APPENDIX 16
Supplementary memorandum submitted by
the BMA Foundation for AIDS
INTRODUCTION
We would like to thank the Committee for inviting
the BMA Foundation for AIDS to join the panel for its session
on drugs and HIV/AIDS. We regret we were unable to accept the
invitation, but we are grateful to be given the opportunity to
comment on the transcript of that session, including the verbal
evidence from Mr James Cochrane (Glaxo Wellcome plc) and Mr Saul
Walker (National AIDS Trust), and to offer additional thoughts.
COMMENTS ON
THE TRANSCRIPT
In this memorandum, the numbers refer to question
numbers in the transcript of the Committee session, and the evidence
given in response to these.
380 The drug to reduce mother-to-child
transmission of HIV, referred to in the last paragraph of
this answer, is nevirapine, which we discussed in our first memorandum
to the Committee. Following the release of research on this drug
at the 13th International AIDS Conference in Durban (9-14 July
2000), nevirapine's manufacturer Boehringer Ingelheim announced
its intention to provide nevirapine free of charge for the prevention
of mother to baby transmission in developing countries to all
who cannot afford to pay for it.
381 South Africa is in some respects
a special case. It has a higher per capita GDP and better infrastructure
than many other African countries badly affected by HIV/AIDS.
On the other hand, the present Government has shown particular
reluctance in relation to AZT and there has recently been international
criticism of the president's priorities in relation to AIDS. It
is arguable that in South Africa, although unaffordability is
certainly an issue, there have been other factors at play as well.
382 While broadly agreeing with the emphasis
on partnership, we have some concerns about what forms
such partnership might take. For example, there have been proposals
in the USA for a loan fund to enable developing countries to buy
HIV drugs. However, many of the countries which most need these
drugs are already struggling under a heavy burden of debt. There
is a risk that such a loan fund might be set up to prevent developing
countries from buying cheaper versions of the drugs from manufacturers
based in countries which do not respect international patent law
or are able to produce cheaper generic versions of some drugs.
This might benefit the pharmaceutical companies more than the
people of developing countries.
In assessing affordability, attention
needs to be paid to more than just the price of the drugs themselves.
Hospital and laboratory facilities are required, as are trained
staff who understand the treatments and, if current guidelines
are followed as in developed countries, three-monthly tests to
monitor each patient's viral load and CD4 counts. These tests
alone can be prohibitively expensive. (The Panos Institute quotes
a cost of $70 and $20 respectively per test in Zambia, where the
government is unable to meet the basic annual health budget of
$14 per capita.) While access to anteretroviral (ARV) drugs may
be the ultimate goal for all and the short-term option for a small
number of wealthy individuals, greater benefit is likely to accrue
in most developing countries, especially the poorest, from investment
in adequate nutrition, clean water and sanitation, as well as
in primary health care, with access to cheaper drugs for the prevention
and treatment of opportunistic infections and for palliative care.
For countries which are able to afford limited
provision of ARVs, there may be some hope for new, cheaper treatment
regimes in the future. For example, evidence was presented at
the 13th International AIDS Conference in Durban (July 2000) from
research into structured intermittent therapy, which would
reduce the quantity of drugs needed for each individual, offering
the possibility of expanding the numbers able to access treatment
somewhat. However, despite a few early cases which appeared to
show success, more time is needed before the effectiveness of
this therapy can be demonstrated (or not).
386 It is true that the infrastructure is
not in place in many developing countries to provide treatment
with ARV drugs. However, the sweeping statement that "there
are no committed governments in place who really want to
do something about it" should be challenged. Firstly, providing
ARVs may not be the most effective way to "do something"
(see above). Secondly, some governments have taken steps
to introduce ARVs, even if limited. Many have failed to show adequate
leadership and commitment to tackling HIV/AIDS, but where they
have (eg Thailand, Senegal, and some countries in Latin America),
this should be recognised and applauded, and the learning disseminated.
