"Homework" (fallacies about Gardasil)

Last week I posted on research that shows that Gardasil, the Merck vaccine against four strains of the Human Papilloma Virus, may actually give partial protection against 8 more strains.

There's a comment today on that post from someone who warns us to do our "homework" and gives a link to a video on "You Tube" that appears to be made in a radio station, during an interview between a host called "Alex" and Cathie Adams of the Texas Eagle Forum.

(Mrs. Adams and I agree on 98% of things. I admire the work that she does and am thrilled when we can work together. But, we've disagreed before and we probably will in the future.)

I believe that "Alex" is Alex Jones, of "InfoWars" radio network and something called "Prison Planet." Alex screams and cusses (Texas slang for cursing and bad language) while spreading falsehoods that he could so easily check. First, the vaccine is not a live virus. Alex Jones got that one completely wrong. It's certainly not the first vaccine of its kind, other than having antigens against four strains of HPV.

In fact, Gardasil is made the same way as most of the commercially available insulin that diabetics inject into themselves several times a day, like Humulin N, and Lantus.

We've used "recombinant DNA vaccines" for well over 20 years to make vaccines like the Hepatitis B vaccine and proteins like insulin. Strains of yeast or bacteria - in Gardasil its Saccharomyces cerevisiae, common bakers' yeast and for insulin, it's E. coli- are induced to make the proteins.

This vaccine uses alumininum. But so do many other vaccines that we've been using for years.

There is a mention of the thimerosal that has been used in some vaccines as a preservative. Thimerosal contains mercury, and there has been concern about the cumulative doses that babies were exposed to due to the 20 to 30 vaccinations that they get the first two years of their lives.

The biggest fear was that the mercury caused autism. A couple of years ago, lawsuits caused the removal of thimerosal from most vaccines, but the number of cases of autism have not gone down. This week, the New England Journal of Medicine reported a new study - and published it with free access - that gives us more evidence that there is probably no connection.

Results Among the 42 neuropsychological outcomes, we detected only a few significant associations with exposure to mercury from thimerosal. The detected associations were small and almost equally divided between positive and negative effects. Higher prenatal mercury exposure was associated with better performance on one measure of language and poorer performance on one measure of attention and executive functioning. Increasing levels of mercury exposure from birth to 7 months were associated with better performance on one measure of fine motor coordination and on one measure of attention and executive functioning. Increasing mercury exposure from birth to 28 days was associated with poorer performance on one measure of speech articulation and better performance on one measure of fine motor coordination.

Finally, there's a call from a woman whose daughter developed vasculitis after receiving her first dose of the vaccine. Vaculitis is the inflammation of the blood vessels. Except for some known infectious causes - like scarlet fever caused by certain strains of the strep throat bacteria - it is a rare autoimmune condition. Most of the time we can't find the cause and some times we find that it is caused by diseases, including Rheumatoid arthritis, lupus, and an over reaction of the immune system after an infection such as Hepatitis B and Hepatitis C. Antibiotics and many medicines can cause it. It can also happen after a vaccination that stimulates the immune system. We have seen vasculitis after the flu vaccine, for instance.

A certain number of people will develop vasculitis each year. We cannot know whether the vaccination caused this girl's vasculitis.

I'm one of those doctors who prefers to wait a while before adopting new medicines. However, it's not true that we don't have much information on Gardasil. The vaccine has been tested for nearly eight years now, in the US, Canada, and Europe.

We should do our homework, especially before we spread information that will frighten others. Beware of shouters and conspiracy theories. Bad things happen and people do bad things, but most of the time it's not so hard to check up on them. Check the sources, or better yet read several sources, and learn which ones are reviewed and reliable.

Gardisil protects against other HPV strains

Medscape Medical News reports that Gardisil, the vaccine against 4 strains of Human Papilloma Virus that cause cervical cancer and warts, also causes the body to make antibodies against other strains of the virus. The information comes from data obtained in the last 7 years of research on the vaccine:

The first evidence of this cross-protection comes from the original and ongoing Merck trials of the vaccine, which protects against HPV types 6, 11, 16, and 18. These new data were presented here at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

The dominant HPV 16/18 strains account for about 70% of all cervical cancers; the vaccine protects against approximately 99% of infections and almost 100% against the development of lesions by those strains. Ten other strains of HPV (31, 33, 35, 39, 45, 51, 52, 56, 58, and 59) account for approximately an additional 20% of cervical cancers worldwide.

