Response of the authors to the Letter “Concerns with regard to an article” published online on April 5, 2019

Response of the authors to the Letter “Concerns with regard to an article” published online on April 5, 2019 (DOI: 10.20529/IJME.2019.014) on the IJME website.

Consultations on human infection studies in India: Do people's voices really count?

The Controlled Human Infection Model or CHIM, sometimes described as a human challenge study, is a relatively specialised medical research technique. Researchers infect healthy participants with a weakened strain of a pathogen in a controlled setting, in order to learn more about the infection and the disease, or to develop new vaccines for that disease. Unlike in other human clinical trials, where participants face a risk of harm because of, for example, the drug’s side effects, healthy participants in CHIM trials are deliberately harmed through infection – contrary to every principle and guideline of medical practice and research.

New Drugs and Clinical Trials Rules, 2019: The market trumps ethics and participant rights

The enactment of the New Drugs and Clinical Trials Rules, 2019 (hereafter New Rules), on March 19 by the Ministry of Health and Family Welfare (MoHFW), Government of India (1), is the use of power delegated to the political executive by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940. Has this power been used wisely? Whose interests do these rules represent?

Public communication about CHIM: What is the role of the media?

The possibility of introducing the Controlled Human Infection Model of research into India is being discussed by some Indian scientists in order to develop biomedical technologies such as vaccines. CHIM studies involve the deliberate introduction of an infectious agent into a healthy person in order to observe the development and progression of the disease, or test potential treatments. This idea will be alarming to the Indian public who will demand the assurance that CHIM is needed and safe. Health communication is viewed by researchers as vital to getting communities on board in public health programmes. The role of the media, however, is to provide information and analysis that represents the public’s interests, and enables the public to make informed decisions. The starting point for journalists will be the environment in which CHIM would be conducted in India: poor healthcare, poverty, vulnerabilities of various kinds, ethical violations, weak regulation, and industry’s impunity. They will also consider that research agendas may be driven by a focus on technological solutions to complex problems, and promote unnecessary vaccines that subsidise the private sector vaccine industry. When talking to the media about its interest in conducting human challenge trials, the research community will have to be honest about its plans, transparent in its functioning, and also ready to admit the possibility that we should not introduce this technology in India.

Response to proposed research to reverse brain death: more than regulatory failure.

In early May 2016, reports of a bizarre study to attempt a reversal of brain death made the headlines, but there was not even a squeak from the authorities. The “Reanima Project” is a collaboration between an Indian surgeon, Himanshu Bansal, and a US-based biotech company, Bioquark Inc. The research will be conducted by Bansal’s own biotech company, Revita Life Sciences, at his Anupam hospital in Rudrapur, a city in Uttarakhand state.

Have scientists met their ethical responsibility towards research participants.

Pramesh and colleagues have not responded to my central thesis: it was unethical to have a “no screening” control arm in the VIA trials when proven screening methods existed

Ethics of ‘standard care’ in randomised controlled trials of screening for cervical cancer.

Cervical cancer is the second most common cause of cancer-related death worldwide and kills over 70,000 Indian women every year.

Standing committee report on CDSCO: hard facts confirm an open secret.

You would think the mandate of the Central Drugs Standard Control Organisation (CDSCO) is to ensure that medicines on the Indian market are safe, effective, and necessary for public health. But the government thinks differently. According to a statement by the ministry to the Department Related Standing Committee on Health and Family Welfare, the CDSCO’s mission as stated in the committee’s report, is to “meet the aspirations…. demands and requirements of the pharmaceutical industry”. It is no wonder, then, that this industry can do just about anything it wants, at the cost of people’s health.

HPV vaccine trials and sleeping watchdogs.

In April 2010, the government announced an enquiry into the conduct of a study on the Human Papilloma Virus (HPV) vaccine in Andhra Pradesh and Gujarat. More than a year later, the committee’s final report is yet to be made public. The committee’s preliminary report records a number of ethical violations but does not assign responsibility to any individual or institution. Further, the central information commission has refused to provide any details of the study protocol that might constitute “intellectual property”. As the project is described as a feasibility and acceptability study of an approved vaccine, it is not clear what intellectual property is involved here. The CIC’s refusal raises concerns that commercial research is being conducted in the garb of providing a public service.