- The product information of the four-type (6,11,16,18) human papillomavirus (HPV) vaccine Gardasil® has been updated to include the clinical efficacy and safety information of the vaccine for women up to 45 years of age.*,1

In a clinical study which included 3,819† women between 24 and 45 years of age, among those who were not infected with the relevant virus type at vaccination‡ and who received all three doses of the vaccine (3,351 women§, Gardasil® prevented 90.5%** of HPV 6-, 11-, 16-, or 18-related persistent infection, cervical lesions (CIN††) of any grade, adenocarcinoma in situ (AIS), cervical cancer, vulvar and vaginal lesions and genital warts.1,2

Gardasil® was generally well tolerated and demonstrated a good safety profile with fever as well as redness, swelling and pain at the injection site as the most commonly reported side effects.1,2

“Vaccination recommendations or campaigns from health authorities will continue to focus on adolescent girls. However, women may remain at risk of HPV infection and developing related diseases during their adult life. Women should be aware of the efficacy and safety of Gardasil® up to 45 years. They should make an informed decision about individual vaccination following discussion with their doctors taking into account their personal and HPV disease histories“, says Professor Xavier Bosch from the Catalan Institute of Oncology in Barcelona, Spain.

All women should continue regular screening for early detection of cervical cancer whether they have been vaccinated or not. Gardasil® is a preventive vaccine and can therefore not treat preexisting infections or disease. The vaccine cannot protect against all HPV types.

Gardasil® is the only HPV vaccine to have clinical efficacy and safety for women up to 45 years added to its product information. Gardasil® is a four-type (6,11,16,18) HPV vaccine. In addition to unsurpassed and sustained cervical cancer protection, Gardasil® can protect from cervical, vulvar and vaginal pre-cancer, and from genital warts caused by HPV types 6, 11, 16 and 18. These four types together cause the vast majority of HPV-related genital diseases.1,3,4,5

©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.

Fresh controversies are heating up over the marketing of products to prevent cervical cancer

The U.S. Food & Drug Administration is gearing up to make critical decisions about two controversial vaccines. On Sept. 9 an FDA advisory committee will consider whether Merck (MRK)’s Gardasil, given to girls to prevent cancer-causing human papilloma virus (HPV), should be approved for use in boys, who can be HPV carriers. The same panel will also advise the agency on whether it should allow a new HPV vaccine, GlaxoSmithKline (GSK)’s Cervarix, to enter the U.S. market. The FDA doesn’t have to follow its panels’ recommendations, but it usually does.

Sales of Gardasil to prevent cervical cancer hit a respectable $1.4 billion last year, but they are already starting to slump, and fresh controversies could pour more cold water on this whole class of vaccines. Ever since Gardasil was approved in 2006, health-care watchdogs have griped that Merck has been overselling the vaccine’s cancer-beating power without having a full understanding of potential long-term risks. On Aug. 19, Columbia University professors Sheila M. and David J. Rothman published an article in the Journal of the American Medical Assn. blasting the company for paying grants to medical organizations that are strong advocates for vaccination. “Telling every mom she needs to get her daughters vaccinated to protect them from cancer is creating a market out of thin air,” David Rothman says. “They’re already protected” through regular pap smears, he adds.

Such criticisms mark a stark turnabout for a product once hailed as a breakthrough. Cervical cancer is a scourge: 11,000 cases are expected to be diagnosed this year, and 4,000 women will probably die of the disease, says the National Cancer Institute. The vaccine could prevent more than 70% of such cases. But from Day One, Merck has been lambasted for tactics such as lobbying lawmakers to make vaccination mandatory. After a strong start in the first two years, Gardasil sales fell 5% in 2008 and second-quarter sales are down 18% from a year earlier.

Dr. Richard M. Haupt, who heads the Gardasil research program for Merck, defends the company’s marketing. “Our goal is to act in the best interest of public health,” he says, noting that many organizations have spent money to promote the cause. Should boys be vaccinated? Merck has given the FDA data showing Gardasil prevents 90% of HPV symptoms in men, but since related male cancers are rare, the main justification is to protect their partners from cervical cancer. (Gathering data is also dicey because even if there were a drop-off in cases after widespread male vaccination, Merck could never prove its vaccine deserved more of the credit than, say, improved screening.)

