Guest guest Posted June 28, 2005 Report Share Posted June 28, 2005 True .. but if we get a large scale clinical trial (and remember one is about to start in Mali) and that trial proves the validity of LDN then they will have no choice but to listen and market LDN. I think the LDN patent runs out in 2025 so it would be nice to think it could become an over the counter medication at that point. Until then, the pharmaceutical companies could make a nice profit. This is the double edged sword. If LDN gets FDA recognition for MS and other diseases (and I think it will) then the pharmaceuticals will start making LDN, but then we won't be able to get it cheaply from say Skips anymore .. and the pharmaceuticals will charge about 10 times the price it is now. It is criminal the way the system works .. but then the insurance companies would cover it and those who need it can get it. I do believe it will be over the counter one day though ... just because the truth always gets out in the end and I am an optimist. I really believe things are about change. > asked: > > " I just don't understand why there is total silence from the > pharmaceutical companies on LDN. Aren't they aware of the growing > grass roots usage of LDN? " > > Hi . There are a lot of factors... governmental, legal, and > corporate. The single most important factor is profit. Naltrexone > is a generic medication. No individual company can hold exclusive > marketing or manufacturing rights to Naltrexone. > > This means that no company can make big profits from Naltrexone. It > doesn't matter how beneficial any medication might be, the > pharmaceutical companies are not in business to help humanity. They > are in business for profit. > > In order to manufacture and market LDN for MS, they would have to do > clinical trials to get FDA approval. Clinical trials are very > expensive, and no company is going to fund such trials with so > little hope of big profit. > > Hope this helps clarify a little. > > Maureen Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 28, 2005 Report Share Posted June 28, 2005 Grass roots use is not a sufficient market base. Clinical trials could easily suck up $200,000,000. Profits would have to carry the research, etc… and now you are looking at perhaps 3 to 5 BILLION dollars worth to make the big money required to devote time and effort. Any way you slice it, that is a lot of dollars. And a few hundred thousand doses at a whack will take too long to see a return on investment. That, unfortunately, is reality. It may be possible to keep the generic form available by demonstrating a base use, but I would be more than surprised to see it come as an FDA approved application. And, as a user myself, I wish there was more that could be done to assure its continued manufacture. It will not go away in the near future, but how long it lasts is anyone’s guess. Bruce Guilmette, Ph.D. Survive Cancer Foundation, Inc. http://www.survivecancer.net From: low dose naltrexone [mailto:low dose naltrexone ] On Behalf Of bentleyfam26 Sent: Tuesday, June 28, 2005 10:06 AM low dose naltrexone Subject: [low dose naltrexone] To ... about the asked: " I just don't understand why there is total silence from the pharmaceutical companies on LDN. Aren't they aware of the growing grass roots usage of LDN? " Hi . There are a lot of factors... governmental, legal, and corporate. The single most important factor is profit. Naltrexone is a generic medication. No individual company can hold exclusive marketing or manufacturing rights to Naltrexone. This means that no company can make big profits from Naltrexone. It doesn't matter how beneficial any medication might be, the pharmaceutical companies are not in business to help humanity. They are in business for profit. In order to manufacture and market LDN for MS, they would have to do clinical trials to get FDA approval. Clinical trials are very expensive, and no company is going to fund such trials with so little hope of big profit. Hope this helps clarify a little. Maureen Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 28, 2005 Report Share Posted June 28, 2005 It would seem to me that LDN will not go out of production. I think if it becomes FDA approved for nero degenerative problems, it will be good and bad. I think it would become more expensive, but on the good side it would help so many people that are afraid to try a non-FDA approved treatment. The validity is why I think it would be good to get the trials completed. Aletha RE: [low dose naltrexone] To ... about the Grass roots use is not a sufficient market base. Clinical trials could easily suck up $200,000,000. Profits would have to carry the research, etc… and now you are looking at perhaps 3 to 5 BILLION dollars worth to make the big money required to devote time and effort. Any way you slice it, that is a lot of dollars. And a few hundred thousand doses at a whack will take too long to see a return on investment. That, unfortunately, is reality. It may be possible to keep the generic form available by demonstrating a base use, but I would be more than surprised to see it come as an FDA approved application. And, as a user myself, I wish there was more that could be done to assure its continued