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November 27 2013

The Amazon whisperer, invisible interfaces, FDA vs 23andMe, and robots usher in a new polical order

The Radar team does a lot of sharing in the backchannel. Here’s a look at a selection of stories and innovative people and companies from around the web that have caught our recent attention. Have an interesting tidbit to contribute to the conversation? Send me an email or ping me on Twitter

  • The edges of connected realities — Steve Mason’s TEDxSF talk, in which he discusses the evolution of connected environments and quotes Yves Behar: “The interface of the future is invisible.” (Jenn Webb, via Jim Stogdill, via Rachel Kalmar) Mason’s talk is a must-watch, so I’ll just provide direct access:
  • Why the FDA is targeting Google-backed 23andMe: Unnecessary MRIs, mastectomiesChristina Farr wrote: “One San Francisco-based neurologist, who asked to remain anonymous, told me that some of her healthiest patients — all 23andMe customers — have begun demanding unnecessary and expensive MRI tests for Alzheimer’s disease. ’23andMe’s test is creating chaos with people in their 20s and 30s,’ she said. ‘They generate havoc and walk away.’” (Via Jim Stogdill)
  • A Letter I Will Probably Send to the FDA — From the other side of the FDA vs 23andMe spat, Dr. Scott Alexander wrote: “…23andMe has raised awareness of genetics among the general population and given them questions and concerns, usually appropriate, which they can discuss with their doctor. Their doctor can then follow up on these concerns. Such followup may involve reassurance, confirmation with other genetic testing, confirmation through other diagnostic modalities, or referral to another professional such as a genetic counselor. In my experience personal genomic results do not unilaterally determine a course of treatment, but may influence an ambiguous clinical picture in one direction or the other, or be a useful factor when deciding between otherwise equipotent medications. Banning the entire field of personal genomics in one fell swoop would eliminate a useful diagnostic tool from everyone except a few very wealthy patients.” (Via Mike Loukides)
  • Chaim Pikarski, the Amazon whispererJason Feifer wrote: “[Pikarski] has an entire team of people who read reviews on Amazon, looking for moments when people say, ‘I wish this speaker were rechargeable.’ Pikarski then makes a rechargeable version. … This is the heart of C&A: Each buyer has a specialty — beach products, cellular accessories, and so on. Their job is to scour the web to learn all the features people wish a product had, and hire a manufacturer, often in China, to make the desired version. (Via Tim O’Reilly, via Kevin Slavin)
  • The Robots Are HereTyler Cowen wrote: “The rise of smart machines — technologies that encompass everything from artificial intelligence to industrial robots to the smartphones in our pockets — is changing how we live, work and play. Less acknowledged, perhaps, is what all this technological change portends: nothing short of a new political order. The productivity gains, the medical advances, the workplace reorganizations and the myriad other upheavals that will define the coming automation age will create new economic winners and losers; it will reorient our demographics; and undoubtedly, it will transform what we demand from our government.” (Via Jenn Webb)

Related:

June 15 2012

Games for Health covers current status of behavior change

I had a chance yesterday to attend one day of the Games for Health conference, which covers one of the fastest-growing areas of mobile apps and an area of innovation that clinicians and policy-makers are embracing with growing enthusiasm.

The gamification of everyday life has become a theme of modern business, as well as public health and other groups interested in motivating people. Fun is now the ally, not the enemy, of intelligence, productivity, social engagement, and well-being. Here are a few existing or upcoming projects that illustrate what games are doing in health care:

  • A researcher developed a game for people with Attention Deficit Disorder that pops distractions up from time to time. If the player gives in to the distraction, the game ends. Over time, as the player gets better at ignoring distractions, they increase in order to test him further. The researcher claims that a few hours of this game eliminated the symptoms of ADD for several months afterward in many children, achieving more than drugs and other therapies.

  • A company is working with the Department of Defense on a game that encourages wounded soldiers to do their physical therapy. Normally, PT is an hour or more of boring, repetitive, painful exercise (I know, having undergone it). The game simply presents you with obstacles that you have to remove by performing one of the motions prescribed by the physical therapist. Thus, it keeps you engaged and randomizes the exercises to keep them fresh.

  • A web-based game asks you to wager game currency on whether an individual is likely to get a particular disease. The game presents you with increasing amounts of information about the relationships between genes and disease. The overall message of the game is that knowing your personal genome doesn't offer much guidance on whether you'll get the disease or how to avoid it.

  • A soccer ball is loaded with a device that measures how much it's moving. From this, a hub can determine how much children are playing and track activity over time.

