In October 2018, Dr. Raeford Brown was attending a meeting of the American Society of Anesthesiologists in San Francisco when, back in Washington, the Food and Drug Administration advisory committee he headed met to review Dsuvia, a powerful new opioid.
Brown, who until recently headed the FDA’s advisory committee on analgesics and anesthetic drug products, was upset. In his absence, the committee had voted 10-3 to recommend approving Dsuvia, which likely influenced the FDA’s final decision. Members of Congress, patient safety experts and public health advocates share the FBI’s worry and say that with several hundred opioids already on the market there is no need for another one. The drug’s critics point out that Dsuvia may be particularly dangerous because it is available only in a single dosage, and therefore can’t be adjusted for a given patient’s weight or overall health.
The controversy over Dsuvia, a synthetic opioid, illustrates the competing pressures of a country whose attention has turned from an opioid epidemic to a coronavirus pandemic in the course of just a few months. The government spent several years trying to crack down on painkiller abuse and limit production, and now hospitals are seeing shortages of some opioids needed to intubate patients.
“When I arrived in Iraq, three months after we had gone over in 2003, that was the only drug we had for pain at the time, and it was not optimal for the environment that we were working in then,” recalled Buckenmaier, a retired colonel who is now director of the pain clinic at Walter Reed National Military Medical Center, in an interview with Yahoo News. “And so the need was clearly defined. That was obvious to everybody.
The answer, she thought, might be a drug called sufentanil, which could be delivered in pill form and thus, Palmer said, would not be as likely to trigger an accidental overdose. “Everyone would take a pill if they could,” she said, “if it worked as well and as quickly.” Buckenmaier, according to Palmer, said he loved her idea of using sufentanil, but the military needed something twice as strong. Medics couldn’t realistically re-up individual soldiers’ pain medication every 20 minutes during a combat fight.
While battlefield deaths may have been declining, the Pentagon was still looking at how it dealt with pain from injuries. One increasingly popular option was ketamine. Military medical specialists describe ketamine as a nearly ideal battlefield drug, due to the fact that it does not slow breathing or lower blood pressure the way narcotic opioids do. It is also relatively inexpensive and easy for medics to carry.
The committee also recommended that military health leaders “explore all options” and make intramuscular ketamine auto-injectors and intranasal ketamine available to medics treating injured soldiers in the battlefield. A comparison study should have been “funded as a high-priority item, and it wasn’t,” the military official said.
By the time AcelRx was ready to submit for FDA approval, in 2017, the situation for the company was dire. At that point it had been in business for more than a decade, with nothing ready to market in the United States . Its fate rested largely on the FDA, and the response was not good. At one point, Defense Department allies in Congress became so frustrated by the FDA’s slow progress that they proposed shifting the authority to approve certain high-priority battlefield drugs and medical devices from the FDA to the Pentagon. “The chairman has perfect moral clarity on this provision, and there is no doubt in his mind that it is the right thing to do for the troops,” a House Armed Services Committee spokesman told Politico at the time.
“A whole new group of new people that had some history with the FDA were inserted in the line,” Brown told Yahoo News. “One has to presume that there was a reason that they didn’t want people who were going to ask hard questions to be at the meeting.” How critical the Pentagon’s support for Dsuvia was to the approval is up for debate, but the same day that Dsuvia was approved, the FDA announced a new focus on collaborating with the Department of Defense. The initial “memorandum of understanding” authorized the FDA to “expedite the development of medical products” deemed important to the military. Gottlieb, then the FDA commissioner, also appeared to indicate that the FDA decision was influenced by the Pentagon.
Opioids should be evaluated based primarily on whether they are better than what is already on the market, Gottlieb said: “In the setting of an opioid epidemic, I think the agency ought to have that authority.” Palmer insists Dsuvia won’t be easy for addicts to get their hands on. While she acknowledges that no amount of regulation can ever be foolproof, Dsuvia is available only in medical settings, and doctors can’t write prescriptions for its use elsewhere. AcelRx also created a “single-use applicator” to make it easier for hospitals and clinics to detect if doses are stolen.
The FBI appears to share those concerns. The intelligence bulletin obtained by Yahoo News stated that the agency “assumes Dsuvia’s high potency will be attractive to criminals seeking to divert and abuse synthetic opioids.” The bulletin went on to note the “historic abuse and diversion of IV sufentanil, despite the strict delivery methods and limited number of medical professionals with access to the drug. The potency and ease of administration of Dsuvia tablets increase these risks.
Back in California, the FDA approval meant things were finally looking up for AcelRx, but time was critical for the small company. With relatively little cash on hand, only two closely related opioids in its portfolio and only one with FDA approval, it was critical that the company sell something to keep itself alive.
Even so, it’s possible Dsuvia will never be widely used by the military. The Army Medical Research and Development Command doesn’t dictate what gets bought — that’s typically determined by commanders — and Dsuvia isn’t yet included in the Committee on Tactical Combat Casualty Care guidelines, and it’s unclear when that will happen, if ever.
Palmer said AcelRx also sees ERs a natural fit, though emergency medicine standard bearers have begun to warn clinicians about giving powerful opioids to patients who report to the emergency room with relatively minor trauma. “This is a no-brainer in an emergency room,” Palmer said in an interview at her office. “That’s like the battlefield except moved inside. You come in with a broken leg. You’re in a lot of pain.
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