The Gardasil Vaccine Series - An Interview with Merck & Co., Inc.

Merck is the developer of the HPV vaccine Gardasil. The company has an independent website, gardasil.com, devoted to explaining the product, complete with social marketing tools to "help spread the word about cervical cancer and HPV." It features responses to "Questions about what you are hearing," as well as a vertical labeled "More for parents."

Throughout the site, certain information appears with regularity. Merck states that their product is "the only cervical cancer vaccine that helps protect against four types of human papilloma virus (HPV). Two types that cause 70% of cervical cancer cases; two types that cause 90% of genital warts cases."

The vaccine is targeted at girls and women from 9 - 26. It is administered in three injections over a six-month period. It is acknowledged that the vaccine does not provide full protection for everyone, or for all types of cervical cancer. Merck endorses continued pap smears.

Regarding adverse reactions, Merck stresses that those who are severely allergic to yeast or women who are pregnant should not receive the vaccine. It also warns of potential reaction for those who may be sensitive to the "other" ingredients found in the vaccine.

Possible side effects listed include "swelling, itching, bruising, redness at injection site, headaches, fever, nausea, dizziness, vomiting and fainting." It is noted that fainting can be accompanied by falling, shaking, stiffening, or other seizure-like activity. Patients are advised to remain in the doctor's office for fifteen minutes after receiving the shot, for observation.

I talked with Media Relations spokesperson, Pam Eisele, about the vaccine. I submitted a series of questions for the company to answer via e-mail, referencing red flags that had come up in my research. All my queries were responded to, and Eisele offered to put me in touch with a clinical researcher if I required further explanations.

Eisele also forwarded me a comment on how parents should respond to side effects from the Gardasil vaccine. She wrote, "We would encourage parents to report any adverse experience associated with any Merck medication or vaccine to their healthcare provider, Merck or the FDA. Patients can report adverse events through their healthcare provider, the Merck National Service Center (1-800-444-2080), or FDA MEDWatch or call 1-900-FDA-1088. Consumers should speak with their doctor if they have any concerns or questions."

Based on my findings, I would suggest that anyone experiencing a problem report it directly via the Vaccine Adverse Event Reporting System (VAERS).

* * * * *

HOW LONG IS THE VACCINE EFFECTIVE?

Gardasil has demonstrated duration of protection for five years with no disease breakthrough against all four of the targeted HPV types. We also have data from a follow-up study of the HPV 16 component of Gardasil, which demonstrated an average 8.5 years of protection. We also are conducting several studies to assess long-term safety and duration of efficacy, including a post-licensure evaluation of 44,000 people to evaluate general safety and pregnancy outcomes and a pregnancy registry to further monitor pregnancy outcomes in women who received Gardasil inadvertently. In addition, 5,500 people from one of our Phase III studies will be evaluated for long-term safety and efficacy for a minimum of 10 years through the Nordic Cancer Registry Program, a population-based evaluation of Gardasil in Nordic countries that have a mandatory HPV vaccine registry. We also are following participants (girls and boys) in one of our adolescent studies for 10 years to evaluate long-term safety and effectiveness in the adolescent population.

WHAT ARE THE LONG TERM SIDE EFFECTS?

Known side effects with Gardasil include pain, swelling, itching, bruising and redness at the injection site; headache, fever, nausea, dizziness, vomiting and fainting. Currently, no signal for long-term side effects has been identified in the evaluation of reports of adverse events in the post-licensure time period. [I]Would refer you to the recent CDC and FDA statement released on August 20, 2009 reaffirming that, "based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks."

ARE BOOSTERS NECESSARY? HOW OFTEN?

No boosters are currently required. Long-term studies are ongoing. We cannot speculate on whether or not a booster will be recommended in the future.

WHY IS THE VACCINE A BETTER SOLUTION TO PREVENTING CERVICAL CANCER THAN A REGULAR PAP SMEAR?

Vaccination with Gardasil is not a replacement for routine Pap or other cervical screening and women who receive Gardasil should continue to undergo screening. Screening has shown great benefit to women and is an important part of cervical cancer prevention; however, screening can sometimes miss cell abnormalities that might progress. In addition, not all women get screened or screened regularly. We believe vaccine prevention along with routine cervical cancer screenings is the best way to help reduce the significant health burden associated with HPV diseases.

