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Friday, September 16, 2011

Nikki Haley Supports HPV Vaccine Too! For Young Minority Girls On Medicaid!
















Rising GOP star Haley has own history with HPV vaccine fallout

As the debate over Texas Gov. Rick Perry mandating the HPV vaccine continues between Republican presidential candidates, a woman whose endorsement is coveted by all them, South Carolina Gov. Nikki Haley, has her own complicated history on the issue.

In 2007, shortly before Perry issued an executive order requiring that schoolgirls be vaccinated against the sexually transmitted human papillomavirus, or HPV, that causes most cervical cancers, Haley was throwing her support behind a similar bill in South Carolina. At the time she was in her second term as a state representative.

State Rep. Joan Brady introduced the Cervical Cancer Prevention Act in South Carolina, and the Republican corralled more than 60 legislators, including Haley, to sponsor the bill. Unlike the executive order for which Perry is taking heat, this legislative mandate did not include a provision for parents to opt out of inoculating their daughters.

Within months, fierce opposition mounted, and legislative records back up accounts from sources who recall sponsors "dropping like flies" before a unanimous vote killed the bill on April 18, 2007.

More than a dozen legislators formally requested to be removed as sponsors from the bill, but the future governor of South Carolina was not one of them.

State Rep. Kris Crawford, a physician who led the debate to discredit the policy resulting in the bill's demise, said even though Haley voted against the bill like everybody else he wondered why she didn't remove herself as a bill sponsor if she opposed the mandate.

"If you're a co-sponsor of a bill and it's a bad bill, take your name off of it," Crawford said.

Haley's office declined to comment and pointed CNN to information about the vote on her campaign website.

Palmetto Family Council President Oran Smith was among the conservative activists actively lobbying legislators to oppose the bill.

"When we finally got to them and explained the full story, they were very quick to pull their names off," Smith recalls. "Sure we wish (Haley) had done that as well, but ultimately when it came up on the big board, she voted the way we wanted her to vote twice."

On her campaign website, Haley acknowledges her initial support for the bill but said in a statement, "Through the legislative process, it became clear to me that an opt-out provision was not going to be included in the bill and it sought to mandate that middle-school girls obtain a vaccine -- and strip parents of the right to make the choice for their daughter. In light of that turn of events, I voted to kill the bill."

Haley voted against the opt-out provision she says in her statement would have made the bill palatable.

Smith said that was likely part of legislative strategy by Haley and other conservative Republicans in the state House to vote against the opt-out provision so the bill with a straight mandate wouldn't have a chance of passing.

Crawford, a Republican, said he is not so sure.

"There are exactly two groups of people who can claim they were against this giant overreaching of government -- those who never sponsored the bill and those who were sponsors but subsequently removed their names from the bill when it was explained to be a boondoggle mandating vaccination of little 12-year-old girls against a sexually transmitted disease," Crawford said. "Everyone else was either for the bill or riding the fence trying to claim victory regardless of outcome."

Smith said, "In our view, the opt-out (amendment) did not remove the mandate; it just purported to remove the mandate. That was a position that then-Rep. Haley accepted, and she ultimately voted with other conservatives to not fall for that amendment."

Sheri Few, president of South Carolina Parents Involved in Education and an adviser to Haley's 2010 gubernatorial campaign, said many of the bill's co-sponsors were "misled" by those pushing it.

"Nikki was not the only one misled -- more than a third of Republicans in the House co-sponsored the bill," Few wrote in a statement on Haley's website. "When the facts came to light, even the primary sponsor moved to kill her own bill and it was defeated -- an action that included (Rep.) Haley's vote against it."

Perry's 2007 executive order was repealed two months later by the Texas Legislature, but the issue has been dogging the governor on the presidential campaign trail.

Read more about Perry's HPV executive order

Rep. Michele Bachmann of Minnesota has criticized her opponent in the GOP presidential race for being politically motivated by Merck & Co. Merck, the first company to offer a Food and Drug Administration-approved HPV vaccine, engaged in a well-documented campaign in 2007 to lobby legislators to pass laws that would add the vaccine to the list of required immunizations before attending public school.

The Texas governor denies those allegations, saying his decision to protect females against cancer-causing HPV resulted after meeting a young woman who later died from cervical cancer.

But Perry has admitted that bypassing the Texas Legislature and employing an executive order was a mistake. On Wednesday, speaking to reporters in Virginia, Perry acknowledged the order "should have had an opt-in instead of an opt-out."

The debate over Perry's executive order reminds Smith of the legislative fight in South Carolina more than four years ago. He said he empathized with Perry when the candidate was asked about his 2007 decision in recent debates.

"It was how I felt in 2007 and 2008. We didn't want cervical cancer to take the lives of women, but at the same time, we were militantly opposed to weakening parental rights," Smith said.

Smith, who advocates an "educate but not mandate" approach to the HPV vaccine, said he believes Perry will need to convince voters motivated by social issues that his HPV vaccine decision is an anomaly in his 10-year tenure as governor.









