February 8

More Re: Merck’s “Help Pay for Vioxx” Mandatory Vaccine Campaign

News reports about Merck's aggressive marketing campaign aimed at obtaining
state government mandates forcing 11 and 12 year old girls to be vaccinated
with its Human Pappilomavirus (HPV) vaccine, Gardasil, is the latest example
of irresponsible marekting targeting America's female population. 

Another is the recruitment of female students at university campuses who are asked
to enroll as human subjects in an experimental Herpes vaccine trial co-sponsored by GlaxoSmithKline and the National Institute of Allergy and Infectious Diseases. . Below is a form letter sent out to all female
students at the Unviersity of Maryland offering $358.

Since doctors agree that condoms are the safest and most effective
protection against sexually transmitted diseases– Why are only females
being sought for risky experimental vaccine trials?

Gardasil is touted as prevention for cervical cancer which Merck says is the
second-leading cancer among women around the world.
But as The Wall Street Journal reports (below) the prevalence of cervical
cancer is actually low in the U.S.
  The American Cancer Society estimates
that 11,150 women will be diagnosed with cervical cancer and 3,670 will die
from it in the U.S. this year. That's equivalent to 0.77% of cancers
diagnosed in the U.S. and 0.65% of U.S. cancer deaths each year. By
comparison, the society estimates that 178,480 American women will get
diagnosed with breast cancer in 2007 and 40,460 will die from it.

These numbers underscore Merck's strictly commercial motivaiton: Gardasil's
price tag is exorbitant-three shots at $360-is being forced on American
children-not because they are at particular risk-but rather to ensure that
the company profits hugely.
So what is the justification for even considering mandatory vaccination of children? 

Since 80% of cervical cancer occurs in underdeveloped countries, clearly,
those who might benefit the most are denied access because they can't afford
the vaccine.  The WSJ confirms that Merck is "desperate" for funding streams
and "vaccination across the U.S. would make Gardasil an automatic
blockbuster." The campaign has been dubbed: "Help pay for Vioxx" litigation.

Inexplicably, influential media sources have demonstrated a blind willingness to accept without evidence, unsubstantiated promises about a new vaccine from a company whose ignoble record of fraudulent claims and illegal marketing of a lethal drug caused thousands of preventable deaths.

An editorial in The New York Times rendered its position on the side of commerce reflecting a faith-based belief rather than a critical appraisal of evidence. Not only does the editorial endorse Merck's vaccine for all preteen girls, it offered "congratulations to Texas for becoming the firs state to REQUIRE vaccinating young schoolgirls-ages 11 and 12"-even as it acknowledges that "many parents are
appalled at the notion of vaccinating such young girls against a sexually transmitted disease."

"GARDASIL has not been shown to protect against disease due to non-vaccine HPV types.The health-care provider should inform the patient, parent, or guardian that vaccination does not substitute for routine cervical cancer screening.  Women who receive GARDASIL should continue to undergo cervical
cancer screening per standard of care."

Gardasil will not prevent cancer–it does not protect against ALL HPV types
[e.g., 31, 33, 35] . The vaccine will merely result in a change of prevalent serotypes.

"Tina Walker, the mother of an 11-year-old girl in Flower Mound, Texas, told The Wall Street Journal that she would prefer to wait until the vaccine has been on the market for several years before subjecting her child to it. "We are the guinea pigs here," she says.

Under what moral authority do the editors of New York Times decree that Tina Walker's rights as a responsible parent should be nullified-and her daughter exposed to potential harm by a company that has a proven record of concealing the lethal hazards of its products?

The Times editors would do well to examine how often the Times got it wrong when it endorsed  any number of medical treatments that proved harmful. For example, on  November 18, 1994, Times health columnist, Jane E. Brody, gave a ringing endorsement to hormone replacement therapy (New Therapy For Menopause Reduces Risks, http://tinyurl.com/ysoogb ), reporting that it protects women "not only against the risk of uterine cancer but heart attacks as well."  In time, these claims were overturned by science-but not before untold number of women died as a result of bad medical advice. 

Furthermore, Merck does not deserve our trust in disclosing all we need to know about its products. Merck marketed Vioxx as an effective, safer alternative to non-steroidal anti-inflammatory drugs for the treatment of pain associated with osteoarthritis, but-as its secret documents later uncovered during litigation revealed–Merck concealed the fact that Vioxx increased the risk of cardiovascular disease.
What guarantee do we have that Gardasil is not another Merck hoax?

Contact: Vera Hassner Sharav

Moves to Vaccinate Girls For Cervical Cancer Draw Fire
As Merck Lobbies States To Require Shots, Some Fret Over Side Effects, Morals
February 7, 2007; Page D1

Bills being drafted in some 20 U.S. states that would make a cervical-cancer<br />vaccine mandatory for preteen girls are sparking a backlash among parents<br />and consumer advocates.

The bills coincide with an aggressive lobbying campaign by Merck & Co., the<br />maker of the only such vaccine on the market. Called Gardasil, the<br />three-shot regimen provides protection against the human papillomavirus, a<br />sexually transmitted virus that is responsible for the majority of cases of<br />cervical cancer.<br />If the state bills become law, they would guarantee the Whitehouse Station,<br />N.J., drug maker billions of dollars in annual revenue from the vaccine.

