Boghuma Kabisen Titanji: Ethical riddles in HIV research

Translator: Joseph Geni Reviewer: Morton Bast

Prevodilac: Rajko Orman Lektor: Boško Eraković

I'd like to share with you

Htela bih sa vama da podelim

the story of one of my patients called Celine.

priču o jednoj mojoj pacijentkinji po imenu Selin.

Celine is a housewife and lives in a rural district

Selin je domaćica i živi u ruralnom okrugu

of Cameroon in west Central Africa.

Kameruna u zapadnom delu Centralne Afrike.

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

Pre šest godina, u vreme kad joj je otkriven HIV

she was recruited to participate in the clinical trial

bila je regrutovana da učestvuje u kliničkim ispitivanjima

which was running in her health district at the time.

koja su sprovođena, u to vreme, u njenom zdrastvenom okrugu.

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

Kada sam prvi put srela Selinu, pre malo više od godinu,

she had gone for 18 months

prošla je 18 meseci

without any antiretroviral therapy,

bez ikakve antiretrovirusne terapije

and she was very ill.

i bila je veoma bolesna.

She told me that she stopped coming to the clinic

Rekla mi je da je prestala da dolazi u bolnicu

when the trial ended

kada se ispitivanje završilo,

because she had no money for the bus fare

jer nije imala novca za autobusku kartu

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

i bila je previše bolesna da bi pešačila razdaljinu od 35 kilometara.

Now during the clinical trial,

U toku kliničkog ispitivanja,

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

dobijala je antiretrovirusne lekove besplatno

and her transportation costs

i troškovi prevoza

had been covered by the research funds.

su bili pokriveni istraživačkim fondom.

All of these ended once the trial was completed,

Sve ovo se završilo kada je istraživanje završeno,

leaving Celine with no alternatives.

ostavljajući Selin bez alternative.

She was unable to tell me the names of the drugs

Nije mogla da mi kaže imena lekova

she'd received during the trial,

koje je primala u toku istraživanja

or even what the trial had been about.

ili čak u vezi sa čim je istraživanje bilo.

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

Nisam se trudila da je pitam koji su bili rezultati istraživanja,

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

jer mi je bilo očigledno da ona to ne bi znala.

Yet what puzzled me most

Ipak, ono što me je najviše zbunjivalo

was Celine had given her informed consent

bio je njen pristanak

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

da bude deo istraživanja, iako ona očigledno nije razumjela

the implications of being a participant

koje su implikacije ako je učesnik

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

ili šta će joj se desiti kada istraživanje bude gotovo.

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

Podelila sam ovu priču sa vama, kao primer

of what can happen to participants in the clinical trial

šta se dešava učesnicima bolničkih istraživanja

when it is poorly conducted.

kada su loše sprovedena.

Maybe this particular trial yielded exciting results.

Možda je ovo konkretno istraživanje iznedrilo uzbudljive rezultate.

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

Možda je čak i objavljeno u uglednom naučnom časopisu.

Maybe it would inform clinicians around the world

Možda je informisalo bolnice širom sveta

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

o tome kako da se poboljša klinički tretman prema HIV pacijentima.

But it would have done so at a price

Ali sve bi to bilo urađeno po ceni

to hundreds of patients who, like Celine,

stotina pacijenata koji su, kao Selina,

were left to their own devices

bili prepušteni sami sebi,

once the research had been completed.

kada je istraživanje završeno.

I do not stand here today to suggest in any way

Ja ne stojim ovde da kažem, na bilo koji način,

that conducting HIV clinical trials

da je sprovođenje HIV kliničkih istraživanja

in developing countries is bad.

u državama u razvoju loše.

On the contrary, clinical trials are extremely useful tools,

Naprotiv, klinička istraživanja su veoma korisne alatke

and are much needed to address the burden

i veoma potrebna da se obrati pažnja na teret

of disease in developing countries.

bolesti u državama u razvoju.

However, the inequalities that exist between

Međutim, nejednakosti koje postoje između

richer countries and developing countries in terms of funding

bogatih država i država u razvoju, u pogledu finansiranja

pose a real risk for exploitation,

predstavlja stvarnu opasnost za eksploataciju,

especially in the context of externally-funded research.

posebno u kontekstu spoljno-finansiranog istraživanja.

