Congenital
Cytomegalovirus (cCMV) and Connecticut’s New Law
by
Lisa Saunders
In May 2015, Connecticut became the second
state in the U.S., after Utah, to pass a law on the leading viral cause of
birth defects, which causes more disabilities than Down syndrome. Governor Dan Malloy signed House Bill 5525-An Act Concerning Cytomegalovirus:
This act states: "any newborn infant who fails a newborn hearing screening, as described in section 19a-59, a screening test for cytomegalovirus, provided such screening test shall be administered within available appropriations on and after January 1, 2016. Such screening tests shall be administered as soon after birth as is medically appropriate."
This act states: "any newborn infant who fails a newborn hearing screening, as described in section 19a-59, a screening test for cytomegalovirus, provided such screening test shall be administered within available appropriations on and after January 1, 2016. Such screening tests shall be administered as soon after birth as is medically appropriate."
"With bipartisan support, the legislature
approved and the governor signed a bill that will help mitigate the devastating
impact that this disease has on families. The bill requires that hospitals and
other health care institutions test newborn infants for CMV if they fail a
newborn hearing test. This will help parents intervene early and get their
newborn child the help it needs," states the State Senate Democrats of the Connecticut General
Assembly in a press release.
Ever since Lisa Saunders, the parent representative of the Congenital Cytomegalovirus (CMV) Foundation and mother of
Elizabeth born severely disabled by this preventable virus, learned Utah passed a CMV bill in 2013, she has been asking Connecticut to do the same. A
Connecticut CMV bill was passed by the House in 2014, but the Senate failed to
vote on it before the end of the legislative session. So, Lisa and others parents
whose children were disabled by congenital CMV, plus those in the medical
community who supported the bill (see their Public Hearing Testimonies), had to start
their campaign all over again in January 2015. House Bill 5525: "An Act
Concerning Cytomegalovirus" finally became law when passed by the Public
Health Committee, House (watch Lisa’s representative urge support and remember her daughter),
Senate, and signed by Governor Dan Malloy on May 26, 2015.
When Lisa learned the governor had signed the bill, she was ecstatic. She hopes that testing will not only save Connecticut’s residents heartache by quickly diagnosing and providing early intervention for children born with cCMV, but that the money saved by the state will lead to more funds being invested in prevention education until an effective vaccine is developed.
When Lisa learned the governor had signed the bill, she was ecstatic. She hopes that testing will not only save Connecticut’s residents heartache by quickly diagnosing and providing early intervention for children born with cCMV, but that the money saved by the state will lead to more funds being invested in prevention education until an effective vaccine is developed.
Q. What is Congenital Cytomegalovirus (cCMV)?
A. It is the #1 viral cause of birth defects. It causes mental retardation, liver disease,
cerebral palsy and deafness as a result of infection in pregnant women. Congenital
CMV “is the most common
cause of nonhereditary sensorineural hearing loss in childhood.” According to the Centers for Disease Control and
Prevention (CDC), in the U.S.:
- Every hour, cCMV causes one child to become disabled.
- Approximately 1 in 150 children is born with cCMV infection (30,000 each year).
- About 1 in 750 children is born with or develops permanent problems due to congenital CMV infection.
- More than 5,000 children in the U.S. each year suffer permanent problems caused by cCMV.
- Between 50% and 80% of adults in the U.S. are infected with CMV by 40 years of age.
Q. What is the benefit of this law?
A. “CMV is known to cause hearing loss and therefore to test for it is
reasonable. Testing infants who fail their newborn hearing screen
will not only increase awareness and hopefully prevention of CMV transmission,
but we will be able to identify early those infants with congenital CMV and
therefore have the opportunity to intervene earlier to optimize their
outcomes,” states Dr. Brenda Kinsella Balch, a Connecticut pediatrician and
Chapter Champion for the American Academy of Pediatrics Early Hearing Detection
and Intervention Program.
“The law encourages the proper timing of
the test, so that diagnosis is not delayed beyond the critical time period of
diagnostic accuracy for congenital CMV--the first three weeks of life,” states
Dr. Demmler-Harrison of Texas, Director, Congenital CMV
Disease Research, Clinic & Registry.
"This is a
game-changing step forward in our ability to determine CMV causality and give
parents a viable option for early treatment," said Scott R. Schoem, MD,
FAAP, Director of Otolaryngology, Connecticut
Children’s Medical Center.
