Thanks to Anna for giving us the link to a very important MSNBC news story which just aired, regarding the outsourcing of drug trials to India. Impoverished Indians are recruited as human guinea pigs for US drug trials, with inadequate monitoring and protections.
Here's the link to the article and program. It's a must see/read.
link
Drug trial outsourcing to foreign countries is rapidly becoming an attractive alternative for pharmaceutical companies that are looking to save millions of dollars, avoid regulatory scrutiny and tap into a seemingly endless supply of drug study participants.
But a year-long Dateline investigation into one of the preferred destinations for overseas drug trials, India, raises questions about lax regulatory oversight in these studies, the integrity of some of the companies contracted to run them and the reliability of the data they produce.
Foreign drug trials have become crucial to pharmaceutical companies looking for approval from the U.S. Food and Drug Administration to sell their products to Americans. Eighty percent of the drugs that the FDA reviews for approval now rely on some tests done on foreign soil, according to a 2010 report issued by the U.S. Health and Human Service’s Office of Inspector General.
The same report included another startling figure: The FDA inspects fewer than 1 percent of foreign drug trial sites, a number slightly higher than the percentage of sites inspected in the U.S.
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Why did this story catch my eye?
I recently read a news story on a very prominent MS specialist traveling to India to make a presentation on the new MS drugs. I found this quite odd, as MS rates in India are rather low--
estimated at 3/100,000 people.
Despite a modest estimated prevalence of MS in India of 3/100,000, in this a nation of 1.2?billion people, there are probably more than 30,000 people with MS.
http://www.hindawi.com/journals/ad/2011/937586/
Yet, here is the news story about MS specialist Dr. Richard A. Rudick's visit to India--
the article is titled, "Multiple Sclerosis Curable, says doc"
Multiple sclerosis is no longer untreatable, asserted Dr Richard A. Rudick. While delivering the T.S. Srinivasan endowment oration in the city on Saturday, the Director of Mellen Centre for multiple sclerosis, neurological institute, Cleveland clinic in the US, revealed that with today’s medical advances about 30 to 50 per cent of patients afflicted with MS can be treated.
MS is one of the most debilitating of neurological disabilities that has a hugely negative impact on a patient’s quality of life. The disease that affects about one in 1,000 people in the US may be affecting almost as many Indians, which means the numbers are huge here.
According to Dr Rudick, MS in India remains largely under-recognised and under-diagnosed, but that may change soon.In his speech titled, ‘Meeting the Challenge of Multiple Sclerosis - The Road Ahead’, Dr Rudick, said “MS, an auto-immune disease that affects the brain and the spinal cord (central nervous system), is a neurological disorder on the rise. We’ve made more progress in the last 15 years in MS than we did in the last 200 years in the history of this condition.”
link to article
Was this presentation a way to find more participants for MS drug trials in India? To make it appear that US drug makers can CURE MS? And how are the MS drug companies participating in this out-sourcing of medical research? This is upsetting on many levels. I hope NBC News continues to follow this story.
Here is a recent MS drug study that took place in India--
Daclizumab as reported at ECTRIMS
But there was one worrisome note in the trial: A patient's death from a psoas abscess that developed following a skin wound. "We think daclizumab may be related to this complication," Giovannoni said at a late-breaking abstract session where he presented the findings.
link to story
Joan
