5 ms·

I think the FDA will fight to your death for your right to safe medicine.

notyourday 9y ago
I'm baffled by the snark. Could someone please attempt to reconcile the following positions for me: 1. We need regulation of drugs/medicine/etc because we do not want some snake oil peddlers peddling arsenic as medicine? 2. Regulations prevent us from getting shit cheap! Baaaaa!
- ztjio 9y ago
  FDA is given power to do a necessary job: keep us from eating poison instead of medicine, or whatever. But the same power is abused to prevent competition by "suggestion" of the industry that provides these medicines. It's hardly a complicated situation.
  - notyourday 9y ago
    Exactly: it is a very simple situation - we collectively as the society decided that we do not want garbage peddled as medicine. FDA established how we determine "not garbage". Full stop.
    - notyourday 9y ago
      Edit: yes, based on our current position Export from US->Other Country->Import to US for medicine violates "Not Garbage" state. It is no different than importing USB chargers that sell in China for $1.02. We do not want the vast majority of the population engaging in this though those who know how to are allowed to do it themselves.
- jsjohnst 9y ago
  I think you are jumping to a conclusion without having enough supporting evidence. Regulation on drugs didn’t suddenly get 8,000x more expensive for drug companies in the last few years. An alternative theory, which I can’t prove any more than you can prove yours, is that due to some pharmaceutical companies realizing they were leaving serious money on the table, they tried hiking prices. Once they realized there would be little repercussions, all jumped in and we have a new industry norm.
  - notyourday 9y ago
    It contradicts basic economics. If you raise prices 8000x and I will go into competition with you and raise prices 7999x i.e. do what MCI did to ATT and Vizio did to Samsung.
    - jsjohnst 9y ago
      In the examples you gave, they were huge markets and they were ripe for disruption. As the article laid out, most of the drugs which have experienced this huge hike are ones with very limited markets. It’s not worth it for a pharmaceutical company to jump into a new drug with almost no market for it.
      - notyourday 9y ago
        Medications blow electronics market out the water.
        jsjohnst 9y ago
        That’s such a vague statement you could either be wildly wrong or mostly right. If you’re talking average profit margin, yes medications generally have higher, but electronics are fairly good margins generally too. If you’re talking market cap / overall market size, you definitely aren’t correct. Even the biggest pharmaceutical company pales in comparison to the electronics top three.
    - yequalsx 9y ago
      Not if there is collusion or cartel pricing. There are also regulatory means of limiting competition. The basic economics notion works in a market that is mostly free. I suspect that most things related to the American health care system do not qualify as a free market.
      - notyourday 9y ago
        There's no cartel pricing in medicine. If there was there would be a competing cartel as it is the case everywhere. The reality is that companies that make generics are simply too small to be able to compete with Pfizer, Merc, Glaxo etc and for all big talk our scientists in R&D and FDA are bought and sold like trading cards and their opinions change with the opinions of their owners, which is, for example, why FDA accepts garbage studies from Pfizer and does not from itty bitty company that competes with it.
- ashelmire 9y ago
  Presumably, other first world nations also regulate drugs. Are the drugs as expensive in those nations? If not, why not?
  - notyourday 9y ago
    They have different rules than we do. Adjusting rules is fairly easy: change the bloody FDA. Agency lives at the pleasure of administration. We had (D)s in control of all three branches of government. Now we have (R)s in control of all three branches of government. The reason why this is not changing is because a compelling case is made that the current rules for !Garbage are better than the proposed alternatives.
- dragonwriter 9y ago
  The reconciliation is that some countries have what appears to be perfectly adequate regulations to address #1, but much smaller effect of #2, suggesting that some aspect of the US regulatory environment is suboptimal.
- jklein11 9y ago
  I enjoy having the option of buying drugs that are covered by strict regulatory controls. I understand that there is a cost associated with this. If I choose to forgo that cost and roll the dice that I am getting arsenic as medicine that should be my prerogative.
  - notyourday 9y ago
    And it is - you can import those drugs just fine. It simply means you have to jump through some hoops. What we do not want as a society is that the guy on a corner stall that sells $4.00 USB chargers that may or may not explode sell a million pills to little old ladies which may or may not do what they are supposed to. This is the current societal contract. [Edit:] Now I personally think we should live in the more Darwinian society and in my view we should allow dude on a corner sell pills just like he can sell chargers and should some benefit manager buy the pills from the corner dude from Nigeria without vetting the corner dude from Nigeria and his suppliers and therefore killing and maiming a few thousand old ladies, we should throw the book at the benefits manager and not the corner dude from Nigeria (who should be thrown a book based on fraud and not manslaughter) but that's just me.
- dmm 9y ago
  1. The vast majority of the cost of FDA regulation is in ensuring the effectiveness of medicines, yet whenever someone defends the purpose of the FDA they cite examples of medicine safety. 2. The FDA keeps arsenic out of our medicines and that's totally related to fulfilling arbitrary and expensive effectiveness regulations! Ineffective and dangerous medicines like fen-phen getting through just proves we need more regulations! Baaa!
