gardasil

“If Only There Were A Vaccine for Hysteria” Redux*

World Net Daily sometimes goes off the path, but this time, they are posting emotional noise in the article, “’My headache’s about to explode’: U.S. girls just dropping dead.”  Author Joe Kovacs even goes so far as to support the claim by the organization, Judicial Watch, that the vaccine against Human Papilloma Virus, Gardasil, is harmful by citing a case of “meningococcal disease,” caused by the bacteria, Neisseria meningitides.

The article or the claims have no basis in fact. There was one case of anaphylactic shock, but no other deaths due to the vaccine. There has been no pattern of serious adverse effects and the major problems have been sore arms and fainting which looks like a seizure to those who haven’t seen it before. (I’m a Family Physician who has had fathers faint in my office and the hospital while watching procedures or shots. Mothers tend to sit when I ask them to, so they’re less likely to faint.)

Gardasil is not derived from the actual HPV virus. It is made the same way that insulin is made for patient injection for diabetes: bacteria is tricked into producing proteins that “look” like bits of the virus, but are never in any way active as an infectious agent.

The article notes that there have been over 35 Million doses of Gardasil given in the United States. We have 10 years of experience. Back in 2006, before Governor Rick Perry made news my adding Gardasil to the list of mandatory vaccines for school children, we already had five years of history and reviews of the vaccine. We have all sorts of studies and surveillance going on currently. Take a look at the world-wide surveillance.

Everything that has an effect is likely to have a side effect. However, this article and the hullabaloo over Gardasil is hysteria. There are mechanisms that allow us to predict bodily reactions and enable us to practice medicine: we know how the body is likely to react to disease, a new exposure or stress, or to medications. There is no mechanism for the “my head is going to explode” symptom.

We do know enough to be able to say what does not have a basis in science. Science and medicine are getting *better* at predicting outcomes, not worse. Read up on “biological plausibility.”

In the comments, people are saying that the CDC and FDA are part of big conspiracy, that people shouldn’t trust their doctors. The reason that there are more recommended vaccines is because we are doing research to find more vaccines to prevent diseases, not because some horrible conspiracy is growing.

* We don’t have a vaccine for hysteria, although Michael Fumento called for one back in 1999, in his op-ed on a similar hullabaloo surrounding the anthrax vaccine.

One more time: Perry, Gardasil and the facts

Governor Sarah Palin and Congresswoman Michelle Bachmann went on Greta Van Sustern’s “On the Record” show on Fox News to accuse Governor Rick Perry of “crony capitalism” because of his Executive Order RP65, which would have mandated Gardasil and which did make it much easier for parents to opt out of all mandatory vaccines.

None of the players explain one very pertinent point: Merck was the only company making the only approved vaccine against the viruses that cause the changes that cause abnormal Pap smears and which lead to cervical cancer. (The only reason to get a pap smear is to check for changes from HPV. Gardasil provides immunity to the specific strains that cause nearly 3/4 of all cervical cancer.)

The Gardasil vaccine (more, here ) was recommended the FDA’s vaccine approval committee, more than 6 months before Governor Perry’s Executive Order. All girls who qualified for the Federal Vaccines for Children program were eligible to receive the vaccine free of charge: Medicaid, CHIPs, and uninsured or those with insurance that won’t pay for vaccines. The Texas Legislature had previously delegated unconditional authority to mandate new vaccines to the Department of State Health Services, which is under Governor Perry and the Executive Branch.

Congresswoman Michelle Bachmann showed her profound ignorance about the germ theory and modern medicine in general, and the Human Papilloma vaccine, Gardasil, in particular. She seems ignorant of the fact that newborns (little, innocent newborns) receive a shot against the STD, Hepatitis B, on the first or second day of their lives, before they go home from the hospital. They get 2 more of the shots by the time they are 6 months old. And (little, innocent) 12 year old boys and girls get a (measles/mumps/rubella) MMR and a tetanus and diphtheria booster (Td)  about the same time. Tetanus, or “lock jaw” is not a communicable disease.

in her zeal to attack Governor Rick Perry, Bachmann did even worse in her post-debate interview with Greta Van Sustern on Fox News. Her emotional, anti-vaccine remarks should be an embarrassment to her.

