Cancer Facts

Cancer begins in cells, the building blocks of tissue which make up the organs.  Normally, cells grow and divide to form new cells as the body needs them. When cells grow old, they die and are replaced with new cells.   The problem comes in when abnormal cells "appear" and start multiplying.   The abnormal multiplications form masses resulting in growth or tumors.  In the case of cervical cancer, abnormal cells found in pap smear screenings do not necessarily mean "cancer".    Abnormal cells can lead to cancer.  However, they do not define cancer of the cervix.

Cervical cancer, in the lining of the cervix, affects about 13,000 women in the U.S. each year. Cervical cancer occurs at an average age of 54.  About 4,000 die. Worldwide, a half million get the disease and 225,000 die.

In the 1970s, herpes simplex virus (HSV) was touted as the cause of cervical cancer.  This based on population studies that showed a correlation of the disease with HSV dna. The blame shifted to human papillomavirus (HPV) in the 1980's.

The HPV is a group of more than 100 viruses.  About 30-40 of which are supposedly linked to cervical cancer. Of these 30 or so, HPV-16 is said to be found in 50% of cervical cancers. HPV-18 supposedly accounts for 20%.

In 1992 molecular biologists of the University of California at Berkely, Peter Duesberg and Jody Schwartz, questioned the theory that HPV causes cervical cancer.   They were concerned about the lack of consistent HPV DNA sequences and consistent HPV gene expression in tumors that were HPV-positive. They said quite possibly "carcinogens may be primary inducers of abnormal cell proliferation rather than HPV or HSV." And here’s the key point: "Since proliferating cells [cancer cells dividing wildly] would be more susceptible to infection than resting cells, the viruses would just be indicators rather than causes of abnormal proliferation."  Even though the National Cancer Institute (NCI) admits that the "direct" cause of cervical cancer has not been demonstrate, they work with the theory that it has been.  Since 2003 even the FDA has been well aware that the human papillomavirus (HPV) does NOT cause cervical cancer. They acknowledged this fact in their statement March 31st, "most infections by HPV are shortlived and not associated with cervical cancer. Most women who become infected with HPV are able to eradicate the virus and suffer no apparent long term consequences to their health." Repeated transient HPV infections even when caused by high risk types of HPVs are characteristically not associated with an increased risk of developing squamous intraepithelial lesions, the precursor lesion of cervical cancer.

According to the New England Journal of Medicine, women face an increased risk of cervical cancer if their mothers took the world's first synthetic female hormone during pregnancy. These women were known as 'DES daughters' because their mothers took diethylstilbestrol (DES) and labeled to have higher rates of infertility and miscarriages. DES has also been linked to a higher risk of developing a relatively uncommon type of cancer at an early age, known as clear-cell adenocarcinoma of the vagina and cervix. 

Current guidelines from the American College of Obstetricians and Gynecologists suggest that most women should have annual Pap tests. The American Cancer Society guidelines suggest that screening less frequently than every year might be adequate for women who have had three negative annual tests.  CDC backs this up by warning in a 2000 weekly report (MMWR), that women who get annual pap smears may receive no benefit over women who are tested less frequently.  They even say it may in fact be causing harm since frequently tested women may also be at increased risk of unnecessary treatment and anxiety.

"Many times, especially for low-grade abnormalities, there's a lot of false positives (results which appear positive, but are in fact negative), and women may be biopsied and receive other treatment because of the Pap test result," Dr. Mona Saraiya from the CDC told Reuters Health. "These symptoms might have gone away if we'd left (the women) alone," she added. ""There needs to be more research to show what actual harmful morbidity is associated with an abnormal Pap."

The [CDC] researchers concluded that "Women who were screened annually rather than less frequently might have worse health outcomes if low-grade results of undetermined clinical importance lead to further testing and unnecessary patient morbidity and anxiety".  Thus the reason for recommending pap screenings once every three years only.   

