Incremental Agglomeration, Creative Destruction, and the Impending Forest Fire of the American Medical Establishment

Part 1: Introduction

The great promise of every modern medical initiative has been “cost savings.” Indeed, what magnanimous medical aspiration in print or powerpoint could preclude a fast-fact stat about the alarming overspending in American healthcare? Yet, as America continues to realize these health initiatives —ostensibly in the spirit of “cost savings” —yet, health spending inexorably grows despite typically marginal improvements in care.

Electronic records, evidence-based medicine, patient-centric care, personalized medicine, universal coverage, and genomics —sure, they all sound good, but can America afford another revolutionary “cost saving” medical industry initiative? No, because revolution is destructive, and what institution willfully destroys itself? Not institutions that still exist. So like the non-directive flaws of biological group selection theory, the drastic improvements promised by revolution are beyond the incremental and self-sustaining mechanisms of institutionalism —as intellectually unaesthetic as that may seem.

Every new medical initiative purports revolution by some combination of better education, savings, standards by implementing some new discovery, invention, or idea. But there’s no grand medical conspiracy inhibiting the potential of these ideas; the mundane simplicity is that change is hard work, people are busy, and everyone stakes in the status quo.  Only outside competitors are willing and able to metabolize the medical establishment, and while these well-minded initiatives may snuff immediate needs, rather than sparking significant change, they continue to agglomerate like a thicket. Thus the longer revolutionary fire is procrastinated, the more dead wood accumulates, and the greater the inevitable conflagration in healthcare will be.

But today, two decades of information technology has made healthcare revolution imaginable. First, medicine has matured from scholarly practice to information science, and science needs no priesthood. Next, decades of accumulated initiatives choke American healthcare in waste information, a problem information technology solves well… too well. From problems like “pager tag” to communicate simplistic information like blood pressure and on-calls to “governance by bureaucratic harassment” like insurance coding and liability threats outside strict procedure, the revolutionary solution destroys the existing systems and their vested interests. But, destroying useful systems is locally suboptimal, and institutions can act for their own immediate growth and survival. Thus, revolution is fundamentally unachievable by insider initiatives despite theoretical feasibility and best intentions. So finally, a willing and able outsider is necessary to imagine revolution, and the elite groups behind information technology giants like Google have announced their revolutionary intentions with ventures like 23andMe and Google Health. However, revolution is unpredictable, and by the power of the Internet, the eventual leading health revolutionaries could be anybody.

So manifests the quintessential American pragmatic hypocrisy: all tout the wealth-building virtues of creative destruction until the torch of change is under you. Then, change is “unethical.” Only law is more artificially sustained by its own ethical sophistry and willfully abstruse erudition as is the gross establishment of American health. America hates its healthcare, revolution is coming, and no insider medical initiative can stop it forever.

This is a four part serialized essay which will discuss what a revolution in health will and will not look like, why revolution is possible today, and why direct-to-consumer genomics is sparking our imaginations. Subscribe to Think Gene to be notified when new sections are published.

[1] Introduction

[2] Picture of Revolution (coming soon)

[3] Why Revolution Today (coming soon)

[4] The Spark of Direct-to-Consumer (coming soon)

Yesterday, I donated my personal genome at the Coriell Institute for Medical Research to participate in the Coriell Personalized Medicine Collaborative. I also got lost in the Camden ghetto and learned to hate New Jersey. In all, it was a mixed day for magnanimity.

What is the Coriell Personalized Medicine Collaborative? (PMC)

So, what if a government institution, figuring they’ve already spent $3 billion dollars on the Human Genome Project, shrugged, and threw down a few spare million to learn how this information is actually relevant to medicine? What if this study had the institutional support of the medical establishment, the scientific establishment, and American government and thus was unlikely to try something illegal like operate a non-CLIA laboratory or suggest profit-sharing to doctors to sell tests?

And what if it was free?

Thus: the Coriell Personalized Medicine Collaborative.

The Coriell genomic test itself is like direct-to-consumer tests Navigenics, 23andMe, deCODEme… but better. Functionally, the tests use the same technology: Oragene saliva kits, Affymetrix SNP chip machines, and a web portal for reports. Both strive to test for all meaningful genomic variations that aren’t already patented, are identifiable by a single nucleotide change, and don’t risk the crushing liability and ethical problems of reporting untreatable, terminal genetic diseases like Huntington’s. But Coriell’s genomic test so much better because:

• It’s free. Navigenics costs $2500 plus subscription, 23andMe and deCODEme both cost $1000.
  So: More people can and will participate and benefit. I believe Coriell has already recruited more participants than all other direct-to-consumer competitors combined.
  So: The resulting medical research will be better because the sample size is bigger.
• It’s newer, so it includes more, newer, better reviewed research.
  So: Test results will be qualitatively and quantitatively better.
• It’s medical information and is presented as such.
  So: Medical and pharmagenomic tests like “Warfarin metabolism” can be offered. (Useful if you ever need to take blood-thinning drugs.)
  So: Doctors can apply test results to practice better medicine. (How can a doctor credibly use “explicitly non-medical” information in medicine? Even if non-medical test results were available, the doctor would be obligated to repeat the test.)
• It’s offered by a well-established medical research institution. (founded: 1953)
  So: Institutional support and funding exists.
  So: The Coriell institution can be trusted to last… unlike unprofitable, venture-funded companies less than ten years old.
  So: All people, including patients, doctors, and scientists will be more willing to invest time and money in the program.
  So: The medical establishment will be more comfortable applying the test results in medical practice.
  So: The scientific establishment will be more comfortable trusting the medical research produced by the program.
  So: Patients, medicine, and science will better benefit from their test results.

