Wednesday, June 11, 2008

T. McGarity & W. Wagner's "Bending Science"

Thomas O. McGarity & Wendy E. Wagner are professors at the University of Texas School of Law.

They applied the “Page 99 Test” to their new book, Bending Science: How Special Interests Corrupt Public Health Research, and reported the following:
In a 400 page book teeming with reports of the misappropriation of science by corporations, attorneys, interest groups, and even the federal government, it is not terribly surprising to find that page 99 cuts right to the center of one of the more expanded illustrations of these battles over regulatory research. Unlike many of the other examples in the book, however, the account on page 99 is both more familiar (the scientist’s travails formed the basis for John le Carre’s book, The Constant Gardener) and also more complex than most of its companions in this and other chapters.

Here, the researcher – Dr. Olivieri – discovers that a drug used to treat a terrible childrens’ disease, thalassemia, may not be effective. When she communicates the preliminary results to some of her patients, the drug company sponsoring the research pulls their funding and threatens to sue her. After publishing additional preliminary research that suggests that the drug might also be causing liver scarring in patients, Olivieri is dismissed as “nuts” by some scientists and revered as a hero by others.

Ultimately, Dr. Olivieri’s story reveals the power that the sponsors can have over research, the contentious nature of applied regulatory research, and the high stakes involved for scientists who decide they “will not be bullied” and proceed to conduct research that is unwelcome by sponsors. But, unlike some other examples of regulatory science, this story doesn’t have a clear ending. Dr. Olivieri feels victimized and is certain that the drug makes patients worse off. However, the truth about the drug remains shrouded in mystery to this day, even while doctors in twenty-five countries prescribe it (the drug is not approved for use in the U.S. or Canada).

A reader that continues past page 99 will find that the Olivieri case is only the tip of the iceberg. The types of pressures – both legal and economic – that sponsors and others place on research used for regulation are immense and surely have an impact on the types of scientific findings that emerge, as well as on the researchers themselves. Yet, these problems that afflict regulatory research are not necessarily intractable. The last three chapters of Bending Science offer a range of proposals for legal reform, building in part on the approaches developed informally from within the scientific community. These reforms are only a start, but at least they will limit the role that sponsors can play in controlling regulatory research and should help bring respected scientists to the government table to assist regulators in sorting out reliable studies from the rest.
Read an excerpt from Bending Science, and learn more about the book and its authors at the Harvard University Press website and the book's University of Texas School of Law website.

--Marshal Zeringue