"I told you so!"

[Denis Franklin, MD]

A few years ago when others at the ID EX were extolling the virtues of Theranos medical lab test system - one not requiring a doctor's order for the tests and requiring only a tiny amount of blood, I said that from the vague description of the technology, it seemed impossible to me, and that it would prove to be bogus.

In january its CEO was convicted on four counts of fraud.

Today Elizabeth Holmes, the young Stanford grad who headed the company, was sentenced to 135 months in jail for those frauds.

I've also been unconvinced by cryptocurrency. Seemed to me it was ripe for fraud. Now we have had Wormhole and FTX. Which makes me even less willing to involve myself with it.

Denis

[Pat Gulliford]

Denis,
There was one good thing that came out of Theranos. Now I can order routine labs without a doctor’s order. Yes i have to pay out of pocket-but it’s worth it to me.

Can’t see any good from crypto glad I stayed far far away from it

Pat Gulliford

Sent from my iPhone

> On Nov 18, 2022, at 5:13 PM, Denis Franklin, MD <denisf...@uchicago.edu> wrote:
>
> A few years ago when others at the ID EX were extolling the virtues of Theranos medical lab test system - one not requiring a doctor's order for the tests and requiring only a tiny amount of blood, I said that from the vague description of the technology, it seemed impossible to me, and that it would prove to be bogus.

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[Denis Franklin, MD]

"Now I can order routine labs without a doctor’s order. Yes i have to pay out of pocket-but it’s worth it to me."

Based upon medical practice as i was during my 40 years I would have thought that a bad idea, Pat. But the way things are now it may be that at least having access to the tests may make up for the lousy doctoring that has become the norm.

Denis

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[warren egmond]

I'm happy to recognize this case where Denis' medical expertise paid off.  

Thanks to his warnings, I kept my eye on the case and so was not surprised by

the eventual result.

I do think Elizabeth Holmes got treated a bit too harshly though.  I always countenanced

her explanation that, in order to get a new technique based on a new technology working

you have to supply enough hype to get the investors to cough up more than they might

rationally do, and so give a large enough buffer to get the technology going.

The investors losing their money is their proper punishment.  If Holmes genuinely

believed she could get it to work and sincerely tried as hard as she sould with the

resources she had available, her public failure should be punishment enough.  

She should not be further punished with jail time simply because she misjudged 

and oversold the technology.  That's merely the investors piling on an unwarranted 

personal vengeance to assuage their own culpability.

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[Denis Franklin, MD]

I was never sure about Ms Holmes, whether she was duped by the assurances of the people who "invented" the bogus technology and was used by them as a glamorous figurehead, or whether it was she who concealed the absolute lack of science behind the scheme and repeatedly concealed the lack of data from the regulators who kept asking for the evidence of efficacy.

I don't know whether she was gullible or culpable, but the court seemed to conclude it was the latter.

Denis

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[Korky Day]

Lying should be all right if it brings in investment, Warren?

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[warren egmond]

Frankly, that's the way business works.

But then, technically, it can't be calle "lying" if you really believe

in what you're saying.

[Korky Day]

Even if she believed it to be true, I believe she should have known, so it sounds like people should be convicted when 'business works' so fraudulently.

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[Jim Delton]

Korky, you "believe she should have known" what?

Jim Delton ¨¨°°¨°°¨Ô¨°°¨°°¨¨ 

To view this discussion on the web visit https://groups.google.com/d/msgid/phxidex/1335372797.2630901.1669403646025%40mail.yahoo.com.

[Korky Day]

That her blood tests would not perform as she said.

> To view this discussion on the web visit "I told you so!".

"I told you so!"

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"I told you so!"

[Jim Delton]

The whole point of the enterprise was because those machines weren't on the market when she started and she was going to make such machines a reality.  I don't see it as her thinking it was true but as thinking/believing it was possible and pursuing it.  As I read the charges and convictions, she wasn't convicted of not delivering the blood test equipment/methods, that is, that wasn't the fraud she was convicted of.  The conviction was over misstatements of how far along they were which lead people to invest who otherwise probably would not have.

Don't you think that at some point in the future what she envisioned, nearly non-invasive, small sample quantity blood samples, will be the norm for routine blood tests?  Simple, fast, cheap and available directly to the consumer.

Jim Delton ¨¨°°¨°°¨Ô¨°°¨°°¨¨ 

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[Denis Franklin, MD]

The difference between medical practice and business practice is that medicine deals in what is actually possible and already proven safe and efficacious.  Business deals in promises often never delivered.

Medical devices and laboaratory procedures are subjected to the same process of proven safety and efficacy as medications, and by the same agency, the FDA.

