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.”