walkitout (walkitout) wrote,
walkitout
walkitout

Long BI piece on Holmes/Theranos

It's by Kevin Loria and it reflects both thought and careful research. It is, however, extremely skeptical of Theranos, and in the end, it moved me from being somewhat skeptical of Holmes and Theranos to being not at all skeptical, mostly because I ultimately found the arguments unconvincing.

http://www.businessinsider.com/science-of-elizabeth-holmes-theranos-2015-4

The strongest argument against Theranos is the makeup of the board, because it is extremely odd and very light on medical/industry people. It points to a Fortune piece on the Board's makeup, which is instead very heavy on civil servants, military and previously elected officials.

http://fortune.com/2014/06/12/theranos-board-directors/

Loria says: "other than Frist, who has not practiced medicine in many years, only Foege is a medical professional"

While Loria acknowledges Foege's service as a former director of the CDC, that sort of undercuts what Foege has actually done, which is devise the strategy to eliminate smallpox, improve immunization rates in developing countries and advise the Bill & Melinda Gates Foundation. The wikipedia entry on Foege points to this article from the Seattle PI:

http://www.seattlepi.com/local/article/Carter-hails-UW-s-shy-hero-Foege-1197932.php

If Foege's participation on the Board of the company doesn't convince you that Theranos is for real, then it can only be because you think Foege is too old to be taken seriously any more. I wouldn't know.

I think Loria knows that this line of argument -- while the strongest of the piece -- is unconvincing. He moves onto the science. Theranos and Holmes have been quiet about a lot of the details, altho they are working with regulators so this isn't some sort of complete scam. Loria points to the lack of published, peer reviewed studies using its testing, and "the company hasn't allowed independent experts to publicly assess its labs, citing the need to protect its intellectual property." This is basically complaining that the company with the hot shit is making everyone sign an NDA; it is not compelling.

Dr. Jerry Yeo is the main expert cited for the balance of the piece.

I think this is Jerry Yeo: https://www.linkedin.com/in/jerryyeophd

That looks like a pretty relevant background and education to ask questions of, from a clinical/academic/medical perspective, but falls woefully short when it comes to answers to the questions Dr. Yeo then asks and Loria repeats:

""Why haven't they shown us that information, why haven't they been willing to publish it, and why haven't they shown comparisons with existing technology?" Yeo says."

The answer is easy and obvious, readily available from your own imagination or Theranos, altho Loria is extremely careful to avoid pointing out that the more information Theranos makes available, then more likely they will be undercut or pre-empted by the two (yes, two) existing lab networks. We live in a world in which every fucking medical test you get is provided by a cartel of _two_ labs. Two. Easiest cartel enforcement ever, especially since payment is through a third party (insurance), undercutting any vestigial market influence on cost.

Basically, at this point in the article, it is pretty clear that Loria is fronting for Quest and and LabCorp.

There is discussion of whether capillary tests are as good as venous tests. It hardly matters -- this is an area where dropping the price would mean you could use the capillary almost all the time and go back to the venous as a double-check only. There are tons of tests that _are not_ done because they are not cost effective (or they are done less often than would be ideal, because they are not cost effective) and if we could do them, we could drastically reduce side effects (yes, Dear Reader, we could finally titrate the appropriate dose of, basically, anything, for each individual user, every freaking time they took anything at all. Even if it just let us know who should take a half pill and who should get a pill and a half of OTC stuff like Dramamine, it would probably save some lives and make everyone a lot happier). Arguments that capillary tests can cause cellular damage, without referencing the horrible things that can go wrong with venous blood draws is just wrong. It's like saying we should go back to horses because cars are polluting, while completely forgetting about everything being ankle deep and worse in horse shit all the time.

"Still, it's an area where, if the phlebotomist operating the machine is improperly trained, there could be problems no matter how small the amount of blood drawn."

Improperly trained phlebotomists right now can cause sepsis. I'm not worried about a capillary draw machine. Altho I think anyone out there happy about the bank they make with their phlebotomy cert vs just a CNA (or whatever they call it now) should probably come up with a new career plan, because I foresee a dramatic drop in demand for phlebotomy once Theranos makes it through the regulatory process.

An investor at the venture stage in other healthcare companies, Ambar Bhattacharyya, is quoted: "he thinks it'll need to open up more to the scientific community to "win the trust of folks that would be deciding whether to refer [patients] to Theranos versus LabCorp or Quest.""

That's just dumb. Once it's a choice between 10x the cost and a 2 day wait vs. do it now for basically free in the office, the doctors will switch as soon as the regulators tell them they can. And if they don't, the insurers will balk at paying for the more expensive test. This is a no brainer. The regulators are the roadblock. Bhattacharyya also points out business risks involved with building out, however, he fails to note that if Theranos opens up too much to its cartelized competition, it will sink for sure before it even gets going. The existing cartel is powerfully motivated to preserve their existing business; if Theranos succeeds, they can only survive by playing catch-up and as we've seen with every other disintermediated, high margin, cartelized industry, that's a tough sell, and almost as destructive as just going under. Bhattacharyya does recognize that Quest and LabCorp might attempt to legislate some roadblocks for Theranos, and the makeup of the board clearly indicates that that is the fight Theranos is set up to win.

