User:Bluerasberry/Indore trials

The public protest of the scandal led to broad mass media coverage.

A writer for Frontline compared the research to the plotline of the novel Coma, in which a villainous hospital sells unethical medical treatments for profit.

Participating research institutions were Mahatma Gandhi Memorial Medical College, Indore and Maharaja Yeshwantrao Hospital.

Jawaharlal Nehru Cancer Hospital & Research Centre declined to share the clinical trial agreements after a 2010 Right to Information request.

The problems with the trail escalated to mass media attention and public discussion.

Right to information request
In 2011 medical doctor Anand Rai was a physician at Maharaja Yeshwantrao Hospital in Indore. He complained about ethics violations in clinical trials to the National Human Rights Commission for information, and that organization referred the matter to the Madhya Pradesh Human Rights Commission. The trial became the subject of more media attention. Rai made a Right to Information request. The information in that request found that at least 81 people experienced serious adverse events related to their clinical trial participation. Merck and Pfizer were among the trial sponsors.

After the court case there was a six-month pause in the government approving any new clinical trials. The government finally begin approving trials again starting with a group of 50 in one day in July 2013.

In January 2012 the government prohibited two doctors from conducting trials because of violations. Related to those suspensions, in 2017 the Medical Council of India suspended the licenses of 8 additional physicians.

Swasthya Adhikar Manch told the court that psychiatrists at Mahatma Gandhi Memorial Medical College, Indore has enrolled 233 psychiatric patients into clinical trials without getting their informed consent.

In October 2012 Justices Rajendra Mal Lodha and Anil R. Dave demanded data about the clinical trials with the consequence for failure to be national suspension of clinical trials throughout India.

The psychiatrists were accused of testing a polio vaccine on babies without consent. The accusation was that the researchers told parents that they were providing free vaccines as part of a government healthcare program. In one case, the researcher gave the vaccine to a child shortly after birth when the drug was intended for a child who was older. When the child experienced side effects from the drugs the doctor refused to acknowledge them.

Motivations for the doctors to conduct the trials in the way that they did included money and prospects of career advancement.

Headlines Today acquired copies of both the official informed consent document and the alternative explanation which the researchers were providing to the people they were researching. The original document was 16 pages of text, but the researchers were only providing a page of information to research subjects.





Further consideration
A journalist complains about the trial... and the researchers respond.