7 ms·

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.

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.

aaavl2821 8y ago
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
mirimir 8y ago
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 8y ago
  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.
  - mirimir 8y ago
    Thanks. So the next version will be monetizing the delivery system.
  - 09bjb 8y ago
    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.
    - randomacct3847 8y ago
      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.
      - loeg 8y ago
        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).
        cheerlessbog 8y ago
        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 https://www.gao.gov/mobile/products/GAO-18-40
        mirimir 8y ago
        The pharmaceutical industry inflates costs of drug development. https://www.nytimes.com/2014/11/19/upshot/calculating-the-real-costs-of-developing-a-new-drug.html https://www.nytimes.com/2014/11/19/upshot/calculating-the-re...
  - marssaxman 8y ago
    "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.
    - randomacct3847 8y ago
      Ok - but just isolating the active part of the drug makes it patentable. Still ridiculous given how cheap Ketamine is.
      - marssaxman 8y ago
        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.
        mirimir 8y ago
        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.
        loeg 8y ago
        Sure; we know they have a valid patent or else it would not have been worth their time to bring the drug to market.
        mirimir 8y ago
        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.
  - refurb 8y ago
    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+Janssen+&cntry=&state=&city=&dist=&Search=Search https://clinicaltrials.gov/ct2/results?cond=&term=Esketamine...
  - atomical 8y ago
    Any psychiatrist can likely prescribe ketamine off label for use at home if they choose. Mine does.
- aaavl2821 8y ago
  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.
  - mirimir 8y ago
    > 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.
    - loeg 8y ago
      > 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.
loeg 8y ago
> 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.
- danmaz74 8y ago
  We really really need some public body to pick up those cases. Or, at least, some non-profit. I'm sure many would contribute.
  - loeg 8y ago
    https://maps.org/ 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.
    - danmaz74 8y ago
      Interesting, thank you.
dangrossman 8y ago
The ketamine clinic in my area requires a psychiatrist referral: you can't just walk in off the street and get ketamine.

aaavl2821 8y ago

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

mirimir 8y ago

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 8y ago
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.
- mirimir 8y ago
  Thanks. So the next version will be monetizing the delivery system.
- 09bjb 8y ago
  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.
  - randomacct3847 8y ago
    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.
    - loeg 8y ago
      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).
      - cheerlessbog 8y ago
        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 https://www.gao.gov/mobile/products/GAO-18-40
        mirimir 8y ago
        The pharmaceutical industry inflates costs of drug development. https://www.nytimes.com/2014/11/19/upshot/calculating-the-real-costs-of-developing-a-new-drug.html https://www.nytimes.com/2014/11/19/upshot/calculating-the-re...
- marssaxman 8y ago
  "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.
  - randomacct3847 8y ago
    Ok - but just isolating the active part of the drug makes it patentable. Still ridiculous given how cheap Ketamine is.
    - marssaxman 8y ago
      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.
      - mirimir 8y ago
        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.
        loeg 8y ago
        Sure; we know they have a valid patent or else it would not have been worth their time to bring the drug to market.
        mirimir 8y ago
        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.
- refurb 8y ago
  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+Janssen+&cntry=&state=&city=&dist=&Search=Search https://clinicaltrials.gov/ct2/results?cond=&term=Esketamine...
- atomical 8y ago
  Any psychiatrist can likely prescribe ketamine off label for use at home if they choose. Mine does.
aaavl2821 8y ago
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.
- mirimir 8y ago
  > 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.
  - loeg 8y ago
    > 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.

loeg 8y ago

> 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.

danmaz74 8y ago
We really really need some public body to pick up those cases. Or, at least, some non-profit. I'm sure many would contribute.
- loeg 8y ago
  https://maps.org/ 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.
  - danmaz74 8y ago
    Interesting, thank you.

dangrossman 8y ago

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