She told Greta about a conversation with a crying mom who came up to her after the debate, saying that the woman’s daughter suffered from “mental retardation” after receiving the vaccine. “Mental retardation” would not be diagnosed at 9-12 years old. In fact, in over 10 years more than 50 million doses of Gardasil have been given in the United States. There has been more than the usual scrutiny and surveillance for adverse effects. The Center for Disease Control, the FDA and the Institute of Medicine have all reached the conclusion that even with this heightened awareness and concern, there have been no adverse effects from this vaccine other than fainting and allergic reactions that can happen with any medical procedure or treatment.

At the time, Gardasil had over 5 years of history of study in boys and girls, with an official “Four Year Follow Up” article published in the British Medical Journal. To learn more, please see “A Dose of Reason.”

Answer to Bias Against Governor Rick Perry

“We would be wise to remember a universal truth: No government has ever taxed and spent its way to greater prosperity.” Governor Rick Perry, 2005

This is in response to a post by blogger “MarkAmerica” at FreeRepublic.com. Unfortunately, there are many bloggers out there making the same accusations and false statements. Hopefully, this will clear up some of the questions less biased people might have.

To MarkAmerica:

Incredulously, your statements here imply that you are privy to the thinking and motives not only of Governor Perry, but of Mark Davis! Your comments are skewed bias and nothing more useful than shotgun accusations without evidence to back them up.

You falsely state that the Governor does not represent the same ideals as those of us in the Tea Party. I attended my first Tea Party event on February 27, 2009 in San Antonio and I say that you are flat wrong. Governor Perry met with 3 separate Tea Party groups on Tax Day, April 15th, 2009 – the day he’s accused of suggesting that Texas might secede. We know he never suggested any such thing, but he has always firmly stated his belief in small government, less taxation, and greater accountability to the people.

You also falsely claim that Governor Perry has less in common with regular Texans than with Wall Street “types.” I think his history is at least more familiar to Texans: he grew up far away from the city on a tenant farm, became an Eagle Scout, flew C-130’s as an Air Force pilot, and spent a few more years back on that farm as an adult.
You falsely claim that the Governor is uninterested in individual rights. A review of his speeches and of his books prove that to be a lie. He said in his first State of the State in 2001, that “We must preserve freedom and opportunity by extending it, one Texan at a time.” In his 2003 State of the State address, the Governor made his concern for the individual even more clear by telling the Legislature to remember that “behind every government program, there is a real taxpayer funding it.” He also reminds us that “The right to life is a fundamental right declared by our forefathers” and has consistently championed prolife laws each session.

Your false claim that the Governor only talks tough when he’s running for office is easily dis-proven by looking at 2003, when he had just won re-election for four years. Texas, like the Nation was reeling from the financial fallout of September 11, 2001. The Governor had already led State agencies to cut spending for the fiscal year by 7-13% and called on the Legislature to pass the first budget to cut State spending since World War II by prioritizing education, security and “fiscal responsibility, because neither of these priorities can be met unless our spending is disciplined.”

The Governor has always been adamant about cutting taxes, too. He’s repeatedly called for cuts in property taxes. Look at this, from the 2005 “State of the State”speech:

It is time to cut property taxes for the hardworking people of Texas. In fact, let’s not only give Texans property tax relief…let’s give them appraisal relief too.

Texans don’t like taxation without representation, and they are sick and tired of taxation by valuation.

The time has come to draw a line in the sand for the taxpayer: Let’s cap appraisals at three percent.

If you oppose a three percent cap on the philosophical grounds of local control, I can respect your position. But then I would hope you would be consistent, and advocate for the repeal of the ten percent cap on the same basis. There is no point in being lukewarm on this issue. Either be hot or cold; either provide real appraisal relief, or none at all. But let’s stop this false pretense of taxpayer protection at ten percent.

