As in all new discoveries, there is much hype and euphoria over Gardasil, a vaccine that could prevent 70% of cervical cancer, caused by human papillomavirus (HPV). Gadasil also guards against the strains of HPV that cause 9 out of 10 cases of genital warts.

Nonetheless, being a new drug that has not been tested widely over time, there are questions over :

(1) the efficacy - the dosage to be administered, the period of immunity, requirement for booster shots?

(2) is it suitable or necessary for all women to be vaccinated?

(3) unknown long term side effects.

Effectiveness, Immunity

An MD from Mayo Clinic admitted that they don't even know if three doses of vaccines are necessary because it is still unknown what levels of antibody provide adequate protection against HPV.

Professor Tony Cunningham, a specialist in viral medicine and director of the Westmead Millenium Institute for Medical Research, says "we just don't know if the vaccine will work as well in women who may be exposed to multiple STIs, where a T cell response as well as an antibody response, is required." He says T cells are the second arm of the immune response, which attack virus-infected cells that penetrate the frontline immune response.

Side Effects
While clinical tests so far have shown the vaccine to be safe, it is still too early to state conclusively. The most common short term side effects are sore arm, itchiness, pain, fever and flu-like symptoms.

About one in 1,000 participants dropped out because of adverse side effects, according to Merck, the drug company. This was a rate greater than in the placebo group.

A more recent in January 2007 stated that over 500 people have complained of post-vaccination side effects such as fainting and dizziness, and there have been three recorded cases of the Guillain-Barré syndrome. According to health professionals, the syndrome is a rare disorder within the nervous system that sometimes causes complete paralysis. But it did not appear to convince or warrant additional tests or placing warnings on vaccine labels.

The long-term side effects are unknown. Most of the subjects for the vaccination programme are school girls in their teens and young women below 27. Birth defects, interaction with other drugs and other effects on overall health and wellbeing of the subjects will probably take many years to track to show conclusive results.

Limitations

The vaccine does not prevent all cervical cancers. It is still important for all women to keep up to date with regular Pap smears. Some have expressed concern over whether existing cervical cancer screening programs will suffer, if vaccinating against some HPV strains will lead to other strains "taking over".

Vested Interests

We are often at the mercy of drug companies who conducted the clinical trials. Would negative results be suppressed from the public for their self-serving interests?

"Merck, the company that makes Gardasil, has been criticized for the high cost of the product. The company has spent millions of dollars on advertising and donations to politicians with the authority to mandate these vaccines at the state level. These criticisms are especially salient because Merck did not fully disclose fatalities in a study of one of their most popular prescription drugs, Vioxx.19

With Gardasil, as is always the case with new medical products, the safety and risk information available to health professionals and patients is almost entirely dependent on the information reported by the company that makes the product."

Preventable
Is the vaccine desirable from the moral standpoint? Sexually transmitted diseases are preventable with appropriate education. Some American and Australian critics charging that the vaccine promotes promiscuity. It raises the question of how to convince parents that vaccinating their children against sexually transmitted infections (STIs) is a good idea.

As for all STI, a sound advice on prevention is to limit the number of sexual partners. Not smoking also helps to reduce the risk of cervical cancer

Alternatives

Is there any other HPV vaccine in the pipeline? GlaxoSmithKline's HPV vaccine, Cervarix, is in clinical trials. Cervarix targets the same two cancer-causing HPV types that Gardasil does, but it does not protect against the two types that cause genital warts.

Ponderings

Should parents consent or opt out of cervical cancer vaccination for their school going daughters? Perhaps it is worth serious contemplation instead of jumping on the bandwagon? It's your call.

