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Sama’s New Relaeases

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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-à-vis clinical trials. 

 

The research study is priced towards the cost of postage etc. If you would like to place an order please contact Sama directly at sama.genderhealth@gmail.com

 

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This multi-site study was conducted by Sama during 2011-2013 exploring the perspectives of the clinical trial participants with regards to various aspects of clinical trials. The study was conducted across 37 institutions located in seven cities from four states of India. During the study, total 67 interviews were conducted which included 36 clinical trial participants and 31 other key informants. This study examined the perspectives of the clinical trial participants with respect to the various components of the clinical trials such as recruitment, reasons for participation, informed consent, adverse events, compensation and post trial access. In the process of recruitment, various pathways through which the participants reach the clinical trial have been explored along with the most common places for recruitment of the participants. 

The study elaborates various push and pull factors such as economic status, free health services, trust on the doctor etc. which influence the decision of participant of enrolling in the clinical trial. Informed consent has been discussed in its conceptual paradigm in detail dealing with comprehension of the information in consent form and voluntariness of the consent. The issues related to adverse events and compensation including the recent regulatory developments in the area of compensation and issues related to them are discussed from the perspective of the participants. The complex issue of post trial access and current obligations under the law have been explored in the report. The report provides recommendations and future research agenda in the area of clinical trials.

 

The research study is priced towards the cost of postage etc. If you would like to place an order please contact Sama directly at sama.genderhealth@gmail.com

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

Letter to Hon’ble Minister of Health and Family Welfare, raising issues and concerns related to assisted reproductive technologies (ARTs) and surrogacy

To,

Shri Ghulam Nabi Azad,

Hon’ble Minister of Health and Family Welfare,

Government of India,

New Delhi

 

Dear Shri Ghulam Nabi Azad,

Sama-Resource Group for Women and Health and Jan Swasthya Abhiyan has been raising issues and concerns related to assisted reproductive technologies (ARTs) and surrogacy for the past many years. This is to bring to your notice a case of medical negligence resulting in the death of a 26 years old Yuma Sherpa, following   an egg donation procedure at New India Clinic, Lajpat Nagar, New Delhi. The woman belongs to Darjeeling and was working in Delhi as a shop assistant in Lodhi Colony.

 

As per the newspaper reports in The Hindu and The Indian Express dated 1 February 2014 and the statement issued by the All India Democratic Women’s Association (AIDWA) who visited the family of the victim as well asafter the procedure of donation of the eggs on January 29th, the woman spoke to her husband on the phone from the recovery room of the clinic. When her husband reached the clinic, he found out that she was not responding. Even after he told this to the staff, he was told that it was because of the medications given to her. Later she was shifted in a critical condition to another hospital at a distance rather than other hospitals like AIIMS on the way. Her death in these circumstances raises many questions which need serious investigation.

 

We request you to take up this matter urgently and expedite an investigation into the case. Strict action should be taken against those who are found guilty and compensation should be paid to the family of the woman. We demand an  immediate investigation into the case and punishment to the guilty and justice to the family.

 

We have seen in the last few years, that ethical practices almost cease to exist and worrying stories of unscrupulous means to maximize profit by cashing in on egg donors’ or surrogates’ vulnerability abound.

 

This incidence once again underscores the long overdue need to set up regulatory framework for the Assisted Reproductive Technologies (ARTs) for dealing with such cases. We have repeatedly submitted our concerns on the ART Draft Bill in order to ensure protection of rights of the surrogates and egg donors. The present ART Draft Bill (2013) needs to reviewed; we have sent our comments and recommendations on the 2010 Draft Bill and also on the ART Draft Bill (2013) [copied below]. We are attaching again the concerns of Sama on the Draft Bill and the proposed Act, and urge you to consider our concerns and recommendations.

 

As we have repeatedly argued for years, protections offered to egg donors and surrogates are completely inadequate, including in the current Draft ART Bill 2013, especially in terms of the medical risks they undertake. There is no mention of “death” in the entire Draft Bill.

 

The medical regimen, its implications and the experiences of egg donors or surrogates pose questions that are deeply political and have significant connotations at the policy level, which need to be addressed for protecting the rights of the egg donors and surrogates. It is therefore imperative that the number of oocytes ‘retrieved’ and embryos to be ‘harvested’ and “transferred” need to be restricted and strictly regulated taking cognizance of health implications and safety, age and other health conditions, etc., of women undergoing these procedures/arrangements. The focus should be on ensuring the protection of donors from any injury or death. Privileging the financial interests over considerations of egg donors and surrogates’ health, while evading any scrutiny by grounding all decisions in being “medically indicated”, poses a great challenge to the ethics of medical practice. 

 

We hope that urgent attention will be paid to the Draft legislation (2013) and processes for review and incorporation of concerns will be initiated. We also hope that immediate action is taken against those involved in the death of Yuma Sherpa and justice is rendered to her family.

 

Sarojini N.

(Sama Resource Group for Women and Health )

Deepa Venkatachalam

(Jan Swasthya Abhiyan)

Medico Friend Circle (MFC) 40th Annual Meeting

Dear Friends,

 

Greetings from the Medico Friend Circle (MFC)!

 

We cordially invite you to join us on the evening of 13th February 2014, 40 Years and Onwards! The Journey that is Medico Friend Circle (MFC), at the India Islamic Cultural Centre, Lodhi Road, Delhi on the occasion of 40 years of the Medico Friend Circle. It would be wonderful to have you with us while we celebrate, reminisce about our history and imagine the years ahead. 

