For immediate release

9th October 2009

ALLIANCE FOR NATURAL HEALTH CALL FOR AN URGENT SCIENTIFIC INQUIRY INTO THE HPV VACCINE USED IN THE UK

The Alliance for Natural Health today is calling on all Members of Parliament in the UK to help stimulate an independent and transparent scientific inquiry on the safety of the HPV vaccine.

Reports of serious and even lethal adverse reactions to the Human Papilloma Virus (HPV) vaccine, Cervarix, manufactured by GlaxoSmithKline, raises grave concern over the safety of the vaccine.  While its closely related vaccine, Gardasil, manufactured by Merck, is recognised by the US Centers for Disease Control (CDC) to trigger severe reactions, namely hospitalisation, permanent disability, life-threatening illness or death, equivalent data in the UK appears not to be publicly available.

In addition, the tragic case of 14-year-old Natalie Morton’s death just two hours following her vaccination, which was considered by the pathologist in her post mortem as being completely independent of the vaccine, has raised further questions in the minds of many about the accuracy of reporting.

The role of the HPV vaccines in the development of disabling symptoms in the cases of Stacey Jones (18), Rebecca Ramagge (13), Lisa Wickenden (13), Carly Steel (13) and Ashleigh Cave (13), appears to be unresolved and circumstantial evidence would suggest that Cervarix may have been at least a contributing factor in their respective conditions.

Dr Diane Harper of the University of Missouri, who was directly involved in clinical trials on HPV vaccines, is among a growing number of scientists who have publicly expressed their concerns over the vaccines’ safety.

Cervarix was approved for use in the European Union in September 2007 for the prevention of precancerous changes in the cervix in girls and women between the age of 10 and 25.  The vaccination programme started in September 2008 for girls aged 12 to 13, delivered in three injections over 6 months.  There is a new, accelerated catch-up programme for girls aged 15 to 18 years starting in September 2009, due to complete by end of the academic year 2010.

Given the number of girls, the lack of transparency on the frequency and type of adverse reactions, as well as the possibility of long-term effects on the reproductive system, the Alliance for Natural Health is requesting all Members of the UK Parliament to put pressure on the Government to initiate an independent and fully transparent scientific inquiry on the short and long term effect of the vaccine.

The Alliance for Natural Health is an international campaign organisation comprised of scientists, doctors, lawyers, practitioners and consumers, working to promote natural and sustainable approaches to health through the use of ‘good science’ and ‘good law’.

Executive Director of the Alliance for Natural Health, Robert Verkerk, stated: “Young girls in the UK—as well as their parents and guardians—deserve to have the full facts on the risks and benefits of this vaccine to help them make properly informed choices. The NHS position is that the vaccine is safe, but the facts would suggest otherwise.  Presently, there are no adequate data available on the comparative risks of Cervarix and Gardasil. Neither is there adequate information on the factors which may predispose certain individuals to serious adverse reactions, nor about the duration and effectiveness of immunity following single and multiple vaccinations.  It is in the public interest—and of utmost urgency—that these key questions are answered by an independent scientific review panel and are made public.”

FOR FURTHER INFORMATION, PLEASE CONTACT:

Sophie Middleton
Campaign Administrator
The Alliance for Natural Health
The Atrium
Curtis Road
Dorking
Surrey
RH4 1XA

Tel: +44 (0)1306 646 600
info@anhcampaign.org

NOTES FOR THE EDITOR:

For more information about the HPV vaccine (by ANH Medical Director, Dr Damien Downing):
http://anhcampaign.org/news/anh-feature-the-hpv-vaccine-gardasil-in-the-spotlight

For more information about cases which may be linked to the HPV vaccine:
http://anhcampaign.org/news/brain-damage-follows-hpv-vaccination-in-uk

The ANH Vaccine Choice campaign page:
http://anhcampaign.org/campaigns/vaccine-choice

About the Alliance for Natural Health:
http://www.anhcampaign.org

The Alliance for Natural Health (ANH) is an international, non-governmental organisation, based in the UK. It was founded in 2002, and works on behalf of consumers, medical doctors, complementary health practitioners and health-product suppliers worldwide, to promote natural and sustainable health, using the principles of good science and good law.

Robert Verkerk DIC PhD MSc BSc
Executive and Scientific Director
The Alliance for Natural Health
Curtis Road
Dorking
Surrey RH4 1XA
United Kingdom

tel:  +44 (0)1306 646 600
fax: +44 (0)1306 646 552
email: info@anhcampaign.org
www.anhcampaign.org

©2012 An Inconvenient Woman. All Rights Reserved.

In twin votes likely to add considerable force to U.S. marketing efforts for HPV vaccines, an FDA expert panel has voted to back GlaxoSmithKline’s long delayed application to market its HPV vaccine Cervarix to women and soon after supported Merck’s application to extend the use of Gardasil to males. Glaxo shares gain 0.5 pct, Merck shares gain 1.9 pct.

