Wednesday, August 21, 2019

What Trump is Talking About


What Trump is talking about, from June 23, 2019:

Some Congressional Democrats expressed concern at the fast approval process. “I am incredibly alarmed by reporting today that suggests Spravato, a controversial new drug, is being rushed through critical reviews and may be prescribed to veterans before fully vetting the potential risks and benefits,” said Mark Takano, Democrat of California and chairman of the House Committee on Veteran’s Affairs, in a prepared statement released Wednesday.

The top Republicans on the House and Senate Veteran’s Affairs committees said this week that they had yet to take a position on the issue.

The V.A. has rushed to distribute Spravato through its system ever since the Food and Drug Administration approved the drug, in March, for severe depression. The approval stirred excitement among doctors, because it represented a new direction in depression treatment: Spravato is a nasal-spray derived from an old and widely used anesthetic, ketamine, rather than an iteration of commonly used antidepressants like Prozac.

The spray contains esketamine, an active portion of the ketamine molecule, and the recommended course is twice a week, for four weeks, with boosters as needed, along with one of the commonly used oral antidepressants.

But psychiatrists, pharmacologists and suicide experts who have seen the data presented to the F.D.A. are far from persuaded that the drug will be a game-changing addition.

“It’s doing something, all right, but it’s not all it’s cracked up to be,” said Dr. Erick Turner, a former F.D.A. reviewer and an associate professor of psychiatry at Oregon Health & Science University. “I just don’t think it’s going to live up to all the hype.”

In other words, it still needs study, and the proposal is to make veterans the guinea pigs:

“The V.A. has prioritized suicide prevention at every level, and it is in a unique position to address it in a way no one else can,” Dr. Bossarte said. “In this case, they could perform trials of this drug, so we can see who benefits and who has unintended reactions to fast-track studies, rather than have a blanket rollout policy” where everyone deemed at risk of suicide gets the drug.
Of course, Trump can't authorize the VA buying anything that Congress hasn't already provided funds for.

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