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.

PRESS RELEASE

We greatly appreciate and welcome the 72nd Parliamentary Standing Committee on Health and Family Welfare’s Report on the “Alleged Irregularities in the Conduct of Studies Using Human Papilloma Virus (HPV) Vaccine by PATH in India” that was presented in the Rajya Sabha and laid on the table in the Lok Sabha on30 August 2013.  Indeed it is an extraordinary report and we commend its candid, transparent contents, which reflect the Committee’s acknowledgement of the unethical nature of the HPV trials conducted in the country. According to this 72nd report, the Parliamentary Standing Committee has been looking into the issue of HPV trials on children in Andhra Pradesh (Khammam district) and Gujarat (Vadodara district) since April 2010 following reports of deaths of some of the children.

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

The Committee’s findings, endorsed by MPs from all political parties, are wide-ranging: the nature of the project, the role of ICMR, the role of Drug 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 Committee 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.

Nature of Project: The Parliamentary Committee clearly stated that the demonstration project was a clinical trial, no matter what  PATH called it. The report further states, “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”.

PATH by carrying out the clinical trial on the pretext of observation/demonstration project has violated all laws and regulations laid down for clinical trials by the Government of India.

Role of ICMR: The Committee questions the role of ICMR in the entire trial. Section 3.10. of the report states, “unable to understand as to how ICMR could commit itself to support the use of the HPV vaccines in an MOU signed in 2007 even before the vaccine was approved for use in the country. The Committee questions the decision of ICMR to commit itself to promote the drug for inclusion in the UIP even before any independent study about its utility and rationale of inclusion in the UIP was undertaken.

The Committee observes that ICMR representatives, instead of ensuring highest levels of ethical research standards in research studies, apparently acted at the behest of PATH who was promoting the interest of manufacturers of the HPV vaccine.

The Role of DCGI: Report section 4.3: “The Committee examination has proved that DCGI has played a very questionable role in the entire matter. The DCGI has remained as a silent spectator thereafter even when its own rules and regulation were being so fragrantly violated the approvals of the clinical trials, marketing approvals and import licenses by DCGI. Therefore the role of DCGI in this entire matter should also be enquired into”.

Conflict of Interest: The Committees ought information from the MOHFW as to whether the members of the Inquiry Committee were asked to file a conflict of interest declaration. To this the Ministry had responded that no written conflict of interest declarations were sought from the core members of the inquiry Committee as well as experts. The Committee picked just one member of the Committee from AIIMS and found that MSD, the manufacturer of HPV vaccine Gardasil, was sponsoring and funding the trial in the member’s department. This demonstrates a serious conflict of interest of this member of the inquiry Committee. The Committee has strongly deprecated the government for appointing the Committee to inquire into such a serious matter in such a casual manner even without ascertaining as to whether any of the members of the said inquiry Committee have any conflict of interest with the subject matter of inquiry.

The report also observes that ICMR representative “instead of ensuring highest levels of ethical standards in research studies, apparently acted at the behest of PATH in promoting the interest of the manufacturers of the HPV vaccine”.

The Committee report also found that “the Ministry appointed a senior official of ICMR (described as Resource Person) to assist the Inquiry Committee. The concerned individual was the main link between ICMR and PATH, and had participated actively in all discussions, meetings and helped PATH to carry out the project proactively in every respect right from the beginning in October, 2006. As such he had a clear conflict of interest and could not be relied upon to give correct information and unbiased opinion. Indeed he should have been summoned as a witness to answer questions and not as an official Resource Person attached to the Enquiry Committee.”

The Committee takes a serious view of the violations and strongly recommends that on the basis of the facts, PATH should be made accountable and the Ministry should initiate appropriate action in the matter including taking legal action against PATH for breach of various laws of the land and possible violation of laws of the country of its origin.

The Committee, therefore, recommends that every effort should be made to expedite the report Committee so that real facts about the HPV vaccine trial are made known without any further delay and collective measures, not only in respect to this trial, but for all such ongoing /proposed clinical trials of drugs/vaccines, are taken.

The Committee also recommends that the department should, at least now, work in close coordination with other concerned departments/ organizations to undertake a comprehensive analysis of the process of granting permission to research studies having hazardous effects on health and put in place a foolproof system for pre-empting unethical research studies. The Committee has taken serious note of the fact that both the Ethics Committees were registered only as a formality and they did not play their designated role, a clear dereliction of their duty.

The Committee states that the act of PATH is a clear cut violation of the human rights of these girl children and adolescents and is a serious breach of medical ethics. The Committee recommends that “the National Human Rights Commission (NHRC) and National Commission for Protection of Children Rights (NCPCR) may take up this matter further from the point of view of violation of human rights and child abuse”.

Though, the Committee brought up the 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 following the administration of the trial. We demand that the parents of the girls who died and the children must be compensated for the grave violations of their rights, as clearly informed consent was not taken from a large number of parents of the girls 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. The Committee report also does not mention on the funding from Gates and other sources; and money spent by ICMR and state governments.

