In this article I focus on two issues concerning bioethics in
Argentina: reproductive health and ethics in research. Although these
topics are quite dissimilar, they share a particular feature: their
special relationship with context.
Argentina is a multifaceted and paradoxical South American country
whose population is basically of European descent. It has a history of
good public healthcare and education, and it can boast several Nobel
Prize winners in science. Laboratories are working on new trends in
genetic research and have managed to clone cows with special milk.
Sophisticated medical technologies—from organ transplantations
and assisted reproductive technologies (ART) to genetic and
preimplantatory testing—are quick to be adopted. The 2002 Human
Development Index ranked Argentina thirty-fourth among the countries
with the highest levels of human development. The same report points
out that the 2000 survey shows a life expectancy of 73.4 years and a
literacy rate of 96.8.
However, Argentina is a developing country. The report also reveals
that the percentage of the population with ameliorated water is 79%,
and the percentage of the population with access to essential drugs is
between 50% and 79% (prior to the 2001 economic crisis). Hence, there
are and had been wide gaps in and between the social classes, and the
2001 economic crisis deepened these gaps even further. According to a
new United Nations report, indicators from 1999 to 2002 in
Argentina's urban areas show that poverty rates almost doubled,
going from 23.7% to 45.4%, and indigence grew threefold, from 6.7% to
20.9%.1
The economic crisis
devastated our traditionally large middle class and left the country
poorer. Malnutrition and poverty are now part of our everyday life.
Against this backdrop we face another factor: the Catholic Church and
its strong political power. It shapes nearly all regulations and laws
regarding sexual and reproductive rights, which institute a highly
conservative legal framework with dramatic consequences on public
health.
In this report I focus on these contextual factors and related
bioethical concerns. Reproductive issues are associated with a lack of
respect for women's rights and the broad political influence of
the Roman Catholic Church. Many of the concerns over research ethics
are related to the environment within which research is conducted:
poverty and the possibility of exploitation.
Reproductive issues and ethics in research are hot topics in
Argentina, though their impacts and the areas of discussion are quite
different. Whereas the first—reproductive rights—implies
legislation, public policies, and a public debate, the
second—research ethics—has had a narrower discussion,
mainly within academic and scientific circles. Both topics have
generated literature, workshops, and training. In this brief report I
present some of the issues under discussion, their link to the context,
and the activities that have ensued.
Reproductive Issues
I first consider some of the relevant problems concerning
reproductive health, illustrating the strong barriers established by
the Catholic Church and how embryo protection has restricted basic
reproductive rights and led to high levels of hypocrisy and some absurd
practices. I will focus on three points: (1) the lack of respect for
reproductive rights and the first attempt to reverse some of these
omissions; (2) the restrictive abortion laws and their consequences on
pregnancies, for example, with the anencephalic fetus; and, (3) the
incoherence of adopting techniques like preimplantatory genetic
diagnosis or ART and of maintaining specific conceptions of embryos.
Contraception
The teachings of the Catholic Church are present throughout most of
the legal framework. However, there is also the practice of a
“double moral standard.” One thing is what religion says;
another is what people do. The great majority of the population have
had a Catholic upbringing (84.4% claim to be Catholic) but do not
follow Catholic teachings. Nor are they truly devout. Abortion laws are
highly restrictive. However, illegal abortions are carried out
continuously. In Argentina, between 450,000 to 500,000 illegal
abortions are performed every year. The problem with this double moral
standard is how it impacts the vulnerable population, especially poor
women and teenagers.
Forty-five percent of the beds in obstetric wards in public hospitals
are occupied by women with postabortion problems. In fact,
complications due to illegal abortions are the main cause of maternal
death. The WHO indicates that Argentina has 38 maternal deaths per
100,000 live births, whereas Canada, for instance, has 4 per 100,000.
Argentina does not fare well even when compared to Chile,
21/100,000, or Uruguay, 23/100,000. In some provinces of
northern Argentina, the situation is even worse: Formosa shows
177/100,000.
Another pressing issue is the matter of teenage pregnancies. They are
on the rise at a rate of 20% of all live births. In the city of
Rosario, 30% of the deliveries occur with girls under age 19, and a
high percentage are single mothers. Additionally, babies born to
mothers under 15 years of age suffered double the average mortality
rate.2
Reporte Sombra on the Third Report
by Argentina before the Human Rights Committee.
