Drug approval in different countries - Why????

bill j. · 10-14-2002, 04:21 PM

I recently read an article about Prozac, a depression drug, being introduced into Japan now some 18 years or so after it was introduced in the U.S. The company manufacturing Prozac had to sponsor clinical trials in Japan to gain approval from their agency that is equivalent to our FDA. All these years, the suicide rate has been much higher in Japan than the U.S., very likely at least partly due to depression. Many people probably died needlessly while Japan had no depression drug available.

A couple of month ago I read about another depression drug, Celexa. It was first used in Europe for many years. Finally, a small company, Forest Labs, bought the rights to market the drug in the U.S. Before marketing, however, Forrest Labs had to spend huge amounts of money for clinical trials. Finally, Celexa won approval from our FDA after several years of clinical study that cost many millions of dollars. Many people believe Celexa is superior to Prozac.

My point is why all the duplication? It is absurd for every country to insist on clinical trials for a drug's approval when it has been used successfully in other countries for many years and passed all the clinical testing in that country. If this truly is a "global economy" is it not foolish to run duplicate clinical studies in one country when they have already been run in another and the drug has been in use for many years? Why can't this whole process be streamlined to save money and benefit humanity?

I am raising this issue in regards to sci. What if a drug is approved in Europe for sci? How long and how many studies will it take to get approval in the U.S.? Or visa versa?
Are these government agencies just protection their own turf, or do they really want to serve humanity?

I'll tell you what. If a therapy for sci is found to work in Germany, China, or wherever, I'm buying a ticket. I will not wait years for it to be approved by the U.S..

Would like to hear discussion on this matter. Why can't there be a centralized clearing house for world-wide drug and therapy approval? Bill

Leo · 10-14-2002, 05:45 PM

Hey Bill, Good thought!!!!!!!!

It must be true great minds think a like, well here in SD anyway.

I was just thinking that also is a front we need to look into is the FDA fast track options if there are any. If some things proven that's all we need is them slowing things down. I'll do what digging into it I can.

Leo

alan · 10-14-2002, 06:01 PM

Every country has different standards, just as they have different governments. Here, we have high standards, maybe in part because a company that releases a dangerous drug gets their butt sued off. In other countries, companies may not be as liable or vulnerable as they are here.

antiquity · 10-14-2002, 09:06 PM

Each government has an oversight agency that is responsible for the approval and release of every drug submitted for review. If the approved drug causes death or disease, that agency and/or the government is held responsible. After the disaster that resulted from the use of Thalidomide, a drug that was approved for use in Germany and Britain but rejected in the US, each country established its own FDA which uses standards for approval that are more or less thorough than the standards used by agencies in other countries. It seems tedious and redundant but I think it's justified and has proven to be necessary.

DA · 10-15-2002, 07:04 AM

finally someone is waking up. i have been stressing this point for years.
artifical blood has been used in europe for years. here in the usa we still
preferr the blood shortages.
i had a doctor from canada tell me how their are drugs in canada better than usa drugs but fda wont approve them.

the fda is a weapon. the fda is very corrupt. example; if drug company B discover a drug better than drug company A current drug, drug company A will use FDA to keep out drug company B...UNLESS drug company B can over bribe drug company A.

REMEMBER THIS....its the non sick making all the choices for the sick. those choices are rarely in our best interest.

Jeff · 10-15-2002, 09:11 AM

Worldwide cooperative clinical trials could be conducted. If the data pleased some countries they could approve the drug. If other countries thought there was too much risk in the drug they could reject it. All that's necessary is a set of standards for testing. What each country does with the data would be up to them.

