Report Blasts Unethical HPV Vaccine Trial in India

The Tribune and The Deccan Herald report (below) that a report submitted by a high level committee appointed by the government of India, after seven girls died while enrolled in an HPV vaccine trial testing the safety of vaccines manufactured by GlaxoSmithKline, Merck, and Dohme, brought out “shocking findings” about gross violations in the project, questioning the suspension of ethical standards. The trial was financed by the Bill and Melinda Gates Foundation.

First, the trial was misrepresented as "a post-licensure observational study," when it was, in fact, a large safety trial.

“Strong action is required against the officials at various levels… The project itself must be scrapped and in future no NGO should be allowed to take up such a project involving a large number of children,” the CPM’s Politburo member said in the letter.

“There has been a serious dereliction of duty by many of the institutions involved. In particular the role of the Indian Council for Medical Research (ICMR) has been extremely questionable.” An investigation panel set up by the Centre picked up many holes in the entire trial but stopped short of fixing the responsibility on any specific individual.

A team of three Delhi-based senior doctors who assisted the investigation panel found almost everything was wrong in the HPV vaccine trial, the most prominent one being “questionable lack of ethical standards.”

The trial flagrantly violated every aspect of ethical standards: the most glaring being violations of informed consent standards:

 "The most glaring example was related to consent form. In any drug trial involving the minors, informed consent of their parents is absolutely must before the inoculation. However, Andhra Pradesh government brought out an official order (dated June 2, 2009) asking the deputy medical and health officer in Bhadrachalam block to issue orders to all the hostel wardens and Ashram schools to sign the consent forms on behalf of the parents. In case of 2,763 girls, consent documents were signed en bloc by teachers, hostel wardens and head masters. This is illegal. In another 1948 cases, illiterate parents were asked to put thumb impressions on documents, which they could not understand."

Adverse events were not recorded or reported and even deaths were not promptly reported. 

The government inquiry expressed "concerns over a hidden agenda (vaccines came free from pharma giants Glaxo Smith Kline and Merck Sharp and Dohme) to push the expensive injections into India’s Universal Immunisation Programme (UIP)." 

The Bill and Melinda Gates Foundation has been in the forefront of aggressive promotion of mass vaccination programs in Third World countries. Those economically underdeveloped populations are a huge new market and revenue source for Big Pharma. Critics have questioned the cost / benefit for local populations of the vaccines being promoted. These initiatives divert scarce resources for patented expensive vaccines of questionable value.

 Vera Hassner Sharav

 

THE TRIBUNE

‘Serious lapses’ in HPV vaccine trial
Aditi Tandon/TNS

New Delhi, May 9
The government’s inquiry into linkages, if any, between the administration of HPV (Human Papilloma Virus) vaccine to seven adolescent tribal girls in Andhra Pradesh and Gujarat last year and their deaths has found serious lapses in the conduct of the said trial by partners-foreign NGO PATH and the Indian Council for Medical Research (ICMR).

Though proclaimed as a “post-licensure observational study of HPV vaccination against cancer of the cervix”, the project, suspended in April last following deaths, was indeed a clinical trial and needed to have followed protocols mandated by the Drugs and Cosmetics Act, 1954 which it didn’t, a government inquiry has concluded, without fixing anyone’s responsibility despite evidence of violation by PATH and ICMR members.

The inquiry voices concerns over hidden agenda (vaccines came free from pharma giants Glaxo Smith Kline and Merck Sharp and Dohme) to push the expensive injections into India’s Universal Immunisation Programme (UIP). Considering 1.25 crore girls enter 9 to 15 years target group annually, and vaccination per girl costs Rs 9,000, annual financial benefit to pharma majors would be Rs 11, 250 crore, were the Government to buy injections under the UIP.

Though the Committee doesn’t link vaccinations to deaths in Andhra’s Khammam (where 13, 791 girls were vaccinated) and Gujarat’s Vadodara (where 9,637 were vaccinated), it doesn’t rule it out either, observing: “The reported deaths were most probably unrelated to the vaccine. However, the cause of death in all cases could not be established with certainty”.

Read this with a shocking observation by Dr Y.K. Gupta of AIIMS, an expert assisting the inquiry, who said it was most unusual for a large observational study to not have diary card-based reporting of serious adverse events (SAE) and for it to target “vulnerable” girls despite directions that no research would be done on tribals unless of specific use to them.

