IGNORING RAIL SAFETY – EDITORIAL OF PEOPLE’S DEMOCRACY : PLAYING WITH PEOPLE’S LIVES

YET another rail accident has claimed over 60 lives and has left over a hundred seriously injured. Yet another conspiracy theory has been woven by the union railway minister. It is, indeed, a shame for our country that we have, in the present political leadership of UPA-II government, ministers for whom precious human life comes so cheap that death does not even merit a thoughtful moment of human sadness and sympathy.

Sabotage theories have come even before the customary expression of pretensions of remorse on such occasions. The railway board, following the cue from the minister, has declared that it does not rule out sabotage with its chairman hinting at “willful interference”.

Between May 2009 when this UPA-II government assumed office and July 2010, there have been 16 major rail accidents in which at least 269 people lost their lives and over a thousand seriously injured. If all minor incidents are taken into account, then there have been 162 accidents since May 2009 in which 428 people died.

Absolving herself of any responsibility or moral torment, the railway minister, at the accident site said, “I am suspicious about the cause of the accident. We have some doubt in our mind. Whatever happened is not a casual thing. We will take strong steps against those who are behind this.” On May 28, 2010, following the derailment and collision of the Jnaneswari Express in West Bengal that killed 149 people, the minister said: “There was a political conspiracy behind the derailment. I feel bad at the way the incident was engineered to fulfill one’s political interest. Those who have done this sabotage and played with so many lives should not be pardoned.” Earlier, on October 21, 2009, after the Goa Express – Mewar Express collision near Mathura that killed 21 people, the minister said: “Somebody is saying that chain pulling was the reason and others say there was a signal problem. It may be a case of criminal offence also. I’ll let the CBI decide.” Shockingly, when two people died and many injured in a stampede at the New Delhi railway station caused by an abrupt change in the platforms announced by the railways, the minister once again absolving all responsibility with impunity said: “It is not the failure of the administration. People are responsible for such chaos. It is difficult to control such situations.”

On this occasion of the collision of the Uttar Banga Express with the Vananchal Express, the union home ministry shot down the railway minister’s suspicion on the cause of the collision, which hinted at foul play. The home ministry officials have said that the accident pointed to a system failure where both man and equipment failed. This is the second time that the union home ministry has negated the claim of the railway minister. It had earlier ruled out the use of explosives, which the railway minister so promptly announced, in the collision of the Jnaneswari Express.

Undeterred, the railway minister and her Trinamul Congress (TMC) continues to churn out conspiracy theories targeting the CPI(M) and the Left. The Jnaneswari Express accident, we are told, occurred just two days before the municipal elections in West Bengal. This is a fact. But then, it was the TMC that gained in these elections. Where does the needle of suspicion point to? From the TMC’s own standards of conspiracy theories, it is clear that the `boot is on the other foot’. This unfortunate accident happened again two days before an annual gathering of people that the TMC organises every year in Kolkata.

This accident, as with the string of others, leaves many important questions unanswered. All of these have been widely reported and, hence, need no repetition. All of these, however, point to a massive systems failure during the last one year. And, all invariably point to the lack of the required concentration and attention to efficiently and safely run the world’s largest railway network. The Indian railways today transports over 18 million passengers a day apart from large-scale transportation of goods and freight. Safety on the railways has, obviously, been neglected. Nearly 90,000 sanctioned posts remain vacant as the railways under the union minister fails to find time for these appointments. Shockingly, over 20,000 of these are directly related to safety! The anti-collision devise (ACD) which automatically prevents train collisions was curiously developed by the former managing director of Konkan railways when the current railway minister was the minister in an earlier stint. The Konkan railways, today, uses the ACDs. Yet today, during the course of this entire year, the railways have not found the time or the inclination to introduce these in its all-India network.

Clearly, India cannot afford such dangerous state of affairs in our railway network, which is so crucial for the country’s existence. The union railway minister, pre-occupied, as she is, with other activities, is not discharging her responsibilities as the union minister that have been sanctioned and sanctified by the oath of office. The collective responsibility of our system of cabinet functioning includes the individual accountability of the ministers. It is the prime minister’s responsibility as the leader of the cabinet minister to ensure this.

