p Government officials, AIDS organizations and the media unanimously agree that the recent decline in AIDS cases and deaths is an unprecedented occurrence due to a new combination of drugs that include protease inhibitors, chemicals said to block the replication of HIV However, a careful look behind the headlines reveals that there is no medical evidence to support these popular claims about the protease inhibitor “combo cocktails.”

p The declines in AIDS deaths attributed to combination therapies actually began several years before protease inhibitor drugs became available for general use.^^72^^ Since the first protease inhibitor received Food and Drug Administration (FDA) approval in December of 1995, a more likely explanation for decreased deaths would be the change in the official AIDS definition adopted in 1993 which allows HIV positives with no symptoms or illness to be diagnosed with AIDS. Since 1993, more than half of all newly diagnosed AIDS cases are counted among people who are not sick.^^73^^

p Reported AIDS Cases Before and After Release of Protease Inhibitors^^74^^ 1987 to 7998 USA 40 r o I 30 Non-illness AIDS definition introduced First protease inhibitor approved for use 8 20 10 - _r_ ’   j J iri 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 Quarter-year of report

p CDC data also show that decreases in AIDS cases commonly ascribed to “AIDS cocktails" preceded the introduction of the new drug treatments by three full years. According to the CDCs HIV I AIDS Surveillance Report, AIDS diagnoses peaked in the third quarter of 1991, increased once in the first quarter of 1993 as a result of the 1993 expanded AIDS definition, and have dropped each year since.^^75^^

p News stories of AIDS patients who rise from their death beds to run marathons after taking the drug cocktails, are just that—stories. In science, such unverified accounts are dismissed as anecdotal, a term that comes from the Greek word anekdotos, meaning unpublished. None of the anecdotal tales of recoveries attributed to new drug combinations have been substantiated by controlled studies published in peer-reviewed medical journals, a fact acknowledged in the fine print of pharmaceutical advertisements:

p > “At this time there is no evidence that Ziagen will help you live longer or have fewer of the medical problems associated with HIV or AIDS."

p > “It is not yet known whether Crixivan will extend your life or reduce your chances of getting other illnesses associated with HIV"

p > “At present, there are no results from controlled clinical trials evaluating the ejects ofViramune [on] the incidence of opportunistic infections or survival."

p > “There have been no clinical trials conducted with Combivir"^^76^^

p Incomplete and inconclusive data from one 1997 study are used to claim that mortality rates are lower among HIV positives treated with protease inhibitors.^^77^^ This particular trial was prematurely terminated before statistically significant results could be obtained, and no placebo control comparing unmedicated HIV positives was used, no recurrent AIDS-defining illnesses that appeared among participants were recorded (except recurrent pneumonia), and the results mentioned in the final report are for only a small fraction of the patients enrolled in the study.^^78^^ Current pharmaceutical ads use this study to declare that their new drugs are “proven to help people with HIV live longer, healthier lives" while simultaneously admitting that “because the study ended early, there was insufficient data to determine [the drug’s] statistical impact on survival.”^^79^^

p While there is no evidence that cocktail therapies produce clinical health benefits, well-documented side effects include headache, fever, nausea, vomiting, diarrhea, oral lesions, abdominal pain, severe fatigue, sexual dysfunction, general ill feeling, skin rashes, a hypersensitivity reaction that can result in sudden death, nervous system damage, enlarged liver, liver failure, kidney stones, kidney sludge, physical deformities including hunchbacks, sunken cheeks, and “stick-like limbs,” diabetes, heart disease, “unmasking” of various opportunistic infections including CMV retinitis (a viral infection which can lead to blindness), and spontaneous bleeding in hemophiliacs.^^80^^

Media reports attributing declines in AIDS to protease inhibitor cocktails often neglect to mention the high rate of drug failure or the considerable number of HIV positives who either quit the new combinations because of intolerable side effects or have never taken them at all. Recent studies place drug failure rates at 50% while others note that as many as 40% of participants drop out of protease inhibitor drug trials due to adverse effects, and as AIDS expert Dr. James Curran laments, “fewer than 10% of US AIDS patients have access to and are on the new wonder drugs.”^^81^^ For more information on the chemotherapy/ protease inhibitor drug combinations known as HAART, please see A Sobering Report on AIDS Cocktails and What’s Up with Viral Load? on pages 32 and 36.