[PAA-Discuss] Fwd: Sharav - Scientists Question Health / Economic Value of HPV Vaccine

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Sent: Fri, 22 Aug 2008 6:35 pm
Subject: Sharav - Scientists Question Health / Economic Value of HPV 
Vaccine



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                         Vera Sharav


http://www.ahrp.org andhttp://ahrp.blogspot.com




FYI

Two articles in The New England Journal of Medicine focus on the 
commercial
success of Merck's HPV vaccine, Gardasil and GlaxoSmithKline's HPV 
vaccine,
Cervarix.

An editorial by Dr. Charlotte Haug, the editor of The Journal of the
Norwegian Medical Association, 
focuses on the medical /scientific 
reasons
for caution: "Despite great expectations and promising results of 
clinical
trials, we still lack sufficient evidence of an effective vaccine 
against
cervical cancer." "The bad news is that the overall effect of the 
vaccines
on cervical cancer remains unknown. See:
http://content.nejm.org/cgi/content/full/359/8/861

The second is a Harvard analysis of the health and economic 
implications of
HPV vaccination in the U.S by Jane J. Kim, Ph.D., and Sue J. Goldie, 
M.D.,
M.P.H. The authors challenge prior cost estimates-- $30,000 to $70,000, 
or
higher-calculating that if all U.S. girls and women up to age 21 were
vaccinated, the cost per year of life saved by vaccinating would be
$120,400. "And if the vaccines prove to require a booster shot, as many
critics believe, that cost rises to $140,000. In such cases it might 
make
more economic sense to rely on Pap smear screening alone, the 
researchers
said."
http://content.nejm.org/cgi/content/short/359/8/821

A front page article in The New York Times by Elisabeth Rosenthal 
(below)
describes how the commercial success of these two medically and 
economically
questionable vaccines was driven by aggressive marketing not medicine.

In developed countries, Pap smear screening and treatment have 
effectively
reduced cervical cancer death rates to very low levels already. There 
are
3,600 deaths annually from cervical cancer in the United States, 1,000 
in=0
D
France and 400 in Britain.

Cervical cancer, like skin cancer, can generally be caught at 
precancerous
or non-invasive stages and treated. Because the vaccine prevents 
infection
with only some of the cancer-causing strains, Pap smear screening must
continue even in those who are vaccinated.

Most vaccines take three years to get FDA endorsement and then 5 to 10 
more
years for universal acceptance. But, Dr. Haug points out, the HPV 
vaccines
have been studied for a relatively short period - both were licensed in 
2006
and have been studied in clinical trails for at most six and a half 
years.
Researchers have not yet demonstrated how long the immunity will last, 
or
whether eliminating some strains of cancer-causing virus will decrease 
the
body's natural immunity to other strains.

Furthermore, because cervical cancer develops only after years of 
chronic
infection with HPV, Dr. Haug said there was not yet absolute proof that
protection against these two strains of the virus would ultimately 
reduce
rates of cervical cancer - although in theory it should do so.

So what is the basis for the sudden panic about cervical cancer in the 
US,
Britain, and France, and the urgency for getting pre-teenage girls
vaccinated???
Answer: aggressive lobbying / marketing campaigns by Merck and GSK.

Key physicians, professional medical associations, legislators and 
public
health policy makers were enticed with cash:


"M
erck lobbied every opinion leader, women's group, medical society,
politicians, and went directly to the people - it created a sense of 
panic
that says you have to have this vaccine now," said Dr. Diane Harper, a
professor of medicine at Dartmouth Medical School. Dr. Harper was a
principal investigator on the clinical trials of both Gardasil and 
Cervarix,
and she spent 2006-7 on sabbatical at the World Health Organization
developing plans for cervical cancer vaccine programs around the world."


In the US the public was bombarded with both ads and promotional 
inserts in
TV programs such as "Sex in the City."

Angela Raffle, a specialist in cervical cancer screening with the 
National
Health Service in Britain, where 400 people die of the cancer each year,
says: "There is no need to rush. If we do this quickly and badly, we 
could
cause more deaths," from side effects, for example, or from giving girls
false security that they are protected for life and no longer need to be
screened."


