Boghuma Kabisen Titanji: Ethical riddles in HIV research

Translator: Joseph Geni Reviewer: Morton Bast

Translator: Rubén Ventoso Martínez Reviewer: Serv. de Norm. Lingüística U. de Santiago de Compostela

I'd like to share with you

Gustaríame compartir convosco

the story of one of my patients called Celine.

a historia dun dos meus pacientes, Celine.

Celine is a housewife and lives in a rural district

Celine é ama de casa e vive nunha área rural

of Cameroon in west Central Africa.

do Camerún, en África Central.

Six years ago, at the time of her HIV diagnosis,

Hai seis anos, cando lle diagnosticaron VIH,

she was recruited to participate in the clinical trial

escollérona para participar nun ensaio clínico

which was running in her health district at the time.

que nese momento se levaba a cabo no seu distrito de saúde.

When I first met Celine, a little over a year ago,

Cando coñecín a Celine, hai pouco máis dun ano,

she had gone for 18 months

levaba 18 meses

without any antiretroviral therapy,

sen terapia antirretroviral

and she was very ill.

e estaba moi enferma.

She told me that she stopped coming to the clinic

Contoume que parou de ir á clínica

when the trial ended

ó finalizar o ensaio

because she had no money for the bus fare

porque non tiña cartos para o autobús

and was too ill to walk the 35-kilometer distance.

e estaba demasiado enferma para camiñar 35 quilómetros.

Now during the clinical trial,

Durante o ensaio clínico

she'd been given all her antiretroviral drugs free of charge,

déranlle de balde os fármacos antirretrovirais,

and her transportation costs

e os custos de transporte

had been covered by the research funds.

cubríanllos os fondos da investigación.

All of these ended once the trial was completed,

Ó final, o ensaio rematou

leaving Celine with no alternatives.

e Celine quedou sen alternativas.

She was unable to tell me the names of the drugs

Non era quen de me dicir o nome dos fármacos

she'd received during the trial,

que lle deran durante o ensaio,

or even what the trial had been about.

nin o que se investigaba nel.

I didn't bother to ask her what the results of the trial were

Tampouco lle preguntei polos resultados

because it seemed obvious to me that she would have no clue.

porque me parecía obvio que non ía saber nada.

Yet what puzzled me most

Porén, o que máis me desconcertou

was Celine had given her informed consent

é que Celine dera o seu consentimento informado

to be a part of this trial, yet she clearly did not understand

para formar parte deste ensaio aínda que evidentemente non entendía

the implications of being a participant

o que implicaba participar

or what would happen to her once the trial had been completed.

ou que lle sucedería ó acabalo.

Now, I have shared this story with you as an example

Compartín convosco esta historia como exemplo

of what can happen to participants in the clinical trial

do que lles pode pasar ós participantes nun ensaio clínico

when it is poorly conducted.

cando se organiza mal.

Maybe this particular trial yielded exciting results.

Se cadra tiráronse resultados importantes desta investigación.

Maybe it even got published in a high-profile scientific journal.

Se cadra incluso se publicou nunha revista científica importante.

Maybe it would inform clinicians around the world

Se cadra axudoulles a médicos clínicos de todo o mundo

on how to improve on the clinical management of HIV patients.

a mellorar o trato ós pacientes con VIH.

But it would have done so at a price

Mais teríao feito cun custo

to hundreds of patients who, like Celine,

para centos de pacientes que, ó igual ca Celine,

were left to their own devices

foron abandonados á súa sorte

once the research had been completed.

ó rematar a investigación.

I do not stand here today to suggest in any way

Non vin aquí para suxerir

that conducting HIV clinical trials

que os ensaios clínicos sobre o VIH

in developing countries is bad.

en países en desenvolvemento están mal.

On the contrary, clinical trials are extremely useful tools,

Ó contrario, son ferramentas moi útiles

and are much needed to address the burden

e precísanse para enfrontar o problema

of disease in developing countries.

das enfermidades nos países emerxentes.

However, the inequalities that exist between

Porén, as desigualdades que hai entre

richer countries and developing countries in terms of funding

os países ricos e os pobres no relativo ao financiamento

pose a real risk for exploitation,

implica un risco real de explotación,

especially in the context of externally-funded research.

especialmente en investigacións financiadas de forma privada.