Readings :
http://www.center4research.org/ibriefHPVvaccine.html
http://www.cbsnews.com/stories/2007/04/17/health/webmd/main2696886.shtml
http://www.mayoclinic.com/health/cervical-cancer-vaccine/WO00120
http://www.usatoday.com/news/health/2006-06-08-cancer-vaccine-qa_x.htm
www.health.gov.au/internet/standby/publishing.nsf/Content/young-women
www.school-vaccine.com/sideeffects.htm
http://www.usatoday.com/news/health/2006-06-08-cancer-vaccine-qa_x.htm
http://www.abc.net.au/science/news/health/HealthRepublish_1490302.htm

There's pressure to get both boys and girls to be vaccinated in view of the latest study on the link between HPV and oral cancer.
However, the vaccine is still new on the market.

http://oneworldtalk.freeforums.org/viewtopic.php?p=1671#1671

Little Egret has brought up the subject of vaccination against cervical cancer in another thread on early detection and home kits.

http://oneworldtalk.freeforums.org/mouth-rinse-to-detect-cancer-t724.html#3024

Please see the first post on this thread for the pros and cons of having gardasil vaccination.

From the doctor's perspective, gardasil is a breakthrough. Statistically, it could serve as a preventive measure against most likely causes of cervical cancer.
It is hailed as a wonder drug especially in more liberal societies.

However, from an individual's point of view, one should assess if it is needed and weight the side effects of the drug. If the female is not promiscuous, they would not consider gardasil. It is effective when taken at an early age but requires followup with booster shots. As noted in the research, gardasil only protects against two types of HPV. Routine screening is essential.

More information on vaccination against cervical cancer.

Little Egret, is there a programme for vaccinating school girls and if so, is this subsidized or paid by the government?

Timetable to beat a virus

Quote:

In secondary schools across Australia, teenage girls are wincing their way towards the front line of the battle against cancer. A new school year means a new round of vaccinations in a program that many researchers believe has the potential to wipe out cervical cancer within two generations. The vaccine targets four sub-types of the human papillomavirus (HPV), which is the most common sexually transmitted disease. Two of these sub-types are responsible for about 70 per cent of all cervical cancer. Girls in their first year of high school will get three jabs under a national immunisation program now in its second year. Until June next year, schoolgirls up to year 12 and women up to the age of 26 will also receive free immunisation under a catch-up program that began last April. Cervical cancer is the second most common cancer in women worldwide - after breast cancer - and is the leading cause of cancer-related death among women in developing nations, with an estimated half a million women diagnosed each year. "Eventually, we hope that this disease will be eliminated," says Professor Jim Bishop, chief executive of the Cancer Institute of NSW. "In places such as equatorial Africa, this is a major cancer in women. The vaccines may reduce the terrible situation with cervical cancer in the developing world where women present late and very often die. "There, [the situation with] cervical cancer is quite different [to] this country where it's now becoming a fairly minor cancer." Routine screening through Pap smears and early treatment of pre-cancerous lesions have significantly reduced the number of Australian women who die from cervical cancer. However, there are still about 800 new cases and 300 deaths each year, and screening and treatment are costly. Human papillomavirus is implicated in more than cervical cancer, however. There are many sub-types and early research suggests they may contribute to less common cancers, such as anal and penile cancers and some head and neck cancers. "The majority of people who are exposed to HPV don't get cervical cancer," Professor Bishop says. "There are usually no symptoms, apart from a few strains that cause genital warts, which are treatable." Studies of US college students have shown that within three years of becoming sexually active, about 50 per cent of students had contracted at least one strain of genital HPV. Infection rates in Australia are thought to be similar. Practising safe sex will have a big impact on HPV rates, says Professor Michael Quinn, the director of the Oncology and Dysplasia Unit at the Royal Women's Hospital in Melbourne. "These studies have also shown that if males continually use condoms, women will get the same level of protection against cervical cancer. There are so many HPV sub-types that safe sex is an important strategy, even if you have been vaccinated." Two vaccines are now commercially available, following research breakthroughs by Professor Ian Frazer, Australian of the Year in 2006. Gardasil protects against four sub-types, while Cervarix protects against two strains of HPV. Younger people usually acquire stronger immunity from vaccination than older people - and trials suggest that women over 26 may fare better with the less-complex Cervarix. At present, with the budget for the two-year program set about $530 million, only women under 26 are eligible for subsidised vaccines. However, the HPV vaccines have been approved for use in females aged between nine and 45 and for boys aged 10 to 15 years. "It's a cost issue," Professor Quinn says. "Vaccinating pre-adolescent girls maximises the chances of most of the population achieving immunity before HPV exposure." Without the subsidy, the necessary three doses of vaccine costs about $450, a price that some young women are happy to pay to lessen their risk of developing cervical cancer (see box). Professor Quinn says the vaccine would also benefit teenage boys and women up to the age of 45. "We hear anecdotally that the gay community has taken up this vaccine enthusiastically and that's terrific," he adds. The Department of Health and Ageing reports that 2.2 million doses of the Gardasil vaccine have already been issued, with protection promised for five years. Professor Quinn says it is too early to know if a booster shot will be required, but follow-up research to test immunity levels is already underway. xxxxxx

