Breakthrough Of Instant Diagnosis

[vt]

• THE WEEKEND INTERVIEW
• September 7, 2013, 12:06 a.m. ET

Elizabeth Holmes: The Breakthrough of Instant Diagnosis

A Stanford dropout is bidding to make tests more accurate, less painful—and at a fraction of the current price.

smaller

• By
• JOSEPH RAGO
• CONNECT

Palo Alto, Calif.
'The reality within our health-care system today is that when someone you care about gets really sick, by the time you find that out it's most often too late to do anything about it. It's heartbreaking. Because in those moments, there's nothing you wouldn't do to change it, and too often you're helpless," says Elizabeth Holmes. "We're finding cancer when you have a tumor, or heart disease by virtue of the fact that you're having a heart attack."
She wants to change that.
Ms. Holmes, a 29-year-old chemical and electrical engineer and entrepreneur, dropped out of Stanford as an undergraduate after founding a life sciences company called Theranos in 2003. Her inventions, which she is discussing in detail here for the first time, could upend the industry of laboratory testing and might change the way we detect and treat disease.
Ten years ago, Ms. Holmes was working out of the basement of a group college house, a world away from her current headquarters at a rambling industrial building in a research park just off campus. The company's real estate was one of the few Theranos facts known to Silicon Valley, but one suggestive of the closely held business's potential: The space was once home to Facebook, and before that Hewlett-Packard.
The secret that hundreds of employees are now refining involves devices that automate and miniaturize more than 1,000 laboratory tests, from routine blood work to advanced genetic analyses. Theranos's processes are faster, cheaper and more accurate than the conventional methods and require only microscopic blood volumes, not vial after vial of the stuff. The experience will be revelatory to anyone familiar with current practices, which often seem like medicine by Bram Stoker.
Enlarge Image






