Gardasil is a Bad Idea: Part II

Written By: admin - May• 27•10
In Part one we looked at some reasons to suppose that Gardasil will likely have zero affect on cervical cancer rates and may make things worse.  These may be summarized as:
  • There is zero direct clinical evidence that Gardasil decreases cervical cancer rates.  The FDA approval was made based off an effect on immunity to human papilloma virus.
  • Western medicine does not have a great track record in treating cancer, let alone trying to prevent it decades down the line.
  • There has never been a preventive cancer vaccine that has been seen to work in the past.
  • HPV, against which the vaccine is directed, may simply be a “disease marker” in the same way that nicotine stained yellow fingers are a disease marker for lung cancer, while washing ones hands would have zero affect on lung cancer rates.
  • If one accepts that HPV is necessary for cancer development, it would seem highly reckless without massive safety data to suppose a-priori that inoculation with 4 strains of HPV viral epitope would be inherently safe and might not itself promote cervical cancer while any evidence for this would take decades to be seen.
  • Vaccine based immunity declines over time and there is no evidence that Gardasil induces a necessary long term immunity to HPV, while any decline in protection is magnified because the vaccine only protects against a portion of strains of HPV found to be associated with cervical cancer.
  • The regulatory process had been compromised by direct financial ties between the vaccine manufacturer and regulators, not to mention the political pressures brought to bear by a well-funded lobbying effort.
  • Even if the vaccine showed some degree of efficacy, a resulting decline in annual surveillance for early cervical cancer might still lead to a net increase in cervical cancer deaths

All this might just be some sort of billion dollar a year joke with Merck laughing all the way to the bank if Gardasil had proven to be an exceptionally safe vaccine.  Unfortunately Gardasil has proven to be an exceptionally unsafe vaccine.

If we return now to the excellent, lengthy articleon this issue recently published at “Age of Autism” it begins with a series of case histories of young women who died subsequent to Gardasil inoculations.  In light of these and similar developments 5 scientists from the CDC along with 7 from FDA recently published in JAMA an analysis of the CDC’s Vaccine Adverse Event Reporting System database.  They came to the conclusion from their analysis that the number of deaths was no different than what would be expected from the coincidental background rate, “nothing to see here, move along.”  Unfortunately, there are a number of glaring and obvious methodological flaws in their analysis.

One of the most obvious, that was quickly pointed out by other scientists in a Dec 2009 letter (Debold V, Hurwitz E. JAMA. 2009 Dec 23;302(24):2657) to JAMA, is that the wrong number was used as the denominator for determining the adverse event rate.  That is to say the paper used as the denominator the number of Gardasil vaccinations sold in a given time period.  This is invalid, however, for two reasons, first a significant portion, estimated as 1/3 of the sold vaccines were not used in the time period being analyzed.  Secondly, and more dramatically, the relevant question is “what is the cumulative toxicity of repeated exposures from the series of Gardasil injections?” Indeed many parents found that their child was either not harmed or in retrospect only mildly harmed by the first and/or second shot.  Therefore the true denominator needs to be decreased by 1/3 then again divided by three for the three shots in the Gardasil series.  This would give an adverse event rate some 5 times greater than would be expected from the background rate.

Secondly the numerator is in error as approximately one third of the deaths attributed to Gardasil were not entered in the VAERS database for the time frame under analysis.  In addition, the background rate is a comparison against a vaccinated population.  So adverse events that are a class effect from vaccination in general would not be discernible.  Or put another way, without comparison to an unvaccinated population one could only show that the vaccine is more or less safe than other vaccines.  One other caveat I would add here is that the study made no differentiation on the background death rate as to cause of death, that is to say a young woman might be expected to die in a car accident, they don’t often die saying they are going out for a jog then dropping dead in the elevator.

Finally, the VAERS database massively under reports adverse events, especially serious adverse events.  It does not take some sort of conspiracy of all physicians everywhere to understand why this is the case, simply put yourself in their shoes.  A young woman’s grief stricken parents come in to see you and note that their daughter died two weeks after receiving a vaccination and tearfully ask, “Do you think the vaccination could have had anything to do with it?”  What are you going to say?  “Yes, that’s it, I took your perfectly healthy daughter, jabbed her with a needle and killed her, now if you’ll excuse me I am a bit tired and have my afternoon clinic to attend to, you will be bringing her baby sister in for her well baby check next week, right?”  Of course not, as a defense mechanism few would likely ever even consciously entertain the possibility.  This state of affairs is compounded in that in the past most vaccines were for serious and highly infectious communicable diseases so that even if a death or adverse event occurred one would not want to report it as “we don’t want to risk Public Health by having people stop their vaccinations.”  While that line of thinking was always unscientific and condescending it holds even less water for vaccines for indications such as chicken pox, hepatitis B in infants, generally mild rotoviral diarrhea and “cervical cancer.”  However, the meme to never criticize vaccines has taken hold while there is great emotional interest vested in not believing one could be harming or killing one’s patients through one’s injections.

