The Scientific Facts About Pharmaceutical AIDS Drugs

  1. In their Application the “TAC” and the “South African Medical Association” represent to the High Court that ARV drugs are a scientifically proven therapy to treat HIV infection and AIDS. These statements are false.
  2. Witness after witness in this Application make representations to the effect that ARV drugs prevent the development of AIDS, increase survival time, and can potentially even cure AIDS. All these statements are equally false.
  3. The assertions that ARVs can prevent the development of AIDS in HIV-infected patients or even cure AIDS is so provably false that none of the pharmaceutical companies producing ARV drugs is allowed or even dares to make such unsubstantiated claims.
  4. It takes organizations like the “TAC” and the “South African Medical Association” to make such unproven claims. The only explanation for such irresponsible action is that the Applicants until now essentially ignored the risk of product liability lawsuits from patients harmed by taking ARVs, which the manufacturers of these drugs cannot.

    Remedy for such irresponsible action can only come if new legislation is being passed that not only binds the manufacturers of drugs, but also anyone promoting their merchandise to be held legally responsible for any claims made, both to patients and publicly.
  5. Because of the objective scientific facts about ARV drugs, namely
    1. the high toxicity of these drugs, and
    2. the inability of these drugs to prevent or cure neither HIV infections nor the development of AIDS
    there exists an objective interest on behalf of the pharmaceutical companies manufacturing ARVs to promote these controversial drugs with the help of other organizations.
  6. In light of the fact that both Applicants, the “TAC” and the “South African Medical Association”, are heavily involved in promoting ARV drugs, their statements have to be particularly scrutinized as to their scientific accuracy and their credibility.
  7. In the context of this litigation it must be avoided at all costs that judges are mislead by deceptive representations of ARV-promoting organizations – such as the Applicants – into making rulings on the therapeutic value of ARV drugs which not even the manufacturers of these drugs can scientifically substantiate or are allowed to make.
  8. This is particularly important since once before the “TAC” has used this ruse to have a South African Court make a ruling – entirely outside the scientific facts of the ARV manufacturers – based solely on the “pseudo expertise” of ARV promoting organizations and individuals. That highly publicized case had far-reaching implications for the people of South Africa , for it forced the Government of South Africa to roll out ARVs without any proven efficacy to treat HIV or AIDS to tens of thousands of South African people.
  9. In the current Application the ARV promoting “TAC” is being officially joined by the board of the “South African Medical Association” in trying to use this ruse a second time in a South African Court by – once again – representing ARVs in a false, deceptive and malicious manner as the only scientifically proven method to prevent and treat and even cure AIDS.
  10. In light of the necessity not to let any “pseudo-scientific” opinions by organisations promoting ARVs affect the fact finding during this litigation it is important to review the official statements made by the manufacturers of ARV drugs about their products. Following are just a few examples taken from the official product information of and the manufacturers:
    1. Nevirapine (“Viramune”)
      Manufacturer: Boehringer-Ingelheim (Germany/USA)
      “VIRAMUNE is not a cure for HIV-1 infection; patients may continue to experience illnesses associated with advanced HIV-1 infection, including opportunistic infections. Patients should be advised to remain under the care of a physician when using VIRAMUNE.” (Annexure ‘Viramune’)
    2. Tipranavir (“Aptivus”)
      Manufacturer Boehringer-Ingelheim (Germany/USA)
      “Patients should be informed that APTIVUS is not a cure for HIV-1 infection and that they may continue to develop opportunistic infections and other complications associated with HIV disease. The long-term effects of APTIVUS are unknown at this time.” (Annexure ‘Aptivus’).
    3. Zidovudine (“Retrovir”)
      Manufacturer: GlaxoSmithKline ( UK )
      “RETROVIR is not a cure for HIV infection, and patients may continue to acquire illnesses associated with HIV infection, including opportunistic infections. Therefore, patients should be advised to seek medical care for any significant change in their health status.” (Annexure ‘Retrovir’).
    4. Lamivudine + Zidovudine (“Combivir”)
      Manufacturer: GlaxoSmithKline ( UK )
      “COMBIVIR is not a cure for HIV infection and patients may continue to experience illnesses associated with HIV infection, including opportunistic infections. Patients should be advised that the use of COMBIVIR has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination.“ (Annexure ‘Combivir’).
