I thought Nick’s response warranted reposting here. In the spirit of full disclosure, Nick Batik is my husband and partner in Pleiades Publishing Services and the designer of the Iconic Woman and  Holy Hormone sites.

Gardasil, By The Numbers

I view the question of Gardasil more from and economic prospective:

US 2000 Census places girls age 10-14 at 6.9% of the total female population of 151,627,727.
That would be 10,462,313 girls.

Gardasil is currently on the market for $120 per single dose. Three doses are required over a 6-month period, making the total cost for the HPV vaccine $360. On top of that, some doctors are charging office visit fees when the vaccine is given.

That would be a total expenditure of $3,766,432,680 not including office visits. In your article you state that 11,070 cases of cervical cancer were reported in the US. Assuming that 100% of those could be prevented by Gardasil (which it cannot – it only affect 4 of the 72 variations) that would be a cost per case of $340,238.

If you look at the 11,070 reported cases, 3,870 resulted in death. If you measure the cost of Gardasil based on the lives saved (again assuming 100% save rate), that would be $973,238 spent per life. It should be noted that 7,200 (65%) did not die, and that had nothing to do with Gardasil.

Recent congressional reports indicate that an increasing number of cancer related deaths are due to “lack of access” to health care, as opposed to the failures of current treatments. The relatively high cost of the vaccine is just as much a barrier to the poor and uninsured – those most at risk.

The World Health Organization states that there are a number of low-cost, highly effective diagnostic screening options (e.g. PAP test – avg. $27 USD*) and that cervical cancer is one of the most treatable (with access to health care).
*NOTE:  Using PAP Test Recommended guidelines for most women from:
http://www.womenshealth.gov/faq/pap-test.cfm#pap04

• If you are younger than 30 years old, you should get a Pap test every year.
• If you are age 30 or older and have had 3 normal Pap tests for 3 years in a row, talk to your doctor about spacing out Pap tests to every 2 or 3 years.
• If you are ages 65 to 70 and have had at least 3 normal Pap tests and no abnormal Pap tests in the last 10 years, ask your doctor if you can stop having Pap tests.

It would be a reasonable expectation for a woman to have 25 PAP test throughout her lifetime. At $27 USD per test, a woman would invest $675 USD for a life time cervical cancer prevention plan.

Lets be real clear here — even with the Gardasil HPV vaccine the current medical direction is to continued with your regular PAP test schedule. So why risk the possible side effects of the vaccine?

One great unanswered question: increasing outbreaks of diseases though to be eradicated or under control has shown that the efficacy of inoculations given to school age children diminishes over time. Since cervical cancer does not manifest in most women until after age 40, will the Gardasil treatment still be effective, or will it need to administered again?

Considering the number of high-death rate diseases, is this REALLY the best use of our limited health care resources?

Resources:
http://factfinder.census.gov/servlet/STTable?_bm=y&-geo_id=01000US&-qr_name=ACS_2007_3YR_G00_S0101&-ds_name=ACS_2007_3YR_G00_

©2012 An Inconvenient Woman. All Rights Reserved.

The Environmental Protection Agency is poised to rule that it will not set a drinking-water safety standard for perchlorate. This component of rocket fuel has been linked to thyroid problems in pregnant women, newborns and young children across the nation.

The story broke last week in a number of major newspapers; but was pushed to the back pages by the looming “debt-bomb” about to dropped on the taxpayers in the name of friendly fire from our elected representatives. No one in good conscious could refer to anyone in Washington, of any political stripe, as “leaders”, but that is another story for another day.

The EPA’s “preliminary regulatory determination” estimates that up to 16.6 million Americans are exposed to perchlorate at a level many scientists consider unsafe. Independent researchers, using federal and state data, have put the number at 20 million to 40 million.

Most perchlorate contamination in U.S. drinking water is the result of improper disposal by rocket test sites, military bases and chemical plants. A nationwide cleanup could cost hundreds of millions, if not billions, of dollars, and several defense contractors have threatened to sue the Defense Department to help pay for it if one is required. The Government Accountability Office reported this spring that the Pentagon had pressured the EPA for several years not to regulate perchlorate.

“They have distorted the science to such an extent that they can justify not regulating” the chemical, said Robert Zoeller, a University of Massachusetts professor who specializes in thyroid hormone and brain development and has a copy of the EPA proposal. “Infants and children will continue to be damaged, and that damage is significant.”

Zoeller said scientific studies have shown that a small reduction in thyroid function in infants can translate into a loss of IQ and an increase in behavioral and perception problems. “It’s absolutely irreversible,” he said. “Even small changes in thyroid functions early on have impacts on functioning through high school and even into people’s 20s.”

According to a Washington Post article, OMB officials deleted any references to those studies in the EPA’s proposal.

