Showing posts with label Gardasil. Show all posts
Showing posts with label Gardasil. Show all posts

Friday, April 8, 2011

ONE LESS Demographic for Merck! FDA Rejects Gardasil for Use in Most Adult Women

I wondered if I had read this correctly at first, but it's true. FDA announced it refused approval for Merck's HPV vaccine for use in women 27-45, as it had not demonstrated to 'prevent' HPV-related cervical cancer in women older than 26.

This is a real blow and setback to Merck's marketing department, as FDA had previously postponed and refused approval for this age demographic, even after requesting and reviewing additional studies.

The vaccine is already approved to protect against the 6, 11, 16 and 18 strains of the human papillomavirus, which can lead to cervical cancer, in girls and women ages 9 to 26. Gardasil is also approved to prevent genital warts, anal cancer, anal dysplasias and precancerous lsesions in males of the same age.

It's no surprise that Gardasil sales have slowed substantially, from $1.4 billion in 2008 to $988 million last year.

Gardasil has been a hot button for Laguna Natural Health. Read more about Gardasil in the LNH blog archives.


OC



source: http://www.pharmalot.com/2011/04/fda-rejects-gardasil-for-use-in-most-adult-women/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+Pharmalot+%28Pharmalot%29

Saturday, February 19, 2011

FDA Misquotes Merck's Gardasil Claims




The misinformation regarding Merck's billion dollar baby, Gardasil, has spiraled out of control. The FDA has claimed the three part intramuscular vaccine "prevents" cancer, yet Merck does not. In a recent article, the FDA also approved Gardasil "for the prevention of anal cancer", as claimed below:

"PRNewswire-USNewswire/ --The U.S. Food and Drug Administration today approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.

Gardasil already is approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females. It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females.

Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research."

Note: The word "prevention" was erroneously used FOUR times in the opening paragraphs of this report.

More here:

So where did PRNewswire/USNewswire get this information? This claim is made on the FDA website:

Consumer facts:
Merck, the manufacturer of Gardasil, does not use the word "prevent" in it's claims regarding what the vaccine does, rather it claims it "protects against", and repeatedly so, as quoted directly from Merck's Gardasil website:

"INFORMATION ABOUT GARDASIL

GARDASIL is the only human papillomavirus (HPV) vaccine that helps protect against 4 types of HPV. In girls and young women ages 9 to 26, GARDASIL helps protect against 2 types of HPV that cause about 75% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases. In boys and young men ages 9 to 26, GARDASIL helps protect against 90% of genital warts cases.

GARDASIL also helps protect girls and young women ages 9 to 26 against 70% of vaginal cancer cases and up to 50% of vulvar cancer cases.

GARDASIL may not fully protect everyone, nor will it protect against diseases caused by other HPV types or against diseases not caused by HPV. GARDASIL does not prevent all types of cervical cancer, so it’s important for women to continue routine cervical cancer screenings. GARDASIL does not treat cancer or genital warts. GARDASIL is given as 3 injections over 6 months."

Merck clearly claims that Gardasil "protects against", and clearly states that is does NOT PREVENT all types of cervical cancer (as it only protects against 4 of the over 100 strains of HPV as mentioned above), and DOES NOT treat cancer or genital warts.

Now, who would YOU believe? We believe the manufacturer for many reasons -- legal liability being in the top five on the list.

source: http://www.gardasil.com/

So, what's the big deal?

The purpose of the FDA, as it is stated on their website, is as follows:

"The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation, and by regulating the manufacture, marketing, and distribution of tobacco products.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods, and to reduce tobacco use to improve health."

Safety of drugs? Seriously? According to an article published in the American Journal of Preventative Medicine, unintentional poisoning from prescription opioids, sedatives and tranquilizers have surpassed motor vehicle crashes as the leading cause of unintentional injury death, making prescription drugs the second leading cause of unintentional injury death in the US.

source: http://www.care2.com/greenliving/the-surprising-second-leading-cause-of-death-in-the-us.html#ixzz17ovCGPmg

As for our food supply....how are those "frankenfood" GMO/GE seeds and crops working out for ya? There's no nutritional value there, so the crops contribute to worldwide malnourishment and (US) over-feeding, which has been linked to many preventable diseases. GMO/GE seeds don't yield the crops promised -- at five times the cost to farmers. They aren't renewable, and pollute non-GMO crops and soils. And then there's that pesky toxicity-factor from the built-in pesticides/herbacides in every bite.