This is importantly required on another count as well. The prime minister has repeatedly declared that Maoist violence constitutes the single gravest threat to India’s internal security. Growing evidence contained in statements made by Maoist leaders reconfirms, if such a reconfirmation was ever necessary, that the TMC had helped the Maoists penetrate in West Bengal and continues to maintain links with them. This contradiction urgently needs to be resolved by the prime minister.

In the interest of the country, its internal security, in the interest of the safety of nearly two crores of people who use the railways every day, it is high time that the UPA-II government and the prime minister take a call. The country cannot afford and the people do not tolerate the continued lack of accountability that jeopardises the safety of both the country and the people.
(July 21, 2010)

Courtesy: www.pd.cpim.org

WHO BENEFITS FROM CLINICAL RESEARCH IN INDIA? - Amit Sen Gupta

IN recent months there have been a spate of reports that raise concerns about the conduct of clinical trials on human subjects in India. These ranged from reports of a number of deaths in trial subjects in the All India Institute of Medical Sciences in 2008, to the gross ethical violations alleged in trials of a vaccine to prevent cervical cancer among adolescent girls in Andhra Pradesh and Gujarat in 2010. There have also been reports of growing number of deaths in trial subjects that led, in one instance, to the Drug Controller General of India stepping in to stop the concerned trial in Bangalore. What is disturbing about all these reports is the absolute lack of transparency regarding how these trials are being conducted. The government, when forced by media reports to make a statement, has chosen to maintain this veil of secrecy to the extent possible.

These reports, raising misgivings about the way clinical trials are being conducted in India, coincide with a very rapid expansion of the number of clinical trials conducted in the country. The flood gates opened in 2005 when India changed the rules regulating clinical trials in the country. To understand how this happened we need to understand the process involved while conducting clinical trials.

CLINICAL TRIALS AND ETHICS

When new drugs are researched, they need to be tested on human subjects before they are given a marketing approval by drug regulatory agencies. Before a new drug is tested on human subjects, they have to be tested on animals to establish the safety and efficacy of the drug. However, this is not enough to establish the safety and efficacy of the drug in humans. The final step involves testing the drugs among human subjects. These tests are carried out in four phases. In the first phase of human trials, the drug is tested on a small number of human subjects to show that the drug is indeed safe for human consumption. Generally phase I trials are conducted on healthy subjects and the intent is to establish the safety of the drug. Phase II and III are conducted on subjects who have a condition that may benefit from the use of the drug, and thus these trials are designed to establish that the drug is effective in treating a particular disease. Phase IV trials are also called post-marketing surveillance and are designed to collect data from an even larger sample of patients, after the drug is introduced.

Because clinical trials are essentially experiments that are conducted on human beings, all countries have rules that regulate how these trials should be conducted. Globally, the Helsinki declaration, sets the benchmark of how such rules should be framed. All rules related to drug trials are concerned with the ethics of how trials are conducted. The first, and perhaps the most important aspect of these rules, are those related to “informed consent”. Because trials are an experiment they carry a potential risk. So it needs to be ensured that those who participate in clinical trials should be aware of the risks and should formally consent to be part of the trial after the risks are explained in details. The concept of informed consent is also premised on the assumption that trial subjects consent to be a clinical trial subject without being coerced, directly or as a consequence of the circumstances in which the person might find himself. The second fundamental concern about ethics in clinical trials is that trials should be allowed in a population who would later benefit from the introduction of the drug that is tested. In other words clinical trials should not be permitted where trial subjects in a particular country or community are used as mere guinea pigs.

There are several other critical issues that determine whether a trial is ethical. In recent years, a major concern has related to “placebo” controlled trials. A placebo is a substance that has no significant effect on a human subject – it could be a capsule containing a small amount of salt or sugar, for example. In placebo controlled trials, some trial subjects are given the placebo while others are given the drug that is being studied. Through this route researchers can decide if the drug is a better alternative to no treatment. However placebo trials are unethical if a treatment already exists for the disease for which the new drug is being tested, for it means that those who are given the placebo are being denied treatment, even though a treatment for the disease exists. The Helsinki declaration clearly states that in general placebo trials should be avoided if treatment already exists. However there is no unanimity on this among researchers. Laws in the US, for example, have different standards for placebo controlled trials depending on whether the trials are being conducted in the US or being conducted in a third country.