Sadly enough, the fact remains that

É sorprendente, mais é un feito

a lot of the studies that are conducted in developing countries

que moitos dos estudos que se levan a cabo en países en desenvolvemento

could never be authorized in the richer countries

nunca se autorizarían nos países ricos

which fund the research.

que financian a investigación.

I'm sure you must be asking yourselves

Seguro que vos estades a preguntar

what makes developing countries,

que fai que os países emerxentes,

especially those in sub-Saharan Africa,

especialmente os da África subsahariana,

so attractive for these HIV clinical trials?

sexan tan atractivos para estes ensaios clínicos sobre VIH.

Well, in order for a clinical trial to generate

Ben, por unha parte,

para que un ensaio clínico produza resultados válidos e aplicables

valid and widely applicable results,

they need to be conducted with large numbers of study participants

precísase unha gran cantidade de participantes

and preferably on a population

e preferentemente nunha poboación

with a high incidence of new HIV infections.

con grande incidencia de novas infeccións de VIH.

Sub-Saharan Africa largely fits this description,

A África subsahariana encaixa nesta descrición

with 22 million people living with HIV,

con 22 millóns de persoas infectadas con VIH,

an estimated 70 percent of the 30 million people

arredor do 70% dos 30 millóns

who are infected worldwide.

de infectados que hai en total no mundo.

Also, research within the continent

Ademais, a investigación neste continente

is a lot easier to conduct due to widespread poverty,

é máis doada de levar a cabo, debido á extensión da pobreza,

endemic diseases and inadequate health care systems.

enfermidades endémicas e sistemas sanitarios deficientes.

A clinical trial that is considered to be

É máis posible que se autorice

potentially beneficial to the population

un ensaio clínico

que sexa potencialmente beneficioso para a poboación.

is more likely to be authorized,

and in the absence of good health care systems,

En ausencia de bos sistemas sanitarios,

almost any offer of medical assistance

case calquera oferta de asistencia médica

is accepted as better than nothing.

acéptase por ser mellor ca nada.

Even more problematic reasons include

Incluso hai motivos máis problemáticos,

lower risk of litigation,

como menor risco de demandas,

less rigorous ethical reviews,

estándares éticos menos rigorosos,

and populations that are willing to participate

ademais do desexo de participar por parte da poboación

in almost any study that hints at a cure.

en calquera estudo que ofreza unha cura.

As funding for HIV research

Debido a que aumentan os fondos para investigación sobre o VIH

increases in developing countries

en países en desenvolvemento

and ethical review in richer countries become more strict,

e os estándares éticos nos países ricos se endurecen,

you can see why this context becomes

podedes ver por que este contexto se volve

very, very attractive.

moi atractivo.

The high prevalence of HIV drives researchers

A alta incidencia do VIH leva os investigadores

to conduct research that is sometimes scientifically acceptable

a desenvolver investigacións que ás veces son aceptables

but on many levels ethically questionable.

desde un punto de vista científico, mais non desde unha perspectiva ética.

How then can we ensure that, in our search for the cure,

Como nos podemos asegurar de que, na nosa busca para a cura,

we do not take an unfair advantage

non nos aproveitamos

of those who are already most affected by the pandemic?

de quen xa está afectado pola pandemia?

I invite you to consider four areas I think we can focus on

Convídovos a considerarmos catro áreas en que creo que nos deberiamos centrar

in order to improve the way in which things are done.

para mellorar a forma en que se fan as cousas.

The first of these is informed consent.

A primeira é o consentimento informado.

Now, in order for a clinical trial to be

Para que un ensaio clínico

considered ethically acceptable,

se considere aceptable eticamente

participants must be given the relevant information

hai que darlles ós participantes a información relevante

in a way in which they can understand,

de tal xeito que a poidan entender,

and must freely consent to participate in the trial.

ademais de aceptar participar sen estaren condicionados.

This is especially important in developing countries,

Isto é moi relevante nos países en desenvolvemento,

where a lot of participants consent to research

onde moita xente acepta a participación

because they believe it is the only way in which

porque cre que é a única forma

they can receive medical care or other benefits.

de recibir atención médica ou outros beneficios.

