Friday, 28 October 2011

With Health Secretary - 25-10-2011

Minutes of discussion held with Dr.Rajeev Sadanandan IAS, Health Secretary, Government of Kerala by Mr.Gouridasan Nair, Chairman, Jananeethi Institute and Advocate George Pulikuthiyil, Executive Director, Jananeethi on 25th November 2011 at Health Department, Secretariat, Thiruvananthapuram.

Submission  1. We urge the Government of Kerala to introduce strict regulations in the area of clinical drug trials – i) in the constitution, composition and functioning of Ethical Committees, ii) selection of trial participants, iii) informed consent, iv) identification cards to the subjects of clinical drug trials,  v) insurance coverage to trial participants, vi) ban or strict control of the Contract Research Organizations  and vii) steps to ensure transparency and accountability in the process of clinical drug trials.

Response:   A State Regulatory Board will be constituted to look into all issues raised. The Health secretary promised that positive steps will be initiated forthwith in all Government institutions. However, he honestly admitted that the state government has absolutely no control over the private hospitals and health institutions. Nevertheless, he said that he would take up these issues with the Chairperson of ICMR for necessary action.

Submission  2.  Kindly take appropriate steps to introduce Best Practices and Ethical Standards in Clinical Drug Trials into the curriculum of Medical Education (including medical and para-medical education).

Response:  An urgent meeting of concerned department heads is being held on 29th November 2011 at Secretariat consider the issues highlighted.  The Health Secretary requested Jananeethi delegation to provide a list of potential consultants who can assist the Department in the process.

Submission  3.  State Government has to declare a Policy on Patients’ Rights (Charter of Rights) and make every medical practitioner and health institution (hospitals, laboratories, research institutions etc.) liable to any violation/infringement of those rights.

Response:  Accepted in principle. Jananeethi Institute has promised to submit a draft of Patients’ Rights at the earliest. Here again, the state government in the present context has limitations to impose strictures / liabilities on institutions in the private sector.

Submission  4.  State Government must declare  that every registered private hospital (of all denominations – allopathy, ayurveda, alternate medicines etc) comes under the purview of Right to Information Act.

Response:  The Health Secretary was very positive with regard to government hospitals and other health institutions. However, he was helpless to make any promise with respect to private sector until specific legislation is made for that matter.

Submission  5. Hundreds of parents of students who are weak in studies and have fears of low marks in SSLC examination approach government medical college for certification of learning disability or being mentally challenged. If they produce a certificate, such students get considerable grace marks and get promoted to higher studies. Further, they are given financial help from Government. This certification is issued often without proper examination of the students.  There are parents who threaten concerned staff in the hospital and get by coercive methods such certification. This has a great danger of stigmatization of normal students as deviants and it goes on records depriving their prospects in future.

Response:  Instead of a single test and certification before  SSLC examination, concerned students will be examined by a 3 member competent Board in concerned medical college consistently in standards VIIIth , IXth and Xth.

Thursday, 27 October 2011

Comments on Clinical Drug Trial

From the study done so far by Jananeethi in this area, we would like to make following comments for your consideration.

  1. Flaws in informed consent process

The existing national (ICMR) and international guidelines on clinical drug trials make it mandatory that participants could be recruited to trials only after taking their informed consent. From our experience it is found that the participants are not even informed that they are recruited into a drug trial. The details of drug trials, risks and possible side effects of the trials are not communicated to the participants. One of the strange justifications put forward by a principal investigator is that if everything is communicated to the patients as required, they (patients) won’t agree to participate in the trial. He says, due to their low level of understanding in this area they will misinterpret the information and will hesitate to participate. Being a medical doctor he should know the after effects and possible consequences of the trial. Hence he gives only censored information that will amount to professional cheat as the patients totally confides in the doctor.  The patients are not given the copy of the signed informed consent form depriving them any document to prove their participation in a given trial. It is also found that the doctor is recruiting his own patients without any monitoring by an independent doctor who is supposed to check the conflict of interests involved in such cases. The doctor is exploiting the trust reposed on him by the patient.