The current EPA document states that establishing a drinking-water standard for perchlorate “would not present a ‘meaningful opportunity for health risk reduction for persons served by public water systems,’ ” but it also reveals that many Americans will be exposed to the compound at levels higher than recommended if nothing is done to remove it. Perchlorate impedes the functioning of the thyroid gland, which produces hormones that foster mental and physical development and control metabolism. The notice indicates that the agency plans to finalize its decision by December 1st, 2008.

In response to the “dust-up” over the preliminary report, the EPA’s assistant administrator for water, Benjamin H. Grumbles, stated; “Science, not the politics of fear in an election year, will drive our final decision.”

“Until then, final numbers and strategies are mere speculation,” Grumbles added. “We know perchlorate in drinking water presents some degree of risk and we’re committed to working with states and scientists to ensure public health is protected and meaningful opportunities for reducing risk are fully considered.”

In January 2002, the EPA issued a draft risk assessment finding that 1 part per billion should be considered safe; in March 2006, the Massachusetts Department of Environmental Protection set a maximum contaminant level of 2 ppb; last year, California adopted a standard of 6 ppb.

A National Academy of Sciences panel prepared a risk analysis in 2005 that, according to the EPA’s traditional models, would produce a protective standard of 1 to 6 ppb. The academy’s study came under attack because two of the committee’s members had financial ties to defense contractors that face legal liability because of perchlorate disposal.

The EPA’s proposed ruling assumes that perchlorate contamination of 15 ppb is safe. But its regulatory document states that “between 16,000 and 28,000 pregnant women” and 900,000 to 2 million Americans could be exposed to higher levels.

The EPA document also finds that bottle-fed infants would be exposed to more than five times the level the National Academy of Sciences deemed safe — 700 nanograms per kilogram of body weight per day — if parents mix formula with drinking water containing perchlorate levels of 15 ppb.

OMB officials said during the drafting process that there was “no need” for detailed data to flesh out a table suggesting that infants would be exposed to perchlorate levels above the academy’s recommendation.

To determine safe levels of exposure, the OBM opted not to use the academy’s “reference dose,” a formula that includes a tenfold safety factor to protect children and vulnerable populations, and instead used a computer model developed by the Chemical Industry Institute of Toxicology. EPA officials initially inserted language in the document calling this a “novel approach,” but the OMB deleted that language.

Federal officials have yet to determine the extent of perchlorate contamination nationwide, but it is known to be widespread. The GAO, which produced a 2005 report calling for a better federal tracking system for perchlorate, found that limited EPA data show the chemical compound has polluted the soil, groundwater and drinking water in 35 states and the District and has contaminated 153 public water systems in 26 states.

Stay tuned, and don’t drink the water, or swallow the Kool-Aid.

©2012 An Inconvenient Woman. All Rights Reserved.

FDA Approves Expanded Uses for Gardasil® to Include Preventing Certain Vulvar and Vaginal Cancers

The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined.

“There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer,” said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research. “While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV.”

The FDA originally approved Gardasil in 2006 for girls and women ages 9 to 26 for the prevention of cervical cancer caused by HPV types 16 and 18, precancerous genital lesions caused by HPV types 6, 11, 16, and 18 and genital warts caused by HPV types 6 and 11.

HPV includes more than 100 related viruses and more than 30 types can be transmitted via sexual contact. According to the U.S. Centers for Disease Control and Prevention, HPV is the most common sexually transmitted infection in the United States with 6.2 million Americans becoming infected with genital HPV each year.

For most women, the body’s own defense system will clear HPV, thereby preventing serious health problems. However, some HPV types can cause abnormal cell growth in areas of the cervix, vagina, vulva, and other areas that years later may turn into cancer.

Regarding the prevention of vulvar and vaginal cancer, Gardasil’s manufacturer, Merck & Co. Inc., followed more than 15,000 participants from the original studies for about two additional years. Approximately half had received Gardasil as part of the original study—the other half did not receive Gardasil and served as a control group.

Among females who tested negative for HPV types 16 or 18 at the start of the study, Gardasil was highly effective in preventing these types of HPV-related precancerous vulvar and vaginal lesions, which are considered to be the precursors for cancer. In the control group that did not receive the vaccine, 10 individuals developed precancerous vulvar lesions and nine developed precancerous vaginal lesions, all related to HPV types 16 or 18. No one in the Gardasil group developed either kind of precancerous lesion due to HPV types 16 or 18.

There was no evidence for benefit among women found to have been previously infected, prior to immunization, with the HPV types included in the vaccine. Therefore, to receive Gardasil’s full potential for benefit, it is important to be vaccinated prior to becoming infected with the HPV strains contained in the vaccine.

Gardasil’s label has been revised to note that presently available information is insufficient to support use beyond age 26, the current FDA-approved age. Also, new information has been added showing that Gardasil does not protect against diseases caused by HPV types not contained in the vaccine.

No vaccine is 100 percent effective, and Gardasil does not protect against HPV infections that a woman may already have at the time of vaccination. Therefore, all women should get regular Pap tests, even after they have been vaccinated. Routine Pap screening remains critically important to detect precancerous changes, which would allow treatment before cancer develops.

