Glaxo shifts risky-drug trial to India

Glaxo Plc, under fire for large-scale global clinical trials of a diabetes drug that is said to spawn heart risks, is looking to shift the trials to countries like India, Pakistan and China.

“The Drugs Controller General of India (DCGI) has given them permission to conduct the trials in India,” said Chandra M Gulhati, editor of Monthly Index of Medical Specialties (MIMS), a journal on drugs available for prescription in India.

Efforts to contact the DCGI, Surinder Singh, were unsuccessful.

Gulati said Glaxo has started recruiting patients in India, Pakistan, China owing to the difficulty in getting subjects in the west.

“Two potential sites for the trial in the US have already withdrawn citing, difficulty in finding patients. Hence they are coming to India,” Gulati said.

A Glaxo spokesperson told DNA Money institutional review boards and ethics committees around the world have approved the study, and patient safety is monitored by an independent data monitoring committee, which includes international experts in heart diseases, diabetes, and statistics.

Glaxo has added 53 new testing sites for the medicine since March this year.

Of these, 10 are in India -Bangalore, Kochi, Karnal, Mumbai, Nashik, Pune, Kottayam and Vijayawada.

The company is conducting trials to assess the cardiac safety of diabetes medicine rosiglitazone compared with another of its products, pioglitazone.

The trials, codenamed TIDE, are being conducted on 16,000 people in 14 countries.

“This is unethical as the aim of the trials is to prove which of the two drugs is more dangerous,” said a healthcare expert, not wishing to be named.

The US Food and Drug Administration is also assessing the situation.

Ruth Macklin of the department of epidemiology & population health, Albert Einstein College of Medicine, New York, said the Glaxo trials violate principles in research ethics.

“The Belmont Report, by the National Commission in 1979, states that the principle in research is to maximise possible benefits and minimise possible harms. The study is deliberately harming subjects,” Macklin said.

Sidney Wolfe, director, Health Research Group, Public Citizen, a consumer advocacy group in Washington DC, said there are well-documented studies in the US, UK, Canada, showing heart risks associated with rosiglitazone.

“Hence this trial defies a basic tenet that trials should be conducted to determine the balance of risks and benefits, and not simply to provide absolute proof of harm.”

Glaxo is also facing about 13,000 lawsuits filed by former users of the medicine who allege that the company failed to adequately research their medication or warn users about serious side effect.

Wolfe said it is tough to imagine any patient willingly participating in the trial involving a medicine that has known safety concerns.

“Why would patients agree, especially if they have been properly informed about the advice of the American and European diabetes associations,” added Macklin.

Sacin Nikarge, programme/research officer with Mumbai-based Centre for Studies in Ethics and Rights, said the clinical trials protocol mandates that informed consent is undertaken, whereby participants are informed about the the plus and minuses of the trial.

He said it is very unlikely that anyone would willingly subject himself to harm unless the information provided to participants is not clearly legible.