The National Vaccine Information Center warned state officials to investigate the safety of a cancer vaccine as Texas became the first state to make the HPV vaccine mandatory for school-age girls (this webpage was updated with articles through 2007)...

http://www.medinstitute.org/content.php?name=HPVVaccineStatement 

[The articles found here have been rearranged in approximate chronological order for a better flow of information. Scroll to end for latest items.] 

The info below was forwarded by a Texas legislator who is a survivor of cervical cancer and who opposes Gov. Perry’s mandate for her 15 year old daughter as well as for her state.  This is "another misguided move promoted by pharmaceutical companies, who will profit enormously".

HPV Vaccine Mandate for 6th Grade Girls

What Do We Really Know About the HPV Vaccine?

QUESTIONABLE NECESSITY AND EFFECTIVENESS

The American Cancer Society says that even though infection with the sexually transmitted virus HPV is an important risk factor for cervical cancer, most women with HPV infection do not get cervical cancer.

Doctors believe other factors must come into play for this cancer to develop. Some of these factors are smoking, HIV infection, Chlamydia infection, diet, long-term use of birth control pills, multiple pregnancies, low income, mothers who took hormonal drug DES, and family history. [1]   These are not typical risk factors affecting junior high girls.

According to the National Institutes of Health National Cancer institute, in more than 90% of the cases, HPV infections are harmless and go away without treatment. [2]

Also, according to the CDC, most cervical cancer can be prevented and cervical cancer is very rare in women who get regular PAP tests.[3]  

Cervical Cancer is not a major killer in the state of Texas thanks to PAP screenings: in 2000, there were 371 deaths from cervical cancer, in 2001 there were 352 and in 2002 there were 329. [4] 

The CDC says there are more than 100 strains or types of HPV and over 30 strains are sexually transmitted. [5] Yet the vaccine under consideration for mandate covers only 4 strains. [6]   Merck says that about 30% of cervical cancers can’t be prevented by the vaccine, so women will still need regular cervical cancer screenings. [7].

The only current vaccine manufacturer for the HPV vaccine, Merck, admits on their package insert that the duration of immunity from the vaccine is unknown. [8]  In clinical trials, the vaccine’s effectiveness was followed for 4 years.[9]  Yet we do know from the CDC that the incubation period for the HPV virus is about 20 years [10] and the median age of women diagnosed with cervical cancer is 48 [11]. 

Therefore, no claims to proof of cervical cancer prevention by vaccinating preteen girls should be made. 

QUESTIONABLE SAFETY

The HPV vaccine Gardasil was approved by the FDA on June 8, 2006 after 6 months of review.[12]  It has been on the market for less than 1 year. 

The chairman of the American Academy of Pediatrics committee on infectious diseases was quoted in the Washington Post in response to a proposed mandate in Washington D.C. saying that he thought it was premature to recommend making the vaccine mandatory. "I think it's too early," said Joseph A. Bocchini,…"This is a new vaccine. It would be wise to wait until we have additional information about the safety of the vaccine." [13]

Dr. Martin Meyers, director of the National Network for Immunization Information, was quoted in the Baltimore Sun in response to a proposed bill in Maryland to mandate HPV vaccines for 6th grade girls, “A lot of us are worried it's a little early to be pushing a mandated HPV vaccine."  He also said "It's not the vaccine community pushing for this."

The article spotlighted HPV vaccine manufacturer Merck’s aggressive role in pushing for a mandate where across the U..S., HPV vaccine mandates could mean $4 billion dollars in sales for Merck [14] who is currently plagued by lawsuits for withholding critical safety information to doctors and patients about their popular painkiller drug Vioxx.[15] 

The FDA’s Vaccine Adverse Events Reporting System has already received 82 reports of serious adverse events following HPV vaccination with Gardasil since its approval last June. [16]

More questions remain.  Disclaimers printed on the manufacturer’s package insert state that the vaccine has not been tested for it’s own ability to cause cancer [17] and the effect on a woman’s reproductive capacity is unknown. [18]

Additionally, the vaccine is genetically engineered yet the manufacturer admits it has not tested the vaccine for genotoxicity[17] (testing to see if the vaccine is toxic to our own human DNA). 

Each dose of the vaccine contains 225 mcg of aluminum [6] which means girls receiving all 3 HPV doses will be directly injected with 675 mcg of aluminum. 

QUESTIONABLE COST

The retail cost of the vaccine is $120 per dose, or $360 for the full series of 3 shots. [7]  According to the bill’s author Sen. Leticia Van de Putte, there are 162,000 6th grade girls[19] which translates to forcing Texas families paying over $58 million dollars not including the doctor visits for a vaccine not proven to prevent cervical cancer.  This is a high price to force families to pay especially for families skeptical of the necessity, efficacy, or safety of the vaccine.  Merck is absolved from liability for the injuries and deaths caused by the HPV vaccine through the National Childhood Vaccine Injury Act of 1986 [20] leaving families to deal with the emotional and monetary costs of the harm caused by the vaccine to their daughters on their own.

The vaccine is available to anyone who wants it, so it does not need to be mandated. 

Federal health programs such as Vaccines for Children cover the HPV vaccine to children and teens under 19 years of age, who are either uninsured, Medicaid-eligible, American Indian, or Alaska Native. The VFC Program also allows children and teens to get VFC vaccines through Federally Qualified Health Centers or Rural Health Centers, if their private health insurance does not cover the vaccine [7], so insurance mandates which raise the cost of insurance for everyone who does not want or need the vaccine are not necessary.

[1] The American Cancer Society, What Causes Cancer of the Cervix.

Link: What Causes Cancer of the Cervix

[2] The National Institutes for Health, National Cancer Institute . 

[3] The Centers for Disease Control and Prevention, Cervical Cancer Screening and Prevention. 

Most cervical cancer can be prevented

[4] The Centers for Disease Control and Prevention United States Cancer Statistics.  http://apps.nccd.cdc.gov/uscs/

[5] Centers for Disease Control and Prevention, Sexually Transmitted Diseases, Genital HPV Infection – CDC Fact Sheet.  http://www.cdc.gov/STD/HPV/STDFact-HPV.htm

[6]  Gardasil package Insert. 2006. Page 1.  http://www.fda.gov/cber/label/hpvmer060806LB.pdf

[7] Centers for Disease Control and Prevention, HPV Vaccine Questions and Answers.

http://www.cdc.gov/STD/HPV/STDFact-HPV-vaccine.htm

[8] Gardasil package Insert. 2006. Page 5, paragraph 6.  http://www.fda.gov/cber/label/hpvmer060806LB.pdf

[9] Gardasil package Insert.  2006. Page 2, paragraph 2.  http://www.fda.gov/cber/label/hpvmer060806LB.pdf

[10] Centers for Disease Control and Prevention, National Immunization Program, Advisory Committee on Immunization Practices, Minutes of the October 26-27, 2005 ACIP meeting, p. 57.

http://www.cdc.gov/nip/acip/minutes/acip-min-oct05.pdf

[11] National Institutes of Health, National Cancer Institute, Cancer Stat Fact Sheets

http://seer.cancer.gov/statfacts/html/cervix.html

[12] FDA News, Press Release. http://www.fda.gov/bbs/topics/NEWS/2006/NEW01385.html

[13] The Washington Post, “D.C. Bill Would Mandate Vaccine” by Nikita Stewart and Rob Stein.  January 10, 2007, p. A01.  Link: Washington Post article - D.C. Bill Would Mandate Vaccine

[14] The Baltimore Sun, “Drug Firm Pushes Vaccine Mandate, Merck Lobbies Md. On HPV Preventive. by Laura Smitherman, January 29, 2007 .  

[15] The Star-Ledger, “Attorneys Lay Out Cases to Open Double Vioxx Trial”, by Susan Todd, January 23, 2007 .

[16] www.medalerts.org

[17] Gardasil package Insert. 2006, Page 8, paragraph 17.  http://www.fda.gov/cber/label/hpvmer060806LB.pdf

[18] Gardasil package Insert. 2006, Page 9, paragraph 1.  http://www.fda.gov/cber/label/hpvmer060806LB.pdf

[19] Houston Chronicle, Vaccine Proposal Likely to Stir Debate,  by Todd Ackerman.  Jan. 10, 2007.  http://www.chron.com/disp/story.mpl/front/4459579.html.

[20] U.S. Department of Health and Human Services Health Resources and Services Administration National Vaccine Injury Compensation Program.  http://www.hrsa.gov/vaccinecompensation/

[prepared by Dawn Richardson,  http://www.vaccineinfo.net/]

~October 2006
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

http://www.vaccineinfo.net/immunization/vaccine/hpv/doc_against_HPV.shtml

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.
Cc: NVIC, AAPS, PROVE
References
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:
http://www.cdc.gov/std/HPV/STDFact-HPV.htm. 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; 106: 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.
 

5 February 2007 

Negative side effects of Gardasil, a new Merck vaccine to prevent the sexually transmitted virus that causes cervical cancer, are being reported in the District of Columbia and 20 states, including Virginia. The reactions range from loss of consciousness to seizures.

"Young girls are experiencing severe headaches, dizziness, temporary loss of vision and some girls have lost consciousness during what appear to be seizures," said Vicky Debold, health policy analyst for the National Vaccine Information Center, a nonprofit watchdog organization that was created in the early 1980s to prevent vaccine injuries.

Following federal approval of the vaccine in July 2006, a storm of legislation was introduced across the nation that would make the vaccine mandatory in schools. The District and Virginia are part of a group of at least 17 states considering such legislation. A measure had been introduced in Maryland, but it was shelved last week over concerns about the mandatory language in the bill.

Yesterday, Texas Gov. Rick Perry signed an order making Texas the first state to require the vaccine. Girls ages 11 and 12 would receive the human papillomavirus (HPV) vaccine before entering the sixth grade starting in September 2008.

The American Cancer Society estimates there were 9,710 new cases of cervical cancer in the United States in 2006. The District's cancer control center estimates a total of cervical cancer cases in the city last year,  and the American Cancer Society estimates that last year Maryland and Virginia each had 210 cases of cervical center.

Merck began marketing Gardasil last year after the Food and Drug Administration (FDA) approved it for females ages 9 to 26.

The vaccine is the first of its kind to build immunity against four strains of HPV: HPV types 16 and 18 lead to 70 percent of cervical cancer cases in the United States, and 6 and 11 which cause 90% of genital warts.

According to an independent physician, this vaccine has been studied in detail on over 24,000 women and serious side effects were no different from the placebo in essentially all categories, including mortality. 

Since moderate to severe dysplasia is known to precede cervical cancer if untreated, it should dramatically reduce the rates of cervical cancer RELATED TO HPV 16 and 18.
 
The vaccine is not yet known to be effective for men, who can get cancer from other strains of HPV. Evaluating HPV and penile cancer in men appears to be a different and more difficult issue, too early to be determined.

Merck studied a group of women for 4 1/2 years and the antibody levels are stable. Merck plans to continue to study these groups to see any signs which would indicated the need for a booster and let us know.  This protocol is just like with any other vaccine.  If you have an efficacious vaccine, there is no need to wait 10 or 20 years to learn of the need for a booster.  We have and continue to challenge Merck on these issues so we do not just take their word for it.

Its side effects were reported to the Vaccine Adverse Event Reporting System, a federal reporting system for consumers to notify federal regulators of bad reactions to medications. The adverse events began being reported in July 2006, when an advisory panel to the Centers for Disease Control and Prevention recommended girls ages 11 and 12 receive the series of shots.

The types of side effects reported are not cause for alarm, according to the American Cancer Society.

"We have not been informed of an instance that would call into question the overall safety of the vaccine," said Debbie Saslow, director of breast and cervical cancer control at the American Cancer Society, adding that about 70 similar events had been known in October 2006.

Likewise, the CDC will not alter its approval of the vaccine despite the number of adverse events revealed through the reporting system.

"A report to the Vaccine Adverse Event Reporting System does not necessarily mean the adverse event was serious or that it was caused by the vaccine," said CDC spokesman Curtis Allen. "This vaccine has been tested around the world and has been found to be safe and effective."

Merck is heavily promoting the vaccine through its salespeople imploring doctors to provide it and running TV ads urging young women to get vaccinated so there will be "One Less" cancer patient.

But physicians disagree with public health officials over whether Gardasil is the panacea for cancer. Clayton Young, an obstetrician/gynecologist in Texas, objects to Merck's claim that Gardasil will prevent cervical cancer.

"There is no proof Gardasil will stop cervical cancer," he said. "They haven't been studying it long enough to make that claim."

Merck spokesman Chris Loder said the vaccine is effective for five years and the Whitehouse Station, N.J., drug maker is not sure how long afterward the vaccine will work. Critics point out that an additional booster shot may be necessary.

Advocates for a mandatory vaccine say that although the vaccine does not prevent all causes of cervical cancer, Gardasil is an effective vaccine against the most prevalent cause and therefore is a correct public health measure.

Gardasil is delivered in three separate injections that cost $120 to $150 per injection. Blue Cross Blue Shield, an omnipresent health insurer in the Mid-Atlantic region, covers the vaccine for girls in the federally recommended age groups.

Merck revenue from Gardasil reached $155 million for the fourth quarter of 2006 and $255 million for the entire year. [3Feb07, The Washington Times, G. Lopes,
http://www.washingtontimes.com/business/20070202-100152-9747r.htm, News World Communications, Inc.; independent physician's comments, 5Feb07]

5 February 2007 

The Medical Institute's Statement on HPV Vaccine

An HPV (human papillomavirus) vaccine[1] received FDA approval in June 2006. This vaccine is intended to provide immunity against four common HPV types – 16, 18, 6, & 11.

Scientific evidence on immunization with the quadrivalent vaccine suggests that it substantially reduces the risk of pre-cancer and cancer of the cervix caused by HPV types 16 & 18[2,3,4] (responsible for ~70% of all cervical cancers in the US)[5], substantially reduces the risk of genital warts caused by HPV types 6 & 11[6] (responsible for ~90% of all genital warts in the US)[7], and is cost effective when administered to adolescent females[8].

However, there is no evidence to suggest that the vaccine...

--reduces the risk for cervical cancers caused by other HPV types (responsible for ~30% of all cervical cancers in the US)

--reduces the risk of other sexually transmitted infections (STIs)

--offers any protection against the other consequences of nonmarital sexual activity such as pregnancy and emotional damage.

Furthermore,
--currently the duration of immunity following immunization is unknown
--the role of the vaccine for males is uncertain

Therefore, we promote abstinence for unmarried persons as a primary method to prevent pregnancy,[9,10] STIs including HIV,[11] and the emotional consequences of sexual activity[12];

we promote monogamy as a primary method to prevent STIs including HIV[13]

--encourage further research into the duration of immunity and the optimal timing of immunization
--recommend continued regular health screening and counseling including pelvic examinations, Pap tests, and appropriate STI screening

Finally, we encourage physicians to counsel all their patients regarding sexual health.

References:
1. FDA. FDA licenses new vaccine for prevention of cervical cancer and other diseases in females caused by human papillomavirus. Available at http://www.fda.gov/bbs/topics/NEWS/2006/NEW01385.html. Accessed July 17, 2006.
2.Koutsky LA, et al. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med.
3.Villa LL, et al. Lancet Oncol 2005;6(5):256-7.
4. Skjeldestad FE, Koutsky LA. Phase III trial of prophylactic quadrivalent HPV 6, 11, 16, 18 L1 virus-like particle (VLP) vaccine. Presented at Merck Phase III HPV Vaccine Steering Committee
5. Munoz N,et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003;348 (6):518-27.
6. Skjeldestad & Koutsky.
7. Villa LL, et al. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18)L1 virus-like vaccine in young women: a randomized double-blind placebo-controlled mutlicentre phase II efficacy trial. Lancet Oncol. 2005;6(5):271-8.
8. Goldie SJ, et al. Projected clinical benefits and cost-effectiveness of a human papillomavirus 16.18 vaccine. J Nat Cancer Inst. 2004;96(8):604-614.
9.Vincent ML, et al. Reducing adolescent pregnancy through school and community–based education. JAMA 1987;257:3382-86.
10. Doniger AS, et al. Impact evaluation of the "Not Me, Not Now" abstinence-oriented, adolescent pregnancy prevention communications program, Monroe County, New York J Health Communications 2001.
11.Green EG. Rethinking AIDS Prevention: Learning from success in developing countries. Westport,CT: Praeger, 2003.
12. Hallfors DD, Waller MW, Bauer D, et al. Which comes first in adolescence--sex and drugs or depression? Am J Prev Med. 2005;29(3):163-70.
13. Michael, RT, et al. Sex in America: A Definitive Survey. 1st ed. viii, 300 p vols. Boston: Little, Brown, 1994, 1-300. 2002;347(21):1645-51.
[February 05, 2007,  http://www.medinstitute.org/content.php?name=hpvVaccine_09082006; COMMENT:  This article doesn't address the cost, which for the three injections, is over $300.]  