Glaxo had originally tried and failed to gain FDA approval for Cervarix back in 2007 but was thwarted by the agency’s desire to see more information on potential side effects, particularly a heightened risk of miscarriage. Since that time the pharma giant has gained approvals in more than 100 countries, while biding its time with the FDA. And while the panel concluded that the link between Cervarix and miscarriages is tenuous, the experts suggested a warning to prevent pregnant women from getting the vaccine. The panel vote makes it all but certain that Glaxo will gain final marketing approval from the FDA, opening the door to the world’s biggest drug market and finally offering Merck some competition for Gardasil. Glaxo’s shares were buoyed by the news.

Food and Drug Administration advisers, in an 11-1 vote, said Cervarix appeared safe despite miscarriages reported around the time of vaccination and a small number of autoimmune problems such as rheumatoid arthritis and lupus. Panelists urged monitoring for those issues after approval to see if there was any link to the vaccine.Merck, meanwhile, is seeking an FDA approval to use its HPV vaccine to guard against genital warts in boys and men. The panel gave Merck its support, but there was widespread agreement that the use of an HPV vaccine for males 9 to 26 offered little protection against cancer, as HPV-related penile and anal cancer cases are extremely rare. The FDA has indicated that any final approval on Gardasil’s use in males will require post-marketing safety studies.

Check out full story in  the Los Angeles Times
Read  Reuters Report

©2012 An Inconvenient Woman. All Rights Reserved.

In a July 9th story, ‘WHO clears Glaxo’s Cervarix for developing world’ Reuters reported that  GlaxoSmithKline’s (GSK.L) cervical cancer vaccine Cervarix has won a green light from the World Health Organisation (WHO) for use in developing countries, although how the shot will be paid for has yet to be resolved.

WHO “prequalification” —  a key hurdle for gaining wider use of Glaxo’s HPV vaccine Cervarix, an necessary endorsement for UN agencies and the non-profit GAVI Alliance to purchase the vaccine, and Glaxo said on Thursday it hoped the move would help speed access to Cervarix globally.

And Glaxo quickly followed up, saying that the company plans to explore new financing mechanisms that would ensure broad availability. “We’re exploring a variety of distribution partnerships to ensure Cervarix will protect women and girls around the globe,” Jean Stephenne, head of vaccines, tells Reuters.

WHO had already approved Gardasil and the Global Alliance for Vaccines and Immunization, a broad umbrella group of international health organizations, has made access to cervical cancer vaccines a top priority. Dan Thomas, a GAVI spokesman stated “We’re very eager to offer women in developing countries these vaccines because without early screening, they are arguably more vulnerable to cervical cancer.”

It’s likely that Glaxo will work out discount prices for global health agencies and nonprofits, a common avenue for Big Pharma companies selling expensive therapies in poor countries.

For full Reuters story Click here: http://www.reuters.com/article/rbssHealthcareNews/idUSL948126520090709

For AP Coverage, ‘WHO approves cervical cancer vaccine Cervarix’ Click Here:

http://www.google.com/hostednews/ap/article/ALeqM5gLW3aCaSxKeKddyL_g7p2uerLjkgD99AT25G0

©2012 An Inconvenient Woman. All Rights Reserved.

LONDON (Reuters) – GlaxoSmithKline Plc’s Cervarix is the first product of its kind to show it protects against the five most common cervical cancer-causing viruses, Europe’s biggest drug company said in a statement on Tuesday.

A study, published in Tuesday’s issue of The Lancet, said that as well as protecting against the two most common virus types, the vaccine also provides protection against the next three most common cancer-causing virus types.

Glaxo said the additional efficacy could translate into approximately 11 to 16 percent extra protection against cervical cancer over and above the protection afforded by efficacy against the two most common types alone.

“This is really good news for primary prevention of cervical cancer as it indicates the vaccine could offer women additional protection … beyond what had at first been anticipated,” said Thomas Breuer, head of global clinical R&D at GSK Biologicals.  Click here for the full article published by Reuters.

©2012 An Inconvenient Woman. All Rights Reserved.

I have been reviewing my Gardasil files these past few weeks. I have been tracking the HPV-vaccine since 2005.  The Gardasil issues I researched were the relatively limited trial period, the sketchy trail data; the cost benefit of a drug that was design to prevent a cancer that has been declining in both incidence and mortality for over 40-years. Cervical cancer is easily detected by regular PAP screening and in the early stages, the most treatable cancer.

The other aspect of Gardasil roll-up that didn’t pass the smell test was the Merck Marauder School of lobbying today for a more profitable tomorrow. Merck literally carpet-bombed the halls of power and influence with cash to get GARDASIL approved by the FDA (while holding up the Glaxo HPV-vaccine, Cervarix), they got Gardasil endorsed by the CDC and mandated in many states as yet another vaccine necessary to attend school, and managed to get state legislators to pass bills to force insurance companies to pay for the Gardasil shot.  As I researched the payouts and pay offs of state, local and federal representatives, I asked. “when did safety go on sale?” Then I found out about Merck paying doctors to go on the stump to endorse Gardasil. Some docs with great speaking skills picked up several hundred thousand dollars in a year. Then there was the scandal about “Medical Journal-Like’ publications written by’ bought and paid for’ doctors who dutifully regurgitated the WORD according to Merck.

