Gardasil and pelvic familiarization

The HPV vaccine Gardasil

Gardasil Cervical Cancer Vaccine More Cost-Effective Than Cervarix

“(Research: Comparing bivalent and quadrivalent human papillomavirus vaccines: economic evaluation based on transmission model)

http://www.bmj.com/cgi/doi/10.1136/bmj.d5775
(Editorial: Comparing bivalent and quadrivalent HPV vaccines)
http://www.bmj.com/cgi/doi/10.1136/bmj.d5720

The quadrivalent cervical cancer vaccine (Gardasil) is more cost-effective than the bivalent vaccine (Cervarix) if the two are equally priced, concludes a study published on bmj.com today. This is despite the fact that Cervarix may provide better protection against cervical cancer.

However, the authors stress that considerable uncertainty remains about the differential benefit of the two vaccines.

Human papillomavirus (HPV) is a common sexually transmitted infection seen most often in young women and adolescents. There are more than 100 types of HPV - some cause genital warts, but others cause cancers including cervical cancer.

Two HPV vaccines (Cervarix and Gardasil) are currently available. Both protect against HPV types 16 and 18, which cause over 70% of cervical cancer cases, as well as several other types of cancer. Gardasil also protects against types 6 and 11, which cause the majority of genital warts as well as a rare disease called respiratory papillomatosis.

In 2008, the UK government chose the bivalent vaccine Cervarix for its HPV vaccination programme, based partly on analyses by Mark Jit and his colleagues at the Health Protection Agency suggesting that Cervarix would have to be £15 to £23 cheaper per dose to be as cost-effective as Gardasil. However, the choice of vaccine will be re-evaluated when the current tender for the vaccination programme ends.

Since then, further evidence has emerged to differentiate the two vaccines. For instance, Cervarix appears to give better protection against cervical cancer caused by HPV types other than 16 and 18. Gardasil has now also shown protection against vulvar, vaginal and anal cancer.

Using this latest evidence within a mathematical model, Mark Jit and his team set out to re-evaluate the two vaccines to inform the next round of vaccine tendering.

They found the price differential between the two vaccines was larger than their 2008 analysis. Based on the most recent evidence, Cervarix would have to be £19 to £35 cheaper per dose to be as cost-effective as Gardasil, mainly due to a lack of protection against genital warts.

When all differences between the two vaccines are considered, "the quadrivalent vaccine (Gardasil) is still more cost effective if the two are equally priced," conclude the authors. However, they stress that "considerable uncertainty remains about the differential benefit of the two vaccines."

An accompanying editorial says that modeling can help decision makers, but ultimately the tender price is the final determinant of cost-effectiveness.”

Personal comment: St Lucy’s was fortunate that we had good advice when we chose Gardasil as protection against cervical cancer as now it has been found to protect against genital warts as well as vulvar, vaginal and anal cancer. This year all new St Lucy’s students must have completed the series of three Gardasil injections over an interval of six months before they are allowed on campus for orientation. All our male partner/instructors have had the full Gardasil regimen as well to provide maximum protection to themselves and their student partners. Gardasil has recently become a topic of debate among candidates for the Republican nomination for the 2012 presidential election. The conservative candidate Michele Bachmann seems to be very poorly informed and continues to blunder on about mental retardation and the dangers of vaccines. Sigh!

New St Lucy’s entry requirements, Pt II: I was remiss when posting about changes to St Lucy’s entry requirements for the 2011/12 school year. I failed to mention that all entering students must have had at least four years of ballet training consisting of not less than four hours a week for at least fifty weeks per year. We aren’t a ballet academy, but the physical and mental development (poise, grace, discipline, confidence and pelvic muscle development) of the students is so closely tied to ballet training and discipline that any less and a student has a very difficult time keeping up. One might think that this requirement would dissuade parents from enrolling their daughters at St Lucy’s, but that hasn’t been the case as highly qualified applicants far outnumber the seats available for new students. Parents (especially their mothers) are determined to begin preparing their daughters years in advance to get into St Lucy’s.

Pelvic Familiarization for post-menarche students: Because the health syllabus at St Lucy’s is heavily weighted toward teaching female sexual skills we require all post-menarche students to take a pelvic familiarization (PF) course. This course covers menstruation, feminine hygiene products and their proper use, reproductive tract devices for contraception (IUDs, condoms and cervical barriers), dealing with the hymen and sex toys. The course purpose is not only to familiarize the student with the range of products and devices available, but to have her become comfortable and confident about touching her own genitals so she won’t be afraid or embarrassed when she takes Contemporary Sexual Health and Advanced Sexual Techniques. To that end we teach and recommend the students masturbate to learn what arouses them and what doesn’t so they can guide a male partner/instructor when that time arrives.