Fred Harper


A Theranos technician first increases blood flow to your hand by applying a wrap similar to one of those skiing pocket warmers, then uses a fingerstick to draw a few droplets of blood from the capillaries at the end of your hand. The blood wicks into a tube in a cartridge that Ms. Holmes calls a "nanotainer," which holds microliters of a sample, or about the amount of a raindrop. The nanotainer is then run through the analyzers in a Theranos laboratory. Results are usually sent back to a physician, but a full blood work-up—metabolic and immune markers, cell count, etc.—was in my inbox by the time I walked out the door. (Phew: all clear.)
It's the kind of modern, painless service that consumers rarely receive in U.S. health care, though Ms. Holmes makes the point the other way around: "We're here in Silicon Valley inside the consumer technology world . . . and what we think we're building is the first consumer health-care technology company. Patients are empowered by having better access to their own health information, and then by owning their own data."
And a Theranos clinic may be coming soon to a pharmacy near you. On Monday the company is launching a partnership with Walgreens for in-store sample-collection centers, with the first one in Palo Alto and expanding throughout California and beyond. Ms. Holmes's long-term goal is to provide Theranos services "within five miles of virtually every American home."
Diagnostics is one of those corners of the health markets that is more irrational the closer you look. Tests account for between 2% and 2.5% of health spending, but Ms. Holmes notes that they drive an estimated seven or eight of every 10 clinical decisions by physicians, with 6.8 billion lab tests annually in the U.S.
"The art of phlebotomy originated with bloodletting in 1400 B.C. and the modern clinical lab emerged in the 1960s—and it has not fundamentally evolved since then," she says. The billions of tests generally follow the same ritual: In a hospital or clinic, "you go in, sit down, they put a tourniquet on your arm, stick you with a needle, take these tubes and tubes of blood," as Ms. Holmes describes it.
The specimens are then transported, via a courier or hospital pneumatic tube, to a centralized lab, where they are manually removed from the tubes with a pipette and mixed with a chemical reagent or sent through instruments like a centrifuge or mass spectrometer. After days or weeks of waiting, your doctor finally gets the results.
One major problem, Ms. Holmes says, is that physicians rarely have "the best actionable information to make the best possible diagnosis at the time it matters." She posits a hypothetical patient whose doctor orders a test and discovers that she has a dangerously low hemoglobin count, so he puts her on an anti-anemia drug. He must order another test to find out what kind of anemia she has, and days later it turns out to be merely an iron deficiency. The best final treatment was actually "take some iron pills or eat more spinach."
Theranos's technology eliminates multiple lab trips because it can "run any combination of tests, including sets of follow-on tests," at once, very quickly, all from a single microsample. Ms. Holmes estimates that patients and doctors will receive readouts in "as little as two hours" and can even do so before an office visit based on their physician's recommendation for better, or at least less ad hoc, consultations.
Only about 62% of tests that doctors order are ultimately carried out, according to health-policy researchers at the Lewin Group. One reason tests aren't performed: not enough blood. To ensure that labs don't reject samples, several studies have documented that medical institutions sometimes collect as much as 45 times the amount of blood from patients that conventional tests actually require.
Luckily, blood is a renewable resource, though the small Theranos sample size is a particular advance for the elderly, for whom blood draws can be agony because of collapsed veins. It's also good news for children who fear needles, and for oncology patients, whose blood is being constantly tested.
Another Theranos advance is its testing's accuracy. Ms. Holmes believes the chain of conventional laboratory custody introduces too many opportunities for error, "which is basically wherever humans are involved." The integrity of lab specimens can be contaminated if they sit too long on the bench, or if they're mistakenly processed by a tech, or by temperature, and so forth.
A 2002 review in the journal Clinical Chemistry found error estimates ranging from one out of every 33-50 tests to one of every 8,300, though the rate has likely since improved. The same sample sent to two different labs can yield two varying results, and the same lab testing the same sample twice can yield different results too.
That's because the precision of lab instruments, and their reference ranges, vary from manufacturer to manufacturer. Labs buy from different vendors and often don't calibrate the machines to each other. Certain tests may be reported with fairly wide margins of error, such as a plus-or-minus 30% of allowable error for HDL cholesterol. Ms. Holmes notes that a measurement that is essentially a 60% error range isn't very useful, especially over time, since disease itself is a progression over time.
Theranos's technology is automated, standardized, and attempts to subtract human error from the process. It can thus achieve much lower variance ranges for a given test. Ms. Holmes says its tests have margins of "allowable error" targets less than 10%.
The medical promise of this speed and better information means catching disease in its earliest stages before the onset of symptoms. The company's analytic tools might also help realize the possibilities of truly personalized medicine, as scientists gain a better understanding of the heterogeneity of disease and how to treat individuals based on their own bodies, not large averages.
Theranos's tools may also allow doctors to analyze data "longitudinally"—to see trends, clusters and rates of change that they can't now. Medicine would ask fewer on-off, do-you-have-this-disease-or-not questions, and instead "meaningfully and powerfully answer the question of how to detect and manage these diseases early on," says Ms. Holmes.
She first funded Theranos at age 19 by cashing out an education trust that her parents set up, which allowed her to hire her first employee and rent lab space. Later rounds of funding were raised from venture capital and private equity. Once Theranos was more established, it started to earn revenue from contracts conducting pharmaceutical testing in cancer drug and other clinical trials.
A word about costs and what that investment bought, which doesn't follow the usual rules about a new medical technology. Ms. Holmes says Theranos can conduct a battery of tests for "tens of dollars," a phrase that does not exist in U.S. health care. She calls it "a watershed opportunity to change the trajectory of health costs through price transparency."
Since 1984, the Medicare Clinical Laboratory Fee Schedule has set reimbursements for 1,140 unique lab tests across 57 U.S. jurisdictions. That's 64,980 different price controls. Meanwhile, the prices that private insurers negotiate with providers are virtually trade secrets.
Theranos is committing to a half-off discount on Medicare fees. "So a test that costs $100 now, we'll do $50 or less. The quote-unquote payer community I don't think has ever seen someone walk in and say we want to bill you at less than you're willing to reimburse," she says. If this strategy succeeds in squeezing down prices—say, lowering testing as a share of total health costs to 1.5% from 2.3% now—it could save Medicare $61 billion over 10 years and Medicaid $96.1 billion, according to what Theranos calls a conservative estimate.
Ms. Holmes says her larger goal is increasing access to testing, including among the uninsured, though she might also have a market-share land grab in mind. For instance, she says Theranos will publish all its retail prices on its website. The company's X-ray of self-transparency also includes reporting its margins-of-error variations online and on test results and order forms, which few if any labs do now.
This strategy may be inviting a hell of a battle with the health industry, where the incentives are rigged against startups and the empire usually finds a way of striking back. Witness the medical-practice regulations that make medicine a cartel against competitors. Pathologists, lab scientists and technicians won't be pleased if their jobs go the way of travel agents.
Ms. Holmes declines to discuss Theranos's future plans, though one may speculate. There could be military applications in the battlefield, especially given the numerous framed American flags across the Theranos office and the presence on its corporate board of retired Gens. Jim Mattis and Gary Roughead, former Defense Secretary Bill Perry and former Secretary of State George Shultz.
The other obvious tech reality is that the devices keep shrinking, and over the last several years Theranos has been granted several patents for portable diagnosis system at the point of care. One of them even invokes—forget the iWatch—a wearable diagnostic device that would attach to the body with silicon microneedles "about the size of a human hair."
The biggest question is whether Ms. Holmes has discovered one of those often promised, more often elusive disruptive innovations designed to cut costs while improving quality. In a conversation about a year ago, Secretary Shultz said Ms. Holmes could be "the next Steve Jobs or Bill Gates."
When I put it to him again on my recent visit, he smiles slyly. "This is not the last thing she's going to invent or create."
Mr. Rago is a member of the Journal's editorial http://online.wsj.com/article/SB1000...mod=hp_opinion

