FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV

The U.S. Food and Drug Administration today approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers.

Gardasil 9 is a vaccine approved for use in females ages 9 through 26 and males ages 9 through 15. It is approved for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, and for the prevention of genital warts caused by HPV types 6 or 11. Gardasil 9 adds protection against five additional HPV types—31, 33, 45, 52 and 58— which cause approximately 20 percent of cervical cancers and are not covered by previously FDA-approved HPV vaccines.

“Vaccination is a critical public health measure for lowering the risk of most cervical, genital and anal cancers caused by HPV,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The approval of Gardasil 9 provides broader protection against HPV-related cancers. 

A randomized, controlled clinical study was conducted in the U.S. and internationally in approximately 14,000 females ages 16 through 26 who tested negative for vaccine HPV types at the start of the study. Study participants received either Gardasil or Gardasil 9. Gardasil 9 was determined to be 97 percent effective in preventing cervical, vulvar and vaginal cancers caused by the five additional HPV types (31, 33, 45, 52, and 58). In addition, Gardasil 9 is as effective as Gardasil for the prevention of diseases caused by the four shared HPV types (6, 11, 16, and 18) based on similar antibody responses in participants in clinical studies.

Due to the low incidence of anal cancer caused by the five additional HPV types, the prevention of anal cancer is based on Gardasil’s demonstrated effectiveness of 78 percent and additional data on antibodies in males and females who received Gardasil 9.

The effectiveness of Gardasil 9 in females and males ages 9 through 15 was determined in studies that measured antibody responses to the vaccine in approximately 1,200 males and 2,800 females in this age group. Their antibody responses were similar to those in females 16 through 26 years of age. Based on these results, the vaccine is expected to have similar effectiveness when used in this younger age group.

Gardasil 9 is administered as three separate shots, with the initial dose followed by additional shots given two and six months later. For all of the indications for use approved by the FDA, Gardasil 9’s full potential for benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains covered by the vaccine.

The safety of Gardasil 9 was evaluated in approximately 13,000 males and females. The most commonly reported adverse reactions were injection site pain, swelling, redness, and headaches. 

Congresswoman Rosa DeLauro in Milford

              

ONE WEEK LEFT - REGISTER ONLINE TO VOTE

MERRILL: JUST ONE WEEK TO REGISTER ONLINE TO VOTE BEFORE NOVEMBER 4, 2014 GENERAL ELECTION

SECRETARY OF THE STATE REMINDS VOTERS THAT ONLINE AND MAIL-IN REGISTRATIONS MUST BE COMPLETED BY OCTOBER 21ST; MORE THAN 23,000 CT VOTERS HAVE USED ONLINE REGISTRATION SYSTEM SINCE FEBRUARY

HARTFORD: Secretary of the State Denise Merrill today reminded eligible voters in Connecticut with driver’s license that they have just one more week to go online to register to vote if they wish to cast a ballot in the November 4, 2014 general election.   Secretary Merrill is encouraging every eligible Connecticut voter with a driver’s license to go online at htpps://voterregistration.ct.gov to register to vote securely and quickly. Since online voter registration in Connecticut launched in February of 2014, more than 23,000 voters have used the system to either become new voters or change their voter registration.  The online voter registration processed can also be accessed through mobile apps available on either Google Play or the Apple app store.  For any eligible voters in Connecticut, the deadline to register either online or through the mail is Tuesday October 21st; and the final deadline to register to vote in-person at town or city offices is Tuesday October 28th. 

“We are now approaching some key voter registration deadlines, and I want to encourage any eligible voter in our state with a driver’s license to go online and register to vote,” said Secretary Merrill, Connecticut’s top elections official.  “Online voter registration is so easy and convenient, you can even do it from your smartphone or tablet.  But anyone who wants to register online to vote must sign up by Tuesday October 21st in order to vote November 4th.  I urge every eligible voter: don’t sit on the sidelines.  Critical decisions about our state and federal government will be made by the people we elect to represent us Election Day.  Make sure your voice is heard and register to vote!”

