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Will it take a second pandemic to move flu vaccines from private enterprise to national defense?

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I predict that flu vaccines in the developed world will follow the trajectory of AIDS drugs in the third world: similar lethargy, death toll, threats to bypass patents to produce generic substitutes, and finally various forms of production and/or resale agreements that allow wider local ministration to the disease. The step that bothers me is the death toll part.

With the avian influenza strain A(H5N1) on our doorstep, we seem to have forgotten the 20+ million dead of the 1918-1919 Spanish Flu pandemic in an era that predated today's global transportation systems as well as the 2002-2003 near miss of SARS (Severe Acute Respiratory Syndrome) which itself is still not contained yet has lulled many into a sense of complacence as WHO notes that "SARS has entered a time of great danger" as "people tend to become overconfident and lower their guard when outbreaks wane."

The breeding grounds of Asia in which cages of chicken and birds are stacked atop monkeys and small mammals, in turn stacked atop pigs remain as do the humans who slaughter them on the same tables. A(H5N1) "continues to kill the majority of people it infects. Health officials are expressing worry that the longer the H5N1 strain remains active, the greater its chance to acquire genetic material from more common types of influenza, creating a virus that is highly lethal and readily passed among humans. That could occur if a person caught avian and human strains of flu simultaneously." China recently disclosed that "scientists had detected two strains of bird flu, including H5N1, in pigs. Since pigs can contract human influenza, they could also serve as the source of a hybrid strain that could cause a pandemic."

Think when, not if, and you have a grasp of the looming problem. Think death toll of startling proportions with consequent economic interruption. (During the SARS epidemic, we created a hierarchy of symptom to impact to interruption for clients in order to predict when and where global supply chains would fail. The list started with restaurants closing and ended with regional economic collapse.)

We have utterly failed to solve the "chronic mismatch of public health needs and private control of production of vaccines and drugs" for a variety of reasons:

  • Expensive investment and production costs not recovered unless there is a pandemic
  • Unsettled intellectual property rights over new vaccine manufacturing techniques
  • Financial liability of fielding new vaccines without lengthy safety tests
  • Profit margins for vaccines is less than prescription drugs
  • A(H5N1) negates the normal method for making flu vaccines
  • Only two vaccine manufacturers, Aventis Pasteur and Chiron Corporation, wiling to proceed

The non-solution is to stockpile an expensive, limited production antiviral, Tamiflu, that may only work if "given in the first two days after the onset of symptoms," too late for most. The discovery that A(H5N1) "is more active at cooler temperatures" suggests that the summer slowdown will ebb into winter. And should the disease strike, distributing limited stocks of vaccine and antivirals will become a madhouse of strife and blackmarketeering.

So back to AIDS as an example. When do we leap past the death toll step and involve governments in the directed production of vaccines and antivirals as a matter of national security, at lease national economic continuance?

The bright spot seems to be more on early detection than upon containment and cure. In an approach that I think essential in searching for a "disease without a name," i.e., a bioagent or disease variant not yet identified with a protocol for treatment, or the presence of multiple agents -- natural and manmade, I applaud the research into syndromic systems such as ESSENCE (Electronic Surveillance System for the Early Notification of Community-based Epidemics) for the National Capitol Region (NCR), composed of the District of Columbia and 12 local jurisdictions, and BioSense for larger regions, eventually the entire nation. Departing from traditional disease reporting systems that focus on a specific, already known disease such as "tuberculosis, chicken pox or measles, they look for unusual clusters of general symptoms such as high fevers and respiratory distress, which could be warnings of emerging diseases such as severe acute respiratory syndrome."

I am aware that "Syndromic surveillance only sets off alarms [and no] matter how well a syndromic surveillance system performs, its benefits ultimately depend on how effectively it is integrated into the broader public health system." That is not cause for rejection but for more research and embedding as the most frequently used detection algorithms can detect both fast-spreading and slow-moving agents.

The lessons learned from Nevada's 2003-2004 influenza season showed that syndromic surveillance identified the influenza season earlier, allowed better tracking as the season progressed, and was good as the people evaluating the data.

Now we need the vaccines.

Experts Confront Hurdles in Containing Bird Flu
By KEITH BRADSHER and LAWRENCE K. ALTMAN
New York Times
September 30, 2004

Lethal Bird Flu Reemerges In Four East Asian Countries
By Alan Sipress
Washington Post Foreign Service
September 15, 2004

Investigation of Disease Outbreaks Detected by "Syndromic" Surveillance Systems
Julie A. Pavlin
Journal of Urban Health, New York Academy of Medicine Vol. 80, No. 2, Supplement 1 2003

Gordon Housworth



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