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Gottlieb Dead Wrong on Lethal, Highly Addictive Medication

Dec. 11, 2018

Gottlieb Dead Wrong on Lethal, Highly Addictive Medication

Dsuvia Will Be Abused, Not Help Injured Soldiers, Public Citizen Says

WASHINGTON, D.C. – Scott Gottlieb, the head of the U.S. Food and Drug Administration (FDA), is misleading the public regarding potential “unique” benefits of a controversial, highly potent opioid pain relief medication, Public Citizen and the head of a key FDA advisory committee said today in a letter (PDF) to Gottlieb.

The FDA approved the medication, called sufentanil sublingual tablet (brand name Dsuvia), on Nov. 2 to be used to treat moderate-to-severe acute pain in a medically supervised setting. It is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine.

Public Citizen and Dr. Raeford Brown, chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, warned the agency in October (PDF) not to approve the medication. Brown’s public stance was highly unusual because he bucked his committee’s recommendation and publicly warned against allowing Dsuvia on the market.

In a statement issued on the day the agency approved the medication, Gottlieb cited nonexistent benefits for Dsuvia and omitted known risks.

Gottlieb said that Dsuvia could help treat soldiers “on the battlefield”; however, the use of Dsuvia in any setting of severe trauma-induced pain and shock, as encountered in the battlefield, has never been studied. Clinical trials of the medication have been conducted only on patients who had undergone minor surgical procedures.

In a Dec. 11 interview with StatNews investigative reporter Ed Silverman, Gottlieb said, “I don’t want to say (Dsuvia) was only approved because we thought it had application in battlefield settings… but this was a product priority for the military.”

But Dsuvia can take up to an hour to achieve clinically meaningful pain relief, unlike intravenous pain relief provided by other medications, suggesting the pill would not meet either the needs of seriously injured soldiers or even post-operative patients in hospitals.

The commissioner also said “very tight restrictions” would be placed on the distribution and use of Dsuvia to reduce the risk of misuse. However, Gottlieb provided no examples, and none are known to exist, of a currently approved opioid not being abused, no matter the number of “restrictions.”

Dr. Sidney Wolfe, founder and senior adviser for Public Citizen’s Health Research Group, said that “Dr. Gottlieb has previously given eloquent speeches, acknowledging the life-taking seriousness of the opioid epidemic and the FDA’s future plans for dealing with it. And on the day of Dsuvia’s approval, Gottlieb stated, ‘We won’t sidestep … the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction.’”

“But in the same statement,” said Wolfe, “Gottlieb dodged the obvious, public health-oriented answer to this question – NO – citing nonexistent unique benefits for Dsuvia, but entirely omitting mention of the known risks of doctor diversion and life-threatening abuse of the previous intravenous version of sufentanil. All of this represents a pitifully unconvincing effort by Gottlieb to justify its dangerous, unacceptable approval.”

Added Brown, “Some have suggested pressure by the U.S. Department of Defense to approve this formulation. Unfortunately, the desire to obtain a quick fix for a problem that may not have been real—lack of the availability of rapid, potent battlefield analgesia—was not investigated in the run-up to the approval. No clinical trials emulated battlefield conditions, and the assertion that this formulation would be useful in patients with multitrauma or shock was never demonstrated. Our troops deserve the best that we can give them. Dsuvia is not even an approximation of what is required to treat the acute pain of battlefield injury.”

Read the full letter (PDF.)