First Opinion gives people working across life sciences, health care, and research a place to make arguments that are illuminating, provocative, and grounded in their experience. STAT also publishes selected reader letters responding to those essays, making the debate part of the coverage. You can submit a Letter to the Editor here; the form is also available at the end of every First Opinion essay.
Theranos: a flawed business model and a film that leaves room for doubt
The story: “I was a Theranos whistleblower. In ‘You Can See Everything,’ Elizabeth Holmes is still lying”, by Tyler Shultz.
Kent Zimmerman, M.D., writes: Tyler Shultz deserves respect for speaking out and enduring the fallout from Elizabeth Holmes’ fraud. But the problems with Theranos went beyond its Edison device. Its business plan also ignored how clinical laboratories work in ordinary medical care.
Finger sticks hurt more than routine blood draws, and the tiny sample they produce leaves little room for follow-up. A standard venipuncture provides several milliliters of extra serum or plasma. Laboratories can store that material for up to a month, rerun a test when a clinician questions an unusual result, or perform additional tests the physician requests—often without bringing the patient back. Theranos’ single drop of blood couldn’t support that kind of care.
Zimmerman, formerly medical director of Sonora Quest Laboratories in the Phoenix area, says physicians there became frustrated with Theranos’ limitations after the company introduced its services locally. Conversations with his successor confirmed that doctors were contacting Sonora Quest about the problems.
There was also a mismatch with the insurance system. Theranos promoted easy access to self-directed testing, but insurers generally require a licensed physician to submit the proper diagnosis codes before they will pay. Zimmerman’s conclusion is blunt: even a working Theranos machine wouldn’t have rescued an economic model built around a poor fit with routine care.
Beret E. Strong writes: Tyler Shultz’s account of Holmes, Theranos, and the documentary You Can See Everything is illuminating, particularly for anyone interested in medical research, ethics, and patients’ rights. Strong wonders whether the filmmaker was fooled when Holmes showed him the wrong medical device. That seems plausible, she says, though filmmakers can also become too closely aligned with their subjects.
Strong recalls an older ideal of documentary filmmaking: filmmakers should work like journalists, investigating while keeping a neutral stance. Editing complicates that ideal. A filmmaker may shape roughly 70 hours of footage into a film with a point of view. Strong hasn’t seen the Holmes documentary, but understands it to move from a conventional documentary into reenactment and more experimental forms. She’s unsure why it takes that turn, and argues that ambiguity can be productive: viewers should have to make sense of what they see.
Still, she sees a special problem when a filmmaker’s subject is manipulative and criminally convicted. Strong found Shultz’s inside account compelling—and says reading it spared her the need to watch the film.
Katherine Reed writes: Shultz’s personal history with Holmes helps explain why he might resist the documentary’s approach. Reed says he endured the consequences of Holmes’ fraud and would understandably want any discussion of her to foreground her crimes. To Reed, Holmes is a habitual liar and likely a psychopath.
But Reed sees Nathan Fielder and Lance Oppenheim’s project as an inquiry into deceit, not an effort to put Holmes on trial again. She says the film doesn’t cast doubt on her culpability. Instead, it asks how someone like Holmes is formed—and what we can ever know about another person. Reed recalls Holmes saying as a child that she wanted to be rich, and points to Silicon Valley’s tolerance for exaggeration and lying as an environment in which fraud could thrive. She considers the film a documentary masterpiece. Its answer to what can be known about another person, she says, is unsettling.
Why patients stop taking medication
The story: “I thought I knew why patients stopped taking their medicine. I was wrong”, by Marcela Gottschald.
Jeanne McDonough-Jarvis writes: Six years after a mitral valve replacement, McDonough-Jarvis continues to take her medication as prescribed. Even so, she understands why patients may resent needing medicine for the long term, or feel that medication changes who they are.
In her home health work, she says, clinicians often explain missed medication as a problem of understanding or cost. She rarely hears them discuss the emotional burden of relying on medication for life. McDonough-Jarvis says she had to grieve the loss of control over her body and adjust to lifelong treatment herself. Gottschald’s essay helped her recognize that other patients may be wrestling with the same feelings. Now, she argues, clinicians need to recognize those concerns and talk about them.
