H1N1: A Case Study in Governance

In the book No Harm, No Foul the protagonist questions the usefulness, timeliness and quantity of the government vaccine necessary to counteract a terrorist imitated virus. Today people across the globe are confronted with the same three decisions regarding the H1N1 vaccine.

The H1N1virus pandemic began in April, 2009 when a young boy was infected by a pig on a hog farm in La Gloria, Veracruz,Mexico. The government failed to recognized the virus until March and the World Health Organization (WHO) didn't declared it a pandemic until June. By September, WHO reported that the number of laboratory-confirmed cases amounted to more than 296,471 with 3,486 reported dead. The Americas has the highest death toll - 2,625 - followed by the West Pacific region with 337 deaths. These numbers, WHO reports, are understated since some countries are no longer required to test and report individual cases to them.

Nonetheless, since the beginning of the pandemic in April to the 5^th of September, some 80 countries have reported 105,002 positive flu cases to the National Influenza Centres (NICs). Of these, 62,719 (59.7%) were pandemic H1N1, 5,899 (5.6%) were seasonal A (H1), 15,284 (14.6%) were A (H3), 17,313 (16.5%) were A (Not subtyped) and 3782 (3.6%) were influenza B. The conclusion: this years flu season is dominated by H1N1 that started when a pig infected the young boy in Mexico. While the infected pig did not come from a known terrorist cell, it nonetheless did become infected because of the failure of the farms owners -U.S. Based Smithfield Foods - to properly vaccinate their one million pigs for such viruses and thus avoid the pandemic event in the first place.

The U.S. based Center for Disease Control (CDC) reports that all 50 states are reporting cases with 21 of them reporting widespread activity. This activity, they say, is about twice that expected for this time of year. Children, young adults and people 65 and older are the hardest hit since either their immune systems have not fully develop, as in the case of the young, or their immune system have declined, as in the older population. These dynamics make the development of a vaccine highly problematic.

Currently, in the United States, the Food and Drug Administration (FDA) has licensed a H1N1 vaccine from only four of the five U.S manufacturers. Overall the government plans to purchased 195 million doses, from all five manufacturers. Meanwhile, French drugmaker Sanofi-Aventis is on track to deliver 800 million doses to help recover from the pandemic event. While the licensing delays delivery of vaccines, it is nonetheless,necessary to protect the public. When the vaccines are ready for U.S. consumption, they still must be delivered to some 90,000 provider sites around the country. This logistic process, is far from efficient and creates yet other delays in meeting medical needs.

Between licensing, manufacturing and logistic delays, U.S. manufacturers will deliver about 3.4 million doses, supplemented by French contributions, by October (six months after the pandemic event began. Even then, the initial product will be the live attenuated nasal spray. The attenuated nasal spray is only good for people who are younger than 2 and older than 49 and pregnant women. An injectable vaccine will be needed for those not covered by the spray. But it will not be available until December which is seven months into the event. Regardless, rationing will be required. First in line will be younger people, adults with underlying illnesses, and people who are at risk of transmitting the illness, such as health care workers or people who live with or care for infants younger than 6 months. At 6 months, vaccination is not possible.

Vaccines are generally considered effective at preventing disease. However, individuals and parents are advised to consult their doctors for specific instructions on all health matters.

There are newer vaccination approaches that would reach more people, and act against a wider variety of illnesses that are being researched, and in some cases have entered various trial phases. Advances in immunology have revealed how new classes of "adjuvants" (ingredients that stimulate immune responses to vaccines) can allow vaccine designers to target specific populations and pathogens. Novel adjuvants can make existing vaccines more effective and make previously impossible vaccines a reality. These advances are absolutely necessary if the government hopes to deal with a bio-terrorist event and the government must overcome the regulatory supply and demand issues associated with such research. This work must be accelerated through funding and resourced if the Nation is to meet future bio-events more effectively.

How many could die from the H1N1 flu is anyone's guess. CDC models spit out numbers suggesting that 30,000 to 90,000 could die. These figures, CDC insists, are not meant to estimate the real number of deaths which they say would be in the few thousands.

Unfortunately, modeling physical and environmental situations remains more an art than a science. Nonetheless, the the results must be carefully evaluated for clues that will enhance both planning and response strategies. For example, in 2006, the National Institute for General Medical Services modeled the impact of a non-interventionist strategies in addressing either a high or a low contagiousness bio-event. The results suggested that a low contagiousness event would peak after 117 days but it would infect about 33 percent (12 million) of the 2002 U.S. Population. A highly contagious virus could peak after 64 days and infect about 54 percent (20 million) people.

