Thursday, February 22, 2007

No Mandatory HPV Vaccines for Girls

By Andrea Lafferty, Executive Director
Traditional Values Coalition

Merck, the giant drug company, has come under fire in recent weeks over its lobbying efforts to have their drug, Gardasil, forced upon public school girls throughout the nation. Traditional Values Coalition is calling upon the Department of Justice to investigate the behind-the-scenes scheming that Merck has done to influence the votes of state legislators to push mandates of this drug on girls. If this isn’t the sort of activity which interstate commerce regulation and federal racketeering statutes were designed to prohibit -- what is?

The public outcry has gotten so loud that Merck announced on February 20 (2007) that it would stop its lobbying campaign to persuade state legislatures to mandate this HPV vaccine for all girls as young as nine years old. It was doing much of its lobbying through an organization called Women in Government.

This decision to stop lobbying for mandating this vaccine is clearly intended to put off any possible investigation of the company or the drug itself. TVC wants to know how many politicians were influenced by political contributions by Merck. How much money has Merck dropped into the political campaigns of politicians – both Republican and Democrat – in order to buy favor in state legislatures. Clearly, having a drug mandated for grade school girls is a gold mine for Merck, who will reap billions in profits each year.

Merck’s lobbying turnaround is suspect – and should not be considered a victory. Legislation on forced mandates are still being considered in at least 20 states where Merck has already gotten a foothold. The National Conference of State Legislatures has a detailed report on the progress of legislation in states to mandate the vaccine for grade school girls.

The fact is that the American public is poorly educated about HPV and its relationship to cervical cancer. According to the Henry J. Kaiser Foundation, Women’s Health Policy Facts, “In the U.S. cervical cancer is relatively rare, but there are nearly 10,000 cases and 3,700 deaths from cervical cancer annually.” Moreover, according to the CDC, HPV infects approximately 20 million people in the U.S. with 6.2 million new cases each year. (Source: National Conference of State Legislatures, HPV Vaccine report, February 20, 2007)

The Henry J. Kaiser Foundation is on target when it says that cervical cancer in the U.S. is relatively rare with only 10,000 cases annually out of a potential population of 20 million who are infected with HPV already.

U.S. Epidemic That Isn’t

According to the National Cervical Cancer Coalition, there are an average of 3,700 women in the U.S. each year who die from cervical cancer. Women in developing countries “account for about 85% of both the yearly cases of cervical cancer (estimated at 493,000 cases worldwide) and the yearly deaths from cervical cancer (estimated at 273,500 deaths worldwide).

While these 3,700 deaths are a tragedy, this is not a national health crisis nor does it require that states like Texas should rush to mandate an HPV vaccine upon girls. Mandatory vaccines should only be required when outbreaks of polio, tuberculosis or other easily transmitted diseases may threaten a school or community.

HPV is contracted through sexual contact and is not contagious. Therefore, almost all cases of HPV could be prevented through responsible sexual behavior, including fidelity in marriage and abstinence outside of marriage.

The mandating of a vaccine such as Gardasil sets a dangerous precedent. What other drugs will be mandated for our children in public schools? And, who must pay for them? Who will be criminally liable if a girl becomes disabled or dies from a mandated drug?

Expensive Drug – And Boosters Needed

Gardasil requires a series of three shots spaced out over several weeks. The cost is $360 for these shots and taxpayers will be forced to pay for them. This is the most expensive vaccine in history. It is nine times more expensive than a measles vaccine. Current evidence indicates that the shots only last 5 years, so booster shots will be required as well. Since Gardasil only protects against the strains of HPV accountable for 70% of cervical cancer cases, will governments then mandate a second drug to cover the other 30%? What other drugs will be mandated for our children under the guise of fighting “cancer”? Will there be mandates for birth control pills for girls?

Merck Wins Big In Texas

One of the most significant victories achieved by Merck was the announcement by Texas Governor Rick Perry that he was ordering the vaccination of all girls in public schools beginning with 6th graders!

This HPV vaccine is designed to provide protection against four of more than one hundred strains of a sexually-transmitted disease known as the human papillomavirus, which can cause cervical cancer. The four strains protected by Gardasil are found in 70% of the cases of cervical cancer.

Medical doctors are deeply concerned about the mandating of this new drug on pre-teen children.