WAS A FIVE-YEAR CLINICAL TRIAL AMPLE TIME TO DO THE NECESSARY FOLLOW UP ON THE SAFETY OF THE VACCINE?

Yes. The clinical trials for Gardasil were robust with ~ 25,000 subjects in the database submitted to the FDA as well as broadly internationally-based (33 countries on 5 continents).

WHAT ARE THE OTHER INGREDIENTS BESIDES YEAST THAT PEOPLE CAN BE ALLERGIC TO IN THE VACCINE?

Individuals should not get Gardasil if they have or have had an allergic reaction after getting a dose of Gardasil or a severe allergic reaction to yeast, amorphous aluminum hydroxyphosphate sulfate or polysorbate 80. Signs of an allergic reaction may include difficulty breathing, wheezing (bronchospasm), hives or rash.

IF THE VACCINE DOES NOT LAST 15 YEARS, WHY GIVE IT AS SUCH AN EARLY AGE (9 years old)?

The best time to administer any preventative vaccine is before individuals are exposed to the virus in question. Gardasil works when given before there is any contact with HPV types 6, 11, 16 and 18. Because it is not feasible to conduct HPV vaccine studies in younger adolescents who have not yet possibly been exposed to the HPV virus and who are not yet sexually active, Merck and the FDA agreed that efficacy findings in 16- to 26-year-olds can be applied to younger adolescents using immunogenicity data. The immune response in younger adolescents was higher than in older adolescents and adults, which supports this approach. Immunogenicity "bridging data" is an accepted surrogate for efficacy for most childhood vaccines.

MERCK REPORTED 68% OF THE ADVERSE EFFECTS. HOWEVER, 90% OF THOSE REPORTS HAD TO BE THROWN OUT BY THE CDC FOR INADEQUATE INFORMATION? WHAT IS MERCK'S PLAN IN THE FUTURE TO IMPROVE THIS PROTOCOL?

The reports were not thrown out by CDC. They were included in CDC's quantitative analysis. Merck has a robust process for seeking follow-up information on every case but this is a voluntary system and cannot control whether health care providers will take the time to provide all of the requested follow-up information. It is important to remember that spontaneous reports are one element of the post-marketing safety system and are complemented by information from clinical trials and observational studies. The FDAAA-mandated Sentinel Network is being developed in part out of recognition of the well known limitations of spontaneous reporting.

WHAT IS MERCK DOING TO ADDRESS THE REPORTED SIDE EFFECTS TO GARDASIL?

Nothing is more important to Merck than the safety of our products. We carefully monitor the safety of Gardasil on a routine basis. Merck monitors vaccine safety by conducting comprehensive analyses of adverse events reported to Merck, and we share these adverse event analyses with the CDC, the U.S. Food and Drug Administration (FDA) and regulatory and medical authorities around the world to support their efforts. After carefully reviewing all of the information available to us about reported adverse events, Merck continues to be confident in the safety profile of Gardasil. While no vaccine or medicine is completely without risk, leading health organizations throughout the world including the US Centers for Disease Control and Prevention (CDC) and the European Medicines Agency (EMEA) have reviewed all of the safety information available to them about Gardasil and continue to recommend its use. Please see our statement on the safety of Gardasil. Also, this is our statement specific to the recent JAMA publication:

HOW DO YOU RESPOND TO THE CHARGES OF AN OVERLY AGGRESSIVE MARKETING CAMPAIGN FOR GARDASIL, AND THE ARTICLE IN The Journal of the American Medical Association, "Marketing HPV Vaccine - Implications for Adolescent Health and Medical Professionalism"?

The article in JAMA is a mischaracterization of our efforts. We are committed to the prevention of HPV diseases including cervical, vaginal and vulvar cancers as well as genital warts caused by the HPV types included in Gardasil. Education is a critical component toward achieving that goal. As such, Merck will continue to provide independent grant support to professional medical associations that develop and distribute their own educational information about HPV and cervical cancer to broad audiences, including underserved communities.