~See you at the SCIWire-used-to-be-paralyzed Reunion

~

10-14-2002, 04:21 PM	#1
bill j. Senior Member Join Date: Jul 2001 Location: Stratford, SD Posts: 6,667	Drug approval in different countries - Why???? I recently read an article about Prozac, a depression drug, being introduced into Japan now some 18 years or so after it was introduced in the U.S. The company manufacturing Prozac had to sponsor clinical trials in Japan to gain approval from their agency that is equivalent to our FDA. All these years, the suicide rate has been much higher in Japan than the U.S., very likely at least partly due to depression. Many people probably died needlessly while Japan had no depression drug available. A couple of month ago I read about another depression drug, Celexa. It was first used in Europe for many years. Finally, a small company, Forest Labs, bought the rights to market the drug in the U.S. Before marketing, however, Forrest Labs had to spend huge amounts of money for clinical trials. Finally, Celexa won approval from our FDA after several years of clinical study that cost many millions of dollars. Many people believe Celexa is superior to Prozac. My point is why all the duplication? It is absurd for every country to insist on clinical trials for a drug's approval when it has been used successfully in other countries for many years and passed all the clinical testing in that country. If this truly is a "global economy" is it not foolish to run duplicate clinical studies in one country when they have already been run in another and the drug has been in use for many years? Why can't this whole process be streamlined to save money and benefit humanity? I am raising this issue in regards to sci. What if a drug is approved in Europe for sci? How long and how many studies will it take to get approval in the U.S.? Or visa versa? Are these government agencies just protection their own turf, or do they really want to serve humanity? I'll tell you what. If a therapy for sci is found to work in Germany, China, or wherever, I'm buying a ticket. I will not wait years for it to be approved by the U.S.. Would like to hear discussion on this matter. Why can't there be a centralized clearing house for world-wide drug and therapy approval? Bill

10-15-2002, 09:11 AM	#6
Jeff Senior Member Join Date: Jul 2001 Location: North Brunswick, NJ, USA Posts: 6,858	I don't think the studies need to be duplicated Worldwide cooperative clinical trials could be conducted. If the data pleased some countries they could approve the drug. If other countries thought there was too much risk in the drug they could reject it. All that's necessary is a set of standards for testing. What each country does with the data would be up to them. ~See you at the SCIWire-used-to-be-paralyzed Reunion ~

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10-14-2002, 05:45 PM	#2
Leo Senior Member Join Date: Jul 2001 Location: Yankton, South Dakota Posts: 3,950	Hey Bill, Good thought!!!!!!!! It must be true great minds think a like, well here in SD anyway. I was just thinking that also is a front we need to look into is the FDA fast track options if there are any. If some things proven that's all we need is them slowing things down. I'll do what digging into it I can. Leo

10-14-2002, 06:01 PM	#3
alan Senior Member Join Date: Jul 2001 Location: Baltimore, MD Posts: 6,169	Every country has different standards, just as they have different governments. Here, we have high standards, maybe in part because a company that releases a dangerous drug gets their butt sued off. In other countries, companies may not be as liable or vulnerable as they are here.

10-14-2002, 09:06 PM	#4
antiquity Moderator Join Date: Jul 2001 Posts: 14,540	Each government has an oversight agency that is responsible for the approval and release of every drug submitted for review. If the approved drug causes death or disease, that agency and/or the government is held responsible. After the disaster that resulted from the use of Thalidomide, a drug that was approved for use in Germany and Britain but rejected in the US, each country established its own FDA which uses standards for approval that are more or less thorough than the standards used by agencies in other countries. It seems tedious and redundant but I think it's justified and has proven to be necessary.

10-15-2002, 07:04 AM	#5
DA Senior Member Join Date: Jul 2001 Location: beaumont tx usa Posts: 32,390	finally someone is waking up. i have been stressing this point for years. artifical blood has been used in europe for years. here in the usa we still preferr the blood shortages. i had a doctor from canada tell me how their are drugs in canada better than usa drugs but fda wont approve them. the fda is a weapon. the fda is very corrupt. example; if drug company B discover a drug better than drug company A current drug, drug company A will use FDA to keep out drug company B...UNLESS drug company B can over bribe drug company A. REMEMBER THIS....its the non sick making all the choices for the sick. those choices are rarely in our best interest.