"With so many essential questions still unanswered, there is good 
reason to
be cautious."


But with so much cash to be had.. the precautionary principle that has
guided good medicine has been overthrown by medical "authorities" who 
get
$4,500 per lecture promoting Gardasil, and patient "advocacy" groups 
who've
been bought and paid for.

The Times reports how the vaccine makers "have provided money for 
activities
by20patients' and women's groups, doctors and medical experts, lobbyists 
and
political organizations interested in the disease, sometimes in ways 
that
skirt disclosure requirements or obscure the companies' involvement."

The voluntary Vaccine Adverse Events Reporting System maintained by The
Centers for Disease Control has received 9,749 adverse event reports, 
almost
all from doctors and nurses, about patients experiencing adverse events
after receiving the vaccine, the CDC announced in a joint report with 
the
Food and Drug Administration at the end of June. Ninety-four percent of 
them
were not serious, ranging from arm pain to fainting, and 6 percent were
classified as serious, including blood clots, paralysis and at least 20
deaths.

But such facts are countered by Merck's YouTube clips and 
advertisements on
popular shows like "Law and Order," whose multiethnic cast of young
professionals urges girls to become "one less statistic" by getting
vaccinated.


Contact: Vera Hassner Sharav
veracare at ahrp.org
212-595-8974




http://www.nytimes.com/2008/08/20/health/policy/20vaccine.html
THE NEW YORK TIMES
August 20, 2008

The Evidence Gap
Drug Makers' Push Leads to Cancer Vaccines' Rise
By ELISABETH ROSENTHAL

In two years, cervical cancer has gone from obscure killer confined 
mostly
to poor nations to the West's disease of the moment.

Tens of millions of girls and young women have been vaccinated against 
the
disease in the 
United States and Europe in the two years since two 
vaccines
were given government approval in many countries and, often, 
recommended for
universal use among females ages 11 to 26.

One of the vaccines, Gardasil, from Merck, is made available to the 
poorest
girls in the country, up to age 18, at a potential cost to the United 
States
government of more than $1 billion; proposals to mandate the vaccine for
girls in middle schools have been offered in 24 states, and one will 
take
effect in Virginia this fall. Even the normally stingy British National
Health Service will start giving the other vaccine - Cervarix, from
GlaxoSmithKline - to all 12-year-old girls at school this September.

The lightning-fast transition from newly minted vaccine to must-have
injection in the United States and Europe represents a triumph of what 
the
manufacturers call education and their critics call marketing. The 
vaccines,
which offer some protection against infection from sexually transmitted
viruses, are far more expensive than earlier vaccines against other 
diseases
- Gardasil's list price is $360 for the three-dose series, and the total
cost is typically $400 to nearly $1,000 with markup and office visits 
(and
often only partially covered by health insurance).

Award-winning advertising has promoted the vaccines. Before the film 
"Sex
and the City," some moviegoers in the United States saw ads for 
Gardasil. On
YouTube and in advertisements on20popular shows like "Law and Order," a
multiethnic cast of young professionals urges girls to become "one less
statistic" by getting vaccinated.

The vaccine makers have also brought attention to cervical cancer by
providing money for activities by patients' and women's groups, doctors 
and
medical experts, lobbyists and political organizations interested in the
disease, sometimes in ways that skirt disclosure requirements or 
obscure the
companies' involvement.

Even critics of the marketing efforts recognize the benefits of the
vaccines. Girls who get the shots are less likely to have Pap tests with
worrisome results that would lead to further treatment, saving 
themselves
anxiety and discomfort and, in those cases, saving money. When it 
occurs,
cervical cancer is a dreadful disease; genital warts, partly prevented 
by
the Merck vaccine, can be a painful nuisance.

But some experts worry about the consequences of the rapid rollout of 
the
new vaccines without more medical evidence about how best to deploy 
them.
They say that because of the aggressive marketing, even parents of 
girls who
are far from being sexually active may feel pressured into giving them a
vaccine that is not yet needed and whose long-term impact is still 
unclear.
Legislative efforts to require girls to have the vaccine only add to the
pressure.

