Merck's Gardasil cleared - now you can inject your 9 year old girl against an STD

Whilst the role of the Human Papilloma Virus (HPV) in 99% of cervical cancer cases has only become apparent in the last ten years, action has been swift to provide some protection as it's the second most common cancer among women, with more than 270,000 deaths reported each year worldwide.

In the U.S., deaths from cervical cancer are relatively low, but the costs of screening for the HPV virus and treating infections and cervical cancer add up to $6 billion a year. ( A UK / NHS test costs US $ 80) An estimated 80% of deaths from cervical cancer occur in the developing world, where pap tests and cancer screening are rare and hugely expensive.

HPV has many variants only some of which are connected with cervical cancer - the virus is sexually transmitted (between female / female as well) and exposure increases with number of partners and activity.

The Food and Drug Administration (FDA) yesterday approved Merck's (MRK:NYSE) Gardasil, the first vaccine against a virus that causes cervical cancer and genital warts.Merck licenses the Gardasil technology from CSL Ltd. of Australia. The vaccine was approved in Mexico last week. Merck has filed applications in five continents, including the large European Union market as well as Australia, Argentina and Brazil. The company is also trying to expand Gardasil's availability to developing countries.

The agency gave the product broad approval Thursday, saying that the vaccine is appropriate for treating girls as young as 9 years old and women as old as 26.

The vaccine is approved for two types of HPV, that Merck says accounts for 70% of cervical cancers. The vaccine also prevents two types of HPV that account for 90% of genital warts.

Rivals GlaxoSmithKline (GSK:NYSE) , which is developing the HPV vaccine called Cervarix. GlaxoSmithKline expects to file an application with the FDA by the end of the year. This does not target the strains that cause genital warts.

"Use of Gardasil can help significantly reduce the human and economic burden of cervical cancer, precancerous or low-grade lesions and genital warts," said Dr. Kevin Ault, associate professor in the department of gynecology and obstetrics at Atlanta's Emory University School of Medicine, in a press release issued by Merck. Ault was the clinical study investigator for Gardasil.

The vaccine is now available for ordering. The Gardasil regimen requires three injections over six months. Merck is charging $120 per dose. The company has created a new program in which it will provide free vaccines to adults who are uninsured and can't afford vaccines. Merck vaccines, including Gardasil, will be covered by this program in the Q3 2006r.

The FDA notes that Merck will conduct additional studies, including those to further evaluate Gardasil's safety and long-term effectiveness. Merck will monitor women who receive Gardasil while unknowingly pregnant, and the company also is studying whether Gardasil is safe and effective for treating genital warts in males.

The FDA says human papillomavirus is the most common sexually transmitted infection in the U.S. The Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with genital HPV each year and that more than half of all sexually active men and women become infected at some time in their lives.

On average, there are 9,710 new cases of cervical cancer and 3,700 cervical-cancer deaths each year in the U.S. Worldwide, cervical cancer is the second most common cancer in women, with an estimated yearly toll of 470,000 new cases and 233,000 deaths.

The FDA bluntly points out that the vaccine is only effective when given prior to infection. However, Merck says that if Gardasil is given to a woman infected with one type of HPV targeted by the vaccine, she still could be protected from the three other types covered by the vaccine.

Because Gardasil doesn't protect against less common types of HPV, the FDA says routine and regular pap tests "remain critically important to detect precancerous changes in the cervix to allow treatment before cervical cancer develops."

The Bill & Melinda Gates Foundation, endowed by Microsoft (MSFT ) founder Bill Gates, has earmarked $50 million for the prevention of cervical cancer. "But it remains to be seen whether the developing world will be willing to invest in a vaccine where the reduction in cancer will not be seen for many years because of the long interval between infection and development of the cancer," says Dr. Douglas R. Lowy. He headed the research team at the National Institutes of Health in Bethesda, Md., whose original discovery is the basis of both the Merck and GSK vaccines.

A lot rides on the success of these vaccines - GSK has lost two of its best-selling drugs, antidepressants Paxil and Wellbutrin, to generic competition, and it will be at least 2 years before any of its most promising new medicines hit the market. Merck, which has had several drugs fail in clinical trials, is desperate for good news after it pulled its blockbuster painkiller Vioxx from the market in September because of a link to heart attacks and stroke.

Moral hurdles

Despite the obvious benefits, the vaccines will not be an easy sell: There are social and moral hurdles to overcome. "The biggest problem for companies will be convincing society of the need to vaccinate young girls against what is essentially a sexually transmitted disease," says Dr. Anne Szarewski, a clinical consultant at Cancer Research UK, which is conducting phase iii trials of Cervarix at Margaret Pyke Centre in London. Who claim on their website to be one of the biggest contraceptive centres in the world seeing between 600 and 900 patients per week. Their research team, is part of the Academic Department of Obstetrics & Gynaecology, University College London,

"Mom, do you really want to vaccinate your nine year old against Sexually Transmitted Disease"?

"Mom ? Why do I need these shots ?"

Gardasil HPV Cervical cancer vaccine - adverse reactions and 3 recorded deaths in US

Judicial Watch, The US public interest group Judicial Watch released documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing 1,637 reports of adverse reactions to the recently introduced vaccination for human papillomavirus (HPV), Gardasil developed by CSL Ltd of Australia and marketed under licence by Merck (MRK:NYSE). Merck is reported to have acheived sales of US$365 million for Gardasil in Q1 / 2007 - in the US a course of three shots, costs approxiamtely US$120 a dose.. Judicial Watch filed its request on May 9, 2007, and received the adverse event reports from the FDA on May 15, 2007.

3 deaths were related to the vaccine.

1. A physician’s assistant reported that a female patient “died of a blood clot three hours after rceiving the Gardasil vaccine.”

2. Two other reports, on girls 12 and 19, reported deaths relating to heart problems and/or blood clotting.

Of the 1,637 adverse vaccination reactions reported to the FDA via the Vaccine Adverse Event Reporting System (VAERS) by May 11th there were 371 serious reactions.