Some interesting evidence to support this position may also be seen at Jenny’s Journey a website started by parents who lost their young daughter to amyotrophic lateral sclerosis, a debilitating progressive neurological disease which began shortly after her third Gardasil inoculation. As ALS is extremely rare the parents reported the event to the VAERS database.  The CDC considered this to be an isolated and single event, unrelated to Gardasil vaccination, Jenny’s family was dissatisfied with the CDC’s unwillingness to look into the matter further and took matters into their own hands:

The CDC does not inspire confidence, so we conducted our own shoestring search to determine whether Jenny was alone. We created a website (jenjensfamilyblogspot.com). Although this website has only drawn 40,000 visitors, it has out-performed the federal government in finding girls ominously similar to Jenny (current score is: Jenny site 2; CDC’s VAERS: 0).

One does not need to be a statistician to see how unlikely it is that these two other girls are the only cases out there—or how frightening it is that we already know of three documented cases of girls (those two plus Jenny) who developed ALS within several months after their vaccinations. After all, if the odds of ALS in teenaged girls are 1 in 3 million and we found 3 in only 40,000, it is very possible that many other of the 6 million girls vaccinated have already developed severe neurological collapse, like Jenny.

If one has the time and inclination, I also highly recommend reading the whole three part,”A License to Kill” series on Age of Autism.  If the medical community were honest and responsible stewards of health, much of the analysis in part two likely belongs in the New England Journal of medicine as opposed to a blog,  Most competent epidemiologists would acknowledge that the analysis of death rates as calculated from pooled prospective clinical trials is generally considered a more accurate assessment than a population based approach as seen with the VAERS analysis.  From this analysis of the pooled clinical trial data, the death rate per 10,000 in those given Gardasil is seen as 8.5 as opposed to an expected background death rate of 3.9/10,000.  Extrapolated to a population of 4 million young women per year receiving the vaccination this equals 2,000 excess deaths per year.  This compares with an estimated 4,000 deaths per year from cervical cancer.  Though even the vaccines proponents acknowledge the vaccine would only have an effect in 70% of those 4,000, while as I have reasoned previously I fully expect, if this program continues, it will be seen tens of years and tens of billions of dollars down the line that this “cancer vaccine” will have no beneficial effect on cervical cancer deaths.  Finally we are discussing death rates here and have not also added in the large number of people who are claiming to have been seriously injured by exposure to Gardasil.

It is one thing to discuss the statistics and methodology surrounding this issue.  It is another to read the stories of parents and families affected by this vaccine. The Truth about Gardasil is a website started by two mothers whose daughters were severely injured by Gardasil.  While it is difficult reading one may read in the memorial section, the “case histories” of those who lost their daughters, these stories are also accompanied by stories of the many serious and debilitating injuries believed to be caused by Gardasil.

As a physician one’s advice carries great weight and often even involves even life and death decisions.  Now as one who frequently criticizes others as being entirely off base in many health related issues it must at least be entertained that one might fall victim oneself to those errors of reason which one claims are so frequent in others.  Having said that, my strong recommendation to any patients or parents of patients is to unequivocally avoid Gardasil vaccination.  And I have attempted to clearly present the reasoning and evidence for my position.  To physicians, I would also say that we have a responsibility both out of necessary compassion and to arrive at a well-supported diagnosis to first and foremost listen to what our patients are telling us.  Well our patients have organized an international support group to deal with the tragic health effects they are telling us were caused by Gardasil vaccination.  That should tell us something.

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10 Comments

  1. Rosemary Mathis says:

    Thank you so much for your research and article. The Gardasil Girls are suffering with what seems little help from the CDC or the FDA. Gardasil should be pulled from the market. Young girls should not have to suffer the way these girls are. Please mothers, investigate before you vaccinate. The life you save may be your childs.

    Please go to http://WWW.TRUTHABOUTGARDASIL.ORG for the stories of injury and death from Gardasil. The life you save may be your child's.

  2. Anonymous says:

    Thank you so much for giving our injured girls a voice. They are suffering daily with no help from doctors or support from the media. Parents have a right to know what the possible side effects are before they say yes to Gardasil.

