By Maggie Lu
With a 29% rate of misuse and $78.5 billion dollars spent annually to combat it, the opioid crisis in the United States is only escalating in its devastation, currently claiming the lives of over 90 victims a day. What’s worse is that in November 2018, FDA approved a new synthetic opioid drug, Dsuvia, that is ten times stronger than previous fentanyl opioid drugs. Despite vocal opposition including Brown and Kentucky University professors, the FDA commissioner has held firm on his stance for approving the drug. With positions on both ends of the spectrum, Dsuvia remains a controversial issue in regards to its social impacts on present and future US health administration.
Last year, Congress passed legislation to combat the nation’s opioid epidemic. The Comprehensive Addiction and Recovery Act (CARA) that became law in 2016 authorizes over $181 million each year for education and prevention programs. After declaring the opioid crisis a public health emergency, President Trump signed into law H.R. 6, the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act,” which tackles the opioid crisis by cutting the supply and access to opioids as well as augmenting prevention, treatment and recovery services.
However, passing legislation is not effective when FDA still continues to approve fentanyl painkillers that do more harm than good. Despite an addictive compound called Sufentanil, former FDA commissioner Scott Gottlieb affirmed that Dsuvia’s “unique features” have a “specific and important role.” One unique feature that he brings up is that the medicine is well suited for military members, who may be incapacitated and therefore need sublingual “under the tongue” administration of the medicine. While Gottlieb affirms that Dsuvia is is useful because of its unique sublingual administration, he also acknowledges that its usefulness is very specific to military members and therefore rather “limited”.
Anesthesiology Professor at the University of Kentucky, Raeford Brown, wrote an open letter denouncing the drug in light of the already dire opioid public health crisis. Apart from its limited applications he also notes serious health hazards to consider like “respiratory depression” and the fact that “abusers of this intravenous formulation often die when they inject the first dose.”
Brown University Professors Michael Bernstein and Francesca Beaudoin also agree that the risks of Dsuvia potentially outweigh the benefits. In their view, Dsuvia’s application in the military field is definitely warranted, but the drug’s approval may have been premature. Before it should be used in medical settings, there needs to be concrete evidence that Dsuvia is safer than existing alternatives. However, Gottlieb believed that Dsuvia will be “safer” because it will be tightly regulated by AcelRx’s REMS, Risk and Evaluation Mitigation Strategy, which includes measures like Dsuvia not being used for more than 72 hours, no take-home use, and only in a single-dose applicator. According to The New York Times, Dsuvia will carry a “boxed warning” to warn of the serious side effects like respiratory depression, unconsciousness, and death. The FDA also pledges to thoroughly monitor the implementation of the REMS by working quickly to make regulatory adjustments if problems arise.
While the FDA pledges to thoroughly monitor drugs, they have been lax in the past with similar potent drugs. Will vague actions like pasting a “boxed warning” and “tight regulation” achieve their desired effect? Skeptics can’t help but question this, because similar “tight restrictions” failed to do their job on other opioids that are currently being wrongly prescribed and uncurbed by the FDA, such as a class of fentanyl drugs approved for cancer patients only. According to The New York Times, after two car accidents, a woman needed pain medication; she was given a specific type of fentanyl drug, which is only intended for cancer patients due to its extreme potency, and died with extremely high blood levels of fentanyl. Instead of tightly regulating the distribution of the drug themselves, FDA entrusted the regulation of these drugs to a group of pharmaceutical companies that make and sell the drugs, causing a death that could have been avoided if the correct prescription had been given to her.
Apart from the lack of responsibility on the FDA’s part, there is the problem of the people themselves lacking responsibility by abusing harmful drugs knowingly and willingly to get high. Opana ER is a form of opioid that was approved in 2006 for painkiller usage. Abuse began when drug users used it for pleasure instead by crushing, snorting, and injecting it. The parent company did try to curb the abuse of the drug by replacing the original drug with a form that was meant to make the pills harder to crush or dissolve into liquid, but users found other ways to snort or inject it, and the problem remained unmitigated until the parent company took it off the market. Indeed, not only has the FDA failed to regulate opioid abuse, but users themselves also pose an extensive risk to their own health by abusing drugs willingly.
In addition, the FDA commissioner argues that “the medicine [will be] restricted” because it will only be administered by “healthcare professionals” in hospitals and clinics. Health care professionals are not necessarily the most reliable personnel to entrust drug regulation to. In fact, a doctor from Kansas was charged with selling prescription opioids in high quantities to people without a medical need in exchange for cash, resulting in the death of an addicted patient. Selling prescription drugs outside medical practice is illegal, yet this social issue regarding opioids still is widely prevalent due to the easy cash flow generated by selling to addicted users, who will unwaveringly come back for more of the drug to feed their addiction. The lingering questions on how to regulate illegal sale of prescription drugs, prevent abuse from addicted users, and even correct the FDA’s own lack of responsibility in curbing prescriptions all render the approval of yet another potent opioid, Dsuvia, deeply controversial.
Whether one looks at it from a biological or social standpoint, Dsuvia seems to have more capacity for harm rather than good. With its potential for addiction by the biological inducing of the midbrain reward system and negative impact on the respiratory and endocrine system, along with social issues of illegal sale of prescription drugs, FDA’s lack of regulation, and addicted users knowingly abusing opioids, the outlook for Dsuvia and the larger opioid epidemic looks bleaker than ever. According to The New York Times, opioid overdose deaths peaked to more than 40,000 last year, 30,000 resulting from fentanyl and other opioids. Dsuvia will definitely help people who actually need the drug for acute pain, but risks being abused in a country already overrun by opioid misuse. Apart from acknowledging the opioid crisis as a “public health emergency” in 2017, The US government has not been proactive in devoting more resources to combat it. Rather than letting FDA and drug companies determine how to regulate the drug, new governmental policies need to not only be enacted but enforced to start breaking down the entrenched cycle of opioid abuse.