Gardasil and 1 out of 912

This has already been well debunked over at Internet Myths, Lies and Misinformation.  I am going to add my own two cents, but I want to give credit to one of the first things I read on this.  I used to write and link more about Gardasil when Bachmann was running for President.

9/15/11 HPV Vaccine does not cause retardation

9/17/11 12 year old girls might mistake a HPV vaccine for a HIV vaccine
10/19/11 Flashback to Gardasil

11/15/11 Bachmann: "Ravages of this Vaccine"

1/13/12 Many Teen Girls Mistakenly Think HPV Vaccines Cut Risk for All STDs 

Today, I came across this meme from Cancer Truth.  

The source cited is a blog written by Dave Hodges, September 17, 2013. Hodges wrote.

Merck and the CDC have determined that 1 out of every 912 who received Gardasil in a large study, (see page 8) died. Yet, the cervical cancer death rate is only 1 out of every 40,000 women per year. In other words, girls are better off not taking the shot because the Gardasil shot kills the girls in greater numbers than does the disease it purports to treat.

The study linked is a great study.  They analyzed seven clinical trials which used placebos as a control.

• 29,323 received injections.     
• 15,706 received Gardasil
• 13,023 received a placebo

With both the Gardasil and the placebo only 0.1% died: 21 in the Gardasil group and 19 in the placebo group. (In case you were wondering 1 out of 912 is 0.1%.)  Honestly if Gardasil was increasing mortality rates, you would expect to see more people dying with vaccines than injecting someone with a placebo.  However that is not what the data shows.  The meme could just as easily read:

Still you might say that 0.1% is still pretty bad right? Who cares about the 99.9% if you are the 0.1% right?  Well, lets look at the causes (plural) of death. 

The events reported were consistent with events expected in healthy adolescent and adult populations. The most common cause of death was motor vehicle accident (5 individuals who received GARDASIL and 4 individuals who received AAHS control), followed by drug overdose/suicide (2 individuals who received GARDASIL and 6 individuals who received AAHS control), gunshot wound (1 individual who received GARDASIL and 3 individuals who received AAHS control)

That's right the most common causes of death break down like this:

Hodges is such a honest guy *cough* that he is including 5 traffic accidents, 2 suicides, and for good measure, a gunshot, in his statistic, because in his own words "the Gardasil shot kills the girls"...with traffic accidents and causing girls to get shot.  He is literally arguing that "the Gardasil shot" gets you shot.  Again going back to the placebo, our control group, one could just as easily say that the "[placebo] shot kills the girls".  By injecting people with essentially nothing, they managed to get three times as many suicides and three times as many gunshot victims.  If Gardasil was really killing people, we would expect to see greater rates of death among Gardasil than placebo.

So what about these 13 and 6 deaths that are left? Well, both Gardasil and Placebo had a death attributed to pulmonary embolus/deep vein thrombosis. So that brings us to 12 and 5 deaths.

In addition, there were 2 cases of sepsis, 1 case of pancreatic cancer, 1 case of arrhythmia, 1 case of pulmonary tuberculosis, 1 case of hyperthyroidism, 1 case of post-operative pulmonary embolism and acute renal failure, 1 case of traumatic brain injury/cardiac arrest, 1 case of systemic lupus erythematosus, 1 case of cerebrovascular accident, 1 case of breast cancer, and 1 case of nasopharyngeal cancer in the group that received GARDASIL; 1 case of asphyxia, 1 case of acute lymphocytic leukemia, 1 case of chemical poisoning, and 1 case of myocardial ischemia in the AAHS control group; and 1 case of medulloblastoma in the saline placebo group.

Dying after taking a vaccine or a placebo does not demonstrate cause and effect.  In order for cause and effect to be demonstrated cause of death must occur more often in the vaccinated community than in the non-vaccinated community.  One or two cases is not enough to demonstrate that.  Remember what the paper blamed?

The events reported were consistent with events expected in healthy adolescent and adult populations.

Now it would be one thing if Hodges was arguing honestly. However:

• He excludes the placebo group which had the same mortality rate
• He includes traffic accidents, suicides, and gunshots in his statistic
• He rewords the paper to argue Gardasil kills when the paper actually attributes the causes to "events expected in healthy adolescent and adult populations."

