Transcript The Trovan Trial Case Study: After profits or to save lives?

The Trovan Trial Case Study: After
profits or to save lives?
Available at: http://www.amanet-trust.org/discuss/viewtopic.php?t=2
Aceme Nyika
Ethics Coordinator
AFRICAN MALARIA NETWORK TRUST
Tanzania Commission for Science and Technology Building
P.O. Box 33207, Dar es Salaam, Tanzania
Tel: 255 (022) 2700018, Fax: 255 (022) 2700380
E-mail: [email protected]
Outline of presentation
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Epidemic outbreak of bacterial meningitis in
Kano
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Treatment of patients and testing of Trovan at
Kano government hospital
Scientific rationale for testing Trovan in
children given by Pfizer
 The aftermath of the Trovan Trial
 Different schools of thought
 Unpacking the ethical issues: interactive
discussion
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Epidemic outbreak of bacterial
meningitis in Kano
Bacterial (meningococcal) meningitis
epidemic in Tudun Wada, Kano, Nigeria in
1996
 Overpopulated, filthy and hot conditions
prevailing in Kano were ideal for the
spread of the infectious disease.
 An estimated 15 000 people died and
thousands of children were permanently
disabled
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Treatment of patients and testing of
Trovan at Kano government hospital
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A non-governmental organisation (NGO) called
Medecins Sans Frontieres (MSF) provided free
emergency treatment at the government
Infectious Diseases Hospital in Kano.
Pfizer team joined the government and the MSF
at the government hospital in Kano.
The Pfizer team recruited children to test a drug
called Trovan, or Trovafloxacin.
At least 200 children were recruited into the trial.
The government hospital and the MSF were
using chloramphenicol for treatment of children.
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Scientific rationale for testing
Trovan in children
Trovan is a flouroquinolone, and other
similar drugs in the same antibiotic class
had been successfully tested in children
before.
 Ciprofloxacin, a flouroquinolone, was cited
as an example that had been used in
infants without any serious side effects.
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The aftermath of the Trovan Trial
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Pfizer has been accused of conducting trial without
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Approval from relevant regulatory authorities
Ethical approval
Informed consent
It is alleged that Trovan maimed or killed some children
recruited into the trial, and that Pfizer left before the
epidemic was over
Pfizer dismissed the accusations, and claimed that Trovan
lowered the mortality rate to 6%, while chloramphenicol
lowered the rate to 9.1%.
Pfizer responded that it was invited to help fight the
epidemic; could not obtain informed consent because of
illiteracy; they were given permission by the authorities
The case is now in the courts in the USA and Nigeria
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Different schools of thought (1)
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Pfizer researchers took advantage of
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The absence of a functional ethics committee
(institutional one at Kano or national
committee).
 The desperation of the affected poor, illiterate
people.
 The emergency situation that greatly
facilitated recruitment of participants at a
single site.
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Different schools of thought (2)
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Pfizer went to Kano to assist the Nigerian
government during a serious epidemic, and they
offered free treatment. Whereas some of the 200
children they treated with Trovan may have
experienced some serious side effects that in
some cases led to death, some participants in
the trial responded well to Trovan and thus
benefited.
 After
all, some patients in the government and MSF
camp responded poorly to chloramphenicol treatment
and died. Thus the deaths would probably have
occurred anyway even if Pfizer had not come on
board.
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Different schools of thought (3)
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The trial was led by a local Nigerian physician, with
some local Nigerian nurses and doctors
participating. Thus even if there was no approval
and oversight from an ethics committee and/or
government, participants were afforded respect and
protection by the local Nigerian collaborators. Pfizer
merely provided the antibiotic to be tested and
other resources.
If Pfizer team indeed left Kano before the bacterial
meningitis epidemic was significantly contained
then they were not in Nigeria on a humanitarian
mission in the first place but to conduct a clinical
trial.
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Questions to guide discussion
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(1) Is it possible to conduct research ethically during an
epidemic?
(2) Did Pfizer exploit the poor desperate people with
severely ill children?
(3) Does illiteracy justify the fact that Pfizer researchers did
not obtain proxy consent for the children they enrolled into
their trial?
(4) Did they help to fight the meningococcal meningitis
epidemic at all or they had their own agenda?
(5) Are the local health personnel who collaborated with
Pfizer researchers to blame for the unethical recruitment of
children into the Trovan trial?
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Questions to guide discussion
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(6) Who had invited Pfizer to come to Nigeria in
the first place, and for what purpose?
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(7) The trial took place in Nigeria and the
children who were enrolled into the trial were
Nigerians, but Pfizer is an American company
and the legal battle is being fought in America,
with American lawyers representing the Nigerian
families. Are there no legal mechanisms of
dealing with such issues locally (i.e. in Nigeria or
in Africa)?
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Who are the players who should
be involved in preventing
unethical health research from
taking place in developing
countries?
Some stakeholders and gatekeepers
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a. Collaborating researchers from the developed
countries?
b. Local collaborating researchers
c. Ethics committees in the developed countries
d. Local ethics committees in the countries where
the research is taking place
e. Institutions where the research is based
f. Local drug regulatory authorities
g. Ministries of Health
h. The participants themselves once they know
their human and civil rights
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Stakeholders have complementary roles to play
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