Cancer vaccine kicks up controversy in India.

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Cancer vaccine kicks up controversy in India

30 Dec 2008, 1122 hrs IST, IANS

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

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 commonest major cancer

in women.

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.

Its exorbitant

listed price - $120 (Rs 5,800) per dose and three shots are required - is the

least of the concerns about the vaccines, says Puliyel, consultant

paediatrician at the St. s 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.

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 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

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 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.

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