India Government-Appointed Panel Accuses U.S.-Based Non-Profit Group, PATH, Of Violating Clinical Trial Norms During Its Cervical Cancer Study On Children, Women

A committee appointed by India's parliament has accused PATH, a Washington, D.C.-based non-profit group, of violating clinical-testing norms while testing cervical cancer drugs on hundreds of women and children in two Indian states, and has recommended strong government action against the group.

The committee, in a report submitted to the Rajya Sabha -- the upper house of the country’s parliament -- on Friday, claimed that PATH was promoting the business interests of drug companies such as Merck & Co. Inc (NYSE:MRK) and GlaxoSmithKline Plc.( NYSE:GSK), and said:

“Its (PATH's) sole aim has been to promote the commercial interests of HPV vaccine manufacturers who would have reaped windfall profits had PATH been successful in getting the HPV vaccine in the Universal Immunization Program of the country."

PATH, which has refuted the committee's allegations, conducted phase IV trials, in 2009, of the human papillomavirus, or HPV, vaccine to treat cervical cancer in Khammam district in the southeastern state of Andhra Pradesh, or AP, and in Vadodara district in the western state of Gujarat.

The Indian Council of Medical Research, or ICMR, the apex regulatory body for biomedical research in the country partnered with PATH in an advisory role during the tests, which used vaccines manufactured and marketed under the brand name Gardasil by Merck and as Cervarix by GlaxoSmithKline.

Merck’s vaccine was administered to 108 girls aged 9 to 15 and GlaxoSmithKline’s vaccine was given to 162 women aged 18 to 35. The study, funded by the Bill and Melinda Gates Foundation, was suspended after five girls from the Gardasil group and two women from the Cervarix group, who were given the vaccines, died. The house panel committee was formed, in April 2010, to probe the incident.

However, an analysis of the seven deaths did not reveal a common pattern that would suggest the women died from the vaccines, according to a report in Mint.

The committee claimed that many consent forms were only partially filled indicating that proper permission was not sought from the subjects before enrolling them in the trials, noting that most of the women and girls subjected to the tests were illiterate, and came from poor backgrounds and local tribal populations.

“In A.P, out of 9543 forms, 1948 forms have thumb impressions while hostel wardens have signed 2763 forms. In Gujarat, out of 6217 forms, 3944 have thumb impression... revealed large number of parents/ guardians are illiterate," the committee noted, according to a report in the Economic Times, a national business daily.

The committee also criticized ICMR for its role in partnering in clinical trials conducted by a private foreign agency, despite being a regulatory body charged with controlling and monitoring clinical research in the country, and pointed to the conflict of interest involved in the issue.

However, PATH and ICMR, at the time, described the project as an observational study and not a clinical trial, but the committee maintained that the project was a clinical trial, regardless of what name the research agency chose to use.

The committee also accused PATH of conducting the study directly on children before it was tested on adults -- a clear violation, it claimed, of Indian laws -- and said ICMR had gone out of its way to support PATH in India and that it had promoted the vaccines to be included in the Universal Immunization Program even before an independent study on the drugs were undertaken.

“In their over-enthusiasm to act as a willing facilitator to the machinations of PATH, they have transgressed  into the domain of other agencies which deserves the strongest condemnation and strictest action against them,” it noted.

The committee also sharply criticized the Drugs Controller General of India for being negligent about ensuring that clinical trial norms were followed by the PATH study. And, the committee advised the Indian government to inform other countries where PATH is conducting similar studies, about the nonprofit's alleged violations.

According to a report by Down TO Earth, a New Delhi-based magazine, trials are being conducted by PATH in three more countries -- Uganda, Vietnam and Peru. The committee also observed, the magazine reported, that PATH violated medical ethics as well as the rights of children and called on the health ministry to "report violations ... by PATH to international bodies like WHO and UNICEF so as to ensure that appropriate remedial action is initiated by these agencies worldwide."

The house committee also advised the Indian government to notify authorities in the U.S. and to investigate if PATH had violated any regulations in that country regarding the cervical cancer trials in question.

PATH Disputes Allegations

PATH, in a statement issued on Monday, refuted the allegations made by the house panel and said that it strongly disagrees “with the findings, conclusions, and tone of the released report and its disregard of the evidence and facts.”

“The report ignores the now voluminous evidence on the safety and efficacy of HPV vaccines and falsely suggests that deaths may be causally linked to the vaccines. This is not only inaccurate, but may have tragic consequences for delivering these and other lifesaving vaccines to those who need them most,” the statement added.

“At the time of its review, ICMR determined the project was a post-licensure observational study and not a clinical trial,” and hence the rules of clinical trials did not apply to the study, according to PATH.