2- Absence of insurance coverage and compensation to the participants

The existing guidelines require ensuring proper insurance coverage or adequate compensation scheme for the trial participants.  The truth is that there is no insurance coverage as such for the participants; in fact insurance coverage is available to the doctor who conducts the trial in order to meet any liability that may occur due to any serious adverse event during the conduct of clinical drug trial.  It was also revealed that these poor patients are denied of their trial benefits including daily wages and traveling expenses. Where those who don’t know that they are recruited into a drug trial how we can expect the enforcement of basic rights available to trial participants?

3- Denial of post trial benefits

 Good clinical practices require that once the trial drug found effective the trial participants of the drug trial are entitled to get that drug either freely or at a subsidized rate. But this beneficial clause is not observed by the persons responsible for the conduct of drug trials. Hence the participants are not getting the benefits.  Here we would like to highlight an instance from our own experience. During an interview with a leading oncologist in Kerala who conducts several drug trials. One question asked to him was that why he should conduct clinical drug trials. His answer to the question was that he was actually doing a service to his patients by recruiting them in to drug trials because many of the patients were from poor background and they were not in a position to buy available standard treatment for their ailment. However, he had no answer to the question whether the trial subjects were getting those drugs at concessional rate once the trial was successfully completed.  Here two issues come to surface; one – once the drug gets marketing license and comes to market these poor patients are not able to buy the same because of because of its exorbitant costs. Two- during the trial period most of the trials are done on Placebo method hence seriously ill cancer patients are denied of available standard treatment. So, ultimately these patients due to their poverty are becoming guinea pigs for giant pharmaceutical companies and their vulnerability is exploited in the name of service.

4- The ‘Ethics Committees’ are unethical/dysfunctional/totally ineffective

Maintenance of ethical standards and best practices in clinical drug trials are the most sacred duty of the Ethics Committees (Institutional Review Board). But from our experience it is found that the present ethics committees are in no way useful and effective to check the unethical and corrupt practices in drug trials. The reasons are manifold- starting from the composition it fails to bring any positive result. After interviewing the Chairmen and members of ethics committees of government and private medical colleges and hospitals, it was manifestly exposed that most of the members were totally ignorant about their role and responsibilities as a member of ethics committees. Many of the private hospital managements act like co-operatives helping each other, defeating the basic purpose of ethics committees. Committee meetings take place rather irregularly, and members other than doctors from the concerned hospital are not attending these meetings, hence the ethics committee’s approval becomes a mere sham on procedures. Most of the members are in someway related to hospital managements and close associates of the principal investigator.
Out of many members interviewed, only one member got some training in this field. As per the GCP Guidelines the members should get some basic training in the good clinical practices but it is not happening and in result they are not in a position to question the unethical trials that lead to gross violations of the rights of human participants.

5- Lack of Transparency

One of the most disturbing facts in clinical drug trials was the deliberate, willful denial of any information with regard to the drug trials. The area of drug trials remains completely dark, not even the names of Ethics Committee Members are not disclosed. Not even queries under RTI were duly answered. Concerned chief investigators behave with arrogance and disrespect to norms established in a civilized society. Everything is done in a clandestine manner. Many of our requests were turned down by the authorities raising the confidentiality clause. We honestly believe that the confidentiality clause, meant to protect the best interests of human participants actually works against the interests of participants and hence needs a review. The government departments and concerned institutions are abysmally ignorant or insensitive in this regard.   

6- Questionable role of the CROs

The emergence of a new entity by name the Contract Research Organization (CRO) has caused much concern and alarm in the area of medical research. CRO is only a private business enterprise, concerned of sheer profits. With their entry in the fray, the pharmaceutical companies have gone behind the curtain. Now, the research institution does not come in the picture. Drug trial takes place based on a secret understanding between the agents of the CRO and the concerned chief investigator. Seldom only is the hospital management informed of such a trial on patients in the hospital. We also have information that the trials are being conducted in fairly large laboratories and post graduate departments of few colleges. Doctors practice drug trials in their private clinics too. Hospital managements and medical practitioners are offered huge incentives and remunerations for obliging for such trials. It means clinical drug trials with the advent of CROs have become merely a commercial enterprise, at the cost of the life mostly poor and illiterate and marginalized people. This amounts to sheer violation of international covenants and mandatory norms and guidelines.  For these reasons, we honestly feel that the CROs should be banned forthwith. Let every drug trial be based on a MoU signed by the research institution and the concerned pharmaceutical firm, the terms and conditions should be clearly spelled, transparent and the stake holders are held liable to any possible adverse effects on the participant.

