A powerful and controversial new opioid analgesic has been approved by the federal government this month, largely thanks to the work of a doctor from the University of Minnesota, who has always worked to defend the interests of the pharmaceutical industry.

On November 2, Dsuvia, an opioid five to ten times stronger than fentanyl, was approved by the US Food and Drug Administration, following clinical research, public awareness campaigns and public testimony by Dr. Jacob Hutchins, Dr. U., On behalf of the manufacturer.

In an interview, Hutchins said the new painkiller was warranted – even though the country was struggling with an epidemic of opioid abuse – as it would fill a gap in pain control at home. hospital for patients as a result of injuries or surgeries. Research has shown that Dsuvia relieves pain faster than other opioids because it is administered in soluble strips rather than intravenously, which can be difficult to put in place for doctors, nurses or paramedics.

"This fills a gap that we have nothing else to fill," said Hutchins, adding that he was speaking as a paid consultant to the drug maker AcelRx, and not as a Anesthetist for the U or director of his ambulatory surgery center. .

Hutchins is hardly the only one among Minnesota doctors to advise or speak on behalf of pharmaceutical companies, and he has fully disclosed his payments to the industry, by university policy.

Federal Open Payments database shows drug companies paid $ 40 million in 2017 to doctors and other medical providers in Minnesota for counseling, speech fees, travel expenses or consulting services . Sixty Minnesota physicians, including Hutchins, received more than $ 100,000 in manufacturers' compensation last year.

But his advocacy for Dsuvia drew attention because it was one of the most controversial drug approvals in recent years. Drug addiction researchers and surveillance groups such as Public Citizen have lobbied to make him fear of being abused.

"It is certain that Dsuvia will worsen the epidemic of opioids and will kill people unnecessarily," said Dr. Sidney Wolfe, founder and senior advisor of Public Citizen's health research group, on the day of the outbreak. Drug approval by the FDA. "It will be taken by medical staff and by other people for whom it has not been prescribed, and many of them will overdose and die."

In Minnesota, the number of deaths related to illicit or prescribed opioid abuse has increased from 54 in 2000 to 401 in 2017, according to a Star Tribune death registry study. The increase in the number of deaths is related to the misuse of a powerful version called fentanyl, but Dsuvia contains an opioid (sufentanil) five to ten times more potent.

Hutchins stated that concerns about the strength of the drug were exaggerated, as the dosage was proportionally smaller in Dsuvia's sublingual (under the tongue) test strips than in other opioids. In addition, the FDA has restricted Dsuvia to facilities under medical supervision, such as hospitals.

"Health professionals have access to [drugs with] doses much higher than that at the hospital, "said Hutchins. So, there will always be the risk of "misused or abused drugs.

Among the supporters of Dsuvia are the US military, which has teamed up with AcelRx to fund a 2017 clinical trial by Hutchins and colleagues that showed Dsuvia was controlling pain safely and could be subject to approval. from the FDA. The military has been looking for an opioid that can be given faster than intravenous pain medications to treat battlefield injuries.

Hutchins testified in favor of Dsuvia before an FDA Drug Advisory Committee on Oct. 12, as did Dr. James Miner, Chief of Emergency Medicine at Hennepin Health in Minneapolis. Miner conducted a separate study funded by AcelRx and the US military that showed that Dsuvia was managing the pain of emergency patients quickly.

At first, not less than one in four intravenous implantation failed, delaying the relief of pain and increasing anxiety in traumatized patients, said Miner in his testimony. "The sublingual route would allow us to relieve their pain earlier, which would be particularly important in case of trauma and burns in patients during the first few minutes of their treatment."

AcelRx took care of moving the doctors to the audience. It is unclear exactly how much the company has paid for one or the other. Since the company did not manufacture an FDA regulated product to date, it was not obliged to report the amount of money that it gave to doctors to talk about. in his name. The latest Medicare Open Payment data is from 2017

"We will have a product covered next year and we will start reporting in 2019," said Jon Saia, General Counsel of AcelRx.

A safer opioid?

Miner, whose sole compensation to pharmaceutical companies in 2017 was a $ 113 meal refund by CSL Behring, said it was right to note that potential conflicts of interest existed between doctors . However, he said that it is absurd to think that doctors would be influenced to the point of supporting a drug that could be dangerous.

"We would not support it if the system was less secure, it's the last thing we want," he said.

Hutchins sparked controversy in 2016 when he administered to his patients an anesthetic drug, Exparel, in the context of an unnoticed use on labels and rejected by the FDA for the purpose of relieving postoperative pain long-lasting action. Some colleagues criticized Hutchins for using the drug in this way – and for telling his colleagues to do the same – while he was paid by Pacira, the drug's manufacturer.

Hutchins said that his decision to accept money from the industry to discuss with colleagues nationwide about drugs and drug use that & # 039; 39 he believes – and does not hesitate to recommend a competing drug while he thinks it's better.

His plea for an unnoticed use on Exparel's label, he said, was aimed in part at controlling post-surgical nerve pain and reducing the need for it. opioids causing addiction of patients.

Dsuvia could also reduce the excessive consumption of opioid drugs, he added. Doctors often prescribe high doses of such pills during the transition of pain patients with intravenous pain medications, and neglect to reduce the doses in take-out prescriptions. Duvia's strips could be a transition painkiller, he said, and would give patients initial doses of weaker pills once they get home.

"I am 100% anti-opioid and I really want to fight this crisis," he said. "But as much as I wish we could be 100% opiate-free, it's just not possible." After major surgeries and acute fractures, opiates are what there is has better. "