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From the CEO

How Not to Fight the Swine Flu Pandemic

Editorial commentary by Michael K. Wilhelm

It’s official.  With well over 67,000 confirmed swine flu cases in more than 100 countries, the World Health Organization has declared an official pandemic.   With about half of those cases in the U.S., healthcare agencies and providers here are bracing for a big jump in H1N1 infections when the warm weather fades.  That’s exactly what happened in 1918.

To her credit, Health and Human Services Secretary Kathleen Sebelius isn’t waiting for the headlines to get worse.  Under a recently announced program, HHS is pouring $1 billion into testing and developing ingredients for an H1N1 vaccine which can be rapidly manufactured in the event of a large scale outbreak.   The White House has also just asked Congress for an additional $2 billion to respond to swine flu.

This all sounds like good news.  The reality is that nearly all of these funds will go to the major drug companies that dominate the vaccine business.   Left out of the program are dozens of smaller firms developing next-generation drug candidates which could prove more effective than existing therapies in fighting novel forms of influenza like H1N1.  As a result, instead of finding and funding the best defense against swine flu, the US may end up giving a boost to “big pharma” shareholders and putting Americans at risk.

It’s like fighting a modern war with weapons from the last century.

If a terrorist group unleashed a deadly virus like anthrax in the U.S., we would fight the outbreak with whatever works – not whatever sells.  That’s exactly why Congress established the Biomedical Advanced Research and Development Authority (BARDA) in 2004.   Its mandate is to rapidly develop and manufacture countermeasures to health emergencies like bioterrorism or pandemic disease — even if these countermeasures are still in the lab.

It’s time to implement the procedures established under BARDA and expedite testing of promising potential drugs that could protect the population against a full blown pandemic.  With the right leadership from Congress, health officials can set clear criteria for a safe, efficient process of identifying and fast-tracking strong pre-clinical drug candidates.   Instead of competing, big pharma firms would be able to cooperate to develop and manufacture the best treatments – regardless of whose lab they come out of.

As the world heads into the summer of 2009, more than 300 people are dead from swine flu and the number is only going to get higher.  We simply can’t wait for a repeat of 1918.

The good news is we have the money and the science to get this right.  We also have an opportunity to create an effective policy response.  What we don’t have is the time to get it wrong.

Michael K. Wilhelm is President, Chief Executive Officer and Director of ImmuneRegen BioSciences, a development-stage biotechnology company based in Scottsdale, Arizona.