Category Archives: meaning

On Medical Student Burnout…

Lydgate discovers that he has become a mouthpiece for benighted views he initially abhorred, arguing that “I must do as other men do and think what will please the world and bring in money.” Everyone needs to make compromises, but such compromises should not come at the cost of abandoning core aspirations. Quite the reverse, the primary goal should be to allow such aspirations to develop and express themselves in the challenging world of contemporary medicine.

http://www.theatlantic.com/health/archive/2014/02/for-the-young-doctor-about-to-burn-out/284005/

For the Young Doctor About to Burn Out

Professional burnout is the sum total of hundreds and thousands of tiny betrayals of purpose, each one so minute that it hardly attracts notice.

Tertius Lydgate from Middlemarch by George Eliot (The Jenson Society, NY)

Our health depends in part on health professionals, and there is mounting evidence that many young physicians are not thriving. A recent report in the journal Academic Medicine revealed that, compared to age-matched fellow college graduates, medical students report significantly higher rates of burnout.

Specifically, they are suffering from high rates of emotional exhaustion, depersonalization, and a diminished sense of personal accomplishment. College students choose careers in medicine because they care, because people matter to them, and because they want to make a difference. What is happening to the nearly 80,000 U.S. medical students to produce such high rates of burnout?

It is tempting to invoke the usual suspects: too many hours of study, too little contact with patients, and overwhelming anxiety concerning grades and test scores. Such stressors are compounded by exploding rates of change in medical science and technology and the general cloud of socioeconomic uncertainty hanging over the profession of medicine.

Yet the real roots of the problem go far deeper, and it is only by plumbing their full depth that we can hope to formulate an accurate diagnosis and prescribe an effective therapy. On closer inspection, burnout turns out to be a symptom of a more fundamental disorder that calls for curative—not merely symptomatic—therapy.

Nothing is more needed than nourishment for the imagination. Medical educators, learners, and those who care about the future of medicine need to understand not only the changes taking place in medicine’s external landscape but the internal transformations taking place in minds and hearts. Humanly speaking, are we enriching or impoverishing students? What alterations are we asking them, explicitly or implicitly, to make in the ways they act, think, and feel? In what ways are we bringing out the best elements in their character—courage, compassion, and wisdom—as opposed to merely exacerbating their worst impulses—envy, fear, and destructive competitiveness?

To a minority of students who care very little about such matters, such questions are likely to seem of little moment. Such students see clearly what they want to achieve—to gain admission to medical school, to graduate, to obtain a residency training position, and to take up the practice of medicine—and they do not trouble themselves about the ways in which their education is reshaping their humanity. When such students show up in class, they simply want to know what will be on the exam, and no matter how intricate or abstruse the material might be, they learn it sufficiently well to pass—and in many cases, ace—the tests.

But there are other students for whom medical school is not simply a proving ground, a gauntlet to be run, or a ticket to a well-paying and secure career. When they see a patient treated poorly, encounter a fellow student who is struggling with confusion and discouragement, or deep in a maze of tests and grades find themselves beginning to lose sight of the goals that brought them into medicine in the first place, they do not merely knuckle down and redouble their efforts. Instead they take such matters into their hearts, muse over them, and find themselves questioning whether medicine is what they really want to do with their lives.

Where can we turn to understand what goes on in the minds and hearts of highly intelligent, genuinely compassionate young adults who find themselves in a state of moral distress about the path they have chosen in life? Who or what can help them find the words to describe what they are going through, to know that they are not alone, and to locate a light at the end of the tunnel that can give them the hope and courage necessary to carry on? To understand and help such students, we need to find and apply the best resources available. One of the best guides on the matter I have ever encountered also happens to be one of the greatest novels in the English language.