It makes sense that intervening in a bio-event would result in fewer deaths as reflected in the CDC modeling effort. However, why Institutes modeling effort suggests that the non-interventionist strategy would peak earlier than the current interventionist strategy addressing H1N1 must be understood in better detail. It is likely that the model inputs, and processes are simply so different that different outcomes are too be expected. But this difference is critical to understanding bio-events. Drastically different modeling inputs, processes, outputs and outcomes, from different organizations dealing with the same health problems, lead to wasted funding. More importantly, these differences confuse decision makers and lead to poor planning and execution of mission strategies.

This is not the first flu season the Nation has encountered. Indeed, these events are predictable. Therefore the processes required to deal with the event are correctable. Certainly, the characteristics of the virus differ, and therefore the vaccine solution would differ. But, given advances in information sharing and collaborative decision making these medical research decisions should be made quicker. Indeed, the entire process should be measured in a few weeks, not months.

Dealing with the H1N1 virus is a case study in the expected delays when dealing with government regulated processes. However, many of these processes are necessary and citizens should avoid falling into the deregulation trap that has devastated the financial market. Health care, unlike free enterprise, must be both integrated into a nation-wide network of networks. Such integration would bring researchers, health care providers, first responders, logistics professionals, and government decision makers together to quickly and effectively deal with bio-events in near real-time. This is easy to say, but hard to implement.

The ability to govern requires constant correction to in-place processes. This is especially true in a democracy which, by its nature, is diffused into far too many disagreeable parts. Nonetheless, difficult and costly corrections to the entire health care system must be implemented immediately.

The Commission on the Prevention of Mass Destruction reports that decisive action is necessary in order to prevent a bio-terrorist attack by 2013. Yet, total prevention is impossible and the idea itself gives people a false sense of security. Making such assertions is irresponsible. This does not mean that the Global Law Enforcement community should not act to prevent such a catastrophe. Indeed they should. Regardless,, their effort will not be 100 % successful. The ingenuity of evil minds prohibits such wishful thinking.

Even if bio-terrorism could be prevented, the Global community is still subject to biological events evolving either from careless animal producers or nature itself. Thus, a concentrated effort must be made to vastly improve the response and recovery activities necessary to minimize the loss of life.

(For more lessons in what to expect during a significant biological event read: No Harm, No Foul, now available in book or digital form at: http://www.iwpinc.net/html/books.html)

Sources

Center for Disease Control (CDC) "2009 H1N1 Flu: Situation Update," at: http://www.cdc.gov/h1n1flu/update.htm

Center for Disease Control (CDC), "Pandemic (H1N1) 2009 - update 66," at: http://www.who.int/csr/disease/swineflu/laboratorysurveillanceupdate/en/index.html

Center for Disease Control (CDC) "Press Briefing Transcripts, Weekly 2009 H1N1 Flu Media Briefing, September 18, 2009," at: http://www.cdc.gov/media/transcripts/2009/t090918.htm

Commission on Prevention of Weapons of Mass Destruction, "World at Risk," at: http://documents.scribd.com/docs/2avb51ejt0uadzxm2wpt.pdf

Coping with Disbelief, "Swine flu vaccines, adjuvants, equity, safety," at: http://scienceblogs.com/effectmeasure/2009/09/swine_flu_vaccines_adjuvants_e.php

InterWorld Publications Inc., "No Harm, No Foul," at: http://www.iwpinc.net/html/books.html

Reuters, "Sanofi to deliver H1N1 flu vaccine soon: report," at: http://www.reuters.com/article/GCA-SwineFlu/idUSTRE58K0QQ20090921

The Congressional Budget Office, at: http://www.cbo.gov/

The National Institute for General Medical Services, "Computer Model Examines Strategies to Mitigate Potential U.S. Flu Pandemic," at: http://www.nigms.nih.gov/News/Results/FluModel040306.htm

United States Census Bureau, "Census by States," at: http://factfinder.census.gov/servlet/GCTTable?_bm=y&-geo_id=01000US&-_box_head_nbr=GCT-T1-R&-ds_name=PEP_2008_EST&-_lang=en&-format=US-40S&-_sse=on

Wikipedia, "Food and Drug Administration," at: http://en.wikipedia.org/wiki/Food_and_Drug_Administration_(United_States)

Notes:

Twenty-one states are reporting widespread influenza activity at this time. They are: Alabama, Alaska, Arizona, Arkansas, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, Nevada, New Mexico, North Carolina, Oklahoma, Pennsylvania, South Carolina, Tennessee, and Virginia. Any reports of widespread influenza activity in September are very unusual.

U.S. Population in 2002 was: 287,726,647..33 % = 94,949, 794 million people. .54 % = 155,372,389 million people. If 13 % of those populations died the number would be between 12,343,473 and 20,198,410 million people. 13 % is the percent of the death toll from H1N1 as of September, 2009.