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Reports of Health Concerns Following HPV Vaccination


VAERS Limitations


VAERS data cannot be used to prove a causal association between the vaccine and the adverse event. The only association between the adverse event and vaccination is temporal, meaning that the adverse event occurred sometime after vaccination. Therefore, the adverse event may be coincidental or it may have been caused by vaccination, however we cannot make any conclusions that the events reported to VAERS were caused by the vaccine.


HPV Vaccine Safety


There are two licensed HPV vaccines, Gardasil® and Cervarix®, available to protect against the types of HPV infection that cause most cervical cancers. Gardasil® was licensed for use in females, age 9-26 years in June 2006 and for males age 9-26 years in Oct 2009. Cervarix® was licensed for use in females age 10-25 in October 2009.

The safety of HPV vaccines was studied in clinical trials worldwide before licensure. For Gardasil® , over 29,000 males and females participated in these trials. For Cervarix®, over 30,000 females participated in several clinical trials.

Since licensure, CDC and FDA have been closely monitoring the safety of HPV vaccines. There are 3 systems used to monitor the safety of vaccines after they are licensed and used in the U.S. These systems can monitor adverse events already known to be caused by vaccines, as well as detect rare adverse events that were not identified during pre-licensure clinical trials. The 3 systems are:

The Vaccine Adverse Event Reporting System (VAERS)–a useful early warning public health system that helps CDC and FDA detect possible side effects or adverse events following vaccination.

The Vaccine Safety Datalink (VSD) Project–a collaboration between CDC and 10 health care organizations which monitors and evaluates adverse events following vaccination.

The Clinical Immunization Safety Assessment (CISA) Network– a collaboration between6 academic centers in the U.S. which conduct research on adverse events that might be caused by vaccines.

Reports to VAERS Following Gardasil®

As of June 22, 2011, approximately 35 million doses of Gardasil® were distributed in the U.S. and VAERS received a total of 18,727 reports of adverse events following Gardasil® vaccination: 17,958 reports among females and 346 reports for males, of which 285 reports were received after the vaccine was licensed for males in October 2009. VAERS received 423 reports of unknown gender. Of the total number of VAERS reports following Gardasil®, 92% were considered to be non-serious, and 8% were considered serious.


Non-serious adverse event reports


VAERS defines non-serious adverse events as those other than hospitalization, death, permanent disability, or life-threatening illness.

The vast majority (92%) of the adverse events reports following Gardasil® vaccination have included fainting, pain, and swelling at the injection site (the arm), headache, nausea, and fever. Syncope (fainting) is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries, which can be prevented by closely observing the person for 15 minutes after vaccination.

Serious adverse event reports

Any VAERS report that indicated hospitalization, permanent disability, life-threatening illness, congenital anomaly or death is classified as serious. As with all VAERS reports, serious events may or may not have been caused by the vaccine.


Guillain-Barré Syndrome (GBS)


Guillain-BarrĂ© syndrome (GBS) has been reported after vaccination with Gardasil® . GBS is a rare neurologic disorder that causes muscle weakness. It occurs in 1-2 out of every 100,000 people in their teens. A number of infections have been associated with GBS. There has been no indication that Gardasil® increases the rate of GBS above the rate expected in the general population, whether or not they were vaccinated.

Blood Clots

There have been some reports of blood clots in females after receiving Gardasil®. These clots have occurred in the heart, lungs, and legs. Most of these people had a risk of getting blood clots, such as taking oral contraceptives (the birth control pill), smoking, obesity, and other risk factors.


Deaths


As of June 22, 2011 there have been a total 68 VAERS reports of death among those who have received Gardasil® . There were 54 reports among females, 3 were among males, and 11 were reports of unknown gender. Thirty two of the total death reports have been confirmed and 36 remain unconfirmed due to no identifiable patient information in the report such as a name and contact information to confirm the report. A death report is confirmed (verified) after a medical doctor reviews the report and any associated records. In the 32 reports confirmed, there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine and some reports indicated a cause of death unrelated to vaccination.

VAERS Reports Following Cervarix®

Since licensed in October 2009, uptake of Cervarix® vaccination in the U.S. has been low. As of June 2011, there have been 39 VAERS reports of adverse events following Cervarix® vaccination in the U.S. The majority of these reports (97%) were considered to be non-serious.

Cervarix® has also been in use in other countries such as England and Europe prior to licensing from the FDA.

Summary

Based on all of the information we have today, CDC recommends HPV vaccination for the prevention of most types of cervical cancer. As with all approved vaccines, CDC and FDA will continue to closely monitor the safety of HPV vaccines. Any problems detected with these vaccines will be reported to health officials, healthcare providers, and the public and needed action will be taken to ensure the public's health and safety.



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Sources: Center For Disease Control.gov, CNN, MSNBC, Youtube, Google Maps

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