Outrage of the Month: In Face of Raging Opioid Addiction Crisis, FDA Fuels the Fire

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Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.

 

Health Letter, January 2019

Michael Carome, M.D.

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Image: arloo/Shutterstock.com

In November, the Centers for Disease Control and Prevention reported that for the third consecutive year, life expectancy in the U.S. declined in 2017. Such a continuous multi-year decline in U.S. life expectancy — a key measure of the country’s overall public health — has not occurred since 1915 through 1918, a period that included World War I and the Spanish flu pandemic, which killed 675,000 people in the U.S.[1]

Among the many key factors contributing to this appalling downward trend in life expectancy is the opioid addiction crisis, which led to more than 47,000 overdose deaths in the U.S. in 2017 — a record high.[2] Since 1999, the annual number of deaths related to opioids has increased nearly sixfold.

Despite the clear indicators of a worsening public health emergency caused by the misuse and abuse of opioids, the Food and Drug Administration (FDA), a leading agency within the U.S. Public Health Service, on Nov. 2, 2018, made the incomprehensible and reckless decision to approve sufentanil sublingual tablets (DSUVIA), another superpotent opioid, for treatment of moderate-to-severe acute pain in medically supervised settings. The drug is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine.

Clinical trials of Dsuvia paradoxically showed that it was not very effective for treating pain following minor surgical procedures because meaningful pain relief took almost an hour to achieve. However, the drug does carry significant risks of impaired breathing, diversion, abuse and death.

In a highly unusual move, the chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, Dr. Raeford Brown, on Oct. 22, 2018, joined Public Citizen in urging the FDA to reject AcelRx Pharmaceuticals’ application for approval of Dsuvia.

Noting that strong opioids often are abused by medical personnel, Dr. Brown wrote that if the FDA approved the medication, “I predict that we will encounter diversion, abuse and death within the early months of its availability on the market.” He added that “sublingual sufentanil represents a danger to the general public health and will make our job of protecting Americans more difficult.”

In response to the FDA’s approval of Dsuvia, Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, lambasted the agency: “It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly. It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die. It is likely, if not certain, that Dsuvia will be banned after ‘enough’ such deaths occur and the inevitable House oversight hearings are held investigating why the FDA approved this opioid with no unique benefit but unique harms.”

On the day the FDA announced its approval of Dsuvia, FDA Commissioner Scott Gottlieb issued a misleading statement defending the agency’s action. He claimed, among other things, that the drug had “unique features…that make it ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible. This includes potential uses on the battlefield.”

However, as Brown and Wolfe explained in a detailed letter refuting Gottlieb’s claims, the use of Dsuvia in any setting of severe trauma-induced pain and shock, such as that encountered in the battlefield, has never been studied. Thus, there is no evidence that it is safe and effective for use in such settings.

Moving forward, the FDA must, in contrast to this case, make public health implications a primary consideration when evaluating new opioid medications.


References

[1] Bernstein L. U.S. life expectancy declines again, a dismal trend not seen since World War I. The Washington Post. November 29, 2018. https://www.washingtonpost.com/national/health-science/us-life-expectancy-declines-again-a-dismal-trend-not-seen-since-world-war-i/2018/11/28/ae58bc8c-f28c-11e8-bc79-68604ed88993_story.html. Accessed December 18, 2018.

[2] Ibid.