With respect to this dramatic public health situation, this is the
first time that a political power such as the Ministry of Health has
explicitly acknowledged the lack of reproductive rights as a problem.
Consider that until 2003 no national law existed concerning sexual and
reproductive rights. Law 25,673 created a national program that
stipulated the provision of contraceptives in public hospitals, as well
as the provision of information about sexual education, and the
diagnosis and treatment of sexually transmitted diseases and ovarian
and breast cancers. However, the proposal of the program generated
strong criticisms from the Catholic Church. A prolife nongovernmental
organization (NGO) interfered legally and obtained a judge's
support. Her extreme position reached the point that she tried to
forbid all use and sale of contraceptives, even in cases of medical use
for gynecological and fertility problems. Although the case underwent
various legal steps, it nevertheless could not stop the program.
Note that this is a program for reproductive health and responsible
procreation—basic issues for a healthy reproductive life. It is
one of the paths toward preventing abortions. It offers choices
regarding when to have a child and helps prevent sexually transmitted
diseases that in many cases cause secondary infertility. One concern to
the Church was the possibility of its providing information to
teenagers, so they opposed it on grounds of patria potestas or
parental authority. What this legal battle did achieve was to foster a
discussion in the media and bring about an awareness of the problems
involved. However, this was merely the tip of the iceberg, and the
polemic and legal barriers that arose illustrate how difficult it is to
legislate this area in Argentina.
Abortion and the Anencephalic Fetus
If we consider abortion and its impact on certain problematic cases,
here too we find problems concerning the position of the Catholic
Church. The restrictive abortion laws have consequences on pregnancies,
for example, with anencephalic fetuses.
In Argentina, Article 86 of the Penal Code bans abortion. Exceptions
are considered ambiguous by many judges. There are three exceptions:
(1) when the mother's health and life are in danger, (2) when the
pregnancy is the consequence of rape, and (3) when the pregnancy is the
result of a dishonest act on a demented woman. However, the current
interpretation reads the exceptions as only two: the first rarely
considers the mother's health and only a life-threatening
condition is grounds for abortion; the second conflates the second and
third exceptions and accepts abortion only when a demented women is the
victim of rape.
However, not even these extreme exceptions are respected. What is
worse, physicians at public hospitals choose not to perform these
accepted abortions3
An example of the lack
of respect of the accepted exceptions even within the more conservative
framework is the dramatic case of a demented girl of 13 who had been
raped but was denied an abortion in a public hospital.
and
petition a judicial authorization even when the law does not require
it. While judges and physicians deny their responsibility and refuse to
perform the requested abortion, the pregnancy continues.
Cases of fetuses with serious genetic problems or illnesses that will
result in the death of the newborn are ignored. During the past few
years, some cases of anencephalic-fetus pregnancies have been taken up
by the media. Women or couples wanting to end such pregnancies face
endless legal battles. Because of these cases, legislation was passed
for the City of Buenos Aires (the most “progressive” part
of Argentina). This law sanctions an “early delivery” in
cases of anencephalic fetuses or any analogous condition that is
incompatible with life, only if viable after 24 gestational weeks.4
Note that the law does not speak of “abortion” but of
“early deliveries.” In no way does this legislation open
the door to “eugenic/genetic abortions.” Moreover,
consider that this law is not a fitting solution: a woman may be
diagnosed at week 16 or even earlier. Under this law, however she has
to wait two painful months with the physical, psychological, and
emotional costs this may imply.
However, the worst aspect of this law is that it impedes a better
solution. If the three exceptions of the penal code are to be seriously
and correctly interpreted, this is a case of nonpunitive abortion. It
is implicit in the first exception. If we consider health not only as
merely biological functions but also psychological ones, a woman who
does not wish to carry out the pregnancy of a deformed fetus that will
die immediately upon delivery may have to endure great psychological
suffering. This embraces the correct application of the first
exception, owing to the psychological harm such a pregnancy can inflict
on the woman. According to this interpretation, there is no need to
wait until week 24. In fact, this was the position of the Ombudsman of
the City of Buenos Aires, who participated in the legal resolution of
several of these cases. Hence, even if the law was an attempt at a
first step with the best of intentions, it fell short.