Combining analysis of all 10 strains showed cross-protection that reduced incidence of precursor lesions by about 38%. The effect was most dramatic with strains 31 and 45, where protection reached about 45%.

Lead investigator Darron Brown, MD, PhD, professor of medicine, microbiology, and immunology at the Indiana University School of Medicine, Indianapolis, said this analysis had been built into the initial study design. The foundation for the work "came from in vitro cross-neutralization studies that showed some suggestion that antibodies to closely related types may be able to cross-neutralize other close types.

"But I think that we all are pleasantly surprised with the high degree of cross-protection that was shown to occur, both in terms of resisting infection and, more importantly, disease," he told Medscape Infectious Diseases.

Dr. Brown suspects that the different degrees of cross-protection the researchers observed are probably related to the level of antibody generated, and perhaps to memory B cells, both of which are likely have an individual genetic component to them.

Dr. Brown mentions a point that I believe is important: the different types of immunity to viruses. When we contact HPV through the skin or mucus membranes, our bodies fight the disease with T-cell immunity. Gardisil induces B-cell immunity. The latter lasts much longer, because of so-called "memory cells" that lie dormant in the body for many years. That is why infection with one virus may not give immunity to other strains or even that strain with future exposure.


There is more on-line at KaiserNetwork.org the AP/Philadelphia Daily News.

There are more than 60 strains of the HPV virus. About 15 are thought to cause cervical cancer; Gardasil protects against 12 of those, plus two more that cause genital warts but not cancer.

Two strains cause 70 percent of cervical cancer. Merck studies following 17,600 young women for three years found the vaccine to be 99 percent effective in blocking those strains.

New analysis of that data shows that the vaccine reduced incidence of HPV-caused precancerous lesions by nearly two-thirds for the three next most common HPV strains in North America. While those three strains are less common elsewhere, together they cause about 11 percent of cervical cancer worldwide.

Follow-up: HPV Testing, Men, and Prevalence

I did a little research on testing for HPV, especially in men.

The CDC site on HPV is here and it's up to date. http://www.cdc.gov/std/HPV/STDFact-HPV.htm

Digene, http://www.digene.com/labs/labs_hpv_01.html is a swab test for women. Negatives are true negatives for current risk of cancerous changes at the cervix. If negative, then 99.5% accurate - no HPV present at that time. (Can not rule out past infection, but only 1 in 1000 chance of cancerous changes without active infection.)

There is no approved test for males. A few urologists will test with the Digene test - but it's not very sensitive and can miss a lot of disease.

There is a blood test for some of the strains of HPV. However, one article (free online) states that less than 60% of the women who had HPV never become "seropositive."

The new article in the Journal of the American Medical Association from March on the numbers of infection in women is free at http://jama.ama-assn.org/cgi/content/full/297/8/813
Table 1 is very good - and look at the married women: infection rate is 17%. However, for those who said they'd never had sex, the infection rate is 5% and for those with only one partner, 11%.

More on HPV, mandates, and tax money

All State Medicaid programs must offer the vaccines recommended by the (Federal) Advisory Committee on Immunization Practices, under the Vaccines for Children program. The States don't have to mandate the vaccine, however.

Some of the docs I've talked to are convinced that Medicaid and uninsured patients will have an easier time accessing and affording Gardasil than insured patients - unless the insurance companies are forced to cover it somehow.

I predict that within just 2 or 3 years, the private insurers will see that the girls who receive the vaccine don't have to have nearly as many repeat paps, fewer colposcopies and biopsies. Eventually, in 5 or 6 years, there will be fewer freezing and laser therapy treatments. Somewhere in there, they will begin to cover and strongly encourage the vaccine, without being forced.

It turns out that the transition from infection with the more virulent strains to a precancerous or even carcinoma intraepithelial neoplasm (cancerous cells in the surface layer - the kind that leads to repeat pap smears, colposcopy and biopsies and then freezing or laser ablation or removal of the surface layer of the cervix. The pathology-reported names given to these spots on the cervix include "Low Grade Squamous Intraepithelial Lesions, High Grade SIL, Carcinoma in Situ ) can occur within 2 to 3 years, although most take 10 years or so.

