Comments on: FDA abandons Declaration of Helsinki for international clinical trials http://www.socialmedicine.org/2008/06/01/ethics/fda-abandons-declaration-of-helsinki-for-international-clinical-trials/ An Alternative to Corporate Health Thu, 04 Dec 2008 04:05:46 +0000 http://wordpress.org/?v=2.6.5 By: Saqib Altaf http://www.socialmedicine.org/2008/06/01/ethics/fda-abandons-declaration-of-helsinki-for-international-clinical-trials/#comment-1460 Saqib Altaf Mon, 01 Dec 2008 06:50:14 +0000 http://www.socialmedicine.org/?p=85#comment-1460 Declaration of Helsinki is a key document that will always ans should always remain part of any guideline, may it be ICH - GCP. DoH is a policy and the guidelines are always made to clarify those policies in an elaborate manner. US FDA should also keep it as a reference document instead of trashing it. Declaration of Helsinki is a key document that will always ans should always remain part of any guideline, may it be ICH - GCP.
DoH is a policy and the guidelines are always made to clarify those policies in an elaborate manner.
US FDA should also keep it as a reference document instead of trashing it.

]]> By: filip http://www.socialmedicine.org/2008/06/01/ethics/fda-abandons-declaration-of-helsinki-for-international-clinical-trials/#comment-1415 filip Thu, 20 Nov 2008 08:32:23 +0000 http://www.socialmedicine.org/?p=85#comment-1415 FDA was always the benchmark for good clinical practice. Now, using the name of Science and the all mightly dollar, it is abandoning the declaration of Helsinki. It is like abandoning the universal declaration of Human rights altogether. The Helsinki declaration safeguards humans from turning into experimented creatures... I wonder, movies showing mutants are in one step becoming a reality if the research becomes unregulated and unethical. I also wonder if the head of the FDA would allow his/her kids, his/her wife/husband be given ineffective drugs for the sake of research. I wonder, are we about to go back to Auschwitz experiments conducted by nazi doctors to jews, the infirm, the lame, the vulnerable population? The best thing the FDA can do is not recognizing research being done in Countries that do not follow the Declaration. FDA was always the benchmark for good clinical practice. Now, using the name of Science and the all mightly dollar, it is abandoning the declaration of Helsinki. It is like abandoning the universal declaration of Human rights altogether. The Helsinki declaration safeguards humans from turning into experimented creatures… I wonder, movies showing mutants are in one step becoming a reality if the research becomes unregulated and unethical. I also wonder if the head of the FDA would allow his/her kids, his/her wife/husband be given ineffective drugs for the sake of research. I wonder, are we about to go back to Auschwitz experiments conducted by nazi doctors to jews, the infirm, the lame, the vulnerable population? The best thing the FDA can do is not recognizing research being done in Countries that do not follow the Declaration.

]]> By: BZ http://www.socialmedicine.org/2008/06/01/ethics/fda-abandons-declaration-of-helsinki-for-international-clinical-trials/#comment-1259 BZ Tue, 04 Nov 2008 08:26:00 +0000 http://www.socialmedicine.org/?p=85#comment-1259 Helsinki document refers to populations that are underrepresented in medical research and states that should be provided appropriate access to participation in research. limiting clinical trials in some countries just beacuse some people /some trials went beyond the limits is not fair for all the other people getting benefit of new treatments like antibiotics, cancer drugs.... if you limit research in those countries we would have only pills for obesity, hair grow, etc....is that ethical for those countries? Are US guilty or the rest of the world for not promoting reaserch at all? Helsinki document refers to populations that are underrepresented in medical research and states that should be provided appropriate access to participation in research.
limiting clinical trials in some countries just beacuse some people /some trials went beyond the limits is not fair for all the other people getting benefit of new treatments like antibiotics, cancer drugs….
if you limit research in those countries we would have only pills for obesity, hair grow, etc….is that ethical for those countries? Are US guilty or the rest of the world for not promoting reaserch at all?