CHANGE IN LAW OPENS FLOOD-GATES

Before 2005, the Indian law was designed to actively discourage the use of Indians as mere subjects for experimentation by foreign companies. The law required that if a foreign company wished to conduct trials in India, it needed to repeat the trials from the same phase in India as had already been conducted in locations outside India. Thus if a company had already conducted phase I trials outside India, it could not directly start phase II trials in India – it would have to conduct phase I trials again in India, before permission was conducted to conduct phase II trials in the country. This allowed Indian regulatory agencies greater control over the kind of trials being conducted in India and was a vital tool for protection of trial subjects against unethical trials. In 2005, however, this requirement was waived (by and amendment to schedule Y of the drugs and cosmetic rules) and concurrent phase II and III trials were allowed. This means that a phase II or III trial can be conducted concurrently in India, along with similar trials in other centres in the world, even if the drug has not undergone a phase I or II trial in India.

The result of this change in the law has been spectacular. In 2005, less than a 100 trials were being conducted in India. The number jumped to over 250 by 1997-98 and is projected to exceed a 1000 by the end of 2010. It is now estimated that one in four clinical trials in the world are conducted in India, and the turnover for the industry is expected to touch US$ 1.52 billion by 2010. The Association of Indian Contract Research Organisations (ACRO) chairman Dr S P Vasireddi is quoted as claiming: "We have now a share of 24 per cent while China has 33.3 per cent of the global business."

REASONS BEHIND BOOM IN CLINICAL TRIALS

What explains this boom in clinical trials in the country? Does it indicate a rapid expansion of capability and capacity for conducting medical research in the country? Unfortunately the answer to this is largely in the negative. While capacity and capability have increased, the sudden rise in number of trials far outstrips the enhancement in capacity and capability. Even industry sources admit that at present levels there is a need for about 5,000 new professionals trained in good clinical practice (GCP) in the industry to augment the 600 odd who are available in the country. What is perhaps an even bigger concern is that regulatory capacity has not kept pace with the sudden spurt in clinical trials. While the law was changed in 2005, it was only in late 2009 that the government deemed it prudent to make it mandatory to register clinical trials in the country. While rules now specify that all clinical trials need to be overseen by institutional ethics committees, the constitution and functioning of these ethics committees are fraught with numerous problems. Primary among these is the issue of conflict of interest -- ethics committee members can have vested interest in ensuring that a trial is given permission because they have links with the company or the local contractor or the researcher who is engaged in promoting the trial. Further, there is little interaction between ethics committees in different locations, thereby allowing the practice of "ethics committee shopping": sponsors whose trial is rejected by one ethics committee approach a different centre for approval.

The sudden boom in clinical trials, in fact, can be explained precisely because of the incapacity to regulate clinical trials. Companies are rushing to India to conduct trials which they would have problems in justifying in their home countries. This is happening in a situation where most patients in India are particularly vulnerable because they have poor or no access to public health facilities. Thus, poor and vulnerable patients sign up for trials as they see this as the only opportunity to access treatment for their disease. A study done by the Mumbai based Centre for Studies in Ethics and Rights quotes a survey that showed that just 11 per cent of trial subjects enrolled to advance scientific knowledge. In contrast the rest joined the trials because they were looking for better or free treatment, or they were advised by their treating physician to enroll. Five per cent even admitted that they joined because they were paid money to do so! Poor access to public health in India has another advantage that trial sponsors seek to exploit – most Indians are treatment naïve, that is they have not been exposed to treatments before enrolling in a trial. In other words, all that is wrong with the public health system in the country has become the primary motive force for India becoming the favoured destination of clinical trials in the world.

