23September2018

Andaman Chronicle

The Daily Diary of the Islands

Drug trials need to be monitored

A Right to Information query filed by Indore-based medical rights activist AnandRai revealed that of the over 2,000 who died during drug trials in last four years only 22 received compensation. 

 

The information provided by the Drug Controller-General (India) revealed that 2031 people died as a result of Serious Adverse Events (SAEs) caused during drug trials but only about 1 per cent of them received any compensation.

The figures of SAE-related deaths for 2008, 2009, 2010 and 2011 are 288, 637, 668 and 438. However, compensation was provided only in 2010 and only in 22 cases of deaths, according to information available with the DCG (I).

While no compensation was paid for 2008 and 2009, data for 2011 has yet to be compiled. Pharma companies paid compensation in cases where it was established that a person’s death was caused by the drug trials and not merely during the trial which was the main reason for such few people receiving financial assistance.

In a flagrant violation of the principals of justice, it’s the companies themselves which decide whether a death was caused by a trial or otherwise. As Rai puts it, “The companies would want to pay compensation in the lowest possible number of cases.” DrRai, who founded the Clinical Trial Victim Association of Madhya Pradesh, feels, “We believe all cases of SAE-related deaths should receive compensation. We have filed a petition in the Supreme Court on the matter.”

Despite DrRai asking for the SAE-related death figures for the year 2012 and for details of the trial sites/hospitals where the 2,031 deaths occurred and their State-wise location, the DCG (I) said it did not maintain such data.

Following an appeal by the petitioner, the CIC directed the DCG (I) to provide the State-wise trial site details by August 15, 2012 and directed the DCG(I) to provide the petitioner with figures for SAE-related deaths till January 2012. The DCG(I) told the Commission the data up to January 2012 had not been compiled as it was compiled four to six months after the end of the calendar years. “The Commission feels such data should be available every month,” Mr Gandhi noted in order passed.

It may be recalled that in 2011 May, the health ministry had asked 44 drug-makers to explain why they have not provided compensation, mandatory under the current law.

Among those queried were Eli Lilly, Novartis, Pfizer, Bayer, Merck, Johnson & Johnson and Sanofi-Aventis. The data compiled by the ministry revealed there were 152 deaths reported during Sanofi trials and 138 took place in Bayer trials.

A clinical trial investigator maintained the deaths were not caused by a medication, but were due to the progression of underlying diseases and compensation was not required in such cases. Other drug-makers swiftly followed suit offering a similar argument.

It was alleged that most deaths, attributed to cancer or cardiovascular and cerebrovascular disorders, seemed to have occurred due to the advanced stage of illness among volunteers. The committee had initiated the probe because the ministry did not have records on the number of deaths and the socio-economic status of the clinical trial subjects who died.

Following four teenage girls taking part in a test of human papillomavirus (HPV) vaccines before succumbing to it, the Indian government was charged with permitting its citizens to be used as guinea pigs to test dangerous vaccines.

An investigation exonerated the vaccines but exposed issues of ethical irregularities.

A committee of three scientists from All India Institute of Medical Sciences (AIIMS) in New Delhi, commissioned by the government to look into the trial, confirmed the three deaths were not linked to the vaccines. Two of the girls died of poisoning, one of drowning and the fourth due to a fever.

The study, however, involved several serious ethical violations. Reportedly, the participants were recruited from vulnerable tribal populations and consent was improperly obtained. Why, apparently, headmasters of the girls' schools signed the forms and adverse events were poorly recorded.

Indian regulators were critised for classifying the HPV study as an observational rather than a clinical trial, which meant that it was subject to different regulations, including looser reporting of side effects.

The expert committee deemed it to be a clinical trial because it was a “study of a pharmaceutical product carried out on human participants” and “4 of 5 primary outcome measures proposed related to evaluation of the safety of the vaccine.”

The episode also exposed the fact that international researchers were obliged to work within the ethics capacity of the host country. 

India continues to be perceived by the Western world as a robust testing ground for drugs due to its huge population and loose regulations that help dramatically cut research costs for lucrative products to be sold in the West.

With restrictions on drug trials relaxed in 2005, the industry has more than 1,50,000 Indians involved in at least 1,600 clinical trials, conducted on behalf of British, American and European firms including AstraZeneca, Pfizer, and Merck. 

Between 2007 and 2010, reportedly at least 1,730 people died in India while, or after, participating in such trials. Many of those people, often only eligible for the studies because they were ill, might have died anyway. But, in the case of complications that result in death, there’s an associated failure to investigate too. 

A lot of crucial trials are carried out in accordance with appropriate guidelines but activists say a lack of oversight has led to a surge in poor even illiterate individuals, recruited from city slums or else tribal communities, getting used in the trials without offering proper informed consents – that is, without fully understanding what they are signing up for.

Need to address imbalance

Till date, the media has been on its toes reporting on deaths that have occurred from clinical trials but oddly remains silent on the issues that are of pivotal importance.

The larger picture is that of the routine exploitation of those who participate in the trials.

The participants include those who are often poor, uneducated and unable to read and write.

Issues of consent inevitably surface when examined as almost all participants, in interviews, maintain that they agreed to take part solely owing to recommendation of their doctor also the person conducting the trials.

Also, as most of those selected to participate were from some of the poorest communities, they have little possibility of redress.

“There are ethical violations at every level,” said Ms N Sarojini, director of the Sama resource group for women, which recently held a forum on clinical trials. There is a lack of accountability, a lack of monitoring and regulation.

International guidelines, formulated to protect the rights of trial subjects, stipulate the interests of the individual should take precedence over the good of science and every drug company has policies which conform to these standards which, in reality, are not adhered to.

MP?Brinda Karat had even called for investigations into abuses saying, “There is a gross violation of guidelines and laws concerning clinical trials in our country.”

Every institution carrying out a trial must receive an approval from the ethics committee which should be, in turn, held accountable by law.

Incidentally, globally, there are wide disparities in economic development,in burden of disease and in health outcomes.

The accelerating trend towards globalisation, without the requisite safeguards and protection of human rights, will only worsen these health inequalities.

Although the private sector has played an increasingly important role, public health programmes hold the key to achieving health goals in most developing countries.

Decisions about these and other interventions must be based on scientific evidence.

Research funding in developing countries has also been the subject of much attention recently. According to the Global Forum for Health Research, less than 10 per cent of the world’s research resources are earmarked for 90 per cent of the health problems.

To address the imbalance, there’s an urgent need to promote equity in health research globally and to strengthen the capacity within developing countries to undertake research that is relevant to them.

Readers keen on seeking help on drafting RTI applications may write in to This email address is being protected from spambots. You need JavaScript enabled to view it. or call Gajanan Khergamker on 022-22841593 for any assistance on RTI or to have their findings / issue featured on this page