Of the 42 women who receiving the vaccine whilst pregnant, 18 of them experienced side effects ranging from spontaneous abortion to fetal abnormities.

Manufacturers Merck & Co. warn the public about potential pain, fever, nausea, dizziness and itching after receiving the vaccine. These are not uncommon side effects to receiving vaccines, more serious side effects reported include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures.

Judicial Watch President Tom Fitton is reported to view the matter with deep concedern and is quoted as saying ...“The FDA adverse event reports on the HPV vaccine read like a catalog of horrors,” ..... “Any state or local government now beset by Merck’s lobbying campaigns to mandate this HPV vaccine for young girls ought to take a look at these adverse health reports. It looks as if an unproven vaccine with dangerous side effects is being pushed as a miracle drug.”

About 10,000 women were diagnosed with cervical cancer in the U.S. in 2006 and nearly 4,000 died from the disease, according to the American Cancer Society. Bloomberg reported on 30/5/07 that GlaxoSmithKline Plc's competing product, Cervarix cervical cancer vaccine won't get priority review from U.S. regulators - a priority reviews may be given to products that serve an unmet need or represent significant improvements over currently available therapies. Glaxo is also awaiting a decision from the European Medicines Agency on the application it filed for Cervarix in Europe in March 2006. Financial analysts who are interested in the field (well money anyway) claim that Glaxo could be looking at the potential to generate US$1.5 billion a year by 2010 rising to US$5 billion.

Lord Patel has posted previously about the development, approval and the intense marketing of the vaccine, in what appears indecent haste, especially in schools - see especially the controversial Women in Government (WIG) campaign in Texas.

Anyone contemplating a course wuld be well advised to consult their doctor and the following two reports......

Click here for the Gardasil Related Deaths Reported to VAERS / May 11, 2007

Click here for the Vaccine Adverse Event Reporting System (VAERS) Reports / May 11, 2007

UPDATE

Meanwhile - literally hot off the Press .......

The Lancet (subscription only but Summary on Lord Patel's registration here) has published results today show that Merck’s cervical cancer vaccine, GARDASIL [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] was 100 % effective in preventing high-grade vulvar and vaginal dysplasias caused by HPV types 16 and 18, 2 types that are strongly associated with these diseases.

The 100 % protection was observed in women who were not infected with HPV types targeted by the vaccine -- 6, 11, 16 and 18 -- at the start of the study and through one month after receiving the third dose. Data published in The Lancet represent an additional year of follow up since data were presented to the U.S. Food and Drug Administration (FDA) for approval of GARDASIL.

All three studies were double-blind, placebo-controlled randomized studies and were conducted at 157 sites in 24 countries. More than 18,000 women participated in three trials and were between the ages of 16 to 26 at the time of enrolment. They received three doses of either GARDASIL or placebo at day one, month two and month six. The combined analysis evaluated the impact of GARDASIL on the incidence of high-grade vulvar and vaginal pre-cancers (VIN 2/3 and VaIN 2/3), common precursors to vulvar and vaginal cancers in younger women, caused by HPV types 16 and 18.

In the per-protocol population of this combined analysis, GARDASIL was 100 percent effective in preventing HPV 16- and 18-related VIN 2/3 and VaIN 2/3 in women who were not exposed to the relevant HPV types until at least one month after completing the vaccination series; no cases were observed in the vaccine group (n=7,811) compared to 15 cases in the placebo group (n=7,785).

In clinical studies for GARDASIL, vaccine-related adverse experiences that were observed at a frequency of at least 1.0 percent among recipients of GARDASIL and also greater than those observed among recipients of placebo, respectively, were pain (83.9 percent vs. 75.4 percent), swelling (25.4 percent vs. 15.8 percent), erythema (24.6 percent vs. 18.4 percent), fever (10.3 percent vs. 8.6 percent), nausea (4.2 percent vs. 4.1 percent), pruritis (3.1 percent vs. 2.8 percent) and dizziness (2.8 percent vs. 2.6 percent). Presumably, in absence of report no deaths recorded.

This is an interesting website which is opposed to Gardasil vaccination in Europe. It appears to be called LancetRecommendsCompulsoryVaccinationsForChildren - which refers to a Lancet editorial October 2006 which said Europe should take its lead from the US state of Michigan, which passed a bill on September 21 ruling that all 11 to 12-year-old sixth grade schoolgirls should be vaccinated.

PS : It may be said of course that vaccinating females does not preclude males passing the virus about, so there is a good argument, endorsed naturally by Merck and Glaxo that mlaes should be vaccinated as well.

Ther are a large number of blogs reporting / discussing the Lancet report Google Blogsearch

Gardasil® gets 7,802 adverse reports to CDC by VAERS system

On June 8, 2006, the FDA licensed Gardasil®, the first vaccine developed to prevent cervical cancer caused by certain kinds of human papillomavirus (HPV) and was licensed for use in the United States by the FDA on June 8, 2006

More than 12 million doses of the 3 stage vaccine have been distributed, 2,151,000 in 2006 and a further 1,317,902 by the end of 2007. AS there is no national registry the number of people vaccinated is unknown.

Initial tests, only performed on females were undertaken on 11,00 people between 9 and 26 worldwide and found the most common side effect was injection site pain. While Gardasil was being tested in the U.S. before it was licensed, 10 people in the group that received the HPV vaccine and 7 people in the placebo group died during the trials. None of the deaths was considered vaccine-related.

The US national Vaccine Adverse Event Reporting (VAERS) system has received 7,802 reports after Gardasil vaccination in the U.S. (June 8, 2006 through April 30, 2008) Less than 7% reported serious side effects, about half of the average for vaccines overall.

An adverse event by the Code of Federal Regulations as adverse events involving hospitalization, death, permanent disability, and life-threatening illness.