390 It is not true that ARVs should be
taken as soon as a person is known to be infected with HIV,
and this is not what UK treatment guidelines recommend. However,
it is true that these treatments are more effective if started
before severe damage to the immune system.
394+ We agree there should be more investment
in female-controlled methods of HIV prevention.
The female condom is on the market but
its use is still on a very small scale compared to the male condom
and it is much more expensive. The 13th International AIDS Conference
in Durban gave evidence of its acceptability among women in a
number of countries, although it has not always been found popular
with users. It is more controllable by women than the male condom,
although this control is limited because it cannot usually be
used without the man's knowledge. For some women, whose main risk
of HIV comes from sex with a husband or regular partner with whom
they want to have children, it may be no more acceptable than
the male condom because of its contraceptive effect. But if there
is a proportion of the population at risk who would use the female
condom and not the male condom, it could still prove a cost-effective
part of the prevention toolkit. Sex workers have had particular
attention in this regard, as the female condom can be an option
when male clients are unwilling to use the male condom.
Re-use of the female condom by women
who are unable to access or pay for a new one on each occasion
of sexual intercourse has been reported in a number of countries,
and this is often likely to occur where the risk of infection
is higher (eg among sex workers). Because of its potential to
make the female condom more affordable, re-use offers interesting
possibilities for prevention, but there is a lack of data on the
risk of infection to the woman and her new partner(s) from this
practice. The WHO and UNAIDS convened a consultation on the safety
and feasibility of re-use, with a view to issuing guidance on
risk-reduction strategies (eg washing). The consultation concluded
that currently available evidence was not conclusive and that
therefore re-use of the female condom was not recommended at present.
A draft protocol for disinfection, washing, drying, storage and
relubrication is currently being tested and the results from this
could have a significant impact on the potential future role of
the female condom in prevention strategies.
Although microbicides to date have been
disappointing, including the recently reported unsuccessful trial
of nonxynol 9 (not monoxalmine as in answer to question 534),
other products are undergoing clinical trials, using a number
of approaches. There are several potential advantages of microbicides,
including female control and the possibility of preventing infection
without preventing pregnancy. Their likely effectiveness in comparison
with the condom is as yet uncertain, but if found to be less effective,
they would still provide some protection for those unable to negotiate
the use of condoms as well as perhaps providing additional protection
if used with the condom. However, because of the questions about
relative levels of protection, there may be ethical and practical
difficulties in conducting clinical trials (and eventually in
promoting a new product).
The investment to date in microbicide
research has been relatively small, and perhaps one of the
strongest arguments for scaling this up is the potential for getting
a usable product onto the market more quickly than can be hoped
for with vaccines. On the other hand, the technical complexities
should not be underestimated and it is still far from certain
that they can be overcome (for example, ensuring adequate contact
in the vagina for the product to work, or eliminating the risk
of inflammation which increases susceptibility to HIV).
Research on female-controlled technologies is
needed to complement vaccine research. Vaccine development
is a slow process and even once an effective vaccine is found,
there are likely to be significant challenges in implementing
an effective vaccination programme.
The focus on development of new preventive technologies
should not obscure the value of existing prevention approaches
which have been shown to work and could be further developed.
Although not 100 per cent conclusive, research has indicated that
treatment of other sexually transmitted infections (STIs) in a
population can significantly reduce rates of HIV infection, and
because of this, UNAIDS and WHO have designated the control
of STIs as one of the priority interventions for the prevention
of HIV transmission. Integration of STI services into primary
health care and the use of the "syndromic approach"
(which reduces the need for expensive laboratory tests) should
be key elements of effective STI control in developing countries.
Primary prevention is essential for avoiding the acquisition of
viral STIs as well as HIV, and prevention interventions will be
essentially the same. At national policy level, HIV and STI
programmes should be integrated, or at least coordinated.
