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FDA approves intranasal esketamine formulation (nytimes.com)
107 points by pizza 14 days ago | hide | past | web | favorite | 127 comments



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.


What's the risk of legitimizing ketamine? The majority of the research and meta-reviews support ketamine as a treatment for depression too. The S-isomer may be better in some ways, but maybe not $3k better if you're poor.

On a risk/harm scale, it's comparable to alcohol or cigarettes[1].

[1]: https://en.wikipedia.org/wiki/Drug_harmfulness#/media/File:D...


When you get ketamine from a doctor, it is in metered in sub-psychedelic and sub-anesthetic doses.

When you get ketamine from the internet, you're getting a mystery powder that is, at best, a potent form of an addictive drug in quantities that are not metered and are ripe for abuse. At worst, you're getting some form of fentanyl because internet drug dealers are inept.


You have a lot of opinionated adjectives in that second sentence that aren't related to the chemical, which is the same one as in the first sentence.

> a potent form of an addictive drug

It's literally the same chemical; you didn't use those adjectives when you described it earlier.

> quantities that are not metered

Readily fixed for < $20: https://www.amazon.com/dp/B07D1NNGM6/

https://erowid.org/chemicals/ketamine/ketamine_dose.shtml#or...

> At worst, you're getting some form of fentanyl because internet drug dealers are inept.

That's not a ketamine problem; it's a prohibition problem.


> Readily fixed for < $20: https://www.amazon.com/dp/B07D1NNGM6/

My friend had one like this. It was barely accurate enough for all the funny RCs we had.


> It's literally the same chemical; you didn't use those adjectives when you described it earlier.

I would talk the same way about treating ADHD with Desoxyn prescribed by a doctor versus buying a pile of methamphetamine online to self-medicate with.

> Readily fixed for < $20: https://www.amazon.com/dp/B07D1NNGM6/

If you're going to make bad choices, volumetric dosing is one of the less bad choices.

> That's not a ketamine problem; it's a prohibition problem.

It's a regulation problem. The supplement market is full of bunk or outright fake products. It took the FDA to reel actual medicine in.


Interestingly, at least in the US, a take-home prescription for ketamine is already suprisingly cheap - $38 USD for 100ml: https://www.drugs.com/price-guide/ketamine

At least near me, there are "ketamine centers" that already to ketamine clinics - $500 per session, and insurance doesn't cover it. Ends up being around $3000. I haven't done it, so I can't comment on its effectiveness.

It's pretty lame that the cost difference is so large. I guess the barrier is a psychiatrist's willingness to prescribe. Maybe all of this research will open up psychiatrists to prescribe take-home ketamine more readily?


Basically most clinics will give u a month supply after 6 sessions for 80$ a month


No, they won't, because the only form available is the IV form. There are no ketamine pills or tablets. Some doctors will prescribe ketamine nasal spray or lozenges to be made by a compounding pharmacy, but the vast percentage of doctors who are willing to administer ketamine in their offices are not at all willing to prescribe a take home dose, and if they are, it's in a very different form with different effects than the IV session. I get regular IV sessions and have compounded lozenges that I take daily, and in my experience neither the nasal spray (which I hated) nor the lozenges are anything like the infusion, and it was extraordinarily difficult to find a doctor in the Boston area that would write any kind of take home prescription. No clinic anywhere is going to give you a bottle of ketamine and some syringes, and neither is CVS.


That's what I meant by maintenance dose . A nasal spray or lozenge. The maintenance doses are great for the vast majority but if you feel that they don't do it for you and able to get a nasal formulation you can do your own IM injection which I know a few people personally that do it once a month

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

It's been a long time since I lived in Canada, but one of the "small problems" was that prescription medicine wasn't covered. You need private health insurance, or you need to be covered by one of many confusing provincial health care plans. Generally, you can find a way, but at least 15 years ago (when I left) it could be pretty dicey. I remember several of my friends having difficulty affording their insulin when I was in university -- too rich to qualify for aide, too poor to be able to pay for their life saving drugs without hardship. My dad (who still lives there) tells me things have improved, but he still pays more for prescription drugs than I do (living in Japan) I think.

The UK's NHS seems to be a better system to compare to ;-) I lived there for 2 years and was really surprised at what the NHS covers. Interestingly they will even pay for emergency treatment for non-residents who happen to be in the country!


>The UK's NHS seems to be a better system to compare to ;-) I lived there for 2 years and was really surprised at what the NHS covers.

