4 ms·

“I don’t think it takes a cynic such as myself to see most of these drugs are being developed to preserve patent protection,” said David Nathan, a Harvard Medic

“I don’t think it takes a cynic such as myself to see most of these drugs are being developed to preserve patent protection,” said David Nathan, a Harvard Medical School professor. “The truth is they are marginally different, and the clinical benefits of them over the older drugs have been zero.” -- quote from article And there you have it. I have seen this myself. One year ago, the insulin I was on was removed from the pharmacy, and coverage by my insurance company was also voided. My only choice, I was told, was to switch to a new insulin (which - as article states - was only marginally better, if at all), but which had a fresh patent and thus ensures new profits for another 20 years to come. And so the wheel keeps churning. Patients are not given a choice, because we are not humans. We are merely a commodity to pharmaceutical companies' profits and shareholder value.

marvin 9y ago
I always thought that when patents expire, a generics company will duplicate the drug (or treatment mechanism) and the prices will plummet to close to marginal cost due to competition. I get the impression that this happens in Europe, given the generic options that I am encouraged to choose when I’m picking up a prescription at the pharmacy. They are invariably cheaper. What is different for diabetes, or the United States, to cause this to not be an option? Seems almost like a human rights violation, or at least deeply unethical.
- pja 9y ago
  Generics still require FDA approval, which costs on the order of single digit $millions to obtain. Plus you’ve got to set up the plant to create the drug, which costs more $. Would you invest $millions in a product when a competitor (who probably already has plant capacity from when they made the drug while it was under patent) could come in and undercut you at a moments notice? Obviously not - so the system ends up in a metastable state where one monopoly producer can charge high prices for a drug & no competitor will enter the market because they know the producer can and will undercut them the moment they try and do so. This one of the reasons why the health care system in the US is completely borked.
  - shadowtree 9y ago
    Only true for rare and ultra-rare diseases.
    - pja 9y ago
      As far as I’m aware, all generic manufacturers must prove what the FDA calls bioequivalence: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/default.htm https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrug...
  - ABCLAW 9y ago
    This is accurate for niche drugs, but the business model for producing generics isn't solely one in which small players exist. Large omnibus generics manufacturers almost always have a larger industrial base and better chemical engineers than one-off drug producers. If the drug has a fairly stable high volume demand, they can finance expenditures for approval, then leverage their production and distribution networks to produce substantial margin even if they dramatically slash prices.
- shadowtree 9y ago
  Insulin is being “grown” genetically modified organisms in vats. It is not a simple molecule you get by mixing chemicals together. The very first application of the human genome project. The whole process of production is non-trivial, every step heavily patented and secured. Also pretty expensive. There are new biotechs currently working on CURING diabetes, but no one is doing trials on humans yet. Means we’re at least 10 years away from a cure. And no, those are not crazy 18 year olds in a garage. Spark Therapeutics now has an injection to cure macular degeneration, Moderna is building a whole RNA modification platform with 19(!) individual drugs in the pipeline. It is very likely that we’ll see a major shift of medicine to curing, rather than treating in the next 20-25 years. Hep-C now has a cure. Still so, so amazing. The Human Genome project will turn out to be one of the most live-saving accomplishments of humanity, next to the green revolution in farming.
  - ABCLAW 9y ago
    The process for introducing an insulin-gene plasmid, then selecting for and breeding the resulting recombinant bacteria is 101 level biochemistry that a Masters student could do in almost any decently equipped laboratory. Isolating the chemical on an industrial scale is where the difficulty comes in, but most of the equipment is fairly commoditized and it isn't prohibitively expensive or skill intensive. The marginal cost following the relatively inexpensive setup is exceptionally low, too - you feed the bugs, they make your drugs. Insulin would be priced as a commodity if not for the IP, approval and distribution issues - small biotech suffers from very poor distribution networks.
    - shadowtree 9y ago
      what was groundbreaking 25 years ago is now 101 biochem. progress!
      - heavenlyhash 9y ago
        Which is why it's very confusing that products with such an utterly trivial production pipeline are remaining so expensive -- to say nothing of growing in cost over the years.
- rbultje 9y ago
  Don't forget that switching insulin is not easy. You have to adjust and refine the amounts you take for several days or even weeks, while closely monitoring your blood sugar during that period. It's stressful and unpleasant. Here, you are forced to do that once (one year before the patent runs out) and it sucks. Why do it twice? If the insurance company covers the new insulin anyway? But the insurance company masks the real price. All our insurance policies are getting more expensive and cover less because we are all paying for it, together. We all know it, but we all take the easy way out. Including me. You are right, it is deeply unethical. Europeans more often think holistically about health care (and its cost), which is a good thing. In the US, health care (and its cost) is primarily driven by corporations whose primary goal is profits and shareholder value. They are not aligned.
- maxerickson 9y ago
  Many generics in the US do cost around $5 a month or less. For some drugs, the manufacturers work the system, withdrawing their previous version from the market and launching a new version with some tweak. Withdrawing the old version makes it more difficult for someone else to get permission to manufacture and sell it. The basic problem is that (the majority of) the engaged, wealthy part of the country gets their insurance from someone else and doesn't give a shit about how much medical stuff costs. And we have a medical system where the primary regulatory impact on prices is from capture.