Since the FDA approved Gardasil in 2006, the majority of reported adverse events have not been serious. The most commonly reported adverse events have included syncope (fainting), pain at the injection site, headache, nausea, and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries, which can be prevented with simple steps, such as keeping the vaccinated person seated for up to 15 minutes after vaccination. This observation period is also recommended to watch for severe allergic reactions, which can occur after any immunization.

As part of the original approval, Merck committed to a safety surveillance study of 44,000 individuals in a managed care organization. The study is assessing short- and long-term safety for all of Gardasil’s approved uses.

As with all vaccines, the FDA and the CDC continue to closely monitor Gardasil’s safety. Updated safety information on Gardasil was published on July 22 and can be found at www.fda.gov/cber/safety/gardasil071408.htm.

Product approval information for Gardasil can be found at www.fda.gov/cber/products/gardasil.htm.

Merck & Co. Inc. is located in Whitehouse Station, N.J.

Me

©2012 An Inconvenient Woman. All Rights Reserved.

Psychologists found memories of painful emotional experiences linger far longer than those involving physical pain.

They quizzed volunteers about painful events over the previous five years.

Writing in the journal Psychological Science, they said evolutionary brain changes which allow us to work better in groups or societies could be key.

“The cerebral cortex may also have had an unintended effect of allowing humans to relive, re-experience and suffer from social pain.

— Zhansheng Chen, Purdue University

The volunteers, all students, were asked to write about painful experiences, both physical and emotional, then given a difficult mental test shortly afterwards.

The principle was that the more painful the recalled experience, the less well the person would perform in the tests.

Test scores were consistently higher in those recalling physical rather than “social” pain.

Psychological scoring tests revealed that memories of emotional pain were far more vivid.

Social evolution

Researcher Zhansheng Chen, from Purdue University in Indiana, said that it was much harder to “re-live” physical pain than to recall social pain.

He said the evolution of a part of the brain called the cerebral cortex, which processes complex thinking, perception and language, might be responsible.

He said: “It certainly improved the ability of human beings to create and adapt, to function in and with groups, communities and cultures, and to respond to pain associated with social interactions.

“However, the cerebral cortex may also have had an unintended effect of allowing humans to relive, re-experience and suffer from social pain.”

The researchers now plan to repeat the experiment in older people, who are more likely to have experienced chronic pain.

Michael Hughesman, a child psychologist based in Germany, agreed that it was likely that emotional pain was handled in a different part of the brain from physical pain, and likely to be longer-lasting.

He said: “There is something very intangible about emotional damage – with physical pain, you can see the bruise, but in emotional abuse there is often fear and anxiety which remains.

“If someone tells you in the playground that they are going to get you after school, then you tend to be anxious and afraid about it far more than if someone just punches you there and then.”

©2012 An Inconvenient Woman. All Rights Reserved.

In June of 2006, my writing partner, Leslie Botha, and I, started writing articles cautioning women against the use of Gardasil® for girls and young women. We cited the limited nature of the clinical trials (the number, and ages of women tested) and the length of time from the clinical trials and the FDA approval; which in our opinion precluded a reasonable amount of time to follow-up for adverse reaction to the injection.

The RUSH-TO-APPROVAL, combined with MERCK’s, MEGA-Money State and Federal legislative-lobbying efforts, made us very nervous. Anytime a State or Federal agency mandates the use of a vaccine, the manufacturer is essentially, held harmless. That means adverse reaction victims cannot sue them directly. MERCK gets hide behind the shield of the very government agencies WE pay to protect us.

In our articles, Leslie and I cited European researchers who questioned not only the efficacy of the HPV vaccination plan, but the cost effectiveness of what could be one of the largest transfers of public money to private industry in history. With early detection, cervical cancer can be successfully treated; and the best early detection tool is the inexpensive, easily attainable PAP test.

“In developed countries, Pap smear screening and treatment have effectively reduced cervical cancer death rates to very low levels already. There are 3,600 deaths annually from cervical cancer in the United States, 1,000 in France and 400 in Britain.”

Each of those women were mothers, daughters and sisters, and very dear to their families. Most of the deaths were a result of lack of access to preventive medical care. The poor and uninsured can’t get a $30 PAP test, but our public heath officials think its justifiable to mandate BILLIONS of dollars to inoculate young girls with a vaccine that could do more harm than good.

MERCK has sold $1.5 BILLION worth of Gardasil® vaccine in less than two years. Those Gardasil® sales are saving their Vioxx-ravaged balance sheet. How many PAP tests would that amount provide women who have limited, or no, access to preventative care? If the safety of young girls doesn’t make you want to take action and stop this madness, how about cost-effect, use of limited health care resources?

Breast cancer kills hundreds of thousands of women every year…and the numbers are rising. Would 1.5 BILLION dollars be better spent on breast cancer research? We think so.