In the United States, hundreds of doctors have been recruited and 
trained to
give talks about Gardasil - $4,50
0 for a lecture - and some have made
hundreds of thousands of dollars. Politicians have been lobbied and 
invited
to receptions urging them to legislate against a global killer. And 
former
state officials have been recruited to lobby their former colleagues.

"There was incredible pressure from industry and politics," said Dr. Jon
Abramson, a professor of pediatrics at Wake Forest University who was
chairman of the committee of the Centers for Disease Control and 
Prevention
that recommended the vaccine for all girls once they reached 11 or 12. 
"This
big push is making people crazy - thinking they're bad moms if they 
don't
get their kids vaccinated," said Dr. Abby Lippman, a professor at McGill
University in Montreal and policy director of the Canadian Women's 
Health
Network. Canada will spend $300 million on a cervical cancer vaccine
program.

Merck's vaccine was studied in clinical trials for five years, and 
Glaxo's
for nearly six and a half, so it is not clear how long the protection 
will
last. Some data from the clinical trials indicate immune molecules may 
wane
after three to five years. If a 12-year-old is vaccinated, will she 
still be
protected in college, when her risk of infection is higher? Or will a
booster vaccine be necessary?

Some experts are concerned about possible side effects that become 
apparent
only after a vaccine has been more widely tested over longer periods.

And why the sudden=2
0alarm in developed countries about cervical cancer, 
some
experts ask. A major killer in the developing world, particularly 
Africa,
where the vaccines are too expensive for use, cervical cancer is 
classified
as very rare in the West because it is almost always preventable through
regular Pap smears, which detect precancerous cells early enough for
effective treatment. Indeed, because the vaccines prevent only 70 
percent of
cervical cancers, Pap smear screening must continue anyway.

"Merck lobbied every opinion leader, women's group, medical society,
politicians, and went directly to the people - it created a sense of 
panic
that says you have to have this vaccine now," said Dr. Diane Harper, a
professor of medicine at Dartmouth Medical School. Dr. Harper was a
principal investigator on the clinical trials of both Gardasil and 
Cervarix,
and she spent 2006-7 on sabbatical at the World Health Organization
developing plans for cervical cancer vaccine programs around the world.

"Because Merck was so aggressive, it went too fast," Dr. Harper said. "I
would have liked to see it go much slower."

In receiving expedited consideration from the Food and Drug 
Administration,
Gardasil took six months from application to approval and was 
recommended by
the C.D.C. weeks later for universal use among girls. Most vaccines take
three years to get that sort of endorsement, Dr. Harper said, and then 
5 to
10 more for universal acceptance.

"In th
at time, you learn a lot about safety and side effects and how to 
use
it," Dr. Harper said. "Those getting it early should be the ones who 
really
want it and willing to accept the risk."

Dr. Richard Haupt, medical director at Merck, said the vaccine had not 
been
rushed into use, saying that five years in clinical trails was normal 
before
applying for licensing. He said Merck educated physicians, politicians 
and
the public about the new vaccine to "accelerate and facilitate access."
Spokesmen for Merck and Glaxo say all indications are that their 
vaccines
are safe and effective, and there is no evidence that a booster shot 
will be
needed. A Glaxo spokeswoman, Sarah Alspach, said its formulation 
produces a
"stronger and longer-lasting immune response" than conventional 
vaccines.

"You can only study a vaccine for so long before you license and use it 
in a
population where it has enormous value," said Dr. Haupt at Merck. "Our 
hope
and belief is that this is a remarkable vaccine that will have huge 
impact
on women."

But with their high price, the vaccines are straining national and state
health budgets as well as family pocketbooks. These were the first 
vaccines
approved for universal use in any age group that clearly cost the health
system money rather than saved it, in contrast to less expensive shots,
against measles and tetanus, for example, that pay for themselves by
preventing costly disease
s.