February 5, 2007
 
Governor Perry... sign[ed] an executive order which mandates that all sixth-grade girls entering public schools by the fall of 2008 must be vaccinated for HPV. (Gardasil is produced by Merck Pharmaceuticals.) 
 
A public debate in the Legislature should have preceded such a drastic move, and all the medical data and parents' rights issues should have been brought forward for careful consideration. 
 
To justify his executive order, Gov. Perry said that receiving an HPV vaccination is no different than receiving a polio vaccination; but obviously polio does not involve sexual behaviors. Certainly a girl's parents should be the sole decision makers in making the choice for such a vaccination.  

Now parents are being told they must get their young daughters vaccinated against HPV as if to say to the child, "We do not expect nor believe that you will stay abstinent until marriage." 

The decision to get young girls vaccinated for HPV is not an easy decision to make. In less than a year since approval, 82 cases of serious adverse events following HPV vaccinations of Gardasil have been reported (http://www.medalerts.org/vaersdb/findfield.php?PAGENO=1&PERPAGE=10&VAX=HPV4).  These incidents should have been discussed thoroughly in open forum in the Legislature before any mandate was even considered.
 
Texas parents can opt their children out of the HPV vaccinations by going to www.vaclib.org/exempt/texas.htm and following the instructions which state, "An affidavit signed by the applicant or, if a minor, by the applicant's parent or guardian stating that the applicant declines immunization for reasons of conscience, including a religious belief. A form must be obtained at the Health Department."
 
Parents need to evaluate all aspects of the HPV vaccine since there are no long-term studies yet on the way these sixth graders might be affected in future years when it comes time for them to have their own babies. Also, since the vaccine has only followed girls for five years, nobody knows for sure how long the vaccination may last without having a booster.

The HPV vaccine covers 4 out of types of HPV (Types 6, 11,16,18) which account for 70% of cervical cancers and 90% of genital warts. That still leaves 30% of cervical cancers and 10% of genital warts which are not covered by the HPV vaccine.

Also, it will be important for the public to be continually reminded that there are many more sexually transmitted diseases than just HPV (e.g., chlamydia, herpes, hepatitis, trichomoniasis, gonorrhea, syphilis, HIV/AIDS, etc.)

A definite drawback to Gardasil is that girls must get three full doses of the vaccine for it to be effective. How many families are going to understand the urgency of making sure their girls get three full doses over a six months' period of time?  

The seriousness of HPV has been one of the driving forces behind the plea for teens to remain abstinent until marriage.  Condoms do not offer adequate protection against HPV since the virus is often carried on the parts of the body which are not covered by the condom.

It is important NOT to downplay the seriousness of HPV. Close to 90% of women who are infected with HPV will clear it; but according to the American Cancer Society webpage (Link: Cancer.org - How many women get cancer of the cervix=), "The American Cancer Society predicts that there will be about 11,150 new cases of invasive cervical cancer in the United States in 2007. About 3,670 women will die from this disease that same year." 

In other words, only a small percentage of 80% of women will develop cervical cancer; but because 80% represents a huge number of women, the small percentage of 80% adds up to a very sizeable population -- 11,150 new cases with 3,670 yearly who will die of HPV.

Women in Government [is] a powerful group which is pushing Merck's agenda  http://www.womeningovernment.org/prevention/documents/LargeCampaignActivityMap2-1-2007.pdf).  Gov. Perry's executive order gives the public another reason to doubt politicians...

Gov. Perry and his wife may have been very well meaning in trying to protect girls from this dangerous disease; but an executive order was the wrong way to gain public acceptance of the HPV vaccination.

Middle-income taxpayers will be hit twice: once to pay higher private insurance premiums and second, to pay for higher taxes to cover the cost of free immunizations for girls on Medicaid and other state/federal programs.

A better solution would have been for the Governor to have thrown the power and influence of his office behind abstinence-until-marriage programs and to have enlisted all state agencies, public schools, the film industry, and the media to surround our teens with the unequivocal abstinence message. 

If after studying all the medical information about the HPV vaccination, the parents want their daughters to have the vaccination, then that should be the parents' decision and not one made by a politician.
Donna Garner

7 February 2007

Andy Schlafly, General Counsel for the Association of American Physicians & Surgeons, successfully debated against the proposed mandate for the HPV vaccine.  View MSNBC's live coverage of the debate.
 
Attorney Schlafly adds that groups providing abortion and/or abortion referral services would receive billions in new revenue from HPV vaccine mandates.  A tip from a legislative staffer in Wisconsin alerted us to the following press release (Feb. 2, 2007) from an abortifacient provider:
 
"Family Planning Health Services (FPHS) has taken a leadership role in protecting Wisconsin women from cervical cancer by working to improve access to the vaccine. Over the course of 2007, FPHS will be working to educate women throughout central Wisconsin about the vaccine, cervical cancer and HPV. The agency expects to launch a major public awareness campaign including educational workshops, advertising and collaboration with other professionals to provide the vaccine to as many girls and women as possible. FPHS has been providing the vaccine at all seven of its reproductive health clinics since 10-2-2006." www.thewheelreport.com (PDF)

For every dollar spent on the vaccine itself, there will be another $1-2 spent by taxpayers and insurance companies administering the vaccine.  That's billions of dollars, and much of it could go to abortion providers and referral services as they administer this vaccine under the proposed mandates.
[A. Schlafly, 7Feb07]

20 February 2007 

Merck gives up push for girls to get shots: The Opposition to STD vaccine called 'distracting'       
Drug-making giant Merck & Co. has announced that it will halt its efforts to pressure states into making the vaccination of all young girls against a sexually transmitted disease mandatory.
 
According to a report in the Wall Street Journal, the drug manufacturer said the lobbying had become a distraction because of the backlash among physicians, consumer advocates, parents and even legislators.
 
The report said the "aggressive lobbying campaign" was designed to boost the sales of Merck's Gardasil, the only vaccine approved by the Food and Drug Administration for the few strains of the human papillomavirus that it affects.
 
Its costs are estimated to be in the $360-$400 per person range, which could have meant billions in revenue for the company, depending on the number of state legislatures convinced that requiring the vaccine is appropriate.
 
Strains of HPV have been connected to cervical cancer cases. However, HPV cannot be transmitted easily; it is gotten only through sexual contact.
 
The lobbying was distracting from the company's goal of immunizing women, Richard Haupt, Merck's executive director of medical affairs, told the WSJ. Instead the company has "decided at this point not to lobby for school laws any further."
 
Only days earlier, U.S. Rep. Phil Gingrey, R-Ga., launched a proposal in Congress that would have discouraged states from requiring parents to have their underage daughters – those heading into sixth grade – vaccinated for the STD.
 
The campaign was sweeping across the nation to implement state requirements that young girls be vaccinated with Gardasil.
 
An updated report from the National Conference of State Legislatures said the requirements have been implemented in Texas by executive order of Gov. Rick Perry, but the District of Columbia and more than 30 other states are considering plans.
 
There has been so much activity that the NCSL has set up a special website just to track and update the various campaigns.
 
The mandates appear to be a coordinated effort because a number of the sponsors of the plans are members of Women in Government, an organization set up for female state lawmakers that runs an attached website promoting the vaccine and mandates that would require its use.
 
Merck & Co. is a financial contributor to Women in Government, although both Merck and Women in Government, a 501(c)(3) non-profit organization, have declined to release how much that support is.
 
But Gingrey, a medical doctor, announced he has introduced the Parental Right to Decide Protection Act, a plan that "prohibits federal funds from being used to implement mandatory state human-papillomavirus (HPV) vaccination programs."
 
"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," Gingrey said. "But for states to mandate vaccination for young women is both unprecedented and unacceptable."
 
When Perry mandated the vaccinations by executive order, David Welch, of the U.S. Pastor Council, said 7,000 Christian churches were warned of the threat to parental influence on their daughters. Lawmakers also immediately introduced a plan to overturn Perry's decision.
 
Welch told WND he wondered why by executive order schoolgirls were being ordered to be treated with "a broad and possibly risky vaccination … when this is a behavior-based problem?"
 
Merck had been asked several times for a comment on the connections, but did not return a call to WND... 
 
[http://www.worldnetdaily.com:80/news/article.asp?ARTICLE_ID=54360
20February07, WorldNetDaily.com]
 
 

February 20, 2007
Merck Suspends Campaign to Make Gardasil Vaccination Mandatory
Merck & Co. said it would stop lobbying states to pass laws requiring that preteen girls be vaccinated against cervical cancer in the face of a growing backlash among parents, physicians and consumer advocates.
 
Merck's aggressive lobbying campaign was intended to boost sales of its Gardasil vaccine, which received Food and Drug Administration approval last year. Gardasil provides protection against two strains of the human papillomavirus that are thought to cause the majority of cervical-cancer cases.
 
But unlike a number of other diseases that U.S. schoolchildren are required to be vaccinated against, HPV isn't an airborne virus that can spread easily in a group setting. Rather, it is sexually transmitted. Gardasil also stands apart from other vaccines that are compulsory because of its high cost: $360 for a three-dose regimen.
 
In recent weeks, opposition to state mandates has grown among parents who want the freedom to make such a medical decision on their own and are worried about exposing their children to the unforeseen side effects of a new vaccine. Physicians and consumer advocates have also questioned the need to immunize young girls against a disease that is no longer very prevalent in the U.S. and doesn't develop until much later in life.
 
Merck's lobbying efforts have become a distraction from the company's goal of immunizing as many women as possible against cervical cancer, said Richard Haupt, Merck's executive director of medical affairs. Merck has "decided at this point not to lobby for school laws any further."
[John Carreyrou at and Sarah Rubenstein at February 20, 2007]

This is very good news but the problem is not over. And don't forget to watch out for "Women in Government" who have been lobbying your state for Merck.  If you look on the group's website, you'll see the director for your state.  Keep an eye on these women (Laura Hall in AL) and the campaign donations they receive. [B.P., 21Feb07]

VACCINE SAFETY GROUP RELEASES GARDASIL REACTION REPORT
Calls on FDA and CDC to Warn Doctors and Parents to Report to VAERS

Washington, D.C. - The National Vaccine Information Center (NVIC) today released a new analysis of the federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck's GARDASIL) during the last six months of 2006. Out of the 385 individual GARDASIL adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with GARDASIL. NVIC is calling on the FDA and CDC to warn parents and doctors that GARDASIL should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal (collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of tingling, numbness and loss of sensation in the fingers and limbs, all of which should be reported to VAERS immediately.

"Because Merck only studied GARDASIL in fewer than 1200 girls under age 16 in pre-licensure trials, it is critical that doctors and parents be made aware of the nature of the initial adverse event reports coming into VAERS and that they report serious health problems after vaccination when they occur," said NVIC President Barbara Loe Fisher. "There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a GARDASIL vaccination compared to those getting a Tdap (tetanus-diphtheria-acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome. And doctors who give GARDASIL in combination with other vaccines are basically conducting an experiment on their young patients because Merck has not published any safety data for simultaneous vaccination with any vaccine except hepatitis B vaccine."

According to NVIC's report, a majority of GARDASIL adverse event reports to VAERS involved those who suffered fever, nausea, headache or pain; 14 percent were for syncopal episodes with or without neurological signs; and 8 percent experienced tingling, numbness and loss of sensation, facial paralysis or Guillain-Barre Syndrome.
Although adverse event reports to VAERS do not prove causation, they can provide an early warning sign that a new vaccine may be causing health problems that could be important. For example, reports to VAERS of bowel blockage (intussusception) in babies following receipt of Merck's Rota Teq (rotavirus) vaccine prompted the FDA to issue a public warning to doctors and consumers on Feb. 13. [1]

"About 4 reports per day were filed with VAERS in December 2006 for the HPV vaccine," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "Some of these girls are being injured when they collapse after getting the vaccine and others are complaining of neurological symptoms that should not be ignored. Doctors and nurses should take note of the patient safety issues related to giving this vaccine. Giving GARDASIL simultaneously with any of the 18 vaccines Merck did not study in combination is not an evidence-based guideline and should involve informed consent and a signed patient release. To avoid unnecessary injuries, teenage girls should be vaccinated laying down, not be left unattended and probably should not walk or drive themselves home from the doctor's office after they get vaccinated."

NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after GARDASIL vaccination. It is unknown if the girls were infected with HPV before being vaccinated or if GARDASIL failed to protect them. One case of HPV infection occurred in a 22-year-old girl who had participated in a Merck GARDASIL trial in 2003 when she had shown "strong conversion to all 4 vaccine types" but "tested positive for high risk HPV" in 2006, according to the VAERS report.

In a May 18, 2006 Background Document for the FDA Vaccines and Related Biological Products Advisory Committee (VRPBAC), the FDA staff stated that Merck clinical trial data indicated there may be "the potential for GARDASIL to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination."  [2] Girls and women now being vaccinated with GARDASIL are not routinely being tested for active HPV infection before vaccination.

The FDA staff also questioned whether the “HPV types not contained in the vaccine might offset the overall clinical effectiveness of the vaccine.” There are more than 15 types of HPV associated with cervical cancer but GARDASIL only contains HPV types 16 and 18. It is unknown whether non-vaccine HPV types will become more dominant in the future. However, there are indications this could occur because some of the seven strains of pneumococcal contained in Wyeth’s PREVNAR vaccine, which was recommended by the CDC for universal use in all babies in 2000, have been replaced by some of the more than 80 other pneumococcal strains not contained in the vaccine. [4] [5] [6]

VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health care providers report vaccine adverse events. There have been estimates that fewer than 10 percent, even as low as 1 to 4 percent, of adverse events which occur after prescription drug or vaccine use are ever reported to government adverse event reporting systems. [7] [8] [9] [10]

"If only 1 to 4 percent of all adverse events associated with GARDASIL vaccination are being reported to VAERS, there could have been up to 38,000 health problems after GARDASIL vaccination in 2006 which were never reported," said Fisher. "How many girls are really having short-term health problems associated with getting this vaccine that could turn into long-term neurological or immune system disorders? And how many will go on to develop fertility problems, cancer or damage to their genes, all of which Merck admits in its product insert that it has not studied at all? We just don't know enough to be mandating GARDASIL for anyone, much less vulnerable 11 to 12 year old girls entering puberty."

For a copy of NVIC's Report on VAERS and GARDASIL, references for this statement and information about how to report a vaccine reaction to VAERS, go to www.nvic.org.