Back to Gardasil and vaccines...Did you know the FDA approves the use of Thimerosal? Thimerosal is used as a preservative in vaccines...even the ones that are 'thimerosal-free', as the FDA ruled that "Vaccines with trace amounts of thimerosal contain 1 microgram or less of mercury per dose", and are ok with them.

source: http://www.fda.gov/biologicsbloodvaccines/safetyavailability/vaccinesafety/ucm096228.htm

In fact, Thimerosal is mercury. Mercury is a neurotoxin -- it breaks the blood-brain barrier, and contributes to a host of debilitating neurological disorders. It is a major polluter of the environment and health risk, and yet our FDA claims that mercury and thimerosal are 'safe'. Seriously? How are those mercury amalgams workin' out for ya? The EPA says you're 'overlimit' to spit in a sink if you have four in your mouth.

So much research, so much proof, yet so much misinformation continues to spread....to what end?

It is believed that the misinformation regarding Gardasil has confused the public, and given young men and women false hope and expectations regarding the purpose of the vaccine. It seems to have given it's users 'carte blanche' to have unprotected sex, as they believe that they are completely protected against HPV, genital warts, herpes and cancer...all untrue. It also contributes to the belief that Gardasil is mandatory for school aged children, while the controversy over mandating vaccines remains unconstitutional to date.

LNH believes everyone has a right to be informed of any and all health-related issues and risks. It has been reported that many doctors are not completely informing these children and their mothers of all sides of the vaccine issue...indications as well as contraindications. Perhaps they haven't been trained by their drug rep. Doctors are compensated for every Gardasil vaccine they sell to a patient. Allergic reactions are a risk when using drugs and vaccines, ranging from redness and swelling to paralysis to death.

Go to VAERS for more information: http://vaers.hhs.gov/index

Ask questions. Become informed. Knowledge is power.

OC

Wednesday, August 4, 2010

Could the Gardasil Vaccine CAUSE Cancer?

The very first blogs I wrote were about vaccines (generally speaking), and the Gardasil vaccine. Vaccines remain a hot button for LNH for many reasons --- one is due to the questionable ingredients being injected into millions of trusting and unsuspecting people, resulting in deleterious effects to health and well being.

*****

HPV Testing and Vaccination: 56 Experts Ignore the Facts

According to a recent abstract in PubMed, 56 experts in cervical cancer gathered to review the current state of HPV typing in the vaccinated population of the United States and the potential for typing this population over the next five years.

Their conclusions were startling, to say the least. On one hand, they conclude that HPV DNA screening and genotyping may be the future in the post-HPV vaccination United States.

On the other hand, they state, "HPV typing should not be used to determine who should be vaccinated against HPV."

Anyone who has an ounce of common sense, has to ask why not?

More here:

http://www.examiner.com/x-40801-Vaccines-Examiner~y2010m7d11-HPV-testing-and-vaccination-56-experts-appear-to-ignore-the-facts


****

NOTE: I'm still not onboard with Gardasil. There are just too many things wrong with and about it.

OC

Tuesday, October 20, 2009

British Immigrant, 17, Denied US Citizenship After Refusing HPV Gardasil Vaccine

Simone Davis, a 17 year old British immigrant, was abandoned by her mother while still a baby and now lives with her paternal grandmother in Port St Joe, Florida. Because Simone has refused to take the controversial HPV vaccine, Gardasil, she has been denied citizenship. HPV vaccine is required of all female immigrants to the United States.

In the article "Despite Debate, Reactions to the HPV Vaccine Rare", published in the August 19, 2009, Glove and Mail, it was revealed that 23 million doses of the HPV vaccine have been administered to young women in the United States, resulting in 32 deaths, 12, 424 adverse reactions, including 772 severe reactions (blood clots, pancreatic failure, motor neuron disease and anaphylaxis).

