Flu vaccines 2008

Ever since I first became aware of the vaccination question, I have dreaded the arrival of the "flu season", and its attendant, required flu shots. Some sort of flu vaccine, either the shot or the snorted version, is required for pretty much anyone who works in a hospital, whether you're a physician, nurse, or work in the laundry. Getting the shot per se doesn't bother me. It may even almost make sense from an epidemiologic standpoint. What bothers me is the fact that - sooner or later - the shot is going to be manufactured using cell cultures derived from aborted babies, and that will put it on the "morally tainted" list. When this happens, I will no longer be able to passively roll up my sleeve and let the corpsman jab me in the arm (full disclosure: I'm too old for the snorted version). Rather, I shall have to refuse on moral grounds and this shall jam me up with my bosses for sure: I have no doubt that I will find myself standing, not sitting, in front of the big boss's big wooden desk, trying to explain why, as a Catholic, I should refrain from partaking of a vaccine whose manufacture involved the use of cell lines derived from aborted babies. Not being of martyr material, I dread that this day may come, as I have many mouths in my house who depend on me for their daily bread. So, for the past year or two have found myself reviewing the package inserts for all the year's current crop of flu vaccines so as to see where I stand. This year is no different. I went to the FDA's "Resources for health professionals" and obtained the list of all the vaccines and inhaled mists for this flu season. Then I checked their package inserts, generally a pretty good way of finding out what you need to know about a thing. Whew! They're all manufactured the good ole' fashioned way, culturing the viri in embryonated chicken eggs. That's bad news if you're a chicken embryo, but it's good news for me: I can put off doing the rug dance in the boss's office for another year.

Gardasil's a money-maker!

An interesting observation, to be found towards the bottom of this article from MarketWatch:

"Gardasil has been somewhat controversial, as some parents are uncomfortable with giving pre-teens a vaccine to prevent sexually transmitted diseases.
But in the third quarter, Gardasil generated revenue of $418 million, roughly a third of the Whitehouse Station, N.J., company's sales from vaccines."

Follow up on Sanofi-Pasteur avian flu vaccine.

The FDA has approved an avian flu vaccine for government stockpiling, such as we discussed in Human Technology Manufacturing Platforms. It is not being sold or distributed at this time, and it is not the PER C.6 based vaccine. It is the one grown in embryonated chicken eggs, (see paragraph 11 of the manufacturer’s label found here) and thus does not raise the moral problems associated with the one based on PER C6. The FDA approval is here:

Product Approval Information Sanofi Pasteur Inc. Influenza Virus Vaccine, H5N1

However, to quote the final paragraph of the document found here, “With the support of FDA, the U.S. National Institutes of Health and other government agencies, Sanofi-Pasteur and other manufacturers are working to develop a next generation of influenza vaccines for enhanced immune responses at lower doses, using technologies intended to boost the immune response.” That “next generation” vaccine is based on PER C6.

What in the world is going on with Gardasil?

Last Friday, Texas Governor Rick Perry issued an executive order - an executive order - that Merck’s HPV vaccine, Gardasil, be required for all Texas girls entering 6th grade, beginning September, 2008.[1] Well.

We discussed The HPV Vaccine a couple of weeks ago, and we’ll recall that human papilloma virus (HPV) is a virus, transmitted by sexual contact, and which causes venereal warts (condylomata) and cervical dysplasia, a precursor to cervical cancer. Since most cervical cancers originate in HPV induced cervical dysplasia, it is fair to call cervical cancer a sexually transmitted disease. Transformation from dysplasia to malignancy takes years, even decades, and it’s quite predictable; that's why cervical cytology screening programs - the venerable Pap smear and its modern congeners - are so effective. Prior to the 1950’s, cervical cancer was the number one cancer killer of women in the U.S. It still is, in the third world, but in developed countries cervical cancer has been pushed way down: in 2007, the NCI estimates 11,000 new cases, and 3700 cancer related deaths.[2] However, HPV infection remains ubiquitous and costly, in terms of dollars for treatment and screening programs, as well as medical morbidity.

