
FDA approves intranasal esketamine formulation - pizza
https://www.nytimes.com/2019/03/05/health/depression-treatment-ketamine-fda.html
======
mabbo
There's an interesting risk to all of this: legitimizing the illegal drug.

Let's say my doctor says to me "you're depressed, I'm prescribing esketamine,
go to this clinic and pay them $3000". Well, I do my research and learn that
really this stuff has the same antidepressants effect as ketamine. And the
same number of doses of ket on the darknet markets are going to cost me a heck
of a lot less.

Sure, there's the question of legality. But if I can't afford esketamine but
can afford dodgy internet ket, and I'm desperate for something, anything, to
help with this nagging constant psychic pain weighing down my life...

Suddenly I appreciate my Canadian single payer health care system a lot more,
even with the small problems it has.

~~~
Pristina
>single payer health care system

is just a system that forces healthy people to pay for unhealthy people.

~~~
Broken_Hippo
This is what insurance and health care does, though. Do you think your
premiums are really based on how healthy you are currently? Especially when
you have insurance through your employer?

In this last case, you might pay more for certain markers (smoking,
uncontrolled high blood pressure, and other wellness marks), but not if you
have asthma or migraines, for example. Part of your premium is literally
paying for folks that are sick. Paying for other people's pregnancies and
children and stuff like that.

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ketamineuser
I'm really happy to see this finally happening. I've used ketamine in a
homemade emergency nasal spray in times when I have been extremely depressed,
and I do believe it has saved my life.

My DIY nasal spray is made from liquid ketamine vials purchased off the dark
net. The vials are 1g in 10ml saline and are intended for veterinary use. They
come factory sealed with holographic labeling, and I'm confident they are
legit. They cost $100-$150 each which is a lot more than powder but I am much
more confident in what I'm getting and it's already in liquid form. I use a
needle to extract the ketamine from the vial and put it into an amber glass
nasal spray bottle after sterilizing it. The solution is already isotonic, no
need to add any salt.

I'll do a squirt on each side of my nose against the nasal wall when I'm
really depressed / suicidal, which is usually no more than once a month. It's
not magic, but it really brings me back to reality about half the time.

I have also tried an IV ketamine clinic, paid about $3k to go 3 times.
Unfortunately that is super expensive and the last time I had what amounted to
a bad trip and I haven't been back.

If anyone has any questions about these I'm happy to answer them.

To anyone feeling depressed: If you haven't done so already, get the basics
out of the way: Get a physical and get your thyroid levels checked. Consider
supplementing vitamin D, fish oil, and magnesium. You can find academic
evidence that those may help in people who are deficient.

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randomacct3847
Interesting that there doesn’t seem to be a therapy component to the
treatment...meaning you’re just going to a clinic to sort of watch over you as
you take it.

The price of $3k for 8 doses is so high compared to regular ketamine. I wonder
if there is any real difference or if you’re really just paying for the
comfort of doing it legally under the guidance of a doctor.

~~~
mirimir
You're paying for their patent on the delivery system ;)

Edit: It's a common delusion that pharmaceuticals are sold for therapeutic
uses. Actually, they're a mechanism to monetize intellectual property.

Edit: Oops. For having just the active isomer.

Edit: That comment about monetizing intellectual property comes from an expert
economist :)

~~~
randomacct3847
Actually I just read that Esketamine is patented while Ketamine is not, even
though it’s essentially the same thing. So JNJ can charge these ridiculous
prices because they changed one small thing about the drug so they could
slapped a patent on it.

~~~
09bjb
Welcome to pharmaceuticals in general (and many of the biggest biotech
companies, come to think of it). I didn't find the exact number in a cursory
search, but I've read that a fairly preposterous proportion of the drugs that
have ever been produced are (unpatentable) plant molecules that were
deliberately reverse-engineered and tweaked for patentability.

~~~
aaavl2821
I'd be interested in seeing data on that, as I have never heard that argument

A cursory look at the top selling drugs of all time doesn't appear to show any
plant derived drugs [0]. Obviously this does not disprove your statement but
its the quickest heuristic i could think of

[0]
[https://en.wikipedia.org/wiki/List_of_largest_selling_pharma...](https://en.wikipedia.org/wiki/List_of_largest_selling_pharmaceutical_products)

~~~
loeg
That list is sorted by price; i.e., it will bias towards recent patents on
complicated drugs.

OP's statement was about sheer number of patented drugs. I don't know that
OP's statement was accurate, but the wikipedia link doesn't really refute or
confirm the idea.

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gojomo
FTA:

 _F.D.A. approval requires that doses be taken in a doctor’s office or clinic,
with patients monitored for at least two hours… The safety monitoring will
require doctors to find space for treated patients, which could present a
logistical challenge, some psychiatrists said._

I can kill a few birds with one stone here. Doctors should offer the 2-hour
sessions in the evening, in darkened "clinics" with dance floors and DJ music.

~~~
empath75
Basically every drug that ravers were doing is turning into a breakthrough
treatment for various psychological disorders.

