Theranos, hype, fraud, solutionism, and eHealth

Anyone who has had to either give or take a blood sample has surely thought “there must be a better way.” The promise of replacing the pain of the needle and the seeming waste of multiple blood vials has an immediate appeal. If there was a technology that could

Theranos were one of the hottest health teach startups of the last decade. Indeed, their USP – that existing blood testing could be replaced by a pin prick – would have been a genuinely disruptive one.

Theranos was founded in 2003 by Elizabeth Holmes, then 19 years old, who dropped out of studying engineering in Stanford in order to start the company. In 2015 she was named by Forbes magazine as the youngest self-made female billionaire in history, with an estimated worth of $4.5 billion. In June 2016, Forbes revised their estimate to zero. What happened?

At times of writing, Holmes has been charged with “massive fraud” by the US Securities and Exchange Commission, and has agreed to pay a $500,000 fine and accept a ban from serving as a company director or officer for ten years. It is unclear if a criminal investigation is also proceeding.
At its height, Theranos had a seemingly stellar team of advisors. The board of directors has included such figures as Henry Kissinger, current US Secretary of Defence James “Mad Dog” Mattis, various former US Senators and business figure. In early 2016, in response to criticism that, whatever their other qualities, the clinical expertise of Mad Dog Mattis et al was perhaps light, it announced a medical advisory board including four medical doctors and six professors.

 

Elizabeth Holmes’ fall began in October 2015, when the Wall Street Journal’s John Carreyrou published an article detailing discrepancies between Theranos’ claims and the actual performance of their technology. This was in response to a Fortune cover story by Roger Parloff, who subsequently wrote a thoughtful piece on how he had been misled, but also how he missed a hint that all was not what it was.

 

Theranos’ claims to be able to perform over 200 different investigations on a pinprick of blood were not borne out; and it turned out that other companies’ products were used for the analysis of many samples.

 

The fall of Theranos has led to some soul-searching among the health tech stat up community. Bill Rader, an entrepreneur and columnist at Forbes, wrote on What Entrepreneurs Can Learn From Theranos:

 

     I have been watching first in awe of perceived accomplishments, and then feeling burned, then later vindicated, when the actual facts were disclosed. Don’t get me wrong, I really wanted their efforts to have been both real and successful – they would have changed healthcare for the better. Now, that seems unlikely to be the case.

 

… By now, almost everyone has heard of Holmes and her company, and how she built Theranos on hype and secrecy, and pushed investors into a huge, $9 billion valuation. Now everyone in the industry is talking about this and lawsuits are flying.

Just a couple months ago, a Silicon Valley venture capitalist appeared on CNBC’s “Closing Bell” and instead of talking about the elephant in the room, he diverted to a defense strategy for the Theranos CEO.

 

He claimed Elizabeth Holmes had been “totally attacked,”and that she is “a great example of maybe why the women are so frustrated.”

He also went on to say, “This is a great entrepreneur who wants to change health care as we know it.”

 

The last statement was the strangest thing he said. Wouldn’t we all like to change things for the better? But “wanting” and “doing” are two different things.

 

 

 

Rader’s piece is worth reading for clinicians and IT professionals involved in health technology. The major lesson he draws is the need for transparency. He describes being put under pressure by his own board; why wasn’t he able to raise as much money as Theranos? It transpires that Theranos’ methods may make life more difficult for start-ups in the future, and Rader fears that legitimate health tech may suffer:

 

Nothing good has come of the mess created by Theronos secrecy, or as some have characterized, deception. The investor has been burned, the patient has been left with unfilled promises (yet again) and life science industry start-ups, like my company, have been left with even more challenges in raising much needed investment. And worse of all, diagnostic start-ups in general are carrying an unearned stigma.

 

In this interesting piece, Christine Farr notes that the biggest biotech and health care venture capital firms did not invest in Theranos, nor did Silicon Valley firms with actual clinical practices attached. As Farr writes, the Theranos story reflects systemic issues in funding of innovation, and the nature of hype. And one unfortunate consequence may be an excessive focus on Elizabeth Holmes; a charismatic figure lauded unrealistically at one point is ripe to become a scapegoat for all the ills of an industry the next.

