Tuesday, August 25, 2009

Gardasil — Exempt from Truth in Advertising Standards?

People who ask questions about Gardasil are invariably told that they’re scientific ignoramuses, endangering their children with their crazy paranoia. Last week, however, JAMA, the Journal of the American Medical Association, issued stinging critiques of the over-selling of the HPV vaccine and the potential skewing of any risk/benefits analysis. It was rare criticism from the medical profession.

The truth is, we have more legal protection from an under-powered blender than we do from a vaccine.

Gardasil could well be the best thing since the invention of SmartPhones. But it could also alter our life for the worse, permanently, or it could simply be a waste of time and money. Merck and the FDA are making highly educated guesses, but you’d never know that from the hype. As consumers, isn’t it time we started demanding a little respect and honesty? Don’t we deserve sufficient information to come to a reasonable decision?

Under the Federal Trade Commission Act, advertising must be truthful and fair, and it must not deceive. Advertisers must have evidence to back up their claims. An ad is considered deceptive if it either contains a statement or omits information that might well mislead consumers who are acting reasonably under the circumstances. It also must not omit information that is important to a consumer’s decision to use or buy the product.

With Gardasil’s unprecedented marketing, said Drs. Sheila and David Rothman in JAMA, “by making the vaccine’s target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to adolescents was maximized, and the sub-populations most at risk practically ignored…the material [put out by Merck-funded PMAs] did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on the risks and benefits.”

Science can be defined as ‘what we know so far.’ Or as Dr. Charlotte Haug put it in her JAMA editorial about Gardasil, “medical knowledge is typically incomplete and ambiguous.” Often, what we think we know turns out to be wrong, or just the tip of the iceberg. It would be totally irrational to reject all medical science on the basis that we might find out something to the contrary later, but it is equally irrational to try to make a decision about a new treatment without being in possession of all the known facts, particularly when huge financial benefits to the vendor weigh in.

“GARDASIL is the only cervical cancer vaccine that helps protect against 4 types of human papillomavirus (HPV): 2 types that cause 70% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases,” says Merck. “Be one less,” say the ads. The implication: if you don’t get Gardasil, you do get cervical cancer.

Here’s my Truth in Advertising version.

Gardasil targets the two strains of the HPV virus that currently cause 70 percent of cases of cervical cancer and two strains that cause genital warts. Your chance of dying from cervical cancer is extremely small if you have regular check-ups. HPV may also cause (even more rarely) cases of oral cancer, anal cancer, and penile cancer. We do not yet know whether Gardasil will be effective against these cancers and will not know for several decades, but the hypothesis seems likely to some degree.

You can reduce your small chance of developing HPV-related cancers dramatically by eating healthy foods, by not smoking, by limiting your sexual partners, and by undergoing regular screenings. 95 percent of cases of HPV are currently shrugged off by the body. You should consider your lifestyle honestly when making a risk/benefit analysis.

Gardasil may offer some further protection. After 3.6 years, the results from two randomized, placebo-controlled trials following 17,622 women who were vaccinated with Gardasil after showing no previous exposure to 14 HPV types and had normal Pap smears to begin with were:

· 17 to 22 percent reduction in ASC-US: atypical squamous cells of undetermined significanceassociated with a high-risk type of HPV

· 17 percent reduction in LSIL: low-grade squamous intraepithelial lesion

· 36 percent reduction in ASC-H: atypical squamous cells/cannot exclude high-grade squamous intraepithelial lesion

· 45 percent reduction in HSIL: high-grade squamous intraepithelial lesion

Colposcopies were reduced by 20 percent, cervical biopsies by 22 percent and surgery and other invasive treatments by 42 percent.

Protection against genital warts appears to be extremely good.

We do not know whether replacement diseases will occur should non-vaccine strains of the virus (there are more than 100, and at least 15 are known to be oncogenic) fill the biological niche left by vaccine strains. We do not believe that this is likely but the vaccine Prevnar has shown that it can happen.

We do not know how Gardasil will affect natural immunity to the more than 100 strains of HPV.

We do not know how long immunity will last and whether single, or perhaps multiple, booster shots will be necessary. We do not know whether, should immunity to HPV-16 and HPV-18 wear off, older adults will be able to fight off the virus as well as younger adults.