References:

[1] Food and Drug Administration, Center for Biologics Evaluation Research. Feb. 13, 2007. FDA Public Health Notification: Information on Rota Teq and Intussusception.
[2] Food and Drug Administration. May 18, 2006 FDA Background Document for Vaccine and Related Biological Products Advisory Committee. Gardasil HPV Quadrivalent Vaccine. Page 13.
[3] Ibid. Page 25.
[4] Porat N, Barkai G et al. 2004. New antibiotic resistant clones of Streptococcus pneumoniae unrelated to the pneumococcal conjugate vaccine serotypes causing acute otitis media in Southern Israel.  J Inf Dis 189: 385-392. 
[5] Temine L, Guillemot D et al. 2004. Short and long-term effects of pneumococcal conjugate vaccination of children on penicillin resistance. Antimicrobial Agents and Chemotherapy 48 (6): 2206-2213.
[6] Kyaw MH, Lynfield R et al. 2006. Effect of introduction of the pneumococcal conjugate vaccine on drug resistant Streptococcus pneumoniae. NEJM 354 (14): 1455-1463. 
[7] Scott HD, Rosenbaum SE et al. Rhode Island physicians’ recognition and reporting of adverse drug reactions. RI Med J 1987; 70:311-316.
[8] Rosenthal S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995; 85:1706-9.
[9] Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations. John’s Hopkins Bloomburg School of Public Health. www.vaccinesafety.edu/VAERS.htm
[10] Food and Drug Administration, Center for Drug Evaluaton and Research. The clinical impact of adverse event reporting. MedWatch. October 1996.
[http://www.nvic.org:80/Diseases/HPV/pr022107HPV.htm]
 
Other Sources:
Family Resource Council:
http://www.frc.org/get.cfm?i=IF07B01 or

http://www.frc.org/get.cfm?i=IF07B01&f=WA07C01

Medical Institute of Sexual Health:
http://www.medinstitute.org/content.php?name=HPVVaccineStatement

Focus on the Family
http://search.family.org/query.cfm?qt=gardasil&style=family&Search=Go

Green Journal:
http://www.vaccineinfo.net/immunization/vaccine/hpv/doc_against_HPV.shtml

21 February 2007 Perry's staff discussed vaccine on day Merck made donation: Spokesman says timing a coincidence.
Gov. Rick Perry's chief of staff met with key aides about the human papillomavirus vaccine the same day its manufacturer donated money to his campaign, documents obtained by The Associated Press show.
 
Chief of staff Deirdre Delisi's calendar shows she met with the governor's budget director and three members of his office for an "HPV Vaccine for Children Briefing" on Oct. 16.
 
That day, New Jersey-based Merck & Co.'s political action committee donated $5,000 to Perry and $5,000 total to eight state lawmakers.
 
The calendar and other documents obtained by the AP show Perry's office began meeting with Merck lobbyists about the vaccine as early as mid-August, months before social conservatives – who are now those most outraged by the order – helped re-elect him in November.
 
Perry spokesman Robert Black said the timing of the meeting and the donation was a coincidence. He said Delisi had asked budget director Mike Morrissey to update her on the cost of providing the newly FDA-approved HPV vaccine free to young women on Medicaid.
 
"There was no discussion of any kind of mandates," Black said.
 
The order the governor issued earlier this month directed the Texas Health and Human Services to adopt rules requiring the shots for girls entering sixth grade as of September 2008. The vaccine protects girls and women against the HPV strains that cause most cases of cervical cancer.
 
The mandate inflamed conservatives, who say it contradicts Texas' abstinence-only sexual education policies and intrudes too far into families' lives. They also say the shots are too new and too costly to force on young girls.
 
On Wednesday, the House public health committee voted 6-to-3 in favor of a bill that would override Perry's mandate by barring state officials from requiring the vaccine for school attendance. Ninety-one state representatives – or nearly two-thirds of the House – are co-sponsoring the bill, which now can be considered by the full House.
 
Perry has repeatedly said the vaccine's lifesaving potential far outweighs opponents' concerns. He has declined to say whether he would veto the bill but has said he is open to changes to his order.
 
The documents obtained Wednesday by The AP under Texas' open records law provide new detail about the relationship between the governor's office and Merck, which makes the only HPV vaccine on the market.
 
Critics had previously questioned Perry's ties to the company. Mike Toomey, Perry's former chief of staff and Delisi's predecessor, lobbies for the drug company. And the governor accepted a total of $6,000 from Merck during his re-election campaign, including $1,000 in December 2005.
 
According to Delisi's calendar, she met with Toomey three times in the sixth months before the order was issued. One meeting happened in August, on the same day two other Perry staffers met with a different Merck lobbyist for a "Merck HPV Vaccine update." The other meetings came just after the November election and just before the legislative session began in January.
 
Black said he did not know what the two discussed. He said the pair have been friends for years and pointed out that Toomey has many clients other than Merck. He also insisted that the governor did not decide to issue the mandate until well after the election.
 
Neither Delisi nor Toomey returned telephone calls seeking comment. A spokewoman for Merck also did not return a telephone message.
 
Cathie Adams, president of the conservative Texas Eagle Forum, said Black's explanation of the timing of the campaign contribution didn't wash.
 
"We have too many coincidences," she said. "I think that the voters of Texas would find that very hard to swallow."
 
Merck has waged a behind-the-scenes lobbying campaign to get state legislatures to require 11- and 12-year-old girls to get the three-dose vaccine as a requirement for school attendance. But it announced Tuesday it was suspending those efforts.
 
The drug company had mainly funneled money through Women in Government, a bipartisan group of female state lawmakers. Many of the group's members have sponsored legislation in other states that would require the vaccine for schoolgirls.
 
One member of Women in Government is Texas state Rep. Dianne White Delisi, Deirdre Delisi's mother-in-law. Despite her ties to the group, the elder Delisi has opposed Perry's order and voted for the bill aimed at overriding it.
 [21February07, AP,Austin, http://www.dallasnews.com/ ]
 

21 February 2007

Cancer-virus vaccine targets wrong age group. Lawmakers looking to force preteen girls to take Gardasil, a new vaccine against a virus that causes cervical cancer, are targeting the wrong age group, cancer data shows. 

Middle-school girls inoculated with the breakthrough vaccine will be no older than 18 when they pass Gardasil's five-year window of proven effectiveness -- more than a decade before the typical cancer patient contracts the sexually transmitted human papillomavirus (HPV). 

Infectious disease specialists and cancer pathologists say the incubation period for HPV becoming cancer is 10 to 15 years -- meaning the average cervical cancer patient, who is 47, contracted the virus in her 30s and would not be protected by Gardasil taken as a teen. 

"It is a delicate balancing act," said Debbie Saslow, director of breast and cervical cancer control at the American Cancer Society. "If the vaccine is given at too young an age, it may wear off. Yet if it is given too late, it won't work."

Merck & Co. is still studying the longevity of Gardasil, the lone HPV vaccine on the market, which won approval from the Food and Drug Administration in June. But that hadn't impeded its lobbying efforts. Legislators in at least 20 states and cities, including Virginia and the District of Columbia, are considering HPV vaccinations for girls 11 to 13 as a requirement for school attendance. Texas already has done so.

"We are doing further tests and follow-up. But right now, we know it is effective for five years," said Dr. Richard Haupt, executive director of medical affairs in Merck's vaccine division.

Gardasil, a $360 series of three shots over six months, protects against two HPV strains that cause nearly 70 percent of cervical cancer cases. It also prevents two strains linked to 90 percent of genital warts cases.

Merck, which did not respond to repeated requests for its HPV incubation statistics, unexpectedly suspended its lobbying campaign yesterday.
"Our goal is about cervical cancer prevention. ... We're concerned that our role in supporting school requirements is a distraction from that goal," Dr. Haupt told the Associated Press. 
    
By the numbers
Dr. Joseph Bocchini, chairman of the committee on infectious disease of the American Academy of Pediatrics, says HPV can take up to 20 years to cause cervical cancer.

"It can occur more rapidly, but very commonly, it is a 20-year period before it leads to cancer," said Dr. Bocchini, whose group has endorsed HPV vaccinations on 11- and 12-year-olds but has withheld support for its mandated use. Even when applying a longer 20-year incubation period, requiring Gardasil for sixth-grade girls, as nearly all the legislation does, would not prevent the overwhelming majority of cervical cancer cases in the U.S.

American Cancer Society numbers show that from 2000 to 2003, more than 70 percent of cervical cancer patients were older than 40 -- still outside Gardasil's five-year protection window if given to sixth-graders.

Merck is working on a booster shot to extend Gardasil's five years of protection. "We are aware of some evidence of immune memory. But if a booster shot is necessary, it would likely be another dose of Gardasil," Dr. Haupt said. 

None of the HPV vaccine legislation being considered addresses the potential for booster inoculations that could fall outside the enforcement mechanism -- rules that bar students from school unless they have the required shots.

Vaccine boosters vary in longevity. A hepatitis B booster is required every 10 years, while others can provide lifelong immunity.

Lawmakers pushed HPV legislation to the fast track after the Advisory Committee on Immunization Practices, run by the Centers for Disease Control and Prevention, in July endorsed such an inoculation for girls 11 to 12.
"The point in vaccinating kids 9 to 12 is not to reduce number of cases found in that age group, but to vaccinate prior to beginning sexual activity," said CDC spokesman Curtis Allen. "The benefits of the vaccine decrease as women age because they are more likely to have already been infected by one of the HPV strains."

Seventy percent of females are sexually active by age 18, according to the CDC. But based on cancer statistics, cervical cancer incubation periods, and the five-year life-span of Gardasil, state lawmakers -- who have billed the inoculations as a cure to cervical cancer -- would have a much greater effect on cervical cancer rates by mandating its use later.

Cervical cancer rates are less than one per 100,000 women until age 20 and then begin to pick up in the late 20s and early 30s. Thus, women who likely contracted HPV in their early 20s could be protected by Gardasil taken at 17 or 18.

GlaxoSmithKline is developing another HPV vaccine, Cervarix, which has not been licensed but is expected to be released later this year. It is effective for 4½ years, according to an April 2006 study in Lancet, a British medical journal. 
     
Risk vs. reward
Dr. Mona Saraiya, a medical epidemiologist in the Division of Cancer Prevention and Control at the CDC, says nearly all sexually active woman are exposed to HPV. 

"However, only a few will get an infection that stays and won't go away, and only a portion of those will get a precancerous lesion. At that point, only a few will eventually develop cervical cancer," Dr. Saraiya said.

Fewer than one-hundredth of 1 percent of the 108 million U.S. women older than 18 (0.009 percent) get cervical cancer and even fewer die from it. There were an estimated 9,700 new cervical cancer cases and 3,700 fatalities in 2006, according to the American Cancer Society.

But the fact that very few U.S. women are affected by cervical cancer, statistically speaking, hasn't stopped the rush by lawmakers to push mandatory HPV vaccines for school girls.

Earlier this month, Texas became the first state to enact an HPV vaccine law when Gov. Rick Perry bypassed the Legislature and signed an executive order mandating all girls entering sixth grade be inoculated. Mr. Perry drew fire when it was revealed that his former chief of staff was lobbying for Merck. Lawmakers are trying to reverse the order.

In Maryland, HPV legislation was pulled days after a Baltimore Sun report on Merck's lobbying efforts in Annapolis. The bill's sponsor, state Sen. Delores Kelley, Baltimore County Democrat, cited the growing burden on families because of the high costs of mandatory vaccinations.

Virginia Delegate Phillip A. Hamilton, Newport News Republican, sponsored the HPV-vaccination legislation that his state's House passed earlier this month and is expected to become law. "What was intriguing to me was that it was a cancer vaccine," he said. 

Mr. Hamilton, who has received contributions from Merck in the past, said the pharmaceutical company played no role in his decision to the sponsor the bill.
"It was a positive step. It was about preventing cancer, nothing else," Mr. Hamilton said.

D.C. officials have just begun hearings on a proposal to require HPV vaccinations before girls turn 13 and to create an HPV reporting program in the city's Department of Health. Merck has waged an extensive lobbying campaign in statehouses, and has helped raise the profile of HPV through a large-scale communications campaign, highlighted by the "Tell Someone" TV ad being shown on channels with high-teen viewership, such as MTV.

Wall Street analysts predict that Gardasil, which is projected to generate $2 billion to $4 billion this year without state mandates, will help offset losses Merck endured after it pulled Vioxx off the market in 2004.

Vioxx, an FDA-approved anti-inflammatory drug for osteoarthritis and acute pain that was used by 2 million people, was linked to increased risk of heart attack and stroke. "Merck's goal is to support efforts to implement policies that ensure that Gardasil is used to achieve what it was designed to do: help reduce the burden of cervical cancer -- the second-leading cancer among women around the world -- and other HPV-related diseases for as many people as possible, and as quickly as possible," Merck said about its lobbying efforts. 
    
Fast track vs. family values
Merck's lobbying efforts and the legislative push for mandatory HPV vaccinations have attracted the attention of pro-family groups such as Focus on the Family, which supports HPV vaccinations but says they should not be mandatory. Other conservative groups such as the Family Research Council say requiring HPV inoculations is tantamount to endorsing premarital sex.

"Because HPV infection is caused by sexual activity, it is not transmitted by casual contact and therefore is not in the same class as other diseases like polio for which mandatory, school-based vaccination is a public-health imperative," Family Research Council President Tony Perkins said in an alert sent to its members to lobby Mr. Perry to rescind his Texas order. 

Delegate John J. Welch III, Virginia Beach Republican, opposes his state's measure for several reasons. 

 "I think parental rights are paramount. They should trump everything," Mr. Welch said.

"When we have a drug that can cure cancer, of course I'm all for it," he said. "But given the fact the drug is so new, I don't think that the commonwealth should mandate it."

Once a major killer in the U.S., cervical cancer has been nearly wiped out since the creation of the Pap test, which detects precancerous lesions and early cancer and is credited with a 74 percent drop in cervical cancer deaths since 1955.

The CDC says most cervical cancer diagnoses in the U.S. are in women who either have never had a Pap test or have not had a Pap test in the previous five years. Those inoculated with Gardasil still will have to have regular Pap tests for the disease, which is hard to detect because it does not usually cause pain.

Cervical cancer does have high mortality rates in low-income regions of U.S. and poor nations where health care coverage is not routine. Cervical cancer is the fifth most common cancer among women worldwide, according to the World Health Organization, and kills about 230,000 women a year, most in developing countries. Because of these figures, public health officials still back use of the vaccine.

"The vaccine is not nearly as effective as vaccines for mumps or measles, but it is an important step forward in public health," said Dr. John Swartzberg, director of public health policy at the University of California at Berkeley. "The vaccine will decrease the two most common strains of HPV that cause cancer, and we'll be left with strains that have far less potential to cause cancer. In this case, the benefits outweigh the risks." 
    
What we don't know
As with any new drug, there are potential risks that short-term studies used for federal approval don't detect.

Dr. Clayton Young, an obstetrician-gynecologist in Texas, is concerned that Gardasil will actually strengthen cancer-causing strains of HPV. 

"My concern is that we are pushing ourselves into something worse than we already have," Dr. Young said. "Vaccinating for only two strains may lead to an increase in infection with other and possibly more aggressive strains." 

Gardasil is effective against two of 10 carcinogenic HPV strains. Those two strains dominate the current statistics, estimated to have caused 6,800 new cervical cancer cases in 2006, while the other eight strains combined affected 2,900 women.

The probability of additional cancer-causing HPV strains leading to as many cervical cancer cases as today is minute, said Dr. Haupt, executive director of medical affairs in Merck's vaccine division.

Despite Merck's doubt, the company is studying the additional cancer-causing HPV types in Scandinavian countries, where national cancer registries allow drug companies to track people with the disease.

"It is an important issue to us," Dr. Haupt said. "But we think the two types of HPV that Gardasil work for are unique, and if other types become more common, they will not cause cancer at the same rate and won't over time."

Physicians also point to concerns about Gardasil that cast doubt on the vaccine's overall capability to stop cervical cancer from occurring in females. For instance, clinical trials for the vaccine's effectiveness at preventing cervical cancer did not include the age group of girls for whom the vaccine is being recommended.

"The number one problem with the vaccine is that it has not been tested adequately on the group that is recommended to get it," said Dr. Joseph DeSoto, a fellow in the American Institute of Chemists and a physician-scientist at the National Institutes of Health.

According to Merck's clinical study documents on Gardasil, 20,541 women ages 16 to 26 participated in four studies. The documents show some data is available on 9-year-old girls related to immune responses to the vaccine but not whether it prevents cancer.

Because most 9-year-old girls are not sexually active, it is not possible to test the effectiveness of Gardasil against cervical cancer, Mr. Haupt said. Instead, the clinical trials measured antibody responses against HPV as a proxy for cervical cancer.

Merck conducted two clinical trials that involved 1,121 girls ages 9 to 15, according to Merck's labeling documents for Gardasil.