The novel in question is Middlemarch. Written by Mary Ann Evans (1819-1880) who, in order to be taken seriously felt compelled to write under the pen name George Eliot, Middlemarch concerns the affairs of a fictitious British Midlands town of the same name. The title evokes not only a kind of provincial mediocrity but also a deep authorial concern with what happens to people training for the professions, echoing the opening of Dante’sDivine Comedy, “In the middle of life’s journey … ”

One of its principal characters is an idealistic if somewhat unreflective young physician, Dr. Tertius Lydgate, a character whose story provides deeper insights into burnout than any social science study I have encountered.

Lydgate is a handsome, well-born young physician with high aspirations as both a medical scientist and a servant of the needy. He comes to Middlemarch intending to found a charity hospital and to write a scientific treatise on typhus, one of the great scourges of the poor. Yet there is a problem. Over time, he abandons his ideals. He allows prevailing attitudes toward success to supplant his deeper sense of calling. He ends up investigating not typhus but gout, a rich man’s disease. Though outwardly successful, he comes to see himself as a failure. In short, he burns out because he loses his way. To paraphrase the novel, Middlemarch not only swallowed Lydgate whole. It assimilated him very comfortably.

Such changes can and do occur among contemporary medical students. Studies have documented both declining empathy and rising cynicism over the course of medical education. What happens? Having enrolled in medical school with a goal of helping people, students soon find financial considerations—including their own exploding debt—dominating their career plans.

With a growing avalanche of new knowledge and skills bearing down on them, they feel increasingly overwhelmed by what they do not know. They soon discover that, instead of expanding their capacity to make a difference in the lives of others, the rigors of medical school have constricted their field of view to their own survival.

Burnout at its deepest level is not the result of some train wreck of examinations, long call shifts, or poor clinical evaluations. It is the sum total of hundreds and thousands of tiny betrayals of purpose, each one so minute that it hardly attracts notice. When a great ship steams across the ocean, even tiny ripples can accumulate over time, precipitating a dramatic shift in course. There are many Tertius Lydgates, male and female, inhabiting the lecture halls, laboratories, and clinics of today’s medical schools. Like latter-day Lydgates, many of them eventually find themselves expressing amazement and disgust at how far they have veered from their primary purpose.

Lydgate discovers that he has become a mouthpiece for benighted views he initially abhorred, arguing that “I must do as other men do and think what will please the world and bring in money.” Everyone needs to make compromises, but such compromises should not come at the cost of abandoning core aspirations. Quite the reverse, the primary goal should be to allow such aspirations to develop and express themselves in the challenging world of contemporary medicine. Books like Middlemarch are no panacea, but they offer precisely the imaginative nourishment so often missing from contemporary medical education, a powerful antidote to the insidious forces that produce burnout.

PRESENTED BY

RICHARD GUNDERMAN, MD, PhD, is a correspondent for The Atlantic. He is a professor of radiology, pediatrics, medical education, philosophy, liberal arts, and philanthropy, and vice-chair of the Radiology Department, at Indiana University. Gunderman’s most recent book is X-Ray Vision.

Wellthcare

Lissanthea put me on to this project.

Sounds highly aligned to my own ambitions, similarly requiring more focus…

http://www.wellthcare.com/

Wellthcare is an exploration

It’s an attempt to find new ways to value and create health

Health care contributes only 20% to our health and yet it dominates the health discourse;
80% of our health comes from our genes, behaviours, social factors and the environment

Wellthcare is about the 80% 
It’s about finding new sources of health-related value
It’s about creating health

At Wellthcare we believe that much of this value resides in our networks and communities

We call this value Wellth

Recent Log posts 

Pernicious moralising: when public health fails
22 Feb 2014
Wellthcare receives its first grant 
6 Feb 2014
It’s time to prioritise health creation – not just care and prevention 
30 Jan 2014
How a talking pet can keep us healthy
15 Jan 2014
Angelina Jolie, the end of standard, confused value, and not enough failure: why 2013 mattered
30 Dec 2013

Despatches from the Wellthcare Explorers 

Despatches are detailed descriptions of the debates being had between the Wellthcare Explorers as they further discuss health creation. 

