A Catholic medical school has dismissed concern over its controversial drug tests, saying all precautions have been taken to avoid major health risks to volunteers.
“If there are some minor risks, we weigh the risks with the benefits,” Prem Pais, dean of St. John’s Medical College in Bangalore, told ucanews.com on June 8.
The school is among 10 institutes in India selected to conduct tests comparing two anti-diabetic drugs.
Pais’ assertion came amid newspaper reports alleging that the tests expose volunteers to risk.
India’s Drugs Controller General gave Glaxo Plc permission to conduct trials in the country after two US testing sites failed to get volunteers, Chandra M. Gulati, editor of the Monthly Index of Medical Specialties, was quoted in an Indian newspaper.
Glaxo Plc is conducting trials to assess the cardiac safety of its diabetes medicine, rosiglitazone, in comparison with another of its products, pioglitazone, the Daily News & Analysis English newspaper reported on June 4.
The trials are reportedly being conducted on 16,000 people in 14 countries.
St. John’s Medical College has taken all precautions to avoid major risks, said Pais, who also heads his college’s Clinical Trials Division.
The school conducts such tests only after its Ethical Review Board approves of them, he said. The board comprises doctors, health professionals and religious people.
His college began conducting such tests about 10 years ago and would never undertake them if they involved major life-threatening risks, he said.
The school also conducts the trials in three phases. Trials on humans are “phase three” after laboratory tests and trials on animals, the dean said.
The Catholic Bishops’ Conference of India founded the school in the southern Indian city of Bangalore in 1963.