"The clinical trials tested younger girls, but they only looked at immune response to the vaccine, not whether it prevented cervical cancer," Dr. Young said. "It has not been studied long enough to know that it prevents cervical cancer."  [21Feb07, Gregory Lopes and Christopher M. Dolan,  Jim McElhatton contributed to this report, The Washington Times ]

    
    
    
21 February 2007 

Merck Drug Company Drops Campaign for Mandatory HPV Vaccine: Alarm raised over incomplete disclosure of serious side effects.
The drug company Merck & Co. has canceled nationwide lobbying efforts to make their new vaccine against the sexually transmitted human papilloma virus mandatory for all school girls.
 
Growing opposition among family and medical organizations, along with allegations that the vaccine was inadequately tested and had produced serious side effects, together convinced the massive drug conglomerate to pull back from campaign efforts promoting the Gardasil vaccine, Bloomberg reported Feb.20.
 
Among the groups opposed to the campaign was the American Academy of Pediatrics and the U.S. Centers for Disease Control and Prevention in Atlanta.
 
“Merck’s early push was not the way to go,” said Larry Pickering, executive secretary of the Advisory Committee on Immunization Practices (ACIP) for the CDC. “We want to convince people to use the vaccine because of its benefits.”
 
The vaccine’s benefits were sharply questioned by the National Vaccine Information Center prior to the CDC’s approval of the Gardasil vaccine for all pre-adolescent girls in June 2006.
 
In a statement to the press June 27, 2006, the NVIC criticized the Food and Drug Administration for “fast-tracking) the vaccine without adequate tests of its safety for young girls, and accused Merck of obscuring side effects that resulted from clinical trials of the vaccine.
 
“Merck and the FDA have not been completely honest with the people about the pre-licensure clinical trials," said NVIC president Barbara Loe Fisher. "Merck's pre and post-licensure marketing strategy has positioned mass use of this vaccine by pre-teens as a morality play in order to avoid talking about the flawed science they used to get it licensed. This is not just about teenagers having sex, it is also about whether Gardasil has been proven safe and effective for little girls.”
 
In particular, the use of aluminum in the vaccine and placebo used in trials raised concern, since studies have linked aluminum to brain cell death and joint inflammation. About 60 percent of those participating in trials experienced headache, fever, nausea, dizziness, vomiting, or diarrhea, the NVIC reported. Among those who received Gardasil, more serious side effects included gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis.
 
"Merck and the FDA do not reveal in public documents exactly how many 9 to 15 year old girls were in the clinical trials, how many of them received hepatitis B vaccine and Gardasil simultaneously, and how many of them had serious adverse events after being injected with Gardasil or the aluminum placebo,” the statement said.
 
“Clinical trial investigators dismissed most of the 102 Gardasil and placebo associated serious adverse events, including 17 deaths, that occurred in the clinical trials as unrelated.
 
"There is too little long term safety and efficacy data, especially in young girls, and too little labeling information on contraindications for the CDC to recommend Gardasil for universal use, which is a signal for states to mandate it," said Fisher. "Nobody at Merck, the CDC or FDA know if the injection of Gardasil into all pre-teen girls -- especially simultaneously with hepatitis B vaccine -- will make some of them more likely to develop arthritis or other inflammatory autoimmune and brain disorders as teenagers and adults.
 
More than 20 states are considering legislation that would make the vaccine mandatory for all girls entering high school. Texas Gov. Rick Perry earlier this month bypassed the state legislature to push through a requirement that girls aged 11-12 receive the shot, with an opt-out clause included for parents who object.
 
Apart from the revelation of serious health concerns and inadequate testing of the vaccine, parents and concerned groups have objected to the vaccine’s promotion for girls and young women, since HPV is a sexually transmitted disease linked to promiscuity.
 
Read NVIC statement on dangers of Gardasil :

Previous: Drug Conglomerate funds campaign to impose Mandatory HPV Vaccine on Young Girls
 
Texas Gov. Issues Executive Order Approving Mandatory HPV Vaccines for Girls 9-11

HPV Condom Study Shows The Failure of Condom Education
[21Feb07, LifeSiteNews.com, Gudrun Schultz, WHITEHOUSE STATION, New Jersey]
 
 
 

"...and it will cost $71.7 million a year to pay for the shots for low-income Texans"
 
Perry surprised by backlash to HPV order: Mandate was months in the making, but few were in the loop.
23 February 2007
In the days before his Feb. 6 State of the State address, Gov. Rick Perry dribbled out announcements of several initiatives so they wouldn't get lost in bigger news the day of the speech. On Jan. 30, a disaster contingency fund. On Feb. 1, higher education reforms. And on Feb. 2, the mandate that schoolgirls be vaccinated against the human papillomavirus.
 
That turned out to be one of the most controversial initiatives of Perry's tenure, but the governor's office never saw the backlash coming.
 
...the governor's office had been talking about HPV with drug maker Merck for at least five months and that the same state agency that the governor directed to implement the executive order actually drafted the order. And they show that... the governor's office had simply failed to predict the firestorm.
 
Critics have blasted the executive order, with some saying Perry overstepped his authority and others worrying about the vaccine itself: that it's too new to know about long-term effects or that getting vaccinated against the sexually transmitted virus could encourage young girls to be promiscuous.
 
A House health panel led by state Rep. Dianne White Delisi, R-Temple, a member of Perry's own Republican Party and the mother-in-law of the governor's chief of staff, Deirdre Delisi, this week recommended that the full chamber pass a bill that would essentially overturn Perry's mandate.
 
"Did we expect such an uproar?" Perry spokesman Robert Black asked during an interview. "I think it's fair to say no. Would it have changed (Perry's) mind if he would have known that? No. What people thought of his order or the fact that we were the first state in the nation — for the governor, none of that really comes into play." Rather, it is a women's health issue, Black said.
 
Much of the controversy has centered on Merck, which this week suspended efforts to lobby statehouses around the country to mandate the vaccine, Gardasil.  

Merck  had been funneling money through an advocacy group, Women in Government.
 
In Texas, some had questioned Perry's Merck ties: Mike Toomey, Perry's former chief of staff, is one of Merck's lobbyists here, and Merck gave $6,000 to Perry's re-election campaign. Black said that Toomey and Perry have never discussed HPV and that "it's a bit of a red herring" since another drug company, GlaxoSmithKline, is also developing an HPV vaccine.
 
However, documents show that on Nov. 7, the day Perry was re-elected, a gubernatorial policy adviser sent an e-mail to Toomey and to Lara Keel, both of the Texas Lobby Group, with the subject "HPV numbers." The e-mail included projected costs of providing the HPV vaccine to low-income Texans.
 
In fact, the governor's office was talking with Merck representatives not long after Gardasil was approved by the FDA in June, documents show.
 
In an Aug. 17 e-mail to Dr. Charles Bell, deputy executive commissioner of the Health and Human Services Commission, gubernatorial adviser Heidi McConnell wrote: "There is a good chance that we are going to do something on the HPV vaccine, so (a colleague) and I met with Merck representatives earlier this week to get an update on the vaccine."
 
Black said that conversations between the governor's office and Merck "shouldn't surprise anyone. They're the ones who had the vaccine," he said.
 
When preparing to announce the executive order, Perry's staffers apparently worried about coming across as too Merck-friendly.
 
On the day before the executive order was issued, in response to a draft of the news release, the governor's assistant director of budget, planning and policy wrote: "(T)hat first line sounds almost like a Merck commercial."
 
The draft was not provided to the Statesman. The governor's office has asked the attorney general's office for an opinion on whether it may keep HPV-related draft documents confidential, said Chelsea Thornton, the governor's assistant general counsel.
 
While the governor's office was worrying about the wording of the announcement, key lawmakers were out of the loop. State Sen. Jane Nelson, R-Lewisville, chairwoman of the Senate Health and Human Services Committee, told reporters Feb. 5 that she was surprised Perry hadn't contacted her about the mandate. She called on him to rescind it, saying, "I just don't think he thought this one through."
 
The same day, Brandon LeBlanc, the governor's community affairs public liaison, wrote an e-mail to colleagues with the subject "Why the rush?" He asked for an answer to "why we didn't let HPV vaccine run its course in the Leg.? Preferably one I can use in public."
 
Even some members of the governor's staff were blindsided by the executive order.
 
Ken Armbrister, a retired state senator who is the governor's new liaison to lawmakers, was inadvertently left off the list of officials who were to be notified ahead of time. Because Armbrister was unaware, he was unable to alert key lawmakers to what was coming.
 
Perry's support of mandating the vaccine surfaced during the gubernatorial race, though few took notice.
 
In September, after Democrat Chris Bell had said he favored mandating the vaccine, the Fort Worth Star-Telegram reported that Perry spokesman Ted Royer said: "Perry supports requiring the cervical cancer vaccine, as long as parents retain the right to opt their children out."
 
At the time, perhaps because Bell and Perry agreed, "no one batted an eye," Black said.
 
After Election Day, when Perry switched from campaigning to preparing for the 2007 legislative session, he began to consider how to implement the mandate, Black said.
 
State health officials could have added the vaccine to the required list without the drama of an executive order.
 
But "after spending a lot of time thinking about it, talking to folks, not the least of which was Mrs. Perry, who feels very strongly about this issue, I think the governor felt so strongly that it was the absolute right thing to do to protect life, that when we had an opportunity like this to prevent a cancer in young women, that he needed to put the weight of the entire executive branch behind it," Black said.
 
The executive order directs the Health and Human Services Commission to adopt rules that mandate the vaccination against HPV for girls before starting sixth grade.
 
But documents show that state health officials were the ones writing a draft of the executive order that directs their own agency to write the rules.
 
On Jan. 18, Dr. Charles Bell of the commission wrote an e-mail to a gubernatorial adviser:
 
"(A)ttached is the draft Executive Order that was requested by the Governor's Office staff. Neither my staff nor I have ever drafted such a document so we just patterned it off the ones that we found on the Governor's website. I hope the draft is satisfactory to edit and create the official document."
 
Commission spokeswoman Stephanie Goodman said it's not surprising that the agency drafted the order because "we know the language necessary to implement the vision laid out by the governor's office."
 
The order says that beginning in September 2008, sixth-grade girls must be vaccinated against the four strains of HPV that cause 70 percent of cervical cancers. The shots cost $360 for the three-dose series, and it will cost $71.7 million a year to pay for the shots for low-income Texans, Perry spokeswoman Krista Moody said. Parents may opt not to have their daughters vaccinated.
 
Three weeks after Perry issued the order, he is standing by it despite widespread opposition from lawmakers and the social conservatives who have traditionally backed him. Perry is trying to shape the debate into one that's more about people with cervical cancer and less about politics and money. On Monday, Perry introduced reporters to a 31-year-old Houston woman who is dying of cervical cancer caused by HPV.
 
"This debate should be based on whether or not this state is going to do everything it can to prevent cervical cancer in young women, to save women's lives," Black said. "Anything else is a distraction from the real issue." [23Feb07, American-Statesman, http://www.statesman.com/news/content/region/legislature/stories/02/23/23govhpv.html 
Corrie MacLaggan, L. Copelin]

February 2007 

Homosexual men seek 'female cancer' HPV Vaccine. Homosexual men are requesting a controversial "sex disease" vaccine designed to prevent a female cancer. Gardasil protects against the most common of sexually transmitted infections, human papillomavirus (HPV), which can cause cervical cancer.

But HPV also causes genital warts and anal and penile cancer, and men argue the vaccine would guard against these.

Many private clinics are offering it to men. One in London says it has immunised dozens in the last six weeks.

Controversy
Gardasil has been causing controversy since it was launched in the UK late last year, mainly because it is designed to be given to children before they become sexually active and can catch HPV.

The government is considering whether all girls, and possibly boys, aged 11 or 12 should get it routinely in schools, ultimately to cut cervical cancer rates.
Gardasil is licensed for boys and girls aged nine to 15 and women aged 16 to 26. But doctors can opt to give it to other people "off licence" if they wish.

Strong demand
Dr Sean Cummings at the Freedom Health clinic in Harley Street, where dozens of men have had the jab, said he was happy to recommend Gardasil to his adult men, at £450 for a three-dose course.

"We've had a strong demand for it. I had a man come in for the vaccine this morning. He was 24. Then I have one this afternoon who is 67 years old.
"The motivation is to protect themselves and to prevent spreading HPV to their partners." Opponents say there is no point in immunising people who are already sexually active.

More proof
But Dr Paul Fox, a genito-urinary medicine expert at the Chelsea and Westminster and Ealing hospitals, believes it can be worthwhile. He argues that it is unlikely a person will have encountered all of the four strains of HPV found in Gardasil, including the two linked to cancers, even if they are leading a very promiscuous sex life.

"We should not just be looking at vaccinating people in their pre-teen years. Other people would benefit as well."
Dr Jo Longstaff, of the Independent General Practice private clinic in Cardiff, which also offers the Gardasil vaccine, agrees.
"Our first enquiry about Gardasil was from a male patient. I think they should be considering it."
Dr Anne Szarewski, clinical consultant for Cancer Research UK who has been involved in evaluating both Merck's Gardasil and GSK's rival jab Cervarix, says there may be a case for immunising men.
"Men who have sex with men are at a much higher risk than average of anal cancer and genital warts, particularly if they are HIV-positive.
"Clearly it would be very important if the vaccine could protect. The problem is we do need proof."

Trials in men
Merck is currently testing the vaccine's efficacy in 4,000 men, including 500 men who have sex with men. And the US National Institute of Health is also carrying out trials to see what benefits it could have for people with HIV.

Merck said its priority was to tackle cervical cancer, but has not ruled out giving the vaccine to other groups - including men who have sex with men.
Roger Peabody of the Terrence Higgins Trust said if the trials were successful, there would be a good case for vaccinating young boys, not only to stop the spread of HPV to women, but to protect men against HPV-related disease.
Dr Szarewski agreed, saying: "It is bad enough suggesting to people that their 12-year-old daughter might need a vaccine against a sexually transmitted infection.
"I would be interested to see the response of suggesting to parents that they should vaccinate their boys at 12 in case they become gay."
She said heterosexual men and women also risked anal cancer.

About 400 people are diagnosed with anal cancer each year in the UK. The disease is slightly more common in women than men.
[last updated 23Feb07, By Michelle Roberts, BBC News,  http://news.bbc.co.uk/2/hi/health/6342105.stm]

27 February 2007

CDC Doctor Opposes Law for Vaccine. The chairman of the federal panel that recommended the new cervical-cancer vaccine for pre-teen girls says lawmakers should not make the Gardasil inoculation mandatory, as the District and more than 20 states, including Virginia, are considering.

Dr. Jon Abramson, chairman of the Centers for Disease Control and Prevention's advisory committee on immunization practices (ACIP), also said he and panel members told Merck & Co., the drug Gardasil's maker, not to lobby state lawmakers to require the vaccine for school attendance.

"I told Merck my personal opinion that it shouldn't be mandated," Dr. Abramson told The Washington Times. "And they heard it from other committee members."

Dr. Abramson said he opposes mandating Gardasil, which prevents the cervical-cancer-causing human papillomavirus (HPV), because the sexually transmitted HPV is not a contagious disease like measles and he is not sure states can afford to inoculate all students.

"The vaccines out there now are for very communicable diseases. A child in school is not at an increased risk for HPV like he is measles," Dr. Abramson said.

In addition, Dr. Abramson said a discussion about making the vaccine mandatory should not be made until states show the money is available to vaccinate every child, adding, "I don't see that yet."

Taken in a series of three shots at $120 each, Gardasil is the most expensive vaccine on the market. About 45 percent of children would be eligible for free vaccines from the federal Vaccinations for Children program, while the other 55 percent would depend on the state programs and insurance companies.

The ACIP, a 15-member panel charged with developing vaccine schedules and dosages, recommended Gardasil for 11- and 12-year-olds in July, spurring Merck's lobbying efforts and the legislative push to make the HPV vaccine mandatory for sixth-grade girls.

Merck suspended its lobbying efforts last week amid criticism from parents, who said it would interfere with control over their children, and from conservative groups that said it would encourage premarital sex.

Merck responded yesterday to Dr. Abramson's comments with a statement it had made previously: 
    "We have had ongoing discussions with a number of key public health experts and listened to their thoughts regarding the timing for school requirements of the HPV vaccine. We do not want any misperception about Merck's role to distract from the ultimate goal of fighting cervical cancer, so Merck has re-evaluated its approach at the state level and we will not lobby for school requirements for Gardasil."