marvin 9y ago

I always thought that when patents expire, a generics company will duplicate the drug (or treatment mechanism) and the prices will plummet to close to marginal cost due to competition. I get the impression that this happens in Europe, given the generic options that I am encouraged to choose when I’m picking up a prescription at the pharmacy. They are invariably cheaper. What is different for diabetes, or the United States, to cause this to not be an option? Seems almost like a human rights violation, or at least deeply unethical.

pja 9y ago
Generics still require FDA approval, which costs on the order of single digit $millions to obtain. Plus you’ve got to set up the plant to create the drug, which costs more $. Would you invest $millions in a product when a competitor (who probably already has plant capacity from when they made the drug while it was under patent) could come in and undercut you at a moments notice? Obviously not - so the system ends up in a metastable state where one monopoly producer can charge high prices for a drug & no competitor will enter the market because they know the producer can and will undercut them the moment they try and do so. This one of the reasons why the health care system in the US is completely borked.
- shadowtree 9y ago
  Only true for rare and ultra-rare diseases.
  - pja 9y ago
    As far as I’m aware, all generic manufacturers must prove what the FDA calls bioequivalence: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/default.htm https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrug...
- ABCLAW 9y ago
  This is accurate for niche drugs, but the business model for producing generics isn't solely one in which small players exist. Large omnibus generics manufacturers almost always have a larger industrial base and better chemical engineers than one-off drug producers. If the drug has a fairly stable high volume demand, they can finance expenditures for approval, then leverage their production and distribution networks to produce substantial margin even if they dramatically slash prices.
shadowtree 9y ago
Insulin is being “grown” genetically modified organisms in vats. It is not a simple molecule you get by mixing chemicals together. The very first application of the human genome project. The whole process of production is non-trivial, every step heavily patented and secured. Also pretty expensive. There are new biotechs currently working on CURING diabetes, but no one is doing trials on humans yet. Means we’re at least 10 years away from a cure. And no, those are not crazy 18 year olds in a garage. Spark Therapeutics now has an injection to cure macular degeneration, Moderna is building a whole RNA modification platform with 19(!) individual drugs in the pipeline. It is very likely that we’ll see a major shift of medicine to curing, rather than treating in the next 20-25 years. Hep-C now has a cure. Still so, so amazing. The Human Genome project will turn out to be one of the most live-saving accomplishments of humanity, next to the green revolution in farming.
- ABCLAW 9y ago
  The process for introducing an insulin-gene plasmid, then selecting for and breeding the resulting recombinant bacteria is 101 level biochemistry that a Masters student could do in almost any decently equipped laboratory. Isolating the chemical on an industrial scale is where the difficulty comes in, but most of the equipment is fairly commoditized and it isn't prohibitively expensive or skill intensive. The marginal cost following the relatively inexpensive setup is exceptionally low, too - you feed the bugs, they make your drugs. Insulin would be priced as a commodity if not for the IP, approval and distribution issues - small biotech suffers from very poor distribution networks.
  - shadowtree 9y ago
    what was groundbreaking 25 years ago is now 101 biochem. progress!
    - heavenlyhash 9y ago
      Which is why it's very confusing that products with such an utterly trivial production pipeline are remaining so expensive -- to say nothing of growing in cost over the years.
rbultje 9y ago
Don't forget that switching insulin is not easy. You have to adjust and refine the amounts you take for several days or even weeks, while closely monitoring your blood sugar during that period. It's stressful and unpleasant. Here, you are forced to do that once (one year before the patent runs out) and it sucks. Why do it twice? If the insurance company covers the new insulin anyway? But the insurance company masks the real price. All our insurance policies are getting more expensive and cover less because we are all paying for it, together. We all know it, but we all take the easy way out. Including me. You are right, it is deeply unethical. Europeans more often think holistically about health care (and its cost), which is a good thing. In the US, health care (and its cost) is primarily driven by corporations whose primary goal is profits and shareholder value. They are not aligned.
maxerickson 9y ago
Many generics in the US do cost around $5 a month or less. For some drugs, the manufacturers work the system, withdrawing their previous version from the market and launching a new version with some tweak. Withdrawing the old version makes it more difficult for someone else to get permission to manufacture and sell it. The basic problem is that (the majority of) the engaged, wealthy part of the country gets their insurance from someone else and doesn't give a shit about how much medical stuff costs. And we have a medical system where the primary regulatory impact on prices is from capture.