  - notyourday 9y ago
    We have one very interesting and totally unregulated market that is quite similar. The market is cosmetics and beauty products. As long as products make no medical claims it is total buyer beware. I seriously doubt anyone in the United States wants that to be applied to medicine and medical instruments.
- matthewmacleod 9y ago
  In line with the enduring trend of public discourse, all nuance is cast aside. We self-evidently need regulation of medicines and medical devices, at least until we hit some glorious future utopia of flawless consumer knowledge. Otherwise, people will come along, and they will sell products and devices that will harm people, and they will do it by lying about them and covering up their problems. On the other hand, it's possible that the relatively slow pace of regulation and medical testing could cause problems bringing potentially beneficial treatments to market. This might represent an excess focus on safety at the expense of the benefits in access to new and innovative treatments. Naturally the argument should be something along the lines of "I think we should reform medical testing to enhance the availability of innovative treatments" versus "I think that the loosening of medical regulation will result in an increase in the harmful outcomes of dangerous and untested treatments". Both ideas that are totally reasonable to think might be the case, and for which you can imagine undertaking some kind of evidence-based process to establish if reform is needed, and if so what form it might take. But of course, snark is much easier.
- mikeash 9y ago
  Safety might be a good reason to prohibit imports from a place like Tanzania, but it makes no sense as a reason to prohibit imports from Canada. Canada has some equivalent to the FDA which is about as good as ours, so there should be no safety problem when it comes to importing their medicine.
  - notyourday 9y ago
    We do not have reciprocity agreement with Canada regarding drug approvals.
    - mikeash 9y ago
      Anything approved in both countries ought to be OK, no?
      - notyourday 9y ago
        You are describing this: Canada->US, approved US->Canada, approved i.e. Canadian companies are successfully selling to the united states medicine that is manufactured in Canada and is regulated by the US. US companies successfully selling products to Canada that are manufactured in the US and regulated in Canada. If we had a reciprocity then we would have: US->Canda->US auto-approved Canada->US->Canada auto-approved i.e. if a product is sold to Canada then it can be re-imported into the US.
        mikeash 9y ago
        I’m saying that even if we don’t have reciprocity, if the drug is separately approved in both countries, it should be legal to buy in Canada and take to the US.
        notyourday 9y ago
        No, because our system of approvals does not treat re-import the same as direct import.
- vorotato 9y ago
  Both of these things can be true?
  - notyourday 9y ago
    Only if you can define lines.

I'm baffled by the snark. Could someone please attempt to reconcile the following positions for me: 1. We need regulation of drugs/medicine/etc because we do not want some snake oil peddlers peddling arsenic as medicine? 2. Regulations prevent us from getting shit cheap! Baaaaa!

ztjio 9y ago
FDA is given power to do a necessary job: keep us from eating poison instead of medicine, or whatever. But the same power is abused to prevent competition by "suggestion" of the industry that provides these medicines. It's hardly a complicated situation.
- notyourday 9y ago
  Exactly: it is a very simple situation - we collectively as the society decided that we do not want garbage peddled as medicine. FDA established how we determine "not garbage". Full stop.
  - notyourday 9y ago
    Edit: yes, based on our current position Export from US->Other Country->Import to US for medicine violates "Not Garbage" state. It is no different than importing USB chargers that sell in China for $1.02. We do not want the vast majority of the population engaging in this though those who know how to are allowed to do it themselves.
jsjohnst 9y ago
I think you are jumping to a conclusion without having enough supporting evidence. Regulation on drugs didn’t suddenly get 8,000x more expensive for drug companies in the last few years. An alternative theory, which I can’t prove any more than you can prove yours, is that due to some pharmaceutical companies realizing they were leaving serious money on the table, they tried hiking prices. Once they realized there would be little repercussions, all jumped in and we have a new industry norm.
- notyourday 9y ago
  It contradicts basic economics. If you raise prices 8000x and I will go into competition with you and raise prices 7999x i.e. do what MCI did to ATT and Vizio did to Samsung.
  - jsjohnst 9y ago
    In the examples you gave, they were huge markets and they were ripe for disruption. As the article laid out, most of the drugs which have experienced this huge hike are ones with very limited markets. It’s not worth it for a pharmaceutical company to jump into a new drug with almost no market for it.
    - notyourday 9y ago
      Medications blow electronics market out the water.
      - jsjohnst 9y ago
        That’s such a vague statement you could either be wildly wrong or mostly right. If you’re talking average profit margin, yes medications generally have higher, but electronics are fairly good margins generally too. If you’re talking market cap / overall market size, you definitely aren’t correct. Even the biggest pharmaceutical company pales in comparison to the electronics top three.
  - yequalsx 9y ago
    Not if there is collusion or cartel pricing. There are also regulatory means of limiting competition. The basic economics notion works in a market that is mostly free. I suspect that most things related to the American health care system do not qualify as a free market.
