How ICMR and DGCI helped American NGO in unlawful Cancer Vaccine Trials in India ?

Reports are pounding in about Cancer-Gate Scandal where two Union government health agencies  and a Foreign NGO conducted an unlawful cervical cancer vaccine tests on number of girls in India during 2009-10.

A Report by Parliament Standing committee suggests that Indian Council of Medical Research (ICMR) and the Drugs Controller General of India (DGCI) partnered with American organization PATH (Program for Appropriate Technologies in Health) to promote commercial interests of two companies manufacturing a controversial cervical cancer vaccine, linked to the deaths of some young Indian girls.

It has questioned how ICMR could commit itself to support the use of the vaccine even before the vaccine was approved for use in the country. It says that about 20,000 girls between the ages of 10 years and 14 years received the vaccine in Andhra Pradesh and Gujarat. A vaccine called Gardasil, manufactured by US company Merck, was used in Andhra Pradesh and a vaccine called Cervarix by GlaxoSmithkline was used in Gujarat.

The Union health ministry stopped the campaign in 2010 after health activists had documented ethical irregularities, including the absence of genuine informed consent from the parents or guardians of the girls.

The parliamentary committee has observed that had PATH been successful in getting the vaccine included in the universal immunisation programme, it would have meant “windfall profits” for the manufacturers year after year, without any promotional or marketing expenses.

“To achieve this end without going through the arduous and strictly regulated route of clinical trials, Path resorted to an element of subterfuge by calling the (vaccination campaign) a demonstration project,” the parliamentary committee said in a report tabled today.

The committee has observed that ICMR officials, “instead of ensuring highest levels of ethical standards, apparently acted at the behest of Path in promoting the interests of the manufacturers of the vaccine.”

The panel report also points out the careless manner in taking informed consent – forms signed by people when they agree to participate in a trial where a medicine is tested on them.

In this case, the report says, in Andhra Pradesh, of the 9,543 forms, 1,948 had thumb impressions while hostel wardens had signed 2,763 forms.

The committee also questions an earlier independent enquiry that said the death of the tribal girls was not linked to the vaccines. Pointing out that drugs are linked to suicidal thoughts, the report said: “therefore, HPV vaccine as a possible, if not probable, cause of suicide ideation cannot be ruled out.”

“It is established that PATH by carrying out the clinical trials for HPV vaccines in Andhra Pradesh and Gujarat under the pretext of observation / demonstration project has violated all laws and regulations laid down for clinical trials by the Government,” observed the Parliamentary standing committee reported tabled in the Rajya Sabha on Friday.

The PAC has recommended action against ICMR and DGCI officials involved in the project and also the US based NGO PATH