Students in this course usually range in age from 13 to 15 as all train heavily for ballet which often delays menarche. You would be surprised at the number of girls who have been brought up to think that touching themselves “down there” is dirty or shameful so PF has reduced the number of girls needing counseling due to psychological issues from becoming more intimately aware of their own bodies. We are very pleased with the PF student’s response to the classes on the clitoris, condoms, dildos and vibrators and all have delighted in their new found source of self-pleasuring with the toys provided each student for lab exercises.

Having pelvic familiarization taught in a gentle, non-threatening and supportive way our psychologists believe will result in very young students not suffering from stress related Vaginismus: http://en.wikipedia.org/wiki/Vaginismus a condition where any vaginal penetration – or sometimes in severe cases even the thought of penetration occurring - causes clenching of the pelvic muscles making any penetration extremely painful and so tight penetration is impossible for an erect male. There are physiological reasons – which we test for and if found prevent the student from entering St Lucy’s - as well as psychological reasons for Vaginismus. In the past we have had an occasional case of stress related vaginismus after a student has been accepted so our psychologists believe the PF course should prevent that from occurring

Pointes, pain, gas masks and Gardasil

The US Army M40 Gas Mask

Pointes, pain and eroticism: I was chatting with a friend this morning while I was doing pointe maintenance. He has a new master at work who requires him to do a lot of physical training and he was just back from a session that worked his arms until he could hardly use them for much other than keyboarding.

I was telling him about a ballet teacher in school who was like that. In her pointe classes she kept us on our toes forever until most of us were bleeding regardless of how well our toes were taped or what padding we used in our shoes. The good news was that those of us who survived Miss Willoughby’s classes were much better and stronger dancers and some few of us found we enjoyed the pain. I think pain caused by standing en pointe is erotic! Of course you have to come off pointe occasionally or your toes go numb and you lose sensation. Toes going numb can be a blessing if you are trying to get through a long and difficult piece of choreography w/o mistakes, especially toward the end where your leg muscles are burning. But if you are into pain for pleasure as I sometimes am (usually at the end of my cycle when I’m nearing my period) I find it's best to come off pointe every 8 to 10 minutes to keep the pain going during the entire sexual encounter, class or rehearsal where I’m using pain for pleasure or as a performance tool.

Men in gas masks: My friend is into gas masks and his fave is the M40 currently used by the US Army. [The M40 is pictured in the image accompanying this entry.] Most of my circle both men and women wear Mestel SGE 400 gas masks for fetish-sex so I’ve been penetrated by a lot of men in Mestel gas masks, but I’ve had sex with guys who were wearing Israeli or Russian masks they got from surplus stores or on-line and a few in the Czech M10 with cheek filters. The men say they enjoy wearing a gasmask for sex because it makes them look scary and conceals their identity while causing dread in their partner. I like guys in gas masks because it makes it harder for them to breathe when they are fucking me and I love to see the man sweat and the lenses of his mash fog up as he begins to thrust more urgently when he nears orgasm.

HPV Vaccines in Canada: “Gardasil, a vaccine against human papilloma virus (HPV), has been approved as a treatment to prevent genital warts in males aged nine to 26 in Canada, the vaccine's manufacturer said Tuesday.

Health Canada approved Gardasil to prevent infection caused by human papilloma virus Types six, 11, 16, and 18 and genital warts caused by HPV types six and 11.

HPV is the most common sexually transmitted infection in Canada, said Merck, the vaccine's manufacturer.

In 2006, Health Canada approved Gardasil to prevent cervical cancer and genital warts in females aged nine to 26. All provinces and territories now offer school-based programs using Gardasil, which works best if given to females before they become sexually active.

Two weeks ago, GlaxoSmithKline announced that Health Canada has approved its HPV vaccine, Cervarix, in girls and women. Cervarix protects against three other cancer-causing strains, HPV 31, 33 and 45.

In most people who develop genital warts, the infection clears up on its own. For some women, the infection persists and can lead to cervical cancer.

A study published last year in the Journal of the American Medical Association concluded that Gardasil in females has a safety record on par with other vaccines.

In January, researchers in Montreal published a study in the journal Sexually Transmitted Diseases showing 56 per cent of young people in a new sexual relationship were infected with at least one type of HPV.

The federal government announced in its March 2007 budget that $300 million over three years will be available to the provinces and territories in support of a national HPV vaccination program for girls and women.

It is up to provinces and territories to recommend vaccines for use within their jurisdiction. Doctors may also prescribe any approved vaccine.

An estimated 40,000 new cases of ano-genital warts are diagnosed each year in Canadian men and women”.

Gardasil in the news, again

Merck's Gardasil Has Higher Rates of Fainting, Clots

The Wall Street Journal - Health
AUGUST 18, 2009, 4:15 P.M. ET
By PETER LOFTUS

“Recipients of Merck & Co.'s Gardasil cervical-cancer vaccine had higher rates of fainting and blood clots than those receiving other vaccines, but it doesn't appear to raise the risk of certain severe adverse events, according to a new safety analysis.