MIDDLEMEN MILK THE SYSTEM

The story would not be complete without a mention of the prime movers of the clinical trials industry in India. There has been a mushrooming of Clinical Research Organisations (CROs) and Site Management Organisations (SMOs) in the recent past. To put it bluntly, they are the middlemen or fixers who grease the machinery and ensure that more and more clinical trials are outsourced into India. They liaise between the drug companies and the clinical researchers (many of them of extremely dubious quality). They ensure that the drug regulatory authorities are kept happy, they draw up the protocols, advise the researchers as to how patients are to be recruited and even help in formation of the ethics committees. Their prime motivation is not an interest in research but the billions of dollars that are flowing into the industry. When researchers are drawn from the private sector, they are paid on a pro rata basis depending on the number of subjects who are recruited. Such payments can range from $1,500 (Rs 70,000) to $3,000 (Rs1,40,000) per patient.

Recently, in a reply to a question in parliament, the ministry of health reported that deaths among clinical trial subjects increased from 132 in 2007 to 637 in 2009, and 462 deaths had already been reported till June 2010. While deaths can occur among clinical trial subjects (largely in cases where the subjects are suffering from terminal diseases such as cancers), such a rapid increase is a cause for concern. The concern is compounded by the fact that there appears to be an absolute lack of transparency in reporting regarding how trials are being conducted and the outcomes of these trials.

This is not to suggest that good quality researchers are not present in India and that excellent research is not being conducted in several centres. Unfortunately these would constitute a small minority of the total number of clinical trials being conducted in the country. Given the huge and growing concerns about the dubious quality and ethical gaps regarding most clinical trials being conducted, there is a danger that the entire system of clinical research will stand discredited in the global arena. If this is to be avoided drug regulatory authorities and the Indian Council of Medical Research must step in to ensure transparency, ethics and quality in clinical research. At the same time, there is a clear need to separate the unethical and the incompetent from genuine researchers. Only better regulation with much larger regulatory capacity and resources can ensure this. Finally, there is also an urgent need that CROs and SMOs be regulated and perhaps phased out of the entire system of conducting clinical research in the country.

Courtesy: http://www.pd.cpim.org/

WHO BENEFITS FROM CLINICAL RESEARCH IN INDIA? - Amit Sen Gupta

IN recent months there have been a spate of reports that raise concerns about the conduct of clinical trials on human subjects in India. These ranged from reports of a number of deaths in trial subjects in the All India Institute of Medical Sciences in 2008, to the gross ethical violations alleged in trials of a vaccine to prevent cervical cancer among adolescent girls in Andhra Pradesh and Gujarat in 2010. There have also been reports of growing number of deaths in trial subjects that led, in one instance, to the Drug Controller General of India stepping in to stop the concerned trial in Bangalore. What is disturbing about all these reports is the absolute lack of transparency regarding how these trials are being conducted. The government, when forced by media reports to make a statement, has chosen to maintain this veil of secrecy to the extent possible.

These reports, raising misgivings about the way clinical trials are being conducted in India, coincide with a very rapid expansion of the number of clinical trials conducted in the country. The flood gates opened in 2005 when India changed the rules regulating clinical trials in the country. To understand how this happened we need to understand the process involved while conducting clinical trials.

CLINICAL TRIALS AND ETHICS

When new drugs are researched, they need to be tested on human subjects before they are given a marketing approval by drug regulatory agencies. Before a new drug is tested on human subjects, they have to be tested on animals to establish the safety and efficacy of the drug. However, this is not enough to establish the safety and efficacy of the drug in humans. The final step involves testing the drugs among human subjects. These tests are carried out in four phases. In the first phase of human trials, the drug is tested on a small number of human subjects to show that the drug is indeed safe for human consumption. Generally phase I trials are conducted on healthy subjects and the intent is to establish the safety of the drug. Phase II and III are conducted on subjects who have a condition that may benefit from the use of the drug, and thus these trials are designed to establish that the drug is effective in treating a particular disease. Phase IV trials are also called post-marketing surveillance and are designed to collect data from an even larger sample of patients, after the drug is introduced.

Because clinical trials are essentially experiments that are conducted on human beings, all countries have rules that regulate how these trials should be conducted. Globally, the Helsinki declaration, sets the benchmark of how such rules should be framed. All rules related to drug trials are concerned with the ethics of how trials are conducted. The first, and perhaps the most important aspect of these rules, are those related to “informed consent”. Because trials are an experiment they carry a potential risk. So it needs to be ensured that those who participate in clinical trials should be aware of the risks and should formally consent to be part of the trial after the risks are explained in details. The concept of informed consent is also premised on the assumption that trial subjects consent to be a clinical trial subject without being coerced, directly or as a consequence of the circumstances in which the person might find himself. The second fundamental concern about ethics in clinical trials is that trials should be allowed in a population who would later benefit from the introduction of the drug that is tested. In other words clinical trials should not be permitted where trial subjects in a particular country or community are used as mere guinea pigs.