During 2006, as I followed the Gardasil roll-out, I was reminded of a scene from the original Star Wars, were Obi-Wan Kenobi, uses his legendary, Jedi Master powers of mind control to convince two storm troopers that, “these are not the droids you are looking for, move along.”  Merck was using every “mind trick” in a very thick book to misdirect our attention, while building a sense of urgency around the need to get our daughters vaccinated to save them from cervical cancer.  You can read my past Gardasil Blogs to get details on my views concerning cervical cancer and the HPV vaccine and Merck.

In the meantime I invite you to read one of my favorite articles, written by Terry J. Allen, in March of 2007, as a Special Report for CorpWatch, “Merck’s Murky Dealings: HPV Vaccine Lobby Backfires”

Merck’s Murky Dealings: HPV Vaccine Lobby Backfires

by Terry J. AllenSpecial to CorpWatch
March 7th, 2007

In early January Marilyn Canavan and Andrea Boland, two legislators from wintry Maine, traveled to the tourist resort of Marco Island, Florida, for a conference organized by Women in Government (WIG), a non-profit organization.

The annual, bi-partisan event for elected women in state governments around the U.S. had a number of issues on its agenda from higher education to the state of women in politics.

One focus, preventing cervical cancer, included information on Gardasil a new vaccine manufactured by pharmaceutical giant  Merck, that protects against the two human papilloma virus (HPV) strains that cause 70 percent of cervical cancers.

“The tenor of presentations – they were not discussions … (they) seemed one-sided to me,” said Canavan,  a four-term legislator. “I remember thinking as I was leaving the meeting, ‘I just don’t want to do this … we need to have public dialogue.’”

Boland also reported “a pull to get on board [promoting vaccination]… and when I raised questions, the response was ‘Do you want your daughter to die of cancer?’”

Boland, a first-time legislator, joined Canavan, a WIG state director, at a small planning session, where she was taken aback by the extent to which corporations influenced WIG. “When discussing what the agenda for next year would be,” participants were told to ‘wait to see who’s funding things.” Similarly before fixing the program for next year, they “had to see what the sponsors want,” said Boland.

Boland’s suspicions were further raised by a casual conversation one evening over a glass of wine with one of the conference speakers, Boston pop singer Christine Baze. “She was a young attractive woman with a beautiful voice and a moving tale of surviving cervical cancer,” said Canavan. Baze mentioned that a pharmaceutical company had paid for her appearance.

Both legislators believed that preventing cervical cancer was a worthy project, but it wasn’t until a month later that Canavan and Boland learned that, more than making the vaccine available, Merck and WIG were campaigning to make Gardasil mandatory for all 11-12 year old girls.

Then, after the Governor of Texas, Rick Perry, passed an executive order mandating vaccination for all girls entering sixth grade, Canavan learned something that shocked the former director of the State Ethics Commission: She discovered that WIG had taken funding from Merck.

On March 2nd, Canavan resigned from WIG. “An organization that stands to profit, like a pharmaceutical company, shouldn’t be driving the health agenda in public realm,” said Canavan. “You see so many front organizations, I’m not going to say Women in Government is one, but it matters who’s funding them. My early training emphasized doing the right thing and being guided by conscience.”

What Boland and Canavan had come to realize was that the Florida conference presentations had been part of a state-by-state lobbying campaign spearheaded by WIG to support Merck’s efforts to make Gardasil mandatory. WIG members were well placed to promote bills in state legislatures or help convince governors to promote that agenda. But revelations of money trails and the rush to make a new vaccine mandatory created a backlash and forced Merck, on February 20th, to publicly abort its lobbying campaign for mandatory vaccination of school girls.

Launching the Vaccine

Cervical cancer affects 10,000 women in the United States every year, and kills 3,700. The toll is far greater in the developing world, where most women lack the diagnostic Pap tests that catch signs of cancer when it is still treatable.

New Jersey-based Merck, one of the world’s largest pharmaceutical companies had been hoping to reap billions of dollars from Gardasil. Most of the world’s sexually active men and woman and every child over 9 years of age are potential customers for the expensive course of injections.

A quick and successful launch was crucial, both for Merck’s failing financial health and because rival GlaxoSmithKline was developing a similar HPV vaccine. Things looked good for Merck when the U.S. Food and Drug Administration (FDA) agreed to fast-track Gardasil in February 2006 and approved it in June, pronouncing the vaccine effective and safe for girls as young as nine. Soon after the FDA approved Gardasil, WIG was helping introduce bills in some 20 states, with Merck actually writing the legislation in at least one state: Florida.

Merck also launched a subtly frightening advertising campaign featuring quick images of vital young girls: a young drummer, a child with a skateboard, two playing basketball, and three skipping rope. The drummer says: “I want to be one less woman who will battle cervical cancer,” as she starts tosses her drumsticks and starts to play, the others spell out a chant: : “O-N-E-L-E-S-S. I want to be one less. One less.”