The caveat is all of the stuff that the NHS won't cover. The service is largely free at the point of use, but there has always been some element of rationing which has drastically increased in recent years due to Conservative government cuts.

Mental health gets the short end of the stick in this respect - it represents 23% of the disease burden but only 13% of NHS spending. Most patients with a mental health condition will never see a psychiatrist and receive no more than six half-hour sessions of psychotherapy. If esketamine does prove to be effective, the NHS is exceedingly unlikely to offer it to more than a handful of patients until the patent expires.

https://www.nuffieldtrust.org.uk/resource/rationing-in-the-n...


As well as emergency care being free for non residents, contraceptives and STI treatment are too [1]

[1] https://www.nhs.uk/using-the-nhs/nhs-services/visiting-or-mo...


Ketamine isn't an illegal drug, it's been FDA-approved for decades. They're both schedule III.


It was not legal to prescribe as an antidepressant outside experimental setting.


This is completely wrong. For quite a long time it has been legal for doctors to prescribe FDA approved drugs off-label, that is, for reasons other than what they're FDA approved for. But if it's not FDA approved, insurance companies won't pay for it. That's what this ruling changes, for this one form of the drug.


Although that's not necessarily true either. Insurance contract typically pay for FDA-approved indications, but they also usually have some process where they will pay for off-label use if you can submit evidence that it's scientifically justified and cheaper alternatives would not work. Of course this is pretty stressfull, but it's really necessary in the U.S. because getting FDA to approve a new indication is really expensive for the drug companies, so there are a lot of drugs which are not approved for some of their main uses. For example, SSRIs are commonly used for anxiety even though this is off-label.[1] And monoclonal antibody-based immunosuppressives like adalimumab are often only approved for a few conditions, like Crohn's and arthritis, even though they are useful for auto-immune diseases in general.

In the specific case of ketamine for depression, some people do seem to have successfully gotten insurance companies to pay for it.[2] Even without FDA approval, this would probably get easier over time, as more studies show effectiveness.

[1] https://www.aafp.org/afp/2003/0801/p498.html [2] https://www.ketaminewellnesscenters.com/getting-insurance-to...


If insurance companies will pay for esketamine anyway, wouldn't they be more inclined then to also just pay for ketamine if it's cheaper?


Probably not directly, but I'm pretty sure it is legal to prescribe medicines for off-label use as well. Is there some sort of restriction on this particular drug that I'm not aware of?


False. Off label prescribing is perfectly legal.


That is exactly why there is a massive h eppidemic in the us. Drug companies lied about oxys , everyone got hooked, couldn't afford it and moved onto h. Now that's laced with fent and everyone is dying


I don’t know if it’s changed recently, but back when I was clubbing, street ketamine was mostly just stolen from vets offices and dried into a powder.


I wouldn't call it a risk but rather a benefit, in which it makes impossible to not see the absurdity of prohibition laws.


Most people probably lack the technical aptitude to use darknet markets, so this is probably more relevant to hacker news readers than the general public.


No . It does not have the same anti depressant effects as racemic ketamine .


>single payer health care system

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


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.


Or, you know, themselves when they get unexpectedly ill.


Yes, just like we're forced to pay for police even if we've never been robbed...


That’s literally what insurance is.


If you truly care about costs, and not punishing the sick, single-payer systems are cheaper than private insurance by an average factor of 3[1].

[1] https://en.wikipedia.org/wiki/List_of_countries_by_total_hea...


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.


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.


> 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.

You're really paying for the cost of bringing a new drug to market for a specific label use. It wouldn't be worth the multi-million dollar expense for any for-profit company to do the FDA process to show that ordinary ketamine is effective for depression, because they couldn't privatize the profits to recoup their costs.

Instead they make an arbitrary but likely nonfunctional[0] chemical change[1], get it approved, and use their patent to demand high costs to recoup their FDA process fees (and if they're lucky, to make a profit).

[0]: Edit/clarification: Apparently some (meta)studies suggest the S-isomer is better than the racemic mixtures in some ways (waving my hands; I did not read or understand the details).

[1]: Edit/clarification: I don't know enough chemistry to be sure if describing the extraction of the S-isomer from the racemic mixture is a "chemical change," exactly, but you get the idea.


