Toothless Lokpal Bill This is no way to clean political dirt by Justice Rajindar Sachar (retd)

THE headlines in the media, the constant talk in the market of how deep corruption has sunk in our body politic and how nefarious role is played by the ill-gotten money contributed to all political parties are like a spectre which is haunting the public all the time. Why is it so that, in spite of the CBI investigation in the 2G spectrum scam under the Supreme Court monitoring or the demand for a JPC or PAC probe, it is still not possible to persuade the government to consider seriously to enact effectively genuine Lokpal legislation to deal with the menace of corruption? If the draft of the Lokpal Bill 2010 is any indication, it would appear that the realisation of a grave urgency is still missing with the government.
No one, of course, suggests that an evil like corruption in public life can be eliminated merely by legislation. A clean public life, the standards and character of political parties have to be built on grounds of moral conscience and public pressure. Of course, the ultimate remedy to the various evils like corruption in public life can only be eliminated, as Mahatma Gandhi said, when “A small body of determined spirits fired by an unquenchable faith in their mission can alter the course of history.”
We must, however, face the reality. Such spirits are rare to find and we ordinary mortals must make efforts to find some mechanism which may hopefully be able to keep in check the demoralisation and corruption in our public life. One such mechanism that almost all governments since 1996 have been promising but have done nothing about it is the institution of Lokpal, an independent body to enquire into the lapses and complaints against legislators, including members of Parliament.
That corruption in various segments of our public life is eating into the vitals of our nation is freely admitted. The global Corruption Perception Index has put India at the 87th place out of 178 countries, showing the country slipping from the 84th position in 2009. The result is that India has 100,000 billionaires and 8.7 crore families (a minimum of 40 crore people) living below the poverty line.
The Central Government has at last proposed the Lokpal Bill 2010, but unfortunately it fails even to be a cosmetic exercise to fight corruption. It is shamefully toothless and meant just to give a false reassurance to the people that the government is serious in its fight against corruption.
The Lokpal is a three-member body consisting of the chairperson, who is a former Chief Justice or a judge of the Supreme Court and two members who are have been judges of the Supreme Court or High Court Chief Justices. I feel restricting it to judges is too narrow a view. Outstanding social scientists or academicians should also be eligible, and it should be a five-member body.
The jurisdiction of the Lokpal under Section 10 apparently covers the Prime Minister, ministers and members of Parliament. But hypocrisy is exposed when at the same time it nullifies the same by providing that the Lokpal shall not enquire into any allegations of corruption against any member of either House of Parliament unless the recommendation of Speaker or the Chairman of the Council of States, as the case may be, is received by it. One is amazed at the effrontery of such a provision that the Lokpal, having the status of highest judiciary, is powerless to act on its own even when it prima facie finds a strong case for enquiry. Not only that, but insultingly after the enquiry and even when the Lokpal finds that any of the charges have been proved against members of Parliament, all he can do is to send a report of his finding to the Speaker and Chairman of the Council of States, and they alone will determine what action is to be taken — obviously it may include rejecting the report of the Lokpal.
Of course, the presiding officers have to place the report before the two Houses of Parliament. A formal courtesy is to be shown by informing the Lokpal as to what action is taken or proposed to be taken which includes the rejection of the findings of guilt by the Lokpal. What sardonic joke is being played on the public? The government is treating the members of Parliament like sacred idols in a temple who cannot be touched by the Lokpal, but only by the Brahmanical priesthood of co-legislators, who will decide finally. This reduces the authority of the Lokpal to worse than a lower-level magistrate whose order has to be complied with by even the highest in the land, including the President. The sheer effrontery of the Law Ministry in proposing such an insulting provision is a direct negation of the institution of Lokpal, and it amounts to making it toothless. Rather what should have been done was to provide that the finding of guilt by the Lokpal would be treated in the same manner as under Section 8 of the Representation of the People Act, 1951, considering it as a disqualification for contesting election for a period of six years. Further, the Lokpal should have been authorised to impose a penalty for the recovery of any amount found to have been lost by the action of legislators or ministers.
The Lokpal under Section 11 is forbidden to enquire into any memo of complaint if it is made after the expiry of five years from the date when the offence is alleged to have been committed. Has the government realised the absurdity of providing a limitation period in such complaints, which, if they were to be tried under the Prevention of Corruption Act, would have no limitation bar, because there is no limitation for initiating proceedings under the criminal law where the punishment provided is more than three years. What kind of a skewed provision is this which, instead of making the legislators’ liability more strict, gives them immunity.
Also, has the UPA government considered that if a five-year period were to be provided, then by the same logic, would they not be barred from holding an enquiry into the 2G spectrum scam of 2001-02 during the BJP-led government (which, by all standards, should be held along with the enquiry into the 2G scam against former minister A. Raja) ? Are not people entitled to demand an explanation as by what perverse logic is this high-sounding body called Lokpal, headed by the Chief Justice of India, being reduced to the position of a domestic pet? I am certain that no judge with even a modicum of self-respect will accept such a demeaning, low-grade post and the inevitable result would be that the Lokpal Bill will collapse — an event that legislators have always evidently desired. So, goodbye to cleaning the political dirt, notwithstanding the high-sounding calls by all the governments.
Regrettably, cynics may be right when they say “who cares” if in the process some dedicated Gandhians, fighting for integrity in public life, fast unto death at this unforgivable lapse by the government.

The writer is a former Chief Justice of the High Court of Delhi.

