What Yeast, Richard Nixon, a CIA agent, a Teenager, Donald Trump and $9 billion dollars have to do with a Fake Medical Device

Bad BloodBad Blood: Secrets and Lies in a Silicon Valley Startup was at the top of my 2018 summer fun reading list.  It was released in May 2018 and written by John Carreyrou (the two time Pulitzer winning journalist at the Wall Street Journal that questioned the validity of the diagnostic device work done by Theranos).

Unless you have been living under a rock the last few years, you will recall that Theranos launched a remarkable blood analysis system made available through WalGreens and Safeway which only required a small finger prick of blood and offered a menu of over 200 blood tests using that drop of blood.  It was such a revolutionary system that Theranos raised over $700 million dollars, employed 800 engineers and scientists at its height and was valued over $9 billion dollars!  The catch:  it was a fraud.

This book covers the tale in remarkable detail and eloquently demonstrates the importance of properly developing medical devices under ISO 13485.  Or rather, is a case study in why not to develop a medical device outside of ISO 13485 QMS system.  Carreyrou does an incredible job of weaving hundreds of hours of interviews with just the right amount medical device development and VC procedural detail with first person accounts of the high stakes world of investigative journalism into a highly enjoyable page turner that I could not put down.  I highly recommend this book to anyone in the medical device field, and suggest that it becomes required reading for diagnostics developers.  The book is now in our library at StarFish Medical.

During my read through the book I learned a number of interesting things that I’d like to share in the form of a top ten list.  Here it is:

10. The original name for Theranos was “Real-Time Cures”. In many respects this name is much more appropriate for the company as it evokes the incredulous responses the technology and undocumented claims should have received and harkens back to the snake oil sales people of old.  Though, not bad for the founder of the company. Elizabeth Holmes dreamed up the name in her Stanford dorm room before dropping out at 19.

9. Richard Carl Fuisz, the former CIA agent, serial med-device inventor and creator of the NBC show: LifeLine and The CBS Human Body Documentaries I loved from the 1980’s was Elizabeth’s Holmes’ neighbor when she was growing up.   There are a few scathing chapters in the book as to how they interacted and how some very shady patent poaching took place.

8. Elizabeth Holmes is the great-great-great-granddaughter of Charles Louis Fleischmann (the manufacturer of the first commercially produced yeast revolutionizing bread production).  I suppose making things rise with little more substance than air is in her blood.

7. In a roundabout way it was through this family connection that Holmes was introduced to the former secretary of state George Shultz (under president Nixon) who was instrumental in recruiting the “all star” Theranos board of directors which included William Perry (former secretary of defense), Henry Kissinger! (former secretary of state) and General James Mattis (current secretary of defense under the Trump Administration) to name a few.  I’d argue that it was the names and influence of this board that allowed the snowball effect of ignoring the lack of data (financial and scientific) to facilitate the Theranos fiasco to occur.

6. Equally impressive, the members of Theranos’ medical advisory board included board members of the American Association for Clinical Chemistry such as Susan A. Evans and William Foege, former director U.S. Centers for Disease Control and Prevention (CDC). “the who’s who list” on the medical advisory board likely gave the snowball of ignorance a solid push down the hill.  As the list of larger than life names were recruited to the board of Theranos it was easy to see how the facts were ignored because every assumed that certainly someone had checked the data. Otherwise, why would all these big names be associated with Theranos?

5. Watching interviews with Elizabeth Holmes (like the TED MED talk here), I was struck by her distinct voice and engaging speaking style. In the book, Carreyrou describes an interview with a source who shared some instances where they met with Elizabeth Holmes “out of character” in a candid setting speaking with in a normal voice.  I’m not sure what to make of this, or the validity of the account, but I found it remarkable to think of the great lengths and efforts it must have taken her to not only push the façade of the technology but even her speech pattern every day.  Talk about commitment!

4. Elizabeth Holmes dropped out of Stanford at 19 to start Theranos. Think about what you were doing at 19…  Yes, she made some bad choices, but her ability to take her desire to improve the world of diagnostic lab testing and convince the world to follow her through sheer charisma (there never was any data the technology worked) was absolutely remarkable.  In my mind the real crime in this story is that Elizabeth Holmes did not get the proper guidance she deserved to go about doing this the right way.

3. Theranos did actually develop an approved medical device! The Nanotainer™ (this is the blood collection device iconically held up by Elizabeth Holmes in many of the Theranos Publicity shots).   After a false start, the container eventually did get a substantial equivalence decision (K143236).  In July 2015, the Food and Drug Administration approved the use of the company’s finger stick blood testing device for the herpes simplex virus (HSV-1) outside a clinical laboratory setting.  But just the collection container.

2. ISO 13845 is boring! If Theranos had implemented QMS system that complied with ISO 13485 Bad Blood probably would not have been written. The design control processes associated with the ISO standard for the design and manufacture of medical devices would likely have identified some of the most basic issues with the Theranos technologies long before the extensive cover ups and subterfuge occurred.  Interestingly at the time of writing, a recent internet article highlights an April 2018 letter from Elizabeth Holmes to angry shareholders suggesting that Theranos would soon be implementing an ISO13485:2016 based QMS system.

And finally, the number 1 thing I learned by reading Bad Blood… binge reading the book over two nights during a family vacation results in some very bad blood in our house.  Please make sure you give yourself time before you start this book.

Nick Allan is the StarFish Medical Biotech Manager. He applies creative thinking and innovation to biomedical project commercialization  from product definition through sustaining engineering.

 


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