Health economists estimate that depending on how they are used, the two
cervical cancer vaccines will cost society $30,000 to $70,000, or 
higher,
for each year of life they save in developed countries - a cost commonly
seen in treating people already suffering from deadly cancers. That 
number
will be far higher if a booster is needed.

Looked at another way, countries that pay for the vaccines will have 
less
money available for other health needs. "This kind of money could be 
better
used to solve so many other problems in women's health," said Dr. 
Lippman at
McGill. "Some of our provinces are running out of money to provide 
primary
care. I'm not against vaccines, but in Canada and the U.S., women are 
not
dying in the streets of cervical cancer."

By contrast, if the vaccine were to become cheap enough to be used in 
the
developing world, particularly Africa, it would revolutionize women's
health. Charities like the Global Alliance for Vaccine and 
Immunizations,
backed by the Bill & Melinda Gates Foundation, are trying to devise a
solution.

The vaccines offer partial protection against infection from human
papillomavirus, or HPV, a common and generally benign sexually 
transmitted
virus that can in rare cases cause cancer after years of silent 
infection.
The Merck vaccine also prevents some genital warts that are caused by 
other
strains of the virus.

In Britain, "this initiative was seen as
 a good use of resources that 
fits
with the government's health priorities and political priorities," said
Professor David Salisbury, who heads the Department of Health's Vaccine 
and
Immunization Committee.

But critics urge restraint. "There is no need to rush," said Angela 
Raffle,
a specialist in cervical cancer screening with the National Health 
Service
in Britain, where 400 people die of the cancer each year. "If we do this
quickly and badly, we could cause more deaths," from side effects, for
example, or from giving girls false security that they are protected for
life and no longer need to be screened, Ms. Raffle said.

The Campaigns

Stephanie Levi decided to give her two daughters the vaccine in late 
2006
after receiving a newsletter from their physician. "When you get a 
letter
saying this is what you need to do to protect your girls, of course you 
do
it," she said, adding that she was curious because she had not realized
cervical cancer was a problem.

That week, she noticed articles and advertisements for the vaccine. "I
remember thinking I had better do this quickly," said Ms. Levi who 
lived in
New York then and now lives in Rome.

It is not hard to hear about Gardasil.

In television advertisements, a cast of hip people in their 20s - 
artists,
writers and professionals - describe why they got the shots, in the 
language
of liberation, such as, "I chose to get vaccinated becau
se my dreams 
don't
include cervical cancer." The advertisements direct viewers to 
gardasil.com,
which includes patients' stories, buddy icons and downloads for holding 
an
event at sororities.

Girls of any age who have had one dose of the vaccine can ask for
text-message "reminders" from Merck to get the next two shots. The 
offers
come with another reminder: "I understand that the information I provide
will be used by Merck or those working on behalf of Merck for market
research purposes."

For such efforts, Merck last May swept the 2008 Pharmaceutical 
Advertising
and Marketing Excellence awards, and Gardasil was named Brand of the 
Year by
Pharma Executive Magazine.

The marketing helped make Gardasil one of Merck's best sellers, with a
projected sales of $1.4 billion to $1.6 billion outside Europe this 
year,
and more from sales in Europe, where Merck sells the vaccine through a 
joint
venture with Sanofi Aventis.

Aggressive pharmaceutical advertising is nothing new, but the campaign 
was a
revolution for a vaccine. Vaccines were traditionally the orphans of the
pharmaceutical world because they were cheap and not particularly
profitable. But the two for cervical cancer are the latest in a wave of
high-priced vaccines that have come to market since 2001, opening a
lucrative new field.

Co-opting Doctors and Nurses

Girls and their families are by no means the only marketing target.

In 2006, hundreds of do
ctors and nurses were signed up as unofficial
spokesmen for Gardasil, trained by Merck, provided with a multimedia
presentation and paid $4,500 for each 50-minute talk, delivered over
Merck-sponsored meals. Many were paid for attending Merck "advisory 
board"
meetings to discuss the shots.

Merck said it provided assistance to speakers "to make sure they are
providing accurate information in accordance with F.D.A.-approved 
labeling
and to make sure dissemination of information is always appropriate," 
said
Amy Rose, a company spokeswoman.

