5 ms·

Paywall, but I'm going to go ahead and assume the real answer is that some drug company will get monopoly rights to sell it, and has outlined an effective strat

by kolbe 9y ago

Paywall, but I'm going to go ahead and assume the real answer is that some drug company will get monopoly rights to sell it, and has outlined an effective strategy to get it overprescribed at the expense of US taxpayers. That's how it became a 'breakthrough therapy' edit: I'm not saying it's bad to treat MDMA as a useful therapy. I'm just saying what force was at play to change the cultural opinion.

popopo1 9y ago
You guessed wrong moron.
- dang 9y ago
  Posting like that is a bannable offense on HN. We're trying for a (much!) higher level of quality here, though of course we don't always succeed at that. Would you please read and follow https://news.ycombinator.com/newsguidelines.html https://news.ycombinator.com/newsguidelines.html when using this site? I normally would have banned a new account that posted like this, but https://news.ycombinator.com/item?id=15406879 https://news.ycombinator.com/item?id=15406879 looks pretty good, so we'll assume you want to use HN as intended. Please do read those guidelines though!
nugga 9y ago
I don't think you can patent and steal a monopoly on a drug synthesized in 1912.
- trendia 9y ago
  Sometimes this is true, however there are many tricks that biotech companies use to prevent generics. The first is the very high cost ($ billions) of getting through FDA approval for a drug. Once a company has done this approval, then other companies must show drug equivalence in order to produce generics that can stand in. They have to wait for the patents to expire, or figure out how to get around existing patents, but that's still not enough. They must show that their drug is equivalent to the existing drug. But this is not easy task, because the incumbent will do everything they can to prevent anyone else from getting the drug for research purposes. (e.g. the incumbent will claim that a particular company trying to get the drug does not fit their safety protocols, and thus refuse to provide the drug. Because the company cannot get access to the drug, they can't prove equivalence.) Another method is that a prescription for one drug does not always guarantee that the prescription can be used for a generic drug of the same sort [0]. The incumbent company will spend lots on marketing by buying lunch for doctors, giving them notepads and pens, etc. Then, the doctor will write a prescription for that drug as write "Dispense as Written." This prevents the pharmacist from providing a generic alternative, even if they're biologically equivalent! A final method is to develop a drug with a particular injection mechanism. For instance, if a drug company puts MDMA in a patch, then they can get a patent for the combination MDMA + patch, get approval, and then get doctors to prescribe it. (Maybe it provides a small dose over a long period?) This can occur even if MDMA was first synthesized a century ago. The prescription for the patch cannot be used for a pill form, or vice versa. This guarantees the drug company revenue as long as they can convince doctors to prescribe it. So, to make a long story short, there are a lot of ways that drug companies guarantee their $$$ and prevent competitors from eating their lunch. [0] https://www.washingtonpost.com/national/some-doctors-insist-on-brand-name-drugs-even-when-cheaper-generics-are-available/2011/06/13/gIQAmC0L9H_story.html https://www.washingtonpost.com/national/some-doctors-insist-...
  - L_Rahman 9y ago
    I was about to type this depressing sequence of roadblocks myself so I thank you for already having done this. The drug development ecosystem in America makes me sad.
  - refurb 9y ago
    You're ignoring how hard it is to do a lot of those things. First off, getting a new drug approved is not "preventing generics". Generics need a new drug approve before they can get their generic approved (since they based their application off the original drug's data). This is a feature, not a flaw of the system. Without some guarantee of market exclusivity, nobody will spend on R&D to get approval. Second, yes, a doctor can write "DAW - dispense as written", however most insurance companies won't cover the originator drug if a generic is available. The patient is then on the hook for the entire cost. That's a strong incentive to go generic. Finally, unless the new administration method (patch, etc) has some benefit over the generic, doctors won't prescribe it and insurance company's won't cover it.
