March 13, 2007, 5:03PM
TX House Votes to Override Vaccine Order


By APRIL CASTRO Associated Press Writer
© 2007 The Associated Press


AUSTIN — The Texas House approved a bill Tuesday that would keep the human papillomavirus vaccine off the list of required shots for school attendance, tentatively circumventing Gov. Rick Perry's executive order.

The vaccine protects girls against strains of HPV, a sexually transmitted virus that causes most cases of cervical cancer.

The measure, approved 119-21, still needs final approval in the House and approval in the Senate. It's also possible that Perry will veto the legislation, but the 119 voters that approved the bill Tuesday are more than enough to override a veto.

Perry's order asked Health and Human Services Executive Commissioner Albert Hawkins to adopt rules to vaccinate all girls entering the sixth-grade as of September 2008. Parents could have refused the shots for their daughters.

Perry's chief of staff met with key aides about the new vaccine on the same day its manufacturer donated money to his campaign, The Associated Press reported in February.

A calendar for chief of staff Deirdre Delisi obtained under Texas' open records laws shows she met with the governor's budget director and three members of his office for an "HPV Vaccine for Children Briefing" on Oct. 16. That same day, Merck & Co.'s political action committee donated $5,000 to Perry and a total of $5,000 to eight state lawmakers.

A spokeswoman for Perry estimated only 25 percent of young women in Texas would get the vaccine if it is not required.

"Governor Perry's executive order on HPV would help to protect 95 percent of young women in Texas against the strains of HPV that cause cervical cancer," said spokeswoman Krista Moody. "The governor believes we should protect as many young women as possible _ rich and poor, insured and uninsured _ while maintaining parents' rights to opt their daughter out of receiving the vaccine."

Perry's order angered lawmakers who said the governor circumvented the legislative process.

The bill adopted Tuesday "will not take away the option for a single girl or a single family in this state to choose to vaccinate a child," said Republican Rep. Dennis Bonnen of Angleton, the lead author of the bill. "It simply says a family must make that choice, not a state government."

Perry acknowledged weeks ago that the Legislature has the authority to supersede his mandate. But he has also insisted a requirement is good public policy that will save young women's lives.

Critics argued that the vaccine, called Gardasil, was too new and its effects needed to be further studied before mandating it for Texas schoolgirls. The Food and Drug Administration approved Gardasil last year.

On Monday, two prominent lawmakers said Attorney General Greg Abbott told them state health officials are not required to follow Perry's order because it does not carry the weight of law.

Republican Sen. Jane Nelson and Rep. Jim Keffer had asked Abbott to clarify the governor's authority to issue executive orders and the Legislature's ability to overrule them.

Cervical cancer can usually be prevented if precancerous cervical lesions are found by a Pap test and removed. Doctors recommend women get Pap tests once a year, but about half of the women in the U.S. who develop cervical cancer have never had a Pap test, according to the Centers for Disease Control and Prevention.

___

The measure is HB 1098.



http://www.chron.com/disp/story.mpl/ap/fn/4626405.html





March 12, 2007, 7:24PM
HPV order does not carry weight of law, Abbott tells lawmakers


By LIZ AUSTIN PETERSON Associated Press Writer
© 2007 The Associated Press


AUSTIN — Gov. Rick Perry's anti-cancer vaccine order does not carry the weight of law and state health officials are not required to follow it, two prominent lawmakers said Monday after meeting with Attorney General Greg Abbott.

Abbott's informal opinion comes a day before the Texas House is scheduled to vote on a bill that would bar state officials from requiring the human papillomavirus vaccine for school attendance.

Lawmakers were outraged in early February when Perry issued an executive order directing the Texas Health and Human Services Commission to adopt a rule requiring the vaccine for girls entering the sixth grade as of September 2008.

The vaccine protects girls against strains of HPV that cause most cases of cervical cancer.

Days after Perry issued the order, Republican Sen. Jane Nelson, of Lewisville, and Rep. Jim Keffer, of Eastland, asked Abbott to clarify the governor's authority to issue executive orders and the Legislature's ability to overrule them.

Nelson said she and Keffer met with Abbott on Thursday and he told them the order "was more like a suggestion to the head of the agency."