Q. What does this law mean to health care
providers?
A. According to Clinical Advisor’s article, Connecticut passes cytomegalovirus screening
law for newborns, “Timing
is key when identifying CMV infection. Providers should test via viral urine
culture or urine PCR within the first three weeks of life. If a newborn tests
positive, the next step is to refer the infant immediately to a pediatric
disease specialist…”
According to Dr. Demmler-Harrison,
Director, Congenital CMV
Disease Research, Clinic & Registry, “This law is not dictating what doctors should do, but rather
provides them the tools to practice good medicine in all arenas, including
newborn care of babies with congenital hearing loss. Often, CMV is the last
thing doctors think of, and it should be one of the first things they think
of.”
Q. How many people know about congenital
CMV?
Q. Why haven’t most people heard of this
leading cause of birth defects before?
A. Doctors don’t realize how prevalent it
is. Fewer than half
(44%) of OB/GYNs surveyed reported counseling their patients about preventing
CMV infection. “The virtual absence of a prevention
message has been due, in part, to the low profile of congenital CMV. Infection
is usually asymptomatic in both mother and infant, and when symptoms do occur,
they are non-specific, so most CMV infections go undiagnosed,” according to “Washing our hands of the congenital cytomegalovirus disease
epidemic.”
Q. Is this the “kitty litter” disease?
A. No, that is toxoplasmosis, which causes
fewer birth defects than cCMV. Like toxoplasmosis, cCMV is
preventable, but most women of childbearing age have never heard of the
precautions to take.
Q. What about a vaccine against CMV?
A. Researchers have been working on a
vaccine against HCMV (human cytomegalovirus) for years. One reason for delay in
successful development is “there has been
insufficient education about the problem of HCMV infection…” Pharmaceutical
companies need to know that a vaccine will be used because people know about
the disease.
Q. Overall numbers of newborns
affected by cCMV in Connecticut?
A. In 2013, the number of live births in
Connecticut was 36,085. Assuming that is the approximate number born in
Connecticut each year, and using the CDC's statistics that 1 in 750 babies are
born disabled by cCMV, then it can be estimated that there are 47 children
born disabled by cCMV in Connecticut each year [ 36,085
births X .0013 (1/750)
cCMV disabled = 47 babies born with cCMV in Connecticut].
Q. How many women are infected with
cytomegalovirus while pregnant?
A. “The annual rate of a pregnant woman
who is CMV antibody negative catching CMV for the first time in pregnancy has
been estimated to be between 1-4% of all pregnant women. Higher risk groups may
have higher rates of infection per year: day care workers estimated 10%, and
women who have a toddler shedding CMV in the home, who do not practice
precautions, up to 50%,”states Dr. Demmler-Harrison of Texas, Director, Congenital CMV Disease Research, Clinic and Registry.
Q. Which women are most at risk for
contracting CMV?
A. “75% of women with a primary infection
during pregnancy acquire CMV from their own child under two years of age,” said
Stuart Adler, M.D.
Data from a variety of day care
center studies indicate that between 44 to 100% of two year olds at a single
given time were shedding CMV. Day-care workers are at greater risk according to the
article, Cytomegalovirus as an occupational risk in
daycare educators.
Q. What is the estimated cost of caring
for children disabled by cCMV in Connecticut?
A. “In the early 1990s, the expense to the
US health care system associated with congenital HCMV [Human Cytomegalovirus]
infection was estimated at approximately $1.9 billion annually, with a average cost per child of over
$300,000." Although
$300,000 per child annually is an old cost figure, Connecticut’s annual cost of
caring for children disabled by cCMV can still be estimated at: 36,085
births X .0013 cCMV
disabled = 47 babies (born disabled by cCMV in Connecticut each year) X
$300,000/year = $14,100,000, or, over $14 million annually.
“This figure is almost certainly an
underestimate, especially now with enhanced mobility aids, surgical
interventions, cochlear implants, antiviral therapies, occupational and
physical therapies, etc., which were not likely included in the older cost estimates,”
says Dr. Demmler-Harrison of Texas, Director, Congenital CMV Disease
Registry and Research Program. For example, one of her patients born in 2001 needed a
hemispherectomy [half of her brain removed] to control intractable seizures
from polymicrgyria cortical malformation of one side of her brain caused by
congenital CMV.