Integrative oncology and the standard of evidence
The story: “The science on relieving cancer symptoms is clear. Why isn’t insurance paying for it?”, by Lorenzo Cohen.
Paul A. Delaney, M.D., clinical assistant professor at Wake Forest University School of Medicine, writes: Cohen argues that integrative oncology has become evidence-based and should be part of standard cancer treatment. He points to professional guidelines as a way to decide which practices qualify. Delaney accepts that as a reasonable standard, then questions how Cohen applies it.
Delaney argues that some integrative practitioners use established supportive care—such as exercise, medical massage, biofeedback, and yoga—to lend credibility to less established claims. Cohen co-authored the Society for Integrative Oncology’s guidelines on complementary therapies and botanicals; those guidelines say energy therapies have “no antitumor effects.” Yet Cohen’s essay attributes cancer-cell growth and metastasis inhibition to biofield therapy.
Delaney also challenges Cohen’s claim that the Department of Veterans Affairs offers biofield practices such as reiki, healing touch, and therapeutic touch. Delaney says the VA source Cohen cites doesn’t mention those therapies.
For Delaney, the concern goes beyond weak evidence: the energies that supposedly underpin biofield therapies have never been detected under controlled conditions, despite being testable. In a 1998 JAMA study, practitioners couldn’t sense the energy field they claimed to manipulate; their results were no better than chance. A separate review says it is “somewhat puzzling” that nursing organizations and textbooks continue to support therapeutic touch given the lack of quality evidence. Reiki, Delaney adds, rests on a similar premise and is said to work remotely, even over Zoom.
Delaney invokes physician Harriet Hall’s label for research on an unproven premise: “Tooth Fairy science”. Researchers might consistently measure how much money the Tooth Fairy leaves under a pillow, he writes, but those results wouldn’t establish that the Tooth Fairy exists. In the same way, evidence that some accepted treatments carry the label “integrative oncology” doesn’t validate every practice grouped under that name.
Galleri’s limits as a cancer screening test
The story: “Why the FDA should not approve an ineffective multi-cancer screening test”, by H. Gilbert Welch.
The letter writers: The writers agree with Welch that the Galleri multi-cancer test shouldn’t receive FDA approval, arguing that it could cost taxpayers billions of dollars and might delay cancer diagnoses, with potentially fatal consequences.
They dispute the idea that Galleri offers early detection. In the company’s two studies, the test missed 86% and 79% of stage 1 cancers and about two-thirds of stage 2 cases. Even among the most advanced cancers, it detected only 60% to 63%. The writers say there’s no evidence the test saves lives, and warn that a negative result could falsely reassure someone who later develops symptoms and put off a visit to the doctor.
False positives bring a different harm. Among patients who eventually learned they didn’t have cancer despite a positive Galleri result, half underwent an invasive procedure, such as a biopsy, endoscopy, or surgery. They waited a median of 75 days for confirmation. The letter writers attribute that delay to a shortage of experts able to conduct and interpret follow-up testing. They question whether those harms outweigh any benefit, given the test’s low detection of early prostate, breast, ovarian, and skin cancers and insufficient accuracy evidence for many others.
The screening promise comes with a capacity test
Galleri’s potential benefit depends on what happens after a result raises concern. If millions take the test, the resulting demand for follow-up procedures could stretch appointment queues for both those patients and people already living with cancer. That risk deserves more attention than the promise of an early signal.
In a health system with ample time for clinicians to explain the test’s limits, patients who keep up with standard screening, and people able to absorb an alarming result without panic, Galleri might prove useful. Those conditions are far from guaranteed. A flood of suspicious results could instead burden clinics and delay diagnosis for patients who have cancer. The test’s value will depend not only on what it detects, but on whether the system can investigate those signals without slowing other care.
—Diana Zuckerman and Akashleena Mallick, M.D., M.P.H., National Center for Health Research
Cancer, diagnostics, ethics, health tech, Medical devices
Submit a correction request · Reprints
Torie Bosch, Editor, First Opinion. Torie Bosch is the First Opinion editor at STAT. X · Bluesky