Exploratory study on clinical trials conducted by Swiss Pharmaceuticals companies in India: Issues concerns and challenges (September, 2013)

Sama Resource Group for women and Health in collaboration with Bern Declaration (BD), a Switzerland based NGO carried out to a Study to explore the conduct of clinical trials sponsored by Swiss pharmaceutical companies in India. The main objective  is to verify if these companies comply with the relevant ethical standards and with the regulatory environment in India from the perspective of various constituencies and stakeholders. The study was conducted across four states of India and 17 clinical trial participants were interviewed.  The study focused on informed consent, sourcing and recruitment of participants and the issues related to compensation vis-a-vis clinical trials.Image

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Capacity Building Workshop on Ethics and Regulation of Clinical Trials in India,organized by Sama–Resource Group for Women and Health, to be held at Bhopal on December 18-19th, 2013

A similar workshop was conducted at Delhi in February, 2013. Sama has been consistently working on the issues of rights violations and ethical misconduct in clinical trials in India over the last 4 years. In recent past there have been many examples of clinical trials that have taken place that disregarded ethical aspects and participant rights. At the levels of planning, design and implementation, there exists a striking lack of transparency thus jeopardizing the reliability and validity of drug research in the absence of adequate regulatory jurisdiction and systematic review of the industry. Recent parliamentary a standing committee reports on the functioning of the CDSCO office and on the clinical trials conducted by PATH validate the concerns raised by civil society groups. Subsequent developments in the regulatory framework for the clinical trials make it even more appropriate to discuss the issues regarding clinical trials. In this context, we are organizing this capacity building workshop to inform and initiate dialogue with regard to existing regulatory and provisions regarding clinical trials.

 

Activists hail report on HPV vaccines, but PATH says no violations

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AARTI DHAR

September 3, 2013

Report points to a serious dereliction of duty by many of the institutions involved

Health activists have appreciated the Parliamentary Standing Committee’s report on the “Alleged Irregularities in the Conduct of Studies Using Human Papilloma Virus (HPV) Vaccine by PATH in India.” They commended “its candid, transparent contents, which reflect the committee’s acknowledgement of the unethical nature of the HPV trials’’ conducted in the country.

In the trials, Program for Appropriate Technology in Health (PATH), with the support of Bill and Melinda Gates Foundation (BMGF), approval from the Western Institutional Review Board (WIRB) [all three private international parties], donations from Merck Sharp and Dohme (MSD) and Glaxo SmithKline (GSK), in partnership with Indian Council of Medical Research (ICMR) and along with the governments of Andhra Pradesh and Gujarat, through the national vaccination programme, delivered and administered HPV vaccines to 10-14-year-old girls in Khammam (A.P.) and Vadodara (Gujarat) districts.

The committee’s findings are wide-ranging: the nature of the project, the role of ICMR, the role of the Drugs Controller General of India (DCGI), the Informed Consent Process, the role of Ethics Committees (EC), the process of inquiry committee formation and function and the role of PATH.

The report points to a serious dereliction of duty by many of the institutions involved. In particular, it questions the role of the ICMR, DCGI, EC members and PATH.

The committee clearly stated that the demonstration project was a clinical trial, no matter what PATH called it.

The report said, “The demonstration project is a study of a pharmaceutical product carried out on humans and since the primary objective includes the study of serious adverse events, it is clear that clinical trial rule should apply.”

A statement issued jointly by Jan Swasthya Abhiyan, Sama – Resource Group for Women and Health, and LOCOST / All India Drug Action Network said PATH, by carrying out clinical trials on the pretext of observation/demonstration project, has violated all laws and regulations laid down for clinical trials by the government.

Though, the committee brought up insurance to the girls, it has not mentioned the compensation in its report from the sponsor or an ex-gratia to the parents of the girls who died after the administration of the trial, the statement said, while demanding that the parents and children be compensated for the grave violations of their rights, as clearly informed consent was not taken from a large number of parents and no assent was taken from the girls who were given the HPV vaccine, and no follow-up or proper management of adverse events and serious adverse events during the trial was done.

