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Stow the politics, this isn't the place for it. Take it to Reddit. A few points: 1. Consumer Reports messes up, your dishwasher might break down before the en

Stow the politics, this isn't the place for it. Take it to Reddit. A few points: 1. Consumer Reports messes up, your dishwasher might break down before the end of the warranty. 2. A drug company messes up, hundreds, potentially thousands die or have their lifespans severely curtailed in terms of quality of life or length. That's the last I'll say on it, the magnitude of what's at stake should be otherwise self-evident.

maxharris 16y ago
The common case isn't the drug company messing up. It's that the FDA gets in the way of a new drug (stopping it forever in some cases), and the patient with the incurable disease dies because there is no legally available treatment. With the FDA, his right to pursue what remains of his life is sacrificed to the FDA's illusion of safety. Human life is so important, and the needs of each individual body are frequently so diverse from one another, that we can't trust decisions like these to a one-size-fits-all regulatory body. This is yet another case where ethics and politics is a life-and-death matter (and for more people than you'd ever care to think about).
- barrkel 16y ago
  A death owing to a mistake by a drug company is worth at least 100 deaths owing to lack of drug innovation and experimentation. It's psychology in the large, and it's very difficult to counteract. It's simply much easier for the free media to demonize the evil profit-grubbing soulless corporations killing babies than an abstract notion of opportunity cost.
  - maxharris 16y ago
    I voted you up. But I think that we can make a difference against ignorance, just by speaking up. In years past, I used to make the mistake of just being quiet when political or moral topics came up, just because I didn't think it would be of any use. I don't think that's true any longer because I realized that if you can state your case clearly enough, and it's a rational position, at least some people will listen. You don't have to immediately convince everyone, or even the majority of people. Just making the correct argument shifts the debate toward a better direction, and that's a powerful thing.
  - ramanujan 16y ago
    That's why you need to interview all the people who had family members die during the seven year average FDA induced lag between drug submission and clearance. That dramatizes opportunity cost.
- ck2 16y ago
  Big pharma screws up ALL THE TIME. They simply escape liability. http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195247.shtml http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195...
  - maxharris 16y ago
    This makes my point exactly. The cure is to oppose the FDA. (Copied from my post below, just like the OP.) Immoral businesses love regulations because they provide huge barriers to entry for new competitors. Observe how GSK uses the FDA and other regulatory agencies to shield themselves. From the article you linked: "GSK's manufacturing division has a strong track record of quality and compliance with current Good Manufacturing Practice (cGMP) requirements. Various regulatory agencies - including the FDA - conduct an average of more than 100 inspections each year at over 80 GSK manufacturing sites located in over 30 countries. The FDA has raised no material issues as a result of its very thorough inspections. ... GSK worked to bring the Cidra facility to a high level of operating performance that satisfied both GSK and the FDA." We need to separate the state from economics, just like we separate it from church. Unscrupulous companies (not all of them are this way) use and promote regulations to keep their competitors down, and to escape legal reprecussions that they should properly face (just as your article demonstrates). Remember that Enron lobbied for strict price controls on rates charged for access to power grids. (http://www.theatlantic.com/past/docs/issues/2002/04/orourke.htm http://www.theatlantic.com/past/docs/issues/2002/04/orourke....)
    - ck2 16y ago
      The solution is not to remove government regulation, the solution is a "death penalty" for corporations and prison time for dangerous decision makers in corporations. That does not exist in the USA for ANY kind of industry, it's the nutshell of the problem for our entire country.
      - maxharris 16y ago
        I once interviewed with a company that wrote medical imaging software. He explained that if anything ever went wrong with their product, their CEO would end up in jail (his words), and I'd be fired. This is for a product that didn't drive any medical equipment, but is regulated by the FDA anyway. Needless to say, I didn't take the job! Your proposal would kill the last ounce of innovation that hasn't been already crushed by the vast number of regulations already in place. When someone is injured or their property is damaged, that's what civil courts are for. When someone is killed intentionally, or by many instances of negligence, we have criminal courts to see that justice is done. All we need is to eliminate the regulations that people (and groups of people) hide behind and let the appropriate court do its job. And in some instances, bad precedent has to be overturned. At any rate, this is a much better idea than legislating and regulating more (which is like trying to dig your way out of a hole.)
ck2 16y ago
The thing is, big pharma escapes liability ALL THE TIME. http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195247.shtml http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195...
- maxharris 16y ago
  This makes my point exactly. The cure is to oppose the FDA. Immoral businesses love regulations because they provide huge barriers to entry for new competitors. Observe how GSK uses the FDA and other regulatory agencies to shield themselves. From the article you linked: "GSK's manufacturing division has a strong track record of quality and compliance with current Good Manufacturing Practice (cGMP) requirements. Various regulatory agencies - including the FDA - conduct an average of more than 100 inspections each year at over 80 GSK manufacturing sites located in over 30 countries. The FDA has raised no material issues as a result of its very thorough inspections. ... GSK worked to bring the Cidra facility to a high level of operating performance that satisfied both GSK and the FDA." We need to separate the state from economics, just like we separate it from church. Unscrupulous companies (not all of them are this way) use and promote regulations to keep their competitors down, and to escape legal reprecussions that they should properly face (just as your article demonstrates). Remember that Enron lobbied for strict price controls on rates charged for access to power grids. (http://www.theatlantic.com/past/docs/issues/2002/04/orourke.htm http://www.theatlantic.com/past/docs/issues/2002/04/orourke....)