Gardasil is nearly 100 percent effective against two strains of HPV that lead to 70 percent of cervical cancer cases in the United States. Nearly 11,000 cervical-cancer cases occur in the U.S. each year, killing more than 3,700, according to the American Cancer Society.

But cancer data show that lawmakers looking to force pre-teen girls to take Gardasil, the lone vaccine on the market, are targeting the wrong age group.

Middle-school girls inoculated with the breakthrough vaccine will be no older than 18 when they pass Gardasil's five-year window of proven effectiveness -- more than a decade before the typical cancer patient contracts HPV, The Washington Times reported last week.

Infectious disease specialists and cancer pathologists say the incubation period for HPV becoming cancer is 10 to 15 years -- meaning the average cervical cancer patient, who is 47, contracted the virus in her 30s and would not be protected by Gardasil taken as a teen.

Dr. Abramson said the panel thinks the vaccine will last for at least 10 years.

Even if it provides 10 years of protection, it would still leave girls given the inoculation in the sixth grade vulnerable during their late 20s and early 30s, when most cervical-cancer patients contract HPV. At that point, another round of Gardasil would be necessary.

Merck is still studying Gardasil's longevity and the potential for a booster shot.

ACIP is the only entity in the federal government to issue immunization recommendations and does not recommend a vaccine be made mandatory; those decisions are left to the states.

But the committee's recommendation on the use of a vaccine often plays the lead role in whether states will act to make it part of their mandatory vaccine list, said Barbara Fisher, president of the National Vaccine Information Center, which is opposed to laws making Gardasil mandatory.

"They are the signal for states to act," she said. "The committee knows that and I think they see people getting upset about it."

Earlier this month, Texas became the first state to enact an HPV vaccine law when Gov. Rick Perry bypassed the state Legislature and signed an executive order mandating all girls entering sixth grade be inoculated. Mr. Perry, who drew fire when it was revealed that his former chief of staff, Mike Toomey, lobbies for Merck, said his order is based on the CDC recommendation.

The Virginia General Assembly last week approved legislation that would require that girls receive the Gardasil before entering sixth grade starting Oct. 1, 2008. The legislation allows parents to opt not to have their daughters vaccinated.
[27Feb07, The Washington Times, Gregory Lopes http://www.washingtontimes.com/business/20070226-115014-2031r.htm]

March 2007

HPV Vaccine: The Hype, The Fear, The Facts
The campaign to mandate Merck's Gardasil vaccine may be the biggest boondoggle since the pet rock.
But in defense of pet rocks, they were low-priced, people knew what they were getting for their money, and they didn't cause any adverse health consequences.

The same cannot be said for the Gardasil campaign.
It's been billed as: A block-buster breakthrough! The first-ever vaccine against cancer!

Merck launched an unprecendented marketing and lobbying campaign to convey two messages:
     -- Sexually-transmitted human papillomavirus (HPV) the cause of cervical cancer, will infect 75% of sexually active American women at some point in their lives, therefore EVERY female needs the Gardasil vaccine.
     -- Laws to fund and mandate vaccination of all pre-teen girls (before they start having sex and contract HPV) are urgently needed because cervical cancer is "the second most common cancer worldwide among women".

The statistics are technically true, but largely irrelevant. Here's why.

There IS an HPV epidemic. The CDC reports that 20 million Americans are currently infected, and 6.2 million new cases occur each year. Research published last month in the Journal of the American Medical Association (JAMA) found a much higher figure of current infections: almost 25 million American women ages 14-59.

Being infected with HPV does NOT mean, however, that one is going to get cervical cancer, much less die from it. Most HPV infections are eliminated by one's immune system: almost 70% are cleared within one year and 91% are cleared within two years. Only about 10% of women infected with HPV will develop persistent infections.

The study found that only 2.3% of women aged 14-59 were infected with one of the two persistent strains of HPV tarteted by Gardasil.

Even a 10% likelihood of a persistent infection that could lead to cervical cancer and death seems urgent. But cervical cancer does not morph overnight. It typically takes at least 10-15 years to develop invasive cancer that could become life-threatening.

Since 1955, U.S. deaths from cervical cancer have plummeted 74% due to routine "pap" tests to screen for pre-cancerous cell changes and lesions that can then be eliminated in a doctor's office or out-patient surgery.

Newer tests -- a liquid-based pap test and an HPV DNA test -- promise greater accuracy and early detection and treatment.

Dr. Mona Saraiya [medical epidemiologist, Division of Cancer Prevention and Control, Centers for Disease Control/CDC] told the Washington Times last month: "Fewer than one-100th of 1% of the 108 million U.S. women older than 18 (0.009%) get cervical cancer and even fewer die from it."

So how can Merck claim that cervical cancer is the second most common cancer among women worldwide? Because while U.S. women who are insured or on Medicaid have routine pap tests at very high rates (approaching 90%), women in the rest of the world do not. Which prompts the question: Why is Merck trying to vaccinate American girls when they face the least risk of any nationality?

Lack of screening is the single most important risk factor associated with cervical cancer.

Women who have never been screened account for 50% of the U.S. cervical cancer cases; another 10% occur in women who haven't been screened in five years.

"Nearly all cases [of cervical cancer] can be prevented if a woman is screened regularly," says the American Cancer Society. "When detected at an early stage, invasive cervical cancer is one of the most successfully treated cancers, with a five-year survival rate of 92% for localized cancers."

That is why the Centers for Disease Control ranked cervical cancer 13th in cancer prevalence and 12th in cancer mortalities in 2002.

Here are 2007 estimates on cases of cancer in women:
New cases of all cancers - 678,060
New cases of breast cancer - 178,480
Lung cancer -- 98,260
Cervical cancer -- only 11,150

Here are the estimates of cancer deaths for women in 2007:
Total cancer deaths - 270,100
Breast cancer deaths - 40,460
Lung cancer deaths - 70,880
Cervical cancer deaths - 3,670

Cervical cancer will account for 1.4% of all cancer deaths among women in 2007. Any cancer death is tragic, but this figure is lower than 14 other cancer-related causes of death.

TO RECAP: Despite an HPV epidemic, cervical cancer mortality is low, and can be virtually eliminated through improved access to routine pap screening for uninsured women not covered by Medicaid.

Merck stresses that, even with Gardasil vaccinations, routine screening will remain essential.

Improving accesss to screening would cost far less than vaccinating every pre-teen girl in the United States at $360 for the three-shot series (not counting office visits and doctors' charges, which could bring the total price to $600 or more each -- and not counting the Gardasil booster shots which may be needed every five to 10 years.)

And since most cervical cancers are diagnosed among women in their late 30s and 40s, vaccinating girls at ages 9-12 may not protect them when they are exposed to cancer-causing persistent strains of HPV in their early to mid-20s.

Dr. Jon Abramson [chairman, CDC Advisory Committee on Immunization Practices], whose committee approved of Gardasil, told Merck, and later told reporters, that he opposes Gardasil vaccine mandates because "a child in school is not at an increased risk for HPV like he is for measles."

His committee's executive secretary, Dr. Larry Pickering, stated that "more data on its safety, efficacy and cost" were needed before it was made mandatory.

Yet in February, Texas Gov. Rick Perry ordered mandatory Gardasil inoculations and Virginia's General Assembly passed a law requiring them. Five other states are poised to approve Gardasil funding or mandates -- apparently without considering the alternative of wider screening or Gardasil's adverse effects [or the fact that another HPV vaccine has just been released by another pharmaceutical company and other alternatives are coming down the pipes].

The incidence of arthritis was three times greater among those given Gardasil than in the placebo group.

The National Vaccine Information Center reported, "There were twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a Gardasil vaccination compared to those getting a Tdap (tetanus-diptheria-acellular-pertussis) vaccination.

There have been reports of facial paralysis and Guillain-Barre syndrome," a disorder in which the body's immune system attacks part of the peripheral nervous system.

Can Gardasil cause harm to an unborn child or affect reproductive capacity? In pregnancies that began within 30 days following an innoculation, five cases of congenital anomaly occurred in the Gardasil group while none occurred in the placebo group.

Examining Merck's clinical trial data, FDA staff noted that vaccinating women who are already infected with strains of HPV targeted by Gardasil may actually worsen their cervical disease.

Yet testing for prior HPV infection before vaccination is not now being done or recommended. FDA staff also questioned whether other high risk strains not targeted by the vaccine could become more dominant after Gardasil suppresses the two most prevalent strains. Some of the seven strains of pneumococcus in Prevnar, a vaccine recommended for universal use in babies in 2000, were offset by some of the more than 80 other pneumococcal strains not contained in the vaccine.

Lawmakers should study these issues before voting on Gardasil mandates.

[Susan E. Wills, NCR, March 18-24, 2007]

9 March 2007 

HPV VACCINE RESOLUTION
Colorado BOE Resolution Calling for the rights of parents to be respected as they make health decisions for their own children.
 
WHEREAS requiring school-aged children to receive certain vaccines in order to attend school started as a public health concern so as to avoid widespread outbreaks of communicable diseases.
 
WHEREAS HPV does not present the same level of public health hazard as do the measles, mumps, rubella, and whooping cough. There is a reason why vaccines for these other illnesses are mandated: they are contagious disease that can be transmitted by virtue of an infected child walking in a classroom and breathing.  From these ALL children are at risk.
 
WHEREAS HPV can only be spread through sexual contact, mandating this vaccine is unprecedented and we believe it is an egregious overstep by government into what should only be a parent-physician-patient conversation.
 
WHEREAS the Food and Drug Administration (FDA) just approved the first vaccine that protects against the HPV types 6,11,16, and 18 in June of 2006.
 
WHEREAS the long term consequences of the vaccine are not known as there is no long-term study of the HPV vaccine. Children in the 9-year-old age group have been monitored for only 18 months and there have been no studies on the carcinogenic risk or the general toxicity of the vaccine itself. Between July 2006 and January 2007, there were 82 reports of adverse events filed with the Vaccine Adverse Event Reporting System (VAERS) following the receipt of the vaccine.
 
WHEREAS the length of efficacy is not known for certain.  Young girls vaccinated at 9 to 10 years of age can lose protection in the 15- to 30-year range when they are most susceptible to infection.
 
THEREFORE BE IT RESOLVED that the Colorado State Board of Education does not support the mandatory HPV Vaccine program by making it a requirement in order to attend school, including home schools and private schools in the state of Colorado.
 
BE IT FURTHER RESOLVED that the Colorado State Board of Education will not support the extortion of parents or taxpayers to fund this vaccination series.

[At time of posting (9Mar07), unknown if this resolution has passed.] 

Comments by Physicians to AAPLOG

AAPLOG does not take a position on HPV vaccination question. (It is not an abortion related issue)

If you will allow me a personal comment: The major vector in HPV
transmission is the male. Certainly a major pool of the virus is in the male population...In fact, the FDA doesn't even approve it for men. Would this be like exempting men from the measles immunization, or the polio immunization?

Anyway, fyi, here are the unedited comments we received from doctors:

Being a prolife gyn with four teenagers of our own I have definite opinions,
as you would imagine.
As we all do in medicine, I try hard to keep our patients in mind, and am
happy to individualize into a risk benefit analysis.
We have been waiting at least since 1994 for this vaccine and for those of us out here doing colpos for HPV and CIN, I, for one, am delighted we have the vaccine.
However to globally want it for all teenagers, now, is a litte too much legislation.
It is similar to sunscreen for California children...great idea...but how
many will get skin cancer...do they really need UVA/UVB blocking clothing-or are we bad parents and doctors...
So I have offered the vaccine happily and individually, with appropriate gyn caution.

xxxxxxxxxxxxxxxxxxxx
Although I feel it is not an issue that should be mandatorily legislated, individually there is the concern about the potential spouses of our young women so that I am inclined to offer them protection from a potentially life threatening exposure. Just a personal thought.

xxxxxxxxxxxxxxxxxxx
The National Vaccine Information Center releases new information on adverse events associated with the new Guardasil vaccine for HPV. It apparently is not as benign as has been advertised. Any adult or child experiencing an adverse event to the vaccine should make a report to the center. Of note in this report is the fact that the vaccine may or may not protect against only 2 of the 15 known virus subtypes that can cause cervical cancer.

http://www.nvic.org/Diseases/HPV/pr022107HPV.htm

xxxxxxxxxxxxxxxxxxxxx

Thanks for your careful handling of a delicate topic... as an old duffer, I
would like to see federal funding for the shingles (herpes zoster) shot. On a cost/suffering analysis-I think the shingles shot is more important (I'm 72 yrs old).How nice it would be if there was a Geriatrics Medical Lobby with the resources of ACOG.
xxxxxxxxxxxxxxxxxxxxxx

I am currently in Thailand with CMDE and just now decided to check my email as I just finished giving a lecture on HPV and HPV vaccine-ironic. You may know that CMDA has a statement supporting the use of the vaccine but of course supporting abstinence til marriage. I think its very important to offer immunization on a medical and ethical basis since cervical cancer is the number 2 cancer killer for women in the world...I am not commenting on parental rights,drug company lobbying etc but the scientific facts. What a nice opportunity to have another opening to discuss the importance of abstinence with their child.

On 13March07, by a vote of 119-21, a veto-proof margin, the Texas House voted (HB 1098) to dismiss Gov. Perry's HPV vaccine mandate. The bill will now go to the Senate.

14 March 2007

Researcher blasts HPV marketing
BY CINDY BEVINGTON
Wednesday, March 14, 2007

http://www.kpcnews.com/articles/2007/03/14/online_features/hpv_vaccine/hpv01.txt
[subscription only]

Diane M. Harper, a lead researcher in the development of the humanpapilloma virus vaccine, says giving the drug to 11-year-old girls "is a great big public health experiment."

LEBANON, N.H. — A lead researcher who spent 20 years developing the vaccine for humanpapilloma virus says the HPV vaccine is not for younger girls, and that it is "silly" for states to be mandating it for them.

Not only that, she says it's not been tested for effectiveness in younger girls, and administering the vaccine to girls as young as 9 may not even protect them at all. And, in the worst-case scenario, instead of serving to reduce the numbers of cervical cancers within 25 years, such a vaccination crusade actually could cause the numbers to go up.

"Giving it to 11-year-olds is a great big public health experiment," said Diane M. Harper, who is a scientist, physician, professor and the director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School in New Hampshire.

"It is silly to mandate vaccination of 11- to 12-year-old girls There also is not enough evidence gathered on side effects to know that safety is not an issue."

Internationally recognized as a pioneer in the field, Harper has been studying HPV and a possible vaccine for several of the more than 100 strains of HPV for 20 years - most of her adult life.

All of her trials have been with subjects ages 15 to 25. In her own practice, Harper believes the ideal way of administering the new vaccine is to offer it to women ages 18 and up. At the time of their first inoculation, they should be tested for the presence of HPV in their system.

If the test comes back negative, then schedule the follow-up series of the three-part shots. But if it comes back positive?

"Then we don't know squat, because medically we don't know how to respond to that," Harper said.

Harper is an independent researcher whose vaccine work is funded through Dartmouth in part by both Merck & Co. and GlaxoSmithKline, which means she is an employee of the university, not the drug companies. Merck's vaccine, Gardasil, protects against four strains of HPV, two of which cause genital warts, Nos. 6 and 11. The other two, HPV 16 and 18, are cancer-causing viruses.

Merck's vaccine was approved last year by the Food and Drug Administration, and recommended in June for females ages 9 to 26 by the Centers for Disease Control's Advisory Committee on Immunization Practices (ACIP).

Glaxo has stated publicly that its vaccine, Cervarix, which protects against the two cancer-causing strains, should be on the market by 2008.

As the director of an international clinical trial for these vaccines, and as author of lead articles about the vaccines' effectiveness, Harper has been quoted widely as saying this vaccine could have enormous potential to eradicate the great majority of cervical cancers.

Not tested on young girls

Picking up on this, but before the trials were even completed, major news media and women's advocacy groups began trumpeting the vaccine as an answer to cancer of the cervix.

Once it was approved by the FDA and ACIP, Women In Government (WIG), a non-profit organization comprised of female state and federal legislators, began championing Merck's vaccine in their home states, with many of the ladies introducing legislation that would mandate the vaccine for 11- and 12-year-olds.

