First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others.
To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected Letters to the Editor received in response to them. You can submit a Letter to the Editor here, or find the submission form at the end of any First Opinion essay.
The story
“I was a Theranos whistleblower. In ‘You Can See Everything,’ Elizabeth Holmes is still lying,” by Tyler Shultz
The response
I have a lot of respect for Tyler Shultz and the ordeal he suffered as another victim of Elizabeth Holmes. Perhaps less exciting is the fact her failures are more than just the flawed Edison machine. The economic model she proposed does not fit in how clinical laboratories are integrated into routine health care.
First, finger sticks are far more painful than routine venipuncture. Venipuncture yields several milliliters of excess serum or plasma, from which we can perform repeat tests, which are often requested by clinicians when they receive what they believe is an aberrant result. More often, results lead to further requests from the ordering doctor, which we can perform since we store excess serum or plasma for up to one month and can do without requiring the patient to come back to the draw station. None of this can be done with the single drop of blood Theranos collected from patients.
I had retired from the position as medical director of Sonora Quest Laboratories in the Phoenix area where Theranos first rolled out their services. Conversations with my replacement confirmed that local physicians were frustrated with Theranos over these shortcomings and communicating with our laboratory about them.
Theranos also was designed to allow easy access to self-directed testing, which does not fit our insurance-based medical system. No one will pay for tests unless you have proper diagnosis codes submitted by a licensed physician.
Even if Theranos had a functioning testing machine, the economic model on which is was based would result in failure.
— Kent Zimmerman, M.D.
The response
As a documentary filmmaker who is interested in medical research, ethics, and patients’ rights, I am grateful to Tyler Shultz for his illuminating essay about Elizabeth Holmes, Theranos, and the new film “You Can See Everything.” I’m intrigued by the question of whether the filmmaker was duped by the Holmes’ trickery when she showed him the wrong medical device.
I think that’s plausible. But filmmakers sometimes lean too far in the direction of our film subjects. I came of age as a filmmaker when we were supposed to be akin to journalists — neutral and investigative. Of course, that goes out the window a bit during the edit, where we take perhaps 70 hours of footage and turn it into a film, a winnowing that usually results in a point of view. I haven’t seen the film about Elizabeth Holmes. Structurally, I gather that it presents more or less as a standard documentary and then does a strange hybrid genre glide into re-enactments and more experimental strategies. Why? Ambiguity is OK; audiences need to do some work.
But manipulation of material and audience by a filmmaker whose topic is a manipulative, criminally convicted, and arguably sociopathic person is another matter. I was fascinated by this essay and glad to have the disturbing inside story revealed. Frankly, it beats having to see the film!
— Beret E. Strong
The response
It’s easy to see why Tyler Shultz would struggle to appreciate the new film about Elizabeth Holmes (which is indeed a documentary, despite his feelings about what it documents). As a person who was dragged through the mud and suffered personally in the vortex of her fraud, clearly he would love for every mention of her name to carry with it a review of her crimes. It is obvious to Tyler and anyone else who has followed the Theranos story that Holmes is a consummate liar and probably a psychopath.
Nathan Fielder’s project with Lance Oppenheim wasn’t about reprosecuting her crimes; it was intended as a deep exploration of deceit as practiced by a virtuoso of the art. Tyler need not worry that it raises doubts about her culpability. What it does leave one to wonder is how a person this bad is “made.” I found myself scrutinizing her strange, injured-looking parents in the film and looking for clues but then recalled that as a child — when asked what she wanted to be when she grew up — little Lizzie said “rich.” That little girl was apparently perfectly built for fraud, somehow, and found the perfect environment in Silicon Valley, where exaggeration and outright lying were de rigueur. Unlike Tyler, I think the film is a kind of masterpiece as a documentary and addresses in numerous ways the question of what is truly knowable about another human being. The answer it offers isn’t a happy one.
— Katherine Reed
The story
“I thought I knew why patients stopped taking their medicine. I was wrong,” by Marcela Gottschald
The response
As a person who is adherent to a medication regime after mitral valve replacement six years ago, I still completely understand the perspective described in this article. It makes perfect sense to me that patients do not want to be dependent on medications long term even though they know that they are necessary.
While I have not experienced it myself, I can also understand how patients may feel as if medication makes them a different person. I am in the home health field and the clinicians always assume that non-adherence is related to a lack of patient understanding or a lack of funds. I’ve never heard anyone discuss a patient’s reluctance to take medication long term due to the psychological factors involved in an understanding that they must rely on medication for the remainder of their lives.
I am an overthinker and recovering control freak, so while I grieved the loss of control over my body and tried to wrap my head around having to depend on medication for my entire lifetime, it did not occur to me that other people might feel the same way. So thank you for bringing this factor to the forefront. Now we just need all clinicians to understand it and to have those conversations.
