There are many great and altruistic scientists out there working to bring the best medicinal product to people that needed them most. People like Robert Weinberg who discovered Her-2/neu gene in 1979 for breast cancer, which gave rise to one of the best breast cancer drug, Herceptin (Bazel, 1998). How about Dr. Druker, who worked on Gleevec and worked so hard to get the drug tested and approved? The “Researcher behind the Drug Gleevec” stated “I don’t see a penny, though, that never was an issue for me. When I obtained the compound, it was already patented. I wasn’t going to get to test it if I tried to put my mark on it. I wanted to work on it because I thought it was going to be the way to treat C.M.L.” (Dreifus, 2009).  This being said, the main reasons for biotech and pharmaceutical “co-operations” started the exploration or exploitation of clinical trial outsourcing are as follows;

1) It cost about $800 million to $1 billion to bring a product in the market (including R & D, regulatory fees, and the three phases of clinical trial) within developed countries such as the US and some part of Europe. In developing countries, the cost is about more than 60% less.

2) Clinical trial alone cost about $150 to $180 million in the US. For Example, in India, it is about 60% less (Whitmore, 2004).

3) There is naïve population available for clinical trials in developing countries.

4) For co-operations that intend to avoid the FDA oversight, conducting an outsourced clinical trial in non-FDA regulated sites or less strictly regulated regions, becomes an attractive alternative (bad Idea)

These are some of the loop-holes facing globalization of clinical trials. Perhaps, if a clinical trial outsource is cheaper, safe and are intended for the subjects participating in the studied area in question, then there is no ethical concern.  Nevertheless, when the subjects will not directly benefit from the trial, then it constitutes a violation of the Nuremberg code, Belmont report and other international regulation, which guide ethical clinical practices.

References

Bazel, R. (1998). Her-2: The making of Herceptin, a revolutionary treatment for breast cancer. NY:Publisher.

Dreifus,C. (2009). Researcher Behind the Drug Gleevec. Retrieve from http://www.nytimes.com/2009/11/03/science/03conv.html?pagewanted=2& _r=3&ref=science.

Whitemore, E. (2004). Development of FDA-Regulated Medical Products. Quality Press. Milwaukee, WI.