In Indiana, Sen. Connie Lawson, R-Danville, introduced such a bill in this year's General Assembly, but in the face of strong opposition, it was reduced to an education/information-only bill that requires data collection on any Hoosier girls who do get the vaccine. The bill is now awaiting a hearing in the Indiana House.

So far at least 26 states are reported to be considering some form of legislation requiring the new vaccine for younger girls. In February, Republican Texas Gov. Rick Perry bypassed his legislature and mandated it for all 11- and 12-year-old girls in his state. Monday, The Associated Press reported that New Mexico's governor, Democratic presidential contender Bill Richardson, is set to sign a bill requiring sixth grade girls in his state to get the vaccine.

The idea is to inoculate them before they become sexually active, since HPV can be spread through sexual intercourse.

But that idea, no matter how good the intentions behind it, is not the right thinking, Harper said. The zealousness to inoculate all these younger girls may very well backfire at the very time they need protection most, she said.

"This vaccine should not be mandated for 11-year-old girls," she reiterated. "It's not been tested in little girls for efficacy. At 11, these girls don't get cervical cancer - they won't know for 25 years if they will get cervical cancer.

"Also, the public needs to know that with vaccinated women and women who still get Pap smears (which test for abnormal cells that can lead to cancer), some of them will still get cervical cancer."

The reason, she said, is because the vaccine does not protect against all HPV viruses that cause cancer - it's only effective against two that cause about 70 percent of cervical cancers.

For months, Harper said, she's been trying to convince major television and print media to listen to her and tell the facts about the usefulness and effectiveness of this vaccine.

"But no one will print it," she said.

The rest of the story

According to Harper, the facts about the HPV vaccine are:

• It is not a cancer vaccine or cure. It is a prophylactic - preventative - vaccine for a virus that can cause cancer. "Merck has proven it has zero percent effectiveness for curing cancer," Harper said. "But it is a very, very good vaccine that prevents types of HPV responsible for half of the high-grade cervical lesions that cause about 70 percent of cervical cancers. For the U.S. what that means is the vaccine will prevent about half of high-grade precursors of cancer but half will still occur, so hundreds of thousands of women who are vaccinated with Gardasil and get yearly Pap testing will still get a high-grade dysplasia (cell abnormality)."

• It is not 100 percent effective against all HPVs. It is 100 percent effective against two types that cause 70 percent of cervical cancers.

• The vaccine only works if the woman/girl does not have a current vaccine type related infection (in other words, the vaccine only works when the woman/girl does not have HPV 6, 11, 16 or 18 - the viruses that Gardasil targets when she receives her first vaccine shot).

• The vaccine doesn't care if the girl/woman has been sexually active, Harper said. "HPV is a skin-to-skin infection. Although the only way to get cervical dysplasia is through an HPV infection, and HPV is most often associated with sexual activity, HPV is not just spread through sex. We have multiple papers where that's documented. We know that 3-year-olds, 5-year-olds, 10-year-olds, and women who have never had sex have been found to be positive for the cancer-causing HPV types."

• Therefore, for example, if a girl is positive for HPV 16 when she is inoculated with the vaccine at any age, she will not be protected against it later, Harper said. "That means it's a failure and those people are at risk for getting the HPV 16 and 18 cancers later."

• The only way to test for the presence of HPV is through a vaginal swab - which is inappropriate for young girls, she said.

• So what happens if the girls are vaccinated anyway, not knowing whether they were carrying the virus at the time of their inoculation? "They will not be protected if they were positive for the virus at the time they are vaccinated," Harper said.

• That is why it is important to note that the vaccine has not been tested for efficacy (effectiveness) in younger girls, she said. Instead, the effectiveness was "bridged" from the older girls to the younger ones - meaning that Merck assumed that because it proved effective in the older girls, it also would be effective in the younger ones. The actual tests on the younger girls, ages 9 to 15, were only for safety and immune response, Harper said, and then only as a shot by itself, or in combination with only one other vaccine, Hepatitis B. It has not been tested in conjunction with any other shots a girl receives at about age 11, Harper said.

• So far more than 40 cases of Guillian-Barre syndrome - a dangerous immune disorder that causes tingling, numbness and even paralysis of the muscles have been reported in girls who have received the HPV vaccine in combination with the meningitis vaccine. Scientists already know that sometimes a vaccine can trigger the syndrome in a subject. "With the HPV vaccine, it is a small number but higher than is expected, and we don't know if it's the combination of the two, or the meningitis alone," Harper said.

• In the end, inoculating young girls may backfire because it will give them a false sense of protection. And, for both young girls and women, because the vaccine's purpose has been so misinterpreted - and mis-marketed - Harper feels that too many girls and women who have had the vaccine will develop a false sense of security, believing they are immune to cancer when they are not, and failing to continue with their annual Pap exams, are crucial to diagnosing dysplasia before it can develop into cancer.

Keep getting pap smears

The message to consumers, Harper said, is don't stop getting Pap smears just because you've gotten the HPV vaccine.

"This vaccine is good, and it will save a huge number of lives around the world," Harper said. "But an important point is that, if women get the vaccine and then not get their Pap smears, or decide to get them infrequently, what will happen in the U.S. is that we will have an increase in cervical cancer, because the Pap screening does a very good job.

"That's my main diatribe. We don't need mandatory vaccinations for little girls. What we do need to ask, though, is how long does it last, and when do you need a booster?"

Message for governors

For the governors of the states in this country, Harper has another message. One has to do with the fact that vaccinating little girls now is not going to protect them later. Since it can take a decade or more to even manifest itself as dysplasia, the HPVs against which this vaccine works may infect a little girl at the age she needs the vaccine most - meaning she will have to have a booster at the right point in time or she will not be protected. And, remember, it won't work at all if she was positive for the virus when she was inoculated in the first place.

Merck knows this, Harper said. "To mandate now is simply to Merck's benefit, and only to Merck's benefit," she said.

Merck was required to put together a database on the efficacy in children before Gardasil was approved, Harper said. But instead, the company put together four study sites that "are not necessarily representative, and may not even have enough numbers to determine what they need to know."

Since she doesn't personally have access to the money Merck and GlaxoSmithKline pay for her HPV vaccine research, Harper doesn't know exactly how much either has paid Dartmouth for her work.

The trials are expensive, between $4,000 and $5,000 for each patient, she said. With over 100 patients in her study, some big bucks could be in the balance, should Merck or Glaxo become upset with her for making these comments.

Why, then, would she risk speaking out like this - at a time when her words very well could influence legislation across the country, and prompt legislators to drop the mandates? Isn't she afraid of losing her funding?

"I want to be able to sleep with myself when I go to bed at night," Harper said. "My concern is still, let's get women's health better. It is still a good vaccine. But let's be honest. Don't over-promise."

24 May 2007

 
JUDICIAL WATCH UNCOVERS 3 DEATHS RELATING TO HPV VACCINE: Event Reports Obtained from FDA Detail 1,637 Adverse Reactions to HPV Vaccination Gardasil.

Judicial Watch, the public interest group that investigates and prosecutes government corruption, today released documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing 1,637 reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil.Three deaths were related to the vaccine. One physician's assistant reported that a female patient "died of a blood clot three hours after getting the Gardasil vaccine."

Two other reports, on girls 12 and 19, reported deaths relating to heart problems and/or blood clotting.As of May 11, 2007, the 1,637 adverse vaccination reactions reported to the FDA via the Vaccine Adverse Event Reporting System (VAERS) included 371 serious reactions.

Of the 42 women who received the vaccine while pregnant, 18 experienced side effects ranging from spontaneous abortion to fetal abnormities.Side effects published by Merck & Co. warn the public about potential pain, fever, nausea, dizziness and itching after receiving the vaccine. Indeed, 77% of the adverse reactions reported are typical side effects to vaccinations. But other more serious side effects reported include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures.

"The FDA adverse event reports on the HPV vaccine read like a catalog of horrors," stated Judicial Watch President Tom Fitton. "Any state or local government now beset by Merck's lobbying campaigns to mandate this HPV vaccine for young girls ought to take a look at these adverse health reports. It looks as if an unproven vaccine with dangerous side effects is being pushed as a miracle drug."

Judicial Watch filed its request on May 9, 2007, and received the adverse event reports from the FDA on May 15, 2007. Judicial Watch has posted the adverse event reports on their Internet site at: http://www.JudicialWatch.org. [23May07, DC, LifeSiteNews.com]

Serious reactions attributed to HPV vaccine. Causes of death were myocarditis, coronary artery thrombosis, and pulmonary embolism. Two of the deaths were of girls aged 12 and 19 years. The interval from vaccination to death ranged from several hours to about 2 weeks. [24May07, Association of American Physicians and Surgeons, Inc., http://www.aapsonline.org/nod/newsofday429.php; 25May07, R Doekel]


Related from Britain: HPV VIRUS VACCINE LINKED TO THREE DEATHS - health officials want to give to all 12-year-old girls.Doctors suspect the jab, which protects against a sexually transmitted human papilloma virus that causes cervical cancer, may also be linked to 1,700 “adverse reactions”. 

Reports from the US, where the Gardasil vaccine has been used for nearly a year in some states, reveal that three victims died soon after receiving the injection. They were aged 12, 19 and 20. They seem to have suffered blood clots or heart attacks. Hundreds of others suffered what could be adverse side effects, including paralysis, seizures and miscarriages.
 
The news comes just days after the Department of Health announced the drug would be added to the childhood immunisation programme from autumn 2008.

The findings have alarmed UK health experts. Jackie Fletcher from the vaccine damage support group Jabs, said: “Trials of this jab have mostly been on adults, so we don’t have any idea of the long-term effect on children.”Dr Peter Mansfield, a former GP who runs the Good HealthKeeping clinic in Lincolnshire, said: “It’s absolutely wrong that girls of 12 should be given this jab.”

Dr John Oakley, a west Midlands GP said the trials for Gardasil had been so limited that the children taking it would be like “guinea pigs”.

The manufacturers, Sanofi Pasteur MSD, had not planned to release the data, but it was obtained under freedom of information laws by lobbyists Judicial Watch. The findings read like “a catalogue of horrors”, said its  president, Tom Fitton.

Other serious possible side effects  include paralysis, seizures and neurological conditions such as Bell’s palsy and Guillain-Barré Syndrome, which leaves patients paralysed for months and can kill.

Gardasil has stirred up a huge controversy. There is excitement because it is the first vaccine to be approved to fight cancer – but moral campaigners say it will encourage teenagers to have sex early. Others have argued that boys, who also carry the virus, should be vaccinated as well.
 
A spokesman for the Medicines and Healthcare products Regulatory Agency (MHRA), meanwhile, said no “proven, serious new risks have been identified” by the findings, but said the effects would be monitored when

Gardasil is used in the UK.Nicholas Kitchin, medical director of Sanofi Pasteur MSD, said the fact that symptoms were reported after a vaccination did not necessarily mean they were caused by the vaccine. [24June07, Lucy Johnston, Daily Express, http://www.express.co.uk:80/news/view/11110/Sex+virus+vaccine+linked+to+three+deaths 

 

May 2007

 
UCSF DOCTORS WARN ON WIDE USE OF CERVICAL CANCER VACCINE. They urge caution while clinical trials are still under way. Nearly a year after a controversial cervical cancer vaccine won federal approval and hit the market to a whirlwind of interest from doctors and parents, at least two UCSF physicians are warning against widespread use of the drug until much more extensive studies are complete. 
 
In an editorial published in today's New England Journal of Medicine, the UCSF doctors suggest that there are still too many questions about both the efficacy and the long-term safety of the vaccine, called Gardasil, to warrant making it mandatory for all girls -- as has been suggested in several states, including California. 
 
"At this stage, vaccination can still be considered experimental," said Dr. Karen McCune, an associate professor of obstetrics and gynecology at UCSF, who co-authored the editorial. "To be discussing mandatory vaccination when the main clinical trials are still ongoing seems extremely premature. We're feeling like the enthusiasm is driving policy rather than data." 
 
The cervical cancer vaccine, manufactured by Merck & Co., was approved by the Food and Drug Administration in June 2006 and became widely available last fall. The vaccine is designed to prevent infection from the sexually transmitted human papilloma virus that causes cervical cancer.

The same virus also increases the risk of developing other cancers -- including throat cancer, according to a study also released today in the New England Journal of Medicine. 

The vaccine, to be most effective, should be given to girls before they have sex and may be exposed to the virus that causes cancer [Merck also says pregnant women should not receive it].

Researchers are hoping that the vaccine also may prove effective at preventing other cancers, although there have yet to be any thorough studies addressing the possibility. 

Cervical cancer is the second-most common cancer among women worldwide and the third-most fatal, causing 290,000 deaths a year. The disease is rare in the United States, where regular screening for adult women catches most precancerous cases; about 3,700 American women die of cervical cancer every year. 
 
Shortly after the vaccine won FDA approval, a federal advisory panel recommended that all 11- and 12-year-old girls be vaccinated. Since then, several states have considered proposals making vaccination mandatory for girls. 
 
A bill in the California Legislature requiring vaccination stalled in committee in March over concerns about parental rights and the lack of information about the long-term effects of the vaccine. The author has amended his bill to address the wider issue of how California requires vaccinations. In Texas, Gov. Rick Perry backed off this week from orders to force all sixth-grade girls in the state to be vaccinated. 
 
In clinical trials, the vaccine has proved very effective at preventing infection from two strains of HPV that cause 70 percent of cervical cancer cases. Researchers released new data today -- also published in the New England Journal of Medicine -- based on a study of 15,000 women, that showed the vaccine was about 98 percent effective in preventing infection of the two HPV strains. 

But the primary concerns of doctors like McCune are that long-term side effects of the vaccine are unknown -- the most recent study followed women for three years -- and that earlier research hasn't considered what effect the vaccine has on the remaining 13 strains of HPV that also cause cervical cancer. 
 
It's possible, McCune said, that the remaining strains may fill a "niche" left if the two most common strains are wiped out entirely. If that happens, the vaccine might not make any difference on overall cervical cancer rates, she said. 
 
http://sfgate.com/cgi-bin/article.cgi?f=/c/a/2007/05/10/MNGAMPO48N1.DTL[10May07, Erin Allday, San Francisco Chronicle page A5]
 

 

 

28 June 07

Another Cervical Cancer Vaccine Nearer. A new vaccine designed to prevent cervical cancer has passed a key clinical trial that involved UAB researchers and Alabama patients, according to an article released Wednesday in the medical journal The Lancet.

This is the second vaccine developed in recent years to prevent infections by the human papillomavirus, HPV, which causes cervical cancer.

Dr. Warner Huh, a researcher who led the University of Alabama at Birmingham's portion of the clinical trial, said the new vaccine, if approved by the Food and Drug Administration, will add competition to a multibillion-dollar market and dramatically increase the number of women who could get the cancer preventive.

"It's an extremely important study," Huh said.

For one thing, the study of the vaccine Cervarix was huge, involving more than 18,000 women from 14 countries. About 50 women from Alabama participated in the trial, Huh said.

The clinical trial was the last one required before FDA approval of the vaccine. Dr. James Tursi, director of medical affairs for cervical vaccines at GlaxoSmithKline, Cervarix's maker, said if all goes well the vaccine could be available next year. "We're looking at early 2008," he said.

Cervarix will enter a massive medical market to compete against Gardasil, a similar vaccine produced by Merck & Co. and approved by the FDA last year. Analysts have estimated that Merck's revenue from Gardasil could hit $3 billion a year.

Some of that market is in the United States, but much is in poverty-stricken countries where 80 percent of the world's 500,000 annual cases of cervical cancer occur.

In Alabama last year, 76 women died of cervical cancer and 226 new cases were diagnosed. Nationally, 3,000 women a year die from cervical cancer and 10,000 are diagnosed.

Huh said bringing Cervarix to the market has some advantages for women. First, the clinical trial showed conclusively the vaccine not only worked with the two strains of HPV virus at which it was aimed, but it also prevented other strains of the cancer-causing virus.

"It works exceptionally well," he said. "And it's exceptionally safe."