Data from the passive VAERS system that is used to monitor vaccine adverse events, along with data from clinical trials, appears to indicate that Gardasil is well-tolerated by the vast majority of individuals. The FDA has determined a slightly greater risk of fainting and associated injury and of blood clots.

Anecdotal evidence and VAERS reports associate Gardasil with an increased risk of auto-immune disease and neurological problems, including rapid-onset ALS, arthritis, Graves Disease, paralysis, seizures, chronic headache, etc., predominantly in very active girls, but no causal link has been found at this time and incidence does not occur at a very significantly greater rate than in the general population. Incidence of auto-immune disease, which may be triggered in genetically pre-disposed individuals and more often in women by environmental factors, is generally rising. We do not know why. We do not know if a rapidly increasing lifetime burden of vaccine adjuvants plays some part, although high levels of aluminum have reportedly been found in spinal taps from some affected girls.

There was concern that initial studies of Gardasil showed a 44.6 percent increase in CIN 2/3 (the highest grade of pre-cancerous lesion) in a sub-group of individuals who had existing vaccine-type infections at time of vaccination. Further analysis showed that an unbalanced proportion of these subjects may have had enhanced risk factors such as a current smoking habit or a history of cervicovaginal infection or STD. Background evidence provided to the committee approving Gardasil concluded that, after balancing risk factors and sub-dividing sub-groups, vaccination could be said to reduce CIN2/3 by a modest 5.5 percent. Overall, a combined figure for subgroup studies showed an enhanced risk of disease of 11.7 percent in subjects who tested positive for vaccine-relevant HPV at the beginning of the study.

You may wish to get an HPV test and/or a pregnancy test prior to vaccination. You may wish discuss the advisability of vaccination with your doctor if you or your family has a history of autoimmune disorders.

You should not get Gardasil if you’re allergic to yeast or if you’re pregnant or planning to become pregnant soon.

You should report any and all potential adverse reactions to VAERS, being sure to include valid contact information, and not just all immediately post-vaccination allergic reactions, as the CDC’s handout implies.


Teresa Allen said...

Part 1...

Please show us ONE document that proves that Gardasil prevents cervical cancer!

Merck only did 'clinical trials' for 5 years. They also did not complete their clinical trials on

girls ages 9-15. They ALSO used reactive aluminum (we dont know how much)in their

placebo's which made the numbers of reactions to be false.

Reactive aluminum is considered toxic at 1 microgram. Each Gardasil
shot has 225 micrograms (all 3 shots equal 675 micrograms!).

Along with the other toxic chemicals in Gardasil:

Each 0.5-mL dose of the vaccine contains approximately 225 mcg of aluminum (as

Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant), 9.56 mg of sodium chloride,

0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, < 7 mcg yeast


Do some research into those chemicals and see what you find. None of those chemicals

need to be injected into anyone!

Under the ruse of attempting to eradicate cervical cancer, Merck is actually engaged in

the first large scale, real world deployment and testing of genetically modified DNA,

genetically engineered proteins and genetics produced by the combining of genetic

material from more than one origin or species in a vaccine.

The wide spread promotion and attempts to mandate the use of this drug in the United

States is clearly not predicated on preventing deaths from cervical cancer as the drug has

only been approved in the U.S. for use in girls 9-26, ages when deaths from cervical

cancer happen rarely, if ever. Cervical cancer has been steadily decreasing in the U.S.

since 1955.

Teresa Allen said...

Part 2...
The American Cancer Society states:

"Cervical cancer was once one of the most common causes of cancer death for American

women. The cervical cancer death rate declined by 74% between 1955 and 1992. The

main reason for this change is the increased use of the Pap test. This screening

procedure can find changes in the cervix before cancer develops. It can also find early

cervical cancer in its most curable stage. The death rate from cervical cancer continues to

decline by nearly 4% a year. Cervical cancer tends to occur in midlife. Most cases are

found in women younger than 50. It rarely develops in women younger than 20. Almost 20

percent of women are diagnosed with cervical cancer when they are over 65."