New twist in dispute with China - Never ignore India’s strategic interests

by Gen V.P. Malik (retd)

ONE does not require much intelligence to realise that India-China relations over the territorial integrity of India have been on the back-slide for some time. After the joint statement of the Prime Ministers of India and China in April 2005, the Chinese government has backed out on the principle which accepted that “in reaching a boundary settlement, the two sides shall safeguard due interests of their settled populations in the border areas”. In November 2006, in complete disregard of diplomatic norms, the Chinese Ambassador in India publicly announced China’s claim to the whole of Arunachal Pradesh. Since then China has called this Indian state as Southern Tibet. It strongly opposed a proposal in the Asian Development Bank for a soft loan for some hydel power stations in the state. It protested when Prime Minister Manmohan Singh visited Arunachal Pradesh, and when the Dalai Lama visited Tawang.
About three years ago, China started issuing “stapled visas” to visitors from Jammu and Kashmir, thus bringing into question the status of J&K as part of India. It refused a visa to Lt-Gen B.S. Jamwal, GOC-in-C, Northern Command, who was to make an official visit to China as part of ongoing military-level exchanges. Meanwhile, it has increased its civil and military presence in Gilgit-Baltistan in Pakistan-occupied Kashmir (PoK), purportedly to improve infrastructure there. Among the infrastructure reconstruction projects to be given priority are those related to the repair, upgradation and recommissioning of the Karakoram Highway, which was damaged recently. China also plans to construct railway tracks and oil pipelines from Kashgar in Xinjiang to Gwadar port in Pakistan.
Much, therefore, was expected when Prime Minister Wen Jiabao, who had signed the joint statement in April 2005, visited India on December 15-17. But the sheer inanity of the India-China joint communiqué issued after the talks between the two Prime Ministers came as a surprise and disappointment. The joint communiqué had much to state on developments and new benchmarks in the economic and cultural fields. On other strategic issues, however, there was only the often repeated “firm commitment to resolving the outstanding differences, including the boundary question, at an early date through peaceful negotiations”, and the “commitment to the Agreement on Political Parameters and Guiding Principles for Settlement of the Boundary Question agreed in 2005 and the process of negotiations being undertaken by the Special Representatives”.
From Delhi, Premier Wen Jiabao went to Islamabad. There he highlighted China’s economic solidarity with Pakistan and the growing strategic partnership and military relations between the two countries. When top leaders of Pakistan’s defence forces called on him (in India, the Services Chiefs were not invited by the President or the Prime Minister to the meetings and dinners hosted for the Chinese Premier), he agreed to their proposals to enhance military links. Addressing a joint session of the two Houses of the Pakistan Parliament, Wen Jiabao stated, “To cement and advance the all-weather strategic partnership of cooperation between China and Pakistan is our common strategic choice… The two neighbouring countries are brothers forever. China-Pakistan friendship is full of vigour and vitality, like a lush tree with deep roots and thick foliage. China-Pakistan relationship is strong and solid, like a rock standing firm despite the passage of time.” Talking to the media after Wen’s address to Parliament, Pakistan’s Interior Minister Rehman Malik described it as a strong message to the “enemies” of Pakistan.
Recently, it has come to light that Beijing perceives the length of the common border with India to be about 2000-km, around 1600 km less than what is believed by India’s Ministry of External Affairs. On December 14, 2010, Indian Ambassador S. Jaishankar in an interview to a Chinese newspaper, Global Times, had stated the length of the common border to be 3,488 km. The newspaper, while publishing this interview, added its own comment: “There is no settled length of the common border. The Chinese Government often refers to the border length as being about 2,000 km.”
Such a discrepancy is too large to be treated as an inadvertent error by China. This, in fact, is the length of the boundary/LAC that separates J&K with Xinjiang and Tibet, which is not being recognised by China. The Chinese are known to be far-sighted and deliberate on such strategic issues and statements. They have made the figure 2,000 km as a new norm in the official characterisation of the border with India.
The boundary confusion gets further confounded as the length of the India-China border is considered by the Ministry of Defence to be 4,056 km and not 3,488 km as stated by the Indian Ambassador. This length includes 2,175 km in the western sector (including PoK, the Shaqsgam valley — ceded by Pakistan to China in an India-disputed agreement in March 1963 — and Aksai Chin), 556 km in the central sector, and 1,325 km in the eastern sector.
It is now becoming obvious that in the India-China boundary discussions, (a) India seems to have given up its claim to PoK, Shaqsgam and Aksai Chin; (b) China has knocked off almost the whole of the Western sector boundary; and (c) by reducing nearly 1,600 km from its definition of border with India and questioning Indian sovereignty over J&K, it has added a new twist to the India-China boundary dispute.
The strategic implications of such a move can be as follows: One, China has become a new factor in the Indo-Pak debate over J&K. Two, the India-China boundary dispute may get divided into two parts. While the eastern and middle sectors remain a bilateral issue, the western sector becomes a trilateral issue involving India, China and Pakistan. Three, repeated references to the length of the India-China border as 2,000 km with the exclusion of the boundary that separates J&K from Xinjiang and Tibet would impact any future global discourse on J&K relating to subjects like construction and international loans or the financing of development projects. Four, China can now question India’s locus standi to discuss the western sector while its own territorial integrity and authority over Aksai Chin remains secure. Five, in the security scenario and defence planning for the western sector, Indian armed forces would now have to seriously factor in joint, two-front Pakistan-China threats.
Without going into other Chinese military-related developments in Tibet and the Indian Ocean, it is obvious that India-China economic and security relations are moving in opposite trajectories. The competitive relationship over our long-term security interests outweighs the cooperative one in trade, commerce and culture. China is known to be assertive in its diplomacy over security and military issues. Strategically, it will attempt to exploit our appeasement postures to its advantage. It will become more aggressive and create new pressures on the border issues as it completes its projected military modernisation.
India, on the other hand, is perceived as a soft state. Our leaders and governments, more often than not, have lacked strategic thinking. There is a sense of self-righteousness and singular faith in words without looking for underlying falsehoods and incompetence. We have seldom been demanding on strategic issues. At the strategic level, one requires a long memory and a longer foresight and vision. With China, we need to balance our strategic, security and economic relationships. Our dialogue with China must not compromise our present or future national interests. I hope that we will not agree to any change in the ground rules, which may restrict the border talks only to the eastern and middle sectors and exclude the western sector.
The writer is a former Chief of Army Staff 