You falsely claim that the Governor has had a “more recent conversion” on tightening border security, ignoring the fact that Texas spends about a (edit 21:00 8/28/11) 100 dollars of our own tax funds each year to secure the border. Back in the Spring of 2001, he vetoed a driver’s license bill because it didn’t limit illegal aliens. He has consistently demanded that the Federal government do its job on border control by authorizing National Guard deployment. In 2005, he used money from his own office budget to increase funding for local law enforcement and set aside a task force from the Department of Public Safety.

You falsely accuse that the Governor is guilty of “corporate-cronyism.” The Governor promotes privatization rather than growth of government and taxes wherever possible, encourages Texas to compete with other States for jobs and business investments, and most of the business owners appreciate his efforts. Our 2005 tort reform – and the new “loser pays” law – has benefited every business except the trial lawyers. The Toyota plant that opened in San Antonio and a $3 billion dollar Texas Instruments plant are just two strong examples that our Texas policies work to bring jobs to Texas.

Your false claim that the Governor is a “statist” is ridiculous. The entirety of the book Fed Up!: Our Fight to Save America from Washington is proof against your statement. Here’s just a couple of quotes:

“The statists believe in a powerful, activist central government that advances a radical secular agenda in the name of compassion. The hide behind misguided notions of empathy and push token talking points about fighting for the little guy, all the while empowering the federal government to coercively and blatantly undermine state-, local-, and self-governance.” Location 320

“The truth is, I don’t care what party the statist is in. The fact of the matter is, it is the statist, and those who support or enable him, who is the problem. For too long he has undermined this country by empowering the national government at the expense of liberty. An America defined by the statist in Washington is an America doomed to fail.” ” Location 338

(both quotes from Perry, Rick; Newt Gingrich (2010-11-15). Fed Up!: Our Fight to Save America from Washington. Little, Brown and Company. Kindle Edition., the Kindle PC edition. And, no I don’t get a dime from Amazon.com, either. I just do my homework.)

Since you dismiss anything since 2010, here’s an earlier example that the Governor has a clear understanding about personal responsibility, opportunity and a better understanding than most about the differences in power of local governments, the States and the Federal government. He testified before the US House of Representatives against federalization of emergency first responders in 2005. (Testimony here.) (Yes, the response of Washington to the crises after Katrina was to propose to federalize EMS.)

I’ve blogged on the Gardasil Executive Order at LifeEthics.org since February, 2007 and have written more in the last month at WingRight.org. It’s foolish to continue to claim that the Governor was bribed by $6000 in donations (he raised $20 million dollars that year). There is no evidence that the Governor had any motive other than to decrease disease, speed up the coverage of the vaccine by private insurance, and to strengthen parents’ rights by making it easier for them to opt out of any or all mandatory vaccines.

Which leaves the TransTexasCorridor. That was a now-defunct attempt to solve a lot of problems including the need to move more traffic and freight faster, safer and outside city congestion by a combination of privatization and tolls. We had concrete examples of the need for more roads leading across the State during the evacuation of South Texas in response to Hurricanes Katrina, Rita, and Ike. The Governor encouraged the 2005 law to protect private property rights through the control of eminent domain and signed even stronger protections this year.

Conservatives and Republicans shouldn’t forget that our enemy is big federal government and that States are better suited and have the Constitutional authority to try many more solutions to many more problems. As someone who’s been accused of being a “Perry operative” due to my answers to the multiple political rants against Governor Perry, I assure you that some of us have sincerely come to the opinion that Governor Perry should be our next President by the same process that others have decided to advocate for their own particular candidate. We recognize that in his 10 years as Governor, he has boldly practiced what he professes: that States should be “laboratories of democracy.” Not every experiment works, but the Governor has demonstrated that he can learn from mistakes and has the flexibility to change course when the people object.

No Deaths Due to Gardasil

I’m still getting emails from people warning about deaths due to Gardasil and there are repetitive false reports in the “lame-stream media” and by bloggers repeating the same lies.

One email and an “alert” on one of the big forums has no link to real data, but does link to a law firm in Florida that is looking for cases to use in a suit against Merck. Unfortunately for them, the trial lawyers link to the CDC web page showing that they have no case.