— Jeanne McDonough-Jarvis
The story
“The science on relieving cancer symptoms is clear. Why isn’t insurance paying for it?” by Lorenzo Cohen
The response
In a recent opinion piece, Lorenzo Cohen makes the case that the field of “integrative oncology” now lives up to the standard of being evidence-based, and thus should become a standard part of cancer therapy. He cites guidelines published by professional organizations as the basis for deciding what counts as evidence-based.
Using such guidelines as the standard is reasonable, which is exactly what makes his handling of them so telling. “Integrative” practitioners have historically co-opted mainstream therapies to lend their field legitimacy, then, once a degree of acceptance is secured, introduce more far-fetched ideas. His essay follows this “bait-and-switch.” The Society for Integrative Oncology’s guidelines for Complementary Therapies and Botanicals, of which Cohen is himself a co-author, cover mainstream supportive care such as exercise, medical massage, biofeedback, and yoga. Those same guidelines also state that energy therapies “have no antitumor effects.”
Yet his essay credits biofield therapy with inhibiting cancer-cell growth and metastasis. In another mischaracterization of sources, Cohen stated, “The Department of Veterans Affairs now includes biofield therapies such as reiki, healing touch, and therapeutic touch among its integrative health offerings.” Those terms are conspicuously absent from the VA link he provides, which makes no mention of any biofield therapy.
The problem runs deeper than weak evidence. The basis of energy therapies, which Cohen terms biofields, is not merely unproven: The “energies” on which they rest have never been detected under controlled conditions, despite being directly testable. Consider therapeutic touch. In a 1998 JAMA article, an author showed practitioners could not detect the very energy field they claim to manipulate, performing no better than chance. And yet “given the deficiency of quality research evidence, it remains somewhat puzzling why nursing organizations and textbooks continue to support [therapeutic touch].” Reiki rests on the same premise but, ostensibly, can be done remotely, even via Zoom.
Researching the effects of an undemonstrated biofield is what Harriet Hall, M.D., termed “Tooth Fairy science”: “doing research on a phenomenon before establishing that the phenomenon exists.” You can gather reproducible, statistically significant data on how much money the Tooth Fairy leaves under the pillow and draw data-driven conclusions. But they are meaningless, because the underlying premise was never established. That some valid therapies have arbitrarily been labeled as “integrative oncology” is not an argument for accepting the discipline wholesale.
— Paul A. Delaney, M.D., clinical assistant professor, Wake Forest University School of Medicine
The story
“Why the FDA should not approve an ineffective multi-cancer screening test,” by H. Gilbert Welch
The response
Kudos to Gordon Welch for explaining why the Galleri multi-cancer screening test does not merit FDA approval and would cost taxpayers billions of dollars. We agree and add that it could potentially increase delays in cancer diagnoses and possibly deaths.
Despite its name, Galleri is not an early detection test because it misses most early cancers. The company’s two studies missed 86% and 79% of stage 1 cancers and about two-thirds of stage 2 cancers. That means that most of the people who have early cancers will be told that they are cancer-free. That’s not as good as a coin toss. Even the most advanced cancers were correctly detected only 60% – 63% of the time. That’s why we agree with Dr. Welch that there is no evidence that these tests save lives.
Meanwhile, many patients will be falsely reassured. If the test shows they don’t have any type of cancer, when they start to have symptoms, there will be a tendency to delay going to the doctor. They may want to put it off for just a few weeks or months — until after the holidays or a deadline at work — but those delays may last longer than planned.
That could be deadly. Will those risks outweigh the benefits, especially with extremely low early-stage detection for prostate, breast, ovarian, skin, and inadequate evidence of accuracy for many other cancers? What happened to patients who eventually learned that they did not have cancer despite a Galleri result suggesting they had cancer? Half underwent an invasive procedure such as biopsies, endoscopies, or surgery. They waited a median of 75 days before being told they didn’t have cancer. That’s a very long, anxious waiting period and is inevitable due to a lack of experts to conduct and interpret test results.
If millions of people take Galleri tests, the added demand for follow-up testing could lengthen waits for them and for people who have cancer. In the ideal world, where doctors have unlimited time to explain these test results to patients, and where patients understand the shortcomings of the tests, continue other screening, and don’t freak out if told the test indicates cancer, then the test might be promising.
But that’s not the world we live in. The tests could easily do the opposite, as people with results suggesting cancer require follow-up testing that overwhelms our healthcare system, potentially delaying diagnoses for people with cancer.
— Diana Zuckerman and Akashleena Mallick, M.D., M.P.H., National Center for Health Research