Alex Gibney Book & movie reviews Diagnostic tests & procedures Edison Elizabeth Holmes fraud HBO Health Fraud lying Medical devices motivation naturopathy Science and the Media Tech The Inventor Theranos Walgreens

An HBO Documentary about the Theranos Fraud Raises Concerns – Science-Based Medicine

An HBO Documentary about the Theranos Fraud Raises Concerns – Science-Based Medicine


Alex Gibney’s movie The Inventor: Out for Blood in Silicon Valley first aired on HBO on March 18, 2019. It is an expertly accomplished portrayal of Elizabeth Holmes’ incredibly successful rise and catastrophic downfall. Holmes had a dream: she needed to revolutionize the world of drugs by enabling patients to bypass docs, order their own blood checks, and avoid venipunctures. She founded the company Theranos to develop a machine referred to as the Edison that would do 200 blood checks on a single drop of blood from a fingerstick. She thought it will save lives. After she turned the world’s youngest self-made female billionaire, the fraud was exposed: the machine did not work and couldn’t probably work. The company folded and Holmes and the corporate president (her colleague/lover Ramesh “Sunny” Balwani) have been indicted for multiple counts of wire fraud and conspiracy. The trial is in progress; they’re out on a half-million-dollar bail. They pleaded not guilty; if convicted, they may resist 20 years in jail.

There have been a couple of issues improper with the film, however much more was fallacious at Theranos. It’s a cautionary story that has many classes to show us.

Elizabeth’s story

The story virtually beggars belief. Elizabeth Holmes was a Stanford engineering scholar with no background in science or drugs who dropped out of faculty at age 19 to found a blood-testing company. Young, engaging, charismatic, enthusiastic, and articulate, she was easily capable of enlist outstanding individuals as board members and monetary backers, including Henry Kissinger, Betsy DeVos, George Shultz, James Mattis, Carlos Slim, and the Waltons. Rupert Murdoch put up $125 million. She received an unimaginable amount of favorable media exposure, was revered as a genius, gained awards, turned a billionaire, and used bulletproof glass, personal planes, and bodyguards. When the lies have been exposed, her internet value went from $9 billion to zero virtually overnight.

Lies, distortions, and secrecy

Theranos criticized the establishment. “We’re going towards a whole system that doesn’t consider prevention is feasible.” They attacked a competitor, Quest Diagnostics, saying “Their complete product strategy is lies, constructed round getting individuals sick after which dwelling off their illnesses.” They claimed to have government contracts that by no means existed.

The one knowledgeable scientific professional in the company, Ian Gibbons, tried to inform Elizabeth the know-how wasn’t working and defined the science that showed the objective of getting 200 correct blood checks in a single minute from one fingerstick was simply unimaginable. She didn’t pay attention. Confronted with having to testify and both lie or betray his company by telling the truth, Gibbons committed suicide.

A tradition of secrecy developed. Pieces of the gadget would fall off during testing, they usually didn’t need anybody to see. They received inaccurate outcomes. There was a false adverse price of 35% on their check for syphilis; out of 100 sufferers with syphilis, 35 can be falsely advised they didn’t have it. They really did a lot of the exams on business machines with blood samples from venipunctures, not fingersticks. When sufferers asked why they have been getting a standard venipuncture, they equivocated. They played games with regulators and inspectors. That they had a huge celebration when the FDA lastly accredited ONE not often used check for herpes to be run on the Edison gadget. The other 200 checks never earned approval. Solely about 15 exams have been ever truly run on the Edison; for all the remaining, they used business machines.

Many staff turned suspicious. Those that realized the reality and tried to report their observations have been threatened with legal action. They have been advised that they had signed non-disclosure agreements that prohibited them from revealing commerce secrets and even criticizing the company. George Schultz’s grandson Tyler labored for the corporate and showed his grandfather clearly documented evidence of malfeasance, however his grandfather refused to consider the proof. He believed no matter Elizabeth informed him, and he ordered his grandson not to speak to reporters. Tyler was pressured to resign. When the reality lastly got here out, George praised his grandson for his integrity, for being responsible to fact and affected person safety.

Staff have been spied on and prevented from speaking with one another. There have been two worlds in Theranos: the carpeted world of hype about changing the world, and the tiled world that knew nothing labored and it was all a lie. Staff who questioned the dimensions of the Edison system have been accused of missing imaginative and prescient and being stuck in the previous ways; they have been advised they may be happier working elsewhere. They have been requested to have religion that Theranos would ultimately succeed.

Walgreens and Arizona regulation

They partnered with Walgreens to do the checks. They hoped that ultimately everyone would have the ability to get their blood checks from a Walgreens within 5 miles of their house. They lobbied Arizona and acquired the regulation changed making it legal for shoppers to get lab checks with no doctor’s order. They provided vouchers and present cards. They expressed the objective that “no one should be stabbed by an enormous needle to get blood any extra.”

