M e d i c i n e A ve 2 Communications as a watchdog for the communications industry to the present day. Under the leadership of Jack Angel and John Kamp, it has defended the rights of industry to speak, and of patients and consumers to receive truthful, balanced information about pharmaceuticals and medical devices. For example, in the late 1990s, the coalition supported the first legal challenge to the FDA on a communications issue, mounted by the Washington Legal Foundation. The next important event was the initiation of a national campaign to provide universal healthcare in the US during the Clinton Administration. While the actual objective of reformers was not the reform of healthcare, but rather the expansion of health insurance to cover disadvantaged populations, advocates lost no opportunity to demonize the pharmaceutical industry and its marketing practices—including its communications—claiming that such practices were key drivers of cost inflation in healthcare. At the same time, a new, restrictive standard known as "the Precautionary Principle" was imported from Europe and began to gain favor among American activists. Originated in Germany by environmental and public health advocates in the 1970s, this ideology suggests that new technologies should be considered dangerous until proven otherwise, and that governments should refrain from approving such technologies until a scientific consensus has been reached that all potential risks are understood. As observed by Gilbert S. Omenn in this book1: "Each of us...must be keenly aware of the delicate balance that exists between communicatingjust the light amount ofinformation about emerging technologies, and prematurely overstepping the boundaries of what is known into speculative areas unsupported by data. To prevent the pendulum from swinging toofar to one side or the other in policy debates over what has been called the Precautionary Principle, we must acknowledge the tension that exists between those who view advances in disciplines such as nanotechnology and the neurosciences as rampant novelty that must be regulated by "anticipatory governance," and those who callfor a balanced, temperate approach that protects the public without a chilling effect on innovation—and we must work to manage that tension publicly." The potentially stifling effect of such a standard applied to the innovative life sciences has not yet been determined. "Healthcare faces many of the same barriers that other industries have faced in striving toward ultrasafety," wrote Amalberti et al.2in 2005. Yet healthcare faces at least three additional factors, the authors note— risks in healthcare are not homogeneous, the magnitude and impact of human error 50
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