The FDA is letting PTSD patients suffer.

Last week, FDA rejected an application for MDMA-assisted therapy, a potentially game-changing treatment for PTSD, despite successful phase 3 results that a peer-reviewed study in Nature Medicine described as "highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities." The therapy looks more compelling in PTSD than ketamine did for depression, yet FDA approved JNJ's application for esketamine while rejecting little-known Lykos' application for PTSD. Ask yourself why.

One of FDA's reasons for rejecting the Lykos product is supposedly "functional unblinding" of the phase 3 studies - that is, patients on the drug arm experienced euphoria while patients on the placebo arm didn't - which means the trial wasn't really "blinded" to the patients or physicians, which could theoretically introduce bias in recording study results.

But that's bogus for at least two reasons: (i) that side effect is inextricably linked to MDMA's mechanism of action and may even account for its therapeutic effect, and (ii) FDA knew about that side effect and signed off on the phase 3 plan regardless...which caused a company to waste exorbitant resources only to be denied at the end. Meanwhile, PTSD patients suffer & are deprived of therapy as a consequence.

This is a strong case for federal court appeal in a post-Chevron world. But here's the problem: no biotech or pharma has the stones to even try it, because they know FDA will retaliate against them on their future products. "FDA never forgets," as the age-old adage goes in pharma. Everyone in the industry knows it, but they also know better than to say it too loudly.

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[ClaytonDecker]

We need to be discussing psilocybin as well.

[Maisie]

We need companies in America to provide our medications, food... America needs to depend on America. Not communis countries.

[IronwolfSOF]

Vivek please clean up our poisonous foods ..

[MisterHolaMan]

thank You for the positive shift to the Overton window 🤗❤

[Nanan]

Why cure the problem when they can treat the symptoms forever and make billions doing so.

[justmeVann]

I'm a survivor suffering from CPTSD and I thought at first there was no help.
I created my own it's drug free.

[americangirl]

There's no patents or money in it.

[murph]

MDMA has fixed most of my marital issues, my wife feels the same. We went to around 10 couples therapy sessions which made things worse. This drug works wonders if used responsibly

[StitchetyDoodah]

I have. CPTSD and I have to pay $200-400 every 3-5 weeks in order to get ketamine injected or IV. This whole thing is terrible.

[LucVNO]

Ive done a lot of drugs in my life & I do not recommend doing drugs for most people, like none at all. Most people are not actually ready for the kind of mental fortitude it takes to keep your self from or get your self out of addiction.

I think everyone should do a dose of MDMA at 20ish years old.

[gracenote]

Do you have any desire to rework the entire patent and copyright system? I think that is a culprit in throttling our economy and other things in this country.

[dryciderz]

But they'll let people have weed and ketamine??? 🤯🤮They want people to suffer!!!

[MrsHornesgdnm]

VIVEK... I AM A US ARMY VETERAN... I KNOW FOR A FACT THAT MANY VETS SHARED VIDEOS ON LINE OVER THE YEARS THAT CBD OIL HELPED THEIR PTSD BETTER THAN ALL OF THE MEDS THE VA OFFERED!!! PLEASE LOOK INTO THIS, CBD OIL DOES NOT HAVE THE THC DRUG, IF YOU WANT ME TO SEND YOU THOSE VIDEOS I WOULD BE HAPPY TO... 😊😊😊😊😊😊

[solopractitioner]

The transitioning from a deployment is the one thing all veterans talked about. We flew from a hostile area back home in one day, you need to ease us back into society.

[myvibe]

You may not read the comments, but your popularity is increasing daily. Listening from Australia, you come across to me as a patriotic American, not a Hindi refugee. Good luck; you're fun to listen to, and you are a balanced thinker. Left-brain thinkers are not good for politicians/bureaucrats.

[jody]

Hey Vivek, I was thinking, it’s so important that Trump win, that would it be possible for all the podcasts in favor of Trump get together and help advise him. I keep hearing all the podcasts talk about being worried, but no one is telling Trump. And try and give a heads up to all the Republicans about making sure the Democrats don’t get away with all cheating they will be doing.

[chachis-censored]

Ecstasy? Really? I guess its better than SSRI's, but doping people instead of helping them overcome problems is not the way to go.

[raphmcafee]

The second and third quote is relevant to this topic:

[GeneJohnson-vyci]

Please speak out against the India Day Parades in New York City and other cities in the USA. This is American soil so foreign national holidays shouldn't be celebrated here. I even hear that they are hoisting the Indian flag in America. That should only happen with Olde Glory. Our Star Spangled Banner. Not foreign flags.

[mainegreengrower]

Im still a mushroom man..try fungus..it could change your life..Ecuadorians will work good for military people