 

The “stealth mode” in which Theranos operated in for the first ten years of its existence is incompatible with the values of healthcare and of the science on which it is based. Farr points out how unlikely it would be that a biotech firm vetting Theranos would let their lack of peer reviewed studies pass. The process of peer review and building evidence is key to the modern practice of medicine.

Another lesson is simply to beware of what one wants to be true. As written above, the idea of Theranos’ technology is highly appealing. The company, and Holmes, sailed on an ocean of hype and admiring magazine covers. The rhetoric of disruptive and revolutionizing healthcare featured prominently, as the 2014 Fortune magazine cover story reveals:

 

Perhaps a healthy scepticism of claims to “revolutionise” health care will be one consequence of the Theranos affair, and a more robustly questioning attitude to the solutionism that plagues technology discourse in general.

Clinicians and health IT professionals should be open to innovation and new ideas, but also hold on to their professional duty to be confident new technologies will actually benefit the patient.

The turtle menace – the peril of ICD-10 code W5922XD

Have you heard of the menace represented by ICD-10 code W5922XD?

If you don’t know what the hell I am on about, check it out here.

There’s also the menace of other species.

There’s fires in perhaps unexpected places.

Injuries can happen anywhere – such as here or here or here,

For those who may be offended by my tone, having survived multiple turtle and macaw attacks while being burnt while watersking in the prison pool en route to the library while singing arias, apologies.

At least you don’t have to face this. Repeatedly.

#LivingLibrary – College of Psychiatrists of Ireland event for #GreenRibbon month, 31st May 2018

I will be speaking as a living book in this:

The College is delighted to announce our 4th annual event in partnership with See Change for Green Ribbon Month – A Living Library
When it comes to mental health everyone has a story to share and we find comfort, empathy and compassion in shared experiences. Social contact is known to be one of the most effective ways of reducing mental health related stigma and discrimination so with this in mind, and to mark Green Ribbon month, the College is delighted to announce our ‘Living Library’ event, a library come to life in the outdoors!

At our library the ‘books’ are a little different, they are people; people with different experiences and stories to tell related to mental health including those who have experienced mental health issues and illness, their family members and carers, and the psychiatrists who help them towards the path of recovery. Mental health stigma too often creates discrimination and misunderstanding so we want to give members of the public the opportunity to connect and engage with psychiatrists and people they may not normally have the occasion to speak with.

The aim is to better understand the lived experiences of others who have experienced or facilitated recovery from mental illness and distress and to challenge their own assumptions, prejudices and stereotypes. We invite you to ‘read’ the human books through conversation and gain understanding of their experiences.

For Green Ribbon Month Let’s End the Stigma by not judging a book by its cover and develop a greater understanding of each other’s stories.

Thursday 31st May 2018
12.30pm – 2.30pm
St Stephens Green, Dublin

This is a Free Event, but space is limited. Book your place here.

A Way Out of Burnout: Cultivating Differentiated Leadership Through Lament

Some interesting (and provocative) thoughts from the world of church leadership. “Lament” is not prominent in our culture anymore, at least not in our official culture… and one could wonder how to translate these ideas into a secular setting. Nevertheless, there is much to ponder here and I would feel that all in leadership positions – or roles susceptible to burnout – could benefit from reading this, whether they have religious faith or not.

I found the following paragraphs (of what is a long paper) especially resonated:

 

Leaders who are most likely to function poorly physically or emotionally are those who have failed to maintain a well-differentiated position. Either they have accepted the blame owing to irresponsibility and constant criticism of others, or they have gotten themselves into an overfunctioning position (that is, they tried too hard) and rushed in where angels and fools both fear to tread.[12]

Many programs often aim to cure clergy burnout by offering retreats that focus on rest and relaxation. However, Friedman asserts, “Resting and refreshment do not change triangles. Furthermore, because these programs focus on the burned-out ‘family’ member, they can actually add to his or her burden if such individuals are inclined to be soul searchers to begin with.”[13] These same soul-searching and empathetic clergy are vulnerable to seeing the overwhelming burdens that they carry for others as crosses that they ought to bear. Friedman calls this way of thinking “sheer theological camouflage for an ineffective immune system.”[14] When clergy bear other people’s burdens, they are encouraging others not to take personal responsibility. And often in bearing other people’s burdens, clergy easily tend to ignore their own “burdens” (ie. marriage issues, financial problems, etc.) and thus fail to be personally responsible for themselves.