7- Placebo method

As per the existing national and international guidelines placebo based trial can be carried only when there is no available standard treatment for the disease. But the fact is that most of the drug trials are done on placebo that results in the denial of available treatment.

In the light of above mentioned observations we would like to make following suggestions-

  1. We need a specific legislation with stringent provisions to punish violators and to safe guard the rights of trial participants. From our experience so far and discussions with members of ethics committees and doctors who are actually conducting clinical drug trials make it obvious that at present protection of the rights of participants solely depends on the personal integrity and honesty of the doctor and his team who conduct drug trials. State governments are ignorant about huge number of drug trials that are being conducted in the state. So it is of paramount importance to have a state level mechanism apart from the DCGI and ICMR in order to have strong monitoring on drug trials that are being carried out in respective states.
  2. The composition, selection and function of ethics committee need a through revamping in order to make this body more effective. They should monitor the trial and must be allowed to meet trial participants on a random basis to ensure whether there is any serious adverse event reported or not. This will help to check the genuineness of the informed consent and to eliminate the chances of corruption in the process of recruitment. It must be ensured that members of the committee are independent and got sufficient training on GCP. The details of ethics committee members (name, address and contact numbers etc.) must be publicly exhibited in the hospitals, conducting clinical drug trials and the same has to be given to each trial participant. The decision of the ethics committee whether approved or disapproved must be published along with the reasons for the same and the same has to be shared among different ethics committees. It is also ideal to have a central authority to monitor the functioning of ethics committees. The name and contact details of ethics committees must also be given in CTRI Registry.
  3. Every participant must given an identity card apart from the signed copy of the informed consent form with necessary details regarding drug trials. This will serve as a strong evidence of participation and will be useful for claiming insurance / compensation for any adverse effects and also to ensure the availability of post trial benefits to trial participants.
  4. Insurance coverage to trial participants must be ensured before they are recruited in to a drug trial.

  1. Review the confidentiality clause; it is high time to review the confidentiality clause that goes against the interests of trial participants. In the name of protecting the commercial and trade interests of the company the confidentiality clause makes everything related to drug trials secretive. So, in our view except in case of disease like HIV and similar diseases which may invoke social stigmatization on patients the details of drug trials and patients must be made public.

  1. The details of drug trials including the patient’s details must be retained for a minimum period of five years. Because in many cases the principal investigator leaves the hospital after or in the middle the trial and the side effects of the trial may occur after the trial period. It is also necessary that the drug trial must be done by the doctor with the full knowledge of the hospital management so that even if the doctor leaves the hospital the management could be held responsible for the reparation of participant’s rights. Because during our study it was found that the doctor conducted a drug trail even without the knowledge of hospital management and once it was exposed there was no record available in the hospital.  

  1. It is also necessary to have a contract or a memorandum of understanding between all the parties involved in the drug trial process i.e. between the pharmaceutical company, CRO if they are involved, the principal investigator and the hospital management. This will help to ensure better transparency and accountability in the conduct of clinical drug trials.

  1. The use of placebo must be avoided except where there is no alternative treatment available for the disease in question.


Call for regulation of drug trials in India

Participants at the National Consultation on Regulation of Drug Trials, in New Delhi on 26-27 September, 2011, expressed their deep concern about the unregulated proliferation of ill-regulated clinical trials in India following the liberalisation of norms for conduct of such trials in 2005.

The government has aggressively encouraged foreign drug trials in India without even putting in place structures protecting participants. Regulatory mechanisms have proved to be grossly inadequate and ineffective. The Central Drugs Standard Control Organisation (CDSCO), the principal regulatory agency, lacks both capacity and will to carry out its functions that include the scientific review of trial protocols and monitoring the conduct of trials. Ethics committees are ill-equipped, untrained, and not accountable for their decisions.

