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Three Deaths Linked To Merck’s HPV Vaccine - Gardasil. Does the benefit really outweigh the risk?

Posted by Catherine Morgan on June 11, 2007

Since my original post on the controversy surrounding the Gardasil vaccine, I have already added three updates. Recently I was made aware of new information released by the FDA regarding the more serious adverse reactions to this vaccine. Most upseting is the fact that at least three young girls have died within hours of receiving this controversial vaccine.

(Washington, DC) — Judicial Watch, the public interest group that investigates and prosecutes government corruption, today released documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing 1,637 reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil. Three deaths were related to the vaccine. One physician’s assistant reported that a female patient “died of a blood clot three hours after getting the Gardasil vaccine.” Two other reports, on girls 12 and 19, reported deaths relating to heart problems and/or blood clotting. — read full article

As of May 11, 2007, the 1,637 adverse vaccination reactions reported to the FDA via the Vaccine Adverse Event Reporting System (VAERS) included 371 serious reactions. Of the 42 women who received the vaccine while pregnant, 18 experienced side effects ranging from spontaneous abortion to fetal abnormities.

Side effects published by Merck & Co. warn the public about potential pain, fever, nausea, dizziness and itching after receiving the vaccine. Indeed, 77% of the adverse reactions reported are typical side effects to vaccinations. But other more serious side effects reported include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures. — – read full article

What troubles me the most about this is; Parents understand that with all vaccines there will be a very small percent of people (in this case young girls) that will have an adverse reaction ending in death. The major difference is that vaccines like the MMR vaccines (given to our children to prevent Measles, Mumps, and Rubella) are essential in saving many lives from these highly contagious and often fatal diseases. So, the benefits of these vaccines most definitely outweigh the risks…(the small percent of serious adverse reactions with MMR vaccine is still only a tiny fraction of the amount of deaths we would see without this vaccine).

Unfortunately this is not the case with the HPV vaccine. I think if a parent thought that their daughter might die from a vaccine that has limited protection against a treatable (non life-threatening) virus, they might not see a benefit that outweighs that risk.

A possible scenario…

Even if these girls (who have or will die from this vaccine) had been exposed to a strain of HPV that eventually caused them to develop cervical cancer, and they never went to routine doctors appointments, or had had a routine PAP test…Even if all of this took place, more than likely that daughter would still have lived a long and productive life before tragically dying of cervical cancer in her (late) adulthood. However, even more likely would be that within the ten year period that it would take for this type of cancer to become fatal…this woman would have been diagnosed and successfully treated and gone on to live a long life. Instead a young girl (between age 9 and 11) has died because of a vaccine that has no guarantee of preventing the above scenario anyway.

Essentially the girls currently getting this vaccine are the “test subjects” or “guinea-pigs” of the pharmaceutical companies. How many will have serious reactions? How long will the vaccine work? Will this vaccine really reduce the amount of deaths due to cervical cancer? The account of the three girls that have died from this vaccine are reported from practitioners that gave this vaccine to them (they were not part of any trial), that is why the information is only coming out now. The long term “trial” or “experimentation” of the effectiveness of this vaccine is literally happening right now, with our daughters. This would be o.k. if it was our choice to be a part of this trial, but instead we are being told it is safe, effective, and possibly even mandatory.This is just wrong, and is why I am so adamant in having the facts get out to the public. It’s o.k. to get this vaccine for your daughter, but you should be told all the facts up front…you shouldn’t have to stumble upon the facts on the internet…not when it comes to the safety of our children.

For more information you can see the original post & comments…

Gardasil — The Three Faces of the HPV Vaccine…Fear, Facts, and Profits.

First Update

Second Update

Third Update

For the sake of argument some are trying to explain away this new information, for instance this Huffington Post article. However, it only addresses one aspect of the controversy, there is no mention of the fact that the girls getting this vaccine are essentially the “test subjects” on whether the benefits of this vaccine outweigh the risks.

More to the point, the three deaths reported to VAERS after HPV were heart attacks that followed administration of the vaccine by three hours, a week and two weeks, respectively. It’s a good thing that they were reported to VAERS. We need to know if people are dying after vaccination. But when people die following a vaccination, it isn’t necessarily the vaccination that caused it, a fact that generations of vaccine critics have failed to clearly see as they bungle their interpretations of VAERS data.

Doesn’t “necessarily” mean that it wasn’t due to the vaccine either.

When the CDC, responding to the three death reports, interviewed doctors and examined the charts, they found that one, a case of myocarditis, was caused by influenza virus. The other two were blood clots in adolescents taking birth control pills. Birth control pills are known to raise the risk of blood clots. “These deaths are tragic but appear to have causes unrelated to vaccination,” says Dr. John Iskander, co-director of the Immunization Safety Office at the CDC.