Merck’s targeting of young girls and eventually boys who are carriers and on rare occasions develop HPV-caused cancers is based in rational public health principles. Since the vaccine is only effective in preventing, not treating HPV infection, it needs to be dispensed before exposure to the viruses. And while 11-12 year old girls are unlikely to be sexually active, policy makers could make their entry into middle school contingent on vaccination in the same way that 5-6 year olds are required to be vaccinated for polio and measles before entering elementary school. If officials waited until the more common age of sexual initiation, around 16, public health officials would not have the leverage to compel vaccination.

As with any new drug, concerned parents and public health officials had to balance Gardasil’s obvious promise against potential problems. They understood that Merck’s contention that its HPV vaccine is safe and effective was only as sound as its data and only as solid as the independence and rigor of the FDA review process that approved the drug. But while most people applauded the new protection Gardasil offered, both experts and consumers found good reasons for waiting before making the vaccine mandatory. (They did not include fears that all vaccines are dangerous, or that protecting against a sexually transmitted disease encourages girls to have sex.)

The data Merck presented to the FDA were based on some 21,000 test subjects between ages 16 and 26, half of whom received Gardasil and half a placebo. All subjects, followed for up to five years, were found free of pre-cancerous changes from the targeted strains.

Some critics pointed out that the test period was too short to assess long-term effects and efficacy. In fact, the studies on children, who often react differently to drugs, were shorter yet, and smaller. Only 1,184 subjects in the nine to 15 year-old age test group got Gardasil, and they were followed for 18 months, according to New Scientist magazine. A Merck spokesperson refused to break down the data further to reveal how many of that small sample were below the age of puberty.

And then there is the possibility that, given time and real-world conditions, side effects will emerge. FDA briefing papers noted a small increase in birth defects in the babies of women given the vaccine within 30 days of becoming pregnant over those who took a placebo. The number, while not establishing causality, triggered an FDA recommendation that pregnant women not be vaccinated. The background documents also raised questions about whether selectively targeting a few HPV viruses (there are more than 100) would “advantage others.” Another concern “was the potential for Gardasil to enhance disease among” subjects already infected “with vaccine-relevant HPV.”

These kinds of concerns are not necessarily alarming or unusual for a new drug, According to a 2002 study in the Journal of the American Medical Association, “The safety of new agents cannot be known with certainty until a drug has been on the market for years. Serious ADRs [adverse drug reactions] commonly emerge after Food and Drug Administration approval.”

“The published data look great, but at the very least, I would like to see efficacy data among 11 and 12 years old, which won’t emerge until they are sexually active,” says Karen Smith-McCune, a University of California associate professor of obstetrics and gynecology.

And so too, would many medical experts, public health officials and consumers. The American Academy of Pediatrics had urged the company to go slow and focus first on raising public awareness of HPV and monitoring the vaccine’s safety. The U.S. Centers for Disease Control panel that recommended routine HPV vaccination told Merck that it opposed making Gardasil mandatory, the Washington Times reported.

In addition to questions about the data, was the FDA approval process itself. The drug was recommended for approval by the FDA’s advisory committee comprised of “qualified experts with minimal conflicts of interest … [who] provide FDA with independent advice,” according to agency guidelines. While the committee’s recommendations are not binding, the FDA almost always accepts them.

But at least two members of the advisory panel that found Gardasil safe had the appearance of a conflict of interest: They were former Merck employees connected with development of the vaccine. Vaccine expert Dr. John Boslego was executive director of Biologics, Clinical Research at Merck for ten years, and had left the company just two months before the committee ruled on Gardasil in February 2006. Another panel member, Alan Shaw, was part of Merck’s Vaccine & Biologics Research and had represented the company as late as May 2005 at a conference on cervical cancer where he presented a paper on HPV Vaccines. The FDA granted waivers to both men, finding them free of any conflicts of interest.

The integrity of the FDA review process is also vulnerable to charges of conflict of interest over the fees the cash-strapped agency accepts from the drug companies. Under a law sponsored by U.S. Senator Richard Burr a decade ago, the FDA charges from nearly $50,000 to nearly $900,000 to fast track a drug, according to the Winston-Salem Journal. Since 1992, drug companies have paid the FDA $1.7 billion to speed up the approval process for particular drugs.

Of course, none of this means that Gardasil is unsafe. Few things in medicine are guaranteed, and many believe that the odds are that Gardasil is exactly what Merck says it is: a life-saving breakthrough with no significant side effects.

A Controversy in Texas

But new drugs, and vaccines in particular, raise not only promise but fear. And touching as it did on issues of teenage sexuality, Gardasil was particularly controversial.

Religious conservatives, already concerned that vaccination would encourage sexual activity, opposed making vaccination mandatory. “My main reason is that it is parents that have the right to decide when is the appropriate time to discuss sexuality,” said Debi Vinnedge, the head of Children of God for Life. “One of my young grandchildren is more mature, but there is nothing that I can say to these kids” that won’t send the wrong message.

It was perhaps the potential controversy in mind that Texas governor Rick Perry took the bull by the horns and circumvented abstinence junkies, public discussion, and the legislature to issue an executive order requiring vaccination for all girls entering the sixth grade, unless parents opted out.

