[Ip-health] submission

[THD Blog]

Glaxo, AstraZeneca Accused of Running Unethical Trials in India
http://www.gooznews.com/archives/001321.html

The Dutch non-profit Wemos International, which works to protect human
subjects in clinical trials, today accused GlaxoSmithKline of having
run a breast cancer trial in India that violated international norms
on protecting human subjects.

The trial involved lapatinib (brand name Tykerb), which has been
approved in the U.S. for women stricken with breast tumors that
overexpress the HER2 gene -- less than a quarter of cases. The NGO's
press release suggested the 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.

Hopefully, some reporter will ask the companies to respond to the
allegations contained in the report. The U.S. recently 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.gooznews.com/archives/001321.html