1 December 2013
Our investigation in India shows that 80% of participants in “Swiss” studies take place in rural areas and in situations of poverty. The urban population, more educated, is in contrast a lot more reticent to take part. While certain patients respond to advertisements, most are recruited by their doctor, to whom they accord a high level of confidence. The opportunity of getting free treatment – normally too expensive for them – is often the main reason for their participation.
Dangerous conflicts of interest
Conflicts of interest are also very common in this country, where the doctor often also fulfils the role of principal study coordinator. In such circumstances, the notion of obtaining informed consent in a situation of independence is unrealistic, especially where vulnerable people are concerned. There are also many “institutional” ethical committees in India, which are attached to a health infrastructure that welcomes clinical trials and benefits financially from them. Whatever their degree of independence, these organisations rarely verify consent procedures. Like the Indian drugs agency, they only check the existence of such forms.
No treatment at the end of the trial
In spite of the very high expectations of the participants, our investigation revealed that access to treatment at the end of “Swiss” clinical trials is far from being guaranteed. The doctors questioned are often incapable of answering this question, and refer to the proponents’ policy on this matter
Many deaths and little compensation
The reporting of side-effects during drug testing is rare in India. Rather than putting the study at risk, companies prefer to conceal them, and thus avoid creating anxiety among the participants. According to official sources, more than 2600 deaths have occurred in India as a result of clinical trials between 2005 and 2012, out of 40,000 participants. More worrying still, more than half of these deaths were recorded between 2010 and mid-2012. In total, only 22 deaths were attributed to drugs tested in 2010, and 16 in 2011. The families who received compensation obtained sums between 3000 and 4000 francs – a paltry sum compared with the millions generated by the sales of these products and the suffering involved.
Novartis is one of the companies involved, with 7 and 57 deaths occurring in 2010 and 2011 respectively. When questioned on this point, a representative from the Basel-based giant declared that none of the deaths were due to the trials. This affirmation has not been verified by a second opinion. According to our sources, Novartis has not paid any compensation.
In case of serious side-effects, the injured parties must be prepared for a long struggle if they wish to prove the link with the product being tested. Unless they have the means to do so, they generally have to abandon this option.
The “guinea-pigs” of Bhopal
In 1984, the streets of Bhopal became a death-trap, with 3500 people killed on the spot and a resulting 20,000 subsequently dying. Twenty years later, in a free hospital reserved for victims of the industrial catastrophe that around 10 companies – among them Pfizer, GlaxoSmithKline and Astra Zeneca – found “guinea-pigs” to test drugs that were not initially designed to treat conditions linked to this tragedy. These clinical trials, which were highly cynical, were stopped in 2008.
The clinical trials sector in India, which has expanded greatly, has been shaken by several scandals of this type, direct consequences of a laxity in the regulation of studies. Although the question is now being debated at a political level, restricting solutions are slow to be implemented, due to a conflict of interests.
This investigation has not (and probably will not) be followed up or updated. The results published on this web site are those obtained during our research in 2013.
Investigative Report by Public Eye: Exploratory Study on Clinical Trials Conducted by Swiss Pharmaceutical Companies in India (2013)