Indian Court Wants Stricter Clinical Trial Oversight

Amid ongoing concern over the conduct of clinical trials in India and patient protection, the Indian Supreme Court has slammed regulators for shoddy oversight that is creating "havoc" and leading to the deaths of many citizens.

In sharp remarks, the government was criticized for going into a “deep slumber” and failing to establish mechanisms to stop “rackets” of multinational drugmakers, which are allegedly conducting illegal clinical trials around the country, according to various media reports (see here and here).

"There has to be some sense of responsibility (on the part of the government). Human beings are being treated as guinea pigs. This is unfortunate," the justices said, according to NDTV. "...There are so many legal and ethical issues involved with clinical trials and the government has not done anything so far."

The comments were made during a hearing on a petition submitted by doctors and the non-profit organisation Swasthya Adhikar Manch, which claimed that citizens in the Madhya Pradesh region had been involved in drug trials without their permission The regional government has argued that states cannot be blamed because permissions for trials were granted by the central government without consultation, PM Live writes.

The court also acknowledged another petition that accused GlaxoSmithKline of failing to provide proper treatment to some of the 24,000 tribal girls in two states who were given its HPV vaccine in trials and experienced adverse events, according to NDTV. Seven girls are alleged to have died as a result. We asked Glaxo (GSK) for comment and will update you accordingly.

In general, clinical trials conducted by global drugmakers and their proxies, contract research organizations, have generated increased scrutiny in recent years as the pharmaceutical industry seeks to run studies in countries with lower costs and populations where patients are not exposed to as many medications that can confound results.

India, however, has recently experienced a backlash amid controversial reports of increasing deaths and various efforts to address the problem. Last summer, one Indian newspaper reported that between 2007 and 2011, trials led to 2,193 deaths, while compensation was paid only in 22 cases. Some critics, however, have argued that public disclosure of analyzed figures indicating direct causal links between trials and patient deaths have been lacking, suggesting other reasons may be a factor.

In response, the Indian Central Drugs Standard Control Organization a few months ago issued new draft guidelines that would allow investigators, who are accompanied by officials from the State Drug Control Authority, to enter trial sites without prior notice and to “inspect, search and seize any record, data, document or books” (read here).

[UPDATE: A Glaxo spokesman sent us this: "These issues relate to a demonstration project led by an organization called PATH which looked at whether and how to incorporate HPV vaccination into a comprehensive cervical cancer prevention program in India where cervical cancer is the most prevalent cancer amongst women. It did not seek to evaluate the efficacy or long-term safety of either of the vaccines used – Cervarix and Gardasil. The project was conducted by PATH in collaboration with government agencies in India. GSK’s vaccine, Cervarix, was administered in the region of Gujarat and during the duration of the project, two deaths were reported. One was attributed to a snake bite and the other to malaria and severe anaemia."

guinea pig pix thx to mjames on flickr