Promotion and marketing for Cervarix, Glaxo's version of the vaccine, 
has
been far less visible, in part because it has not been approved yet for 
use
in the United States, and because consumer advertising of medicines is
prohibited in much of Europe. Outstanding data from final clinical 
trials
will probably be submitted to American drug regulators early next year, 
the
company said.

There has also been a proliferation of cervical cancer awareness 
conferences
and campaigns, sponsored by a host of new or newly energized scientific 
and
patient groups financed with the help of Merck and Glaxo. In some cases 
the
financial support has been indirect, so patients are unaware that expert
advice has been at last partly paid for by the vaccine makers.

Gregory A. Poland, a vaccine expert at the Mayo Clinic, was a nonvoting
member on the C.D.C. panel that recommended Gardasil in 2006 and has
publicly=2
0defended the panel's decision. Records show he received at 
least
$27,420 in expenses and consulting fees from Merck from 1999 to 2007. 
Both
the C.D.C. and Dr. Michael Camilleri, chairman of the Mayo Clinic 
Conflict
of Interest Review Board, speaking on Dr. Poland's behalf, said the 
payments
complied with institutional requirements.

To encourage vaccination on campus, Merck provided the American College
Health Association with an unrestricted grant to train its officers to 
speak
about the new vaccine and to create kits to discuss cervical cancer and
promote the vaccine for college health services. The association now
recommends the shot for all female college-age students, even though 
many in
that group already have HPV, rendering the vaccine less useful.

Dr. James Turner, president-elect of the association, said it accepted
Merck's grant to undertake the campaign because "HPV is a very important
health issue for college students," adding that his group was "a very 
small
organization, and we don't have funds."

Small charities have also benefited from Merck's contributions.

At the second annual patient conference of the National Cervical Cancer
Coalition, planned for Los Angeles this October, four of the seven 
scheduled
speakers have received money for research or consulting from Merck, 
Glaxo or
other companies involved in HPV screening or detection, though the
conference organizers do not mention that. The coalition, which supports
widesp
read use of the cervical cancer vaccines, is headed by a 
businessman,
Alan Kaye, who owns a pathology lab that performs Pap smears and HPV 
tests,
among other services. "We are a poor nonprofit, and I've been working on
this issue for years," said Mr. Kaye, who hopes to receive grants from 
the
drug makers to help pay for the conference.

Persuading the Governments

In country after country, Merck and Glaxo also appealed to politicians.
Vaccines, unlike antibiotics, tend to be recommended or mandated by
governments. "We support policy leaders and try to educate 
legislators," Dr.
Haupt said.

In the United States, 41 states have passed or begun considering 
legislation
on cervical cancer, according to the National Conference of State
Legislatures, and 24 have considered proposals to mandate the vaccine 
for
girls, generally in middle school.

Many bills, like ones passed in Colorado, New Jersey and New York, 
allocate
more money for HPV and cervical cancer education or to promote the 
vaccine.
Others, like proposals in Iowa and Louisiana, require insurers to cover 
it.

The only state to pass a bill requiring the vaccine for school entry is
Virginia; it takes effect in October, after school begins, so will first
apply in 2009.

Merck has a growing economic interest in Virginia. In December 2006, 
Merck
announced it would invest $57 million to expand its Elkton, Va., plant 
to
make Gardasil, helped by a $70
0,000 grant from a state economic 
development
agency that is part of the executive branch. Two months later, Gov. Tim
Kaine, who has been mentioned as a possible Democratic vice presidential
candidate, signed legislation requiring Gardasil for schoolgirls. Four
months after that, Merck pledged to invest $193 million more in the 
plant to
make drugs and vaccines, helped by a state grant of $1.5 million.

Delacey Skinner, a spokeswoman for the governor, said the state's
vaccination program included an unusually broad freedom to decline the 
shot.
To exempt children from other vaccines, parents must provide a medical
reason; for Gardasil, they do not. "It is a very easy step that we can 
take
to prevent a sometimes deadly but certainly serious form of cancer," Ms.
Skinner said.

