- The Washington Times - Monday, January 23, 2006

As the world responds to the recent news of the spread of avian flu virus (H5N1) in Turkey, it is now more apparent than ever that we must aggressively prepare for an influenza pandemic at home and abroad.

As of Jan. 10, the World Health Organization (WHO) reported 78 deaths due to avian flu and 147 confirmed human cases in six countries. Infected fowl have been found in at least 14 countries. To date, the virus has not demonstrated easy human-to-human transmission. But should this occur, the spread around the globe likely would be fast — possibly within three months, according to WHO.

The biotechnology industry is working aggressively to make available promising life-saving vaccines, antivirals and diagnostics, and we are excited about the progress to date. However, we face significant challenges. We have seen critical aspects of our public health infrastructure stagnate or decline over the years, including the dramatic reduction in the number of influenza vaccine manufacturers. Simply put, we currently do not have the capacity to provide all Americans a vaccine in an emergency.

Our race against time puts us at a further disadvantage. We do not know when a pandemic may arise, or exactly what the virus would look like, but we must begin preparing for one immediately. Having life-saving medicines available too late is simply ineffective and not acceptable.

There are practical consequences to these challenges. Industry is working closely with regulators to develop the safest and most effective products possible. But because of the ability of viruses to mutate unpredictably, to become deadly, and to spread quickly, we most likely will not have time for years of clinical trials against any specific pandemic strain. Decisions on use of these countermeasures will need to be made with the best information available, recognizing they likely would be our greatest — and perhaps only — defense to a virus that could kill or seriously injure millions of Americans.

In advance of a pandemic and without government support, there would be no market to sell these products. And the risk of debilitating liability due to known and unforeseen side effects during wide-scale use in an emergency presents a strong disincentive for the creation of these products. The reality is that most companies simply cannot responsibly invest hundreds of millions of dollars to develop products for which there is no market and for which they’ll be bear massive liability exposure.

For these reasons, the recent emergency legislation proposed by the president and approved by Congress was absolutely necessary to enhance the availability and acceptance of these life-saving products. It provides a significant level of short-term funding for the development, production and stockpiling of pandemic countermeasures, and it establishes a process for providing compensation to individuals who suffer injuries that may be caused by such products. It also responsibly protects manufacturers, doctors and others from frivolous lawsuits relating to their participation in this program at the government’s request. The need for these types of reforms has broad bipartisan support.

The good news is that with sufficient support, science can save lives. Additionally, the synergies and value beyond preparing for pandemic influenza are enormous. An expanded domestic vaccine production capacity and new technologies fostered through pandemic influenza preparedness can facilitate the development and availability of additional vaccines and antivirals for other infectious diseases, such as seasonal influenza, childhood diseases and HIV.

The federal government must act expeditiously to implement the emergency pandemic preparedness legislation passed last month by Congress. It represents a necessary first step to demonstrate to manufacturers and the public that the government is taking strong actions to enhance public health emergency preparedness and to protect our national security. This must be followed by additional reforms to improve the development and approval process of products essential for national security and to demonstrate the federal government’s long-term commitment that is necessary to sustain private sector involvement in this critical public health area.

James C. Greenwood is president and CEO of the Biotechnology Industry Organization (BIO) in Washington, D.C., which represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 31 other nations. He is a former Republican member of the U.S. House of Representatives.

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