There are several other critical issues that determine whether a trial is ethical. In recent years, a major concern has related to “placebo” controlled trials. A placebo is a substance that has no significant effect on a human subject – it could be a capsule containing a small amount of salt or sugar, for example. In placebo controlled trials, some trial subjects are given the placebo while others are given the drug that is being studied. Through this route researchers can decide if the drug is a better alternative to no treatment. However placebo trials are unethical if a treatment already exists for the disease for which the new drug is being tested, for it means that those who are given the placebo are being denied treatment, even though a treatment for the disease exists. The Helsinki declaration clearly states that in general placebo trials should be avoided if treatment already exists. However there is no unanimity on this among researchers. Laws in the US, for example, have different standards for placebo controlled trials depending on whether the trials are being conducted in the US or being conducted in a third country.

CHANGE IN LAW OPENS FLOOD-GATES

Before 2005, the Indian law was designed to actively discourage the use of Indians as mere subjects for experimentation by foreign companies. The law required that if a foreign company wished to conduct trials in India, it needed to repeat the trials from the same phase in India as had already been conducted in locations outside India. Thus if a company had already conducted phase I trials outside India, it could not directly start phase II trials in India – it would have to conduct phase I trials again in India, before permission was conducted to conduct phase II trials in the country. This allowed Indian regulatory agencies greater control over the kind of trials being conducted in India and was a vital tool for protection of trial subjects against unethical trials. In 2005, however, this requirement was waived (by and amendment to schedule Y of the drugs and cosmetic rules) and concurrent phase II and III trials were allowed. This means that a phase II or III trial can be conducted concurrently in India, along with similar trials in other centres in the world, even if the drug has not undergone a phase I or II trial in India.

The result of this change in the law has been spectacular. In 2005, less than a 100 trials were being conducted in India. The number jumped to over 250 by 1997-98 and is projected to exceed a 1000 by the end of 2010. It is now estimated that one in four clinical trials in the world are conducted in India, and the turnover for the industry is expected to touch US$ 1.52 billion by 2010. The Association of Indian Contract Research Organisations (ACRO) chairman Dr S P Vasireddi is quoted as claiming: "We have now a share of 24 per cent while China has 33.3 per cent of the global business."

REASONS BEHIND BOOM IN CLINICAL TRIALS

What explains this boom in clinical trials in the country? Does it indicate a rapid expansion of capability and capacity for conducting medical research in the country? Unfortunately the answer to this is largely in the negative. While capacity and capability have increased, the sudden rise in number of trials far outstrips the enhancement in capacity and capability. Even industry sources admit that at present levels there is a need for about 5,000 new professionals trained in good clinical practice (GCP) in the industry to augment the 600 odd who are available in the country. What is perhaps an even bigger concern is that regulatory capacity has not kept pace with the sudden spurt in clinical trials. While the law was changed in 2005, it was only in late 2009 that the government deemed it prudent to make it mandatory to register clinical trials in the country. While rules now specify that all clinical trials need to be overseen by institutional ethics committees, the constitution and functioning of these ethics committees are fraught with numerous problems. Primary among these is the issue of conflict of interest -- ethics committee members can have vested interest in ensuring that a trial is given permission because they have links with the company or the local contractor or the researcher who is engaged in promoting the trial. Further, there is little interaction between ethics committees in different locations, thereby allowing the practice of "ethics committee shopping": sponsors whose trial is rejected by one ethics committee approach a different centre for approval.