Remember, this is Hodges' source.  He even gave the page number.  At best his "1 out of every 912" is actually 1 out of 1208 without any real evidence to imply cause and effect.  In case you were wondering, the death rate in the US is actually 807.3 out of 100,000 or about 1 out of every 125 (yes, I know there are reasons not to reduce it that much).  In the mean time cervical cancer killed 4,092 in 2011.

For further reading I found these on NPR.

HPV Vaccine Doesn't Raise Risk Of Blood Clots, Study Finds

Parents And Teens Aren't Up To Speed On HPV Risks, Doctors Say

Cervical Cancer Vaccine Also Helps Prevent Genital Warts

Girls Vaccinated For HPV Not More Likely To Be Sexually Active

Many Teen Girls Mistakenly Think HPV Vaccines Cut Risk for All STDs

WEDNESDAY, Jan. 4 (HealthDay News) -- Nearly one in four girls who gets the human papillomavirus (HPV) vaccinemistakenly thinks that her risk of getting other sexually transmitted diseases is lowered, a new study indicates.

HPV is the most commonly transmitted sexually transmittedinfection (STI) in the United States, with nearly 30 percent of sexually active girls aged 14 to 19 infected. Some virus types can raise the risk for genital warts and cervical cancer.

"I think it's important to counsel [girls] about what the vaccine protects against," said lead researcher Dr. Tanya Kowalczyk Mullins, an assistant professor of pediatrics at the Cincinnati Children's Hospital Medical Center and the University of Cincinnati College of Medicine.

The findings were reported in the January issue of the Archives of Pediatric and Adolescent Medicine.

Two HPV vaccines are now licensed in the United States. One, Gardasil, protects against two HPV strains linked with genital warts and two HPV types linked with cervical cancer. Another vaccine, Cervarix, induces immunity to the two HPV types linked with cervical cancer.

The HPV vaccine is recommended by the U.S. Centers for Disease Control and Prevention for boys and girls aged 11 to 12, with catch-up immunizations recommended to the age of 26 for women and 21 for men.

In the study, Mullins polled 339 girls, average age nearly 17, after their first of three HPV doses, and their mothers. Nearly 60 percent of the girls were sexually experienced.

Mullins wanted to know the girls' perceived risk of getting HPV after the vaccination, their perceived risk of getting other STIs and their perceived need for continued safer sex behaviors.

"Most girls correctly thought the vaccine does not protect them against STIs other than HPV," Mullins said.

However, 24 percent of the girls mistakenly thought they were at lower risk for other STIs such as syphilis and gonorrhea after the HPV vaccine, she found.

Girls who thought this were less likely to have information about the vaccine and about HPV infection.

Doctors who discuss the HPV vaccine with girls and their parents ''may need to emphasize the limitations of the vaccine and to specifically address that the vaccine does not prevent other STIs,'' the researchers wrote.

Mullins said it is not known how girls perceive risk after the entire three-dose series.

The study was supported by the U.S. National Institutes of Health.

Some study co-authors reported receiving grants from Merck, which makes Gardasil. One reported doing consulting work for Sanofi Pasteur, which has marketed Gardasil in Europe.

The study results bear "no big surprises," said Dr. H. Hunter Handsfield, a member of the board of directors for the American Social Health Association and a professor of medicine at the University of Washington Center for AIDS and STD in Seattle. He is an advisor to Merck for its HPV vaccine.

"If anything, it's a fairly pleasing result that it's only 24 percent [who think the HPV vaccine protects against other STIs]," he said.

Before the vaccines were available, Handsfield said, "social and religious conservatives" expressed worries that teens would practice safe sex less often after getting the vaccine. The latest findings suggest this isn't happening by and large, he noted.

Doctors do need to be clear with their young patients when giving them the HPV vaccine, Handsfield said. They need to tell them that the vaccine does not protect against all STIs, and that when the patients become sexually active they need to practice safer sex behaviors, such as using condoms. [1]

Bachmann: "Ravages of this Vaccine"

A concerned mother told Bachmann that the HPV vaccine caused her 16 year old daughter to have: chemical sensitivities, an irregular menstrual cycle, insomnia, headaches, seizures, temporary paralysis, and debilitating joint pain.

As a raised hand came up during the Q&A portion of Michele Bachmann’s stop here Monday night, so did a controversial vaccination issue that in September flooded the candidate’s campaign with both criticism and praise.