There is no evidence that the liberalization of norms is contributing to an improvement in access to essential medicines in India or to the enhancement of the country’s scientific and research capacity.

On the other hand there is mounting evidence of human rights violations and other harms to participants in these trials. Physicians receive incentives to recruit patients into trials, and do this without obtaining informed consent. Participants are subjected to unethical practices such as deprivation of effective medicines. Medical treatment and compensation are denied for the growing number of trial-related injuries and deaths. Bioequivalence trials offer participants large payments in blatant violation of existing ethical guidelines, inducing poor people to risk their lives in these trials.

Such practices are situated in the overall context of unethical medical practice in a system where health care is either inaccessible or unaffordable.

Clearly, liberalization of norms for the conduct of clinical trials in India has belied its promise and introduced fresh challenges for the health care needs of the country.

The Consultation also made the following specific recommendations:

Update laws and guidelines on clinical trials
1.      The 2005 amendments to Schedule Y of the Drugs and Cosmetics Act liberalizing the conduct of clinical trials in India need to be reversed and various gaps, leading to deficiencies in regulation, need to be addressed. Noncompliance with provisions in the DCA needs to be made justiciable and punishable.  Various pending draft guidelines related to trial monitoring must be finalized urgently.

2.      The Bill on Biomedical Research on Human Participants, incorporating the ICMR’s ethical guidelines for research on human participants, has been pending since 2006. The Bill must be circulated for public consultation, finalized, and codified in law, with rules for its enforcement.

3.      The ICMR’s ethical guidelines must be revised to remove many inconsistencies and loopholes, and updated to take into account developments since 2006.

Regulate sponsors, trial organizations and investigators
1.      Pharmaceutical companies, who are the major sponsors of clinical trials, work through Contract Research Organizations (CROs) and a network of individual researchers in government and private medical colleges as well as in large and small hospitals.

2.      Regulation is necessary at all levels of this network – the drug company, the CRO, the institution conducting the trial and the individual researchers involved – to ensure that drug trials are conducted in compliance with the ICMR’s ethical guidelines in addition to guidelines of Good Clinical Practice.

3.      CROs must be regulated through registration, accreditation of those who meet standards, and a code of ethical conduct. Violations of this code should be actionable. Trial sponsors as well as CROs will be held accountable for any violations.

4.      Recruitment incentives to investigators should be banned. Compensation to participants cannot be so large that it serves as an incentive.

5.      Complaints of unethical research must be investigated immediately and punitive action taken when necessary. The reports of unethical and illegal drug trials in Bhopal, Indore, Ahmedabad and Bhadrachalam as well as elsewhere must be investigated, the findings made public and the perpetrators punished.

6.      Whistleblowers must be provided protection.

Ensure reporting, treatment and compensation in injury or deaths in trials
1.      Companies should be required to provide comprehensive health insurance for all trial participants to take care of all health needs (including ancillary care).

2.      The CDSCO must ensure that CROs send prompt notification of all injuries or deaths in a trial, followed by the investigation findings and the action taken on these findings. It must follow up on all reports to ensure that participants are provided immediate and long-term medical treatment and compensation is given for injury or death. Compensation details must be finalised before the start of any trial.

3.      In case of study related injury, disability and death in human participants, the law should hold the sponsor accountable and liable.

Strengthen regulating institutions
1.      The CDSCO must be assured sufficient resources and trained human power to conduct technical review of applications and monitor the conduct of trials including surveillance and safety studies.

2.      Ethics committees (ECs) must be registered, accredited, and made accountable and liable for their decisions.  EC members must trained, and it needs to be ensured that ECs have the capacity, resources and independence to review and monitor drug trials.

3.      The current system of ethics review needs revision. The current law in no way addresses the important issue of conflict of interest amongst EC members and other aspects of clinical trials. At the same time, ethics review and monitoring cannot be run on a voluntary basis. Alternate structures need to be considered, such as public funding of central, state, regional and local ethics committees.