Embryos and Assisted Reproductive Technologies
The same pattern occurs in a related arena, ART. Religious background
appears to play a role in the provision of treatment, as well as in
treatment-seeking behavior. Embryos are considered
“persons,” which, in turn, leads to problems with their
manipulation. However, Argentina counts with quite sophisticated
centers. These centers manipulate embryos—creating, selecting,
and cryopreserving them. As no law regulates these practices, these
centers face no legal impediments. However, because they do not wish to
alter the status quo, or the approval and perception of their
activities, they may ultimately prioritize embryos over the well-being
of the woman and may limit the options a woman or a couple is
offered.
Even if the importance and beneficial aspects of cryopreservation are
recognized,5
Latin American Network for
Assisted Reproduction. Consenso Latinoamericano en aspectos
ético-legales relativos a las técnicas en
reproducción asistida. Reñaca, Chile: ;
1996:13–7.
Argentine ART centers limit the number of
embryos that can be frozen. Hence, women may have to submit more
frequently to hormones and medication, with their associated
inconveniences and harms. There is an ongoing trend by which centers
are cryopreserving fewer embryos.
6 Personal conversations with directors of Argentine
fertility centers.
No option for discarding embryos is
offered, and the
only alternative available—when a
person does not choose to transfer the remaining embryos to
herself—is to donate the embryos to another couple. This
“compulsive donation” is quite a strong obligation and can
also have disturbing psychological effects. It may prove to be
especially painful when the donor cannot achieve pregnancy.
A second consideration arises with the practice of “embryo
donation” and its current denotation. Terminology carries weight;
it implies a particular way of understanding facts. The term
“prenatal adoption” is deceptive and conveys the idea of an
“actual adoption.” It is not a neutral term, much less so
in a region where embryos are sometimes more protected than women. I
will not enter here into the controversy regarding the ontological or
ethical status of embryos. However, with the current denotation,
embryos are treated as “orphans,” an analogy that leads to
paradoxes. If we were to grant embryos the condition of persons, the
whole process of cryopreservation would, at least, be odd—how
could we freeze persons? Moreover, in vitro fertilization could be seen
as a massacre, owing to the losses of embryos when transferring them to
the woman's uterus. Additionally, the same practice of giving them
up for adoption (with the obvious intention of protecting them) may
imply their death and destruction.7
Luna
F. Assisted reproductive technology in Latin America: some ethical and
socio-cultural issues. In: Vayena E, Rowe P, Griffin D, ed. Current
Practices and Controversies in Assisted Reproduction. Geneva:
World Health Organization; 2002:31–41.
Another problem relates to the embryo's health status and the
prohibition against discarding embryos. Whereas the International
Federation of Fertility Societies encourages screening for serious
diseases that would be a potential threat to the potential child's
health,8
Jones H, Cohen J. Surveillance
1998. Fertility and Sterility 1999;71(6):S18.
the
majority of Argentine ART centers reject the discarding of embryos.
However, genetic testing is offered.
This poses a paradox. Even if embryos are tested and proven to be
genetically abnormal or to have severe genetic problems, they
“must” be transferred (because they cannot be discarded).
This transfer leads to the nightmare of a woman who has to accept the
transference of an embryo and pregnancy with the knowledge that her
future offspring will carry a serious or even fatal illness.9
Also at stake here is the physician's
responsibility and the couple or woman who is denied rights. A number
of thorny questions arise: Can we knowingly seek a pregnancy resulting
in a handicapped or severely ill offspring? What are our
responsibilities toward this future human being? Should we avoid
bringing “evitable suffering” into the world?
Hence, if this conservative framework is to be followed,
preimplantatory prenatal diagnosis should be banned, and this might be
harmful to the couple and the future offspring, especially if they are
undergoing these procedures to avoid transmitting a genetic disease.
Or, conversely, a preimplantatory prenatal diagnosis could be made and
embryos with genetic problems discarded. However, this is an option the
majority of fertility centers deny doing—another example of
hypocrisy and double standards, not to mention possible harm to the
couple or the offspring, because of the embryo's status in the
culture. The practical solution that many centers are finding is simply
to avoid the problem and freeze the genetically disabled embryos.
Instead of confronting the problems and paradoxes that an extreme
respect for the embryos poses, ART centers and physicians ignore the
issue and conceal the problem. The pattern of hypocrisy and double
moral standards is once again replicated.
