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The Flu Snafu — The Story Behind Strain A (H2N2)

Are we overlooking the need for heightened security for contagious diseases?

April 18, 2005

Are we overlooking the need for heightened security for contagious diseases?

As luck would have it, I first read about the World Health Organization's rush order to destroy vials of the influenza strain A (H2N2) — which had caused the 1957 "Asian flu" pandemic — around midnight on April 12th.

I was still exhausted from participating in my university's 50th anniversary celebration of the first effective polio vaccine that very same day.

Still in the haze of symposia, panels and speeches articulating visions for the future of global public health, I was astounded to learn that the A (H2N2) strain, which killed between one and four million people in 1957, was inadvertently sent to nearly 5,000 laboratories in 18 countries — 99% of them in the United States.

Why on earth, you may wonder, would such dangerous stuff be sent around anyway? Why isn't it kept under the tightest lock and seal?

The answer has a lot to do with quality control: To measure clinical microbiology laboratories' ability to detect and identify various strains of influenza, they are periodically required to take tests whereby they work with — and identify — "unknowns".

But as a rule, while there is a literal library of the many strains of influenza virus we have encountered, health departments have a policy of excluding those microorganisms that can harm people who use these test panels.

Public health departments and medical associations have monitored such procedures for decades. What is troubling, though, is that since the 1980s, more and more of the materials distributed are made by small, privately contracted bio-firms with increasingly less federal regulation or oversight.

In this particular case, it is the venerable College of American Pathologists that directs the testing process. However, living in a world marked — and sometimes marred — by outsourcing, the project itself was contracted out to Meridian Bioscience, Inc., based in suburban Cincinnati.

Its principal task was to produce all of the testing kits for almost 5,000 laboratories. How this potential strain was included in the kits — it has not been included in the flu vaccine since 1968 and, hence, no one born after that year has any immunity to it — is unclear.

And the Meridian Bioscience people aren't saying much. There were news reports indicating that they "felt the virus they had was a safe virus."

But this may have been inspired by their consultation of a U.S. government manual that classified the A(H2N2) strain as a "biosafety Level 2″ microbe — the second-lowest level of danger in a four-class rating.

Meridian apparently did not know about recent discussions between the CDC and the National Institutes of Health to upgrade the strain to a Level 3 rating.

This raises a few critical questions, the first being: Don't these guys talk to their outsource producers? And if they do, don't these companies listen up? And why did Meridian even have this dangerous viral strain in their library?

Taking no chances, the international public health agencies responded quickly and appropriately. True, these steps were criticized by some experts on epidemics as “overkill” and “unnecessary.”

But this criticism only underpins the dictum that it is a whole lot easier to dissect retrospectively the anatomy of an epidemic than it is to combat one in real time.

Since 9/11, the specter of bioterrorism looms over almost every infectious event, although every indication suggests there were no villains, just a lack of communication between different members of an increasingly disjointed public health network.

In the United States, there is no government regulation over the 1957 flu strain. In fact, federal officials at the CDC do not even know how many U.S. laboratories keep this deadly strain in their “viral libraries.”

Beginning in 2002, the federal government established a program that monitors a list of some 300 dangerous biological toxins and agents that are tightly controlled in terms of experimental use, scientific study and distribution.

The list includes anthrax, the Ebola virus and smallpox, but — amazingly — the 1957 flu strain has not been deemed to be included in this murderer’s row of agents “that have the potential to pose a severe threat to public health and safety.”

As Michael Osterholm, the director of the University of Minnesota's Center for Infectious Disease Research and Policy, wisely — albeit tartly — observed: "We can't have this happen. Who needs terrorists — or Mother Nature — when through our own stupidity, we do things like this?"

Perhaps the most disturbing thing about this event is that it never should have happened in the first place. Late in the evening of April 12, 2005, Dr. Klaus Stohr, the influenza chief at the WHO, announced the recall — even though there is relatively low risk that a lab worker might accidentally contract the flu strain and infect others.

While we can applaud the WHO, the CDC and other public health agencies around the globe that are responding appropriately and rapidly, due credit should go to a microbiologist named Frank Plummer who directs the National Microbiology Laboratory of Canada in Winnipeg.

He called the CDC in Atlanta on March 26, 2005, about a specimen his lab had received from a woman recuperating from a respiratory infection. "We found this out in the middle of the night on Good Friday. For several hours, we were very concerned."

The woman tracked down proved to be a red herring. Thanks to a team of intrepid Canadian epidemiologists, the flu strain was traced to Meridian.

Apparently, a lab technician who was analyzing the woman's viral sample in Winnipeg contaminated the woman's specimen with the 1957 strain while working on both strains.

A dragnet ensued and on the morning of April 13, 2005, the CDC chief, Dr.Julie Gerberding, held a press conference explaining the situation.

The situation was quickly and well contained and — fortunately for all — the public health network held up. Once again, we were lucky — an essential element in microbe hunting.

Quite simply, influenza is enjoying a renaissance of attention and, more importantly, funding — even though we really need a lot more cash to keep flu and other emerging or re-emerging infections at bay.

We also need stringent and international regulations of how vaccines are developed, how scientists gain access to dangerous microbes, and a variety of other technical and quality measures that are being continuously eroded in a world that increasingly becomes smaller.

As any responsible public health expert will tell you, the battle never ends — the war against deadly germs always continues, so don't forget about us by tomorrow. We need more resources and more money to protect the nation's health every day — not just the headline-days.

When it comes to the control of vaccines, especially in the United States, we have divested public health agency oversight for piecemeal production.

This is why we had a shortage of flu vaccine in the winter of 2004/05, as a result of one of two companies who produce our supply having quality control issues. This is why we have occasional scares over test kits and clinical laboratory snafus on a regular basis.

We live in an era of epidemics — not just the epidemics of overindulgence and wealth, such as obesity, tobacco and substance abuse — but the good, old-fashioned kind of epidemics caused by germs that travel and spread from person to person, wreaking havoc.

Purely social and quite egalitarian, they go wherever we do and respect neither borders nor boundaries.

And yet, history repeats itself time and again, with the profound amnesia we exhibit that accompanies the close of every epidemic scare — until the next time, that is, some deadly germs gain another foothold in the endless battle between them and human beings.

What we need to do is transform the fear and hoopla of occasional media events, be it the reported shortage of a vaccine, or the potential mistakes in the handling of microbes, or worse threats to the global health by developing a global, comprehensive public health strategy for the 21st century.