Indian children treated as guinea pigs by US firms: Study

Indian children treated as guinea pigs by US firms: Study

 

american companies conduct clinical trials of medicines that might never be sold in the country

 

 

A study published in the latest issue of American medical journal 'Pediatrics' has said that almost one-third of clinical trials by American pharmaceutical companies are being conducted on children in developing nations like Uganda and India. What's surprising is most of these medicines might ultimately not be sold in India or Uganda at all, because of their high cost. The study is all set to kick off a debate on scientific and ethical issues of clinical trials.

The study included sites in 54 countries, including developing or transitioning countries in Eastern Europe, Asia, Africa, and South and Central America. Researchers said this was likely due to lower costs of conducting research overseas and fewer regulatory requirements. Paediatric diseases are rarer than others, which is why choosing many sites will help US firms speed up research.

"It's much cheaper and less time consuming to conduct research outside the US," said Dr Sara Pasquali, the study's lead author from Duke Clinical Research Institute. More than one-third of published trials performed under the 1997 US legislation, Pediatric Exclusivity Provision, were carried out partly in developing or transitioning nations, such as Uganda and India.

"Once testing is done in a country, it's unclear if effective drugs will be marketed there and whether they will be affordable," said Dr Pasquali.

The article asked whether research was done in sync with the health needs of the population and whether the treatments would be readily available to children after the study had ended. There was concern about whether doctors might have been used to persuade families and children to participate in the trials, given people's tendency to trust them completely. The study also pointed out that for many families trial participation may be the only access to medical care and compensation and that ensuring informed consent may be difficult in countries with widespread illiteracy.

The Indian government has, however, denied permitting pharmaceutical companies from developed countries use its citizens as guinea pigs for clinical trials of drugs that may never be used here.

"This study is talking about general presumptions. It has given no figures … India has strong checks and measures. Clinical trials are monitored for utility and ethical rights," director general of Indian Council of Medical Research (ICMR), Dr VM Katoch, said. He clarified that no first-time clinical trials are allowed on children unless it has been conducted elsewhere.

"There are very few trials related to children conducted in India, and those too are allowed only if children in other countries have been tested. Similarly, we allow only those trials that are relevant to us," Katoch said.

The ICMR chief, however, said that trials are like double-edged weapons. There are many new generation drugs that should be tested in developing countries keeping in mind their future requirement. "For instance, the new anti-allergic drugs, which may be used in India also some time later. We have to test in advance its efficacy on Indian population…Similarly, this study says that trials are being conducted in developing countries for malaria and HIV drugs. Isn't it obvious that malaria and HIV are the main problems of developing countries and it is developing nations who will benefit from such medicines," Katoch said.

Among the 174 trials the researchers examined, drugs against infectious diseases were most likely to be tested in the developing world, closely followed by heart, allergy and arthritis medications. "We are now using vulnerable people in vulnerable countries as drug laboratories. It is all about dollars," said Dr Marcia Angell, who was not involved in the research.