]]> By: Odessa-man http://www.socialmedicine.org/2008/06/01/ethics/fda-abandons-declaration-of-helsinki-for-international-clinical-trials/#comment-1132 Odessa-man Thu, 16 Oct 2008 16:39:59 +0000 http://www.socialmedicine.org/?p=85#comment-1132 Such trials are resricted all over the world so why do the US think they can do whatever they want. Their attitude towards other nations makes me sick. Such trials are resricted all over the world so why do the US think they can do whatever they want. Their attitude towards other nations makes me sick.

]]> By: Art-Light http://www.socialmedicine.org/2008/06/01/ethics/fda-abandons-declaration-of-helsinki-for-international-clinical-trials/#comment-1094 Art-Light Sun, 12 Oct 2008 12:20:24 +0000 http://www.socialmedicine.org/?p=85#comment-1094 The US has always treated other nations as slaves! This practice shoul be stopped, the US should pay the life-long insurance to those who has been injured while the experiment! The US has always treated other nations as slaves!
This practice shoul be stopped, the US should pay the life-long insurance to those who has been injured while the experiment!

]]> By: SouthMedia http://www.socialmedicine.org/2008/06/01/ethics/fda-abandons-declaration-of-helsinki-for-international-clinical-trials/#comment-1085 SouthMedia Fri, 10 Oct 2008 21:50:21 +0000 http://www.socialmedicine.org/?p=85#comment-1085 Clinical tryals should not be made in any countries while it's restricted by the Declaration of Helsinki. Poor counties should be protected by the powerful ones and the assosiations Clinical tryals should not be made in any countries while it’s restricted by the Declaration of Helsinki.
Poor counties should be protected by the powerful ones and the assosiations

]]> By: nathan mulure http://www.socialmedicine.org/2008/06/01/ethics/fda-abandons-declaration-of-helsinki-for-international-clinical-trials/#comment-1082 nathan mulure Fri, 10 Oct 2008 15:38:48 +0000 http://www.socialmedicine.org/?p=85#comment-1082 There should be no trials for poor countries and those for rich countries. All must be the same, same guidelines, same laws, same everything. Otherwise, there is no harmonisation! Nathan Mulure from Kenya There should be no trials for poor countries and those for rich countries. All must be the same, same guidelines, same laws, same everything. Otherwise, there is no harmonisation!

Nathan Mulure from Kenya

]]> By: Michael Smih http://www.socialmedicine.org/2008/06/01/ethics/fda-abandons-declaration-of-helsinki-for-international-clinical-trials/#comment-1030 Michael Smih Sat, 20 Sep 2008 12:57:34 +0000 http://www.socialmedicine.org/?p=85#comment-1030 So the Declaration of Helsinki restrikts using placebo for the people who are realli sick? So the Declaration of Helsinki restrikts using placebo for the people who are realli sick?

]]> By: franklin http://www.socialmedicine.org/2008/06/01/ethics/fda-abandons-declaration-of-helsinki-for-international-clinical-trials/#comment-1022 franklin Sun, 14 Sep 2008 06:09:48 +0000 http://www.socialmedicine.org/?p=85#comment-1022 It is indeed depressing that the growth of clinical research which is supposed to be ethical is currently being ignored just for the success of clinical trials at the expense of human subjects. It is sad that the helsinki declaration which had set rules for so many years is being by newer consolidated rules...Truly sad FAD ..SAD It is indeed depressing that the growth of clinical research which is supposed to be ethical is currently being ignored just for the success of clinical trials at the expense of human subjects. It is sad that the helsinki declaration which had set rules for so many years is being by newer consolidated rules…Truly sad FAD ..SAD

]]> By: Nelson Robson Mendes de Souza http://www.socialmedicine.org/2008/06/01/ethics/fda-abandons-declaration-of-helsinki-for-international-clinical-trials/#comment-696 Nelson Robson Mendes de Souza Wed, 02 Jul 2008 03:38:30 +0000 http://www.socialmedicine.org/?p=85#comment-696 It is very sad see an agency that has done so much for the world forget that sciences was made to mankind and must be governed by ethics and morals principles. Menguele returns the condition of doctor. Nelson from Brazil It is very sad see an agency that has done so much for the world forget that sciences was made to mankind and must be governed by ethics and morals principles.

Menguele returns the condition of doctor.

Nelson from Brazil

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