Protect participants’ rights
1.      A charter of participant rights must be developed and made justiciable. The details must be proactively disclosed by all parties responsible for the conduct of clinical trials.

2.      A database of participants must be developed to monitor for any long-term effects of trial participation. A study of trial subjects, including their backgrounds, reasons for entering trials and treatment received, is also necessary.

Restrict research on vulnerable populations
1.      Poor and marginalized sections of society and in areas without health services are particularly vulnerable to the medical establishment which has a dubious track record in matters of patient safety.

2.      Research on vulnerable populations must have explicit justification -- such as a condition found primarily among them -- and assurance that these participants will have health benefits from participation.  This assurance should not be viewed as an incentive to enter the trial.

Ensure post-trial access
1.      All drugs developed through trials in India must be made available to the trial population free of cost until they are available in the country, after which time they must be available to everyone at an affordable price. Drug sponsors must be required to sign an agreement to this effect.

Ensure transparency
1.      Trial-related information of public relevance – including applications made, sites, ethics review decisions, adverse events and follow-up, and positive and negative results – should be available in the public domain. Modifications are necessary in the Clinical Trials Registry-India to enable tracking of changes in trial data.

2.      It is falsely claimed that information about trials is covered by Intellectual Property provisions. The Indian IP Act does not provide for such protection; neither is such protection a requirement of the TRIPS agreement. Confidentiality clauses, in agreements between trial sponsors and regulators, and sponsors and investigators, need to be modified so that they do not prevent bona fide access to information on clinical trials which has a bearing on the health of trial participants.

Support public research
1.      Industry-funded drug trials do not constitute research. We need to develop a strong research base starting from basic research to development and testing of drugs and other technologies relevant for public health and healthcare in India.  Public funding is necessary for research to be driven by our health needs rather than potential profitability.

2.      An independent body must develop the scientific basis for government decisions in health. This includes undertaking studies on specific health conditions, public health issues, and the impact health policy measures; making recommendations on new and existing therapeutic and preventive medical technologies, and formulating quality indicators for various levels of and aspects of health care.

3.      All medical research in India must incorporate the principles of transparency, accountability, respect for trial participants’ rights, and benefit to the community