[lektrode]

Re: Breakthrough Of Instant Diagnosis

nice find/snag here, vt....

....
'The reality within our health-care system today is that when someone you care about gets really sick, by the time you find that out it's most often too late to do anything about it. It's heartbreaking. Because in those moments, there's nothing you wouldn't do to change it, and too often you're helpless," says Elizabeth Holmes. "We're finding cancer when you have a tumor, or heart disease by virtue of the fact that you're having a heart attack."
She wants to change that.

Ms. Holmes, a 29-year-old chemical and electrical engineer and entrepreneur, dropped out of Stanford as an undergraduate after founding a life sciences company called Theranos in 2003. Her inventions, which she is discussing in detail here for the first time, could upend the industry of laboratory testing and might change the way we detect and treat disease.

.....

am beginning to think that the best way to create JOBS, fix the problems is to encourage more COLLEGE DROPOUTS
(only 1/2 sarc)

interesting stuff here tho....

A Theranos technician first increases blood flow to your hand by applying a wrap similar to one of those skiing pocket warmers, then uses a fingerstick to draw a few droplets of blood from the capillaries at the end of your hand. The blood wicks into a tube in a cartridge that Ms. Holmes calls a "nanotainer," which holds microliters of a sample, or about the amount of a raindrop. The nanotainer is then run through the analyzers in a Theranos laboratory. Results are usually sent back to a physician, but a full blood work-up—metabolic and immune markers, cell count, etc.—was in my inbox by the time I walked out the door. (Phew: all clear.)

It's the kind of modern, painless service that consumers rarely receive in U.S. health care, though Ms. Holmes makes the point the other way around: "We're here in Silicon Valley inside the consumer technology world . . . and what we think we're building is the first consumer health-care technology company. Patients are empowered by having better access to their own health information, and then by owning their own data."

And a Theranos clinic may be coming soon to a pharmacy near you. On Monday the company is launching a partnership with Walgreens for in-store sample-collection centers, with the first one in Palo Alto and expanding throughout California and beyond. Ms. Holmes's long-term goal is to provide Theranos services "within five miles of virtually every American home."

