Pharmaceutical companies have often used developing countries to conduct research
and clinical trials. The ethics of these practices have always been controversial,
especially as many of the drugs researched are not sold in the Third World after
the trials, giving rise to accusations of exploitation.
The reasons for this are two-fold. One is that prices set for the drugs are simply
beyond what poor people can afford. The other is that there are medical considerations
with regard to drug misuse in the Third World: non-compliance with drug regimes,
due to low levels of education and poorly functioning medical systems, can render
drugs useless by causing resistance to develop within short periods of time, squandering
the millions of dollars spent by pharmaceutical companies on research.
There are valid reasons for conducting drug trials in developing countries. Exposure
to certain diseases is much higher in the Third World, for reasons of poverty, leading
to high incidence (new cases per year) and prevalence (proportion of the sick in
the population). For some diseases, such as AIDS and other infectious diseases, the
time and therefore money required to recruit enough participants in a developed country
to make a trial valid can be problematic.
The concerns of the sex workers and their advocates about the ethics of the coming
Tenofovir trial in Cambodia do have justification, especially if the information
provided by the researchers is not clear enough for all involved to understand. It
must be borne in mind, however, that to clearly understand all the issues associated
with clinical trials the participants must have at least a basic level of life-science
education. Many children in Cambodia do not go to school at all, especially females,
as they have to work or look after their younger siblings, and this aspect of the
trial, therefore, may prove to be the most problematic.
A lack of adequate information is clearly reflected in many comments and demands
made by both the potential participants and their advocates. Comments suggesting
the trial will treat Cambodian women as experimental animals are misguided. Clinical
trials have a clearly defined structure, beginning with pre-clinical phases that
are conducted in a laboratory where the biophysical and biochemical qualities of
the drug being investigated are assessed.
The drug then has to be tested on animals, preferably those genetically close to
humans, to assess its general safety. Many drug trials are abandoned at this stage
and only those that do not produce serious adverse reactions in animals can finally
be tested on humans. Human testing is first carried out on healthy volunteers (phase
I) and then on people exposed to or affected by a specific illness (phase II and
III).
The whole process lasts on average about 10 years before the drug can be certified
as effective and safe and registered for use. Then there is still a long follow-up
(phase IV), which can last for decades, to assess long-term side effects. Potentially
life-saving drugs can often be registered prior to completion of the whole process,
but they still have to undergo all the testing.
Randomized controlled trials are generally regarded as the "gold standard"
method to answer clinical questions, because when well conducted they provide very
strong evidence.
The issue of the participants of the trial feeling falsely protected against risk
and therefore not using condoms should not be a problem, as properly designed trials
(randomized controlled trials) use a "placebo" and have to be "double-blinded".
A "placebo" is a neutral substance that has no effect whatsoever. "Double
blinding" means that neither the researchers nor the participants know who is
getting the real drug and who is getting the "placebo" until the trial
is finished and the results are analyzed. Therefore, provided that all the participants
are well informed and realize that they could be receiving the "placebo"
and not the actual drug, they would not be encouraged to engage in risky practices.
With regard to incentives or compensation provided for taking part in the trial,
it would certainly be unethical to make these in any way substantial, as poverty
and desperation in a group such as this, and in a country such as Cambodia, would
be very likely to lead to participation for even relatively small amounts of money.
People must participate for reasons other than financial gain.
Requests for long-term health insurance for the participants in the trial have been
made, but even setting aside the argument with regard to unsuitable incentives, there
is a difficulty in that the potential side effects of the treatment (or in this case
prophylactic use) are unknown and insurers would therefore have to provide cover
for unforeseeable risks. For example, participants could potentially claim compensation
for unrelated illnesses, claiming they were side effects of the drugs being taken
for the purposes of the trial. It is likely then that insurers would refuse claims,
even those involving genuine side effects, because they are not backed up by enough
scientific evidence. For these simple reasons it is a bit too early to even negotiate
such insurance.
Securing cheaper access to antiretroviral drugs and those that can potentially prevent
HIV infection would be of much greater benefit to both sex workers and the health
care system in Cambodia. Of course it would have to come with a proper health education
campaign as well as putting in place strict regulations on the sale of drugs. At
the moment practically all drugs in Cambodia can be obtained over the counter, and
the provision of healthcare is of questionable value, leading to improper use of
drugs and consequently creating more resistant strains of microbes.
The single most important factor in allowing the trial to go ahead lies in ensuring
a proper educational campaign for all participants is conducted in order to enable
them to understand the design and reasoning behind such trial. At the end of the
day, it is only when everybody is well informed that they will be able to decide
whether the potential benefits outweigh the risks of participating in the trial.
A single trial on 960 women may not provide enough scientific evidence as to the
success of Tenofovir as prophylaxis for HIV infection. It is more likely that if
it proves successful, there will need to be further research done in other countries
to achieve any conclusive results. But the faster that these trials can get under
way, the faster conclusions can be drawn and the closer the day comes when lives
that today are lost can be saved.
