
Stealth Research and Theranos:  Reflections and Update 1 Year Later - mmastrac
http://jama.jamanetwork.com/article.aspx?articleid=2524161
======
danso
I would love to hear more of the reasoning as to why Theranos thought Dr.
Ionnadis, famous for being hugely skeptical of medical research claims [0],
would be someone to reach out to (assuming they weren't intending to just buy
him out). There are plenty of other medical experts who would have cooperated
with Theranos (given its pedigree) before the WSJ investigation.

[0]
[http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1182327/?report=...](http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1182327/?report=classic)

~~~
w1ntermute
Holmes probably (delusionally) believed she could convince Ioannidis to recant
his comments in the February 2015 JAMA article regarding "the rationale for
promoting massive diagnostic testing," and maybe even the criticism of stealth
research, by demonstrating how ground-breaking their technology was, and that
the IP needed to be "protected."

At its time of publication, that article was (I believe) the only one in the
scientific literature that said anything about Theranos, and the company
seemed to be pretty disconnected from the mainstream biotech research
community. Holmes was probably only vaguely aware of Ioannidis' background.

------
chmaynard
Theranos needs to prove that a blood sample oozing from an open wound (a
finger prick) is in any way comparable to sterile blood extracted directly
from a vein. They also need to show that analyzing a diluted and contaminated
blood sample with the Siemens instrument produces an accurate result.

At this point, I think we should assume that because Theranos won't publish
any studies about the scientific foundations of their work in peer-reviewed
journals or preprint sites, they have nothing of value to show us.

------
Aelinsaar
I maintain that as this story continues to unfold, it will contain a serious
criminal element at its core.

~~~
atomical
Are you an expert?

~~~
Aelinsaar
Did I claim to be?

~~~
tokensimian
While you make no explicit claim, I suppose the responder was reacting to your
opener of "I maintain".

That implies you have been saying this all along, in a forum that we would
expect to have heard it, but yet you have not been heeded.

In my perspective, there is an element to your statement that is claiming
authority, thus making you appear as a self-proclaimed expert.

~~~
dekhn
This is overinterpretation.

Also, I agree that it seems likely Ms. Holmes will face criminal charges. It
would have been one thing if Theranos simply substituted venous blood draws
for nanodraws, pivoting to not use Edison. However, they not only did that,
they denied this publicly, promised to release data showing the validity of
their platform (neither of this are lawsuit-worthy) and then proceeded to
provide false test results at a very high rate. The problem here is that Ms.
Holmes would have to have known of this- she's the CEO of the company, in very
tight contact with the labs, etc, holds nearly all the power, and is the
ultimate decider. Because of that, she is the direct target of lawsuits.

I expect both government action (which is already ongoing; it's likely she
will be sanctioned) and class action lawsuit.

Obviously, the above is speculation, based on my intuition of watching
biotechs for 20+ years.

------
Animats
Stealth research is a byproduct of the weakening of the patent system. It used
to be that, for something like this, you got a patent before talking to VCs.
This allowed more review of whether the technology actually works.

Now we have VC money being invested based on how well someone can pitch. This
doesn't work for things which are technically hard. Hence Theranos, uBeam, and
possibly Cruise.

~~~
petra
Has the patent system really weakend ? or it's simply that today, the options
to build something are so varied, and people have more knowledge of that, so
you cannot patent them all ?

~~~
Animats
At least three things made it much more expensive to enforce a patent:

1\. The America Invents Act (2011), with its new post-grant review provisions.
Now, if you try to enforce a patent, the infringer can tie you up for a few
years with review proceedings, which means the inventor has to spend money to
defend the patent.

2\. The _eBay Inc. v. MercExchange, L.L.C._ decision (2006), which made patent
infringement injunctions much harder to get. This decision basically means
that the worst thing that can happen to an infringer is that someday they have
to pay royalties. It's essentially compulsory licensing of patents. So
infringers have no incentive to negotiate.

3\. The _In re Seagate Tech_ decision (2007) and some related decisions
changed the standard for willful infringement (and triple damages) to include
a requirement of "reckless disregard", which is almost impossible to prove.
These decisions also reduced the power of juries in patent cases.

It's also harder to get discovery in patent cases now, which means that if
infringement can be kept a secret, it's usually possible to get away with it.

------
radnam
"The problem that some patients do not have tests performed when they
genuinely need them is also real but probably of lesser magnitude."
Anecdotally speaking, I have seen many instances when testing was
procrastinated only to reveal a chronic condition (hypothyroidism, pre-
diabetic sugar levels) needing immediate attention sometimes with medications.

I am genetically disposed to hyperlipidemia and like to watch my cholesterol
level as a tangible indicator/reward for my life style changes.

"Better financing and organization of health care and, perhaps, reduction of
the profit margin could markedly decrease testing cost, even if very old (but
appropriately validated) diagnostic technologies are used."

Reduced pricing was a hype created by Theranos. When we started working in
this area, we found that if one is willing to pay out of pocket some labs will
offer pricing very close to Theranos.

------
jerryhuang100
_> Theranos does stand for well thought-out and useful therapy and diagnosis
and does not represent the harms suggested by another similar Greek word,
thanatos (death)._

This is gold. Yesterday Theranos just voided its two years of testing results
by its Edison.

~~~
SilasX
I saw another wordplay in that part: they say Theranos comes from "therapy"
and "[diag]nos[is]". But if you combine the "ther" and the "agnos" as Greek,
you get "beast without knowledge". :-O

------
RA_Fisher
Funny thing about JAMA is that almost all (?) the articles they publish don't
include code nor data. The research they publish is stealth!