This story was found at: http://www.smh.com.au/articles/2008/03/06/1204779952297.html

It was a curious observation made by a doctor in Florence in 1842.

Quote:

He noticed that prostitutes and married women died of cervical cancer, but nuns almost never did. Though he might have discerned that it was sexually transmitted, he was thrown off by another fact: nuns often died of breast cancer. His conclusion was that nuns’ corsets were dangerously tight.

Approximately 70 % of cervical cancers are caused by HPV types 16 or 18.

HPV vaccine, GARDASIL, was first licensed by the US Food and Drug Administration in June 2006 and is recommended for use for vaccination among females aged 9 – 26 years in US.

According to the President of the Society for Colposcopy & Cervical Pathology of Singapore in his Letter of 7 March 2008 to the Society, the advent of the HPV vaccine has to be one of the greatest breakthroughs in cervical cancer research in recent years. There are 2 such vaccines* that are now available in Singapore, both backed by very extensive research in terms of efficacy and safety.

Although there was a ‘CervicalScreen Singapore’ campaign launched by the Health Promotion Board in August 2004, there is presently no programme to vaccinate school girls against HPV. Screening is optional and is currently available at all polyclinics in Singapore, which are subsidised by the state.

Quadrivalent HPV vaccines:
• GARDASIL produced by Merck Sharp & Dohme
• CERVARIX produced by GlaxoSmithKline

Some of the information has already been covered in earlier posts but there is a need to highlight them again together with other important information.

Background information :

http://www.mayoclinic.com/health/cervical-cancer/DS00167/DSECTION=3

http://www.mayoclinic.com/health/cancer-prevention/CA00024

HPV increases risk of cervical cancer. The more sexual partners, the more likely one will have HPV.

http://www.mayoclinic.com/health/cervical-cancer/DS00167/DSECTION=9

cervical cancer prevention :

In addition to using condoms, the best ways to prevent cervical cancer are to:
- Delay first intercourse
- Have fewer sexual partners
- Avoid smoking

Although the vaccine could prevent up to 70 percent of cervical cancer cases, it can't prevent infection with every virus that causes cervical cancer.
Routine Pap tests to screen for cervical cancer remain important.

HPV is found in nearly almost all cervical cancers but many women with HPV, a common virus do not develop cervical cancer.
Other factors such as genetic makeup, environment and lifestyle choices determine if one would develop cervical cancer.

Who really needs Gardasil?

http://www.renewamerica.us/columns/janak/070227

Did you know that 80% of cases of cervical cancer occur in low-income countries? That means that only 20% happen in the more developed countries like the US.

http://www.who.int/reproductive-health/publications/hpvvaccines/text.pdf

The average age of a woman with cervical cancer is 48. The effectiveness or dangers of this vaccine will not be known for at least a decade. Putting things in perspective : Cervical cancer results in just 3,700 deaths nationally every year compared to heart disease, which kills over 300,000 women annually.

http://www.wnd.com/news/article.asp?ARTICLE_ID=54219

Negative effects of Gardasil :

http://www.mayoclinic.com/health/vaccines/ID00016

Don't get this vaccine if you have ever had a life-threatening reaction to yeast or to the HPV vaccine, or you're pregnant or moderately to severely sick.

http://www.advancedhealthplan.com/TMIW_cancer_vaccination.html

Negative side effects of Gardasil are being reported in the District of Columbia and 20 states, including Virginia. The reactions range from loss of consciousness to seizures.

