A potent and controversial new opioid painkiller won federal approval this month based heavily on the work of a University of Minnesota doctor with a history of paid advocacy for the pharmaceutical industry.
Dsuvia, an opioid that is five to 10 times stronger than fentanyl, won approval from the U.S. Food and Drug Administration on Nov. 2, following clinical research, advocacy and public testimony by the U's Dr. Jacob Hutchins, among others, on behalf of the manufacturer.
In an interview, Hutchins said the new painkiller is justified — even though the nation is struggling with an epidemic of opioid abuse — because it will fill a gap in hospital pain control for patients after injuries or surgeries. Research has shown Dsuvia relieves pain faster than other opioids because it is administered in dissolvable tablets rather than by intravenous lines that can be tricky for doctors, nurses or paramedics to set up.
"It fills a gap that we don't have anything else to fill with," said Hutchins, who added that he was speaking as a paid consultant for drugmaker AcelRx, and not as an anesthesiologist for the U or director of its ambulatory surgical center.
Hutchins is hardly alone among Minnesota doctors in advising or speaking on behalf of pharmaceutical companies, and he has fully disclosed his industry payments, per university policy.
The federal Open Payments database shows that drugmakers paid $40 million in 2017 to doctors and other medical providers in Minnesota for consulting, speaking fees, travel expenses, or advisory services. Sixty Minnesota doctors, including Hutchins, received more than $100,000 in compensation from manufacturers last year.
But his advocacy for Dsuvia drew attention because it was one of the most disputed drug approvals in recent years, with some substance-abuse researchers, and watchdog groups such as Public Citizen, lobbying against it for fear that it would be too easily abused.
"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly," Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, said on the day the FDA approved the drug. "It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die."
In Minnesota, the number of deaths linked to abuse of illicit or prescription opioids has increased from 54 in 2000 to 401 in 2017, according to a Star Tribune review of death records. A surge in deaths has been related to misuse of a potent version known as fentanyl, but Dsuvia contains an opioid (sufentanil) that is five to 10 times stronger.
Hutchins said concerns about the drug's strength are overblown, because the dosage is proportionately smaller in Dsuvia's sublingual (under the tongue) tablets than other opioids. In addition, the FDA limited Dsuvia to medically supervised settings such as hospitals.
"Medical professionals have access to [drugs with] a lot higher doses than this in the hospital," Hutchins said. "So there will always be the risk" of drugs being misused or abused.
Advocates supporting Dsuvia include the U.S. military, which joined with AcelRx in financing a clinical trial in 2017 by Hutchins and colleagues that showed Dsuvia controlled pain safely and could be advanced for FDA approval. The military has sought an opioid that could be administered more quickly than IV pain medications to manage battlefield injuries.
Hutchins testified in support of Dsuvia to an FDA drug advisory committee on Oct. 12, as did Dr. James Miner, the chief of emergency medicine at Hennepin Health in Minneapolis. Miner conducted a separate study funded by AcelRx and the U.S. Army that showed that Dsuvia quickly managed pain for ER patients.
As many as one in four IV vein placements fail initially, which delays pain relief and increases anxiety for ER trauma patients, Miner said in his testimony. "The sublingual route would allow us to relieve their pain earlier. … This would be especially important in trauma and burn patients during the initial minutes of their treatment."
AcelRx paid for the doctors' travel to the hearing. Exactly how much the company has paid either one is unclear. Because the company wasn't manufacturing an FDA-regulated product until now, it hasn't been required to report how much money it gave to doctors to speak on its behalf. The latest Medicare Open Payment data is from 2017
"We will have a covered product next year and will begin reporting in 2019," said Jon Saia, AcelRx's general counsel.
A safer opioid?
Miner, whose only drug company compensation in 2017 was a $113 meal reimbursement from CSL Behring, said it is fair to note when doctors have potential conflicts of interest. However, he said it's folly to think that doctors would be influenced to the point of backing a drug that could be dangerous.
"We wouldn't support it if it was going to be less safe. It's the last thing we want," he said.
Hutchins generated controversy in 2016 when he gave patients an anesthetic drug, Exparel, in an off-label and FDA-rejected use to provide long-acting postoperative pain relief. Some colleagues criticized Hutchins for using the drug in this way — and telling colleagues to do the same — while being paid by Pacira, the drug's manufacturer.
Hutchins said he hasn't wavered from his decision to accept industry money to speak to colleagues nationally about drugs and drug uses in which he believes — and doesn't hesitate to recommend a rival drug when he thinks it's better.
His advocacy for the off-label use of Exparel, he said, was in part to control post-surgical nerve pain and reduce patients' need for addictive opioids.
Dsuvia might reduce overuse of opioid pills as well, he added. Doctors often prescribe high doses of such pills when transitioning surgery patients off IV painkillers, then neglect to reduce the dosages in the take-home prescriptions. Dsuvia tablets could be a transitional painkiller, he said, and result in patients receiving lower initial doses of pills when they go home.
"I am 100 percent anti-opioids as much as possible, and really want to fight this crisis," he said. "But as much as I'd love that we could be opiate free 100 percent, that's just not possible. After big surgeries, and acute fractures, opiates are the best things that we have."