4 ms·

Hmm. So the way I read this: We have an old drug that helps diabetes to treat cancer.. The drug costs $.05/pill, for diabetes. It will be called "Nocan", and

Hmm. So the way I read this: We have an old drug that helps diabetes to treat cancer.. The drug costs $.05/pill, for diabetes. It will be called "Nocan", and feature a $24/pill cost, due to a new patent being granted. * *Just like Eli Lilly with PMS-PMDD and name change of Prozac to Sarafem. All you need do is bribe FDA for new "disease" name, and you have another 17 yr patent.

danielweber 14y ago
Orphan Drug Law. If you want someone to do all the work to actually prove it works, which is incredibly expensive, they must be compensated in some way. There are certainly other ways to compensate people who do this research, but this way maps pretty well to our current laws.
- huxley 14y ago
  Some drugs are very expensive, but most orphan drugs aren't. Average costs are between $25-60 million per drug. http://www.palgrave-journals.com/biosoc/journal/v6/n1/full/biosoc201040a.html http://www.palgrave-journals.com/biosoc/journal/v6/n1/full/b... http://www.cptech.org/ip/health/rnd/evidenceregardingrnd.pdf http://www.cptech.org/ip/health/rnd/evidenceregardingrnd.pdf
tptacek 14y ago
Huh? How do you patent metformin? It's an extremely widely prescribed drug.
- stephengillie 14y ago
  You don't. You patent "Nocan", a drug with an extremely similar (most would say "identical") chemical structure. Metformin is a diabetes medication, while Nocan will be a cancer drug, so they're totally different. The diseases aren't even handled by the same medical specialists. ;)
  - tptacek 14y ago
    If metformin works for cancer the way aspirin does for heart disease, with an overall long-term prophylactic effect, people will just take metformin. It is very easy to get metformin.
    - danielweber 14y ago
      I was going to say that your doctor won't be allowed to prescribe metformin, but I checked and the FDA is fine with your doc independently prescribing drugs for off-label use. The manufacturer of metformin isn't allowed to market it as an anti-cancer drug, but what doctor won't be aware of this?
- cowsandmilk 14y ago
  at least it is a new indication, see the Makena Pricing Controversy to learn about what the Orphan Drug Law allows https://en.wikipedia.org/wiki/KV_Pharmaceutical#Makena_pricing_controversy https://en.wikipedia.org/wiki/KV_Pharmaceutical#Makena_prici...
- timClicks 14y ago
  It's possible to receive a patent for applying a known drug to a new area.
  - tptacek 14y ago
    First of all, are you sure about that? Second of all, how does that even work? Metformin is very very widely prescribed.
    - refurb 14y ago
      It's called a "use" patent. There are many different ways to patent a drug. Composition patents, formulation patents, use patents, etc. The problem is that if you get a "use" patent, it only stops other company from promoting the drug for the use you patented. In the case of metformin, it's already available as a cheap generic. So if a company were to conduct studies proving that it reduced the risk of cancer and got a patent on it, there is nothing to stop a doctor from prescribing the generic version. So unless a company can find a way to recoup their R&D costs associated with running the trials, they won't bother.
      - DigitalJack 14y ago
        I wasn't aware of use patents. Informative post, thank you.
    - pyre 14y ago
      The parent is saying you can patent "using Metformin to prevent Cancer" separately than "using Metformin to help with diabetes." I'm not 100% sure of this, but I'm pretty sure that this is the way the FDA approval process for drugs work. You can't just 'decide' to prescribe Metformin for cancer one day. A single drug has to go through the approval process N separate times for N separate applications/diseases.
      - tptacek 14y ago
        Yes, you can. Doctors prescribe drugs for off-label use all the time. The FDA approves the marketing of drugs for specific health problems, but nobody cares about marketing metformin.
batgaijin 14y ago
Patents are the foundation for knowledge trickle-down-theory.
aptimpropriety 14y ago
A somewhat similar corollary - 'Lovaza', sold by GSK. It contains Omega-3-acid ethyl esters. Also widely known as fish oil, and is prescribed for the same reasons fish oil is recommended in supplementation. Only difference is fish oil is marginally less concentrated, much cheaper, doesn't have the 'pharma' tag and isn't prescribed. In the industry it's known as one of the biggest cash cows for GSK - it's earned them many billions. http://www.omegavia.com/lovaza-vs-fish-oil/ http://www.omegavia.com/lovaza-vs-fish-oil/
- guylhem 14y ago
  They might as well have called the drug "snake oil". It would have made more sense :-)

danielweber 14y ago

Orphan Drug Law. If you want someone to do all the work to actually prove it works, which is incredibly expensive, they must be compensated in some way. There are certainly other ways to compensate people who do this research, but this way maps pretty well to our current laws.