Clinical trials in developing countries Unethical practice or a product of necessity? Emmaline Brouwer Kano, Nigeria, early 1996. An outbreak of cerebral spinal meningitis kills 15 000. Médecins sans Frontières (MSF, Doctors without Borders) are the first NGO to arrive and work around the clock to treat the over 115 000 infected. The epidemic constitutes a severe public health crisis to the Nigerian government. A few weeks after the onset of the outbreak, Pfizer, the largest pharmaceutical company in the world, sends employees to Nigeria to conduct a clinical trial with the newly developed antibiotic trovafloxacin (Trovan®). Pfizer aims to bring Nigeria a life saving, innovative, less painful and cost effective form of antibiotic that could be used effectively to treat epidemic meningococcal meningitis, including in children. Almost 200 children are included in the study. Half of them receive trovafloxacin, the others are treated with the ‘best practice medication’, ceftriaxon. At least eleven of the children in the study group die, many others develop mental or physical disorders during or after the treatment. In 2001, the Nigerian federal government starts a lawsuit against Pfizer, claiming $7 billion for the victims and their relatives. The government declares that the authorities did not approve this clinical trial and the patients and their families did not give informed consent before treatment. Pfizer denies all accuses. The court case proceeds until today. The Trovan® case has become famous as the illustration of negative consequences of clinical testing in developing countries. Although exact numbers are unknown, it is clear that an increasing part of clinical trials by pharmaceutical companies is conducted in low-income countries. Large companies such as GlaxoSmithKline, Wyeth and Merck report to perform 29-70% of their trials in ‘non traditional research areas’; scientists estimate this number to be 40% on average for all pharmaceutical trials. Reasons for testing in developing countries The main reason for the companies to choose new locations for their trials is that costs are 10-50% lower than in traditional research areas. Furthermore, less strict (or lack of) legislation helps research protocols to be easier and earlier accepted. If preparatory procedures take less time, more years for profit making within the patent period remain. Another pull factor is the fact that volunteers for trials are more easily found. This is partly because populations are larger and thus more patients with a certain disease are available. Yet, in many cases participation in a trial is the only chance for a patient to receive any treatment at all, and often the (financial) incentives form an important encouragement. A medical argument for testing in developing countries is that the outcome of research has a higher validity if the subjects of study have received less medication (similar to the one studied) before participating in the trial. Finally, there are high economical benefits for hosting governments, an important incentive to relocate trial venues to their countries. For example, India receives an estimated income of $1.7 billion in 2010, when 2 million Indians are estimated to take part in clinical trials. Informed consent? Non Governmental Organizations (NGOs) critically follow this transition to trial locations in developing countries. Their main argument against most of the clinical trials is that they are unethical, for they do not comply with the Helsinki Declaration, a document adopted by the World Medical Association stating ethical principles regarding human trials. One of the concerns is the issue of informed consent. Due to analphabetism, language difficulties and a hierarchic doctor-patient relationship, informed consent is complex to obtain. Furthermore, poverty and dependency on the offered treatment make informed consent a subjective matter of discussion and question the voluntarism of the participants. Moreover, the Helsinki Declaration states that after the trial ends, the participants should be assured access to the best proven therapy identified by the study. This is often not the case in developing countries and was true for the meningitis outbreak in Kano, Nigeria, too. Social and public health aspects of the debate include the shortages of educated health personnel in developing countries. Working for the trials means a large burden on the already heavy workloads of doctors and nurses. On a larger scale, it is often argued that most drugs on trial are developed to combat welfare diseases (as this entails greater profit) and to a lesser extent to combat tropical diseases that local residents mostly suffer from. Responsibility A large responsibility is with the local medical ethical committees that approve the research protocols. Assessment of these local committees has shown that 25% of the clinical trials in developing countries has had no ethical evaluation at all and that less than a quarter of the ethical committees follow the existing guidelines when reviewing a proposal. If guidelines are in place, there is often a lack of legislation to support them. Large differences between the committees make it easy for pharmaceutical companies to choose the lenient ones to send their protocols to. They should promote responsible behaviour among themselves to comply with international guidelines and regulations. NGOs urge stronger stakeholders to take responsibility in this matter. The European Union and the US Food and Drug Administration (FDA), as drug approving institutions, should help local governments to comply with the Helsinki Declaration. Strict control of medical ethical committees will force them to review their protocols critically. Development support (e.g. training of health care workers) could also strengthen local health care systems. Another recent development is an (online) database of clinical trials that are being conducted worldwide. This ensures an easier method of control for NGOs and Western governments, as well as making sure no double research is conducted. Because of the lower costs, lack of ethical evaluation, guidelines and supporting legislation, it remains attractive for pharmaceutical companies to conduct clinical trials in developing countries. Informed consent procedures that are adhered to are inadequate. Also, patients are often denied the best available care after trial completion. Responsibility for changing this situation is shared by local ethical committees, pharmaceutical companies, NGOs, the EU and the FDA. The Helsinki Declaration The World Medical Association (WMA) compiled a document with ethical principles regarding clinical trials on human subjects. The Helsinki Declaration is regarded as the basis of human research ethics for all doctors, researchers and other health care workers worldwide. A summary of relevant paragraphs is listed below. 2. It is the duty of the physician to promote and safeguard the health of the people. 5. The well-being of the human subject should take precedence over the interests of science. 8. Vulnerable research populations require special protection. 13. The protocol for a clinical trial should be reviewed by an independent ethical review committee. 20. Participation in a trial must be voluntary and participants must be informed. 29. A new method should be tested against the best current method. 30. At the conclusion of the study, all trial participants should be assured access to the best proven therapy identified by the study. In developing countries, it is often difficult if not impossible to comply with all guidelines. Therefore, alternatives have been proposed. For example, the Nuffield Council of Bioethics, London, has recommended to test against the best available treatment for a disease in that national public health system. Further reading Pfizer: Trovan fact sheet SOMO 2008: Ethics for Drug Testing in Low and Middle-income Countries Wemos & SOMO: Examples of unethical testing Wemos: “A bitter pill” WMA: Helsinki Declaration Nuffield council of bioethics: The ethics of research related to health care in developing countries (2002) Photo © by Amfion Fotoshoots (Antonette de Groot-Klootwijk), photos for Global Medicine only, all rights reserved.

How safe is your data?

How safe is your data?

It's the age of contract research organisations conducting clinical trials for global pharma companies. But there is always suspicion when it comes to sharing sensitive information. Arun Bhatt and Rutika Vara talk about the security concerns in CROs


Arun Bhatt
“We take data protection and privacy very seriously. The accountant in India can see the data on his screen but he can not take a download of it or print it out—our program does not allow it.” — Jaithirth Rao, MphasiS, in The World Is Flat by Thomas Friedman.

“To cope and recover from a single security breach the cost on average is $14 million per company per breach”— Ponemon Institute.