Could it be that if these girls were not on the birth control pill this vaccine would not have killed them? Maybe. But if they hadn’t received the vaccine, might they have gone on to live without ever having a blood clot? Maybe. This is the problem, we just don’t know. For this reason parents and medical practitioners need to weigh the benefits of a vaccine that prevents some strains of a non life-threatening virus, against the risks and possible unknown risks of this vaccine.

UPDATE: This is from a comment to this Huffington Post article

This is from Moira Dolan, M.D. from Medical Accountability Network:

Since HPV is found in connection with most cervical cancers, the theory was that a vaccine against HPV would prevent cervical cancer. However the vaccine studies couldn’t demonstrate this, simply because there were no cases of cervical cancer in the vaccinated group or in the group that got dummy shots. So they used a substitute measure (a ’surrogate marker’) for cancer. They compared abnormal pre-cancerous Pap results in people who were vaccinated versus not vaccinated.

The vaccine is nearly 100% effective in preventing four types of HPV infection. Two of the four subtypes included in the vaccine are currently responsible for 70% of cervical cancer. So we would expect a 70% reduction in precancerous Pap results, right? However pre-cancerous Paps only went down by 12% to 45%, depending on which population was studied. (See below for the different populations and the reasons for this spread.) Why didn’t the vaccine cause a 70% reduction in pre-cancers in the general population?

This could be explained by some method of viral shift. Since the vaccine HPV types got pretty much wiped out as being a cause of pre-cancers SOMETHING must have taken their place because pre-cancers only reduced by 12.2% to 16.5%. The alternate explanation (raised by an FDA scientist) is that the theory that ‘HPV causes cancer’ could be backwards. Maybe HPV is just a so-called ‘opportunistic infection’ that is allowed to flourish un-checked in the vicinity of cancer cells.

U.S. statistics show there are 30 to 40 cervical cancer cases per year per one million women age 9-26, the ages the vaccine was tested on. Gardasil®’s reduction of pre-cancers by 12.2% to 16.5% in the general population would mean that instead of 30 to 40 cases of cancer, there would only be 26 - 35 cancers. So it would take vaccination of a million girls to prevent cancer in 4 to 5 girls

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What do you think of this new information. Do you think the “possible” benefit outweighs the risk?

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27 Responses to “Three Deaths Linked To Merck’s HPV Vaccine - Gardasil. Does the benefit really outweigh the risk?”

  1. Catherine Morgan Says:

    I did go to the article at the Huffington Post, and add a comment about my concerns that the most important aspects of this Gardasil controversy are not addressed in the article.

    http://www.huffingtonpost.com/arthur-allen/the-hpv-vaccine-debate_b_51542.html

    It hasn’t posted yet, but I imagine it will soon.

  2. Monday - WordPress PoliSci « oldephartteintraining Says:

    [...] Three deaths linked to Merck’s HPV vaccine - Gardisil [...]

  3. skywindows Says:

    This is exactly what I was afraid of with this vaccine. Thank you so very much for sharing this information!

  4. Catherine Morgan Says:

    “Skywindows” — Your welcome, I plan to keep a very close eye on this because my daughter will be at the age to get this very soon. At this point I think I will be holding off on it, at least until more time goes by and more information is available.

  5. skywindows Says:

    yea… I have 2 girls that will be affected by this. We live in VA where a law was passed forcing them to get vaccinated. So scary!

  6. Catherine Morgan Says:

    If you don’t want your daughter to have this vaccine yet, usually there is a way you can “opt-out” even when mandatory. You might want to look into that. Maybe then you could get a better idea of any side effects others are experiencing, and have her get it later if you feel more comfortable about it. Just an idea, I think each parent has to weigh all the information, and make a decision regarding it on their own. I don’t think it should be mandatory.

  7. Teresa Hartnett Says:

    Hi Ladies,

    I’m very grateful for finding out about this new vacine, because I was going to take my daughter into the doctors office for it this week, but not now. I feel so bad for the the families that have lost their children because of this, how sad.
    If its not safe, no one should get it, and they cannot make you get this injection for your child with 3 deaths conected to this vacine. Big lawsuits ahead for them……………..

  8. momma Says:

    Maybe the two girls were on the pill for other issues, but I thought that nobody who was already sexually-active was supposed to get this shot?
    I thought that was why they said they want young girls to get it, and there actually is a cut-off age, I thought that was due-to the idea that once you have sex you could be exposed to hpv?
    What is the risk for someone who is not a virgin, possibly exposed to hpv?
    I know they say it will not cure someone who is already infected, but could it do something else?
    Three deaths already from this ginny-pig trial on our daughters????
    I’m wondering-if there is a hormone-effect??

