Do the government itself are willing to minimize protocols

Do you agree that western
companies should only carry out research in vulnerable populations where it is
a response to their health needs? Critically analyse this question using
principles of bioethics and the current regulation of clinical research in low
and middle-income countries.

 

“Medical
research with a vulnerable group is only justified if the research is
responsive to the health needs…of this group”. Although I agree with this
guideline from the Helsinki Declaration, there are several difficulties that
surround the problem of carrying out research in low-income countries. There
are three main issues from which controversies have stemmed: the use of placebo
groups, the validity of participants’ consent and the exploitation of vulnerable
populations. In this essay, I will examine whether the above guideline by the Helsinki
Declaration is adhered to and address the main controversies with reference to the
health needs of vulnerable populations.

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In
2002, Benjamin Mason Meier published an article discussing some of the issues
surrounding medical research in international countries. He provided explanation
on how the governments of low-income and middle-income countries are the
reasons why vulnerable communities are exploited, as the government itself are willing
to minimize protocols and alter legislations so that researchers face fewer hindrances
when organising trials. It could be argued that the reason they do this is
because of their own desperation to bring medical aid to the countless dying inhabitants
of their country. Many nations of Africa are guilty of this where they are disinclined
to enforce any limitations on medical research conducted on their inhabitants
merely to reap the benefits that may come from the medical research. But should
this be done at the expense of a human life?  With reference to Paragraph 20 of the Helsinki
Declaration, medical investigation is only justified if the research is for the
health needs of a vulnerable group. I strongly approve of this guideline and
believe that research should only be carried out as a response to a particular
health requirement. Countries such as India are at risk of becoming a medical ‘sweat
shop’, as pharmaceutical companies take advantage of the few regulations
surrounding clinical trials. However, I support the statement that “western
companies should only carry out research in vulnerable populations where it is
a response to their health needs” in order to safeguard the lives of many
vulnerable individuals.

 

The
term ‘clinical trial’ is the study done on a human participant in order to gain
a further understanding about a particular drug or treatment. The AIDS Clinical
Trial Group (ACTG) 076 was an important study that determined that the drug
‘zindovudine’ (AZT) would dramatically reduce the vertical transmission of HIV
between mother and newborn. However, Paul Lurie and Sidney Wolfe criticized the
unethical actions of clinical trials such as ACTG 076, in their 1997 article,
where they went into detail about the exploitation of low-income countries. They
first criticized the use of placebo control groups, deeming it to be unethical
as these groups would normally be forbidden in developed countries.

 

A
placebo control group is where a certain population is given the inactive
version of the drug being tested (or no drug at all) in order to assess the
true effect of the treatment. If a study such as this was to take place in a western country e.g. USA, an
ethics committee would not approve the use of a placebo group and instead would
require that the placebo group receive the “gold standard of care” which is the
existing recognized treatment method. The Council for International Organizations of Medical Sciences (CIOMS)
and other international ethics committees have stated that investigators must
have a valid reason to not give the participants the gold standard of care.

 

However,
researchers have upheld the view that it is vital that there is a placebo
group, in order to make accurate comparisons and to evaluate whether the
treatment is indeed effective. This was seen in the PETRA trial where
scientists concluded that the drug being tested had no better effect on HIV
transmission than the placebo did. Regardless of the scientific necessities of
a control group, could this be deemed ethical at the expense of a human life?

 

With
the ACTG 076 trial, the AZT drug being tested was proven to dramatically reduce
HIV transmission to newborns, and yet the placebo control group were deprived of
this. Lurie and Wolfe criticized the unnecessary harm caused by these trials
where over one thousand newborns became infected with HIV during the trial,
merely because they were part of the placebo group. This goes against Article
11.3 of the Declaration of Helsinki which states that “every patient including those of control group, if any should
be assured of the best proven diagnostic and therapeutic methods and no patient
should suffer from unnecessary pain.” Patients of the control group are not
receiving the “best proven diagnostic and therapeutic methods” if they are then
deprived of proven effective treatment. Beauchamp and Childress’
principle of ethics can be used as a basis to analyse ethical situations such
as this. The use of a placebo group goes against the principle of non-maleficence
where we have the duty to “above all do no harm”. I strongly agree that this paternalistic approach to
clinical research is unethical and concur with Lurie and Wolfe, that the use of
placebo control groups is immoral.

 

However, it has been argued by researchers that
there are different standards of care between developed and low-income countries.
It has been emphasized that these researchers have no duty to provide enhanced
medical care for individuals, than what “is generally available in the community from
which the subjects are drawn,” in turn, sanctioning the use of placebo control
groups. Using this distinction, researchers have stated that there is no difference
between the placebo itself, and the normal standard of care that the participants
would receive in their low-income countries. I strongly oppose this notion which
also infringes upon the principle of non-maleficence. Researchers must not take
advantage of a countries lack of health provisions in order to achieve the
results of a trial. There is evidence that alterative trial designs can produce
similar results to a placebo group with less risk to a participant such as the practice
of a gold standard of care, as used in developed countries.