Data security is today's buzzword in the biz world. With the adoption of the BPO model and dependence on Contract Research Organisations (CRO) for clinical trial management, the pharma industry has to wake up to the data security threat. CROs, particularly, are expected to provide effective data security.

Data covers all the facets of information shared between the sponsor and the CRO during the clinical trial project. Data flows from the sponsor to the CRO starts with the request for proposal and continues throughout the duration of the clinical trial project. The data includes paper or electronic documents —protocol, case record form (CRF), investigator's brochure, regulatory dossier for IND submission, informed consent documents, completed CRFs, monitoring reports, audit and inspection reports, raw data, statistical tables, and final study report. The CRO needs to share these data with both internal stakeholders—employees, external stakeholders—investigators, EC, trial subjects, health authorities, and vendors—central lab, couriers, translators, EDC suppliers. As the CRO is central to the sponsor's relationships with these stakeholders, it has to put in place, effective security measures.

For the sponsor and the CRO, data security is driven by the business need to protect data from loss, unauthorised access, modification, destruc-tion or disclosure. In addition, regulatory guidelines ensure the authenticity and integrity of data. ICH-GCP guidelines, Indian GCP and USFDA's September 2004 guidance for Computerised Systems Used in Clinical Trials, recommend that the sponsors maintain a security system that prevents unauthorised access to the data.

The level of data security differs depending on the types of data:

Public data is available to general public, including individuals outside the CRO. Public data may be shared without limit.
Internal data is insensitive information that is used in the daily course of managing clinical trials. If internal data, for example, staff phone numbers are made public, little or no loss would be incurred.
Confidential data is sensitive data. If this data is altered inappropriately loss could occur. Examples include protocols, sponsor SOPs. Access to confidential data should be provided to limited personnel in the CRO on a need-to-know basis.
Restricted data is highly sensitive data. If such data is compromised or inappropriately modified, it will lead to significant loss, which can lead to regulatory compliance breach. Examples are the raw data after database lock, statistical tables and study report. Access to this data should be closely controlled. Technical safeguards like passwords and encryption should be used to prevent access by unauthorised personnel.
Breach of data security can occur during any data transaction, that is, during transfer of data within or among clinical study sites, from clinical trial CRO to data management CRO and from CRO to central lab. Sometimes, employees accidentally disclose information while working during travel. Employees who have remote access to company intranet might leave documents open, exposing the data to leakage or tampering. There are instances of intentional break-ins by using another person's identity, for example, badge or password. Sometimes an unhappy employee or site staff might destroy the records by inserting a virus. Besides, loss or damage to data can also occur as a result of major calamities. For instance, a lot of research data was lost during the recent Katrina hurricane. The sponsor and the CRO should have data security system policies and procedures to guard against all major security concerns.

The security policy should cover both paper and electronic data. It should include relevant physical and electronic security procedures including disaster recovery measures.

The physical procedures would consist of:

Access control—swipe cards, restricted entry to visitors and vendors, limited access to archival section, alarm system to notify in case of tampering the login username and password or the act of forceful entry to the premises.
Paper trail—archived control copies, controlled distribution of document copies, confirmation of destruction of unused copies, for example, protocol synopsis for feasibility studies, draft and final reports.
Secure storage—fire proof cabinets, locked cabinets for paper documents and CDs, fire safety, smoke and fire alarms and burglar alarms.
Security obstacles— disallowing mobile phones with camera, CDs, pen drives, record of laptop model and numbers.
The electronic proce-dures would include:

Access control— authentication to validate identity of employees, encryption, to ensure that information is not viewed or tampered with during transmission, secure passwords or biometric identification for logging in, read only access to prevent accidental data modification, automated screen savers and log-out to inhibit access to unattended displays after particular time.
Non-repudiation—to establish an indisputable time-stamped audit trail of creation, modification, maintenance and transmit using the data entry system.
Digital signing—to attach legally binding electronic signatures to documents and forms.
Technological obstacles—firewalls to isolate internal and external networks, restricting use of pen drives and CDs in computers and laptops.
Back up procedures—regular backup through CDs or tapes storage in bank lockers and another location.
Data security system should describe legal procedures, for example, confidentiality of disclosure agreements from all persons who are likely to receive data like employees, investigators and vendors. The policy should also discuss necessary actions in case of a breach of security, for example, dismissal from employment, civil liability or criminal prosecution.

In the post-IPR era, there is a tug-of-war in India between global pharma companies expecting data exclusivity and Indian pharma companies opposing this move
The system will work only if the employees are adequately informed about their responsibilities for guarding the sponsor's data and are thoroughly trained to the use of physical and electronic systems. To quote Bruce Schneier, “People often represent the weakest link in the security chain and are chronically responsible for the failure of security systems.”

In the post-IPR era, there is a tug-of-war in India between global pharma companies expecting data exclusivity and Indian pharma companies opposing this move. Besides, Indian industry's capability of reverse engineering to make economic generics, has created an atmosphere of suspicion in post-IPR era. These concerns have made the global sponsors obsessive on the potential misuse of their valuable data. The sponsors expect the Indian CROs to establish a comprehensive data security system to ensure that their data is in safe hands. If Indian CROs want global business, they have to be ready to face the security challenge!

(The writers are the President and Assistant Manager of Data Management of ClinInvent Research Pvt Ltd)

Unethical practice or a product of necessity?

Clinical trials in developing countries

Unethical practice or a product of necessity?

Emmaline Brouwer

 

Kano, Nigeria, early 1996.

An outbreak of cerebral spinal meningitis kills 15 000. Médecins sans Frontières (MSF, Doctors without Borders) are the first NGO to arrive and work around the clock to treat the over 115 000 infected. The epidemic constitutes a severe public health crisis to the Nigerian government. A few weeks after the onset of the outbreak, Pfizer, the largest pharmaceutical company in the world, sends employees to Nigeria to conduct a clinical trial with the newly developed antibiotic trovafloxacin (Trovan®). Pfizer aims to bring Nigeria a life saving, innovative, less painful and cost effective form of antibiotic that could be used effectively to treat epidemic meningococcal meningitis, including in children. Almost 200 children are included in the study. Half of them receive trovafloxacin, the others are treated with the ‘best practice medication’, ceftriaxon. At least eleven of the children in the study group die, many others develop mental or physical disorders during or after the treatment. In 2001, the Nigerian federal government starts a lawsuit against Pfizer, claiming $7 billion for the victims and their relatives. The government declares that the authorities did not approve this clinical trial and the patients and their families did not give informed consent before treatment. Pfizer denies all accuses. The court case proceeds until today.