POINTS OF CONTENTION<br />Concerns over mandating shots:<br />. Some parents say a vaccine for HPV, the sexually transmitted disease that<br />can cause cervical cancer, effectively condones premarital sex.<br /> <br />. Long-term efficacy and risk of side effects are unclear. There have been<br />82 reports of adverse events associated with the vaccine.<br /> <br />. Gardasil is typically covered by insurance, but is costlier than many<br />other common vaccines.<br /> <br />Proposed legislation varies from state to state, but the bills generally<br />would require girls to show proof that they have received the inoculation in<br />order to enter school. A number of immunizations — including those for<br />measles, chicken pox and polio — are mandatory for U.S. schoolchildren<br />because they block highly contagious diseases that can be spread easily in a<br />group setting. But HPV is different because it is transmitted sexually. At<br />$360 for the three shots, Gardasil is also costlier than many vaccines (a<br />measles-mumps-rubella shot costs about $42.85 per dose, for instance),<br />though it is generally covered by insurance.

Conservative Christian groups have long voiced opposition to the vaccine,<br />saying it would conflict with their message of abstinence because it would,<br />in effect, condone premarital sex. However, concern has spread beyond the<br />religious right as momentum has grown for making inoculation mandatory. A<br />growing number of parents are worried about exposing their children to the<br />unforeseen side effects of a new vaccine to protect them from a disease that<br />is no longer very common in the U.S. and often doesn't develop until much<br />later in life.

Tina Walker, the mother of an 11-year-old girl in Flower Mound, Texas, says<br />she would prefer to wait until the vaccine has been on the market for<br />several years before subjecting her child to it. "We are the guinea pigs<br />here," she says.

Last week, Texas Gov. Rick Perry issued an executive order mandating that<br />the vaccine be administered to all girls entering the 6th grade in the state<br />as of September 2008. The Texas executive order, which includes an opt-out<br />clause for religious or other "reasons of conscience," enabled the governor<br />to bypass what would have likely been a heated debate in the Texas<br />Legislature.

Many of the state bills contain opt-out clauses, but a few don't. The bill<br />pending in Florida would bar students ages 11 or 12 from being admitted to<br />public or private school in the state unless they can provide proof that<br />they have been vaccinated or that their parents opted them out after<br />receiving information about cervical cancer and the vaccine.

Merck says cervical cancer is the second-leading cancer among women around<br />the world, but the disease's prevalence is actually low in the U.S. The American Cancer Society estimates that 11,150 women will be diagnosed with cervical cancer and 3,670 will die from it in the U.S. this year. That's equivalent to 0.77% of cancers diagnosed in the U.S. and 0.65% of U.S.<br />cancer deaths each year. By comparison, the society estimates that 178,480<br />American women will get diagnosed with breast cancer in 2007 and 40,460 will die from it.

Adding to some parents' concern, 82 adverse events among both teens and<br />adult women have been reported since Gardasil became available last June.<br />Many involve common immune-system responses to vaccines, such as nausea,<br />fever or rashes. But a number of patients suffered syncopes, or fainting spells.

Richard Haupt, Merck's executive director of medical affairs, says the<br />syncopes are caused by patients' anxiety at having a needle stuck in their<br />arm and not due to any neuro-immune reaction to the vaccine. Mr. Haupt adds<br />that the number of adverse events is small compared with the hundreds of<br />thousands of doses of the vaccine administered so far in the U.S.

However, with any newly approved drug or vaccine, side effects often don't<br />become apparent until a regimen has been on the market for a while, leading<br />some patient and consumer advocates to urge states to hold off on requiring<br />vaccination until Gardasil's safety is more clearly established.<br />Of the more than 25,000 patients who participated in clinical trials of<br />Gardasil, only 1,184 were preteen girls. "That's a thin base of testing upon<br />which to make a vaccine mandatory," says Barbara Loe Fisher, co-founder of<br />the National Vaccine Information Center, an advocacy group that lobbies for<br />safer vaccines.

Gardasil is approved for females ages 9 to 26, and the three-dose regimen is<br />the same for all age groups. The vaccine protects against four strains of<br />HPV that cause 70% of cervical cancer cases. So it would not eliminate the<br />need for vaccinated women to have regular Pap smears to detect cancerous<br />cells caused by other HPV strains. HPV is also the virus that causes genital warts.

Merck acknowledges that it doesn't know yet whether an initial vaccination<br />will offer lifetime protection or whether patients will need booster shots.<br />So far, the company has shown only that the vaccine lasts five years.

Merck started lobbying state legislatures to pass laws requiring vaccination<br />last year after the Centers for Disease Control and Prevention's Committee<br />on Immunization Practices recommended that all girls get the vaccine when<br />they turn 11 or 12. Another HPV vaccine, called Cervarix, is in development<br />from GlaxoSmithKline PLC, but so far Gardasil is the only regimen on the market.

