Page Comparison

Whose Benefits Outweigh the Risks?

Documented effects of AZT, also known as Zidovudine, Retrovir-Zidovudine,
and ZDV. AZT is also one of the two active ingredients in Combivir.

"HIV-1 infected children with mothers who were treated with zidovudine had a 'higher probability of developing severe disease' compared with untreated children. These children also had a higher probability of severe immune suppression and lower survival."

Reuters Health, June 2, 1999 on a report in the
May 28, 1999 issue of AIDS 13:927-933

"Concerns are being fueled by a study from a team at the National Cancer Institute near Washington, DC. In the journal AIDS (Vol 13 p 919), the researchers report that AZT is incorporated into the DNA of white blood cells in people treated with the drug-including pregnant women and their babies. This is because AZT mimics thymidine, one of the four nucleosides that make up the genetic code. Olivero and her colleagues warn that the changes may increase the chance of developing cancer."

Michael Day, New Scientist, June 26, 1999

"In reviewing the frequency of birth defects in this population [of HIV positive women taking AZT during pregnancy] we noted eight birth defects (10%) out of 80 live births."

Kumar et al, Zidovudine Use in Pregnancy: A Report on 104 Cases and the
Occurrence of Birth Defects, Journal of AIDS, Vol. 4, 1994

"Concerns stem from a study led by StÅ1⁄2phane Blanche of the Necker Hospital in Paris. He has examined the cases of around a thousand pregnant women with HIV and found that eight gave birth to babies who, though HIV-negative, suffered from a neurodegenerative condition that kills its victims in infancy. The condition highlighted by Blanche is thought to be caused by abnormalities in mitochondria, the energy 'factories' within our cells. The babies' mothers had all taken a combination of the drugs AZT and 3TC from week 32 of their pregnancy. This condition is an extraordinarily rare mitochondrial disorder that you might expect to see in only 1 in 10,000 or 1 in 100,000 births."

Michael Day, New Scientist, June 26, 1999

"At present, data regarding the effects of ZDV use on vertical [mother to child] transmission rates are inconclusive and incomplete. In addition, the long-term effects of ZDV use during pregnancy and after birth on the woman and any resulting child are yet to be discovered. The possibility has not yet been ruled out that this 'risk-reducing' measure may not be effective and may prove detrimental to the health of both mother and child."

Bennett, Mandatory Testing of Pregnant Women and Newborns:
A Necessary Evil? AIDS/STD Health Promotion Exchange, 1998

"A total of 172 participants died [169 while taking AZT, 3 while on placebo]...The results of Concorde do not encourage the early use of zidovudine in symptom-free HIV-infected adults...Representatives of the Wellcome Foundation who were also members of the Coordinating Committee have declined to endorse this report."

Concorde Coordinating Committee, Concorde: MRC/ANRS Randomised Double-blind
Controlled Trial of Immediate and Deferred Zidovudine in Symptom-free
HIV Infection, The Lancet, Vol 343, April 9, 1994

"Following combination antiretroviral therapy administered during pregnancy, most HIV positive mothers and their children developed one or more adverse events, according to the results of an observational study.

"Dr. Lorenzi's group evaluated 37 pregnant women with HIV infection and the 30 infants who had been born at the time of the study. All of the women received two reverse transcriptase inhibitors, and 16 women were also given a protease inhibitor. Among the infants, the most common adverse event was prematurity (10 infants), followed by profound anemia (8 infants). The investigators also noted two cases of cutaneous angioma, two cases of cryptorchidism, and one case of transient hepatitis. Two infants whose mothers were on triple therapy with a protease inhibitor developed non-life-threatening intracerebral hemorrhage. One infant, also exposed to triple therapy, developed extrahepatic biliary atresia."

Reuters, January 1, 1999

"New York researchers report a case of severe anemia in a newborn infant that was probably caused by treatment of the HIV positive mother with the antiretroviral combination of zidovudine, lamivudine and zalcitabine. The male infant, who was pale and developed respiratory distress soon after birth, '...was diagnosed with high output congestive heart failure secondary to profound anemia.'

"Dr. Wendy J. Watson of the University of Rochester Medical Center and colleagues ruled out infection, nutritional deficiencies, congenital leukemia and congenital red blood cell aplasia in the child. 'The cause of the life-threatening anemia in our infant is presumed to be utero bone marrow suppression by one or more of the antiretroviral agents administered to the mother,' they report in the May issue of The Pediatric Infectious Disease Journal."

Reuters, June 8, 1998

"...the estimated probability of developing [Non-Hodgkin's] lymphoma [in patients taking AZT alone, or in combination] by 30 months of therapy was 28.6%...and by 36 months, 46.4%."

Pluda et al, Development of Non-Hodgkin's Lymphoma in a Cohort of
Patients with Severe Human Immunodeficiency Virus (HIV)
Infection on Long-Term Antiretroviral Therapy, Annals of
Internal Medicine, 1990; 113(4): 276-282

"The long-term consequences of in-utero and infant exposure to zidovudine are unknown. The long-term effects of early or short-term use of zidovudine in pregnant women are also unknown."

Retrovir, Canadian Pharmaceutical Association Compendium
of Pharmaceuticals, 1997; 1357-1361

"A long-term federal government study of AZT begun in August 1991 involving 839 children at 62 hospitals was halted. An independent committee monitoring the trial recommended it be halted because 'the children receiving AZT had more rapid rates of disease progression, AIDS-related infections, impaired neurological development and death.'"

The New York Times, February 14, 1995

"Proven Power For HIV: Because of her baby, because she vows to be there for her family, because her kids remind her to take her combination of anti-HIV medicines everyday...There are no adequate and well-controlled studies of Combivir [lamivudine/zidovudine tablets] in pregnant women. Combivir should be used in pregnancy only if the potential benefits outweigh the risks."

Glaxo-Wellcome ad for Combivir, April 1999

AZT's manufacturer Glaxo-Wellcome reported $2.35 billion in annual
sales of AZT and their other antiviral drugs for 1997. (107)