Spending 1.5 billion on Gardasil®, chasing the ghost of “possible cancer” in the distant future, is not good stewardship of time, talent and treasure — unless you own MERCK stock.

Two years ago Leslie and I sent information to major media outlets, asking that they at least investigate the possibility that HPV vaccines might not be effective or safe for young girls.

We felt like the mythical Cassandra…no one was interested in the news.

To date, there have been 17-deaths and thousands of reported hospitalizations of previously healthy young women and girls. As adverse reactions started to be recorded to the NVIC database, investigative reporters began questioning the HPV vaccine’s safety and cost-effectiveness. Harvard just published a “Follow the Money” report delineating the cost benefit of the mostly, publicly, funded HPV-vaccination initiative.

In the fall of 2006, using published US census data, Leslie and I estimated the number of targeted girls and women (nine to twenty-six year old) and the reported cost of the series of three of the Gardasil® inoculation and estimated the cost to public health budgets. I was sure some bean counter in the bowls of MERCK had preformed the same calculations, with far better resources, when determining the Lobbying budget that got Gardasil® approved.

I wish I could say, we are please to report that with about 20-hrs work, an old calculator and a new MAC laptop we came within a $60K of the Harvard study; but it is actually kind of depressing. All it proves is that we need more inconvenient women, asking more questions, more often, with greater insistence.

Excerpt of Harvard Study

“The vaccines, which require three shots for a complete series, cost about $400 to about $1,000, depending on the country and the fees for doctors’ visits. Unlike older vaccines that save money by preventing costly disease, these vaccines cost health systems money.

The Harvard study concluded that giving the vaccine to 12-year-olds would cost $43,600 for every “quality adjusted year of life” it saved by preventing a cancer death; that price would often be considered acceptable by health officials in wealthy countries, experts say.

But if the vaccine were given to all girls and women up to age 21, the cost per year of life saved would be far higher — $120,400, the Harvard study concluded. And if the vaccines prove to require a booster shot, as many critics believe, that cost rises to $140,000. In such cases it might make more economic sense to rely on Pap smear screening alone, the researchers said.”

Read the full text of following NY Times article.

Email the links to as many women, and health professions as you can.

Inconvenient Women take ACTION!

Click here for the full ELISABETH ROSENTHAL’s NY Times article on Gardasil®, Published: August 20, 2008

“Two vaccines against cervical cancer are being widely used without sufficient evidence about whether they are worth their high cost or even whether they will effectively stop women from getting the disease, two articles in this week’s New England Journal of Medicine conclude.”

“The two vaccines, Gardasil by Merck Sharp & Dohme and Cervarix by GlaxoSmithKline, target two strains of the virus that together cause an estimated 70 percent of cervical cancers. Gardasil also prevents infection with two other strains that cause some proportion of genital warts. Both vaccines have become quick best sellers since they were licensed two years ago in the United States and Europe, given to tens of millions of girls and women.

“Despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer,” Dr. Charlotte J. Haug, editor of The Journal of the Norwegian Medical Association, wrote in an editorial in Thursday’s issue of The New England Journal. “With so many essential questions still unanswered, there is good reason to be cautious.”

In her article, Dr. Haug points out the vaccines have been studied for a relatively short period — both were licensed in 2006 and have been studied in clinical trails for at most six and a half years. Researchers have not yet demonstrated how long the immunity will last, or whether eliminating some strains of cancer-causing virus will decrease the body’s natural immunity to other strains.

More to the point, because cervical cancer develops only after years of chronic infection with HPV, Dr. Haug said there was not yet absolute proof that protection against these two strains of the virus would ultimately reduce rates of cervical cancer — although in theory it should do so.

Both vaccines target the human papillomavirus, a common sexually transmitted virus that usually causes no symptoms and is cleared by the immune system, but which can in very rare cases become chronic and cause cervical cancer”

For more information read:

The Evidence Gap: Drug Makers’ Push Leads to Cancer Vaccines’ Rise (August 20, 2008)

Send these links out to anyone who cares about the health issues of women and girls!

Inconvenient Women do not get angry…We get ACTIVE!!

©2012 An Inconvenient Woman. All Rights Reserved.

Corporate Greed and the FDA’s Failure to Protect

Reported by Barbara Loe Fisher

The vaccine reaction reports keep coming into the National Vaccine Information Center (NVIC) from mothers describing how they took their healthy teenage girls into a pediatrician or gynecologist’s office where they were given a GARDASIL shot and, then, nothing was ever the same again.

The reports of HPV vaccine reactions, injuries and deaths continue to roll in, not only to NVIC but also to the federal Vaccine Adverse Events Reporting System (Search HPV4 at: http://www.medalerts.org/vaersdb/index.html) newspapers, and television stations.

 And the only response that comes from officials at the CDC, FDA and drug companies when perfectly healthy teenage girls collapse into unconsciousness, suffer a massive seizure, get paralyzed or die suddenly after being injected with GARDASIL is the zombie mantra: “It is a coincidence.”