The hand belonged to Julie Weppler, a Sheldon mother who attended the event with her daughter:

“Michele, on behalf of myself and a lot of other mothers that have a child that’s sick from the Gardasil vaccine, I would like to thank you for the attention that you brought to it,” she said. “This is my daughter, Jessica, and she’s been sick for three years now from that vaccine.”...

..In Sheldon, Weppler went on to tell Bachmann that her daughter can’t go to school because of chemical sensitivities to everything from magic markers to certain cleaning supplies. She uses Skype, a video chat software, to attend high school classes from home

Jessica, age 16, began having headaches three years ago and described them to her mother as “a samurai sword stuck” in her head. Weppler said her daughter hasn’t gone a day without one since. Jessica also suffers from debilitating pains in her joints and spine, an irregular menstrual cycle and insomnia. She’s also experienced seizures and temporary paralysis, Weppler said.

“I praise you that you brought it to the attention of people, and I hope you continue to keep it in the forefront and educate people and try to get this vaccine pulled off the market,” Weppler said.

“Well, I thank you for bringing it up,” Bachmann said. “Parents have to make that decision for their kids because it isn’t the schools that are going to follow up with Jessica. It isn’t the schools that live with Jessica every day. It’s Jessica who’s having to have her body live with the ravages of this vaccine.”

Bachmann then decried Perry’s former chief of staff, Mike Toomey, who lobbied for Merck, the company that produces Gardasil, and gave $16,000 to Perry’s gubernatorial campaigns.

“And that’s a very big issue, and we can’t sacrifice the health of even one child on the altar (for) profits for some big drug company,” Bachmann said.

In an interview with The Des Moines Register, Weppler said she loved seeing Bachmann on television linking negative side effects to the drug.

She wasn’t upset when the Minnesota congresswoman later backed off on the issue. She said she’s happy with any negative attention the vaccine gets.

“I think she believes it’s having adverse reactions,” Weppler said. “That’s probably going to make me decide who I’m going to vote for: If I think a presidential candidate is getting bought out by a drug company, there’s no way I’m going to vote for that person.”

The Wepplers have traveled across the U.S. to meet with other families who believe they’ve been harmed by the vaccine. She also speaks daily with mothers in an online support group. She said they’d never support Perry.

“Oh gosh, no,” she said. “None of these families is going to vote for a presidential candidate who’s being bought out by a drug company.”

Bachmann gets it, Weppler said, because she too is a mother.

“I really like Michele. I’m sure Gardasil’s not something she’s investigated a whole lot,” she said. “I hope she does.”[1]

Assuming she reported this to the Vaccine Adverse Event Reporting System (VAERS), she is one of about 1600 people that have had a serious adverse event after taking the vaccine.  As of September 2011 about 40 million doses of the vaccine have been given with some young people receiving multiple doses[2].  The FDA explains the risks this way.

Given the large number of doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in this large population during the time period following vaccinations. Our monitoring and analysis of reports, including in-depth medical review, statistical data mining techniques, and analysis of reporting rates (number of adverse events/number of doses distributed) are designed to detect serious events that occur at rates greater than expected.[3]

Ms. Weppler may have acquired her condition from the HPV vaccine, however her condition did not occur at rates greater than expected.  Her condition could simply be the result of a chance correlation.  The thing is, we know that Bachmann knows this.

Women Can Self-Test for HPV, Easily and Accurately

Women Can Self-Test for HPV, Easily and Accurately 

A team of German researchers has shown that women can accurately test themselves for human papillomavirus (HPV) infection, the most common cause of cervical cancer. The research is published in the October Journal of Clinical Microbiology. 

"The high sensitivity of this self-sampling method guarantees to identify nearly all HPV-infected women," says first author Yvonne Delere, of the Robert Koch Institute of the Ministry of Health, Berlin. 

Worldwide, cervical cancer is the second most common cancer in women, with half a million new cases and a quarter million deaths, annually, according to the World Health Organization. Virtually all cases are linked to certain strains HPV. 

