Boghuma Kabisen Titanji: Ethical riddles in HIV research

Translator: Joseph Geni Reviewer: Morton Bast

翻译人员: Meng Wang 校对人员: Sharon Loh

I'd like to share with you

我想和大家分享

the story of one of my patients called Celine.

关于我的病人赛琳的故事。

Celine is a housewife and lives in a rural district

赛琳是一位家庭主妇

of Cameroon in west Central Africa.

生活在非洲中西部喀麦隆的乡下。

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

六年前，她被诊断患有艾滋病

she was recruited to participate in the clinical trial

她被招募参与了某个药品的临床实验

which was running in her health district at the time.

实验刚好在赛琳的围生区进行

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

一年多以前，我第一次见到赛琳

she had gone for 18 months

她当时已经停止治疗超过18个月了

without any antiretroviral therapy,

完全停止使用抗逆转录病毒药物(是一类于治疗逆转录病毒，主要HIV感染的药物)

and she was very ill.

她当时病的很重。

She told me that she stopped coming to the clinic

她告诉我，自那临床实验结束后

when the trial ended

就再也没去那儿接受过治疗了

because she had no money for the bus fare

因为她负担不起巴士车费

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

身体也太虚弱 没法走35公里路去诊所

Now during the clinical trial,

在实验进行的时候

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

她可以获得免费的抗逆转录病毒药物

and her transportation costs

并可以报销交通费

had been covered by the research funds.

这些费用统统由实验研究承包。

All of these ended once the trial was completed,

然而这一切都随着实验的结束而结束

leaving Celine with no alternatives.

只留下当时走投无路的赛琳。

She was unable to tell me the names of the drugs

她没法告诉我在实验中

she'd received during the trial,

试过什么药

or even what the trial had been about.

甚至也不知道那是个什么实验。

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

我没有再追问她实验的结果

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

因为很明显她是一头雾水的。

Yet what puzzled me most

然而最令我想不通的是

was Celine had given her informed consent

赛琳曾经签署过参与实验的

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

同意书，然而她当时肯定不明白

the implications of being a participant

参与临床实验到底意味着什么

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

实验结束后有会怎样。

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

现在，我跟你们分享的这个故事，是一个真实的

of what can happen to participants in the clinical trial

发生在参于实验的人身上的故事

when it is poorly conducted.

当实验不负责任的结束之后。

Maybe this particular trial yielded exciting results.

也许这个实验会获得一些令人鼓舞的成果。

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

也许结果会被发表在某个知名的科学期刊上。

Maybe it would inform clinicians around the world

也许它能帮助一些临床医生们

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

提升他们在艾滋病临床管理的经验。

But it would have done so at a price

可是这些成果都要付如此浩大的代价！

to hundreds of patients who, like Celine,

数百名和赛琳一样的病人

were left to their own devices

随着实验的结束，

once the research had been completed.

他们失去了所有的帮助。

I do not stand here today to suggest in any way

我今天站在这里并非要告诉大家

that conducting HIV clinical trials

在发展中国家做

in developing countries is bad.

艾滋病临床研究是不对的。

On the contrary, clinical trials are extremely useful tools,

相反，要改善病人状况，它绝对是一种行之有效的方法

and are much needed to address the burden

而且那些发展中国家也非常需要临床实验来

of disease in developing countries.

减轻他们的医疗负担。

However, the inequalities that exist between

然而，我们都知道，一些存在于富国跟穷国之间

richer countries and developing countries in terms of funding

的不公平情况，尤其是资金方面

pose a real risk for exploitation,

这让研究工作带来剥削的可能

especially in the context of externally-funded research.

尤其是那些来自外界投资的临床研究。

Sadly enough, the fact remains that

让人够难过的，现实告诉我们

a lot of the studies that are conducted in developing countries

很多在发展中国家进行的研究

could never be authorized in the richer countries

永远也不会在发达国家得到授权

which fund the research.

并且得到投资。

I'm sure you must be asking yourselves

我肯定你一定会问

what makes developing countries,

什么驱使这些发展中国家

especially those in sub-Saharan Africa,

特别是那些位于非洲撒哈拉沙漠的国家

so attractive for these HIV clinical trials?

被吸引去参与这些艾滋病临床实验？

Well, in order for a clinical trial to generate

为了让临床实验获得

valid and widely applicable results,

人数和复盖率过多而有令人信服的结果

they need to be conducted with large numbers of study participants

大量的病人会被招募参与实验

and preferably on a population

这些病人都优先从

with a high incidence of new HIV infections.

艾滋病新感染率很高的地区找来的

Sub-Saharan Africa largely fits this description,

非洲撒哈拉地区最能符合以上的要求

with 22 million people living with HIV,

有2200万人生活在艾滋病的阴霾中

an estimated 70 percent of the 30 million people

据估算，全世界3000万艾滋病感染人数中，

who are infected worldwide.