What made me very suspicious from the beginning was that Holmes was presenting her laboratory procedures in a business format, and was later persistent in postponing and delaying the presentation of the usual kind of proofs.     Medical procedures and tests are traditionally developed openly and with full scientific disclosure.  Rarely are secrets held, although for decades there have been instances when research has been done quietly and processes patented for gain.

In this case Theranos was trumpeting its success while withholding all the relevant chemical and technical information. 

This is more the pattern seen in quackery, where the ingredients or components of Doctor Stupendo's  Magic Elixer (or device), curing everything from warts to cancer, were secret, and intended to defraud the public.

Thus, to the medical professional, Theranos looked more like quackery than medicine from the beginning.  And increasingly so as things went along.

I think that Holmes was a business graduate who knew exactly where things stood scientifically from the beginning, and was employing a business ethic where the laws and ethics of medical practice should have been applied.

Prosecutors would probably apply whatever laws they found to be provable, and, thinking with my "big" head,  I would yield to their judgment and the court's about the sentence.   Thinking with my "little" head, I would probably excuse the beautiful young blonde and set her free.  ;-)

Denis

[Pat Gulliford]

Don't you think that at some point in the future what she envisioned, nearly non-invasive, small sample quantity blood samples, will be the norm for routine blood tests?  Simple, fast, cheap and available directly to the consumer.

I wonder Holmes’ conviction has discouraged any further  innovation for blood testing.  If so, that’s too bad.

Pat Gulliford

[Denis Franklin, MD]

Don't you think that at some point in the future what she envisioned, nearly non-invasive, small sample quantity blood samples, will be the norm for routine blood tests?  Simple, fast, cheap and available directly to the consumer.    ---Jim

I wonder Holmes’ conviction has discouraged any further  innovation for blood testing.  If so, that’s too bad.---Pat

From my perspective, any technological advances that occur in the future will be the result of a well-established set of scientific and administrative rules, well known by scientists and practitioners of medicine and not because some medically unqualified person develops a marketing plan as a first step, based solely upon wishful-thinking and a desire to be rich and famous, or merely to "do good".

Medically untrained patients who want to order and interpret their own tests are victims of their own Dunning-Kruger effect.  They completely underestimate the complexity of the medical diagnostic process.  Statistically, this group will probably suffer the Darwinian consequences of being "the unfittest" to practice medicine.

The legislators and regulators who have allowed health care to be "delivered" by largely unsupervised nurse practitioners (NP's) are conducting a large-scale experiment that depends upon similar lack of understanding of how medical practice works.  Nurse practitioners, with a couple of years of training, can deal with simple, common problems using "cook book" protocols.  They can treat the simple, most obvious cause of the symptoms, but are clueless regarding the six or seven other serious things that might be presenting the same picture and must be ruled out before merely treating the easy stuff.  I mentored an NP from the first class graduated from UC Davis, and supervised NPs in our clinic for about a dozen years.  I fired one who repeatedly would not follow my instruction not to suture up hand lacerations until I had checked the wounds for nerve or tendon injury, which would have required referral to a hand surgeon for repair in an operating room.

An elderly friend of mine had fallen four times in the month following Thanksgiving a year ago. His "doctor", actually an NP, examined his bruises and got x-rays and brain imaging.  The latter showed brain atrophy, which might have explained the falling.  Then she ordered an orthopedic consult, and ignoring the brain imaging report, not a neurological one.  I tried for several days to get past the phone operators at the Bay Area clinic (60,000 patients) to talk to a physician supervisor. In the end I demanded to talk to the Medical Director of the practice.  Normally, in my day, getting connected to another doctor would have taken less than five minutes, but in this case, after a week or two of deflections, I was given the NP's "supervisor", "Doctor so-and-so".  (This would have been the first person I would have talked to who was NOT a phone operator).   Who turned out to be not a doctor, but another NP.  I explained the situation to her and asked to talk to a physician supervisor, but was again deflected.  The Medical Director was "not available" and they "did not know his number".  

Eventually my friend, who did not want me to pursue it further, fell in the tub and broke his pelvis.  Bedridden, he now needs care 24-7 and has continued to decline.

It's sad to see the film "Idiocracy" come to life before our eyes.

Denis

[Lynda Zeise]

"The difference between medical practice and business practice is that medicine deals in what is actually possible and already proven safe and efficacious"......

Except if it's an mRNA shot.

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[Korky Day]

Fools like to gamble.

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[Korky Day]

As you say, Jim, the crucial point is when.  She misled on speed, not on possibility some day.

[Korky Day]

It won't deter true research and development, I don't think.