The last device, clever as it is, arouses depressing thoughts in me. When I was a kid (insert appropriate background music here), nobody had to provide sensors or track our progress to persuade us to take a ball to an empty lot across the street for a game. But that particular lot is now covered with tract housing and the street is so busy that not even the most danger-immune wild child would try to cross it. Meanwhile, parents are afraid (sometimes for good reason and sometimes not) of letting kids wander unattended, and the lures of cable TV and social networks keep them on their couches. So I'm happy to see the digital incentives to increase exercise.

And although gaming hasn't reached the mainstream of health care yet, it's getting there. The Department of Health and Human Services has championed games, and major research centers in health care are developing programs for clinicians.

Getting to the conference at the Hyatt Harborside on the Boston waterfront was the first challenge, and after earning that badge, my next hurdle was avoiding the breakfast buffer. But as an attendee pointed out to me, being physically isolated helped keep people on site and talking to each other. Certainly, the location was spectacular, with lunch on the patio facing a view of the Boston skyline.

Personal control and empowerment in all areas of life were the theme of the day, and were expertly introduced in the opening keynote by well-known researcher Jane McGonigal. She started by reviewing the major regrets people express at the end of their lives. I don't think that I'll regret spending time listening to Jane McGonigal. Although she was pushing the use of her SuperBetter tool for personal growth, the basic principles are easy to follow independently. Pick a difficult but achievable goal that means a lot to you. Measure what you do each week. Enlist friends for support and positive thinking, etc. I'm doing it myself, and maybe next year I won't eat the muffins.

Jane McGonigal's keynote
Jane McGonigal's keynote.

The government is here to help you

There's a fine line between games that promote general health and games that have a special medical purpose. I would guess (as a lay person) that the latter category includes the game to combat ADD and the game to promote PT. And this category is subject to regulation by the FDA. We had a session by lawyer James M. Flaherty, Jr. on this seemingly dull topic, and I'm happy that a lot of people came and treated the subject respectfully. When we trust something with a medical matter, even a game, we need to trust that it will have the desired effect and not harm us.

Thus, if a game is tied to a particular medical device that the FDA is already regulating, the game is subject to the same regulation. That may require the manufacturer to go so far as to arrange a clinical trial and get approval from an Institutional Review Board. A game could also be subject to FDA regulation if the manufacturer claims a medical benefit. (On the other hand, a doctor is free to advise patients to use a game for some medical purpose without triggering FDA regulation.)

FDA regulations are undergoing major changes in this area. A year ago they release a Draft Guidance Document on Mobile Medical Applications, which may be worth consideration by gamers, and some documents on games are likely to follow. Recognizing that current registration procedures are cumbersome, Congress is well along the way to passing legislation that would reform the regulations and ask the FDA to hold discussions with people in the field--discussions that Flaherty urged us all to join. Game-makers also have to start thinking of experiments that can demonstrate the safety and effectiveness of their products.

Too healthy for your own good?

I brought away only a couple dystopic thoughts from Games for Health. One revolved around the privacy worries that accompany every activity modern people do online. Doctors and other professionals engaged in our care are regulated concerning whom the share our information with, and for what purposes. But game manufacturers and sites that offer to track us are not covered by rules like HIPAA. We should check their privacy policies before using them, and be aware that they have lots of incentives to mine the data and use it for marketing and other purposes.

The other, related, worry was about compelled participation. If your employer forces you to enroll in a program to lose weight, or your insurance company bases its premiums on your blood sugar levels, it's a game-changer. One journalist recently compared self-tracking and Quantified Self to B.F. Skinner-like behaviorism, which struck me as absurd because in self-driven health movements the individual is making choices all along. The comparison takes on more relevance if an outsider is trying to control your behavior.

And if external rewards are tied to game-playing, incentives to cheat tail along. People will hack devices to report better results than they actually achieve, hire people to do things that they report themselves doing, etc. Certificates and encryption will have to be put in place. The landscape of health and gamification will be degraded.

Let's reserve these concerns for policy-making, while keeping them in mind while designing games that people use voluntarily and enjoy.

May 02 2012

Recombinant Research: Breaking open rewards and incentives

In the previous articles in this series I've looked at problems in current medical research, and at the legal and technical solutions proposed by Sage Bionetworks. Pilot projects have shown encouraging results but to move from a hothouse environment of experimentation to the mainstream of one of the world's most lucrative and tradition-bound industries, Sage Bionetworks must aim for its nucleus: rewards and incentives.

Previous article in the series: Sage Congress plans for patient engagement.

Think about the publication system, that wretchedly inadequate medium for transferring information about experiments. Getting the data on which a study was based is incredibly hard; getting the actual samples or access to patients is usually impossible. Just as boiling vegetables drains most of their nutrients into the water, publishing results of an experiment throws away what is most valuable.