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epmaybe
I posted on the original story about the FDA panel recommending approval a few
weeks ago. In that post, I mentioned that Icahn school of medicine holds the
patent on the racemic ketamine (instead of S-ketamine) intranasal formulation
for treatment of depression.

I heard about the approval on NPR, where they interviewed a doctor from Icahn
school of medicine to talk about the benefits of such a formulation, without
any mention of this patent. Is there any way to find out if J&J licensed their
patent?

Edit: meant racemic instead of non racemic

~~~
jboogie77
I listened to it on NPR as well and they did mention the patent

~~~
epmaybe
Thanks for the clarification, so do we know if J&j licensed this patent? I'd
assume yes considered Icahn even wished to discuss it.

~~~
jboogie77
Good question. Honestly not sure, but I would assume yes as well

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mirimir
FYI

[https://www.drugs.com/history/spravato.html](https://www.drugs.com/history/spravato.html)

[https://www.drugs.com/alpha/sp.html](https://www.drugs.com/alpha/sp.html)
[not listed yet]

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GuillaumeBrdet
Seems interesting, I need to take the time to look further into this one.
Hopefully, it will help some people.

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Cynddl
The original title is "Fast-Acting Depression Drug, Newly Approved, Could Help
Millions". Not everyone reading HN lives in the US nor knows what the FDA
stands for.

The article reports the experiment, the results, and not only FDA approval.

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gurumeditations
Any idea when this will actually be available for patients?

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pmarreck
I know a guy who suicided after getting REALLY into ketamine.

Color me doubtful.

~~~
ebg13
I know a guy who suicided after getting really into fishing, so now I'm
skeptical of fishing. That's how science works, right?

~~~
pmarreck
Everyone who responded wins the Internet for pointing out my obvious anecdotal
fallacy.

------
AnIdiotOnTheNet
Having been through chronic suicidal depression, the idea that we're now going
to be treating it with yet another psychoactive medication, this time way more
powerful and costing significantly more money, doesn't sit right.

~~~
loeg
It's just one more option on the market; theoretically supported as safe and
effective by scientific evidence. If you have some personal grudge with the
chemical, you're free to tell your doctor you don't want to try it.

~~~
AnIdiotOnTheNet
It is my experience that if you tell a doctor they can't just throw a drug at
a problem they get very upset.

~~~
RankingMember
If you said it that way with a hostile inflection, maybe, but why wouldn't you
just say "I want to try [therapy/a non-drug alternative] first."? If your
doctor would react negatively to that, it might be time to find a new doctor.

~~~
AnIdiotOnTheNet
Here's the thing, the doctor is supposedly the expert, so why am I the one
recommending a course of treatment? If I were confident in my own diagnosis
and treatment, why do I need the doctor? They're just useless red tape at that
point. I explain the reasons I don't want to do the drugs again, and I just
get arguments.

Because this is the US we're talking about, I've had to change doctors pretty
frequently in my life and there are only a small handful I would say wouldn't
react negatively. I'm pretty sure the proliferation of Epic has made it worse
too.

~~~
RankingMember
If it's your GP, they're really not the expert though when it comes to
psychological issues. If you're expecting your GP to do more for that than
offer medication or a specialist, you're probably asking too much.

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brisance
A whistleblower has pointed out that Janssen is “the same company where 31
children died while taking Risperdal, another 1,207 were permanently injured &
14-year-old boys grew breasts, is bringing a ketamine-like nasal spray for
depression to market.“

[https://twitter.com/melaynalokosky/status/110311449708494028...](https://twitter.com/melaynalokosky/status/1103114497084940289)

~~~
apsec112
"The same company where 31 children died" is incredibly misleading. 31
children died while taking a drug they made, over 15 years, not all of which
are necessarily the drug's fault (side effect reporting is very broad).
Tylenol kills around 500 people a year, but we don't blame this on the Tylenol
manufacturers.

~~~
rubyn00bie
Umm to be fair, scale should be accounted for, acetaminophen is probably used
hundreds of millions times a year. How many times was that drug used when the
31 people died? A million? Not bad. 32? Not good.

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rygxqpbsngav
Why do people get depressed? Break up, lost loved ones, lose a job etc. etc.
Why don't they prescribe these people to have some voluntary work at a local
charity and take a break from life's stress and enjoy the joy of giving? etc.
r understand or fix the reason they got depressed in the first place? Or
simply some consoling or support. Why does everything need a chemical cure
that messes up the brains natural balance and harmony?

When you give and bond with people, your body releases oxytocin. When you do
cold showers, your body releases seretonin. When you laugh or meditate, your
body releases endorphin. I can go on and on. All of which helps bring back
balance to the mood and get people rid of depression.

You create a chemical/toxic & selfish society,where everything MUST be fixed
through chemical drugs backed by greed of pharma companies that does half-
dashed studies, you are doing humanity endless harm.

~~~
cr1895
>Why do people get depressed? Break up, lost loved ones, lose a job etc. etc.

This is not depression.

