TEDxGoodenoughCollege
Boghuma Kabisen Titanji: Ethical riddles in HIV research
Filmed:
Readability: 5.8
537,704 views
A woman in sub-Saharan Africa is part of a cutting-edge HIV clinical trial -- but she can't afford a bus ticket to her health clinic, let alone the life-saving antiretrovirals she'll need. Boghuma Kabisen Titanji asks an important question: How can researchers looking for a cure make sure they're not taking advantage of the people most affected by the pandemic?
Boghuma Kabisen Titanji - Clinical researcher
Boghuma Kabisen Titanji set out to research HIV drug resistant viruses. In the process, Titanji met a woman who changed the way she thinks about research subjects. Full bio
Boghuma Kabisen Titanji set out to research HIV drug resistant viruses. In the process, Titanji met a woman who changed the way she thinks about research subjects. Full bio
Double-click the English transcript below to play the video.
00:17
I'd like to share with you
0
1577
1996
00:19
the story of one of my patients called Celine.
1
3573
3837
00:23
Celine is a housewife and lives in a rural district
2
7410
3153
00:26
of Cameroon in west Central Africa.
3
10563
3072
00:29
Six years ago, at the time of her HIV diagnosis,
4
13635
3687
00:33
she was recruited to participate in the clinical trial
5
17322
3001
00:36
which was running in her health district at the time.
6
20323
3071
00:39
When I first met Celine, a little over a year ago,
7
23394
3704
00:42
she had gone for 18 months
8
27098
1684
00:44
without any antiretroviral therapy,
9
28782
2287
00:46
and she was very ill.
10
31069
2737
00:49
She told me that she stopped coming to the clinic
11
33806
2398
00:52
when the trial ended
12
36204
1551
00:53
because she had no money for the bus fare
13
37755
2711
00:56
and was too ill to walk the 35-kilometer distance.
14
40466
3728
01:00
Now during the clinical trial,
15
44194
1744
01:01
she'd been given all her antiretroviral drugs free of charge,
16
45938
4385
01:06
and her transportation costs
17
50323
2031
01:08
had been covered by the research funds.
18
52354
2607
01:10
All of these ended once the trial was completed,
19
54961
3354
01:14
leaving Celine with no alternatives.
20
58315
2992
01:17
She was unable to tell me the names of the drugs
21
61307
2676
01:19
she'd received during the trial,
22
63983
2027
01:21
or even what the trial had been about.
23
66010
2757
01:24
I didn't bother to ask her what the results of the trial were
24
68767
3549
01:28
because it seemed obvious to me that she would have no clue.
25
72316
4407
01:32
Yet what puzzled me most
26
76723
2269
01:34
was Celine had given her informed consent
27
78992
3107
01:37
to be a part of this trial, yet she clearly did not understand
28
82099
3832
01:41
the implications of being a participant
29
85931
2470
01:44
or what would happen to her once the trial had been completed.
30
88401
4409
01:48
Now, I have shared this story with you as an example
31
92810
3395
01:52
of what can happen to participants in the clinical trial
32
96205
2929
01:55
when it is poorly conducted.
33
99134
2459
01:57
Maybe this particular trial yielded exciting results.
34
101593
3865
02:01
Maybe it even got published in a high-profile scientific journal.
35
105458
3689
02:05
Maybe it would inform clinicians around the world
36
109147
2807
02:07
on how to improve on the clinical management of HIV patients.
37
111954
5535
02:13
But it would have done so at a price
38
117489
2786
02:16
to hundreds of patients who, like Celine,
39
120275
2947
02:19
were left to their own devices
40
123222
2244
02:21
once the research had been completed.
41
125466
3071
02:24
I do not stand here today to suggest in any way
42
128537
3338
02:27
that conducting HIV clinical trials
43
131875
2013
02:29
in developing countries is bad.
44
133888
2215
02:32
On the contrary, clinical trials are extremely useful tools,
45
136103
4367
02:36
and are much needed to address the burden
46
140470
2298
02:38
of disease in developing countries.
47
142768
2471
02:41
However, the inequalities that exist between
48
145239
2859
02:43
richer countries and developing countries in terms of funding
49
148098
3702
02:47
pose a real risk for exploitation,
50
151800
3157
02:50
especially in the context of externally-funded research.
51
154957
3885
02:54
Sadly enough, the fact remains that
52
158842
2606
02:57
a lot of the studies that are conducted in developing countries
53
161448
3984
03:01
could never be authorized in the richer countries
54
165432
2576
03:03
which fund the research.
55
168008
2248
03:06
I'm sure you must be asking yourselves
56
170256
2247
03:08
what makes developing countries,
57
172503
1916
03:10
especially those in sub-Saharan Africa,
58
174419
2544
03:12
so attractive for these HIV clinical trials?
59
176963
3567
03:16
Well, in order for a clinical trial to generate
60
180530
3272
03:19
valid and widely applicable results,
61
183802
3116
03:22
they need to be conducted with large numbers of study participants
62
186918
4000
03:26
and preferably on a population
63
190918
2643
03:29
with a high incidence of new HIV infections.
