FRED DE SAM LAZARO: A central tenet of clinical research is that it should benefit the larger society. And Kahn says there cannot be two societies, one taking the risks, the other the benefits. JEFFREY KAHN: There needs to be some assurance that the benefits of it would go to the population from whom the participants come, so that the drugs would be used, say, in diabetics in India if it was a diabetes clinical trial using Indian subjects, and not to develop a new drug that would be used in western Europe and the United States solely. FRED DE SAM LAZARO: But the company's doing clinical trials here say doing the research in India will lower costs and make drugs affordable to everyone, including Indian patients. Dr. Swati Piramal heads a family-owned conglomerate that's branched into clinical trials. DR. SWATI PIRAMAL: In the year 2010 there are going for more diabetics everywhere in the world, most of them will be in India. And I think the drugs which are being developed in India and will not only benefit our country but will benefit people everywhere at an affordable cost and very good quality. Enforcing guidelines FRED DE SAM LAZARO: Questions of quality worrisome experts. Will people desperate to enroll just to get health care lie about their medical histories? Will doctors take advantage of patients whose poverty and illiteracy make them especially vulnerable in India? In November, the Indian government announced plans to register and then monitor all clinical trials in the country, also to create laws to enforce ethical guidelines. But even with laws on the books, India has seen widespread abuses in medicine. For example, millions of ultrasound scans are done solely to abort female fetuses. Kidneys are routinely purchased from poor people for transplantation. For their part, clinical trials companies say it is in their business interest to conduct trials cleany, to ensure subjects are protected from undue risk and given sufficient information to give truly informed consent. Many international pharmaceutical companies seem sold. Whether it's good for the Indian public or not, analysts say as many as 2 million Indians may be enrolled in research trials by 2010. Just three years ago that, number was perhaps 2,000 |