Gardasil protects against four of the most common high risk HPV subtypes, which account for 70% of cervical dysplasia and 90% of genital warts. The three shot series costs $360.00. Duration of action and need for boosters is unknown. It is not manufactured using material derived from aborted babies, and therefore does not have the moral problems of those other Merck products, Varivax and the rubella component of MMR II. Gardasil does not eliminate the need for screening programs. The presumption is that cervical cancer rates will decrease with mass vaccination, but that is by no means certain, and it may be years (decades?) before the effect, if any, will be seen, due to the long latency from infection to invasive disease.

In June, 2006, the Advisory Council on Vaccine Practices “recommended” universal vaccination with Gardasil for all girls starting at age 11, but starting as early as age 9. That same month, it was approved by the FDA. These recommendations were incorporated into the American Academy of Pediatrics immunization guidelines.[3] ACIP recommendations quickly the form of law, and twenty six states including Texas are considering mandating the vaccine,[4] [5] [6] The Catholic Medical Association encourages its use, but “...rejects efforts...to mandate that girls be vaccinated.”[7] The National Catholic Bioethics Center has taken a similar position.[8]

With all this data firmly in hand, it is time to consider Governor Perry’s action. An executive order. That seems to imply a clear and present danger, so great that things cannot await their usual course. The Governor likened HPV to polio, but that comparison is absurd. HPV is not “like polio”, or smallpox, or any other serious, highly transmissible vaccine preventable illness. It is a disease obtained by sexual intercourse, vaginal, anal or oral, and by no other route. It is slow and indefinite in its effects (many cases spontaneously regress). Yes, it is a big public health problem. But it is not a public health emergency. A little girl who goes to school is not going to get HPV by sitting next to someone who has it. Parents may elect to vaccinate their little girls with Gardasil, and there is nothing wrong with that. However, it is a violation of the Catholic social principle of subsidiarity for a governing body to require this vaccine, because the State is arrogating to itself a right and a role which belongs to the parents: proper training of the child regarding sex. In other words, the State has no moral right to order me to vaccinate my girls with Gardasil. Governor Perry’s executive order strikes me as a florid misuse of his power.

So, what in the world is going on with Gardasil? I don’t know. Perhaps many of the people involved in this, including Governor Perry, are truly well meaning. But they are misinformed. The question isn’t whether Gardasil is a potentially useful vaccine. It is; and I’m not against the vaccine per se. If the state wants to allocate money to make it available, that’s fine. But the disease doesn’t warrant universal mandatory vaccination.

Merck will make a ton of money on this. Wall Street estimates that 60% of the price of the vaccine will be profit[9], which comes to $72.00 profit per shot. Seventy two dollars times every American girl age 11 or more, then that number times three (three shots, remember?) and that’s a lot of dollars - estimates up to $4 billion[10]. There is much on the internet about a money trail between Merck and those who make public policy.[11] Now, companies give money to politicians of their choice, which is to be expected. However, if the allegations are true, it is wrong for Merck to try to purchase legislation requiring that people use their product.

Finally, we have the nanny state. The State is increasingly usurping the rights of parents, usually under the guise of “what’s best for the child,” and the medical establishment has been a willing accomplice. Regarding Gardasil, the American College of Obstetricians and Gynecologists recommends it "...be routinely given to girls when they are 11 or 12...".[12] The American Academy of Family Practice concurs with the ACIP recommendations,[13] and we have already discussed the AAP. This should come as no surprise, insofar as these organizations have pushed contraception among minors, with or without parental knowledge, for years.[14] It becomes increasingly difficult for me to view these organizations dispassionately when so much of what they teach so blatantly reflects left wing political agendas.

