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Unethical collusion tag on vaccine campaign
-The Telegraph


Two Union government health agencies colluded with a foreign entity to conduct a mass vaccination campaign on thousands of girls in India four years ago, violating medical ethics and national laws, a parliamentary committee said today.

The parliamentary standing committee on health and family welfare has blamed the Indian Council of Medical Research (ICMR) and the Drugs Controller General of India for collaborating with the US-based Program for Appropriate Technologies in Health (Path) for the vaccination campaign in Andhra Pradesh and Gujarat.

The committee has also questioned the legitimacy of Path in India. The non-government organisation designed the campaign jointly with the ICMR to deliver a vaccine against the human papillomavirus (HPV), a sexually-transmitted virus implicated in cervical cancer. Doctors say the vaccine needs to be given to girls during adolescence to curb the risk of cervical cancer in adulthood.

But Path today denied any wrongdoing and claimed that the parliamentary committee has inaccurately characterised the vaccination project.

Some 20,000 girls between the ages of 10 years and 14 years received the vaccine during 2009-10 in the two states. But 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.

Two companies, GlaxoSmithKline and Merck, had provided vaccines for the campaign.

Millions of girls across North America, Europe and Australia have received the HPV vaccine since it was approved in 2006. The vaccines have also been used in the private sector in India for nearly five years.

The ICMR and Path had labelled the campaign as a "demonstration project" that would help guide health authorities to make informed decisions relating to the possible introduction of the HPV vaccine into the government's free universal immunisation programme."

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 Drugs Controller General of India initially ruled that the campaign should be treated like a clinical trial, but "remained a silent spectator even when rules and regulations were being fragrantly violated," the committee said.

The committee has confirmed violations of informed consent rules, establishing that the role, usefulness and the pros and cons of the vaccine had not been properly communicated to the parents or guardians of the vaccinated girls.

"There's a lesson from this episode," said Chandra Gulhati, a pharmacologist and editor of the Monthly Index of Medical Specialities, India, who has been tracking questionable practices by medical regulatory authorities in India. "It shows how our own medical regulators and officials can be influenced to facilitate projects that are unethical or violate laws of the land."

Path has said it is "troubled by the (parliamentary committee's) report's inaccurate characterisation" of the project. In a statement emailed to The Telegraph tonight, Path said the project did not seek to evaluate the efficacy or long-term safety of the vaccines which had already undergone clinical evaluation and were approved for use in India.

"The ICMR, India's highest medical research authority, reviewed and approved the protocol for this project," Path said. "We designed a project that met or exceeded the country's existing regulatory standards for demonstration projects."

The parliamentary committee also said its efforts to understand the legal status of Path in India suggest that Path does not have the mandatory approvals required by foreign non-government agencies to operate in India.

The committee said Indian rules require that foreign non-commercial organisations such as Path wanting to establish a presence in India need permission from external affairs ministry "from political angle" and from the home affairs ministry "from security angle."

When questioned about this, Path provided the committee a copy of its income tax PAN number card, a certificate from the Reserve Bank of India, and a letter from the Union health ministry, none of which can serve as substitutes for the mandatory approvals.

"We believe we've been compliant with all laws of the land," Tarun Vij, Path's country manager told this newspaper. "But we're available to any agency for any additional information that they might want to seek from us."