The Association of American Physicians and Surgeons has issued a statement opposing the forced vaccinations of grade school girls. In a letter to Governor Rick Perry, the AAPS stated: “This vaccine mandate violates parental rights, informed consent and privacy; the efficacy and safety of this specific vaccine are unproven; it is an unjustified expansion of the taxpayer’s burden; it constitutes an unwarranted overreaching of executive power; and it violates sunshine-in-government.”

The AAPS notes that clinical trials were conducted on fewer than 2,000 of the target population of girls aged 9 to 15! “The studies were far too short to demonstrate that the vaccine prevents the HPV transforming into cancer. Further, since the duration of the protection is estimated at 5 to 7 years, it would wane about the time that some of these girls are becoming sexually active,” says the AAPS.

The Texas Medical Association (TMA) and the American Academy of Pediatrics (AAP) are both opposed to the forced vaccination of pre-teen girls.

The TMA says that Governor Perry’s mandate of HPV vaccines is premature and must be carefully investigated before moving ahead. “There are issues, such as liability and cost, that need to be vetted first,” said Dr. Bill Hinchley, a San Antonio pathologist and president-elect of the TMA. Hinchley also notes that there are unknown long-term or rare adverse side effects from the HPV vaccine.

The AAP detailed its opposition to mandating of the HPV virus in early February. Dr. Joseph Bocchini, AAP’s infectious-disease chairman notes: “Much of the public doesn’t know about HPV and its link to cervical cancer and other diseases. You can’t put a mandate ahead of that.”

The AAP notes that school vaccines evolved to protect pupils against outbreaks of contagious diseases, not to compel immunization. (Currently, 20 states are considering pushing for mandated HPV vaccines for children.)

Merck’s Political Strategy And Gov. Perry’s Merck Connection

If Merck can get every state to mandate its vaccine, it could make as much as $4 billion a year with more girls coming into the sixth grade each year. One wonders what influences were involved in Gov. Perry’s decision to mandate this drug for school girls. Merck hired Mike Toomey, Perry’s former chief of staff for $250,000 a year. In addition, Women in Government (WIG), which has received Merck funding, has hired Dianne White Delisi to run one its state chapters. Delisi is the mother-in-law of Gov. Perry’s current chief of staff Deirdre Delisi. (Associated Press story, 2/2/2007) Perry also received $6,000 from Merck during his re-election campaign in 2006.

Women in Government (WIG) lists its supporters on its web site. Of the 81 companies listed, more than half are pharmaceutical and health-related organizations. WIG is lobbying in numerous states for the mandating of Gardasil. Women in Government also receives support from GlaxoSmithKline, which is developing another HPV vaccine. The Glaxo vaccine should be on the market by spring or summer of this year.

It would appear that Merck is trying to get a monopoly hold on vaccine mandates for girls before Glaxo can get its drug on the market. Are preteen girls to be the sacrificial lambs in a war over two powerful drug companies who are fighting for a monopoly in the public schools? It seems likely.

Merck has also contributed to the political campaigns of pro-vaccine mandate legislators in Virginia. Delegate Phil Hamilton (R-Newport News), for example, received a $1,000 donation from Merck just weeks before he introduced a bill requiring mandated Gardasil vaccines for school children. Hamilton has received more than $10,000 from Merck in the past decade, according to a report in the Virginian-Pilot (2/15/2007).

Senator Janet Howell (D-Fairfax) offered a companion bill in the state Senate. She had received a $500 donation from Merck just 60 days before introducing her bill. Merck has given Howell $3,500 in the past decade.

According to the Virginian-Pilot, Merck has given more than a million dollars to politicians around the country in the past two election cycles. Virginia politicians received $13,000 last year.

Texas State Legislature To Block Perry’s Mandatory HPV Vaccine

As this report was being completed, it was learned that Texas state Representative Dennis Bonnen is offering H.R. 1098 to block Governor Perry from implementing his executive order on mandatory HPV vaccinations. ... H.R. 1098 will protect the rights of parents to be the sole decision-makers when it comes to Gardasil or any other similar vaccine!