64
193561
3781
03:33
Sub-Saharan Africa largely fits this description,
65
197342
3471
03:36
with 22 million people living with HIV,
66
200813
3202
03:39
an estimated 70 percent of the 30 million people
67
204015
3640
03:43
who are infected worldwide.
68
207655
2481
03:46
Also, research within the continent
69
210136
2430
03:48
is a lot easier to conduct due to widespread poverty,
70
212566
4112
03:52
endemic diseases and inadequate health care systems.
71
216678
3851
03:56
A clinical trial that is considered to be
72
220529
2789
03:59
potentially beneficial to the population
73
223318
2750
04:01
is more likely to be authorized,
74
226068
2307
04:04
and in the absence of good health care systems,
75
228375
2800
04:07
almost any offer of medical assistance
76
231175
2954
04:10
is accepted as better than nothing.
77
234129
2918
04:12
Even more problematic reasons include
78
237047
2586
04:15
lower risk of litigation,
79
239633
2287
04:17
less rigorous ethical reviews,
80
241920
2467
04:20
and populations that are willing to participate
81
244387
2556
04:22
in almost any study that hints at a cure.
82
246943
4664
04:27
As funding for HIV research
83
251607
3625
04:31
increases in developing countries
84
255232
2256
04:33
and ethical review in richer countries become more strict,
85
257488
4007
04:37
you can see why this context becomes
86
261495
2085
04:39
very, very attractive.
87
263580
2561
04:42
The high prevalence of HIV drives researchers
88
266141
3680
04:45
to conduct research that is sometimes scientifically acceptable
89
269821
4484
04:50
but on many levels ethically questionable.
90
274305
3279
04:53
How then can we ensure that, in our search for the cure,
91
277584
3439
04:56
we do not take an unfair advantage
92
281023
2320
04:59
of those who are already most affected by the pandemic?
93
283343
3504
05:02
I invite you to consider four areas I think we can focus on
94
286847
3856
05:06
in order to improve the way in which things are done.
95
290703
3575
05:10
The first of these is informed consent.
96
294278
2827
05:13
Now, in order for a clinical trial to be
97
297105
2368
05:15
considered ethically acceptable,
98
299473
3681
05:19
participants must be given the relevant information
99
303154
2824
05:21
in a way in which they can understand,
100
305978
2435
05:24
and must freely consent to participate in the trial.
101
308413
4217
05:28
This is especially important in developing countries,
102
312630
2678
05:31
where a lot of participants consent to research
103
315308
2902
05:34
because they believe it is the only way in which
104
318210
2688
05:36
they can receive medical care or other benefits.
105
320898
3570
05:40
Consent procedures that are used in richer countries
106
324468
2967
05:43
are often inappropriate or ineffective
107
327435
2802
05:46
in a lot of developing countries.
108
330237
2353
05:48
For example, it is counterintuitive to have
109
332590
2973
05:51
an illiterate study participant, like Celine,
110
335563
2999
05:54
sign a lengthy consent form that they are unable to read,
111
338562
3327
05:57
let alone understand.
112
341889
2107
05:59
Local communities need to be more involved
113
343996
3080
06:02
in establishing the criteria for recruiting participants
114
347076
3273
06:06
in clinical trials, as well as the incentives for participation.
115
350349
4701
06:10
The information in these trials
116
355050
1816
06:12
needs to be given to the potential participants
117
356866
2951
06:15
in linguistically and culturally acceptable formats.
118
359817
4428
06:20
The second point I would like for you to consider
119
364245
2821
06:22
is the standard of care that is provided
120
367066
2438
06:25
to participants within any clinical trial.
121
369504
2946
06:28
Now, this is subject to a lot of debate and controversy.
122
372450
3697
06:32
Should the control group in the clinical trial
123
376147
2981
06:35
be given the best current treatment which is available
124
379128
3273
06:38
anywhere in the world?
125
382401
2080
06:40
Or should they be given an alternative standard of care,
126
384481
2968
06:43
such as the best current treatment available
127
387449
2888
06:46
in the country in which the research is being conducted?
128
390337
3312
06:49
Is it fair to evaluate a treatment regimen
129
393649
3340
06:52
which may not be affordable or accessible
130
396989
3076
06:55
to the study participants once the research has been completed?
131
400065
3970
06:59
Now, in a situation where the best current treatment
132
404035
3741
07:03
is inexpensive and simple to deliver,
133
407776
2639
07:06
the answer is straightforward.
134
410415
2028
07:08
However, the best current treatment available
135
412443
3150
07:11
anywhere in the world is often very difficult
136
415593
2887
07:14
to provide in developing countries.
137
418480
2687
07:17
It is important to assess the potential risks and benefits
138
421167
3552
07:20
of the standard of care which is to be provided
139
424719
2777
07:23
to participants in any clinical trial,
140
427496
2481
07:25
and establish one which is relevant for the context of the study
141
429977
5448
07:31
and most beneficial for the participants within the study.
142
435425
3497
07:34
That brings us to the third point I want you think about:
143
438922
3251
07:38
the ethical review of research.
