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This is the equivalent of a cigarette company refuting the required warnings that are made on a cigarette package. The cigarette companies are free to fight the cigarette warning labels as they are being considered, but once a federal body requires those warnings, the companies must not act to undermine the required warnings. In this case, Pfizer's actions are more grievous than those of a cigarette company undermining a package warning because the black box warnings are required by a federal regulatory safety agency, rather than by a Congressional act. More specifically, the black box warnings are an official part of the formal approval of the marketing and sale of the drug. The company may not sell the drug without the warning. By publicly undermining and refuting the warning, the company is essentially violating the terms of the drug's approval.

Dr. Henningfield: "Dr. Henningfield is a Principal at, and derives most of his income from, Pinney Associates, a firm that currently provides to GSK on an exclusive basis consulting services regarding smoking-cessation products. His formal title is: Vice President, Research & Health Policy. Through his association with Pinney Associates, Dr. Henningfield advises GSK specifically on the development of nicotine-replacement therapies and treatments for tobacco dependence. Pinney Associates has received on average more than $2 million per year in revenue from pharmaceutical companies, more than half of which relates to smoking-cessation products. In addition, during the last decade, Dr. Henningfield has received grant support for research and writing from GSK on at least eight occasions. Dr. Henningfield is also a partner in a company that holds patents for a nicotine replacement-therapy product. He has estimated that, if thess patents are successfully licensed, they could be worth more than $1 million to him as a partner in that company. Thus, Dr. Henningfield has a financial interest in bringing about regulatory policies that will drive current smokers to use nicotine-replacement-therapy products."

This is not a public health policy. It is a moral crusade.


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