- A new anti-depression drug that is now on the market, and even some in VA can still get it. No matter that six people died in the only - one - small trial (all lived who received the placebo).
Experts question Esketamine (Spravato) safety and effectiveness.
By Peter Cary, reporter - Public Integrity.org - June 21, 2019
Excerpts:
A Department of Veterans Affairs panel has pushed back against efforts to rush a controversial anti-depression drug into use for its patients, voting not to include the drug, Spravato, on its list of drugs available through prescription at its pharmacies. . . .
. . . The “No” vote, which occurred Thursday, is likely to be a blow to Janssen Pharmaceuticals, the drug’s maker, and its parent, Johnson & Johnson, which hopes Spravato will be a $600 million blockbuster by 2022. . . .
. . . Despite claims by Janssen and the FDA that the drug is fast and effective, some psychiatrists said they had concerns about balancing the drug’s effectiveness against its dangers.
Questions have been raised about the protocols of the drug’s clinical trials, the FDA’s speedy approval process,
and the known effects of the drug -
– dissociation (an out of body experience), dizziness, sedation, and heightened blood pressure.
In the drug’s trials, three people who had taken it committed suicide and three others died — as opposed to none on placebos — though the FDA and Janssen said there was no evidence the drug and the deaths were linked. . . .
. . . The FDA approved the drug March 5, setting aside its usual rules for anti-depressant approval and accepting one short-term trial instead of the usual two. . . .
[Full article at link above. So many more key details.] -