Dr. Nancy Lee is the Associate Director for Science, within the Division of Cancer Prevention and Control of the National Centers for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia.  She testified before the House Committee March 16, 1999 that the incidence rate for all U.S. women is about 8 per 100,000 and that cervical cancer rates have [already] been dropping for several years. The cervical cancer death rate declined 45 percent between the periods 1972-74 and 1992-94 and the overall incidence of the disease has decreased steadily from 14.2 per 100,000 in 1973 to 7.4 per 100,000 in 1995.  According to the American Cancer Society, "Between 1955 and 1992 the number of cervical cancer death in the united states dropped by 74%"

Most young adults who have been sexually involved and exposed to HPV naturally clear the virus from their body, thus going on to live normal healthy lives.  Deaths associated with cervical cancer are very low on the totem pole of leading cancer killers for women with lung cancer at 68,000 deaths annually, breast cancer at 42,000 deaths, colorectal cancer at 29,000 deaths, ovarian cancer at 14,000 deaths, skin cancer at 9,600 deaths, and uterine cancer at 6,500 cancer deaths.  Pap smears potentially prevent nearly 100% deaths caused by cervical cancer.    One can only ask why Merck and CDC are pushing for a vaccine when the war against cervical cancer is practically already a success story.

HPV is not only sexually transmitted.   It is a skin-to-skin transmission also.  It is well documented in multiples papers.  3 year olds, 5 year olds, 10 year olds and women who have never had sex, have been diagnosed with HPV markers. 

At last, now there's a vaccine touted as a medical break through in combating cancer.  However, neither Merck, CDC nor the FDA have been forthright about the trials prior to vaccine licensure of Gardasil June 2006. 

Merck’s clinical trials did not prove the human papillomavirus (HPV) vaccine, designed to prevent cervical cancer and genital warts, is safe to give to young girls.  Merck and the FDA do not reveal in public documents exactly how many 11 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. For example, if there were fewer than 1,000 little girls actually injected with three doses of Gardasil, it is important to know how many had serious adverse events and how long they were followed for chronic health problems, such as juvenile arthritis.

The study consisted of 2,392 young women. 36 percent were disqualified primarily because they had detectable HPV markers before the trial.   The study was selected for women who showed some sort of robust natural immunity that kept them from expressing the HPV markers.   859 were excluded from the final data analysis for technical reasons and the vast majority were found to be infected with HPV-16 before getting the vaccine.

Of 1,533 women who remained, half were given the vaccine and half the placebo shot.  The placebo used contained a potentially reactive aluminum and a non-reactive saline solution. A reactive placebo can artificially increase the appearance of safety of an experimental drug or vaccine in a clinical trial. 

Animal and human studies have shown that aluminum adjuvants can cause brain cell death and that vaccine aluminum adjuvants can allow aluminum to enter the brain, as well as cause inflammation at the injection site leading to chronic joint and muscle pain and fatigue. Nearly 90 percent of all Gardasil recipients and 85 percent of aluminum placebo recipients reported one or more adverse events within 15 days of vaccination, particularly at the injection site. About 60 percent of those who got Gardasil or the aluminum placebo had systemic adverse events including headache, fever, nausea, dizziness, vomiting, diarrhea, myalgia. Gardasil recipients had more serious adverse events such as headache, gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis. Gardasil contains 225 mcg of aluminum and, although aluminum adjuvants have been used in vaccines for decades, they were never tested for safety in clinical trials. Merck and the FDA did not disclose how much aluminum was in the placebo.

Fifteen women in the Gardasil group and 16 in the placebo group gave birth to babies with abnormalities. Five of the babies were conceived by women 1 month after they received the vaccine.   The rest were conceived by women after 1 month of injection with Gardasil.   In the same report, Gardasil was also found to cause an increase in abnormal/precancerous cells in the cervix.  It doesn't take rocket science to intelligently translate that into an increased risk for cervical cancer.   Contradictory to Merck's add campaign of "one less", girls taking the vaccines are actually at an increased risk of being one more in the cervical cancer statistics.  Of those who received the placebo shot, 41 women became infected with HPV-16, and nine of them had precancerous cervical growths.

Then the study used a cancer detection method which is known to be inaccurate, with a rate of false negative test results that ranges from 1 percent to 93 percent, despite the fact that it is the only test currently available in the United States to screen women for signs of cervical cancer. (A false negative result means that women who have cervical cancer or precancerous tissues are not being identified when they have a Pap smear.)"

The women in this study were only monitored for HPV infection if they show a positive Pap smear. But since even the CDC recognizes that the Pap test produces a wide range of false negative results, the HPV study’s Pap test is so unreliable that the rest of the study is raises much suspicion.

A positive result was defined as any PCR signal that exceeded the background PCR level associated with an HPV-negative sample of human DNA. This is a risky protocol because PCR tests are plagued with false positive reactions (a positive signal that is not a true detection of the target). Since the authors show no data or reference to data on a secondary test that confirms the gene sequence of a positive signal, they cannot conclude that they are measuring HPV." 