    - monocasa 9y ago
      > Second, yes, a doctor can write "DAW - dispense as written", however most insurance companies won't cover the originator drug if a generic is available. The patient is then on the hook for the entire cost. That's a strong incentive to go generic. I've heard rumors of the insurance companies backing off of this stance in the past few years. Essentially, since the ACA puts a hard cap on profit margins, insurance companies are looking for ways to spend more so they can have the same margins on a bigger pie and still increase real profit year after year. Policies like relaxing generic vs proprietary let's them achieve that in a controlled manner.
      - refurb 9y ago
        Wouldn't that take collusion between insurance companies? If I'm Google and United says "you're premium went up 20% this year", but Aetna is only 10%, Google is going to change insurance companies.
- wintercharm 9y ago
  If they Modify MDMA to increase efficacy, or bioavailability they could potentially patent it. Or, if they found a way to reduce side effects. Small modifications can have that effect. It's why we see so many sulfonamide drugs... small modifications that increase the efficacy of the drug.
- refurb 9y ago
  The first chemical entity approved by the FDA gets data exclusivity - that is, no other company is allowed to use the originator's data to get their generic approved. I think the standard is 5 years, with rare disease drugs getting 7 year.
- GuB-42 9y ago
  It works for Adderall, which is just good old amphetamine. They use specific salts and specific isomer ratios in order to make it patentable.
Synaesthesia 9y ago
It's not the sort of drug that gets prescribed regularly, you're only supposed to do it once, or maybe a few times at most. Therefore it doesn't fit their sales model, hence their probable hostility to the drug, and it's the same with Ketamine, LSD etc too
- kolbe 9y ago
  Not supposed to prescribe oxy very much either....
  - Afton 9y ago
    That's just not true. Opioids are a standard part of pain management. There are plenty of people who will be taking opioids as a breakthrough pain management technique for the foreseeable future. That makes it quite different from a "1 and done" type prescription model.
    - kolbe 9y ago
      "Though Percocet and other oxycodone-containing medications were originally used only for acute (short-term) pain, changes in government recommendations and aggressive marketing by pharmaceutical companies have led to a dramatic increase in the use of this drug in patients with chronic (long-term) pain since the 1990s." https://drugabuse.com/library/the-effects-of-percocet-use/ https://drugabuse.com/library/the-effects-of-percocet-use/
      - Afton 9y ago
        Pain doesn't easily divide up in to long-term and short term. What do you call someone who typically manages their pain with tylenol and mental techniques, but sometimes has to use opioids to make it through the day? Many people with chronic pain find themselves in this situation, for the rest of their life. Also, beware of false causation. The (extremely detrimental) effects of pain were not well circulated in the medical profession in the '80s. The more aggressive pain management that has occurred since is at least in part due to this sea change, and not merely "aggressive marketing". The "changes in government recommendations" did not occur by happenstance, nor were they solely motivated by pharma marketers.
maxxxxx 9y ago
Overprescribing and somebody taking a super expensive variation to market worries me too. But it's probably unavoidable.
- kolbe 9y ago
  I'm not saying it shouldn't be a legal drug. I'm just guessing at what the "force" was at play here to get the change to come about. The psychological benefits of E have been highly advocated for a while.

