GE AIDS Vaccine Trial : Unanswered Questions.

December 25, 2007

http://www.ijme.in/153co111.html Indian Journal of Medical Ethics EXCERPT: Harm and wrong Ms Nayyar makes a strong point that “the vaccine was safe and well tolerated amongst the European population”. We agree that as per available evidence she is absolutely right. Surely then, she and readers of this journal have a right to ask us: “what is all this fuss about?” if no harm has been demonstrated. But the bioethics literature provides sufficient evidence that the absence of data showing harm is not sufficient justification for scientists to expose participants to potential risks. Also, even if one does not cause harm doing wrong is also unethical. In this case, the Belgium-Germany trial showed that not

only was the vaccine being tested at NARI safe for the “European population”, but as per the press release of the Targeted Genetics on its website, it “did not elicit significant immune responses” in that population. Ms Nayyar interprets this result as: “while the vaccine candidate was not disappointing, the European results had fewer responses than expected”. Perhaps she is correct in her interpretation. But the problem remains that this information was with IAVI before the first person was recruited in the trial at NARI. And all those recruited up until the information was made available to the Indian researchers (and the protocol amended to incorporate that information) had the right to know of these results, as such information has significant bearing on people’s readiness to participate in an experiment. Evidently, none of those recruited was harmed. But is it possible to say that they were not wronged since the information

was available to the sponsor but not made available to them when informed consent was first sought? There is no longer any serious doubt that health officials are covering up a big story, trying to side step a growing swell of evidence that threatens the very foundation of medical science and practice. It is obvious that the medical profession cannot afford to have the public ever find out the truth about vaccination for there is simply just too much at stake for them. - Dr Mark Sircus, MD.

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