Thursday, June 4, 2015

June 3, 2015: Elizabeth Holmes, Charlie Rose

http://www.charlierose.com/watch/60570963

 These are my personal "notes to self" as I listened to the television program.

20150603
Elizabeth Holmes at Charlie Rose

Elizabeth Holmes, Found and CEO, Theranos, blood analytics, innovation.
Tests detect dozens of medical conditions on a few drops of blood.
Transform healthcare through prevention and early detection.
Started when she was 19, it is now worth $9B.  One of TIME's most influential people of 2015.

PEPPERDINE:
Define what is non negotiable to you, what you will fight for.  That is our mission.
Realizing a change in a stagnant industry that resulted in so much loss and pain.
One day - people won't say good buy to soon to dying loved ones.
Theranos is a vehicle to do well by doing good, what I am doing with "My time in the world."

Charlie Rose:
We've wanted you here for a while.  Tell me about the speech.

EH:
Our mission is to make actionable information, accessible to every person, when it matters.
Realizing a world where early detection and prevention are realities of healthcare.
If we can make it possible to see the onset of disease, in time for therapy, we change outcomes.
Often today we find out someone is really sick when it's too late.
Earlier intervention - we can facilitate that, and change the cost structure.

CR:
Personalized medicine - you don't have to go to a lab?

EH:
Yes, we are still a lab, but it's decentralized, distributed access, a local retail pharmacy.
Late at night.  On a weekend.

CR:
The process is easier, finger prick.

EH:
I'm scared of blood draws myself.
Smaller samples, period, for urine, blood, we can do finger drops.  Or from the arm, but less blood.

CR:
Less expensive? Quicker? If widespread, you could have a huge impact?

EH:
That's our goal and dream.
We're just getting started.  12 years building the tech infrastructure.
We're now applying it.  Transforming cost and accessibility.
With recent work in changing the AZ law, to make people have the human right to order lab tests.
We'll see the shift in information.  

CR:
Not through a physician.

EH:
That's right, with protections for physician engagement.
The purpose of direct access, IS to engage a physician.
But there has been such liabilities to prevent physicians from engaging with consumers.
We added blanket protections for physicians.

CR: 
Part is process, it's also science.  You get the same results, if in fact they want to a doctor.

EH:
We do.  The same.

CR: 
What are the results?

EH:
Lab results, like a lab report from a traditional doctor visit.
Chemistry, glucose, blood count.  
We want the report, so individuals can better engage with it.
We are the first to say, every lab test should be submitted to the FDA.
Lab tests haven't historically been regulated by FDA.

CR:
Can you share the process, so it can be applicable beyond Theranos?

EH:
We want to share the work.
We're early.

CR:
Ten years, beyond blood testing?  

EH:
Maybe...it's far away.  We're doing broader lab testing already.
How we can build distributed care, infrastructure.

CR:
Scaling, the next 18 months?

EH:
Scaling the right way, incredibly high quality.

CR;
Primary growth in Arizona? the US?

EH:
We'll expand into more states from there.  We have a wellness center in Palo Alto.
We're looking at other metropolitan areas.

CR:
With the idea, the mission, I see something I find unacceptable, how do you from that (mindset) to Theranos?

EH:
You're here to make a difference in the world, I feel I was born to do this.
I believe this problem, there's nothing more than matters to save lives.
I was doing this, not going to classes, at Stanford, where I strated in Chem and Electrical Engineering.  
I filed a patent, and was doing this 24/7.

CR:
One aspect, you have a board of directors...enormously respected.  Henry Kissinger...
Where did that idea come from?  Superb judgement...And how do you get them?

EH:
It both evolved. Over 10 years.  We didn't have a website or press release.
Then we realized we could begin serving individuals directly.  I wanted the strategically brilliant guidance.

We billed Medicare and Medicaid, for the first time ever, at less than they are willing to pay.
Rates will drop.
We'll have savings without raising taxes or cutting programs.

CH:
So you called these board members?

EH:
I met them over time.  George Schultz wrote a book on healthcare.
[Shoeven & Schultz, 2008, Putting our House in Order; Social Security & Health Care Reform]
He saw it as something that could be very meaningful.  Person by person - I met these people after that.
They are all helping us because it is a mission that will have such enormous implications.

CH:
How will this change physician/patient relationships?

EH:
Raise engagement earlier, not when all the symptoms appear.
People only get lab tests from insurance when the present with a symptom.
Otherwise "payment was not justified." And 40-60% of Americans don't fulfill the test order.
People are so far progressed in their disease (when detected) so we recreate the system,
we the lab facilitate the engagement before you are sick.

CH:
What's the scientific change? You discovered, created - what?