In the study, the researchers compared self sampling with conventional endocervical brush samples obtained by gynecologists in two groups of women 20-30 years of age, with (55 women) and without (101 women) a recent suspicious cytological smear. The two sampling methods were in accord in the two groups 84 and 91 percent of the time, respectively. Overall, the women rated the self-sampling method easy, at 12 on a scale of 0 (easy) to 100 (difficult).
The Netherlands has already introduced the new technique into cervical cancer screening programs, and Delere hopes to see the method become widespread in developing countries, where women frequently lack easy access to medical personnel and testing. 

The researchers note that concordance between the conventional and the self-sampling methods is good despite the fact that the techniques sample different areas. The cervical brush sampling is directed towards the transformation zone, the area on the cervix where abnormal cells most commonly develop, while the lavage includes the whole cervical area. 

"The higher prevalence of HPV, hr-HPV, and HPV16 in cervicovaginal lavage samples may be explained by additional infections at extracervical sites," according to the paper. "Since these infections may be a reservoir for virus infecting the cervical epithelium at the transformational zone, they are probably epidemiologically relevant. Therefore, cervicovaginal lavage sampling may be superior to cervix-directed sampling for future HPV prevalence studies." 

Among teenaged girls, the transformation zone lies on the cervix's outer surface, where it is more vulnerable to infection than it is in adult women. 

The self-sampling device, the Delphi Screener, is a sterile, syringe-like device containing five milliliters of buffered saline. One operates it by plunging the handle, releasing the saline into the vagina, holding it down for five seconds, then releasing the handle, so that the device retrieves the fluid. Next, one plunges the lavage specimens into prelabeled coded tubes, and mails it to the laboratory. 

(Y. Delere, M. Schuster, E. Vartazarowa, T. Hansel, I. Hagemann, S. Borchardt, H. Perlitz, A. Schneider, S. Reiter, and A.M. Kaufmann, 2011. Cervicovaginal self-sampling is a reliable method for determination of prevalence of human papillomavirus genotypes in women aged 20 to 30 years. J. Clin. Microbiol. 49:3519-3522.)

Flashback to Gardasil

With all the reading that I have been doing about Mifepristone, I thought that it would be interesting to compare the adverse events to Gardasil, one of the HPV vaccines.

According to the April 2011 FDA report. Since September 2000 there were a total of[1]

• About 1,520,000 women had taken mifepristone
• 2207 Adverse Events including
• 14 Deaths
• 8 deaths from sepsis
• 2 deaths from ruptured ectopic pregnancy
• 1 case each of substance abuse/drug overdose, methadone overdose, 
• 1 suspected homicide, 
• 1 delayed onset of toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and fibroid cultures were positive for Prevotella)
• 58 ectopic pregnancies
• 339 cases of blood loss so severe that they required transfusions
• 256 Infections
• 48 cases of serious infections

Gardasil was approved June 2006 and as of June 2011[2],

• 35,000,000 doses have been dispensed meaning that about half of girls 13 to 17 have received at least one dose of their three doses.[3] 
• 18,727 Adverse Events including
• 92% included fainting, pain, and swelling at the injection site (the arm), headache, nausea, and fever.Syncope (fainting) is common after injections and vaccinations, especially in adolescents.
• 8% were severe adverse events that included hospitalization, permanent disability, life-threatening illness, congenital anomaly or death
• 68 deaths
• 54 females 
• 3 males
• 11 unknown gender
• 32 deaths have been confirmed while 34 have not been confirmed, because of lack information in the report.

The Mifepristone adverse events would easily qualify as severe adverse events in the CDC research.  As with the Gardasil severe adverse events, the Mifepristone adverse events cannot be proven to have a casual relationship to the drug.  Also they are both extremely rare.  99.92% of those that take Gardasil and 99.85% of those that take Mifepristone will not have these events.  Both of these are exceptionally safe medications.  

12 year old girls might mistake a HPV vaccine for a HIV vaccine

[Update 12/4/14: The video link for this clip has broken so I am going to link to an ibtimes story.  For some reason this post has become one of the most popular things on the blog, so I am going to try to clean it up.

Pressed on her opposition to a vaccination aimed at preventing cervical cancer, the congresswoman offered a new reason for her stand, the Los Angeles Times reported.
It gives a false sense of assurance to a young woman when she has that, that if she's sexually active that she doesn't have to worry about sexually transmitted diseases.]