The little girl’s mother, Sandra Salerno
of Texas, who resigned from her position as a financial analyst to be the
primary caretaker of Lillian, said of her daughter’s medical costs, “I have tried to sum up
her medical costs for the first three years of life and they exceed $1.4
million. The surgery and five-week subsequent hospital stay was probably half
of the total costs. She attends ten weekly therapies that last an hour each. At
one point, she was taking seven medications. I believe she's been sedated 20
times in her life. Multiple MRI's, heart echos, PET scan, brain surgery, ear
tube placement and several Auditory
Brainstem Response studies. Something that is probably underappreciated is
also the cost of education for people with significant disabilities due to
congenital cytomegalovirus. Lillian was offered (but we turned down) placement
at the age of three for a full day school program with our district. The class
ratio is 3:1 and she also qualified under multiple impairments for additional
services. I have no idea how much that costs the state, and my daughter is
probably higher functioning than others with cCMV, so I can't imagine the costs
of children more disabled.”
Q. What are the costs of screening?
A. “The cytomegalovirus test costs
approximately $150.00. As only a few infants annually fail the newborn hearing
screening at UCHC [University of Connecticut Health Center], any cost incurred
at UCHC is expected to be minimal,” states the House Bill 5525 webpage.
Q. How does the cost of screening compare
to the costs saved through early detection?
A.
1. “Usually, if the CMV test is positive,
no further testing, such genetic testing (which can cost thousands of dollars
and may require pre-approvals), is done, unless there are unusual
circumstances. Certainly, on rare occasion, a poor baby can be born with two
conditions, but that is not at all common. Therefore, early diagnosis of a
clear condition with a clear diagnostic test saves the doctor and the family a
costly and heart breaking/stressful diagnostic odyssey,” states Dr.
Demmler-Harrison, Director, Congenital CMV
Disease Registry and Research Program. Fox News reported on the terrible consequences of a delayed cCMV diagnosis for the child Lillian
Salerno mentioned above.
2. In addition to saving on the cost of more
expensive diagnostic tests by first testing for CMV when a baby fails their
hearing screen, an earlier diagnosis of cCMV means earlier intervention,
which can mean a less disabled child. The less disabled a child is, the less
they cost the state to care for.
“The Connecticut legislation
extends important education and protection to families and infants from
the devastating effects of CMV. The impact on lives and the reduction of state
dollars needed to serve those impaired by CMV is immeasurable,” said
Ronda Rudd Menlove, Ph.D., the representative responsible for passing and
enacting the bill in Utah. She is the co-founder of the Utah CMV Council,
along with her daughter Sara Menlove Doutre, a special education and early
intervention policy consultant whose daughter is affected by congenital
CMV.
Q. What do we do if a baby tests positive
for cCMV?
A. Until Connecticut develops their own protocol, Utah posts informational flyers on cCMV to health care providers on their webpage at: http://www.health.utah.gov/cshcn/CHSS/CMV.html
There, you will find:
PRINTABLE BROCHURES:
CMV What Childcare Providers NEED TO KNOW (Lo qué los proveedores de cuidado infantil NECESITAN SABER sobre CMV)
For Health Care and Newborn Hearing Screening Providers:
***FREE ONLINE WEBINAR!***
"cCMV 101: Congenital Cytomegalovirus from Prevention to Treatment"
Presented by: Dr. Michael Cannon of the Centers for Disease Control and Prevention (CDC)
Q. Can cCMV be treated if diagnosed?
A. The treating physician may recommend
treating the child with an antiviral. “CMV infection in newborns can be treated
with ganciclovir by IV or valganciclovir by oral route -- treatment reduces
hearing loss progression and improves growth and head size/brain growth and
improves developmental milestones,” says Dr. Demmler-Harrison, Director, Congenital CMV
Disease Research, Clinic and Registry.
According to the article, “Valganciclovir for Symptomatic
Congenital Cytomegalovirus Disease,” by Kimberlin, M.D., et al. (2015), which studied very
affected babies, “Treated infants had fewer developmental delays…than untreated
infants.”
Q. How much does this cCMV antiviral cost?
A. Cost is estimated at $1,000 TO
$1500 per 100 ML bottle. One bottle is needed each month for a
6-month treatment. [This figure needs confirmation.]
Q. Will all babies destined to lose their
hearing from cCMV show a hearing loss in the newborn screen?