"Without hesitation or question," she added, the decisions about the 
plant
and about the mandate legislation "were completely separate."

But, as in many states where cervical cancer legislation has been
considered, there have been ties between drug makers and members of
government. In 2006, one of Merck's newly hired Virginia lobbyists was
Sandra D. Bowen, who had spent years as Virginia's secretary of
administration. And Bill Bolling, the state's lieutenant governor, 
became an
outspoken participant in the "Ending Cervical Cancer in Our Lifetime"
campaign, a program started in 2006 by the National Lieutenant Governors
Association and financed largely by Merck and Glaxo.

"T
his is an important public health issue," said Randy Marcus, Mr. 
Bolling's
spokesman.

In Texas, Merck hired Gov. Rick Perry's former chief of staff as a 
lobbyist,
and contributed $6,000 to the governor and $38,000 to other legislators.
Last February, Mr. Perry ordered that all schoolgirls be inoculated with
Gardasil, a pronouncement that was overturned by the Texas Legislature, 
181
to 3, a few months after the financial conflicts were revealed.

Early last year, Merck announced that it would no longer actively lobby 
for
state mandates. But Dr. Haupt defended the initial impulse, saying that
historically such school requirements had been a successful way to 
increase
access to and financing for vaccines.

Other forms of lobbying continue: Merck and Glaxo have both paid into a
program run by Cornerstone Government Affairs, a Washington firm, to 
lobby
the C.D.C. and Congress for more federal money for vaccines.

In Britain, drug makers paid for breakfast meetings with politicians and
visited the nurses and family practitioners who are the backbone of the
National Health Service, urging them to offer the vaccine.

In Belgium, the health minister approved the vaccine before the 
country's
health technology evaluation committee had finished deliberating.

Unanswered Questions

Many questions about the vaccines remain unanswered, including how long
immunity will last. Even commercials for Gardasil say - in small print -
that "the duration o
f protection has not been established."

Dr. Harper said that in the data from Merck's clinical trials, which she
helped conduct, the vaccine was no longer protective after just three 
years
in some girls. "The immunity of Gardasil will not last - that is 
dangerous
to assume," she said.

She said she believed that at least one booster shot, and probably more,
would be needed over a lifetime. Dr. Haupt of Merck said that the
"durability of immunity" would ultimately be defined through widespread 
use
of the vaccine, but that the company's research strongly suggested that
immunity would be long lasting - far more than five years.

Other independent experts worry that eliminating the two cancer-causing 
HPV
strains covered by Gardasil and Cervarix might allow the other
cancer-causing strains of HPV to increase in frequency, reducing the
vaccine's effect. But Dr. Haupt said such "theoretical possibilities" 
should
not deter rapid distribution of an important vaccine. "We'll worry about
whether boosters are needed down the road," he said.

The question of side effects, however, has nagged the vaccine.

The Centers for Disease Control asks health care centers to report side
effects through its Vaccine Adverse Events Reporting System; reporting 
is
voluntary. There have been 9,749 reports, almost all from doctors and
nurses, of patients experiencing adverse events after receiving the 
vaccine,
the agency announced in a joint report with the Food 
and Drug 
Administration
at the end of June. Ninety-four percent of them were not serious, 
ranging
from arm pain to fainting, and 6 percent were classified as serious,
including blood clots, paralysis and at least 20 deaths.

But 16 million doses of the drug have been distributed by Merck in the
United States, and in a population so large, "by chance alone some 
serious
adverse effects and deaths" will occur, the F.D.A. and C.D.C. said.

The agencies said there was no indication that the deaths or serious 
side
effects were caused by the shot, concluding that "Gardasil continues to 
be
safe and effective and its benefits continue to outweigh its risks."

Both the agencies and Merck acknowledge that there does appear to be a 
high
rate of fainting, so doctors are now advised to observe patients for 15
minutes after receiving a shot.

For some couples, the vaccine has raised agonizing questions over how to
safeguard their children's health. Phillip and Barbara Tetlock, both
professors at the University of California at Berkeley, are asking 
whether
Gardasil shots that their daughter, Jenny, received last year 
contributed to
her illness, an extremely rare form of progressive paralysis that has 
left
her bed bound and needing assistance to breathe at age 14.

