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E-DRUG: Breast feeding and HIV

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E-DRUG: Breast feeding and HIV The new policy - Will this ship be unsinkable?

[Moderators comment: While this is rather a long posting it does report on
an important issue and on the process of decision making by policy making
bodies. How often are policies decided with limited evidence? Richard Laing
Co-Moderator]

In a thought-provoking article in the Bulletin of the WHO the authors focus
on how to choose interventions for improving health(1). They suggest a key
flow diagram where the first question to be asked in assessing whether an
intervention will do harm or good is as follows: "Is there an adequate
systematic review of the effects of all alternative interventions to
prevent or treat the health problem?"
In the recent consensus statement from  UNICEF WHO and UNAIDS on breast
feeding and HIV (the full statement is given below), the health problem
being addressed is vertical spread of HIV from mother to child by breast
feeding. The answer to the above question in this area is "No, there is no
systematic review available to look at all alternative interventions to
prevent or treat this problem".
It may be that the scope of the problem needs to be widened to one that is
even more pertinent: "Is there a review to look at the survival and
well-being of babies after all interventions to reduce the risks where HIV
and breast feeding are concerned". Again the answer is: "No; no such review
has been undertaken". The article referred to makes it clear that the first
step wherever such a situation exists is to initiate such a systematic
review. This has to be the prime responsibility of the above authorities
before launching into an intervention with unknown effects.

Medical science is moving towards a more rigorous scrutiny of health
interventions and their supposed benefits with the movement for
"Evidence-based-medicine" and the Cochrane reviews. These have questioned
many of the assumptions of betterment with interventions that are based on
bad science. The reviews have tried to grade the quality of the evidence
that is used to support purported benefits into the following ranking:
Level                                  Type of Evidence
Ia      Evidence obtained from meta-analysis of randomized controlled trials
Ib      Evidence obtained from at least one randomized controlled trial
IIa     Evidence obtained from at least one well-designed controlled study 
         without randomization.
IIb     Evidence obtained from at least one other type of well-designed
         quasi-  experimental study.
III     Evidence obtained from well-designed non-experimental descriptive  
         studies, such as comparative studies, correlation studies and case
         control studies.
IV      Evidence obtained from expert committee reports or opinions and/or 
    clinical experiences of respected authorities.

If the only evidence for an intervention lies at the lowest level, then the
scientific substantiation is flimsy and further studies will be needed
before launching into a major programme. This is the trap that UNICEF, WHO
and UNAIDS have now fallen into with their new consensus statement. In the
future it could easily be judged as falling into the category of a mistaken
health manoeuvre that was based on bad science.

The draft consensus statement reads as follows
............................................................................
....
UNICEF, WHO, UNAIDS ANNOUNCE CONSENSUS ON INFANT FEEDING AND HIV

In a concerted effort to stop the spread of HIV/AIDS among young children
and mothers, the UNAIDS program and two of its co-sponsors have supported
the use of alternatives to breastfeeding for infants born to HIV positive
women.  The World Health Organization (WHO), the United Nations Children's
Fund (UNICEF) and the Joint UN Programme on HIV/AIDS (UNAIDS) has endorsed
the implementation of new guidelines on HIV and infant feeding.  The
guidelines were the product of a meeting and further discussions which took
place in Geneva recently.  

The guidelines are intended to help governments devise national policies to
fight the spread of HIV/AIDS and to assist health care managers in
providing appropriate services and support.  The
guidelines stress the importance of protecting, promoting and supporting
breastfeeding as the best method of feeding for infants whose mothers are
HIV-negative or who do not know their HIV status.  But at the same time,
they recognise the need to support alternatives to breastfeeding for
mothers who test positive for the human immuno-deficiency virus that causes
AIDS.  

Participants at the meeting emphasized the need to support HIV-positive
mothers in their right to choose an infant feeding method appropriate to
their needs. They stressed that those mothers who decide not to breast-feed
their children must be ensured access to sufficient quantities of 
nutritionally adequate breastmilk substitutes. They also agreed there is an
urgent need for the resources and information required to enable women to
prepare these replacements as safely as possible.  

"These guidelines bring together two important goals: reducing
mother-to-child HIV transmission, and affirming the benefits of
breastfeeding, which is the optimal source of nutrition for most infants"
said Dr Tomris Turmen, Executive Director, Family and Reproductive Health,
WHO. 

