Elizabeth Holmes, Theranos, & lessons for the stem cell field

When I read about Elizabeth Holmes and her blood testing startup Theranos I see parallels to hucksters in the arena of stem cells and cell therapy. I’m thinking especially of the unproven stem cell clinics out there.

It goes farther than that though too, including people who aren’t hucksters at all but get caught up in the hype around stem cells.

They sometimes take it way too far.

Elizabeth Holmes, Theranos
Elizabeth Holmes at 2015 Fortune Global Forum. Photograph by Stuart Isett/Fortune Global Forum. Creative Commons license.

Theranos and its too-good-to-be-true device

The idea behind Theranos was to have a relatively simple desktop device that could measure numerous substances in blood quickly and easily.   These devices could even be in patients’ homes. The small boxes could generate lab results and patients could get the data quickly via their doctors.

It’s an intriguing idea, but making it a reality proved extremely difficult.

So it seems to keep the idea and the company afloat, data was fudged or made up, and all kinds of problems arose. If you want to learn more about this train wreck I recommend the book Bad Blood.

Stem cell parallel: STAP cells

In reading the book I was also brought back to the STAP cell “acid bath” fiasco that began in 2014. If you aren’t familiar with this scandal, long story short, a research team including a Harvard lab and scientists in Japan reported they could make pluripotent stem cells from ordinary cells simply by treating them with acid or other stressors.

Turns out, they couldn’t. Some of the supposed data was the result of misconduct by primary STAP research Haruko Obokata.

This kind of magical thinking with STAP ensnared some famous scientists and led to tragedy.

Theranos post-mortem

Now that Ms. Holmes has been convicted of fraud, people are trying to understand how her too-good-to-be-true claims continued for so long.

The Theranos post-mortem already started years before her convictions this week.

There was hype of course and secrecy at the heart of Theranos’ ballooning to an almost $10-billion valuation with basically nothing to show for it at the biomedical science level for their device.

There’s something fascinating about the idea of a magical box that would so simply test people’s blood for scores of things at once and bring health autonomy in some way to the public.

Just don’t ask too many questions.

Theranos & Holmes parallels to stem cell clinics

I bet Holmes could have gone far in the stem cell clinic world if she had tried. There are some characters out there in the stem cell arena who remind me of her somewhat.

I’m not the only one who senses such parallels.

On the Bolded Science blog Kerry McPherson says that Holmes reminds her of John Kosolcharoen of Liveyon:

Throughout the podcast, I could not help but draw parallels between Kosolcharoen and Elizabeth Holmes. Similar to Holmes, Kosolcharoen was proud, impatient and lacked education in science. The growth of his company was not for the advancement of medicine and the well-being of others, but for the swelling of his own hubris and financial advancement. He refused to wait for proper research of their product before marketing and selling to the public. And, Kosolcharoen inherently did not understand the science of the stem cells he was selling. He is educated mostly by Google and Wikipedia.

Liveyon is a biologics supply company whose products got contaminated including with E. coli and landed many people in the hospital. It’s unclear if Liveyon or Kosolcharoen will face any further consequences here in the U.S.

The expose podcast Bad Batch gave exhaustive detail on Liveyon and its leader, which is similar in name to the Bad Blood book on Holmes and Theranos.

There are remarkable parallels between Theranos and what has been going on in some corners of the stem cell and broader cell therapy world that is my universe.

Stem cell clinics and other firms often mislead the public and their investors.

The idea that one small device could substitute for 100 or more lab tests reminds me of the exaggerated assertion that one cell type, like MSCs from fat or birth-related tissues like umbilical cord, can treat dozens of unrelated health conditions.

Looking ahead

Someday maybe there will be a single device that can do all those lab tests at home or a pharmacy given how fast technology advances, but I don’t see one cell type being able to ever treat a vast array of conditions.

There have been times when I have asked questions of those making too-good-to-be-true claims about cell therapies that I end up just scratching my head.

The answers don’t fall into the scope of the real world. As with Theranos, the key is to ask for real data to analyze yourself.

Law enforcement hasn’t done a good job with the stem cell fraud out there so far. We’ll see if that changes in 2022.

Beyond the stem cell clinics, stem cell researchers need to be cautious too not to get overexuberant or engage in anything like magical thinking.

Stem cells are exciting and there is a vast amount of solid data out there, but especially when you start talking about possible clinical impact you need to be cautious and not go beyond the data. Otherwise it can be a disservice to patients and the broader public, eventually eroding trust.

8 thoughts on “Elizabeth Holmes, Theranos, & lessons for the stem cell field”

  1. While I understand the need for expertise, the idea that biology is somehow incomprehensible to someone without extensive formalized secondary education is a slap in the face to pretty much the entirety of the scientific enterprise. Where do you think all the data comes from? Full professors working at the bench, lol!?!

    The scientific method is taught in grade school and can be refined with practice. I’ve met plenty of high-level thinkers who have their ‘street PhDs’ from the School of Actually Accomplishing Things. There’s more groupthink and irrational hate toward reasonable ideas in the upper echelons of academia than most would like to admit.

    Doubling down on elitism isn’t exactly a winning strategy with the public, and I can imagine future congressional majorities enacting drastic research budget cuts in the future because massive trust has been lost in science (whether deserved/rational or not) over this whole COVID fiasco.

    Point is, I wouldn’t get caught up in labels like ‘Dr.’ when initials an incredible scientist don’t make.

    That being said, adult MSCs have been clinically proven to be pretty much good for nothing, and Theranos– even if it was real– was never worth anywhere near 100M. Their astronomical valuation assumed every home worldwide was running numerous tests daily at 20 bucks a pop from the Edison machine because moar data better!

  2. When you are investing in a biotech startup company please make sure the scientific founder and CEO has completed at least their undergraduate degree and strongly preferably a PhD or MD. While Steve Jobs and Bill Gates were visionaries in computer sales beyond what they could learn more about it college, I am not aware of any recent college dropouts who have revolutionized biomedicine and this case sure suggests it is unlikely. Holmes had worked in a lab doing PCR and probably had basic physics but apparently was unaware of the basic law that an object of matter can’t occupy two places at one time. Had she considered this she would have realized it was physically impossible to do that many tests on a single drop of blood.

  3. I prefer to focus on the positive news of Viacyte news with transplantation of insulin producing cells, Mesoblast four phase III trials including their FDA agreement for data for GvsHD, Lineage Cell Therapeutics deal with Roche for OpRegen RPE cells , Cynata deal with Fuji films…..

  4. I’m the last to be a fan of Holmes. I do believe the idea will be implemented sometime in future though. The pattern of rushing ahead of Science on account of patients is horrible. The idea of not thinkig big is disastrous too. Our regulatory platform is mature enough to balance.

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