India Supreme Court Accepts Writ of Petition on Gardasil & Cervarix Licensing & Trial Violations

Press Release January 7, 2013

Supreme Court admits writ petition against licensing and trials with “Cervical Cancer” vaccines implicating the Drugs Controller of India, PATH, ICMR and others ordering Government of India to immediately  respond

Gardasil and Cervarix are two unproven and hazardous HPV vaccines purported to prevent cervical cancer, marketed in India by MSD Pharmaceuticals Pvt. Ltd. (subsidiary of Merck) and GlaxoSmithKline Ltd. The petition challenging their licensing for use in the private sector and attempts to introduce them in the public sector has been filed by Kalpana Mehta, Nalini Bhanot and V. Rukmini Rao representing (Gramya Resource Centre for Women from Andhra Pradesh). The petition implicates the Drugs Controller for having licensed the vaccines without adequate research on safety and efficacy;  the Health Ministry for not carrying out an enquiry into licensing of these vaccines as ordered by the Parliamentary Standing Committee on Health and Family Welfare in April 2010 nor taking any action on the report of the enquiry committee set up by itself despite all irregularities of PATH project being confirmed. Rather than looking at safety and efficacy of these vaccines in India, this project was meant to influence the government to adopt these vaccines for introduction in the public sector.

The petitioners are represented by the well known public interest senior advocate Colin Gonsalves of Human Rights Law Network who presented the case before the Supreme Court on January 7, 2013. The Supreme Court admitted the case and has asked the Government of India to immediately file its reply in the matter.

PATH had initiated a project for the introduction of the two vaccines in India by signing an MoU with ICMR even before they were licensed by the Drugs Controller of India. This project was funded by Bill and Melinda Gates Foundation (BMGF) who had substantial stakes in Merck that produced the vaccine and hence there was a direct conflict of interest.  PATH was helped by ICMR in carrying out large scale trials in the states of Andhra Pradesh and Gujarat unethically and without regard for health of poor tribal girls. The unethical nature of the study and deaths of girls became the subject of Governmental enquiry in 2010 when the matter was repeatedly raised by activists. This enquiry concluded that there were many gross violations in the project with respect to procedures for taking informed consent, inadequate health  facilities for dealing with adverse events and medical emergencies. Yet after two years of the enquiry the government had not even initiated any action to redress the situation and to punish PATH and ICMR as admitted  by Ghulam Nabi Azad before the Indian Parliament in December 2011.

The petitioners are health activists who have been raising the issue with the Health Ministry, the Drugs Controller,  National Commission for the Protection of Child Rights and other authorities including the government of Andhra Pradesh and have not made any headway. Hence a petition was filed under article 32 of the Constitution by them..

Hazards of the vaccines and unproven benefits :

The vaccines are genetically engineered and their hazards are unknown even to the scientific communities. Though r-DNA has been detected in Gardasil in samples from many countries including India, in their application for licensing MSD pharmaceuticals claimed that there was no hazard because there was no r-DNA. GlaxoSmithKline uses a novel technique for producing Cervarix which involves the use of insect cells. Their product information admitted to their vaccine containing insect cells and proteins only in July 2011 though the vaccine was already in use since 2007. These residues or adventitious agents enter the blood stream when the vaccine is injected and are acknowledged to have the capacity to cause infections, tumours and cancer. What is noteworthy is that neither of these vaccines has been studied to determine their potential to cause cancer. In addition, the Drugs Controller has not even set standards of acceptable limits for such contamination in vaccines on the basis of which he could have found them safe for licensing.

Though both the vaccines are claimed to prevent cervical cancer, the truth is that cervical cancer takes twenty or more years to develop and the vaccines have just not been around that long to prove their efficacy in preventing cancer. But what is known with certainty is that if these vaccines are given to women who already are infected with the virus then they do raise the incidence of cervical cancer among those women.

Gardasil was first licensed in the USA in June 2006. This licensing was done on fast track with numerous conflicts of interests not only on the review board but also in that that the vaccine patent was held in PPP and the FDA itself as a part of the health department would benefit from the sales.

Licensing issues:

Both vaccines were licensed for use among girls and women in India on the basis of very small studies that flouted even the liberalized Indian law. This law allows easy access to the Indian market for drugs and vaccines produced by multi-national companies once they are approved in the home country. In 2005 this law also made it possible for multi-national companies to hold trials for unapproved drugs in India simultaneous to international trials.

Targeting adolescents

These vaccines are supposed to work best when administered to girls in the age group of 9-14, before sexual debut. In the case of Cervarix GlaxoSmithKline did a trial with just 176 adult women and was granted a license for an age group of 10-45 year old women. This trial just looked at anti-body levels achieved and immediate side effects. No trial was done among Indian girls.