Glaxo, for its part, doesn’t plan to market Cervarix to boys because it doesn’t think the strategy would be worth the expense. The Centers for Disease Control estimates that vaccinating males would cost the health-care system at least twice as much per year of added life as it costs to vaccinate females.

As for payments to medical organizations, Glaxo, Merck, and their beneficiaries say their disclosures are adequate. Two recipients, the American College of Obstetricians & Gynecologists and the Society of Gynecologic Oncologists, say they put the money to many uses beyond endorsing a specific vaccine. Meanwhile, Merck’s Haupt says the scandals are drawing attention away from what could be a public health boon. “I vaccinated both my daughters,” says the father of four. And if Gardasil is approved for boys, he says, “I plan to vaccinate both my sons.”

Arlene Weintraub is a senior writer for BusinessWeek‘s Science & Technology department and published this article in Businessweek, online August 27th, 2009.

©2012 An Inconvenient Woman. All Rights Reserved.

This week has shown that a large number of reports stating that Gardasil is proving unsafe. News stations around the world have reported that Gardasil the HPV vaccine has been found to cause adverse reactions. The adverse reactions range from mild, such as headaches, nausea and fainting, to the more severe such as seizures, blood clots, Guillian Barre Syndrome and even death.

Christina England, The American Chronicle

This week has shown that a large number of reports stating that Gardasil is proving unsafe. News stations around the world have reported that Gardasil the HPV vaccine has been found to cause adverse reactions. The adverse reactions range from mild, such as headaches, nausea and fainting, to the more severe such as seizures, blood clots, Guillian Barre Syndrome and even death. This information has come to light since the publication of the
JAMA papers on the 19th August 2009, showing the results of the VAERS Vaccine Adverse Event Reporting System. The Gardasil data published was collected from June 1, 2006 through December 31, 2008.

Merck has only recently changed packaging showing acknowledgement that this vaccine causes fainting and seizures in some children.

Information Pertaining to Labeling Revision for Gardasil

“On June 9, 2009, the Food and Drug Administration (FDA) approved a revised label for Gardasil, a vaccine to protect against cervical, vulvar and vaginal cancers caused by Human Papillomavirus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11. In the new label, information pertaining to syncope (fainting) is now also included in the Warnings and Precautions section, and this section has new information noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity. The addition of syncope to the Warnings and Precautions section emphasizes that healthcare providers and consumers should be alert that fainting may occur following vaccination with Gardasil, sometimes resulting in falling and injuries. To prevent falls and injuries all vaccine recipients should remain seated or lying down and be closely observed for 15 minutes following vaccination.”

Cynthia Janak a USA journalist has been writing and proving this vaccine is unsafe for the last few years. Her website Only the Truth gives tribute to the many girls who have lost their life after taking Gardasil shots. This site points out and lists the adverse reactions, showing pictures of beautiful young woman now no longer with us, other pages have stories of girls suffering every day from the adverse reactions to this vaccine. There is up to date news and views on Gardasil.

News stories have been hitting America for three years about the dangers of this vaccine. Stories like this one 2007 Did Gardasil Vaccine Cause a 12-yr-old Girl’s Paralysis and Girl Dies after HPV Jab – CDC Blame Birth Control Pill

Merck says however, Merck Says FDA And CDC Reaffirm Safety Profile Of Gardasil – Update

“Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks.”

Confusing that because if Merck were so convinced that their vaccine was safe why have they recently changed the labelling?

Diane Harper who worked on the Gardasil trials has reservations. Harper told CNN she has concerns about the safety of the HPV vaccine for pre-adolescents, noting that a small number of girls have died or suffered neurological damage after receiving the shot.

However, despite the controversy surrounding this vaccine, with much information proving it to be unsafe, it appears not only is still being offered to teenage girls across the USA and the world today but is a mandatory vaccine for immigrants wanting to come into the USA. In a sickening story in a letter passed to me a grandmother who has been raising her grandchild and was trying to escape to the USA from domestic violence was refused entry because she refused after researching Gardasil. to let her grandchild have it. The letter also shows 140 immigration rights, women´s rights, public health, medical, and reproductive justice organizations including an attorney have joined a coalition in NYS.The letter to the CDC was written as the author felt the vaccine activists might want to know the names of political organizations opposing the US immigration regulation that requires immigrants receive the Gardasil shot.

