We are entering the age of personalized medicine, where the therapy that’s best for you will be based on your physiology and genetic makeup—and may not be right for any other patient. Wondrous developments are taking place in medical science, including implantable or attachable devices that can monitor patients with numerous chronic conditions, such as diabetes, asthma, and heart failure.
These devices will allow patients and doctors to modify therapeutic regimes and tailor treatments to individual needs and responses. Genetic testing is reaching the point where patients can be directed to take certain drugs or avoid other drugs, based solely on the patient’s own genes.
Bureaucracy vs. Progress
Standing in the way of this boundless potential is an approach to health reform which revolves around the idea that patients are not unique and bureaucrats can develop standardized treatments that will apply to almost everybody with a given condition. When former White House health adviser Ezekiel Emanuel told CNN recently that “personalized medicine is a myth,” he was fully reflecting the worldview of the authors of President Obama’s health care law.
Everything about ObamaCare—from its emphasis on pilot programs and demonstration projects to its faith in “evidence-based care”—is about standardization. It’s about treating all patients the same way. Call it herd medicine, cookbook medicine, or assembly-line medicine. It’s as different from personalized care as can be.
Bias of Establishment
It’s not just the Obama administration. Underlying an enormous amount of medical research is the idea that we are all alike. Think about a clinical trial in which one group drinks coffee and the other group abstains. Suppose nondrinkers turn out to have a statistically significantly higher rate of colon cancer. Doctors responding by telling everyone to drink a cup of coffee every morning would be called “evidence-based” advice.
However, we are not all alike. Clinical trials like the one I just described are absurd. At least the way the results are used is absurd.
Think of the controversy surrounding the cancer drug Avastin. The clinical trials showed the drug doesn’t work. But individual doctors and their patients were convinced the drug worked for them. Both conclusions may be right. That is, the drug may not work for randomly selected individuals. But it may be a lifesaver for patients with the right genes.
The same applies to side effects. Vioxx, an anti-inflammatory drug, was taken off the market because of dangerous side effects. But if we had enough genetic information, we might discover that Vioxx is a safe remedy for many patients, especially those with no risk factors for heart disease.
Five Policy Hurdles
Today, personalized medicine faces five public policy hurdles. First, in order to get paid for implanting a sensor or conducting a genetic test, there has to be a billing code. If the sensor or the test is new, getting Medicare to create a code can take both significant time and money.
Second, even if there is a code, Medicare must agree to pay for the service. In general, Medicare has not been willing to pay for genetic testing, with two notable exceptions. By contrast, UnitedHealthcare spent $500 million on genetic and molecular testing for its members last year, including Medicare and Medicaid patients enrolled in the insurer’s private health care plans.
Third, Congress has imposed price controls on what Medicare can pay laboratories for conducting such tests.
Fourth, the FDA has authority to regulate sensors and apparently is now requiring full clinical trials before it will approve new ones. Clinical trials are time-consuming and expensive. But the bigger problem is that with personalized medicine, doctors are going to react to the information the sensor provides and change their therapy accordingly. As a result, every patient in the clinical trial could be treated differently—which defeats the whole purpose of a trial.
Finally, personalized medicine is running up against out-of-date and inflexible malpractice laws. If a problem later develops, a lawyer might argue that the caregiver should have seen it.
Bottom line: we need to bring public policy into the modern age.