Additionally, since the clinical trial was so large, Cervarix will likely be approved for a larger group of women than Gardasil, Huh said. The FDA decided Gardasil was appropriate for females 9 to 26 years old. Cervarix will likely be made available to women 9 to 45 years old, Huh said.

Cervarix also will bring healthy competition to the market and keep prices low, Huh said. That's an important consideration for a vaccine critically needed throughout the developing world.

Gardasil is expensive, although it is often covered by private insurance. It costs $360 for three doses given over six months. Cervarix also will be given in three doses, but GlaxoSmithKline has not yet announced the price.

Tursi said Cervarix was created for women living in poverty hot spots. "We're looking at this primarily as a developing-world vaccine," he said. [28 June07, DAVE PARKS, The Birmingham News, www.al.com:80/news/birminghamnews/index.ssf?/base/news/1183018753300800.xml&coll=2;
K Parker]  

 

27 August 2007

Guillain Barre syndrome reported after human papillomavirus vaccine. As of May 31, there have been 13 cases of Guillain Barre syndrome (GBS) in association with human papillomavirus (HPV) vaccine (Gardasil) reported to the Vaccine Adverse Event Reporting System (VAERS).

The Centers for Disease Control and Prevention (CDC) notes that six of the patients had received Gardasil alone, and six had also received meningococcal vaccine (Menactra). Since the end of May, an additional two cases have been reported.
[27August 2007,  http://www.aapsonline.org/nod/newsofday458.php, Association of American Physicians and Surgeons, Inc.]

 

20 September 2007

Deaths Associated with HPV Vaccine Start Rolling In, Over 3500 Adverse Affects Reported
As Canada, in large part due to aggressive behind the scenes lobbying, rolls out the not-comprehensively-tested Merck HPV vaccine for girls as young as nine, a look at developments on the vaccine south of the border should cause Canadians serious concern.

In the United States a similar lobby campaign by the same company launched the mass HPV vaccination of girls beginning in June last year.
 
In just little over a year, the HPV vaccine have been associated with at least five deaths, not to mention thousands of reports of adverse effects, hundreds deemed serious, and many that required hospitalization.
 
Judicial Watch, a US government watchdog, became concerned while noting large donations to key politicians originating from Merck.  A freedom of information request from the group in May of this year discovered that during the period from June 8, 2006 - when the vaccines received approval from the U.S. Food and Drug Administration (FDA) -  to May 2007 there were 1,637 reports of adverse reactions to the HPV vaccine reported to the FDA.
 
Three deaths were related to the vaccine, including one of a 12-year-old.  One physician's assistant reported that a female patient "died of a blood clot three hours after getting the Gardasil vaccine." Two other reports, on girls 12 and 19, reported deaths relating to heart problems and/or blood clotting.
 
As of May 11, 2007, the 1,637 adverse vaccination reactions reported to the FDA via the Vaccine Adverse Event Reporting System (VAERS) included 371 serious reactions.  Of the 42 women who received the vaccine while pregnant, 18 experienced side effects ranging from spontaneous abortion to fetal abnormities.
 
Side effects published by Merck & Co. warn the public about potential pain, fever, nausea, dizziness and itching after receiving the vaccine.  Indeed, 77% of the adverse reactions reported are typical side effects to vaccinations.  But other more serious side effects reported include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures.
 
Judicial Watch informed LifeSiteNews.com that a subsequent request for information on adverse reactions to the HPV vaccine, covering the period from May 2007 to September 2007, found that an additional 1800 adverse reactions have been reported, including more deaths.  Exactly how many more deaths occurred will be released in the coming days, Judicial Watch's Dee Grothe informed LifeSiteNews.com.
 
The LifeSiteNews.com report on the moneyed lobbying efforts of Merck in the US was reported in February.  (see http://www.lifesite.net/ldn/2007/feb/07020204.html )
 
However the Canadian lobby effort by Merck's Canadian affiliate Merck Frosst Canada has been underway using powerful lobbyists with close connections to the politicians who have signed off on massive government funded vaccination programs.
 
The Toronto Star recently reported that Merck Frosst Canada Ltd hired public relations giant Hill & Knowlton to push the immunization strategies using some well-connected lobbyists: Ken Boessenkool, a former senior policy adviser to Prime Minister Stephen Harper; Bob Lopinski, formerly with Premier Dalton McGuinty's office; and Jason Grier, former chief of staff to Health Minister George Smitherman.
 
Harper's Conservative Government approved Merck's HPV vaccine Gardasil in July and later announced a $300 million program to give the vaccine to girls from ages 9-13. That of course is only the beginning of what Merck likely hopes will be a much larger vaccination of all potentially sexually active women in Canada who are not already HPV infected. In August, McGuinty's Ontario Liberals, on the advice of his Health Minister George Smitherman, announced that all Grade 8 girls will have free access to Gardasil.
 
One of the major complaints by physicians is that the HPV vaccination program has been implemented before adequate testing has been completed.  Long-term effects of the vaccine remain unknown.  Many are asking why the seemingly reckless rush?
 
At least one answer to that question comes from the fact that Merck currently is the sole provider of an HPV vaccine with its Gardasil product.  A competing HPV vaccine, Glaxo Smith Kline's Cervarix, is set to hit the market in January 2008. As more children are vaccinated with Gardasil, fewer will be able to later receive the necessary repeat boosters of a competing, incompatible vaccine. Merck is in a race to capture as much of the market as it can, consuming many millions of taxpayer dollars.
 
US sales of Gardasil are expected to reach $1 billion in the first year of its availability.
 
The reports from the FDA Vaccine Adverse Event Reporting System detailing the three previous deaths are available here:
http://www.lifesitenews.com/ldn/2007_docs/GardasilVAERSDeath...
 
The reports detailing all 1637 adverse effects are here:
http://www.lifesitenews.com/ldn/2007_docs/GardasilVAERSRepor
[20Sept2007, LifeSiteNews.com; Source URL: http://www.lifesite.net/ldn/2007/sep/07092004.html;
By John-Henry Westen, Toronto]

 

27 September 2007

Gardasil -- New Video Reveals Hidden Dangers
http://articles.mercola.com/sites/articles/archive/2007/09/27/gardasil-new-video-reveals-hidden-dangers.aspx
 
The dangers surrounding Merck’s cervical cancer vaccine Gardasil continue to be revealed. In this video, hear one parent’s heartbreaking story of her 14-year-old daughter’s serious side effects to Gardasil, which are now threatening her physical and mental health.
 
(Watch this video -- 9 minutes 56 seconds)
 
In the case of Gardasil, which is, according to this video, the world’s first genetically altered vaccine, the evidence stacking up against this vaccine is striking.
 
As of August 2007, a review of the National Vaccine Information Center revealed the following, quite alarming, statistic about this unnecessary vaccine: 2,207 adverse reactions to Gardasil have been reported. Among them:
 
    * 5 girls died
    * 31 were considered life-threatening
    * 1,385 required a visit to the emergency room
    * 451 of the girls have not recovered as of July 2007
    * 51 of the girls were disabled
 
This vaccine is also the most expensive vaccine on the market, so you can follow the money trail to find out why Merck is now trying to push this cervical cancer vaccine on boys!
 
Getting the Facts About HPV
 
Health care officials and the media are portraying Gardasil as the long-awaited cure for cervical cancer, and they’re telling people that the side effects are minimal.
 
However, the side effects of this brand-new vaccine are just beginning to surface, and as time goes by, their severity seems to be increasing.
 
Further, while cervical cancer is a serious issue, it is not the epidemic that the media is portraying it to be.
 
Of the more than 6 million cases of HPV that occur each year, about 90 percent of them clear up on their own within two years. If you eat right, exercise, and keep stress in your life under control, your immune system should be healthy enough to clear up HPV. Secondly, the vaccine is not fool-proof. You can still get "non-vaccine" types of HPV even if you get vaccinated.
 
Finally, remember that HPV is a sexually transmitted disease, which means that it is nearly 100 percent avoidable by modifying your lifestyle habits.
 
If you have friends of family members who are considering the Gardasil vaccine for their daughter (or son), please forward this video to them so they can make an informed decision.
[http://articles.mercola.com/sites/articles/archive/2007/09/27/gardasil-new-video-reveals-hidden-dangers.aspx; LifeSiteNews.com, 28Sept07]

 

28 September 2007

~~~~~~~~~~~~~~~
Check Online Yourself - HPV Vaccine Associated with 7 Deaths, 3000+ Adverse Reports through 7/07.
The Free Public Database Lists 44 Life Threatening Reactions & 94 Hospitalizations. An online database, freely available to the public, allows one to search for reported adverse effects from vaccines. The vaccine database covering data for the United States includes the controversial Merck HPV vaccine Gardasil, identified as "HPV4" in the database. This data covers the period of time from the start of the VAERS program in 1990 through the end of July, 2007.
 
The US Government's Vaccine Adverse Event Reporting System (VAERS) database indicates that there have been 7 deaths associated with administration of Gardasil. Age is listed for four of the girls who died at: 11, 12, 15 and 19. VAERS lists 3,137 reported adverse effects stemming from Gardasil. The database is voluntary and thus is unlikely to include all adverse effects from the vaccine.
 
The database, placed online by the National Vaccine Information Center, also indicates 44 adverse effects associated with the vaccine's administration were considered "life threatening".  In 1921 cases, vaccine recipients visited the ER; in 94 cases, vaccine recipients required hospitalization and 20 recipients had extended stays in the hospital. Of the total 1530 are known to have recovered; how much cost and physical and emotional trauma were involved in this experience may never be evaluated.
 
To search the database online visit:
http://www.medalerts.org/vaersdb/index.html
[28Sept07, By John-Henry Westen, Washington, LifeSiteNews.com]
 

 

5 October 2007

~~~~~~~~~~~~~~
US Death Toll Associated with HPV Vaccine Jumps to 11 with 3779 Adverse Reactions Reported:
Judicial Watch files lawsuit against FDA for its failure to fully respond to Freedom of Information request
 Judicial Watch, the public interest group that investigates and prosecutes government corruption, yesterday released new documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing a total of as many as eleven deaths related to Merck's HPV vaccine Gardasil. Those deaths resulted between June 8, 2006 - when the vaccine received approval from the U.S. Food and Drug Administration (FDA) - and August 2007 when the latest data was available.

The adverse reports coming from the HPV vaccine are increasing daily at an alarming rate. A LifeSiteNews.com report which scanned a publicly available database of adverse affects coming from the HPV vaccine found 3,137 adverse effects reported on September 28, 2007. Today the US Government's Vaccine Adverse Event Reporting System (VAERS) lists 3,779 adverse effects. 52 of the cases were deemed "life threatening" and 119 required hospitalization.

In one case highlighted by Judicial Watch a 17 year old girl who was vaccinated in June 2007 died the very day she was vaccinated. According to the report, she "was vaccinated with a first dose of Gardasil…During the evening of the same day, the patient was found unconscious (lifeless) by the mother. Resuscitation was performed by the emergency physician but was unsuccessful. The patient subsequently died."

Other serious reported side effects associated with Gardasil include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures. Says one report: "Initial and follow-up information has been received from a physician concerning an "otherwise healthy" 13 year old female who was vaccinated with her first and second doses of Gardasil. Subsequently, the patient experienced…paralysis from the chest down, lesions of the optic nerve…At the time of the report, the patient had not recovered."

"In light of this information, it is disturbing that state and local governments might mandate in any way this vaccine for young girls," said Judicial Watch President Tom Fitton. "These adverse reaction reports suggest the vaccine not only causes serious side effects, but might even be fatal."

The toll from the HPV vaccine may be greater still. Judicial Watch filed its request on August 20, 2007, and received the adverse event reports from the FDA on September, 13 2007, in what the agency described as a "partial response." On October 3, 2007, Judicial Watch filed a new lawsuit against the FDA for its failure to fully respond to Judicial Watch's FOIA request as required by law.

See the death reports obtained by Judicial Watch:
http://www.judicialwatch.org/archive/2007/GardasilVAERSUpdatedDeaths0907.pdf
[5Oct07, By John-Henry Westen, DC, LifeSiteNews.com]

18 October 2007

Support for HPV Vaccine Gardasil Helps Planned Parenthood Says LDI President. Gardasil, Merck’s questionable new vaccine against cervical cancer is expected to rake in at least a billion dollars in profits from sales, which will leave the pharmaceutical giant with more cash to donate to abortion giant Planned Parenthood.
 
Merck has a long history of supporting abortion and Gardasil profits could turn into a financial boost for Planned Parenthood, especially as US states and Canadian provinces begin either to encourage or require HPV vaccination for girls as young as 9.
 
“You’re going to increase their profits, which mean it’s going to increase the amount [for Planned Parenthood],” said Douglas Scott, President of Life Decisions International (LDI), a group that has a boycott list of organizations that give financial support to the abortion movement. Scott told LifeSiteNews.com that although PP has “more money than they can count” or approximately $480 million in the bank, “You still don’t want Planned Parenthood to get any more money to do any more damage than its already doing.”
 
However, Scott added that Merck’s endorsement is even more important to the abortion provider than its slice of the Gardasil profits.
 
“What they want is the corporate stamp of approval, the (cream of the) crop endorsement. They want to be able to tell people, ‘Merck supports us; we’re a legitimate organization,’” Scott stated. “Any sort of a connection between Planned Parenthood and any corporation only benefits Planned Parenthood on the public relations side, which is a lot more important and more devastating.”
 
Merck waged a heavy campaign earlier in the year advertising Gardasil as a vaccine for cervical cancer caused by the human papilloma virus (HPV) to convince states to mandate vaccination against cervical cancer. However the vaccine only prevents some, not all, of HPV forms contracted through promiscuous sexual activity. The campaign would edge out a competing HPV vaccine, Glaxo Smith Kline's Cervarix, which is incompatible with Gardasil and hits the market in January 2008.
 
Judicial Watch, a government watchdog organization, has uncovered least 11 deaths from Gardasil injections, from a partial release of information from the US Food and Drug Administration. In early October the U.S. Government's Vaccine Adverse Event Reporting System (VAERS) listed at least 3,779 adverse effects of which 52 were deemed "life threatening" and 119 required hospitalization. JW has filed a lawsuit demanding full release of the information from the FDA. Related:  US Death Toll Associated with HPV Vaccine Jumps to 11 with 3779 Adverse Reactions Reported - http://www.lifesite.net/ldn/2007/oct/07100507.html
 
Canada's Conservative Government Distributes $300 Million to Provinces for Controversial HPV Vaccination
http://www.lifesite.net/ldn/2007/mar/07032106.html
[18Oct07, Peter J. Smith, DC, LifeSiteNews.com]
 

6 December 2007

FDA: 28 Miscarriages Not Reason to Reexamine Gardasil
 Since June 2006, when the HPV vaccine Gardasil was approved by the Food and Drug Administration, there have been 28 reported cases in which pregnant women miscarried after receiving the vaccine.

Nonetheless, based on the clinical trials done prior to approval of the drug - which indicated that miscarriages among pregnant women given Gardasil were statistically consistent with miscarriages among women given placebos and in the general population - the FDA remains convinced the vaccine is safe and is not further investigating its effect on pregnant women.

In May, a 24-year-old woman suffered a miscarriage, which an investigator in a report issued to the federal government said, "may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy." 

In July, a 17-year-old girl from Texas was unaware she was pregnant when she got her second dose of Gardasil. She miscarried, but the cause of the miscarriage hasn't been determined, according to a report. The reasons for two other miscarriages this year in Florida - one by a 16-year-old and another by a 24-year-old both - are undetermined, according to reports. But it is known that both women had Gardasil vaccinations shortly before the miscarriages.

Gardasil is the vaccine to prevent the Human Papillomavirus (HPV), a sexually transmitted disease and the leading cause of cervical cancer in women. The package insert for Gardasil states there is "no evidence" the vaccine will cause "impaired female fertility or harm the fetus."

Most of the 28 reports of miscarriage, which were drawn from the Vaccine Adverse Event Reporting System (VAERS), were attributed to "other medical event." VAERS reports contain raw, unanalyzed data sent by concerned parties to the FDA and the U.S. Centers for Disease Control and Prevention. The only Gardasil side effect the FDA has expressed concern about is dizziness immediately after the shot, FDA spokeswoman Karen Riley said. "We've not seen signals" of a disproportionate problem with Gardasil and pregnant women, she said. "If you're pregnant, then it means you've been sexually active," Riley said. "So it would be somewhat dubious to get a vaccine you're supposed to have before you're sexually active."

