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HIV-drug lunacy and the FDA

I counted 14 accelerated approvals. 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.
Here is the URL to a list of all the anti-HIV drugs and other "AIDS-related"
drugs approved by the FDA through Feb. 19, 2002.

 http://www.fda.gov/oashi/aids/stat_app.html

click on the underlined words for more information.

I counted 14 accelerated approvals. 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
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.