Perry’s February unilateral decision sparked a public relations disaster that Merck’s orchestrated ad campaigns, lobbying efforts through WIG, and courting of the religious right had failed to anticipate.

Perry’s February order also raised suspicions over his politics (the governor has previously shown little interest in health policies), his speed (just months after the FDA approved the vaccine and before all the data had been published), the financial arrangements (Merck got a statewide monopoly without concessions and without negotiating a discount for clinics and poorer Texans) and the stealth timing (Perry issued the order late on Friday before Super Bowl Sunday, the nation’s biggest sporting event).

Questions about cronyism soon led to Perry insiders connected to Merck and to WIG: The WIG state director is the mother-in-law of Perry’s current chief of staff, and his former chief of staff is now one of Merck’s three Texas lobbyists. A Merck executive served on WIG’s Business Council in 2006.

And then there was the money trail. In September, greasing the skids for Gardasil’s November public relations blitz, “Merck’s PAC spent $74,250 in a single day to influence elections in five states. It directed 60 percent of that money to 82 candidates in Texas,” according to Lobby Watch, a newsletter put out by Texans for Public Justice. (A Public Action Committee or PAC is an advocacy group that buys political advertisements to support elections or legislation).

In late February, less than three weeks after Perry’s executive order to make the vaccine mandatory for all Texas schoolgirls entering sixth grade, Merck abandoned the lobbying campaign.

“Our goal is to prevent cervical cancer,” Dr. Richard M. Haupt, executive director for medical affairs in Merck’s vaccine division told the Associated Press. “Our goal is to reach as many females as possible. Right now, school requirements and Merck’s involvement in that are being viewed as a distraction to that goal.”

A Financial Shot in the Arm

Facing the storm of controversy that threatened to overwhelm news about preventing cancer, Merck’s president for vaccines, Margaret McGlynn, defended her company. “Each and every day that a female delays getting the vaccine there is a chance she is exposed to human papilloma virus,” she told the New York Times.

But Merck, like any corporation, is motivated by more than altruism. If Gardasil becomes routine, the $360-$400 course will generate annual sales of $3.2 billion by 2010.

Merck needs this financial shot in the arm to offset liabilities caused by Vioxx, its arthritis drug that may have caused almost 28,000 deaths, according to FDA estimates. Merck now faces some 4,000 lawsuits and potentially billions in payouts. In one Texas liability trial, lawyers produced documents and e-mails from Merck scientists discussing Vioxx’s potential heart risks as early as 1997, more than two years before it went on the market.

This history of hiding data has done little to reassure Gardasil skeptics. “It used to be that funding for research was provided by government,” says Canavan, the Maine legislator. “But now it comes from private corporations that stand to gain and the information can be – I won’t say skewed – but made to work for the company.”

What is clearly not working for Merck are the controversies around Gardasil that have derailed corporate plan to make vaccination mandatory and to capture the market before Glaxo releases its own vaccine.

The last few years have not gone smoothly for one of the world’s biggest drug companies. On September 30, 2004, after it became known that Vioxx was doubling the rate of heart attacks and strokes, Merck withdrew the painkiller and saw its stock plummet nearly 27 percent. Taking the drug off the market wiped out $2.5 billion in annual sales.

In 2005, Merck’s new chief executive officer Richard Clark announced a plan to cut the company’s world-wide work force by 11 percent or 7,000 jobs and to close or sell five of its manufacturing facilities. The company’s 2005 sales were down four percent and its net income had fallen by 20 percent. The company’s financial woes will not be eased by the fact that its patent for cholesterol drug Zocor, with $5 billion in sales, expired in 2006, while patents on other best selling drugs, including, Folsom and Cozaar, are nearing expiration.

Merck’s also announced on February 14 that it had signed an agreement that essentially brings to a close the U.S. Internal Revenue Service’s (IRS) examination of the company for the period 1993-2001. Under the agreement, the final net cash cost to Merck is expected to be approximately $2.3 billion which covers federal tax, net interest after federal tax deductions and penalties.” Merck, noted the “reasonableness” of the IRS settlement and said that it had reserved the funds so the payment would not impact 2007 earnings.

“As CEO, my priorities are clear,” says Clark, “meeting the needs of patients and building shareholder value.”

Those priorities are particularly hard to juggle given America’s love-hate relationship with pharmaceuticals. In 2004, 82 percent of the U.S. population reported that they had taken at least one prescription drug, over-the-counter medication, or dietary supplement in the previous week; 30 percent of respondents reported using five or more, according to a study by the Sloan Epidemiology Center at Boston University. Even kids are consuming drugs in great quantities. In 2005, according to an analysis performed by Medco Health Solutions for the New York Times, “approximately 1.6 million U.S. teenagers and children (almost 300,000 of whom were under 10) were given at least two psychiatric drugs in combination.”

