Months later, many girls started falling ill
and by 2010 five of them died. Two more deaths were reported from
Vadodara, Gujarat, where an estimated 14,000 children studying in
schools meant for tribal children were also vaccinated with another
brand of HPV vaccine, Cervarix, manufactured by GSK. Earlier in the
week, the Associated Press reported that scores of teenaged girls were
hospitalised in a small town in northern Colombia with symptoms that
parents suspect could be an adverse reaction to Gardasil.
A standing committee on health and family
welfare that investigated the irregularities pertaining to the
observation studies in India tabled its report a year ago, on August 30.
The committee found that consent for
conducting these studies, in many cases, was taken from the hostel
wardens, which was a flagrant violation of norms. In many other cases,
thumbprint impressions of their poor and illiterate parents were duly
affixed onto the consent form. The children also had no idea about the
nature of the disease or the vaccine. The authorities concerned could
not furnish requisite consent forms for the vaccinated children in a
huge number of cases.
The committee said it was “deeply shocked to
find that in Andhra Pradesh out of the 9,543 [consent] forms, 1,948
forms have thumb impressions while hostel wardens have signed 2,763
forms. In Gujarat, out of the 6,217 forms 3,944 have thumb impressions
and 5,454 either signed or carried thumb impressions of guardians. The
data revealed that a very large number of parents or guardians are
illiterate and could not even write in their local languages, Telugu or
Gujarati.”
Earlier this month, taking a serious view of
the death of seven tribal girls in the context of the observation
studies, the Supreme Court asked the Drug Controller General of India
(DCGI) and the Indian Council of Medical Research (ICMR) to explain how
permissions were given.
The SC bench of justices Dipak Misra and V
Gopala Gowda asked the Centre to produce relevant files that pertained
to the grant of licence for trial of the HPV vaccine in India. The court
also asked the Centre to appraise it of steps taken on the report of the
parliamentary committee.
When a team of health activists from an NGO
that specializes in women’s health named Sama visited Khammam in March
2010 on a fact-finding mission, they were told that as many as 120 girls
experienced adverse reactions such as epileptic seizures, severe stomach
ache, headaches and mood swings. The Sama report also said there had
been cases of early onset of menstruation following the vaccination,
heavy bleeding and severe menstrual cramps among many students. The
standing committee pulled up the relevant state governments for the
shoddy investigation into these deaths. It said it was disturbed to find
that “all the seven deaths were summarily dismissed as unrelated to
vaccinations without in-depth investigations…the speculative causes were
suicides, accidental drowning in well (why not suicide?), malaria, viral
infections, subarachnoid hemorrhage (without autopsy) etc.”
The committee said that in the context of deaths of girls classified
as suicide, the role of the “HPV vaccine as a possible, if not probable,
cause of suicidal ideation cannot be ruled out.”
It said that an American NGO — Program for Appropriate Technology in
Health (PATH) — had carried out the studies.
The committee found that the objective behind the observation studies
in India primarily was to collect and record data on the effect of the
vaccines on the minor subjects. Another objective was to help the
relevant authorities in India make an informed opinion on introducing
the vaccine into India’s immunization programme. Providing a background,
the report states that on June 1, 2006, American drug regulator, the US
Food and Drug Administration (USFDA) approved the first vaccine —
Gardasil — to prevent HPV. According to the World Health Organisation
(WHO), two HPV types causes 70% of cervical cancers. In the very same
month, PATH embarked upon a large-scale, five-year project that involved
observation studies, covering Peru, Vietnam and Uganda, apart from
India.
The committee observed that on November 16,
2006, a draft memorandum of understanding (MoU) between PATH and the
ICMR was circulated by the latter. The MoU states that the two parties
desire “…to explore collaboration to support public sector decision
regarding HPV vaccine introduction in India and to generate necessary
evidence to allow the possible introduction of HPV vaccine into India’s
Universal Immunization Programme.” That idea appears to have hit a
roadblock following the deaths of the children during the observation
studies.