VAERS received 15 reports of death following Gardasil vaccination in the U.S and only 10 reports contained the level of information adequate for further analysis none could establish the causal relationship between vaccination and death. The details of the other 5 reports of death were insufficient to make any judgement.

Guillain-Barré Syndrome (GBS)

Note: GBS cases take longer to verify because each case must be confirmed manually by CISA staff after reviewing the patient's medical record.

VAERS received 31 reports of Guillain-Barré Syndrome (GBS) after Gardasil vaccination in the U.S. Ten have been confirmed. Of the 10 confirmed GBS cases, 5 reported vaccination with Menactra ( A meningococcal vaccine) and Gardasil at the same time. Of the remaining 21 reports, 7 did not meet the case definition for GBS (when evaluated by the Clinical Immunization Safety Assessment (CISA) group), 1 had symptoms of GBS prior to vaccination, 4 are unconfirmed reports, and 9 are pending additional follow-up.

Because GBS occurs at a rate of 1 to 2 per 100,000 person-years during the second decade of life, it is likely that some cases occur after vaccination by chance alone and are not caused by vaccination. Among 9 to 26 year-olds, the number of reports of GBS received by VAERS are within the range that could be expected to occur by chance alone after a vaccination. Studies are underway to evaluate the risk of GBS that may be associated with receipt of Menactra vaccine.

Merck shares (MRK:NYSE) dropped nearly US$2 (5%) but recovered slightly today to close at US$36.60 as analysyst and TV companies digested the news. FOX CBS WKBW CBC

Canada

Health Canada approved Gardasil® on July 18, 2006. Since then, all 10 provinces have started or said they would be starting vaccination programs. Nova Scotia were the first province offering vaccinations to girls in Grade 7 from JUne 2007.

As of Jan. 8, 2008, the Public Health Agency of Canada had received a total of 145 reports of adverse events following vaccination with Gardasil®, none of which were of death or Guillain-Barré syndrome, according to the agency.

Texas schoolgirls to get Merck Gardasil HPV vaccine -1 Down, 49 States to go in WIG campaign,

A slew of Google searches from the US have found Lord Patel's posting of Friday, June 9 2006 Merck's Gardasil cleared - now you can inject your 9 year old girl against an STD

When the Food and Drug Administration (FDA) approved Merck's (MRK:NYSE) Gardasil, the first vaccine against 2 strains (HPV 16/18) of the Human Papilloma Virus (HPV) that causes cervical cancer and genital warts. Merck licenses the Gardasil technology from CSL Ltd. of Australia. Invented by Australian Ian Frazer,it was first licensed there and costs around AU$460 (US$348) for a full three-dose course. GlaxoSmithKline are hoping for approval this year of their competitive product CERVARIX™ which they claim provides higher levels of immune response in trials to date.

In August 2006 a committee of the European Medicines Agency (EMEA) has recommended that Gardasil be fully licensed and was quickly approved for sale within Europe from October. European authorities recommend that treatment be extended to boys as well as young girls and the UK Gubment are said to be looking at introducing a nationwide vaccination program for schoolchildren.

Around 80% of sexually active women can expect to receive an HPV infection at some stage in their life. Cervical cancer, which is caused by only some of the the strains of the HPV virus, kills an estimated 1,100 women in the UK every year - which has been stable for many years and appears irreduceable. The 1.5 Mn cervical smears that are undertaken throughout the UK each years cost approximately £40 each.

This interest in Lord Patel's previous post must reflect the common sense decision of the Governor of Texas, Rick Perry to issue a Directive Order to ordered the Texas Health and Human Services Commission to adopt rules requiring Merck & Co.'s new Gardasil vaccine for girls entering the sixth grade as of September 2008. He also also directed state health authorities to make the vaccine available free to girls ages 9 to 18 who are uninsured or whose insurance does not cover vaccines. Parents can elect to have their children void the vaccinaion by filing an affidavit outlining their religious or philosophical objections. He also ordered Medicaid to offer Gardasil to women ages 19 to 21 , making the Lone Star the first US State to introduce such measures.

This Order follows a Bill filed by 2 Democrats late last yera with the same objectives.

Texas State Senator Jane Nelson, chairwoman of the health and human services committee considered this was hasty and asked for more consultation. See pic of the lady - whose health would be improved by 3 litle words "Calorie Controlled Diet". Neither will she be enjoying "weekend long" stays at the Austin Gubernatorial Mansion like Condi used to do when Dubya graced the Mansion.

Republican Lt. Gov. David Dewhurst wasn't too happy about the Governer's groundbreaking health measures either

'I don't think the government should ever presume to know better than the parents what to do with children.'

Governor Perry, counts on support from the conservative Christian right , he opposes abortion and stem cell research using embryonic cells and claims cervical cancer vaccine is no different from the one that protects children against polio.

"Providing the HPV vaccine doesn't promote sexual promiscuity any more than providing the Hepatitis B vaccine promotes drug use," he said in a Monday statement. "If the medical community developed a vaccine for lung cancer, would the same critics oppose it claiming it would encourage smoking?"

Such enlightened thinking by Gov. Perry fails to square with the odd fact that the largest State legislates to prevent the sale of sex toys. Joanne Webb a company consultant for "Passion Parties" in Clebane, 50 miles from Dallas, TX was charged in 2004 with a misdemeanor for hawking her battery-operated handjob helpers (she sold a vibrator to undercover narcotics officers posing as a dysfunctional married couple in search of a sex aid) — although the case (possibly as a result of an attempt to get her company membersof the local Chamber of Commerce) was eventually dismissed.... which probably tells you more about the narcotics officers than the state of morals in Texas.

Maybe the Governor's move shows that they are all too aware that the HPV virus can be transmitted orally, between female sex partners and also (uuuggghhhhh!!!) by sharing sex toys.

One thing is for certain, it's good news for Merck and their shareholders.... and the teenagers of rural Texicana.... who won't need much encouragement anyway.

Governor Perry has however (Surprise...surprise!!) very close ties to Merck, having received US$6,000 from them for his re-election campaign .