Abbott spokesman Jerry Strickland said the attorney general's office does not discuss the content or substance of its discussions with lawmakers.

The governor acknowledged weeks ago that the Legislature has the authority to supersede his mandate. But he has also insisted the requirement is good public policy that will save young women's lives.

"Because Gov. Perry's executive order is consistent with current law, nothing has been issued today that in any way alters the governor's directive," Perry spokesman Robert Black said in a Monday statement.

Some conservatives have said the order contradicts Texas' abstinence-only sex education policies and strays too far into families' lives. Others have balked at the $360 cost for the vaccine, called Gardasil, and questioned the vaccine's efficacy and safety.

With or without Perry's order, state law gives Health and Human Services Executive Commissioner Albert Hawkins the authority to require schoolgirls to get the vaccine. Opponents of the mandate have argued that it would be difficult for Hawkins to defy Perry since he's appointed by the governor.

The bill the House is set to debate on Tuesday would add a sentence to the existing law stating that the HPV vaccine is not required for school attendance. With 93 co-sponsors, the proposal is almost sure to pass. An identical bill has been filed in the Senate.

Black said 65 percent fewer women will be vaccinated if lawmakers make the shots optional.

"While some would make this debate about the separation of powers, it is about saving lives," he said in the statement.

Nelson, chairwoman of the Senate health and human services committee, said her committee will hear several bills about the HPV vaccine, including one that would institute a requirement similar to the one Perry has sought.

In the month since Perry issued the order, lawmakers in Virginia and New Mexico have approved similar requirements. The governors of both states have said they will sign the bills into law.

http://www.chron.com/disp/story.mpl/ap/tx/4623490.html



March 13, 2007, 1:08PM
HPV Notification Passes Wa. House


By JENNIFER BYRD Associated Press Writer
© 2007 The Associated Press


OLYMPIA, Wash. — The Washington state House has voted to require that all schools in the state provide information about a sexually transmitted virus that can cause cervical cancer and about a vaccine to protect against it.



http://www.chron.com/disp/story.mpl/ap/fn/4625529.html



March 12, 2007, 10:15PM
N.M. lawmakers approve cancer vaccine


By MATT MYGATT Associated Press Writer
© 2007 The Associated Press


ALBUQUERQUE, N.M. — New Mexico is on the verge of becoming the latest state to require sixth-grade girls to be vaccinated against a sexually transmitted virus that can cause cervical cancer, a spokesman for the governor said Monday.



http://www.chron.com/disp/story.mpl/...n/4623956.html



why can't they just _offer_ them for free, instead of the executive order ???

heck, even the manufacturer of the vaccine saw the writing on the wall of what the 'executive order' of perry's was doing, why can't the Governer ???


TSS

I am glad they voted this way

me too!

i am hoping the mass emails that got sent out helped spread the word.

i know our threads here got a lot of views. thanks flounder for posting the update.

March 17, 2007, 7:50PM
Dose of reality
First, let's inoculate with the facts
Controversial Gardasil may be better for Merck than it is for Texas girls


By SIGRID FRY-REVERE


There's nothing wrong with a drug maker publicizing its products and their benefits, but the lure of lucrative government contracts can prompt them to play fast and loose. In lobbying Texas lawmakers to make its latest vaccine mandatory, Merck has exaggerated both the threat of a disease and the ability of a drug to prevent it.

The drug in question is Gardasil, a vaccine for four types of human papillomavirus, two of which are responsible for cervical cancer. The federal Food and Drug Administration approved Gardasil last year for use against human HPV in females aged 9 to 26. By a veto-proof majority of 119 to 21, the Texas House of Representatives voted last week against mandating Gardasil for middle school-aged girls, but the Texas Senate has yet to weigh in on the issue, and Gov. Rick Perry is expected to veto the bill.

If he does — and the Texas Legislature doesn't have the votes to override his veto — then his earlier executive order mandating vaccination will stand.

These mandates would be quite a boon for Merck, as Gardasil is one of the most expensive vaccines on the market. With a price tag of $360 for a series of three shots, vaccinating approximately 30 million middle school-aged girls in the United States would bring in more than $10 billion.