by kolbe 9y ago

popopo1 9y ago

You guessed wrong moron.

dang 9y ago
Posting like that is a bannable offense on HN. We're trying for a (much!) higher level of quality here, though of course we don't always succeed at that. Would you please read and follow https://news.ycombinator.com/newsguidelines.html https://news.ycombinator.com/newsguidelines.html when using this site? I normally would have banned a new account that posted like this, but https://news.ycombinator.com/item?id=15406879 https://news.ycombinator.com/item?id=15406879 looks pretty good, so we'll assume you want to use HN as intended. Please do read those guidelines though!

nugga 9y ago

I don't think you can patent and steal a monopoly on a drug synthesized in 1912.

trendia 9y ago
Sometimes this is true, however there are many tricks that biotech companies use to prevent generics. The first is the very high cost ($ billions) of getting through FDA approval for a drug. Once a company has done this approval, then other companies must show drug equivalence in order to produce generics that can stand in. They have to wait for the patents to expire, or figure out how to get around existing patents, but that's still not enough. They must show that their drug is equivalent to the existing drug. But this is not easy task, because the incumbent will do everything they can to prevent anyone else from getting the drug for research purposes. (e.g. the incumbent will claim that a particular company trying to get the drug does not fit their safety protocols, and thus refuse to provide the drug. Because the company cannot get access to the drug, they can't prove equivalence.) Another method is that a prescription for one drug does not always guarantee that the prescription can be used for a generic drug of the same sort [0]. The incumbent company will spend lots on marketing by buying lunch for doctors, giving them notepads and pens, etc. Then, the doctor will write a prescription for that drug as write "Dispense as Written." This prevents the pharmacist from providing a generic alternative, even if they're biologically equivalent! A final method is to develop a drug with a particular injection mechanism. For instance, if a drug company puts MDMA in a patch, then they can get a patent for the combination MDMA + patch, get approval, and then get doctors to prescribe it. (Maybe it provides a small dose over a long period?) This can occur even if MDMA was first synthesized a century ago. The prescription for the patch cannot be used for a pill form, or vice versa. This guarantees the drug company revenue as long as they can convince doctors to prescribe it. So, to make a long story short, there are a lot of ways that drug companies guarantee their $$$ and prevent competitors from eating their lunch. [0] https://www.washingtonpost.com/national/some-doctors-insist-on-brand-name-drugs-even-when-cheaper-generics-are-available/2011/06/13/gIQAmC0L9H_story.html https://www.washingtonpost.com/national/some-doctors-insist-...
- L_Rahman 9y ago
  I was about to type this depressing sequence of roadblocks myself so I thank you for already having done this. The drug development ecosystem in America makes me sad.
- refurb 9y ago
  You're ignoring how hard it is to do a lot of those things. First off, getting a new drug approved is not "preventing generics". Generics need a new drug approve before they can get their generic approved (since they based their application off the original drug's data). This is a feature, not a flaw of the system. Without some guarantee of market exclusivity, nobody will spend on R&D to get approval. Second, yes, a doctor can write "DAW - dispense as written", however most insurance companies won't cover the originator drug if a generic is available. The patient is then on the hook for the entire cost. That's a strong incentive to go generic. Finally, unless the new administration method (patch, etc) has some benefit over the generic, doctors won't prescribe it and insurance company's won't cover it.
  - monocasa 9y ago
    > Second, yes, a doctor can write "DAW - dispense as written", however most insurance companies won't cover the originator drug if a generic is available. The patient is then on the hook for the entire cost. That's a strong incentive to go generic. I've heard rumors of the insurance companies backing off of this stance in the past few years. Essentially, since the ACA puts a hard cap on profit margins, insurance companies are looking for ways to spend more so they can have the same margins on a bigger pie and still increase real profit year after year. Policies like relaxing generic vs proprietary let's them achieve that in a controlled manner.
    - refurb 9y ago
      Wouldn't that take collusion between insurance companies? If I'm Google and United says "you're premium went up 20% this year", but Aetna is only 10%, Google is going to change insurance companies.
wintercharm 9y ago
If they Modify MDMA to increase efficacy, or bioavailability they could potentially patent it. Or, if they found a way to reduce side effects. Small modifications can have that effect. It's why we see so many sulfonamide drugs... small modifications that increase the efficacy of the drug.
refurb 9y ago
The first chemical entity approved by the FDA gets data exclusivity - that is, no other company is allowed to use the originator's data to get their generic approved. I think the standard is 5 years, with rare disease drugs getting 7 year.
GuB-42 9y ago
It works for Adderall, which is just good old amphetamine. They use specific salts and specific isomer ratios in order to make it patentable.

Synaesthesia 9y ago

It's not the sort of drug that gets prescribed regularly, you're only supposed to do it once, or maybe a few times at most. Therefore it doesn't fit their sales model, hence their probable hostility to the drug, and it's the same with Ketamine, LSD etc too

kolbe 9y ago
Not supposed to prescribe oxy very much either....
- Afton 9y ago
  That's just not true. Opioids are a standard part of pain management. There are plenty of people who will be taking opioids as a breakthrough pain management technique for the foreseeable future. That makes it quite different from a "1 and done" type prescription model.
  - kolbe 9y ago
    "Though Percocet and other oxycodone-containing medications were originally used only for acute (short-term) pain, changes in government recommendations and aggressive marketing by pharmaceutical companies have led to a dramatic increase in the use of this drug in patients with chronic (long-term) pain since the 1990s." https://drugabuse.com/library/the-effects-of-percocet-use/ https://drugabuse.com/library/the-effects-of-percocet-use/
    - Afton 9y ago
      Pain doesn't easily divide up in to long-term and short term. What do you call someone who typically manages their pain with tylenol and mental techniques, but sometimes has to use opioids to make it through the day? Many people with chronic pain find themselves in this situation, for the rest of their life. Also, beware of false causation. The (extremely detrimental) effects of pain were not well circulated in the medical profession in the '80s. The more aggressive pain management that has occurred since is at least in part due to this sea change, and not merely "aggressive marketing". The "changes in government recommendations" did not occur by happenstance, nor were they solely motivated by pharma marketers.

maxxxxx 9y ago

Overprescribing and somebody taking a super expensive variation to market worries me too. But it's probably unavoidable.

kolbe 9y ago
I'm not saying it shouldn't be a legal drug. I'm just guessing at what the "force" was at play here to get the change to come about. The psychological benefits of E have been highly advocated for a while.