A. No. Hearing loss from cCMV is known to
be progressive, and therefore, not all children who will have disabilities from cCMV will
be detected early. That is why many in the medical community are proponents of
screening every newborn for CMV. But this law will at least help 25% of the
children who will experience a hearing loss from cCMV receive early
intervention.
Q. How can CMV be avoided?
·
Wash
hands often with soap and water for 15-20 seconds, especially after wiping
runny noses, changing diapers, picking up toys, etc. If soap and water are not
available, use alcohol-based hand gel.
·
Use
soap and water or a disinfectant to clean hard surfaces that have been
contaminated by secretions.
·
Don’t
kiss young children on the lips or share food, drinks, or eating utensils with
them.
·
If
you work in a day care center, limit close contact with children younger than
2½ years of age, especially if you've never been infected with CMV or don't know if you've been infected.
Q. Will Connecticut save money if CMV
prevention is taught?
A. Yes, because teaching prevention reduces the
rate of transmission of CMV, according to studies in the U.S. and France. “Studies have shown that women who know
they are CMV seronegative, know they are pregnant, and know about their
toddler's CMV shedding are the most likely to prevent CMV transmission and
reduce their risk from over 50 percent during pregnancy to a risk of less
than 5 percent during pregnancy. It is not likely that isolated
instances of exposure to saliva or drool will result in transmission. Most
studies suggest prolonged repeated exposures over time are important for CMV
transmission,” says Dr. Demmler-Harrison.
Q. In addition to testing newborns for CMV
if they fail their hearing screen, Utah’s H.B 81 requires CMV prevention brochures for doctors, parents, and
daycare providers.
Why doesn’t the Connecticut law require prevention education?
A. There is a cost to prevention education.
In 2014, Connecticut estimated the cost to the state at $40,000 the
first year, then $26,000 the following years.
Q. Shouldn’t we try to educate the public
that pregnant women shouldn’t kiss their toddlers around the mouth or share
food with them? Shouldn’t that be common knowledge like pregnant women
shouldn’t change the kitty litter to prevent the birth defects caused by toxoplasmosis?
A. “Yes. In addition to
saving money, you can prevent indescribable human suffering by providing
prevention education,” said Lisa Saunders, parent representative, Congenital Cytomegalovirus (CMV) Foundation. “In fact, the United States Senate
passed legislation designating the month of June as National
Congenital CMV Awareness Month, while recommending that ‘more effort be
taken to counsel women of childbearing age of the effect this virus can have on
their children.’” Saunders’ daughter, Elizabeth, was born
severely disabled by cCMV. She didn’t know she was putting her pregnancy at
risk when operating a licensed daycare center in her home. Saunders hopes
Connecticut will now add cCMV prevention information to their daycare licensing
literature and post cCMV flyers at daycare centers.
Q. The cost for prevention education
seems minimal compared to cost of caring for a child disabled by cCMV ($40,000 annually for prevention education versus $300,000 annually to care for EACH child disabled by cCMV).
Without using state dollars, how can we start our own prevention campaign?
A. "You can start by providing
cCMV prevention education on your website. Perhaps you know an organization that
would provide grant money for printing brochures and posters, and/or you can
contact colleges who have an internship programs for medical, public health or
marketing students. Since daycare workers are at higher risk for contracting
CMV and passing it onto their unborn, daycare centers can easily post
flyers on how to minimize one’s risk. You can easily post downloadable cCMV
prevention brochures such as the CDC's flyer: ‘What
Women Should Know About Cytomegalovirus (CMV)’ on your website, which can be found at: http://congenitalcmv.org/CDCbrochure.pdf,” states Lisa Saunders, parent
representative, Congenital Cytomegalovirus (CMV) Foundation.
If you would like to replicate Utah’s
prevention brochures for
doctors, parents, and daycare providers by inserting your organization’s contact information and logo, contact
Stephanie Browning McVicar, Au.D., CCC-A, Utah Department of Health, Director,
Early Hearing Detection and Intervention / Cytomegalovirus Public Health
Initiative. McVicar said, “I am so excited that another state is bringing attention
to congenital cytomegalovirus. Utah is looking forward to partnering with
Connecticut in their upcoming endeavors."
For more information on how Utah is handling
their CMV law, contact the Utah Department of Health Early Hearing Detection
and Intervention program at (801) 584-8215 or smcvicar@utah.gov. To see Utah’s cCMV brochures and
information, which also includes the free webinar, "cCMV 101: Congenital Cytomegalovirus from Prevention
to Treatment," by
Dr. Michael Cannon of the Centers for Disease Control and Prevention (CDC),
visit their website at: http://www.health.utah.gov/cshcn/CHSS/CMV.html.