As part of its lobbying campaign, Merck has been funding Women in<br />Government, a Washington, D.C.-based advocacy group made up of female state<br />lawmakers. An executive from Merck's vaccine division, Deborah Alfano, sat<br />on Women in Government's business council last year, and many of the bills<br />across the country have been introduced by members of the group.

Merck declined to say how much money it has funneled into its lobbying campaign, or contributed to Women in Government. A spokeswoman for Women in Government, Tracy Morris, declined to say how much it had received from Merck. In Texas, one of Merck's lobbyists is Gov. Perry's former chief of<br />staff, and Merck's political action committee contributed $6,000 to the governor's re-election campaign.<br />"Parents should be concerned that the only company that makes this vaccine<br />is pushing behind the scenes for mandatory laws," says Maryann Napoli,<br />associate director for the Center for Medical Consumers, a consumer group<br />based in New York.

At a Merrill Lynch conference yesterday, Margaret McGlynn, the president of<br />Merck's vaccine division, acknowledged the company's aggressive lobbying<br />campaign but said, "States decide what works for them." She added that she<br />had her own daughter vaccinated with Gardasil and "immunizing females<br />against cervical cancer is absolutely the right thing to do."

Mandatory vaccination across the U.S. would make Gardasil an automatic<br />blockbuster for Merck at a time when the patents on some of its bestselling<br />drugs are expiring and it's desperate to replace their revenue streams.<br />Gardasil's sales in 2006 were $235 million.

Cervical cancer is a much bigger problem in the developing world, which<br />accounts for more than 80% of cases of the disease. Merck says it's<br />committed to bringing the vaccine to developing countries, but for now its<br />availability is limited there to a few studies and demonstration programs.

Write to John Carreyrou at <a href="mailto:john.carreyrou@wsj.com">john.carreyrou@wsj.com</a>   <br />~~~~~~~~~

Subject: Herpes Vaccine: Glaxo

Dear student, 

The National Institute of Allergy and Infectious Diseases (NIAID) of the
National Institutes of Health (NIH) has joined forces with GlaxoSmithKline
Biologicals to develop the Herpevac Trial for Women.  The Herpevac Trial for
Women is investigating a promising vaccine to protect women against genital
herpes, an infection that hundreds of thousands of women acquire each year.
With more than 20 trial sites across the country, the Herpevac Trial for
Women is testing the vaccine in women between the ages of 18 and 30 who have
not been infected with herpes simplex virus (HSV), which causes cold sores
and genital herpes.

The University of Maryland College Park is one of these centers and we are
aiming to recruit 500 eligible women into the study.  Participants will be
given an investigational vaccine.  There is a $380 compensation for
successful completion of the study. 
We would like to use this medium to reach you and other young ladies.  We
have been having health talks and information sessions in classes and would
love to speak with you and answer your questions. 

Please check out our website <http://www.herpesvaccine.nih.gov>

Or Contact us at:

University of Maryland Center for Vaccine Development/ Maryland Cares
Room 2165 University Health Center
College Park, MD 20742

Phone (301) 314-7575

Jane Cowan RN, BSN
Research Coordinator
(301) 314-4747 (fax)
mdcares@health.umd.edu <mailto:mdcaers@health.umd.edu>

Thank you for your interest

February 6, 2007
A Vaccine to Save Women's Lives

Congratulations to Texas for becoming the first state to require vaccinating
young schoolgirls – ages 11 and 12 – against a sexually transmitted virus
that causes cervical cancer and genital warts. Other states would be wise to
follow the same path.

There is no doubt that Merck's vaccine against the human papillomavirus,
given in three shots over eight months, is highly effective. It provides
nearly perfect protection against two strains that cause 70 percent of all
cases of cervical cancer, and against two other strains that cause 90
percent of genital warts cases. (That still leaves 30 percent of the
cervical cancer cases to worry about, so women are urged to keep getting
regular Pap tests to screen for signs of the cancer.) The side effects are
generally mild: pain or tenderness at the site of the injection.

Many parents are appalled at the notion of vaccinating such young girls
against a sexually transmitted disease. But the medical reality is that the
vaccine will generally not work after a woman has been infected, so it is
best for girls to be vaccinated well before they become sexually active. The
nation's top advisory committee of immunization experts has recommended that
the vaccine be routinely given to girls 11 and 12 years old.
The most contentious issue is whether the shots should be required or simply
recommended to parents through a strong educational campaign. Those opposed
to compulsory vaccination complain that there are already a slew of required
vaccinations, so why heap on another, especially for a disease that is
spread only through sexual contact? Critics also fear that HPV vaccination
may lead some students to wrongly assume that they are protected against all
sexually transmitted diseases, perhaps encouraging them to engage in risky

None of these objections seem strong enough to forgo the protection against
a devastating disease. The United States records some 10,000 new cases of
cervical cancer each year, and 3,700 cervical cancer deaths. Gov. Rick Perry
of Texas, a conservative Republican, has taken an "opt out" approach, in
which vaccination is required but parents can seek an exemption for reasons
of conscience or religious beliefs.
That makes sense to us. All students deserve protection against HPV
infection, and the presumption should be that they will get it.

Copyright 2007 The New York Times Company

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