A heart-drug trial that was ”outsourced” to India and China -- an approach many industries are taking to save money -- demonstrates the potential for doing life-saving medical research on a budget, scientists said Monday.
The study shows that clinical trials, typically used to test the value of new drugs and treatments, do not have to be done in the United States and Europe, said Dr. Salim Yusuf of McMaster University in Ontario, Canada, who led the research.
His team experimented on 15,000 heart-attack patients in India and China, and found that the use of an inexpensive blood-thinning drug called rivaparin can save lives in poor countries without having to resort to expensive treatments or brand name drugs.
“Who says you can’t do good studies in less-developed countries?” Yusuf said at a news conference during a meeting of the American Heart Association.
Most drug trials are done in Western nations, where a well-established system exists for experimenting on patients.
But Dr Raymond Gibbons of the Mayo Clinic in Rochester, Minnesota, who organized the medical conference, said such trials have become increasingly difficult in the United States. The studies are typically expensive and researchers complain that patients are not always cooperative.
Yusuf said his study had better and more-consistent cooperation than studies done in Canada.
He said his study could not have been done in a richer country, where more paperwork and management of patients is required in clinical trials. His team also had the luxury of treating patients in the hospital, where they could be watched, for seven days straight.
“It would have cost us 50 times more because of the pressures, especially in North America, to get people out of the hospital very rapidly,” said Yusuf.
Findings may help poor and rich countries
The heart-attack patients were given standard treatment when they arrived at the hospital, and then a third of them got a high dose of rivaparin, a second third got a lower-dose, and the remaining third got no additional treatment, Yusuf said.
After seven days of treatment they saw a 13 percent reduction in death, heart attack and stroke in the patients who got rivaparin, which belongs to a class of drugs called heparins.
After 30 days the benefits of treatment grew. Yusuf predicted that adding a heparin drug to the treatment people already get after heart attacks would save 500,000 to a million lives a year around the world.
The side-effects were small, he said.
“This treatment is simple, it is inexpensive, it can be used in rich and poor countries, it can be used in big and small hospitals,” Yusuf said.
The finding may also show doctors that the drugs called low-molecular-weight heparins, which help prevent the blood from clotting, might be a good addition to aspirin and other drugs that heart patients typically get, he said.
Yusuf believes his findings will translate globally.
“Every risk factor behaves identically in every ethnic group in the world,” he said.
The trial is part of a larger study that is looking at 20,000 patients in 21 regions, including India, Pakistan, China, Argentina, Chile, Brazil, Venezuela as well as countries in Europe and the Middle East.
The study was sponsored by a group of academic centers and did not involve a commercial sponsor.