In summary: I am not opposed to mass vaccination in principle. I am not opposed to Gardasil in principle. I am opposed to mandatory vaccination with Gardasil. If you want to use Gardasil, or have your little girls vaccinated with it, go right ahead. But its use should not be mandated.

Endnotes.
[1] Texas Gov. orders anti-cancer vaccine. by Liz Austin Peterson, AP Writer, Available at http://news.yahoo.com/s/ap/
[2] Cervical cancer. National Cancer Institute Cancer Topics, available at http://www.cancer.gov/cancertopics/types/cervical
[3] Recommended Immunizations Schedules for Children and Adolescents - United States, 2007. Pediatrics 2007; 119:207-208. Available at http://www.pediatrics.org/cgi/content/full/119/1/207
[4] Drug firm pushes vaccine mandate. by Laura Smitherman BaltimoreSun.com, 29 January 2007, available at http://www.baltimoresun.com
[5] Daily Women’s Health Policy in Daily Reports, 1 Feb 2007, kaisernetwork.org
[6] STD vaccine campaign sweeping the nation. by Bob Unruh WorldNetDaily 8 Feb 2007 at http://www.worldnetdaily.com/news/article.asp?ARTICLE_ID=54143
[7] CMA Issues Statement on Implementation of HPV Vaccine. 18 January 2007. Catholic Medical Association, www.cathmed.org
[8] NCBC Statement on Vaccination against Human Papilloma Virus (HPV). National Catholic Bioethics Center, 11 July 2006. www.ncbcenter.org/06-07-11-hpv_vaccine.asp
[9] Drug firm pushes, ibid. See the pie chart labeled “HPV Vaccine”
[10] STD campaign, ibid.
[11] Drug firm pushes, ibid. See also:
STD campaign, ibid. See also:
Family group compares HPV vaccine to condoms. by Bob Unruh WorldNet Daily 6 Feb 2007 at http://www.worldnetdaily.com/news/article.asp?ARTICLE_ID=54102 See also:
Trouble for Texas Catholics: Governor Violates Parental Authority - Kowtows to Merck. Children of God for Life 5 February 2007, available at http://www.cogforlife.org
[12] HPV Vaccine - ACOG Recommendations, 4 August 2006. American College of Obstetricians and Gynecologists, at http://www.acog.org/departments/dept_notice?recno=7&bulletin=3945
[13] AAFP Provisional Recommendations for the Use of Quadrivalent HPV Vaccine. 7 September 2006. American Academy of Family Practice, available at http://www.aafp.org/online/en/home/clinical/immunizationres/hpv.html
[14] Policies and Materials on Adolescent Health of the American College of Obstetricians and Gynecologists. 29 January 2007. American College of Obstetricians and Gynecologists, at http://www.acog.org The entire section reads as follows:
Sex and Family Life Education:"The American College of Obstetricians and Gynecologists supports the inclusion of age-appropriate sexuality education from grades kindergarten through 12th grade as an integral part of comprehensive health education in schools and communities. The American College of Obstetricians and Gynecologists encourages its members to advocate for and participate in such education." "All sexuality education programs should provide scientifically accurate information about sexuality, STDs, contraception, and preventive health care." ACOG supports “ongoing rigorous evaluation of the effectiveness of a variety of forms of sexuality education in terms of their effect on sexual behavior, as well as unintended pregnancy and abortion rates."
Contraception or Family Planning for Minors:"Health professionals have an obligation to provide the best possible care to respond to the needs of their adolescent patients. This care should, at a minimum, include comprehensive reproductive health services, such as sexuality education, counseling… [and] access to contraceptives ..." "Legal barriers that restrict the freedom of health care practitioners to provide these services should be removed."
Reproductive Health Services For Adolescents:"The potential health risks to adolescents if they are unable to obtain reproductive health services are so compelling that legal barriers and deference to parental involvement should not stand in the way of needed health care for patients who request confidentiality. Therefore, laws and regulations that are unduly restrictive of adolescents' confidential access to reproductive health care should be revised."
Confidentiality: " Because the involvement of a concerned adult can contribute to the health and success of an adolescent, policies in health care settings should encourage and facilitate communication between a minor and her parent(s), when appropriate." "Most adolescents underuse existing health care services. A major obstacle to the delivery of health care to adolescents is their concern about confidentiality." "… physicians should work with the political process to eliminate laws unduly restrictive of confidential health services for adolescents." “To overcome barriers to confidentiality imposed by legal and economic constraints, physicians should discuss confidentiality with both the adolescent girl and, where appropriate, her parent(s) or guardian(s). Health care provides should be familiar with current state and local statutes on the rights of minors to consent to healthcare services, as well as those federal and state laws that affect confidentiality. It also is important to involve and inform office staff about those policies and procedures that facilitate and ensure confidentiality." Available at http://acog.org/departments/dept_notice.cfm?recno=7&bulletin=4107