Merck is heavily promoting the vaccine through its salespeople imploring doctors to provide it and running TV ads urging young women to get vaccinated so there will be "One Less" cancer patient.

But physicians disagree with public health officials over whether Gardasil is the panacea for cancer. Clayton Young, an obstetrician/gynecologist in Texas, objects to Merck's claim that Gardasil will prevent cervical cancer.

"There is no proof Gardasil will stop cervical cancer," he said. "They haven't been studying it long enough to make that claim."

This is what the WHO had to say about corruption in the pharmaceutical market.
http://www.who.int/bulletin/volumes/84/2/news.pdf


a public interest group responsible for investigating and prosecuting government corruption. The organization released significant documents today, obtained from the U.S. Food and Drug Administration (FDA) under provisions of the Freedom of Information Act.
http://www.vaccinerx.com/news/cervical-cancer/gardasil-has-dangerous-side-effects-says-public-interest-group-20070525-293-26.html

The documents detailed 1,637 reports of negative reactions to Gardasil, a vaccination for human papillomavirus (HPV). Three deaths related to the vaccine were reported. One patient receiving the vaccine died of a blood clot only three hours later, and two other patients, girls ages 12 and 19, died of heart problems and/or blood clotting.

Of the 1637 negative reactions contained in the May 11th report, 371 were serious reactions. According to the Vaccine Adverse Event Reporting System (VAERS), out of 42 women who received the vaccine while pregnant, 18 of them – a shocking 42% - experienced serious side effects such as spontaneous abortion and fetal abnormalities.

Patients are warned of side effects such as pain, fever, nausea, dizziness and itching by the drug manufacturer, Merck & Co. These typical side effects account for 77% of the 1637 adverse reactions to Gardasil. But more serious side effects including paralysis, Bells Palsy, Guillain-Barre Syndrome, seizures, and blood clots are not mentioned, and account for the remaining instances of negative reactions to the drug.

Comments :

* The vaccination is not mandatory, if it is made so, they will draw vehement protests. It's up to invidivduals and parents to assess the relative costs and benefits.

* Speak to doctors, scientific and medical researchers, and they are divided over the necessity and benefits of vaccination against HPV.

A drug is generally considered "safe"if it has done extensive clinical trials and made available to public for 20 years. HPV vaccine are too new in the market.
We know why the pharmaceutical firms are actively promoting it and have not come clean on the negative effects.
What if one happens to fall in the small percentage of those who would have negative reactions and some may not show up immediately after years?

Is there such thing as a very safe New Drug?

We all know before a drug is put on the market by its manufacturer, it would have undergone extensive pilot trials on volunteers. In Singapore, such pilot trials are continuing all the time at major public hospitals and these are usually sponsored by the drug companies. But these pilot trials cannot continue forever. At some point in time, the new drug has to be introduced to the market and used on the patients in general. It can be said that the initial patients would be human ‘guinea pigs’, whether for a new drug, or for a new surgical procedure. Sometimes, such patients get the treatment free.

If doctors have to wait up to 20 years before a drug is considered absolutely safe to administer, patients wanting a cure by the drug may have died before they can have a taste of it. In the management of patients, there is no such thing as an absolutely safe drug or medical treatment. There will always be some side effects, the degree of which depends on an individual’s metabolic composition. One has to examine whether the benefits outweigh the risks involved for the patient taking the new drug. In almost all instances, the doctor who manages the patient would have explained the pros and cons of the drug to be used, especially if it is new and more powerful than the traditional one in use, and he would get the patient’s choice, or consent, before he proceeds. It is not only advisable, but imperative, for every patient to find out as much as possible from his doctor beforehand on the kind of risks involved when it comes to surgery, or any prolonged medical treatment.