A separate article accompanying the safety study, published Tuesday in the Journal of the American Medical Association, criticized Merck's marketing of Gardasil, including the company's funding of education campaigns by professional medical associations, which the authors said didn't provide a balanced view of the vaccine.

The two articles add to questions about the safety, effectiveness and marketing of Gardasil, which have dogged the vaccine since its 2006 introduction.

Doctors have questioned how effectively the vaccine prevents cervical cancer, given that its regulatory approval was for protecting against two strains of human papilloma virus, or HPV, that can cause cancer, but not all cancer-causing strains. Also, the vaccine was tested in only a few hundred 11- and 12-year-old girls, which some doctors said was too small a number to declare it safe for that age group. Critics assailed Merck's efforts to get states to require HPV vaccination, a push Merck backed away from in 2007.

Gardasil sales have stalled over the past year after brisk growth initially. U.S. Gardasil sales for the first six months of 2009 declined 34% to $363 million. Merck has had a particularly tough time persuading women ages 18 to 26 to get the shot--which costs nearly $400 for the full three-dose regimen.

The shot is designed to prevent infection by some types of HPV, a sexually transmitted virus that can cause cervical cancer, rarer forms of cancer and genital warts. Merck is seeking regulatory approval to market its use in males.

The U.S. health authorities who led the safety review say the vaccine is safe, despite the higher rates of fainting and blood clots they identified. The vaccine's benefits and potential to prevent cervical cancer outweigh the risks, said Barbara Slade, the study's lead author and a medical officer in the immunization safety office of the U.S. Centers for Disease Control and Prevention.

But others urge greater caution among doctors and patients in deciding on Gardasil vaccination. Cervical cancer takes decades to develop, and there are established methods for detecting and treating it, said Charlotte Haug, editor in chief of the Journal of the Norwegian Medical Association. Ms. Haug, who wrote an accompanying editorial in this week's JAMA, called Merck's marketing for Gardasil "pushy" and "disturbing."

Researchers at the CDC and U.S. Food and Drug Administration analyzed more than 12,400 reports of adverse events following Gardasil vaccination that were filed between June 2006 through December. During this time, more than 23 million doses of Gardasil were distributed in the U.S.

About 6% of the reported events resulted in hospitalization, permanent disability or death, Dr. Slade said. This was a smaller percentage than other vaccines, and the 32 deaths weren't higher than would be expected among the vaccine's target population--females ages nine to 26. Plus, nothing suggested that Gardasil caused the deaths, Dr. Slade said.

Of nearly 1,900 reports of fainting, 200 resulted in falls that caused head injuries including fractures and dental injuries. Anxiety and pain from the shot may be causing the fainting spells, Dr. Slade said. The study's authors recommended health-care professionals keep recipients in the office for about 15 minutes after vaccination to mitigate fainting.

Blood clots were less common, occurring 56 times, according to the study. They included four deaths due to pulmonary embolisms. But the authors say the clot data should be viewed with caution because 90% of those with clots had other risk factors, such as being smokers or using oral contraceptives.

Rick Haupt, program lead for HPV vaccines at Merck's research arm, said the study supports Merck's view that Gardasil has "high efficacy" and a "favorable safety profile."

In the marketing critique, researchers from Columbia University wrote that Merck's strategy maximized the threat of cervical cancer to adolescents, minimized the sexual transmission of HPV, and "practically ignored" the sub-populations most at risk, including African Americans in the South, Latinos along the Texas-Mexico border and whites in Appalachia.

Merck, of Whitehouse Station, N.J., funded professional medical associations to help spread the word about Gardasil, including groups of gynecologists and doctors working at colleges. These groups developed lecture programs and other educational materials that, according to the Columbia researchers, "did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on risks and benefits."

Spokespeople for the groups say their educational campaigns were developed with no oversight from Merck, and that the information used was consistent with recommendations by health authorities.

Merck said it provided about $750,000 to the three groups highlighted in the JAMA article to help improve understanding of HPV. Also, Mr. Haupt said, Merck's marketing focused on cervical cancer because two HPV types targeted by the vaccine are believed to cause about 70% of all cervical-cancer cases, and health authorities believe routine vaccination of adolescent girls will prevent many cases.”

Personal comment: There is no evidence in this research to suggest that Gardasil is more dangerous or less effective than the initial studies suggested. I think the most criticism is coming from religious conservative individuals or groups who are uncomfortable with anything that might protect women from the danger caused by some forms of HPV. Are there effective alternatives? In some cases there are, but not from genital warts if a partner is shedding cells. Do many women still die each year from cervical cancer? Yes, because they aren’t getting routine PAPs that will pick it up in time. Gardasil has a place as an effective vaccine for young women. As I’ve posted before all the students at St Lucy’s get the Gardasil vaccine as do all my female casino performers and escorts.