The sudden boom in clinical trials, in fact, can be explained precisely because of the incapacity to regulate clinical trials. Companies are rushing to India to conduct trials which they would have problems in justifying in their home countries. This is happening in a situation where most patients in India are particularly vulnerable because they have poor or no access to public health facilities. Thus, poor and vulnerable patients sign up for trials as they see this as the only opportunity to access treatment for their disease. A study done by the Mumbai based Centre for Studies in Ethics and Rights quotes a survey that showed that just 11 per cent of trial subjects enrolled to advance scientific knowledge. In contrast the rest joined the trials because they were looking for better or free treatment, or they were advised by their treating physician to enroll. Five per cent even admitted that they joined because they were paid money to do so! Poor access to public health in India has another advantage that trial sponsors seek to exploit – most Indians are treatment naïve, that is they have not been exposed to treatments before enrolling in a trial. In other words, all that is wrong with the public health system in the country has become the primary motive force for India becoming the favoured destination of clinical trials in the world.

MIDDLEMEN MILK THE SYSTEM

The story would not be complete without a mention of the prime movers of the clinical trials industry in India. There has been a mushrooming of Clinical Research Organisations (CROs) and Site Management Organisations (SMOs) in the recent past. To put it bluntly, they are the middlemen or fixers who grease the machinery and ensure that more and more clinical trials are outsourced into India. They liaise between the drug companies and the clinical researchers (many of them of extremely dubious quality). They ensure that the drug regulatory authorities are kept happy, they draw up the protocols, advise the researchers as to how patients are to be recruited and even help in formation of the ethics committees. Their prime motivation is not an interest in research but the billions of dollars that are flowing into the industry. When researchers are drawn from the private sector, they are paid on a pro rata basis depending on the number of subjects who are recruited. Such payments can range from $1,500 (Rs 70,000) to $3,000 (Rs1,40,000) per patient.

Recently, in a reply to a question in parliament, the ministry of health reported that deaths among clinical trial subjects increased from 132 in 2007 to 637 in 2009, and 462 deaths had already been reported till June 2010. While deaths can occur among clinical trial subjects (largely in cases where the subjects are suffering from terminal diseases such as cancers), such a rapid increase is a cause for concern. The concern is compounded by the fact that there appears to be an absolute lack of transparency in reporting regarding how trials are being conducted and the outcomes of these trials.

This is not to suggest that good quality researchers are not present in India and that excellent research is not being conducted in several centres. Unfortunately these would constitute a small minority of the total number of clinical trials being conducted in the country. Given the huge and growing concerns about the dubious quality and ethical gaps regarding most clinical trials being conducted, there is a danger that the entire system of clinical research will stand discredited in the global arena. If this is to be avoided drug regulatory authorities and the Indian Council of Medical Research must step in to ensure transparency, ethics and quality in clinical research. At the same time, there is a clear need to separate the unethical and the incompetent from genuine researchers. Only better regulation with much larger regulatory capacity and resources can ensure this. Finally, there is also an urgent need that CROs and SMOs be regulated and perhaps phased out of the entire system of conducting clinical research in the country.

Courtesy: www.pd.cpim.org

WEST BENGAL CPI (M)'S NEW WEBSITE LAUNCHED

In a short formal observance, a new website of the Bengal state committee of the CPI (M) was launched by state secretary, Biman Basu at the Muzaffar Ahmed Bhavan on 10 September. He tapped the keyboard of a laptop computer at the Muzaffar Ahmad Bhavan and the Bengal CPI (M) website (accessible at http://www.cpimwb.org.in/) floated into sharp focus on the big screen via video technology.

The website is done up using the matrix of the free software and is written in a language that can be accessed from every form of Gnu and non-Gnu software, including the Microsoft ‘Windows’ OS in its various avatars.

Biman Basu said on this occasion that a continuous stream of lies kept on pouring out in an orchestrated manner in the form of slanders and utter untruths about the CPI (M) and the Left Front from the entire gamut of the corporate media, and that a large chunk of it was also polluting the cyber space. The present site, like other sites run by the CPI (M), the various Left parties and by Left mass organisations, would be utilised to counter the lie campaign.

The websites are also used to provide information inputs to the present generation of youth who are active on the information highway and surf the web constantly, sending out and receiving every day prodigious numbers of electronic mail. The site would eventually be made trilingual, to feature English, Hindi, and Bengali. In attendance on the occasion was Bengal CPI (M) state secretariat member Sridip Bhattacharya.

Courtesy: www.pd.cpim.org