"He also has ties to Women in Government, (WIG) a Merck-funded (see footnote) advocacy group made up of female state legislators around the country (click here for website as banner here) . Their website says this is a "bipartisan initiative (that) mobilizes state legislators to address cervical cancer prevention in their states" . His current chief of staff's mother-in-law, Texas Republican state Rep. Dianne White Delisi, is a state director for the group," and past Chairman other State Directors are Rep Ruth McClendon, Rep. Alma Allen, and Sen. Senfronia Thompson. Dianne White Delisis is also Chairman of the Committee on Public Health and member of the Committee on Public Education.

Rep. Alma Allen (TX) and Sen. Senfronia Thompson (17 terms and chairs the Texas Legislative Black Caucus )(TX)are also on the Membership Roster of WIG.


5 term Ruth McClendon is a strong Christian and is committed to childen's health and welfare and lays claim to fact that The University of Texas Health Science Center - San Antonio has a new $200 million children's cancer center due to funding pushed the legislative process with her help. McClendon created a law that designates August 26^th as Women's Independence Day in Texas to increase public awareness and serve as a reminder of the struggle both men and women endured to gain the right to vote. August 26^th is the day the 19^th Amendment granting women the right to vote was ratified in 1920. It's a fair bet Dubya would have invited her over to discus Democracy and the woman's ...er ...vote.

"WIG is national 501(c)(3), non-profit, bi-partisan organization of women state legislators providing leadership opportunities, networking, expert forums, and educational resources to address and resolve complex public policy issues.WIG also campaigns for Chronic Kidney Disease

Perry's former chief of staff Mike Toomey is one of the three Merck lobbyists in the State on their payroll.

Over 75 commercial subscribers and sponsors are listed without details of financial help and cover many pharma companies, Novartis, Novo Nordisk, Pfizer, Roche, Lilly, Schering Plough, Solvay, Glaxo Smith Kline, Wyeth, Bristol Myers Squibb, Astra Zeneca, and Bayer, the largest Pharmacy Dispensary service in the US, CVS as well Mc Donald's, Proctor and Gamble, Exxon, Entergy and Duke Energy.

A Business Council has representatives on from Digene ,Exxon ,GlaxoSmithKline , Verizon Communications,Wellpoint, Inc.

This HPV/Gardasil/ Cervical cancer campaign is one to watch - as well as the Merck share price.

Merck herpes zosta vaccines have a production hiccup - HMP Gardasil vaccine is delayed for use in older women.

When we posted on Wednesday, May 31, 2006 about Merck Zostavax shingles vaccine could be a US$1 Bn. seller we were more concerned about finding a happy home for investment funds.

Big Pharma rides on blockbuster drugs that a (relatively) few people need to take forever, statins, anti - diabetic drugs,retrovirals or medication that is used on enormous populations eg vaccines. Zostavax seemed a likely candidate and so it has proved .

When we wrote about "an important tool that can help prevent an illness that affects many older Americans and often results in significant chronic pain" we didn't then , but do now know what it means.

If you are over 60 or you have family who are give this serious consideration and see your doctor. Shingles is fucking painful... and it lasts. BTW shingles is not a one off, it can re-occur.

The bad news is that Merck are having production problems. They make a product called bulk varicella which goes into both Zostavax (annual sales approx US$230 Mn.) and a chicken pox vaccine for children Varivax both of which afford protection from the herpes zosta virus.

Difficulties with less potent batches have resulted in production delays as manufacturing changes require approval before vaccine production recommences so they have given priority to Varivax after a national program since 2006 suggested a second dose for children which doubled sales to a robust US$855 Mn. out of total vaccine sales last year of approximately US$3 Bn.

Merck have also hit problems with their preparation for protection for Human Papilloma Virus, the cause of most cervical cancers. Whilst the Merck vaccine Gardasil has approval from the FDA for the age range from 9-26 they have not yet approved extending use to the 27-45 age range. Merck said it also failed to win FDA approval to expand Gardasil to protect against more strains of the Human Papilloma Virus that causes cervical cancer (currently acts against types 6, 11, 16, 18) . The company for now is dropping plans to pursue that expansion. There is also a potential to expand usage into males who can transmit the virus to their partners.

In the US Gardasil typically costs US$120 per dose, which means it costs US$400 to US$500 for the three-shot series plus physicians' charges. (Net Doctor details for use in UK)

Global sales of Gardasil rose 7 percent in the first quarter to $390 million. Cowen and Co has predicted annual sales of the vaccine would reach $1.9 billion in 2008 and jump to $3 billion by 2012.

Merck shares have fallen 37 % this year, principally due to setbacks to its cholesterol franchise and delays on introducing a new drug.


***** Zostavox vaccine is not currently available in the UK. A frozen formulation of the vaccine was granted a marketing authorisation (MA) in the EU in May 2006 for the prevention of shingles in individuals aged 60 years or older; a variation to the MA has been filed with the European Medicines Agency for a refrigerated formulation, but a final decision on approval has not yet been made. Zostavax is the first and only vaccine registered in Europe for this indication.

PS : Monday : An enquiry at a pharmacy today produced this response "Yes we do provide Zostavax although the product is currently on a manufactures backorder, with no release date, and we are now out of stock."

Vaccination of schoolgirls for HPV using Cervarix ® should be stopped. NOW

The fevered and prurient interest by educators in the sex lives of school girls takes a curious turn when they return to school next month.

With little or no discussion it has been decided to commence mass vaccination of all 12 and 13-year-old girls at all schools in the UK. This will start with the first of 3 doses of a vaccine that will reduce the chances of harbouring a sexually transmitted human papilloma virus which is now known to be proven agent of causing cervical cancer.

70% (ish) of all HPV viruses so transmitted can cause cervical cancers - a lethal (if undiscovered by regular smear examinations) and terrifying illness. This claims about 100 lives in Scotland every year - the average age at death being about 60.