See also:
Adolescent Health Care. American Academy of Family Practice, at http://www.aafp.org
Specifically, the subsection entitled. "Sexuality and Contraception", Part C. "Adolescents receiving contraceptive services should be accorded strict patient confidentiality." Available at http://www.aafp.org/online/en/home/policies/a/adolescent.html
It is true that many state laws require physicians to provide contraception without parental knowledge, but the medical establishment has not opposed these laws.

The HPV Vaccine.

posted on Introibo ad altare Dei 5 December 2006

Human papilloma virus, or HPV, is a virus which causes cancer of the cervix in women. The only way HPV is transmitted is by sexual intercourse, one doesn't get it from a toilet seat or by shaking hands. Since virtually all cervical cancers are related to HPV infection, it is correct to say that cervical cancer is a sexually transmitted disease. Interestingly, those of us who used to put it in those terms were pooh-pooh'd not infrequently. Now, however, with the advent of Merk's Gardasil HPV vaccine, everybody is talking about HPV, cervical cancer, and the vaccine. Let's flesh in some details.

There are over a hundred subtypes of HPV, and over thirty of these are associated with cervical diseases including genital warts ("condylomata") in both ladies and gentlemen, cervical dysplasia (pre-cancerous cervical changes) and frank, invasive cancer. The viruses don’t cause cancer directly, they cause dysplasia. The dysplasia may, in turn, progress to cervical cancer if left untreated. The dysplasia is detected by the Pap smear and its more modern derivatives. If the Pap smear detects dysplasia, especially of the high grade variety, a biopsy of the cervix is recommended. If the biopsy confirms the high grade dysplasia, a LEEP (loop electrosurgical excision procedure) is usually performed, where a thin strip of the cervix containing the abnormal tissue is removed. This is frequently, but not always, curative. Here are some important points: first, dysplasia is not invasive cancer. It is a precursor to cancer. Secondly, a lot of dysplasia spontaneously regresses without further treatment. Thirdly, some cervical dysplasia, if untreated, progresses. Progresses to what? Invasive cervical cancer. But the important thing is this: the progression is slow, orderly, and well understood. That's why the Pap smear works so well as a screening tool for cervical cancer: it detects the precursor lesions before they become cancer. HPV infection is the most common sexually transmitted disease in the world, and prior to the widespread use of the Pap smear in the 1950's, cervical cancer was the most common cancer killer of women worldwide. It still is in parts of the world where Pap screening is not done. In the U.S., cervical dysplasia is very common. LEEP’s for high grade cervical dysplasia are very common (this procedure is done several times per day in my hospital). Cervical cancer, however, is relatively uncommon, due to the Pap smear (5000-7000 cases in the U.S. annually). Wouldn’t it be nice if there were a vaccine that would prevent all this?