    - notyourday 9y ago
      There's no cartel pricing in medicine. If there was there would be a competing cartel as it is the case everywhere. The reality is that companies that make generics are simply too small to be able to compete with Pfizer, Merc, Glaxo etc and for all big talk our scientists in R&D and FDA are bought and sold like trading cards and their opinions change with the opinions of their owners, which is, for example, why FDA accepts garbage studies from Pfizer and does not from itty bitty company that competes with it.
ashelmire 9y ago
Presumably, other first world nations also regulate drugs. Are the drugs as expensive in those nations? If not, why not?
- notyourday 9y ago
  They have different rules than we do. Adjusting rules is fairly easy: change the bloody FDA. Agency lives at the pleasure of administration. We had (D)s in control of all three branches of government. Now we have (R)s in control of all three branches of government. The reason why this is not changing is because a compelling case is made that the current rules for !Garbage are better than the proposed alternatives.
dragonwriter 9y ago
The reconciliation is that some countries have what appears to be perfectly adequate regulations to address #1, but much smaller effect of #2, suggesting that some aspect of the US regulatory environment is suboptimal.
jklein11 9y ago
I enjoy having the option of buying drugs that are covered by strict regulatory controls. I understand that there is a cost associated with this. If I choose to forgo that cost and roll the dice that I am getting arsenic as medicine that should be my prerogative.
- notyourday 9y ago
  And it is - you can import those drugs just fine. It simply means you have to jump through some hoops. What we do not want as a society is that the guy on a corner stall that sells $4.00 USB chargers that may or may not explode sell a million pills to little old ladies which may or may not do what they are supposed to. This is the current societal contract. [Edit:] Now I personally think we should live in the more Darwinian society and in my view we should allow dude on a corner sell pills just like he can sell chargers and should some benefit manager buy the pills from the corner dude from Nigeria without vetting the corner dude from Nigeria and his suppliers and therefore killing and maiming a few thousand old ladies, we should throw the book at the benefits manager and not the corner dude from Nigeria (who should be thrown a book based on fraud and not manslaughter) but that's just me.
dmm 9y ago
1. The vast majority of the cost of FDA regulation is in ensuring the effectiveness of medicines, yet whenever someone defends the purpose of the FDA they cite examples of medicine safety. 2. The FDA keeps arsenic out of our medicines and that's totally related to fulfilling arbitrary and expensive effectiveness regulations! Ineffective and dangerous medicines like fen-phen getting through just proves we need more regulations! Baaa!
- notyourday 9y ago
  We have one very interesting and totally unregulated market that is quite similar. The market is cosmetics and beauty products. As long as products make no medical claims it is total buyer beware. I seriously doubt anyone in the United States wants that to be applied to medicine and medical instruments.
matthewmacleod 9y ago
In line with the enduring trend of public discourse, all nuance is cast aside. We self-evidently need regulation of medicines and medical devices, at least until we hit some glorious future utopia of flawless consumer knowledge. Otherwise, people will come along, and they will sell products and devices that will harm people, and they will do it by lying about them and covering up their problems. On the other hand, it's possible that the relatively slow pace of regulation and medical testing could cause problems bringing potentially beneficial treatments to market. This might represent an excess focus on safety at the expense of the benefits in access to new and innovative treatments. Naturally the argument should be something along the lines of "I think we should reform medical testing to enhance the availability of innovative treatments" versus "I think that the loosening of medical regulation will result in an increase in the harmful outcomes of dangerous and untested treatments". Both ideas that are totally reasonable to think might be the case, and for which you can imagine undertaking some kind of evidence-based process to establish if reform is needed, and if so what form it might take. But of course, snark is much easier.
mikeash 9y ago
Safety might be a good reason to prohibit imports from a place like Tanzania, but it makes no sense as a reason to prohibit imports from Canada. Canada has some equivalent to the FDA which is about as good as ours, so there should be no safety problem when it comes to importing their medicine.
- notyourday 9y ago
  We do not have reciprocity agreement with Canada regarding drug approvals.
  - mikeash 9y ago
    Anything approved in both countries ought to be OK, no?
    - notyourday 9y ago
      You are describing this: Canada->US, approved US->Canada, approved i.e. Canadian companies are successfully selling to the united states medicine that is manufactured in Canada and is regulated by the US. US companies successfully selling products to Canada that are manufactured in the US and regulated in Canada. If we had a reciprocity then we would have: US->Canda->US auto-approved Canada->US->Canada auto-approved i.e. if a product is sold to Canada then it can be re-imported into the US.
      - mikeash 9y ago
        I’m saying that even if we don’t have reciprocity, if the drug is separately approved in both countries, it should be legal to buy in Canada and take to the US.
        notyourday 9y ago
        No, because our system of approvals does not treat re-import the same as direct import.
vorotato 9y ago
Both of these things can be true?
- notyourday 9y ago
  Only if you can define lines.