manufacture. It will not go away in the near future, but how long it lasts is anyone’s guess. Bruce Guilmette, Ph.D. Survive Cancer Foundation, Inc. http://www.survivecancer.net From: low dose naltrexone [mailto:low dose naltrexone ] On Behalf Of bentleyfam26Sent: Tuesday, June 28, 2005 10:06 AMlow dose naltrexone Subject: [low dose naltrexone] To ... about the asked: "I just don't understand why there is total silence from the pharmaceutical companies on LDN. Aren't they aware of the growing grass roots usage of LDN?"Hi . There are a lot of factors... governmental, legal, and corporate. The single most important factor is profit. Naltrexone is a generic medication. No individual company can hold exclusive marketing or manufacturing rights to Naltrexone. This means that no company can make big profits from Naltrexone. It doesn't matter how beneficial any medication might be, the pharmaceutical companies are not in business to help humanity. They are in business for profit.In order to manufacture and market LDN for MS, they would have to do clinical trials to get FDA approval. Clinical trials are very expensive, and no company is going to fund such trials with so little hope of big profit. Hope this helps clarify a little. Maureen Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 28, 2005 Report Share Posted June 28, 2005 very well put worth repeating [low dose naltrexone] To ... about the asked: "I just don't understand why there is total silence from the pharmaceutical companies on LDN. Aren't they aware of the growing grass roots usage of LDN?"Hi . There are a lot of factors... governmental, legal, and corporate. The single most important factor is profit. Naltrexone is a generic medication. No individual company can hold exclusive marketing or manufacturing rights to Naltrexone. This means that no company can make big profits from Naltrexone. It doesn't matter how beneficial any medication might be, the pharmaceutical companies are not in business to help humanity. They are in business for profit.In order to manufacture and market LDN for MS, they would have to do clinical trials to get FDA approval. Clinical trials are very expensive, and no company is going to fund such trials with so little hope of big profit. Hope this helps clarify a little. Maureen Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 28, 2005 Report Share Posted June 28, 2005 I am all in favor of having trials. There again, a lot depends on how the trials are conducted. Is LDN a stand-alone treatment? Is it used in conjunction with something(s) else? Duration of tests, overall condition of participants, prior histories, etc… are all part of the mix. To make good studies, things need careful regulation so the results don’t end up in the “junk science” category that ultimately does no good for anyone. Structuring the tests takes specific skills and ultimately the person(s) heading the project are responsible for validation of results. The tighter the controls, the better the results, the more valid the claims. However, just the cost issues may ultimately prove prohibitive. There are so many factors that get thrown into the mix including politics that the ultimate outcome is anyone’s guess. You are fighting a system that cures people in spite of their ailments. I was never a conspiracy theorist until I developed terminal cancer. Now, all I see is roadblocks being thrown up to anyone who bucks the system, no matter how much good or noble the cause. If there are trials scheduled for cancer, I want to be on the top of the list. Bruce Guilmette, Ph.D. Survive Cancer Foundation, Inc. http://www.survivecancer.net From: low dose naltrexone [mailto:low dose naltrexone ] On Behalf Of Aletha Wittmann Sent: Tuesday, June 28, 2005 11:13 AM low dose naltrexone Subject: Re: [low dose naltrexone] To ... about the It would seem to me that LDN will not go out of production. I think if it becomes FDA approved for nero degenerative problems, it will be good and bad. I think it would become more expensive, but on the good side it would help so many people that are afraid to try a non-FDA approved treatment. The validity is why I think it would be good to get the trials completed. Aletha [low dose naltrexone] To ... about the asked: " I just don't understand why there is total silence from the pharmaceutical companies on LDN. Aren't they aware of the growing grass roots usage of LDN? " Hi . There are a lot of factors... governmental, legal, and corporate. The single most important factor is profit. Naltrexone is a generic medication. No individual company can hold exclusive marketing or manufacturing rights to Naltrexone. This means that no company can make big profits from Naltrexone. It doesn't matter how beneficial any medication might be, the pharmaceutical companies are not in business to help humanity. They are in business for profit. In order to manufacture and market LDN for MS, they would have to do clinical trials to get FDA approval. Clinical trials are very expensive, and no company is going to fund such trials with so little hope of big profit. Hope this helps clarify a little. Maureen Quote Link to comment Share on other sites More sharing options...
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