Sadly enough, the fact remains that

Nažalost, ostaje činjenica

a lot of the studies that are conducted in developing countries

da dosta istraživanja koja su sprovođena u zemljama u razvoju,

could never be authorized in the richer countries

nisu mogla da budu odobrena u bogatijim zemljama

which fund the research.

koja finansiraju ta istraživanja.

I'm sure you must be asking yourselves

Sigurna sam da se pitate,

what makes developing countries,

šta čini zemlje u razvoju,

especially those in sub-Saharan Africa,

pogotovu one u podsaharaskoj Africi,

so attractive for these HIV clinical trials?

toliko privlačnim za HIV istraživanja?

Well, in order for a clinical trial to generate

Pa, da bi klinička istraživanja proizvela

valid and widely applicable results,

validne i široko primjenjive rezultate,

they need to be conducted with large numbers of study participants

ona moraju biti sprovedena sa velikim brojem učesnika

and preferably on a population

i poželjno, na populaciji

with a high incidence of new HIV infections.

sa velikom incidencijom novih HIV zaraženih.

Sub-Saharan Africa largely fits this description,

Podsaharaska Afrika u velikoj meri odgovara ovom opisu,

with 22 million people living with HIV,

sa 22 miliona ljudi koji žive sa HIV-om,

an estimated 70 percent of the 30 million people

što je 70 posto od 30 miliona ljudi

who are infected worldwide.

koji su zaraženi u svetu.

Also, research within the continent

Takođe, istraživanje unutar kontinenta

is a lot easier to conduct due to widespread poverty,

je mnogo lakše da se izvede zbog rasprostranjenog siromaštva,

endemic diseases and inadequate health care systems.

endemskih bolesti i neadekvatnog sistema zdrastvene zaštite.

A clinical trial that is considered to be

Bolničko istraživanje koje se smatra

potentially beneficial to the population

potencijalno korisnim za populaciju

is more likely to be authorized,

je verovatnije da bude odobreno,

and in the absence of good health care systems,

a u nedostatku dobrog sistema zdrastvene zaštite,

almost any offer of medical assistance

skoro svaka ponuda medicinske pomoći

is accepted as better than nothing.

je prihvatljivija nego nikakva.

Even more problematic reasons include

Još problematičniji razlozi uključuju

lower risk of litigation,

manji rizik suđenja,

less rigorous ethical reviews,

manje rigorozne etičke kritike

and populations that are willing to participate

i populacije koje žele da učestvuju

in almost any study that hints at a cure.

u bilo kojem istraživanju koje nagoveštava lek.

As funding for HIV research

Kako se finansiranje HIV istraživanja

increases in developing countries

povećava u zemljama u razvoju

and ethical review in richer countries become more strict,

i etičke kritike u bogatim zemljama postaju strožije,

you can see why this context becomes

možete videti kako ovaj kontekst postaje

very, very attractive.

veoma, veoma atraktivan.

The high prevalence of HIV drives researchers

Visok porast HIV-a tera istraživače

to conduct research that is sometimes scientifically acceptable

da izvode istraživanja koja su ponekad naučno prihvatljiva,

but on many levels ethically questionable.

ali u mnogo pogleda etički diskutablna.

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

Kako onda možemo osigurati to da u našim traganjima za lek,

we do not take an unfair advantage

ne iskoristimo nepravednu prednost

of those who are already most affected by the pandemic?

od onih koji su već najviše pogođeni pandemijom?

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

Pozivam vas da razmotrite četiri oblasti na koje mislim da možemo da se fokusiramo

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

u cilju unapređenja načina na koji se stvari rade.

The first of these is informed consent.

Prvi od tih je informisani pristanak.

Now, in order for a clinical trial to be

Da bi kliničko istraživanje bilo

considered ethically acceptable,

razmatrano kao etički prihvatljivo,

participants must be given the relevant information

učesnicima moraju biti date važne informacije

in a way in which they can understand,

na način na koji oni mogu da razumeju

and must freely consent to participate in the trial.

i moraju slobodno pristati da učestvuju u istraživanju.