Enter Merck and Gardasil. Approved for use by the FDA in June, 2006, it protects against the four most common types of high risk HPV,[1] which account for 70% of cervical cancers, and 90% of genital warts. It’s a three shot series given at 0, 2 and six months, and need for a booster is unknown at this time. A second vaccine is under development by GlaxoSmithKline. On June 29, 2006, the Advisory Council on Vaccine Practices (ACIP - the group which formulates vaccine recommendations for the CDC) voted to “recommend” universal vaccination with the HPV vaccine for all girls age 11-12, but beginning as early as age 9[2]. ACIP recommendations, once accepted by the CDC, take the de facto force of law, as local school boards and others turn the recommendations into requirements. The ACIP recommendations that all adult nonpregnant women (>19 years old) be vaccinated were published in the CDC’s publication, Mortality and Morbidity Weekly Reports (MMWR) on 13 October 2006. The recommendations for the universal childhood vaccinations are scheduled to be published in November, but are unavailable as of this writing. Not too surprisingly, the medical machine, as represented by the New England Journal of Medicine, is all for this,[3] and well funded pro-teenage contraception organs like Advocates for Youth are simply livid that those religious conservatives might not think universal HPV vaccination for children is such a swell idea.[4]

Why isn’t it a swell idea? First. The vaccine does not remove the need for Pap smears nor will it do anything for a lady already infected. Second, it doesn’t do anything about other sexually transmitted diseases, although it’s easy to imagine a 12 year old (remember, that’s the target audience) who thinks it does. For that matter, I can easily imagine a 20 year old who might think it does, but that’s neither here nor there. Thirdly, there are concerns that the FDA has "fast-tracked" licensure of Gardasil, without adequate study of its safety in little girls.[5] Fourth, and most importantly, no one knows what effect universal vaccination of 9 year olds might have on adolescent tendency to have sex. However, the data of the past forty years of social experimentation suggest that it would tend to increase sexual activity. That’s been the outcome of all the other experiments on early immersion of young children into the fetid world of “sex ed” and teenage contraception, and there’s no reason this should have a different effect. Regarding the morality of the vaccine itself, its manufacture does not involve aborted babies[6]. So the moral problems attached to, say varicella or rubella vaccines do not apply here.

HPV is a sexually transmitted disease. You don’t get it if the person next to you coughs, and you don’t get it from a water fountain or a toilet seat. Requiring HPV immunizations for young girls (and that is what ACIP “recommendations” amount to: requirements) is, in my view, no different from requiring that all school age girls be put on contraception. The decision to vaccinate one's little girl with Gardasil should reside strictly within the family. Legislating its use is inappropriately paternalistic. The National Catholic Bioethics Center has summarized it appropriately:

“The NCBC considers HPV vaccination to be a morally acceptable method of protecting against this disease, but asks that civil authorities leave this decision to parents and not make such immunization mandatory.”[7]

[1] “HPV and HPV Vaccine: Information for Healthcare Providers” Centers for Disease Control, August, 2006. www.cdc.gov/std/healthcomm/fact_sheets.html
[2] “ACIP Provisional Recommendations for the Use of Quadrivalent HPV Vaccine”. available at www.cdc.gov
[3] Steinbrook, R. “The Potential of Human Papillomavirus Vaccines.” NEJM 354(11):1109-1112; 16 March 2006.
[4] “Will the Politics of Teen Sex Stop a Cancer Vaccine?” Advocates for Youth Media Brief, www.advocatesforyouth.org
[5] "Merck's Gardasil vaccine not proven safe for little girls." National Vaccine Information Center, Press Release, 27 June 2006. www.909shot.com/PressReleases/pr62706gardasil.htm
[6] Gardasil package insert, Merck & Co., 2006. Available at Institue for Vaccine Safety, www.vaccinesafety.edu/package_inserts.htm
[7] NCBC Statement on Vaccination against Human Papilloma Virus (HPV). National Catholic Bioethics Center, 11 July 2006. www.ncbcenter.org/06-07-11-hpv_vaccine.asp