Gardasil is not all it is cracked up to be. A recent study in the Journal of the American Medical Association indicates that among women ages 14 to 24, the rate of all 37 types of sexually transmitted HPV combined is 33.8 percent — already a number much lower than the 50 percent figure sited on Merck's Web site. But the rates for the two types of HPV responsible for 70 percent of all cervical cancers (16 and 18), are far lower: only 1.5 percent and 0.8 percent, respectively.

The American Cancer Society sees its fight against cervical cancer as a success story even without Gardasil. When detected early through Pap testing, the survival rate for cervical cancer is over 90 percent. Thus, when early detection methods are used, only around 0.2 percent of the girls being vaccinated are actually at risk of dying of cervical cancer from HPV 16 or 18 even without the vaccine.

Under these circumstances, are we really prepared to spend $10 billion administering this vaccine?

And while it's horrible that anyone at all should die of cervical cancer, the long-term risks that may be associated with Gardasil are totally unknown. Studies followed the women who participated in drug trials for an average of less than three years. What if some horrible unexpected side effect materializes?

This possibility isn't as far fetched as you might think. In 1976, swine flu caused only one documented death in the United States, but the vaccine administered by government mandate seriously injured or killed hundreds. It turned out that the vaccine caused Guillain-Barré Syndrome, a rare paralytic disease similar to polio, with a 5 percent fatality rate and a 10 percent rate of permanent paralysis.

Mandatory Gardasil vaccinations would certainly brighten Merck's future, but it's not so clear that they're in the best interest of American girls. In all but the clearest cases, health risk assessments should be left up to individual families, not only because making such determinations rightly rest with families, but because it's simply not sensible policy to experiment on such a large portion of our population all at once. What if, 10 years from now, we discover that the vaccine causes infertility or another form of cancer?

To add insult to injury, not only has Merck left Texas lawmakers in the dark about the myriad of possible downsides to mandatory HPV vaccination, it has actively lobbied and paid large campaign contributions to politicians willing to support such policies.

According to documents obtained by the the Associated Press last month, Merck donated $5,000 to Gov. Perry on the same day his chief of staff met with his budget director for an "HPV vaccine for Children Briefing."

To the casual observer, it looks a lot like Merck is paying politicians to do its bidding. Mandating HPV vaccinations would bring Merck huge profits, possibly at the expense of ordinary Texans — or at least at the expense of little girls.

Fry-Revere is director of bioethics studies at the Cato Institute, a Washington-based think tank with a libertarian orientation.



http://www.chron.com/disp/story.mpl/...k/4640022.html




TSS

Former science chief: 'MMR fears coming true'
By SUE CORRIGAN, Mail on Sunday - Last updated at 16:08pm on 22nd March 2006



A former Government medical officer responsible for deciding whether medicines are safe has accused the Government of "utterly inexplicable complacency" over the MMR triple vaccine for children.

Dr Peter Fletcher, who was Chief Scientific Officer at the Department of Health, said if it is proven that the jab causes autism, "the refusal by governments to evaluate the risks properly will make this one of the greatest scandals in medical history".

He added that after agreeing to be an expert witness on drug-safety trials for parents' lawyers, he had received and studied thousands of documents relating to the case which he believed the public had a right to see.

He said he has seen a "steady accumulation of evidence" from scientists worldwide that the measles, mumps and rubella jab is causing brain damage in certain children.

But he added: "There are very powerful people in positions of great authority in Britain and elsewhere who have staked their reputations and careers on the safety of MMR and they are willing to do almost anything to protect themselves."

His warning follows reports that the Government is this week planning to announce the addition of a jab against pneumococcal meningitis for babies, probably from next April. It is also considering flu jabs for under-twos - not to protect the children, but adults they may infect.

In the late Seventies, Dr Fletcher served as Chief Scientific Officer at the DoH and Medical Assessor to the Committee on Safety of Medicines, meaning he was responsible for deciding if new vaccines were safe.

He first expressed concerns about MMR in 2001, saying safety trials before the vaccine's introduction in Britain were inadequate.

