RESEARCH TRIANGLE PARK — What price can one put on hope?
What is the value of an answered prayer?
What is the value of the AIDS drug Fuzeon, formally approved by the FDA on Thursday?
The team of scientists, researchers and entrepreneurs at Durham-based Trimeris deserve a chance to celebrate today — and deserve to be saluted for helping provide hope and longer life to thousands or hundreds of thousands of people longing for a new, effective treatment of HIV. As many as 50,000 have tried other drugs and either have grown immune to the effects or the treatments failed to work.
Of course, FDA approval is wonderful financial news for Trimeris and its partner, Roche. But what is the greater value — money or hope?
Way to go, Dr. Dani Bolognesi, chief executive officer at Trimeris and one of the team that discovered Fuzeon.
The FDA had put Fuzeon on the fast track for approval based on its showing in trials and its ability to treat people with advanced HIV symptoms. Formal approval had been expected by March 16. The good news was fast-tracked even faster than expected.
“The accelerated approval of this new drug should provide new hope for those suffering from advanced HIV infection,” said Tommy Thompson, secretary of health and human services.
Fuzeon is not a cure. And recent trials of a possible vaccine fell short of expectations. But progress is being made in the fight.
“Fuzeon adds an important dimension to our armamentarium of anti-HIV treatments,” added Dr. Mark McClellan, FDA commissioner. “By affecting viral spread in a different way from existing medications, it helps reduce viral loads, which have been shown to slow HIV progression in patients who have developed resistance to currently available medications.”
Fuzeon, a so-called fusion inhibiter, fights HIV outside cells rather than inside. By doing so, Fuzeon blocks the virus from infecting and destroying immune system cells.
A deadly toll
The AIDS plague the world faces today is devastating — from the cost in lost human life to the lost productivity and creativity of those infected to the incredible costs of treatment. As many as 1 million people in the United States alone are fighting AIDS, and another 40,000 a year are infected a year.
Worldwide, more than 40 million people have AIDS. Africa is being wrecked from within.
The death toll stands at 28 million — death on a scale the world hasn’t seen since the Nazis and the Communists killed millions in Europe, the Soviet Union and China.
But Fuzeon, which is being manufactured by Roche in partnership with Trimeris, isn’t cheap. Costs are estimated at $20,000 a year, substantially more than other treatments. And the price tag has some people howling. State and federal health coverage plans, which are already under considerable financial pressure, will be hard pressed to help underwrite the costs.
Production hurdles also remain. Roche manufactures Fuzeon at a plant in Boulder, CO. Capacity is being expanded but is limited, so not everyone who wants to the drug can get it right away. Some 15,000 may get Fuzeon this year with the number hitting 32,000 next year and 39,000 in 2005.
The New England Journal of Medicine is releasing today details of a Fuzeon study, and its lead author told United Press International: “It’s a very good day for people with HIV, particularly for those in trouble.”
Fuzeon, said Dr. Jacob Lalezari of Quest Clinical Research, “has been extremely potent as a new agent and I think it opens the door to a paradigm shift.”
Good news. Welcome news. Wonderful news.
Rick Smith is managing editor of Local Tech Wire.