According to Merck's product insert, there was 1 case of juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of arthritis, and 1 case of reactive arthritis in 11,813 Gardasil recipients plus 1 case of lupus and 2 cases of arthritis out of 9,701 participants primarily receiving an aluminum containing placebo. 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.

Dr. Diane Harper is a lead researcher in the development of the HPV vaccine and she criticizes the way Gardasil has been marketed.  She has studied the Human papillomavirus for over 20 years.  She admits that giving this vaccine to girls as young as 11 years old is a "great big public health experiment" and that it has NOT been tested for effectiveness for them.  She also says that it will not protect girls at all that are as young as nine years old.

Harper feels the ideal way to vaccinate women is to offer it at 18 years of age.  She says these women should be screened for HPV.  If the test results are negative then they should schedule the 3 shot series.  She admits that if the test comes back positive there is truly no understanding of how to medically respond to that.

"The zealousness to inoculate all these younger girls may very well backfire at the very time they need protection most." Harper says.  "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."  Clearly if it has not been tested for efficacy in 11 year old girls, it is neglectful and wrong for CDC and politicians to even suggest [much less recommend] the vaccine to be effective or safe for nine year old girls.  Physicians should be careful not to follow in such disgrace by administering the vaccine to these young girls. 

“Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now,” Angela Raffle, a specialist in cervical cancer screening with the National Health Service in Britain said “There is no need to rush...If we do this quickly and badly, we could cause more deaths,” from side effects, for example, or from giving girls false security that they are protected for life and no longer need to be screened..

"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," says Harper.

Merck has not been able to prevent cancer.  Not in the trials and not now.  Gardasil is not 100% effective against HPV.  Harper reminds us that it is only 100% effective against two types of HPV. Those would be the two high risk types [HPV-16 and PHV-18].  The other two [HPV-6 and HPV-11] are low risk and have not been associated with cervical cancer.  As stated earlier, 3 year olds, 5 year olds, 10 year olds etc. have been diagnosed with HPV infection without sexual contact.  If a young girl already has HPV-16 and HPV-18 markers before inoculation, the vaccine will not protect her from infection of those strains.  The only way to test for the presence of HPV is to conduct a vaginal swab, which is inappropriate to do with young girls.    Merck assumed that because older girls did not show up with HPV markers after inoculation, the young girls (as young as 9 years old) would be protected as well.  Sound science does not run on assumptions.

Clearly, three years of studying the safety and efficacy of a vaccine against a cancer that takes decades to develop is not long enough.  There is no science in fast tracking trials or a vaccine for cervical cancer and then presuming safety and efficacy.  The third phase of the trial was not even completed before the vaccine was licensed.  "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," says Barbara 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. With cervical cancer causing LESS than one percent of all cancer deaths in American women due to routine pap screening, it was inappropriate for the FDA to fast track Gardasil. It is way too early to direct all young girls to get three doses of a vaccine that has not been proven safe or effective in their age group."   

Not missing a step shortly after it's FDA approval, the CDC ACIP branch recommended Gardasil for children registered in school (girls) June 2006.  In September Michigan was the first US state to propose a bill that would recommend the vaccine for girls registered in the public schools.  While Virginia, Colorado and Texas push for GARDASIL mandates, Michigan ends up banning the vaccine.

Since the approval of the vaccine there were just under 400 reports listed of adverse effects to the [CDC and FDA] compiled database for 2006.  Starting in July [month after it was FDA approved] the number of reports continued to escalate coming from 43 states by December 2006.  Below are some of those reported reactions listed on the VAERS database experienced by girls given only GARDASIL [no other vaccines administered at appointment].

• the patient experienced extreme pain at the injection site.  The onset of the pain was immediate
• 1 hr after vaccination, pt reported to feel dizzy, weak, vision went black for a few seconds, got pale with purple lips x 1/2hr. Felt better after drinking OJ. Then got temp 101F and chills x 1 day.
• Vaccine given after physical. Pt fainted, vasovagal, hit head on carpeted cement floor. Loss of consciousness 1 min, had tonic posturing of right hand only some shaking.
• pt developed a rash and hives. It was reported that this was not an injection site rash. The pt presented to her physician's office on 18Aug06 with hives all over her body.
• patient developed a swollen thumb and her palms became red and hot. The patient later developed a tightness in her chest. The patient was immediately taken to a physician (an allergist who was the mother's employer) who immediately gave the patient a huge dose of cetirizine hydrochloride and acetaminophen as an intervention.
• experienced slurred speech
• patient experienced profuse nausea, vomiting, low grade fever and myalgia
• the patient fainted (this appeared to be common in the database after HPV injections)
• patient developed "flu-like symptoms"
• patient stated that "right after getting the shot" she experienced pain in the upper arm on and off throughout the day.  She also stated that the pain"feels like she has a knife in her arm".

