There has been plenty written about the dangers of Opioids. I have written repeatedly about the challenges Opioid use has affected. Florida, and much of America, is experiencing far too many Opioid overdoses and deaths. And, some of the patients are repeat customers. There have been reports of patients saved repeatedly from an overdose, some needing help more than once in a day (Boynton Beach, 2017), and another needing reviving twice in a 12-hour period (the first required hospitalization, Flagler County, 2018).
Jacksonville News 4 reports that city is spending $15,000 a month ($180,000 annually) purchasing the Narcan it uses for such events. The population of Jacksonville is about 1.5 million, the population of Florida is about 22 million. In a non-scientific thumbnail, using Jacksonville's estimate and its 7% of the state's population, the Narcan expense might be as high as $2.6 million a year statewide. overdose is expensive in impacts on lives and finances.
I was somewhat surprised recently to hear a radio host decry the efforts of state leadership to combat the problem. He criticized the recent limitation on prescriptions and excoriated the attorney general's lawsuit against opioid manufacturers. His polestar was essentially that any and all decisions about treatment should be between the doctor and patient. Limits on pain pills are anathema to him. One statement was essentially that the government should get out of the way of physicians.
The radio host is not alone. There are various critics of constraining pain medication access. And, there are some tragic outcomes. A Vermont man committed suicide when denied pain medication. Some contend that "millions of patients who are dependent on painkillers are being abandoned by the medical system." Last spring the Washington Post labeled this Unintended Consequences. That article features a patient driving 367 miles monthly to obtain "an opioid prescription no doctor nearby would write." Is there room to discuss whether that patient experience is because that prescription is itself inappropriate, or whether regulations or prosecutorial fear are precluding an otherwise appropriate prescription?
Coincidentally, a psychiatrist recently penned an opinion piece published by Florida Politics that took a similar tone regarding drugs used to treat opioid addiction. He asserts that there is a process "systematically denying physicians the option of offering patients an FDA-approved and widely accepted opioid addiction medication." The article stresses that this limitation exists despite "several (alternative medications) that are currently in use and are considered effective." There is no criticism of the one that is approved, but the doctor stresses that "different patients react differently to different medications," suggesting that perhaps other medications might be better suited to a particular patient's needs.
Thus, some want the government out of the pain medication regulatory process. Others want the government out of the process of treating those who have become dependent on those medications. There are critics, it seems, in all directions. And in the midst, people continue to have pain, and too many are dying.
In the midst of considering these recent pain stories, a WorkersCompensation.com story caught my attention: California Startup Wins FDA Pain Device Challenge. This documents a contest directed at the "FDA's ongoing commitment to address the opioid crisis." The Food and Drug Administration (FDA) effort:
"was intended to spur the development of medical devices, including digital health technologies and diagnostic tests, that could provide new solutions to detecting, treating and preventing addiction, addressing diversion and treating pain"
The contest attracted 250 entrants. Submitted solutions included medication dispensers to control dosage, virtual reality, magnetic stimulation, overdose detection, and more. Eight were selected for recognition. This is out-of-the-box thinking to address a clear issue. The fact is pain exists. If you doubt it, try it (most will not want to try it, empathy is better). There is support that pain can become chronic, and that our bodies can adjust to (adapt to) modalities like opioids, thus perhaps leading to increased dosages of pills. It is a conundrum to be sure.
But solutions are somewhat elusive. A colleague recently sent me an article from the Associated Press (AP) regarding a South Carolina man seeking pain relief. He was prescribed a "medical device" that "wouldn’t fix the nerve damage in his mangled right arm," but "would cloak his pain, making him 'good as new.'” It is a story of alternatives, promises, and ultimately failure.
Instead of miraculous relief, this patient today says he is "a prisoner in his own bed, barely able to get to the bathroom by himself." The device was a "spinal cord stimulator," and the Associated Press claims "medical device companies and doctors have touted" them "for years" as "a panacea for millions of patients suffering from a wide range of pain disorders." It claims that they are "one of the fastest-growing products in the $400 billion medical device industry."
The AP says that the FDA tracks patient complaints about "4,000 types of devices." Of those, these stimulators "account for the third-highest number of medical device injury reports," amounting to "80,000 incidents flagged since 2008" (the last ten years). That is a small percentage, however, as "some 60,000 are implanted annually." If that rate has been consistent since 2008, that is about 600,000 of the devices implanted, and the 80,000 complaints amount to about 13%. It is unlikely each of those is as serious as the example reported by the AP. Is that an acceptable rate of discontent?
The AP contends there are broader issues with the FDA complaint and regulatory processes, including:
Devices are rarely pulled from the market, even when major problems emerge.
(FDA pushes) devices through an abbreviated approval process, then responds slowly when it comes to forcing companies to correct sometimes life-threatening products.
Proponents, however, claim that new devices are safe and that the approval process is appropriate. Critics complain about the volume of dissatisfied, and sometimes more profoundly affected, patients. It is clearly an area in which there is disagreement and various perspectives. Should that be a concern as various companies race to deliver new options to those fighting pain?
Another idea is revising medication recipes to achieve pain relief without addiction. The news has been focused recently on one, "called AT-121." It "successfully relieved pain in rhesus monkeys without resulting in harmful side effects or causing the monkeys to become addicted." And it is not alone. Another touted by the news is NFEPP, which has been shown to have "dampened pain responses." And, there are more. Many show promise, but none yet "the" solution. Perhaps that thinking, that there is one be-all and end-all is fallacious? Maybe such a "the" solution mindset is an unattainable goal?
These news reports suggest that many are working on some solution to ameliorate pain. Those solutions may include new chemical recipes or new devices. The consensus is clear, pain must be addressed, without causing harm in the process.
It is a major issue for the workers' compensation industry, where injuries and pain are fundamental, daily, and too often debilitating. But it is, of course, a broader issue. It is complicated by the simple fact that each of us perceives and reacts to pain in our own way. We have similarities certainly in our biology and neurology, but each of us is unique, at least somewhat. Thus, the astonishing spectrum of suggested tools to manage pain. Note for example the various forms that opioids are marketed under (20 main types, 40 name-brand combinations, and more generics according to RehabCenter.net). Even within a subset of treatment alternatives, opioids, there is great variety and diversity.
The end of this discussion is troubling. First, there is a reality that people experience pain. Patients were led to opioids in the 1990s, doctors embraced opioids (some believe foolishly), and there was hope, belief, and unrequited trust. That approach ended in disappointment, overdose, and death for too many. The Cato Institute reported last month that deaths continue to rise despite the recent recognition and efforts. 70,000 Americans died from overdose in 2017. How many more were close, saved by some fortuitous delivery of Narcan, a similar miracle?
The medical community is awakened to the need for alternatives, and the news of those efforts is encouraging. But some of those remain hopes for the future while we are cautioned that others may be exchanging one problem or side effect for another, as illustrated by the stimulator news above. Doubtlessly, time will bring alternatives and progress. However, there are people who are in need of relief today.
The sense of immediacy cannot be ignored. Patients, families, businesses, and communities need solutions. Solutions that provide a measure of pain relief and which do not present an untoward level of risk for malfunction, addiction, or other complications. That there is ongoing effort and even progress may be of little solace to those with chronic, debilitating, pain today. As we focus on the new start of 2019, it is time for a redoubled effort to find and implement relief that is compassionate, effective, and safe. This is not an insurmountable challenge unless we let ourselves believe it is.