  9. Catherine Morgan Says:

    Hi “Momma” — All good questions. But I can’t say I know the exact answers. I would suspect the girls on the pill where on it for other issues, but even if they were sexually active they may have been given the shot anyway in hopes that they were not yet infected with HPV. But it is well known that if you are on the birth control pill you are at a greater risk for blood clots, so it would seem that giving any additional medication that had the possibility of blood clots would be a bit irresponsible. Certainly, a young women with HPV is better than no young women/girl.
    As far as your other questions, I would hope that the vaccine would not have negative effects on girls already exposed…but I can’t say for sure. And I’m also not sure of what this vaccine is made of…I don’t believe it is a hormonal thing…because it is actually an “anti-viral” if it is preventing a virus…but I could be wrong.
    Sorry I couldn’t be more help. But if you happen on the answers to any of these questions…please let me know.
    Thanks for the comment.

  10. Serena Says:

    This is why I was opposed to the government making the vaccine mandatory for girls attending public school. Aside from the recent deaths, we still don’t know the long term impacts of the vaccine. Thanks for sharing this really important information!

  11. Catherine Morgan Says:

    Hi Serena — Thanks for you comment, I agree with you. We really need to learn much more about the adverse reactions and effectiveness of this drug before it is made mandatory.

  12. Concerned Pedi Says:

    If anybody took the time to actually read the evidence you would see there is no cause and effect link between the vaccine and the deaths. On the two autopsies that have been released both had long standing heart problems which lead to their clots. On the third death there is still no confirmation (only an unconfirmed claim by a PA) that the patient received the vaccine at all.
    This vaccine is safe and effective and I would give it to my daughter in heartbeat.

  13. Julie Anderson Says:

    My daughter was one of the 26 girls who collapsed at her school in Victoria, Australia. On advice from the Royal Childrens hospital saying that it was a mild reaction and she should still have the rest of the course. She had the 2nd one and had another reaction, this time in hospital. It now seems that the gardasil caused her blood pressure to drop extremely low and it may have affected ber heart- she had a abnormal ECG. She is having tests in the coming weeks. I have 4 daughters. I thought I was doing the right thing!!!

  14. Catherine Morgan Says:

    Hi Julie.

    I’m so sorry to hear about your daughter…But, it sounds to me like you are somehow blaming yourself for this…and that could not be further from the truth. You were following the advice of your doctor, and that is what mothers are suppose to do.

    I think the true blame goes to MERCK, for having such an aggressive ad campaign (that basically makes mothers feel that if they don’t get this vaccine for their daughters, they are saying it’s “o.k.” for their daughter to be “one more” who gets cervical cancer). The truth is…If parents want their daughters to not get cervical cancer, they need to make sure they know the importance of getting the pap test (whether they have had the vaccine or not).

    If parents are told the facts about this vaccine…that it prevents “some” strains of the HPV virus…that the majority of HPV viruses go away totally on their own or with available treatment (even without this vaccine)…and that cervical cancer is virtually eliminated as a possible cause of death in women who get annual pap screening. If parents are just told these facts, in a “non fear-based” manner, then they can make an educated decision about this vaccine.

    If HPV was a deadly, highly contagious virus, with no cure…Then almost any risks of this vaccine would be acceptable. But, that is just not the case, and parents deserve the opportunity to make a decision on whether or not to get this vaccine, based on the facts (not fear). Parents should not be made to feel guilty if they want to take a pass on this vaccine for now.

    Anyway, I hope your daughter makes a complete recovery. And, you really should not feel any responsibility for her reactions to this vaccine. You did what you thought was best, and that is all any of us can do.

    Catherine

  15. Ana Says:

    I took this shot which was recommended by my physician and minutes later fainted while in the waiting room. It took me several hours to get back to normal and my blood pressure dropped to a ver low level. One of my best friends also got it and felt faint the same day, she got the second dosage and has been having headaches everyday since and nausea. I am definetly not taking another one… =\

  16. Catherine Morgan Says:

    Hi Ana — The most important thing to remember (whether you get the shots or not), is to follow your doctors recommendations about getting yearly PAP testing (or what ever they recommend for your age group). Thanks for sharing your experience with the HPV vaccine.

  17. Alexandra Says:

    As a daughter, I find it absolutely crazy that in certain states, such as VA, I could have been forced by the government and my parents to receive a new vaccine for a disease that I can only contract if I’m having sex. I think this decision should be made only by the person receiving the vaccination, since she is the one choosing whether or not to expose herself to the virus.

  18. Catherine Morgan Says:

    Thanks Alexandra,

    I think you are absolutely right. Thank for commenting.

  19. scared Says:

    I was going to get the vacine but with these new anouncements i ame most definently not going to anymore. Are they really forcing girls to get the shots. It should be their choice. What states require (or are going to soon)the vaciene to be given to school age girls?

