BACTERIA used in Japanese food have cured hookworm infections – at least in hamsters.

Two billion people around the world are infected with parasitic worms, or helminths, which are found in the soil. The drugs used to treat them were developed to treat parasites in farm animals.

Now the first steps have been taken towards developing a drug designed specifically for people. from the University of California, San Diego, infected 12 hamsters with the hookworm Ancylostoma ceylanicum, which can infect people. Half the animals were given food mixed with the strain of Bacillus subtilis bacteria used as an ingredient in , a popular soybean dish in Japan. The others received a genetically engineered version of the same bacteria that expressed a protein with anti-worm properties.

Five days later, the guts of hamsters exposed to the protein were hookworm-free whereas the others were still infected. The study was presented at the in Washington DC.

The next step is to carry out the study with other animals and parasites. Since the bacterial strain is already part of the Japanese diet, the modified version should also be safe for human consumption.

This article appeared in print under the headline “Eat GM bacteria to kill hookworms”

“Foreign companies are treating India as a heaven for clinical trials, but it is proving hell for India.” So said an Indian Supreme Court judge on 30 September as he pressed the pause button on the country’s clinical trials, ruling that all drug trials must be halted for two weeks. That period is now up, but there is no sign of the ban being lifted.

In recent years, India has emerged as the destination of choice for foreign companies looking to conduct clinical trials, .

But while the companies reap the rewards, the Indian people enrolled in the trials may be paying the price. In March, the Indian health minister Ghulam Nabi Azad testified in the Rajya Sabha, the upper house of parliament, that The government has found that , 89 of which have been directly linked to the trials.

To put this in context, Ken Getz, founder of the in Boston says the global risk of dying in a clinical trial is 1 in 10,000. In India, the risk in 2011 was an order of magnitude higher.

Parliament involved

The Supreme Court’s ruling, which halted 162 clinical trials, was triggered by a published last month. It investigated trials of two human papillomavirus (HPV) vaccines conducted in 2009 and 2010 by the US-based non-profit organisation PATH, together with the Indian Council for Medical Research (ICMR) and drug companies Merck and GSK.

The trials involved around 20,000 girls aged between 10 and 14. The report noted that seven of them died and that there was no proper system for keeping track of side effects. It also found that parental consent forms were often inadequately completed, and that the information given out to participants implied that they were being immunised as part of a national programme rather than a clinical trial.

Ajay Gambhir from the website , which provides unbiased advice to Indian citizens on immunisation, says that the HPV vaccine case is an all too common story in drug trials in India.

New regulations

The government is trying to make things better. In March, it ruled that all clinical trials have to be approved by an independent ethics committee, as opposed to a panel set up by the drug company as was previously the case. The new regulations also require the body conducting the trial to bear full responsibility for any injury or death that is shown to be a direct result of the trial.

This has come as an unwelcome move to many foreign drug firms who fear they may now be liable for the long-term healthcare of their trial participants. A spokesperson for , one of India’s largest biotechnology companies, says the new regulations could lead to a situation where “global pharma innovators are bypassing India and shifting to other South-East Asian countries”.

This fear isn’t entirely unfounded. Since the new regulations were announced, the US National Institutes of Health has , as have several US and Canadian companies. The rules are still being discussed and may be watered down when they are debated again in India’s parliament later this year.

While the changes are a must to reposition India as the preferred destination for clinical trials, says Hitesh Sharma of industry analysts , the near- to mid-term outlook for the industry looks bleak as it undergoes changes. However, he says: “The efforts will take some time to have an effect on the industry; but long term, the outlook still looks positive for Indian clinical trial industry”.

, director of the National Institute for Research in Tuberculosis in Chennai, agrees that the difficulties clouding Indian clinical trials are a temporary phase. “This whole year has been a learning experience for the Indian clinical trial scene. I think it will end with a positive change leading to better volunteer protection and a resumption of trials” she says.