We value our relationships with these groups and conduct our interactions with strict adherence to the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals. Merck closely follows the standards for commercial support of Continuing Medical Education established by the Accreditation Council for Continuing Medical Education. Merck also discloses grants over $500 provided by the company's Global Health Division to U.S. organizations in support of independent accredited educational programs for health care professionals. Disclosure is to respond to public interest and to broaden the visibility of Merck's support of key stakeholders to advance health, science, community welfare and the economy.

* * * * *

My final inquiry to Merck involved looking for a clarification about the relationship between Women In Government, an organization of women state legislators, and Merck. I had repeatedly read articles questioning the connection, including in The Washington Post (2/21/07), Medical News Today (12/31/07), and SourceWatch (1/31/07). In addition to the qualification from Merck, the following is a statement via e-mail from Mary Brooks Beatty, the President of Women In Government. She responded to my phone call asking if her organization had been promoting state legislation of mandatory vaccination for girls. On October 21, 2009 she wrote:

"Women In Government is a non-profit, bi-partisan organization that provides educational resources to female state legislators on diverse topics, including energy and the environment, the economy, transportation, healthcare, and education. Our goal is to provide information for legislators to make sound policy decisions.

Women In Government's policy and conference programming is guided by our Board of Directors, a group of 13 female state legislators that represent various geographical segments of our country and the two major political parties. The Board of Directors has never taken a position on how states should deal with HPV/Cervical Cancer issues. Further, the organization has never promoted any commercial product. All information provided to legislators originates from the medical community, or from government agencies such as the Centers for Disease Control (CDC) or the Food and Drug Administration (FDA).

Women In Government's Board of Directors decided that the organization should educate female legislators on HPV and cervical cancer because of the strong interest female legislators have in preventing cancer and saving lives. Every two and half hours a woman dies from cervical cancer in the United States, a cancer that is 100% preventable. The organization's interest in this policy topic is based on saving the lives of women."

Question to Merck:

CAN YOU ADDRESS THE RELATIONSHIP BETWEEN MERCK AND THE WASHINGTON D.C. ORGANIZATION WOMEN IN GOVERNMENT? ON THE SITE, MERCK IS LISTED AS A CONTRIBUTOR. HOW MUCH HAS MERCK CONTRIBUTED TO THE ORGANIZATION IN THE LAST FIVE YEARS? IN THE PAST, DID MERCK LOBBY THIS GROUP OF FEMALE STATE LEGISLATORS TO MAKE THE HPV VACCINE MANDATORY FOR SCHOOLGIRLS? WILL MERCK HAVE A PRESENCE AT THE WOMEN IN GOVERNMENT 5TH ANNUAL HPV & CERVICAL CANCER SUMMIT BEING HELD IN NOVEMBER IN WASHINGTON D.C?

Merck supports organizations that support policies that can expand access to important medical advances, so that the greatest number of individuals can benefit from them. One example is our support of Women in Government, a group that through its education efforts has successfully advanced numerous health issues for many years. We did not lobby this group. The fight against cervical cancer and other HPV related diseases is just one of the current initiatives led by Women in Government and we too support that fight. We support Women in Government and other organizations by providing resources that these groups independently direct toward programs to provide education regarding the importance of fighting cervical cancer, the second leading cancer among women around the world.

Our financial support of Women in Government is in line with Merck and industry guidelines on grants. Starting in October 2008, Merck began disclosing grants provided to U.S. organizations on a quarterly basis. As noted within those disclosures, we have provided a non-continuing education grant of $200,000 in June of this year to Women in Government for HPV education outreach meetings, which includes support for the upcoming November event.

In the next article: Doctors speak out.

This article originally appeared on Empowher.

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Comments

[Laurie Dean-Smith]

My daughter, 14 at the time of the one and only shot is still vomiting every day and has been in and out of hospitals for the last 6 months now. She was sick within 20 minutes of the vaccine and her little life has changed from cheer leader, track runner, soccer player, honor roll student and just plain vibrant, smart teenager to being fatigued, sick all the time and grades that are barely passing! She is now one less, thanks to Merck. And the devestation this has caused our single mom home has been completely shocking. Only our faith in God and His Grace has gotten us this far. We recently moved back to Texas in hopes of finding a doctor at the Children's Hospital that will look outside of the box. So many deal with the typical "If I can't find it, then you must be faking" narcisistic doctors. Just keep us in your prayers. I don't know how much longer we can go on like this. I have met other moms with daughters that have the same exact symptoms. Comforting to not be alone, but scarey because one has been vomiting every day for over a year now! I wish I had a dollar for every time I heard a mother say, "If I had only researched first!!" I could have afforded to stay in our home in Tennessee. Shame on you Merck. And shame on you FDA!