The standing committee report was a shocker
but it became even more significant when it was mentioned that the study
was sponsored by the Bill & Melinda Gates Foundation (BMGF).
Over the past decade, Bill Gates has transformed from an IT
businessman into a global philanthropist. The foundation that he set
up along with his wife is involved in hundreds of projects related
to healthcare for the poor. Vaccination is a significant area of
work and BMGF has projects running in almost every country that’s
counted as poor. BMGF continues to partner PATH in a number of
studies such as the ones for a Rotavirus vaccine and pneumococcal
vaccine in several countries, mainly Africa and Asia.
The health ministry also has not stopped PATH, in any manner,
from becoming a part of such studies in India. The NGO has been
roped in for other vaccine observation studies in India wherein it
partners the department of bio-technology and other government
departments. Health secretary Lov Verma refused to give an answer
when ET Magazine asked why PATH continued to be allowed to carry out
observation studies in India even after the studies which allegedly
turned fatal.
According to the BMGF, the WHO, the International Federation of
Gynaecology and Obstetrics, and the Federation of Obstetric and
Gynaecological Societies of India have all recommended vaccination
“as a proven and highly effective preventive measure for cervical
cancer. “The project used vaccines that are licensed in India and
that have been administered safely around the world tens of millions
of times, preventing countless cases of cervical cancer illness and
death,” maintains a BMGF spokesperson in an emailed response (see
GAVI & PHFI create incentives…).
The Wrong PATH
BMGF’s role in funding the controversial studies, however, has
led to many healthcare activists in India voicing their
apprehensions. “BMGF has to take full responsibility because PATH is
funded by them. It is also unethical when people championing the
cause of vaccines are the same ones who are also investing in
vaccine development,” said V Rukmini Rao, one of the activists who
filed a writ petition before the Supreme Court in connection with
the HPV vaccine studies.
BMGF has funded two organizations that over the past five years
have played a significant role in the country’s immunization
programme and are both under fire for conflict of interest. The
organizations are GAVI (earlier known as Global Alliance for
Vaccines and Immunization), a global aid organization that
specializes in vaccination, and Public Health Foundation of India
(PHFI), a public-private partnership society that BMGF co-founded
with the UPA government in 2006.
Activists allege that these two institutions have a working
relationship with pharma companies. The main charge against GAVI is
that it has representatives from pharmaceutical companies on its
board while the PHFI accepts grants from pharma companies. “BMGF and
GAVI are pushing the [vaccine] agenda with governments around the
world, including India,” says Ritu Priya Mehrotra, professor of
Social Medicine and Community Health and School of Social Sciences,
Jawaharlal Nehru University, Delhi. The community health activist
says the biotechnology industry was pushing more and more vaccines
into India and that the health ministry was not ensuring that
adequate testing was done before recommending their use in
government programmes.
“We need to follow the precautionary principle when it comes to
vaccines. We do need more vaccines…but we should ensure that enough
time is given for research to prove the efficacy and safety of new
vaccines. The vaccines that are to be brought here should also fit
our epidemiological profile,” adds Mehrotra. Mehrotra adds that a
network of people in aid agencies and the health bureaucracy were
pushing this agenda. “They have the advantage of an existing
medicalized mindset that believes vaccines are the perfect, safe,
effective, low-cost solution for prevention of infectious diseases.
There is ample evidence that this is not always the case.”
The current trend is to dilute safety testing criteria and cut
short on time required to conduct proper observation studies. “The
best example is the Pentavalent vaccine against which there is
evidence to be wary of and yet we are going ahead [with its use in
the immunization programme],” points out Mehrotra.
Wrong Dose
In recent years, the deaths of many
infants allegedly soon after they were immunized with the
Pentavalent vaccine, a five-in-one shot, has contributed towards
anxiety around vaccines. The vaccine has been controversial in Sri
Lanka, Bhutan and Vietnam, too, where it was temporarily suspended
on account of some reported post-vaccination deaths of infants.