This is especially important in developing countries,

Ovo je posebno bitno u zemljama u razvoju,

where a lot of participants consent to research

gdje dosta učesnika prihvati istraživanje

because they believe it is the only way in which

jer veruju da je to jedini način na koji

they can receive medical care or other benefits.

oni mogu dobiti medicinsku brigu i druge pogodnosti.

Consent procedures that are used in richer countries

Procedure saglasnosti koje se koriste u bogatijm zemljama

are often inappropriate or ineffective

su često neprikladne ili neefikasne

in a lot of developing countries.

u dosta zemalja u razvoju.

For example, it is counterintuitive to have

Na primer, nelogično je dati

an illiterate study participant, like Celine,

nepismenom učesniku, kao Selin,

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

da potpiše poduži obrazac za saglasnost, koji on ne može da pročita,

let alone understand.

a kamoli razume.

Local communities need to be more involved

Lokalne zajednice moraju biti više uključene

in establishing the criteria for recruiting participants

u postavljanju kriterijuma za regrutovanje učesnika

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

u kliničkim istraživanjima, kao i kod podsticaja za učestvovanje.

The information in these trials

Informacije o ovim istraživanjima

needs to be given to the potential participants

moraju biti date potencijalnim učesnicima

in linguistically and culturally acceptable formats.

u jezički i kulturno prihvatljivom formatu.

The second point I would like for you to consider

Sledeća stvar koju bih želela da razmotrite

is the standard of care that is provided

je standard zaštite koji je obezbeđen

to participants within any clinical trial.

učesnicima kliničkih istraživanja.

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

Ovo je predmet mnogih debata i kontraverze.

Should the control group in the clinical trial

Treba li kontrolnoj grupi u medicinskim istraživanjima

be given the best current treatment which is available

dati trenutno najbolji tretman koji postoji

anywhere in the world?

bilo gde u svetu?

Or should they be given an alternative standard of care,

Ili im treba dati alternativni standard brige,

such as the best current treatment available

koje je trenutno najbolji tretman, koji je dostupan

in the country in which the research is being conducted?

u zemlji u kojoj se istraživanje izvodi?

Is it fair to evaluate a treatment regimen

Da li je fer proceniti režim lečenja

which may not be affordable or accessible

koji nije novčano moguć ili dostupan

to the study participants once the research has been completed?

učesnicima kada je istraživanje završeno?

Now, in a situation where the best current treatment

U situaciji gde je trenutno najbolja terapija

is inexpensive and simple to deliver,

jeftina i jednostavna za isporuku,

the answer is straightforward.

odgovor je jasan.

However, the best current treatment available

Međutim, trenutno najbolju dostupnu terapiju

anywhere in the world is often very difficult

bilo gde u svetu je često veoma teško

to provide in developing countries.

obezbediti u zemljama u razvoju.

It is important to assess the potential risks and benefits

Važno je proceniti potencijalne rizike i benefite

of the standard of care which is to be provided

standarda brige koja je obezbeđena

to participants in any clinical trial,

učesnicima u bilo kom bolničkom istraživanju

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

i uspostaviti one koje su relevantni u kontekstu studije

and most beneficial for the participants within the study.

i najkorisniji za učesnike u istraživanju.

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

To nas dovodi do treće stvari, o kojoj želim da razmislite:

the ethical review of research.

etičke kritike istraživanja.

An effective system for reviewing the ethical suitability

Efikasan sistem za razmatranje etičke ispravnosti

of clinical trials is primordial to safeguard participants

bolničkih istraživanja je primaran za zaštitu učesnika

within any clinical trial.

u okviru bilo kog istraživanja.

Unfortunately, this is often lacking

Nažalost, ovo često nedostaje

or inefficient in a lot of developing countries.

ili je neefikasno u dosta zemalja u razvoju.

Local governments need to set up effective systems

Lokalne vlade bi trebalo da postave efikasne sisteme

for reviewing the ethical issues around the clinical trials

za razmatranje etičkih problema oko kliničkih istraživanja

which are authorized in different developing countries,

koja su ovlašćena u zemljama u razvoju

and they need to do this by setting up

i moraju da urade ovo postavljajući

ethical review committees that are independent

odbore za razmatranje, koji su nezavisni

of the government and research sponsors.

od vlade i sponzora istraživanja.

