A Guilty Plea and A Global Flu Emergency

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APRIL 2009 IS ON ITS WAY TO BECOMING A MILESTONE MONTH for the laboratory testing industry. On April 15, even as corporate officials from Quest Diagnostics Incorporated were walking into a federal courthouse to plead guilty to a criminal felony charge, health officials in Mexico were in the first stages of identifying a new, troubling strain of the influenza virus.

That means two major developments in the history of laboratory medicine are happening in the same month. As you will read in our detailed coverage of Quest Diagnostics/Nichols Institute Diagnostics’s (NID) guilty plea, $40 million criminal fine, and related $262 million civil settlement, it is probably the first time that a respected public laboratory company has pled guilty to a federal criminal charge directly related to corporate behavior that caused harm to a significant number of patients. (See pages 3-6.) It is a black eye on our entire profession. One wonders what MetPath founder and pathologist Paul A. Brown, M.D., is thinking about how the lab testing company he founded in 1967 and sold in 1982 could knowingly engage in behavior it knew was harmful to patients—even 27 years after he sold it.

Next comes our intelligence briefing on the chaos unfolding in Mexico. Its inhabitants are reacting to the news that patients usually considered less vulnerable to influenza—young and mid-adult aged individuals—have died. What was originally classed as “atypical pneumonia” now has been identified as influenza virus A/H1N1. This is a new combination of genetic material from human, pig, and bird flu strains. It was just last Friday that the CDC issued its first public alert about the threat posed by this new form of influenza. By Saturday, the World Health Organization (WHO) was cautiously characterizing the known outbreaks in Mexico and in two U.S. border states as a “public health emergency of international concern.” (See pages 7-8.)

However, health officials are privately discussing the possibility that, because containment is unlikely at this stage, there continues to be the potential for A/H1N1 influenza to evolve into a pandemic. As a challenge to clinical labs in the United States and across the globe, the emergence of A/H1N1 is another reminder—like SARS in 2003—that virulent diseases remain an ever-present threat to public health. Physicians who must diagnose and treat patients with these new diseases rely on accurate reliable laboratory testing. In turn, that is a reminder that laboratories should never betray the public trust.

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