The participants included government officials responsible for maternal and
child health, nutrition and HIV/AIDS programmes as well as representatives
of non-governmental organisations, the infant feeding industry, and
scientists with expertise in infant feeding and
HIV/AIDS.

Three Million Children Infected Worldwide

HIV can be transmitted from an infected mother to her child: children born
to HIV positive mothers have a one-in-three chance of contracting the
virus.  Of these, one-third become infected by breastmilk, with the other
two-thirds infected in utero or during birth.

To date, 3 million children world-wide have been infected with HIV, and the
rapid and accelerating spread of the disease world-wide has reinforced
predictions that HIV/AIDS is becoming a major killer of children,
especially in the developing world. In 1997 alone, more than
half a million children were infected globally.


Offering a Solution

Recent results from a study conducted in Thailand among non-breast-fed
infants showed a 50 per cent reduction in mother-child transmission with a
short-course regimen of the antiretroviral drug AZT during pregnancy and
childbirth.  Participants at a meeting convened by UNAIDS in March 1998,
reviewed issues related to the implementation of effective interventions in
developing countries, particularly those involving the short course AZT
regimen. 

In addition to the key recommendation of increasing access to alternatives
to breast feeding for HIV positive women, the HIV infant feeding guidelines
emphasise the need to improve access to voluntary and confidential HIV
counselling and testing, particularly for pregnant women as well as proper
infant feeding counselling. 

The participants also endorsed the need to implement measures to prevent
breastfeeding from being undermined among HIV negative women and among
those whose HIV status is unknown. There was a consensus that methods for
procuring, distributing and making available replacements for breastmilk
must comply with the International Code of Marketing of Breastmilk
Substitutes, and subsequent resolutions of the World Health Assembly. 

Health care services, especially in developing countries, were also a
priority on the meeting agenda.  There was a focus on the need to
strengthen health services, particularly reproductive and child health
services, to implement interventions that would reduce HIV infection in
women and reduce mother to child transmission of HIV, and to ensure care
and social support for HIV positive mothers and their children.


Working Together to Prevent HIV/AIDS

Professor Fred Sai, the Chair of the meeting, pointed out that "WHO and
UNICEF are committed to working together with UNAIDS and its partners to
take concrete action to prevent mother to child transmission of HIV
infection.  They know that HIV positive women and their families must
receive the care and support they need." 

As a result of a consensus at both the March and April meetings, a working
group will be established to facilitate and support accelerated action on
the part of the United Nations agencies and organizations, UNAIDS and
others. This working group will move as quickly as possible to implement
interventions to reduce mother-to-child transmission, including adequate
infant feeding alternatives.   
............................................................................
....

The major departure in this new policy is of recommending widespread
testing of women for HIV during pregnancy even in low-income-countries in
order to offer them infant formula as an alternative feeding method to
breast-feeding in order to reduce the risk of HIV spread by breast-feeding.
A number of questions arise from this recommendation which departs
radically from previous policy:

1. Is there evidence that HIV is spread by breastfeeding? Most authorities
will agree that the answer to this is "Yes" although a researcher recently
questioned this in a review article2. The evidence for this is from case
studies and seems good although scientifically weak.

2. How often does this occur when the mother is HIV positive and the baby
is still not infected when breast feeding commences? The consensus
statement is based on a figure of 13% which means that 87% of infants do
not get infected when being breast-fed by an HIV positive mother. The
scientific evidence here is from statistical probabilities from cohort
studies. Only some 30 cases of vertical spread by this route have been
shown by case studies in a more rigorous way. Of course no randomized
controlled trials have been done nor even controlled trials and so the
scientific evidence is weak according to the ranking given above, but the
level sounds plausible.

3. What evidence is there that non-breast-feeding is protective of HIV
spread by this route? This has only been studied in high-income-countries
but the evidence that alternative feeding gives protection from HIV spread
seems sound.

4. What evidence is there that non-breast-feeding of infants in
low-income-countries where the mother is HIV positive leads to increased
survival? Here there is no evidence whatsoever and it is worrying that this
is the assumption on which the whole consensus statement and the new
intervention rests. It is not enough to claim as the proponents do that by
the new measure they are reducing HIV spread. This is irrelevant if the
end-result in decreased survival of infants. 

