeyed from trying to make a business out of his patient-powered research network to realizing that monetizing the site didn't align with his personal values. But if there is no return on investment, funding and support for the site is extremely difficult to find. Currently, Crohnology is kept alive with the help of the Patient-Centered Outcomes Research Institute (PCORI).

Key issues for this type of platform include:
1. Funding: How do you keep true to your philanthropic goals without selling yourself out? The website needs to be supported monetarily.
2. Open Access: How do you maintain open access and protect privacy?
3. Integration: Can data be shared between other information sources? For example, health data from Fitbit?

I thought that the challenges presented here were particularly interesting because the idea of "patient powered" research seems erroneous. Scientists would be skeptical in the validity of this research because of the sheer amount of subjectivity and myriad confounding variables (McKenna 2011). However, more and more, patient-reported outcomes (PROs) are becoming a valid research model - because a patient's happiness, outlook, and support group correlates with survival (Kyte 2013). I would argue that the more data they can obtain over a specific population, the more we could try to deduce and intrepret. Traditionally, we look at PROs with questionnaires that calculate an outcome measure on a scale or a score so it is less subjective and mores scientific. 

The key to creating a digital health commons, however, is giving patients the tools and the guidelines for them to look at their health objectively. In Crohnology's case, the system--a perceived health rating scale alongside other tools for recording objective data and the potential to add in data from other sources like wearable devices--is simple enough for patients to understand and comprehensive enough for self-awareness development.

In thinking about some of the problems Sean was dealing with, I thought about the potential of the VisionTree platform my team is working on implementing with Dr. Damato and Dr. Dunn. The cloud-based platform stores clinical information from existing EHR and creates a portal for patients to log in and answer questionnaires--thus creating a central space for data analytics to take place between PROs and clinical outcomes. Our main goal, ergo, is to enable research in PROs, based on validated psychometric and psychosocial measures. But a platform for patients to simply log in and fill in questionnaires seems too limited in scope.

What if we built in a forum or an analogous health data commons within VisionTree? UCSF patients could have a single portal where they learn about their disease and look at their medical records and images, fill in questionnaires for the hospital's own research, and provide a personal account of their own outcomes, thoughts, and feelings. Provided a patient was willing to volunteer their anonymous personal data via informed consent, they could freely participate in the data commons and learn about how other anonymous patients are dealing with their issues. Patients could then build a community within VisionTree that doctors could also see - enabling unprecedented feedback and understanding of their patients.

However, I foresee plenty of things wrong with this idea.

1. Institutional protection of data and lack of open access to other people outside of the community may conflict with the values of a truly "shared" community. This could create an "Uber" of the health industry.
2. Privacy concerns are always present. Although a patient signs informed consent, it does not mean they will always know how to manage their anonymity on the internet. This is an inherent "internet of things" problem.
3. A radically different relationship between doctors and patients could develop as patients will naturally discuss their misgivings about the care they receive from the healthcare institutions. This could have a negative impact on the economic incentive of the institution enabling a Data Commons within the platform. Antagonism may be inherent in this kind of community. On the other hand, this would encourage hospitals and providers to become more patient-centric.
4. A lot of developer work and maintenance is required. A large commission would be needed to develop a platform and maintain it. As mentioned, funding is very difficult to obtain because, in general, the return on investment for obtaining patient-reported outcomes data is uncertain. The trade-off, of course, is the sheer amount of subjective data we could obtain in conjunction with the objective data collected in the clinics, including medical images, tumor sizes, genetic factors, visual acuity, etc. But thinking of the kinds of questions we could answer from a research funding standpoint is a whole new ballpark.

So is this a feasible idea? Is it better to leave digital health commons to more separate entities, subject to altruistic funding? Or would institutions be willing to take on the potential challenges associated with hosting a platform?

I don't really know much about the landscape from a clinical or logistics standpoint - I am mostly, out of curiosity, laying out my thoughts and wanted to bounce it off of someone.

References:
1. Stanford Medicine X <https://medicinex.stanford.edu>
2. Crohnology <https://crohnology.com/>
3. Patient-Centered Outcomes Research Institute <http://www.pcori.org/about-us>
4. Measuring patient-reported outcomes: moving beyond misplaced common sense to hard science. Opinion. McKenna, Stephen. doi:10.1186/1741-7015-9-86 <http://www.biomedcentral.com/1741-7015/9/86>
5. Patient-reported outcomes helped predict survival in multiple myeloma using partial least squares analysis. Kyte, Derek. doi:10.0001/jama.2013.277222 <http://jama.jamanetwork.com/article.aspx?articleid=1741830>
6. VisionTree Software, Inc. <http://www.visiontree.com/>