The Smorgasbord
 
Saturday, 25. October 2003
Clinical trials

Call me naive. I don't care. But deep down, I find this whole business of clinical trials so terribly unethical. But damn my ethics. Consider these numbers.

The business of pharmaceutical and medical device clinical trials is a $15 billion per year business in the U.S., and $35 to $40 billion globally. U.S.-based spending on clinical trials is growing fast – at a 12 percent per year pace that should generate $26.5 billion by 2007. So far, so good. But this is where my problem lies. There are more than 2,500 FDA clinical trials underway in the U.S. for new drugs. Because Phase II trials often use up to several hundred people and Phase III trials often require several thousand people, the need for a very large ‘patient market’ with a particular disease is enormous. The problem for biotech, pharmaceutical, and medical device companies is that it is increasingly difficult and expensive to find the large pools of people needed to thoroughly test new drugs and devices.

Enter India. With a billion people and a few hundred million below the poverty line, hundreds of thousands are queuing up to offer their bodies to be tested. For pharma companies, India is turning out to be the cheapest alternative anywhere in the world and they're queuing up by the dozen.

Reports Red Herring in a recent story on how India is emerging as the new drug trial hotspot, India appeals to businesses trying to run clinical trials because not only is it relatively easy to find treatment-naive patients, there is also a low attrition rate among them while participating in long trials. In an interview in India Abroad, Santosh Hegde, a business development executive for clinical testing management company Neeman Medical International, explained that “Indian patients have the highest return rate in the world, so critical time is not lost by patients dropping out of trials.”

There's money to be made. Fuck!

 
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