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www.thelancet.com Published online October 1, 2013 http://dx.doi.org/10.1016/S0140-6736(13)61812-7 1
Questions raised over Iraq congenital birth defects study
The release of a study on congenital birth defects in Iraq has been met with controversy, with
some experts questioning its methodology and peer review. Paul C Webster reports.
WHO officials have stepped in to
defend an unsigned and sharply
criticised report released by the
Iraqi Ministry of Health (MOH) on
congenital birth defects in areas where
US-led coalition forces used toxin-
laced munitions.
Although several recent studies
from Iraq reported worrying ratesof congenital birth defects in areas
where highly toxic munitions such as
depleted uranium shells were used by
British, US, and other coalition forces,
the new study, which was cofunded
by the Iraqi Government and WHO,
found no clear evidence to suggest
an unusually high rate of congenital
birth defects in Iraq. After initially
referring questions about the study
to Iraqi offi cials, Jaffar Hussain, WHOs
Head of Mission in Iraq, told the
The Lancet last week that the report isbased on survey techniques that are
renowned worldwide and on the
work of international experts who peer
reviewed the data extensively.
The study, which is based on a
2012 survey of mothers in 10 800
households from 18 Iraqi districts,
relies largely on mothers memories
of the details of spontaneous
abortions, stillbirths, and births with
congenital defects since the 1980s
(43 387 pregnancies). Citing a lack of
medical records for older events, theIraqi Government interviewers were
able to view medical files for only 32%
of the total reported cases.
Although warning that the surveyed
mothers recollections might not
be accurate, the report does note a
three-fold increase in reported birth
defects between 198892 (76 per
1000 births) and 200307 (262 per
1000 births). Nonetheless, it asserts
the rates for spontaneous abortion,
stillbirths and congenital birth defects
found in the study are consistent
with or even lower than international
estimates. The reported stillbirth rate
for 200812 is considerably lower
than WHO-established norms, the
study indicates, leading it to suggest
possible underreporting of stillbirths,
or that stillbirth rates in Iraq are lower
than estimated elsewhere.
WHO says that since the issueof associating birth defects with
exposure to depleted uranium has
not been included in the scope of
this particular study, establishing alink between the [congenital birth
defects] prevalence and exposure to
depleted uranium would require further
research. According to Jaffar, there is
still further room for more detailed
analysis and WHO is discussing
producing a more detailed report with
the Iraqi MOH.
The study notes that WHO offered
technical services to the Ministry,
and that WHO convened an expert
peer review meeting on the study
in late July with six experts from theLondon School of Hygiene and Tropical
Medicine (LSHTM), University College
London (UCL), the US Centers for
Disease Control and Prevention (CDC),
and the Norway-based Fafo Research
Foundation. WHO says this meeting
was organised after it was determined
the work should also undergo the
scientific standard of peer review.
That may not have been fully
achieved, however. Simon Cousens,
professor of epidemiology and
statistics at LSHTM, who was among
those invited by WHO to review the
study, says he attended a relatively
brief meeting of around one and a half
hours, so just gave some comments
on an early presentation of the results.
I wouldnt classify that as thorough
peer review.
At the CDC in Atlanta, Georgia,
spokeswoman Belsie Gonzalez confirm-ed that CDC officials did participate
in the peer review meeting at the
invitation of the WHO Regional Offi ce
for the Eastern Mediterranean. CDC did
not participate in any aspects of the
study. We provided data interpretation
advice on the report.
Several of WHOs expert reviewers
raise methodological concerns about
the study. Its main limitation is that
it is largely based on what people
reported, without any medical
examination, says Cousens. Atthe Fafo Foundation in Oslo, social
anthropologist John Pedersen adds
that the studys limited geographical
scope (Iraq has more than 100 districts)
sharply reduces its relevance in
understanding the national pattern
and prevalence of birth defects in Iraq.
I wouldnt necessarily have designed
the study in the same way as it was
designed, explains Pedersen, who
Children who were born with birth defects in Fallujah (pictured November, 2009)
The study...relies largely on
mothers memories of the
details of spontaneous
abortions, stillbirths, and births
with congenital defects since
the 1980s...
GettyImages
Published Online
October 1, 2013
http://dx.doi.org/10.1016/
S0140-6736(13)61812-7
For thereport on congenital
birth defects by the Iraqi
Government see http://www.
emro.who.int/images/stories/
iraq/documents/Congenital_
birth_defects_report.pdf
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World Report
notes that lower rates of birth defects
could be expected from mothersrecollections than if doctors had been
asked to report them.