他们占70%

Also, research within the continent

并且，在那里开展研究

is a lot easier to conduct due to widespread poverty,

还比较其他地区容易， 因为那里充斥着

endemic diseases and inadequate health care systems.

贫穷，疾病以及不完善的医疗保健体系

A clinical trial that is considered to be

因此，考虑到临床实验

potentially beneficial to the population

可能会给当地带来帮助

is more likely to be authorized,

所以研究很容易就会得到授权

and in the absence of good health care systems,

由于缺乏完善的医疗保健体系

almost any offer of medical assistance

所以任何的医疗援助都很容易被接受

is accepted as better than nothing.

因为总比什么都没有好

Even more problematic reasons include

而且还有一些有问题的理由，像

lower risk of litigation,

负比较少的法律责任

less rigorous ethical reviews,

比较低的道德压力

and populations that are willing to participate

更有大量的病人愿意加入各种类似的研究

in almost any study that hints at a cure.

这些临床实验都号称能治好他们。

As funding for HIV research

随着越来越多的艾滋病研究

increases in developing countries

得到投资并且在发展中国家开展起来

and ethical review in richer countries become more strict,

道德审查却在发达国家变得越来越严格

you can see why this context becomes

这就是为什么这个话题变得

very, very attractive.

这么的引人注目。

The high prevalence of HIV drives researchers

艾滋病的高发病率促使研究员们

to conduct research that is sometimes scientifically acceptable

作这方面的研究，这在科学研究上是可以接受的

but on many levels ethically questionable.

但在很多道德伦理方面就出现疑问

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

我们怎么才能保证，在研究治疗的过程中

we do not take an unfair advantage

不会损害那些参与实验而

of those who are already most affected by the pandemic?

又在与疾病抗争的病人们的利益？

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

我恳请大家考虑下以下这四个方面

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

为了改善这个现状。

The first of these is informed consent.

首先是要提倡参加者的知情权。

Now, in order for a clinical trial to be

时至今日，为了让临床实验

considered ethically acceptable,

在道德上容易被接受

participants must be given the relevant information

参与者必须有权获得相关的资料

in a way in which they can understand,

而且是他们可以理解的

and must freely consent to participate in the trial.

必须专重参加者的参与自由。

This is especially important in developing countries,

这在发展中国家尤其重要

where a lot of participants consent to research

因为大量的参与者同意参加研究

because they believe it is the only way in which

他们相信这是他们唯一的机会

they can receive medical care or other benefits.

得到治疗或者其他方面的帮助。

Consent procedures that are used in richer countries

然而发达国家那套用来保障知情权的方法

are often inappropriate or ineffective

在很多发展中国家

in a lot of developing countries.

基本上是形同虚设。

For example, it is counterintuitive to have

就拿赛琳来说吧，那简直是荒谬的

an illiterate study participant, like Celine,

让一个没受过教育的参加者

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

去签一份又长又看不懂的

let alone understand.

同意书。

Local communities need to be more involved

我们需要更多本地政府的参与

in establishing the criteria for recruiting participants

建立一套合理的参与者招募准则

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

须要提到临床实验，而不仅仅是吸引参与者。

The information in these trials

所有跟实验相关的信息

needs to be given to the potential participants

应该要用参加者的语言和方式

in linguistically and culturally acceptable formats.

让他们理解。

The second point I would like for you to consider

我要提出的第二点是

is the standard of care that is provided

我们应该提供治疗的标准

to participants within any clinical trial.

给这些参与临床实验的人。

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

现在，这个话题带有争议性。

Should the control group in the clinical trial

参与实验的对照组病人是否也

be given the best current treatment which is available

应该得到顶级的治疗

anywhere in the world?

就像发达国家的病人一样？

Or should they be given an alternative standard of care,

或者他们应该被区别对待

such as the best current treatment available

只能得到进行实验的国家的那些

in the country in which the research is being conducted?

所谓的顶级的治疗待遇呢？

Is it fair to evaluate a treatment regimen

我们是否能公正的评价一种

which may not be affordable or accessible

让参与研究的病人们感觉遥不可及的疗法

to the study participants once the research has been completed?

当这些疗法问世的时候？

Now, in a situation where the best current treatment

此时此刻，我们身处一个顶级医疗

is inexpensive and simple to deliver,

触手可及的国度

the answer is straightforward.

答案是明显的。

However, the best current treatment available

然而，这些这些在发达国家

anywhere in the world is often very difficult

触手可及的事情

to provide in developing countries.