The Trovan® case has become famous as the illustration of negative consequences of clinical testing in developing countries. Although exact numbers are unknown, it is clear that an increasing part of clinical trials by pharmaceutical companies is conducted in low-income countries. Large companies such as GlaxoSmithKline, Wyeth and Merck report to perform 29-70% of their trials in ‘non traditional research areas’; scientists estimate this number to be 40% on average for all pharmaceutical trials.

Reasons for testing in developing countries

The main reason for the companies to choose new locations for their trials is that costs are 10-50% lower than in traditional research areas. Furthermore, less strict (or lack of) legislation helps research protocols to be easier and earlier accepted. If preparatory procedures take less time, more years for profit making within the patent period remain. Another pull factor is the fact that volunteers for trials are more easily found. This is partly because populations are larger and thus more patients with a certain disease are available. Yet, in many cases participation in a trial is the only chance for a patient to receive any treatment at all, and often the (financial) incentives form an important encouragement. A medical argument for testing in developing countries is that the outcome of research has a higher validity if the subjects of study have received less medication (similar to the one studied) before participating in the trial. Finally, there are high economical benefits for hosting governments, an important incentive to relocate trial venues to their countries. For example, India receives an estimated income of $1.7 billion in 2010, when 2 million Indians are estimated to take part in clinical trials.

Informed consent?

Non Governmental Organizations (NGOs) critically follow this transition to trial locations in developing countries. Their main argument against most of the clinical trials is that they are unethical, for they do not comply with the Helsinki Declaration, a document adopted by the World Medical Association stating ethical principles regarding human trials.

One of the concerns is the issue of informed consent. Due to analphabetism, language difficulties and a hierarchic doctor-patient relationship, informed consent is complex to obtain. Furthermore, poverty and dependency on the offered treatment make informed consent a subjective matter of discussion and question the voluntarism of the participants. Moreover, the Helsinki Declaration states that after the trial ends, the participants should be assured access to the best proven therapy identified by the study. This is often not the case in developing countries and was true for the meningitis outbreak in Kano, Nigeria, too.

Social and public health aspects of the debate include the shortages of educated health personnel in developing countries. Working for the trials means a large burden on the already heavy workloads of doctors and nurses. On a larger scale, it is often argued that most drugs on trial are developed to combat welfare diseases (as this entails greater profit) and to a lesser extent to combat tropical diseases that local residents mostly suffer from.

Responsibility

A large responsibility is with the local medical ethical committees that approve the research protocols. Assessment of these local committees has shown that 25% of the clinical trials in developing countries has had no ethical evaluation at all and that less than a quarter of the ethical committees follow the existing guidelines when reviewing a proposal. If guidelines are in place, there is often a lack of legislation to support them.

Large differences between the committees make it easy for pharmaceutical companies to choose the lenient ones to send their protocols to. They should promote responsible behaviour among themselves to comply with international guidelines and regulations.

NGOs urge stronger stakeholders to take responsibility in this matter. The European Union and the US Food and Drug Administration (FDA), as drug approving institutions, should help local governments to comply with the Helsinki Declaration. Strict control of medical ethical committees will force them to review their protocols critically. Development support (e.g. training of health care workers) could also strengthen local health care systems. Another recent development is an (online) database of clinical trials that are being conducted worldwide. This ensures an easier method of control for NGOs and Western governments, as well as making sure no double research is conducted.

Because of the lower costs, lack of ethical evaluation, guidelines and supporting legislation, it remains attractive for pharmaceutical companies to conduct clinical trials in developing countries. Informed consent procedures that are adhered to are inadequate. Also, patients are often denied the best available care after trial completion. Responsibility for changing this situation is shared by local ethical committees, pharmaceutical companies, NGOs, the EU and the FDA.

The  Helsinki Declaration

The World Medical Association (WMA) compiled a document with ethical principles regarding clinical trials on human subjects. The Helsinki Declaration is regarded as the basis of human research ethics for all doctors, researchers and other health care workers worldwide.

A summary of relevant paragraphs is listed below.

2. It is the duty of the physician to promote and safeguard the health of the people.

5. The well-being of the human subject should take precedence over the interests of science.

8. Vulnerable research populations require special protection.

13. The protocol for a clinical trial should be reviewed by an independent ethical review committee. 

20. Participation in a trial must be voluntary and participants must be informed.

29. A new method should be tested against the best current method.

30. At the conclusion of the study, all trial participants should be assured access to the best proven therapy identified by the study.

In developing countries, it is often difficult if not impossible to comply with all guidelines. Therefore, alternatives have been proposed. For example, the Nuffield Council of Bioethics, London, has recommended to test against the best available treatment for a disease in that national public health system.

Further reading

Pfizer: Trovan fact sheet

SOMO 2008: Ethics for Drug Testing in Low and Middle-income Countries

Wemos & SOMO: Examples of unethical testing

Wemos: “A bitter pill”

WMA: Helsinki Declaration

Nuffield council of bioethics: The ethics of research related to health care in developing countries (2002)

Photo © by Amfion Fotoshoots (Antonette de Groot-Klootwijk), photos for Global Medicine only, all rights reserved.

Today marks the ninth anniversary of the horrific attack on Parliament which sparked off India’s attempt at military coercion vis-a-vis Pakistan. But the lessons learnt seem to have been ignored. Lack of political will and a coherent decision making process are still lacking, thereby undermining the nation’s credibility

LOST OPPORTUNITIES

Gurmeet Kanwal

INDIA'S first attempt at military coercion achieved only limited success. Operation Parakram, launched in the wake of the December 13, 2001 terrorist attack on Parliament, was the first full-scale mobilisation since the 1971 Indo-Pak war. It began on December 15, 2001 after the Cabinet Committee on Security’s (CCS) decision and was completed on January 3, 2002. It finally ended on October 16, 2002 when CCS belatedly recognised that the law of diminishing returns had been operative for many months already. In a face-saving move, CCS declared that troops were being "strategically relocated" and constant vigil would be maintained, especially in J&K.