To learn more about congenital cytomegalovirus and how to prevent it, visit the
Centers for Disease Control and Prevention at: http://www.cdc.gov/cmv/index.html.
###
* Lisa Saunders of
Mystic, Connecticut, is author of memoir, "Anything But a Dog! The perfect pet for a girl with congenital CMV
(cytomegalovirus)," and
the parent representative of the Congenital Cytomegalovirus Foundation, which raises awareness about maternal
testing for first infection during pregnancy, newborn testing and the need to
develop a vaccine (Lenore Pereira, Ph.D., Professor,
Cell and Tissue Biology Department, University of California San Francisco, is
the Foundation founder and can be reached at: lenore.pereira@ucsf.edu).
Saunders said, “My OB/GYNs didn’t tell me how to
prevent congenital CMV, namely by avoiding kissing my toddler near the mouth or
sharing food with her, until after my second daughter was born profoundly
mentally and physically disabled by the disease. It was then that I received
literature stating women who work in daycare, or have a young child in daycare,
are at a higher risk for catching it as toddlers are the majority of carriers.
While I was pregnant with Elizabeth, I not only had a toddler of my own, I was
also running a licensed daycare center in my home. Nowhere in the licensing
literature was there a CMV prevention message. In milder cases, children
may lose hearing or struggle with learning, but Elizabeth's case was not a
mild one.” Elizabeth died at age 16 during a seizure in 2006.
CONGENITAL
CYTOMEGALOVIRUS CONTACTS
Dr. Brenda K. Balch, MD, CT’s American Academy of Pediatrics Early Hearing Detection & Intervention Chapter
Champion. She has a strong interest because congenital CMV is a major cause of
hearing loss. bkbalch@sbcglobal.net. (Sent Testimony to
CT’s HB 5525).
Gail J Demmler-Harrison, MD, Professor, Pediatrics, Section
Infectious Diseases, Baylor College of Medicine, Attending Physician,
Infectious Diseases Service, Texas Children's Hospital, CMV Registry, CMV
Research and CMV Clinic. Contact: 832-824-4330, gjdemmle@texaschildrens.org. The CMV Registry supports CMV research, disseminates information and
provides parent support. (Sent Letter
of Testimony to CT’s HB 5525).
CDC’s Michael Cannon, Ph.D.
mrc7@cdc.gov, a research epidemiologist at
the Centers for Disease Control and Prevention. Dr. Cannon is particularly
interested in developing strategies to prevent congenital CMV infection through
public awareness and education.
Lenore Pereira, Ph.D., Founder of
Congenital Cytomegalovirus Foundation, and Professor, Cell and Tissue Biology
Department, University of California San Francisco. lenore.pereira@ucsf.edu, or visit www.congenitalcmv.org. The Congenital CMV Foundation raises awareness about
maternal testing for first infection during pregnancy, newborn testing and the
need to develop a vaccine.
Stuart Adler, M.D., Professor Emeritus of
Pediatrics and Professor of Microbiology and Immunology, Virginia
Commonwealth University. sadler@vcu.edu (sent Letter of
Testimony to CT’s HB 5147).
Staley Plotkin, MD, Professor Emeritus of
Pediatrics, University of Pennsylvania, Vaccinology Consultant (sent Letter of Testimony to CT’s HB 5147). Contact: stanley.plotkin@vaxconsult.com
Sara Menlove Doutre, President and Education Policy Consultant at
Doutre Consulting (her daughter was affected by congenital cytomegalovirus) and
co-founder of Utah CMV Council. Contact: sara@doutreconsulting.com
Stephanie Browning McVicar, Au.D., CCC-A, DOCTOR OF AUDIOLOGY (worked tirelessly to pass the Utah bill),
Specialty Services Program Manager, State EHDI Director, State of Utah
Department of Health, Children with Special Healthcare Needs, Children's
Hearing and Speech Services, (801) 584-8218, smcvicar@utah.gov.
Ronda Rudd Menlove, PhD. She was the representative responsible for passing and
enacting the bill in Utah (2013) and has offered to advise CT politicians about
the legislation and needed funding. Utah CMV Council, Ronda.menlove@gmail.com.
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