Public accountability needs to be promoted

Javna odgovornost mora da bude promovisana

through transparency and independent review

kroz transparentno i nezavisno razmatranje

by nongovernmental and international organizations

od strane nevladinih i međunarodnih organizacija

as appropriate.

kao što priliči.

The final point I would like for you to consider tonight

Poslednja stvar koju želim da razmotrite večeras

is what happens to participants in the clinical trial

je šta se dešava sa učesnicima kliničkog ispitivanja

once the research has been completed.

kada je ono završeno.

I think it is absolutely wrong for research to begin

Mislim da je potpuno pogrešno da istraživanje počne

in the first place without a clear plan

bez jasnog plana

for what would happen to the participants

šta će se desiti sa učesnicima

once the trial has ended.

onda kada se istraživanje završi.

Now, researchers need to make every effort to ensure that

Istraživači bi trebalo da se potrude da obezbede

an intervention that has been shown to be beneficial

da je intervencija koja se pokazala korisnom

during a clinical trial

tokom kliničkog ispitivanja,

is accessible to the participants of the trial

dostupna učesnicima istraživanja

once the trial has been completed.

onda kada se istraživanje završi.

In addition, they should be able to consider the possibility

Pored toga, trebalo bi da budu u stanju da razmotre mogućnost

of introducing and maintaining effective treatments

upoznavanja i održavanja efikasnih tretmana

in the wider community once the trial ends.

širim zajednicama kada se istražvanje završi.

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

Ako, iz bilo kog razloga, oni smatraju da to ne bi bilo moguće,

then I think they should have to ethically justify

onda mislim da bi trebalo etički da opravdaju

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

zašto kliničko istraživanje i treba uopšte da bude sprovedeno.

Now, fortunately for Celine,

Sada, srećom za Selin,

our meeting did not end in my office.

naš sastanak se nije završio u mojoj kancelariji.

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

Bila sam u mogućnosti da je upišem na besplatni HIV tretman

closer to her home,

bliže njenoj kući

and with a support group to help her cope.

i sa grupom za podršku da joj pomogne da se izbori.

Her story has a positive ending,

Njena priča ima pozitivan kraj,

but there are thousands of others in similar situations

ali ima na hiljade drugih u sličnim situacijama

who are much less fortunate.

koji su mnogo manje srećni.

Although she may not know this,

Iako možda ona ne zna ovo,

my encounter with Celine has completely changed the way

moj susret sa Selin je totalno promenio način

in which I view HIV clinical trials in developing countries,

na koji sam posmatrala HIV klinička istraživanja u zemljama u razvoju

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

i učinilo me odlučnijom da budem deo pokreta

to change the way in which things are done.

koji menja način na koji se stvari rade.

I believe that every single person

Verujem da svaka osoba

listening to me tonight can be part of that change.

koja me sluša večeras može biti deo promene.

If you are a researcher, I hold you

Ako ste istraživači, pozivam vas

to a higher standard of moral conscience,

na veće standarde moralne savesti,

to remain ethical in your research,

da zadržite etiku u vašim istraživanjima

and not compromise human welfare in your search for answers.

i ne ugrožavate dobrobit ljudi u potrazi za odgovorom.

If you work for a funding agency or pharmaceutical company,

Ako radite za agencije za finansiranje ili farmaceutske kompanije,

I challenge you to hold your employers

izazivam vas da navodite svoje poslodavce

to fund research that is ethically sound.

da finansiraju samo istraživanja koja su etički ispravna.

If you come from a developing country like myself,

Ako dolazite iz zemlje u razvoju kao ja,

I urge you to hold your government

podstičem vas da navodite svoju vladu

to a more thorough review of the clinical trials

na detaljnije razmatranje kliničkih istraživanja

which are authorized in your country.

koja su odobrena u vašoj zemlji.

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

Da, postoji potreba da nađemo lek za HIV,

to find an effective vaccine for malaria,

da se nađe efikasnija vakcina za malariju,

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

da se nađe dijagnostički instrument za tuberkulozu,

but I believe that we owe it to those who willingly

ali ja verujem da onima koji voljno

and selflessly consent to participate in these clinical trials

i nesebično prihvataju da učestvuju u tim kliničkim istraživanjima,

to do this in a humane way.

dugujemo da uradimo ovo na human način.

Thank you.

Hvala vam.