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An Open Letter to the FDA and the HIV Community
Regarding Approval of Ultra-Sensitive Viral Load Testing

Cathy Zoon, FDA, Director of CBER

Phone- (301) 827-0372
Ed Tabor, FDA, Dir of DTTD
Phone- (301) 827-3008
Indira Hewlett, FDA, Lab Chief of Lab for Molecular Biology
Phone- (301) 827-0795
Michael Freidman, FDA, Acting Commissioner
Phone- (301) 827-3310
Richard Klein, FDA, Office of Special Health Issues
Phone- (301) 827-4460

The HIV Consumer Community

The individuals and organizations listed below are writing to urge the FDA to place a high priority on the application submitted by Roche Molecular Systems for expedited review of the ultra-sensitive HIV-1 RNA assay. We are concerned that unless a speedy approval occurs best interests of people living with HIV will not be served. It is our belief that lack of access to ultrasensitive viral load testing results in less than optimal treatment for HIV.

Many researchers including NIH researchers have declared that the goal of therapy is to achieve less than 50 copies/ml of viral load, because treatment failure is more likely if viral load remains above 50 copies/ml. In fact, mounting evidence of data supports that position. Many of us have access to using ultra-sensitive testing, but it is the most vulnerable in our society who lacks access. Leading researchers recently reported at a press conference in Washington DC, that it is the poor under-served populations and the underinsured who receive the worst treatment for HIV. Lack of access to ultra-sensitive testing is a reflection of that situation. As you know, Medicaid and Medicare are not paying for the test. In NYC public hospitals, doctors refuse patients access to ultra-sensitive testing even when the patient requests it. Obviously, FDA approval would go a long way towards remedying this problem.

The community is concerned that diagnostic tests are not accorded the same priority as therapeutics; sub-optimal use of antivirals, which can occur without proper diagnostic tools, can lead to resistance and cross-resistance. This can leave patients with less treatment options than they would have had. Please assist our community in providing access to appropriate treatment

We urge the FDA to place a high priority on review and approval of the ultrasensitive test. Since the application was submitted in June 1998, we believe the FDA should move towards making an immediate decision.on this application. It is our understanding that the data is good and there would be no reason for a delay. We will be in touch to follow-up on your response.

This letter will be distributed throughout the broader community by fax, email and the internet. We urge all who read this letter to consider supporting this need by contacting the FDA. Following are contact information for key FDA officials


Act Up Goldengate
Alberto Avendano
Moisis Agosto, National Minority AIDS Council
Bill Bahlman, ACT UP
Ron Baker, San Francisco AIDS Foundation
Larry Bresslour, The ALERT Network
Jill Cadman, Gay Men's Health Crisis
Brian Coppedge, STEP
Angela Gaetano, Community AIDS Resource
Rueben Gamundi, AIDS Project LA
John S. James, AIDS Treatment News
Richard Jeffries, AIDS Treatment Data Network
Jules Levin, NATAP
Enid Vazquez, Test Positive Aware Network