EH:
There's many elements.  Test by test, redeveloping the chemistry of the traditional lab.
Working on small samples.
Redevelop the hardware.  The software.  Automating.  Collection technology.
It's an engineering question...
We've invested in all the areas.  And bring them together.

CH:
I'm interested, ideas are born by asking questions, is there a better way.
Going out and figuring out, can it be yes?

Has anyone challenged the science? Why don't you show us, we'd be comfortable.

EH:
The major lab companies [say that.]  They...we had been...we didn't talk...
We wanted to do it, then talk.
So we did.
Now we talk about it.  We want people to understand.  The information is transformative.
The response of major labs, "Too much secrecy...why don't they show us?"
We're small, we don't need to tell competitive companies.

CR:
Competitive businesses are concerned about ideas in products...
But you want people to understand it's revolutionary...

EH:
We have a long term plan.  Someone says, "We want to know" we don't have to respond.

CR:
You went to FDA?  Can people do something else?

EH:
We think the first place is the FDA. FDA may review a platform for years.
You have to enroll prospective studies.  FDA will be sure the data is right, no
one will look as thoroughly as FDA.  Without question, the best way for a binary test,
right or wrong, the FDA is the gold standard.  Decision summaries will come out
through the FDA process.

CR:
Rather than some other appraisal.  This approach is in your interest...to be able to document the results.

EH:
We have no issues with the independent appraisal process, as we work with hospital systems, they will do that also.

No laboratory has ever done publications around the integrity of their lab developed tests.  That's what we were asked to do.

CR:
Some might suggest, for the best of reasons, created a company that produces something to change healthcare,
but your reason, like Steve Jobs, he was very protective about his closed system of products.
This is a business decision.

EH:
Without question, we are the first lab to publish our data on our website, our scores, audits, customer satisfaction, turnaround time.
We can talk about accuracy that way.  The timing for disclosing more pieces, not reactive, part of a business plan.

CR:
Starting when?

EH:
With the FDA.  (How long?"  I can't predict.  

CR:
What will FDA tell you?

EH:
We have a really good relationship.

CR:
Don't they focus on no falsehood in communication?

EH:
Integrity of the test, how it performs, precision, and it should be used this way.
For individuals, FDA does the clinical piece, the use, that's central to interpretation.

CR:
Do you worry about...if you do good, why worry...but people are developing systems that will
even eliminate a needle?  Maybe you are too?

EH:
This is the amazing thing about USA, Silicon Valley, we love the speed of innovation.
You have to be on version 10 when everybody else is on version 1.

CR:
If we can eliminate the small blood test, we will!

EH:
Only the paranoid survive, said Andy Grove.

CR:
His book.
Does making a difference, within you, you feel, I have to do this, important things.

EH:
I grew up in a house with pictures of my Dad in tough places in the world, as a disaster relief worker.
I thought I would do that.
If today were my last day on earth, I could say, the people who have never been able to afford the ability to get care for their family, now can.
People who have gone through hell, can get the test done.
Then I've done something to make the world a better place.

CR:
Is how much you are worth, is it a measure of the importance of the company?

EH:
Personal worth ($) is not what matters.  It is to do more, better, less expensive, it's about that.

CR:
Your life is at work, go the stories.  Unless you are there, you may miss something.
Whatever you miss outside work, what satisfies you is being "there" at Theranos.

EH:
It is.  I've thought alot, it's what I love.  I love it more, I have a very simple life, this work and my family.
It becomes addictive!

CR:
Thank you.






Monday, April 20, 2015

April 17, 2015 - Holmes CBS Morning News Interview

Rough running notes of CBS interview.

She's been compared to Steve Jobs.  She's part of the new Time 100 list.  Her mission - blood testing revolution.


CBS - Do you own a TV? "No."
CBS - Why not?  "I work all the time, from the time I wake up, til I go to sleep every day."

At 19, she dropped out of Stanford.  With a little tuition money and a lot of ideas.   Now at 31 she has what many strive for - to be the youngest billionaire in the world.  
CBS - Is that heady?
EH - It's not what matters, what matters is how well we do in changing the world, that's why I work, why I love what I'm doing.

What Holmes is doing is running Theranos, the biotech she founded in 2003.
She's either in a black turtleneck or a white lab coat.
She markets Theranos as a faster, cheaper alternative to a process that hasn't changed in decades.

EH: We created these tiny tubes, Nanotainers, and replace the big traditional tubes.

Theranos has a partnership with Walgreens to build thousands of wellness centers.   Each offers a menu of blood tests, cancer to cholesterol, direct to consumers, and half of Medicare prices.
Some say, That's not enough blood.
EH: Every time you create something new, there should be questions.  That means you've done something transformative.

