I'm not too fond of the FDA. I know these guys protect consummers and save lives, but too much strictness is not good either.
To me, not approving a good drug is just as negative as approving a bad drug. And there are many drugs that are effective and safe and have not been approved by the FDA - only God knows why.
A good example is oral phentolamine for erectile dysfunction (the late Vasomax). This drug is safe, effective (I've tried it with excellent results) and it is available in South America. There are many studies that show its efficacy and safety, it is a popular treatment that Brazilian doctors prescribe everyday, but it is not available in the USA because the FDA doesn't want to - I never really understood why. Thank God for the Internet, or I wouldn't be able to buy my phentolamine pills here in Europe.
And then there's the bureaucracy. It's outrageous that a new treatment that could potentially save lives takes so long to be approved - ten years or more. Phase 3 trials are usually the most expensive, time-consuming and difficult trials to design and run. All caution is necessary when examining new drugs, but most of the times these delays seem to be unjustified and will do more harm than good.
Let's hope and pray the FDA doesn't screw things up with gene therapy for erectile dysfunction and the new baldness treatment by Intercytex.
To me, not approving a good drug is just as negative as approving a bad drug. And there are many drugs that are effective and safe and have not been approved by the FDA - only God knows why.
A good example is oral phentolamine for erectile dysfunction (the late Vasomax). This drug is safe, effective (I've tried it with excellent results) and it is available in South America. There are many studies that show its efficacy and safety, it is a popular treatment that Brazilian doctors prescribe everyday, but it is not available in the USA because the FDA doesn't want to - I never really understood why. Thank God for the Internet, or I wouldn't be able to buy my phentolamine pills here in Europe.
And then there's the bureaucracy. It's outrageous that a new treatment that could potentially save lives takes so long to be approved - ten years or more. Phase 3 trials are usually the most expensive, time-consuming and difficult trials to design and run. All caution is necessary when examining new drugs, but most of the times these delays seem to be unjustified and will do more harm than good.
Let's hope and pray the FDA doesn't screw things up with gene therapy for erectile dysfunction and the new baldness treatment by Intercytex.