 

London also discusses how “lament” and in some ways “passing the buck onto God” has Biblical roots:

God responds with sympathy to Jesus’ ad deum accusation and lament. Furthermore, one may easily interpret the empty tomb at the end of the Gospel as a sign of God’s ultimate response to Jesus’ lament: the resurrection (Mark 16:4-7). In the psalms of lament and in the cry of dereliction, we see that God does not respond with hostility but with a sympathetic openness to our struggle, our need for someone to blame and, in the words of Walter Brueggemann, our “genuine covenant interaction.”[34] God responds with sympathetic openness to Jesus’ ad duem accusation and then dispels the blame and emotional burden that no human could ever bear. Jesus receives the blame that humans cast upon him and then gives it to God who receives it, absorbs it and dispels it. Jesus let go of the blame by giving it to God. His cry of dereliction became his cry for differentiation. In this way, Jesus serves as a role model for leaders who receive blame from others and then need to differentiate in order to not take accusations personally. By practicing lament, leaders can turn the ad hominem accusations against themselves into ad deum accusations against God, who responds with sympathetic openness while receiving and dispelling the blame. Moreover, leaders can respond with empathy to the suffering of others, knowing that they will not have to bear the emotional burden that they have taken on, indefinitely. They can let go of the emotional burden by passing it on to God through the practice of lament.

This “passing of the buck” to God does not encourage irresponsibility. Rather, it gives the emotional baggage away to the only One who can truly bear it, thus freeing the other to take personal responsibility, without feeling weighed down by unbearable burdens. With this practice, a pastor can therefore receive blame and emotional baggage from parishioners in a pastoral setting because they can differentiate through lament. They can take the blame like Jesus because they, like Jesus, can also pass the buck to God through ad deum accusation. Eventually, the pastor will want to teach the parishioners to redirect their human need to blame onto God as well so as to occlude the cycle of scapegoating in the community.[

 

DANIEL DeFOREST LONDON

This is the final paper I wrote for the class “Leading Through Lament” with Dr. Donn Morgan at the Church Divinity School of the Pacific.

INTRODUCTION

On August 1, 2010, New York Times published an article titled “Taking a Break From the Lord’s Work,” which began with the following statements:  “Members of the clergy now suffer from obesity, hypertension and depression at rates higher than most Americans. In the last decade, their use of antidepressants has risen, while their life expectancy has fallen. Many would change jobs if they could.”[1] Although these are troubling reports, some of the statistics that came out of a study conducted by Fuller Theological Seminary in the late 1980s prove more disturbing: “80 percent [of pastors] believe that pastoral ministry is affecting their families negatively, 90 percent felt they were not adequately trained to cope with the ministry demands placed upon them, 70 percent…

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“Working here makes us better humans”

A daily thought from Leandro Herrero:

I have had a brilliant two day meeting with a brilliant client. One aspect of my
work with organizations that I truly enjoy is to help craft the ‘Behavioural DNA’ that shapes the culture of the company. This is a set of actionable behaviours that must be universal, from the CEO to the MRO (Mail Room Officer). They also need to pass the ‘new hire test’: would you put that list in front of a prospect employee and say ‘This is us’?

There was one ‘aspirational’ sentence that I put to the test: ‘Working here makes us better human beings’.

It was met with scepticism by the large group in the meeting, initially mainly manifested through body language including the, difficult to describe, cynical smiles. The rationalists in the group jumped in hard to ‘corporatize’ the sentence. ‘Do you mean better professionals?’ The long discussion had started. Or, perhaps, ‘do you mean…’ – and here the full blown corporate Academy of Language – from anything to do with skills, talent management, empowerment to being better managers, being better leaders, and so on.

‘No, I mean better human beings. Period!’- I pushed back. Silence.

Next stage was the litany of adjectives coming form the collective mental thesaurus: fluffy, fuzzy, soft, vague…

I felt compelled to reframe the question: ‘OK, so who is against working in a place that makes you inhuman? Everybody. OK, ‘ So who is against working in a place that makes you more human? Nobody. But still the defensive smiling.