So why is it that USA citizens in many states have the option to choose whether they or their children have the HPV vaccine but immigrants can not? In order to become a permanent, legal resident of the U.S, immigrants now must receive a vaccine that is not required of U.S. citizens. This is like saying these people are less important or more likely to be infected. This surely is wrong.

For The complete article go to: http://www.americanchronicle.com/articles/view/115767

Christina England is a  UK journalist studying for an HND in journa and a member of ICAP International Coalition of Advocates for the People
i.c.a.p.org

©2012 An Inconvenient Woman. All Rights Reserved.

In the wake of new safety data on Merck’s human papillomavirus vaccine, both FDA and the Centers for Disease Control and Prevention have issued a statement supporting the product. “Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks,” the agencies said, calling the vaccine an “important cervical cancer prevention tool.”

Earlier this week the Journal of the American Medical Association published an analysis of safety data that found the most common serious side effect was fainting, though some more severe adverse event occurred in Gardasil patients, including more than two dozen deaths. But the FDA and CDC say there’s no evidence the deaths or other severe effects were actually caused by the shot, and the agencies emphasize that they have reviewed the same safety data repeatedly.

In response to the government support, Merck sought to reassure parents, encouraging them to “look to the CDC and FDA, and to the advice of their own physicians” to help them decide whether to have their children vaccinated. ”We hope that the many parents who may have been frightened this week by misleading reports understand that Merck people are parents, too,” Dr. Richard Haupt, who heads up the Gardasil program, said in a statement. “Our own children are vaccinated with Gardasil.”

- see the FDA/CDC statement
- read the release from Merck
- get the story in the Wall Street Journal

©2012 An Inconvenient Woman. All Rights Reserved.

The latest issue of JAMA delivered a mixed blessing to Merck’s Gardasil. In a headliner study published by the Journal of the American Medical Association, the side effects of the human papillomavirus shot were deemed reasonable. Serious adverse events cropped in up those who got the vaccine–including some 32 deaths and two cases of Lou Gehrig’s disease–but there’s no evidence the shot actually caused them. The most common complications were fainting and clot risk.

Overall, there were 54 adverse event reports for every 100,000 doses, and some 6 percent of those were serious. “We feel confident recommending people get the vaccine; the benefits still outweigh the risks,” Dr. Barbara A. Slade, lead author and a medical officer with the Centers for Disease Control and Prevention, told the New York Times. The company sent out a release touting the news: “We are pleased that the study published by JAMA today further reinforces the safety profile of Gardasil,” Merck’s Richard Haupt said in a statement.

That’s the good stuff. The not-so-good: JAMA asks in an editorial whether any level of risk is appropriate in the case of HPV vaccination. “I wouldn’t accept much risk of side effects at all in an 11-year-old girl, because if she gets screened when she’s older, she’ll never get cervical cancer,” the editorial’s author, Dr. Charlotte Haug, told the Times.

And another JAMA study dropped a bombshell: Merck gave money to three medical societies to fund their promotion of Gardasil.

Researchers from Columbia University said the American College Health Association, the American Society for Colposcopy and Cervical Pathology and the Society of Gynecologic Oncologists used Merck funding on educational materials and lectures that offered lopsided information about the vaccine’s risks and benefits. “I think what happened here was that marketing and medical education got blurred,” co-author Sheila Rothman told the Washington Post.

“This shows how [Merck was] able to influence physicians,” Diane Harper of the University of Missouri, who helped test the vaccine, told the paper.

Merck, however, says that the $750,000 it gave to those three groups was intended to help them develop “independent” information for their membership. “[O]ur activities with these societies were done in an appropriate and independent manner,” Haupt said. The groups themselves say the funding didn’t affect the content of their materials or programs.

Read the Merck release

- check out the NYT story

- See Washington Post Article:

- read the news from FirstWord

-  find the AP story

©2012 An Inconvenient Woman. All Rights Reserved.

Merck (MRK) is expected to report Q2 earnings Tuesday, July 21, before market open, with a conference call scheduled for 8:30 am ET.

Guidance

Analysts are looking for EPS of 77c on revenue of $5.84B. The consensus range is 75c-79c for EPS, and $5.70B-$5.98B for revenue, according to First Call. On April 21, Merck reaffirmed its FY09 EPS guidance of $3.15-$3.30 versus a consensus of $3.25.