Diagnostics is one of those corners of the health markets that is more irrational the closer you look. Tests account for between 2% and 2.5% of health spending, but Ms. Holmes notes that they drive an estimated seven or eight of every 10 clinical decisions by physicians, with 6.8 billion lab tests annually in the U.S.
"The art of phlebotomy originated with bloodletting in 1400 B.C. and the modern clinical lab emerged in the 1960s—and it has not fundamentally evolved since then," she says. The billions of tests generally follow the same ritual: In a hospital or clinic, "you go in, sit down, they put a tourniquet on your arm, stick you with a needle, take these tubes and tubes of blood," as Ms. Holmes describes it.

The specimens are then transported, via a courier or hospital pneumatic tube, to a centralized lab, where they are manually removed from the tubes with a pipette and mixed with a chemical reagent or sent through instruments like a centrifuge or mass spectrometer. After days or weeks of waiting, your doctor finally gets the results.

One major problem, Ms. Holmes says, is that physicians rarely have "the best actionable information to make the best possible diagnosis at the time it matters." She posits a hypothetical patient whose doctor orders a test and discovers that she has a dangerously low hemoglobin count, so he puts her on an anti-anemia drug. He must order another test to find out what kind of anemia she has, and days later it turns out to be merely an iron deficiency. The best final treatment was actually "take some iron pills or eat more spinach."
.......

Only about 62% of tests that doctors order are ultimately carried out, according to health-policy researchers at the Lewin Group. One reason tests aren't performed: not enough blood. To ensure that labs don't reject samples, several studies have documented that medical institutions sometimes collect as much as 45 times the amount of blood from patients that conventional tests actually require.

....
A word about costs and what that investment bought, which doesn't follow the usual rules about a new medical technology. Ms. Holmes says Theranos can conduct a battery of tests for "tens of dollars,"a phrase that does not exist in U.S. health care. She calls it "a watershed opportunity to change the trajectory of health costs through price transparency."

Since 1984, the Medicare Clinical Laboratory Fee Schedule has set reimbursements for 1,140 unique lab tests across 57 U.S. jurisdictions. That's 64,980 different price controls. Meanwhile, the prices that private insurers negotiate with providers are virtually trade secrets.

Theranos is committing to a half-off discount on Medicare fees. "So a test that costs $100 now, we'll do $50 or less. The quote-unquote payer community I don't think has ever seen someone walk in and say we want to bill you at less than you're willing to reimburse," she says. If this strategy succeeds in squeezing down prices—say, lowering testing as a share of total health costs to 1.5% from 2.3% now—it could save Medicare $61 billion over 10 years and Medicaid $96.1 billion, according to what Theranos calls a conservative estimate.

Ms. Holmes says her larger goal is increasing access to testing, including among the uninsured, though she might also have a market-share land grab in mind. For instance, she says Theranos will publish all its retail prices on its website. ....

This strategy may be inviting a hell of a battle with the health industry, where the incentives are rigged against startups and the empire usually finds a way of striking back. Witness the medical-practice regulations that make medicine a cartel against competitors. Pathologists, lab scientists and technicians won't be pleased if their jobs go the way of travel agents.

just hope they (along with the med-ins-legal-drug mob, never mind with the medicare/caid-industrial complex dont find some way to....
uhhhh...
make her behave (or 'somehow' have an accident...)

[shiny!]

Re: Breakthrough Of Instant Diagnosis

This would be a godsend! I'm one of those "for whom blood draws can be agony because of collapsed veins."

Currently, my doctor demands "routine bloodwork". The technicians can't get it because my veins are just too bad. The doctor won't prescribe my necessary thyroid meds without lab results. So I buy my thyroid pills without an Rx from a supplier in another country, and make my best guess as to dosage. My doctor then scolds me for treating myself. So I stop going to the damn doctor. Then "for my protection" the FDA bans the import via mail of my pharmaceutical-grade thyroid meds. I have to jump through all sorts of shady hoops to stay alive.

Then there's the cost. After paying my atrocious monthly insurance premium, I can't afford to see a doctor or pay for my labs out of pocket until I meet my high deductible. The only place where I can have a successful blood draw is a hospital, where they use an ultrasound machine to find a good vein. But I can't afford to go to the hospital. I can't afford any healthcare at this point.

This new test would let me walk in to a Walgreen's and buy my own tests at a reasonable cost. Where do I sign up to invest?

