GoozNews reported that the Dutch non-profit Wemos International, which works to protect human subjects in clinical trials, accused GlaxoSmithKline of having run a breast cancer trial in India that violated international norms on protecting human subjects.
The trial involved Tykerb (lapatinib), which had been approved in the United States for woman stricken with breast tumors that overexpress the Her2 gene. The NGO's press release suggested Indian women could not offer meaningful informed consent to participate in the trial since it was the only way for most Indian women to gain access to the drug.
The Wemos report also accused AstraZeneca of running a trial for a schizophrenia drug that used placebos in the comparison arm when other approved treatments were available.
The U.S. withdrew from the Helsinki Declaration, which prohibits placebo-controlled clinical trials to test new drugs for serious or life-threatening diseases when other effective therapies are already available.
http://www.wemos.nl/en-GB/Content.as...e=news&id=3095
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