Last week a nurse who is an administrator in the outpatient department for a group of hospitals in California called and asked if NVIC had been getting reports of unusual collapse after GARDASIL vaccination. I said, yes, we are getting those reports and she said “A lot of our patients are collapsing after the shot is given. It happens with GARDASIL more frequently than with any other vaccine we give.” That same week, NVIC received a report from the mother of a 15-year old daughter who got her first GARDASIIL shot last month. Within 10 minutes of being injected, she collapsed and had her first grand mal seizure, became incontinent, temporarily lost vision in her right eye, suffered uncontrolled vomiting and had to be taken by ambulance to the hospital. Another report to NVIC that week also involved first-time seizures in a 15-year old girl after she got a GARDASIL shot.

Through June 30, 2008, there have been reports that at least 17 to 20 deaths have occurred following GARDASIL and were filed with the federal Vaccine Adverse Events Reporting System (VAERS), although the FDA has yet to admit even one death is causally related to the vaccine, suggesting that the girls would have died that day even if no vaccine had been given.

Many of the teenage girls, who die suddenly after vaccination without explanation, were among the brightest and the best and in top physicial condition. This was true for 17-year old Jessica Ericzon, a New York softball player, snowboarder and honor roll student who dropped dead within 48 hours of getting a GARDASIL shot. A coroner could find no cause for her death after an autopsy.

There have been so many reports of reactions, injuries and deaths following GARDASIL vaccination (20-25 percent of all vaccine adverse event reports being filed with VAERS are for GARDASIL vaccine reactions) that the FDA and CDC issued a statement defending the vaccine’s safety on July 22, 2008.

But one of the vaccine’s developers has urged caution and offers practical advice about the need for continued use of Pap screening to prevent cervical cancer rather than relying on the vaccine to do the job. ” If you are at all concerned, then don’t have the vaccine – have regular Pap smears and you will be equally protected from cervical cancer….Pap screening is still the only proven method we have for cervical cancer prevention,” said Professor Diane Harper, Ph.D. “We don’t know how long the vaccine will protect a woman from HPV infection, and the vaccine does not protect against all types of HPV infection that cause cervical cancer.”

The “coincidence” defense mounted by doctors and drug-company officials every time a vaccination is followed by injury and death is as old as it is unscientific.

It is amazing that they have been able to get away with it for so long. Babies can’t talk and babies can’t walk so who they will become is still a dream. But young girls and women have already become much of who they will be and, on the cusp of fulfilling the dream, their vaccine deaths and injuries are much more difficult to sweep under the carpet.

It is immoral for doctors in government and industry to continue to look away from the damage done when vaccines cut down the brightest and most physically fit among us. The suggestion that these healthy, high functioning girls were biologically compromised and would have died or been injured that day even if no vaccine had been given is ludicrous. If those in government responsible for protecting the public health and safety look the other way when healthy individuals die and are injured by pharmaceutical products pronounced by government as “safe” for public use, then we cannot be assured that any licensed drug or vaccine is safe.

Last year, the head of the FDA in China was executed for allowing toxic pharmaceutical products to be licensed and released for public use that ended up killing and crippling people.

Sources: http://www.vaccineawakening.blogspot.com

http://www.NVIC.org

http://www.StandUpBeCounted.org

©2012 An Inconvenient Woman. All Rights Reserved.

Canadian reporters struggle to shed light on a muddled debate that’s as much about business as it is about health.

When federal Finance Minister Jim Flaherty announced $300 million in funding for a program to vaccinate girls and young women against the virus known as human pappiloma, it was hailed as the most important development in women’s reproductive health since the Pill.

This vaccine promises to tackle more than the warts caused by certain strains of HPV. It is billed as the first-ever anti-cancer vaccine designed to prevent the vast majority of cervical cancer cases.

But it’s too early to tell whether this is just a victory for women’s health or also the triumph of an aggressive, multimillion-dollar marketing campaign that has infiltrated our living rooms and the political backrooms.

The process has been so tainted by one drug company pursuing its own commercial interests that it’s difficult to know whether financing the human pappiloma virus (HPV) vaccine is the right decision from a public health perspective. It might well be, but the heavy lobbying effort, from the prime minister’s former aide on down, muddles the debate.

In coming weeks, the Ontario government is expected to announce its financing of the vaccine, which in partnership with federal funds, is crucial to the establishment of an HPV vaccine program. The province, like Stephen Harper’s Conservatives, has come under intense drug company lobbying.

Meanwhile, we have seen health officials and women’s groups debate the merits of this vaccine on the front pages of newspapers. Many are in favour of the vaccine, calling it a revolution in health care, while others aren’t so sure it’s necessary and wonder if other health care needs are more pressing, such as reducing wait times for cancer surgery or the doctor shortage.

Parents have weighed in, admitting they don’t know whether they want their preteens and teens vaccinated.

