Outsourcing,Engineering Controls

Perspectives on Pre-Clinical Outsourcing in China

Article Posted: July 01, 2008

Mark Twain has been credited with the oft-quoted observation that “A lie can travel halfway around the world while the truth is putting on its shoes.” In the Internet age, lies travel much faster, and they lose little, if any of their punch in translation.

In 2006, the president of a U.S.-based pharmaceutical company that had developed a preclinical testing facility in China, commented to the media that global pharmaceutical companies (“pharmas”) were moving to China because it is cheaper and faster to do animal work there, and in addition, there are no regulations. That quotation was referenced several times at a recent Animal Welfare Forum in Shanghai (March 30, 2008). Were the comments based on fact? Fiction? Accurate in 2006, but not now? It doesn’t really matter. The story continues to circulate, and it supports the public’s preferred perception of the pharmaceutical industry and its use of animals to develop and test new products.

In a 2006 Boston Globe story entitled “ Outsourcing animal testing: US firm setting up drug-trial facilities in China, where scientists are plentiful but activists aren’t,” damaging statements were made by PETA’s Asia- Pacific director, “We are very aware and very concerned about this recent and disturbing trend of companies to contract with laboratories in countries in which animal welfare oversight is poor and public awareness is low. There is no doubt this is intended to circumvent American animal welfare laws, as minimal and unenforced as those may be.”1

Both of these examples highlight several lessons: Don’t believe everything you read. Don’t believe everything you hear, even at a professional meeting. Don’t underestimate the reach and the growing acceptance of the animal rights movement around the world. Most importantly, don’t buy into the buzz that companies and institutions outsourcing animal-based research don’t adhere to the highest international standards of animal welfare by every Contract Research Organization (CRO) with which they choose to do business, no matter where they are based.

The price of cutting corners to cut costs is always too high and can ultimately hurt the entire industry. Consequently, decisions about the outsourcing of animal work must take more than economics into account; there are scientific and ethical considerations as well.

Within the industry, much attention is being paid to the issues of outsourcing in vivo research. Recent articles that offer excellent guidance for assessing CROs, include Dr. Stacy Pritt’s “Working with Contract Research Organizations”2 and “How to Conduct an Audit of an Outsourcing Provider”3 by Andy McCallum.

There are still many questions concerning animal work in other countries; however, that require first-hand experience of the market or detailed knowledge gained by those familiar with the area. When considering preclinical CROs in China, start by reviewing the lessons mentioned above.

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