Consent procedures that are used in richer countries

Os procedementos de consentimento que se usan nos países ricos

are often inappropriate or ineffective

moitas veces non son apropiados nin efectivos

in a lot of developing countries.

en moitos países en desenvolvemento.

For example, it is counterintuitive to have

Por exemplo, é contraditorio facer

an illiterate study participant, like Celine,

que un participante analfabeto coma Celine

sign a lengthy consent form that they are unable to read,

firme un consentimento que non pode ler,

let alone understand.

e, moito menos, entender.

Local communities need to be more involved

Precisaríase que as comunidades locais se involucrasen máis

in establishing the criteria for recruiting participants

á hora de establecer os criterios para a selección dos participantes

in clinical trials, as well as the incentives for participation.

de ensaios clínicos, e tamén os incentivos pola participación.

The information in these trials

Nestes ensaios, a información

needs to be given to the potential participants

ós participantes potenciais ténselles que dar

in linguistically and culturally acceptable formats.

nun formato aceptable desde a perspectiva cultural e lingüística.

The second point I would like for you to consider

O segundo tema que me gustaría que tivésedes en conta

is the standard of care that is provided

son os estándares de coidados

to participants within any clinical trial.

cara ós participantes nos ensaios clínicos.

Now, this is subject to a lot of debate and controversy.

Sobre este punto discutiuse moito.

Should the control group in the clinical trial

Habería que darlle ó grupo de control do ensaio

be given the best current treatment which is available

o mellor tratamento

anywhere in the world?

que haxa en calquera parte do mundo?

Or should they be given an alternative standard of care,

Ou habería que lles dar un estándar de coidados alternativo,

such as the best current treatment available

como pode ser o mellor tratamento dispoñible

in the country in which the research is being conducted?

no país en que se fai o ensaio?

Is it fair to evaluate a treatment regimen

É xusto analizar un tipo de tratamento

which may not be affordable or accessible

ó que os participantes do estudo

to the study participants once the research has been completed?

non terán acceso cando o ensaio acabe?

Now, in a situation where the best current treatment

Nun contexto en que o mellor tratamento

is inexpensive and simple to deliver,

non é caro e se pode enviar dunha forma doada

the answer is straightforward.

a resposta é clara.

However, the best current treatment available

Porén, ás veces é complicado proporcionar

anywhere in the world is often very difficult

o mellor tratamento dispoñible no mundo

to provide in developing countries.

ós países en desenvolvemento.

It is important to assess the potential risks and benefits

Hai que valorar os riscos e beneficios

of the standard of care which is to be provided

do estándar de coidados que se lles vai dar

to participants in any clinical trial,

ós participantes no ensaio clínico,

and establish one which is relevant for the context of the study

e establecer un que sexa adecuado no contexto do estudo,

and most beneficial for the participants within the study.

ademais do mellor para os participantes.

That brings us to the third point I want you think about:

Isto lévanos ó terceiro punto sobre o que quero reflexionar:

the ethical review of research.

os estándares éticos das investigacións.

An effective system for reviewing the ethical suitability

Un método efectivo para revisar a adecuación ética

of clinical trials is primordial to safeguard participants

dos ensaios clínicos é fundamental para protexer os participantes

within any clinical trial.

de calquera ensaio clínico.

Unfortunately, this is often lacking

Por desgraza, a miúdo isto falta

or inefficient in a lot of developing countries.

ou non é eficiente en moitos países emerxentes.

Local governments need to set up effective systems

Os gobernos locais precisan establecer sistemas efectivos para supervisar

for reviewing the ethical issues around the clinical trials

as cuestións éticas arredor dos ensaios clínicos

which are authorized in different developing countries,

que se autorizan en varios países en desenvolvemento.

and they need to do this by setting up

E isto téñeno que facer

ethical review committees that are independent

creando comités de estándares éticos

of the government and research sponsors.

independentes do goberno e dos patrocinadores.