From the Coriell website:

The Coriell Personalized Medicine Collaborative is a pioneering research study that seeks to explore the utility of using genome information in clinical decision-making. The goal is to better understand the impact of genome-informed medicine and to guide its ethical, legal and responsible implementation. This research study is a forward-thinking, collaborative effort involving volunteer study participants, physicians, scientists, ethicists, genetic counselors and information technology experts. The study seeks to enroll 10,000 participants by the end of 2009, with an ultimate goal of 100,000 individuals.

With a budget of “the government,” no accountability to profit, a goal of “research,” scientific and medical institutional support, and the low, low price of free…

…screw it. I was going to say something banally optimistic like “I’m confident Coriell will continue to succeed in their endeavor to integrate genomic science into medicine.” But, really, how can Coriell fail? Not profit? They’re non-profit and funded by the government. Not get enough volunteers for their free, riskless, non-invasive saliva test worth over $2500 in sexiest, newest medical field? The government will pay to hand some nurses orgenes and waivers to distribute at a few hospitals and universities. Not able produce any successful research? Impossible: the successful research will then be “we were unable to produce any successful research.”

Basically, the only way Coriell can screw this up is if they embarrass themselves mishandling samples. This is unlikely considering they operate an international biobank of human cell lines. I met the lab director for the Coriell PMC. Where DTC companies were busted by the government for operating without certification, this guy rattled off CLIA specifications like they were trivial. Considering the hundreds-of-thousands living cell cultures preserved in liquid-nitrogen-cooled vats downstairs, to him, for a few SNP chip machines and some dead somatic cells in spit, they were.

The good news for genomic testing DTC competitors 23andMe, Navigenics, and deCODEme is that they were the trailblazers and that Coriell is following their lead. The bad news is that another word for “trailblazer” is “cannonfodder.” Sure, you might get a statue, but you’re going to be dead. (It’s typically bad for business when an established, well-funded, experienced competitor releases a better version of your product for free.) So what will these statues look like?

• 23andMe: 23andMe is the biggest winner because it has already accomplished everything it was founded to do: launch the biologist wife of a nerdy silicon valley billionaire into high society while ostensibly achieving something important. Technically, deCODEme launched before 23andMe, and technically, a .5MM SNP chip isn’t a genome, but 23andMe, particularly, Anne Wojcicki, will be remembered for being the first to realize the $1000 genome. (If this is confusing, what’s called “philanthropist” is called “web 2.0 startup founder” in Mountain View, CA.)
• deCODEme: deCODE clearly expected to profit from deCODEme eventually, but how does one expect to compete in a market with immortal competitors like Coriell? deCODE will continue to sell its genomic tests, but deCODEme has been notably quiet lately and will likely continue to get quieter… Fortunately, deCODE didn’t invest much into deCODEme since they already have a lab and websites are comparably cheap.
• Navigenics: To Navigenics, the “serious medical brand” of DTC genomics, Coriell’s PMC isn’t so much “bad news” as it is a big “F-You” shouted self-consciously at effigy of Craig Venture in a Navigenics t-shirt.  It wasn’t enough to demolish Navigenics’ business model; Coriell had to completely discredit any hope of Navigenics ever being considered as a credible medical tool by any medical establishment. Fortunately, “Navigenics does not provide medical advice, diagnosis or treatment,” so that’s not a problem for Navigenics… right?

While I know that Coriell will be successful, the degree of that success is uncertain. Coriell is a non-profit science company trying to reach the mass public, so its greatest weakness will be marketing. For example, a Google search reveals 471 hits for “Coriell Personalized Medicine Collaborative” versus 365,000 for 23andMe.

Coriell will also need some help with their web software portal. (for example: coriell.org is temporarily offline). But as a smart 15 year old can run a basic web server, Silicon Valley has already built several good genomic web UIs for “inspiration” (hint: Print Screen + View Page Source + Django | Ruby on Rails == ++Inspiration), this is an feasibly addressable issue.

So what does the Coriell PMC mean for the future of genomic medicine?

First, the market for expensive SNP chip tests for unpatented mutations is dead. Genomic testing companies will still exist, but they’ll be more like products offered by commodity medical test providers than sexy consumer brands. I must repeat: any customer of DTC genomic testing can get a better test for free from Coriell. There is no reason for anyone to ever again buy any DTC genomic test other than to conspicuously spend money (up to 100,000 participants, but that is enough to kill today’s $1000 SNP test market.)

A market for expensive patented genomic tests like BRCA will continue to exist because it’s illegal for organizations like Coriell to provide them for free (even though they could easily do so). However, the good news for consumers is that these patents will become increasingly unenforceable as full-genome sequencing replaces SNP chip technology. At first, testing companies will refuse to provide official interpretations of legally conflicted results, leaving them as “exercises for the reader.” But as patents are public and “trade secret” medical science is quackery, eventually, BRCA-type patents will seem ridiculous and fade away. Maybe not in five years, but certainly in a few decades.

Ultimately, if the government is willing to pay to bring SNP chip genome testing to the masses, then it will be willing to pay to bring genome sequencing testing to the masses when it’s cheap enough. It will be. Eventually, a genome sequence will be performed with as much institutional banality as childhood vaccines. Your genome will go into some medical record where it will be used to aid every medical decision. This will normal and unnoticed except the occasional slow news day when MSN Health reports some prole alarmist dreck like “Is Your Genome Really Private?” or “Top Ten Mutations That Affect Your Health.”

Every variable: cost, medical application, availability, liability, institutional capacity… inexorably points to this the “genome banality scenario” except one: some pseudo-religious aversion to sharing one’s genome. However, the pressures to solve mounting health care costs, provide better care, and to avoid liability will be too great. GINA may protect Americans from discrimination based on what one’s genome says, but it does NOT protect discrimination based on not having a one’s genome on record.

EDIT: GINA statement may wrong, I’m looking into this..