E-drug: 11th WHO Model List of Essential Drugs (cont'd)
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I strongly disagree with Richard Laing's opinion that anti-retroviral
drugs (ARV) are not essential drugs. I'd like to offer my answers to
the arguments to that effect which he put forward on this list.
RL: "[The WHO Essential Drugs Model List] is not a list for
registration. In that case, the criteria for inclusion is based only
on safety, quality and efficacy. For an essential drug list
additional criteria are needed, and these I would suggest would
include ease of use without difficult monitoring systems,
relative efficacy in terms of whether these drugs cure or
alleviate a condition and some assessment of relative cost."
Also a criterium which would seem worthy of consideration in an
Essential Drug List, is what the population - or a considerable portion
of the population - will require to survive. Certainly drugs which
represent the only therapeutic response to a critical public health
threat may be deemed essential to public health. AIDS *is* officially
the top killer in Africa now - "and soon the world" - after all.
RL: "If we look at anti-retrovirals, I think that for many countries the
condition of their health systems is such that they would not be
able to use these drugs effectively."
In the case of such an epidemic as AIDS, this doesn't make ARV
inessential; rather, this makes *upgrading health systems* essential.
RL: "For example if a country is unable to screen and treat syphilis
in pregnancy, then I do not think that country could manage a
zidovudine vertical transmission program effectively."
This view might be oversimplifying, because it fails to take into
account an obvious factor of countries' ability to rise up to a public
health challenge: severity of threat. Surely, in that regard also, syphilis
and AIDS aren't really comparable.
RL: "Neverapine has been included on the list on the basis of one
study in Uganda in which nearly 80% of eligible participants
were excluded. I think that the inclusion of nevirapine was
premature. We need more evidence."
The matter of how much evidence is needed depends, in part, on the
benefit from lesser uncertainty Vs the detriment from not treating - so,
again, the fact that we're talking millions necessarily has an impact on
it. As it happens, in the history of HIV/AIDS treatments in the North,
demand and urgency have always been such, that the level of
evidence requirements has always been markedly lower than for other
pathologies (eg the seriousness of side effects of most ARV).
The indication for which nevirapine was included in the EDL list is for
MTCT prevention, and so far, consists of two pills, one during birth,
one 8 hours later. The extreme potency of nevirapine at immediately
and dramatically reducing virus levels in the blood (childbirth blood is
the overwhelming vector for MTCT), as well as the extreme shortness
of drug exposure time, are the very qualities which give this treatment
its clear indicatedness for MTCT reduction. It is safe, active, easy to
use, without difficult monitoring, preventive, and inexpensive (in this
indication).
RL: "When we come to anti-retrovirals, we have even less evidence
than in the public sector environments that are the venue for
the use of these drugs, that they can be used effectively. We
have a very good comparison disease, Tuberculosis. This is a
disease which can be diagnosed with a simple microscopic slide
test of a sputum specimen. It requires daily treatment with four
drugs for two months and two drugs for six months. In some
environments these drugs are combined into single tablets or
combo packs. Minimal monitoring is required, only observation
that the individual takes the drugs and a repeat smear at 2 and
6 months. Yet for such an easy disease to cure, many countries
cure less than 50% of their patients."
Right now no one anywhere *cures* any HIV/AIDS patient, regardless
of environment. What developed health environments achieve is to
restore, for a period of time, a minimum working immunity in the
patient. In many countries in the world, even 50% success at doing
just that would mean near infinite progress compared to the current
situation. This is what we're facing.
RL: "Also as I understand it, present practice is to require regular
monitoring with CD4 counts and viral load measurements.
These are difficult, sophisticated tests that may well be beyond
the means of these public health systems to provide."
I don't know that they are such difficult tests; after all, in France, they
are now routine - including VL (every 6/8 weeks, baring exceptions).
VL testkits are expensive, but they are proprietary, like ARV, so we
can't know how much they cost.
RL: "Some countries like Brazil and Thailand which are at a more
advanced stage of health system development may be able to
use these drugs effectively and so those countries may choose
to add these ARV's to the list. [......] When better drugs are
available or if evidence is provided that the existing drugs can
be used empirically without monitoring and with good
outcomes, then I would consider them to qualify to be termed
"essential"."
Whereas medical indication is indeed not the only criterion for an
essential drug list, it obviously cannot just be dismissed as a criterion
at all. ARVs are hugely indicated for public health response to AIDS,
as is testified in rich country's willingness to cough up $9,000 per
year per patient in ARVs (triple therapies are the standard of care).
Considering the unusual world health threat that AIDS is, it seems
hardly doubtful that ARVs' medical indication outbalances their lesser
characteristics, such as sophistication level of efficient use. Because
there's just nothing else yet, and people are dying NOW.
RL: "There are already drugs on the essential drug list which can be
used for prophylaxis which are not being used. Surely these
should be the first priority."
There are two issues here: countries which don't apply WHO's
recommendations (such as using a drug for prophylaxis), and
incompleteness of the Essential Drug List. Surely the priority where
the EDL is concerned, is that essential drugs be in fact on the list.
RL: "I think the WHO Expert committee would have made a mistake
to declare anti-retrovirals "essential" on the Model List. These
drugs are difficult to use, do not achieve a cure, require
sophisticated monitoring and would take resources away from
the treatment of diseases such as TB, ARI, STD's and other
such conditions that should be addressed first."
Again, this seems to me a schematic view of the situation. Not
treating AIDS takes away more resources from the treatment of TB
than treating it (how can you keep TB strains sensitive in an
immunodepressed body; how can you control contagion when 20% of
the population will not respond to drugs because of HIV). Not treating
AIDS probably takes away more resources from the treatment of all
the other diseases than treating AIDS does, if only because of the
death toll among doctors and nurses (in the worst-stricken country in
the world, Malawi, there are now less than 400 doctors).
In conclusion, I would like to add that I agree with Richard Laing that
successful anti-retroviral therapy requires a lot more than just drugs.
However, my strong belief in the uniqueness of the threat that AIDS
poses to global public health induces me to think that the challenge
cannot be to learn to make do without treating PHAs; the challenge
has to be to find the resources, the humanist will, to beef up
healthcare systems and treat PHAs.
Khalil Elouardighi
Act Up-Paris
e-mail: gerrold@wanadoo.fr
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