Az Gelişmiş Ülkelerde Klinik Araştırmalar ve Etik İhlaller: Nijerya Faz III Antibiyotik Deneyi Örneği

Year 2017, Volume: 22 Issue: 3, 212 - 219, 25.09.2017

M. Kemal Temel

https://doi.org/10.21673/anadoluklin.336697

Abstract

Dünyadaki en büyük ilaç şirketlerinden biri olan X, yeni
bir antibiyotik ajanı test etmek için 1996’da Nijerya’da çocuklar üzerinde
kanuna ve tıp ahlakına aykırı faz III bir klinik deney gerçekleştirmiş olmakla suçlanmıştır.
Uluslararası medyada yer bulan bu iddialar sonrasında şiddetli tepkilere neden
olmuş ve mahkemeye taşınmıştır. Vakaya dair Nijerya hükumetince hazırlatılan
inceleme raporunda varılan ve yıllarca gizli tutulan sonuç, X’in Helsinki
Bildirgesi’ne ve Birleşmiş Milletler Çocuk Hakları Sözleşmesi’ne aykırı bir
araştırma gerçekleştirdiği olmuştur. Nitekim yalnızca sözlü onam almış olduğunu
kabul eden X, dava edilince, denek çocukların ailelerine tazminat niteliğinde
ödemeler yapmıştır. Bu retrospektif çalışmada, yirminci yüzyıl ortalarındaki
gayriahlaki klinik deneylerin yinelenmemesi için geliştirilmiş olan tüm çağdaş etikolegal
mevzuata karşın doksanlar gibi yakın bir tarihte yine de gerçekleşmiş olan bu olay,
dönemin belge, rapor ve haberleri üzerinden sunulmaktadır. Söz konusu skandal, ahlaken yol gösterici metinlerin varlığı kadar bu metinlerde yazanı yapmayı
ya da yapmamayı seçecek olan ahlaki öznenin karakterinin de önemli olduğuna
dair, tarihten bir başka örnek niteliğindedir. 

Keywords

trovafloksasin, klinik araştırmalar, Kano trovafloksasin deneyi, etik bildirgeler

Clinical Trials in Underdeveloped Countries and Ethical Violations: the Nigerian Case of a Phase III Antibiotic Trial

Abstract

X, one of the globally leading pharmaceutical companies, has
been accused of having performed an illegal and unethical phase III clinical
trial on Nigerian children to test its new antibiotic agent in 1996. The allegations
reported by the international media subsequently met with intense reaction and
were brought to court. The conclusion arrived at in the long-obscured
investigation report ordered by the Nigerian government was that the company X
conducted a clinical trial violating the Helsinki Declaration and the United
Nations Convention on the Rights of the Child. Indeed, the company admitting having
obtained only verbal consent made, when litigated, compensatory payments to the
families of the child subjects. The present retrospective study reviewing the contemporaneous
reports and documents aims to present this case that did occur as recently as
the mid-1990s despite the vast body of contemporary ethicolegal regulations developed
to prevent the reoccurrence of unethical clinical trials similar to those in
the mid-20^th century. The discussed scandal constitutes another
historical example indicating that what is as important as the presence of a
body of established ethical guidelines is the character of the moral agent who
is to choose to follow or not to follow what has been recommended in these
texts. 

Keywords

trovafloxacin, clinical trials, the Kano trovafloxacin trial, ethical declarations

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