Re: FDA Fast–track Approval of Promising Treatments for HCV and Other Liver Diseases

As my representative, you ought to know liver disease is one of the major killers in America today.

Hepatitis C alone has been called a "silent epidemic" by former surgeon general Everett Koop, MD.

It is estimated that as many as 4 million Americans are infected. The death rate due to complications from this disease is expected to quadruple in the next 10 years. It is the number one cause for liver transplants and those numbers are rising exponentially.

There is no known cure and current treatment has an inadequate success rate (while often causing debilitating side effects).

The FDA needs to fast-track treatment development for this deadly disease.

A study presented at the American Association for the Study of Liver Diseases meeting on Tuesday November 9, 1999 concluded that long-term damage from hepatitis C infections may cost the U.S. economy more than $81 billion by 2019.

The study, by researchers from the New England Medical Center and Tufts University School of Medicine, looked at what costs can be expected in the ten years from 2010 to 2019 as a result of the long-term effects of hepatitis C infections.

Most people infected by the virus do not notice any symptoms until serious liver damage starts 20 years or so later, although testing can detect the infection and lead to early treatment.

The study used a computer model to estimate the level of disease and death expected in the period 2010-2019 from existing and future infections. It found that the medical costs of treating such liver damage as cirrhosis and cancer would total at least $10.3 billion in those ten years.

Productivity lost to the work force from hepatitis C complications and death would equal another $71.5 billion, the researchers, led by Dr John Wong, said. "Our results suggest that hepatitis C will be an awakening health issue that should be addressed now," Wong said in his paper.

While some progress has been made of late in drug treatment development, there are simply not enough options available to people with this potentially deadly disease.

The FDA is infamous for its long approval process for new drug therapies.

Exceptions have been made for high profile widespread diseases such as HIV/AIDs. Such exceptions are appropriate for hepatitis C and other liver diseases given the scope of the problem.

I am requesting that you investigate this important area of public health and sponsor or co-sponsor legislation allow the FDA to fast track approvals for promising drugs for liver disease treatment..

Thank you for your attention and consideration in regard to this serious matter.

Sincerely,

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