    5. Abacavir (“ Ziagen”)
      Manufacturer: GlaxoSmithKline ( UK )
      “ZIAGEN is not a cure for HIV infection and patients may continue to experience illnesses associated with HIV infection, including opportunistic infections. Patients should remain under the care of a physician when using ZIAGEN. Patients should be advised that the use of ZIAGEN has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination” (Annexure ‘Ziagen’).
    6. Abacavir + Lamivudine (“Kivexa/Epzicom[US]”)
      Manufacturer: GlaxoSmithKline ( UK )
      “EPZICOM is not a cure for HIV infection and patients may continue to experience illnesses associated with HIV infection, including opportunistic infections. Patients should remain under the care of a physician when using EPZICOM. Advise patients that the use of EPZICOM has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination.” (Annexure ‘Epzicom’).
    7. Fosamprenavir (“Telzir/Lexiva[US]”)
      Manufacturer: GlaxoSmithKline ( UK )
      “Patients should be informed that LEXIVA is not a cure for HIV infection and that they may continue to develop opportunistic infections and other complications associated with HIV disease. The long-term effects of LEXIVA are unknown at this time. Patients should be told that there are currently no data demonstrating that therapy with LEXIVA can reduce the risk of transmitting HIV to others” (Annexure ‘Lexiva’).
    8. Enfuvirtide (“Fuzeon”)
      Manufacturer: Roche ( Switzerland )
      “FUZEON is not a cure for HIV infection or AIDS. FUZEON does not prevent the transmission of HIV. People taking FUZEON may still get opportunistic infections or other conditions that can happen with HIV infection” (Annexure ‘Fuzeon’).
    9. Saquinavir (“Invirase”)
      Manufacturer: Roche ( Switzerland )
      “Patients should be informed that INVIRASE is not a cure for HIV infection and that they may continue to acquire illnesses associated with advanced HIV infection, including opportunistic infections” (Annexure ‘Invirase’).
    10. Nelfinavir (“Viracept”)
      Manufacturer: Pfizer ( USA ) / Roche ( Switzerland )
      “VIRACEPT is not a cure for HIV infection or AIDS. People taking VIRACEPT may still develop opportunistic infections or other conditions associated with HIV infection. Some of these conditions are pneumonia, herpes virus infections, Mycobacterium avium complex (MAC) infections, and Kaposi’s sarcoma” (Annexure ‘Viracept’).
    11. Delavirdine (“Rescriptor”)
      Manufacturer: Pfizer Inc. ( USA )
      “Patients should be informed that RESCRIPTOR is not a cure for HIV-1 infection and that they may continue to acquire illnesses associated with HIV-1 infection, including opportunistic infections. Treatment with RESCRIPTOR has not been shown to reduce the incidence or frequency of such illnesses, and patients should be advised to remain under the care of a physician when using RESCRIPTOR. Patients should be advised that the use of RESCRIPTOR has not been shown to reduce the risk of transmission of HIV-1” (Annexure ‘Rescriptor’).
    12. Lopinavir + Ritonavir (“Kaletra”)
      Manufacturer: Abbott Pharmaceuticals ( USA )
      “Patients should be informed that KALETRA is not a cure for HIV infection and that they may continue to develop opportunistic infections and other complications associated with HIV disease. The long-term effects of KALETRA are unknown at this time.” (Annexure ‘Kaletra’)
    13. Ritonavir (“Norvir”)
      Manufacturer: Abbott Pharmaceuticals ( USA )
      “Patients should be informed that NORVIR is not a cure for HIV infection and that they may continue to acquire illnesses associated with advanced HIV infection, including opportunistic infections. Patients should be told that the long-term effects of NORVIR are unknown at this time” (Annexure ‘Norvir’).
    14. Atazanavir (“Reyataz”)
      Manufacturer: Bristol-Myers Squibb ( USA )
      “Patients should be informed that REYATAZ is not a cure for HIV infection and that they may continue to develop opportunistic infections and other complications associated with HIV disease. Patients should be told that there are currently no data demonstrating that therapy with REYATAZ can reduce the risk of transmitting HIV to others through sexual contact” (Annexure ‘Reyataz’).
    15. Efivarenz (“Sustiva”)
      Manufacturer: Bristol-Myers Squibb ( USA )
      “Patients should be informed that SUSTIVA is not a cure for HIV-1 infection and that they may continue to develop opportunistic infections and other complications associated with HIV-1 disease. Patients should be told that there are currently no data demonstrating that SUSTIVA therapy can reduce the risk of transmitting HIV to others through sexual contact or blood contamination” (Annexure ‘Sustiva’).
