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Volume 4, Number 38 - February 28, 2003


 

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AIDS Group: Vaccine Claims Misleading

   Some of the country's major AIDS treatment activist groups signed on to a statement admonishing the developer of a potential AIDS vaccine for claiming that a recent clinical trial shows it might protect Asians and blacks.

   The groups slammed VaxGen Inc. of Brisbane, Calif., saying the data does not back up the company's claims and could raise false hopes.

   "AIDSVAX fails to protect; VaxGen's claims of efficacy in black and Asian participants are misleading and premature," the groups said in the statement. "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 ..."

   The company said Monday that initial results of an important clinical trial of the AIDSVAX vaccine showed it did not prevent HIV infection better than a placebo.

   But it claimed "statistically significant" data showing that the vaccine might protect ethnic minorities, particularly blacks.

   HIV infection in the United States is growing most rapidly among minorities, and AIDS has become a leading killer of black males, according to the National Institute of Allergy and Infectious Diseases in Bethesda, Md.

   The crisis caused by high rates of HIV infection and AIDS in Africa is undermining the future of entire countries.

   AIDS groups say the data doesn't support VaxGen's claim because the number of minority patients in the trial was very small, making it impossible to draw any conclusions.

   VaxGen pins its assertions on nine infections among 111 blacks receiving a placebo and four infections out of 203 blacks who received the vaccine, according to the advocacy groups. The statement from the groups says the company's interpretation of the data could spur false hopes and stir racial divisions.

   "The smaller the sample size, the less certain the results ... 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," the activist organizations said in their statement.

   Major AIDS treatment activist groups including the AIDS Vaccine Advocacy Coalition, Project Inform and the Treatment Action Group have already signed the statement. Representatives of the groups predict many more signatures from other groups.

   "We are going to ask (VaxGen) to stop leaving the impression that this thing is effective in the African American community," said Martin Delaney with Project Inform in San Francisco.

   VaxGen Chief Executive Officer Lance Gordon described the data on blacks as a "marvelous result" on the CNN Financial Network. He said the company would still push for approval of the vaccine by the Food and Drug Administration, possibly for use with high-risk groups or populations where the vaccine might be effective.

   VaxGen did not return calls seeking comment.
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Copyright 2003 by United Press International.
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ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.