Can someone please send this story to EJ behind the paywall? He might find Theranos very interesting from an investment standpoint.

[jpatter666]

Re: Breakthrough Of Instant Diagnosis

This would be a godsend! I'm one of those "for whom blood draws can be agony because of collapsed veins."

Currently, my doctor demands "routine bloodwork". The technicians can't get it because my veins are just too bad. The doctor won't prescribe my necessary thyroid meds without lab results. So I buy my thyroid pills without an Rx from a supplier in another country, and make my best guess as to dosage. My doctor then scolds me for treating myself. So I stop going to the damn doctor. Then "for my protection" the FDA bans the import via mail of my pharmaceutical-grade thyroid meds. I have to jump through all sorts of shady hoops to stay alive.

Then there's the cost. After paying my atrocious monthly insurance premium, I can't afford to see a doctor or pay for my labs out of pocket until I meet my high deductible. The only place where I can have a successful blood draw is a hospital, where they use an ultrasound machine to find a good vein. But I can't afford to go to the hospital. I can't afford any healthcare at this point.

This new test would let me walk in to a Walgreen's and buy my own tests at a reasonable cost. Where do I sign up to invest?

Can someone please send this story to EJ behind the paywall? He might find Theranos very interesting from an investment standpoint.

I think you'll find more of these types of stories. I work in the IT industry and the capabilities of the cloud architecture, big data stores and new free/shareware software which can really take advantage of it all is really opening up some new possibilities. I feel we are on the verge of another IT leap forward.....

[shiny!]

Re: Breakthrough Of Instant Diagnosis

I think you'll find more of these types of stories. I work in the IT industry and the capabilities of the cloud architecture, big data stores and new free/shareware software which can really take advantage of it all is really opening up some new possibilities. I feel we are on the verge of another IT leap forward.....

Man, I hope you're right, and that new technologies and business models will be able to overcome entrenched resistance.

[reggie]

Re: Breakthrough Of Instant Diagnosis

Yet, another cardboard cutout company suppoedly founded by the super-genius lone-dropout. How many more of these stories do we have to stomach. First, how much do you wanna bet that Ms. Holmes is linked to some pretty important people. Second, this system is being developed to support the people-identification and segregation systems planned for the future. No ID card will be needed, folks.

If Ms Holmes wants to cure cancer, or a myriad of other diseases, all she has to do is educate the public on proper nutrition and protection from environmental toxins.

Wait, but I thought it was only the lower uneducated classes that were subject to, and bought into, bread and circus?

[ltullos]

Re: Breakthrough Of Instant Diagnosis

Yet, another cardboard cutout company supposedly founded by the super-genius lone-dropout. How many more of these stories do we have to stomach. First, how much do you wanna bet that Ms. Holmes is linked to some pretty important people. Second, this system is being developed to support the people-identification and segregation systems planned for the future. No ID card will be needed, folks.

Reggie, seriously has your view become so distorted that you can't recognize that technology can perform simple screening tests so much more efficiently and cheaper than current practice, and give much clearer results to patients than a lot of doctor speak? It's not for everyone, but is a major step towards bringing a portion of the healthcare costs down while improving service as well. BTW, another huge problem is that so many people are on so many medications that they are unable to keep track of them and are constantly over or under-medicating themselves or their loved ones. This problem is easily solved by real-time monitoring was well. God knows that there is plenty of reason to be paranoid when it comes to our privacy; but sometimes there can be some real benefits to giving up a bit of it. We just have to make sure the insurance companies don't have access; but then again if we had a single payer system even that would be a much smaller issue.

[c1ue]

Re: Breakthrough Of Instant Diagnosis

Sorry, but I don't see what is so magical here.

Silicon chip-based tests are not a new idea. I don't know if that is precisely what Theranos is doing, but the silicon chip based tests are simply MEMS based tests which are fabricated by a semiconductor foundry as opposed to a test tube + chemical type setup - which is what most lab testing is now. The premise behind silicon chip based testing was that the automation and cost reduction would lead to far cheaper lab testing, as well as more consistent quality.