 

40 Years and Onwards! The Journey that is MFC

Venue: India Islamic Cultural Centre, Lodhi Road

Date/Time: 13th February 2014 / 5.00 pm – 8.30 pm

Programme

5.00 pm – 5.30 pm: The Journey that is MFC!

5.30 pm – 7.30 pm: Presentations and Discussion on key MFC Themes and Issues (Primary Health Care, Universal Health Care, Medicines, Communalism, Social Determinants of Health)

7.30 pm – 8.30 pm: Music by Vidya Shah

 

 

Do also join us for the day long programme on the 13th February and the Annual Meet on Discrimination and Health on the 14th-15th at the Indian Social Institute, Lodhi Road (Details given below).

 

Looking Back Looking Ahead! Through 40 years

We also invite you to be part of the 40 MFC years through the day long programme on the 13th February (11 am – 4 pm) at the Indian Social Institute (ISI), as we journey through history – pausing at each decade with friends who founded and joined the Circle, specific themes, debates, songs.

 

Venue: Indian Social Institute (ISI), 10 Institutional Area, Lodhi Road, New Delhi

Date / Time: 13th February (11 am – 4 pm)

 

Annual Meet: Social Discrimination and Health

You are also welcome to join the Annual Meet on 14th and 15th February at the Indian Social Institute (ISI), Lodhi Road, to be part of discussions and debates on the Annual Meet Theme: Discrimination and Health. (A detailed programme schedule is attached).

Venue: Indian Social Institute (ISI), 10 Institutional Area, Lodhi Road, New Delhi

Date / Time: 14th – 15th February / 9.30 am – 6.00 pm

 

You may be already familiar with MFC, a nation-wide platform of secular, pluralist, and pro–people, pro-poor health practitioners, scientists and social activists interested in the health problems of the people of India. Since its inception in 1974, MFC has critically analyzed the existing health care system and has tried to evolve an appropriate approach towards health care which is humane and which can meet the needs of the vast majority of the people in our country. Its only commitment has been to intervene in and understand the debates, policies and practices of health in Independent India. Such an organization would doubtless have as many different narratives of history as it has perspectives through its life.

 

MFC is a non funded group of members from various backgrounds from across the country – public health professionals, medical doctors, nurses, health activists, researchers, students and professors at medical colleges and others. The MFC bulletin (first published in 1975) and the MFC Annual Meets have contributed to many debates and discussions on a range of health related issues, for example, primary health care, universal health care, nutrition, occupational health, communicable and non communicable diseases, women’s health, medical education, etc.  

 

 

We look forward to seeing you there for the event,

 

Dr. Sunil Kaul (Convener), Ms. Sarojini N. (EC Member) and 

Ms. Manisha Gupte (Managing Trustee) on behalf of MFC

Website: www.mfcindia.org

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.

 

SATHI (Pune) in collaboration with Sama (Delhi) is organizing a workshop, on ‘Promoting patients’ rights and ensuring social accountability and rationalization of care in the private medical sector’ on 25-26 October 2013 at ISI, New Delhi

As we are aware, today denial of Patients’ rights, gross overcharging, irrational, unnecessary investigations and procedures by private hospitals are on the rise. Significant social unrest is emerging due to these practices of the private medical sector, which is today largely unregulated. Besides social and health activists, there is a small section of rational practising doctors who are also quite dissatisfied due to gross commercialization of the profession, as well as the inroads being made by a growing corporate healthcare sector. In this context, we need to document various cases of denial of patients’ rights, along with recording some testimonies of rational doctors who are in favour of social regulation, and we should use such evidence towards strongly demanding social regulation and accountability of the private medical sector.

With the advent of the Clinical Establishments Act (CEA) enacted by the central government in 2010, regulation of the private medical sector is now coming onto the agenda. Some states like Himachal Pradesh, Arunachal Pradesh, Mizoram, Sikkim, Rajasthan, Jharkhand, and Uttar Pradesh have adopted the central act in its existing form, while states like Chhattisgarh and Odisha have their own existing state acts, and states like Kerala and Tamil Nadu are in the process of coming out with their own separate acts. Delhi has its own redundant ‘Delhi Nursing Home Registration Act’.  

Given the major gaps in various existing regulatory frameworks, it is important that further steps be taken urgently for effective regulation, which would address the rights and needs of ordinary patients, as well as concerns of rational doctors. Otherwise the regulatory process would be completely dominated by bureaucrats and corporate hospitals, leading to continued irrationality and exploitation, compounded by corruption by officials.

Given this background, for health activists/ civil society organisations working in health and interested activists from all over India it has become an urgent need to engage with the issues related to patients’ rights and regulation of private medical sector in their respective areas and states.

 

Sama is organizing a two and half day workshop, The Way Ahead: Strengthening the Response of the Health Care System to Gender Based Violence, New Delhi, 27-30 November 2013

Over the past two years Sama has been involved in initiatives for developing collective, strengthened understanding / perspectives of gender based violence as a health issue and strengthening health sector response to survivors of violence, through workshops with community based organisations, networks, health workers in the states of Bihar, Uttar Pradesh, Jharkhand, Orissa, Chhattisgarh, Rajasthan, Madhya Pradesh, Delhi, Assam and others.

Towards taking forward the discussions and outcomes of these workshops, and consolidating understanding and capacities of organizations from the different states Sama is organizing this two and half day workshop. Specifically this workshop will seek to:

  • Enable an understanding and analysis of the health system in which response to gender based violence (sexual violence as well as ‘domestic’ violence) is located
  • Build capacities in engaging with the health system to initiate / or strengthen response.
  • Strengthen understanding and analysis of the law, policy, recent amendments, standard protocols and proformas.
  • Learn from existing strategies amongst participants to initiate responses at different levels of the health system.

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.

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