When can I get this in Washington or New York?
EH: That's underway.
Little is known about how Theranos tests work, so there's concern about putting this in patients and doctors hands.
It's a really important area.  Traditionally, you need a doctor's order for a code on a lab form.  But drop the price low, and preventive testing becomes possible.

CBS - You're on magazines, transforming healthcare.  Where is the revolution?
EH - "It's making it personal, making it possible, cancer, child, elderly, getting around a traditional blood draw is a big deal."
Holmes is a real, rare example of what perseverance makes possible.
EH - "When I was little, I wrote a letter to my Dad, I was exciting about moving to Texas which I thought was big on science.  I was 9.  I grew up in a family of people who wanted to make a difference."

She hasn't wasted time, the youngest member ever of the Horatio Alger association - and the only woman among the older white men.
EH - What's wonderful is that young girls can see this and connect.  Living proof that dreams are possible.
Where's there's a glass ceiling, there's an iron woman right behind it.

She has the most impressive board of any startup, Kissinger, Schultz.  Kissinger says she has an iron will.

CBS staff:  Why did she do this?   She has an aversion to needles.  Someone in her family had cancer. 

Tuesday, March 10, 2015

March 9, 2015: Fox interviews Theranos and Cleveland Clinic.

http://video.foxbusiness.com/v/4100844587001/theranos-cleveland-clinic-ceos-on-innovation-partnership-/?#sp=show-clips

Note: These are my running notes and not a transcript.

Elizabeth Holmes, CEO Theranos, Toby Cosgrove MD, CEO Cleveland Clinic.

TC:  Theranos has developed some new technology with the opportunity to reduce the cost and trauma of lab tests.  A real game changer for patients, and improve access.

FOX:  The one thing people hate, "giving blood."

EH:  We've focused on bringing access to actionable health information to everyone, driven by lab data, and people have such a fear of having blood drawn.  We've spent 12 years redeveloping every lab test for tiny samples.  And access to tests that uniform transparent prices, regardless of insurance, and very low pricing, 50% of Medicare.  We've dropped further for some tests, to 90% off Medicare.  Everyone can afford getting tested. Moves us to the dream of early detection.

FOX:  We are getting in front of disease.  I was at your innovation summit, Craig Venter said, we'll live into the second century (> age 100).

TC:  That's correct, and people won't be afraid of a finger prick, and it will be cheaper.  For hospital patients, we can make them anemic. We avoid that.

FOX:  Elizabeth, you already have Wellness Centers, in California, in Arizona.  How come, the hospital, they take an enormous amount of blood?

EH:  It's effectively an infrastructure unchanged for a long time.  We have redeveloped the infrastructure.  We can do the combinations of tests from tiny samples.  We redeveloped the whole infrastructure.   It's a privilege to partner with Cleveland Clinic.  Not just outpatient, but inpatient. the exact same technology as outpatient world.

FOX:  We talked about the outpatient world, Walgreens.  You use it differently?

TC:  Think about a new born baby, if you can do a two drop heel prick, a huge advantage.  Tremendous potential.  Inpatient and outpatient.

FOX:  It's a marriage of health care and technology.  The worlds are merging.

TC:  We see tremendous opportunity with new technology - Theranos is one.  We also see opportunities with IT, looking at collecting the knowledge, the Big Data.  We see virtual visits.  Take the care to the patient.   We've done that with stroke, a CT scanner in an ambulance.  It's coming together as rapidly as we can.  We've been less technologically facile in the past.

EH:  I deeply believe, the answer to health challenges lies in the individual, engaging them, in the management of health, the more we can impact outcomes.  Access, engagement, dovetails with technology, you can connect with people and in our work getting them more and more focused on the power of this information, that they've never paid much attention to.  They know more about their credit cards than their lab data.  But you can do alot from a lifestyle perspective, you see the powerful change in your blood.  We provide technology, they allow engagement, connect to the healthcare process.  We are developing the retail Wellness Centers, a wonderful experience for patients.

TC:  You asked about tech and virtual reality.  We are partnering with Microsoft, VR goggles, for teaching, someday for patients.

FOX: It's exciting.  It's consumerism.  Taking responsibility.  Final question: What about the privacy end?  All that info in that drop of blood?

EH:  That's critical. It doesn't tell the world - individuals own their own data, we will never sell data or advertise on it.  We can delete it on request, or transfer it on request.  

TC:  The privacy of health information is better off electronic than a paper chart just floating around a hospital with access by many people.

FOX: Phenomenal.  Thanks.





Thursday, March 5, 2015

Arizona HB2645 Direct Access testing.

Note:  Some FDA IVD test approvals require the test to be ordered by a physician, which would ?likely supersede state law.  For a news article, see here.