“We welcome the recommendations and sincerely hope the contents and recommendations of the 72nd report by the Parliamentary Standing Committee will be acted upon, that there will be concrete early follow-up and outcomes of the committee’s observations and recommendations,” the statement said.

PATH STAND

Reacting to the report, PATH said it was troubled by the report’s “inaccurate characterisation of this important work.”

“PATH, a non-profit organisation, is committed to meeting the highest scientific, ethical, and legal standards in our work and to contributing our experience and expertise to address the burden of cervical cancer through transformative innovations such as vaccines, a statement issued by it said.

“The demonstration project in India was part of a four-country project to explore suitable vaccine delivery strategies and help provide evidence for national health authorities to make informed decisions about the potential benefits and challenges of introducing vaccines against HPV, the primary cause of cervical cancer,’’ the statement said.

ICMR APPROVAL

PATH said ICMR reviewed and approved the protocol for this project, including its design and methodology. At the time of its review, the ICMR determined the project was a post-licensure observational study and not a clinical trial.

“The project did not seek to evaluate the efficacy or long-term safety of the vaccines, which had undergone clinical evaluation in India and had been licensed and approved by the Drugs Controller General of India.’’

ICMR’s view was crucial, as it established the approval processes and protocols for the work that followed. PATH designed the project protocols in compliance with ICMR’s instructions and fully complied with ICMR’s requirements regarding the necessary approval processes and the requirements of the State governments regarding consent processes, according to the statement.

“We believe that by following the guidance provided by ICMR, as well as the two State governments and three ethical review committees, we designed a project that met or exceeded the country’s existing regulatory standards for demonstration projects while providing the greatest health benefit to Indian women,’’ PATH said.

The National Consultation on Regulation of Drug Trials

We would like to announce the release of the report on ‘The National Consultation on Regulation of Drug Trials.’ The Consultation held on 26-27thSeptember, 2011, was an effort towards initiating a dialogue around the existing gaps in policy and its implementation vis-à-vis the regulation of drug trials, towards developing an appropriate framework for future intervention strategies in this regard. The Consultation was organised by Sama –Resource Group for Women and Health, Centre for Studies in Ethics and Rights (CSER); Low Cost Standard Therapeutics (LOCOST), All India People’s Science Network (AIPSN),Drug Action Forum, Karnataka (DAF-K) along with Dr Amar Jesani.

 Recognising the urgent need for furthering transparency in trials, protection of participant rights, and implementation of the highest standards of independent inquiry, this National-level Consultation was attended by nearly 60 participants, who mainly comprised of representatives from health networks, the medical and scientific community, research organisations, media, activists, legal experts, women’s groups and policy makers towards evolving concrete recommendations for policy and regulation on these issues.

 Some of the main themes that were discussed at the Consultation include –

The new division of labour in commercialised research and the CRO industry;

Regulatory standards vis-à-vis the conduct of clinical trials in India;

Pressing dilemmas and Issues with regard to the existing systems of regulation;

Issues of public health vis-à-vis clinical trials;

Role of ethics committees and dilemmas in governance.

The concluding session facilitated a platform for collective strategizing over future interventions towards people-centric clinical research.

The speakers included Amar Jesani, Kaushik Sundar Rajan, Pushpa Bhargava, Brinda Karat, Arun Bhatt, Sandhya Srinivasan, Vasantha Muthuswamy, Sarojini, Anjali, C.M.Gulhati, Deapica, Parsottam Parmar, Rachna, Roli Mathur, Sujith Chandy and many others. The sessions were moderated by Anant Phadke, Amit SenGupta, Vineeta Bal, Satyajit Rath, Chinu Srinivasan, Jacob Puliyel, Samiran Nundy, Nandini Kumar to name a few. Discussions were also held with VM Katoch (DG ICMR), officials from MOHFW and DCGI.

The report in documenting its proceedings closely follows the structure of the Consultation. While presentations have been addressed in verbatim to maintain their authenticity the central concerns and points discussed following the presentations have been highlighted at the end of each session along with the comments from the chairs and discussants.

 If you would like copies, please do write to us at sama.womenshealth@gmail.com .