JACKHAMMER BAR

[samuelsons]

May 30, 2004

Re: Bush Administration HIV/AIDS Vaccine Cover- up

George W. Bush and his entire Administration need to be sent packing and booted from the White House as soon as possible. Maybe some time in prison with required multiple behavior change workshops sprinkled throughout their stay would be the best therapeutic remedy for their criminal behavior.. The latest discovery is the most disgusting.

There is a potential life-saving HIV/AIDS Vaccine that currently has two names depending upon which organization is reviewing the drug. The Department of Defense which now manages the HIV/AIDS research of The National Institute of Allergy and Infectious Diseases names the drug HVTN 048 and Epimmune, Inc. The manufacturer, names the drug EP HIV-1090.
HIV Vaccine Trials Network (HVTN) is coordinating the clinical trials of the drug.

Additional information regarding the drug can be located at the government website at
www.clinicaltrials.gov One report says “significant data support the hypothesis that HIV-specific cytotoxic T lymphocyte (CTL) responses are likely to be well suited for treatment of HIV infection”. The report is titled “Safety of Immune System Response to an HIV Vaccine (EP-HIV-1090) in HIV Infected Patients” located at www.clinicaltrials.gov/ct/show/nctooo52182
Another report says “Epidemiological and animal model data support the hypothesis that HIV specific cytotoxic T lymphocyte (CTL) responses contribute to control and
“clearance of the virus”. The title of this report is “Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Uninfected Adults and located at:
www.clinicaltrials.gov/show/NCT00054860 The clinical trials have already been studied with human volunteers by the manufacturer Epimmune, Inc.

The Epimmune, Inc. website has a Press Release listed titled “Epimmune Receives FDA clearance to Initiate Phase I/II Therapeutic HIV Vaccines Trial” dated June 13, 2002. Additional information says “Completion of the Phase I/II trial and final data analysis are expected in late 2003". But no final data analysis to be found. This Press Release is located at:
www.epimmune.com/news/showarticle.cfm

Also, if you “click” on “Phase I” at either of the www.clinicaltrials.gov web pages listed above, you will also will not get any results. The Bush Administration is hiding the results of clinical trials of EP-HIV-1090. However, in the clinical trial using Uninfected Adults, what limited information is available, does say “This design is predicted to induce an immune response in 85% of individuals in the general population”. How could they “predict” 85% if there were not already results?

Another clinical trial of the drug was expected to be completed in Botswana, Africa but I am not sure if EP HIV-1090 was used. A PR Newswire says “Epimmune, Inc. Today announced that the National Institute of Allergy and Infectious Diseases a component of the NIH holds an active investigational New Drug from the FDA to test Epimmune’s multi-epitope vaccine, EP HIV-1090, to prevent HIV infection”. “A multi-site, Phase I trial was recently initiated by the HIV Vaccine Trials Network (HVTN), which is conducting the trial. Trial sites include several New England and one African (Botswana) site associated with Harvard University, and one site associated Saint Louis University” This information is located at:
www.aegis.com/news/pr/2003/PR030417.html

However, another News Release says: “Medicines Control Council Begins Phase I clinical Trial of South Africa’s First AIDS Vaccine” but does not mention either EP HIV-1090, HVTN 048 or Epimmune, Inc. Of San Diego, CA., but rather a company by the name of AlphaVax Inc. Located in Durham, N.C. This news release is located at:
www.avac.org/prSAphase1.htm
The article says it is to be tested among 96 Uninfected volunteers, half in So. Africa and half in the U.S. “Though it will be years before we know whether the Vaccine actually works, it is one of the more promising scientific approaches”.
Well, if the volunteers are HIV Negative and they are receiving abstinence and safe-sex counseling during the trial, then of course it will take years to make any conclusions.

Plus, until the Department of Defense clinical trial of Epimmune Inc. EP HIV-1090, the drug had never been tested in HIV negatives. Another report titled “Information About the HVTN 048 Vaccine Trial” (updated 5/15/03) located at the HIV Vaccine Trials Network (HVTN) website at www.hvtn.org says: “What will happen to volunteers if they become HIV infected from behavior during the course of the trial”? The response is: “If the volunteer becomes HIV infected during the study due to sexual behavior or drug use, he or she will not receive any additional injections”. This is a huge violation and very scary. What if the Vaccine Trial itself is the cause of a conversion in HIV status? It is also interesting that the Vaccine Trial Consent Form recently has been “entirely” changed.

Epimmune, Inc. studied EP-HIV-1090 with volunteers that were exclusively HIV positive and now the U.S. Government and the Department of Defense, with a new name for the drug
(or disguised name) of HVTN 048, is being tested primarily on HIV Negative volunteers. And if you become HIV Positive while enrolled in the HVTN 048 clinical trial you are kicked out.
Again, this information is located at: www.hvtn.org under the title “Information About the HVTN 048 Vaccine Trial”.

Another note of interest is the fact that during the trials Epimmune Inc. may have merged with Anosys, Inc. “Epimmune will file a proxy statement concerning its proposed merger with Anosys, Inc. with the SEC Investors and security holders are advised to read the proxy statement related to the proposed merger, because it will contain important information related to the merger”. Information regarding this possible merger is located at:
www.aegis.com/news/pr/2003/PR030417.html

Please help to stop this obvious criminal behavior by the Bush Administration and uncover the truth about EP HIV-1090 (HVTN 048) so we can get back to taking care of people living with HIV/AIDS.