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Pathologists predicted the Theranos debacle, but their voices were missing from most news coverage

The following guest post is written by Benjamin Mazer, MD, a resident physician in the departments of pathology and laboratory medicine at Yale-New Haven Hospital. His views are his own, and don’t represent those of his employer.

Benjamin Mazer MD

Theranos, the fraudulent laboratory company whose rise and fall is recounted in a recent exposé entitled “Bad Blood,” was a darling of investors and news outlets for a more than a decade. The company suffered a rapid change of fate in late 2015 after Wall Street Journal reporter John Carreyrou revealed the shaky underpinnings of its technology, which launched the company into a gauntlet of financial and legal jeopardy.

For many of us in the pathology community, the writing was on the wall long before Carreyrou’s article was published. Had journalists consulted pathologists as expert sources, the news coverage of Theranos might have been less fawning and more skeptical. Patients might have been spared erroneous tests.

Pathologists are physicians who are experts in laboratory medicine. When patients undergo laboratory testing – on bodily fluids, cells, or biopsied tissues – those tests typically are overseen by pathologists. We ensure that tests are run using accurate and reliable methods and we provide actionable interpretations for complex tests, such as cancer diagnoses or genetic testing.

Unchecked enthusiasm

Elizabeth Holmes, founder of Theranos, promised to disrupt the system, suggesting that traditional pathology methods were stale, outdated, and even inhumane. Health and technology reporters regularly quoted her making such claims. Yet as “Bad Blood” revealed, Holmes hired a dermatologist as her laboratory director after a pathologist questioned the company’s commitment to safety and accuracy, ultimately quitting as director. This makes me wonder how little she trusted pathologists – or perhaps how much she wanted to obscure her company’s deficiencies.

It was a pathologist, however, who provided a tip to Carreyrou, which in turn led to the reporting that brought down the company. Before that, journalists didn’t seek us out. Consider this glowing 2014 article in WIRED magazine. No pathologists were interviewed to provide perspective on Holmes’ astonishing claims. The same year, Fortune magazine published an equally enthusiastic article, in which a hospital CEO and an orthopedic surgeon provided admiring quotes. (I wonder if the same journalists would have called up a cardiologist for an expert opinion about an innovative new cancer treatment.) In a 2015 Inc. magazine profile, a couple of paragraphs are dedicated to questioning the validity of the tests, but they’re lost in a sea of flattery. Criticism is chalked up to unnamed “competitors and some in the medical community.”

Pathologists’ unrest

For years, I’ve discussed Theranos amongst my pathologist colleagues, most of whom were skeptical from the beginning. The promises were, quite simply, too good to be true. If the thousands of laboratory tests being done on standard venous blood samples could be so easily replicated with finger-stick blood, it surely would have been done. Both the source of the tested blood, as well as the volume, are critical elements to laboratory testing. Many tests do now have both standard and finger-stick options, such as blood sugar testing in diabetes. Finger-stick tests require careful validation – by correlating results to standard tests – and often still do not achieve perfect accuracy.

Could pathologists have warned the public sooner? No one can replay history, but consider this detailed examination of Theranos published by a pathologist before Carreyrou published his stories. Robert Boorstein, MD, deftly breaks down Theranos’ business model, which claimed their technology would allow blood collection and testing to occur in retail drugstores. While news reporters parroted such claims, Boorstein found that blood samples were not being tested in-store because the company had not hurdled necessary FDA regulations. He wrote:

As it operates today, it appears that Theranos has moved to a typical hub-and-spoke model with minimal advantages and several disadvantages compared with competing labs.

Given these observations, Theranos does have one factor that works in its favor: This is the general belief by many smart people that Theranos “can’t be making it up.” Obviously, I have no better idea about this as any other outsider. Having said that, it is always useful to remind oneself that “if it sounds too good to be true,” it probably is!

Pathologists would have provided knowledgeable perspective for some of Holmes’ more extravagant visions, such as her promise that a Theranos test that would be able to “see the onset of pancreatic cancer 17 years before a tumor forms.” Diagnosing cancer, however, doesn’t happen by algorithm – it requires a pathologist’s examination and judgment.

Room for improvement

Let me be clear – there are surely many laboratory tests that could be automated or improved. In my view, Theranos could have developed accurate fingerstick testing for some tests (as other companies have in the past). However, the company promised not only easier blood draws, but faster, more accurate, and cheaper testing – and not just for a single test, but for an entire menu of options. All this from an ambitious but inexperienced engineering student.

Notable Silicon Valley successes have perhaps primed us to be open to such an incredible possibility, but it seems to me that journalists and investors threw common sense out the window. Anyone should know that simultaneously better, faster, and cheaper technologies are hard to create. Admittedly, laboratory testing is a topic that spans biology, engineering, medicine, and the law. Too often, even diligent journalists may reach for the most accessible quote, instead of the most reliable one, when they’re faced with a deadline.

It’s easy to blame news outlets, as I have done. There will be no shortage of journalism autopsies detailing the inadequacies that led us to overly rosy takes on Theranos. Physicians also have a responsibility when they act as expert sources for journalists. A recent set of media ethics guidelines from the American Medical Association implores doctors to only provide only information that is “commensurate with their medical expertise.” Laboratory testing is a conundrum, as all physicians utilize laboratory tests – it’s easy to think that because you know how to interpret a test, you also understand how it’s performed. Viewing laboratory testing as a mysterious black box plagues other doctors as much as it does journalists.