At the same time as they are popping pills, Americans are widely distrustful of a pharmaceutical industry that has a long record of marketing wonder drugs with misleading advertising and dangerous side-effects. A 2007 health poll by the Kaiser Family Foundation found that fewer than 18 percent of Americans “say they can trust what pharmaceutical companies say in their ads most of the time.” Some 70 percent “agree that drug companies put profits ahead of people.”

By choosing to promote making Gardasil mandatory, Merck fell deep into the chasm between the public’s desire to see drugs as the cure for all ills and its profound skepticism that pharmaceutical companies put the public’s interests before profits.

“When we lose trust in company like pharmaceuticals or a group like Women in Government,” said Canavan from her home in Maine, “we start to become suspicious about everything. We need to have public dialogue. The point is not that the vaccine is bad, but that the public agenda has all been company-driven.”

©2012 An Inconvenient Woman. All Rights Reserved.

When GlaxoSmithKline announced that it would unveil head-to-head trial data on its HPV vaccine long after the fact and at a lesser-known meeting, folks speculated that the drugmaker might be embarrassed of the trial’s outcome. Not so–emphatically not so. The company trumpeted the comparative study, saying that its Cervarix vaccine prompted a much stronger immune-system response than Merck’s Gardasil did.

The Glaxo shot generated two times as many antibodies for one HPV strain than Gardasil did, the data showed, and more than six times as many for another. Plus, Cervarix  patients produced 2.7 times more memory B cells for HPV than patients who received the Merck vaccine. Another study due to be presented at the same conference found that Cervarix provided sustained antibodies against HPV through more than seven years of follow-up, the company said.

“The presence of neutralising antibodies at the location of the infection (the cervix) appears to be an important part of vaccine-induced protection against HPV,” said Glaxo’s R&D chief Thomas Breuer in a statement. “This study offers the first evidence that these two vaccines do not generate the same immune response.”

Merck was ready to rumble though; the Gardasil maker said that the comparative data isn’t clinically relevant because there’s no evidence a higher immune response actually made much difference to the long-term risk of developing cancer, Reuters reports. Sanofi Pasteur MSD, a joint venture between Merck and Sanofi that sells Gardasil in Europe, also got into the act: ”We see no clinical relevance in the results of this study … and we don’t see the point of doing such a comparison,” Bennett Lee, medical director, told the wire service. “If you want to compare vaccines, you compare clinical efficacy.”

Nonetheless, it’s something of a coup for Glaxo, which was betting the farm on Cervarix when it chose to pit its HPV shot against Merck’s. Now if only Glaxo can get Cervarix past the FDA, then it will really have a fight with Merck on its hands.

©2012 An Inconvenient Woman. All Rights Reserved.

Issued: Friday 8 May 2009, London, UK & Malmö, Sweden

Key results from three important studies of the cervical cancer vaccine, Cervarix®, will be available as of today at the 25th International Papillomavirus Conference (IPV) in Malmö, Sweden.

Comparative trial of Cervarix® and Gardasil® (Study 010)
Results from the first, large-scale comparative trial between licensed human papillomavirus (HPV) vaccines show that Cervarix® generated a significantly higher immune response compared to Gardasil® .1 The comparative study looked at two key measures of immune response, neutralising antibodies and memory B cells. Although the post-vaccination immune correlates of protection for cervical cancer are still unknown, neutralising antibodies and B cells are believed to play an important role in protecting women from HPV infection and subsequent cervical cancer over the long term.2-7 Across all ages studied (women 18 – 45 years), neutralising antibody levels for Cervarix ® were more than two times higher than those for Gardasil ® for HPV type 16, and more than six times higher for HPV type 18. These results were highly statistically significant  (p<0.0001).1 In addition, the proportion of women with detectable levels of neutralising antibodies in cervical secretions was higher in the group that received Cervarix® .1 Compared toGardasil® , GSK’s vaccine also produced nearly three (2.7) times more memory B cells for HPV types 16 and 18.1

Compliance with the full vaccination course was high and comparable for both vaccines8 which indicates that both were well tolerated. Rates of solicited symptoms were higher for Cervarix® with injection site reactions being most common.8 However, in both groups solicited symptoms tended to be of short duration. It is expected that the full results from this comparative study will be published in a peer reviewed journal.

Thomas Breuer, Head of Global Clinical R&D and Chief Medical Officer of GSK Biologicals commented: “The presence of neutralising antibodies at the location of the infection (the cervix) appears to be an important part of vaccine-induced protection against HPV. This study offers the first evidence that these two vaccines do not generate the same immune response against HPV types 16 and 18, the two most common cancer-causing virus types. We are confident that these results, along with new results from additional key studies being presented this week, demonstrate the potential of Cervarix® .”

Phase III efficacy trial (Study 008)
Results from the final analysis of the Phase III study (HPV-008) will be presented for the first time at the conference, showing that Cervarix® provided a high and statistically significant level of efficacy against pre-cancerous lesions associated with each of the HPV types included in the vaccine (HPV 16 and HPV 18).9  In addition,the data demonstrated that the vaccine also provided type-specific protection against pre-cancerous lesions associated with some additional common cancer-causing HPV types other than HPV 16 and HPV 18.10 In women without evidence of prior cancer-causing HPV infection the overall efficacy demonstrated against any lesion, regardless of HPV type, was much greater than would be expected for a vaccine targeting only HPV types 16 and 18.11

Rates of serious adverse events and medically significant conditions were similar between study and control groups.9 These data have been submitted to regulatory authorities including the US FDA and publication is expected in a peer reviewed journal.