It went on for a while until the group, ‘organically’, by the collective hearing of pros and cons, turned 180 degrees until everybody agreed that ‘Working in a place that makes you a better human being’ was actually very neat. But – there was a but – ‘Our leadership team wont like it. They will say that its fluffy, fuzzy, soft etc… In the words of the group, it was not ‘them’ anymore who had a problem, it was the infamous ‘they’.

The “difficult to describe” cynical smiles are familiar…. indeed I am sure I have perpetrated such smiles more than once myself!

Medicine can be a dehumanising profession, sometimes literally. Dehumanising in both ways – patients, especially some categories of patient, colleagues, but also we ourselves. Of course, the rationalist part of us can pick apart what “better humans” means…

Information underload – Mike Caulfied on the limits of #Watson, #AI and #BigData

From Mike Caufield, a piece that reminds me of the adage Garbage In, Garbage Out:

For many years, the underlying thesis of the tech world has been that there is too much information and therefore we need technology to surface the best information. In the mid 2000s, that technology was pitched as Web 2.0. Nowadays, the solution is supposedly AI.

I’m increasingly convinced, however, that our problem is not information overload but information underload. We suffer not because there is just too much good information out there to process, but because most information out there is low quality slapdash takes on low quality research, endlessly pinging around the spin-o-sphere.

Take, for instance, the latest news on Watson. Watson, you might remember, was IBM’s former AI-based Jeopardy winner that was going to go from “Who is David McCullough?” to curing cancer.

So how has this worked out? Four years later, Watson has yet to treat a patient. It’s hit a roadblock with some changes in backend records systems. And most importantly, it can’t figure out how to treat cancer because we don’t currently have enough good information on how to treat cancer:

“IBM spun a story about how Watson could improve cancer treatment that was superficially plausible – there are thousands of research papers published every year and no doctor can read them all,” said David Howard, a faculty member in the Department of Health Policy and Management at Emory University, via email. “However, the problem is not that there is too much information, but rather there is too little. Only a handful of published articles are high-quality, randomized trials. In many cases, oncologists have to choose between drugs that have never been directly compared in a randomized trial.”
This is not just the case with cancer, of course. You’ve heard about the reproducibility crisis, right? Most published research findings are false. And they are false for a number of reasons, but primary reasons include that there are no incentives for researchers to check the research, that data is not shared, and that publications aren’t particularly interested in publishing boring findings. The push to commercialize university research has also corrupted expertise, putting a thumb on the scale for anything universities can license or monetize.

In other words, there’s not enough information out there, and what’s out there is generally worse than it should be.

You can find this pattern in less dramatic areas as well — in fact, almost any place that you’re told big data and analytics will save us. Take Netflix as an example. Endless thinkpieces have been written about the Netflix matching algorithm, but for many years that algorithm could only match you with the equivalent of the films in the Walmart bargain bin, because Netflix had a matching algorithm but nothing worth watching. (Are you starting to see the pattern here?)

In this case at least, the story has a happy ending. Since Netflix is a business and needs to survive, they decided not to pour the majority of their money into newer algorithms to better match people with the version of Big Momma’s House they would hate the least. Instead, they poured their money into making and obtaining things people actually wanted to watch, and as a result Netflix is actually useful now. But if you stick with Netflix or Amazon Prime today it’s more likely because you are hooked on something they created than that you are sold on the strength of their recommendation engine.

Let’s belabor the point: let’s talk about Big Data in education. It’s easy to pick on MOOCs, but remember that the big value proposition of MOOCs was that with millions of students we would finally spot patterns that would allow us to supercharge learning. Recommendation engines would parse these patterns, and… well, what? Do we have a bunch of superb educational content just waiting in the wings that I don’t know about? Do we even have decent educational research that can conclusively direct people to solutions? If the world of cancer research is compromised, the world of educational research is a control group wasteland.