I agree with Jon Pedersen that
there are limitations in the study
design, says Bernadette Modell,
emeritus professor of community
genetics at UCL. However, it is really
difficult to conduct epidemiological
studies of congenital disorders
outside a high-income setting,
because many congenital disorders
are difficult to diagnose without
sophisticated clinical and laboratoryfacilities and a relatively high
proportion of those that occur in
lower-income settings may be due to
environmental causes.
Taking these limitations into account,
Modell adds, I think the Iraq study was
pretty good, and as objective as was
feasible. I was particularly impressed
with the efficient organisation of
data-collection when the study was
underway. The reviewers all agreed
that the data provide no evidence
to support claims of an epidemic ofcongenital anomalies either nationally,
or in any particular area. However, the
study amassed a very large amount
of data, which needs further analysis,
ideally with expert assistance.
Keith Baverstock, author of a
2004 UN report that highlighted the
potential seriousness of Iraqs legacy
of intensive exposure to depleted
uranium ordinance employed by
British and American troops both
during the First Gulf War of 1991,
and after the US-led occupation in2003, says the reports reliance on the
term peer review does not conform
with conventional usage. Its really
misleading, he charges. I have to
question what the role of WHO is in
this study as a whole, Baverstock adds
after noting that the study names no
authors from WHO or the Iraqi MOH
although a WHO website does explain
it did provide technical assistance
on study design, methodology, data
collection, data analysis and report
writing. For his part, WHOs Jaffar
confirms that the ownership of study
and the authorship of the report iswith the MOH from the outset.
Researchers in Iraq, the UK, and the
USA who have probed congenital birth
defects and have published recent peer-
reviewed studies also express concerns
about the methodology employed by
the Iraqi MOH and WHO.
Although WHO says that at this
point no effort to neither substantiate
nor negate the findings of other studies
can be employed because the study is
not aiming to establish cause-effect
associations between [congenital birthdefects] prevalence and environmental
risk factors, the study issued by the
Iraqi Government states that in recent
years there have been several anecdotal
reports of geographical regions with
an unusually high prevalence ofcongenital birth defects in Iraq. Most
of the reports did not meet the norms
for an objective study of birth defects,
and a review of the published literature
could find no clear evidence to support
their findings.
Samira Alaani, a paediatrician
in Fallujah, Iraq, who copublished
a 2011 study utilising hospital
records to conclude that congenital
malformations accounted for 15% of
all births in Fallujah since 2003, says
the new study cofunded by WHO andthe Iraqi Government should have
employed hospital records more
comprehensively.
Muhsin Al-Sabbak of the Basrah
Medical School in Basrah, Iraq, who
copublished a 2012 study reporting
a 17-fold increase in birth defects in
the Al Basrah Maternity Hospital since
1994, warns that the data from Basrah
in the new study does not match local
hospital records.
Alison Alborz is a specialist on
learning disabilities in children at
the University of Manchester, UK,
who published a 2013 study present-ing data from a 2010 survey of
6032 households in four Iraqi govern-
ates including data for more than
10 000 children and young people
showing a prevalence of congenital
birth defects more than 25 times
higher than reported in the Iraqi
Government study. She says the new
report gives little information about
sampling and does not offer any
discussion of whether the districts
chosen for analysis reflect the charac-
teristics of the governorate as a whole.Mozhgan Savabieasfahani, a toxic-
ologist based in Michigan, USA, who
coauthored the Alaani and Al-Sabbak
studies, agrees with Alborz that the
selection criteria determined by the
MOH are not sufficiently explained.
Based on information available
in this report, we cannot rule out
selection bias issues, she warns.
She also questions the decision not
to employ hospital records more
comprehensively, and notes that the
report suffers from a lack of detailregarding which areas were exposed
to bombardment or heavy fighting
and which areas were not. The exposed
and unexposed populations remain
unidentified throughout.
Tariq Al-Hadithi of the Hawler
Medical University in Erbil, Iraq, who
undertook the literature review cited
by the Iraqi Government in describ-
ing the work of Alaani, Al Sabbak,
Alborz, and Savabieasfahani as not
meeting objective norms, reached a
conclusion that was far more tenta-tive than the Iraqi Government
suggests. As not enough data
on pre-1991 Gulf War prevalence
of birth defects are available,
Al-Hadithi stresses, the ranges of
birth defects reported in the reviewed
studies from Iraq most probably do
not provide a clear indication of a
possible environmental exposure
including [depleted uranium] or other
teratogenic agents.
Paul C Webster
...it is really diffi cult to conduct
epidemiological studies of
congenital disorders outside
a high-income setting...
For thepaper by Samira Alaani
and colleaguesseeInt J Environ Res Public Health
2011;8:8996
For the paper by
Muhsin Al-Sabbak and
colleaguessee
Bull Environ Contam Toxicol2012;
89:93744
For the paper by Alison Alborz
and colleaguessee
Med Confl Surviv2013; 29:2644