A case for pathologists

Theranos will soon be yesterday’s news, but the promise of easier testing still holds immense appeal. Stories about liquid biopsies – blood-based tests for cancer – continue to appear in the news and continue to be misreported. If journalists writing these stories consulted pathologists, they could help readers understand why such tests are a long way off. Liquid biopsies are essentially genetic tests and most cancer diagnoses today are still made by examining cells under a microscope. Because only a minority of cancers are now treated based on genetic mutations, blood-based diagnostic tests will not replace traditional biopsies anytime soon.

Even as I argue that journalists should speak to pathologists as experts in laboratory testing, I must point out that like any physician, pathologists can have conflicts of interests, which might bias their view.

Still, I encourage journalists to reach out to pathologists for topics such as:

  • Cancer diagnosis and screening
  • Laboratory safety, quality, and accuracy
  • Laboratory regulation
  • Genetic testing and hereditary diseases
  • Precision medicine
  • Infectious diseases

How to find a pathologist? Reach out to pathology faculty at academic medical centers or call the College of American Pathologists to help coordinate an interview with an appropriate expert. (Disclosure: I volunteer for this organization, but it had no involvement in this article). We want to lend our expertise and engage in a dialogue to help journalists and consumers better understand how laboratory medicine affects patients.

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Comments (5)

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David Grenache, PhD

June 11, 2018 at 10:50 pm

Dr. Mazer eloquently notes what many lab professionals, both pathologists and doctoral clinical scientists, have said and believed about Theranos. Reporters aren’t aware of the role we play in health care . Our advocacy will make a difference.

Timothy Church

June 18, 2018 at 3:56 pm

Every thinking scientist I know realized immediately that what they were selling was unadulterated BS, but the news media and commentators were unabashedly enthusiastic about the idea. We need better science reporters, like the ones on this website.

Stelios Serghiou

June 19, 2018 at 10:48 am

Very well said. Unfortunately, the most relevant individuals in the “healthcare disruption” saga, doctors, tend to be the least frequently consulted. In fact, the first published doubt about Theranos that I know of came before Carreyrou’s account from Stanford Prof. John Ioannidis in JAMA, early in 2015: https://jamanetwork.com/journals/jama/fullarticle/2110977

W Howard Hoffman, MD, pathologist

June 23, 2018 at 11:52 pm

Theranos appeared to us pathologists to be fraudulent from its beginning: no published analytical methods; no peer revue; excessive secrecy, no transparency; minimal or no evidence of validation and quality control; incessant bragging about using fingerstick samples to avoid dreaded venipunctures when fingersticks are more painful; massaging the finger toward the tip before fingersticks (https://news.ycombinator.com/item?id=9442324), to contaminate the samples with tissue thromboplastin, I suppose, and cause clotting and artifactually elevated potassium, etc. (https://www.ncbi.nlm.nih.gov/pubmed/23020733; https://www.ncbi.nlm.nih.gov/pubmed/6654554; sarcasm intended); unwarranted disparagement of established laboratories; a board of famous people rather than experts in pathology and other medical and scientific disciplines; incessant advocating for doing hundreds of nonindicated laboratory tests (not interpreted by physicians) on millions of healthy people, which would be a huge misallocation of scarce economic resources, in short, a massive waste of money and time (https://www.yalemedicine.org/stories/avoid-unnecessary-lab-tests/). It is no wonder that established high quality laboratories such as Quest Diagnostics showed little alarm or concern about Theranos (http://www.chicagotribune.com/business/ct-theranos-blood-tests-study-20160329-story.html). It is no surprise that all of Theranos tests (except one) had to be done with standard methods and equipment, not with Theranos proprietary “Edison” “technology”; how dare the disgraced Elizabeth Holmes (the opposite of Sherlock) exploit Edison’s name and reputation?! (https://www.bloomberg.com/news/articles/2015-10-16/theranos-limits-new-blood-technology-to-one-in-200-tests)
The truth will out; her fraud has come to light (https://www.bizjournals.com/sanfrancisco/news/2018/03/14/theranos-elizabeth-holmes-sunny-balwani-fraud.html).
Elizabeth Holmes is a far worse fraudster (at least $700 million) than Pharma bro Martin Shkreli (about $10 million), but he, the obnoxious, was far more severely punished, so far, than she, the Keane big-eyed waif with the Steve Jobs turtleneck (part of the keen Con) who never seems to blink (https://www.theguardian.com/artanddesign/2014/oct/26/art-fraud-margaret-walter-keane-tim-burton-biopic; another fraud here). However, she may yet get her proper justice, since she has now been charged with criminal fraud!! (https://www.theguardian.com/technology/2018/jun/15/theranos-elizabeth-holmes-ramesh-balwani-criminal-charges). FYI, W. Howard Hoffman, M.D., pathologist
(Full disclosure: I work for, but do not speak for or otherwise represent, Associated Pathologists, Chtd. and Quest Diagnostics, which does not affect the facts of this case, which anyone can research.)

JAMES N HO, MD, FACP

June 24, 2018 at 4:35 am

I always thought it dubious why there was such a glaring absence of pathologists and other laboratory personnel in vetting this instrumentation. I suppose touting names such as Kissinger or Schultz have far more panache and clout. Assuming that Holmes and cronies were woefully aware of the fraudulent approach to this, they
deliberately excluded pathologist input knowing that they might be exposed, hence the absolute secrecy (we still don’t know how this Edison actually works). On the other hand, the investors and the rest of the public, including media, were completely oblivious to the actual role pathologists play in verifying that instrumentation is
indeed accurate and reproducible. These supposed “Steve Jobs wannabees” were so intent on making billions by rejecting the status-quo and conventional approaches, they were willing to disregard or failed to seek appropriate expertise. What a
lesson learned!