Long term follow up study (Study 023)
Results from a third study to be presented in Malmö show that GSK`s cervical cancer vaccine provided high and sustained antibody levels against HPV 16 and HPV 18 through the 7.3 years of follow up after vaccination. This is the longest follow up reported to date for any licensed HPV vaccine.12

Jean Stéphenne, President and General Manager of GlaxoSmithKline Biologicals said, “Preventing cervical cancer is a public health priority in both developed and developing countries. We are pleased with these findings and how they can further the understanding of the role of Cervarix ® in helping to protect women against cervical cancer.”

Notes to editors

About HPV 008
The efficacy and safety results from the interim analysis of the HPV 008 study were previously published in The Lancet.13 The data presented at the 25th International Papillomavirus Conference (IPV) are from the final event driven analysis. Further follow up results will be forthcoming from the end of study analysis in due course.

About the HPV vaccines
Cervarix ® provides protection against the most common cancer-causing virus types – HPV 16 and 18.9 Gardasil ® provides protection against HPV 6, 11, 16 and 18.

Cervarix ® was specifically designed with a novel adjuvant, AS04, to deliver high and sustained levels of antibodies aimed at providing long-term protection against the most common and aggressive HPV types.14 It has been shown to be generally well tolerated. The most common symptoms after vaccination included pain, redness and swelling at the injection site.15

To date, GlaxoSmithKline’s HPV- vaccine, Cervarix ® has been approved in 95 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries including Japan and the United States. GSK also submitted the vaccine to the World Health Organization (WHO) for prequalification in September 2007.

About HPV and cervical cancer
Women are at risk of HPV infection throughout their sexually active lives.16 Approximately 100 types of human papillomavirus have been identified to date17 and, of these, approximately 15 virus types are known to cause cervical cancer.18 HPV types 16 and 18 are responsible for approximately 70 percent of cervical cancers globally, with types 45, 31 and 33 among the next most common cancer-causing HPV strains.19,20 Persistent infection with cancer-causing HPV types can lead to abnormal Pap smears, cervical pre-cancer and cervical cancer. Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer21 and 280,000 women will die from it each year.21

GlaxoSmithKline Biologicals - GSK Biologicals, GlaxoSmithKline’s vaccines business, is one of the world’s leading vaccine companies and a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 13 manufacturing sites strategically positioned around the globe. In 2008 GSK Biologicals distributed 1.1 billion doses of vaccines to 176 countries in both the developed and the developing world – an average of 3 million doses a day.

Through its accomplished and dedicated workforce, GSK Biologicals applies its expertise to discover innovative vaccines that contribute to the health and well-being of people of all generations around the world.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com

Cervarix ® is a registered trademark of the GlaxoSmithKline group of companies.

Gardasil ® is a registered trademark of Merck & Co., Inc.

©2012 An Inconvenient Woman. All Rights Reserved.

Cervarix won out over Merck’s Gardasil in the Netherlands, but has yet to be approved in the United States. That makes European market penetration vital for Glaxo.

“We are delighted with this decision and the fact that since Cervarix received European approval it has been selected as the cervical cancer vaccine for more than half of eligible tenders across Europe,” said Eddie Gray, president of Pharmaceuticals Europe for GSK. “We look forward to working with the Netherlands Vaccine Institute.” Globally, cervical cancer is the second leading cause of cancer death among women.

- check out GSK’s release

©2012 An Inconvenient Woman. All Rights Reserved.

GlaxoSmithKline’s (GSK) cervical cancer vaccine, Cervarix TM, was today confirmed by the Netherlands Vaccine Institute (NVI) as the cervical cancer vaccine for the Dutch National Immunisation Programme (NIP). GSK will supply Cervarixfor the programme, which aims to vaccinate all 12 year old girls.   A catch-up programme for all girls aged 13 to 16 will also start within the first half of 2009, with the aim of reducing the risk of HPV infection and cervical cancer for a broader group of Dutch girls.  The National programme for girls aged between 12 and 13 will commence in September 2009. It is estimated that more than 350,000 girls in total will be vaccinated with Cervarix in the first year.

“We are delighted with this decision and the fact that since Cervarix received European approval it has been selected as the cervical cancer vaccine for more than half of eligible tenders across Europe,” said Eddie Gray, President of Pharmaceuticals Europe for GSK.  “We look forward to working with the Netherlands Vaccine Institute to support the successful implementation of the Public Health vaccination programme so that girls in the Netherlands will benefit from the effective and sustained protection against cervical cancer which Cervarix offers.”

Cervarix has been designed specifically to protect against cervical cancer and has demonstrated high protection against HPV 16 and 18, which are responsible for approximately 70% of cervical cancers1 worldwide. With clinical data from over 6 years of follow-up, Cervarix has the longest duration of protection reported for any HPV vaccine to date.

