Response to AZT/MTC
underscores women's health.
April 6, 1998.
in response to:
April 5, 1998
Joe Thomas, Hong Kong
is to express my concerns in promoting AZT monotherapy among pregnant women in developing countries as it underscore
on the findings of a recent study in Thailand, short courses of AZT may decrease prenatal transmission many
international agencies are currently
advocating the use of AZT based mono therapy for pregnant women living
with HIV in developing countries, to reduce the chance of
vertical HIV transmission. It appears
that promoting AZT mono therapy among pregnant women underscore women's
health and such a policy need wider discussion and through scrutiny before promoted in developing countries.
Glaxo Wellcome (who has the monopoly of AZT) has recently announced their intention to reduce the price of AZT.
However, promoting AZT should not
be based only on the marketing strategy
of one single company. Which is akin to an unethical product endorsement.
It appears that the commercial interest of Glaxo Wellcome has got
prominence over the health care needs of pregnant women in developing countries.
of the key issues which needs further discussions are:
recommendations, which many healthcare workers particularly in developing countries has misinterpreted as
ruling against combination therapy during pregnancy.
there is a global consensus on the ineffectiveness of AZT monotherapy
as on a long term it may contribute to resistance.
the use of AZT mono therapy among the pregnant women under the guise
of reducing the Perinatal transmission underscore the health care needs of the mother.
Thai study, was not reported in a peer reviewed journal or in any scientific meetings so that the data and the
results could have been peer reviewed.
Which was the common practice adopted in other latest findings on
the effectiveness of many other Highly Active Anti Retroviral Therapies.
The investigators of the study did not sufficiently justify the reasons
to deviate from the established practice in reporting the results of Thai study.
treatment group was consist of 198 AZT recipients and 199 placebo recipients. In the placebo group 35 children
where born with HIV and only 17
children were born with HIV among the AZT recipient group. Please, don't fail to take note of the lower transmission
rate of the group which did not
receive any treatment.
of physiological categories such as the duration of labor, procedures
and nature of clinical assistance received during the labor (14%
had cesarean deliveries), the viral load at the enrolment, previous treatment histories, duration of infection
were not taken into consideration
when the result was presented ( it is not available to the readers
if they have considered those issues).
the enrollment the median age of the clinical trial participants was 24 years. What is the significance of age on
vertical transmission ? There
was no data on co-morbidity or the progression rate of infection among the treatment group. What would have
been the impact of co-morbidity on
the rate of transmission?
are some of the serious limitations of this study. Without taking into
consideration of such limitations and promoting AZT mono therapy among
pregnant women in developing countries is not justifiable as it underscore
the health care needs of women with HIV/AIDS in developing countries.
of the brief note is available to those who are keen to engage in
a dialogue on this issue].
Research Program on AIDS,
Chinese University of Hong Kong
Prince of Wales Hospital
N.T., HONG KONG.
When facing public health problems, there are often many reasons people
do not call for action. First, the intervention or prevention activity
may be too costly for governments to consider without raising taxes or
other revenues. Second, public safety needs may conflict with individual
rights to freedom of action. Third, problems of day-to-day living may be
so great that policy issues are left for others to address. All of these
factors have been evident in not addressing HIV/AIDS. Whatever the instance
or the reason, the result all too often is no epidemiologically meaningful
The correspondence of Dr. Joe Thomas concerning AZT administration during
pregnancy (received 4/5/98), should be very welcome by those who favor
inaction. He questions the findings and conclusions of a recent study in
Thailand of low-dose AZT during pregnancy (showing proper scientific skepticism),
but provides little guidance for those attempting to save lives of young
children who otherwise would be born infected with HIV (showing no pragmatism).
Within this context, I would like to briefly address some of the issues
raised by Dr. Thomas.
I personally know Dr. Thomas and remain impressed
with his dedication to his native India, general concern for public health
and his commitment to dealing with the HIV epidemic in Asia. Thus my comments
are not focused on him per se, but rather at the points he raised in his
recent correspondence. My main concern is that his posting may be used
to justify public health inaction.
The study in question was conducted by scientists in Thailand and the United
States working through the HIV/AIDS Collaboration in Thailand and the Centers
for Disease Control and Prevention (CDC) in the United States. I believe
that CDC funded most of the investigation.
Because of the worldwide interest in this topic, the investigators likely
wanted to publish their findings quickly. The first news of the study in
a medical publication occurred in The Lancet on February 28, 1998. The
scientific report appeared one week later (March 6, 1998) in the Morbidity
and Mortality Weekly Report (MMWR) published by CDC. I imagine that full
documentation in a peer reviewed international journal may not appear for
another 8-12 months, because of the need of the Thai/US investigators to
wrap up all aspects of the study and the long time it usually takes from
submission to publication.
Those interested in the MMWR published study can obtain the text
by going to the internet address (no longer available).
They will find that the study was able to follow two groups of pregnant
women, one with 195 who received zidovudine (more widely known as AZT)
and the other with 198 women who received a placebo. All of the pregnant
women knew that they were infected with HIV, had consented to participate
in the study, and knew to avoid breastfeeding (all were provided with infant
formula and counseled not to breastfeed -- none did so).
Following this advice, only 35 of the 199 liveborn children (there
was one set of twins) in the placebo group were documented to be infected.
If they had breastfed, instead of 35/199 or 17.6% being infected, the
percentage would likely be in the 25-35% range. Following the administration
of AZT and advice to not breastfeed, only 17 of the 196 live born children
(again, there one set of twins) were documented to be infected in the treatment
group. The authors state that the study is still not complete and more
analysis needs to be done, but it appears that the treatment group had
about half the risk of viral transmission as the placebo group.
Dr. Thomas states that Glaxo Wellcome is the only company that now sells
AZT and implies that support of AZT is "akin to an unethical product endorsement."
Following this advice would be very inappropriate. Through the recent efforts
of UNAIDS, Glaxo has offered to sell the drug for a deep discount, making
it available to many more pregnant women. Failure to promote the use of
AZT would reduce the sales of Glaxo (which Dr. Thomas implies is beneficial)
but would also result in many more infants being infected (which I am sure
he, like others, would view as harmful).
While some might prefer waiting until all scientific facts on the Thailand
study have been published, confirmed by additional investigations in other
locations, or wait until other companies are able to produce drugs similar
to AZT, there is a epidemiologically-measurable cost to such waiting. Fortunately,
health officials in Thailand have decided that enough information is at
hand, and are moving forward to save the lives of additional infants with
AZT treatment during their mother's pregnancy. Others would do well to
follow their lead, and develop action-oriented public health programs of
their own that feature HIV detection among pregnant women, and low-dose
AZT treatment for those found to carry the virus.
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