 

Regardless,
researchers have maintained that a placebo group is a necessity as it must be
used as a control to compare to the drug being tested. A placebo can aid the
researcher in establishing whether the new drug or treatment is more efficient and
safer in comparison to no drug at all. Without a placebo there maybe the risk
of manufacturing a drug that could cause more harm to a person. Once this drug
is then rolled out to the majority population, there would be a widespread use
of ineffective treatment, dangering the lives of more than just those in the
placebo group. The use of placebo group, therefore, would be in line with
Beauchamp and Childress’ principle of beneficence, where we must perform actions
for the benefit of others. Utilitarianists would also find this the best course
of action as they would strive to find happiness for the maximum number of
people. I concur that there is more harm in developing a drug that has not been
investigated correctly and as a society we should strive for the principle of
non-maleficence and avoid harm to others. Nonetheless we must then establish and critically assess
whether these applicants have provided their informed consent to be a part of
this group.

 

The
issue of consent has been described as the ‘cornerstone of research ethics’ which
has stemmed from the Nuremberg trials where the Nuremberg code stated, “the voluntary
consent of the human subject is absolutely essential”. Consent must be given by
each individual participant, for the treatment to be carried out on them. They
must be explained what the treatment is, and the risks involved. But the main
issue regarding consent is whether it has been gained voluntarily, meaning that
the participant must not have been coerced or threated into giving their
consent. However, variances between the western world and developing countries,
such as language and cultural differences can affect the validity of the
consent received and has made the process more complex and certain vulnerable
populations are at risk of being taken advantage of.

 

One
of the issues that comes with obtaining voluntary consent in low-income
countries, is the language barrier involved. Many of the participants will be
coming from a background of poor education and are therefore provided
information on the trial through oral methods, or provided with translations of
the written consent form into their native language. However, regardless of
these two approaches, how can we be sure that they fully understand the risks
of the trial they are about to undertake? It has been concluded that consent
forms should be accurate and clear about the procedures involved, and the
participant should be aware that they have the opportunity to ask any questions
if necessary. Nevertheless, misunderstandings are bound to occur even with
clearly explained information and therefore increase the risk of an individual
accepting to the terms of a trial without fully understanding the nature of the
study. This lack of understanding breaches the rudimentary prerequisite of
ethical research – “informed consent”. One of the main risks that could occur from
this is a ‘therapeutic misconception’ where the patient has no apparent understanding
that partaking in the trial is to generate data and not for their own health benefit.
But medical professionals have tried to overcome this issue by employing a
‘Teach Back’ method with potential participants, in order to assess their level
of understanding which has drastically reduced the risk of violating the laws
of ethical research.

 

In
addition to issues surrounding language barriers, cultural differences are also
bound to arise when seeking consent from an individual. In many communities, it
is customary that important decisions such as agreeing to a clinical trial
would be taken by the community leader, or the male members of the family as observed
in a study by DeCosta et al. Therefore, investigators face the difficulty of
concluding who they should be discussing consent for the research with. CIOMS
guidelines suggest that sometimes it may be necessary to obtain consent from a
person other than the research participant, so not to offend the community and
their cultural practices. However, this brings into question whether respect
for a community’s culture is above the need to obtain the informed consent of
the individual. However, the CIOMS guidelines have stated that although it is
important to respect the traditions of a particular community, the researcher
must also obtain the participants’ consent as well, which has been outlined in
the CIOMS guideline commentary: “in no case, however, may the permission of a
community leader or other authority substitute for individual informed
consent.” This statement has also been supported by The Nuffield Council on
Bioethics but have further recommended that a researcher has the responsibility
to facilitate an individuals’ non-participation in a trial, regardless of the
community leaders prior consent. 

 

Another
controversy surrounding the issue of consent, particularly effecting vulnerable
populations from developing countries, is about the incentives provided by
researchers. Many critics have argued that trial participants were pressured
into the trial mainly due to their utter desperation for the incentive that was
awarded, which includes access to health care provisions that would not
otherwise have been available to them and monetary incentives (amounts which
would seem miniscule in western countries). Researchers need to be aware that
incentives would have a different affect on individuals from poorer countries
and would evidently influence their rational over whether to participate in the
trial. Critics have argued that these incentives are in a way coercing an
already vulnerable individual to partake as these inducements would be “too
good to refuse”.

