Guest guest Posted July 29, 2006 Report Share Posted July 29, 2006 yes. but heres the kicker. the studies that say Naltrexone was safe at 50 mg were already done. so if its safe at 50 i don't think that 4.5 mg its going to be harmful. and thats the point that Dr Boyle makes. First do no harm.studies go like thisphase i -is it safephase 2-is it effectivephase 3- whats the dosephase 4-long term effects and other drug uses.so in essence phase 1 is done. I think there is enough antedoctal evidence out there to say phase 2 is done-its not rigorous by definition but the problem is are all these supposedly vigorous studies really vigorous.cyndiOn Jul 29, 2006, at 1:12 PM, C wrote: Hi All, I’m not the sharpest tool in the shed and never would say it but, didn’t the drugs like Viox (and others) get the tests that they say LDN needs, didn’t those drugs cause a lot of…well problems (to put it lightly)? I just don’t get how so many drugs can get the “proper” testing and yet hurt people so badly and how so many “smart” doctors see this and still say because LDN doesn’t have this testing they are not going to prescribe it. I just don’t get it. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 29, 2006 Report Share Posted July 29, 2006 > Cyndi Lenz <psychrn@...> wrote: > yes. but heres the kicker. the studies that say Naltrexone was safe at 50 mg were already done. so if its safe at 50 i don't think that 4.5 mg its going to be harmful. and thats the point that Dr Boyle makes. First do no harm. studies go like this > phase i -is it safe > phase 2-is it effective > phase 3- whats the dose > phase 4-long term effects and other drug uses. > > > so in essence phase 1 is done. I think there is enough antedoctal evidence out there to say phase 2 is done-its not rigorous by definition but the problem is are all these supposedly vigorous studies really vigorous. > > > cyndi > Alrightguy here: There is another problem with a drug company seeking extra indications for a drug already on the market. If a new set of Phase 2, 3, or 4 testing uncovers some safety or efficacy issues, the drug company has jeopardized their existing product. Even doing everyday laboratory / test tube testing of an existing molecule can have significant ramifications. I've seen an animal health drug that had been on the market for many years. Everyone liked the product. Someone in some routine analysis laboratory played with a new method to examine the product. Impurities that had always been in the product, that had never been noticed before, were now noticed. Whatever the regulating agency was involved threatened to have the product pulled from the market until new toxicology studies were performed. Fortunately for the company (and all of their employees), broad enough tox studies had already been performed, and the product was allowed to stay on the market. On a personal level, whoever makes naltrexone might be excited that a new use has been found for their molecule. From a business standpoint, they can not, or feel they can not open that can of worms. Quote Link to comment Share on other sites More sharing options...
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