Is there a role for an ‘event’? (PDF)
Published February 28th 2014

Building Resilience: Understanding People’s Context and Assets (PDF)
Published December 11th 2013

Fragmenting Communities and the Wantified Self (PDF)
Published October 22nd 2013

Discovering Wellth (PDF)
Published September 26th 2013

Exploration timeline 

Wellthcare is being explored by its Pioneer, Pritpal S Tamber, and an eclectic group of thinkers and doers called the Wellthcare Explorers.

February 2014

  • The fourth debate between the Wellthcare Explorers on the aims of an international meeting on health creation (Despatch pending)

January 2014 

  • Grant from Guy’s and St Thomas’ Charity received to ascertain whether it is possible to hold an international meeting on health creation (see announcement)
  • Wellthcare Manifesto drafted (publication pending)

December 2013

  • Wellth definition changed to: ‘new, health-related value, defined by what people want to do, supported by their nano-networks and communities’

November 2013 

  • Third debate between Explorers followed by Despatch

October 2013

  • The idea of the ‘Wantified Self’ described
  • Second debate between Explorers followed by Despatch
  • Wellth definition changed to: ‘new, health-related value, defined by what people want to do, supported by their nano-networks’

September 2013 

  • First debate between Explorers followed by Despatch

June 2013

  • Website launched
  • Wellth defined as ‘reclaimed currencies of health, delivered through new technologies, nurtured and protected by intimate communities’

May 2013

Feb 2013

  • Work starts on Wellthcare

Google gunning for the end of death…

Terrific summary of the state of play.

British gerontologist Aubrey de Grey believes achieving human immortality is inevitable. Last October de Grey told the audience at a US technology conference that they could expect to live 1000 years, maybe longer.

 

http://thenewdaily.com.au/life/2014/02/11/medical-science-close-curing-death/

Could medical science be close to curing death?

8:49pm, Feb 11
MICHELLE HAMER
If you were given the chance, would you choose to live forever, or another few hundred years? It may sound like the stuff of fantasy, but some very smart people are working to make death a thing of the past.
Live forever

Scientists are working to stop the ageing process, and extend the living… Photo: Shutterstock

Nanobots in your blood stream, backing up your brain to a computer, swapping your fallible human form for a sophisticated holographic avatar – it might sound like science fiction, but these are just some of the ways that science is hoping to extend human life and inch us closer to living forever.

US futurist, inventor and Google’s head of engineering, Ray Kurzweil has predicted that by the end of the century humans and machines will merge to create super humans who may never face the prospect of death. And Kurzweil, 65, hopes to be among those kicking mortality to the curb.

Ray Kurzweil

Ray Kurzweil: Working to bring an end to death. Photo: Getty

“Twenty years from now, we will be adding more time than is going by to your remaining life expectancy,” Kurzweil told Forbes Magazine. “We’ve quadrupled life expectancy in the past 1000 years and doubled it in the past 200 years. We’re now able to reprogram health and medicine as software, and so that pace is only going to continue to accelerate.”

Kurzweil is no slouch when it comes to accurate predictions. In the 1980s he predicted the incredible rise of the internet, foresaw the fall of the Soviet Union and identified the year when computers would beat humans at chess.

His next predictions include the programming of nanobots to work from within the body to augment the immune system and fight pathogens. By 2045 he sees us backing up our minds to the cloud and downloading ourselves into robotic forms.

And he’s not the only scientist hoping to blow out hundreds of candles in the future.

Immortality: Not if, when

British gerontologist Aubrey de Grey believes achieving human immortality is inevitable. Last October de Grey told the audience at a US technology conference that they could expect to live 1000 years, maybe longer.

Ageing, he says, is a simple case of bad engineering, and once the human body’s kinks are ironed out we’ll be able to reverse its effects and put death on the back burner.