Honestly why would a "young woman" with the HPV Vaccine have "a false sense of assurance" that "she doesn't have to worry about sexually transmitted diseases"? I think Bachmann made a great case for increasing education in Junior High about STDs if young women cannot understand the difference between HPV and HIV.

The "serious adverse event" rate of the HPV vaccines is .08% that is 8 in every 10,000 or 1 in every 80,000. The rate is so low that it is difficult to prove that the event was a side affect of the vaccine. You are just as likely to get a potential neurological disorder (GPS) from the vaccine as you are from not taking the vaccine: 1-2 in 100,000.

HPV Vaccine does not cause retardation

Anecdotal claims, while evidence, are very weak evidence.  Let us suggest for a moment that someone came up to me in a crowd and told me that their daughter received the HPV vaccine.  She then grew 4 inches in the following two weeks after being short all her life.  She lost all acne and started receiving straight A's in her classes.  The mother told me that this was all caused by the HPV vaccine.

Well one, there are lots of things that can cause better grades, clearer skin, and growth spurts.  How am I to know that the HPV vaccine was the cause?  Was she under any other factors? Perhaps she received another type of vaccine?  Two, how am I to know the story is true to begin with.  Perhaps the mother was deceived and her daughter was given the placebo vaccine.  The mother honestly believed that her daughter received the vaccine.  Perhaps the mother was knowingly lying and her daughter never received the vaccine.  How am I supposed to know, if I am in a strange town among strangers?

This is why medical science abhors anecdotal claims.  The claims may be true, but you are not qualified to diagnose the truth.  These claims must be proven true after other alternative explanations have been ruled out.

Bachmann said,

The problem is, it comes with some very significant consequences. There's a woman who came up crying to me tonight after the debate. She said her daughter was given that vaccine. She told me her daughter suffered mental retardation as a result of that vaccine. There are very dangerous consequences. It's not good enough to take, quote, "a mulligan" where you want a do-over, not when you have little children's lives at risk.

 There are no documented cases of mental retardation from the HPV vaccine.  If the mother's daughter is the first, she should submit here daughter to study.  Only 1% of those that get the HPV have "adverse events" after receiving the vaccine. Of this 1% only 8% receive "serious adverse events."

A 1998 study linking autism to vaccines was exposed earlier this year as a complete fraud. However, anti-vaccine activists continue to believe there is a connection.

The Center for Disease Control notes on its website that less than one percent of recipients reported “adverse events” after receiving the vaccine. Of those, 8 percent were “serious adverse events” — including Guillain-Barré syndrome, a rare neurologic disorder that causes paralysis and muscle weakness, not cognitive disability.*

According to the CDC, studies showed no serious side effects to the vaccine and “there has been no indication” that the vaccine “increases the rate of GBS above the rate expected in the general population.” Bachmann cited no specific evidence to back up the anecdote.[1]

Of the 1% that have these "adverse events", 92% are fainting, pain, and swelling at the injection site (the arm), headache, nausea, and fever.  Fainting is common with injections involving adolescents.  Head injuries can be prevented by having the adolescents remained seated for fifteen minutes.    As for the 8% of the 1%, the .08% of those that receive the vaccines:

Any VAERS [Vaccine Adverse Event Reporting System] report that indicated hospitalization, permanent disability, life-threatening illness, congenital anomaly or death is classified as serious. As with all VAERS reports, serious events may or may not have been caused by the vaccine.

It is very difficult to prove that a serious event is caused by the vaccine since these events are so rare. These events already occur at low rates in the population. For example:

Guillain-Barré syndrome (GBS) has been reported after vaccination with Gardasil® . GBS is a rare neurologic disorder that causes muscle weakness. It occurs in 1-2 out of every 100,000 people in their teens. A number of infections have been associated with GBS. There has been no indication that Gardasil® increases the rate of GBS above the rate expected in the general population, whether or not they were vaccinated.

This disorder occurs already in 1-2 out of 100,000 teenagers.  Some have blamed some of these cases on the HPV vaccine, but there has not been an increase in the rate of the disorder.  If the HPV vaccine is sometimes causing this disorder it is not causing it enough to increase the rate of the disorder.  As mentioned earlier GBS does not cause mental retardation and it is the only mental disorder associated with the HPV vaccine.  [2]

Michelle Bachmann should apologize publicly for making such an unsubstantiated medically dangerous claim.