There is good reason to say that those who argue, here and elsewhere, that baclofen should be put through double blind trials before being used are following a scientific approach taken by Nazis and dealt with in the Doctors' Trials at Nuremburg.
It is unethical to give people a placebo when there are other treatments. The principle is that the best treatment available should be used as an alternative to the new treatment.
"Declaration of Helsinki
From the time of the Hippocratic Oath questions of the ethics of medical practice have been widely discussed, and codes of practice have been gradually developed as a response to advances in scientific medicine. The Nuremberg Code, which was issued in August 1947, as a consequence of the so-called Doctors' Trial which examined the human experimentation conducted by Nazi doctors during World War II, offers ten principles for legitimate medical research, including informed consent, absence of coercion, and beneficence towards experiment participants.
In 1964, the World Medical Association issued the Declaration of Helsinki,[2] which specifically limited its directives to health research by physicians, and emphasized a number of additional conditions in circumstances where "medical research is combined with medical care". The significant difference between the 1947 Nuremberg Code and the 1964 Declaration of Helsinki is that the first was a set of principles that was suggested to the medical profession by the "Doctors’ Trial" judges, whilst the second was imposed by the medical profession upon itself. Paragraph 29 of the Declaration makes specific mention of placebos:
29. The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.
In 2002, World Medical Association issued the following elaborative announcement:
Note of clarification on paragraph 29 of the WMA Declaration of Helsinki
The WMA hereby reaffirms its position that extreme care must be taken in making use of a placebo-controlled trial and that in general this methodology should only be used in the absence of existing proven therapy. Source Wiki.
So, the ethical position would be to take the existing methodology including the "best" medical treatment, ie., Campral, and other therapeutic measures used, such as counselling, vitamin therapy and AA and measure that against baclofen. What is happening instead is that alcoholics are being treated like animals in an experiment. Some are given baclofen and others nothing, which is what the Nazis did and what people some trolls here are suggesting.
All of this pre-dates brain imaging technology and that makes double blind trials using placbo completely outdated, irrelevant and misleading. Many of the reasons for failure of some to respond to baclofen is simply their lifestyle which would require full time supervision of dosage to ensure compliance. While those taking the drug cannot possibly be given sufficient support, those taking the placebo are not being treated at all, which is what the Nazi Doctors Trials were about.
Every governing body of doctors will say baclofen can be prescribed legally and safely now without the need for double blind trials.
Ignore all these posters going on about the need for trials etc. It is all hot air and they are putting people's health and lives at risk by posting dangerous misinformation.
It is unethical to give people a placebo when there are other treatments. The principle is that the best treatment available should be used as an alternative to the new treatment.
"Declaration of Helsinki
From the time of the Hippocratic Oath questions of the ethics of medical practice have been widely discussed, and codes of practice have been gradually developed as a response to advances in scientific medicine. The Nuremberg Code, which was issued in August 1947, as a consequence of the so-called Doctors' Trial which examined the human experimentation conducted by Nazi doctors during World War II, offers ten principles for legitimate medical research, including informed consent, absence of coercion, and beneficence towards experiment participants.
In 1964, the World Medical Association issued the Declaration of Helsinki,[2] which specifically limited its directives to health research by physicians, and emphasized a number of additional conditions in circumstances where "medical research is combined with medical care". The significant difference between the 1947 Nuremberg Code and the 1964 Declaration of Helsinki is that the first was a set of principles that was suggested to the medical profession by the "Doctors’ Trial" judges, whilst the second was imposed by the medical profession upon itself. Paragraph 29 of the Declaration makes specific mention of placebos:
29. The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.
In 2002, World Medical Association issued the following elaborative announcement:
Note of clarification on paragraph 29 of the WMA Declaration of Helsinki
The WMA hereby reaffirms its position that extreme care must be taken in making use of a placebo-controlled trial and that in general this methodology should only be used in the absence of existing proven therapy. Source Wiki.
So, the ethical position would be to take the existing methodology including the "best" medical treatment, ie., Campral, and other therapeutic measures used, such as counselling, vitamin therapy and AA and measure that against baclofen. What is happening instead is that alcoholics are being treated like animals in an experiment. Some are given baclofen and others nothing, which is what the Nazis did and what people some trolls here are suggesting.
All of this pre-dates brain imaging technology and that makes double blind trials using placbo completely outdated, irrelevant and misleading. Many of the reasons for failure of some to respond to baclofen is simply their lifestyle which would require full time supervision of dosage to ensure compliance. While those taking the drug cannot possibly be given sufficient support, those taking the placebo are not being treated at all, which is what the Nazi Doctors Trials were about.
Every governing body of doctors will say baclofen can be prescribed legally and safely now without the need for double blind trials.
Ignore all these posters going on about the need for trials etc. It is all hot air and they are putting people's health and lives at risk by posting dangerous misinformation.
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