The Tetlocks, who are not pursuing legal action, are appealing to the 
C.D.C.
and Merck for more data and searching for other girls with similar
conditions throu
gh their blog (www.jenjensfamily.blogspot.com). "Her 
parents
are scientists - they know better than to assume Gardasil caused her
disease," said Terry Murray, a close friend speaking for the family. 
"But
you have to explore the possibility."

Dr. Harper said she believed the vaccine was generally safe. She 
vaccinated
her own children. But with Gardasil's use having grown so fast, she 
added,
"you inevitably find adverse events that you wouldn't have suspected." 
"The
Tetlocks are right to ask these questions," she added.

Dr. Haupt of Merck said that the company knew of the case but saw no 
"causal
association."

Worth the Cost?

Countries and consumers must decide whether it is worth preventing 
cervical
cancer with a costly vaccine.

Cervical cancer is the second-leading cause of cancer death in women, 
with
500,000 new cases worldwide each year. But more than 90 percent of them 
are
in developing countries, according to the World Health Organization; 
274,000
women died of this cancer in 2006, nearly 95 percent in developing
countries.

Where there are Pap smear programs, few women die of cervical cancer. 
In the
United States, it is responsible for 12,000 new cases a year and 3,600
deaths, most in women who did not get Pap smears, said Laurie Markowitz,
head of the HPV working group at the C.D.C. (Women with H.I.V. are
predisposed to the cancer.)

Pap smears work by detecting abnormal cells that 
are cancer precursors 
and
that can be destroyed using techniques like lasers and cryotherapy or,
rarely, surgery. As with any screening test, and most vaccines, the 
process
is not 100 percent effective, and a small number of women with 
precancerous
cells escape detection with false negative tests, for example. But 
because
the transformation from abnormal cell to cancer normally takes a 
decade, and
frequent Pap smears are recommended, it has been a successful strategy -
though the vaccine, used properly, might well prove a useful adjunct.

Indeed, cervical cancer does not even make the American Cancer Society's
list of 10 deadliest cancers. Among American women, it causes well 
under a
10th of the number of deaths caused by lung cancer or breast cancer.

Though classified as a sexually transmitted disease, HPV is nearly 
universal
and generally benign. Eighty percent of people will contract it in their
lifetime and most will clear it on their own.

Dr. Haupt of Merck said the vaccines' price was worth it for the deaths
prevented and the tests avoided. "Most of the old vaccines are 
undervalued,"
he said.

Dr. Abramson said he thought his C.D.C. advisory committee did the right
thing in recommending Gardasil. "Cervical cancer is a worthwhile 
disease to
prevent in a country that has the resources," he said. He believes it 
should
be available to those who want it.

Still, he said he was shocked to hear of propo
sals to mandate the 
vaccine
for students. "Are you really going to say a girl can't start school 
because
she hasn't had this vaccine?" he said.

Meanwhile, the vaccines' proponents are moving to the next frontier: 
older
women and boys. Merck recently applied for approval to market the 
vaccine to
women 26 to 45 and is conducting studies on vaccinating boys, who can 
get
genital warts from HPV.

One rationale for inoculating boys is that entire populations should be
vaccinated to achieve what is called herd immunity. But critics ask 
whether
it is worth conducting a campaign on the scale of the one used against 
polio
to eliminate a generally harmless virus.

Said Dr. Raffle, the British cervical cancer specialist: "Oh, dear. If 
we
give it to boys, then all pretense of scientific worth and cost analysis
goes out the window."