在发展中国家却是难如登天。

It is important to assess the potential risks and benefits

我认为在临床实验中对即将提供给

of the standard of care which is to be provided

临床病人们的医疗品质

to participants in any clinical trial,

是非常有必要进行风险评估的

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

这能帮助我们建立一种既不影响实验

and most beneficial for the participants within the study.

又能给予参与实验的病人们最大利益的准则。

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

说到准则，正好谈一下我第三个观点

the ethical review of research.

希望大思考一下临床研究的伦理审查。

An effective system for reviewing the ethical suitability

一个有效的伦理审查体系

of clinical trials is primordial to safeguard participants

一定是以保护参与者的生命安全为出发点

within any clinical trial.

在临床实验中。

Unfortunately, this is often lacking

不幸的是，这在很多发展中国家

or inefficient in a lot of developing countries.

伦理审查根本就是闻所未闻的事情。

Local governments need to set up effective systems

本地政府需要建立有效的

for reviewing the ethical issues around the clinical trials

临床实验伦理审查体系针对那些

which are authorized in different developing countries,

在发展中国家得到授权的实验

and they need to do this by setting up

并且建立起一个

ethical review committees that are independent

独立的伦理审查委员会

of the government and research sponsors.

不受政府和研究赞助人的干扰。

Public accountability needs to be promoted

应该提倡向公众问责的体系

through transparency and independent review

通过非政府组织或国际机构的

by nongovernmental and international organizations

公开透明且独立的

as appropriate.

伦理审查。

The final point I would like for you to consider tonight

最后我希望大家想一想

is what happens to participants in the clinical trial

那些临床实验的病人

once the research has been completed.

随着实验的结束会面对怎样的情况。

I think it is absolutely wrong for research to begin

我认为这种

in the first place without a clear plan

一旦结束就过河拆桥的

for what would happen to the participants

医学研究

once the trial has ended.

根本不应该开展。

Now, researchers need to make every effort to ensure that

现在，研究者们应该努力确保

an intervention that has been shown to be beneficial

让那些参与实验参的人

during a clinical trial

能够得到妥善的安排

is accessible to the participants of the trial

就像他们在参与实验时那样

once the trial has been completed.

即使在实验完成后。

In addition, they should be able to consider the possibility

不仅如此，研究完成后，研究者们应该尽力

of introducing and maintaining effective treatments

提供一些可行的疗法

in the wider community once the trial ends.

来回馈更多的病人不仅仅是曾经参与的人。

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

如果，无论什么原因，他们做不到的话

then I think they should have to ethically justify

我认为他们应该从伦理上向社会交代

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

自己的实验当初可以开展的理由。

Now, fortunately for Celine,

赛琳是幸运的

our meeting did not end in my office.

我们的会面没有在办公室里结束。

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

我帮她加入了一个离家很近

closer to her home,

而是免费的艾滋病治疗计划

and with a support group to help her cope.

还有一个支持团体在帮助她对抗病魔。

Her story has a positive ending,

赛琳的故事总算有一个正面的结果

but there are thousands of others in similar situations

但还有成千上万像她的病人

who are much less fortunate.

就没这么幸运了。

Although she may not know this,

赛琳肯定没想到

my encounter with Celine has completely changed the way

我们的相遇完全的改变了

in which I view HIV clinical trials in developing countries,

我对在发展中国家进行临床实验的看法

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

并且让我下定决心，成为了改变运动的一部份

to change the way in which things are done.

希望可以改变这些不公义的状况。

I believe that every single person

我坚信今天晚上

listening to me tonight can be part of that change.

在座的各位也会愿义加入成为我们的一部分。

If you are a researcher, I hold you

如果你是研究员，我请你坚持

to a higher standard of moral conscience,

用更高的道德标准来要求自己

to remain ethical in your research,

摸着你的良心做研究

and not compromise human welfare in your search for answers.

不要为了研究成果而牺牲他人的生命。

If you work for a funding agency or pharmaceutical company,

如果你在资助机构或药品公司工作的话

I challenge you to hold your employers

我希望你建议你的老板

to fund research that is ethically sound.

投资那些讲良心的研究。

If you come from a developing country like myself,

如果你像我一样来自一个发展中国家

I urge you to hold your government

我渴望你能敦促你的政府

to a more thorough review of the clinical trials

更加严谨的审查那些在你的国家

which are authorized in your country.

得到授权的临床实验。

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

的确，我们需要可以治愈艾滋病的药物

to find an effective vaccine for malaria,

需要更有效的疟疾疫苗

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

需要能检测结核病菌的机器

but I believe that we owe it to those who willingly

但是我认为我们应该更人道的

and selflessly consent to participate in these clinical trials

对待那些无私、自愿参与

to do this in a humane way.

临床试验的参加者。

Thank you.

谢谢大家。