But the publication system has been built into the foundation of employment and funding over the centuries. A massive industry provides distribution of published results to libraries and research institutions around the world, and maintains iron control over access to that network through peer review and editorial discretion. Even more important, funding grants require publication (but the data behind the study only very recently). And of course, advancement in one's field requires publication.

Lawrence Lessig, in his keynote, castigated for-profit journals for restricting access to knowledge in order to puff up profits. A chart in his talk showed skyrocketing prices for for-profit journals in comparison to non-profit journals. Lessig is not out on the radical fringe in this regard; Harvard Library is calling the current pricing situation "untenable" in a move toward open access echoed by many in academia.

Lawrence Lessig keynote at Sage Congress
Lawrence Lessig keynote at Sage Congress.

How do we open up this system that seemed to serve science so well for so long, but is now becoming a drag on it? One approach is to expand the notion of publication. This is what Sage Bionetworks is doing with Science Translational Medicine in publishing validated biological models, as mentioned in an earlier article. An even more extensive reset of the publication model is found in Open Network Biology (ONB), an online journal. The publishers require that an article be accompanied by the biological model, the data and code used to produce the model, a description of the algorithm, and a platform to aid in reproducing results.

But neither of these worthy projects changes the external conditions that prop up the current publication system.

When one tries to design a reward system that gives deserved credit to other things besides the final results of an experiment, as some participants did at Sage Congress, great unknowns loom up. Is normalizing and cleaning data an activity worth praise and recognition? How about combining data sets from many different projects, as a Synapse researcher did for the TCGA? How much credit do you assign researchers at each step of the necessary procedure for a successful experiment?

Let's turn to the case of free software to look at an example of success in open sharing. It's clear that free software has swept the computer world. Most web sites use free software ranging from the server on which they run to the language compilers that deliver their code. Everybody knows that the most popular mobile platform, Android, is based on Linux, although fewer realize that the next most popular mobile platforms, Apple's iPhones and iPads, run on a modified version of the open BSD operating system. We could go on and on citing ways in which free and open source software have changed the field.

The mechanism by which free and open source software staked out its dominance in so many areas has not been authoritatively established, but I think many programmers agree on a few key points:

  • Computer professionals encountered free software early in their careers, particularly as students or tinkerers, and brought their predilection for it into jobs they took at stodgier institutions such as banks and government agencies. Their managers deferred to them on choices for programming tools, and the rest is history.

  • Of course, computer professionals would not have chosen the free tools had they not been fit for the job (and often best for the job). Why is free software so good? Probably because the people creating it have complete jurisdiction over what to produce and how much time to spend producing it, unlike in commercial ventures with requirements established through marketing surveys and deadlines set unreasonably by management.

  • Different pieces of free software are easy to hook up, because one can alter their interfaces as necessary. Free software developers tend to look for other tools and platforms that could work with their own, and provide hooks into them (Apache, free database engines such as MySQL, and other such platforms are often accommodated.) Customers of proprietary software, in contrast, experience constant frustration when they try to introduce a new component or change components, because the software vendors are hostile to outside code (except when they are eager to fill a niche left by a competitor with market dominance). Formal standards cannot overcome vendor recalcitrance--a painful truth particularly obvious in health care with quasi-standards such as HL7.

  • Free software scales. Programmers work on it tirelessly until it's as efficient as it needs to be, and when one solution just can't scale any more, programmers can create new components such as Cassandra, CouchDB, or Redis that meet new needs.

Are there lessons we can take from this success story? Biological research doesn't fit the circumstances that made open source software a success. For instance, researchers start out low on the totem pole in very proprietary-minded institutions, and don't get to choose new ways of working. But the cleverer ones are beginning to break out and try more collaboration. Software and Internet connections help.

Researchers tend to choose formats and procedures on an ad hoc, project by project basis. They haven't paid enough attention to making their procedures and data sets work with those produced by other teams. This has got to change, and Sage Bionetworks is working hard on it.

Research is labor-intensive. It needs desperately to scale, as I have pointed out throughout this article, but to do so it needs entire new paradigms for thinking about biological models, workflow, and teamwork. This too is part of Sage Bionetworks' mission.

Certain problems are particularly resistant in research:

  • Conditions that affect small populations have trouble raising funds for research. The Sage Congress initiatives can lower research costs by pooling data from the affected population and helping researchers work more closely with patients.

  • Computation and statistical methods are very difficult fields, and biological research is competing with every other industry for the rare individuals who know these well. All we can do is bolster educational programs for both computer scientists and biologists to get more of these people.