Spare a thought for vaccine policies

K. S. Jacob

The Hindu Though the use of vaccines in eradication of smallpox was significant, there are still many ongoing debates on vaccines and their use in India. Here a child is administered a polio vaccination drop in Bangalore. File photo: V. Sreenivasa Murthy.
All stakeholders — government, academia, industry, public health systems, health providers and the community — need to be engaged to formulate rational and relevant vaccine policies.
Vaccines are considered the greatest of public health strategies to prevent disease. The marked reduction of many infectious diseases from regions with good public health programmes argued the case. The eradication of smallpox was a triumph in this area. Nevertheless, there are many ongoing debates on vaccines and their use in India.
Public concern about vaccines dates back to the introduction of vaccine legislation in the mid-1800s. There are recent public apprehensions about vaccines; those who voice them are not against vaccination per se. Such concerns arise because vaccines differ from other medical interventions, as it involves healthy individuals being immunised to achieve a protective public health benefit. The public, empowered by the internet and sophisticated social media, want answers to their concerns. Their questions include safety, schedules, affordability, relevance, benefits, risks and funding. Several factors drive public anxiety: poor immunisation coverage of established inexpensive vaccines, push for newer expensive products, perceptions about the vaccine industry, conflicts of interest among decision makers, perceived pressures on institutions responsible for public policy, scepticism about scientific truths and perceived risks.
PR disasters
There have been several recent public-relations disasters for academia and the vaccine industry. A scientific publication, later discredited and retracted, documenting a link between the measles, mumps and rubella vaccine and autism tapped into a reservoir of public paranoia. The failure of the predicted swine flu pandemic to materialise combined with profits for vaccine and pharmaceutical industries, increased public mistrust of health authorities.
Many factors drive public perceptions. While scientific evidence and economic analysis have a major impact, a complex mix of psychological, socio-cultural and political factors also drives public discernment.
The scene in India
Vaccination programmes and policies in India have to contend with many complex issues.
Adverse effects: Vaccines are very safe and many studies have documented that their adverse effects are very rare or very minor. However, poor monitoring systems in our country do not allow for systematic surveillance. Adverse events after immunisation are strong factors that prompt rumours. Consequent public concern undermines the voluntary nature of vaccination programmes. Although the government does have some information, the lack of systematic data collection does not allow for robust defence of the programme.
Deaths: Sudden deaths after immunisation are not unheard of and occur very, very rarely. However, the system of investigation into such tragedies is non-uniform and many enquiries tend to absolve the vaccine and procedures. The denial of problems and post-hoc compensation for such tragedies put the whole programme at risk. Drastic changes in procedures in response to post-vaccination deaths, as in Tamil Nadu, compound the problems. The insistence that all children be brought to primary health centres for immunisation resulted in markedly reduced coverage. Rumour has it that an error by an individual resulted in far-reaching changes in policy and practice.
Vaccine supply: The sudden forced stoppage of essential vaccine production by government manufacturing facilities resulted in massive disruption to immunisation schedules and programmes. Squabbling among politicians, civil servants and experts did not instil public confidence. The subsequent judicial intervention, months later, restored manufacturing at these facilities but the disaster resulted in public distrust.
Private players: Liberalisation of the Indian economy has increased the number of private players in the vaccine industry. Many private players made a killing when government manufacturing was stopped. The government's neo-liberal agenda and the captive market for vaccines present an obvious business opportunity for exploitation. Consequently, the right-to-health-care argument has found enthusiastic support from the vaccine industry. The recent attempts to argue for expensive vaccines with limited protection (e.g. pneumococcal vaccine) for uncommon disorders fuelled speculation about the role of big business in pushing commercial interests.
International involvement: Many international financial institutions are more than willing to fund vaccine programmes. However, their focus tends to be on the newer and more expensive vaccines and for pre-production and monopolistic pricing arrangements. The high prices, often out of reach of poorer nations, make such ventures suspect.
Failed pandemic: The failure of the swine flu pandemic to materialise, after the initial hype and scare, played into the hands of the vaccine and pharmaceutical industry, which bagged massive contracts. While the post-mortem of the decision making process exonerated international health agencies, procedural lapses like failure to publically declare conflicts of interests among decision makers, resulted in adverse publicity and increased scepticism of health authorities.
Unethical trials: Deaths of young tribal girls enrolled in the human papillomavirus (HPV) vaccine trial in Andhra Pradesh resulted in suspension of the programme. Issues related to conflicts of interests and unethical nature of informed consent and recruitment procedures highlighted a callous approach of industry, non-governmental organisations and health authorities.
International disagreements: International disagreements add to public concerns. These include the American recommendation for the removal of thiomersal (a chemical to prevent biological contamination) from childhood vaccines, the French decision to withdraw the hepatitis B vaccine from school programmes, and the temporary Japanese suspension of the Haemophilus influenza B vaccine. The unwarranted controversies related to the tetanus vaccine and sterilisation in Mexico and the polio vaccine and HIV in Nigeria did not help the cause.
New reality: Deception employed to wage war (in Iraq), massive corruption within governments and collusion between business, politicians and bureaucrats has resulted in public suspicion of authority. Dialogue among consumers, via the internet, has facilitated the questioning of advice from traditional establishments. Media attempts for balanced coverage also allow highlighting of extreme views. Social media have allowed for the building of large virtual coalitions, which create a “social amplification of risk.” Vaccines have been so successful that low statistical risk takes on a different meaning. The internet, a vast archive of misinformation, mandates even greater need for public health education.
Polarised positions: Public concerns have resulted in public interest litigation and the use of the Right to Information Act to elicit information. The polarised positions of those for and against the new vaccines are obvious.
The vaccine industry and health authorities dismiss social context, economic concerns, human rights and political struggles as inconsequential. Scientists cite complex technical arguments, often based on non-Indian data, in support of new vaccines. They imply that all those who raise any objections are part of the anti-vaccine lobby. On the other hand, those against such initiatives emphasise the lack of good Indian data, selective citation of evidence and cast aspersions about business interests. The experts and the community, by their particular locations, differ on experience, perceptions, attitudes, and challenges. The absence, in the public domain, of information, evidence and policies, and the lack of transparency in decision making make it difficult for a rational and robust defence of either stand.
Moving forward
Traditional hierarchies, accepted for centuries, are being challenged in this new context and age. Increased cynicism and suspicion of authority is here to stay. Consequently, health establishments cannot dictate; they need to negotiate with communities and convince them of the need, rationale, efficacy and cost benefit of newer vaccine policies.
India can no longer ignore the elephant in the room, the limited data and the poor systems of information gathering, which do not allow for monitoring, generating evidence and rational policies. There is an urgent need to establish sentinel centres in order to determine the prevalence of the diseases and conduct large-scale trials to assess impact. Even though the vaccines may be efficacious, a detailed cost-benefit analysis from a public health perspective is mandatory for policy-making.
The current wave of public scepticism seen in many parts of the world has been described as a “crisis of confidence.” It mandates the restoration of public trust, essential for sustained vaccine coverage. Vaccine interventions and policies in the current socio-economic and political climate require much more than research evidence for implementation. Engagement with stakeholders and local politics, transparency in decision making, discussing uncertainties about risks and enhancing local ownership are crucial. Until then, arguments, based on polarised positions will continue with each side accusing the other of either obstructing progress or of making sound business investments at the cost of the nation's public health. There is a need for rigorous research to establish need, effectiveness and cost-benefit and for greater efforts at understanding factors that determine public trust. National policies need to be relevant, valid, accountable and participatory. Communication, dialogue and engagement with all stakeholders are crucial to building public trust, mandatory for successful vaccine programmes, and call for a revolution in policy-making.
(Professor K.S. Jacob is on the faculty of the Christian Medical College, Vellore. The views expressed in this article are personal.)