Gupta concludes that the “project design didn’t take the issue of SAE seriously nor appointed an independent monitoring agency which caused unacceptable delays in the reporting of deaths. It resulted in gross underreporting of adverse events and didn’t provide insurance to girls though PATH had a cover.”

Another expert, Dr Rani Kumar, found serious discrepancies in consent forms of the vaccinated girls. Of the 100 forms from Andhra Prasdesh she studied, witness signatures were missing in 69. Over 2,763 forms out of 14,253 in Andhra had been signed by wardens/principals on the behalf of children (by the state government’s order). Kumar concludes: “The project team was very casual in its approach and ignored many ethical issues.”

The inquiry report further questions the ICMR’s role as it sided with PATH to call the project an observational study and no clinical trial. Gupta, whose expert opinion the committee cites, however concluded that the project was a clinical trial and involved the study of a pharmaceutical product on humans and four of its five primary outcomes related to the evaluation of vaccine safety. Even the Drug Controller General of India (DCGI), in April, 2009, asked PATH to follow clinical trial protocols. But in project meetings, the ICMR representative rejected DCGI’s contentions. The ICMR even signed the post-licensure study agreement with PATH in 2007 when vaccine licences were given in 2008.

Gates Foundation was funding the project.

~~~~~~~~~~~~~~~~~ 

 

DECCAN HERALD

Seven adolescent girls in the state reportedly died during the trials

Controversial HPV vaccination in AP becomes murkier

Kalyan Ray, New Delhi, May 9, DHNS:

The tale of the controversial cervical cancer vaccine trials in Andhra Pradesh and Gujarat has become murkier with fresh evidences showing the complicity of the state government and Indian Council of Medical Research (ICMR) to push the unethical trial in clear violation of all norms.

Andhra Pradesh government issued an official order asking hostel wardens and principals of schools to sign the consent form on behalf of their parents. In some cases, illiterate parents were asked to give their thumb impression on the consent without any explanation before their girls were administered the vaccine.

Following the widespread criticism, when the Centre began the investigation, ICMR, which approved the trial in 2007, asked the same officer, who was a part of the planning team, to also be a part of investigation giving him access to probe documents, which activists claim, may be used to clean up the tracks.

More than 24,000 adolescent girls were subject to HPV vaccination in one district of Andhra Pradesh and Gujarat each in 2009 as a part of the trial that was meant to find out whether the vaccine can later be introduced in the universal immunisation programme.

Seven girls died during the trials though it is not known whether the deaths are related to the vaccine trial. In a letter to Union Health Minister Ghulam Nabi Azad, CPM leader Brinda Karat  demanded the scrapping of the project and said in future no NGO should be allowed to take up such a project involving a large number of children.

Quoting a report submitted by a high-level committee appointed by the government to look into the vaccine drive, she said the report has brought out “shocking findings” about violations in the project and questioned the lack of ethical standards.

“Strong action is required against the officials at various levels starting with the ICMR. The project itself must be scrapped and in future no NGO should be allowed to take up such a project involving a large number of children,” the CPM’s Politburo member said in the letter.

“There has been a serious dereliction of duty by many of the institutions involved. In particular the role of the ICMR has been extremely questionable,” she said. An investigation panel set up by the Centre picked up many holes in the entire trial but stopped short of fixing the responsibility on any specific individual.

A team of three Delhi-based senior doctors who assisted the investigation panel found almost everything was wrong in the HPV vaccine trial, the most prominent one being “questionable lack of ethical standards.”

The most glaring example was related to consent form. In any drug trial involving the minors, informed consent of their parents is absolutely must before the inoculation. However, Andhra Pradesh government brought out an official order (dated June 2, 2009) asking the deputy medical and health officer in Bhadrachalam block to issue orders to all the hostel wardens and Ashram schools to sign the consent forms on behalf of the parents. In case of 2,763 girls, consent documents were signed en bloc by teachers, hostel wardens and head masters. This is illegal. In another 1948 cases, illiterate parents were asked to put thumb impressions on documents, which they could not understand.

There are 69 consent forms without the witness signature and there are four cases where the names of parents or guardians given in the consent form do not match with the signature.“All consent forms have been very carelessly filled and are incomplete and probably inaccurate,” said Rani Kumar, dean of All India Institute of Medical Sciences here who was one of the three doctors who assisted the probe panel.