Besides reading the literature on gardasil, that experts do not share a consensus on its usefulness, we need to ask medical experts, not just doctors but researchers. Go ahead and ask them point blank if they would recommend gardasil for their family members - spouse, siblings, children, nieces, cousins, aunts, best friends. You'll find that they are equally divided. If it's proven beyond doubt it is the only preventive measure and there are no harmful effects, there shouldn't be any reservations.

This article cited by "hot chilly" reaffirms previous discussions on pharmaceutical firms influencing results of some clinical tests of new drugs. It may be worthwhile to be patient and wait for more independent test results.

http://oneworldtalk.freeforums.org/pharmaceutical-companies-influencing-medical-publications-t1058.html#3323

72% of 1,000 Singapore women (aged between 17 and 50) polled in a HPV Awareness Survey have not heard of cervical cancer-causing HPV. 80% incorrectly pinned down the cancer’s cause to genetics and other factors such as a stressful lifestyle or smoking.

Global statistics show that 50% of sexually active men and women are likely to be infected with HPV at least once in their lifetime. Some infections clear up naturally. In Singapore, cervical cancer claims more than 100 lives each year. It is the second most common cancer, after breast cancer, among women in the Asia-Pacific region.

Cervical cancer is one of the most preventable cancers in the world, but most people do not know it.

Currently, two types of HPV vaccines are available: Cervarix (manufactured by GlaxoSmithKline, approval application submitted March 2007 to FDA, and approval received in May 2007 in Australia) is designed to prevent HPV types 16, 18, 31 and 45; Gardasil (manufactured by Merck & Co and approved by FDA in June 2006) is designed to prevent HPV types 16, 18, 6 and 11, the latter two types guard against genital warts.

Costing approximately S$600 and to be administered in three injections over six months, the vaccines will provide five years of full protection against two HPV strains that are responsible for 70% of cervical cancer cases. They are available at most hospitals, gynaecologist clinics and some GPs.

Though most effective for women between nine and 26, Assoc Prof Tay Sun Kuie, senior consultant at the Singapore General Hospital, recommends that women start taking the vaccine in their late-teens, preferably before their sexual debut for maximum protection.

Sources: Today, My Paper, Fri April 25, 2008

And in Malaysia, Consultant gynaecology oncologist Datuk Dr Abdul Aziz Yahya (past president of the Obstetrical and Gynaecological Society of Malaysia) says the primary prevention step for cervical cancer is vaccination. This should be followed by an annual Pap Smear test. "Having both the tests is the best way to tackle this disease. Women need to go for regular cervical cancer screening even if they have taken the vaccination," says Dr Aziz.

He says at the launch of Cervarix, a vaccine against cervical cancer for women between 10 and 45 years old, that the vaccine contains antigens for the human papillomavirus (HPV) strain Types 16 and 18 that are responsible for up to 70 per cent of all cervical cancer cases.


It is estimated that up to 80 per cent of women will have HPV infection in their lifetime and up to 50 per cent of those infections will be potentially cancer-causing. The risk begins as soon as they are sexually active. When a woman is infected with HPV, it usually takes from five to 10 years before it becomes cancerous.

http://health.asiaone.com/Health/Women%2527s%2BMatters/Cancer%2BCentre/Story/A1Story20080415-59920.html

In UK, many parents block cervical cancer jab.

Nearly three in ten parents failed to agree to their children receiving a new cervical cancer vaccine during a trial. Approximately 70% of 12 to 13-year-olds in the trial received the vaccine, with a small number of others missing the jab for other reasons. It covers 3,000 girls in 36 secondary schools in Greater Manchester. Doctors leading the project described the trial as encouraging

There had been concerns that parents would not give their consent to the jab because they felt it could encourage early sexual activity, or because it prevented a potential illness many years in the future, rather than addressing a present threat.

It is suggested that vaccinating most teenage girls could save hundreds of lives a year, although the benefits would not be seen until those receiving the vaccine enter middle age.

The government has announced that it will include the vaccine in the school immunisation programme from this September.

http://news.bbc.co.uk/2/hi/health/7365613.stm

Little Egret: Perhaps you can find some articles and data to relate to the incidence of cervical cancer in women with monogamous relationship.