maxharris 16y ago

The common case isn't the drug company messing up. It's that the FDA gets in the way of a new drug (stopping it forever in some cases), and the patient with the incurable disease dies because there is no legally available treatment. With the FDA, his right to pursue what remains of his life is sacrificed to the FDA's illusion of safety. Human life is so important, and the needs of each individual body are frequently so diverse from one another, that we can't trust decisions like these to a one-size-fits-all regulatory body. This is yet another case where ethics and politics is a life-and-death matter (and for more people than you'd ever care to think about).

barrkel 16y ago
A death owing to a mistake by a drug company is worth at least 100 deaths owing to lack of drug innovation and experimentation. It's psychology in the large, and it's very difficult to counteract. It's simply much easier for the free media to demonize the evil profit-grubbing soulless corporations killing babies than an abstract notion of opportunity cost.
- maxharris 16y ago
  I voted you up. But I think that we can make a difference against ignorance, just by speaking up. In years past, I used to make the mistake of just being quiet when political or moral topics came up, just because I didn't think it would be of any use. I don't think that's true any longer because I realized that if you can state your case clearly enough, and it's a rational position, at least some people will listen. You don't have to immediately convince everyone, or even the majority of people. Just making the correct argument shifts the debate toward a better direction, and that's a powerful thing.
- ramanujan 16y ago
  That's why you need to interview all the people who had family members die during the seven year average FDA induced lag between drug submission and clearance. That dramatizes opportunity cost.
ck2 16y ago
Big pharma screws up ALL THE TIME. They simply escape liability. http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195247.shtml http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195...
- maxharris 16y ago
  This makes my point exactly. The cure is to oppose the FDA. (Copied from my post below, just like the OP.) Immoral businesses love regulations because they provide huge barriers to entry for new competitors. Observe how GSK uses the FDA and other regulatory agencies to shield themselves. From the article you linked: "GSK's manufacturing division has a strong track record of quality and compliance with current Good Manufacturing Practice (cGMP) requirements. Various regulatory agencies - including the FDA - conduct an average of more than 100 inspections each year at over 80 GSK manufacturing sites located in over 30 countries. The FDA has raised no material issues as a result of its very thorough inspections. ... GSK worked to bring the Cidra facility to a high level of operating performance that satisfied both GSK and the FDA." We need to separate the state from economics, just like we separate it from church. Unscrupulous companies (not all of them are this way) use and promote regulations to keep their competitors down, and to escape legal reprecussions that they should properly face (just as your article demonstrates). Remember that Enron lobbied for strict price controls on rates charged for access to power grids. (http://www.theatlantic.com/past/docs/issues/2002/04/orourke.htm http://www.theatlantic.com/past/docs/issues/2002/04/orourke....)
  - ck2 16y ago
    The solution is not to remove government regulation, the solution is a "death penalty" for corporations and prison time for dangerous decision makers in corporations. That does not exist in the USA for ANY kind of industry, it's the nutshell of the problem for our entire country.
    - maxharris 16y ago
      I once interviewed with a company that wrote medical imaging software. He explained that if anything ever went wrong with their product, their CEO would end up in jail (his words), and I'd be fired. This is for a product that didn't drive any medical equipment, but is regulated by the FDA anyway. Needless to say, I didn't take the job! Your proposal would kill the last ounce of innovation that hasn't been already crushed by the vast number of regulations already in place. When someone is injured or their property is damaged, that's what civil courts are for. When someone is killed intentionally, or by many instances of negligence, we have criminal courts to see that justice is done. All we need is to eliminate the regulations that people (and groups of people) hide behind and let the appropriate court do its job. And in some instances, bad precedent has to be overturned. At any rate, this is a much better idea than legislating and regulating more (which is like trying to dig your way out of a hole.)

ck2 16y ago

The thing is, big pharma escapes liability ALL THE TIME. http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195247.shtml http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195...

maxharris 16y ago
This makes my point exactly. The cure is to oppose the FDA. Immoral businesses love regulations because they provide huge barriers to entry for new competitors. Observe how GSK uses the FDA and other regulatory agencies to shield themselves. From the article you linked: "GSK's manufacturing division has a strong track record of quality and compliance with current Good Manufacturing Practice (cGMP) requirements. Various regulatory agencies - including the FDA - conduct an average of more than 100 inspections each year at over 80 GSK manufacturing sites located in over 30 countries. The FDA has raised no material issues as a result of its very thorough inspections. ... GSK worked to bring the Cidra facility to a high level of operating performance that satisfied both GSK and the FDA." We need to separate the state from economics, just like we separate it from church. Unscrupulous companies (not all of them are this way) use and promote regulations to keep their competitors down, and to escape legal reprecussions that they should properly face (just as your article demonstrates). Remember that Enron lobbied for strict price controls on rates charged for access to power grids. (http://www.theatlantic.com/past/docs/issues/2002/04/orourke.htm http://www.theatlantic.com/past/docs/issues/2002/04/orourke....)