Since online voter registration in Connecticut launched in February of this year, some 23,438 state voters have used the system, including 18,017 new voter registrations and another 5,421 voters who have changed or updated their voter registration status.  Secretary Merrill urges any U.S. citizen aged 18 or over to go online at www.sots.ct.gov/votewww.sots.ct.gov/vote to find out if they are registered to vote, register to vote, find out where their polling place is located, or download an application for an absentee ballot if they will be out of town or physically unable to be in their polling place on Election Day Tuesday November 4, 2014.  Polls will be open that day from 6:00 a.m. until 8:00 p.m. statewide for the general election.

Teen pregnancies, abortions plunge with free birth control

Teens who received free contraception and were educated about the pros and cons of various birth control methods were dramatically less likely to get pregnant, give birth or get an abortion compared with other sexually active teens, according to a new study.

The research, by investigators at Washington University School of Medicine in St. Louis, appears Oct. 2 in The New England Journal of Medicine.

The study promoted the use of long-acting forms of birth control, such as intrauterine devices (IUDs) and implants, because of their superior effectiveness in preventing unintended pregnancies. Among the 1,404 teens enrolled in the Contraceptive CHOICE Project, 72 percent opted for IUDs or implants. This compares with an estimated 5 percent of U.S. teens who choose long-acting birth control.

In the United States, most teens opt for less-reliable contraceptives such as birth control pills or condoms or no method at all because of cost and other factors.

“When we removed barriers to contraception for teens such as lack of knowledge, limited access and cost in a group of teens, we were able to lower pregnancy, birth and abortion rates,” said Gina Secura, PhD, the study’s first author and director of the CHOICE Project. “This study demonstrates there is a lot more we can do to reduce the teen pregnancy rate.”

From 2008-13, the annual pregnancy rate of teens ages 15-19 in the study averaged 34 per 1,000, compared with 158.5 per 1,000 in 2008 for sexually active U.S. teens. During the five-year span, the average annual birth rate among teens in the study was 19.4 per 1,000, compared with 94 per 1,000 in 2008 for sexually active U.S. teens. 

The abortion rate among teens in the study also dropped dramatically. From 2008-2013, their average annual abortion rate was 9.7 per 1,000, compared with 41.5 per 1,000 in 2008 for sexually active U.S. teens.

“The difference in pregnancy, birth and abortion rates between teens enrolled in the Contraceptive CHOICE Project and U.S. teens is remarkable,” said Jeffrey Peipert, MD, PhD, principal investigator of the CHOICE Project and the Robert J. Terry Professor of Obstetrics and Gynecology.

Among teens in the study, almost 500 were minors ages 14-17 when they enrolled. Half of these minors reported having had a prior unintended pregnancy, and 18 percent had had at least one abortion.

Although the teen pregnancy rate in the United States has declined in the past two decades, it remains far higher than in other industrialized countries. Each year, more than 600,000 teens in the United States become pregnant, with three in 10 teens becoming pregnant before they turn 20.

In addition to the negative health and social consequences suffered by teen mothers and their children, U.S. teen births cost almost $10 billion annually in public assistance, health care and lost income, according to The National Campaign to Prevent Teen and Unplanned Pregnancy in 2010.

The researchers analyzed data on teens enrolled in the Contraceptive CHOICE Project, a study of more than 9,000 St. Louis women and adolescents at high risk for unintended pregnancy and willing to start a new contraceptive method. Participants had their choice of a full array of birth control options, ranging from long-acting contraceptives such as IUDs and implants to shorter-acting forms like birth control pills, patches, rings, condoms or natural family planning. The teens then were followed for two to three years.

This study supports results from a previous study of the Contraceptive CHOICE Project that determined that providing birth control at no cost substantially reduced unplanned pregnancies and cut abortion rates by a range of 62-78 percent compared with the national rate.

Teens in the current study who chose IUDs or implants continued to use them longer than those who opted for shorter-acting methods such as the pill. Two-thirds of teens in the study still were using IUDs and implants at 24 months after beginning their use compared with only a third of teens still using shorter-acting methods such as birth control pills.

“We were pleasantly surprised by the number of teens choosing IUDs and implants and continuing to use them,” Peipert said. “It’s exciting that this study could provide insight into how to tackle this major health problem that greatly affects teens, their children and their communities.” 

