Vaccination Trials-Path

PATH controversy
Cervical Cancer
Prof. Ranjit Roy Chaudhary Expert Committee
Biomedical and Health Research Bill
Ethical Guidelines to be followed for such trials
Ministry of Health and Family Welfare and important departments related to vaccination trials.

The Issue:

The issue pertains to the conduct of the human papilloma virus vaccine trial for cervical cancer.

This trial was carried out by two U.S.-based pharmaceutical companies through PATH. The trial involved tribal school girls in Khammam district in Andhra Pradesh and Vadodara in Gujarat in 2010.

The trials were stopped only after media attention was received following the death of seven girls. A parliamentary standing committee was formed to report the irregularities in these trials which wrote in its report that:

The parliamentary panel raised questions about the roles of the Indian Council of Medical Research (ICMR) and the Drug Controller-General of India (DGCI) in the entire episode.

The actions and responsibilities of these two institutions were subjected to scrutiny and inquiry by the panel.

A MoU was signed as early as February 2007 by the Indian Council of Medical Research and an American agency PATH wherein the regulator committed itself to “promote the drug [vaccine] for inclusion in the universal immunization programme” well before the “utility and rationale” of inclusion was studied. Incidentally, the ICMR is not the body (the National Technical Advisory Group on Immunisation does it) that takes a call on introducing a vaccine in the immunization programme. Thus, by entering into an agreement, the ICMR abdicated its responsibilities of being a watchdog and instead became a “willing facilitator [that] acted at the behest of PATH in promoting the interests of the [vaccine] manufacturer.”

DGCI is equally culpable for being a mute spectator when clinical trial rules were “flagrantly violated.”

On its part, it was ensured by the DCGI that “no accountability was fixed” on the erring officials, and no definite steps were taken to improve the trial process.

Union Health Ministry’s role in scuttling the truth-seeking process is alarming.

The ministry has made a mockery of the trial subjects by choosing people with well-established conflicts of interest to be a part of the inquiry.

Committee to look into the irregularities

Ethics Violated:

Large number of parents/guardians who gave their consents were illiterate and could not even write in their local language, Telugu or Gujarati.
In some forms signs of witnesses, dates, and photos of parents/guardians were missing.
State government directedheadmasters of all private/government/ashram/schools to sign the consent forms on behalf of parents/guardians were highly questionable.
Date of vaccination being much earlier than the date of signature of parents/guardian in the consent forms spoke of grave irregularities.

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Cervical Cancer:

Cervical cancer occurs when abnormal cells on the cervix camera grow out of control. The cervix is the lower part of the uterus that opens into the vagina.

Cervical cancer can often be successfully treated when it’s found early. It is usually found at a very early stage through a Pap test.

What causes cervical cancer?

Most cervical cancer is caused by a virus called human papillomavirus, or HPV.

You can get HPV by having sexual contact with someone who has it. There are many types of the HPV virus. Not all types of HPV cause cervical cancer. Some of them cause genital warts, but other types may not cause any symptoms.

Prof. Ranjit Roy Chaudhary Expert Committee:

The GoI set up in February 2013 an Expert Committee with Professor Ranjit Roy Chaudhury as Chairman to formulate policies, guidelines.

Standard Operating Procedures for approval of new drugs, clinical trials, ethics committee and for banning of drugs already on the market.

The Committee will also provide guidelines on requirements of post marketing trials and on functioning of the New Drug Advisory Committees.

Their suggestions were:

Suggested setting up of a council to oversee the accreditation of institutions, clinical investigators and institute ethics committees for clinical trials in the country. Seeking to set up a Central Accreditation Council.

The panel said the selection of assessors for accreditation and of experts to review new drug applications and other purposes should be made by a random procedure from a Roster of Experts.

Focusing on the importance of informed consent from each participant for clinical trials, the panel said any departure or violation from the approved process should result in blocklisting of the Principal Investigator for at least up to 5 years.

In circumstances where special groups of people who have diminished capacity to protect their interests are involved, the guardian can give consent and this should be witnessed by an independent person who also has to sign the document.

Audiovisual recording of the informed consent process should be undertaken and the documentation preserved, adhering to the principles of confidentiality, it said.

It calls for replacing the existing 12 drug advisory committees by a single broad expertise-based Technical Review Committee to ensure speedy clearance of applications without compromising on quality of data and rules and regulations.

On compensation for adverse effects (AE) or serious adverse effects (SAE) during trial, the committee puts the onus of responsibility on the sponsor investigator for providing medical treatment and care to the patient at his/their cost till the resolution of the AE/SAE.

This is to be given irrespective of whether the patient is in the control group, placebo group, standard drug treatment group or the test drug administered group.

Shortcomings of report:

Not many institutions would be able to meet the criteria.

The report was silent on whether the coverage of clinical trials under the Right to Information Act should be considered.

Biomedical and Health Research Bill:

The government proposes to regulate all biomedical and health research activities by bringing them under a law to ensure ethical research in all institutions with proper care, and a compensation policy for human participants.

