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NOTE: At last - a sensible unbiased article from
outside the US on the serious problems with Gardasil! Wake up
America...think twice before you give this vaccine to your daughters!
http://www.gulf-times.com/site/topics/article.asp?cu_no=2&item_no=263743&version=1&template_id=40&parent_id=22
New cancer vaccine ad blitz sparks controversy
Wed. Dec 31, 2008
BANGALORE: An advertising blitz launched by a multinational
drug company to promote its high-profile but controversial cancer vaccine has
left Indian households confused and health workers worried.
The 15-second commercials seen recently on Indian television urge parents to get
their young girls inoculated with the vaccine Gardasil to protect against
cervical cancer, the second most common major cancer in women.
The vaccine is mired in a controversy in the United States over its safety and
the ethics of administering it to girls as young as nine.
The vaccine manufactured by Merck & Co blocks two strains of the human
papillomavirus (HPV 16 and 18) which are known to cause about 70% of cervical
cancers.The US Food and Drugs Administration authorised sale of the vaccine in
that country in June 2006. The company launched it in India in October 2008 and
followed it with television advertisements that tend to make parents believe
that their daughters risk dying of cervical cancer if not vaccinated.
Advertising prescription drugs on television is unethical enough, but using fear
to sell them is worse, according to medical scientists aware of the controversy
in the US.
Gardasil is an efficient vaccine but the safety and risk information about it
has not been made available to parents to enable them make an informed decision
about vaccinating their daughters, says Kumaravel Somasundaram, a cancer expert
at the Indian Institute of Science in Bangalore. “We did not debate the issues
even within the science community before the vaccine arrived in the market,” he
said.
Its exorbitant listed price - $120 (Rs5,800) per dose and three shots are
required - is the least of the concerns about the vaccine, says Jacob Puliyel,
consultant paediatrician at the St Stephens Hospital in Delhi. “What bothers me
is the reported side effect.”
A Google search with just two key words ‘gardasil+safety’ lists 263,000 reports
relating to side effects.
As of August 31, the US Centres of Disease Control (CDC) had received more than
10,000 adverse event reports, including 27 deaths following Gardasil
vaccination. According to CDC, seizures, blood clots and paralysis accounted for
6% of adverse events classified as “serious”, while fainting, fever and
headaches made up the rest. But the US health officials and Merck have dismissed
the adverse events as “unrelated to the vaccine” and have claimed that the
vaccine is safe.
Puliyel says the Gardasil vaccination raises an ethical issue as it can only
prevent, but not treat HPV infection. Since HPV is sexually transmitted, the
vaccine needs to be given before a girl becomes sexually active, ideally at the
age of 11.
“The underlying assumption here is that adolescent girls in India may all become
promiscuous,” says Puliyel.
An August 21 editorial in the New England Journal of Medicine noted that
Gardasil’s “long-term effectiveness is unclear” since no participants have been
followed for more than five years while most cervical cancers take 10 years to
develop.
“While it has been shown that the HPV vaccines prevent pre-cancerous lesions, we
don’t know if they will prevent cancer itself,” the editorial said.
The journal also raised two other questions: One, most HPV infections clear on
their own in 1-2 years through the body’s natural immune response. Will the
vaccine interfere with this natural process and, if so, in what ways? Two, since
only two of the cancer causing strains of HPV are suppressed by Gardasil, will
other strains take their place? More than 160 types of HPV are known to exist.
“With so many essential questions still unanswered, there is good reason to be
cautious about introducing large-scale vaccination programmes (with Gardasil),”
says Charlotte Haug, editor-in-chief of the Journal of the Norwegian Medical
Association.
“There is too little long-term safety and efficacy data, especially in young
girls,” says Tom Fitton, president of Judicial Watch, a public interest group in
Washington. “It looks as if an unproven vaccine with dangerous side effects is
being pushed as a miracle drug.”
Merck spokesperson Vince Docherty however said that the vaccine was tested in
approximately 25,000 people in the United States and around the world, “and
found to be safe and effective in preventing serious HPV-related diseases.”
According to the company, the vaccine launched in India can be given to women
from age 10 to 26. The office of the Drug Controller General of India did not
reply to questions on how the vaccine was allowed to be sold without the
mandatory clinical trial on local population. The trial in the 16-23 age group,
originally proposed by the Indian Council of Medical Research in early 2008, has
not started for reasons not known.
The Merck spokesperson however said that Indian regulators approved the sale of
Gardasil in July 2008 on the basis of “clinical efficacy and safety data”
generated worldwide and the results of a clinical trial carried out in India in
2007 in 110 healthy girls in the 9-15 age group. The company had outsourced the
trial to unnamed contract research organisations and the results have not been
published. The Merck official said the results are “in the process” of being
published.
According to the American Cancer Society, virtually all cervical cancers can be
prevented if any pre-cancerous cells detected during routine “Pap” test are
treated immediately. The Pap test that costs about Rs200 can detect changes on a
woman’s cervix even before cancer develops, when it is most curable. Between
1955 and 1992 the number of cervical cancer deaths in the United States dropped
by 74% by the use of Pap test alone, without any vaccination.
The American vaccine watchdog, Virginia-based National Vaccine Information
Center, has cautioned that Gardasil vaccine could lull people into a false sense
of security. It says that since the vaccine protects only against a few strains
of HPV responsible for 70% of cervical cancers, “it will be important for women
to continue getting screened by regular Pap tests” to guard against the
remaining 30% of cervical cancers caused by other dangerous strains of HPV.
Critics say that the Indian health ministry which acted so fast to put the
controversial Merck vaccine in pharmacies ahead of the clinical trial in the
16-23 age group should have instead promoted the inexpensive Pap test across the
nation if it was really serious about reducing cervical cancer deaths. – IANS
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