In Scotland the Catholic Church originally raised objections to the vaccination programme - "jab" in tabloid speak) because it may encourage promiscuity. Church elders in SCotland have now performed a screeching U turn after twistin gthe arms of reaching an agreement with health and education staff.

Now girls, when vaccinated will receive no accompanying advice on the need to use condoms to protect themselves from other sexually transmitted diseases. More than half of the 5,000 female chlamydia patients in Scotland last year were under the age of 20.

The programme is due to start next month and schools are set to send out consent forms for the scheme from the beginning of September.

One wonders if the girls (and possibly even their parents) will be advised that another vacccine ,Gardasil (but sold by an American drug company) also provides protection from genital warts - it is marginally more expensive than the British Cervarix® product marketed by GSK.

One also wonders if the Roman Catholic elders have approved further advice for girls and their parents that HPV is transmissable during oral sex (however configured) , between women, by the use of sex toys and anal sex.

This wholesale experiment using a new vaccine (see Friday, March 14, 2008 GSK's claim cervarix HPV vaccine affords long-term protection against fourmain HPV types ) which has not tested (unlike Gardasil see Tuesday, July 08, 2008 Gardasil® gets 7,802 adverse reports to CDC by VAERS system ) on large populations is being forced onto girls (boys who contract the viruses and pass it on are not to be vaccinated) and their parents with litle informed discussion. Monday, July 21, 2008 NHS decide on vaccine from UK based GSK - Cervarix® for teenage girls for cervical cancer causing HPV virus - genital warts ignored - none for boys

Cervical smear testing will continue. Because of medical ethics, if testing discovers the presence of Sexually Transmitted Infections (STI's) this information will not be recorded, or passed on by the laboratory to the doctor or the patient.

This experiment (it is nothing else) is costly, unnecessary, it is for an illness that affects a diminishing number of women - due to the success of the decades of pap smear testing. Like any vaccination programme it will have side effects, some of them devastating and even fatal.

This insane programme should be stopped. NOW.

Lord Patel has been following this pharmaceutical bononaza for some time - Friday, June 09, 2006 Merck's Gardasil cleared - now you can inject your 9 year old girl against an STD For previous posts about HPV vaccines go here.

If you have children (or grandchildren) who will be affected by this policy you should consult your GP immediately.

UPDATE Sunday 7th September 2008 - Apparently pupils will NOT need parental signed consent. They are deemed old enough to make informed consent alone.

NHS decide on vaccine from UK based GSK - Cervarix® for teenage girls for cervical cancer causing HPV virus - genital warts ignored - none for boys

An editorial published in the BMJ on Friday ,claims (the editorial is by Jane J Kim, assistant professor of health decision science Program in Health Decision Science, Department of Health Policy and Management, Harvard School of Public Health, Boston, MA 02115, USA) that the UK government may save 18.6 million pounds ($37 million) annually as a result of its decision to select GlaxoSmithKline's ( a UK based pharma company) cervical cancer vaccine Cervarix for its human papillomavirus immunisation programme rather than Merck & Co.'s (a US basd pharma company) and Sanofi-Aventis' ( a Paris, France based company) Gardasil. (Search this site on "Gardasil" for post on the subject)

This decision is based on a study Economic evaluation of human papillomavirus vaccination in the United Kingdom by Mark Jit, Yoon Hong Choi, and W John Edmunds, Modelling and Economics Unit, Centre for Infections, Health Protection Agency, London NW9 6BT

The model involves 34 variables (Table 1) about which assumptions are made as rationally as possible on the available evidence (We then generated parameter values for cost and utility weights by Monte Carlo sampling (using the Latin hypercube method) from the joint distribution of plausible ranges of values for each parameter - which sounds impresive but is in reality a sort of re-inforced guess, as so litle actual evidence of use is currently available). To make a detailed evaluation of the methodolgy and the evidence supporting the assumptions is skilled and complicated task. Such modelling can easily be "tweaked" ... "We constructed a total of 2700 possible scenarios " . A stricture used is that users of such Monte Carlo simulations rely entirely on the initial subjective estimates and almost never follow up with empirical observation.i.e they place over reliance on the model.. which they have to because no more empirical evidence is available currently.

Faced with a need to make a decsion within a timeframe these limitations must be accepted - however we have the luxury of time, a delay in decsion making makes the position no worse and affords time to refine procedures, undertake critical analysis and consult other viewpoints.

"Only the 72% of model structures that best fit prevalence data for human papillomavirus were used in the analysis, but care should be taken when interpreting model results not to assume that each of the remaining model structures is equally plausible. etc., etc., caveat, caveat ...."

"Although we have included the estimated impact of screening in the model and tried to account for the accuracy of screening in our results, some of the details of the programme (such as rescreening women more often after a suspect result) are difficult to properly implement in the current model structure."

The conclusion arrived at was that Vaccinating 12 year old schoolgirls with a quadrivalent (protection against 4 known HPV virus' 2 of which cause genital warts) vaccine at 80% coverage is likely to be cost effective at a willingness to pay threshold of £30 000 ( Euros 37 700; $59 163) per QALY gained (quality adjusted life years (QALYs), discounted costs and benefits at 3.5% per year in the base case, and adopted a healthcare provider perspective on costs, as required by the National Institute for Health and Clinical Excellence), if the average duration of protection from the vaccine is more than 10 years.

Implementing a catch-up campaign of girls up to age 18 is likely to be cost effective.

Vaccination of boys is unlikely to be cost effective.

A bivalent vaccine (affording protection against HPV virus' that cause cervical cancer NOT genital warts) with the same efficacy against human papillomavirus types 16 and 18 costing £13-£21 less per dose (this is max. 10% of vaccine costs) (depending on the duration of vaccine protection) may be as cost effective as the quadrivalent vaccine although less effective as it does not prevent anogenital warts

Jane Kim in the editorial said that "the decision to select the bivalent vaccine implies the Department of Health is willing to accept foregone health benefits (and additional cost savings) from averting cases of genital warts for the reduced financial outlay."