Now he says the theoretical fears he raised appear to be becoming reality.

He said the rising tide of autism cases and growing scientific understanding of autism-related bowel disease have convinced him the MMR vaccine may be to blame.

"Clinical and scientific data is steadily accumulating that the live measles virus in MMR can cause brain, gut and immune system damage in a subset of vulnerable children," he said. "There's no one conclusive piece of scientific evidence, no 'smoking gun', because there very rarely is when adverse drug reactions are first suspected. When vaccine damage in very young children is involved, it is harder to prove the links.

"But it is the steady accumulation of evidence, from a number of respected universities, teaching hospitals and laboratories around the world, that matters here. There's far too much to ignore. Yet government health authorities are, it seems, more than happy to do so."

'Why isn't the Government taking this massive public health problem more seriously?'

Dr Fletcher said he found "this official complacency utterly inexplicable" in the light of an explosive worldwide increase in regressive autism and inflammatory bowel disease in children, which was first linked to the live measles virus in the MMR jab by clinical researcher Dr Andrew Wakefield in 1998.

"When scientists first raised fears of a possible link between mad cow disease and an apparently new, variant form of CJD they had detected in just 20 or 30 patients, everybody panicked and millions of cows were slaughtered," said Dr Fletcher.

"Yet there has been a tenfold increase in autism and related forms of brain damage over the past 15 years, roughly coinciding with MMR's introduction, and an extremely worrying increase in childhood inflammatory bowel diseases and immune disorders such as diabetes, and no one in authority will even admit it's happening, let alone try to investigate the causes."

He said there was "no way" the tenfold leap in autistic children could be the result of better recognition and definitional changes, as claimed by health authorities.

"It is highly likely that at least part of this increase is a vaccinerelated problem." he said. "But whatever it is, why isn't the Government taking this massive public health problem more seriously?"

His outspokenness will infuriate health authorities, who have spent millions of pounds shoring up confidence in MMR since Dr Wakefield's 1998 statement.

But Dr Fletcher said the Government is undermining public confidence in vaccine safety by refusing to do in-depth clinical research to rule out fears of MMR damage to children.

He added that the risks of brain and gut damage from MMR injections seem to be much higher in children where a brother or sister has diabetes, an immune disorder.

"That is a very strong clinical signal that some children are immunologically at risk from MMR," he said. "Why is the Government not investigating it further - diverting some of the millions of pounds spent on advertising and PR campaigns to promote MMR uptake into detailed clinical research instead?"

Now retired after a distinguished 40-year career in science and medicine in Britain, Europe and the US, Dr Fletcher said that without such research, health authorities could not possibly rule out fears about MMR.

He said: "It is entirely possible that the immune systems of a small minority simply cannot cope with the challenge of the three live viruses in the MMR jab, and the ever-increasing vaccine load in general."

He said he had decided to speak out because of his deep concern at the lack of treatment for autistic children with bowel disease, as revealed in The Mail on Sunday two weeks ago.

He called the sudden termination of legal aid to parents of allegedly vaccine-damaged children in late 2003 "a monstrous injustice". After agreeing to be a witness for the parents, he received thousands of documents relating to the case.

"Now, it seems, unless the parents force the Government to restore legal aid, much of this revealing evidence may never come out," he said.

The Department of Health said: "MMR remains the best protection against measles, mumps and rubella. It is recognised by the World Health Organisation as having an outstanding safety record and there is a wealth of evidence showing children who receive the MMR vaccine are no more at risk of autism than those who don't."



http://www.dailymail.co.uk/pages/liv...n_page_id=1774





Official defends editing climate papers

By H. JOSEF HEBERT, Associated Press Writer Mon Mar 19, 5:54 PM ET

WASHINGTON - A former White House official accused of improperly editing reports on global warming defended his editing changes Monday, saying they reflected views in a 2001 report by the



National Academy of Sciences. House Democrats said the 181 changes made in three climate reports reflected a consistent attempt to emphasize the uncertainties surrounding the science of climate change and undercut the broad conclusions that man-made emissions are warming the earth.



Philip Cooney, former chief of staff at the White House Council on Environmental Quality, acknowledged at a House hearing that some of the changes he made were "to align these communications with the administration's stated policy" on climate change.

