Theranos, hype, fraud, solutionism, and eHealth

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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:

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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.

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An early seventeenth century Donegal Doctor – Nial O’Glacan of Donegal from Dúchas Thír Chonaill

On the wonderful Donegal Heritage site there is a fascinating article about an early modern doctor to Hugh O’Donnell, amongst others.

AMONG the few physicians of the seventeenth century whose names have been preserved from the stream of oblivion, is Nial O’Glacan of Donegal. Forgotten to-day, in his time he was one of the most distinguished members of the medical profession in Spain, France, and Italy, where for many years he had a long and distinguished career. Born in Donegal in the latter half of the sixteenth century, it is probable that he received the rudiments of his medical education from one of the families of hereditary physicians which at that time were attached to the Irish chieftains.

Later we read:

 

Early in life he left Ireland, and settled in Spain as early as 1602. This latter fact is inferred from his statement that he treated the great Hugh O’Donnell, Lord of Tirconnell, with a special poultice for a “venereo bubo” in the royal palace of the King of Spain. It is known that Hugh O’Donnell died at Simancas on 10th September, 1602, after an illness of fourteen days

 

Are we winning the War on Sleeplessness?

Or, as the authors of this paper put it, are we seeing the “first signs of success in the fight against sleep deficiency?”

Abstract:

STUDY OBJECTIVES:

The high prevalence of chronic insufficient sleep in the population has been a concern due to the associated health and safety risks. We evaluated secular trends in sleep duration over the most recent 14-year period.

METHODS:

The American Time Use Survey, representative of US residents ≥15 years, was used to investigate trends in self-reported sleep duration and waking activities for the period 2003-2016 (N = 181335 respondents).

RESULTS:

Sleep duration increased across survey years both on weekdays (+1.40 min/year) and weekends (+0.83 min/year, both p < .0001, adjusted models). This trend was observed in students, employed respondents, and retirees, but not in those unemployed or not in the labor force. On workdays, the prevalence of short (≤7 hr), average (>7-9 hr), and long (>9 hr) sleep changed by -0.44% per year (p < .0001), -0.03% per year (p = .5515), and +0.48% per year (p < .0001), respectively. The change in sleep duration was predominantly explained by respondents retiring earlier in the evening. The percentage of respondents who watched TV or read before bed-two prominent waking activities competing with sleep-decreased over the same time period, suggesting that portions of the population are increasingly willing to trade time in leisure activities for more sleep. The results also suggest that increasing online opportunities to work, learn, bank, shop, and perform administrative tasks from home freed up time that likely contributed to increased sleep duration.

CONCLUSIONS:

The findings indicate first successes in the fight against sleep deficiency. Public health consequences of the observed increase in the prevalence of long sleep remain unclear and warrant further investigation

Here is the American Time Use Survey which the authors used for their study.

“What’s not going to change in the next ten years?” (via Pedro de Bruyckere’s “From experience to meaning” blog)

I normally hate Twitter “threads”, which often seem all too pompous, tendentious, and flat out wrong. But here’s a good one, via Via Pedro de Bruyckere’s From Experience to Meaning blog.  And it is also a thread that makes me think a little better of Jeff Bezos.  Here’s the beginning :

 

When I read the first tweet of this thread by Benjamin Riley I had the feeling we were up to something good. And Benjamin didn’t disappoint. I won’t make it into a habit of posting something like this on this blog, but I do wanted to share this here as I know that many of my readers would otherwise miss this:

Benjamin Riley@benjaminjriley

Please forgive me for the following tweet thread (not to say tirade) that will attempt to connect Jeff Bezos, , predicting the future, and cognitive science together. Get ready!

Benjamin Riley@benjaminjriley

First, here’s the quote from Jeff Bezos about building a business when the future is uncertain (it’ll take a few tweets): “”I very frequently get the question: ‘What’s going to change in the next 10 years?’ And that is a very interesting question; it’s a very common one…”

Benjamin Riley@benjaminjriley

Bezos continues: “I almost never get the question: ‘What’s not going to change in the next 10 years?’ And I submit to you that that second question is actually the more important of the two — because you can build a business strategy around the things that are stable in time.”

I am confident this is the most memorable article ever from the British Journal of Urology

Full access here. This is certainly worth reading all the way to the end…. can’t help but wholeheartedly agree with the author’s conclusion.

How (not) to communicate new scientific information: a memoir of the famous brindley lecture

In 1983, at the Urodynamics Society meeting in Las Vegas, Professor G.S. Brindley first announced to the world his experiments on self‐injection with papaverine to induce a penile erection. This was the first time that an effective medical therapy for erectile dysfunction (ED) was described, and was a historic development in the management of ED. The way in which this information was first reported was completely unique and memorable, and provides an interesting context for the development of therapies for ED. I was present at this extraordinary lecture, and the details are worth sharing. Although this lecture was given more than 20 years ago, the details have remained fresh in my mind, for reasons which will become obvious.

The lecture, which had an innocuous title along the lines of ‘Vaso‐active therapy for erectile dysfunction’ was scheduled as an evening lecture of the Urodynamics Society in the hotel in which I was staying. I was a senior resident, hungry for knowledge, and at the AUA I went to every lecture that I could. About 15 min before the lecture I took the elevator to go to the lecture hall, and on the next floor a slight, elderly looking and bespectacled man, wearing a blue track suit and carrying a small cigar box, entered the elevator. He appeared quite nervous, and shuffled back and forth. He opened the box in the elevator, which became crowded, and started examining and ruffling through the 35 mm slides of micrographs inside. I was standing next to him, and could vaguely make out the content of the slides, which appeared to be a series of pictures of penile erection. I concluded that this was, indeed, Professor Brindley on his way to the lecture, although his dress seemed inappropriately casual.