In the case of Gardasil, Merck through its subsidiary MSD signed an MOU with ICMR in 2005 but did not proceed with the studies that were envisaged involving thousands of women. But once it was licensed in the USA it did a  speedy trial on its own with only 110 Indian girls 10-14 year old again to see immediate immune response. But it got a license by the DCGI to administer it to women from 9-26 years old though not a single adult woman had undergone a trial. According to the Indian law a trial on adults has to precede a trial among children and it was these violations that had been brought to the notice of the Parliamentary Committee that had asked for a proper enquiry into licensing.

Violations in PATH project:

PATH on its own had decided to do studies with the HPV vaccine in four countries and India was one of them. The Indian market is substantial if a vaccine is accepted in the immunization programme. There is documentary evidence that though PATH is an NGO in this case it had entered into business agreement with Merck so that Merck had a ready market for the vaccine in the resource poor countries. In fact PATH got funding from BMGF in the very month that Gardasil was licensed in the USA. It signed an MOU with ICMR for this purpose. ICMR played along though it was clear that the vaccine was too expensive for India to afford. For each girl vaccinated the country would need to spend Rs 10,000 for three shots. The vaccines were marketed by hyping the risk of cervical cancer. Yet the fruits of this approach were not going to be reaped for 30-40 years or when the ten year olds crossed the age of forty – the age group when women are susceptible to cervical cancer. ICMR went ahead though it knew that the country is unable to meet the present needs of medicines to meet the current problems of the population like T.B. and malaria and could ill afford to spend money for these uncertain products. Further through its cancer registries it was also aware that the incidence of cervical cancer was declining and it was not a major health problem of the country.

PATH project was carried out in total disregard to scientific approach. It made false claims about the safety of vaccines and their efficacy. When the project took off there was no data to figure out the need for boosters, how the malnourished girls of India would respond to the vaccine that had so far only been administered to a healthy population. Yet a large number of girls in A.P. and Gujarat were told all kinds of lies and administered a vaccine that had serious side effects including death. When four girls died in Andhra Pradesh women’s groups raised a hue and cry in 2010 and the government ordered an enquiry. The Government of AP, of Gujarat and PATH made depositions and provided data. The Enquiry Committee found that records of even informed consent had been fudged. The girls were not asked for their assent even though the law provides for such assent to be taken in writing. Further no arrangements were made for providing medical care to them if they suffered serious side effects.

Thus the rights of all 24,000 girls who were recruited by PATH in these trials were flouted as they were given the vaccine without a chance to make free informed choice. This assertion of women’s groups was confirmed by the enquiry. However, the Enquiry Committee had no legal expert and could not determine the liability of PATH towards the girls who were duped or forced into participation in PATH trial, those who died during the trial and those who would have suffered serious side effects.

PATH did everything to prevent the problems of the study from becoming common knowledge and sat on data on deaths despite women’s groups making a hue and cry about it at a public meeting organized by them in December 2009. The petitioners have pointed out that the data on death during the project is incomplete, illogical and full of discrepancies yet the deaths were called as being unrelated to vaccine administration. Side effects reported by the Study were very rare and this was also brought out in the Enquiry. Yet there is no provision of continuing health care of these rural girls. Extrapolating from trial data of the two companies the petitioners have estimated that there are at least 1,200 girls in the two states have suffered from serious side effects or have developed auto-immune disorders who need continuing medical care and treatment.

These questions have been put before the Supreme Court with the hope that prompt justice and care would be provided to girls who are suffering as a consequence of an ill designed trial carried out by PATH with the active support of ICMR and the two state governments. By those very governments who are constitutionally bound to protect their life and health. Given the serious violations indulged by PATH, the petitioners have asked that PATH be blacklisted and no other foreign agency be allowed to have field presence.

The petitioners have also asked for the licences of the two products to be suspended and the vaccines recalled as there has been no scientific basis to allow their administration to girls in the private market either. The two companies have also flouted Indian law with impunity and have not done the post marketing studies ordered by the Drugs Controller at the time of licensing. They have not up dated their product information and hence the Indian medical consumer continues to be in the dark about hazards of these vaccines that contain insect cells and r-DNA.MSD Pharmaceuticals went a step further and got the eligible age group extended to 45 year old women in India though this was denied in the U.S.A. thrice.

Kalpana Mehta kalpanaindu@hotmail.com Tel: 9425056985

Nalini Bhanot nalinibeez@gmail.com Tel:9899905851

V. Rukmini Rao vrukminirao@yahoo.com Tel: 9440860271