Launched in 2011 in India, Pentavalent is
a combination of five vaccines in one: diphtheria, tetanus, whooping
cough, hepatitis B and haemophilus influenza type b (the bacteria
that causes meningitis and pneumonia). The vaccine created a furore
after many infants from across the country were reported to have
died after the vaccination. A reply by the health ministry to an RTI
application shows that the deaths of three infants in Tamil Nadu
have “a consistent causal association to immunization”, which means
the ministry confirms that there is a connection between the
vaccination and the deaths. In all, 54 cases of deaths of infants
who were vaccinated with Pentavalent have been classified as
‘adverse events following immunization’(AEFI), nomenclature that
confirms the deaths have occurred soon after vaccination.
ET Magazine’s questionnaires to the health secretary were
unanswered. BMGF, GAVI and PHFI are in favour of Pentavalent even as
a number of paediatricians and health experts have petitioned the
government to take a second look at the vaccine in light of the
deaths of infants.
In an opinion piece published recently in Deccan Herald titled
“New Vaccines: Gates Foundation’s philanthropy or business?”, Dr
Gopal Dabade of the All India Drug Action Network said that GAVI had
committed a $165-million grant for the phased introduction of
Pentavalent in India and provides a subsidy of Rs 145 per injection
for five years after which the government will have to pay the total
cost of the vaccines. “BMGF is a founding partner of GAVI. Its
initial grant helped establish GAVI and it continues to support its
work. Some of the pharmaceutical companies have affiliation with
BMGF to manufacture the vaccine,” Dr Dabade said.
The Controversial Report
A recent strategy document on immunization published this year by
the health ministry suggests doubling the expenditure on purchase of
Pentavalent. The Multi-Year Strategic Plan for the Universal
Immunization Programme (UIP) makes the case that the ministry needs
to double its spend on Pentavalent from Rs 312.7 crore in 2013 to Rs
773.8 crore in 2017. The report also calls for a seven-fold increase
in total spend on vaccines — from Rs 510.6 crore to Rs 3,587.1 crore
by the same year.
The report was drafted by a team of immunization researchers who
work under the PHFI which was co-founded by BMGF and the UPA
government as a public private partnership. A few experts from
UNICEF and WHO were also part of the team. Interestingly, its on the
basis of such multiyear plans that GAVI, also funded by BMGF,
disburses grants to countries.
Started in 2000, GAVI is a
first-of-its kind funding agency that brings together poor
countries, donor nations, global agencies, foundations,
individual donors and pharma companies to enhance vaccination in
poor countries. The funding is split between governments of the
developed world (74%) and corporations, foundations and
individuals (26%). BMGF accounts for about a fifth of the total
contributions. The HPV vaccine, used as a part of the allegedly
fatal observational studies in undivided Andhra Pradesh and
Gujarat, as well as Pentavalent are both part of a range of
vaccines that countries can seek co-financing support for under
GAVI’s scheme for new and underused vaccines.
The GAVI board comprises of a
representative each of the pharma industry from the
industrialized and developing countries, a sore point with some
experts from the aid world. In an article in the The Guardian
three years ago, leaders of international aid agencies such as
Oxfam and MSF said the representatives of companies needed to
step down from the GAVI board. “Pharmaceutical companies’
representation on GAVI’s board creates a conflict of interest.
The current structure is far too cosy,” said the article quoting
Mohga Kamal-Yanni, a senior policy adviser with Oxfam.
In a statement to ET Magazine, GAVI
defended its model: “As a public-private partnership, GAVI harnesses
the capabilities of the public and private sector to maximise its
impact on health and development. While we believe this model is
critical for our mission, we also recognize that it requires us to
manage potential conflicts of interest. Therefore, relationships
with the private sector are managed through strict policies. For
instance, a board member representing manufacturers will be asked to
leave discussions and be excluded from voting on any issue where a
potential conflict of interest is identified.”
Recently, an additional secretary with
the health ministry, Anuradha Gupta, was appointed as the deputy CEO
of GAVI. Gupta was earlier in charge of the National Health Mission.