Analyst Views

Possible positive drivers for Merck this quarter might be seen in its Singulair and Januvia sales. Weighing on this quarters earnings will be the loss of patent protection on Fosamex and slower Gardasil sales. Sales of cholesterol drugs Vytorin and Zetia, co-marketed by Schering-Plough (SGP), might also be disappointing especially in a weak economy with cheaper alternatives.

In late June, UBS mentioned Merck cautiously, citing May as another weak month for Merck’s U.S. vaccines franchise.

On July 9, Natixis downgraded Merck to Hold from Buy.

©2012 An Inconvenient Woman. All Rights Reserved.

Merck’s HPV vaccine, Gardasil, was approved by the FDA and endorsed by the Center for Disease Control (CDC)  in June of 2006. According to the Merck marketing literature, the $360, three shot-series of Gardasil, administered over six months, protects against two HPV strains that cause nearly 70 percent of cervical cancer cases and also prevents two other strains linked to 90 percent of genital warts cases. The nationwide rollout of Gardasil  was accompanied by an award-winning marketing blitzkrieg that helped raise the profile of HPV through a large-scale communications campaign, highlighted by the “Tell Someone” TV adds shown on channels with high-teen viewer-ship. Additionally, Merck waged an extensive lobbying campaign in State-houses, Congress, city councils and regulatory agencies.  Merck & Company carpet bombed the halls of power with cash, goods, services and favors to be named later. The ‘Charm and Cash Offensive’ yielded early victories amongst Federal regulators and ‘soft target’ states.

By early 2007, Wall Street analysts predicted Gardasil would generate $2 billion to $4 billion that year even without the sought-after State mandates. The State mandates offered legal cover and protected Merck shareholders from future vaccine liability losses. Based on projected Gardasil sales, the 2006 Merck Annual Report promised shareholders excellent market share and increased dividends. Good news indeed, for shareholders battered by the losses Merck endured after it pulled Vioxx off the market in 2004 (Vioxx, an FDA-approved anti-inflammatory drug for osteoarthritis and acute pain that was used by 2 million people, was linked to increased risk of heart attack and stroke.)

Things were finally“looking’ good in the Merck neighborhood”…until the public  started to question why politicians were moving so quickly to Mandate the very expensive, newly released, HPV vaccine for school girls.

Critics pointed out that this vaccine is not to prevent childhood disease like mumps, measles or chicken pox…contagious  diseases that can move through schools quickly, effecting large numbers of children. Gardasil is a vaccine for a  sexually transmitted virus, that if left undetected by regular PAP screening, could lead to cervical cancer in a woman’s later years. Gardasil ‘protects’ girls from cervical cancer, the most easily detected and treatable of all the cancers that affect women.

Once a major killer in the U.S., cervical cancer has been nearly wiped out since the creation of the Pap test, which detects precancerous lesions and early cancer, and is credited with a 74 percent drop in cervical cancer deaths since 1955.

The CDC says most cervical cancer diagnoses in the U.S. are in women who either have never had a Pap test or have not had a Pap test in the previous five years. Those inoculated with Gardasil still will have to have regular Pap tests for the disease, which is hard to detect because it does not usually cause pain.

Cervical cancer does have high mortality rates in low-income regions of U.S. and poor nations where health care coverage is not routine. Cervical cancer is the fifth most common cancer among women worldwide, according to the World Health Organization, and kills about 230,000 women a year, most in developing countries. Because of these figures, public health officials still back use of the vaccine.( Note: When Merck is making it’s pitch for the need for Gardasil, they always quote the World HPV infection rates and Cervical cancer deaths, not the cervical cancer numbers for the United States.)

“The vaccine is not nearly as effective as vaccines for mumps or measles, but it is an important step forward in public health,” said Dr. John Swartzberg, director of public health policy at the University of California at Berkeley. “The vaccine will decrease the two most common strains of HPV that cause cancer, and we’ll be left with strains that have far less potential to cause cancer. In this case, the benefits outweigh the risks.”

That sounds like a great justification for childhood inoculation
until you start thinking about everything we just don’t know yet…

As with any new drug, there are potential risks that short-term studies used for federal approval don’t detect. Dr. Clayton Young, an obstetrician-gynecologist in Texas, is concerned that Gardasil will actually strengthen cancer-causing strains of HPV.