  20. KJ Says:

    Thank you for sharing this information! I am a 25 yr old woman with no children living in NYC. My Doctor has been urging me to get the vaccination. I declined and consulted my mother who had a full hysterectamy at the age of 34. She thought it was a good idea to get the shot. Reading this along with the comments from the other women worries me.

  21. Jean Says:

    I have discussed this with my teenage daughters, and they have chosen not to get the vaccine. I explained to them the info the doc told me, and what I’ve read, and that I think we can afford to wait a generation to see the side effects. If no horrible side effects come out, they can get the shot for their daughters. Now that I read a possible complication linked to birth control use, I am glad they made that decision. They both have had a terrible time since reaching puberty and they don’t need any other problems.

    HPV = “Help Pay for Vioxx” (Merck has other motives, not our daughters health)

  22. sarah Says:

    I am 16 years old and just recieved the first dosage of Gardasil on 10/6/08 and I had no complications yet and I’m praying that I never do. I just found out about all of this stuff and its very scary to think about. I’ve also herd that this vaccine can disable you from having kids in the future, is this true? Im begging my mom to not take me back for the rest of the vaccination.

  23. Catherine Morgan Says:

    Hi Sarah. Side effects are rare, you don’t need to be scared. Almost all medications and vaccines have some risk of serious side effects. When you are 16 years old, chances are your mother knows best…and since you didn’t have a reaction to the first vaccination there is no reason to believe you will have a reaction from the next two.

    The problem with this vaccine (as far as I’m concerned) is that there is no guarantee that it will protect you from cervical cancer. The only way to be sure you are protected from cervical cancer, is to have regular GYN exams and PAP tests. The only way you can be sure you will be “one less” is to make sure you continue with regular exams. This vaccine should have been marketed as an HPV vaccine, because that is what it is, and there are still many reasons for you (and your mom) to want you to be protected from HPV. And that is a decision that every mother and daughter should be able to make together…without the government mandating it (requiring that every 12 year old get vaccinated).

  24. Michele Hastings Says:

    My daughter went to a friend’s peds. appointment to keep them company. The peds. doctor started telling her (my daughter) how she needed this HPV vaccine. She told him that she was only 16 and that her mother was not at the office to consent. The doctor stated he did not care that I was not there and that she was not a patient of his, went and got the vaccine and gave her the shot. He had no medical history and no parental consent! What can I do? Her regular doctor said it was very wrong for him to do this but did not offer any information on how to make a complaint. We live in the state of Georgia and it is not a mandatory vaccine and my county health department told me one had to be 18 to consent for any vaccine

  25. anon Says:

    The truth is, people have bad reactions to medications all the time, whether they are new or old doesn’t matter, because it HAPPENS. Losing 3 lives is hard to cope with, but we all have to die sometime, and they died for a good cause. Now more research and time will be spent looking into what went wrong with those select few. I only hope that the parents are breathing down the necks of the doctors that didn’t do the proper research into the girls before giving that shot.

  26. Alina Says:

    hi i’m 17 years old and i got the first two shots of the vaccine. After i had gotten the first one i got very dizzy in the doctors office and i nearly passed out. For a couple seconds my vision had blacked out. it was really scary to me cause i’m a very healthy person and i’ve never had that happen to me before. I’m getting my third one tomorrow and i’m extremely scared to get it ever since i heard the news talking about the deaths. I told my mom that i really dont think that i should get another shot but she says that she wants to talk to the doctor first. The problem is that the doctor is gonna keep telling my mom that its safe. They only want to make money. I’m scared because i dont want to have any bad symptoms from the vaccine. I have my life planned out(moving in with my bf of 3 years and going to law school to become a criminal lawyer) and i dont need to get something that could cause me to die.

  27. Ashley Says:

    Ok…I got the shot twice already. The first time I had a really bad migraine and fell asleep as soon as I got home and the second time, I seemed alright. I told them about the migraine before the second one but they said that it probably wasn’t from that. Now, I don’t really want to get the third shot from reading the notes above and also that I am on birth control as well. I had tried to ask them side effects of the shot but for some reason that had no information on it but seemed really eager to give the shot to people. I tried to ask them and would really like to know, so if you could please help me out, that if I were to get pregnant not while on it but right after could have taking the vaccine do anything to my child. My next shot is scheduled for September and I don’t think I am going to get that one…is that also ok, not following through with the whole vaccination? So, ok, bottom line…If I were to get pregnant in October not taking the last shot and the second one was given in May I believe would there be anything wrong with my baby? I am really worried that they don’t know the side effects to pregnancy because when I asked they didn’t know what to tell me and also that I asked if you were pregnant and didn’t know while being vaccinated if it would harm your baby and they couldn’t tell me either. So, please let me know…Thank you very much I appreciate it.

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