It will provide ways to protect ethical values in accordance with both local cultural values and international standards so as to generate, maintain and restore public trust in research.
Biomedical Research Authority, the proposed law will ensure compulsory registration and evaluation of ethics committees set up in all kinds of research institutions and will have penal provisions for unauthorized research and unethical practices. It will also cover institutions and sponsors undertaking unethical biomedical research at places with inadequate facilities.
The Authority will register, monitor and evaluate the performance of ethics committees; evolve performance appraisal systems, and norms and mechanisms for enforcing accountability and transparency; and assess the need for providing protection to vulnerable sections.
Bill entitles a child in the womb to claim compensation for any research-related injury, caused in utero by the participation of its mother. There is a provision for establishing a “Research Related Injury Relief Fund” from which compensation will be paid.
The Bill will confer statutory powers on the Ethical Guidelines for Biomedical Research on Human Subjects,

Ethical Guidelines:

The ethical guidelines of the Council for International Organizations of Medical Sciences (CIOMS) require that ethical standards governing human subject research be no less stringent in developing nations than in developed nations.

This can be difficult if lower levels of literacy are present, understanding about the nature and causation of diseases is sub-optimal, and personal identity and individuality are not considered important.

The following information must be made clear to potential participants of a clinical trial:

They are being asked to participate in a research study to test a vaccine against HIV.
They have the right to refuse to participate or withdraw at any time without losing the benefit at the trial site.
They will need to commit to a specified number of visits involving certain procedures and collection of specimens.
The vaccine being tested is of an experimental nature with no proven safety and efficacy in humans.
In a placebo-controlled trial, they may receive a placebo. In a blinded trial, they will not be aware of what they receive
They may experience some expected and/or unexpected side-effects of the experimental vaccine.

Potential participants should also be told about the kind of care that would be provided to them during and after the trial, and steps.

That would be taken to maintain confidentiality, with details of who would have access to trial-related data.

Informed consent of competent potential participants must be taken without fraud, inducement or coercion.

Investigators should document informed consent, which may be subject to both external and internal monitoring, and audit. Researchers must also confirm that trial participants have understood the information given to them.

Ministry of Health and Family Welfare:

The Ministry of Health and Family Welfare is an Indian government ministry charged with health policy in India. It is also responsible for all government programs relating to family planning in India. The Ministry regularly publishes the Indian Pharmacopoeia since 1955. Through Indian Pharmacopoeia Commission (IPC) an autonomous body under the ministry for setting of standards for drugs.

Department of Health & Family Welfare:

The Department of Health deals with health care, including awareness campaigns, immunization campaigns, preventive medicine, and public health. Bodies under the administrative control of this department are:

National AIDS Control Organisation (NACO)
13 National Health Programmes
Medical Council of India
Dental Council of India
Pharmacy Council of India
Indian Nursing Council
All India Institute of Speech and Hearing (AIISH), Mysore
All India Institute of Physical Medicine and Rehabilitation (AIIPMR), Mumbai
Hospital Services Consultancy Corporation Limited (HSCC)
Food Safety and Standards Authority of India

The Department of Family Welfare (FW) is responsible for aspects relating to family welfare, especially in reproductive health, maternal health, pediatrics, information, education and communications; cooperation with NGOs international aid groups; and rural health services.

Department of AYUSH:

The Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) is responsible for overseeing various alternative medicine systems in India. These include ayurveda, yoga, naturopathy, unani, siddha, and homoeopathy. AYUSH plays a crucial role in promoting and regulating these traditional and complementary medicine systems in the country.

The department was established in March 1995 and renamed as the Department of Indian Systems of Medicines and Homoeopathy (ISM&H).

The department is charged with upholding education standards in the Indian Systems of Medicines. And Homoeopathy colleges, strengthening research, promoting the cultivation of medicinal plants used, and working on Pharmacopoeia standards

Department of AIDS Control:

It provides leadership to HIV/AIDS control programme in India through 35 HIV/AIDS Prevention and Control Societies.

Department of Health Research:

Department of Health Research (DHR) aims at bringing modern health technology to people by encouraging innovations related to diagnostics, treatment methods as well as prevention- vaccines; translating the innovations into products/ processes by facilitating evaluation/ testing in synergy with other departments of MOH&FW as well as other science departments. Introducing these innovations into public health service through health systems research.

Indian Council of Medical Research:

The Indian Council of Medical Research (ICMR), New Delhi.

The apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world.

As early as in 1911, the Government of India set up the Indian Research Fund Association (IRFA) with the specific objective of sponsoring. And coordinating medical research in the country.

After independence, the organisation and the activities of the IRFA underwent several important changes. In 1949, it was redesignated as the Indian Council of Medical Research (ICMR) with a considerably expanded scope of functions.

The ICMR receives funding from the Government of India through the Department of Health Research, Ministry of Health & Family Welfare.

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Central Drugs and Standards Control Organization (CDSCO):

The Central Drugs and Standards Control Organization (CDSCO) is the National Regulatory Authority (NRA) in India. CDSCO is headed by the Drugs Controller General (India) [DCG (I)].

It approves vaccines that are introduced in the country , grant permission to conduct clinical trials, registers. And controls the quality of imported vaccines, as well as lays down standards for updating India Pharmacopoeia.

It also approves licenses as the Central License Approving Authority (CLAA) for the manufacture of vaccines, coordinates. The activities of the States and advises them on matters relating to uniform administration of the Act and Rules.

National Immunization Technical Advisory Group (NITAG) Resource Center:

The National Immunization Technical Advisory Group (NITAG) Resource Center serves. As a platform to provide information, tools, and briefings to NITAGs.

Its aim is to support the global immunization community in enhancing evidence-based decision making on vaccines and immunization at the national level.

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