“My approach is to start from the straightforward principle that our body is a machine. A very complicated machine, but nonetheless a machine, and it can be subjected to maintenance and repair in the same way as a simple machine, like a car,” de Grey has said. “What I’m after is not living to 1000. I’m after letting people avoid death for as long as they want to.”

Google is on board

It’s a goal that even tech giant Google thinks is worth pursuing.

When Google entered the anti-ageing business last year, with the launch of its new biotechnology company Calico, it brought a new level of interest, respectability and crucially – funding – to the field.

Calico has poached some of the leading anti-ageing researchers from across the world to work on the challenge of extending life.

“I think that if Google succeeds, this would be their greatest gift to humanity,” said David Sinclair, an Australian professor of genetics at Harvard Medical School.

Professor Sinclair led a research team which last year announced it had reversed muscle ageing in mice, the results of which exceeded his expectations.

“We want immortality so badly that we’re always ready to be swept away into unthinkingness … Half in love with the impossible we’ve always wanted to conquer death.”

“I’ve been studying ageing at the molecular level now for nearly 20 years and I didn’t think I’d see a day when ageing could be reversed. I thought we’d be lucky to slow it down a little bit,” he was quoted as saying.

“There’s clearly much more work to be done here, but if those results stand, then aging may be a reversible condition, if it is caught early,” he said.

The research involved improving communication between a cell’s mitochondria and nucleus. Mitochondria are like a battery within a cell, powering important biological functions. When communication breaks down between this and the nucleus, the effects of ageing accelerate.

Human trials of the groundbreaking process are expected to start this year.

Buying life

It’s the sort of breakthrough that can’t come soon enough for several  billionaires across the globe who are pouring their fortunes and hopes into immortality research.

Russian entrepreneur, Dmitry Itskov founded the 2045 Initiative in 2011 with the aim of thwarting human death within three decades. Itskov envisages ‘neo-humans’ who will relinquish clunky human forms and adopt sophisticated machine bodies. He claims humans will eventually download their minds into artificial brains, which will then be connected to humanoid robots he calls Avatars.

According to 2045.com: “Substance independent minds will receive new bodies with capabilities far exceeding those of ordinary humans … Humanity will make a fully managed evolutionary transition and eventually become a new species.”

PayPal co-founder Peter Thiel donated $US3.5 million to Aubrey de Grey’s not-for-profit research foundation, telling the New Yorker at the time that: “Probably the most extreme form of inequality is between people who are alive and people who are dead”.

Clearly Thiel would prefer to remain among the living and he’s prepared to pay for his pitch at immortality, most recently making a large donation to the Singularity Institute, which focuses on creating artificial intelligence that could see the rise of cyborgs (merged humans and machines).

Maximising life, minimising death

US entrepreneur turned science innovator, David Kekich, dedicated his life and impressive bank balance to reversing ageing after he was paralysed from a spinal cord injury in 1978. Kekich initially raised money for paralysis research but then switched to anti-ageing research. He founded the Maximum Life Foundation in 1999 and aims to reverse human ageing by 2033.

On his website Kekich writes: “We are moving from an era in which nothing could be done to defeat ageing into an era in which advancing biotechnology will give us the tools to do overcome it … Now, at the dawn of the biotechnology era, the inevitable is no longer inevitable. The research establishment – if sufficiently funded and motivated – could make spectacular inroads into repairing and preventing the root causes of ageing within our lifetime.”

But given that there are yet to be any proven means for extending human life, these billionaires may be motivated more by ego than altruism.

As US author Adam Leith Gollner writes in The Book of Immortality: the Science Belief and Magic Behind Living Forever (Sribner 2013): “We want immortality so badly that we’re always ready to be swept away into unthinkingness … Half in love with the impossible we’ve always wanted to conquer death.”

Yet he says all humans can really do to live longer is to eat well and exercise.

“We all have to go … whether dying in battle, tumbling off a horse, succumbing to pneumonia or being shivved by a lover. Maybe one day we just don’t wake up. However it happens, we enter the mystery.”

