India's Drug Trials-Thousands have died since rules were eased

In the January 2011 Issue Of Vanity Fair, in the article "Deadly Medicine" the authors Donald L. Barlett and James B. Steele investigated clinical trials conducted overseas. According to the piece some clinical trial participants were;

"Sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves?

This month the Wall Street Journal has brought to light the same unethical trials taking place across India.

India's Drug Trials Fuel Consent Controversy

Thousands have died since rules were eased

Rama Lakshmi
(The Washington Post, January 2, 2012)

"Since India eased guidelines for conducting drug trials in 2005, the number of Indians participating has shot up to 150,000 from close to zero, as international drug companies take advantage of lower costs here. But questions about the consent process have fueled fears that many Indians are entering the trials without knowing the risks...In the wake of the recent controversies, the Indian Council for Medical Research invited public feedback on draft guidelines about compensation for injuries that occur during clinical research…Across India, 1,700 people who participated in clinical drug trials died between 2007 and 2010, the government’s drug regulatory agency said, although no autopsies were carried out to determine the causes of the deaths. In 2010, 22 families of the dead were compensated by U.S. and European drug companies, ranging from $2,000 to $20,000. Clinical drug trials in 2010 generated business worth $300 million in India, according to the Confederation of Indian Industry. Conducting drug trials here saves the companies almost 40 percent of the total cost of drug development because health-care professionals are cheaper and liability is not very high, analysts said. The large pool of patients with diverse illnesses and doctors who speak English also make it an attractive destination for outsourcing trials. 'India is emerging as a hub for drug trials, and Indian patients are like guinea pigs,' said C.M. Gulhati, editor of the Monthly Index of Medical Specialities journal."

Full Text

India outrage over low fine for drug trials

Authorities in the Indian state of Madhya Pradesh have been criticised for letting off lightly 12 doctors who conducted drug trials on children and patients with learning disabilities.

The doctors were fined 5,000 rupees ($94; £60) each for failing to inform the authorities about the tests.

Activists and opposition parties said the fine was a "joke" and called for an investigation by the federal police.

The trials of the drug to treat sexual dysfunction were in the city of Indore.

Millions of people in India are thought to be on clinical trials.

Correspondents say patients are often unaware that they are being experimented on, and that when they are told the high levels of illiteracy mean they are unable to give informed consent.

'Inhuman crime'

It was unclear how the latest case came to light.

However, one Madhya Pradesh doctor who lodged a complaint over the case, Dr Anand Rai, told the Times of India: "Drug trials were performed on patients who had gone to the hospitals for routine treatment. It's a criminal offence to put them under drug trials without consent."

He said the maximum penalty for the offence was 50,000 rupees.

The Congress party, which is the main opposition in Madhya Pradesh, also criticised the state government for levying such a low fine for "a grave, inhuman crime", The Hindu newspaper reported.

"The lives of the poor patients who were victimised in the name of drug trials is just 5,000 rupees? We demand an inquiry by the Central Bureau of Investigation," the paper quoted leader of the opposition in the state assembly, Ajay Singh, as saying.

The authorities said the doctors were fined for failing to inform health officials about the drug trials, not for failing to inform the patients.

Further action would require knowing the identities of the patients and the doctors who carried out the trials cited a law that requires them to keep the identities secret.