Two flaws within the movie

The movie complements journalist John Carreyrou’s guide Dangerous Blood: Secrets and techniques and Lies in a Silicon Valley Startup. It precisely covers the same info and the on-screen interviews and movie clips give it a higher impression than print sources. It lasts two hours and its manufacturing values are wonderful. Nevertheless it made a few mistakes. Even earlier than the movie debuted, it had already been criticized on the Web. Alaric Dearment pointed out two main flaws: it didn’t point out that life sciences venture capital was conspicuously missing, and it chose an ND to talk for the medical group. Enterprise capital is usually invested in risky small startup tasks that seem to point out great promise. Typically they succeed and provides big returns. But extra typically they fail. Not doing any homework earlier than investing is greater than dangerous. It’s positively foolish, or simply plain silly. Nobody needed to take a position life science venture capital. Others should have observed and asked why. They didn’t. They didn’t consult any knowledgeable specialists. They believed a charismatic engineering scholar drop-out’s lies, invested their enterprise capital, and misplaced their money.

The mistake that irritated me probably the most was the movie’s selection of a spokesperson for the medical group. As an alternative of an MD, they interviewed an ND, Stephanie Seitz. She was introduced as “a physician.” She argued that physicians are needed to interpret the outcomes of lab checks and that Theranos would not reply the type of questions she would ask any lab. ND’s are usually not physicians and usually are not thought-about part of the mainstream medical group. They’re solely licensed in 20 states. Naturopathy faculties train pseudoscientific nonsense like homeopathy, and one ex-naturopath who is now exposing the truth calls naturopathy “primarily witchcraft“.

Doesn’t Gibney know the difference between MD and ND? When a documentary makes a critical mistake like this, it discredits the remainder of their message. If you recognize an ND is “Not a Physician”, how are you going to trust that the rest of the knowledge within the documentary is any more correct?

Another very primary drawback

They badly needed a knowledgeable medical spokesperson. Anybody who understands screening checks is aware of that doing 200 blood checks directly is a terrible concept. It isn’t a option to detect diagnoses early and save lives; it’s a option to fear sufferers unnecessarily with false constructive check results. Because of the best way regular lab values are determined, for those who do 20 exams on a traditional, wholesome individual, you’ll get, on average, one abnormal end result that may be a false constructive. So a Theranos fingerstick, even when it have been correct, would average ten false positives. Even true positives is probably not value pursuing; early remedy might do extra hurt than good on account of numerous phenomena we have now discussed on this weblog like lead time bias, sluggish rising lesions that may never develop into symptomatic, and innocent incidentalomas. And false positives can result in a wild goose chase with invasive testing and even demise. So Elizabeth’s entire quest to revolutionize drugs was misguided.

Even her want to keep away from venipuncture is misguided, based mostly on her personal worry of needles. I’ve had blood attracts that have been virtually pain-free and finger-sticks that have been rather more painful, and we all know some exams on fingerstick samples give much less dependable outcomes. If given a selection, I might decide venipuncture each time.

Did she intentionally commit fraud?

Elizabeth believed in herself and was capable of convince a whole lot of very intelligent individuals to consider in her. She was protected for years by her political connections. She nonetheless believes you possibly can fail 10,000 occasions and succeed the 10,001sttime. She stays unrepentant. She does not seem to comprehend that wrong exams can hurt patients. One has to marvel what was happening in her head. Did she consciously know she was mendacity? Was she unconsciously reconstructing reality for self-protection? Did she consider so strongly that she was capable of deceive herself and persuade herself that what she needed to be true really was true? We will by no means know for positive what is occurring in another individual’s mind, and typically they themselves don’t really know. This question has come up repeatedly in our discussions about various drugs. Does that chiropractor really consider he’s repositioning bones which might be out of alignment? Does that homeopath really consider that his extremely dilute cures are distinguishable from water? Does that iridologist really consider he can diagnose you by taking a look at your eyes? Does that quack actually consider he can remedy cancer? I think typically it’s a mix of wishful considering and self-deception somewhat than any acutely aware intention to defraud patients.

Conclusion: Theranos was a fraud, but we will study lessons from it

Don’t spend money on an area you recognize nothing about with out getting input from specialists who do know.

If the specialists are skeptical, they could possibly be improper; however it is best to no less than attempt to understand their reasons for skepticism.

Don’t put your trust in charismatic people; insist on trustworthy knowledge.

If one thing sounds too good to be true, it in all probability is.

When somebody makes a claim, don’t settle for it with out fact-checking.

Straightforward come, straightforward go.

You, too, may be fooled.

For those who’re going to cheat, don’t get caught. (:-)