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The issue of drug trials

The issue of drug trials

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.

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