Tuesday, October 16, 2007

Uganda needs law on trial medicines

October 16, 2007
An estimated 5 million new HIV infections and 3 million Aids deaths occur every year worldwide. And because of the huge magnitude of the HIV/Aids pandemic, the need to develop safe, effective and accessible prevention methods has become one of the most urgent global public health needs.

The latest sero survey results conducted by Uganda’s ministry of health indicate that about 7.9% of women compared to 6% of men are living with HIV/Aids. This grim picture perhaps explains why Uganda at all odds, should join the rest of the world to find a cure for the elusive HIV virus.

Just recently a group of women including Ugandans participated in failed HIV/Aids trials after the microbicide gel that was being tested among them as a potential preventive measure proved ineffective.

Microbicides are women friendly compounds that can be applied inside the vagina or rectum to protect against sexually transmitted infections including HIV. They can be formulated as gels, creams, films or suppositories. At least 1,33 women from six countries including Uganda took part in the failed trials and more became infected than those who didn’t participate in the trials.

The high prevalence of infection with HIV in some poor countries like Uganda combined with such countries’ inadequate resources for purchasing antiretroviral medications makes them ideal testing sites for candidate vaccines.

The problem is; Uganda doesn’t have a legal framework to regulate the conduct of biomedical research. There are no known national ethical guidelines before research is approved. Any country wishing to take part in scientific research involving human beings needs to have a national plan to address ethical and sometimes criminal issues because medical research should not be conducted in isolation of fundamental human rights.

The failed HIV trials in Uganda had been opposed by some parliamentarians who argued that Ugandans were being used as guinea pigs for experiments that could not be done in Europe and America. This was after some Ugandan scientists , a geneticist, a virologist ,and an immunologist raised fears that the people involved in the trials could undergo dangerous mutations that could lead to strange abnormalities.

They feared these could lead to the deaths like in the case of the infamous Tuskegee experiment in which American researchers mitigating the cause of syphilis denied treatment to African- American patients deliberately and without the patients’ knowledge.

There is also the issue of informed consent processes, possible coercion of volunteers and financial inducements against the greater public good/interest. International public law has developed principles to the effect that volunteers or human subjects in medical research should fully understand the risks before taking part in trials. The right to life must be safeguarded in all research. The universal declaration on human rights recognise the need to carry out experiments only when precautionary measures have been taken.

Human rights activists have presented a valid argument that it would be difficult to conduct trials of HIV vaccines in developing countries like Uganda because of scientific, social behavioral , ethical and logistical barriers.

These countries should first develop a valid reliable methodology to ensure the voluntary and informed consent to research. The fundamental legal and ethical principles of informed consent to research are well established: no competent adult may be used as a research subject without his or her voluntary, competent and understanding consent.

The most authoritative written statement of these basic legal requirements – the Nuremberg code, states that research should not deviate from the substantive standard of voluntary informed consent.

The Nuremberg code was passed after the trial of the ‘Nazi doctors’. This trial brought to light some of the most extreme examples of physician participation in human rights abuses , criminal activities and murder carried out in the concentration camps at the instigation of tyrant Adolf Hitler.
The second part of this article will be published next week.
The writer is a journalist and advocate
msserwanga@gmail.com

256 772 43 46 77

3 comments:

Lucio said...

Sir,

I find many of your comments inflammatory, and I think you should have directly contacted the company, CONRAD, or one of the Ugandan scientists who worked on the trial before publishing such rubbish.

How exactly were women participants "exposed to the dreaded HIV virus"? Exposure was only through their normal sexual relations. It is not like the researchers injected the volunteers with HIV. Women are routinely counseled about how HIV is transmitted and are provided with condoms during clinical trials.

Also, you never even specify what trial you are talking about. There are such things as trial numbers and names. You must be referring to the Ushercell microbicide trial, which was halted in January of 2007. It is strange that so many months after the trial was halted, you are writing up such nonsense... i can understand if you were caught up in the wave of inflammatory media reports in February, after the trial was halted, but this is several months later and adequate time has passed for you to familiarize yourself with the issues. Instead you paint scientists as racist Nazis.

Shame.

moses paul sserwanga said...

Thanks for your information.
M.

moses paul sserwanga said...

Thanks for your information.
M.