Think of it this way - personalized medicine has become the mantra for reforming healthcare. Both Obamacare and Romneycare call for greater individual control over services by doctors and patients. The basic idea is that treatment should be customized for each individual according to genetic makeup and varying physiology. It’s an appealing concept to patients who want to take charge of their treatment and not just feel like pawns in an authoritarian system. But can Washington adapt to the faster, personalized system? It can if the respective agencies, like the FDA, take actions that are clearly within their control.
But, greater personal care is a great idea that unfortunately runs into bureaucratic problems throughout government capitals. Politicians and government administrators just do not know how to deliver care. The Food and Drug Administration, one of the largest government agencies involved in patient care, announced that it is developing a policy to regulate mobile applications in healthcare. This may seem like a minor event, but it signals the willingness of government healthcare leaders to control progress and reform rather than embrace it. Even though the FDA may be skeptical about mobile applications’ usefulness, it's hard to see the real harm they present to users and providers. Skepticism, after all, is a risk-adverse strategy. If you believe that competent adults can figure out what's good for them and make decisions accordingly, then onerous oversight by the government is problematic. Physicians and other healthcare providers can figure out for themselves what's going to help the patients. There is no real harm in just making information available. After all, this is the 21st century and age of digital communication.
The former FDA Commissioner, Dr. Andrew C. von Eschenbach, has argued that the agency should focus its efforts just on regulating risk and harm and not get into the business of effectiveness. That's a good argument and certainly relevant to new technologies such as mobile applications that present no real risk to users and clinicians. The rule also applies to other potential diagnostic tools such as quantitative electroencephalography (qEEG) or brainwave technology. The qEEG is a simple office-based procedure that has no potential harm to patients. In fact, it can save lives right now. The technology gives the doctor valuable information on medications to prescribe and the functioning of the patient's brain. The analysis of the qEEG for response to medications takes the trial and error out of the prescribing process. At a time when the military and veterans are seeing an increasing number of suicides, many attributed to the prescription of too many medications, an objective treatment like this should be widely used. But, the FDA is right in the middle of testing qEEG and determining its usage in clinical practice. The qEEG is a simple information-based tool that presents no harm or risk. The harm actually comes from government agencies that are prohibiting the technology by slowing down its use and thereby limiting the information available to doctors and patients to make better decisions.
In my practice, patients expect personalized medicine and treatments customized to their unique characteristics and circumstances. Personalized care is a natural extension of advances in genomics and proliferation of sophisticated therapies. The patients are frustrated with general cookbook solutions. They do their own research on the Internet and demand that their healthcare provider tailor their care. It’s the reason so many drug companies advertise the benefits of their drugs directly to consumers. Patients read, ask questions and demand certain therapies. They object to routinized medicine imposed by regulation and oversight. They want every clinical encounter to put them in charge of their health care and do “what is needed and right.” To them, personalized medicine means that they and their doctors get the information they need, when they need it and decide for themselves how to use it.
That makes sense in the 21st century with the explosion of information technology and capability to connect individuals in ways that were unimaginable even 10 years ago. Better and timelier information and connectivity between doctors and patients can only improve healthcare. Politicians and bureaucrats in Washington should stay out of the patient’s way and stop trying to post speed limits and toll booths on the information highway. They can deliver improvements now and step aside from the politics.
Dr. Xenakis is a retired Army Brigadier General and the founder of the Center for Translational Medicine.