Wednesday, 26 October 2011

Ethical Obligations in Clinical Drug Trials

As the medical research world becomes increasingly globalised, there is a need to make research methodologically valid, and to observe the highest standard of ethics. An increasing number of pharmaceutical companies have started outsourcing drug trials to Contract Research Organizations (CROs) in developing countries; these now make up a specialized global industry focusing on research on human participants. Shifts in the very science of drug development have influenced the decision to increase participant recruitment, with India becoming an attractive destination for international, outsourced clinical trials.

Revealingly, in India, debates over the conduct of drug trials by CROs, research institutions, pharmaceutical industries, international health NGOs, and the State are emerging. Indian sites for the research are without any independent institutions for monitoring and auditing of drug trials. In the absence of such a mechanism, it is difficult to ensure that scientific standards are upheld, and that good research practices and mandated trial protocols are fulfilled. Eventually, the quality, practice, ethics and effectiveness of science itself may be compromised.

Currently, the infrastructure for regulation, ethics review and monitoring is insufficient to regulate clinical trials in the country. In this situation, the government’s push to encourage clinical trials in India must be viewed with concern. There are many examples of drug trials that have taken place without proper protocols of consent. Without adequate and necessary regulatory jurisdiction or systematic review, the reliability and validity of such research is jeopardized. Considerations of transparency along with protection of participant rights have to be made priority for policy that truly engages and respects the public. This is particularly critical in the context of medicine and vaccine trials, placebo-based trials and genetic studies that are often in violation of both, the Declaration of Helsinki as well as the guidelines for biomedical research as laid out by the Indian Council of Medical Research (ICMR). India requires more substantial regulation, and effective implementation, that can institutionalise the highest standards of independent inquiry, good clinical practice, protocols, monitoring, and follow up, so that a strong and pro-people policy framework can be put in place.

Jananeethi Institute has taken up this project for ensuring the clinical drug trials in Kerala ethically sound and corruption-free under the banner of Citizens Against Corruption sponsored by Partnership for Transparency Fund based in Washington facilitated by Public Affairs Centre in Bangalore.