Big Data may be a business buzzword that puts most consumers into a big sleep, but big alarms are sounding for Americans about Big Brother intrusions into their lives via the collection and analysis of vast amounts of highly personal information. Of course, Big Pharma and medical insurers are at the fore of invasive practices — some of which patient-consumers themselves are helping, likely without knowing they’re doing so.
Millions of Americans may be little aware, for example, that they’re now working for GlaxoSmithKline, a global pharmaceutical conglomerate with $9 billion in revenues in just the most recent quarter. GSK just struck a $300-million deal with 23andMe, the company that has persuaded roughly 5 million consumers to spit in a test tube to get a glimpse of their genetic information, notably information about their ancestry and purportedly some of their genomic health risks.
Firms like 23andMe, with promotions at events like Baltimore Ravens pro football games, also have amassed highly personal genetic and medical data on millions of patient-consumers, promising to protect the information but also offering, casually and by the way, that this vital information could be shared — ostensibly for the betterment of public health.
GSK saw the genetic database as a potential gold mine that could boost its bottom line, swooping in to see, for example, if 23andMe information could assist in the difficult development of drugs for treatment of Parkinson’s. As Big Pharma focuses its costly, complex research and development mostly on lucrative medications for chronic and often niche conditions, makers confront major problems, for example, in finding targeted groups of patients, including for required, rigorous clinical trials — a challenge that OTC genetic testing firms may provide one answer to.
Sound like a win-win situation for all? Well, this deal has sent shivers down the spines of medical ethics and privacy experts. They long have warned about problems with over-the-counter genetic testing, saying: Its information is shaky, too often over-stated in its possible benefits, and that users get too little professional counseling about complex data and what it can mean for their health. Further, they caution that OTC testing companies give consumers far too little explanation of details of legal permissions they may sign before using the products — they fail to provide the crucial and fundamental patient right of informed consent for a procedure, in this case medical tests that produce invasive results.
The federal Food and Drug Administration wagged its finger at genetic testing companies but has allowed wide and booming use of their products, provided their makers increased their public information and offered more counseling on test results.
Still, the GSK deal underscores gaping issues that lawmakers and regulators have failed to address: How zealously will testing firms protect patient data, especially when confronted with lucrative deals? In other, clinical settings, researchers must strip patient information used in research of critical identifiers, and face penalties if they fail to do so. But 23andMe already has shown it can and will delve into its database to identify patients with key characteristics, such as those with genetic markers associated with Parkinson’s (to be sure, the individuals consented to participate in potential research follow-up, based on their tests). If successful drugs get developed from individuals’ information, will they be compensated? How will privacy rights be protected of blood relatives who have been tested?
Are such worries overblown? Not, says a recent probe by Pro Publica, the Pulitzer Prize-winning investigative site. There, Marshall Allen reported in a deep, detailed story that:
With little public scrutiny, the health insurance industry has joined forces with data brokers to vacuum up personal details about hundreds of millions of Americans …. The companies are tracking your race, education level, TV habits, marital status, net worth. They’re collecting what you post on social media, whether you’re behind on your bills, what you order online. Then they feed this information into complicated computer algorithms that spit out predictions about how much your health care could cost them. Are you a woman who recently changed your name? You could be newly married and have a pricey pregnancy pending. Or maybe you’re stressed and anxious from a recent divorce. That, too, the computer models predict, may run up your medical bills. Are you a woman who’s purchased plus-size clothing? You’re considered at risk of depression. Mental health care can be expensive. Low-income and a minority? That means, the data brokers say, you are more likely to live in a dilapidated and dangerous neighborhood, increasing your health risks.
What’s the consequence of insurers Big Data diving? As Allen reported:
Patient advocates warn that using unverified, error-prone ‘lifestyle’ data to make medical assumptions could lead insurers to improperly price plans — for instance raising rates based on false information — or discriminate against anyone tagged as high cost. And, they say, the use of the data raises thorny questions that should be debated publicly, such as: Should a person’s rates be raised because algorithms say they are more likely to run up medical bills?
In my practice, I see the harms that patients suffer while seeking medical services, and their struggle to, fairly and appropriately, access and afford safe, efficient, and even medical care. If skyrocketing prices and downright dangerous drugs don’t persuade most of us that Big Pharma cares most about its profits and much less so about patients, well, the unpersuaded may have spent a long weekend howling at the lunar eclipse and expecting answers back.
As for medical insurers, it’s a safe prediction based on experience and past data that they, too, seek to optimize their profits, playing off against each other providers, payers, and patients. Anything that further their buck, they’re two feet in. At the same time, medical debt and bankruptcy plagues Americans, most especially the young (see a telling info graphic, above, posted by the information site Axios and from a newly published study on Health Affairs). Neither medical coverage nor drug costs have diminished, even as companies data mine us like crazy. How soon before an insurer cuts a deal with an OTC genetic testing company?
Lawmakers and regulators need to provide deeper, smarter answers to us on the insidious rise of the sharing and analysis of Americans’ personal data. And, we, too, need to ask ourselves tough questions: Just how important is it to know that great-great-great Auntie Mildred elbowed her way on to a wooden boat a few centuries ago as that vessel headed from England to a new colony? If Uncle Harry downs a few beers, heads to bathroom at halftime, and then stops to spit in a test tube on a whim, will it be worth your spouse getting denied health insurance because you have a million-in-one risk of having a chronic disease? Do you want your oldest son profiled and pulled over in the middle of the night by police because your fitness fanatic cousin thought she could get a better, genetically based work out? As California police have shown, rummaging through public genetic databases can be enlightening, even if it isn’t about guilty perps directly but also their kin, and an occasional wrong suspect.
We’re in a Brave New World but caveat emptor still, folks.