Throughout human history many diseases and epidemics have affected large populations for centuries. However one particular region of the world has had to bear a heavy burden over the past few decades; Africa has had its population decimated by epidemics for many years. Currently they face three dreadful diseases: HIV/AIDS, tuberculosis (TB), and malaria. There are 22 million people living with HIV in sub-Saharan Africa (UNAIDS 2008), an estimated 9.27 million new cases of TB (WHO 2009), and in 2006, there were an estimated 247 million episodes of malaria and an estimated 881,000 malaria deaths (WHO 2009). Given the grave conditions in Africa it has been proposed to begin vaccination trials on the populations in multiple developing countries; however this has raised many ethical issues: Is it right use these populations as test subjects? Or should the vaccines be tested and developed outside of Africa then provided to the populace once they are known to be effective?
In order to explore convergent ethical issues in HIV/AIDS, TB and malaria vaccine trials in Africa, the Ethics, Law and Human Rights Collaborating Centre of the WHO/UNAIDS African AIDS Vaccine Programme hosted a consultation on the Convergent Ethical Issues in HIV/AIDS, TB and Malaria Vaccine Trials in Africa in Durban, South Africa on the 10-11 February 2009 (Mamotte et al.). The five major ethical issues discussed at this conference were community engagement, ancillary care obligation, care and treatment, informed consent, and resource sharing. Addressing community engagement there has been a wide spread effort to inform the people of HIV/AIDS spread and treatment as opposed to TB and malaria. Ancillary care refers to treating other health issues the patients may have while participating in the vaccine trials; these individuals could have multiple medical problems that require medical attention. Moreover, the treatment and care debate is extremely important: treatment for malaria or TB is not too expensive and is available, however HIV/AIDS treatment is much more extensive and expensive as well; thus it has been hard defining a standard level of treatment and care to all participants enrolled in these vaccine trials. Informed consent is also a difficult issue because many of patients needing to seek treatment do not understand their conditions or they have misconceptions about the treatment they will receive. This is largely due to illiteracy and lack of education. Finally, resource sharing between researchers working on each individual disease in the past has been poor. To combat this, many are pushing to have more of a collaborative effort in order to successfully resolve these pressing ethical issues. Overall it boils down to two main ideals, do these desperate times call for desperate measures or with the ability to treat these diseases should we uphold a high ethical standard while it could cost lives in the meantime?
It is an interesting idea to start clinical vaccine trials in third world countries most affected by the diseases. The easy answer would be to say yes, start clinical trials now to start maybe saving lives. But as you point out there are several ethical things that need to be considered.
ReplyDeleteThe one that poses the most problem is the pre-excising conditions these people may have. You may not foresee how one condition could affect how the immune system reacts to the vaccine. If there is an unknown factor that adds stress on the immune system it would skew the data and affect the future of the vaccine. I think it would be better to do the clinical trial on patients who live in industrial countries and have had access to health care their whole lives, thus limiting pre-existing conditions. Another problem is that these diseases are very common in Africa and the trial patients may be naturally challenged, this could also skew the data.
If patients from industrial countries are used there is also a greater chance that they will comply, or be able to comply, with the treatment regiment and make it to all of the medial appointments they may need.
Overall I think it would be better for clinical trials to be done in industrialized country/countries.
I am stuck halfway. If I had to choose, I would vote to start the trials in the underdeveloped countries. Depending on the prevalence within a population, a certain percent of people are basically guaranteed to die an untimely death. With these peoples' clock ticking, I believe that a possible success in a vaccine is better than lost time while that same trial is performed somewhere else on earth. I can see how informed consent and ancillary care are stepping stones to this approach, but if the trial is a failure, will the death rate increase? Probably not. If the trial is a success, then at least it was performed on those who needed it most pertinently and not in a developed country.
ReplyDeleteOverall, I'm not sure of all the ins and outs of such a touchy subject, but from my inexperienced point of view, if trials need to be done, do them where they are most needed.
I think that if the research has the potential to help the population of the region and help slow the spread of the pandemic, then HIV research in underdeveloped countries is justified.
ReplyDeleteIn medical school, I spent a month working at the Perinatal HIV Research Unit at the Chris Hani Baragwanath Hospital in South Africa. The Unit was one of eleven international HIVNET sites for HIV prevention research, and is an international site for the Pediatric AIDS Clinical Trial Group (PACTG). The Unit is at the forefront of HIV vaccine research in South Africa, which has been identified as a priority by the government and is collaborating with both the International AIDS Vaccine Initiative (IAVI) and the South African AIDS Vaccine Initiative (SAAVI).