However, in these days of easy lifestyles, sex for some is like a walk in the park.

And in the words of a Consultant gynaecology oncologist Datuk Dr Abdul Aziz Yahya (past president of the Obstetrical and Gynaecological Society of Malaysia):

Quote:

"The primary prevention step for cervical cancer is vaccination. This should be followed by an annual Pap Smear test. Having both the tests is the best way to tackle this disease. Women need to go for regular cervical cancer screening even if they have taken the vaccination."

More information is coming forth on the use of vaccine to to prevent cervical cancer which is caused by HPV that mainly attacks sexually active women.

Extracts of a report by a Health Correspondent, Straits Times. Thursday July 3, 2008:

Quote:

In Singapore, 200 women are hit every year and more than 80% of whom will die from the disease. Another 1,000 women discover the illnness before it becomes cancerous. The vaccine which has been available in Singapore since end 2006, protects against two common strains of HPV responsible for more than 70% cases of cervical cancer. It has to be given before a girl becomes sexually active. Another reason for girls and young women to get vaccinated is to protect the babies they may want to have later. As it is, former cervical cancer patients find it harder to conceive. But, when they do become pregnant, they are more likely than other women to suffer miscarriages or deliver their babies prematurely, warned a senior consultant at Singapore General Hospital and the Cancer Centre. The O&G Head at National University Hospital called the vaccine ‘an important breakthrough in cervical cancer prevention’. Another senior consultant at KK Women’s and Children’s Hospital noted that the chance to prevent a cancer through vaccination was rare. Cervical cancer is one of two cancers that can be fought off this way – the other, liver cancer, can be prevented by the vaccine for hepatitis B. However, the price of the vaccine might be a deterrent. Given in 3 injections over 6 months, it costs about S$600. Even with the vaccine, women still need to go for regular Pap smear tests, since the protection is not foolproof.

THE cervical cancer vaccine Gardasil is under fresh scrutiny after three women were struck down with p sudden inflammation of the pancreas soon after receiving the injection.

The Therapeutic Goods Administration (TGA) is investigating ...

http://www.smh.com.au/news/national/cancer-jab-linked-to-pancreas-disease/2008/08/16/1218307309515.html

Quote:

Writing in the Medical Journal Of Australia, surgery fellow Amitabha Das said the woman developed a fever, rash, severe pain and vomiting and was diagnosed with pancreatitis. After 10 days the symptoms settled and she was discharged from hospital and remains well. Dr Das and his colleagues said an extensive investigation could find no other cause for the pancreatitis and while a coincidental illness could not be ruled out, "neither can HPV vaccination be excluded as a potential cause". "We suggest that pancreatitis be considered in cases of abdominal pain following HPV vaccination," they wrote. ..... Acute pancreatitis is a sudden, debilitating attack of severe upper abdominal pain. Pancreatic enzymes irritate and burn the pancreas, and leak out into the abdominal cavity. Complications include respiratory, kidney or heart failure, all of which can be fatal. Rachel David, spokeswoman for Gardasil manufacturer CSL, said the firm remained confident the drug was safe and effective, but the reports of pancreatitis would be immediately investigated. .... The TGA has received 1013 reports of suspected adverse reactions to Gardasil, including soreness, swelling, redness or other reaction at the injection site (20percent), headaches (20percent), dizziness (15percent), nausea (16percent) and vomiting (6.9percent). It said the overall level of reporting for Gardasil, following the distribution of 3.7million doses in Australia, was very low and consistent with other new vaccines and rates reported from other countries. Meanwhile the federal program to cover the cost of three doses of the vaccine expires in June. The two-year program provided free Gardasil immunisation delivered by GPs for women aged 18-26 and girls 12-18 who missed out on the injections at school. Once the program ends, Gardasil will cost $150 a dose, or $450 overall, on a private script. The school-based program for girls aged 12-13 will continue but funding for older students will finish at the end of the year.