According to Barbara Loe Fisher of the National Vaccine Infomation Center, "The right to informed consent, to using a pharmaceutical product that carries (a warning of) the right of injury or death is a human right, and this young woman should not be denied the fight to become a US citizen simply because she does not want to be required to take this vaccine asa condition of becoming a US citizen. HPV infections is almost entirely preventable with Pap smear screens, which have been a routine part of health care in the US since the 1960's. It is absolutely unjustified to force women mammograms in this country to use a pharmaceutical product like Gardasil vaccine that carries risks that are not totally known yet."


Need we say more?

OC

Tuesday, August 25, 2009

One Less

August 19, 2009

Monday, August 24, 2009

CDC Report Stirs Controversy For Merck's Gardasil Vaccine

Cervical Cancer Vaccine Linked to Deaths, Incidents of Fainting and Blood Clots
By RADHA CHITALE
ABC News Medical Unit
August 19, 2009

A government report released Tuesday raises new questions about the safety of the cervical cancer vaccine Gardasil. The vaccine has been linked to 32 unconfirmed deaths and shows higher incidences of fainting and blood clots than other vaccines.

Here's a closer look at whether the benefits of a cervical cancer vaccine outweigh the risks:
http://www.youtube.com/watch?v=BBh2mjkI57Q

But while some physicians expressed concern over the findings, other doctors viewed the report as reassuring, showing that the vaccine was not associated with any more unusual and serious side effects as other vaccines.

The results of the report appeared along with an accompanying editorial discussing whether the potential benefit of the HPV vaccine is worth its potential risks in the Journal of the American Medical Association. The editorial, in particular, could give pause to many parents faced with the decision of whether or not to have their 11- and 12-year-old daughters vaccinated against the certain strains of the human papillomavirus, or HPV.

On Wednesday morning, ABC News Chief Medical Editor Dr Timothy Johnson said that he, too, would encourage parents to learn more about the shot before getting their daughters vaccinated.

"I am very much in favor of childhood vaccines," Johnson told Chris Cuomo on Wednesday's "Good Morning America," adding that there is little doubt that the vaccine does have its benefits.

"We know it does what it says – it prevents HPV infections," he said.*

But he added that when it comes to comparing the benefits of the HPV vaccine against its potential risks, he believes there simply is not enough evidence to recommend to all parents that they have their daughters vaccinated.

"I don't think we yet know the long term benefits or risks," Johnson said. "I'm taking a pass on this one and saying to parents, 'Study the issue, read the editorial... talk to your doctor.'"

Those who search for more information on the vaccine may also find stories from other parents who say the vaccine had ill effects on their daughters. One of these parents, Emily Tarsell, started her daughter Christina on Gardasil -- a vaccine that protects against four of the most common cancer-causing strains of the human papilloma virus (HPV) -- after her first visit to a gynecologist and at the doctor's recommendation.

Eighteen days after Christina received her final vaccine shot, she died.

"I know it was the Gardasil," Tarsell said, although the official cause of death was undetermined. "They were really recommending it, saying that there weren't any side effects, that it was safe. So I kind of went against my better instinct [and let her] get the shot."

Deaths like Christina's are one of several types of complications reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) following Gardasil distribution in 2006. Some of these adverse events were serious, including blood clots and neurological disorders, and some were non-life threatening side effects from the vaccine, including fainting, nausea and fever.

Although experts agree that the accuracy of data from VAERS reports -- which can be made by anyone and are not verified or controlled for quality -- is questionable, they remain divided as to whether extreme adverse events, which are serious but rare, are cause enough to stop recommending and administering the Gardasil vaccine without further investigation.

Report Shows Rare But Serious Side Effects May Result From Gardasil Vaccine
"Although the number of serious adverse events is small and rare, they are real and cannot be overlooked or dismissed without disclosing the possibility to all other possible vaccine recipients," said Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at University of Missouri. "The rate of serious adverse events is greater than the incidence rate of cervical cancer."

As of June 1, 2009, the CDC reported that over 25 million doses of Gardasil, which is recommended for women between ages 9-26, have been distributed in the U.S. and there was an average of 53.9 VAERS reports per 100,000 vaccine doses. Of these, 40 percent occurred on the day of vaccination, and 6.2 percent were serious, including 32 reports of death.

