BANGALORE: An advertising blitz
launched by a multinational drug firm to promote its high profile but
controversial cancer vaccine has left Indian households confused and health
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 commonest major cancer
What the ad hides, of course, is that 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 the 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.
listed price - $120 (Rs 5,800) per dose and three shots are required - is the
least of the concerns about the vaccines, 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 six% 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.
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
Merck spokesperson Vince Docherty however told IANS
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
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 Rs 200 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 on chemist shops 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.