The extent of Cooney's editing of government climate reports first surfaced in 2005. Shortly thereafter, Cooney, a former oil industry lobbyist, left the White House to work at Exxon Mobil Corp.

"My concern is that there was a concerted White House effort to inject uncertainty into the climate debate," said Rep. Henry Waxman (news, bio, voting record), D-Calif., chairman of the

House Government Reform Committee.

Cooney's appearance before Waxman's committee Monday was the first time he has spoken publicly, or was extensively questioned, about the issue.

Cooney said that many of the changes he made to the reports — such as uncertainty about the regional impact of climate change and limits on climate modeling — reflected findings of a 2001 National Academy of Sciences report on climate.

Waxman's committee also heard from James Hansen, director of

NASA's Goddard Institute for Space Studies and one of the country's leading climate scientists, who said the White House repeatedly tried to control what government scientists say to the public and media about climate change.

"Interference with communications of science to the public has been greater during the current administration than at any time in my career," said Hansen, who was one of the first to raise concerns about climate change in the 1980s.

Hansen's battles with NASA and White House public affairs officials are not new and resulted in an easing of NASA's policies toward scientists talking to the media about their work.

But that was not always the case.

Hansen said that in 2005 he was told by a 24-year-old NASA public affairs official he could not take part in an interview with National Public Radio on orders from senior NASA public affairs officials. Instead, three other NASA officials were offered for the interview.

The young press officer, George Deutsch, now 26, sat next to Hansen at the witness table Monday and told the committee he had simply been "relaying" the views of higher-ups at NASA that Hansen was not to participate in the interview.

Rep. Darrell Issa (news, bio, voting record), R-Calif., suggested that Hansen was not being muzzled at all and that there is nothing wrong with government scientists being subject to some limits in what they say.

"You're speaking on federal paid time. Your employer happens to be the American taxpayer," Issa lectured Hansen. He said a Google search had shown Hansen cited on more than 1,400 occasions over a year in interviews and appearances.

Hansen said he accepted only "a small fraction" of the requests for interviews and appearances and that, as a matter of free speech, government scientists should not be restrained in their remarks or have public affairs officers listening in on interviews.

"It doesn't ring true," said Hansen. "It's not the American way. And it's not constitutional."



http://news.yahoo.com/s/ap/20070319/...ntists_warming



VACCINES AND CJD 'CONFIDENTIAL'

snip...

2.1.3. _______________, England Ltd) contains BOVINE HEART AND BRAIN SOURCED FROM USA.

This is an oral product which declares a number of bacteria as active ingredients and is said to use BOVINE BRAIN AND HEART in process, sourced from the USA. (It also uses UK derived equine blood.)

This product holds a PLR, and is indicated for the prevention and treatment of bronchial catarrh, sinus and antrum infections and bacterial infections following virus colds. There are no efficacy data.

snip...

4.3 The following companies did NOT KNOW THE SOURCE of some or all of the serum they used

XXXXXXXXXXXXXXXXXXXXXXXX - (Factor VIII)

XXXXXXXXXXXXXXXXXXXXXXXX - (Rabies Vaccine)

XXXXXXXXXXXXXXXXXXXXXXXX - Measles, Rubella, MMR and rabies vaccine.

snip...

http://www.bseinquiry.gov.uk/files/y...9/06011001.pdf


Two million children innoculated with BSE vaccines

The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read (scanned into computer) and so may contain typos and unreadable parts.

TIP740203/l 0424 CONFIDENTIAL


http://www.mad-cow.org/00/may00_news.html#aaa

http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh

http://www.emergingdisease.org/phpbb...9587&view=next



18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.


snip...



64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.

Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD.


snip...



http://www.seac.gov.uk/minutes/95.pdf




3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse

Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve
University

Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years.

***These results indicate that BASE is transmissible to humans and suggest that BASE is more virulent than
classical BSE in humans.***


6:30 Close of Day One


http://www.healthtech.com/2007/tse/day1.asp




SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...


http://www.cjdsurveillance.com/resou...asereport.html



There is a growing number of human CJD cases, and they were presented last
week in San Francisco by Luigi Gambatti(?) from his CJD surveillance
collection.

