Any day of the week you can walk into a pharmacy unsupervised and buy a test kit to find out if you’re ovulating so you can undertake family planning activities. You can buy home testing kits to screen for high cholesterol, illicit drug use, even presence of the HIV virus. You can also pony up $500 and buy yourself a genetic test kit from 23andMe to find out what might be in your genetic blueprint so you can make pre-emptive healthcare decisions if you wish. Not to mention the fact that you can drop by Haight Ashbury any Saturday afternoon and get your future told by someone named Sun Muffin and, as a result, decide to make changes in your life to help shape a better future.
While some might look askance at how you get the information you use to make choices about your life, it is rare that someone steps in and tries to stop you from doing so. In general, the American way is to say, “hey, you’re an adult and it’s your life…if you want to engage in self-actualization, whether or not it has a scientific basis, that’s your beeswax.” As medicine itself has evolved to a point where over-the-counter testing has become more and more accessible, many consumers have responded positively due to the perceived advantages of privacy and convenience (and the concomitant ability to foster early decision-making).
In fact, these are two of the key principles espoused by those who believe that consumers have a right to their own healthcare information. The idea is that the information is personal, about you and of your own making (by virtue of the fact that your actions caused the records to be created) and thus medical information about you should be both readily available to you and yours to do with what you wish. And yet, that is not always or even often the case.
Oddly, our system has evolved in such a way that your medical records are owned by the physician or hospital or insurance carrier that oversees what happens to you, but do not, in the end, belong to you. Except for information that came directly to you by virtue of a home test or was shared with you by your doctor, your medical information is basically owned by someone else and you do not have a fundamental right to control the medical record that sits in your doctor’s office or at your insurance carrier. Many people outside the healthcare system think this is pretty stupid, as it means that it is very difficult to create a patient-centric repository of information about you, the patient. The records are about you, for goodness sake, why shouldn’t you have full access to the data whenever and however you want just as you would if you took a home pregnancy test?
And it is a result of this controversy about who owns your medical data that we see a story like the one that recently came out of UC Berkeley. Apparently, as part of a long-standing tradition, my alma mater has had a mission to examine “issues of profound societal importance for the benefits of students and the public.” To achieve that objective, they have traditionally asked all incoming new students to read a common book; multiple classes then use that common book as part of a grander curriculum to study issues of great societal importance. This year, as an alternative to reading their assignment, the University decided instead to “examine the DNA-based technologies certain to alter medical care in the years ahead. Specifically, students will be offered the opportunity to look at three of their 20,000-plus genes to learn how they digest milk products and metabolize alcohol and whether they need more folic acid, a vitamin found in leafy green vegetables.”
The idea was to use genetic testing to engage students in a debate about the myriad of ethical, legal and social issues raised by the evolving fields of genetics and personalized medicine. The program’s sponsors said “they specifically chose genes that were not connected to serious health issues.” More than 5000 genetic testing kits were sent out to incoming students and 700 samples had come back already when this was reported in the San Francisco Chronicle:
UC Berkeley will not send students DNA results
Friday, August 13, 2010, Victoria Colliver
Under pressure from state public health officials, the professors behind UC Berkeley‘s controversial plan to genetically test incoming freshmen and transfer students said Thursday they will scale back the program so that participants will not receive personal results from their DNA samples.
The university raised the ire of genetic watchdog and privacy groups in May when it first launched “Bring Your Genes to Cal.” The voluntary program is believed to be the largest genetic testing project at a U.S. university.
Why was the program halted? According to reports, “critics said the program was pushing an unproven technology on impressionable students who could misinterpret the significance of their test results.” Two articles from the SF Chronicle note that “the action by state regulators to limit which information students would be able to receive has raised interesting questions for the discussions.”
“Who has authority to tell an individual what they’re allowed to know about themselves?” asked Mark Schlissel, dean of biological sciences at UC Berkeley, “I don’t know the answer to that.” He also said, “We believe this is a flawed reading of the statute that raises questions about who has control over teaching at the university, and in the broader sense, who has control over information about our own genes.”
It is worth noting that participation in the gene-testing program was not mandatory, that participants in the program signed consent forms and that the data would be provided to students on a confidential basis. It is further worth noting that participants in the program were adults, at least as the law defines them. It is right here that you see the conflict between consumer-engagement and traditional medicine in action. Notably, these students are the same adults that could go to any one of at least 5 websites and purchase the genetic tests under discussion here, receiving the results in the privacy of their own home. Yet when performed under the auspices of “the healthcare system”, which is how the State chose to view these University-administered tests, consumers essentially lost their right to get what they bargained for when signing the consent form—data about their own bodies (and not even highly controversial data at that).
I find it interesting that this issue of who owns your medical data is so subject to debate. It seems to me that there could be no more fundamental right than owning data that are, in the end, about you and you alone. This issue seems especially obvious to me when you are the one that purchases the data for your own use, which is effectively what the Cal students did by agreeing to participate as part of their enrollment in the University, to which they paid a handsome tuition.
The loudest arguments against consumers owning or accessing their medical data, generally fall into one of two categories:
- The tests are imperfect and thus we wouldn’t want you to make decisions only from the data provided from these tests; or,
- The information is so sensitive that if we gave it to you without a physician present, you might make terrible choices based on data that aren’t informative enough on a stand-alone basis to make major medical decisions.