The only wrinkle between a successful silicon MEMS test chip vs. Theranos would be the combination of multiple tests into a single 'system on chip'.

Of course, the problem is that blood testing isn't generally as simple as testing pH in your pool. Often you have to do things like separate out specific components of blood, for example. Equally there are a lot of different tests that can be run - I think the number is well into the tens of thousands.

Even a dramatic reduction of test costs for all of the above tens of thousands - I find it hard to see how it would be practical to automatically run all of the above tests in all cases - no matter how cheap each one might be. And one thing silicon MEMS based tests are not is flexible - you absolutely cannot tailor on the fly some subset in any way except by just cutting out the unwanted tests, but in this case the unwanted tests are manufactured (and thus paid for) already.

Smells like a well paid PR effort to me.

[vinoveri]

Re: Breakthrough Of Instant Diagnosis

Yeah, PR indeed, although to be fair, somebody has to commercialize the technology via a successful business, and getting the buzz going to open the funnels of investment is part of the process. micro-fluidics SoC solutions for bio analysis and detection have indeed been around for some time.

[jpatter666]

Re: Breakthrough Of Instant Diagnosis

Could be hype, but am suspecting there is *something* there.

I took a look at Glassdoor to see what the employees themselves are saying. Decent reviews and many seem to believe they are on a mission.

[reggie]

Re: Breakthrough Of Instant Diagnosis

Reggie, seriously has your view become so distorted that you can't recognize that technology can perform simple screening tests so much more efficiently and cheaper than current practice, and give much clearer results to patients than a lot of doctor speak? It's not for everyone, but is a major step towards bringing a portion of the healthcare costs down while improving service as well. BTW, another huge problem is that so many people are on so many medications that they are unable to keep track of them and are constantly over or under-medicating themselves or their loved ones. This problem is easily solved by real-time monitoring was well. God knows that there is plenty of reason to be paranoid when it comes to our privacy; but sometimes there can be some real benefits to giving up a bit of it. We just have to make sure the insurance companies don't have access; but then again if we had a single payer system even that would be a much smaller issue.

What's disappointing here is that only the authorized communication is approved for discussion. Alternative views are derogatorily labelled. In this case, the non-authorized vector of dicussion is called "distorted" in order to thwart any further consideration of this view. Any other member who decides to follow-up on this vector can expect the same treatment, so the discussion is shut down. What a shame.

As as side note, have you ever wondered why it is that there seems to be a high correlation between Harvard, Stanford and MIT drop outs - who create multi-billion dollar global corporations that alter society overnight - and military industrial complex funding levels of these same academic institutions.

On another note, I completely agree with you on the desire to create "real-time monitoring", which most certainly will be deployed to tighten the fidelity of health care's feedback loop - don't take your meds, they'll be an automated system which will dose you "appropriately". Jesus Christ, is everyone so invested in this Simulacrum that the obvious trajectory of these systems is not only unseen, but not discussed as well? And I'm the one who is being called "distorted"?

[reggie]

Re: Breakthrough Of Instant Diagnosis

Could be hype, but am suspecting there is *something* there.

I took a look at Glassdoor to see what the employees themselves are saying. Decent reviews and many seem to believe they are on a mission.

Read the reviews from some of the people who have interviewed there.

[Bundi]

Re: Breakthrough Of Instant Diagnosis

Read the reviews from some of the people who have interviewed there.

In 2001 I attended a presentation by Francis Collins, leader of the Human Genome Project and currently Director of the National Institutes of Health. He made some very intriguing predictions regarding the power of genetic information to improve our understanding of the molecular basis of human pathology and as a result the efficiency of treatments. If I recall correctly, he had a 10ish year time frame in mind. As usual, an overly optimistic timeframe for biomedical research evolution. That said, the current advancing state of big data technology and high throughput molecular screening suggest that some changes may be in the offing.

I think that the whole field of Personalized Medicine is going to matter. I wouldn’t necessarily hazard a guess on timing but there is a lot of progress achieved since the Francis Collins presentation in 2001.