Minority Children As Guinea Pigs

Star Parker is founder of the Coalition on Urban Renewal & Education (CURE), an organization founded to provide resources for African Americans on issues of race, poverty and social policy. In a recent column published by WorldNetDaily, Parker expressed outrage about Gardasil and its forced mandate upon girls. Her concern is that Merck is going to specifically target low-income minority girls for this drug by having state and local governments pay it through the welfare system.

As Parker notes: “The main risks that these girls from low-income families face stem from their promiscuity. Blacks account for 50% of new AIDS cases, and are 18 times more likely to contract a sexually transmitted disease than whites, and are regularly at risk of death through homicides, suicides and accidents that plague these communities. Blacks are twice as likely to die before the age of 20 as whites.

She continues: “It is the collapse of family and values and the attendant sexual promiscuity that drives the deadly poverty cycle in these communities. So mandating Gardasil vaccine for these girls is to validate a lifestyle that is already killing them in order to address a risk that is among the least of their problems.”

Georgia Congressman Proposes Federal Money Ban For Mandated Vaccines

U.S. Representative Phil Gingrey (R-GA) is a medical doctor who is proposing legislation to prohibit federal funding from being used to mandate the HPV vaccine for children. Gingrey’s “Parental Right To Decide Protection Act” “prohibits federal funds from being used to implement mandatory state human papillomarvirus (HPV) vaccination programs.”

According to Gingrey, “As an OB-GYN physician, I understand the importance of protecting Americans from sexually transmitted diseases, and I applaud the development of an HPV vaccine. But for states to mandate vaccination for young women is both unprecedented and unacceptable.”

Rep. Gingrey continues: “States should require vaccinations for communicable diseases, like measles and mumps. But you can’t catch HPV if an infected schoolmate coughs on you or shares your juice box at lunch. Whether or not girls get vaccinated against HPV is a decision for parents and physicians, not state governments.”

The American College of Pediatricians agrees with Dr. Gingrey’s assessment of Gardasil. In a letter sent to the California state legislature on January 25, 2007, this professional group stated that requiring a vaccination for a disease spread by sexual contact is a “serious, precedent-setting action that trespasses on the right of parents to make medical decisions for their children as well as on the rights of the children to attend school.”

Mandated Vaccines: A Bad Idea

In conclusion, it is clear from the lack of long-term research and dangerous side effects of Gardasil that this drug should not be mandated for school girls.

HPV is not a communicable disease; it is a disease resulting from intimate sexual contact. All vaccines should be voluntary unless there is a clear and present danger to the public health from a communicable disease such as Polio or Tuberculosis. Mandating a vaccine for a sexually-transmitted disease sets a bad precedent that could be used to mandate condoms for boys and girls and birth control pills for girls on school campuses. Such mandates would be a financial boon to the manufacturers of drugs and condoms for sex, but will undermine parental rights and encourage girls and boys to believe they are immune from the effects of premarital sexual activities.

Governor Perry’s mandate is wrong, immoral and bad medicine for Texas children. The effort of Merck to monopolize the vaccination of millions of girls in public schools is an example of the dangers of out-of-control greed in the marketplace.

Merck has backed off from its efforts to have this vaccine mandated – but the effort is already far down the road in many state legislatures. If only 20 states end up mandating this drug, Merck will still reap billions of dollars.

The U.S. Department of Justice should look at the behind-the-scenes scheming of Merck to influence politicians who will then push for vaccine mandates, putting billions into Merck’s pocket. In addition, the U.S. Attorney General and the Attorneys General of the 20 states where mandatory use of the HPV is being considered need to take a long hard look at Merck’s role and the role of Women in Government.

Dr. Clayton Young has written an important letter about Gardasil to the American College of Obstetricians and Gynecologists that deserves reprinting in full:

OBGYN Questions HPV Vaccine Gardasil

Editorial Office
Obstetrics and Gynecology
The American College of Obstetricians and Gynecologists
409 12th Street, SW
Washington, DC 20024-2188

I am writing in response to the recent Committee Opinion 344 Published in the September issue of Obstetrics and Gynecology. I have several concerns regarding Gardasil.

First, the Gardasil’s product insert states their endpoint is the prevention of "High Grade Disease", this encompasses CIN II-III and adenocarcinoma in situ (AIS) which are "immediate and necessary precursors" for squamous cell and adenocarcinoma of the cervix.1 The MAXIMUM median follow up in any of their studies is FOUR years.