In contrast, the reports given by the FDA and CDC show no connection to deaths and no connection to any serious reactions. All of the reported events happen at the same rate that they do in the general population, whether or not the people were vaccinated.

From the CDC page linked by that trial lawyer:

As of June 22, 2011 there have been a total 68 VAERS reports of death among those who have received Gardasil® . There were 54 reports among females, 3 were among males, and 11 were reports of unknown gender. Thirty two of the total death reports have been confirmed and 36 remain unconfirmed due to no identifiable patient information in the report such as a name and contact information to confirm the report. A death report is confirmed (verified) after a medical doctor reviews the report and any associated records. In the 32 reports confirmed, there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine and some reports indicated a cause of death unrelated to vaccination.

From the FDA page:

Concerns have been raised about reports of deaths occurring in individuals after receiving Gardasil.  As of December 31, 2008, 32 deaths had been reported to VAERS.  There was not a common pattern to the deaths that would suggest they were caused by the vaccine.  In the majority of cases with available autopsy, death certificate and medical records, the cause of death was explained by factors other than the vaccine.

There have been about 40 Million doses given in the US, closer to 60 million in the world, since 2001. There is no connection to deaths due to the vaccine. The Vaccine Adverse Events Reports confirm a death rate less than that of the general population (around 60/100,000).

There are multiple post-marketing studies going on all over the world, since at least 2001 and yet there are no “red flags.”

I’ve covered this much more extensively elsewhere on WingRight, along with some of the examples of the non-confirmed reports and instructions as to how to look up the VAERS reports for yourself.

The Facts on Gardasil and Perry: Right Wing vs. WingRight

Do you really want to frustrate me? Publish an opinion piece online, but restrict comments so that I can’t tell you where you’re wrong. Sure, it’s your site, and you make the rules. Well! Since I have my own blog  . . .

The mainstream media has rediscovered Executive Order RP65 that Governor Perry issued in February, 2007. I wrote a “A Dose of Reason, Perry and Gardasil” to answer some of the gobbledygook in the media.

Unfortunately, some of the pundits we normally consider conservative are just as mixed up and fail just as miserably in their research and conclusions.

Michelle Malkin (michellemalkin.com ) won’t take new subscribers or comments from the public at all. She has written a disorganized rant calling Governor Perry “Obama-like.”  She claimed that the Governor went over the heads of the Legislature, calls the opt-out clause “bogus,” without researching what it was before the Governor’s EO, and is evidently completely unaware of the funding of vaccines in the US.  I was able to comment at the column’s syndication site, Creators.com,   copying and pasting my coverage of these concerns in “A Dose of Reason, Perry and Gardasil.”

RedState’s  Bill Streiff and Erick Ericson have posted their own articles That site won’t take comments from new subscribers. Ericson reposted his 2007 missive that compared the Executive Order to eugenics and focused on the possibility of corruption due to Merck’s lobbying.

Streiff’s two pieces, here , and  here,  cover the de-bunked corruption charges and provide a succinct list of ethical objections that are less subjective and a bit more organized. Here’s my reply:

1. The recommendation did not include males, though males can carry and transmit HPV. This oversight made the creation of “herd immunity” impossible. This, definitionally, means the vaccine could have only a limited effect in combatting HPV.

The vaccine had not been recommended for boys at the time. The reasoning is that the vaccine prevented cancer. Society was not ready to talk about anal sex and males having sex with males, so there was a delay in adding boys. Since that time, the recommendations have changed to include boys.

2. Not all strains of HPV linked to cancer were affected by the vaccine. While doing something is better than doing nothing… generally… no one knows what the impact will be of creating a better evolutionary environment for the others strains by eliminating competing versions of the virus.

We knew at the time that the vaccines covered the viruses that caused 70% of cervical cancers (16 and 18) and 90% of the strains that cause genital warts (6 and 11). The preventive effect for these strains was 96% to 100%. according to the British Journal of Cancer article on the 5 year follow-up, published in December, 2006. (It was on-line November, 2006 and I accessed it for review today, August 18, 2011.)

We already had evidence, since confirmed, that there might be some cross-immunity for other strains.

