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Press ReleaseDecember 12, 2007

Verdict Of $2.5 Million Over False-Positive HIV Diagnosis
Brings up Basic Problems With AIDS Testing and Treatment, Say Scientists

CHICAGO, Dec. 12, 2007--A lawsuit decided today against the University of Massachusetts Medical Center over consequences of an allegedly false-positive HIV antibody test exposes basic problems with the test and treatments for all persons taking them, according to a high-ranking medical researcher who has advised the plaintiff’s lawyer on the case. The verdict, issued today, awarded $2.5 million to the plaintiff.

The complaint by Audrey Serrano, 45, in court hearings this week in Worcester, Mass., focused on the absence of a “confirmatory” Western Blot test in her records. However, Andrew Maniotis, Ph.D., research assistant professor in the Department of Pathology, University of Illinois-Chicago School of Medicine, contends that, though the reliability of all HIV testing was not on trial in court here, the case history opens questions about it. And, because Serrano developed illnesses commonly defined as “AIDS-related conditions” only after taking HIV medications known as “highly active antiretroviral therapy” (HAART), the drugs themselves appear to have caused “AIDS.”

Rethinking AIDS (RA) has been asking such questions since its founding in 1991. Etienne de Harven, M.D., president of RA, says, “It is urgent that we open a public debate on the highly suspect reliability of all HIV testing. Moreover, I fully share Dr. Maniotis' concern about the safety of HIV drugs.” Further resources are online at the group’s Web site,www.rethinkingaids.com.

Rodney Richards, Ph.D., worked on the development of antibody (ELISA) and genetic “viral load” tests for Amgen and holds some related patents. “The diagnosis of being HIV positive is based on arbitrary combinations of tests, none of which are approved for diagnosing HIV,” he says. “In fact there is no test for HIV. It’s just an illusion.”

Raising issues of informed consent for all persons submitting to HIV antibody testing, the test kits themselves contain disclaimers that doctors rarely, if ever, share with patients. For example, Abbott Laboratories’ ELISA test kit, typically used as a preliminary test, warns:

“ELISA testing alone cannot be used to diagnose AIDS.”

Confirmation of an ELISA result with a Western Blot test is currently required as a “standard of care.” Epitope’s Western Blot package insert reads:

“Do not use this kit as the sole basis for HIV infection.”

“This is somewhat more concerning, since the Western Blot is supposed to be a highly accurate test, used to confirm that an ELISA is not a false positive,” says Dr. Maniotis. “Moreover, the peer-reviewed literature gives substantial evidence that the virus ‘HIV’ has never been isolated in purified form free of contaminating cellular debris in order to generate the so-called ‘specific viral antigens’ used in the test kits.”

Serrano, now acknowledged to have always tested HIV negative and therefore not to have been at risk for developing AIDS, nevertheless suffered from several AIDS-defining illnesses, including wasting, herpes, and oral thrush, while taking HAART. She also suffered from other health problems, including constant diarrhea (AIDS-defining under the African definition), muscle wasting, profound fatigue, non-specific skin lesions, oral thrush, herpes outbreaks, severe nosebleeds, constant gynecological bleeding and pain from ovarian cysts, fibrocystic breast lesions, hyperplastic pituitary lesions, and severe heart and respiratory difficulties.

Labels for HAART drugs actually list these conditions as possible side effects, suggesting that the drugs themselves cause AIDS-related conditions, Maniotis says.

Serrano’s experience is, sadly, not unique. Dr. Maniotis chose to investigate her case because, he says, “it is typical of many cases reviewed and, as it illustrates so clearly the development of AIDS-related conditions in a woman testing HIV negative who was healthy before she took HAART, strongly suggests that profound paradigm shifts are urgently needed to avoid more human rights violations.”

Drs. Maniotis and Richards are available for immediate media interviews and talk show appearances: