3.1 Ebola_Dilemmas.docx

8/11/2019 3.1 Ebola_Dilemmas.docx

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Ebola, an ethical dilemma

The awful ethical questions at the

center of the Ebola emergencyThe Ebola outbreak in Africa has confronted ethicists and health ocials with aterrible dilemma: when a limited amount of an experimental treatment exists,who should get access rst?

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There are currentl- no Ebola treatments on the market. $ut in this deadliestEbola outbreak in histor-, two Americans missionaries recei/ed anexperimental Ebola drug called 01app after getting the disease in 2iberia.

&ow, infectious disease experts around the world are proclaiming that African

Ebola /ictims should ha/e the same right. %n response, both the *bamaadministration and the (orld )ealth *rgani3ation set4up expert groups toweigh the moral debates around the more widespread use of untested drugs inwhat has now been deemed an international health crisis.

To make sense of the thorn- problems at the heart of this outbreak5s moralit-crisis, we called medical ethicists and doctors. )ere are the four 6uestions the-sa- the- are grappling with.

1) Is it okay to skip the drug testing pathway in a crisis?

%n order to get a drug on the market, a rigorous 7though admittedl- 8awed9

process has been established. 'enerall- it works like this: rst drugs are testedin animals, then in a small group of humans for safet-, and if all goes well,testing mo/es to a larger group of people for ecac-.

That5s the path 01app drug was on, said #r. E3ekiel Emanuel, chair of thedepartment of medical ethics and health polic- at +ni/ersit- of enns-l/ania5smedical school. &ow because we ha/e a crisis, we ha/e short4circuited thatpath on the grounds of compassionate use.

Clinical Trials hases

hase %: !esearchers test a new drug or treatment in a small group ofpeople for the rst time to e/aluate its safet-, determine a safe dosagerange, and identif- side e;ects.

hase %%: The drug or treatment is gi/en to a larger group of people tosee if it is e;ecti/e and to further e/aluate its safet-.

hase %%%: The drug or treatment is gi/en to large groups of people toconrm its e;ecti/eness, monitor side e;ects, compare it to commonl-


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used treatments, and collect information that will allow the drug ortreatment to be used safel-.

hase %ustication for potentiall- doing harm to a patientin a moment of crisis, said onathan 1oreno, a professor of medical ethics atthe +ni/ersit- of enns-l/ania. %n addition to the do no harm adage, inemergencies, the ph-sician and philosopher )ippocrates ad/ised that medicsshould be bold. "o, he added: There5s huge lethalit- and we don5t ha/emuch in the wa- of alternati/es, so )ippocrates would ha/e said, 52et5s get inthere5 7with experimental drugs9.

!) "hy did #mericans get an e$perimental drug while hundreds of

#fricans die of Ebola?

$ut it5s not that eas-. 'i/ing the drug to the missionaries raised another ethicaldilemma: (h- did the Americans get to tr- 01app, while Africans did not?

Emanuel said this is a common problem that comes up when -ou skip theclinical trials and drug appro/als processes. *nce -ou do compassionate use,-ou in/ariabl- create ine6ualities, he explained. "ome people get it, andother people don5t get it, and largel- though not exclusi/el- the people whoend up getting it are well connected and somehow much better o;.

That was the case here: 01app is in limited suppl- in America, created usingmostl- #epartment of #efense funding, so Emanuel said he was not surprisedthat Americans with connections to go/ernment were granted access.

%) "hat if the Ebola drug doesn&t work?

"ome ha/e sei3ed on the moment to argue that more experimental Ebola drugsshould be rolled out in Africa, which raises another ethical issue: *n a societalle/el, the benets of rushing 01app to patients ma- not outweigh the harms.

!ight now, all the data we ha/e related to 01app are promising monke-studies in/ol/ing similar drugs 7other monoclonal antibodies9 but the actual01app experiments in non4human primates has ne/er been published. (hat5s


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more, no Ebola4ghting monoclonal antibod- has e/er been tested in humans."o we don5t -et know that the drug works. %f the Americans li/e, that ma- be noindication of 01app5s ecac-. This strain of Ebola kills around @ to B percentof those who get it, so sur/i/al ma- not necessaril- be attributable to an-medication.

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This change would not happen o/ernight. Gou5d ha/e to engage local people inthe process, get informed consent in their language and in their terms, said1oreno. *nce -ou5/e done that, this could take -ears. %f -ou5re a drugcompan- or a go/ernment group, what5s the commitment to that region orcountr-? Gou can5t >ust 8- in and out.

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"-. are con/ening a meeting next week to discuss the use of untestedtreatments for the current Ebola outbreak, which it has declared to be aninternational public health emergenc-.

#r 1arie4aule =ien-, Assistant #irector4'eneral at the (orld )ealth*rgani3ation 7"-.9 explained M(e are in an unusual situation in this outbreak.

(e ha/e a disease with a high fatalit- rate without an- pro/en treatment or/accine.N

(ith a fatalit- rate of recent outbreaks at around JO, and current treatmentsconsisting of little more than reh-dration, it is eas- to see wh- thisexperimental approach is an attracti/e option. erem- Carrar, #a/id )e-mannand eter iot argued con/incingl- in fa/our of such measures.

)owe/er, there are a number of diseases which meet #r. =ien-Ps criteria of Mahigh fatalit- rate without an- pro/en treatment or /accineN. (hile =ien- isreferring to infectious disease, su;erers of other diseases ha/e campaigned forman- -ears for access to untested medicines. Along with se/eral colleagues, %

wrote a paper on this sub>ect with 2es )alpin, who recentl- died from motorneurone disease, ha/ing campaigned for access to medicines for man- -ears.

The case for

% ha/e argued that, when a patient is facing a certain death from an incurabledisease, the relati/e safet- that randomised controlled trials pro/ide isunnecessar-4 especiall- when the pa-o; is a placebo group of patients whorecei/e no benet at all.

*ne common reason in support of randomised controlled trials is safet-. This is

true for most patients: patients for whom there are other good treatmentoptions, or whose disease is not itself life4threatening. $ut for some patients,this concern is a cruel iron-. Their disease is so o/erwhelmingl- unsafe that an-risk is outweighed b- potential benets. +do "chuklenk reports 1artin #elane-,a trial patient for A%#" who described the situation /i/idl-:

It is as if I am in a disabled airplane, speeding downward out of control. I

see a parachute hanging on the cabin wall, one small moment of hope. I

try to strap it on, when a would be government employee reaches out

and tears it o% my bac#, admonishing, &'ou cannot use that( It does not

have a )ederal *viation *dministration stic#er on it. "e do not #now if it

will wor#.+

#gainst Coercion, E$ploitation and In/ustice

%f a patient faces losing their life, the- are bound to be drawn to an- hope thatis o;ered. %s this coercion?


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To o;er patients an untested drug when there are no other options a/ailable isnot coerci/e. The patient, at least in the earl- stages of the disease, still hasthe capacit- to make an autonomous choice. %t is sometimes argued thato;ering experimental treatments to d-ing patients is coerci/e as the- ha/e noother option. This is a mistake. (hen an o;er is made with the status 6uo as anoption, an- choice for the inter/ention is based on an e/aluation that it is animpro/ement on the status 6uo, that is, that it is the rational choice.

(hat people reall- mean when the- raise the spectre of coercion is that suchpatients are exploited. Exploitation occurs when there is background in>usticeand a person is made an unreasonable or unfair o;er that the- would nototherwise accept, except for the po/ert- or in>ustice of their circumstances.Examples are when people li/ing in un>ust po/ert- are paid low prices for theirorgans or risk- labour.

$ut there is no exploitation in o;ering potentiall- lethal or dangerousexperimental treatments to people who ha/e a high chance of d-ing an-wa-.Exploitation would be if we paid poor people small amounts of mone- toengage in challenge studies or if the- were gi/en drugs with no reasonableprospect of impro/ement simpl- to determine ph-siological reactions. $ut forthose who are aQicted with Ebola, or potentiall- aQicted, the- are in a badsituation.

%n the case of some infectious disease outbreaks, the origin of the infectiousdisease ma- be in part, e/en substantial part, because of some prior orbackground social in>ustice R sa- po/ert-, poor housing or lack of e;ecti/epublic health. %n such cases, there are strong reasons to relie/e in>ustice. $utonce an outbreak has occurred, it is not exploitation to o;er participation inexperimental trials.

(e ha/e no third option to o;er these patients, no safe tested cure. Therefore,o;ering an untested, possibl- unsafe option is >ust that, an o;er. A patient ma-,reasonabl- and autonomousl-, refuse the o;er and the- will be in the samesituation as the- were before.

Competency

As the disease progresses, howe/er, it is possible that patients will no longerbe competent to make an autonomous choice. *ne solution is to seek consentat the earliest stage, when Ebola potential /ictims are identied with risk

factors and earl- s-mptoms. A potential /ictim could sa-, for example, if % dode/elop the s-mptoms and signs of Ebola and become unconscious, % agree toexperimental treatment X with risk factors A, $, .

(hat if the treatment is most e;ecti/e in the earl- stages, before the person issure he or she has Ebola? "uch a person might ha/e tra/elled to a danger 3onebut >ust ha/e a cold. The critical issue here is clear explanation of the risks ofha/ing the infection, and the risks and benets of the inter/ention, insofar as


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the- are known. %n some cases, there ma- be great uncertaint- about bothrisks. "till, people should be gi/en the opportunit- to make their own decisions.

Could there E+er be a *ituation "here it is #cceptable to 0i+e

E$perimental Treatments "ithout Consent?%n the most extreme potential cases, experimentation without consent mightbecome necessar- in the public interest. Cor example, imagine that Ebolamutates and becomes as transmissible as 8u, with millions d-ing, or if abioterrorist geneticall- engineered such an infectious strain. Extreme measureswould then need to be taken. This might re6uire a higher condence that an-new inter/ention is of relati/el- low and acceptable risk, compared to thedisease and conser/ati/e management. )igher risk strategies could beemplo-ed with the consent of the patient. This is possible when potential/ictims are identied with risk factors and earl- s-mptoms.

The most dicult case ethicall- is where experimental treatment is possibl-/er- dangerous, e/en lethal, and must be gi/en when the patient isincompetent. %n such a case, it ma- be that patients are used, at least in part,as a wa- of de/eloping e;ecti/e treatment for future patients. $ut if thenumbers of future fatalities are large enough, such potentiall- lethalexperiments on incompetent patients might be >ustied. $ut how shouldpatients be selected as recipients of this potentiall- dangerous but potentiall-life4sa/ing treatment?

The answer is according to some principle of /ustice

According to one theor- of >ustice, egalitarianism, people should be treatede6uall-. "ome kind of lotter- should be emplo-ed to e6uall- allocate theinter/ention to potential recipients.

According to utilitarianism, those with the worst prognosis should be the rstrecipients since the- ha/e the least to lose R the- are most likel- to die .)owe/er, if one group is more likel- to benet, utilitarianism would fa/our thisgroup. These reasons ma- pull in opposite direction and, o/erall, utilitarians willha/e to balance these.

A third theor- of >ustice is prioritarianism R this in/ol/es gi/ing priorit- to theworst o;. %n this case, this will be those with the most to lose, that is, those

with the worst prognosis. This coincides with one utilitarian >ustication andspeaks in fa/our of gi/ing greater weight to gra/it- of prognosis o/er likelihoodof benet, at least in the rst phases of experimentation.

The 2ecision "e 3ace Today


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Cortunatel-, the Ebola outbreak is not of such proportions and consent forexperimentation can reasonabl- be obtained earl- in the course, e/en iftreatment is onl- gi/en in the later stages. %f patients consent to treatmentearl- in the course, there is a downside R patients who might not ha/e diedma- be exposed to the risks of experimental treatments. The expected harm islowest as prognosis deteriorates. This is an argument 7not conclusi/e9 foradministering inter/entions later, rather than earlier. There ma- becounter/ailing reasons of potential ecac- of earl- inter/ention that couldoutweigh these.

%n this time of crisis, % belie/e we should allow Ebola patients to decide whetherto use the untested medications. $ut if we do, we should ask oursel/es wh- wecontinue to den- this to other patients with rare, incurable, fatal diseases whoare asking for the same freedom.

4esponses from readers

*arah says

August B, DFI at FD:SI pm

M% agree to experimental treatment X with risk factors A, $, N: isnPt the troublehere 7in the case of ebola9 that we donPt know risk factors A, $ and ?

As an ebola patient % would know % ha/e a roughl- JO chance of d-ing but thate6uall-, % could also reco/er and be perfectl- health- for the rest of m- life. $ut% donPt know whether the drug will be as safe as paracetemol 7in the right dose9or as dangerous as the &orthwick ark drugs and ha/e a FO chance of killingme, or will be ine;ectual but will harm me in the longer term if % happen to

sur/i/e.

This seems to me to be di;erent and more dicult ethicall- than in diseasessuch as motor neurone disease or A%#" 7prior to e;ecti/e treatment9 where thepatient knows the disease is fatal, and has some idea of the likel- progressiontime of their disease. Therefore, e/en if the risks of the experimental drug aree6uall- unknown as in the ebola case, the onl- rele/ant potential risk is thatthe- will die sooner than the- would ha/e an-wa- which, although a dicultchoice to make is more akin to the ideal situation of being able to sa- M% agreeto experimental treatment X with risk factors A, $, N. The- can pickthemsel/es the point in the disease at which the- are prepared to take that

known risk.5ulian *a+ulescu says

August , DFI at F:FD am

Thanks "arah. Gou are right. The cases are di;erent. $ut as long as thatis explained to patients, it should be up to them to decide, not theirdoctors, health authorities or go/ernments. "ome people will opt for theuncertaint- of the disease, others for the uncertaint- of the medicine.


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2ife is uncertain R being a person is about making -our own choicesabout the risks -ou take, and those -ou donPt.

.wen *chaefer says

August B, DFI at FD:JS pm

% agree that experimental treatments should be made a/ailable, gi/en theab-smal current standard of care. There is some analog- to the right4of4accessclaims that ha/e been successful in the case of )%


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approach has its own downsidesV it would likel- dampen the prots of thede/elopers, disincenti/i3ing de/elopment of neglected diseases like Ebola. $utit ma- ne/ertheless be a demand of >ustice.

5ulian *a+ulescu says

August , DFI at F:DF amThanks *wen but % disagree that patients should be able to withholdtheir data. E/er- person recei/ing anexperimental treatment mustpro/ide the data related to that treatment on a publicl- accessibledatabase R otherwise we canPt condentl- work out if treatment ise;ecti/e and we risk publication bias. E/er- patient has a moralobligation to be a data point in the progress of medicine. The issue -ouraise of patenting and commercialisation is di;erent. )ow treatmentsought to be de/eloped and priced is a separate issue o/er access toinformation and knowledge. ompanies, b- the /er- nature of capitalism,will aim to make a prot out of ! and #. erhaps there should be caps on

this. *r perhaps go/ernments ought to bu- the products. *r perhaps the"tate ought to in/est more in ! and # making its results a/ailable to all.These are all interesting issues but e/er- time a drug is gi/en, whetherin an Ebola experiment or not, data ought to be s-stematicall- collectedand made publicl- a/ailable, with appropriate anon-misation. "o muchmore could be achie/ed, and so man- disasters a/erted, if we used ournow enormous data mining capacities to understand >ust what we aredoing and what we could do.

http:HHblog.practicalethics.ox.ac.ukHDFIHBHethics4of4ebola4and4potentiall-4life4

sa/ing4experimental4treatmentH
http://blog.practicalethics.ox.ac.uk/2014/08/ethics-of-ebola-and-potentially-life-saving-experimental-treatment/http://blog.practicalethics.ox.ac.uk/2014/08/ethics-of-ebola-and-potentially-life-saving-experimental-treatment/http://blog.practicalethics.ox.ac.uk/2014/08/ethics-of-ebola-and-potentially-life-saving-experimental-treatment/http://blog.practicalethics.ox.ac.uk/2014/08/ethics-of-ebola-and-potentially-life-saving-experimental-treatment/

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3.1 Ebola_Dilemmas.docx