[mofmars333]

When's the next article in this series where these doctors are to defend these untested & dangerous shots?

This should be good with so many angry parents on the warpath.

[Robrich]

(Continued from post too long. )
A nurse at the Dystonia place asked me if she had the shot after I described her symptoms. Obviously they had made the connection with other girls. All testing has been very expensive and NORMAL. Yet, there is nothing normal about her health. Ten months later, she still has twitching, random jerking of her limbs, hair loss, very fatigued, extreme pain behind her eyes, very sensitive to light and noises, non epileptic seizures she has lost the ability to concentrate, difficult to test. I could go on and on. She should be enjoying her Senior Year, instead, she worries everyday about having a seizure at school. She is stressed over the fact that she cannot concentrate long enough to take the ACT/SAT tests. She is a very postive girl, refuses to let Gardasil win, she struggles every day to try to make her life normal. All this because I wanted to help her by getting her the vaccine. Pretty much sucks to think you are doing the right thing and it turns out like this. Share this information with every mom you know> save other girls from suffering like mine has.

[Robrich]

My 18 yr old daughters life has been on hold since Feb 09. She received her 1st Gardasil shot in Aug 08, she complained of joint/muscle pain, I thought cheerleading was working her too hard. Second shot in Nov 08, she was very fatigued, constantly complained of joint/muscle pain. She received her 3rd shot on Jan 2, 09. That shot pushed her body over the edge. On Feb 2, she took her first trip in an ambulance to the ER with seizure like activity, struggling to breathe. Our lives were completely changed that day. We now have had FOUR ambulance rides, FIVE ER visits, FOUR hospital stays, a trip to Mayo Clinic, still no help. Drs deny the fact that Gardasil has these kinds of side effects. TEN months later, we are still trying to get our daughter fixed from the damage that Gardasil has done to her. IF Merck had listed joint/muscle pain as a side effect, I would not have taken her back for shots 2 & 3. The only side effect listed at that time was redness/soreness at shot sight. We have spent Thousands of dollars trying to get her body back to where it was prior to Gardasil. Shame on me for NOT researching before vaccinating. But I trusted her DR, I trusted the FDA. Prior to Gardasil, my daughter was a very active A student, cheerleader, dancer and was very healthy.

[ddanimal]

Thanks for sharing your story.

There is an important lesson here for everyone: DO NOT trust the FDA!

[mariangreene04]

My daughter was also one that was injured by this vaccine. Prior to receiving Gardasil, she was running six to ten miles daily, competing in state level meets and being recruited by colleges. However, within days of getting the shot she couldn't breathe and had chest pains. Then nine days after this vaccine, she was admitted to ICU with inflammation and swelling around her heart. The doctor who admitted her said it was an allergic reaction to Gardasil! Holly then went on to have dizziness, fatigue, muscle weakness, numbness and even temporary loss of vision, just to name a few. She became so ill she had to withdraw from school, so while her friends were going to football games and graduating, she was spending her days going back and forth to doctors, trying to find help. Before this she wanted to compete in the Olympics, now she wants to be able to finish high school.
Merck is not telling the truth in this interview. I have contacted them and no one wanted to speak with me. I have reported this to VA

[mofmars333]

Contact a Gardasil Attorney Near You

http://www.adrugrecall.com/gardasil/lawsuits.html

[mofmars333]

Watch this & weep. Now they're targeting our boys.

Preventing Gardasil Vaccine Injuries & Deaths

http://www.nvic.org/NPreventing Gardasil Vaccine Injuries & Deaths http://www.nvic.org/NVIC-Vaccine-News/July-2009/Preventing-Gardasil-Vaccine-Injuries-Deaths.aspx

Read & learn more from the comments at;

http://www.huffingtonpost.com/marcia-g-yerman/the-gardasil-vaccine-intr_b_340292.html

[ccdaddy57]

Gardasil Researcher Drops A Bombshell says she has to sleep at night with her self

http://thebulletin.us/articles/2009/10/25/top_stories/doc4ae4b76d07e16766677720.txt


To bad the FDA and the CDC and the NIH don't see it this way, apparently they don't have a conscience
left. Greed and the threat of law suites has sealed their consciences

Harper: Controversal Drug Will Do Little To Reduce Cervical Cancer RatesDr. Diane Harper, lead researcher in the development of two human papilloma virus vaccines, Gardasil and Cervarix, said the controversial drugs will do little to reduce cervical cancer rates and, even though they’re being recommended for girls as young as nine, there have been no efficacy trials in children under the age of 15.