144
442173
2851
07:40
An effective system for reviewing the ethical suitability
145
445024
3799
07:44
of clinical trials is primordial to safeguard participants
146
448823
4128
07:48
within any clinical trial.
147
452951
2113
07:50
Unfortunately, this is often lacking
148
455064
2912
07:53
or inefficient in a lot of developing countries.
149
457976
3528
07:57
Local governments need to set up effective systems
150
461504
4363
08:01
for reviewing the ethical issues around the clinical trials
151
465867
2877
08:04
which are authorized in different developing countries,
152
468744
3917
08:08
and they need to do this by setting up
153
472661
2274
08:10
ethical review committees that are independent
154
474935
2510
08:13
of the government and research sponsors.
155
477445
3385
08:16
Public accountability needs to be promoted
156
480830
2410
08:19
through transparency and independent review
157
483240
3233
08:22
by nongovernmental and international organizations
158
486473
3039
08:25
as appropriate.
159
489512
1571
08:26
The final point I would like for you to consider tonight
160
491083
3510
08:30
is what happens to participants in the clinical trial
161
494593
3223
08:33
once the research has been completed.
162
497816
2775
08:36
I think it is absolutely wrong for research to begin
163
500591
3474
08:39
in the first place without a clear plan
164
504065
2512
08:42
for what would happen to the participants
165
506577
2079
08:44
once the trial has ended.
166
508656
2440
08:46
Now, researchers need to make every effort to ensure that
167
511096
5128
08:52
an intervention that has been shown to be beneficial
168
516224
2984
08:55
during a clinical trial
169
519208
1732
08:56
is accessible to the participants of the trial
170
520940
3612
09:00
once the trial has been completed.
171
524552
2548
09:03
In addition, they should be able to consider the possibility
172
527100
3524
09:06
of introducing and maintaining effective treatments
173
530624
3601
09:10
in the wider community once the trial ends.
174
534225
3841
09:13
If, for any reason, they feel that this might not be possible,
175
538066
3423
09:17
then I think they should have to ethically justify
176
541489
2967
09:20
why the clinical trial should be conducted in the first place.
177
544456
4027
09:24
Now, fortunately for Celine,
178
548483
2316
09:26
our meeting did not end in my office.
179
550799
2675
09:29
I was able to get her enrolled into a free HIV treatment program
180
553474
4374
09:33
closer to her home,
181
557848
1388
09:35
and with a support group to help her cope.
182
559236
3774
09:38
Her story has a positive ending,
183
563010
2334
09:41
but there are thousands of others in similar situations
184
565344
3703
09:44
who are much less fortunate.
185
569047
2297
09:47
Although she may not know this,
186
571344
2424
09:49
my encounter with Celine has completely changed the way
187
573768
3865
09:53
in which I view HIV clinical trials in developing countries,
188
577633
4271
09:57
and made me even more determined to be part of the movement
189
581904
3720
10:01
to change the way in which things are done.
190
585624
2857
10:04
I believe that every single person
191
588481
2368
10:06
listening to me tonight can be part of that change.
192
590849
4375
10:11
If you are a researcher, I hold you
193
595224
2597
10:13
to a higher standard of moral conscience,
194
597821
2570
10:16
to remain ethical in your research,
195
600391
2427
10:18
and not compromise human welfare in your search for answers.
196
602818
3488
10:22
If you work for a funding agency or pharmaceutical company,
197
606306
3678
10:25
I challenge you to hold your employers
198
609984
3030
10:28
to fund research that is ethically sound.
199
613014
3175
10:32
If you come from a developing country like myself,
200
616189
3186
10:35
I urge you to hold your government
201
619375
3072
10:38
to a more thorough review of the clinical trials
202
622447
2616
10:40
which are authorized in your country.
203
625063
2913
10:43
Yes, there is a need for us to find a cure for HIV,
204
627976
3668
10:47
to find an effective vaccine for malaria,
205
631644
2652
10:50
to find a diagnostic tool that works for T.B.,
206
634296
3842
10:54
but I believe that we owe it to those who willingly
207
638138
3575
10:57
and selflessly consent to participate in these clinical trials
208
641713
4055
11:01
to do this in a humane way.
209
645768
2226
11:03
Thank you.
210
647994
2327
ABOUT THE SPEAKER
Boghuma Kabisen Titanji - Clinical researcherBoghuma Kabisen Titanji set out to research HIV drug resistant viruses. In the process, Titanji met a woman who changed the way she thinks about research subjects.
Why you should listen
Born in Cameroon, Boghuma Kabisen Titanji is a medical doctor and MPhil/PhD candidate at University College London. Her research into HIV drug resistant viruses seeks to better understand the mechanisms of drug resistance and to identify new ways of targeting resistant viruses.
During the course of her research, Titanji met a woman named Celine who forever changed the way she thinks about the people who sign informed consent agreements to be research subjects. Ever since, Titanji has been a vocal advocate for ethical medical research, calling for researchers to find less exploitative ways to study diseases in developing countries.
Boghuma Kabisen Titanji | Speaker | TED.com