Andrew Lehren contributed reporting.
~~~~~~~~~~~



http://www.nytimes.com/2008/08/21/health/21vaccine.html
THE NEW YORK TIMES
August 21, 2008
Researchers Question Wide Use of HPV Vaccines
By ELISABETH ROSENTHAL

Two vaccines against cervical cancer are being widely used without
sufficient evidence about whether they are worth their high cost or even
whether they will effectively stop women from getting the disease, two
articles in this week's New England Journal of Medicine conclude.

Both vaccines target the human papillomavirus, a common sexually 
transmitted
virus that usually causes n
o symptoms and is cleared by the immune 
system,
but which can in very rare cases become chronic and cause cervical 
cancer.

The two vaccines, Gardasil by Merck Sharp & Dohme and Cervarix by
GlaxoSmithKline, target two strains of the virus that together cause an
estimated 70 percent of cervical cancers. Gardasil also prevents 
infection
with two other strains that cause some proportion of genital warts. Both
vaccines have become quick best sellers since they were licensed two 
years
ago in the United States and Europe, given to tens of millions of girls 
and
women.

"Despite great expectations and promising results of clinical trials, we
still lack sufficient evidence of an effective vaccine against cervical
cancer," Dr. Charlotte J. Haug, editor of The Journal of the Norwegian
Medical Association, wrote in an editorial in Thursday's issue of The 
New
England Journal. "With so many essential questions still unanswered, 
there
is good reason to be cautious."

In her article, Dr. Haug points out the vaccines have been studied for a
relatively short period - both were licensed in 2006 and have been 
studied
in clinical trails for at most six and a half years. Researchers have 
not
yet demonstrated how long the immunity will last, or whether eliminating
some strains of cancer-causing virus will decrease the body's natural
immunity to other strains.

More to the point, because cervical cancer develops only after years of
chronic=2
0infection with HPV, Dr. Haug said there was not yet absolute 
proof
that protection against these two strains of the virus would ultimately
reduce rates of cervical cancer - although in theory it should do so.

Dr. Richard Haupt, medical director of Merck, called these concerns 
"very
theoretical," noting that continuing research and monitoring suggested 
that
immunity would be longlasting and that the vaccine would not lead to
problems with other strains.

He added that cervical cancer was "just the tip of the iceberg" and 
that HPV
caused a huge amount of expensive and stressful testing in developed 
nations
that could be avoided with vaccination.

The vaccines, which require three shots for a complete series, cost 
about
$400 to about $1,000, depending on the country and the fees for doctors'
visits. Unlike older vaccines that save money by preventing costly 
disease,
these vaccines cost health systems money.

The second paper published this week, a study by Jane J. Kim and Dr. Sue
Goldie of Harvard, looks at the issue of costs and concludes that the
vaccines will be cost effective only if used in certain ways. In 
particular,
the researchers say the vaccines will be worth the cost only if they 
prove
to protect girls for a lifetime, and if current methods for screening 
for
cervical cancer using Pap smears can be safely adjusted to reduce costs
there. Further research is required in both areas.

"I believe 
the vaccine is a great advance, but we have to implement it
properly to get the benefits, and that hasn't happened," said Dr. Philip
Davies of the European Cervical Cancer Association.

In developed countries, Pap smear screening and treatment have 
effectively
reduced cervical cancer death rates to very low levels already. There 
are
3,600 deaths annually from cervical cancer in the United States, 1,000 
in
France and 400 in Britain.

Cervical cancer, like skin cancer, can generally be caught at 
precancerous
or non-invasive stages and treated. Because the vaccine prevents 
infection
with only some of the cancer-causing strains, Pap smear screening must
continue even in those who are vaccinated.

The Harvard study concluded that giving the vaccine to 12-year-olds 
would
cost $43,600 for every "quality adjusted year of life" it saved by
preventing a cancer death; that price would often be considered 
acceptable
by health officials in wealthy countries, experts say.

Dr. Haupt said the study proved that it was best to vaccinate early. "It
underscores the value of vaccinating pre-adolescent girls," since the
vaccine works fully only in girls who have not been exposed to HPV.

But if the vaccine were given to all girls and women up to age 21, the 
cost
per year of life saved would be far higher - $120,400, the Harvard study
concluded. And if the vaccines prove to require a booster shot, as many
critics believe, that cost rises=2
0to $140,000. In such cases it might 
make
more economic sense to rely on Pap smear screening alone, the 
researchers
said.


Copyright 2008 The New York Times Compan



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