In a statement yesterday from Merck, the pharmaceutical company that manufactures Gardasil, the company backed the vaccine's efficacy and said they encourage further research on its safety.

"We are pleased that the study published by JAMA [yesterday] further reinforces the safety profile of Gardasil," said Dr. Richard M. Haupt, head of the clinical program for Gardasil at Merck. "We welcome continued study and discussion about the safety of this important vaccine."

But some clinicians are not ready to accept wide use of the drug based on the available safety data.

Dr. Jaques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital, said he would not offer the Gardasil vaccine to patients when good cervical cancer screening techniques and treatments exist. He has also chosen not to have his 11-year-old daughter get the HPV shot because of his concerns.

"I'm pro preventing cervical cancer and HPV," Moritz said. "I'm not pro that the physicians don't know the risks and side effects."


VAERS Report Is No Measuring Stick For Gardasil Side Effects
But clinicians on both sides of the vaccination debate agree that data provided by the VAERS report is limited because it lacks any baseline comparison for the adverse events reported. This makes it difficult to draw cause and effect relationships when a death, for example, occurs soon after administering the Gardasil vaccine.

In fact, the JAMA study authors showed that 90 percent of those with blood clots had typical risk factors for clots, outside of having received the vaccine -- using oral contraceptives, for example, or smoking.

"The problem is that there is a difference between an adverse reaction caused by the vaccine, as opposed to an adverse event reported in association with the vaccine," said Dr. Lauren Streicher, an obstetrician-gynecologist at Northwestern Medical School, who supports use of the vaccine. "Patients need to understand the true risk of the vaccine, as well as the risks of not getting the vaccine."

Understanding Risks and Side Effects Essential For Recommending Gardasil
The overwhelming consensus regarding Gardasil use is that physicians who are not well versed in the risks of HPV and cervical cancer and the side effects of the vaccine cannot adequately counsel patients whether or not to be vaccinated.

Dr. Joseph Zanga, chief of pediatrics at the Columbus Regional Healthcare System in Columbus, Ga., pointed out that Gardasil does not prevent women from contracting HPV in every instance, that many people who are infected will spontaneously rid themselves of the virus, and that routine pap smears are still the best prevention against cervical cancer.

"Perhaps the most important, currently missing 'warning' is that the vaccine may not be forever," Zanga said. "We know that it protects for 5-7 years so that a girl getting the series at [age] 11-12 will enter the time of her most likely sexual debut unprotected but believing herself to be."

Many Doctors Will Continue to Provide Gardasil
Dr. L. Stewart Massad, the Practice and Ethics Committees chair for the American Society for Colposcopy and Cervical Pathology, said his organization has educated thousands of clinicians about the risks of HPV and the Gardasil vaccine.

"We based our education [program] criteria on data from the CDC's risk assessment," he said. "Certainly there are differences of opinion when it comes to how adverse events are, you have to balance the risk for each patient."

Massad also noted that the ASCCP was unable to secure government or other non-profit funding for education outreach programs when the vaccine was first introduced and turned instead to private companies, including Merck, which manufactures Gardasil.

Further Investigation of Adverse Reports Needed
Harper said that the next step in determining the severity of the risks associated with the Gardasil vaccine would be for the CDC to investigate the reported adverse events and verify a causal relationship. But this may prove a difficult task, she said, because many of those events were reported by Merck and did not include sufficient information to perform an investigation.

Still, the report is unlikely to prevent most doctors from continuing to provide the vaccine to patients.

"There are 772 serious problems identified in 23 million doses of vaccine," said Dr. Kevin Ault, associate professor of Gynecology and Obstetrics at Emory University. "I usually tell my patients that these serious events are tragic, rare and likely unrelated to the vaccine."

ABC News' Tyeese Gaines-Reid contributed to this report.

******************************
Note:
Why do the doctors on this video say they don't have enough information? Because Merck never released the studies.

* - With all respect, Dr Johnson misquoted/misunderstood/misinterpreted Gardasil's claims, stating the product "prevents cervical cancer". Merck's verbiage does not make any such "prevention" claims, rather claims it "protects against" HPV. That's an important distinction.