 The above are "notes" which were accompanied with other numerous listed symptoms for each individual such as

• speech disorder

• influenza

• tremor

• abnormal thinking

• eyes with fixed upward gaze

• herpes

• herpes simplex

• hepatitis (type not specified)

• anorexia

• Gillian barre syndrome [five cases]

• abdominal pain

• grandmal seizures

• facial paralysis

While the VAERS database only has 5 cases of Gillian Barre Syndrome listed, there were actually  40 cases within the first six months after Gardasil was approved by the FDA.  Dr. Harper confirms this.  These cases are from girls who received Gardasil along with the meningitis vaccine.  Scientists admit that vaccines can trigger GBS and that they didn't expect the numbers to be as high as they are in association with Gardasil.

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

Because Gardasil was only administered by itself or with Hepatitis B during the trials, doctors administering Gardasil with any other vaccine is admittedly conducting experimentation.   Clearly, we are now seeing what is happening with young girls vaccinated with Gardasil and one or more other vaccine(s).  Just look through the VAERS database.  

Now, let's go back to that question of why CDC  and Merck would push to have this vaccine mandated.   The answer: Money.  Where is the  the money coming from?  Merck.   Where is it going to?  Those pushing for the vaccines.   Who's pushing? Politicians...and then it comes back full circle to MERCK who stands to profit billions. 

Hundreds of doctors have been recruited and trained to give talks about Gardasil — $4,500 for a lecture — and some have made hundreds of thousands of dollars in the USA. Politicians have been lobbied and invited to receptions urging them to legislate against a global killer. And former state officials have been recruited to lobby their former colleagues.

“There was incredible pressure from industry and politics,” said Dr. Jon Abramson, a professor of pediatrics at Wake Forest Univeristy  who was chairman of the committee of the CDC that recommended the vaccine for all girls once they reached 11 or 12.

“This big push is making people crazy — thinking they’re bad moms if they don’t get their kids vaccinated,” said Dr. Abby Lippman, a professor at McGill University in Montreal and policy director of the Canadian Women’s Health Network. Canada will spend $300 million on a cervical cancer vaccine program.

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

The only state to pass a bill requiring the vaccine for school entry is Virginia; it takes effect in October, after school begins, so will first apply in 2009.   Merck has a growing economic interest in Virginia. In December 2006, Merck announced it would invest $57 million to expand its Elkton, Va., plant to make Gardasil, helped by a $700,000 grant from a state economic development agency that is part of the executive branch. As in many states where cervical cancer legislation has been considered, there have been ties between drug makers and members of government. In 2006, one of Merck’s newly hired Virginia lobbyists was Sandra D. Bowen, who had spent years as Virginia’s secretary of administration. And Bill Bolling, the state’s lieutenant governor, became an outspoken participant in the “Ending Cervical Cancer in Our Lifetime” campaign, a program started in 2006 by the National Lieutenant Governors Association and financed largely by Merck and Glaxo.Since 1997 Merck has given $197,000 to Virginia politicians and campaign committees.  The Virginia Public Access Project, a nonprofit campaign finance watchdog has found that "The pharmaceutical giant has given $10,000 to Del. Phil Hamilton, R-Newport News, and $4,100 to Sen. Janet Howell, D-Fairfax." With such generous incentives, they have pushed vaccine mandates through the State Senate and House of Delegates claiming that it's not about Merck, but about fighting cancer.  Yah, right.  We can't forget about Texas Governor Perry who also got Merck incentives to push for the Gardasil mandates for fall 2008.  What other state lawmakers pushing for the vaccine are getting incentives from Merck?  What could be driving this? Merck has lost millions in recalls and lawsuits over VIOXX which was found to increase risks of heart attacks and strokes.   Should parents have their hands tied to a vaccine that is clearly dangerous including 14 deaths that took place during trial?