Healthy Skepticism Library item: 18716

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Hype on HPV: for Whose Benefit?
Monthly Index of Medical Specialities 2010 Sep

Full text:

What are the major health problems confronting the country?
Tuberculosis that kills a patient every minute, more than 1,000 every day that adds up to some
500,000 deaths every single year. Apart from human misery, the annual economic cost
to the nation exceeds Rs. 13,000 crores! Malaria that afflicts at least 10 crores
people every year (the government figure of 15 lacs is grossly understated since more
than 80 per cent of the population is dependent on private practitioners whose data is
not included in the official estimates). Diarrhoeal disorders that extinguished the lives
of over 456,000 Indians, mostly children, in 2006 alone and continue to kill even more
now.
But, what is the “talk of the town”? Imported HPV vaccine (Gardasil by
Merck) that is claimed to prevent cervical cancer. It costs Rs. 16,500 (US$ 360) for
three shots per person! Who is being advised to take it? Every girl in the age group
of 10-14 years. That comes to a cool Rs. 1,03,125 crores (four times the Health Ministry’s
total annual budget) income if the company’s dream of 6.25 crores girls getting
vaccinated comes true. It will also mean continuing income of Rs. 20,625 crores every
year since 1.25 crore girls will cross into the specified age group eligible for
vaccination.
The interest in HPV role in cervical cancer is not accidental. In
2004, Merck was compelled to withdraw its blockbuster drug rofecoxib due to serious
side effects depriving the company of billions of dollars in global sales. Soon after money
started flowing into research in HPV role in the causation of cervical cancer.
Investigators were roped in to conduct clinical trials, observational studies and submit articles in professional journals on the serious challenge that HPV poses to humanity. In 2006, Gardasil
was approved by the U. S. Food and Drug Administration after a super fast review
lasting barely six months instead of the usual three years.
Then followed the most aggressive marketing campaign by Merck.
Hundreds of doctors were recruited and trained to give talks about Gardasil and paid US
$4,500 (Rs. 2 lacs) per lecture. Former government officials were employed as lobbyists,
donations made to women groups, sometimes concealing the real source of funds to
promote the use of the vaccine. One major strategy was “to educate legislatures” on
HPV in various countries such as Members of Parliament in India. Why? Because the
best way to sell the vaccine is to somehow get it included it in the state-funded
immunisation programmes that would guarantee automatic income perpetually. In India the
company’s executives sought appointment with MPs to enlighten them about the product. A
bait is being thrown by promising a grant in the first two years to reduce the cost
by 50%. What will happen after two years? It will become a white elephant and cost
exchequer a fortune.
Once introduced it would become impossible to stop state-funded vaccination.
Let us look at the clinical side of the story. HPV is a sexually transmitted infection
common in “sexually active” girls. In 90% of the cases, the infection is transient and
gets spontaneously cleared by the age of 30. According to one study, there are 44
strains of HPV in India including 18 high risk that can cause cervical
cancer. The overall prevalence of high risk HPV infection is 10.3 %. Since it covers just
two strains, the vaccine is not effective against all strains. Besides, cervical cancer
is not merely due to HPV as there are other causes such as genetic, use of OCs etc. The
efficacy of vaccine for period beyond 3 to 5 years has not been ascertained.
Commercial ads for Gardasil admit in small print “the duration of protection has not been
established.”
Hence a booster dose may be required putting additional burden on
scarce resources.
Side effects are also a cause for concern: 6% of those reported have been classified
as serious, including blood clots, paralysis and even deaths.
Eliminating the two HPV strains may allow other strains to increase in frequency apart from
becoming resistant, reducing the vaccine’s efficacy thus giving a false sense of security
to vaccinated girls who will not go in for PAP smear or screening.
We must look at alternative, cost effective strategies such as
extending PAP smear facilities for cytology or screening after the age of 30 to detect at
risk patients and then offer appropriate management. As New England Journal of Medicine has
put it: Let India show a better way to prevent cervical cancer.