To meet the overwhelming challenge of HIV prevention,
no one type of intervention is adequate on its own and a combination
of approaches is essential, including:
— continued promotion of condoms;
— improved STI treatment services;
— research on female-controlled methods;
— education and empowerment to give
girls and women greater control over their own sexual lives;
— HIV information and education for
both sexes to enable informed choices;
— better provision and promotion of
voluntary HIV testing with advice and counselling especially for
couples—there is good evidence that couples who have tested
serodiscordant (ie one positive, one negative) are much more likely
to use condoms than untested couples; and
— strategies to increase openness,
and to decrease the denial, stigma and discrimination associated
with HIV and AIDS—it is important to counter the belief
of some governments that the principles of confidentiality and
informed consent contribute to the spread of HIV (the opposite
is the case).
398 We agree that support, and access to
care and treatment, for people with HIV is essential for effective
prevention. However, this does not necessarily mean access to
ARVs. The concept of "continuum of care" described
in answer to question 400 is helpful.
401 The task of costing the provision of
ARV and other interventions in developing countries, in order
to provide a cost benefit analysis, is daunting. The drug-only
cost could be estimated based on estimated numbers of people with
HIV (itself a very inaccurate figure), but the colossal improvements
in infrastructure required to deliver the drugs would also need
to be costed. In order to provide a baseline measure, it would
be necessary to audit the whole current level of health infrastructure.
The improvements to infrastructure built on top of that baseline,
however, would give much wider health benefits than just providing
HIV-specific therapies. Looked at even more broadly, the health
benefits would in turn provide economic benefits to society (reduced
loss of trained professionals in the workforce, for example).
Thus quantifying both the "cost" and the "benefit"
for a cost benefit analysis would be extremely complex.
Perhaps it is more helpful to say that the question
is misleading in implying an either/or choice between providing
basic health care and providing HIV-specific care. Basic interventions
such as clean water and primary health care will benefit people
with HIV along with the rest of the population, while expensive
medical interventions specific to HIV cannot be delivered until
clean water and primary care infrastructure is already in place.
(However, the potential for significant reduction of mother-to-baby
transmission through the relatively affordable and potentially
feasible use of an ARV should not be overlooked—see our
original memorandum to the Committee.)
409-410 It cannot be assumed that universal
HIV vaccination programmes in developed countries would be introduced,
or effectively implemented, immediately, thus creating a massive
instant market for a new product. It may be worth noting
the rather slow uptake of vaccines for hepatitis B. For example,
the Department of Health in this country has not introduced a
programme of universal hepatitis B vaccination, preferring instead
an approach targetting groups at higher risk (including health
care workers). Even with such a policy in place, implementation
of the targeted approach is patchy, with far from universal vaccination
of health care workers or other groups at risk, such as injecting
drug users. Levels of uptake of an HIV vaccine by individuals
could be affected by perception of personal risk, which among
the majority of the population in this country is low in relation
to HIV, though this might be offset by the degree of fear, which
is higher for HIV than other infections. In addition, proposals
for universal vaccination programmes could face some political
reluctance because of opposition from sections of society arguing
that they would encourage behaviours seen as morally wrong. So
despite the evidence given in response to question 547, there
is a possibility that a vaccine developer might not recoup its
costs within the lifespan of the product's patent. This may partly
explain the apparently limited commercial interest in vaccine
research to date.
411 The inventor of the smallpox vaccine,
Edward Jenner (1749-1823), was voted £30,000 by Parliament
in recognition of the value of his services and the sacrifices
they had entailed.
We have not provided references for this memorandum
but would be happy to on request.
Since our original memorandum to the Committee,
two reports have appeared which may be of interest, both launched
at the 13th International AIDS Conference in Durban (July 2000),
and on which we have drawn in producing this memorandum.
The Panos Institute. Beyond Our Means? The cost
of treating HIV/AIDS in the developing world. (Available to download
from www.panos.org.uk)
The Population Council and International Family
Health. The Case for Microbicides. A Global Priority. (Available
on request from International Family Health, Cityside House, First
Floor, 40 Adler Street, London E1 1EE. Tel: 020-7247 9944. Fax:
020-7247 9224. www.ifh.org.uk)
BMA Foundation for AIDS
September 2000
|
