Earlier this month, in an effort to help stem the nation’s rise in opioid addiction and overdose, Sen. Joe Manchin (D-WV) introduced a bill that purports to solve that problem. The bill would require the Food and Drug Administration to revoke the approval of one opioid pain medication for each new opioid pain medication the FDA approves for health care practitioners to prescribe.
As a practicing surgeon who prescribes pain medication for my postoperative patients, I think the senator’s proposal will not only make the opioid problem worse, but also create new problems as well.
This proposal essentially caps the number of arrows I may have in my quiver. Every patient is unique. It is not unusual for a patient in pain to have a poor response ― or even an adverse reaction ― to a pain medication that works well in most other patients. On many occasions, I need to try on my patient several different types of opioids, sometimes in combination with other types of analgesics, until I get my patient relief from pain. I need as many options as possible. Demanding the removal of one existing option for every new option that arises hampers and intrudes on my ability to complete my primary mission: the relief of suffering.
It also invites unintended consequences. Suppose a new opioid is approved that is found to be faster acting and more effective in relieving pain, yet has a higher potential for addiction and respiratory depression than those already approved. Is it really a good idea to remove from doctors’ armamentarium a less potent and less dangerous opioid to make room for the new one?
It is not rare for a newly approved drug, several months after its introduction into the marketplace, to be found to have serious adverse effects not previously demonstrated during FDA clinical trials, and then be pulled from the market by the manufacturer or the FDA.
Suppose this happens with a new opioid that replaced an older one under Sen. Manchin’s bill? Does the old one get re-approved? Or is the practitioner left with even fewer options?
Finally, if Sen. Manchin thinks that limiting the number of opioids legally available will prevent addicts from obtaining their opioid of choice, then maybe he hasn’t heard about the Heroin epidemic. Heroin was banned in the US in 1924, but remains readily available and in fact has become a popular substitute for opioid addicts who are cut off by their prescribers and turn to the black market for relief. In 1924, morphine was the most common intravenous drug to which people were addicted. When heroin was totally banned, it became much more attractive than morphine for drug dealers to promote, because they had no competition from the legitimate market, and soon heroin overtook morphine in sales.
Removing popular opioids from the legal market merely transfers drug options from health care practitioners to black market drug dealers.
Sen. Manchin’s proposal is another example of a well-intended but inappropriate intrusion into the practice of medicine and the patient-doctor relationship by people who presume the ability to engineer human behavior. I appreciate the senator’s concern, but if he is looking for an answer to the opioid abuse problem the answer lies in “harm reduction.” Let doctors be doctors. Let them exercise their professional judgment and work with patients who have opioid dependency, confidentially and compassionately.
If a doctor decides it is less harmful for the patient to get a refill of the opioid prescription than to send the patient to the street, the doctor should be able to do so.
Naloxone is an effective antidote to the respiratory depression that arises from an opioid overdose. It is available in intravenous, subcutaneous (like an insulin injection), and nasal spray form. Pharmacists should be allowed to dispense naloxone without a prescription, and naloxone should be made more readily available to first responders. This is already happening in some states, such as New Mexico.
If Senator Manchin really wants to help solve the problem, he should stop doubling down on the same strategy that has failed us since the 1920s and try something new.