On meaningless jobs

 

http://www.linkedin.com/today/post/article/20140129133724-69244073-the-1-feature-of-a-meaningless-job

The #1 Feature of a Meaningless Job

January 29, 2014
 

Ask people what they want in a job, and meaningfulness looms large. For decades, Americans have ranked purpose as their top priority—above promotions, income, job security, and hours. Work is a search “for daily meaning as well as daily bread,” wrote Studs Turkel after interviewing hundreds of people in a striking array of jobs. Yet all too often, we feel that our work doesn’t matter. “Most of us have jobs that are too small for our spirit. Jobs are not big enough for people.”

What makes a job meaningless? After more than 40 years of research, we know that people struggle to find meaning when they lack autonomy, variety, challenge, performance feedback, and the chance to work on a whole product or service from start to finish. As important as these factors are, though, there’s another that matters more.

Consider the following jobs. They all meet some of the criteria above, yet about 90% of peoplefail to find them highly meaningful:

  • Fashion designer
  • TV newscast director
  • Revenue analyst
  • Web operations coordinator
  • Airline reservation agent
  • Graphics animator

Why is meaning missing in these jobs? They rarely have a significant, lasting impact on other people. If these jobs didn’t exist, people wouldn’t be all that much worse off. By contrast, here are the jobs that are highly meaningful to virtually everyone who holds them:

  • Adult literacy teacher
  • Fire chief
  • Nurse midwife
  • Addiction counselor
  • Child life specialist
  • Neurosurgeon

They all make an important difference in the lives of others. Not convinced yet? Here’s a taste of the evidence on the link between helping others and meaningful work:

  • A comprehensive analysis of data from more than 11,000 employees across industries: the single strongest predictor of meaningfulness was the belief that the job had a positive impact on others.
  • Interviews with a representative sample of Americans: more than half reported that the core purpose of their jobs was to benefit others
  • Surveys of people around the world: in defining when an activity qualifies as work, “if it contributes to society” was the most common choice in the U.S.—but also in China and Eastern Europe. On multiple continents, people defined work more in terms of contributing to society than as getting paid for a task, doing a strenuous activity, or being told what to do.
  • Studies of people who view their work as a calling, not only a job or career: Yale professor Amy Wrzesniewski, widely regarded as the world’s leading expert on the meaning of work, shows that a core element of a calling is the belief that your work makes the world a better place.

Enriching the Meaningfulness of a Job

Becoming a neurosurgeon isn’t for everyone. The good news is that there are steps we can take to make jobs more meaningful—for ourselves and others.

In many cases, our jobs do have an impact, but we’re too distant from the end users of our products and services. Think of automotive safety engineers who never meet the drivers of their cars or medical scientists who don’t see a patient. By connecting directly with these end users, we can see our past and potential impact. When university fundraisers met a single student whose scholarship was funded by their work, they increased 142% in weekly phone minutes and over 400% in weekly revenue. When radiologists saw a patient’s photo included in an x-ray file, they wrote 29% longer reports and made 46% more accurate diagnoses.

This is why leaders at John Deere invite employees who build tractors to meet the farmers who buy their tractors, leaders at Facebook invite software developers to hear from users who have found long-lost friends and family members thanks to the site, and leaders at Wells Fargo film videos of customers describing how low-interest loans have rescued them from debt. When we see the direct consequences of our jobs for others, we find greater meaning. “The greatest untapped source of motivation,” Susan Dominus explains, “is a sense of service to others.”

Of course, some jobs are simply not designed to have a major impact on others. In these situations, people often make the mistake of treating their job descriptions as fixed, overlooking the fact that they can take initiative to alter their own roles. Wrzesniewski, Jane Dutton, and Justin Berg call this job crafting—adding, emphasizing, revising, delegating, or minimizing tasks and interactions in pursuit of greater meaning. For example, hospital cleaners who lack patient contact stepped up to provide emotional support to patients and their families, and technology associates began volunteering for mentoring, teaching, and training roles.