  • There's a long lag time before one knows the effects of treatments. As Heywood's keynote suggested, this is partly solved by collecting longitudinal data on many patients and letting them talk among themselves.

Another process change has revolutionized the computer field: agile programming. That paradigm stresses close collaboration with the end-users whom the software is supposed to benefit, and a willingness to throw out old models and experiment. BRIDGE and other patient initiatives hold out the hope of a similar shift in medical research.

All these things are needed to rescue the study of genetics. It's a lot to do all at once. Progress on some fronts were more apparent than others at this year's Sage Congress. But as more people get drawn in, and sometimes fumbling experiments produce maps for changing direction, we may start to see real outcomes from the efforts in upcoming years.

All articles in this series, and others I've written about Sage Congress, are available through a bit.ly bundle.

OSCON 2012 — Join the world's open source pioneers, builders, and innovators July 16-20 in Portland, Oregon. Learn about open development, challenge your assumptions, and fire up your brain.

Save 20% on registration with the code RADAR20

May 01 2012

Recombinant Research: Sage Congress plans for patient engagement

Clinical trials are the pathway for approving drug use, but they aren't good enough. That has become clear as a number of drugs (Vioxx being the most famous) have been blessed by the FDA, but disqualified after years of widespread use reveal either lack of efficacy or dangerous side effects. And the measures taken by the FDA recently to solve this embarrassing problem continue the heavy-weight bureaucratic methods it has always employed: more trials, raising the costs of every drug and slowing down approval. Although I don't agree with the opinion of Avik S. A. Roy (reprinted in Forbes) that Phase III trials tend to be arbitrary, I do believe it is time to look for other ways to test drugs for safety and efficacy.

First article in the series: Recombinant Research: Sage Congress Promotes Data Sharing in Genetics.

But the Vioxx problem is just one instance of the wider malaise afflicting the drug industry. They just aren't producing enough new medications, either to solve pressing public needs or to keep up their own earnings. Vicki Seyfert-Margolis of the FDA built on her noteworthy speech at last year's Sage Congress (reported in one of my articles about the conference) with the statistic that drug companies have submitted 20% fewer medications to the FDA between 2001 and 2007. Their blockbuster drugs produce far fewer profits than before as patents expire and fewer new drugs emerge (a predicament called the "patent cliff"). Seyfert-Margolis intimated that this crisis in the cause of layoffs in the industry, although I heard elsewhere that the companies are outsourcing more research, so perhaps the downsizing is just a reallocation of the same money.

Benefits of patient involvement

The field has failed to rise to the challenges posed by new complexity. Speakers at Sage Congress seemed to feel that genetic research has gone off the tracks. As the previous article in this series explained, Sage Bionetworks wants researchers to break the logjam by sharing data and code in GitHub fashion. And surprisingly, pharma is hurting enough to consider going along with an open research system. They're bleeding from a situation where as much as 80% of each clinical analysis is spent retrieving, formatting, and curating the data. Meanwhile, Kathy Giusti of the Multiple Myeloma Research Foundation says that in their work, open clinical trials are 60% faster.

Attendees at a breakout session where I sat in, including numerous managers from major pharma companies, expressed confidence that they could expand public or "pre-competitive" research in the direction Sage Congress proposed. The sector left to engage is the one that's central to all this work--the public.

If we could collect wide-ranging data from, say, 50,000 individuals (a May 2013 goal cited by John Wilbanks of Sage Bionetworks, a Kauffman Foundation Fellow), we could uncover a lot of trends that clinical trials are too narrow to turn up. Wilbanks ultimately wants millions of such data samples, and another attendee claimed that "technology will be ready by 2020 for a billion people to maintain their own molecular and longitudinal health data." And Jamie Heywood of PatientsLikeMe, in his keynote, claimed to have demonstrated through shared patient notes that some drugs were ineffective long before the FDA or manufacturers made the discoveries. He decried the current system of validating drugs for use and then failing to follow up with more studies, snorting that, "Validated means that I have ceased the process of learning."

But patients have good reasons to keep a close hold on their health data, fearing that an insurance company, an identity thief, a drug marketer, or even their own employer will find and misuse it. They already have little enough control over it, because the annoying consent forms we always have shoved in our faces when we come to a clinic give away a lot of rights. Current laws allow all kinds of funny business, as shown in the famous case of the Vermont law against data mining, which gave the Supreme Court a chance to say that marketers can do anything they damn please with your data, under the excuse that it's de-identified.

In a noteworthy poll by Sage Bionetworks, 80% of academics claimed they were comfortable sharing their personal health data with family members, but only 31% of citizen advocates would do so. If that 31% is more representative of patients and the general public, how many would open their data to strangers, even when supposedly de-identified?