huxley 14y ago
Some drugs are very expensive, but most orphan drugs aren't. Average costs are between $25-60 million per drug. http://www.palgrave-journals.com/biosoc/journal/v6/n1/full/biosoc201040a.html http://www.palgrave-journals.com/biosoc/journal/v6/n1/full/b... http://www.cptech.org/ip/health/rnd/evidenceregardingrnd.pdf http://www.cptech.org/ip/health/rnd/evidenceregardingrnd.pdf

tptacek 14y ago

Huh? How do you patent metformin? It's an extremely widely prescribed drug.

stephengillie 14y ago
You don't. You patent "Nocan", a drug with an extremely similar (most would say "identical") chemical structure. Metformin is a diabetes medication, while Nocan will be a cancer drug, so they're totally different. The diseases aren't even handled by the same medical specialists. ;)
- tptacek 14y ago
  If metformin works for cancer the way aspirin does for heart disease, with an overall long-term prophylactic effect, people will just take metformin. It is very easy to get metformin.
  - danielweber 14y ago
    I was going to say that your doctor won't be allowed to prescribe metformin, but I checked and the FDA is fine with your doc independently prescribing drugs for off-label use. The manufacturer of metformin isn't allowed to market it as an anti-cancer drug, but what doctor won't be aware of this?
cowsandmilk 14y ago
at least it is a new indication, see the Makena Pricing Controversy to learn about what the Orphan Drug Law allows https://en.wikipedia.org/wiki/KV_Pharmaceutical#Makena_pricing_controversy https://en.wikipedia.org/wiki/KV_Pharmaceutical#Makena_prici...
timClicks 14y ago
It's possible to receive a patent for applying a known drug to a new area.
- tptacek 14y ago
  First of all, are you sure about that? Second of all, how does that even work? Metformin is very very widely prescribed.
  - refurb 14y ago
    It's called a "use" patent. There are many different ways to patent a drug. Composition patents, formulation patents, use patents, etc. The problem is that if you get a "use" patent, it only stops other company from promoting the drug for the use you patented. In the case of metformin, it's already available as a cheap generic. So if a company were to conduct studies proving that it reduced the risk of cancer and got a patent on it, there is nothing to stop a doctor from prescribing the generic version. So unless a company can find a way to recoup their R&D costs associated with running the trials, they won't bother.
    - DigitalJack 14y ago
      I wasn't aware of use patents. Informative post, thank you.
  - pyre 14y ago
    The parent is saying you can patent "using Metformin to prevent Cancer" separately than "using Metformin to help with diabetes." I'm not 100% sure of this, but I'm pretty sure that this is the way the FDA approval process for drugs work. You can't just 'decide' to prescribe Metformin for cancer one day. A single drug has to go through the approval process N separate times for N separate applications/diseases.
    - tptacek 14y ago
      Yes, you can. Doctors prescribe drugs for off-label use all the time. The FDA approves the marketing of drugs for specific health problems, but nobody cares about marketing metformin.

batgaijin 14y ago

Patents are the foundation for knowledge trickle-down-theory.

aptimpropriety 14y ago

A somewhat similar corollary - 'Lovaza', sold by GSK. It contains Omega-3-acid ethyl esters. Also widely known as fish oil, and is prescribed for the same reasons fish oil is recommended in supplementation. Only difference is fish oil is marginally less concentrated, much cheaper, doesn't have the 'pharma' tag and isn't prescribed. In the industry it's known as one of the biggest cash cows for GSK - it's earned them many billions. http://www.omegavia.com/lovaza-vs-fish-oil/ http://www.omegavia.com/lovaza-vs-fish-oil/

guylhem 14y ago
They might as well have called the drug "snake oil". It would have made more sense :-)