Though the 10-month deployment ended without a conflict, the two nations came close to war on at least two occasions. The first window of opportunity came in the first week of January 2002 soon after the Indian Army had completed its slow-paced mobilisation. In the snow-bound areas of J&K the army had relatively few options to launch offensive operations across the LoC, but in the plains of Punjab and Rajasthan the climatic conditions were ideal.

The United States and other Western governments, however, stepped in with astute diplomatic manoeuvres resulting in General Musharraf's ashen-faced commitment in a nationally telecast speech on January 12, 2002, that Pakistan "will not permit any terrorist activity from its soil". India backed-off, but troops remained in place in their deployment areas on the international border (IB) and the three strike corps remained poised in their concentration areas.

The second opportunity presented itself after a terrorist attack on the family quarters in the Indian army garrison at Kaluchak near Jammu on May 14, 2002. The summer weather was conducive for offensives across the LoC in Kashmir Valley as well as the Jammu division south of the Pir Panjal mountains. In Punjab and Rajasthan, though the 40-degree plus temperatures were hard on man and machine, the disadvantage was common to both the sides and major offensive action was possible. By this time the Pakistan army had also mobilised and was poised in defence. Despite high-pitched rhetoric and extensive saber-rattling, the government did not approve military strikes across the border.

Slow Pace of Strike Corps Mobilisation

While the formations responsible to defend the border - "holding" or "pivot" corps - were ready for battle within 72 to 96 hours of receiving orders, the three "strike corps" (1, 2 and 21 Corps) took almost three weeks to complete their mobilisation because their fighting echelons are based at long distances from the border. Hence, it was only in the first week of January 2002 that major offensive action could have been undertaken by the land forces.

This time the mobilisation was total. All leave was cancelled and the soldiers re-called for active duty. Almost all training establishments were closed down. Extensive operational familiarisation exercises were conducted and operational plans war-gamed, updated and refined. Ammunition trains brought reserve stocks to forward ammunition points. In the first week of January 2002, expectation about the impending offensive action had reached fever pitch and morale was at an all time high. However, the troops had no way of knowing that the national aim was to practice coercive diplomacy.

The army also addressed shortcomings in training that initial mobilisation had revealed. There were unacceptably large casualties and it was officially stated that till March 15, 2002, the army had lost 176 men in the operation due to mishaps in minefields, mishandling ammunition and explosives and traffic accidents. The defence minister reportedly stated in Parliament, that up to July 2003, the army suffered 798 casualties. It clearly emerged that the army's mine laying methodology and training and the system adopted for marking minefields to keep civilians and cattle away needed substantial improvement.

The cost of sustaining Operation Parakram was reported to be have been pegged by India's National Security Advisory Board (NSAB) at Rs 7 crore a day. This works out to approximately Rs 2,100 crore over 10 months and, presumably, does not include the cost of mobilisation and de-induction. The minister told Parliament in October 2002 that Operation Parakram had cost Rs 8,000 crore, excluding Rs 300 crore compensation paid to people in border states where troops were deployed.

Lessons Learned - and not Learned

Perhaps the most important lesson emerging from the standoff was the inordinately long time that strike corps needed to mobilise for war. By the time these elite formations were ready to deliver a massive punch, the international community had prevailed upon India to give General Musharraf an opportunity to prove his sincerity in curbing cross-border terrorism. These strike corps are designed to penetrate deep into Pakistan and run the risk of crossing Pakistan's nuclear threshold early during an offensive campaign.

The lack of coherent politico-military decision-making was clearly evident. It is not at all clear whether any military objectives were actually assigned by the political leadership. Asked whether the deployment was aimed at attacking Pakistan, the then army chief Gen S. Padmanabhan, said, "There were many aims, which were fulfilled." However, he also said, "Whenever there is a situation calling for the army's help, the latter's role should be well defined to avoid confusion."

Gen V. P. Malik, General Padmanabhan's predecessor wrote in the Tribune: "Despite speeches and international commitments…. Musharraf's efforts to rein in Jihadi groups… remained cosmetic and tactical… Infiltration across the LoC and other ISI operations continue… There is no let up in terrorist acts…" When mobilisation began, Vijayanta tanks of 1970s vintage, artillery guns that were even older and many other obsolete equipment were in frontline service. Analysts pegged the overall Indo-Pak combat force ratio at approximately 1.15:1.0 in India's favour during the Operation. Speaking as an MP in the Rajya Sabha less than a week after mobilisation began, former army chief Gen Shankar Roychowdhury blamed the "recurrent political controversies on military procurement in the last 15 years" for having "crippled the army's modernisation programme." Sadly, not much has changed in the last decade despite well-intentioned reforms in defence procurement procedures. Inordinate delays in decision-making and bureaucratic red tape continue to mar acquisitions, a large chunk of the defence budget is still surrendered year after year, large equipment shortages continue to persist and a CDS is yet to be appointed.

Strategic analysts in India were concerned at the adverse impact of the lack of resolute action on the credibility of India's deterrence. Former air chief A. Y. Tipnis said at that time: "We have shown enormous patience, now it is time to show we have resolve too. Inaction is damaging our credibility; people have begun to believe India incapable of taking any action." Brahma Chellaney wrote: "The harsh truth is that the government played a game of bluff not just with Pakistan but also with its own military… When a nation enjoys credibility, it can usually achieve its objectives with a mere threat to use force. However, when there are serious credibility problems, even modest objectives are difficult to accomplish. Vajpayee ended up practising coercive non-diplomacy."

The aim of politico-military coercion is to induce a change in an adversary's policies and actions through a credible threat of devastating punitive action in case of non-compliance. While trans-LoC terrorism from Pakistan continued, there was a definite reduction in its intensity. On the other hand, Pakistan steadfastly refused to either terminate the activities of the LeT and the JeM, detain their leaders and block their funds or to hand over even one of the 20 terrorists India had demanded. Training camps and other facilities for terrorists also continued to operate in POK. Hence, the government's aim of launching Operation Parakram was only partially achieved and the credibility of India's coercive diplomacy and military superiority was seriously undermined. Also, the opportunity to strike at the roots of terrorism in POK was once again squandered. Lack of political will was again demonstrated after the terror strikes in Mumbai on November 26, 2008, despite credible evidence that these had been launched by the LeT at the behest of the Pakistani army and the ISI.