3.Requiring people to receive a vaccine against diseases which they may very well never encounter is a very queasy ethical area. Unlike diseases like measles, whooping cough, etc., HPV is not spread through casual contact.

True. But 50% of people will be infected at sometime in their lives. The true cost is all of those abnormal pap smears – the cellular changes are all – 99.7% due to HPV.  It’s also true that we vaccinate for tetanus – what we used to call “lock jaw” – even though it’s not contagious, and for Hepatitis B, which is only spread through blood and body fluids.

4. Clinical trials were conducted on women aged 16-26 leaving everyone to presume that Gardasil was safe and efficacious in 10 year-olds even though there was zero data pertaining to that age group.

Completely false. Both the 2007 Gardasil insert (no longer available online, but I saved a copy on my computer) and the current insert contain information about early testing on boys and girls 9-15. 1122 girls ages 9-15 received the vaccine during trials to test the immunogenicity, demonstrating the production of antibodies.
There. I feel better, don’t you?

Bogus “14 Reasons” – Here’s the truth

There’s been an email going around with out and out lies about the Texas economy and half truths or lies about our Governor Perry.I worked on this last weekend, sitting up most of Sunday night and rechecking my facts and numbers this morning.

I’ve covered this subject in an earlier review at this blog.

(Edited 8/17/11 for formatting and a couple of typos. Hopefully, it’s easier to read. My answers should be in red.)

Dose of Reason: Perry and Gardasil

Bear with me, this isn’t a “sound bite” subject.

(Edit 8/23/11: The opt out is for 2 years, not 1. BBN )

The Human Papilloma Virus is an infection, and should not be a moral issue. In contrast, the vaccine against four strains of the virus, Gardasil, has become a political issue, even though the Federal Food and Drug Administration (FDA) now recommends it for all boys and girls.

Governor Rick Perry has been criticized for his February, 2007 Executive Order that made the vaccine mandatory for girls before entering the 6^th grade. Very little is said about the part of the EO that affirmed the right of and facilitated parents who wish to “opt out” of not only Gardasil, but other vaccines as well.

We expect the Governor to direct the people that he appoints, right?  The Governor is responsible for management of the Executive Branch, including the Department of State Health Services. He appoints the head of the DSHS, who supervises the people who decide which vaccines will be mandatory. Texas’ Legislature modified Chapter 38.001 of the Texas Education Code over the years to mandate certain vaccines and allow the DSHS to add other mandated vaccines without Legislative oversight.  Just before the Gardasil controversy, the Department had mandated Chicken Pox and Hepatitis A, which are both manufactured using cultures of human fetal tissue obtained at an abortion.

The Governor’s Executive Order (RP 65) that caused all the controversy also ordered the director of DSHS to make it easier for parents to opt out of vaccines. The Legislature had changed the law from “opt in” to a requirement to “opt out” once for all the school years. Next, they changed to a two year limit on the opt out, and then in 2005, the Legislature restricted the period to one year and required a new State form bearing a “seal.” Parents had to go to Austin or start early in the summer. There were bureaucrats who maintained that the only way to get the form with the seal was to go to Austin, find the right office and make the request in person.  Perry used his EO to tell the Director of DSHS to make the request (and the seal) available on-line, making it easier to “opt out.”

In fact, the reason for the Executive Order was to speed up private insurance coverage and to make it easier for parents to exercise their right to opt out.

The Federal government doesn’t have the authority to mandate vaccines in the States.  Not yet, not exactly. However, thirty days after the National Advisory Committee on Immunization Practices (ACIP) recommended the vaccine, Texas was required by Federal law to buy and distribute the vaccine in the “Vaccines for Children” program.  The program provides vaccines without cost to uninsured children up to age 21, those who are insured by Medicaid, and those whose private insurance does not pay for vaccines at all. In effect, the only families who have to pay for Gardasil – for whom the State of Texas will not pay, anyway, under Federal law – are those whose private insurance will only pay for mandated vaccines.