  3. Anonymous says:

    Thank you for supporting the argument of so many families throughout the world. My daughter was injured by Gardasil but it took me a while to put the pieces together. I thank God for helping me find so many caring, compassionate, brilliant women that helped me "save" my daughter from the dangers of Gardasil. She is recovering … but I continue to fight to get this off the market because it is so dangerous. Please see a letter regarding other possible side effects (link below) … pk deficiencies (hereditary and/or environmental) = anemic conditions such as sickle-cell, G6PD, thelassemia, etc. I honestly believe this is a "survival of the fittest" type of vaccine meant to do extreme damage to genetically deficient individuals.

    http://holyhormones.com/sister_song/another-gardasil-mother-speaks-out-to-fda/

  4. Norma Erickson says:

    Thank you for this inciteful article. It is so good to see a medical professional who actually examines the empirical evidence and makes a sound, evidence-based conclusion.

  5. RC says:

    To beat a dead horse a little more:

    Gardasil was tested on a population of women average age 20. Infection with HPV at age 20 and younger is now a non event according to the latest guidelines from the OB/GYN advisory organization ACOG. If fact, PAPs are no longer recommended for women 20 and younger because whatever abnormalities found at that age are all but guaranteed to resolve on their own. That makes all the cervical cone biopsies and cryotherapy unnecessary harms/overtreatment in adolescents.

    Since young women seem to have a natural ability to clear HPV, for all we know blocking infection with gardasil in teens will block life-long natural immunity. As you said the protection from gardasil will likely wear off in 5-10 years, possibly setting up a nightmare scenario with women in their mid 20s and 30s suddenly susceptible to the cancer causing strains 16 and 18.

    Additionally the phenomenon of serotype replacement will come into play in some unpredictable fashion. There are just as many cancer causing strains as benign strains waiting to fill the HPV void caused by gardasil. We won't know if these other strains cause a more or less or equally aggressive cervical cancer until the experiment runs its course over 20-30 years.

    The most expensive routine vaccination in history might do more harm than good. The research to gain approval didn't study cervical cancer but HPV infection and the resulting abnormal PAPs in an age group not intended to get the vaccine.

    Merck put their money into marketing gardasil after the 2 clinical trials failed to show compelling results. This was a massively successful spin campaign. Unfortunately for Merck, mother's tend to hold a grudge when you trick them into allowing untested biologic agents to be used on their 12 yo girls.

  6. PDM says:

    @ Rosemary

    Thank you for all you do at The Truth About Gardasil in providing support to those who have suffered from this vaccine and in educating the public about its dangers.

    @ Anon1

    I will continue to mention the serious health problems associated with this vaccine on this site. I am not overly optimistic that FDA or CDC will pull this product from the market any time soon, however, the number of healthy young women who might be seriously injured can be tremendously lessened by grass roots efforts to get the word out concerning the dangers associated with the vaccine.

    @ Anon2

    I am very sorry to hear about the iatrogenic injury caused to your daughter by this vaccine. Thank you for your link to the letter to FDA. Such efforts are necessary, however, as I mentioned, if history is any guide FDA will act on this issue, slowly, reluctantly and complaining all the way. While I understand your concerns over how such a terrible product could be so widely promoted, if your observation is correct that a disproportionately high percentage of athletic young women are being harmed by the vaccine then it not survival of the fittest, more a harming of the fittest scenario.

    @RC,

    Thanks Doc, you've made a number of excellent points here that I was wither unaware of or hadn't considered.

    I hadn't considered it, but you are correct, many viruses run a far less virulent course in childhood than adulthood. And just as this is a concern with chickenpox vaccination, who knows what the effects of possibly just pushing back exposure to HPV to a later age.

    The point about other cancer associated strains filling the niche had completely escaped me, but makes perfect sense, just as antibiotic resistant strains of bacteria or drug resistant strains of HIV may proliferate in a similarly constrained environment.

    How in heck did this thing ever get on the market?

  7. Anonymous says:

    Hmmm you've made a few statistical errors here in your "adjustment" of the JAMMA article. Not to mention praising the pretty bad math skills and ridiculous epidemiology of AoA. I call "shenanagans" here.

    • Kimberly says:

      It would have been helpful if you would have shown the statistical formula(e) you think is correct.

      • admin says:

        If there was something cogent to reply to I hope I would have. Otherwise to have some fun I call “shenanagans” on the “adjustment” of JAMA to JAMMA and call shenanigans on “shenanagans”.

  8. Anonymous says:

    Lauren.

    Hi im a 22 year old australian, and i have to say i found your article extremely interesting.

    When Gardisal was released in 2006, the Australian media touted it as a wonder drug, which had been designed with the aid of researchers based out of Sydney or Melbourne (i cant rember which now). It was free for all girls to acess 18 months after its release on the maket.

    I myself have recieved two of the three injections and after hearing anecdotal evidency of lethargy, dizziness, neausia from friends after having their third injections of the drug, decided not to pursue the final course of injections