Commentary

FDA Approves Esketamine For Depression; Commissioner Gottlieb Leaving

The Food and Drug Administration yesterday approved the use of esketamine -- a nasal spray similar to the anesthetic and party drug ketamine that Johnson & Johnson will market under the name Spravato -- for people suffering from chronic depression.

In other news, Scott Gottlieb, a medical doctor and former pharmaceutical company executive who proved to be a surprisingly fervent regulator of e-cigarettes, is resigning as FDA commissioner for personal reasons.

“Of the 16 million American adults who live with depression, as many as one-quarter gain little or no benefit from available treatments, whether drugs or talk therapy. They represent perhaps the greatest unmet need in psychiatry,” Benedict Carey writes for the New York Times about the FDA’s approval of Spravato. 

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Patients who have not responded to “at least two antidepressant treatments given at adequate doses for an adequate duration” are considered to have treatment-resistant depression and will be eligible for trying esketamine, according to the FDA’s news release.

“The nasal spray from Johnson & Johnson is a chemical cousin of ketamine, which has been used for decades as a powerful anesthetic to prepare patients for surgery. In the 1990s, the medication was adopted as a party drug by the underground rave culture due to its ability to produce psychedelic, out-of-body experiences. More recently, some doctors have given ketamine to people with depression without formal FDA approval,” the AP reports on CBSNews.com.

“As the first new type of antidepressant since Prozac was released more than 30 years ago, the drug was given a ‘breakthrough therapy’ designation and fast-tracked through the approval process,”  Hannah Kuchler writes for Financial TImes

“Clinical trials showed the spray could have an effect in as little as two days. In longer-term trials, patients taking the spray on top of their existing antidepressant showed statistically significant delays in relapsing into depression. But the risk of serious side effects -- most notably sedation and dissociation -- means the drug will have to be administered in a doctor’s office or clinic, and patients will have to be monitored for two hours after receiving the dose,” Kuchler adds.

“Thank goodness we now have something with a different mechanism of action than previous antidepressants,” Dr. Erick Turner, a former FDA reviewer and an associate professor of psychiatry at Oregon Health & Science University tells the NYT’s Carey. “But I’m skeptical of the hype, because in this world it’s like Lucy holding the football for Charlie Brown: Each time we get our hopes up, the football gets pulled away.”

Meanwhile, FDA commissioner Gottlieb, who has sounded alarm bells regarding the pervasive growth of teen vaping across the U.S., says he will be leaving the FDA next month, after less than two years on the job.

“The 46-year-old physician, millionaire and cancer survivor known for a self-assured, sometimes brash, manner lives in Westport, Conn., with his wife and three daughters -- 9-year-old twins and a 5-year-old,” write the Washington Post’s Laurie McGinley, Lenny Bernstein and Josh Dawsey.

“It was a very hard decision,” Gottlieb tells them. “This is the best job I will ever have. I’m leaving because I need to spend time with my family. I get home late Friday, work on weekends and come back to Washington on Sunday. I did the job 100%.”

Two months ago, Gottlieb adamantly denied in a tweet that he was thinking of leaving the agency after hearing “from friends contacted by an online pharma news pub that’s preparing a story speculating that I’m leaving #FDA.”

Indeed, “the resignation took some senior FDA officials by surprise, and came as Gottlieb’s signature issue -- youth vaping -- is being reviewed by the White House Office of Management and Budget. The plan, detailed by Gottlieb last fall, would sharply restrict the sale of flavored e-cigarettes to curb a surge in underage vaping, which he argues could lead to a whole new generation addicted to nicotine,” McGinley, Bernstein and Dawsey add.

A heap of praise for Gottlieb on Twitter was “sprinkled with a few dissenting opinions,” Megan Thielking reports for Stat.

“Some in the public health and health policy communities praised his work on vaping, drug pricing, and other issues. Others said they would miss his approach to overseeing drug approvals and his efforts to publicly promote vaccinations. But he also faced criticism for not acting aggressively enough to address the rise in vaping among teens, for the agency’s controversial approval of a new opioid painkiller, and for being too close to the pharmaceutical industry,” Thielking writes, posting examples for each point.

President Donald Trump tweeted that Gottlieb “has helped us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. He and his talents will be greatly missed!” HHS secretary Alex Azar called Gottlieb “an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation.”

But the advocacy group Public Citizen was not smitten in the least: “Scott Gottlieb was entangled in an unprecedented web of Big Pharma ties. Good riddance.” 

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