Background
Major
pharmaceutical firm Merck has developed a vaccine (Gardasil) that
protects against two strains of the human papillomavirus (HPV),
including the strains that currently lead to 70% of cervical cancer
cases.
The HPV vaccine was approved by the
FDA in June 2006 and is given in three injections over a six-month
period, at a cost of $120 per dose, or $360 for full series plus medical
administration fees. The vaccine has been found to be effective in
preventing pre-cancerous cervical lesions in women not already
infected. HPV is spread through sexual contact (though mother-to-infant
can occur). Legislation is proposed that would require vaccination of 11
and 12-year-old students (perhaps even younger) for public and nonpublic
school attendance. Nearly 20 other states are considering similar
legislation. Another pharmaceutical company is very close to releasing a
similar vaccine.
1. HB 561 and SB 660
require public and private schools in the state to provide information
to students who are 11 and 12 years of age, as well as their parents,
concerning human papillomavirus, its vaccine, and cervical cancer. The
bills prohibit students from being admitted into public and nonpublic
schools without evidence of vaccination for HPV. The bills provide
that a student's parent or guardian can, after receiving information
about HPV, cervical cancer and the available vaccine, elect that he or
she not receive the vaccine.
2. Parental
Rights
While
the HPV vaccine is a morally acceptable method of protecting against
this form of disease, it is our position that the decision to vaccinate
is ultimately that of the parents and not the state. The proposed
legislation in effect substitutes the parents’ decision-making authority
with a state mandated health procedure. Moreover, the legislation would
require that 11 and 12-year-old children are the recipients of
information regarding the connection between the HPV virus and cervical
cancer and the availability of a vaccine. Any state policy should
respect the belief of many parents that discussions along these lines
should be led and initiated by them – not the state.
3. Further Study of
Vaccine Efficacy is Needed
While results of preliminary studies have been promising,
this vaccine is still very new and its long-term effects are unknown.
State policy makers are urged caution in light of the misgivings issued
by various medical groups that this vaccine should not be required for
school attendance at this time. Among these groups are: the Committee on
Infectious Diseases of the American Academy of Pediatrics, which has
judged that school-based HPV vaccination in premature and should await
several years of practice before mandates are considered; and the
American College of Pediatricians, which opposes HPV vaccination
requirements for school attendance. The National Vaccine Information
Center urges state legislatures to investigate the safety and cost of
mandating Merck's HPV vaccine for all pre-adolescent girls before
introducing legislation amending state vaccine laws. The chair of the
FDA committee that approved the vaccine for use, Dr. Jon Abramson, told
Merck and later the press that he opposed mandating the vaccine for
school entry (Washington Times, 2/27/07). Furthermore, the
Committee's executive secretary, Dr. Larry Pickering stated, "more data
on its safety, efficacy and cost were needed before it is made
mandatory" (New York Times, 2/21/07).
4. HPV Vaccine
Different from Those Currently Mandated for School Attendance
Presently Florida law requires the following vaccinations
for school attendance: poliomyelitis, diptheria, rubeola, rubella,
pertussis, mumps, tetanus and other communicable diseases determined by
rules of the Department of Health. These mandated vaccines prevent
diseases that are spread casually. Since HPV is not spread through
casual contact, there is not justification to require the immunization
for school entry.
5. “Opt-in”
Needed – Not “Opt-out”
The
bill should offer parents the opportunity to “opt-in” to the vaccine not
“opt-out”. The current process of “opting out” is not a simple one, nor
is it a commonly exercised one. It involves obtaining permission from a
Department of Health official, not just one’s physician, and not by
simply expressing a parent’s preference not to have a child immunized.
There are very few parents who object on religious or moral grounds to
the immunization of their children for these casually spread diseases.
6. Catholic
Schools Supportive of "Opt-in" but Opposed to Requirements to
Disseminate Information
Catholic
School leaders are concerned that if
Catholic and other nonpublic schools are required to disseminate HPV
information, parents may interpret that the schools implicitly support
the vaccination. While they do support parents opting in and deciding
to vaccinate their children, they find it premature to suggest to all
parents that the controversial vaccine is safe given that its long-term
effects are unknown and reports by medical groups listed in Item 3 above
state that the vaccine should not be required for school attendance.
7.
Medically Accurate
Information Needed in Vaccine Communications
By requiring that children and parents or guardians
receive information about “the “connection between the HPV virus and
cervical cancer and the availability of a vaccine preventing
human papillomavirus”, as stated in the proposed legislation (emphasis
added), there could be an implication that all HPV strains are
prevented. This is inaccurate. The vaccine addresses two of about 100
strains, which cause 70% of cervical cancer cases.
As public health officials, physicians, patients, parents
of students learn about and discuss the vaccine, several concepts should
always be highlighted, namely, that the vaccine:
-
will not prevent
transmission of HIV or other sexually transmitted diseases (STDs);
-
will not prevent
infection from other strains of HPV, of which there are many;
-
will not prevent
infection with all the HPV strains that cause cervical cancer; and,
-
will not eliminate
the need for regular screening
Messages to 11 and 12-year-olds for whom the vaccine is
intended should not be that the vaccine makes sex “safe”. We strongly
encourage reiterating the message that only abstaining from sex until
marriage is the expected standard for school age children, as is the
case for HIV education in 1003.46, F.S.
8. HPV and STD Prevention
Strategies for Florida Going Forward
Strategies oriented toward risk elimination, such as
those used for tobacco, alcohol and drug use prevention, should continue
to be used in efforts to combat sexually transmitted diseases (STDs).
This is the best way to avoid not only sexually transmitted diseases,
but also unplanned pregnancies, and the range of negative psychological
and social consequences that can result from sexual activity outside of
marriage.
9.
Amendments Needed to Address FCC
Concerns
a.
Language to allow
parents to “opt-in” as opposed to requiring that they “opt-out” of the
vaccine.
b. Language
to allow parents to decide on whether and how to provide information
about HPV and the vaccine.
c. Delay
implementation to allow further study of the efficacy of the vaccine and
unknown long-term effects
Note:
Parents are required to make sure their children have immunizations
(1003.22(7), F.S.). Parental consent is not required to determine if
their child has an STD or to treat an STD (384.30, F.S.). A new kind of
"parental notice" seems necessary to ensure parents are informed as to
whether children have STDs.
Contact: Michael
Sheedy, Associate Director for Health,
msheedy@flacathconf.org, 850-205-6824.