He estimates that it may be up to 14 or 15 persons which display selectively
SPRPSC and practically no detected RPRPSC proteins.


http://www.fda.gov/ohrms/dockets/ac/...006-4240t1.htm


http://www.fda.gov/ohrms/dockets/ac/...006-4240t1.pdf


i don't know whom, or what to believe anymore.

we must get politics and the industry (one of the same), out of science based decision making, that much i do know.

TSS

sorry, my dd got the vaccine. If I can help her to prevent getting HPV, then I will. I have seen the effects of HPV and it is devastating. We are solid strong Christians, as is her dr, but we all felt it would be in her best interests for her to get the vaccine.

Corinna Kaarlela, News Director
Source: Kristen Bole
kbole@pubaff.ucsf.edu
415-476-2557

10 May 2007


Karen Smith-McCune, MD
UCSF experts cautious about vaccine for cervical cancer virus

Unknowns about the effectiveness and safety of the new human papillomavirus (HPV) vaccine demand thoughtful deliberation by clinicians on its role in cervical cancer prevention, according to two UCSF women’s health specialists.

The lack of long-term follow-up to assess vaccine efficacy and safety, as well as the lack of testing in the age group targeted for the vaccine (11 to 12 year-old girls), are among the main reasons for such caution, they say.

Their analysis is reported in today’s issue (May 10, 2007) of the “New England Journal of Medicine,” which focuses on the new vaccine. The editorial and other NEJM articles are available online at http://content.nejm.org.

The vaccine, which has received international attention since its approval by the Food and Drug Administration last June, targets four HPV types, two of which can cause cervical cancer, according to George F. Sawaya, MD, and Karen Smith-McCune, MD, who are co-authors of the editorial and are associate professors in the UCSF Department of Obstetrics, Gynecology and Reproductive Services.

Previously published data about the vaccine have indicated 100 percent effectiveness against the pre-cancerous cervical lesions that are associated with the HPV types targeted by the vaccine. That data applied to women who had not previously been exposed to those viral types. New studies reported in this issue of the NEJM confirm these positive findings, but also provide information about the impact of vaccination in a larger, more representative population of all trial participants, the UCSF co-authors say. The new data cover all participants regardless of prior HPV exposure and all pre-cancerous lesions, regardless of HPV type.

“These new studies provide a preliminary glimpse of what we might expect from vaccinating women up to age 26 who have already been sexually active, as is recommended by the Centers for Disease Control and Prevention,” Sawaya says.

The overall efficacy of the vaccine for reducing pre-cancerous cervical lesions from any HPV type was modest: over 3 years, 3.6 percent of vaccinated women received this diagnosis compared to 4.4 percent of unvaccinated women. Rates of the most severe lesions were not significantly reduced by vaccination, the co-authors say.

“There has been an understandably positive response to the promise of this vaccine, but we have to balance that promise with what is actually known,” says Smith-McCune, who has chosen not to vaccinate her own teenage daughters against HPV at this time.

“The issue here is not whether we want to protect women against cervical cancer, but the safety and efficacy of this specific vaccine,” Smith-McCune says. “One of the largest questions is whether targeting only two of at least 15 HPV types known to cause cervical cancer is enough to impact development of cervical pre-cancer and cancer.”

An estimated 9,700 American women were diagnosed with cervical cancer in 2006, according to the American Cancer Society. The vast majority of those cancers can be avoided with regular cervical cancer screening with the Pap test, the authors say.

“The Pap test is a proven and effective way to reduce cervical cancer risk, whereas we are just beginning to find out about the overall effectiveness and safety of the vaccine,” Smith-McCune says.

“So far, the HPV vaccine looks promising,” says Sawaya. “The diagnosis of a rare cancer usually related to HPV in one woman who received the vaccine, however, gives us pause and argues for a cautious approach until the current studies are completed and final outcomes reported.”

Both stressed that since screening is widely available, cervical cancer is not a public health emergency in this country.