While there is no conclusive evidence that any health problems have been caused by the vaccine, Judicial Watch, the conservative government watchdog group that obtained the VAERS reports through a lawsuit, is concerned that the FDA is not scrutinizing the vaccine more closely.J

udicial Watch President Tom Fitton said his group wants to know more about the FDA's approval of Gardasil and monitoring of potential problems with the vaccine, which some states either have or are considering mandating for school girls. "Merck lobbied for these mandates," Fitton told Cybercast News Service . "There are moral issues here. But the primary issue is public health and safety. It's interesting why our government downplays the apparent adverse reactions of Gardasil. Why are drugs with a distinct social agenda getting less scrutiny in the approval process?"

Riley stressed that the numbers concerning the pregnancies must be placed in context. "Have they (Judicial Watch) compared that to a similar group of young pregnant women of the same age group who haven't had Gardasil?" Riley said. "There is always a certain percentage of children born with abnormalities among any sampling. The only way to say if there is a causality relationship is to compare one group to see if they have a higher rate than another group." 

A total of 3,461 adverse reactions, including eight deaths, were reported to the government through the VAERS system since the FDA approved the drug.

Reproduction studies were conducted on female rats at doses up to 300 times the human dose, according to Merck. The tests on the lab rats showed no adverse effect on reproduction or pregnancy. However, the company literature on Gardasil said, "It is not known whether Gardasil should be given to pregnant women." During Merck's clinical trials of 2,226 women, half got the Gardasil vaccine, and the other half got a placebo or empty vaccine.

In that group, 40 on Gardasil and 41 on the placebo had an adverse event in their pregnancy. The most common adverse events were conditions that can result in cesarean section or premature labor. The portions between the Gardasil and placebo were comparable, Merck said.

Merck spokeswoman Jennifer Allen said 2 to 3 percent of the women who became pregnant during the clinical trials had children with problems, and roughly 15 percent of those had miscarriages. This, she said, mirrors the general public of pregnant women, regardless of whether they had the vaccine. Pointing to the fact that VAERS reports are raw data, she said there was little reason to believe a causal relationship existed.

"It's what you see in the database of the general population," Allen told Cybercast News Service . "VAERS are passive reports. It's plausible someone would get the vaccine, leave the doctor's office and walk into a pole. You could report that and VAERS would accept it."

Much of the controversy surrounding Gardasil pertains to the fact that three states - Massachusetts, New Jersey, and Virginia - are mandating sixth-grade girls get the vaccine, and other states are considering such a mandate.  The three states included an opt-out provision, which would let parents choose not to have the vaccine administered to their child for religious or other reasons.

Meanwhile, 38 other states this year passed or considered some type of legislation either mandating, funding, or educating the public about the vaccine, according to the National Council of State Legislatures. New Hampshire and Alaska adopted a voluntary program that supplies the vaccine for free to girls between ages 11 and 18 who want it. Meanwhile, abroad, the British Department of Health approved a national mandate for school girls to get the vaccine.

After the FDA approved Gardasil, the Advisory Committee on Immunization Practices recommended routine vaccinations for girls ages 11 and 12. HPV infects 20 million people in the United States, with about 6.2 million new cases each year, according to the Centers for Disease Control and Prevention. HPV is responsible for nearly 70 percent of cervical cancer cases. The American College of Pediatrics and the New England Journal of Medicine have voiced opposition to mandating the vaccine.[CNSNews ^ | 12/6/2007 | Fred Lucas www.cnsnews.com/ViewCulture.asp?Page=/Culture/archive/200712/CUL20071206a.html]
 

10 December 2007

Despite Deaths and Miscarriages, FDA Refuses to Investigate HPV Vaccine

Rather than investigate thousands of complaints of adverse effects including reports of miscarriage in a Human Papillomavirus (HPV) vaccine, the FDA has chosen to ignore the complaints and continue paving the way to make the drug mandatory in schools throughout the U.S.

Gardasil, a vaccine designed to prevent HPV, was approved by the FDA in June 2006 for girls as young as nine years old. Since that time, more than 3,000 adverse reactions were reported to the FDA, including eleven deaths and twenty-eight. miscarriages. The deaths were caused by blood clotting, one case in a girl who was only twelve years old.

Gardasil co-creator Ian Frazer and manufacturer CSL dismissed allegations of the deaths being associated with the drug, claiming the women died of unrelated causes.

The miscarriages were all caused soon after the administration of Gardasil, in girls and women who were not aware they were pregnant. Although the drug's packaging states there is no evidence it will cause impaired female fertility or harm the fetus.

Despite the complaints, the FDA said it is only concerned about dizziness as a side effect immediately after the administration of the drug. FDA spokeswoman Karen Riley downplayed the miscarriages, saying that girls should have taken the drug before becoming sexually active, not after.

"If you're pregnant, then it means you've been sexually active," she said. "So it would be somewhat dubious to get a vaccine you're supposed to have before you're sexually active."

Massachusetts, New Jersey, and Virginia have already made the drug mandatory in their schools in an effort to prevent HPV, a sexually transmitted disease and the leading cause of cervical cancer. Thirty-eight states are considering making the Gardasil vaccine mandatory as well.

Judicial Watch, a U.S. government watchdog organization, gathered the information on the drug's adverse effects and traced its progress through legislation. Judicial Watch also noted large donations to key politicians originating from Merck, Gardasil's developer.

"Merck lobbied for these mandates," Said Judicial Watch president Tom Fitton in an interview with Cybercast News Service . "There are moral issues here. But the primary issue is public health and safety. It's interesting why our government downplays the apparent adverse reactions of Gardasil. Why are drugs with a distinct social agenda getting less scrutiny in the approval process?"

Concerned Women for America (CWA), an organization pledged to protect and promote Biblical values among all citizens, has expressed shock that the FDA would not take the reported incidents seriously.

"It's interesting so many drugs have taken so long to process and these are approved almost immediately," said a spokeswoman for CWA. "The refusal to investigate is a disservice to women around the world."

See previous LifeSiteNews coverage:

Deaths Associated with HPV Vaccine Start Rolling In, Over 3500 Adverse Affects Reported
http://www.lifesite.net/ldn/2007/sep/07092004.html

Drug Conglomerate funds campaign to impose Mandatory HPV Vaccine on Young Girls
http://www.lifesite.net/ldn/2007/feb/07020204.html

US Death Toll Associated with HPV Vaccine Jumps to 11 with 3779 Adverse Reactions Reported
http://www.lifesite.net/ldn/2007/oct/07100507.html
[10 December 07, John Connolly, Rockville, MD, www.LifeSiteNews.com] 

19 December 2007

Why Health Authorities Cannot be Trusted on Gardasil HPV Vaccine. Medical health authorities have repeatedly assured us that Gardasil, the vaccine injection given to young girls to allegedly prevent cervical cancer, is perfectly safe. For example, the National Advisory Committee on Immunization, a group of medical specialists, endorsed the vaccine last February. The Society of Gynecologic Oncologists of Canada claims the vaccine is safe, as does Dr. David Butler-Jones, Canada's Chief Public Health Officer. The Canadian Pediatric Society and the Society of Obstetricians and Gynecologists of Canada have also endorsed the vaccine.
 
These medical authorities, however, are puzzled and also indignant that the use of this vaccine still remains controversial, ever since it was rolled out in lightening speed after Ottawa announced a $300 million funding package for participant provinces. After all, they reason, they have approved the drug, so what is the problem? Surely their expert opinion should be sufficient to allay the public's fears about the drug?
 
The reason the public has good reason to distrust the judgement of these medical authorities is because of their experience with them. It is a fact that the public has heard many similar assurances about other drugs, and used them to their lasting regret. For example:
 
- In the 1960's, thalidomide was pronounced a safe drug for pregnant women experiencing morning sickness. It was not safe, as thousands of adults with flipper arms and legs can attest.
 
- In the 1960's, the birth control pill was developed and women were assured that its use had no harmful side effects. Studies now report that the pill can be the cause of a greatly increased risk of stroke, heart attack and blood clots if taken for eight years or more. (British Journal of Medicine, 16 or 17 September, 2007).
 
- Between 1938 and 1971, as many as 4 million U.S. women and many Canadian women took the drug, diethylstilbestrol (DES) to prevent miscarriage. Daughters of these women who were exposed to DES in utero have experienced a range of structural reproductive tract abnormalities in the uterus, cervix and vagina. The incidents of abnormality occurs in 18% of cases, but it may be as high as 33% in women exposed to DES in utero. The male offspring of women who took DES during pregnancy, also have an increased incidence of genital abnormalities and a possibility of increased risk of prostrate and testicular cancer.
 
- Merck Frosst, the manufacturer of Gardasil, also developed a much-acclaimed painkiller called Vioxx, that was subsequently used by thousands of individuals suffering from arthritis. Unfortunately, the drug had the side effect of causing heart attacks and strokes. As a result, the medication was taken off the market in 2004 and Merck Frosst is now facing thousands of class action suits amounting to billions of dollars in claims.
 
- By 2001, 15 million women in the U.S. alone, as well a millions of women in Canada and abroad, were taking hormone-replacement therapy (H.R.T.). It became one of the most popular prescription drug treatments for menopause, supposedly to allow women to lead a long and healthier life. However, in July 2002, estrogen therapy was exposed as a hazard to health, rather than a benefit. It was found to constitute a potential health risk for post-menopausal women by increasing risks of heart disease, stroke, blood clots and breast cancer. The question lingers unanswered, as to how many women may have died prematurely because their physician prescribed this medication? A reasonable estimate would be tens of thousands of women. (New York Times, September 16, 2007).
 
- Europe's largest drug manufacturer GlaxoSmithKline developed and sold the diabetic drug Avandia, it's second best selling product last year, which was subsequently linked to a higher risk of heart attacks according to a study released in May 2007. This caused sales of the drug to drop 38%.
 
These are just a few examples of the here-today gone-tomorrow nature of medical wisdom. What we are advised about with confidence one year is reversed the next. One of the contributing factors to this reversal is that the kind of experimental trials necessary to determine the truth about the medication is excessively expensive and time-consuming and very often does not happen. Hence, the problem with these new drugs so enthusiastically recommended by the medical profession.
 
It is alarming that Gardasil's approval was based on the testing of only a few thousand patients and almost not at all (only 1200) on young girls, 9-13 years old, who are targeted for injection of the drug. (See REALity Sept/Oct. 2007, p. 5)
 
As its marketing plan, Merck Frosst used lobbyists with access to important public officials. In Canada, Ken Boessenkool, now with the public relations firm of Hill and Knowlton in Calgary, lobbied the federal government on Merck Frosst's behalf. Mr. Boessenkool was a former advisor to Prime Minister Stephen Harper when he was opposition leader. Jason Grier, former executive assistant to Ontario Health Minister George Smitherman, also lobbied on behalf of Merck and Ontario has now decided to administer the drug to young girls.
 
Even though only approximately 2-5% of women have Pap smears with cell changes due to HPV, the medication was pushed as a preventative cure for cervical cancer. However, no mention was made of the fact that the drug does not protect against other sexually transmitted diseases, such as chlamydia, herpes, hepatitis, trichomoniasis, gonorrhea, syphilis, HIV, AIDS, etc. It's all promotion; facts do not count.
 
The long-term consequences of Gardasil are not known. The manufacturer admits this and agrees it does not know its effect on young girls' cancer risk, on their immunity system, on their reproductive system, or its genetic effects. In due course, we will know this, possibly in twenty or thirty years from now when these young girls, the innocent subjects of the Gardasil experiment have become grown women and then report the consequences of their having taken the medication in their childhood on medical advice.
[This artcicle was originally published in the Nov./Dec. edition of REAL Women of Canada's Reality magazine. Republished with permission; 19Dec07, LifeSiteNews.com, Gwen Landolt, Toronto]

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CERVARIX

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[ED.The following is in no way an endorsement of Cervarix. It is simply presented as another of the same -- an HPV vaccine with a questionable reason for being pushed (even railroaded through in many cases). While it is certainly good to have an HPV vaccine, testing is still not complete, the age at which girls are being vaccinated is still questionable, there are many adverse effects to the vaccination, most multiple vaccinations have not been studied, and so many questions still remain linking the purpose of this vaccination to political and economic motives,that we must wonder, prior to release of Cervarix in the USA, if the same questions will persist...]

GlaxoSmithKline (GSK) has been granted EU approval of its adjuvanted cervical cancer vaccine Cervarix, and is confident that the jab can challenge the likes of Merck's high-profile Gardasil.
 
The vaccine has been approved for the prevention of pre-cancerous cervical lesions and cervical cancer causally related to human papillomavirus (HPV) (types 16 and 18), and formulated with GSK's novel AS04 adjuvant system is said to offer broad, extended protection to women given the jab.
 
Gardasil beware, Cervarix hot on your heels
By Anna Lewcock  25Sept07
http://www.drugresearcher.com/news/ng.asp?n=80037&m=1DRG925&c=eepddtxhprfgmgi
25/09/2007 - GlaxoSmithKline (GSK) has been granted EU approval of its adjuvanted cervical cancer vaccine Cervarix, and is confident that the jab can challenge the likes of Merck's high-profile Gardasil.
 
The vaccine has been approved for the prevention of pre-cancerous cervical lesions and cervical cancer causally related to human papillomavirus (HPV) (types 16 and 18), and formulated with GSK's novel AS04 adjuvant system is said to offer broad, extended protection to women given the jab.
 
The AS04 adjuvant is formulated with aluminium hydroxide combined with a novel substance known as monophosphoryl lipid A (MPL).  MPL directly activates key immune mechanisms, enhancing the initiation of the immune response by activating innate immunity leading to an improved cellular and humoral adaptive immune response, according to GSK.
 
"We believe our innovative adjuvant provides a real boost, with broader and longer-lasting protection for women," a GSK spokesperson told in-PharmaTechnologust.com.
 
The adjuvant has been shown to offer significant benefits over traditional aluminium salt based adjuvants, such as the one used in Merck's Gardasil vaccine.
 
In clinical trials, Cervarix adjuvanted with AS04 compared to the same antigens adjuvanted with aluminium hydroxide alone showed antibody titres at least two fold higher (analysed up to four years after first dose), 'significantly higher' functional antibody titres (analysed up to four years after first dose), and B cell memory frequency approximately two fold higher (analysed up to two years after first dose).
 
Data from a Phase III clinical study demonstrated that Cervarix provides 100 per cent protection against pre-cancerous lesions causally associated with HPV types 16 and 18, with long term data also showing 100 per cent sustained protection for up to five and half years after vaccination.
 
The vaccine will now be launched across the EU over the coming weeks, offering a new option to protect women against cervical cancer.
 
"The real revolution Cervarix represents is the number of abnormal pap smears that it prevents," the GSK spokesperson commented.
 
"Many women jump to conclusions when they receive an abnormal result, the vaccine will help prevent this emotional turmoil."
 
Head to head
 
So confident is GSK in its cervical cancer vaccine, that in January the company announced that it would be initiating and funding a head to head trial between Cervarix and Merck's high-profile vaccine, Gardasil.
 
Over 1,000 women will be taking part in the trial, which will compare immune responses to cancer-causing virus types 16 and 18 in various age groups, as well as immune responses to other cancer-causing virus types.
 
The trial is "an indication of [GSK's] confidence in Cervarix' superiority," in-PharmaTechnologist.com was told, so Merck should perhaps keep an eye on the new vaccine and the challenge it could pose to its Gardasil franchise.
 
Gardasil itself generated $723m (€513m) over the first half of this year, representing a major contribution to Merck's coffers and a key player in its vaccine portfolio.
 
Cervarix, however, may yet pose a threat to trailblazer's market share.  US approval is anticipated in early 2008, with GSK also planning to apply to the World Health Organization to obtain prequalification status for Cervarix and make it available in developing countries where there is a very high incidence of cervical cancer.
http://www.drugresearcher.com/news/ng.asp?n=80037&m=1DRG925&c=eepddtxhprfgmgi