“My concern is that we are pushing ourselves into something worse than we already have,” Dr. Young said. “Vaccinating for only two strains may lead to an increase in infection with other and possibly more aggressive strains.”

Gardasil is effective against two of 10 carcinogenic HPV strains. In the United States, those two strains dominate the current statistics, estimated to have caused 6,800 new cervical cancer cases in 2006, while the other eight strains combined affected 2,900 women.

In answer to the issue of Gardasil possibly producing  more aggressive HPV strains, Dr. Haupt, executive director of medical affairs in Merck’s vaccine division, has said, “The probability of additional cancer-causing HPV strains leading to as many cervical cancer cases as today is minute.” Despite Merck’s doubt, the company is studying the additional cancer-causing HPV types in Scandinavian countries, where national cancer registries allow drug companies to track people with the disease. “It is an important issue to us,” Dr. Haupt said. “But we think the two types of HPV that Gardasil work for are unique, and if other types become more common, they will not cause cancer at the same rate and won’t over time.”

What about Merck’s early lobbying push for State mandated Gardasil shots for school girls?

State mandated Gardasil shots for preteen girls to protect them from the viruses that causes cervical cancer, are targeting the wrong age group.

Middle-school girls inoculated with the HPV vaccine will be no older than eighteen when they pass Gardasil’s five-year window of proven effectiveness  — more than a decade before the typical cancer patient contracts the sexually transmitted human papillomavirus (HPV). Merck & Co. has repeatedly refused to respond to requests for its HPV incubation statistics, stating that it is still studying the longevity of Gardasil.

Infectious disease specialists and cancer pathologists say the incubation period for HPV becoming cancer is 10 to 15 years — meaning the average cervical cancer patient, who is 47, contracted the virus in her 30s and would not be protected by Gardasil taken as a teen.

“It is a delicate balancing act,” said Debbie Saslow, director of breast and cervical cancer control at the American Cancer Society. “If the vaccine is given at too young an age, it may wear off. Yet if it is given too late, it won’t work”

Lets Look At The Numbers

In July of 2007, the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, endorsed the Gardasil inoculation for girls 11 to 12 and Merck lobbyists persuaded  lawmakers and regulators to start the fast-track push for  mandatory HPV vaccination legislation.

Dr. Joseph Bocchini, chairman of the committee on infectious disease of the American Academy of Pediatrics, says HPV can take up to 20 years to cause cervical cancer. “It can occur more rapidly, but very commonly, it is a 20-year period before it leads to cancer,” said Dr. Bocchini, whose group has endorsed HPV vaccinations on 11- and 12-year-olds but has withheld support for its mandated use.

Even when applying a longer 20-year incubation period, requiring Gardasil for sixth-grade girls, as nearly all the current and proposed legislation does, would not prevent the overwhelming majority of cervical cancer cases in the U.S.

American Cancer Society numbers show that from 2000 to 2003, more than 70 percent of cervical cancer patients were older than 40 — still outside Gardasil’s five-year protection window if given to sixth-graders.

Merck is working on a booster shot to extend Gardasil’s five years of protection. “We are aware of some evidence of immune memory. But if a booster shot is necessary, it would likely be another dose of Gardasil,” Dr. Haupt said.

Vaccine boosters vary in longevity. A ‘hepatitis B’ booster is required every 10 years, while others can provide lifelong immunity. None of the current or proposed HPV vaccine legislation addresses the potential for booster inoculations that could fall outside the enforcement mechanism — rules that bar students from school unless they have the required shots.

According to the CDC, seventy percent of females are sexually active by age 18. “The point in vaccinating kids 9 to 12 is not to reduce number of cases found in that age group, but to vaccinate prior to beginning sexual activity,” said CDC spokesman Curtis Allen. “The benefits of the vaccine decrease as women age because they are more likely to have already been infected by one of the HPV strains.”

But based on cancer statistics, cervical cancer incubation periods, and the five-year life-span of Gardasil, state lawmakers — who have billed the inoculations as a cure to cervical cancer — would have a much greater effect on cervical cancer rates by mandating its use later. Cervical cancer rates are less than one per 100,000 women until age 20 and then begin to pick up in the late 20s and early 30s. Thus, women who likely contracted HPV in their early 20s could be protected by Gardasil taken at 17 or 18.