Many people are confused. No wonder. This isn’t just a health story, it’s a business story, and when we look at it in that light, the urgency around the issue makes more sense.

The multinational drug giant Merck Frosst makes Gardasil, the only approved HPV vaccine available, and it has a lot riding on a successful launch of the vaccine.

According to last week’s Wall Street Journal, Merck faces patent expirations on other best-sellers and legal costs related to Vioxx, the withdrawn painkiller linked to heart attacks and strokes. Some analysts believe Gardasil’s annual sales could reach $2 billion U.S. or more by 2010.

Until its competitors can get their own versions of an HPV vaccine approved (GlaxoSmith Kline has one in the pipe), Gardasil is the only girl in the pageant. And that makes Merck quite keen to see a government program to finance wide-scale vaccination while it has the only vaccine on the market.

But in order to create a public appetite for the vaccine, it must convince us our daughters need this vaccine. It also has to deal with our lapses in medical knowledge (who knew a virus caused cancer?), as well as our squeamishness around an issue most of us don’t want to think about — our preteen girls one day having unprotected sex.

Sheila Murphy, spokeswoman for Merck, explained in an e-mail how difficult it is to explain Gardasil to the masses.

“The fact that a virus causes cancer, in this case anogenital cancers, is a big paradigm shift for many people,” she wrote, adding, “When I started working on the Gardasil team, I didn’t know that HPV was the reason I

was having a Pap test.”

She said it’s equally challenging to communicate to people that a vaccine exists to prevent those cancers.

“We are working with individuals and groups who share our desire to improve the wellness of Canadian women by communicating information on HPV.

“We are using all the channels of communication open to us to get the message about our cancer-preventing vaccine out.”

Gardasil is a three-course vaccination that prevents four strains of the human pappiloma virus, including HPV 16 and 18, thought to cause 70 per cent of cervical-cancer cases. While cervical cancer is common in developing countries, it’s relatively rare in North America. About 400 women will die of cervical cancer each year in Canada. Women already have a very effective method of prevention — regular Pap tests. During the past five decades, this exam has contributed to an 80 per cent reduction in cervical-cancer deaths. However, some critics argue the $300 million would be better spent ensuring Pap tests for immigrants, aboriginals and women who live in poverty — all disproportionately represented among cervical cancer cases.

It’s expected the vaccine will not only reduce cancer deaths but the number of actual infections, the developments of precancerous lesions and the need for biopsies. In Canada and the U.S., even before the vaccine was approved, Merck financed information campaigns that linked the little-talked-about human pappiloma virus with cancer.

Last April in the U.S., Merck began the “Tell Someone” advertising campaign featuring girls (actresses), in interview style, expressing surprise about the cause of cervical cancer and promising to tell other women.

These ads didn’t mention the vaccine — Merck wasn’t allowed because it hadn’t been approved by the Food and Drug Administration — but represented a first step in linking cancer with a virus. At the time, a Merck spokesperson denied the campaign had anything to do with the vaccine.

In Canada, women can consult www.tellsomeone.ca, which describes the link. It also tells viewers about a vaccine against HPV but, of course, Merck’s name isn’t mentioned because direct-to-consumer advertising for cancer therapies is not allowed.

Once the FDA granted approval in the U.S. last June, a full-scale ad campaign began which Canadians are generally exposed to because these advertisements show up in our homes on American TV channels.

In one TV spot, girls skipping ripe on a sidewalk are chanting: “O-N-E-L-E-S-S.

I want to be one less. One less.” In another, a young women skateboarder faces the camera and says, “I could be one less. One less statistic.” The ads are poignant and gripping.

In Canada, we won’t be seeing the “One Less” type advertising. While direct-to-consumer advertising is generally allowed for vaccines, in the case of Gardasil, Merck cannot mention cancer in any ads. This has to do with the classification of the disease.

In the absence of the TV ads, Merck has to rely on various doctors and women’s groups to promote the product. It hasn’t been difficult.

A spokeswoman for the Society of Obstetricians and Gynecologists of Canada told the Citizen that Merck gave the doctors’ group a $1.5-million grant to educate people about HPV. The SOGC’s website on the issue (www.hpvinfo.ca) does not mention Merck, but serves the larger purpose of educating people about the cancer/viral link.

The society, which has come out strongly in favour of the vaccine, was only too happy to oblige when asked by Merck to educate the public about HPV. One of their main mandates is public education, said SOGC spokeswoman Kelly Nolan. Dr. Vyta Senikas, the executive vice president of the SOGC, said that aggressive marketing of products is a fact of life. She likened Merck’s marketing of Gardasil to Microsoft’s marketing of the video game system Xbox. She said physicians are smart enough to withstand any undue pressure and believes Canadians will receive unbiased information about a new product she thinks is revolutionary. She stressed that, despite Merck financing, all information coming from the SOGC is peer-reviewed and fact based.

