U.S. Food & Drug Administration:
"FDA's approval of the efavirenz marketing application was granted as an accelerated approval, a regulatory mechanism that speeds approvals of drugs for people with serious or life-threatening illnesses. The agency bases early approval for a product on laboratory markers such as CD4 cell counts and viral load, rather than on clinical endpoints such as delay in death or reduction in opportunistic infections. FDA may withdraw the approval of products granted accelerated approval if post-marketing studies fail to verify clinical benefits. DuPont Pharmaceuticals of Wilmington, Delaware, manufacturers efavirenz under the trade name Sustiva." Commentary by Professor David Rasnick: Here is the list of all the anti-HIV drugs and other "AIDS-related" drugs approved by the FDA through Feb. 19, 2002. I counted 14 accelerated approvals(1). Accelerated approvals mean that the drugs did not complete phase 3 clinical trials. The approval was based on surrogate markers, e.g. CD4 cell counts and "viral load" numbers, not on whether people taking the drugs lived longer or better lives compared to a similar group of people not taking the drugs. The FDA requires the drug company to provide clinical data later or the FDA can withdraw approval of the drugs. To the best of my knowledge, none of the HIV drugs approved in the 1990s was followed-up with clinical data required for the accelerated approval to justify continued use. However, the clinical data that was provided to the FDA was clearly negative because most if not all of those HIV drugs approved in the 1990s now come with a black box warning label that is the highest FDA warning when severe, life-threatening and fatal reactions to the drugs have been documented. The next step would be to pull the drugs off the marked. In my opinion, all of those HIV drugs should be pulled off the market because none has been shown to prolong life or improve quality of life to justify the risk of the well-recognized severe, life-threatening and even fatal consequences of taking the damn things. One excellent example of the HIV-drug lunacy is the approval of Erythropoietin (EPO, Epogen, Procrit), Amgen. Approved December 31, 1990 for the treatment of anemia caused by AZT therapy in HIV infection. AZT and the other DNA-chain terminators kill the dividing cells in the bone marrow (among others). The bone marrow is where the red and white blood cells are created. Since AZT et al. kill these bone marrow cells it (they) cause(s) anemia and immune suppression‹that is, AZT et al. cause AIDS. To get around the chemically-induced anemia and AIDS, Amgen sells and doctors prescribe EPO to counteract the effects of AZT etc. EPO's ability to elevate or maintain red blood cell level production and to reduce the need for transfusions in the treatment of drug-induced anemia associated with chronic renal failure led to its approval for this indication in June 1989. The EPO/AZT story is a classic case of putting one foot on the accelerator and the other on the brake at the same time. HHS Secretary Louis W. Sullivan said that, "Erythropoietin may help patients with AIDS or AIDS-related conditions stay on life-prolonging AZT therapy". I have testified at court cases where children were treated for "HIV infection" against the will of the parents and without their permission. I asked the attorneys to send me copies of the child's medical records. Even before I see any anti-HIV drug being prescribe to the child I see that every day the poor kid is taking EPO. EPO is a dead giveaway that the child is being poisoned with a DNA-chain terminator of some sort. After a little more inspection of the medical records my suspicion has always been confirmed. The records typically show much greater use of EPO than the DNA-chain terminators, probably because the drug-induced anemia was so severe that even the doctors at some point knew to stop giving the children the DNA-chain terminators. 1. Food and Drug Administration, HHS. New Drug, Antibiotic, and Biological Drug Product Regulations; Accelerated Approval  TORONTO
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