We really really need some public body to pick up those cases. Or, at least, some non-profit. I'm sure many would contribute.


https://maps.org/ is basically running a crowd-funded FDA process for MDMA as a component of PTSD treatment. (Well, major funding came from one random bitcoin millionaire, but still.)

The trouble for anyone (citizens, government, and biotech companies) is sifting the wheat from the chaff as far as what drugs are likely to be safe and effective treatments. You could give away all of your money and not end up with one approved drug.


Interesting, thank you.

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 :)


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.


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.


The list of drugs that have been derived from plant sources is actually quite low.

And just because it’s present in a plant doesn’t mean it can be drugged. It could have a short half life, high toxicity, etc., so derivatives are made to optimize it’s action.

Finally, even if a patent can’t be secured, the first version of a drug is given exclusivity by the FDA - they won’t approve another version up to 7 years (orphan drugs).


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...


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.


It’s a sad joke. If the gov’t wants to fix drug prices then figure out how to stop companies from gaming the system like this.


It could either bring drugs to market itself, negotiate for all consumers (single payer), or loosen FDA regulations around drug safety or efficacy trials. The status quo is that selling a drug is extremely expensive even when if you know a priori it is safe and effective, so companies must use the patent to seek high rents to recoup their costs (as well as cover R&D on other drugs, which may not pan out).


Yet prices are sufficiently high that it is a surprisingly profitable industry. It is also worth bearing in mind that the government find a large share of drug development. [1]

[1] "pharmaceutical and biotechnology sales revenue increased from $534 billion to $775 billion between 2006 and 2015.... Drug industry spending for research and development increased from $82 billion in 2008 to $89 billion in 2014" (I assume there are other costs so one cannot simply divide to get gross profit but it seems illustrative)

https://www.gao.gov/mobile/products/GAO-18-40


Analyses like that are misleading because most of the industry's revenues and profits are concentrated with a few firms. The vast majority of biotech and pharma companies are not profitable and never aim to become profitable -- rather they just do r&d and then sell drugs to big pharma once some of the clinical risk is taken out

In 2018 only like 12% of new FDA approved drugs were developed by big pharma. 63% were developed by small companies. A negligible amount were discovered by universities alone

Pharma acquired these drugs from startups through M&A which doesn't show up in profit and loss statements. It shows up on the balance sheet

That $84B r&d figure seems very low. The top 15 pharma companies spend something like $75B a year in r&d. VC backed startups spend like $10-15B. Then all the firms in between account for the majority of spending. Don't remember the source but I think total global pharma r&d is like $200B


The pharmaceutical industry inflates costs of drug development.

https://www.nytimes.com/2014/11/19/upshot/calculating-the-re...


The costs may be inflated but the actual costs are probably not that different than tufts. Several other studies suggest pharma is getting a return on its r&d investment of under 5% (a Deloitte and McKinsey study as well as a Novartis one). Pharma is also cutting internal r&d because they can't get a return. They buy drugs from startups instead which does not show up in the profit and loss statements

In 2018 only like 12% of new FDA approved drugs were developed by big pharma. 63% were developed by small companies. A negligible amount / zero were developed by universities

The $161M figure cited in that nytimes study is not at all representative because most early stage r&d is done outside of big pharma, and then big pharma buys the drugs and markets them

If drug research was profitable pharma would be doing more of it, not less


"Esketamine" is just the S-isomer of ketamine (thus "S-ketamine"), which has conventionally been an equal ("racemic") mixture of the S- and R-isomers. It's not so much that they've changed anything about the drug as that they've isolated the variant which is more psychoactive.


Ok - but just isolating the active part of the drug makes it patentable. Still ridiculous given how cheap Ketamine is.


It is completely ridiculous. S-ketamine has been available on the black market for years - it's not like anything about this is rocket science.


If that's true, maybe their patent is invalid.

But maybe there's also a patent on the delivery mechansim. Or maybe it's a process patent.


Sure; we know they have a valid patent or else it would not have been worth their time to bring the drug to market.


Seriously?

Janssen obviously believes that it's valid. Or at least, they're confident that they can defend it. Maybe they know that it's not valid, but are confident that others won't figure out why.

In one case that I recall, the manufacturer bribed a chemist to retract a paper that had reported the synthesis of their drug.

Many years of budget cuts have rendered the Patent Office pretty clueless about drugs. And the FDA doesn't do any independent assessment of patent validity. I've seen testimony where FDA staff said that they lack expertise for that.

So basically, patents are valid if they survive litigation.


