NEW Delhi- In another tweak for researchers hoping to conduct trials clinics in India, a parliamentary group has excoriated a nonprofit US and its Indian partner for alleged ethical violations in a trial of a vaccine to protect against cervical cancer caused by human papillomavirus (HPV). The panel report "will have a chilling effect on the entire clinical research," predicts epidemiologist Ramanan Laxminarayan, vice president for research at the Public Health Foundation of India in New Delhi.
HPV infection is a major cause of cervical cancer each year, about 73,000 women in India die from the disease, about a quarter of the global burden of disease a vaccine against the virus was available. the United States since 06. in an effort to expand the use of the vaccine in the developing world, the Program for appropriate technology for health (PATH), a non-profit based in Seattle, in 09 launched a HPV test $ 3.6 million, funded by the Bill & Melinda Gates Foundation, in 24.777 teenagers in Andhra Pradesh and Gujarat states. PATH conducted what it calls "post similar approval for demonstration projects" in Uganda, Peru and Vietnam. But several months in the Indian case, the government pulled the plug after retakes reported the death of seven girls.
investigations absolved state-PATH managers of the trial and the Indian Council of Medical Research (ICMR), New Delhi responsibility -to death. Five were obviously unrelated to the vaccine: A girl drowned in a quarry; another died of a snake bite; two committed suicide by ingesting pesticides; and one died of complications of malaria. The causes of death for the other two girls were less certain: one may pyrexia, or high fever, and a second of a suspected brain haemorrhage. . "Improbable" government investigators concluded that pyrexia was "very unlikely" to be linked to the vaccine, and they even considered a link between stroke and the vaccine as CEO of ICMR, Vishwa Mohan Katoch microbiologist, rejects a connection: "based on the investigation, it is certain that the causality of seven deaths was not at all related to the vaccine against HPV," he insists other experts. say, in the absence of autopsies, it is impossible to determine the actual cause of death.
Probing deeper, a panel appointed by the Ministry of Indian health in 2010 found a number of deficiencies and alleged breaches of ethics in vaccine trial. His report in 2011 noted that the trial repeatedly failed to obtain appropriate informed consent of participants. He also revealed that trial managers did not put in place a mechanism to report adverse reactions, and criticized the lack of a control group and the inclusion of the test daughters protected tribal communities of India without obtaining individual consent. "The trial of HPV has not been well managed. The trial did not respect and comply with good clinical practice standards," said Maharaj Kishan Bhan, an immunologist who led a large clinical trial of a vaccine against rotavirus approved earlier this year in which PATH was also a partner.
now a multi-party parliamentary group fell even harder on PATH and ICMR and drug controller General of India. His report of August 30 explosions PATH and ICMR for not having carried out the post-mortem examinations of the girls who died during the trial and this level astonishing claim. Rather than seeking to protect the health, PATH women, he charged, was a voluntary tool Foreign pharmaceutical companies hope to convince the Indian government to include the vaccine against HPV as a universal vaccine program, a list of vaccinations required that the government has to pay. (vaccine against HPV is still available in the Indian private sector .) ICMR, the panel report says, has "completely failed to execute [its] role and responsibility of the umbrella organization for medical research in the country mandated. ... On the contrary, in [its] over-enthusiasm to act as a volunteer facilitator PATH machinations [it has] even rebelled in the field of other organizations that deserves the strongest condemnation and strict action against [it]. "
Some commentators see the merit of this argument. the series of HPV in three doses cost approximately $ 150 in India. the fact that Merck, which makes Gardasil and GlaxoSmithKline, Cervarix manufacturer donated a $ value of nearly 6 million of their vaccines to the PATH test "was not philanthropy," says Chandra M. Gulhati, editor of Monthly Index of Medical specialties , an influential magazine in India. "It is shocking to see how an American organization has used underhanded methods to set up in India," he charges. "This is a clear case where the Indians were used as guinea pigs," says Samiran Nundy, a gastrointestinal expert intestinal at Sir Ganga Ram hospital in New Delhi and editor emeritus of National Medical Journal of India.
in a statement, PATH said "we strongly disagree with the conclusions the conclusions and tone of the published report and disregard of evidence and facts. "Contacted by science Insider, Vivien Davis Tsu, director of cancer prevention project cervical PATH has not commented on the allegations of the report. "We remain true to our heritage of ethics, work on the basis of evidence on transformative innovations that save lives," she said. The Gates Foundation noted in a statement that the World Health Organization, the International Federation of Gynecology and Obstetrics, and the Federation of obstetrical and gynecological societies of India have all recommended vaccinations "as a preventive measure proven and very effective for cervical cancer. "
Katoch acknowledges shortcomings in the management of the trial. "Our conduct the study tracking material could have been better," he said. New regulations on clinical trials being developed by Parliament will strengthen procedures for testing, he said. "India will emerge stronger after this episode."
Yet the impact of the report of the parliamentary panel could be severe. "After this episode, it will be difficult to do clinical trials in India," predicts geneticist VijayRaghavan Krishnaswamy, secretary of the Department of Biotechnology. Laxminarayan concerned that researchers will abandon clinical trials in India rather than navigate a maze of complex regulations that he believes are bound to be introduced as a result of HPV testing. All eyes are now on the Supreme Court, which on September 26 will resume hearings on a case looking globally for clinical trials in India. Biomedical scientists better reinforcement of trouble: In July, two judges of the court bench observed that although foreign companies "treat India as a paradise for clinical trials, it appears hell for. India "
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