It is likely that these advances will influence the cost structure of medicine in the U.S. in the years to come. Exactly how remains to be seen but given the huge liability that is healthcare costs, people may want to spend some time building an understanding of the basics.

Here are some presentations to help.

Eight high level speakers (bottom left of page) from the Personalized Medicine World Conference – 2011.
http://pmwcintl.com/

Moderator Kevin Davies, author of The $1,000 Genome and editor-in-chief of BioIT World discusses personalized medicine and big data analytics in healthcare with Colin Hill, CEO of GNS Healthcare, Eric Schadt, PhD, Chief Scientific Officer Pacific Biosciences and Felix Frueh, PhD, President of Medco Research Institute.
http://www.youtube.com/watch?v=bj8WXFP6ujc

Howard Jacob speaking on Personalize Medicine at the Illumina Meeting in Feb. of 2013.
http://www.youtube.com/watch?v=WUQ_qVe9HGQ

[c1ue]

Re: Breakthrough Of Instant Diagnosis

I think that the whole field of Personalized Medicine is going to matter.

The question is - will it matter to society overall or will it matter just to the 1%?

One of the fundamental conflicts of profit driven medicine is that it is profit driven. That's why there are billions spent for developing and then using Viagra but far, far less spent to figure out how to handle malaria.

Is there any reason to think this dynamic won't also affect Personalized Medicine?

[Bundi]

Re: Breakthrough Of Instant Diagnosis

The question is - will it matter to society overall or will it matter just to the 1%?

One of the fundamental conflicts of profit driven medicine is that it is profit driven. That's why there are billions spent for developing and then using Viagra but far, far less spent to figure out how to handle malaria.

Is there any reason to think this dynamic won't also affect Personalized Medicine?

I suspect the 1% will fare best in future medical care scenarios. It is certainly possible that any efficiencies that can be derived from “personalized medicine” (warning, buzz word) may simply result in a new value chain structure and a shift in economics to different concentrated players as opposed to lower costs to consumers or to an increased emphasis on previously underserved (lack of profit opportunity) therapeutic areas.

I would not necessarily say that is the only possible outcome however. In other words, I don’t know that it is an either/or future.

An important reality to consider is that big pharma R&D efficiency has lagged for many years now. This is to a meaningful degree because of the lack of new drug targets available to traditional drug discovery approaches. Long story short, there are simply way too many misses compared to wins in drug discovery and the cost is the same or similar in either case. In addition many of the new drugs coming to market are one offs of existing well established mechanisms of action addressing the same exact protein target, typically in a well-trodden mass market with a well-known regulatory pathway. While this is certainly not always the case, it has too often been true that the game is to get an approval and apply mass marketing to gain share. Hardly a winning formula for the industry, especially once generic competition enters a mass market and the efficacy of the branded drugs are marginally, if at all better. Big pharma is acutely aware of the problem and has been for years, so is adjusting.

To your point, there are quite a few diseases with patient populations that simply lack sufficient numbers (or economic clout) to justify all of the R&D expense associated with finding the needle in the haystack treatment. This may be changing, grudgingly and on a disease by disease basis. The idea being that a larger and more nuanced set of data, measuring underlying molecular pathology over the time course of disease progression can be leveraged to identify a more specific cause or multi-factor profile of the disease. Couple this massive data set with an informatics platform capable of providing advanced analytics and some important correlations may be established between genetic profiles, protein physiology, and clinical outcomes. The hope is that in doing so, new and highly specific drug targets are revealed which would increase the likelihood of a drug discovery program yielding a win as opposed to a costly loss. It may also lower the cost of the winning program relative to what it otherwise would have been as well as yield a higher efficacy in the appropriate patient population.

In theory anyway, this is a productive advance that could lower cost barriers to pursuing currently underserved diseases. I think this is where I find some hope. If diagnosing, characterizing, and treating disease can be done in a more efficient/productive manner perhaps there are benefits to be had even if they are not evenly distributed throughout society.

The impact of any of this on big pharm business models is a very interesting topic and one that is being wrestled with by all players.

As an aside, Viagra was originally intended to address hypertension. Interesting story here. http://www.about-ed.com/viagra-history