The remainder of the article is blue-sky: letting people order their own medical tests, personalized medicine, etc. (why doesn't anyone ever talk about getting dosing right when they talk about this stuff? It's almost like they don't realize there is a huge problem that isn't being solved because it is too expensive to solve with the existing testing regime.).

One final quote, however, to show how bad the argumentation of this argument really is:

Yeo says, "unlike the Apple products, this is a product that affects people's lives. If an iPhone is faulty, we go buy something else.""

First off, anyone who has ever worked in tech knows that it's a lot harder to make the distinction between life-affecting tech and non-life-affecting tech. Sure, it's real obvious if you program the radiation machine wrong and a bunch of cancer patients drop dead from too much or the wrong kind of radiation. But if you're a compiler programmer, and something went wrong in the compiler, _you_ might be the cause of the error in the radiation machine. It's fairly trivial to construct -- and not that much harder to find -- an instance where an iPhone or lack thereof is the difference between life and death, or health care promptly and health care later in a life-limiting way.

More importantly, _people die_ due to errors and failures and the slowness of the current testing system. If Theranos speeds things up and makes it cheaper but ever so slightly more error prone, the balance will still be in Theranos' favor. And the current system is far from perfect. Lab mixups occur.

I probably would never have bothered to _write_ this response, except the closing paragraph was so bad, I felt compelled:

"A health innovation has the potential to change people's lives and be transformative in a way that a phone never could, and that's precisely why, as excited as they are, scientists are still skeptical."

Wow. Just. Wow.

[ETA: Ignoring, for the moment, all the "iphone stopped the bullet" stories out of various wars, here's an example of Find My Phone saving someone's life: http://bgr.com/2014/10/16/find-my-iphone-saves-woman/

More examples, including people using the phone to access medical information in emergencies, or GPS to be rescued: http://ismashphone.com/2010/12/true-stories-of-iphone-apps-that-saved-a-life.html
]

I have no idea whether Theranos will succeed at getting through the regulatory process and subsequently as a business or not. But somebody is going to make capillary pricks and microfluidics testing a huge success. It is going to put most phlebotomists right back to the CNA cert that underlies their expertise. It is going to dramatically change the way dosing works on all medications, OTC and script. That _one change_, if implemented relatively quickly, will more than pay for any lives lost because of relative error rates vs. venous testing. And over time, worse-is-better says that that relative error rate will improve in the regime that becomes cheap and ubiquitous. Since Quest and LabCorp aren't in any hurry to roll this out, I'm inclined to bet on Holmes and her amazing Board.

ETA: Forgot to add: if you're wondering what Frist is doing on the Board, it's to make sure they have a Board member to send to any branch of government that is currently run by Republicans. Foege has the Democratic side covered, so even if his competence has declined due to age or anything else, as long as he can convince a group of people predisposed to admire and respect him, he is serving his purpose on the Board. Not that anyone is that cynical when picking Board members, but, oh, wait, yeah, they are!

Link-Fu for existing technology errors by current labs:

http://www.nytimes.com/2009/01/08/business/08labtest.html?_r=0

(The article is worth reading, if only because of things towards the end about solitary confinement of people of color and vitamin D levels from institutional food.)

Quest screwed up some Vitamin D tests, docs put patients on Vitamin D and wound up with too high blood levels -- that can make you sick or even kill you.

"Dr. Binkley said that a few years ago he sent a sample of his blood to six laboratories and got results that ranged from 14 nanograms a milliliter, which would be a deficient level, to 41 nanograms — a level three times as high and considered adequate. While the tests’ consistency has improved since then, there can still be substantial variability, he said."

Theranos has a pretty low bar to meet, if that's the level of accuracy in the current system. Amusingly, in the Vitamin D case, Quest switched from an FDA approved test to a NOT FDA approved test based on mass spectrometry.

[Here's something about a 2 year old, okayed by BK court acquisition by LabCorp getting undone because of antitrust issues.

http://www.mondaq.com/unitedstates/x/117530/Antitrust+Competition/Antitrust+Alert+FTC+Sues+to+Undo+Completed+Acquisition+Approved+by+Bankruptcy+Court]

ETAYA : Therenos Wellness Centers in Palo Alto, and around Phoenix, AZ. AZ has recently passed a law letting Arizona residents order their own tests.

"“Arizona House Bill 2645, signed into law earlier this week by Governor Doug Ducey, will allow Arizona residents to receive blood tests directly from licensed labs without a doctor’s order,” Lakin writes on DeciBio’s blog. “While Arizona residents could order a limited number of tests under previous legislation, this new law would permit customers to access any test offered by (any of the nation’s 251,000 federally certified labs). This law could be pivotal for Theranos, which aims to enable patients to access their health information at the time it matters. As more progressive laws loosen old-fashioned restrictions around patient access to health data, the implications for a ‘consumer health company’ such as Theranos are tremendous.”"

http://americasmarkets.usatoday.com/2015/04/09/arizona-health-law-could-boost-theranos-bio-tech-propects/

Article also mentions Theranos partnering with Cleveland Clinic.
Tags: our future economy today
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