<div dir="ltr">From: "K.M. Gopakumar" <<a href="mailto:kumargopakm@gmail.com">kumargopakm@gmail.com</a>><br><br><div class="gmail_quote"><font size="3" face="Georgia, Times New Roman, Times, serif"><b>TWN
Info Service on Health Issues (Nov17/09)</b></font><br><div dir="ltr"><div class="m_7278126492360708327gmail-WordSection1"><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><b>
28 November 2017<br>
Third World Network</b></font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><b><br></b></font><a href="http://www.twn.my/title2/health.info/2017/hi171109.htm" target="_blank">http://www.twn.my/title2/<wbr>health.info/2017/hi171109.htm</a></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><b><br></b></font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><b>WHO’s Study on Substandard and Falsified Medical Products: Questionable
Data and Analysis.</b></font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">Geneva,
28<sup>th</sup> November (Third World Network): There are significant
concerns that WHO’s study on public health and socio economic impact
of substandard and falsified medical products to be released during
a press conference today afternoon in Geneva, is based on questionable
data, lacking in rigorous analysis.</font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">A
virtual press conference (VPC) is being organised at CET 15to launch
a report on the Global Surveillance and Monitoring System (GSMS) and
a study on substandard and falsified medical products.</font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><br></font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">The
first report compiles 1500 real cases from all WHO regions, giving
estimates on the products most affected and regional prevalence.
The GSMS was established in 2013, with financial support from the
European Union and some of its Member States. The cases however
were reported to the GSMS between 2013 and 2016 and during this time,
the GSMS was using the following categories to capture the data from
various member states: falsified medical products, suspected falsified
medical products, substandard medical products, suspected substandard
medical products, intentionally manufactured substandard medical products,
diverted medical products, stolen medical products and unlicensed
medical products. However the Secretariat has never provided breakdown
of the data captured by the GSMS, according to the terms used by GSMS.</font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><br></font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">In
2016, the World Health Assembly determined that compromised medical
products should be categorized as “substandard” and “falsified” and
adopted working definitions on the same. Given this development, it
is rather concerning that the GSMS cases are automatically categorized
as being “substandard” or “falsified”.</font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><br></font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">The
second report is titled ““Public health and socioeconomic impact of
substandard and falsified products”. This report is the brainchild
of, and supported by the US.</font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><br></font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">The
Member State Mechanism (MSM) has however decided that it would not
formally adopt the study.</font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">Discussions
with several member states familiar with the process leading to the
study revealed that many have concerns with the findings of the Study
especially the estimation of prevalence of substandard and falsified
medical products in the low and middle-income countries using an unscientific
methodology.</font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><br></font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">TWN
has learned that the study examined 100 published papers and one publicly
available database between 1<sup>st</sup> January 2007 to 31<sup>st</sup>
December 2016 covering 48,218 samples. These samples are grouped into
low income countries (11156), middle income countries ( 36884)
and high income countries ( 178). Based on the number of failed samples
in low-income countries (1166) and middle income countries (3906),
the report finds the aggregate failure rate of tested samples of substandard
and falsified medicines in low and middle-income countries is approximately
10.5%. The study then asserts that as the market size for low and
middle income countries is nearly $300 billion, and given the 10.5%
failure rate, the amount countries spend on substandard and falsified
and medicines is $30 billion. </font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><br></font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">The
methodology used by the Study is rather flawed. First, the Study
is based on published papers that use heterogeneous terms and definitions.
The terms and definitions also differ from the working definitions
of “substandard” and “falsified” adopted by the 2017 World Health
Assembly.</font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><br></font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">Secondly
there are significant divergences in terms of methodology and sample
size of the various papers relied on by the study, varying from 10
samples to 15,000 per study. The findings of the papers are thus not
comparable. Thirdly, the samples substantially belong to two types
of medicines i.e. antimalarial (18764) and antibiotics and anti-infectives
(12375).</font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">These
flaws calls into question the data and analysis presented in the Study
and its extrapolation of the failure rate to the total medicines market.</font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><br></font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">The
study gives the impression that 10.5% products valued at USD 30 billion
sold in the low and middle-income countries are substandard and falsified.
The compilation of the 48218 samples from 100 published papers with
a divergent number of samples and different parameters (definition)
for the categorisation of substandard and falsified medical
products cannot be used to measure the prevalence of substandard
medicines in the entire pharmaceutical market of low and mididle
income countries.</font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">The
inherent limitations of data led to the experts commissioned to develop
the study to reject the idea of calculating the economic value of
spending on substandard and falsified medicines. The first draft report
submitted to the Steering Committee meeting in March 2016 did not
contain any figures with regard to the purchase of the substandard
and falsified medicine. The first draft report estimated the prevalence
based on the sample size combining “<i>data from 107 published
field studies that met quality criteria for inclusion, totalling almost
73,000 samples. The mean prevalence rate of substandard medicines
obtained from pooling the samples – the proportion of sampled medicines
that failed laboratory testing based on specified reference standards
- was 8.7%”.</i></font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><i><br></i></font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">Further
it stated, “<i>Most of the studies were conducted in Africa and Asia,
and many focused on anti-malarial and antibiotic medicines. Because
of this sampling bias, it is not possible to use the 8.7% figure as
a global estimate of the prevalence of substandard medicines or as
an estimate for all therapeutic categories</i>”. </font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><br></font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">Then
it concluded: “<i>Empirical data on the public health and socioeconomic
impact of substandard and falsified medicines is also very limited,
particularly from studies where it is possible to track how the authors
of published papers have developed their estimates. All that can be
said at the moment is that the consequences of substandard medicines
for public health, and for patient and health system costs, can be
large in certain cases but as yet the data do not allow a global estimate
of the cost that would be considered methodologically sound</i>”.</font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><br></font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">The
finding of the first version was changed without any valid explanation
in the second draft circulated in November 2016.</font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">The
second draft estimated the economic impact of substandard and falsified
medicine to the value of USD 31.1 billion. The second draft
states: “<i>The approach that is therefore adopted is ascribing the
10.5% ?6.2 prevalence rate to the pharmaceutical market of low-income
countries ($135.2 billion), which produces a projected economic impact
of $14.2 billion (with a 95% confidence interval of ?8.4 billion)
in low income countries as a result of substandard and falsified medicines.
