The U.S. Must Move Away From a "One Size Fits All" Policy...

I started to title this post "The Federal Government Must Move Away From a 'One Size Fits All' Policy..." but changed it at the last moment to widen it in scope. Please read on.

Drones are taking off (pardon the pun) around the world, yet in the U.S. they are being stifled by regulatory oversite by the FAA. In Africa drones are being used for critical life saving needs, such as vaccine and medication delivery, where the infrastructure delivery does not exist. Never mind Amazon delivery, suppose you need rabies vaccine or snake antivenom in a region where it is not cost effective, or where hospitals don't exist, to stock it? Such needs are driving the innovation of new drone platforms and systems.

Yet here in U.S. where you would expect innovation to be highest, the FAA is stifling development by assuming a risk model that is not appropriate for drones. Such is the conclusion by the National Academies of Sciences, Engineering and Medicine. A new Congressionally mandated report concluded that the FAA is using a near-zero risk model, designed for passenger aircraft, to evaluate the safety of drones.

“FAA needs to accelerate its move away from the ‘one size fits all’ philosophy for UAS operations,” said George Ligler, proprietor of GTL Associates and chair of the committee. “The FAA’s current methods for safety and risk management certainly ensure safety within the manned aircraft sector, but UASs present new and unique challenges and opportunities, which make it important for the agency to take a broader view on risk analysis.”

The FAA has brought near perfect safety to the U.S. aircraft industry. This past April, a passenger on a Southwest Airlines flight was killed after the left engine failed. It was 2012 when last a passenger fatality occurred. This safety/risk model has been exported to the world, with a resulting reduction in accidents and deaths, and an incredible rise in safety:

No one would want this safety model to be loosened for passenger aircraft. But applying the same risk model to small drones is inappropriate, and it is stifling the development of drone business in the U.S. where our technology should lead. And what about cost effectiveness? We need infrastructure investments to repair our aging bridges and roads, but if drone delivery could reduce the requirements for ground traffic, would we need to invest as much in the continuing expansion of roads to accomodate delivery vehicles?

This brings to mind another example where the U.S. has implemented a "One Size Fits All" policy: the current opioid epidemic. Deaths due to overdose more than tripled between 1999 and 2016, according to the CDC. The reasons for this, we are told, include the increase in the rate of prescription of opioids for pain, and the increased availability of prescription opioids produced by pharmaceutical companies.

In response, the CDC created guidelines for the prescription of opioids by general practitioners for chronic pain. A CDC report analyzed the incidence of chronic pain in the U.S. and concluded that in 2016 approximately 20% (~50M) of Americans experienced chronic pain, and ~8% (20M) had high-impact chronic pain. Pain is the most frequent cause for patients to contact a physician. The cost of chronic pain in the U.S. was thought to be as high as $635B in 2012.

The issue is even more complicated: The CDC admits that its statistics are poor, because reporting agencies may lump overdose deaths from street drugs, such as heroin and street fentanyl, with those of prescription overdoses. Worse, non-opioid street drugs like cocaine and methamphetamine are being cut with fentanyl, confusing the statistics.

Even that simple model of physicians prescribing too many pain pills is not simple. The number of physicians sanctioned for over-prescribing is low, yet it has caused a real problem of care for physicians caring for chronic pain patients. Many chronic pain patients are having difficulties finding a physician for treatment.

The CDC guidelines for prescribing for chronic pain were written for general practice physicians treating chronic pain. General practice physicians do not receive specialized training for treating pain, nor for prescribing for chronic pain. But many state legislatures and state medical boards have adopted the CDC guidelines as hard and fast rules for all physicians, including pain management physicians who are specifically trained (and in practice) to treat pain, primarily chronic pain, since acute and postoperative pain are generally treated in the ER and hospital, respectively.

The result: chronic pain patients being under or not treated at all. This has lead to a rise in chronic pain patient suicide.

No one wants the opioid crisis to get worse. Yet it is clear (to this author) that there are too many "One Size Fits All" policies being applied in an attempt to "cure" the opioid crisis. Yet the essence of physician practice is the individual treatment of each patient, crafting a treatment plan that is specific to their condition and needs. Like the drone policy, we need better in the U.S. if we are to lead in not only technology but patient care.