According to a 2001 presentation by Elizabeth R. Unger Ph.D., M.D., then Acting Chief,

Papillomavirus Section of the U.S. Centers for Disease Control and Prevention (CDCP):
*HPV infection is very prevalent in the population
*OVERALL 75% of population exposed
*Genital HPV is acquired around the time of sexual debut
*Consistent epidemiologic association of HPV with cervical cancer precursor lesions
*Plausible biologic mechanisms for HPV oncogenesis (cells becoming
*HPV oncogenesis is a rare event with long interval between infection and cancer
*Infection alone is insufficient to cause cancer
*Additional factors required for neoplasia (abnormal proliferation of cells)

Paraphrasing, more than 75% of the population is exposed to HPV. HPV
exposure typically occurs when a woman becomes sexually active. There is an

association between HPV and cervical cancer. HPV causing cervical cancer is plausible,

yet it alone does not cause cervical cancer. Cervical cancer is a rare event and there is a

"long interval" between infection and development of cervical cancer.

Teresa Allen said...

Part 3...
Now follow closely. Cervical cancer typically develops in mid life (around 48 years old) even though HPV exposure typically occurs at sexual debut. This new vaccine is purported to protect against a disease that occurs, if ever, 20 to 35 years after HPV infection. Yet the duration of protection from the vaccine is unknown.

According to the FDA Gardasil approval announcement: "For most women, the body`s own defense system will clear the virus and infected women do not develop related health problems. However, some HPV types can cause abnormal cells on the lining of the cervix that years later (emphasis added) can turn into cancer."

The clinical trials on this vaccine only lasted 5 years. It is chronologically impossible to
have determined efficacy in preventing cervical cancer as a result of administration of this
vaccine in the study population. Speculation as to whether the protection against HPV offered by this vaccine lasts beyond the five years of studies conducted to date is just that, speculation.

By the FDA`s own statement: "For most women, the body`s own defense system will clear the virus". Combined with the frequent Pap tests of study participants who were participating in a study of sexually transmitted disease, it is fair to say that the 20,541
sixteen to twenty-six year old participants in the clinical trials were far from a random
representation of the average female`s risk for contracting HPV or developing cervical cancer.

The studies on nine to fifteen year old girls included far fewer participants and were halted prior to completion.

Teresa Allen said...

Part 4...
Speculation as to whether or not girls vaccinated with Gardasil will experience a lower rate of cervical cancer 10 to 30 years from now is also merely conjecture. As such, there is
currently no official schedule on required booster doses of the drug.

In the FDA`s approval announcement, they state: "While the study period was not long
enough for cervical cancer to develop, the prevention of these cervical precancerous lesions is believed highly likely to result in the prevention of those cancers."

Believed highly likely?

Is the role of the FDA to ensure that a drug has been proven to be a safe and effective or have we reduced the burden down to "likely to convey some benefit, maybe, sometime down the road"?

In addition, according to the FDA announcement of Gardasil`s approval , somehow the
association and plausible mechanism between HPV and cervical cancer with the crystal clear statement that HPV "infection alone is insufficient to cause cancer" stated in the 2001 CDCP presentation magically morphed into "HPV is the cause of 70% of all cervical cancer".

Teresa Allen said...

Part 5...
Promoting a new, unproven, vaccine to an entire generation of young girls as a cancer vaccine, without adequate long-term safety or efficacy testing is unethical and in this author`s opinion immoral.

But wait, there is much more.

This is a whole new type of vaccine called a virus-like particle (VLP) vaccine. Anti-viral

vaccines have traditionally been prepared by using attenuated, or weakened, forms of the infectious virus. This type of vaccine involves complications in manufacturing.

These brand new virus-like particle (VLP) based vaccines including Merck`s Gardasil and
GSK`s Cervarix are the first ever FDA approved VLP vaccines. No long term studies or studies on populations larger than the Gardasil clinical trial (20,541women for up to 5 years) have ever been conducted on VLP technology or the specific inter-species genetic mixing this technology represents.

