AIDS Vccine Fails to Protect: Claims are Misleading, Premature

[Guest guest]

Consensus Statement: AIDSVAX Fails to Protect; VaxGen's Claims of Efficacy

in Black, Asian Participants are Misleading, Premature

Mon Feb 24, 4:43 PM ET

Contact: Huntly of AVAC, 212-367-1051 or 215-248-3452 Lein of

Project Inform, 415-558-8669 Jefferys of TAG, 212-253-7922 NEW YORK,

Feb. 24 /U.S. Newswire/ --

Following is a consensus statement from a group of community-based HIV/AIDS

organizations:

The undersigned Community-Based HIV/AIDS organizations are deeply concerned

by today's presentation of data from the phase III clinical trial of

VaxGen's HIV vaccine candidate, AIDSVAX. While the overall result

demonstrates a clear and disappointing lack of efficacy, VaxGen has chosen

to spotlight several subgroup analyses that were not part of the statistical

evaluation described in the original trial protocol. Specifically, the

company claims that the vaccine showed an efficacy rate of 67 percent in

people categorized demographically as Black, Asian or " Other " and an even

greater efficacy rate of 78 percent when results in Black participants were

analyzed separately. These results should be treated with extreme skepticism

until subjected to a detailed, independent scientific evaluation.

We fear that VaxGen has deliberately emphasized these putatively positive

findings (on the CNN Financial News Network, VaxGen CEO Lance Gordon

described them as a " marvelous result " ), while failing to emphasize that

they are based on very small numbers of infections in a limited sample of

participants. This may serve the commercial interests of the company, but it

does a great and profound disservice to the HIV-affected communities who

must now struggle to make sense of the press stories that the VaxGen release

has generated.

The Numbers Game: Reasons to Emphasize Uncertainty -- The smaller the sample

size, the less certain the results. Among Black trial participants, there

were 9 infections out of 111 placebo recipients compared to 4 infections out

of 203 vaccine recipients. A small difference in these rates would erase the

statistical significance of this finding. VaxGen strongly implies this

result is meaningful by stating that there is a less than 2 percent

possibility that it occurred by chance; however, that does not prove that

the explanation lies with receipt of the vaccine. --

When considered separately, differences in the infection rates between

placebo and vaccine recipients among Asian participants and those

categorized demographically as " Other " were not statistically significant.

Only the arbitrary grouping together of these demographic categories with

Black participants allowed VaxGen to claim a 67 percent reduction in

infection rate " among ethnic minorities, other than Hispanic individuals "

(VaxGen Press Release, 2/24/03). -- Women in the trial experienced a lower

infection rate than men, and women were overrepresented among the non-White,

non-Hispanic populations in the trial.

A breakout of the trial results for women in the different demographic

groups has not yet been presented. While the desperate need for an HIV

vaccine is clear, especially among the underserved communities that bear the

brunt of the pandemic, hope cannot take flight on the gossamer wings of

dubious subgroup analyses. It is critical that the scientific leads that may

be contained in the VaxGen data are vigorously pursued, but the uncertainty

associated with the results presented today must be clearly articulated.

We call on VaxGen to submit the findings to a panel of outside experts

assembled by the National Institutes of Health for a full examination of the

data and report to the public within 30 days.

AIDS Vaccine Advocacy Coalition (AVAC) Project Inform Treatment Action Group

(TAG) Contacts: -- AVAC, Huntly , 212-367-1051 or 215-248-3452, Cell:

267-226-8480, Email: Huntly@...; Huntly@... -- Project

Inform, Lein, 415-558-8669, E-mail: blein@... -- TAG,

Jefferys, 212-253-7922, Cell: 646-554-3963, E-mail:

richard.jefferys@...

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