"Outsourcing" Medical Research
by Betsy McCall, Thu Aug 28, 2008 at 08:41:36 AM EDT
Just as concern is growing over FDA's approval of new drugs and therapies that later prove to harm patients, we find the international pharma industry has found a way to lower the cost of drug development.
They're outsourcing human clinical trials, in countries like India, where costs are low, and regulations lax to non-existent. Not only are patient's losing informed consent rights, the results of the trials have little scientific peer review or oversight and, like the Vioxx trial, may hide data on negative side effects of drugs.
If you think US consumers are protected, you're only barely right. Regulations for having clinical trials research published in professional journals is voluntary only. No doubt pressure on the FDA will grow to approve more drugs based on results of these international clinical trials.
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Just a few figures suffice to explain the glee among the global pharma players and their local partners over the clinical-trial cooperation. The average cost of bringing a new drug to market is estimated at $1 billion. Human clinical trials are the most expensive phase of drug development. As much as 60 percent of the costs can be cut by holding the trials in a country such as India.
On the other side, Global consultancy McKinsey and Company estimates that, by 2010, global pharma majors will spend around $1 billion to $1.5 billion just for drug trials in India. As many as 139 new trials were outsourced to India last year, putting it well ahead of China, which had 98. The market value for clinical trials outsourced to India is estimated to stand at $300 million, having increased by 65 percent over last year.
To be fair, international clinical trials, conducted properly are a very good thing for research and drug development. They foster collaboration within the international research community and can yield faster accrual and results. But they have to be transparent from start to finish and they must follow rigorous rules of scientific and consumer peer review.