The world of Policy and the Salzburg Statement

With his recent elevation to Taoiseach, something Leo Varadkar (who was supposed to work with me when I did a locum in Tallaght in May 2007… but he was occupied with some election or other) said in the late 1990s got a fair bit of coverage. This was to the effect that as a doctor you can help a few people, but as Minister for Health you can help millions. While at first glance this seems like a truism, it has for some reason got under my skin. There are various reasons for this, not all of which I will get into. Perhaps I am jealous of a road not travelled! (I am pretty confident I am not)

In a way it sums up a particular seduction – the seduction of the World of Policy. Get interested in any field – from the natural world to technology to medicine indeed – and sooner or later the siren song of policy will be heard. Wouldn’t it be great to Make A Difference not just on the piecemeal, day-to-day way, but on a grander scale? Increasingly I think not. Clearly someone needs to formulate policy and to think about things on a broad scale – but they should do so without illusions and with a certain humility. People have a habit of behaving in a way that the enlightened policy makers don’t foresee.  The circuit of conferences and “networking” can become an echo chamber of self congratulation. Doing good, perhaps, is best done on a smaller scale.

These thoughts are occasioned by reading about the Salzburg Statement. This is something I heartily approve of – a call for action to ensure all children enjoy the right to play in a nature rich space within ten minutes of their home.  The statement is made up of eight key actions:

Eight actions to transform cities for children

1. Ensure children of all ages, backgrounds, income, and abilities have equitable access to nature and play regularly and in meaningful ways to promote good health and wellbeing.

2. Embed nature in everyday places used by children, such as schools, backyards, parks, playgrounds and city streets, to make the city into a natural outdoor classroom.

3. Involve children in designing and planning natural spaces for recreation, education, inspiration and health, to give them ownership and pride in their local communities, schools and parks

4. Build curiosity, wonder, and care for nature in children (for example by greening school grounds and involving children with community gardens).

5. Protect natural features across cityscapes and create an equitably distributed network of accessible green and nature-rich spaces that all generations can reach on foot.

6. Connect cities with the broader ecosystems in which they are embedded, creating corridors for people, plants and animals to move safely across the city and into its surroundings.

7. Establish more urban conservation areas to increase access to nature and connect cities to the broader protected area network.

8. Work together through cross sectoral and multi-level partnerships to build an inclusive culture of health in cities.

 

There’s nothing there I would disagree with, though as with all these kind of interventions I would like more robust dissection of what, say, Item 3 would mean in practice.

I am always a little wary of dressing up worthy activity in the mantle of Health. What Resting a case for nature on the vagaries of purported health benefits can be a dangerous and debunkable game – especially with the media. This visual  handily shows how media can seize on single studies to generate headlines:

One can easily imagine a Katie Hopkins-ish journalist seizing on the inevitable ambiguities of research to “debunk” the claims for health benefits of nature.

I should state very clearly I have no reason to think that the Salzburg Statement is a wonderful initiative I look forward to hearing more of. But I am a little wary of the siren call of the World of Policy.

Beyond Knowing Nature – 5 Pathways to Nature Connection

Once again I am reblogging an interesting post by psychologist Miles Richardson on connection with nature and well being.

Particularly interesting is the research finding that factual knowledge does not necessarily correlate with emotional connection with nature. As Richardson writes, “the brain feels before it thinks”, and by focusing too much on how well species can be identified, we can miss the potential of emotional, experiential connection.

Finding Nature

Owing to the benefits to both human and nature’s well-being, and wide spread disconnection, a connection with nature is something many people and organisations are keen to increase. So there is a need to know how best to do this. We’ve already developed specific interventions, such as 3 good things in nature, but our wider framework of effective routes to nature connection has just been published in Plos One. I’m excited about this work is it provides guidance for those seeking to re-connect people with nature, indeed it has been central to much of our recent nature connections work, for example, guiding the type of activities promoted as part of The Wildlife Trusts highly successful 30 Days Wild campaign.

General nature contact and knowledge based activities are often used in an attempt to engage people with nature. However the specific routes to nature connectedness have not been examined…

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Leandro Herrero – “The best contribution that Neurosciences can make to Management and Leadership is to leave the room”

A while back I reviewed I Know What You’re Thinking: Brain Imaging and Mental Privacy in the Irish Journal of Psychological Medicine, and discussed a couple of studies which illustrate the dangers of what could best be called neuro-fetishism:

In 2010, Dartmouth University neuroscientist Craig Bennett and his colleagues subjected an experimental subject to functional magnetic resonance imaging. The subject was shown ‘a series of photographs with human individuals in social situations with a specified emotional valence, either socially inclusive or socially exclusive’. The subject was asked to determine which emotion the individual in the photographs were experiencing. The subject was found to have engaged in perspective-taking at p<0.001 level of significance. This is perhaps surprising, as the subject was a dead salmon.

