PHA-Exch> WHO to blame for dangerous child vaccine? UPDATE

[Claudio Schuftan]

   From:    drdabade at gmail.com



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*WHO to blame for dangerous child vaccine?*

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*- Dr. Jacob M Puliyel*



The World Health Organisation (WHO) is facing a crisis of transparency and
accountability over the perverse decision it has made to ignore its own
advice and promote a children's vaccine for pneumococcal disease (now being
introduced in Rwanda!) which does not significantly decrease the incidence
of pneumonia but doubles the number of children with asthma, which can last
a lifetime.



WHO cannot claim ignorance about the dangers of the vaccine because they
published the startling facts in their own bulletin. The statistics show
that for every 2000 infants vaccinated, only seven cases of the uncommon
pneumonia will be prevented. Furthermore, for every five cases of pneumonia
avoided, two children will develop asthma as a direct consequence of the
vaccine.



Pneumonia is a one-off illness that is usually cured with simple
(inexpensive) antibiotics. Asthma on the other hand can be a lifelong
disability, requiring treatment with inhaled drugs and steroids, and
sometimes hospitalisations. The benefit of the vaccine in terms of pneumonia
prevented, pales into insignificance in the face of this risk of asthma.



To add insult to injury, the pneumococcal-vaccine is one of the most
expensive vaccines on the Indian market. The three doses required to
immunise one child costs a whopping Rs. 12,000. In contrast the treatment of
an episode of pneumonia using Septran (as recommended by the WHO protocol)
costs Rs. 10 per child. The vaccine is therefore exorbitantly expensive and
it does more harm than good.



All these facts were documented in studies and known to the experts.
However, in a sinister move by the WHO, the results were cleverly shielded
from the public for 5 years before being finally exposed in the October 2008
WHO Bulletin. It is crucial that the public is informed as to how such a
vaccine came to be advocated by trusted advisors - the WHO, the expert body
of the Government of India (the department of biotechnology (DBT)) and by
individual doctors. This is crucial for accountability and for trust to be
slowly rebuilt.



There is currently an unhealthy nexus between the WHO, the GOI agencies and
the drug industry. These unhelpful relationships need to be exposed and
corrective actions put in place to avoid such risks in the future. The
influence of drug manufacturers on professional medical advice has been
discussed widely in journals like the British Medical Journal, the New
England Journal of Medicine and the Canadian Medical Journal. Such
discussions in professional circles are sterile unless the lay press also
takes it up and demands a change in standards of behaviour.



Perhaps what has led to this dangerous vaccine being given to our children
is the way the WHO has recently lost its independence by getting into bed
with pharmaceutical companies. The 19 January 2008 issue of the British
Medical Journal details how the WHO Expert Group Meetings are now sponsored
by pharmaceutical companies and manufacturers now have access and can
influence the decisions made by Expert Committees. With such obvious
conflicts of interests, how can the WHO possibly be trusted as an honest
broker between the needs of public health and the pharmaceutical industry?



In the case of vaccines the WHO has joined forces with vaccine manufacturers
in the Global Alliance for Vaccines and Immunization (GAVI) to promote
vaccines in third world countries. Shamefully, this promotion is done
without regard to the costs, the lack of benefits in countries with a low
incidence of the problem and the imperatives of more pressing public health
needs.



GAVI has entered an Advance Market Commitment (AMC) with manufacturers.
Through the AMC, donors commit money to guarantee the price of vaccines once
they are developed. In 2007, GAVI began working with partners on a US$1.5
billion AMC pilot to fund the introduction of pneumococcal vaccines in poor
countries. This fund will ensure that manufacturers receive their high
guaranteed rate. Poor countries are enticed to introduce the vaccine with
huge subsidies. For example, the asthma causing pneumococcal vaccine, which
costing Rs. 12,000 per child was being provided for Rs. 50. The subsidy and
co-financing schemes prevent nations from doing a proper cost benefit
evaluation.



Like all introductory offers, it is for a limited time only. Countries are
forced to pay full market rates after the offer is withdrawn. The AMC having
promised manufacturers a guaranteed market for their vaccine at the rate of
Rs. 4000/dose (Rs 12,000 per child), led to both the GAVI and the WHO
glossing over the lack of efficacy and the obvious harms of the vaccine when
marketing the vaccine to poor countries.



In April of this year, experts of the Government of India recommended the
introduction of the vaccine in the country's routine immunization, 'if the
vaccine covered 70% of the strains of the bacteria in the country'! It must
be clarified here that the lack of efficacy reported in the WHO Bulletin
relate to countries where up to 80% of the local strains were covered in the
vaccine! The risks in terms of asthma were available in the literature but
do not seem to have caught the attention of these experts.



The price of a vaccine is inversely proportional to its usefulness. The less
useful the vaccine, the higher the inducements needed to encourage reluctant
doctors to use it. On one end of the spectrum we have the highly effective
DPT (diphtheria tetanus pertusis) vaccine which costs just a few paisa and
on the other end we have the pneumococcal vaccine which costs thousands of
rupees. Out of the Rs 4000 the public pay for one dose of pneumococcal
vaccine Rs 1000 goes directly to the doctor or dispensary that sells the
vaccine. This is a fail-safe marketing strategy by the pharmaceuticals.
Indeed, with these types of incentives it is a win-win situation for
everyone, aside from the child patients who have an increased chance of
getting asthma and having their health impacted for the rest of their life.



India cannot afford such costly public health mistakes like the pneumococcal
vaccine. Currently, we only have around 50% coverage of the basic vaccines
and it is crucial that all the resources available be used to improve this
coverage in the interest of public health for all. Spending money on newer
vaccines of doubtful utility will ensure that even less is available for the
rural poor. Perversely, those parents who don't have access to immunize
their children against pneumococcus may however be relieved that their child
avoided asthma. We can only hope that the pneumococcal faux pas will prompt
the policy makers into developing a more coherent policy for public health
and equity in services.



The WHO website reads that "It is responsible for providing leadership on
global health matters, shaping the health research agenda, setting norms and
standards, articulating evidence-based policy options, providing technical
support to countries and monitoring and assessing health trends." For this
reason, the WHO and the GOI need to ask searching questions as to how they
came to promote a vaccine that does more harm than good. Further to this, by
trying to hide the vaccine's health risks and ignoring requests from civil
society organisations as to the reasons why this decision was made, the WHO
has shown an astonishing lack of both transparency and accountability, which
poses serious questions about the legitimacy, authority and judgment of the
organisation.



Recently the All India Drug Action Network wrote to the Director General
Margaret Chan asking her why she was promoting this vaccine that does more
harm than good. She has replied through her personal assistant that she looks
forward to creating a *world where no person should die of a
vaccine-preventable disease*. So 12 million rupees will be spent to reduce
3.6 cases of pneumonia with this vaccine while millions die of malnutrition.
The letter suggests that the WHO plans to siphon off millions of dollars
contributed by member countries for the Millennium Development Goals to pay
pharmaceutical companies through Advance Market Commitments.





To repair its reputation and to protect people's health rights, both the WHO
and the GOI need to purge the people who have allowed this catastrophe to
take place and safeguards must be put in place to never again allow people's
health rights to be comprised. Furthermore, the WHO and GOI should issue a
full and prompt apology to the children and families who have been adversely
affected by their mismanagement.

*From:-**
*Jacob M. Puliyel MD MRCP MPhil

*(The author is a consultant Paediatrician at the St. Stephens Hospital New
Delhi is a member of the Overview Team for the Public Report on Health.) *
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