Teen pregnancy has been designated by the U.S. Centers for Disease Control and Prevention as one of the six Winnable Battles because of the magnitude of the problem and the belief that it can be addressed by known, effective strategies. The Winnable Battle target is to reduce the teen birth rate by 20 percent, from 37.9 per 1,000 teens in 2009 to 30.3 per 1,000 teens by 2015.

The American Academy of Pediatrics (AAP) recommends IUDs as the first choice for teens

It took quite a bit of time to get around to it, but the American Academy of Pediatrics (AAP) has finally gotten around to making "the recommendation that the first-line contraceptive choice for adolescents who choose not to be abstinent is a Long Acting Reversible Contraceptive (LARC), which is an intrauterine device or a sub-dermal implant."

Here is some history, and today's new recommendation.

In 2011 The American College of Obstetricians and Gynecologists released the following statement:

IUDs Implants Are Most Effective Reversible Contraceptives Available 

June 20, 2011
Washington, DC -- Long-acting reversible contraceptive (LARC) methods—namely intrauterine devices (IUDs) and implants—are the most effective forms of reversible contraception available and are safe for use by almost all reproductive-age women, according to a Practice Bulletin released today by The American College of Obstetricians and Gynecologists (The College). The new recommendations offer guidance to ob-gyns in selecting appropriate candidates for LARCs and managing clinical issues that may arise with their use. 

"LARC methods are the best tool we have to fight against unintended pregnancies, which currently account for 49% of US pregnancies each year," said Eve Espey, MD, MPH, who helped develop the new Practice Bulletin. "The major advantage is that after insertion, LARCs work without having to do anything else. There's no maintenance required." 

More than half of women who have an unplanned pregnancy were using contraception. The majority of unintended pregnancies among contraceptive users occur because of inconsistent or incorrect contraceptive use. LARCs have the highest continuation rates of all reversible contraceptives, a key factor in contraceptive success. 

IUDs and contraceptive implants must be inserted in a doctor's office. Two types of IUDs—small, T-shaped devices that are inserted into the uterus—are available. The copper IUD, which effectively prevents pregnancy for 10 years, releases a small amount of copper into the uterus, preventing fertilization. In addition, copper interferes with the sperm's ability to move through the uterus and into the fallopian tubes. The device can also be used for emergency contraception when inserted within five days of unprotected sex. 

Women using the copper IUD will continue to ovulate, and menstrual bleeding and cramping may increase at first. Though data suggest that these symptoms lessen over time, heavy menstrual bleeding and pain during menstruation (dysmenorrhea) are main causes of discontinuation among long-term copper IUD users. Women considering IUDs should be informed of this adverse effect beforehand. 

The hormonal IUD releases progestin into the uterus that thickens cervical mucus and thins the uterine lining. It may also make the sperm less active, decreasing the ability of egg and sperm to remain viable in the fallopian tube. The hormonal IUD may make menstrual cycles lighter and is also FDA-approved for the treatment of heavy bleeding. The hormonal IUD prevents pregnancy for five years. 

The contraceptive implant is a matchstick-sized rod that is inserted under the skin of the upper arm and allows the controlled release of an ovulation-suppressing hormone for up to three years. It is the most effective method of reversible contraception available with a pregnancy rate of 0.05%. 

Despite the many benefits of LARC methods, the majority of women in the US who use birth control choose other methods. Fewer than 6% of women in the US used IUDs between 2006 and 2008. According to The College, lack of knowledge about LARCs and cost concerns may be to blame. "Women need to know that today's IUDs are much improved from earlier versions, and complications are extremely rare. IUDs are not abortifacients—they work before pregnancy is established—and are safe for the majority of women, including adolescents and women who have never had children. And while upfront costs may be higher, LARCs are much more cost-effective than other contraceptive methods in the long run," Dr. Espey said.

In 2012 the American Academy of Pediatrics issued this statement:

AAP Recommends Emergency Contraception Be Available to Teens 

11/26/2012 For Release:  November 26, 2012
Teen pregnancies have declined over the past few decades, but the United States continues to see substantially higher teen birth rates compared to other developed countries. A new policy statement by the American Academy of Pediatrics (AAP) discusses the use of emergency contraception and how it can reduce the risk of unintended pregnancy in adolescents. The statement, “Emergency Contraception,” will be published in the December 2012 Pediatrics and released online Nov. 26. According to the AAP, adolescents are more likely to use emergency contraception if it’s prescribed in advance.  