When people craft their jobs, they become happier and more effective. In an experiment at Google, colleagues and I invited salespeople and administrators to spend 90 minutes doing the Job Crafting Exercise—they mapped out ways to make their tasks and interactions more meaningful and contribute more to others. Six weeks later, their managers and coworkers rated them as happier and more effective. When they developed new skills to support more significant changes, the happiness and performance gains lasted for at least six months.

Like all things in life, meaning can be pushed too far. As the psychologist Brian Littleobserves, if we turn our trivial pursuits into magnificent obsessions, we gain meaning at the price of manageability. When the weight of the world is on our shoulders, we place ourselves at risk for burnout.

Yet most people are facing the opposite problem in their jobs, of too little meaning rather than too much. Against this backdrop, the chance to help others can be what makes our work worthwhile. “Suffering ceases to be suffering once it finds a meaning,” wrote Viktor Frankl inMan’s Search For Meaning“Being human always points, and is directed, to something or someone, other than oneself—be it a meaning to fulfill or another human being to encounter. The more one forgets himself—by giving himself to a cause to serve or another person to love—the more human he is.”

***

Adam Grant is a Wharton professor and the author of Give and Take,New York Times andWall Street Journal bestseller on the hidden power of helping others. Follow him here by clicking the yellow FOLLOW button and on Twitter @AdamMGrant

Ornish at TED

http://deanornish.com/

  • Wellness vs Illness – We vs I
  • 95% of NCD is preventable
  • NCDs are also reversible
  • Prostate Cancer, Breast Cancer susceptible to diet change
  • Obesity Trends in the US – new categories on the US map
  • Has worked with McDonalds and Pepsi to advise on products – didn’t go anywhere

Ornish Healthways Spectrum Program
http://deanornish.com/ornish-spectrum/

16 min: Healing Through Diet
http://www.ted.com/talks/dean_ornish_on_healing.html

3 min: Your Genes Are Not Your Fate

3 min: Killer Diet

Eternal youth for just $43K per day – or just exercise and eat well????

This is funny, only because for the super rich, this seems like a feasible way forward… instead of eating well and exercising. A really interesting insight into how broken our thinking on health truly is.

https://ama.com.au/ausmed/eternal-youth-may-be-yours-just-43000-day

Eternal youth may be yours, for just $43,000 a day

21/01/2014

Like a bad fairy tale, scientists believe they have developed a way to stop people getting older, but at a cost that puts it out of the reach of all but the super-rich.

A team of researchers at the University of New South Wales, working in collaboration with geneticists at Harvard Medical School, claim to have unlocked the secret to eternal youth, and to have developed a compound they say not only halts the ageing process, but can turn back the years.

The catch is, the treatment is prohibitively expensive, with estimates it would cost the average 86 kilogram man $43,000 a day, and the average 71 kilo woman $35,500 a day.

The compound was developed based on an understanding of how and why human cells age.

A series of molecular events enable communication inside cells between the mitochondria – the energy source for cells, enabling them to carry out key biological functions – and the nucleus. The researchers found that when there is a communication breakdown between the mitochondria and the nucleus of the cell, the ageing process accelerates.

As humans age, levels of the chemical NAD (which initiates communication between the mitochondria and the nucleus), decline. Until now, the only way to arrest this process has been through calorie-restricted diets and intensive exercise.

But the researchers, led by University of New South Wales and Harvard University molecular biologist Professor David Sinclair, have developed a compound – nicotinamide mononucleotide – that, when injected, transforms into NAD, repairing broken communication networks and rapidly restoring communication and mitochondria function.

In effect, it mimics the results achieved by eating well and exercising.

“The ageing process we discovered is like a married couple. When they are young, they communicate well but, over time, living in close quarters for many years, communication breaks down,” Professor Sinclair said. “And just like a couple, restoring communication solved the problem.”