Accessed 03/05/2015.

http://www.azleg.gov/legtext/52leg/1r/bills/hb2645p.htm

HB 2645

Introduced by
Representative Carter


AN ACT

AMENDING SECTION 36‑466, ARIZONA REVISED STATUTES; AMENDING TITLE 36, CHAPTER 4.1, ARTICLE 2, ARIZONA REVISED STATUTES, BY ADDING SECTION 36‑468; RELATING TO CLINICAL LABORATORIES.

(TEXT OF BILL BEGINS ON NEXT PAGE)



Be it enacted by the Legislature of the State of Arizona:
Section 1.  Section 36-466, Arizona Revised Statutes, is amended to read:
36-466.  Advisory committee on clinical laboratories; membership; duties
A.  The advisory committee on clinical laboratories is established consisting of the following members:
1.  Four physicians who are licensed pursuant to title 32, chapter 13 or 17 and who are actively engaged in the practice of medicine.  The director shall appoint these members.
2.  Two physicians who are licensed pursuant to title 32, chapter 13 or 17 and who are employed by a clinical laboratory as pathologists.  The director shall appoint these members.
3.  The director or the director's designee.
B.  The committee shall:
1.  Annually select a chairperson and vice‑chairperson from among its members.
2.  Advise the department in developing a list of direct access tests. The department shall make the list of direct access tests available to the public.
3.  2.  Advise the department on the use and renewal of standing orders.
4.  3.  Conduct regular meetings at the call of the chairperson or a majority of the committee members.
C.  The department's designation of a test as a direct access test does not require that the test be covered by a health insurance plan or product pursuant to title 20 or by any program administered by the Arizona health care cost containment system administration pursuant to chapter 29 of this title.
D.  C.  The department shall adopt rules based on the recommendations of the advisory committee.
E.  D.  Committee members are not eligible to receive compensation or reimbursement of expenses.
F.  E.  The department shall provide necessary staff services to the committee.
G.  F.  The appointed committee members serve three‑year terms.
H.  For the purposes of this section, "direct access tests" means tests that may be obtained without a physician referral including tests that have been granted waived status under the federal clinical laboratory improvement amendments of 1988 (P.L. 100‑518).  Direct access tests do not include tests that are required to be reported to this state for public health and safety reasons.
Sec. 2.  Title 36, chapter 4.1, article 2, Arizona Revised Statutes, is amended by adding section 36-468, to read:

36-468.  Laboratory testing without physician order; results; report; immunity; definition

A.  A PERSON MAY OBTAIN ANY LABORATORY TEST WITHOUT A PHYSICIAN'S REQUEST OR WRITTEN AUTHORIZATION.

B.  IF A LABORATORY TEST OF A PERSON IS CONDUCTED BY OR UNDER THE SUPERVISION OF A PERSON OTHER THAN A PHYSICIAN AND NOT AT THE REQUEST OR WITH THE WRITTEN AUTHORIZATION OF A PHYSICIAN, ANY REPORT OF THE TEST RESULTS SHALL BE PROVIDED BY THE PERSON CONDUCTING THE TEST TO THE PERSON WHO WAS THE SUBJECT OF THE TEST.  THE REPORT SHALL STATE IN BOLD TYPE THAT IT IS THE RESPONSIBILITY OF THE PERSON WHO WAS TESTED TO ARRANGE WITH THE PERSON'S PHYSICIAN FOR CONSULTATION AND INTERPRETATION OF THE TEST RESULTS.

C.  A PHYSICIAN IS NOT LIABLE FOR THE FAILURE TO REVIEW OR ACT ON THE LABORATORY TEST RESULTS OF ANY PATIENT IF THE PHYSICIAN NEITHER REQUESTED NOR AUTHORIZED THE LABORATORY TEST.

D.   THIS SECTION DOES NOT REQUIRE THAT A LABORATORY TEST BE COVERED BY A HEALTH INSURANCE PLAN OR PRODUCT PURSUANT TO TITLE 20 OR BY ANY PROGRAM ADMINISTERED BY THE ARIZONA HEALTH CARE COST CONTAINMENT SYSTEM ADMINISTRATION PURSUANT TO CHAPTER 29 OF THIS TITLE.

E.  FOR THE PURPOSES OF THIS SECTION, "PHYSICIAN" MEANS A PERSON WHO IS LICENSED PURSUANT TO TITLE 32, CHAPTER 13 OR 17.


Sec. 3.  Rulemaking; exemption
The department of health services shall amend or adopt rules to address the changes in direct access laboratory testing as enacted by this act.  For this purpose, the department is exempt from the rulemaking requirements of title 41, chapter 6, Arizona Revised Statutes, for one year after the effective date of this act.