According to National Institute of Health (NIH) documents:

"The underlying technology for the vaccine originated in the laboratories of Drs. John Schiller and Douglas Lowy of the NIH National Cancer Institute. Drs. Schiller and Lowy commenced their research on the molecular biology of HPV nearly 20 years ago. Among their numerous findings, they discovered that the major outer coat protein of the HPV virus, called L1, could self assemble into non-infectious virus-like particles (VLPs) that closely resemble the native outer shell of the actual virus.

Teresa Allen said...

Part 6...
The principle behind the vaccine is that exposure to VLPs triggers the immune system to produce protective antibodies. If an individual is exposed to HPV after receiving the vaccine, the immune system already contains the antibodies necessary to prevent virus infection. The antibodies primarily function by preventing the virus from binding to the cell which is necessary in order for the virus to reproduce and thrive.

The catch is that for induction of HPV neutralizing antibodies the L1
must be in the same conformation as in the intact virus. Unlike some
other viral vaccines, inactivated virus produced in cultured cells was not a viable option because the viruses could not be produced in sufficient quantities in vitro. Also, the inactivated virions would still contain the viral oncogenes, which would preclude use in healthy young people, the primary target population. (In other words, the vaccine would produce cancer, not prevent it.)

Schiller and Lowy demonstrated that large quantities of VLPs could be produced in insect cells (emphasis added) infected with L1 recombinant baculovirus (a genetically engineered protein grown in insect larvae). Critically, they also showed in animal models that the L1 VLPs were able to induce high titers of neutralizing antibodies, comparable to those induced by authentic virions. Furthermore, they and their colleagues demonstrated that L1 VLP vaccination could protect animals from experimental challenge with high dose virus of the corresponding animal papillomavirus (emphasis added) types and that human and animal papillomavirus (emphasis again added) L1 behaved similarly in the ability to assemble into VLP."

Teresa Allen said...

Part 7...
While individual papilloma virus types tend to be highly adapted to replication in a single animal species, researchers have already identified inter-species transmission of papilloma virus in rabbits and cattle. The evolution of papilloma viruses is slow compared to many other virus types. It is believed that papilloma viruses generally co-evolve with a particular species of host over many years.

The long term results of introducing into the human body genetically engineered,
recombinant human, insect and animal DNA, along with human and animal strains of papillomavirus are unknown, untested and unproven, particularly when used as a vaccine, which effectively bypasses all of the body`s natural defenses against outside pathogens (skin, saliva, mucous, etc.)

The current deaths and maiming of young girls used as guinea pigs to test this new technology may be just the beginning. No one can predict what adverse consequences this newest inter-species gene mixing technology may cause. Remember we are dealing with the reproductive systems of an entire generation of young woman.

Furthermore, the two strains of HPV which the vaccine purportedly protects against account for only 70% of all cervical cancers, leaving at least 30% of these young girls with no protection against cervical cancer. To call this a cervical cancer vaccine is a tragic deception.

In addition, many health care experts have publicly predicted that cervical cancer deaths
will increase sharply, with routine Pap tests foregone under a false sense of security that
Gardasil has made them immune to cervical cancer (and not just the two strains of alleged cancer causing HPV for which the vaccine claims efficacy).

Teresa Allen said...

Part 8...
The fact that the vaccine is not effective in girls already exposed to the virus, yet parental
supervision is mandated during the interview to determine if the recipient is sexually active, further undermines the ability to discern "qualified" candidates for this potentially dangerous, new, experimental, unproven, falsely promoted vaccine technology. Imagine a 16 year old girl who does not want to confess that she has been sexually active to a parent stating that she has not and then being administered this drug. According to a reported Merck document, if this young girl has previously been infected with HPV, she has just increased her risk of developing high grade pre-cancerous lesions of the cervix by 44.6%.

Recombinant DNA, genetically engineered proteins, inter-species gene mixing, questionable new vaccine technology, lack of long term safety and efficacy data,
questionable pre-qualifications procedures and now, an extremely high prevalence of reported adverse side effects up to and including miscarriage and death.

This vaccine represents more than just bottom line profit for Merck. This is the first genetically modified drug unleashed across a broad swath of unsuspecting, formerly healthy Americans.

Unfortunately, the target they chose for this grand genetic experiment is the entire female
population of mothers to be for all future generations. Can we really afford to allow this
fraud and deception to continue?