Dr. Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, made these remarks during an address at the 4th International Public Conference on Vaccination which took place in Reston, Virginia on Oct. 2-4. Although her talk was intended to promote the vaccine, participants said they came away convinced the vaccine should not be received.

“I came away from the talk with the perception that the risk of adverse side effects is so much greater than the risk of cervical cancer, I couldn’t help but question why we need the vaccine at all,” said Joan Robinson, Assistant Editor at the Population Research Institute.

[ccdaddy57]

To date 44 young healthy girls have been sacrificed to Gardasil
Untold thousands are left with gulf war syndrome symptoms, because of the aluminum in great quantities in the vaccines. The placebo the FDA allowed had aluminum in it, because they knew that the large amounts of aluminum would be worse on the girls than the ingredients of the vaccine. And they would be able to say the vaccine has a good record because the placebo has the same amount of adverse reactions. The solders are getting the same symptoms as the girls, and some had not even left the states it's been tracked to the anthrax vaccine with all it's aluminum. The girls who end up this way are usually athletic usually higher testosterone than normal the children. Children with autism are unusually higher in testosterone than NT kids and now we are finding out a red flag for SIDS seems to be abnormal higher testosterone in baby's. We do not even know if these girls can even conceive children after this vaccine. And now they want to put it in boys where testosterone is
is very present and in some, in great amounts. These people if you can call them that have no conscience and no moral compass.

[Marcia G. Yerman - Huffpost Blogger]

Thank you to all the readers who have shared comments. Please know that there will be three more installments to this series. They are: Doctors who support the vaccine; An interview with Diane Harper;
stories from families. The goal of this series is to bring as much information as possible to the table so that parents can make informed decisions. To contact me about your experiences or advocacy work you are doing, contact me via Twitter @mgyerman.

[Robrich]

(Continued from post too long. )
A nurse at the Dystonia place asked me if she had the shot after I described her symptoms. Obviously they had made the connection with other girls. All testing has been very expensive and NORMAL. Yet, there is nothing normal about her health. Ten months later, she still has twitching, random jerking of her limbs, hair loss, very fatigued, extreme pain behind her eyes, very sensitive to light and noises, non epileptic seizures she has lost the ability to concentrate, difficult to test. I could go on and on. She should be enjoying her Senior Year, instead, she worries everyday about having a seizure at school. She is stressed over the fact that she cannot concentrate long enough to take the ACT/SAT tests. She is a very postive girl, refuses to let Gardasil win, she struggles every day to try to make her life normal. All this because I wanted to help her by getting her the vaccine. Pretty much sucks to think you are doing the right thing and it turns out like this. Share this information with every mom you know> save other girls from suffering like mine has.

[ddanimal]

Try taurine. Its a natural amino acid made by the body. Can be helpful in neurological disorders.

[Robrich]

I accidently posted my 2nd page as a reply to your comment. Sorry. I had clicked on reply to ask for your email address, since I don't twitter. I would LOVE to share our information, to get my daughters story out there for other moms to read, so they can make an informed decision. Also, if a mom does decide to go ahead and get her daughter the Gardasil shot, at least she will know what to watch for in side effects to save her from shots 2 & 3. I'm not an angry mom, just a mom on a mission to get my daughters life back. I'm also on a mission to help other moms make an informed decision. Do NOT rely on Merck or FDA information, research it. The information is out there, google it, read & learn.

[mofmars333]

Be sure to see Marcia's first article in this series & don't miss the information in the comment section to help make up your own mind on this most urgent matter.

http://www.huffingtonpost.com/marcia-g-yerman/the-gardasil-vaccine-intr_b_340292.html

Dear People,

Please don't take any one's word for anything this important. You need to search it out for yourself because your children are too important not to.