In April 2006,  Lancet, a British medical journal published a study that concluded the GlaxoSmithKline HPV vaccine, Cervarix, is effective for 4½ years. Cervarix is not yet licensed for use in the United States, but is in wide use throughout Europe. So the targeted age group is a problematic for the EU legislators proposing mandatory HPV vaccination polices as well.

What is the probability of a school girl in America contracting cervical cancer later in her life?

Dr. Mona Saraiya, a medical epidemiologist in the Division of Cancer Prevention and Control at the CDC, says nearly all sexually active woman are exposed to HPV.

“However, only a few will get an infection that stays and won’t go away, and only a portion of those will get a precancerous lesion. At that point, only a few will eventually develop cervical cancer,” Dr. Saraiya said.

Fewer than one-hundredth of 1 percent of the 108 million U.S. women older than 18 (0.009 percent) get cervical cancer and even fewer die from it. There were an estimated 9,700 new cervical cancer cases and 3,700 fatalities in 2006, according to the American Cancer Society.

But the fact that very few U.S. women are affected by cervical cancer, hasn’t stopped the rush by lawmakers to push mandatory HPV vaccines for school girls.

“The number one problem with the vaccine is that it has not been tested adequately on the group that is recommended to get it,” said Dr. Joseph DeSoto, a fellow in the American Institute of Chemists and a physician-scientist at the National Institutes of Health.

According to Merck’s clinical study documents on Gardasil, 20,541 women ages 16 to 26 participated in four studies. The documents show some data is available on 9-year-old girls related to immune responses to the vaccine but not whether it prevents cancer.

Because most 9-year-old girls are not sexually active, it is not possible to test the effectiveness of Gardasil against cervical cancer, Dr. Haupt said. Instead, the clinical trials measured antibody responses against HPV as a proxy for cervical cancer.

Merck conducted two clinical trials that involved 1,121 girls ages 9 to 15, according to Merck’s labeling documents for Gardasil.

“The clinical trials tested younger girls, but they only looked at immune response to the vaccine, not whether it prevented cervical cancer,” Dr. Young said. “It has not been studied long enough to know that it prevents cervical cancer.”

Will Gardasil be a Mandated Vaccine For ALL American School Girls?

Well before FDA regulators approved the HPV vaccine, Gardasil,  in mid-2006, Merck’s lobbyists had started “Education Programs” aimed at State Representatives, Governors, and special interest groups to instigate a rapid deployment plan to mandate the Gardasil vaccine  for school girls around the country. In early 2007,  reacting to a furor from some parents, advocacy groups, public health experts, and after several public relation disasters precipitated by inept politicians like Texas Governor Rick Perry, ‘ham-handed’ Executive Order mandating the Gadasil shot for every school girl in Texas, Merck said that it would stop lobbying state legislatures to require the use of its new cervical cancer vaccine. The speed with which legislatures and other Government officials moved to require use of the vaccine before school entry has galvanized critics. Some say making a vaccine mandatory would pre-empt parental choice; others contend that protection from a sexually transmitted virus would encourage promiscuity. These voices were joined by others worried about the influence of pharmaceutical companies over our “Representative” Government. Many of the legislators who have sponsored some of the state laws to make the vaccine mandatory, are members of  Women in Government. WIG is a non-profit organization that is heavily subsidized  by Merck.

Merck representatives are quoted as publicly stating the company would stop lobbying specifically for state mandates, many of which would require girls to be vaccinated before they entered sixth grade. Merck made the decision to stop lobbying legislators  after realizing that their campaign had fueled objections across the country that could undermine adoption of the vaccine.

Dr. Richard M. Haupt, executive director for medical affairs in Merck’s vaccine division, said the company had acted after hearing from public health officials and medical organizations that its campaign was counterproductive. “They believe the timing for the school requirements is not right,” Dr. Haupt said, adding: ”Our goal is to prevent cervical cancer. 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.”

But Dr. Haupt said that Merck would continue to provide health officials and legislators with education about the vaccine and would continue to lobby for more financing for vaccines in general. Public Interest groups continue in their attempts to track the  money and staff resources Merck had expended in its efforts to require use of the cervical cancer vaccine.