“The rush toward mandatory vaccination is puzzling, but it is important to realize that the major studies are on-going,” Sawaya says. “As with any preventive measure, we need to be quite certain that the benefits of vaccination outweigh the harms before we embark on widespread vaccination programs.”

Both doctors urged women to continue to receive regular cervical cancer screening, regardless of whether they have received the vaccine.

UCSF is a leading university that advances health worldwide by conducting advanced biomedical research, educating graduate students in the life sciences and health professions, and providing complex patient care.

###

Additional information:

Part 1

First Appeared Wednesday, 20 September '06

UCSF Panel Discussion Airs Concerns, Hopes for New HPV Vaccines Part 1 of 2

http://pub.ucsf.edu/today/cache/news/200609198.html

Part 2

UCSF Panel Discussion Airs Concerns, Hopes for New HPV Vaccines Part 2 of 2

http://pub.ucsf.edu/today/cache/news/2006092010.html

http://pub.ucsf.edu/newsservices/releases/200705103/



Volume 356:1905-1908 May 10, 2007 Number 19
Next



Politics, Parents, and Prophylaxis — Mandating HPV Vaccination in the United States

R. Alta Charo, J.D.


Cancer prevention has fallen victim to the culture wars. Throughout the United States, state legislatures are scrambling to respond to the availability of Merck's human papillomavirus (HPV) vaccine, Gardasil, and to the likely introduction of GlaxoSmithKline's not-yet-approved HPV vaccine, Cervarix, which have been shown to be effective in preventing infection with HPV strains that cause about 70% of cases of cervical cancer. At the Centers for Disease Control and Prevention (CDC), the Advisory Committee on Immunization Practices (ACIP) has voted unanimously to recommend that girls 11 and 12 years of age receive the vaccine, and the CDC has added Gardasil to its Vaccines for Children Program, which provides free immunizations to impoverished or underserved children.

Yet despite this federal imprimatur, access to these vaccines has already become more a political than a public health question. Though the more important focus might be on the high cost of the vaccines — a cost that poses a genuine obstacle to patients, physicians, and insurers — concern has focused instead on a purported interference in family life and sexual mores. This concern has resulted in a variety of political efforts to forestall the creation of a mandated vaccination program. In Florida and Georgia, for example, efforts to increase adoption of the vaccine have been stalled by legislative maneuvering. The Democratic governor of New Mexico has announced that he will veto a bill that mandates vaccinations. And the Republican governor of Texas came under fire (and under legal attack from his own attorney general) when he issued an executive order to the same effect, mandating that all girls entering the sixth grade receive the vaccine; the policy was attacked as an intrusion on parental discretion and an invitation to teenage promiscuity. But all these measures included a parental right to opt out, whether on religious or secular grounds. The opposition seemed more about acknowledging the realities of teenage sexuality than about the privacy and autonomy of the nuclear family.

For more than a century, it has been settled law that states may require people to be vaccinated, and both federal and state court decisions have consistently upheld vaccination mandates for children, even to the extent of denying unvaccinated children access to the public schools. State requirements vary as to the range of communicable diseases but are often based on ACIP recommendations. School-based immunization requirements represent a key impetus for widespread vaccination of children and adolescents1 and are enforceable even when they allegedly conflict with personal or religious beliefs.2 In practice, however, these requirements usually feature exceptions that include individual medical, religious, and philosophical objections.



View larger version (30K):
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State Laws and Proposed Legislation Mandating HPV Vaccination.
All legislation mandating HPV vaccination includes some form of parental opt-out. The Texas mandate is the result of an executive order from the governor, and its legality is being challenged by the attorney general of Texas. There is also legislation under consideration in Texas that would prohibit a mandate. If passed, it would override the executive order. The Virginia law was passed by the legislature and signed by the governor. The New Mexico legislation was passed by the House and Senate and was then vetoed by the governor. Bills in California and Maryland have been withdrawn for consideration, and the bill in South Carolina has been tabled. Neither Alaska nor Hawaii has considered a mandate. Legislation that makes provisions for funding is under consideration in many states but is not shown here. The various bills would require insurance companies to cover vaccination, allocate state funds, direct agencies to apply for federal funds, or some combination. Information is from the National Conference of State Legislatures and is accurate as of April 27, 2007.