What evidence there is, is very much the other way, i.e. that non
breast-feeding drastically increases infant mortality especially from
diarrhoeal diseases. Five studies from low-income-countries show a 25 fold
increase in mortality from diarrhoea in infants with omitted breast-feeding
in comparison to exclusively breast-fed infants3,4. Of course this is in a
context of alternative feeding where there is not the active support,
training, provision of infant formula etc. that are envisaged in this new
intervention. However the assumption still rests on the expectation that
all these provisions and actions are in place, are functioning
satisfactorily and are likely to be sustained for long enough in order to
have the benefits that are claimed. The experience from many previous
vertical programmes of the sort envisaged here leaves considerable doubt
about all of these assumptions.

5. What evidence is there that the above policy is the most cost-effective
way of reducing the risks of HIV spread in mother and child? Here again the
answer is none and it is serious that an intervention which is likely to be
extremely costly and completely unsustainable apart from permanent massive
support from outside is chosen ahead of well proven other measures which
are more cost-effective and sustainable e.g. better diagnosis and treatment
of STD's 5, protection of young girls from sexual exploitation by
strengthening the Child Convention and encouraging the establishment of
grass-roots movements such as Anti-AIDS Clubs that through peer support may
empower girls to withstand pressures against sexual abuse. They may also
increase understanding amongst boys of their role in respecting individual
freedom of girls to make choices without pressure, encouraging of peer
education amongst boys to consider reducing their number of partners and
where needed the use of condoms for safer sex (the combination of such
measures in young people under 25 years in Uganda has reduced HIV
seroprevalence rates by two thirds over a period of 5 years according to
cohort studies6,7).

6. What evidence is there that the stigmatization which is possible of
mothers who do not breast-feed and are therefore assumed to be HIV positive
is likely to be ameliorated by the programme as envisaged? Again there is
none and there could be serious repercussions which threaten the human
rights and integrity of individuals who have decided to follow the new
strategy.

7. What are the side-effects of weakening a general policy of supporting
breast-feeding by all mothers in poorer communities in
low-income-countries? No one has studied this and so no-one knows.

8. What are the side-effects of wide-spread HIV testing in a setting where
effective triple antiretroviral therapy is not an option? No one knows
since it has not been studied. 

Many other serious weaknesses in the new strategy can be envisaged but it
seems illogical and unscientific to launch into a programme without the
evidence to back it up and at least without positive results from pilot
studies carried out in the relevant setting before taking a leap into the
dark.

We agree with the conclusion implied in the first article cited: if no
systematic review about the alternatives has been carried out and if the
evidence available casts doubt on the intervention proposed then it is back
to the drawing board before the Titanic is launched.

References
1. Irwig L. Zwarenstein M. Zwi A. & Chalmers I. A flow diagram to
facilitate    selection of interventions and research for health care. Bull
WHO 1998  76:17-24
2. Bagasra O. Is infection with HIV-1 possible during delivery and
breastfeeding?       Guest Editorial AIDS Newsletter 1998 13; No 2: 1-2
3. Feachem R.G. & Koblinsky M.A. Interventions for the control of
diarrhoeal    disease among young children: promotion of breast-feeding.
Bull WHO     1984 62: 271-291
4. Huffman S.L. & Combest C. Role of breast-feeding in the prevention and  
    treatment of diarrhoea J. Diarrhoeal Dis Res 1990 8: 68-81
5. Grosskurth H. et al Impact of improved treatment of sexually transmitted
    diseases on HIV infection in rural Tanzania: randomized controlled
trial.       Lancet 1995 346: 530-536
6. Nunn A.J. et al HIV-1 incidence in sub-Saharan Africa. Lancet 1996
348:833-834
7. Mulder DW et al Decreasing HIV-1 seroprevalence in young men in a rural 
    Ugandan cohort BMJ 1995 311: 833-836

Gunnar Holmgren, 
ICH, Uppsala  May 1998
Gunnar.Holmgren@ich.uu.se

[Moderators Comment:The one point which I would add to point 4 is that
surely there is a place for a randomized controlled trial of breast feeding
or substitutes in HIV positive mothers before a global policy is promoted?
The qustion is simple "Do children of HIV positive mothers have better
survival rates if they are not breast fed? The studies would need to be
done in differing environments with and without running water,
refrigeration, urban rural etc. But it would be an easy question to answer.
This is surely a case where a litle scientific method could answer a lot of
questions. 
Eric van Praag of the Unit in WHO who is responsible for putting together
the report of the consultative meeting has pointed out that this article is
in response to a press release and that we should wait until the report is
published before commenting. I disagree and think that E-Drug and possibly
PROCAARE would be suitable fora to discuss what is a statement of
potentially great significance. Richard Laing Co-Moderator]


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