In addition performing research in mother-to-child transmission of HIV and the FIV vaccine trials, the Unit also provides obstetric care for mothers and pediatric follow up of children born to HIV-positive women, with nurse counselling, group education, peer counselling and social support. This combined approach to the care of HIV infected women and their children has been very successful and has been cited as a model for other African settings.
Since I cannot even begin to comprehend the cost of a drug trial, I will propose my view with that as not an issue. I know this is flawed but the savings on a few phases of the test may free up a bit of extra capital for the company to subsidize the extra features of the trial. Given the dire state of affairs I think it should be at least presented as a possibility, once drug is determined safe for human use, to commit one’s self for voluntary submission into the trial where from the onset the patient is informed of the danger and potential lethality of the drug. Especially in the case of HIV/AIDs where it was pretty much a death sentence in the 80’s of America much less in current day Africa where healthcare for minor ailments is hard to come by. To give even the potential option of treatment allows for people, who would most likely not have the chance for it otherwise, to take the risk of it into their own hands and decide for themselves. It should be mandated that where the trial takes place the patients should be set with room and board for the duration of the trial. An additional benefit to keeping them close would be to ensure proper regimens and healthcare should the patient take a turn for the worse.
ReplyDeleteI've been meaning to blog about the following for a while, and it actually seems somewhat pertinent to this topic.
ReplyDeleteRecently (week of November 23rd), I read/heard on www.newyorktimes.com and NPR about a recent trial that was conducted using Truvada (a two drug combination nucleoside reverse transcriptase inhibitor) prophylactically. The article itself (on NEJM.org) gives a 44% increase in protection from HIV infection with the prophylactic use of Truvada. The other sources, where I originally heard this news, quoted other percentages, ranging from 44% to 90% efficacy, depending on the subject's reported pill use, as well as laboratory results of measured blood medication levels. I haven't had time to read the article as carefully as I would like to in order to try and discern these numbers for myself (woohoo, winter break!), but it seems like this prophylactic use of an NRTI could be promising...check out the articles below when you have time.
Anyways, the reason I find this interesting in regards to this blog post is because these Truvada trials were conducted in male sex at birth individuals from 6 countries (Peru, Ecuador, South Africa, Brazil, Thailand, and the United States) who were considered at high-risk for infection. I'm sure the ethics considerations for this study were enormous as well, but they somehow came to the consensus that testing their hypothesis in such a population was executable as well as ethical. From what I have read, the participants were also given safe-sex advice and counseling as well as provided with condoms and encouraged to use these methods as their primary safe-sex practice as the Truvada trial was exactly that...a trial with no known prevention at the start of the study.
In my opinion, if trying a new prevention technique comes with other beneficial preventative measures that are known to work (condoms, education, etc), then the administration of an experimental drug or vaccine to an already high-risk (and, of course, INFORMED) population seems ethical. I say this loosely, assuming that the method of any type of vaccine tested in this manner would be "safe" and known to not infect the recipient with the virus (similar to other vaccines that have already been used effectively in other populations, vaccines that have been tested and not infected other species, etc). Considering the nature of HIV, I understand this "guarantee" might not be possible... in which case, we're back at square one. Here's to hoping...
http://www.npr.org/blogs/health/2010/11/23/131536422/pill-cuts-hiv-infection-risk-significantly-for-a-price
http://www.nytimes.com/2010/11/24/health/research/24aids.html?_r=1&ref=research
Grant, R.M., Lama J.R., Anderson P.L., et al. (2010 November 23). Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men. The New England Journal of Medicine 10 (1056). Retrieved 13 December 2010 from http://www.nejm.org/doi/full/10.1056/NEJMoa1011205#t=articleTop
From a genetics perspective, it is very important where the drug trials are conducted. A vaccination can work well in one population and not be very effective in another based one’s genetic background. Certain populations have evolved to fight many of these epidemics. For example, areas with high prevalence of malaria also have high rates of blood disorders. Genetics are pushed one direction to pick the lesser of the two evils. These populations are under selective pressure which could affect how they react to a specific vaccine.
ReplyDelete