Ani Posted October 1, 2008 Report Share Posted October 1, 2008 If there is a medication that has not yet been approved by FDA, and the doctor says that it might help, and is referring the patient to UCLA. Does this mean that they’re still in the research process and they’re gonna turn the person into a lab rat? Quote Link to comment Share on other sites More sharing options...
Yervant1 Posted October 1, 2008 Report Share Posted October 1, 2008 If there is a medication that has not yet been approved by FDA, and the doctor says that it might help, and is referring the patient to UCLA. Does this mean that they’re still in the research process and they’re gonna turn the person into a lab rat? No, Ginuea Pig! Quote Link to comment Share on other sites More sharing options...
Sip Posted October 1, 2008 Report Share Posted October 1, 2008 Sounds like it's something that's in clinical trials. It's basically one step above the lab rat ... usually they do this after lab rats have passed the tests Quote Link to comment Share on other sites More sharing options...
DominO123 Posted October 1, 2008 Report Share Posted October 1, 2008 (edited) If there is a medication that has not yet been approved by FDA, and the doctor says that it might help, and is referring the patient to UCLA. Does this mean that they’re still in the research process and they’re gonna turn the person into a lab rat? It depend if your description is accurate, ''not yet approved by FDA'' might mean that the request for approval has been submitted and it might be a question of time before it is approved. But even if this was a possibility, it is highly probable it is a clinical trial and that the ''not yet approved'' mean that at least two clinical trials on humans support its efficiency (it takes at least two for the FDA to approve). The reason is simple, they have legally no right to give that medication if the is not approved by the FDA unless it is for research purpouse. Inform yourself and request to know how many trials on humans have been done and the list of side effects reported. Did they offer some $$? Edited October 1, 2008 by DominO Quote Link to comment Share on other sites More sharing options...
MosJan Posted October 1, 2008 Report Share Posted October 1, 2008 If there is a medication that has not yet been approved by FDA, and the doctor says that it might help, and is referring the patient to UCLA. Does this mean that they're still in the research process and they're gonna turn the person into a lab rat? yes cheyi ani Quote Link to comment Share on other sites More sharing options...
Ani Posted October 2, 2008 Author Report Share Posted October 2, 2008 That is exactly what the doctor said “has not been approved yet”, I asked what is the process, he answered “in the process”… i just don’t know what is the right thing to do in this situation, i asked the doctor how effective the med. is in his opinion, he said “well its not something magical.” Quote Link to comment Share on other sites More sharing options...
DominO123 Posted October 2, 2008 Report Share Posted October 2, 2008 That is exactly what the doctor said “has not been approved yet”, I asked what is the process, he answered “in the process”… i just don’t know what is the right thing to do in this situation, i asked the doctor how effective the med. is in his opinion, he said “well its not something magical.” That's good, if they are referring you to UCLA and it is in the process, then he is pretty much sure it will be approved since it means that the request has been submitted and the research which the person is part of (the person who will be taking the med) is not necessary for the approval. One other thing helps, is the drug in question in a category of med already existing, or is classified in a new family all together. (mechanism of action etc.) This makes a difference, because if it is a medecine which is part of an already existing family and that it was filled for approval, it can be considered as pretty much safe. Do you remember its name? You can PM it, I'll check out for you. Quote Link to comment Share on other sites More sharing options...
DominO123 Posted October 2, 2008 Report Share Posted October 2, 2008 (edited) One more thing, more like a warning... Consider that since it is probably a research, you might end up with the placebo. Ask the doctor if is a double blind, or just a little trial with only the actif compound. Edited October 2, 2008 by DominO Quote Link to comment Share on other sites More sharing options...
vava Posted October 2, 2008 Report Share Posted October 2, 2008 One more thing, more like a warning... Consider that since it is probably a research, you might end up with the placebo. Ask the doctor if is a double blind, or just a little trial with only the actif compound. Dr. Domino, For a clinical trial to have any value, it really should be double-blind. I don't think I would participate in any trial that didn't have rigid and explicit controls and objectives. The political and monetary agendas are far too great to place one's trust & health in the hands of "sponsored" research projects that have ulterior goals despite the actual outcomes. We've seen in the past few years several compounds (many even approved by the FDA) that took advantage of incomplete and/or erroneous data and research to gain access to the marketplace. So, unfortunately for the consumer, an atmosphere of distrust has been placed around the development of pharmaceuticals. I would think hard and weigh all other options before taking part in any such study. Quote Link to comment Share on other sites More sharing options...
DominO123 Posted October 3, 2008 Report Share Posted October 3, 2008 (edited) Dr. Domino, For a clinical trial to have any value, it really should be double-blind. I don't think I would participate in any trial that didn't have rigid and explicit controls and objectives. The political and monetary agendas are far too great to place one's trust & health in the hands of "sponsored" research projects that have ulterior goals despite the actual outcomes. We've seen in the past few years several compounds (many even approved by the FDA) that took advantage of incomplete and/or erroneous data and research to gain access to the marketplace. So, unfortunately for the consumer, an atmosphere of distrust has been placed around the development of pharmaceuticals. I would think hard and weigh all other options before taking part in any such study. Vava, I was not referring to clinical trials when I wrote little trial. Double blind is used to support efficiency (a clinical trial), some use ''research'' or ''trial'' without it being double blind, when double blind already support efficiency. But this is not a clinical trial. Under special cases drugs can be provided to the needy before FDA approval, often when someone has a grave disease. Unapproved drugs are already prescribed in the US, and as individual trials (which goal is not to support efficiency of the drug, but see if the drug help the individual) when the doctor has a reasonable reason to believe that there is no alternatives. That's why I asked her if they offered $$ (compensation), which would be the first indication that it is a study (a study is a cilinical trial) as opposed to just trying the active ingredient. Drugs can not be marketed or sold without FDA approval, but there is nothing illegal if the patient obtain it under prescription as a trial for the person. It is usually a ''if everything fails'' argument the physician use to support it. I made a mistake when I wrote they can not legally give the medication, they can if they try it to check if it will help the patient, without selling it. I don't know why I wrote that. I stand corrected here. Edited October 3, 2008 by DominO Quote Link to comment Share on other sites More sharing options...
DominO123 Posted October 3, 2008 Report Share Posted October 3, 2008 it is highly probable it is a clinical trial After checking the US data, I must conclude I was wrong here, apprently 2% of the drugs in the US are not yet approved by the FDA. Surprised. Quote Link to comment Share on other sites More sharing options...
DominO123 Posted October 3, 2008 Report Share Posted October 3, 2008 Dr. Domino, I'm not flattered MD is a fake doctorate degree in North America. Quote Link to comment Share on other sites More sharing options...
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