It's not just budget cuts. It's an exploding legal system behind patents. Try to decipher the patent rules [1] sometime. It's filled with incredibly counter-intuitive self referential legalese that, even when one understand the jargon, is not entirely clear. And it regularly has very major changes made to the entire code. In general as you approach some degree of complexity in anything, the number of individuals who sufficiently grasp it approaches 0. And then as you're mentioning - that's only about the patent legalese itself. Now the patent examiners also need to be able to have an understanding of what are ideally novel new inventions in various fields, which themselves are often increasingly obfuscated.

Anybody could perform a sufficiently capable of job this has way better career opportunities than earning $80k at the patent office. While this does support your notion of budgetary cuts being the primary problem, again I think that misses the core problem which is that the system has become so convoluted that actually having a meaningful holistic understanding requires immense skill and education. Systems that are supposed to be for public, and individual, use should not require a juris doctor to begin to parse.

The whole system needs a major overhaul, frankly like much of our formal structures. Isn't it a bizarre system that people are expected to completely obey laws which they are in no way expected to be able to completely understand?

[1] - https://www.uspto.gov/web/offices/pac/mpep/index.html


It's valid because USPTO approved it, yes. We're first-to-file, not first-to-invent now.


True. But there's still the on-sale bar:

> "A person shall be entitled to a patent unless . . . the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention."[0]

0) https://www.whitecase.com/publications/alert/supreme-court-s...


Right. And unless the inactive R-isomer has some negative effect, it's a meaningless change.


Ketamine isomer (S+) induces less drowsiness, less lethargy and less impairment in clustered subjective cognitive capacity than equianalgesic small-dose racemic ketamine. In addition, S(+) ketamine causes less decline in concentration capacity and primary memory [Pfenninger et al. 2002]. The S(+) isomer of ketamine has about twice the analgesic potency of the clinically used racemic mixture. Therefore, the known side effects may be reduced when one half of the usual dose is administered.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4910398/


Thanks.

But if S(+) ketamine has been commercially available, even if only illegally, it's not patentable.


Not quite, the specific purification process may or may not be patentable.


True. Process patent. But those are harder to defend in litigation, as I recall.


R isomer is quite active too and similarly, which is why nobody bothered with purified S isomer.


They ran 35 clinical trials to get FDA approval.[1]

How could they recoup those costs without IP protection?

[1] https://clinicaltrials.gov/ct2/results?cond=&term=Esketamine...


Any psychiatrist can likely prescribe ketamine off label for use at home if they choose. Mine does.


Thanks.

So the next version will be monetizing the delivery system.


Patents do not create value, they protect value.

Clinical benefit -- making sick patients healthier -- creates value

You need patents because without patent protection, no one would invest the large sums of money and take on the huge risk to bring drugs to market

These days, investors and companies generally only fund development of drugs that provide a significant clinical benefit to really sick patients. This is because they deeply understand that value in pharma is determined by clinical benefit

The statement that pharmaceuticals are not sold for therapeutic uses is just wrong.


> Patents do not create value, they protect value.

That's just semantic hand waiving.

Patents create value. With no patent, as with generic drugs, price approaches marginal cost of production. With a patent, price is limited only by competition with other therapies. And sometimes by regulatory intervention.

> These days, investors and companies generally only fund development of drugs that provide a significant clinical benefit to really sick patients. This is because they deeply understand that value in pharma is determined by clinical benefit

That's because "really sick patients" are desperate.


> With no patent, as with generic drugs, price approaches marginal cost of production. With a patent, price is limited only by competition with other therapies.

Right. But the thing is, bringing a drug to market is extremely expensive. So without patents, there isn't a financial incentive to bring a drug to market. Biotech companies aren't charities.

> That's because "really sick patients" are desperate.

Not sure what you're driving at. The alternative to offering an extremely expensive patented drug to really sick patients is no drug at all (or whatever the previous standard of care was). Yeah, drugs are expensive until the patent runs out, but the patent does eventually run out.

Without this system, we wouldn't have new drugs brought to market by for-profit companies. With this system, sure, new drugs are really expensive the first 17-20 years. But then they're really inexpensive, and exist. In the other timeline, they simply did not exist.


I'm not arguing against patents.

However, I am arguing against patent protection for de minimis structural changes that have no substantial therapeutic benefit. Or bullshit delivery systems.

For example, I use testosterone creme. Androgel costs a bloody fortune, because their formulation (basically hair gel) has patent protection. So I use a compounded cream that costs ~90% less.

