By Gordon Hull
The current New Yorker includes a profile of Theranos, a Silicon Valley start-up that is developing new techniques of blood-testing, and its founder, Elizabeth Holmes. In the old way, you’d go to the doctor, who’d order some tests. You’d then get a blood draw of a couple of vials of blood, and they’d get shipped off to LabCorps or Quest. A few days later, you’d find out your lipid or other levels. Theranos claims to have developed the technology to get much, much more information out of a couple of drops of blood – at a fraction of the cost. Needless to say, such an innovation would be a game changer. There is serious money at stake: Quest and LabCorps apparently generate $75 billion a year in revenue. Medically, it’s not just that routine lipid screenings would be easier; it’s that as researchers discover blood markers for more and more diseases, routine blood testing could enable early detection of some that are currently very difficult to treat. For example, recent research suggests such biomarkers might enable early detection of the most common form of lung cancer (this follows the discovery of another lung cancer biomarker a year ago); such early detection is critical for treatment, and its absence is part of why lung cancer has such a high mortality rate. The automatic testing for cancer biomarkers could simply be folded into the lab result. Holmes puts it this way:
“My own life’s work in building Theranos is to redefine the paradigm of diagnosis away from one in which people have to present with a symptom in order to get access to information about their bodies to one in which every person, no matter how much money they have or where they live, has access to actionable health information at the time it matters.”
What’s not to like? One problem is that Theranos’ development strategy is exhibiting one of the central problems of the medical industry as it is configured: companies have every incentive to keep their data secret, but data secrecy both reduces the value of the data, and makes it much harder to clinically verify claims about its utility. As Frank Pasquale explains, limitations and siloing in early data collection can reduce the utility of downstream research later on: “There is a tension between untrammeled innovation by vendors at any given time and later, predictable needs of patients, doctors, insurers, and hospitals to compare their records and to transport information from one filing system to another” (p. 741).
A background problem is that we, as a society, have a serious and unresolved questions about how much medical paternalism we need, and that companies like Theranos are pushing those questions into renewed salience To put it differently, to what extent should medicine be seen as a consumer good? It seems to me that Theranos should be read in the context of what Nikolas Rose, in his analysis of contemporary biopolitics, called a “presymptomatic” model of illness. Rather than being sick and going to the doctor, patients become aware of what health issues are likely to befall them, and undertake a process of risk management. As Rose documents, the move to risk-management leads to a number of issues; in this case, one might focus on a very precise question: should patients be able to request their own blood testing, without a physician’s order? Theranos is building out an infrastructure that would make this very easy, since the plan is to have pharmacies like Walgreens be able to offer the test. There has been concern about direct-to-consumer marketing of pharmaceuticals for some time, but the current environment seems to pose the problem at a more fundamental level.
Theranos strikes me as significant, because it is the first example I know of outside of genetic testing where consumers are going to have access to so much difficult-to-interpret information at once. Until recently, 23andMe.com offered genetic sequencing directly to consumers, and returned a detailed assessment of particular genetic mutations and risk factors that consumers could then interpret on their own, though the site encouraged them to take the report to their doctors. In 2013, the FDA sent an exasperated letter ordering the company to stop marketing its Personal Genome Service (PGS), which it claimed came under its regulatory authority insofar as the PGS is “intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.” The FDA detailed its own efforts to “help” 23andMe come into compliance, and the company’s apparent failure to take any of the suggested steps. The concern – well documented – is that consumers are poor judges of complicated, risk-based medical information, and 23andMe was therefore putting them at risk. Here is the FDA:
“Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment. For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect. These risks are typically mitigated by International Normalized Ratio (INR) management under a physician’s care. The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported”
The FDA ordered the company to stop, and it currently is somewhere in regulatory limbo; the company now markets itself as providing “ancestry information,” though it continues to make sure that visitors know about developments in genetics, such as the recent discovery that genetics may play a much larger role in ALS than previously thought. What no one doubts is that there will be greater and greater pressure to permit such DTC marketing and medical services. The Theranos case underlines that it won’t just be in the case of genomics.
A correlate question has to do with the status of primary care medicine. Anybody who listened to the rhetoric around the Affordable Care Act could be forgiven for thinking that having a regular primary care provider (PCP) is an essential part of medicine. Indeed, my insurance (which is the NC State Employees plan) cuts your premium if you are willing to commit to a PCP by putting his/her name on the card, and then cuts the copay in half if you visit that practice. At the same time, we see a proliferation of consumer-oriented practices designed to do things like sports physicals, strep tests, vaccines, and so forth – Walgreens and CVS are both pushing in that direction, and various other stand-alone clinics are popping up (some of them, I think, owned by the major hospitals). These facilities have better hours and advertise very short wait times, even for walk-ins, but they often don’t have an MD around. Theranos seems to push the question behind these two networks into greater salience: what will it mean for medicine if the majority of individuals go to a CVS MinuteClinic when they have a sore throat? Will this increase or decrease overall population health? And, how do we weigh whatever population-level health advantages that might come with regulation, versus giving patients the tools to reduce the information asymmetry between themselves and healthcare providers?
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