dChan - Q Origins Project Archive

The FBI called a powerful opioid developed for the military a public threat. The company selling the drug says it'll save lives.

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 had long believed that the drug agency had scheduled the critical vote specifically for a date when he couldn’t attend. He had asked the FDA to move the meeting, and agency officials had refused, he later recalled.

A few weeks later he was working from his home office in Lexington, Ky., when Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, called to tell him that Dsuvia had just been officially approved.

“I told her that I thought that was a bad decision,” Brown, an anesthesiology professor and clinician at the University of Kentucky, said in a recent interview. “I told her exactly why.”

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.

Woodcock, according to Brown, said there had been pressure from the Pentagon to approve the drug, which the military had paid to help develop. “It was her trying to get me to shut up,” he said.

Dsuvia, which is delivered as a pill that is smaller than a Tic Tac, is a close chemical relative of fentanyl. A Drug Enforcement Administration scientist recently testified that it is 1,000 times stronger than morphine. Brown’s opposition to Dsuvia was based on the belief that approving this new drug, amid a nationwide opioid epidemic, would lead to more addictions and deaths.

It turns out he was not alone in his concerns.

Just six months later, in May 2019, the FBI, in an intelligence bulletin marked “for official use only,” warned that this new painkilling drug would likely exacerbate the nation’s opioid crisis.

The FBI warning about Dsuvia was dire. “Because of its potency, Dsuvia likely will cause deaths at a rate surpassing that associated with fentanyl, increasing the overall opioid-related death rate in the near term,” said the bulletin, which was obtained by Yahoo News and has not previously been made public.

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. They are outraged that the FDA would approve a highly potent new opioid at a time when a nationwide epidemic is raging.

https://www.yahoo.com/news/the-fbi-called-a-powerful-opioid-developed-for-the-military-a-public-threat-the-company-selling-the-drug-says-itll-save-lives-090041326.html