Latin America, Argentina, and Research
Ethics
Research ethics is another heated topic in Argentina and Latin
America. I focus here on the recent debates about the Helsinki
Declaration and the proposal of amendments.
After the 2001 economic crisis, Argentina's health situation
deteriorated dramatically. Public hospitals were in higher demand, and
drugs and basic items were practically nonexistent. For many people,
participation in a research protocol was their only chance to acquire a
needed drug.
Meanwhile, since 1997, strong debates have arisen in the
international research setting. Controversial clinical cases, such as
Zidovudine (AZT) trials with pregnant women in Africa, have triggered
different initiatives to change ethical codes. Since then, important
ethical documents have come under scrutiny. For example, the Helsinki
Declaration was updated after a series of discussions and disputes.
The two main points in the controversy over ethical codes, at that
time, were the standard of care during the trial and the use of
placebos. That is, what are research subjects entitled to during
research, and what is the adequate comparator in a clinical research
trial? The first issue considered (1) a single- versus double-standard
discussion and (2) the level of treatment to be offered in a research
trial (e.g., best proven, highest attainable and sustainable, standard
of care, proven effective).
This discussion took place mainly during the redrafting of the
Helsinki Declaration. At that time, different proposals were
presented.10
For details, see: Luna F. Is
“best proven” a useless criterion? Bioethics
2001;15(4):273–88.
The final version (Helsinki, 2000) in
its “renowned” paragraph 29 refers to “the
best
current prophylactic, diagnostic, or therapeutic methods”
endorsing a single standard.
11 World
Medical Association. Declaration of Helsinki. Edinburgh,
Scotland. Oct 2000:section 29 (emphasis added).
Details about this controversy, which have been examined thoroughly,
go beyond this article.12
What I would like to point out is how various
developing countries reacted to this proposal and how Argentina
participates in this context. When this discussion arose, UNAIDS
conducted workshops regarding ethical issues of the human
immunodeficiency virus (HIV) vaccine in Thailand, Uganda, and Brazil,
and UNAIDS regional groups discussed the issues with great dissidence
and controversy. For example, Thailand considered it acceptable not to
offer antiretroviral treatment. The country said that the treatment of
research subjects who became infected during the research (but not as a
result of the research) was to be consistent with that of the rest of
the country. There was no healthcare requirement like the one proposed
by the sponsoring country. Uganda indicated difficulties in
establishing the level of treatment to be given to their research
subjects, but ultimately decided not to give antiretroviral treatment.
It claimed that some treatment should be offered but the sponsoring
country should decide on the appropriate kind and level of the
treatment. It could include immune monitoring, physicians' visits,
prevention and treatment of infections, and palliative treatment but
not necessarily antiretroviral therapy.
In contrast, Brazil claimed it was unacceptable to not offer
antiretroviral treatment and rejected not treating research subjects.
It stated that infected participants should be treated like those in
the sponsoring country. This was later backed by a resolution of
Brazil's National Council of Health.13
Conselho Nacional de Saúde (Brazil). Resolucao N
301 (16 Mar 2000).
UNAIDS reveals significant differences in the way the developing
countries are trying to resolve the issue. Brazil strongly resisted and
prioritized the condition of the research subjects. Thailand or Uganda
privileged the urgency of the researchers and sponsors. Leaving the
decision in the hands of the individual countries can also prove
problematic. Social pressure and the lack of resources may force
countries to accept disadvantaged positions, as Thailand and Uganda
did.
At that time, Brazil took the lead in the region with the Resolution
of their National Council. Argentina, as a country, did not take a
stance. The standard of care and the placebo debate, at that time, was
of personal concern to the author (having been invited to some of the
international forums such as the CIOMS redrafting) rather than being a
public or even academic debate. Even if justified exceptions might
exist, I endorsed the region's position. I considered that, given
the commercialization of drug research and socioeconomic problems, a
double standard might be very dangerous. It could and can open the door
to abusive research.14
The second point—use of placebos—was explicit, for the
first time, in the latest version of the Helsinki Declaration (section
29). So strong were the debates and criticisms over the use of placebos
in the Helsinki Declaration that the World Medical Association (WMA)
issued a Note of Clarification in October 2001.