Jane Kim added: "Assuming 80-percent coverage of current 12-year-old girls (each year cohort has some 350,000 girls) in the UK with the full three-dose vaccine series, this price differential translates to savings of 11.5 million pounds ($23 million) to 18.6 million pounds ($37 million) from the vaccine price alone in the first year of the programme.”

In response, a spokesperson for the Department of Health noted that "the contract has been awarded for the vaccine that scored best overall against a number of pre-agreed criteria and offers best value overall to the NHS."

This policy of limited protection at a reduced costs is not without its critics. Colm O'Mahony, a consultant in sexual health at Chester Foundation Trust, commented that “all the clinical evidence pointed to Gardasil and instead [the government has] chosen a vaccine suitable for the Third World.”

Natika Halil, director of information at the Family Planning Association, remarked that "genital warts has its own financial cost to the NHS which spends 22 million pounds ($44 million) a year treating it, so it will be interesting to see how this has been factored into the cost analysis.”

As part of the cost analysis it was intersting to note that the NHS accept that the basic pap smear at Pap smear (£21.70, 2002 prices) is less than the recently introduced liquid based cytology (£25.40, 2003 prices). Also Costs for screening at sexual health clinics and outpatient clinics are higher (£37 and £68 respectively, 2003 prices). These costs will not diappear because screening will still be required because the vaccine only affords protection against 70% of potential HPV strains.

GlaxoSmithKline stated that data on Cervarix have demonstrated the prevention of pre-cancerous lesions and a strong immune response for 6.4 years, noting that “this is the longest duration of protection reported for any vaccine against HPV 16 and 18.”

The government's vaccination programme in 12-year-old girls is expected to start in September.

The Department of Health has released Press release today "300,000 more girls to be offered vaccine against Cervical cancer - extension of the HPV vaccination progamme ". This trumpets the decision to choose Cervarix at a lower cost - for a routine vaccination of girls 12-13 years old starting in September which it is claimed will eventually save up to 400 lives for each year of girls receiving the vaccine. As a consequence The national vaccination programme against HPV is being extended to offer protection to an additional 300,000 girls aged 17-18, starting in September.

A 2 year ‘catch-up programme’ will start in the school year 2009/10 to vaccinate girls aged between 15 to 18. Today’s announcement means that girls, who would not otherwise have been included in this catch-up programme, will now be vaccinated this school year. Boys will not be vaccinated at any age.

Dawn Primarolo says the cost of the vaccine is commercially confidential. Cervarix® will be purchased by the Department of Health who will supply it free of charge to the NHS.

The financial consequences will be that The Department of Health will provide additional support to PCTs in guidance and funding to ensure that the roll out of the older cohort is a success.

There will be an additional £10 million for PCTs in the 2008/09 financial year to implement this extra programme.

It is not accidental or incidental that programme on Channel 4 Dispatches (in the UK only), "The Jab that can stop Cancer" presented by Jane Moore (who has paid privately for the vaccine for one of her daughters and will eventually for the younger daughter to have Gardasil) will discuss this subject at 8.pm this evening.

Professor David Salisbury , Director of Immunisation,Dept. of Health made great claims for the precision of the modelling and calculation for costs and benefits - making asinine remarks about the amount of computer time spent in running the models - all weekend, when nobody else was using it - as if that was proof of veracity or accuracy.

A lady epidemiologist pointed out that cervical cancer rates and mortality had fallen dramatically since pap screening was introduced and that 40 wome died per million. She queried whether the costs justified he claimed benefits say against the people who will suffer heat diseases or more common life threatening cancers.

A snapshot was also provided how the UK market was softened u by intensive (and dubious) marketing programs, and thiny veiled surveys paid for by the pharma companies were presented to the press as "evidence".

GP's , now used a better educated and better informed patient were asking for protection for their children- simply assuming the benefits it provided on the wave of "astro-turfing" or the unquestioning and incurious wall to wall press coverage.

No mention was made of the details of the modelling, nor was it made clear that Cervarix provides no protection against other HPV strains ( are over 100 known strains) that cause genital warts - nor was the case examined for protecting boys.

In the world of private medicine, Jane Moore has made her decision , US and French (and those in 100 countries where it is currently approved) citizens will make theirs (although different insurers have different policies)

NHS Choice HPV vaccination information site

How does a parent decide ?

As the NHS / Government have made a decision to supply at no extra cost the parent has to first consider ;
1. Any vaccine carries risks when used, what are those risks ?

To date the only large scale usage has been in the US and we posted about the latest report here Tuesday, July 08, 2008 Gardasil® gets 7,802 adverse reports to CDC by VAERS system

2. Having accepted that risk , what risk is there of my daughter eventually coming in contact with a strain of HPV ?

It is not 100% but near it. The more promiscuous (ie the greater number of sexual partners - of either sex, it can be transmitted between women) she is, the greater the chance. There is no clear evidence that sexually transmitted infections (STI) have any effect on increasing / reducing the impact. Please note that the cervical smear test, whilst it will may discover evidence of STI's , that information in the UK will not be passed on to the patient. It is not a genito urinary test. (As an aside it would be a service to women to re-jig the test to incorportate a genito - urinary test)

The "pap" smear testing will continue (remember that results vary regionally, and are reported differently, the NI method of identification is different to the rest of the UK. The report also identiffies that fact that over time it will be necessary ..." to take account of possible changes to the cervical screening programme, such as the introduction of DNA testing for human papillomavirus, .....It is clear that significant further work on the design of optimal screening and vaccination programmes is required, particularly if the introduction of vaccination accelerates the recent trend for the declining uptake of screening.

i.e it is possible (many would say highly likely) that vaccination will lead to lack of detection in the population as women will think or assure themselves that the unpleasant cervical smear routine can be avoided.

The FDA says the human papillomavirus is the most common sexually transmitted infection in the U.S. The Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with genital HPV each year and that more than half of all sexually active men and women become infected at some time in their lives.