From an article available here, free on line,

The traditional view has been that this process takes years, if not decades, to occur after initial HPV infection. Recent studies suggest that these changes may develop more quickly than previously thought. Winer et al followed women after initial HPV infection for the development of CIN 2/3.

As shown in Figure 3, approximately 27% of women with an initial HPV 16 or 18 infection progressed to CIN 2/3 within 36 months [20]. A second study of a large health maintenance cohort found that approximately 20% of women 30 years of age or older who were initially infected with HPV 16 developed CIN 3 or cervical cancer within 120 months.

Women who had an initial HPV 18 infection had approximately a 15% risk of developing CIN 3 or cervical cancer at 120 months [21].

The strong correlation between infection with high-risk types of HPV and LSIL, HSIL, and cervical cancer suggests that HPV DNA testing would be a useful tool for the management of women with abnormal Pap test results, especially in the case of those with equivocal test results. In the case of an equivocal Pap test result, HPV DNA testing can help determine whether the individual should be referred for colposcopic assessment [22].

(Ault, Kevin. "Epidemiology and Natural History of Human Papillomavirus Infections in the Female Genital Tract." Infect Dis Obstet Gynecol. 2006; 2006: 40470. Published online 2006 January 30. doi: 10.1155/IDOG/2006/40470. Copyright © 2006 Kevin A. Ault.)


The biggest financial gain to the Medicaid program and then the insureres - as well as the biggest gain in decreased worry and actual pain and suffering of women - will not be from a decrease in diagnoses of the cancer, itself. It will be from the decrease in the visible warts, as well as precancerous changes from the occult infections that can't be seen with the naked eye and the repeat testing and biopsies, along with the cervical damage from excisions, lasers and freezing which can lead to infertility and premature births.

More information at this summary of another research paper. And this paper reports on 2 year risk of developing CIN.

Med Associations Announce Position Statements on HPV Vaccine

Washington State is planning to offer the Human Papilloma Virus vaccine free to girls. New Hampshire has made the vaccine available on an "opt in" basis. Florida's Legislators are considering following Texas Governor Rick Perry in making the vaccine mandatory, with an "opt out" option, similar to the way that Hepatitis B and other mandated vaccines are regulated. (The vaccine would also have been mandatory under the bills that had been introduced in the Texas Legislature before the Governor's Executive Order.)

Two letters (via email) concerning the HPV arrived since yesterday, one from the Christian Medical and Dental Association and the other from the American Academy of Family Physicians. There is also a newspaper article that covers the Statement of the Texas Medical Association. (I'm a member of each.) Another group forwarded the statement from the Catholic Medical Association.

All encourage the voluntary use of the HPV, because of the safety and efficacy of the vaccine and the ethical practice of preventing disease. And all discourage making the vaccine mandatory.

The Catholic Medical Association (CMA) statement is available online, but in "Macromedia FlashPaper" form, which I've never seen before. The statement is well thought out, with excellent ethics and medical basis. The short statement explained by the 5 page document is:

Does the CMA Support Use of the HPV Vaccine?
The CMA supports widespread use of Gardasil for girls and women in the age range for which the vaccine has been recommended by the ACIP, because it is effective, safe and ethical to use, provided certain conditions are met.

Those conditions include continued teaching concerning abstinence outside of marriage and allowing parents to give informed consent.


The Christian Medical and Dental Association gives the following analogies:

The condom, safe-sex message is like telling your teen not to speed and then giving them a radar detector. HPV vaccination is like telling your teen not to speed, while reminding them to wear their seat belt. You want them to have protection from harm if they are in an accident – whether their fault or not.

and for the Christian philosophical basis for the vaccine:

As Jesus taught us in the story of the woman caught in adultery, Scripture teaches that we can/should show compassion by protecting others from the consequences of sin (while not endorsing sin or promoting continued sin). Facing death by stoning, Jesus protected her and offered forgiveness before calling her to a path of righteousness. He showed grace and compassion, not requiring her to commit to some standard prior to offering protection.

The American Academy of Family Physicians' (AAFP) email contained concerns about the ability to fund the vaccine and to obtain enough vaccine to administer it to all the eligible girls. The AAFP already had a provisional statement, but the move in several states, including Texas, to make the vaccine mandatory prompted the following:

"The AAFP feels it is premature to consider school entry mandates for HPV vaccine until such time as the long term safety with widespread use, stability of supply, and economic issues have been clarified."