Public accountability needs to be promoted

Hai que promover a responsabilidade pública

through transparency and independent review

a través da transparencia e a valoración externa independente

by nongovernmental and international organizations

por parte de organizacións non gobernamentais e internacionais,

as appropriate.

segundo sexa o caso.

The final point I would like for you to consider tonight

O último tema que quero que consideredes esta noite

is what happens to participants in the clinical trial

é o que pasa cos participantes dos ensaios clínicos

once the research has been completed.

cando a investigación rematou.

I think it is absolutely wrong for research to begin

Penso que non está ben que a investigación empece

in the first place without a clear plan

sen un programa claro

for what would happen to the participants

que indique o que pasará cos participantes

once the trial has ended.

cando o ensaio remate.

Now, researchers need to make every effort to ensure that

Os investigadores teñen que se esforzar moito para conseguir

an intervention that has been shown to be beneficial

que unha práctica que demostrou ser beneficiosa

during a clinical trial

durante un ensaio clínico

is accessible to the participants of the trial

se faga accesible para os participantes do ensaio

once the trial has been completed.

cando este remate.

In addition, they should be able to consider the possibility

Ademais, deberían considerar a posibilidade

of introducing and maintaining effective treatments

de introducir e manter tratamentos efectivos

in the wider community once the trial ends.

en toda a comunidade cando o ensaio finalice.

If, for any reason, they feel that this might not be possible,

E se, por algún motivo, ven que non é posible,

then I think they should have to ethically justify

entón creo que deberían xustificar de forma ética

why the clinical trial should be conducted in the first place.

por que se comezou o ensaio clínico.

Now, fortunately for Celine,

Por sorte para Celine,

our meeting did not end in my office.

a nosa reunión non acabou no meu despacho.

I was able to get her enrolled into a free HIV treatment program

Conseguina introducir nun programa gratuíto para tratar o VIH

closer to her home,

máis preto da súa casa

and with a support group to help her cope.

e con apoio grupal para a axudar durante o proceso.

Her story has a positive ending,

A súa historia ten un final feliz.

but there are thousands of others in similar situations

Porén, hai moitas situacións parecidas

who are much less fortunate.

que non acabaron tan ben.

Although she may not know this,

A pesar de que ela non o saiba,

my encounter with Celine has completely changed the way

o meu encontro con Celine cambiou a miña perspectiva

in which I view HIV clinical trials in developing countries,

dos ensaios clínicos sobre o VIH nos países en desenvolvemento

and made me even more determined to be part of the movement

e animoume a participar no movemento

to change the way in which things are done.

para cambiar a forma en que se fan as cousas.

I believe that every single person

Creo que cada persoa

listening to me tonight can be part of that change.

que me está a escoitar esta noite pode formar parte dese cambio.

If you are a researcher, I hold you

Se sodes investigadores, gustaríame

to a higher standard of moral conscience,

convidarvos a subirdes o estándar da consciencia moral,

to remain ethical in your research,

a serdes éticos nas vosas investigacións,

and not compromise human welfare in your search for answers.

e non arriscar o benestar humano na vosa busca de respostas.

If you work for a funding agency or pharmaceutical company,

Se traballades nunha entidade financeira ou nunha compañía farmacéutica,

I challenge you to hold your employers

ínstovos a que pidades ás vosas empresas

to fund research that is ethically sound.

crearen investigacións éticas.

If you come from a developing country like myself,

Se, coma min, sodes dun país en desenvolvemento,

I urge you to hold your government

pídovos que lle esixades ó voso goberno

to a more thorough review of the clinical trials

unha supervisión máis estrita dos ensaios clínicos

which are authorized in your country.

que se autorizan nos vosos países.

Yes, there is a need for us to find a cure for HIV,

Si, precisamos unha cura para o VIH,

to find an effective vaccine for malaria,

atopar unha vacina para a malaria,

to find a diagnostic tool that works for T.B.,

crear unha forma de diagnóstico que funcione para a tuberculose.

but I believe that we owe it to those who willingly

Porén, creo que lle debemos a esa xente

and selflessly consent to participate in these clinical trials

que participa en ensaios clínicos de forma voluntaria e desinteresada

to do this in a humane way.

facelo dunha forma humana.

Thank you.

Grazas.