3. If she contracts an HPV will it be oncogenic (cause cervical cancer) ?

Currently it is felt that the 2 strains afforded protection by both current vaccines accounts for 75-80% of HPV's discovered in pap tests.

Of women conracting oncogenic lesions, the eventual death rate some 40 per 1 Mn a year die, many of course suffer an unpleasant and debilitating illnes for varying periods like all cancers.

4. Will better vaccines become available affording more protection ... ?

No doubt other manufacturers are working , and GSK and Merck will be improving their product - it must be assumed newer products will afford better protection and less risk at lower cost. The timescale is unknown.

To be effective protection must be given prior to any sexual contact - it is not necessary for intercourse to take place for transmission.

This site does not give medical advice, it gives plenty of information and directs the user to sources of further information. Anyone considering having their children vaccinated for HPV must consult their GP.

Joe Moore chose it for her children.

Lord Patel is ;

1. Very sceptical of the need to make a decision - there is no urgency.

2. Not at all impressed by Dr David Sainsbury Salisbury and his fancy modelling - truly it is as good as modern techniques and the data available can provide. The assumptions / guesses used are not based on sufficiently strong evidence .. yet, more will become available as others users / providers take part in a very large experiment on their children. Lord Patel can see no reason why anyone should enter their children in this great experiment. Giving you children a healthy diet, exercise and making sure they never smoke are far greater benefits you can pass on to your kids.

3. Feels that the NHS has higher priorities than providing at zero cost a protection which in essence will stimulate promiscuity rather than restrict it - with the attendant risks of STI's.

4. Is certain that undue pressure (without any proof, but based on wide experience of big pharma) has been put on the decision makers to support a "British" product.

5. It also represents another example of the state usurping personal choices and decisions using a decision making process which is opaque to many people - inlcuding most of the medical profession. (next time you see your GP ask him about the Monte Carlo method usng tjhe latin hypercube method)

HPV - armed and dangerous. Another alarming NHS advertisement

This ad appeared on Page 8 of the Guradian Body & Soul Section on Saturday 13th September (and no doubt elsewhere) it is designed, published, and promoted to support the rushed campaign to vaccinate the cohort of 12 to 13 year old school girls (Year 8) in England. (Click to enlarge text is reversed out of brick wall Guradian printing and half page size ad)

It is misleading. The bold copy line , "Armed for life" , whilst partially explained away in the reversed out text..."will help protect women for life" is untrue. "The new HPV vaccine , which protects against cervical cancer" is again untrue ...it provides partial protection only, and none against genital warts which the competing vaccine, Gardasil does.

The vaccine chosen, Cervarix ® supplied by Gaxo Smith Kline , a British company, affords limited protection for an unknown period (certainly not for life and probably for no more than 10 years - but we won't know how successul it is for many years) against strains (HPV 16 & 18) of the Human Papilloma Virus (HPV) which are now considered to cuase some 70% of cervical cancers.

Whilst HPV is principally transmitted during vaginal intercourse, it can also be transmitted by other complicated routes anally, orally (however configured) , in same sex activity and on sex toys.

At a direct cost for the 3 stage vaccine of approximately £250 per girl, the total cost for the UK's 300,000 Year 8 girls (not boys) will this year be in the region of £60 Mn. plus administration, staffing, advertising etc., It must be remebered the Cervical smear policy will continue to detect cervical cancer in women - a service not available to women younger than 25.

A cute tattoo is featured which provides what might be considered as a novel way of lightening an otherwise pretty grim sbject for 12/13 yera old girls to handle - and is guaranteed to upset some parents. The schoolgirl receiving the vaccination can of course decide themselves to provide consent, parental consent is not required. .. Indeed the information on consent is very confusing... "It is your choice whether to have the vaccine or not ........ If you are in school, and aged under 16, your parent, or carer, is being asked to sign the consent form. Parental agreement is always advised, although it is not always necessary. If you are aged 16 or over it is important you sign and return the form yourself.

There is a website www.nhs.uk/HPV or you can call a helpline 0845 602 3303....@ 5p per minute plus. .. although the website confusingly directs you to a FREEphone number !

The hasty use of this vaccine for mass vaccination is ill considered, and amounts to a vast and needless experiment on our youth, principally for the commercial benefit of GSK. The choice of the British made vaccine which provides less protection than the US Gardasil ® vaccine looks highly suspicious and prompted by commercial motives.

On Friday, January 19, 2007 in a post Hooked ? .... or Horrified ? we brought readers attention to an NHS ad to promote the (then) current "get Unhooked" anti-smoking campaign in a nationwide £8Mn promotion. The ads attracted 774 complaints for the campaign created by Miles Calcraft Briginshaw Duffy which ran across television, poster, national press and magazines, and online. The most complained of advertisement of 2007 - see Wednesday, May 16, 2007 Hooked ...Line and Sinker by the Advertising Standards Authority

If you agree and think the ad is misleading you can complain to the Advertising Standards Authority here .

For more information look at previous posts going back a long time here you can also look here www.nhs.uk/HPV ...evidently aimed at parents not children "the safest way to protect your child" due to regional differences (explained in the very, very small 5pt type on the ads) the ON Line ad has different sections for Wales / Scotland / Northern Ireland.

Why ?

Well, the Scottish part of the website has a Glossary - it covers Consent..."Consent is a formal term for giving permission or agreeing to something." but not condoms ... that's because the Holy Roman Catholic Church has asked them not to mention condoms in the literature.... although condoms do raise their ugly head in at least one section. see post - Sunday, August 17, 2008 Vaccination of schoolgirls for HPV using Cervarix ® should be stopped. NOW

Whilst the website is large and has a great deal of information , nowhere does it mention Gardasil ®, the extra protection it affords, the greater experience in use, or the fact it has been available for use in the UK for nearly 12 months privately.