Many teens continue to engage in unprotected sexual intercourse, and as many as 10 percent are victims of sexual assault. Other indications for use include contraceptive failures (defective or slipped condoms, or missed or late doses of other contraceptives). When used within 120 hours after having unprotected or under-protected sex, selected regimens for emergency contraception, such as Plan B, Next Choice, etc., are the only contraceptive methods to prevent unwanted pregnancy.  

According to the AAP, pediatricians can play an important role in counseling patients and providing prescriptions for teens in need of emergency contraception for preventing pregnancy. Patients should also know that emergency contraception does not protect against sexually transmitted infections (STIs), and pediatricians should discuss the importance of STI testing, or treatment if needed. The AAP also encourages pediatricians to advocate for better insurance coverage and increased access to emergency contraception for teens, regardless of age.

And today tthe American Academy of Pediatrics issued this statement: 

AAP Updates Recommendations on Teen Pregnancy Prevention 

9/29/2014
Over the past 10 years, a number of new contraceptive methods have become available. The American Academy of Pediatrics (AAP) continues to review and update its recommendations on contraceptive methods to provide pediatricians with the information they need in order to counsel and prescribe contraception for adolescents. 

 In an updated policy statement and accompanying technical report in the October 2014 Pediatrics, “Contraception for Adolescents,” (published online Sept. 29), the AAP recognizes the pediatrician’s role as a trusted advisor and source of sexual health information, and supports adolescents and their families to discuss and ask questions about sensitive issues such as sexual health and relationships. 

According to AAP recommendations, pediatricians will conduct a developmentally-targeted sexual history, assess risk for sexually transmitted infections, and provide appropriate screening and/or education about safe and effective contraceptive methods. 

Regardless of which method of contraception is chosen, pediatricians should stress that all methods of hormonal birth control are safer than pregnancy, allow adolescents to consent to contraceptive care, and become familiar with state and federal laws regarding disclosure of confidential information in minors. 

New in this report is the recommendation that the first-line contraceptive choice for adolescents who choose not to be abstinent is a Long Acting Reversible Contraceptive (LARC), which is an intrauterine device or a subdermal implant.  

The past decade has demonstrated that LARCs, which provide 3 to 10 years of contraception, are safe for adolescents. Pediatricians should be familiar with counselling, insertion, and /or referral for LARCs. Additional updates to the policy statement focus on patients with special health care needs, including physical or developmental disabilities, medically complex illness, and obesity.  

It is important for pediatricians to regularly update patients’ sexual histories and allow sufficient time for follow up appointments when needed. Pediatricians are also encouraged to promote healthy sexual health decision-making, such as abstinence and proper condom use.  

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Good Guys PAC Endorsements re Gun Safety

For Immediate Release
September 18, 2014
Contact: Ron Pinciaro
203-895-0651
ronpinciaro@aol.com
CT VOTERS FOR GUN SAFETY ISSUES
GENERAL ELECTION ENDORSEMENTS

Trumbull CT - CT Voters for Gun Safety, a statewide Independent Expenditure Only Political Action Committee organized to help elect candidates who support strong Connecticut gun laws, has finalized its endorsements for the November 4 statewide and General Assembly elections. CT Voters for Gun Safety has received enthusiastic support from leaders of the gun safety and violence prevention partners in our state. We are pleased to be joined in making these endorsements by a coalition of state groups including the CT Chapters of the Brady Campaign to Prevent Gun Violence, The Enough Campaign, The Greenwich Council Against Gun Violence, March For Change, Newtown Action Alliance, The Northwest Corner Committee for Gun Violence Prevention, and Women on Watch.

This coalition of gun violence prevention groups is also pleased to announce that they are joined by the Washington, DC-based Brady Campaign to Prevent Gun Violence for these endorsements.

