Dr. Mary Ruwart on the FDA, Libertarian Party, Licensing, and More . . . .
Show comments start here. Date on this show is two years old, April 20, 2014.
"When you use morally acceptable means, you get good results. When you use aggression as your means to an end, you get aggressive [possibly violent] results." Whether it's banking, small business, pollution, or foreign policy, case after case you get aggression if you use aggression. Aggression boomerangs on the perpetrator.
One of her favorites is the FDA. These regulations 1962, in the wake of the Thalidomide tragedy, have left people to die waiting for life-saving drugs. AIDS community tested and used blackmarket drugs. By the time the FDA gave its approval to test on humans, every AIDS patient in the country who wanted her drugs said they'd already had them and had developed resistance to them. Wow!! So she had to wait for new diagnoses before she could actually do the tests. Incredible. FDA is tragically behind the curve. Regulations that take choice away from the consumer actually harm the consumer. F"DA is going to keep some effective drugs off the market, but it does its job to keep people safe, so maybe it's just a wash" asks Dr. Woods in the hypothetical. Her answer? "Well, actually, it's not a wash.
FDA regulation because we want to be protected from poisonous drugs, particularly from 1962 with the thalidomide tragedy, takes 5 to 15 years to get life-saving drugs to the market. By the time AIDS drugs were marketed, they had to change the drug because people became . . . .
FDA drug policy is not a wash. Problems with drugs are due to the fact that we don't have enough science to test them. We're so different genetically. With the foods we eat. A small group reacts poorly to some drugs--even penicillin--can kill people because drugs have side effects. Adding 10 years to development time increases the costs and time so much, that life-saving drugs aren't developed. People can die from allergic reactions. Development time does not give us protection at all. New life-saving drugs aren't developed because it's too difficult to please the FDA. She has a patent for liver disease. But if you've got a patent or a drug to cure, she doesn't know how much to give. By the time you get the drug to market, your patent has run out, it goes generic, and you can't recover your costs. Long timeline increases costs so much that companies aren't willing to take a chance to design a cure.
"What about licensing?" Tom asks. Certification. It gives people greater choice. With licensing comes monopoly. With certification you've got more choices. Still can have bad players in the market, but certification at least gives you the opportunity to go elsewhere. Whereas licensing only allows you to go to someone else within the same licensed system. You get certification from certain professional groups where you have to meet certain requirements. Beauty is that you always have a choice as a consumer. Certification does signal testing. Example:
Show comments start here. Date on this show is two years old, April 20, 2014.
"When you use morally acceptable means, you get good results. When you use aggression as your means to an end, you get aggressive [possibly violent] results." Whether it's banking, small business, pollution, or foreign policy, case after case you get aggression if you use aggression. Aggression boomerangs on the perpetrator.
One of her favorites is the FDA. These regulations 1962, in the wake of the Thalidomide tragedy, have left people to die waiting for life-saving drugs. AIDS community tested and used blackmarket drugs. By the time the FDA gave its approval to test on humans, every AIDS patient in the country who wanted her drugs said they'd already had them and had developed resistance to them. Wow!! So she had to wait for new diagnoses before she could actually do the tests. Incredible. FDA is tragically behind the curve. Regulations that take choice away from the consumer actually harm the consumer. F"DA is going to keep some effective drugs off the market, but it does its job to keep people safe, so maybe it's just a wash" asks Dr. Woods in the hypothetical. Her answer? "Well, actually, it's not a wash.
FDA regulation because we want to be protected from poisonous drugs, particularly from 1962 with the thalidomide tragedy, takes 5 to 15 years to get life-saving drugs to the market. By the time AIDS drugs were marketed, they had to change the drug because people became . . . .
FDA drug policy is not a wash. Problems with drugs are due to the fact that we don't have enough science to test them. We're so different genetically. With the foods we eat. A small group reacts poorly to some drugs--even penicillin--can kill people because drugs have side effects. Adding 10 years to development time increases the costs and time so much, that life-saving drugs aren't developed. People can die from allergic reactions. Development time does not give us protection at all. New life-saving drugs aren't developed because it's too difficult to please the FDA. She has a patent for liver disease. But if you've got a patent or a drug to cure, she doesn't know how much to give. By the time you get the drug to market, your patent has run out, it goes generic, and you can't recover your costs. Long timeline increases costs so much that companies aren't willing to take a chance to design a cure.
"What about licensing?" Tom asks. Certification. It gives people greater choice. With licensing comes monopoly. With certification you've got more choices. Still can have bad players in the market, but certification at least gives you the opportunity to go elsewhere. Whereas licensing only allows you to go to someone else within the same licensed system. You get certification from certain professional groups where you have to meet certain requirements. Beauty is that you always have a choice as a consumer. Certification does signal testing. Example:
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