 

The
International Conference on Harmonisation (ICH) Guidelines for Good Clinical
Practice outlines the rules around incentives and states that “IRB/IEC should review both the amount and method of payment
to subjects to assure that neither presents problems of coercion of undue
influence on trial subjects.” However, many researchers have contested
against this notion and have argued that these incentives do not amount to
coercion as there were no threats involved. In his 2002 publication, Baruch A.
Brody questioned whether these advantageous incentives should be included
within the perception of coercion. Brody argued that as long as participants were
aware that the incentive was being provided for their involvement in a trial
that may incur risks to their health, and informed consent was received in the
appropriate manner (where cultural practices were respected), then there should
be no reason as to reject these inducements merely because they are benefiting
the trial subjects who would not have received these otherwise. However, I disapprove
of Brodys’ view as he does not fully take into account the desperation and susceptibility
of individuals from poorer countries.  

 

Research
from DeCosta et al also found that there was an apparent different in trust in
the medical field within in low-income countries in comparison to the western
world. In the Haryana state of India, DeCosta et al found that many of the
participants were willing to partake in research due to their “implicit faith
in doctors and the medical system”. They were prepared to participate without
any information about the trial or the risks involved, as they placed their
full trust in the doctors where some described them as “in a way godly”, and
did not require any information about the trial as the doctors would know best,
therefore highlighting the importance of obtaining informed consent within such
a vulnerable community. They are willing to put their lives in the hands of
medical professionals who may not be doing it for the benefit of the
individuals.

 

We
must then look to establish whether these low-income countries are being
exploited after the trial has concluded. Evidently, there may be situations
where individuals will not need treatment after a trial has concluded but for
those who do, it must be made a necessity to provide the necessary treatment
for them. Paragraph 34 of the Helsinki Declaration states that “sponsors,
researchers and host country governments should make provisions for post-trial
access for all participants who still need an intervention identified as
beneficial in the trial.”

Bridget
Haire and Christopher Jordens outlined the importance of post-trial access in
there article ‘Mind the Gap’. They understood the difficulties with implementing
treatment after a trial has concluded but established that host governments
must take a proactive approach to avoid exploiting their own defenseless citizens.
It is clear that issues of treatment expenditure would play a factor here but governments
need to ensure that their countries’ vulnerable populations are not being used
merely to test treatments that would benefit those in developed countries. I strongly believe that depriving a participant,
who aided in the study, of a beneficial post-trial drug would go against the
main principles of medical ethics. Governments must strive to follow the
principle of beneficence, where they have a “duty to do good”.

 

In
his article, Brody argued that although it should be a requirement that
beneficial treatment should be made affordable to everyone who needed it within
a low-income country, this may not be feasible and instead we should aspire for
a more modest approach where those who are at risk of exploitation should
receive treatment. The group that are at risk are those who partook in the
trial and in jeopardy of not receiving anything after the trial has ended. It
would be unfair on them to not seek the benefits after the trial, if it was
proven successful, because in the end, the trial would not have been conducted
without their participation. However, it is the control group that would become
the most exploited. They would not have received any effective treatment from
the beginning and depriving them of a drug that could potentially aid in their
well-being could be deemed to be immoral. What benefit do they receive from
this trial? Brody suggested that the control group be first to be guaranteed access to any effective treatment after the
trial, a view also backed up by the Helsinki Declaration states that “this vulnerable
group should stand to benefit from the knowledge, practices or interventions
that result from the research”

 

In
addition to the above, a critic has quoted that “to use a population as
research subjects because of its poverty…and then to not use that knowledge for
the direct benefit of that population, is the very definition of exploitation.”
The CIOMS has also agreed with this notion and has stated in its 1992
guidelines that “as a general rule, the initiating agency should insure that,
at the completion of successful testing, any products developed will be made
reasonable available to residents of the host community or country.” I believe
that governments should adhere to these guidelines and seek to provide the best
care possible to their vulnerable citizens.  

 

To
conclude, I strongly agree that medical research should on be carried out on
vulnerable populations as a response to their health needs, however we must be
aware of the implications that surround this. I concur with Immanuel Kant and
his deontological viewpoint on human actions, where we should not use others as
“means to an end”. Regardless of the vast amount of people that a treatment
could potentially help, we must not disregard the life of one person for this,
especially a person who is from a vulnerable community. I also agree with a
statement from the Helsinki Declaration “the well-being of the human subject
should take precedence over the interests of science and society” and therefore
it is unethical that a placebo group are given nothing when a proven effective
treatment is available, as seen in the ACTG 076 trial. In my opinion, we must look
to reform the consent procedure with regards to people who are susceptible to incentives.
Governments should also avoid altering their legislations to support
pharmaceutical companies and look to gaining subsidies of treatments, if any, once
the trial has concluded.

 

 

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