E-DRUG: AIDS Drugs: No Compromise on Safety and Quality
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[A different view on the FDC case from Thompson Ayodele at the Institute of
Public Policy Analysis in Nigeria. Quoting from its website
(http://ippanigeria.org/about_ippa.php) the organisation "holds tenaciously
the belief in a free society hinged on certain irreducible minima: That a
good and prosperous society is achievable when government's participation in
certain key spheres is drastically reduced; that prosperity and happiness
are best guaranteed when individuals are able to take beneficial actions
freely without being "controlled" by any central body ; and that the market
order and civil society will be better off under the institutions of private
property, the rule of law, and limited government."
E-drug welcomes discussion, and this contribution will probably elicit some
stiff remarks!
Submitted by Sally Jones <sallymjones22@yahoo.com> WB]
Institute of Public Policy Analysis, Nigeria
AIDS Drugs: No Compromise on Safety and Quality
by Thompson Ayodele
A meeting being held in Botswana will impact millions of people living with
HIV. On March 29-30, drug regulatory authorities, public health leaders,
health care providers, academics, procurement officials, pharmaceutical
companies, and non-governmental organisations converged in Gaborone to
deliberate on the safety of some anti-HIV drugs proposed for distribution in
every nook and cranny of Africa.
In Africa, where the disease has reached an epidemic level, the World Health
Organisation (WHO) plans to treat 3 million HIV/AIDS patients by the year
2005. Part of its strategy includes the development of fixed-dose
combination (FDC) therapies. These are pills containing several different
anti-retroviral (ARV) drugs that are usually administered separately. The
aim is to simplify treatment regimens, improve patient adherence � thereby
reducing the development of drug resistance � and reduce costs.
However, FDCs have not undergone the rigorous testing to which the
individual pills have been subjected. Indeed, they have not really been
tested at all. Rather, the WHO has granted them �pre-qualification� status
on the basis of the fact that the individual components have been tested.
The meeting in Botswana is meant to address legitimate concerns about their
safety and efficacy. [WHO and several African Drug Regulators who approved
FDCs already, will have a different view! WB Moderator]
There is also the worry that rather than reduce drug resistance, FDCs may
increase it. The reason is that many ARVs have side effects, but these vary
from patient to patient. When individual drugs are administered, a doctor
monitors the patient�s progress and gives the combination of drugs that best
balances effectiveness and side-effects. This ensures that patients have an
incentive to return to their doctor for check-ups and also reduces the
likelihood that patients will give up mid-way through a course. But since
such variation won�t be possible on the fixed dose regimen, some patients
may forego the drugs altogether if side effects are too harsh. [FDCs are
actually combined to PREVENT drug resistance; see for example TB and malaria
as well; side-effects do happen, but then doctors should shift to other
combinations or loose tablets. This is not an argument against FDCs, which
have distinct public health benefits; WB moderator]
Some suspect that the WHO�s main reason for promoting FDCs is that they are
cheaper: two fixed-dose combination pills cost $140 per patient compared to
about $600 per year for six pills per day. [misrepresentation: generic ARVs
however are cheaper than FDCs; the figure of $600 is for the branded
versions; WB, moderator]. But the cost of the pills must not be the sole
deciding factor in their use. Many are concerned that the WHO, in its
attempt to provide anti-retroviral drugs to millions of AIDS victims, is
glossing over safety and downplaying efficacy. Indeed, FDCs may well offer
false economy: if the pills lead to increased resistance, then they will not
be cost-effective because in the future more money will have to be spent on
second-line therapies to treat resistant strains.
Health activists have hailed the use of FDCs, saying the all-in-one pill
combinations will revolutionise people�s lives. Can these be the same
activists who protested against the tests of new antibiotics carried out by
a research-based pharmaceutical company in Northern Nigeria? This would be
ironic. There, the main complaint was that the company did not tell patients
about the risks and benefits of the drug. Yet activists are now proposing
that untested FDCs be given to patients willy-nilly. [FDCs are not untested!
WB]
I agree with those activists who demand that treatments for illnesses in
poor countries such as Nigeria must adhere to world class standards. This
applies to ARVs just as much as antibiotics. The extent of the HIV epidemic
and the emergence of resistant strains makes the need for testing more, not
less, acute. HIV medicines, whether original or generic, should meet the
most stringent, rigorous clinical and testing reviews. If the proposed drugs
are rejected by the pharmacies in Brussels, Geneva, London or Washington,
accepting the use of the same drugs in Africa, with little resources and a
lack of equipment to do a proper clinical and scientific evaluation, may
further compound the woes of HIV/AIDS victims.
Even if the FDCs do satisfy all the clinical tests, fundamental problems in
health infrastructure will persist. This is not for lack of funding or lack
of medicines.
African governments have done little to deliver medicines, even when they
have been given the resources to do so, and the majority of drugs are
off-patent. Loans and grants have been given on the basis that governments
will invest in health infrastructure. But corruption and mismanagement have
stymied such hopes. Poor wages in government jobs mean officials are eager
to feather their own nests, for example, by paying inflated prices to
contractors in return for kick-backs. A hospital may be built for twice the
budgeted cost, meaning that there is no money left over to pay for equipment
or staff.
Another visible problem in the fight against AIDS in Africa is the lack of
information-sharing and low morale among health workers. Pharmacists, for
instance, may not know which drugs are available in hospital stores. So the
drugs languish in warehouses until they expire. In addition, the lack of
regular payment of wages results in low morale among health workers, who
then transfer their anger to patients. These factors mean that people are
discouraged from seeking treatment for HIV/AIDS.
The WHO�s intention to help poor African countries tackle AIDS is
appreciated and treatment is an important part of this. Given the problems
faced in effectively delivering medicines in Africa, the WHO�s 3 by 5 AIDS
plan is probably overly ambitious. But that excessive ambition is no excuse
for providing inappropriate treatment. Whatever medicines are used to treat
people must meet world class standards for quality, safety and efficacy.
There should be no compromise over this.
Author: Thompson Ayodele is the Coordinator of the Institute of Public
Policy Analysis based in Lagos, Nigeria, and a Fellow of International
Policy Network, London. This article may be republished without prior
consent but with acknowledgement to the author.
[Tompson Ayodele can be reached at thompson@ippanigeria.org]
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