Nevirapine quotes
[back]
Nevirapine
So egregious are deficiencies in the HIVNET 012 clinical trial which lead to the admission of the extremely toxic drug Nevirapine that by any reasonable scientific standard the findings should be invalidated. Freitag, 11 February 2005 Torsten Engelbrecht
Boehringer, a pharmaceutical company, has been doing studies in Uganda
with a drug called Nevirapine. The FDA refused approval of Nevirapine in the US
for so-called mother to child transmission because it's ineffective and has
deadly side effects, but this is exactly how the drug is being used in Africa -
on pregnant women and unborn children.
In one drug trial, 17 percent of patients taking Nevirapine developed liver
problems. A US health care worker taking Nevirapine had to have a liver
transplant to save his life as a result of drug toxicity. Five women in South
Africa died and dozens developed severe liver problems in a combination AIDS
drug trial that included Nevirapine.
The manufacturer's warning label for Nevirapine itself states that patients
taking the drug have experienced: “Severe, life-threatening and in some cases
fatal hepatotoxicity [liver damage],” and “severe, life-threatening skin
reactions, including fatal cases.”
These are the most toxic drugs known to medicine, and they're being applied to
the most vulnerable part of the population - pregnant mothers, unborn children
and newborns - all based on a faulty test, or no test at all, while their actual
food, shelter and water needs continue to be ignored. "---
Dr. Christian Fiala
[2003] Africa:
Treating Poverty with Toxic Drugs By Liam Scheff
HIVNET 012 was a randomized clinical trial to evaluate the efficacy of two short course antiretroviral drug regimens for prevention of HIV transmission from infected mothers to their babies. The overall goal of the study was to identify a safe, effective means of preventing mother-to-infant HIV transmission that would be applicable and affordable in resource-limited settings. Enrollment in the study began in 1997 and was completed in 1999. Early results were released in 1999. Follow-up continued through July 2004. This landmark study found that a short intrapartum/neonatal regimen of Nevirapine given to the mother at the onset of labor and to the infant within 72 hours of life reduced the risk of perinatal HIV transmission among breastfeeding women in Uganda by 47% at 14-16 weeks and by 41% at 18 months compared to a short intrapartum/neonatal regimen of AZT. This simple, safe regimen has been adopted as the standard of care in resource-limited countries worldwide and has been endorsed by UNAIDS and many other international health organizations. http://www.hptn.org/research_studies/hivnet012.asp
placebo-controlled, double-blind, Phase III trial of 1,500 mother/infant pairs, it wound up being a no-placebo, neither double- nor even single-blind Phase II trial of 626 mother/infant pairs. Virtually all of the parameters outlined for HIVNET 012 were eventually shifted, amended, or done away with altogether, beginning with perhaps the most important—the placebo controls. By a “Letter of Amendment” dated March 9, 1998, the placebo-control arms of HIVNET were eliminated. The study as reconstituted thus amounted to a simple comparison of AZT and nevirapine. On September 4, 1999, The Lancet published HIVNET’s preliminary results, reporting that “Nevirapine lowered the risk of HIV-I transmission during the first 14‒16 weeks of life by nearly 50 percent.” The report concluded that “the two regimens were well-tolerated and adverse events were similar in the two groups.” The article also reported that thirty-eight babies had died, sixteen in the nevirapine group and twenty-two in the AZT group. [Media March 2006] Out of Control AIDS and the corruption of medical scienceBy Celia Farber