Recently, there has been increasing state level action considering mandating HPV vaccination with proof of vaccination required for school attendance among other mandates. Upon review of the situation, the Commission on Science felt that this usage does not fit the classic public health model for infectious diseases such as measles. Several issues arise when considering a mandated school entry requirement. These include:



HPV does not adhere to the public health model for control of infectious disease in a school setting. (e.g. measles, chicken pox)

Universal school entry requirement would come at a cost of approximately $900 million per year to provide coverage for the female birth cohort (2 million girls: $120 per dose plus $25 administration fee; 3 doses). This would be a significant burden on state public health budgets.

There would have to be an assurance of supply of 6 million HPV doses per year to meet the school entry cohort. Given the recent experience with shortages of new vaccines such as the MCV4 for meningitis and Thimerosal-free influenza vaccine for three year olds, it is not clear that this new vaccine could be produced in adequate amounts to meet such demand at this time.

As with the costs for public health departments, there is concern that physician practices may not be able to afford such a large scale requirement at this time.

The Texas Medical Association leaders gave interviews to reporters concerning their reaction to the Governor's Executive order.

"We support physicians being able to provide the vaccine, but we don't support a state mandate at this time," said Dr. Bill Hinchey, a San Antonio pathologist and president-elect of the TMA, which represents 41,000 physicians. "There are issues, such as liability and cost, that need to be vetted first."

Other reasons cited by doctors in Texas and across the country include the vaccine's newness; supply and distribution considerations; the possibility opposition could snowball and lead to a reduction in other immunizations; the possibility it could lull women into not going for still-necessary cervical cancer screenings; gender-equity issues; and the tradition of vaccines starting as voluntary and becoming mandatory after a need is demonstrated.

Hinchey said that TMA leadership expressed their concerns to Perry on Tuesday. He said the TMA arrived at its position after debating the issue in committees in recent days.

A spokeswoman for Perry reiterated Tuesday that the governor stands by the order. She said he is listening to the discussion but thinks the vaccine is safe and effective.

Texas HPV Vaccine

One of my goals is to translate between the pro-life and pro-family community that has a religious background and those who do not necessarily count themselves as religious. Sometimes, it seems that's all I do.

Governor Rick Perry evidently surprised most of the world with his brave move concerning a vaccination against Human Papilloma Virus, a group of sexually transmitted viruses that cause abnormal pap smears and cervical cancer. While he follows a 2003 law, he has been criticized by the Family Policy Center, the American Association of Physicians and Surgeons and many Texas conservatives. Even the Republican Party of Texas issued a statement calling on him to rescind his Executive Order.

Although I normally agree with these groups, I think they are wrong in this case. The Christian Medical and Dental Association agrees with me. And Governor Perry, since he went so far in his EO to protect the right of parents to "opt out."


The vaccine will not interfere with our efforts to teach and encourage our children to abstain from sex outside of marriage. In fact, I hope that by giving the vaccination before 6th grade, younger children will be less likely to connect the vaccine with sexual activity and will be protected when they do have sex for the first time. The fact that the vaccine is so necessary could also be used to teach the fallacy of "safer sex."

The research showed that younger girls show stronger immune responses to the vaccine than older girls and women. And logically, vaccines only work before contracting the disease.

Studies of teen girls have shown that over 2 years, 40% to 80% of them will become positive for HPV, and over 10% of them will have the high risk virus, HPV 16, that is associated with over 50% of cervical cancers. Admittedly, the infected girls must be exposed. However, contrary to popular opinion, the viruses can be spread by the hands during heavy petting.

Besides the pain and cost of the cancers and the 400 deaths per year in Texas from cervical cancer, however, there is the cost of the early precancerous changes from the viruses. There are the every three to six month repeat paps and HPV tests, the freezing and lasers, and the weakened cervices that can result in premature labor.

Gardasil, while new, is produced the same way most insulin for diabetics is manufactured these days: by recombinant DNA. It’s not a weakened or killed virus, isn’t grown in human tissues and doesn’t contain mercury. The vaccine contains copies of antigens that are part of the outside covering of the virus, not the DNA that causes infection and cancer. Vaccinated patients make antibodies against four strains that cause the most harm.