In the Netherlands, the cervical cancer NIP has been added to the existing National Screening Programme that recommends women of 30 years and over have a PAP-smear test every five years in order to combat cervical cancer.  It is estimated that nationally, up to 700 women are diagnosed with cervical cancer and more than 200 die from the disease each year, making it the second biggest killer of women after breast cancer.2 Cervical cancer is the second leading cause of cancer death among women globally, killing one woman every two minutes.3,4 As well as the deaths associated with the disease, cervical cancer and pre-cancerous lesions are also a significant cause of emotional and physical distress in women.5Alongside screening and a healthy lifestyle, vaccination is expected to significantly reduce the lifetime risk of cervical cancer.6

Notes to Editors

About the Dutch National Immunisation Programme

From 2009, cervical cancer vaccination will be routinely recommended for all girls between 12 and 13 years of age (first year of secondary education). There will also be a catch-up programme in the first half of the year where girls aged 13 to 16 years will be offered the vaccine. Cervarix TM was selected as the cervical cancer vaccine for the Dutch National Immunisation Programme.

About cervical cancer and its progression

Approximately 100 types of HPV have been identified to date7 and, of these, approximately 15 virus types are known to cause cervical cancer.1 Virus types 16 and 18 are responsible for approximately 70% of cervical cancers.1 Persistent infection with cancer-causing virus types can lead to the formation of abnormal cells in the cervix, which, over time, may become precancerous or cancerous.8 Throughout their sexually active lifetime, women may be exposed to cancer-causing virus types. The majority of women will clear an infection spontaneously.  However, if the infection persists it can lead to precancerous lesions or cervical cancer.9

Experts believe that neutralising antibodies – so-called because they have the ability to neutralise cancer-causing virus types and prevent them from infecting cells in the cervix – are essential for cervical cancer protection, post-vaccination.10-12 The World Health Organization (WHO) states that neutralising antibodies are the likely mediatorof vaccine-induced protection from infection.11,12

Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and over 280,000 women will die from it each year.4

About the GSK Cervical Cancer Vaccine

CervarixTM has been specifically designed by GSK to provide women with protection against cervical cancer, targeting the two human HPV types, 16 and 18, that are responsible for over 70% of cervical cancer.1

To-date, GSK’s cervical cancer vaccine has been approved in more than 80 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 30 additional countries including Japan. In September 2007, GSK submitted CervarixTM to the WHO for prequalification, towards distribution across the developing world via the United Nations and the GAVI Alliance. GSK also submitted a Biologics Licence Application (BLA) to the U.S. Food and Drug Administration (FDA) for CervarixTM in March 2007.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com

GSK Biologicals (GSK Bio) -  is a global vaccine company which has shown itself to be a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Bio has 14 manufacturing sites strategically positioned around the globe. GSK Bio employs over 9,000 people worldwide including more than 1,600 passionate scientists engaged in research aimed at developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2007, GSK Bio distributed 1.1 billion doses of vaccines to 169 countries in both developed and the developing world – an average of 3 million doses a day. Of those vaccine doses, more than one in every ten doses delivered were combination vaccines intended to prevent up to six diseases in one vaccine.

CervarixTM is a trademark of the GlaxoSmithKline group of companies.

©2012 An Inconvenient Woman. All Rights Reserved.

Merck and Glaxo PR hacks continue to deluge all media with “My Vaccine is Better than Your Vaccine” commercial jingles, youtube videos, interviews, dueling scientific papers, and lobby bucks, lots and lots of lobby bucks.

It’s no mystery why Merck and Glaxo are jostling for ascendancy here. Estimates of the market for HPV- vaccines run to several billions, even if their use was restricted to prevention of cervical cancer. And anyone who doesn’t expect ‘HPV vaccine mission creep’ hasn’t noted Merck’s well-documented market penetration Modus operandi.

My favorite Big Pharma newsletter, FiercePharma, reported on the media wars

It’s Merck v. Glaxo in vaccine battle

Call it the battle of the HPV vaccines. For the past week, either Merck’s Gardasil or GlaxoSmithKline’s Cervarix–or both–have captured headlines:

• Glaxo submits Cervarix for approval in Japan
• Merck donates millions of Gardasil doses for use in developing countries
• Glaxo applies for vaccine prequalification from the WHO
• Gardasil wins best new biotech product
• Cervarix approved for sale in Europe
• Merck hires PR firm to advocate for Gardasil
• Sanofi Pasteur files to extend Gardasil treatment

It’s no mystery why the drug makers are jostling for ascendancy here. Estimates of the market for these vaccines run to several billions, even if their use was restricted to prevention of cervical cancer.

Now there’s evidence that Gardasil may protect against cancers of the vagina and vulva, further bolstering its usefulness for women. Other research shows that HPV may cause throat and neck cancer in men, thus boys may need one of the vaccines, too–creating a whole new, unexpected market. So the stakes are even higher than they first seemed. And they were pretty darn high to start with.

©2012 An Inconvenient Woman. All Rights Reserved.