HPV-vaccination mandates, which are aimed more at protecting the vaccinee than at achieving herd immunity, have been attacked as an unwarranted intrusion on individual and parental rights. The constitutionality of vaccination mandates is premised on the reasonableness of the risk–benefit balance, the degree of intrusion on personal autonomy, and, most crucial, the presence of a public health necessity. On the one hand, to the extent that required HPV vaccination is an example of state paternalism rather than community protection, mandatory programs lose some of their justification. On the other hand, the parental option to refuse vaccination without interfering in the child's right to attend school alters this balance. Here the mandates act less as state imperatives and more as subtle tools to encourage vaccination. Whereas an opt-in program requires an affirmative effort by a parent, and thus misses many children whose parents forget to opt in, an opt-out approach increases vaccination rates among children whose parents have no real objection to the program while perfectly preserving parental autonomy.

Opposition to HPV vaccination represents another chapter in the history of resistance to vaccination and, on some levels, reflects a growing trend toward parental refusal of a variety of vaccines based on the (erroneous) perception that many vaccines are more risky than the diseases they prevent. In most cases, pediatricians have largely restricted themselves to educating and counseling objecting families, since it is rare that the risks posed by going unvaccinated are so substantial that refusal is tantamount to medical neglect. In the case of HPV vaccine, parents' beliefs that their children will remain abstinent (and therefore uninfected) until marriage render it even more difficult to make the case for mandating a medical form of prevention. Even with an opt-out program, critics may argue that the availability of a simple and safe alternative — that is, abstinence — undermines the argument for a state initiative that encourages vaccination through mandates coupled with an option for parental refusal.

But experience shows that abstinence-only approaches to sex education do not delay the age of sexual initiation, nor do they decrease the number of sexual encounters.3 According to the CDC, though only 13% of American girls are sexually experienced by 15 years of age, by 17 the proportion grows to 43%, and by 19 to 70%.4 School-based programs are crucial for reaching those at highest risk of contracting sexually transmitted diseases, and despite the relatively low rate of sexual activity before age 15, the programs need to begin with children as young as 12 years: the rates at which adolescents drop out of school begin to increase at 13 years of age,1 and younger dropouts have been shown to be especially likely to engage in earlier or riskier sexual activity.

Another fear among those who oppose mandatory HPV vaccination is that it will have a disinhibiting effect and thus encourage sexual activity among teens who might otherwise have remained abstinent. This outcome, however, seems quite unlikely. The threat of pregnancy or even AIDS is far more immediate than the threat of cancer, but sex education and distribution of condoms have not been shown to increase sexual activity. Indeed, according to a study conducted by researchers at the University of Pennsylvania, it is the comprehensive sex-education approaches that include contraceptive training that "delay initiation of sexual intercourse, reduce frequency of sex, reduce frequency of unprotected sex, and reduce the number of sexual partners."5 Opposition to the HPV-vaccination mandates, then, would seem to be based more on an inchoate concern: that to recognize the reality of teenage sexual activity is implicitly to endorse it.

Public health officials may have legitimate questions about the merits of HPV vaccine mandates, in light of the financial and logistic burdens these may impose on families and schools, and also may be uncertain about adverse-event rates in mass-scale programs. But given that the moral objections to requiring HPV vaccination are largely emotional, this source of resistance to mandates is difficult to justify. Since, without exception, the proposed laws permit parents to refuse to have their daughters vaccinated, the only valid objection is that parents must actively manifest such refusal. Such a slight burden on parents can hardly justify backing away from the most effective means of protecting a generation of women, and in particular, poor and disadvantaged women, from the scourge of cervical cancer. To lighten that burden even further, the governor of Virginia has proposed that refusals need not even be put in writing. Perhaps it is time for parents who object to HPV vaccinations to take a lesson from their children and heed the words of Nancy Reagan: Just say no.



Source Information

Professor Charo is a professor of law and bioethics at the University of Wisconsin, Madison.

An interview with Professor Charo can be heard at www.nejm.org.

References
http://content.nejm.org/cgi/content/full/356/19/1905


http://content.nejm.org/


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