> The alternative to offering an extremely expensive patented drug to really sick patients is no drug at all (or whatever the previous standard of care was).

That's not the only alternative. Drug development ought to be publicly funded. As it is, the drug industry tends to leech off publicly-funded research. And drug manufacturers ought to be paid only for the manufacturing.


> However, I am arguing against patent protection for de minimis structural changes that have no substantial therapeutic benefit. Or bullshit delivery systems.

Potato, potato. If they don't do the work to get FDA approval, even with the bullshit de minimis change, the alternative isn't a patent-free generic — it's nothing, for any price.

> Androgel costs a bloody fortune, because their formulation (basically hair gel) has patent protection. So I use a compounded cream that costs ~90% less.

So what is the problem with androgel's patent? How does it make your life worse? If they didn't have the patent, you'd still be using the same previous standard-of-care.

> Drug development ought to be publicly funded.

Well, good luck with that.

> And drug manufacturers ought to be paid only for the manufacturing.

Like, at-cost? I think you'd see drug manufacturing die out under that proposed policy.


> If they don't do the work to get FDA approval, even with the bullshit de minimis change, the alternative isn't a patent-free generic — it's nothing, for any price.

No, the alternative is some old generic drug, which is just as effective as the new one. But the manufacturer bribes doctors to prescribe the new one, which has no generic equivalents.

> So what is the problem with androgel's patent? How does it make your life worse?

Because for years there was no commercial alternative. It was only by chance that I found a compounding pharmacy that sold an old-school version.

> Like, at-cost? I think you'd see drug manufacturing die out under that proposed policy.

That's how it works for generics. And there are lots of generics.


> No, the alternative is some old generic drug, which is just as effective as the new one.

This is a little simplistic. The FDA strongly prefers evidence that new drugs are more effective than existing treatments. They look at the target condition and available treatments, including existing generics, to weigh the benefits and risks of a new drug being approved.

And the only reason that "old generic" drug exists at all is because the patent process paid for its R&D more than 20 years ago.

> But the manufacturer bribes doctors to prescribe the new one, which has no generic equivalents.

This is illegal, for obvious reasons. I suspect it is less wide-spread than you think.

> Because for years there was no commercial alternative. It was only by chance that I found a compounding pharmacy that sold an old-school version.

So you're saying there wasn't an alternative treatment available and androgel brought an effective treatment to market and was rewarded for it? And they shouldn't be, because?

> That's how it works for generics. And there are lots of generics.

Generics manufacturers first, absolutely do not sell at-cost; they're for-profit companies trying to make money, not charities. And most importantly, they don't develop novel drugs.


> The statement that pharmaceuticals are not sold for therapeutic uses is just wrong.

I've seen many thousands of internal documents from pharmaceutical firms. It's ~all about the money.


"You need patents because without patent protection, no one would invest the large sums of money and take on the huge risk to bring drugs to market"

Except the government.

They already fund virtually all basic research in the US (and the world). I don't understand why they couldn't start funding pharmaceutical R&D.


At least in 2017-2018 (the only years I know the data offhand), I don't think any FDA approved drugs were developed by academia. It's hard to tell bc you can't see all the licenses, but it's almost never the case that a drug comes straight from academia. Maybe an assay, or some interesting chemical matter, but almost never a drug

Plus 30% or so of NIH money goes to universities for "overhead" and not to research

The odds of a promising academic finding becoming a drug are incredibly low. and there is not enough NIH funding to support drug discovery and development

I also think that if drug research was publicly funded t would be a nightmare. You'd probably end up with drugs costing more than they do now (in terms of added taxes you'd have to pay to bolster NIH budget) and getting fewer drugs approved. Pharma r&d is actually held to a much higher standard in terms of robustness than academic science. The incentives are just messed up in academia -- people want to publish first and foremost, not make medicines. And you can get crappy / irreproducble science published fairly readily

One of the first things pharma companies do when considering licensing academic tech is try to replicate the findings independently. Often they can't

At least in pharma, the incentives are to make drugs that get FDA approval, that docs prescribe to patients and that insurance companies pay for. For all that to happen the drugs have to work and work very well. And even with the profit motive as an incentive there is still poor decision making and incentive alignment


I think the fact that they can't replicate findings should say something about the initial findings themselves


