[Pharm-policy] Pierre Chirac and Richard Laing exchange regarding WHO EDL

[James Love]

The following is an interesting exchange between Pierre Chirac
and Professor Richard Laing on the e-drug list, regarding the
WHO decision about listing HIV/AIDS drugs on its "Essential
Drugs List" (EDL).  Pierre Chirac, who is with MSF, 
argues for an expanded list, and mentioning in particular
HIV/AIDS drugs.  Professor Laing questions the inclusion 
of HIV/AIDS drugs on the WHO list.  

  Jamie

---------------------------------
Subject: [e-drug] 11th Model List of Essential Drugs (cont'd)
     Date: Thu, 13 Jan 2000 04:57:39 -0500 (EST)
    From: Pierre Chirac <pierchir@club-internet.fr>
      To: e-drug@usa.healthnet.org

E-drug: 11th Model List of Essential Drugs (cont'd)
---------------------------------------------

Essential drugs: what about AIDS?

The 11th version of the WHO's essential drugs list (published in late
december) is already outdated. The concept of essential drugs has
been paramount to help countries in selecting drugs according to their
efficacy, safety and cost. The idea was that a minimal list of drugs
could solve most health problems. Countries were invited to devote
most of their limited resources to these drugs. In 1977, when WHO
published its first essential drugs list, this was a major step forward.
Year after year the list has been revised in a way that: enhanced the
number of drugs; enhanced the number of drugs considered as
examples of therapeutic groups; enhanced the number of drugs that
can be used only in specialized wards (see the long list of anti-cancer
drugs for example); enhanced the number of patented drugs (higher
priced).

WHO considers that "The concept of essential drugs is
forward-looking. It incorporates the need to regularly update drug
selections to reflect new therapeutic options and hanging unmet
therapeutic needs; the need to ensure drug quality; and the need for
continued development of better drugs, drugs for emerging diseases,
and drugs to meet changing resistance patterns." (quoted from the
EDM policy page on WHO web site).

Well, so what about AIDS, the first cause of death in Africa? The last
revision of the list has included nevirapine for the prevention of
mother-to-child transmission. But WHO says that zidovudine and
nevirapine are included in the list only for this indication. WHO is so
anxious that somebody could use these drugs for adults that this
limitation is written in bold character. There is something more about
AIDS (also quoted from the EDM page): "treatment of sexually
transmitted diseases reduces transmission of the AIDS virus". That's
all... What is the problem with AIDS drugs for WHO? "They are
beyond the budget of most national drugs programs" (quoted from the
11th list).

Well fortunately there is a special UN Agency for AIDS; just visit its
web site these days. They have found a solution for AIDS orphans:
Swiss citizens sent them toys for Christmas. Of course AIDS is not an
easy problem. But WHO will not help in denying its existence.

Pierre Chirac
MSF - Paris
e-mail: pierchir@club-internet.fr


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Subject: [e-drug] 11th Model List of Essential Drugs (cont'd)
     Date: Thu, 13 Jan 2000 20:58:11 -0500 (EST)
    From: Richard Laing <richardl@bu.edu>
      To: e-drug@usa.healthnet.org


E-drug: 11th Model List of Essential Drugs (cont'd)
---------------------------------------------

The question whether Anti-retroviral drugs in their present form should
be on the WHO Model list of essential drugs is an issue which
depends on an understanding of the term "essential".

Firstly this is a model list and any country can decide to add any drug
not on the WHO Model list to their countries Essential drug list. It is
not a prescriptive list, it is a list which should be a starting point for
considering what drugs should be on the national EDL. Also, we
should remember that we are basically talking about a public sector
drug list. This 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.

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. 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.
In these countries, zidovudine would not be considered as an essential
drug. Neverapine has been included on the list on the basis of one
study in Uganda in which nearly 80% of eligable participants were
excluded. I think that the inclusion of neverapine was premature. We
need more evidence. If larger trials show that it is possible to provide
routine treatment to pregnant mothers and their children without
screening or side effects, and that this treatment is effective in
preventing transmission then this drug could be considered to be an
essential drug. But I do not think we have enough evidence yet.

When we come to anti-retrovirals, we have even less evidence that 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. If we think of trying to
provide multiple different anti-retrovirals, taken at different times
during the day, for years without achieving a cure, then I think the
practical challenges become clear. 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.

So again, I do not think we have enough evidence that these drugs
can be used effectively. We need operational field trials in these
environments to assess whether these drugs can be used effectively
in terms of delivery, compliance and positive effect.

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.

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.

Nothing in what I have said above should detract from efforts to
reduce prices. Some countries will have the capability to use these
drugs and every effort should be made to ensure their availability.

But 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. 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".

So I would support large scale operational field trials of ARV's to see
whether they can be used in this way.

Richard Laing
Associate Professor of International Health
Boston University School of Public Health
715 Albany St, T4W, Boston MA 02118 USA
Tel 617 414-1444 Fax 617 638-4476
E-mail richardl@bu.edu

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Subject: [e-drug] 11th Model List of Essential Drugs (cont'd)
     Date: Fri, 14 Jan 2000 07:58:44 -0500 (EST)
    From: Pierre Chirac <pierchir@club-internet.fr>
      To: e-drug@usa.healthnet.org


E-drug: 11th Model List of Essential Drugs (cont'd)
---------------------------------------------

Dear Richard, 

I am afraid the world has changed...

The major arguments of public health experts against putting AIDS at
the top of the health agenda are well summarized by Richard in one
sentence: "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." I am afraid AIDS is
outdating deeply this classic hierarchy of public health priorities. How
many people will die from AIDS in 2000? How many in 2005?
Choosing between AIDS and other major public health priorities is a
mistake. We have no choice than considering AIDS as one of the
major public health priorities today and very likely the first one for
tomorrow in many countries.

Pierre Chirac
MSF - Paris
pierchir@club-internet.fr

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