As long as the Pakistani army continues to exercise a tight stranglehold over Pakistan's polity, unbridled control over its nuclear weapons, retains its unjustifiable size of 500,000 personnel in uniform and enjoys American patronage as a frontline state with MNNA (major non-NATO ally) status - which brings with it new military equipment, loan waivers and the rescheduling of loan payments on easier terms over longer periods - it will have no incentive to move towards genuine peace with India. The Kashmir issue is only the symptom of a much larger fundamental malaise. The Southern Asian region is likely to continue to witness periodic bouts of hostility between India and Pakistan, tempered by short interludes of tentative peace.

The writer is Director, Centre for Land Warfare Studies, New Delhi

The Operation

OPERATION Parakram was the second major military standoff between India and Pakistan since both countries achieved nuclear weapons capability in 1998. The 1999 Kargil conflict had been the first. The episode had also focused the world's attention on the possibility of a nuclear conflict in South Asia, and the impact any conflict would have on US operations in Afghanistan.

Following Indian deployments, Pakistan moved a large numbers of troops from the border with Afghanistan, where they had been trying to combat the Taliban and Al Qaeda, to the Indo-Pak border. In late December, both countries moved ballistic missiles close to the border, and mortar and artillery fire was reported along the LoC. By January 2002, India had mobilised around 500,000 troops and three armored divisions. Pakistan responded by deploying around 120,000 troops. This was the largest buildup in the subcontinent since the 1971 war.

Tensions decreased somewhat following Mushraff's January 2002 speech, but shot up again in May, when three terrorists killed 34 people iin an army camp near Jammu. On May 18, India expelled Pakistan's High Commissioner. The same day, thousands of villagers fled Pakistani artillery fire in Jammu sector. Separatist leader Abdul Ghani Lone was assassinated on May 21, and the next day Prime Minister Vajpayee warned troops to prepare for a "decisive battle." Beginning May 24, Pakistan carried out a series of missile tests. On June 7, an Indian UAV was reportedly shot down near Lahore in Pakistan.

Alarmed at the possibility of a nuclear war, the US asked all its non-essential citizens to leave India on May 31. A visit by Russian President Vladimir Putin could not mediate a solution. But by mid-June, the Indian government accepted Musharraf's pledge to end militant infiltration into India, and on June 10, restrictions on over-flights from Pakistan were removed by India. Indian warships were also recalled from deployment from the vicinity of the Pakistani coast.

While tensions remained high throughout the next few months, both governments began easing the situation in Kashmir. By October 2002, India and Pakistan had begun to demobilise their troops along their border and in November 2003 both countries agreed to ceasefire along the Kashmir border.