Healthcare activists raised a furore as the international agency’s
board also has representation from pharmaceutical companies. The
Alliance Against Conflict of Interest, an organization fighting for
a legislation on the subject, highlighted Gupta’s move from
government to GAVI as an example.
GAVI’s defences is that “Ms Gupta has
brought to GAVI her deep passion and commitment to protecting
maternal and child health which includes enabling them to access
life-saving vaccines. She strongly supports GAVI’s vision and
mission which is to save children’s lives and protect people’s
health by increasing access to immunization in poor countries.”
Conflict of Interest
Similar controversies on proximity with pharma companies and
conflict of interest have been raised about PHFI. While PHFI is
engaged in public health and is also partnering the government in
UIP, it has accepted grants from a number of pharma companies,
including vaccine manufacturers. In all, PHFI has accepted grants
worth around `57.65 crore from pharma companies, including Merck
Sharp and Dohme, Pfizer and Sanofi, which manufacture vaccines.
Sanofi is one of the many manufacturers of the controversial
Pentavalent vaccine around the world.
PHFI head K Srinath Reddy asserts that the grants “that the PHFI
has received from pharmaceutical companies are meant for broader
educational activities, and are not intended to benefit PHFI, a
pharma company or any other specific organization.”
Another point that provides firepower to the critics is PHFI’s
McKinsey connection. An executive with the consulting company,
Gautam Kumra, is present on the governing body of PHFI. Kumra’s
profile on McKinsey’s website declares that his areas of expertise
include healthcare. He is also credited with helping “one of India’s
leading pharmaceutical companies define its 10-year vision, redesign
its organization and upgrade its capabilities to execute the
vision.”
In 2012, McKinsey published a report titled “Transforming India’s
vaccine market” in association with the Organisation of
Pharmaceutical Producers of India.
The report suggests that India’s vaccine market is much smaller
and underpenetrated than its global peers and discusses impediments
that have hampered growth of the vaccine market. The report also
features a scenario as per which the optimistic case would be that
the market would have hit a value of around $3.2 billion in 2020,
growing at 30-35% year-on-year from 2012 onwards. “In all
likelihood, there will be five “mega” vaccines of over $250 million
each in size, constituting 60% of the market, namely the
anti-influenza, anti-typhoid, HPV, pneumococcal and Hepatitis A,”
the report said.
A McKinsey spokesperson said “the consultancy does not have a
working relationship with PHFI. Gautam Kumra, a senior partner at
McKinsey & Company, is a member of PHFI’s governing board but in an
entirely personal capacity as a healthcare systems expert and not as
a representative of McKinsey.” The consultancy also said it had a
long history of pro bono and volunteer work for private, public and
social sector organizations.
Public health activist and pediatrician Dr Arun Gupta says PHFI’s
links with pharma companies and McKinsey are unacceptable. “It is a
clear conflict of interest. Neither the government nor PHFI has come
out clearly and spoken of their relationship with each other… it
seems to be a private club that helps pharma companies make inroads
into public policy.”
“PHFI is a private society cleverly
disguised as a public-private partnership since some of the
people in the governing body are or have been senior civil
servants or public servants,” adds Supreme Court lawyer and
activist Prashant Bhushan. Bhushan points out that PHFI appears
to have several connections with the big pharma companies and
their consultants. “The PHFI appears to have a conflict of
interest in advising the government of India and directing the
immunization programme.”
PHFI’s Srinath Reddy stresses that
they had received unrestricted educational grants from pharma
companies towards building the capacity of health professionals
for providing appropriate health care of adequate quality in
primary health care settings. However, these were not connected
with the PHFI’s work on the immunization front, he added. “As a
not-for-profit organization, PHFI receives grants from different
stakeholders for funding capacity building programmes which
address broader public health and health system needs, including
quality of healthcare. These grants are in no way tied to any
pharmaceutical product and are meant solely for educational
activities.” But then again the line between transferring
medical knowledge and deriving commercial interests is a thin
one.
Source(s):
articles.economictimes.indiatimes.com