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Violations May Hit Vaccination Plans by Ranjit Devraj

After a government report confirmed major ethical violations in trials of Human Papilloma Virus (HPV) vaccines on Indian schoolgirls, senior doctors are calling for transparency in clinical trials conducted under private-public partnerships.

The report is yet to be placed in the public domain, but its contents were revealed early May by senior doctors who assisted in its preparation, sparking outrage among public health advocates and women’s rights groups.

HPV is an umbrella term for more than 100 strains of a virus, most of which are relatively harmless. About 40 of them can be transmitted sexually, and a small fraction can cause genital warts or cancer.

Ethical concerns in the HPV trials were first raised by the New Delhi-based Sama Resource Group for Women and Children, a non-governmental organisation (NGO), and Brinda Karat, a member of parliament in April last year. The central health ministry consequently suspended what was officially described as a "demonstration project".

The project, conducted by the Programme for Appropriate Technology in Health (PATH), an international NGO, in partnership with the government-run Indian Council of Medical Research, was linked by media reports to the deaths of eight schoolgirls who were given HPV shots.

By the time was project was suspended some 14,000 schoolgirls in western Gujarat and southern Andhra Pradesh states had been given the shots manufactured by pharmaceutical trans-nationals Merck and GlaxoSmithKline.

"Whether or not the deaths had anything to do with the vaccine, they brought into focus the flouting of many laws governing clinical trials in this country," said Dr. Mira Shiva, a well-known expert on pharmaceutical drugs and member of the influential All-India Drug Action Network

Such was the outcry over the deaths that a week after the suspension of the project the health ministry ordered an inquiry by an expert panel that included S.P. Agarwal, former director-general of health services, and Suneeta Mittal, head of obstetrics and gynaecology at the premier All India Institute of Medical Sciences (AIIMS).

The committee’s brief was to examine "alleged irregularities in the conduct of studies using HPV vaccine by PATH in India." But, curiously, while confirming several violations, the committee did not fix responsibility on PATH or any other organisation or individual.

If that raised suspicions, attempts to describe the project as a "post-licensure demonstration," rather than a clinical trial, were seen as "semantic subterfuge".

"There is no such thing as a post-licensure demonstration project. What was done was a clinical trial, pure and simple," Shiva told IPS.

In its report, the committee said that "by whatever name you call it, the project proposal has been carried out as research on human participants. And as such it had to follow all the guidelines and statutory requirements applicable for research on human participants."

Committee member, A.K. Dutta, head of paediatrics at the state-run Kalawati Saran Hospital in New Delhi, said there was no worthwhile reporting system for deaths and adverse events despite there being "direct contact with human participants and intervention that was not part of prescribed prevention."

Y.K. Gupta, who heads pharmacology at AIIMS and who was also on the committee, said he was concerned that the trials were carried out largely among tribal girls when Indian law clearly forbids research on "tribal populations unless of specific benefit to them."

Gupta said it was curious that remote tribal areas were chosen for the study because the standards of medical care were far lower than in the urban areas, at least in terms of handling death-threatening adverse events following vaccination.

According to Dr. Rani Kumar, dean at the AIIMS, "the most significant deficiency in the implementation of the project was the obtaining of consent" from the parents of the girls who were involved in the project.

Though the committee concluded that the deaths of the schoolgirls were "most probably not related" to the vaccine, it noted that there was insufficient information on three of the deaths.

Jacob Puliyel, paediatrician and member of the National Technical Advisory Group on Immunisation (NTAGI), said there is no classification as "most probably not related" in the World Health Organisation’s guidelines on reporting adverse events. "The whole thing smacks of a bad cover-up," he told IPS.

The committee hinted at the "possibility of a hidden agenda to push this prohibitively expensive vaccine into the Indian healthcare system," and said it might have been "prudent if the NTAGI had deliberated on the study prior to its implementation and given its recommendations."

Grounds for suspicion came from the fact that inquiries by SAMA, under the Right to Information Act, were returned saying it was not possible to provide details of a study protocol that might infringe on intellectual property rights.

"Since the project is described as a feasibility and acceptability study of an approved vaccine, it is not clear how intellectual property become involved, and it also raises the question of whether commercial research is being conducted in the guise of public service," said N.B. Sarojini, who heads SAMA.

The committee said it was concerned that "no provision has been made of an insurance cover for any unforeseen event or residual, morbidity, related, or unrelated to the intervention; which is a usual practice."

On the other hand, the committee noted, "PATH has taken an insurance cover for itself."