ancap
Active Member
I justed listened to an interview with Dr. Mary Ruwart, a former research scientist (biochemist, biophysicist and surgeon) for the Upjohn Institute, and found her personal thoughts and experiences regarding the FDA very enlightening. I'll bullet out a couple of her statements, and you can tell me what you think.
-In 1962 the federal government made several ammendments to the Food and Drug Act which created a disasterous environment for medical advancement and disease prevention in the US.
-From the time a drug therapy was discovered to the time it was put on pharmacy shelves was once 5 years. That turnaround is now tripled. This is due to increased regulatory demands by the federal government. The additional testing required on the therapies meant more would die waiting for a cure, and less drugs would be developed due to a severe lacking in cost effectiveness. Estimates put the human death toll at around 4 million lives as a result.
-A staggering 80% of drug development costs are attributed to regulation compliance. Studies Dr. Ruwart refers to estimates a 50% loss in the innovation of new drugs as a result. Drugs which will not recoup the initial investment in sales are never developed. Drug companies bail on these new developments with regularity. If you calculate the number of lives saved from our current innovation and then calculate the cost of NOT having those drugs (a 50% loss in innovation), we can estimate the human death toll rising to somewhere around 16 million lives. These are human beings that have died silently from their diseases when medical advances existed to save them.
-Drug therapies for individuals suffering from less common illnesses have significantly less of a chance for the development of a cure because there is less chance the companies will be able to recoup their development investment through sales. This again is a result of the enormous compliance costs imposed by our government.
-In our fairly recent past a group of cancer patients sued the federal government for the right to purchase a drug in development that showed reasonable signs of either slowing the progression of thier illness or putting their cancer into remission altogether. The court ruled that these individuals had no constitutional right to purchase a drug on the free market that could possibly save them. The Supreme Court refused to hear the case.
-Every day, people fight for the right to purchase life saving drugs, but our government steps in and blocks them through existing regulatory legislation. The FDA claims to be protecting these people by only giving them access to drugs that are "safe and effective". The problem is, no drug is safe and effective for all people, so how many people must the drug be "safe and effective" for before the drug is approved? The line is not clear. Certainly a person who is dying is not concerned about drug side effects if the drug has a reasonable chance of saving their lives.
What are your thoughts?
-In 1962 the federal government made several ammendments to the Food and Drug Act which created a disasterous environment for medical advancement and disease prevention in the US.
-From the time a drug therapy was discovered to the time it was put on pharmacy shelves was once 5 years. That turnaround is now tripled. This is due to increased regulatory demands by the federal government. The additional testing required on the therapies meant more would die waiting for a cure, and less drugs would be developed due to a severe lacking in cost effectiveness. Estimates put the human death toll at around 4 million lives as a result.
-A staggering 80% of drug development costs are attributed to regulation compliance. Studies Dr. Ruwart refers to estimates a 50% loss in the innovation of new drugs as a result. Drugs which will not recoup the initial investment in sales are never developed. Drug companies bail on these new developments with regularity. If you calculate the number of lives saved from our current innovation and then calculate the cost of NOT having those drugs (a 50% loss in innovation), we can estimate the human death toll rising to somewhere around 16 million lives. These are human beings that have died silently from their diseases when medical advances existed to save them.
-Drug therapies for individuals suffering from less common illnesses have significantly less of a chance for the development of a cure because there is less chance the companies will be able to recoup their development investment through sales. This again is a result of the enormous compliance costs imposed by our government.
-In our fairly recent past a group of cancer patients sued the federal government for the right to purchase a drug in development that showed reasonable signs of either slowing the progression of thier illness or putting their cancer into remission altogether. The court ruled that these individuals had no constitutional right to purchase a drug on the free market that could possibly save them. The Supreme Court refused to hear the case.
-Every day, people fight for the right to purchase life saving drugs, but our government steps in and blocks them through existing regulatory legislation. The FDA claims to be protecting these people by only giving them access to drugs that are "safe and effective". The problem is, no drug is safe and effective for all people, so how many people must the drug be "safe and effective" for before the drug is approved? The line is not clear. Certainly a person who is dying is not concerned about drug side effects if the drug has a reasonable chance of saving their lives.
What are your thoughts?