Months earlier, in February 2001, the Food and Drug Administration
(FDA) had seriously been considering endorsing the design of a Surfaxin
trial in Ecuador, Bolivia, Peru, and Mexico. This study proposed a
control group of 325 premature newborn infants with potentially fatal
respiratory distress syndrome (RDS) to be treated with placebos instead
of a lifesaving and already FDA-approved surfactant drug.15
Lurie P, Wolfe S. Request to the Department
of Health and Human Services to halt plans for unethical
placebo-controlled study of drug for respiratory distress syndrome in
Latin America unless it is redesigned to treat all patients: HRG
publication 1558. 22 Feb 2001. Available at:
http://www.citizen.org/publications/release.cfm.
This study would have meant accepting the preventable death of 17
infants.
16 This drug is shown to reduce
neonatal mortality by 34%. See note 15, Lurie, Wolfe 2001.
Even more questionable was the fact that the same manufacturer was
seeking approval for this drug in Europe, where infants would not be
under placebo but would receive an FDA-approved surfactant drug.
The Surfaxin proposal was viewed as completely unethical by the
majority of Latin America. It was considered to repeat a well-known
pattern in the region: exploitative and abusive behavior.
The Note of Clarification of section 29 of the Helsinki Declaration
has two clauses. If we require and consider only “compelling
sound methodological reasons” (the first clause), the flexible
use of placebos might be very dangerous mainly in resource poor
countries. The main and truly relevant clause is the second one: It
considers the use of placebos “for a minor condition and
where the patients who receive placebo will not be subject to any
additional risk or serious or irreversible harm.”17
World Medical Association. Declaration
of Helsinki: Note of clarification on placebo-controlled trials.
Edinburgh, Scotland. October 2000 (emphasis added).
This
allows placebo use in studies with some analgesics, hypnotics,
antihistamines, antiemetics,
provided that the condition is minor
and will not entail additional risk or serious or irreversible
harm, for example, a temporary discomfort. However, no placebo is
acceptable in the case of antiemetic drugs in a chemotherapy treatment.
The second clause's flexibility will allow for cases that are
often deemed important,
18 Levine R. The
need to revise the Declaration of Helsinki. New England Journal of
Medicine 1999;341(7):531–4.
such as mild
hypertension. It accepts the use of add-on treatments because it does
not deny the research subject's treatment. It implies close
monitoring, adequate end points, rescue treatments, and so on.
The first and second clauses should be respected
simultaneously—an issue that the Note of Clarification,
unfortunately, does not require. In this sense, it was widely felt in
Latin America that the Note of Clarification was problematic for
developing countries and that it would not preclude abusive research
like the proposed surfactant study.
As the international debate increased, Argentina's awareness
also grew. In contrast to other debates such as the standard of care
and even the placebo debate, the latest attempt to amend the Helsinki
Declaration raised concern in the academic and medical communities. In
this case the discussion focused on the 2003 attempt to amend section
30. It covered new issues such as the posttrial obligations (though
some people confused this with the double-standard debate).
Argentina's position, and the region's, called for caution
and a wider presence of developing countries. It was felt that they
should have a voice in this international discussion.
This interest in and impetus on research ethics has had many
manifestations in Argentina. Since 2000, a Fogarty Training Program has
begun. It was originally intended as a collaborative effort to be
conducted six months in New York and six months in Buenos Aires. It is
now being fully conducted in Buenos Aires and has had its second year
of trainees. There has also been networking, not only in the region,
but also within Argentina, and this has led to the creation of an
Argentine chapter of FLACEIS (a Latin American network of research
ethics committees created in Mexico in 2000). Additionally,
Perspectivas Bioéticas, the first Argentine journal
wholly devoted to bioethics is preparing a special monographic issue on
research ethics and on the recent debates. There have also been
governmental initiatives, such as the creation of a Central Research
Ethics Committee of the City of Buenos Aires that will have a voice in
all public hospitals of the City of Buenos Aires (where most research
in Argentina is conducted). The Ombudsman Agency of the City of Buenos
Aires has made a survey regarding the situation of research ethics
committees and is counseling the Ministry of Health about these
organizations. The National Regulatory Agency, ANMAT, is preparing a
new regulation with stringent ethical requirements. They are also
trying to implement inspections of the research ethics committees.
Also, multiple seminars and workshops are being held (e.g., FLENI,
University of Buenos Aires School of Medicine). Undoubtedly, research
ethics is one of the relevant topics and one of the main concerns in
Argentina today.