Information from Gardasil.com:
IMPORTANT INFORMATION ABOUT GARDASILGARDASIL 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. GARDASIL is for girls and young women ages 9 to 26.

GARDASIL may not fully protect everyone, and does not prevent all types of cervical cancer, so it’s important to continue routine cervical cancer screenings. GARDASIL does not treat cervical cancer or genital warts. GARDASIL will not protect against diseases caused by other HPV types or against diseases not caused by HPV. GARDASIL is given as 3 injections over 6 months.

SELECT SAFETY INFORMATIONAnyone who is allergic to the ingredients of GARDASIL, including those severely allergic to yeast, should not receive the vaccine. GARDASIL is not for women who are pregnant.The side effects include pain, swelling, itching, bruising, and redness at the injection site, headache, fever, nausea, dizziness, vomiting, and fainting. Sometimes fainting is accompanied by falling with injury, as well as shaking or stiffening and other seizure-like activity. Only a doctor or health care professional can decide if GARDASIL is right for you or your daughter.

Saturday, April 18, 2009

The Great HPV Vaccine Hoax Exposed

Mike Adams, the Health Ranger, has been called "the best health and natural products writer on the scene today" and has openly recommended hundreds of health and green living products without any compensation or kickbacks.  In this case, he's recommending NOT to use a product.

Watch his revealing video where he exposes the facts regarding the inefficacy of Gardasil, including information and reports from the FDA, JAMA and other research sources:

http://www.youtube.com/watch?v=XK97CHQZhq0&feature=related

For his printed report, go to:
http://www.naturalnews.com/Report_HPV_Vaccine_0.html

Bear in mind while watching that no state currently mandates vaccines, although this issue has already been presented to legislation in many states, and has been suspended indefinitely due to the outrage of parents.  Unfortunately, our citizens have already been lead to believe that vaccines are compulsory for their children to gain entry to school.  

There are exemptions in every state.  The link is published in our post titled Your State Laws Regarding Vaccines:

LNH

Gardasil: 32 Deaths from Merck's Claimed Cervical Cancer Vaccine

We at LNH have great concern for the safety of Gardasil, Merck's vaccine claiming to 'protect against' HPV -- a condition which usually clears on it's own (remember, the body IS designed to be self-healing). Furthermore, studies have shown there is no link between HVP and cervical cancer. If you are unfamiliar with this product, feel free to check our April postings for Gardasil: The Facts.  

We have new information linking the Gardasil vaccine to over 12,000 health complaints and 32 deaths (at this time, and the numbers continue to climb).  Get the facts here from Jenny Thompson, Director, Health Sciences Institute and cervical cancer survivor, who speaks against using and mandating the vaccine:
http://www.youtube.com/watch?v=msoyRYSoSJk&o=1672350&u=53111945&l=1608440&g=6810

Please share this information. Doing so could save the lives of your friends and loved ones. 

LNH

Sunday, April 12, 2009

Dear Governor Schwarzenegger....

This is a copy of the letter I mailed to Governor Schwarzenegger on Monday, April 13, 2009.  Feel free to join me in doing the same to stop the effort to mandate vaccines.  This is of national concern.  If you don't live in California, please write your state governor directly.  We all need to do our part to maintain the health freedoms we enjoy in the US today.


oc




April 12, 2009 


Governor Arnold Schwarzenegger 

10th and L Streets 

Sacramento, CA 95814 


Dear Governor Schwarzenegger, 


I am writing to oppose any state mandate for Merck's Gardasil vaccine, which purports to prevent young women from getting cervical cancer, though this claim is still unproven. I have read about 9,700 adverse effects from this vaccine, including paralysis, seizures, blood clots, miscarriage, and in twenty cases still being investigated, death. 


I understand the need to protect citizens from extremely contagious diseases that are easily spread by air or casual contact. In sharp contrast, the virus that causes cervical cancer is usually sexually transmitted. 


As a concerned citizen and health professional, it is the parent’s responsibility, and not that of the state government, to make health care decisions for their children. Please do not take away the right to choose for families whether to take this painful, dangerous, and unproven vaccine. 


Sincerely,


Kristy Mills, Traditional Naturopath, CNHP