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

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.[1],[2],[3] 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.[4]

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.[5]

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.[6] 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. 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.[7]

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."[8]

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

References

[1] Murphy SL, Xu J, Kochanek KD, Arias E. Mortality in the United States, 2017. NCHS Data Brief No. 328, November 2018. https://www.cdc.gov/nchs/data/databriefs/db328-h.pdf. Accessed December 5, 2018.

[2] Centers for Disease Control and Prevention. Mortality in the United States, 2016. December 21, 2017. https://www.cdc.gov/nchs/products/databriefs/db293.htm. Accessed December 5, 2018.

[3] Centers for Disease Control and Prevention. Mortality in the United States, 2015. December 8, 2016. https://www.cdc.gov/nchs/products/databriefs/db267.htm. Accessed December 5, 2018.

[4] 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 5, 2018.

[5] Ibid.

[6] Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s approval of Dsuvia and the FDA’s future consideration of new opioids. November 2, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624968.htm. Accessed December 5, 2018.

[7] Public Citizen. Letter to the Food and Drug Administration opposing approval of Dsuvia. October 18, 2018. https://www.citizen.org/sites/default/files/2451.pdf. Accessed December 5, 2018.

[8] Public Citizen. Press release: FDA makes wrong call; super-strong opioid medication will be abused and kill people. November 2, 2018. https://www.citizen.org/media/press-releases/fda-makes-wrong-call-super-strong-opioid-medication-will-be-abused-and-kill. Accessed December5, 2018.