Merck has also had to convince lawmakers of the vaccine’s value, which has been particularly difficult in some parts of the U.S., where the Christian right feared protection from a sexually transmitted disease might lead to promiscuity.

Still, with the U.S. Centers for Disease Control and Prevention recommending the vaccine for females between the ages of nine and 26, Merck, which has lobbied state-by-state to get vaccination laws passed, has had many successes. Twenty states are considering mandatory vaccination, while Texas* and Virginia required it for girls entering sixth grade.

In February, Merck halted its lobbying when it was learned that at least some of the lawmakers had accepted donations from the company. The Associated Press reported the Texas governor’s chief of staff met with key aides about the vaccine the same day its manufacturer donated $5,000 to the governor’s campaign. An organization backed by the company continues to push for similar laws.

In Canada, the campaign to make the vaccine a must-have for every preteen is more of a backroom affair.

Shortly before Flaherty announced funding for vaccination in the budget, Merck hired Ken Boessenkool, a former aide to Prime Minister Stephen Harper, to lobby the federal government. Boessenkool works for Hill & Knowlton, a giant public relations and lobbying firm. After his hiring was revealed by the Citizen, a Merck spokesperson said Hill & Knowlton

would help explain the importance of the new vaccine to policy makers.

Now, with the federal money committed, Merck is lobbying the individual provinces for matching funding and the establishment of vaccination programs.

Last month in Ontario, two lobbyists registered on behalf of Merck to lobby the health minister and others on “the proposed policy decision to support a childhood immunization program for HPV and funding related thereto.” Both men work for Hill & Knowlton. One of them, Jason Grier, was the former executive assistant to Health Minister George Smitherman.

Merck has also courted other groups with the power and potential to lobby the Ontario government. The seemingly innocuous health committee of the Ontario Chamber of Commerce, for example, is considering a resolution that, once passed, would urge the Ontario government to expedite funding of vaccines.

Why would this group have much interest — except as parents — in the funding of Gardasil? In fact, the committee counts as members representatives of the pharmaceutical industry, including one from Merck.

Another pharmaceutical industry representative on the committee — Jeff Connell, who works for the Canadian Generic Pharmaceutical Association — told the Citizen he has complained about Merck’s involvement in the resolution.

“Once I found out that the OCC Health Resolution was part of Merck Frosst’s international campaign to get governments to pay for Gardasil, I raised concerns with the OCC Health Committee,” he said.

Prior to this resolution, he said the issue of immunization had never been raised at the committee.

He said he told the committee, “I just can’t seem to shake the feeling that the immunization funding resolution represents the voice of Merck Frosst far more than the voice of Ontario business.”

Connell wrote to the group, asking them to reconsider the resolution, although he acknowledged it would still be passed.

So there you have it: A very small glimpse into the lengths Merck has gone in order to convince politicians and the people that millions of Canadian girls and young women need this vaccine.

Reprinted With Permission: Ottawa Citizen

©2012 An Inconvenient Woman. All Rights Reserved.

The updated consumer advice, which is in the FDA’s Center for Devices and Radiological Health (CDRH) section of the website (web address given at the end of this article), now states that:

“Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetus.”

he update follows a lawsuit brought against the FDA by a team of four non profit groups (including Moms against Mercury), two public officials, three dental experts, and two consumers describing themselves as “victims”. One of the plaintiffs, mercury expert Michael Bender, said in a statement issued via PR Newswire in Washington yesterday, 5th June, that:

“After 32 years of delay, the Food and Drug Administration has finally agreed to comply with the law and set a date to classify mercury amalgam as a substance that poses a health risk to pregnant women and unborn babies, and children.”

Click here to view updated FDA consumer advice on amalgams.

Click here for summary of the FDA advisory panel meeting on mercury and amalgam in September 2006.

Sources: FDA, PR Newswire, JAMA April 2006.

http://www.fda.gov/cdrh/meetings/090606-summary.html

Questions and Answers on Dental Amalgam

1. What is dental amalgam?

Dental amalgam is the silver-colored material used to fill (restore) teeth that have cavities. Dental amalgam is made of two nearly equal parts: liquid mercury and a powder containing silver, tin, copper, zinc and other metals. Mercury concentration in dental amalgams is generally about 50% by weight, while the silver concentration ranges from 20-35%.

2. What is FDA’s role in dental amalgam?

Dental amalgams are medical devices and are regulated by FDA’s Center for Devices and Radiological Health (CDRH). CDRH is responsible for ensuring that medical devices are reasonably safe and effective and that the labeling has adequate directions for use and any appropriate warnings.

3. What are the safety concerns about dental amalgam?

Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses. When amalgam fillings are placed in teeth or removed from teeth, they release mercury vapor. Mercury vapor is also released during chewing. FDA’s rulemaking (described in question 7) will examine evidence concerning whether release of mercury vapor can cause health problems, including neurological disorders, in children and fetuses.