The lecture was given in a large auditorium, with a raised lectern separated by some stairs from the seats. This was an evening programme, between the daytime sessions and an evening reception. It was relatively poorly attended, perhaps 80 people in all. Most attendees came with their partners, clearly on the way to the reception. I was sitting in the third row, and in front of me were about seven middle‐aged male urologists, and their partners in ‘full evening regalia’.

Professor Brindley, still in his blue track suit, was introduced as a psychiatrist with broad research interests. He began his lecture without aplomb. He had, he indicated, hypothesized that injection with vasoactive agents into the corporal bodies of the penis might induce an erection. Lacking ready access to an appropriate animal model, and cognisant of the long medical tradition of using oneself as a research subject, he began a series of experiments on self‐injection of his penis with various vasoactive agents, including papaverine, phentolamine, and several others. (While this is now commonplace, at the time it was unheard of). His slide‐based talk consisted of a large series of photographs of his penis in various states of tumescence after injection with a variety of doses of phentolamine and papaverine. After viewing about 30 of these slides, there was no doubt in my mind that, at least in Professor Brindley’s case, the therapy was effective. Of course, one could not exclude the possibility that erotic stimulation had played a role in acquiring these erections, and Professor Brindley acknowledged this.

The Professor wanted to make his case in the most convincing style possible. He indicated that, in his view, no normal person would find the experience of giving a lecture to a large audience to be erotically stimulating or erection‐inducing. He had, he said, therefore injected himself with papaverine in his hotel room before coming to give the lecture, and deliberately wore loose clothes (hence the track‐suit) to make it possible to exhibit the results. He stepped around the podium, and pulled his loose pants tight up around his genitalia in an attempt to demonstrate his erection.

At this point, I, and I believe everyone else in the room, was agog. I could scarcely believe what was occurring on stage. But Prof. Brindley was not satisfied. He looked down sceptically at his pants and shook his head with dismay. ‘Unfortunately, this doesn’t display the results clearly enough’. He then summarily dropped his trousers and shorts, revealing a long, thin, clearly erect penis. There was not a sound in the room. Everyone had stopped breathing.

But the mere public showing of his erection from the podium was not sufficient. He paused, and seemed to ponder his next move. The sense of drama in the room was palpable. He then said, with gravity, ‘I’d like to give some of the audience the opportunity to confirm the degree of tumescence’. With his pants at his knees, he waddled down the stairs, approaching (to their horror) the urologists and their partners in the front row. As he approached them, erection waggling before him, four or five of the women in the front rows threw their arms up in the air, seemingly in unison, and screamed loudly. The scientific merits of the presentation had been overwhelmed, for them, by the novel and unusual mode of demonstrating the results.

The screams seemed to shock Professor Brindley, who rapidly pulled up his trousers, returned to the podium, and terminated the lecture. The crowd dispersed in a state of flabbergasted disarray. I imagine that the urologists who attended with their partners had a lot of explaining to do. The rest is history. Prof Brindley’s single‐author paper reporting these results was published about 6 months later [1].

Professor Brindley made a huge contribution to the management of ED, for which he deserves tremendous gratitude. He was a true lateral thinker, and applied his unique mind to a variety of problems in medicine. These include over 100 publications that focus on the areas of visual neurophysiology and several other aspects of neurophysiology, including ejaculation and female sexual dysfunction. He also published one remarkable paper studying the effect of 17 different drugs used intracorporally to induce erection [2]. Seven of these (phenoxybenzamine, phentolamine, thymoxamine, imipramine, verapamil, papaverine, naftidrofury) induced an erection. It is not clear to what degree Brindley’s own penis served as the test subject for these studies.

This lecture was unique, dramatic, paradigm‐shifting, and unexpected. It is difficult to imagine that a similar scenario could ever take place again. Professor Brindley belongs in the pantheon of famous British eccentrics who have made spectacular contributions to science. The story of his lecture deserves a place in the urological history books.

Efficacy of PRIME, a Mobile App Intervention Designed to Improve Motivation in Young People With Schizophrenia

From Schizophrenia Bulletin:

The onset of schizophrenia occurs during a period critical for development of social relationships and functional independence. As such, interventions that target the early course of illness have the potential to stave off functional decline and restore functioning to pre-illness levels. In this entirely remote study, people with recent-onset schizophrenia spectrum disorders (SSDs) participated in a 12-week randomized controlled trial to determine the efficacy of PRIME (personalized real-time intervention for motivational enhancement), a mobile-based digital health intervention designed to improve motivation and quality of life. Participants were randomized into the PRIME (n = 22) or treatment-as-usual/waitlist (TAU/WL) condition (n = 21) and completed assessments at baseline, post-trial (12 wk), and for people in the PRIME condition, 3 months after the end of the trial. After 12-weeks, WL participants received PRIME, resulting in a total sample of 38 participants completing PRIME. In PRIME, participants worked towards self-identified goals with the support of a virtual community of age-matched peers with schizophrenia-spectrum disorders as well as motivation coaches. Compared to the WL condition, people in the PRIME condition had significantly greater improvements in self-reported depression, defeatist beliefs, self-efficacy, and a trend towards motivation/pleasure negative symptoms post-trial, and these improvements were maintained 3 months after the end of trial. We also found that people in the PRIME condition had significantly greater improvements in components of social motivation post-trial (anticipated pleasure and effort expenditure). Our results suggest that PRIME has the potential to be an effective mobile-based intervention for improving aspects of mood and motivation in young people with SSDs.