In the study, the researchers used mice considered equivalent to a 60-year-old human and found that, within a week of receiving the compound, the mice resembled a 20-year-old in some aspects including the degree of muscle wastage, insulin resistance and inflammation.

Professor Sinclair said that, if the results stand, then ageing may be a reversible condition if it is caught early.

“It may be in the future that your age in years isn’t going to matter as much as your biological age,” Professor Sinclair said.

“What we’ve shown here is that you can turn back your biological age or, at least, we think we have found a way to do that.”

The problem is, the compound is prohibitively expensive, at least at the moment.

It costs $1000 per gram to produce, and in tests so far it has been applied at a rate equivalent to 500 milligrams for every kilogram of body weight, each day.

Professor Sinclair admitted the cost was major consideration, and said the team was looking at was to produce the compound more cheaply.

As part of their research, the scientists investigated HIF-1, an intrusive molecule that foils communication but also has a role in cancer.

It has been known for some time that HIF-1 is switched on in many cancers, but the researchers found it also switches on during ageing.

“We become cancer-like in our ageing process,” Professor Sinclair said. “Nobody has linked cancer and ageing like this before, and it may explain why the greatest risk of cancer is age.”

Researchers are now looking at longer-term outcomes the NAD-producing compound has on mice, and suggest human trials may begin as early as next year.

They are exploring whether, in addition to halting ageing, the compound can be used to safely treat a range of rare mitochondrial diseases and other conditions, such as cancer, type 1 and type 2 diabetes, muscular dystrophy, other muscle-wasting conditions and inflammatory diseases.

The research was published in the journal Cell.

Kirsty Waterford

Notes: Antifragile (from flight)

Commerce and small business (though not large markets and corporations) are activities and places that bring out the best in people, making most forgiving, honest, loving, trusting and open minded… Like antifragile tinkering, mistakes are small and rapidly forgotten [17].
On errors. In the fragile category, the mistakes are rare and large when they occur, hence irreversible; antifragile mistakes are small and benign, even reversible and quickly overcome. They are also rich in information. So a certain system of tinkering and trial and error would have the attributes of antifragility. If you want to become antifragile, put yourself in the situation of “loves mistakes” [21].

FDA rearguard frame…

It’s all happening anyway. Eventually, the tide will surge and the wall will burst.

Already, an explosion of monitoring, testing, and sensing devices are coming on the market, providing consumers with instant analysis of their fitness, blood chemistry, sleep patterns and food intake. It’s only a matter of time before regulators feel compelled by consumer demand to find a way to accommodate better and cheaper innovations, and for slowly changing industries to dramatically restructure themselves in the face of overwhelming new opportunities. The long-term potential of vast databases of genomic data to improve health outcomes, reduce costs, and reorient the debate on medical priorities is too valuable to be held back for long — and arguably the biggest transformation for the healthcare industry since the discovery of antibiotics in the early 20th century.

http://www.wired.com/opinion/2014/01/the-fda-may-win-the-battle-this-holiday-season-but-23andme-will-win-the-war/

Regulating 23andMe to Death Won’t Stop the New Age of Genetic Testing

  • BY LARRY DOWNES AND PAUL NUNES
  • 01.01.14
  • 6:30 AM

 

Image: ynse/Flickr

 

Market disruptions often occur — or not — as the direct result of unintended collisions between breakthrough technologies and their more incremental regulators. In the latest dust-up, the U.S. Food and Drug Administration (FDA) last month ordered startup 23andMe to stop marketing its $99 genetic analysis kit, just before the Christmas shopping season kicked into high gear.

To date, over half a million customers have taken the swab in return for detailed ancestry data and personalized information on 248 genetic traits and health conditions. The company, which launched in 2007 with substantial backing from Google, has been working closely — albeit more slowly than the FDA would have liked — with the FDA to ensure it complies with federal health and safety regulations. But the agency concluded in its recent warning letter that 23andMe was marketing a “device” that was “intended for use in the diagnosis of diseases or other conditions,” and as such, its marketing materials required pre-approval from the FDA, which includes extensive research studies.

