[Congressional Record (Bound Edition), Volume 148 (2002), Part 12]
[EX]
[Page 17350]
[From the U.S. Government Publishing Office, www.gpo.gov]




       DEVELOPING NEW TREATMENTS FOR PEOPLE LIVING WITH HIV/AIDS

                                 ______
                                 

                            HON. MARK UDALL

                              of colorado

                    in the house of representatives

                      Thursday, September 19, 2002

  Mr. UDALL of Colorado. Mr. Speaker, I rise today to share with my 
colleagues news of an important development in medicine that is taking 
place in my district--the manufacturer of a new generation of HIV 
therapy. This complex, breakthrough therapy, called Fuzeon, generic 
name enfurvitide, is the drug formerly known as ``T-20'' Fuzeon is a 
new drug that attacks HIV in a new way, promising new hope for patients 
who have exhausted other therapies. Fuzeon is the product of 
groundbreaking medical research and cutting edge engineering and is an 
example of how the private sector is contributing to dramatic advances 
in healthcare and specifically in helping to manage the most 
devastating infectious epidemic in the recorded history of mankind.
  In July, Fuzeon clinical trial results were presented at the 
International AIDS Conference in Barcelona, the world's largest HIV/
AIDS meeting. These studies included over a thousand patients with 
advanced HIV who demonstrated resistance to a majority of currently 
available HIV treatments and were nearing the end of their treatment 
options. These study results showed that Fuzeon had a significant 
impact in reducing HIV viral load and improving immune response in 
these difficult to treat patients. Fuzeon, once approved by the Food 
and Drug Administration, could be commercially available as soon as 
early 2003.
  At present, there are 800,000-900,000 people living with HIV in the 
United States. Innovative HIV therapies, taken in combination ``drug 
cocktails,'' have allowed many of these individuals to live relatively 
healthy, productive lives. However, HIV is a formidable virus that can 
adapt to become resistant to existing treatments and is doing so. In 
fact, one of the biggest challenges facing people living with HIV today 
is an emerging resistance to currently available treatments. Fifty-one 
percent of AIDS patients are immune to at least two of the three 
available classes of therapies thereby severely limiting the treatment 
options available to them. Fourteen percent are resistant to all three 
classes and are left with no way to control the advancement of their 
disease. These patients are in desperate need of new options.
  That is why Hoffmann-La Roche, the pharmaceutical company that 
introduced the world's first protease inhibitor and the first HIV viral 
load test, has partnered with the biotech company Trimeries Inc., a 
leader in HIV innovation, to develop and manufacture Fuzeon--a new 
generation of HIV therapy. Fuzeon will help to addresses the urgent and 
unmet needs of HIV/AIDS patients who have built up resistance to 
current therapies. This internationally anticipated and complex drug 
will be manufactured right here in the United States--in Boulder, 
Colorado. It requires the creation of one of the most complex drug 
manufacturing processes ever undertaken because the drug is far more 
intricate in its structure and development than any existing drug.
  Roche and Trimeris are investing considerable resources to bring new 
therapies to people living with HIV/AIDS. The importance of these 
discoveries and developments cannot be stressed enough. Breakthrough 
biotechnology advances in the worldwide fight against HIV/AIDS, produce 
vital life-saving alternatives for patients living with HIV. What these 
companies have learned from developing state-of-the-art manufacturing 
facilities for Fuzeon will also improve our nation's ability to develop 
and manufacture new therapies for other diseases.
  The public sector has a role to play as well. I call upon my fellow 
colleagues to support funding of vital and fiscally prudent public 
programs that provide access to life-saving treatments such as Fuzeon. 
The AIDS Drug Assistance Program (ADAP) provides federal contributions 
to state run programs designed to provide innovative, life saving HIV 
drugs to low income, uninsured people living with HIV. I ask my House 
colleagues to include an increase of $162 million for ADAP funding in 
the House Labor, Health and Human Services appropriations bill for FY 
2003. Many states are experiencing budget problems, and demand is 
outpacing available resources lot ADAP programs. From 1996 to 2001, the 
number of clients served nationally by ADAP programs has grown by 144 
percent, with expenditures on drugs increasing by over 300 percent, and 
funding levels increasing at smaller rates. In my own state of 
Colorado, the ADAP has provided life saving HIV treatments to over 
1,300 low income, uninsured people to date this year. Like other ADAPs, 
the Colorado program needs to respond to the increasing number of 
individuals seeking access to these treatments.
  With this recommended increase in funding, we offer a real helping 
hand, send a message that the federal government encourages private 
investment in groundbreaking research, and meet our fiscal objectives.

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