Well, that first reason is definitely worth worrying about. Consumer genetic tests have been highly controversial because they are not FDA regulated and have not proven to provide entirely reliable results. Recent studies of gene testing products that have questioned the utility of these tests, saying that in some cases they deliver inconsistent data more than half of the time and produce false positive results that might lead consumers to make poor healthcare choices.
Well, this would be a much more valid argument if we didn’t have the same problem in widely accepted medical tests used by doctors every day, such as Fasting Plasma Glucose tests (used to screen for diabetes), which are known to be highly inaccurate, or an abundance of diagnostic imaging tests (mammography, for instance), which are also notorious for their false positive findings and wide variance in results based on which clinician is interpreting them. It is probably this truth, in part, that leads people to the second argument: consumers aren’t able to make good healthcare decisions alone.
And you know what, that is probably right. Smart consumers will use their healthcare information in conjunction with experts qualified to help them make definitive treatment decisions. However, that is not the same thing as saying that consumers don’t have a right to see their information (or own it). In a society where we are supposedly in possession of a right to self-determination, we come into possession of information every single day that we need experts to help us interpret. I know that when sparks fly out of my electric socket, I probably need an electrician to help me figure out what the heck is going on. And yet, no one came to my house and prevented me from seeing the sparks fly for my own protection.
I mean seriously; you have a right to bring a baby home from the hospital (your own, I mean) without any guarantee that you know how to take care of it (head end: bottle; butt end: diaper). Your medical record? Can’t take it with you without your physician’s consent, a $.50 per page Xerox fee and a wait of up to 5 days. And then, at least for now, it is going to be handed to you on paper, not in electronic form. Oh, and by the way, you have to traipse around to each provider, lab and insurance carrier separately to get all the data that pertains to you–wear comfortable shoes.
So what is right and reasonable? Is it reasonable for the Department of Public Health to tell individuals that they cannot receive genetic data because it might be too sensitive or not accurate enough and thus might lead them to make bad decisions if they had it? Is it irresponsible to let a bunch of college students know their genes suggest they have a high tolerance for alcohol? That may really be the crux of the matter in the UC Berkeley case. But honestly, don’t you think those same college students are going to run experiments of their own, data notwithstanding, to determine how much beer they can reasonably drink to celebrate beating the Stanford Cardinal?
I find the whole debate to be somewhat of a red herring. As earlier stated, it is very easy (if you have the $$) to find out the same genetic data and even to establish your very own personal health record (“PHR”) on Google Health or the Microsoft Health Vault. It is true that those private PHRs have significant limitations; they don’t yet take much data directly from providers and they rely heavily on consumers inputting their own data, which is not always complete. It is also true that many of these newfangled PHRs are probably not subject to HIPAA privacy rules and thus could more readily accessed or abused by those other than the consumer. Yet consumers are so aggravated by the difficulty in having a comprehensive record of their own health that they are willing to turn to these non-healthcare companies to do it on their own if necessary. They are basically saying, “to hell with it, I’ll take my chances on the privacy front.”
It seems to me that the idea of keeping people from data about their own bodies flies in the face of what we are taught about our right to life, liberty and the pursuit of happiness, privacy and self-determination. I think it is ironic that we are now actively driving the adoption of electronic medical records throughout the healthcare system, but have not passed a law giving consumers ownership of their medical information. Yes, there are provisions in the evolving Meaningful Use criteria to encourage rapid consumer access to information and many activities to encourage this, but we are a long way from nirvana on this one. While Rome burns, providers continue to argue about when and whether they can ever meet some of those Meaningful Use goals.
In any event, it is clear that consumers want more and more access to their medical data and that advances in technology are going to push that information further and further into their hands. As consumers are being asked to take a greater role in paying for their own healthcare and managing their own health insurance, logic tells us that they are going to start seeking out information to help guide them in their new found role as healthcare decision-maker. Paternalistic attempts to keep patients from their own medical data, such as that in the UC Berkeley case, are likely to be hard to enforce. The world where physician-to-patient communication is a one-way street has already begun to erode; patients often come into their physician’s office armed with WebMD print-outs and home diagnostic test results. Even the parlance has begun to change, with “consumer” beginning to displace “patient” as a term of art, implying a person who takes an active role in making decisions about their own healthcare destiny.
While we should all value efforts to ensure that data available to consumers is private and that home diagnostics are reliable and accurate, we must encourage greater transparency and availability of information to ensure that the true goal of consumer engagement can be realized. Companies are emerging throughout the industry to provide consumers with pricing data, quality data, data about medical errors and physician ratings a la consumer reports. Those are incredibly important and meaningful ideas, but it is the real clinical content that will, in the end, be the most meaningful for consumers who wish to actively engage in living a healthier life. To quote that great representative of American self-determination, Jon Bon Jovi:
It’s my life,
It’s now or never,
I ain’t gonna live forever,
I just wanna live while I’m alive
While it may not be life-changing for an 18-year old college student to know that their genes predispose them to effectively metabolize the milk in their triple shot non-fat latte, it is, as they say, the principle of the thing. If Americans are going to get as close as they possibly can to living forever, they are going to need all the tools available to do it. No tool is more powerful than real-time access to personal medical information that enables consumers to benefit from highly individualized health and wellness practices. Information is power in medicine, as it is in every other facet of life, and every effort should be made to eliminate barriers that stand between a person and their own medical information.
Note to readers: an excerpt of this article appeared in the August 22, 2010 edition of thehealthcareblog.com.