WEISS'S NOTEBOOK

The Revolution Will Be Personalized

A Cautious HHS Report on the Latest Buzz In Medicine

“Personalized medicine” is the hot new buzz phrase in medicine. Why settle for diagnostic tests or therapies that were designed for the average patient, the thinking goes, when doctors can use new technology to pinpoint the specific details of your bodily biology and tailor tests and treatments to your exact medical situation?

The idea has potential and may gradually catch on as gene tests and other new technologies become more accurate and affordable. But a candid new report from the Department of Health and Human Services balances those lofty promises with a tally of the daunting challenges that scientists, doctors, patients, and insurers will face as the American healthcare behemoth tries to make the leap to the personalized medicine paradigm.

The issue is gaining importance because healthcare reform is high on the agendas of both Congress and the new president in the coming year. Proponents of personalized medicine want to make sure that whatever reforms are instituted do not undercut progress toward a more personalized future. At the same time, one can’t help but conclude, on the basis of the HHS report, that it is going to be an uphill battle to justify some of the upfront costs of the personalized medicine revolution, given the many technical, political, and educational hurdles that stand between where we are and where we want to get.

Some kind of reform is clearly needed. As HHS Secretary Michael O. Leavitt notes in his introduction to the 299-page report (a follow-up to one published a year ago), U.S. healthcare expenditures amounted to just 4 percent of the nation’s gross domestic product when he was born in 1951 but are now 16 percent of GDP and are projected to hit 20 percent by 2016—a trend he calls “not sustainable.” All told, today’s health expenditures of about $2 trillion are expected to double within less than a decade.

The core of the problem, as described in the report, is that Medicare—by far the nation’s largest healthcare payer and the standard-bearer that other insurers use as a model—bases its payouts on volume rather than on value.

Under this system, there is a positive economic incentive to deliver more care rather than better care since Medicare makes payments made irrespective of quality. Indeed, there is little or no incentive to make a proper diagnosis or choose the best treatment the first time around.

Among the many efficiencies that could be brought to this system, one shines brightest among proponents of personalized medicine: customize treatments based on individuals’ particular situations and especially on the basis of their genetic makeup. By one estimate, simply customizing the doses people get of the blood-thinning drug warfarin could save as much as $1 billion a year. The medicine is one of the most heavily prescribed in the country and can cause serious side effects if not calibrated precisely to a patient’s needs.

But there are a number of difficult hurdles to clear before we can realize that dream.

First, we must create a universally usable electronic health records system capable of managing, in a standardized way, the new kinds of genetic information that will be at the core of personalized medicine.

“At a time when information technology has transformed most other sectors, with particular benefit to the consumer, the health care sector, with its paper files, often inaccessible records, and incomplete patient data, stands out as primitive indeed,” Leavitt laments in the HHS report.

There is, at least, progress on this count. The department proposed standards for embedding genetic data and other family history information into electronic health records in 2008 and is in line to finalize those guidelines in 2009. HHS also set a national goal of getting most Americans switched over to electronic health records within five years, an ambitious if probably unrealistic aim.

But we will need a lot more than electronic records. By one account in the HHS report, patients (who are known in the lingo of personalized medicine as “consumers,” a worrisome shift in nomenclature I will address in a moment) will have to take on more of the job of keeping those records accurate and up to date with the help of “new consumer-friendly tools.”

For the most part we still don’t know when, if ever, medical professionals will understand enough of this information in a way that can really have a positive impact on people’s health or the national health care budget.

Take, for example, the time you generally spend at the beginning of a doctor visit, describing how you’re doing and giving the clues that a trained physician might recognize as medically important. That conversation “unnecessarily consumes precious time from providers,” according to a chapter in the HHS report contributed by Geisinger Health Systems. The solution? Spell out your woes to a touch-screen computer before the doctor comes into the exam room.

As it turns out, this is just one of several ways in which personalized medicine will demand a new (and rather impersonal) level of personal responsibility when it comes to health care. In fact, the hidden bomb in the word “personalized” in this new medical context is that it is going to be very much up to the “person”—that “consumer” we were talking about a moment ago—to decide how to deal with all the incoming information, including how to understand what it means and how to balance it against the economic realities of limited health coverage.

As the group FasterCures notes in the HHS report, a major hurdle for personalized medicine “is a lack of ‘genetic literacy’ among members of the general public. Informed patients are critical to patient-centered care, but as personalized medicine techniques become more sophisticated and information more complex, caregivers will face steeper challenges in communicating effectively with patients of all education levels and backgrounds.”

This education process will get even more dicey as doctors and other caregivers try to convince patents—er, consumers—to upload their personal medical information to giant databases in order to help researchers figure out what all these genetic signals really mean. “Discovery will come more rapidly if large amounts of clinical information are made available to researchers,” the report says. “The largest source of such information is ourselves,” it goes on, noting that this is one of the great advantages of getting people’s information into uniform “interoperable electronic health records”: It’s easier to suck personal data up into a data-crunching combine to speed discovery.

I did find one clause buried in those 299 pages acknowledging that “many issues, including privacy protection,” still need to be addressed.

No kidding.

Patient-consumers (or perhaps impatient consumers, waiting for that automated touch-screen to ask them where it hurts) are not the only ones who may find it difficult to adjust to the brave new world of personalized medicine. There are questions about whether pharmaceutical companies will find any economic incentive to develop medicines that are useful for only small, genetically specialized portions of the population. And then there is the looming question of how many of the countless genetic tests now under development are really going to prove themselves to be valuable at all.

As noted at a Personalized Healthcare Summit held in October, “Genetic and genomic knowledge relating to clinical outcome is missing – does value exist when these markers are used in a real clinical setting? The data don’t exist yet to guide physician action.”

In other words, for the most part we still don’t know when, if ever, medical professionals will understand enough of this information in a way that can really have a positive impact on people’s health or the national healthcare budget.

It doesn’t help that the Food and Drug Administration has opted not to regulate most gene tests, citing a shortage of resources; that HHS has so far resisted calls to create a proficiency testing program that would help ensure that test results are accurate and meaningful; or that the Medicare program for the most part does not reimburse for tests considered “predictive,” which pretty much blows the incentive to create these kinds of tests in the first place.

Health officials can say all they want to convince us “consumers” that it is empowering to take the reins of our own healthcare, but the truth is most people feel totally overwhelmed as it is and will be feeling even more so as health technology advances further. No wonder the HHS report acknowledges that the public may not be ready for personalized medicine.

“Patient education will play a prominent role in the acceptance of personalized healthcare, given that patients will need to become more involved in managing their own health portfolios….”

There’s a lot of work to be done by those designing this revolution before I’ll be waving a red flag at the barricades.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Tags: genetics, healthcare, medicine, privacy, public health

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