However, the time course from CIN III to invasive cancer averages between 8.1 to 12.6 years.2 Claiming this vaccine prevents cervical cancer, with the longest median study subject being 4 years, is inappropriate.

The vaccine only "protects" against 4 high risk HPV subtypes. We are currently screening for 15 "high risk" HPV subtypes. This may lead to an increase in infection with other and possibly more aggressive subtypes.

According to ACOG, “The vast majority of women clear or suppress HPV to levels not associated with CIN II or III and for most women this occurs promptly. The duration of HPV positivity (which is directly related to the likelihood of developing a high grade lesion or cervical cancer) is shorter, and the likelihood of clearance is higher, in younger women.”3 Seventy percent of women clear the virus spontaneously after 18 months and 90 % clear the virus after 2 years.4 Vaccinating children against HPV with a vaccine that is of unknown duration of efficacy may only postpone their exposure to an age which they are less likely clear the infection on their own and be subject to more severe disease, including the cervical cancer which the vaccine is supposedly preventing. This would require an unknown number of boosters and is a setup for complacency in the older population that is a recipe for disaster.

The likelihood for regression to a normal pap from CIN II with expectant management is 40%.5 This beats Gardasil’s reduction of CIN II-III of only 39% in the “general population impact group” which is where most people would currently fall.6 This includes “all subjects who received at least one vaccination (regardless of baseline HPV status at Day 1.”7 Since ACOG does not currently recommend serologic testing for HPV before vaccination this will be the endpoint
from here out. In this case, "first do no harm” rules.

The study of the vaccine in children and adolescents is limited to only measuring the development of antibodies to the HPV subtypes in the vaccine. There is absolutely no evidence that the vaccine prevents anything when administered at this young age. Merck expects you to extrapolate their adult data to the immune response in children. If they were really interested in
vaccine efficacy in children, should it not be studied properly in children? Vaccinating children for this or any other sexually transmitted infection is not without risk. There are over 30,000 immunization reactions reported to the Vaccine Adverse Events Reporting System (VAERS) annually 8, and it has been estimated that only 10% or less of vaccine reactions are reported.9 In light of these facts the integrity of the post marketing surveillance of vaccines is questionable. Currently no vaccine has ever been examined for possible carcinogenic, mutagenic, or teratogenic effects, and yet the pharmaceutical industry stands ready to add Gardasil to the list of vaccines mandated for school admission.

Currently, precancerous lesions are readily identifiable and treatable in the developed world. Cervical cancer causes approximately one percent of all cancer deaths in America. The utility of this vaccine may be in third world countries in which regular screening is not available and cervical cancer is still a major cause of morbidity and mortality. The Committee Opinion states that there continues to be a significant population of women not receiving adequate screening. If you estimate the cost of the series at $360.00 (the most expensive vaccine on the market) administered to all adolescent girls and use that money to expand and enhance screening, I believe the results might be quite impressive. To invest that amount of healthcare dollars in an immunization with no long term efficacy or safety data is unwise.

I have personally witnessed the devastation caused by severe vaccine reaction, including patients, their children, nurses and my own family. To proceed with mass vaccination against this embellished "threat" is premature.

Clayton Young, M.D., F.A.C.O.G.

1. Prescribing information for GARDASIL. Whitehouse Station (NJ): Merck & Co., Inc.; 2006.
2. Management of abnormal cervical cytology and histology. ACOG Practice Bulletin No. 66. American College of Obstetricians and Gynecologist. Obstet Gynecol 2005; 106: 645-64.
3. Ibid.
4. Centers for Disease Control and Prevention. Genital HPV Infection Facts Sheet. Available at: Retrieved September 16, 2006.
5. Management of abnormal cervical cytology and histology. ACOG Practice Bulletin No. 66. American College of Obstetricians and Gynecologist. Obstet Gynecol 2005; 10
6: 645-64.6. Prescribing information for GARDASIL. Whitehouse Station (NJ): Merck & Co., Inc.; 2006.
7. Ibid.
8. Vaccine Adverse Event Reporting System, phone representative, interview with the author, September 13, 2006.
9. Cave, S. What Your Doctor May Not Tell You About Children’s Vaccinations. Warner Books, 2001. p.xviii.

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