Gardasil is manufactured the same way that insulin for diabetics is made these days: using recombinant DNA. In this case, common bakers’ yeast makes the proteins that cause the immune response. Gardasil had been thoroughly studied even in 2007, and is not only included in the Vaccines for Children program, it is the most-requested vaccine for girls. We are even seeing cross-protection from other strains.  It has recently been recommended for boys. The recommended time to give the HPV vaccine is at 11 or 12 years old, when children are scheduled to receive other shots (tetanus and MMR boosters) and before they were likely to be infected.

The only reason that we do “Pap smears” (the papanicolaou test) is to look for changes in the cell nuclear DNA of the cervix, the opening to the uterus or womb. Over the last 15 years, we have found that 99.7% of these changes are due to HPV infections. In the US, 70% of cervical cancers are caused by HPV 16 and 18. (50% by HPV 16.) These are the two types of HPV that result in the most damage and cost, due to repeat paps and the subsequent biopsies, freezing, “LEEP,” or other treatments in which the surface of the cervix (the opening to the uterus or womb) is burned off to remove cancerous and pre-cancerous cells. These treatments lead to infertility and premature births.

Because 15% of girls begin sex before age 15 and half of girls who have sex before 20 say their first time was involuntary, the first trial of Gardasil involved 1200 girls between the ages of 9 and 15. The girls 15 and under had a better response to the vaccine than the older girls and women 16 and above. The researchers compared blood levels of antibodies. The research ethics committee ensured that no paps or pelvics were done on the young girls. (Every one of the young women under the age of 21 when I sent them for colposcopy for cancerous changes had been raped before they were 15 years old.)

The reports of deaths and injuries from Gardasil are poorly documented. The great majority of the adverse effects in the reports include pain, redness, and tingling at the injection site and fainting and headaches. People often faint and complain of headaches after seeing a needle, even without being stuck. It looks awful sometimes, like a seizure. The FDA has ruled that none of the deaths that have been confirmed were caused by the vaccine. In addition, this article from the Canadian Medical Association Journal contains a table showing the numbers of serious events and the numbers of deaths in several studies on the use of the HPV vaccine.

Remember your statistics classes. With 33 million doses, there are bound to be deaths that coincide with the timing of the vaccine use. The teen death rate from all causes is 62 per 100,000 across the US. Most of those are boys, but still: In 10 million girls, 30 deaths are not outside the rate for the age group. They are tragic, but consistent with life on this Earth.

More likely the girls who had severe reactions or death had other risk factors, due to the population presenting to clinics giving the vaccine: those who present with worries about STD’s, the newly sexually active and those entering college. The records show that many were given new scripts at the same visit for birth control pills and other vaccines and medicines, according to the analyses in the medical literature. (Also, remember the silicon, SSRI, and the general vaccine scares that have been blown out of proportion through the years and later proven to be untrue.)

The reports on the possible vaccine-related deaths are available for viewing at” the “Vaccine Adverse Event Report Site” (VAERS),(drop down to the table at the middle of the Page, option #3) using “HPV4” (This is the Merck vaccine), at Option#4, check “YES” at “life threatening” (or you could check “death”) and (top of page)”Sort by submission date.”

Here’s a few examples:

    Administered by: Unknown  Purchased by: Unknown Symptoms: Adverse reaction Write-up: It was reported from an article, published on 29-JUN-2009 that there were “hundreds” of life-threatening reactions said to be associated with GARDASIL. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.

Another:

FINAL DX: Hodgkins lymphoma, nodular sclerosing, stage IIA. Records reveal patient was pale & had firm left clavicular lymph node. Excisional biopsy done 7/23/09 revealed diagnosis. Tx w/chemotherapy & possibly radiation tx when chemo completed.

And another:

    Write-up: Vaccine was administered, patient became dizzy 30 seconds after shot. Patient was pale, diaphoretic & nauseous. Symptoms lasted about 45 minutes. BP dropped to 90/50 & pulse to 50/min. 8/20/09 PCP note received DOS 8/4/09. After shots pt became naseated, pale, diaphoretic, dizzy and had difficulty breathing. BP dropped to 90/50 and pulse into the 50’s. Sx lasted ~45 minutes with return to baseline. Vax record states pt “passed out.”