That was the point I was trying to make but realize I wasn't clear. Pharma knows that academic findings are unreliable so they test for reproducibility before investing in further development


from what i understand when people go to ketamine clinics it can cost $500+ per infusion. the drug itself isnt that expensive but you have to pay for a doc to supervise you for a few hours

some people are studying ketamine + some sort of therapy, but it isnt clear whether this actually works, who it may work for or what the ideal regimen is. the idea is that ketamine treatment provides a very rapid antidepressive effect, but that effect isnt durable after treatment stops. some forms of psychotherapy are more effective when people are only mildly depressed, so ketamine can "prime" people for psychotherapy


The ketamine clinic in my area requires a psychiatrist referral: you can't just walk in off the street and get ketamine.


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.


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


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


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


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.


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


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


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.


Any idea when this will actually be available for patients?


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

Color me doubtful.


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


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


I know a guy who suicided after getting an engineering degree.

Stay away from calculus, kids.


Calculus makes me depressed. Wonder if ket could help


I know a guy who breathed oxygen everyday and he suicided. Be safe and hold your breath everyone.


Probably my favorite response to my mostly-intended obvious anecdotal fallacy.

He was a really good/unique/smart guy, though :/ He was also pretty staunchly atheist... Perhaps he needed to know, once and for all.


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.


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.


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


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.


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.


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.


Having been through the same, I'm of the opposite opinion. We're just computers made of meat. Some of us weren't optimized to function in society. Any help that works, chemical or not, is welcome.


I'm not convinced it works, other than in the short term. That's my problem with it. It feels too much like we're just throwing a drug at the symptoms because that's the lazy way to get you out of the doctor's office and of course pharma inc. prefers those solutions.


I'd rather have more potential treatments than less. Different people will respond to different things.


From what I've read, one of the most exciting properties of ketamine treatment of depression is it's rapid onset. Ketamine seems to become effective in hours and retain benefit for days. If there is a negative reaction, stopping can similarly rapidly cease effect. Conversely, SSRIs or Tricyclics can take weeks to begin taking effect, and if a negative reaction occurs, it can similarly take weeks for effects to extinguish after ceasing dosage.


But is that really an effective long term solution? Ketamine is addictive after all, you can't keep doing that every few days.


SSRI withdrawal symptoms can be pretty rough, seems chronic high-dose ketamine withdrawal is also quite bad. However, ketamine therapeutic dose is ~ 1/4th low recreational dose, so I think withdrawal is likely to be minimal with this dosage regime.

Certainly something to be concerned about. I've read ketamine abusers can often end up with kidney issues (presumably proportional to dosage as its related to elimination), but I'd also think monitoring kidney health with chronic dosing, even at low levels, could be prudent - especially in individuals with pre-existing kidney issues.


> costing significantly more money

It does not have to be the case. In some European countries it is ridiculously cheap, as cheap as any other basic/necessary medications, medications that are super expensive to the Americans.


What other types of treatment do you find more suitable for depression?


I honestly don't know. I found my way out through a path that may or may not work for others. I have a pet theory of how and why depression works, and what can be done about it, but I'm not deluded enough to believe I must be right just because I seem to be from my own perspective.

However, years of experience have led me to believe that throwing drugs at this problem does nothing but mask some of the symptoms temporarily, while often having somewhat undesirable side effects. I think we just keep doing it because depression is not well understood, doctors (like the rest of us) are lazy and incentivized to get you out of their office as quickly as possible, and phrama is big business.


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...


"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.


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.


Ketamine has been used for a long time in veterinary medicine. Its safety profile is super well understood.


It's used in human medicine, too.


I could have sworn it transitioned from human medicine to vet medicine when we found other anesthetics for humans


No, it's still widely used in humans as an anaesthetic.

Most famously, it was used to sedate the boys trapped in the caves in Thailand last year (during their extraction).


Source for the Thai rescue one?


I don't know what level of source you are looking for, but a Google search yields lots of stories that make the claim: https://www.google.com/search?q=thai+rescue+ketamine

The Maclean's story is the one that I first saw it in: https://www.macleans.ca/thai-cave-rescue-heroes/


Yeah, it was heavily reported. I read it first in the Good Weekend article.

https://www.smh.com.au/world/asia/we-didn-t-expect-all-13-ou...


Sure, but it still has niche uses.


That is a wildly unreliable source. Digging into it all you find is someone selling outrage in what seems to be mostly for self-promotion.


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.


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

This is not depression.




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