In contrast, the last two vaccines mandated for schoolchildren in Texas are manufactured using human tissue cultures that resulted from abortions. Many parents object to the “Chicken Pox” Varicella and Hepatitis A vaccines – although the children were not aborted in order to obtain the vaccine, and there is some ethical support for accepting the vaccines because the unethical act is isolated from the intention and act of the vaccine.

(Edit: The Hepatitis B vaccine is also made by recombinant DNA, and not one of the un-ethical methods. This was added to strengthen the case for the safety of the recombinant technique, similar to the evidence due to the wide spread use of insulin from recombinant DNA. I could have added that Hepatitis B is another virus that is unlikely to be spread by casual contact in school. That fact is also true of another mandated vaccine for Tetanus - what we used to call "lock jaw.")

The vaccine against Hepatitis B, which is spread by blood and bodily fluids, has been mandated for school children in Texas since 1998.

The Texas Legislature gave the Governor the power that he exercised as the head of the Executive Branch: the power to regulate the Medical Board and the Department of State Health Services. The Legislature has passed law as recently as 2003 that allows the Department and Board to add vaccines as they deem them necessary.

The Governor's language strongly promotes the parental right to "opt out" and orders the Department to make the “opt out” provision available on the Internet. Currently, parents have to make a request in writing for an affidavit, which has to be notarized and then delivered to the Department - eventually the Department mails the exemption to the parent. (Can you imagine? There's no way we could have ever managed to get parental consent forms this complicated or the process so convoluted for abortions.) The Governor's language would make the opt out process easier.

Governor Perry’s Executive Order: here.

The Texas Education Code: here.

Gardasil prescribing information: here.

Statement from the Christian Medical And Dental Association: here.

Texas Governor pulls a fast one (HPV shot)

In all the excitement about Texas becoming the first State to mandate the vaccination against a Sexually Transmitted Disesase, no one seems to have noticed that Governor Rick Perry ordered the Health Department to make it easier on parents who wish to opt out on vaccinations for their children.

Parents' Rights. The Department of State Health Services will, in order to protect the right of parents to be the final authority on their children's health care, modify the current process in order to allow parents to submit a request for a conscientious objection affidavit form via the Internet while maintaining privacy safeguards under current law.

The current relevant law is all over the website containing Texas Statutes. I'm not at all sure that I tracked it all down, but most of it is in The Education Code, especially Chapter 38 and some is in the Health and Safety Code. The "opt out" provision is in 38.001, which was passed in 2003. I believe that this law was the first time in Texas that there was a formal way for parents to object for philosophical reasons, without having to claim health risks.


However, the law concerning the paperwork is in 161.0041 of the Health and Safety Code, and has higher requirements than the parental consent for abortion rulings!

Sec.A161.0041. IMMUNIZATION EXEMPTION AFFIDAVIT FORM.
a) A person claiming an exemption from a required immunization based on reasons of conscience, including a religious belief, under Section 161.004 of this code, Section 38.001 or 51.933, Education Code, or Section 42.043, Human Resources Code, must complete an affidavit on a form provided by the department stating the reason for the exemption.
(b)The affidavit must be signed by the person claiming the exemption or, if the person is a minor, the person ’s parent, managing conservator, or guardian, and the affidavit must be notarized.
(c)A person claiming an exemption from a required immunization under this section may only obtain the affidavit form by submitting a written request for the affidavit form to the department.
(d)The department shall develop a blank affidavit form that contains a seal or other security device to prevent reproduction of
the form. The affidavit form shall contain a statement indicating that the person or, if a minor, the person ’s parent, managing conservator, or guardian understands the benefits and risks of immunizations and the benefits and risks of not being immunized.
(e)The department shall maintain a record of the total number of affidavit forms sent out each year and shall report that information to the legislature each year. The department may not maintain a record of the names of individuals who request an affidavit under this section.

Added by Acts 2003, 78th Leg., ch. 198, Sec. 2.163, eff. Sept. 1,
2003.

In order to opt-out, the parent has to send a "written request" for the paperwork to the Department. The law actually states that the legal affadavit has to have "a seal or other security device" to prevent copying. Can this be done online?