CT Voters For Gun Safety is proud to announce its endorsement of Governor Dannel P. Malloy in his race for a second term as Governor of Connecticut. His leadership and courage following the tragedy at Sandy Hook Elementary School, and his determination to establish strong gun violence prevention measures in its aftermath, were exemplary.
 [... removed rest of press release in order to get]

For Connecticut Constitutional offices, we endorse the following candidates: 

Governor:               Dannel P. Malloy (D)

Lt. Governor:         Nancy Wyman (D)

Attorney General:  George Jepsen (D)

Secretary of State:  Denise Merrill (D)

State Comptroller:  Kevin Lembo (D)

State Treasurer:      Denise Nappier (D)

For the Connecticut General Assembly, we endorse the following candidates:

                                                                                       

State Senate                                                                  

S-2:           Eric D. Coleman (D)

S-5:           Beth Bye (D)

S-8:           Melissa E. Osborne (D)

S-12:         Ted Kennedy Jr. (D)

S-13:         Dante Bartolomeo (D)

S-15:         Joan V. Hartley (D)

S-17:         Joe Crisco (D)

S-20:         Betsy Ritter (D)

S-22:         Marilyn Moore (D)

S-25:         Bob Duff (D)

S-26:         Toni Boucher (R)

S-29:         Mae Flexer (D)

S-31:         Robert Michalik (D)

S-33:         Emily Bjornberg (D)

                                                                                       

State Representative

H-1:          Matthew D. Ritter (D)                                Hartford

H-2:          Candace Faye (D)                                       Danbury

H–12:        Kelly J.S. Luxenberg (D)                            Manchester

H-15:        David A. Baram (D)                                   Bloomfield

H-16:        John K. Hampton (D)                                 Simsbury

H-21:        Mike Demicco (D)                                      Farmington

H-22:        Elizabeth "Betty" A. Boukus (D)               Plainville

H-23:        Mary J. Stone (D)                                       Lyme

H-26:        Peter A. Tercyak (D)                                   New Britain

H-35:        Tom Vicino (D)                                           Westbrook

H-36:        Philip J. Miller (D)                                      Haddam

H-38:        Marc A. Balestracci (D)                              Waterford

H-40:        Edward E. Moukawsher (D)                      Groton

H-41:        Elissa T. Wright (D)                                    Groton

H-47:        Brian H. Sear (D)                                        Canterbury

H-54:        Gregory S. Haddad (D)                              Storrs

H–55:        Joseph A. LaBella (D)                                Bolton

H-59:        David William Kiner (D)                            Enfield

H-64:        Roberta B. Willis (D)                                  Lakeville

H-65:        Michelle L. Cook (D)                                  Torrington

H-72:        Larry B. Butler (D)                                     Watertown

H-85:        Mary M. Mushinsky (D)                             Wallingford

H-88:        Brendan Sharkey (D)                                  Hamden

H-89:        Vickie Orsini Nardello (D)                         Prospect

H-90:        Mary G. Fritz (D)                                        Yalesville

H-97:        Robert W. Megna (D)                                 New Haven

H–98:        Sean Scanlon (D)                                        Guilford

H-99:        James M. Albis (D)                                     East Haddam

H-103:      Kristen Selleck (D)                                     Cheshire

H–110:      Bob Godfrey (D)                                        Danbury

H-111:      John H. Frey (R)                                         Ridgefield

H-114:      Themis Klarides (R)                                    Woodbridge

H-119:      James J. Maroney (D)                                 Milford

H-123:      Douglas G. Sutherland (D)                         Trumbull

H-125:      Tom P. O'Dea Jr. (R)                                  New Canaan

H-132:      Brenda L. Kupchick (R)                             Fairfield

H–133:      Cristin McCarthy Vahey (D)                      Fairfield

H-134:      Tara Cook-Littman (D)                               Fairfield

H-136:      Jonathan P. Steinberg (D)                           Westport

H-138:      Henry H. Hall ( D)                                      Danbury

H-144:      Caroline B. Simmons (D)                            Stamford

H-147:      William M. Tong (D):                                 Stamford

 

CT Voters for Gun Safety Political Action Committee (CVGS PAC) is a nonpartisan political action committee committed to supporting candidates for Connecticut state office who support strong gun safety laws. Paid for by CT Voters for Gun Safety www.ctvotersforgunsafety.com Top 5 Donor:  CT Against Gun Violence This message was made independent of any candidate or political party. Additional information about CVGS may be found at www.ct.gov/seec/.