    16. Efivarenz + Emtricitabine + Tenofovir (“Atripla”)
      Manufacturer: Bristol-Meyers Squibb
      “ATRIPLA is not a cure for HIV infection and patients may continue to experience illnesses associated with HIV infection, including opportunistic infections. Patients should remain under the care of a physician when using ATRIPLA.” (Annexure ‘Atripla’)
  11. In light of these factual statements about the inability of ARVs to prevent or cure HIV or AIDS by the pharmaceutical companies who researched, developed, patented and market these products globally it is evident that the “TAC” and the “South African Medical Association” build their entire Application on an outright lie: the non-existing ability of ARVs to prevent or treat HIV or AIDS.
  12. In light of the sobering information about AIDS drugs provided by those companies that developed these drugs it is inexcuseable that a South African company - that was not involved in the development ofthese drugs but merely licenses them - tries to market toxic ARV drugs with the misleading promise that the ARV drugs may “improve your condition.” The following product information statements of “Aspen Pharmacare Pty Ltd.” about its leading ARV drugs “Nevirapine” and “Staduvine” have no scientific basis and are deliberately misleading the public:
    1. Aspen Nevirapine
      Manufacturer Aspen Pharmacare Pty. Ltd.
      “Aspen Nevirapine 200 mg may improve your condition, but it is not a cure for your HIV infection. HIV infection is a disease spread by contact with blood or sexual contact with an infected individual. Treatment with Aspen Nevirapine 200 mg has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer” (Annexure ‘Aspen Nevirapine’).
    2. Aspen Zidovudine
      Manufacturer Aspen Pharmacare Ltd. Pty.
      “Aspen Zidovudine 300 mg may improve your condition, but it is not a cure for your HIV infection. HIV infection is a disease spread by contact with blood or sexual contact with an infected individual. Treatment with Aspen Zidovudine 300 mg has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer. Therefore, you must continue to take appropriate precautions to avoid giving the virus to others” (Annexure ‘Aspen Zidovudine’).
  13. This deceptive labelling of “ Aspen ’s” ARV products is a fraud on the public. Without having been involved in the development of these ARV drugs, “Aspen” makes false and deceptive health claims about the possible efficacy of ARVs, that none of the pharmaceutical companies that actually developed them is allowed to make. Thus, there is an immediate need for the respective government authorities to intervene and to hold “ Aspen ” responsible for violating the “Medicines Control Act” and other South African laws. This intervention is particularly important, since “Aspen Pharmacare Pty. Ltd.” is not only promoting its ARVs to thousands of people in South Africa , but also exports them to other African countries with these fraudulent claims.
  14. In summary, the comprehensive list of statements by the pharmaceutical companies that actually developed these ARV drugs unequivocally documents that none of these drugs has been proven to prevent or cure HIV or AIDS and none of these drugs are allowed to be marketed anywhere in the world with such claims.
  15. Considering these facts, it is of utmost concern that the Applicants and their witnesses throughout their Application simply ignore these facts and rather allege the opposite to be true. In order to cover up the fact that ARV drugs have never been shown to prevent or cure HIV or AIDS, the Applicants filed several witness statements by South African doctors. These doctors are apparently trying to blind the Court about the unproven efficacy of ARV drugs with the help of their academic titles and list of publications.
  16. Of course, none of these doctors listed by the Applicants as witnesses is able to change the scientific facts provided by the manufacturers of these drugs themselves. Moreover, these experts now need to be held responsible for making false and misleading statements to the public about unproven health benefits of ARVs.
  17. Thus, most of the witnesses listed in this Application as “experts” on ARVs have in common that
    1. they are economically or academically dependent on the pharmaceutical business with patented ARV drugs,
    2. they try to impress the High Court with ARV-promoting publications published in journals or presented at conferences supported by the pharmaceutical industry,
    3. they do not have any scientific record in the area of micronutrient research or nutritional therapies, while – at the same time – allowing themselves to cast unqualified and false judgements even on the most basic facts of biological sciences,
    4. with their statements to the Court these witnesses try to establish ARV drugs as the only scientifically proven therapy for AIDS,
    5. with their witness statements they openly contradict the official product information by the manufacturers of these drugs that they can neither treat HIV nor AIDS.
  18. By presenting these obviously false facts in this Application these doctors have been identified as “pseudo-experts” and have disqualified themselves as credible witnesses. The key facts of their statements about ARVs are evidently false and their affidavits can no longer be considered relevant.