Sincerely,
Marsha

[Teresa Allen]

...continued...
My daughter started having dizziness, overall weakness, pain and numbness in both legs and left arm BEFORE we found out about any of these other girls having the same issues.
When I called her doctor that gave her the vaccine (as soon as she started with these symptoms) she said it was NOT the Gardasil vaccine that is causing it. How could she be so sure? This is such a NEW vaccine...a DANGEROUS and UNNECESSARY vaccine!
HPV is not an STD (research this!).
Cervical cancers have gone down 70% since the PAP smear came along.
This is NOT an epidemic! Why are they mandating this vaccine for as young as 9 year old girls for a vaccine that doesnt even do what they claim it will do?
Girls are now coming down with cervical lesions and HPV AFTER receiving Gardasil! I'm talking about healthy young girls that did NOT have these things BEFORE getting Gardasil.
This is all about $$$$$ at the expense of our young daughters (and now sons) health and lives!
It is an outrage!!!
...continued...

[Teresa Allen]

...continued...
Everyone should look at the other side of the fence and research this. There are thousands of girls that are coming down with strange illnesses, paralysis, gran mal seizures, etc. after receiving Gardasil.
She was ALWAYS a healthy child, happy and outgoing, active and just a joy to be around.
Now, she is a totally different child. She is always sick..always in pain..and cries a LOT, so scared that she will die in her sleep from the breathing problems. She describes it as breathing through a blanket or that an elephant is sitting on her chest. Also, her veins have basically disappeared. Almost all of the other injured girls that I know of have this same problem with their veins. Coincidence?
She has SO many of the exact same symptoms as all of the other girls that have been injured.
It is NOT a coincidence! All of these Gardasil girls have the same symptoms, some worse than others, but the bottom line is the one thing they all have in common is Gardasil.
These symptoms are NOT in their heads!
...continued...

[Teresa Allen]

...continued...
These 'side effects' are NOT rare! They are happening every day to literally hundreds of thousands of young girls after receiving Gardasil. The numbers in VAERS is estimated to only be between 1-10% of the true numbers! Try asking some of us moms who have to deal with these horrible side effects every day if we consider it to be RARE!
We are now getting reports of girls as young as age 9 that are breaking out with genital warts and severe cases of cervical cancer AFTER receiving Gardasil. Some of these girls/women did not initially have any side effects from the vaccine.
These are perfectly healthy girls all of a sudden come down with all of these strange sicknesses (some that I cant even pronounce) after getting jabbed with Gardasil. All within hours/days/weeks?
Just like Merck's 'wonderful' Vioxx...what will it take? How many dead/injured before someone takes notice?
The doctor that literally pushed this vaccine on us at a routine doctor visit told us that there were no side effects except for soreness or redness at injection site.
She also told us that it would protect her from a whole LIST of things! I had seen the commercials but had not researched it.
As a matter of fact, I never really THOUGHT about vaccines until my daughter suddenly started having all of these strange health issues.
...continued...

[Teresa Allen]

More lies from Merck....
I also have a 16 yr old Gardasil injured daughter.
She had 2 of the 3 injections (Jan 9th and March 9th, 2009). Before Gardasil, she was a happy, healthy and vibrant teenager. Since Gardasil she is sick every day of her life. She has dizziness, overall weakness, numbness and tingling in both legs and left arm, back pain, neck pain, pressure headaches, vision problems, breathing problems, chest pains, racing heartbeats, brain fog, stomach problems, nausea, diarhea, weight loss, hair loss, jerking all over spells...the list goes on and on.
She was an A/B student but failed her 10th grade year because she was too sick to retain what she was trying to learn (brain fog). She no longer has the energy to go off with her friends. Most days she lays in bed, in pain.
This just doesnt happen to a healthy teenager!! And it just doesnt happen to THOUSANDS of other girls with no connection except they all had the Gardasil vaccine.
It doesnt take a rocket scientist to figure this one out.
Please educate yourself as much as you can before you allow anyone to push this unproven and unsafe vaccine on your daughter! The guilt is overwhelming from a mothers' standpoint! I thought I was doing something to protect my daughter. Instead, I allowed the doctor to inject poison into my child and take away her life!
...continued...