…

In 2007, Colorado State University’s McCabe and Castel published research indicating that undergraduates, presented with brief articles summarising fictional neuroscience research (and which made claims unsupported by the fictional evidence presented) rated articles that were illustrated by brain imaging as more scientifically credible than those illustrated by bar graphs, a topographical map of brain activation, or no image at all. Taken with the Bennett paper, this illustrates one of the perils of neuroimaging research, especially when it enters the wider media; the social credibility is high, despite the methodological challenges.

I am becoming quite addicted to Leandro Herrero’s Daily Thoughts and here is another. One could not accuse Herrero of pulling his punches here:

I have talked a lot in the past about the Neurobabble Fallacy. I know this makes many people uncomfortable. I have friends and family in the Neuro-something business. There is neuro-marketing, neuro-leadership and neuro-lots-of-things. Some of that stuff is legitimate. For example, understanding how cognitive systems react to signals and applying this to advertising. If you want to call that neuro-marketing, so be it. But beyond those prosaic aims, there is a whole industry of neuro-anything that aggressively attempts to legitimize itself by bringing in pop-neurosciences to dinner every day.

In case anyone doubts his credentials:

Do I have any qualifications to have an opinion on these bridges too far? In my previous professional life I was a clinical psychiatrist with special interest in psychopharmacology. I used to teach that stuff in the University. I then did a few years in R&D in pharmaceuticals. I then left those territories to run our Organizational Architecture company, The Chalfont Project. I have some ideas about brains, and some about leadership and organizations. I insist, let both sides have a good cup of tea together, but when the cup of tea is done, go back to work to your separate offices.

It is ironic that otherwise hard-headed sceptics tend to be transfixed by anything “neuro-” – and Leandro Herrero’s trenchant words are just what the world of neurobabble needs. In these days of occasionally blind celebration of trans-, multi- and poly- disciplinary approaches, the “separate offices” one is bracingly counter-cultural…

Leandro Herrero – What I learnt from the monks: a little anthropology of leadership and space in one page.

Another Daily Thought from Leandro Herrero that I am tempted to simply cut and paste completely. The whole thing is worth reading. I have blogged on my other site a fair about both the positive side of monastic practice and the risk of romanticising monasticism with the attendant danger of spiritual pride.

Monasteries were, of course, key institutions in the development of Western institutional life and culture. We often like to think that we have moved way way beyond learning from the communal life of monasteries. Of course, the themes and patterns of human interaction recur in superficially different guises:

There is something special about creating space. For me, leadership is mainly architecture: create the conditions, find the spaces, protect them, make them liveable. Architects also have maps, and compasses. The leader needs to provide maps (frameworks, such as the non negotiable behaviours) and navigation tools (a value system). But, above all, it’s about space.

Providing spaces for people to breath, to growth, to deliver something, to get better, to think critically, to interact, to collaborate, to travel together. This is all about space. Space is the psychological sister of place. Space may be only, or mainly, mental. As such, it is a precious asset. No wonder the word space has been often associated to the word sacred. As in sacred spaces. To provide space, to create and protect spaces for others, is something a good leader does. It’s a great deal of his servant-ship.

But we, sometimes, are not very good at this. We take over other people’s spaces by insisting in discussing, wanting to ‘go deeper’, being intolerant with leaving things open, dictating our own terms and providing unreasonable borders to their spaces.

At a threshold point of two people living together in one place, they may come to inhabit one single space. It requires a lot of maturity to live in one single space with others. Occupying one single place, is the easier part, space is not. Indeed, that single space may end up being too much to ask. It may be better to have separate spaces to respect, often overlap. Psychotherapists have known for many years that a temporary split, or making tangential connections for a while, may be the solution to some problems. Un-bundle the spaces that have become blurred, that is.