For middle-income countries, the data used is based on a subset of
field studies that sample the quality of a basket of medicines; 14
such field studies examine various therapeutic categories, selected
on the basis of both availability and essentiality. These studies
not only cover a wide range of therapeutic products, but 13 of the
14 studies were conducted in at least one middle-income country. The
prevalence figure from this subset of 14 field studies is 6.8% ?5.6.
If we apply this figure to the market size of middle-income countries
($249.2 billion), the estimated cost would be $16.9 billion (with
a 95% confidence interval of ?13.9 billion). Combining these estimates,
we arrive at a potential economic impact of $31.1 billion to LMICs</i>.”</font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">The
third draft provided in March 2017 for comments by the expert advisory
group and Member States continues the same approach and estimated
the cost to be 28.6 billion.</font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><br></font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">“<i>The
approach that has therefore been adopted is ascribing the mean prevalence
rate (across 2196 samples) of 10.8% to the pharmaceutical market of
LICs ($112.4 billion), which produces a 2197 projected substandard
and falsified medicines economic impact of $12.1 billion in LICs.
For 2198 MICs, the data used is based on a subset of field studies
that sample the quality of a basket of 2199 medicines; 24 such field
studies examine various therapeutic categories, selected on the basis
2200 of both availability and essentiality. These studies not only
cover a wide range of therapeutic products, but 22 of the 24 studies
(92%) included at least one MICs. The prevalence figure from this
subset of 22 field studies is 6.8%. If this prevalence figure is applied
to the market size of MIC ($242.9 billion), the estimated cost would
be $16.5 billion. Combining these two estimates yields a projected
economic impact of $28.6 billion to LMICs due to substandard and falsified
medicines”.</i></font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><i><br></i></font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">The
final version of the study, according to sources, avoids all explanations,
but continues using the flawed methodology.</font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">The
study also does not provide a break down of numbers that are substandard
and falsified from the total of 4072 failed samples.</font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">[The
2017 World Health Assembly adopted working definitions of substandard
and falsified medicines. The former category generally refers to “out
of specification” medicines produced by licensed manufactures, while
the latter category would generally include activities of unlicensed
manufacturers. ]</font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><br></font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">The
study also overlooks the nuances involved in the health implications
of substandard medicines. Generally, substandard medicines are
grouped into minor, major and critical deviations. Major and critical
deviations from the specifications are usually of a concern from a
public health perspective, requiring regulatory actions. Given the
study fails to provide such details, one cannot conclude that all
the failed samples pose a threat to health. For instance a study
published by WHO titled</font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">“Survey
of the Quality of Anti-Tuberculosis Medicines in Circulating in Newly
Independent States of the Former Soviet Union” (<a href="http://apps.who.int/prequal/info_applicants/qclabs/monitoring_documents/TBQuality-Survey_Nov2011.pdf" target="_blank">http://apps.who.int/prequal/<wbr>info_applicants/qclabs/<wbr>monitoring_documents/<wbr>TBQuality-Survey_Nov2011.pdf</a>)
concludes:</font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"> <i>“A
survey of quality of selected anti-TB medicines in six NIS identified
11.3% samples failing to meet the specifications set for this survey.
Focusing only on extreme deviations as defined in this report, which
are likely associated with direct health implications, the failure
rate reached 1.0%. No sample was suspected to be of spurious, falsely-labelled,
falsified or counterfeit product</i>”</font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><br></font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">The
Secretariat is proposing to widely disseminate this study as part
of the prioritised activities of MSM for the 2018-19 biennium. The
proposed prioritised activities F states: “Disseminate and use
the study on the public health and socioeconomic impact of substandard
and falsified medical products and the report on the WHO Global Surveillance
and Monitoring System for substandard and falsified medical products
as a tool to increase awareness and advocate at the highest policy
levels nationally, regionally and globally for support and resources
to prevent, detect and respond to substandard and falsified medical
products”.</font></p><p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif"><br></font></p>
<p class="MsoNormal" style="line-height:normal"><font size="3" face="Georgia, Times New Roman, Times, serif">A
major concern with this action is the wide dissemination of a study
rooted in unscientific flawed methodology and misleading information,
which does not reflect the on-the ground reality and results in unwarranted
policy response. </font></p>
</div>
<p></p></div>
<br></div><br></div>