Today marks the ninth anniversary of the horrific attack on Parliament which sparked off India’s attempt at military coercion vis-a-vis Pakistan. But the lessons learnt seem to have been ignored. Lack of political will and a coherent decision making process are still lacking, thereby undermining the nation’s credibility LOST OPPORTUNITIES Gurmeet Kanwal INDIA'S first attempt at military coercion achieved only limited success. Operation Parakram, launched in the wake of the December 13, 2001 terrorist attack on Parliament, was the first full-scale mobilisation since the 1971 Indo-Pak war. It began on December 15, 2001 after the Cabinet Committee on Security’s (CCS) decision and was completed on January 3, 2002. It finally ended on October 16, 2002 when CCS belatedly recognised that the law of diminishing returns had been operative for many months already. In a face-saving move, CCS declared that troops were being "strategically relocated" and constant vigil would be maintained, especially in J&K. Though the 10-month deployment ended without a conflict, the two nations came close to war on at least two occasions. The first window of opportunity came in the first week of January 2002 soon after the Indian Army had completed its slow-paced mobilisation. In the snow-bound areas of J&K the army had relatively few options to launch offensive operations across the LoC, but in the plains of Punjab and Rajasthan the climatic conditions were ideal. The United States and other Western governments, however, stepped in with astute diplomatic manoeuvres resulting in General Musharraf's ashen-faced commitment in a nationally telecast speech on January 12, 2002, that Pakistan "will not permit any terrorist activity from its soil". India backed-off, but troops remained in place in their deployment areas on the international border (IB) and the three strike corps remained poised in their concentration areas. The second opportunity presented itself after a terrorist attack on the family quarters in the Indian army garrison at Kaluchak near Jammu on May 14, 2002. The summer weather was conducive for offensives across the LoC in Kashmir Valley as well as the Jammu division south of the Pir Panjal mountains. In Punjab and Rajasthan, though the 40-degree plus temperatures were hard on man and machine, the disadvantage was common to both the sides and major offensive action was possible. By this time the Pakistan army had also mobilised and was poised in defence. Despite high-pitched rhetoric and extensive saber-rattling, the government did not approve military strikes across the border. Slow Pace of Strike Corps Mobilisation While the formations responsible to defend the border - "holding" or "pivot" corps - were ready for battle within 72 to 96 hours of receiving orders, the three "strike corps" (1, 2 and 21 Corps) took almost three weeks to complete their mobilisation because their fighting echelons are based at long distances from the border. Hence, it was only in the first week of January 2002 that major offensive action could have been undertaken by the land forces. This time the mobilisation was total. All leave was cancelled and the soldiers re-called for active duty. Almost all training establishments were closed down. Extensive operational familiarisation exercises were conducted and operational plans war-gamed, updated and refined. Ammunition trains brought reserve stocks to forward ammunition points. In the first week of January 2002, expectation about the impending offensive action had reached fever pitch and morale was at an all time high. However, the troops had no way of knowing that the national aim was to practice coercive diplomacy. The army also addressed shortcomings in training that initial mobilisation had revealed. There were unacceptably large casualties and it was officially stated that till March 15, 2002, the army had lost 176 men in the operation due to mishaps in minefields, mishandling ammunition and explosives and traffic accidents. The defence minister reportedly stated in Parliament, that up to July 2003, the army suffered 798 casualties. It clearly emerged that the army's mine laying methodology and training and the system adopted for marking minefields to keep civilians and cattle away needed substantial improvement. The cost of sustaining Operation Parakram was reported to be have been pegged by India's National Security Advisory Board (NSAB) at Rs 7 crore a day. This works out to approximately Rs 2,100 crore over 10 months and, presumably, does not include the cost of mobilisation and de-induction. The minister told Parliament in October 2002 that Operation Parakram had cost Rs 8,000 crore, excluding Rs 300 crore compensation paid to people in border states where troops were deployed. Lessons Learned - and not Learned Perhaps the most important lesson emerging from the standoff was the inordinately long time that strike corps needed to mobilise for war. By the time these elite formations were ready to deliver a massive punch, the international community had prevailed upon India to give General Musharraf an opportunity to prove his sincerity in curbing cross-border terrorism. These strike corps are designed to penetrate deep into Pakistan and run the risk of crossing Pakistan's nuclear threshold early during an offensive campaign. The lack of coherent politico-military decision-making was clearly evident. It is not at all clear whether any military objectives were actually assigned by the political leadership. Asked whether the deployment was aimed at attacking Pakistan, the then army chief Gen S. Padmanabhan, said, "There were many aims, which were fulfilled." However, he also said, "Whenever there is a situation calling for the army's help, the latter's role should be well defined to avoid confusion." Gen V. P. Malik, General Padmanabhan's predecessor wrote in the Tribune: "Despite speeches and international commitments…. Musharraf's efforts to rein in Jihadi groups… remained cosmetic and tactical… Infiltration across the LoC and other ISI operations continue… There is no let up in terrorist acts…" When mobilisation began, Vijayanta tanks of 1970s vintage, artillery guns that were even older and many other obsolete equipment were in frontline service. Analysts pegged the overall Indo-Pak combat force ratio at approximately 1.15:1.0 in India's favour during the Operation. Speaking as an MP in the Rajya Sabha less than a week after mobilisation began, former army chief Gen Shankar Roychowdhury blamed the "recurrent political controversies on military procurement in the last 15 years" for having "crippled the army's modernisation programme." Sadly, not much has changed in the last decade despite well-intentioned reforms in defence procurement procedures. Inordinate delays in decision-making and bureaucratic red tape continue to mar acquisitions, a large chunk of the defence budget is still surrendered year after year, large equipment shortages continue to persist and a CDS is yet to be appointed. Strategic analysts in India were concerned at the adverse impact of the lack of resolute action on the credibility of India's deterrence. Former air chief A. Y. Tipnis said at that time: "We have shown enormous patience, now it is time to show we have resolve too. Inaction is damaging our credibility; people have begun to believe India incapable of taking any action." Brahma Chellaney wrote: "The harsh truth is that the government played a game of bluff not just with Pakistan but also with its own military… When a nation enjoys credibility, it can usually achieve its objectives with a mere threat to use force. However, when there are serious credibility problems, even modest objectives are difficult to accomplish. Vajpayee ended up practising coercive non-diplomacy." The aim of politico-military coercion is to induce a change in an adversary's policies and actions through a credible threat of devastating punitive action in case of non-compliance. While trans-LoC terrorism from Pakistan continued, there was a definite reduction in its intensity. On the other hand, Pakistan steadfastly refused to either terminate the activities of the LeT and the JeM, detain their leaders and block their funds or to hand over even one of the 20 terrorists India had demanded. Training camps and other facilities for terrorists also continued to operate in POK. Hence, the government's aim of launching Operation Parakram was only partially achieved and the credibility of India's coercive diplomacy and military superiority was seriously undermined. Also, the opportunity to strike at the roots of terrorism in POK was once again squandered. Lack of political will was again demonstrated after the terror strikes in Mumbai on November 26, 2008, despite credible evidence that these had been launched by the LeT at the behest of the Pakistani army and the ISI. As long as the Pakistani army continues to exercise a tight stranglehold over Pakistan's polity, unbridled control over its nuclear weapons, retains its unjustifiable size of 500,000 personnel in uniform and enjoys American patronage as a frontline state with MNNA (major non-NATO ally) status - which brings with it new military equipment, loan waivers and the rescheduling of loan payments on easier terms over longer periods - it will have no incentive to move towards genuine peace with India. The Kashmir issue is only the symptom of a much larger fundamental malaise. The Southern Asian region is likely to continue to witness periodic bouts of hostility between India and Pakistan, tempered by short interludes of tentative peace. The writer is Director, Centre for Land Warfare Studies, New Delhi

The Operation OPERATION Parakram was the second major military standoff between India and Pakistan since both countries achieved nuclear weapons capability in 1998. The 1999 Kargil conflict had been the first. The episode had also focused the world's attention on the possibility of a nuclear conflict in South Asia, and the impact any conflict would have on US operations in Afghanistan. Following Indian deployments, Pakistan moved a large numbers of troops from the border with Afghanistan, where they had been trying to combat the Taliban and Al Qaeda, to the Indo-Pak border. In late December, both countries moved ballistic missiles close to the border, and mortar and artillery fire was reported along the LoC. By January 2002, India had mobilised around 500,000 troops and three armored divisions. Pakistan responded by deploying around 120,000 troops. This was the largest buildup in the subcontinent since the 1971 war. Tensions decreased somewhat following Mushraff's January 2002 speech, but shot up again in May, when three terrorists killed 34 people iin an army camp near Jammu. On May 18, India expelled Pakistan's High Commissioner. The same day, thousands of villagers fled Pakistani artillery fire in Jammu sector. Separatist leader Abdul Ghani Lone was assassinated on May 21, and the next day Prime Minister Vajpayee warned troops to prepare for a "decisive battle." Beginning May 24, Pakistan carried out a series of missile tests. On June 7, an Indian UAV was reportedly shot down near Lahore in Pakistan. Alarmed at the possibility of a nuclear war, the US asked all its non-essential citizens to leave India on May 31. A visit by Russian President Vladimir Putin could not mediate a solution. But by mid-June, the Indian government accepted Musharraf's pledge to end militant infiltration into India, and on June 10, restrictions on over-flights from Pakistan were removed by India. Indian warships were also recalled from deployment from the vicinity of the Pakistani coast. While tensions remained high throughout the next few months, both governments began easing the situation in Kashmir. By October 2002, India and Pakistan had begun to demobilise their troops along their border and in November 2003 both countries agreed to ceasefire along the Kashmir border.