Dr. Larry K. Pickering, executive secretary of the Advisory Committee on Immunization Practices, the federal panel that originally recommended the vaccine’s use, applauded Merck’s decision to stop lobbying. ”They finally are going to stop doing that, which all of us will be happy about,” he said. Dr. Pickering, who works at the Centers for Disease Control and Prevention, said that while the vaccine was useful, more data on its safety, effectiveness and cost was needed. Objections to the vaccine could undermine its use. ”I think it has been somewhat counterproductive. Anything that takes away from the process of getting vaccine into people is deleterious to the whole process.”

Merck Put A Noble Spin to Getting Caught Handing Out Cash For Legislative Favors

“Merck’s goal is to support efforts to implement policies that ensure that Gardasil is used to achieve what it was designed to do: help reduce the burden of cervical cancer — the second-leading cancer among women around the world — and other HPV-related diseases for as many people as possible, and as quickly as possible,” Merck’s Dr. Haupt said about its lobbying efforts.

If you are concerned about the possibility of legistlation concerning mandatory HPV vaccines for school girls keep your eye on your representatives.

The current Merck position on lobbying is all about “For Now”.
Merck has only been delayed, not deterred.

©2012 An Inconvenient Woman. All Rights Reserved.

On June 16, 2009 The FDA issued the following product recall. The recall was triggered when the FDA received more than 130 reports of anosmia associated with the use of Zicam zinc-containing intranasal products. FDA is alerting consumers that Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size, a discontinued product that consumers may still have in their homes, have all been associated with long lasting or permanent loss of smell (referred to as anosmia).  These products, marketed by Matrixx Initiatives, are zinc-containing, nasal cold remedies used to reduce the duration and severity of cold symptoms.

The FDA has received more than 130 reports of anosmia from patients who used zinc-containing nasal products, said Dr. Charles Lee, medical officer at the FDA’s Center for Drug Evaluation and Research.

The agency also issued a warning letter to Scottsdale, Ariz.-based drug maker Matrixx Initiatives Inc. to stop marketing the products and seek FDA approval if it wants to keep them on the market.

Matrixx issued a statement on the FDA’s action on Tuesday afternoon. “The company believes the cumulative body of independent scientific and medical evidence supports both the safety and efficacy of Zicam intranasal cold remedy products,” the statement reads. ”Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia. For this reason, Matrixx Initiatives believes that the FDA action is unwarranted and will seek a meeting with the FDA to review the company’s product safety data.

Right about now, my Inconvenient Women readers are probably asking the same questioned that popped through my head when I read the FDA recall.

Are you telling me that the FDA will pull an over the counter product off the shelves for 130 adverse event reports; and will do NOTHING about the Merck HPV vaccine, Gardasil!

The families of the thousands of girls and young women who have suffered adverse effects after being injected with Gardasil, and those who mourn the over twenty young women who have died after taking the HPV vaccine have to be wondering, why the FDA moved so decisively to remove an over the counter cold medicine, yet the only consession the FDA has made about Merck’s Gardasil has been to issue a “Warning About Fainting” after the Gardasil injection. Am I the only one who thinks the FDA’s safety priorities are skewed? Looking at the Gardasil-related injuries,  the FDA recall of a cold remedy that has injured 130-people is a head-shaker. I’ve included the FDA contact information at the close of this Blog. Call or write the FDA if you feel they should be as proactive about the dangers posed by Merck’s Gardasil as they are over a cold medication that might effect a sense of smell.

Zicam Recall Information

FDA recommends that consumers stop using these products and throw them away.  See the FDA website for How to Dispose of Unused Medicines.

For treating symptoms of the common cold, consumers can take a number of other over-the-counter drugs.  However, the common cold goes away without treatment, usually within seven to ten days.

Since the introduction of Zicam Cold Remedy Nasal Gel to the market in 1999, FDA has received more than 130 reports of anosmia associated with the use of Zicam zinc-containing intranasal products.  The reports vary.  Many people state that the loss of sense of smell occurred with the first dose of the Zicam product, although some people report it happened after later doses. The loss of sense of smell may be long-lasting or even permanent in some people.

Loss of the sense of smell may cause serious problems, such as failing to smell smoke, a gas leak, or spoiled food.  Also, loss of the sense of smell is often linked with a loss of the sense of taste.  People who cannot taste could unintentionally eat spoiled food and not appreciate flavors, and lose much of the pleasure of eating.

FDA recommends that consumers contact their healthcare provider if they experience loss of the sense of smell or taste, or experience other problems after using any zinc-containing nasal products.

Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.

©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.