PS : The Department of Health 25th February 2008 appointed Abbott Mead Vickers BBDO to handle the ad campaign for the introduction of the new HPV (human papilloma virus) vaccination programme - across TV, radio, press, digital and PR. . (3 way pitch including CHI & Partners and WCRS)

The Department of Health On May 6th appointed Consolidated to manage a PR campaign to raise awareness of the new HPV (human papilloma virus) vaccination programme ..

PPS : NHS don't seem to learn or they have terrific loyalty, Miles Calcraft Briginshaw Duffy are still doing anti smoking ads, this time NHS - Smoking, Don't Keep it in The Family http://www.visit4info.com/advert/NHS-Smoking-Dont-Keep-it-in-The-Family-NHS/60022

GSK's claim cervarix HPV vaccine affords long-term protection against fourmain HPV types

Cervical cancer affects the 2nd most common cancer in women aged 15-45, affects over over 1.4 million women, is the third leading cause of death by cancer in women , after breast and lung cancer.

Most of the deaths occur in the developing world. Cervical cancer is an invasive and patient slow growing problem often diagnosed too late for effective action unless regular screening is provided.

The cause is a virus called human papillomavirus (HPV) transmitted by sexual activity both between men and women and between men and men and women and women. Cervical cancer is a sexually transmitted disease. Condom use fails to provide adequate protection as transmission does not require intercours but may occur simply through skin-to-skin contact in the genital area.

As HPV is almost symptomless people can be infected and transmit the without even knowing it.

Of the known 100 known types of HPV only about 15 can cause cervical cancer. Only 4 of these are the most commmon (16, 18, 45 and 31) and appear to devliver some 80% of observed cases.

HPV 16, 18 and 45 are are associated with nearly 90% of cases of adenocarcinoma, a very aggressive form of cervical cancer.

On Monday (International Women's day) at the Society of Gynecologic Oncologists' Annual Meeting on Women's Cancer, Glaxo Smith Kline presented new clinical data for what they call their "cervical cancer vaccine", Cervarix - competitor to Merck's Gardasil.

They show that it provided significant protection against four types of human papillomavirus (types 16 and 18) for almost six and a half years.

These follow-up analyses, involving women aged 15 to 25 years, demonstrated ;

1 . Cervarix was 100 % effective at preventing precancerous lesions caused by virus types 16 and 18 over six and a half years.

2. Cervarix was 78 % and 60 %t effective at preventing incident infection caused by virus types 45 and 31, respectively.

GSK say this shows the "longest duration of consistently high antibody levels demonstrated by a cervical cancer vaccine."

GSK literature promotes the claim of Anna-Barbara Moscicki, MD, Professor of Pediatrics, Universityof California, San Francisco who runs a Teen Colcoscopy Clinic. "Vaccination of pre-teen/adolescent girls against cancer-causing HPV before onset of sexual activity will be an important part of the overall strategy for cervical cancer prevention."

See Wikipedia on Gardasil and HPVresource.org

Merck Zoztavax shingles vaccine could be a US$1 Bn. seller

Had chicken pox ? 90% of people do, ususually in childhood, if so you could develop shingles later in life. Of the approximately one million people in the USA who get shingles each year, nearly half are over 60 that's 50 Mn Americans. More from VZW Foundation here

A market that can pay for a pharma product that has minimal impact on public health anywhere but will a shot in the arm for Merck sales and profits ... perhaps they will use the proceeds on a vaccine for malaria ?

The Shingles Prevention Study, was 5.5-year-trial randomized 19,270 US patients to and active herpes vaccine. The vaccine reduced the burden of illness due to herpes zoster by 61.1% (P<0.001), href="http://www.zostavax.com/clinical" data="">S Food and Drug Administration (FDA) review of the ZOSTAVAX concluded that the vaccine was effective at curbing shingles pain but did not significantly reduce either shingles-related hospitalizations or death.ZOSTAVAX is not a treatment for shingles or postherpetic neuralgia.

Today the FDA have approved a Merck shingles vaccine Zostavax (zoster vaccine live) for prevention of herpes zoster in patients 60 and older (although Merck applied for those aged 50 and over) - The vaccine will not be used for people who have had or now have shingles. Neither will people with weakened immune systems nor HIV patients (who are especially at risk) get the vaccines. Merck said it is ready to accept physician orders, with rapid shipment promised. (Merck Press release here)

Merck will perform a Phase 4 (postmarketing) study to provide additional safety information.Effectivley ZOSTAVAX is a 14 times strength child vaccine so should prove to be very safe in use.

In a statement issued by the FDA, Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research, said the vaccine is "an important tool that can help prevent an illness that affects many older Americans and often results in significant chronic pain."

"It's a breakthrough in that it's the first vaccine that is actually
designed to keep an infection in check," said Dr. Walter Orenstein,
associate director of the Emory Vaccine Center at Emory University, who has
consulted for Merck.

Merck said the catalog price of the vaccine is US$145.35 for a 10-pack of single-dose vials of lyophilized vaccine with sterile diluent and $152.50 purchased as a single-dose vial of vaccine with sterile diluent. A singler dose should provide immunity for 4 years.

Merck is expected to gain approval next month for a cervical cancer vaccine (Gardasil) against the Human Papilloma Virus, that is likely to become popular among teenagers and young adults. Analaysts hope to see this as a US$2MN. seller and be mandated fro schoolchildren to prevent 1/2 Mn cervical cancer deaths annually.

Zostavax could be a US $1 billion's product for Merck per year by the end of this decade.

An der NYSE geben Merck&Co aktuell 0,5 Prozent auf 35,25 Dollar ab.

Merck needs some blockbusters. Vioxx in a global settlement could cost more than US$30 billion.

More bad news in the pipleine is the U.S. patent on Merck's popular cholesterol-lowering drug Zocor, 2md best seller in the US behind rival Lipitor, expires in 2006. The introduction of a generic copy of Zocor by mid-2006 could cut
in half Zocor's current annual U.S. sales of $4.5 billion.

Add this to the US $2.5 billion in annual sales sucked out of the company after Merck pulled Vioxx from the market.