The Sage Bionetworks approach to patient consent

It's basic research that loses. So Wilbanks and a team have been working for the past year on a "portable consent" procedure. This is meant to overcome the hurdle by which a patient has to be contacted and give consent anew each time a new researcher wants data related to his or her genetics, conditions, or treatment. The ideal behind portable consent is to treat the entire research community as a trusted user.

The current plan for portable consent provides three tiers:

Tier 1

No restrictions on data, so long as researchers follow the terms of service. Hopefully, millions of people will choose this tier.

Tier 2

A middle ground. Someone with asthma may state that his data can be used only by asthma researchers, for example.

Tier 3

Carefully controlled. Meant for data coming from sensitive populations, along with anything that includes genetic information.

Synapse provides a trusted identification service. If researchers find a person with useful characteristics in the last two tiers, and are not authorized automatically to use that person's data, they can contact Synapse with the random number assigned to the person. Synapse keeps the original email address of the person on file and will contact him or her to request consent.

Portable consent also involves a lot of patient education. People will sign up through a software wizard that explains the risks. After choosing portable consent, the person decides how much to put in: 23andMe data, prescriptions, or whatever they choose to release.

Sharon Terry of the Genetic Alliance said that patient advocates currently try to control patient data in order to force researchers to share the work they base on that data. Portable consent loosens this control, but the field may be ready for its more flexible conditions for sharing.

Pharma companies and genetics researchers have lots to gain from access to enormous repositories of patient data. But what do the patients get from it? Leaders in health care already recognize that patients are more than experimental subjects and passive recipients of treatment. The recent ONC proposal for Stage 2 of Meaningful Use includes several requirements to share treatment data with the people being treated (which seems kind of a no-brainer when stated this baldly) and the ONC has a Consumer/Patient Engagement Power Team.

Sage Congress is fully engaged in the patient engagement movement too. One result is the BRIDGE initiative, a joint project of Sage Bionetworks and Ashoka with funding from the Robert Wood Johnson Foundation, to solicit questions and suggestions for research from patients. Researchers can go for years researching a condition without even touching on some symptom that patients care about. Listening to patients in the long run produces more cooperation and more funding.

Portable consent requires a leap of faith, because as Wilbanks admits, releasing aggregates of patient data mean that over time, a patient is almost certain to be re-identified. Statistical techniques are just getting too sophisticated and compute power growing too fast for anyone to hide behind current tricks such as using only the first three digits of a five-digit postal code. Portable consent requires the data repository to grant access only to bona fide researchers and to set terms of use, including a ban on re-identifying patients. Still, researchers will have rights to do research, redistribute data, and derive products from it. Audits will be built in.

But as mentioned by Kelly Edwards of the University of Washington, tools and legal contracts can contribute to trust, but trust is ultimately based on shared values. Portable consent, properly done, engages with frameworks like Synapse to create a culture of respect for data.

In fact, I think the combination of the contractual framework in portable consent and a platform like Synapse, with its terms of use, might make a big difference in protecting patient privacy. Seyfert-Margolis cited predictions that 500 million smartphone users will be using medical apps by 2015. But mobile apps are notoriously greedy for personal data and cavalier toward user rights. Suppose all those smartphone users stored their data in a repository with clear terms of use and employed portable consent to grant access to the apps? We might all be safer.

The final article in this series will evaluate the prospects for open research in genetics, with a look at the grip of journal publishing on the field, and some comparisons to the success of free and open source software.

Next: Breaking Open Rewards and Incentives. All articles in this series, and others I've written about Sage Congress, are available through a bit.ly bundle.

OSCON 2012 — Join the world's open source pioneers, builders, and innovators July 16-20 in Portland, Oregon. Learn about open development, challenge your assumptions, and fire up your brain.

Save 20% on registration with the code RADAR20

July 06 2011

OSCon preview: Shahid N. Shah on medical devices and open source

I talked recently with Shahid N. Shah, who is speaking in the health care track at the O'Reilly Open Source convention later this month about The Implications of Open Source Technologies in Safety-critical Medical Device Platforms. Shahid and I discussed:

Podcast (MP3)

  • Why the data generated from medical devices is particularly reliable patient-related information, and its value for improving treatment

  • The value of connecting these devices to electronic health records, and the kinds of research this enables

  • The role of open source software in making it easier for device manufacturers to add connectivity--and to get it approved by the FDA

  • How it's time for regulators such as the Department of Health and Human Services to take a look at how devices can contribute to better health care

Another OSCon health-care-related posting is my video interview about the Indivo X personal health record with Daniel Haas.

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