We welcome the recommendations and sincerely hope that 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. We also hope that the extremely critical insights and recommendations by the Committee will not be sidelined, only to set up further committees without substantive, concrete action.

Signed By:

Sama Resource Group for Women & Health

Jan Swasthya Abhiyan

Locost

All India Drug Action Network

Drug Action Forum Karnataka

Date: 2 September 2013

Please find below the link to the SEVENTY-SECOND PARLIAMENTARY STANDING COMMITTEE REPORT ON “ALLEGED IRREGULARITIES IN THE CONDUCT OF STUDIES USING HUMAN PAPILLOMA VIRUS (HPV) VACCINE BY PATH IN INDIA”

http://164.100.47.5/newcommittee/reports/EnglishCommittees/Committee%20on%20Health%20and%20Family%20Welfare/72.pdf

Womb service: How surrogacy still carries stigma in India

Amrit Dhillon     
Tuesday, 13 August, 2013, 10:37am

Western celebrities such as Elton John and Nicole Kidman have used surrogates to fulfil their desire for parenthood. Now with two of Bollywood’s biggest stars, Shah Rukh Khan and Aamir Khan, and their wives having taken the same route, surrogacy has gained some respectability, if not a hint of trendiness, in India.

While it still carries considerable stigma in the country, the celebrities’ choice has eased the way for other couples to do the same.

They made it seem like a perfectly acceptable way of bringing a baby home.
KABERI BANERJEE, FERTILITY DOCTOR

Even so, critics say the practice is prone to abuse because of the lack of regulation and the severe wealth gap there.

Aamir Khan surprised India when he and his wife, film director Kiran Rao, announced in 2011 that their baby son, Azad, was born to a surrogate. The actor already had children from his first marriage, but Rao opted for surrogacy as a “last resort” after suffering a miscarriage.

“The publicity around their case helped to clear up a lot of misconceptions. They made it seem like a perfectly acceptable way of bringing a baby home. That’s the power of celebrity,” says Dr Kaberi Banerjee, a fertility specialist in New Delhi.

Then, in May this year, Shah Rukh Khan and his wife, Gauri, announced that after trying to have a child for two years, their baby son, AbRam, had been born in Mumbai to a surrogate. The couple have two other children.

Surrogacy is a US$2.3 billion business in India. Its established medical infrastructure, coupled with a surfeit of poor women desperate to earn some money by renting their wombs, have turned the country into a preferred destination for childless couples from around the world looking for a low-cost, straightforward way of becoming parents.

But because the procedure is unregulated, it’s open to malpractice. A study by the Centre for Social Research in New Delhi last year found that most of the 100 surrogate mothers interviewed did not understand the procedure or the contract they signed with commissioning parents and fertility doctors.

While awaiting the births, they are often forced to live in guarded homes and given only limited access to their families.

“We found that 60 per cent were illiterate. That means they are easy to exploit because they won’t understand the possible medical complications,” says the centre’s director, Dr Ranjana Kumari.

Other controversies surround the process, including issues of gender selection and caste.

A survey last year by the Delhi women’s group Sama showed Indian couples were prepared to pay more for a light-skinned surrogate from the right caste.

The survey said couples often used the same adjectives to describe the kind of surrogates they wanted as those used in matrimonial ads – fair, beautiful, high caste.

“Indians are obsessed with religion, caste and fair skin. Even when they are told that the baby won’t have any of the surrogate’s characteristics, they still feel that some mingling of blood and tissue in the womb will affect the outcome,” says Deepa Venkatachalam, Sama’s programme co-ordinator.

But Dr Naina Patel, who runs a fertility clinic in Ahmedabad, says most commissioning parents simply want the surrogate to be healthy.

“They sometimes ask about the caste, but their main concern is that she be healthy and follow a healthy diet while carrying the baby,” Patel says.

But in what is manifestly an unequal relationship, it is the commissioning parents who call the shots and set the conditions. Surrogate mothers are usually too poor and powerless even to demand the right to be with their families during the pregnancy.

Women’s groups point out that this inequality extends to the spousal relationship. When the fee is paid, it is usually the husband who decides how to spend it.

“In some cases, he uses it to pay off a loan, just fritters it away or starts some ill-conceived business which fails. The woman often has no say,” says Brinda Karat, a Communist Party politician and women’s activist.

That is why many surrogates, such as Sangita Rana, offer their wombs a second or third time.

“My husband started a business selling packed meals to office workers. It failed, and he lost the money I made from having a baby. So I’m here to do it again,” Rana says while awaiting a check-up at the Delhi Research Centre.

Fearing being ostracised, they carefully hide this arrangement. “My husband tells our relatives that we are moving for a year because of his job. They would refuse to speak to us if they knew what I do,” Rana says.

So, while becoming a parent by surrogacy is losing its stigma for celebrities, earning money this way is still a disgrace.

 

This article appeared in the South China Morning Post print edition as Womb service