23andMe is an example of what we call a “Big Bang Disruption” — a product or service innovation that undermines existing markets and industries seemingly overnight by being simultaneously better andcheaper than the competition. What’s happening in genomic testing (and healthcare in general) is consistent with our research in over 30 different industry segments, from manufacturing to financial services to consumer products.

When technologies improve exponentially, many industry incumbents — and the regulators who oversee them — are kept constantly off-balance. That’s because incumbents have been indoctrinated by a generation of academic literature and MBA training to ignore disruptive products until they had a chance to mature in the market, assuming they would first appear as cheaper but inferior substitutes that would only appeal to niche market segments.

Doctors — who are also incumbents in this situation — are struggling to respond to disruptive medical technologies that change the power dynamic in the patient relationship. Several 23andMe users have reported taking the FDA’s advice of reviewing their genetic results with their physicians, only to find the doctors unprepared, unwilling, or downright hostile to helping interpret the data.

Often, incumbents’ only competitive response — or the only one they can think of — is to run to the regulators. That’s what’s has been happening to car-sharing services such as Uber, Lyft, and Sidecar; to private drone makers; and casual accommodation services such as Airbnb, to name just a few examples. And now it’s happening to 23andMe, one of hundreds of new startups aimed at giving healthcare consumers more and better information about their own bodies — information that has long been under the exclusive and increasingly expensive control of medical professionals.

Absent any real law on the subject, the agency has strained credulity to categorize 23andMe’s product as a diagnostic “device” — making it subject to its most stringent oversight. The FDA’s letter focuses intently on the potential that consumers will both under- and over-react to the genetic information revealed. The agency fears that users will pressure their doctors for potentially unnecessary surgery or medication to treat conditions for which they are genetically pre-disposed, for example. And it assumes that the costs of such information abuse outweigh any benefits — none of which are mentioned in the agency’s analysis.

The company, of course, has agreed to comply with the FDA’s stern warning, and has ceased providing its customers with anything other than hereditary data. For now. Perhaps it will reach some accommodation with the agency, or perhaps the FDA’s ire will prove untamable, an end to the innovative startup and whatever value its technology might have delivered.

But as with every Big Bang Disruptor in our study, winning the battle and winning the war are two very different things.

The FDA is applying a least common denominator standard to 23andMe, and applying it arbitrarily. Already, an explosion of monitoring, testing, and sensing devices are coming on the market, providing consumers with instant analysis of their fitness, blood chemistry, sleep patterns and food intake. It’s only a matter of time before regulators feel compelled by consumer demand to find a way to accommodate better and cheaper innovations, and for slowly changing industries to dramatically restructure themselves in the face of overwhelming new opportunities. The long-term potential of vast databases of genomic data to improve health outcomes, reduce costs, and reorient the debate on medical priorities is too valuable to be held back for long — and arguably the biggest transformation for the healthcare industry since the discovery of antibiotics in the early 20th century.

The information flood is coming. If not this Christmas season, then one in the near future. Before long, $100 will get you sequencing of not just the million genes 23andMe currently examines, but all of them. Regulators and medical practitioners must focus their attention not on raising temporary obstacles, but on figuring out how they can make the best use of this inevitable tidal wave of information.

Whatever the outcome for 23andMe, this is a losing battle for industry incumbents who believe they can hold back the future forever.

 

Larry Downes & Paul Nunes

Larry Downes and Paul Nunes are co-authors of Big Bang Disruption: Strategy in the Age of Devastating Innovation (Penguin Portfolio 2014). Downes is Research Fellow with the Accenture Institute for High Performance, where Nunes serves as its Global Managing Director of Research. Their book has been selected as a 2014 book of the year by the Consumer Electronics Association.