Since the 1990s, FDA and other government agencies (CDC, NIH) have reviewed the scientific literature looking for links between dental amalgams and health problems. In September 2006, an advisory panel to the FDA reviewed FDA’s research and heard presentations from the public about the benefits and risks of mercury and amalgam.

You can read the summary of the panel meeting at: http://www.fda.gov/cdrh/meetings/090606-summary.html

In addition, a complete transcript is available at: http://www.fda.gov/ohrms/dockets/ac/cdrh06.html#dentalproductspanel

4. Are there other dental filling materials that can be used instead of amalgam?

Yes, there are several other types of dental fillings.

Resin composites are tooth-colored materials made from powdered glass and resin compounds. When composites were initially introduced, they were not very strong and were used primarily in the front teeth. Newer composites are stronger, although they still tend to wear more than metal-based materials and generally need earlier replacement.

Glass ionomer cement is also a tooth-colored material. It is not usually used for long-term fillings because it breaks easily.

Porcelain, gold, and other metals are also used as filling materials. Gold and porcelain are used for inlays, veneers, crowns, and bridges. These fillings are made outside the mouth and cemented into place after they are formed.

5. Should I have my amalgam fillings removed and replaced with these other materials? If I have a cavity, should I choose to get amalgam fillings?

FDA does not recommend that you have your amalgam fillings removed. FDA is engaged in a rulemaking that may lead to revised labeling. It is also reviewing evidence about safe use, particularly in sensitive subpopulations.

If you are concerned about the possible health effects of amalgam fillings, you should talk with your qualified health care practitioner.

Dental amalgam fillings are very strong and durable, they last longer than most other types of fillings, and they are relatively inexpensive. You may want to weigh these advantages against the possibility that dental amalgam could pose a health risk, until further information is conveyed through the rulemaking (see question 7) or otherwise.

6. Should pregnant women and young children use or avoid amalgam fillings?

The recent advisory panel believed that there was not enough information to answer this question.

Some other countries follow a “precautionary principle” and avoid the use of dental amalgam in pregnant women. Advice about dental amalgams from regulatory agencies in other countries is available below.

Canada: http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/1996/1996_63_e.html

France: http://afssaps.sante.fr/ang/pdf/amalgam.pdf

Sweden: http://www.kemi.se/templates/Page.aspx?id=5233

Pregnant women and persons who may have a health condition that makes them more sensitive to mercury exposure, including individuals with existing high levels of mercury bioburden, should not avoid seeking dental care, but should discuss options with their health practitioner.

7. What is the next step for FDA?

In 2002, FDA published a proposed rule to classify dental amalgam as a class II device with special controls. On April 28, 2008, FDA reopened the comment period for that proposed rule. The comment period will be open until July 28, 2008. After reviewing all comments, FDA intends to issue a final rule classifying dental amalgam.

By July 28, 2008, FDA is requesting comments supported by empirical data and scientific evidence concerning this classification and special controls for dental amalgam. In addition, if class II (special controls) is the appropriate classification for these devices, FDA requests comment on whether the two types of special controls proposed by FDA in 2002 (materials and labeling) provide reasonable assurance of the safety and effectiveness of these devices and on whether the special controls FDA described in 2002 should be revised in light of the recommendations and with respect to the discussions by the 2006 joint committee.

Controls on the Materials. For example, should the material controls proposed by FDA address conformance to recognized consensus standards that make recommendations for testing, compressive strength, and identifying the mercury vapor released by the device?

Labeling Controls. For example, how should labeling controls, if any, address the disclosure of composition, including mercury content, and precautions regarding use of the device in sensitive subpopulations composed of individuals who respond biologically at lower levels of exposure to mercury than the general population? If so, which subpopulations should be included (e.g., children under age 6, pregnant and lactating women, hypersensitive or immunocompromised individuals)? Should the labeling controls require more specific patient labeling (e.g., informing patients of identified sensitive subpopulations of the mercury content, the alternatives to the device and their relative costs, and health risks associated with the failure to obtain dental care)?

For the agency’s future analysis of benefits and costs of the regulatory options for dental amalgams, FDA also requests comments, including available data, on the following questions:

(1) How many annual procedures use mercury amalgams? What are the trends?

(2) What are the differences in cost between amalgams and alternative materials (e.g., composite, other metals, ceramics, etc.)? Are there differences in replacement lives?

(3) What are reimbursement rates for dental amalgam and the alternative materials?

(4) How would labeling describing the risks of amalgam for certain subpopulations (e.g., children under age 6, pregnant and lactating women, hypersensitive or immunocompromised individuals) affect the demand for, and use of, mercury amalgam? How would the risks included in the labeling be communicated to those subpopulations?

(5) What is the current exposure to mercury for patients? For professionals? What would be the reduction in exposure associated with the use of alternative materials?

©2012 An Inconvenient Woman. All Rights Reserved.

The FDA released a warning letter sent to Merck’s chief executive, Richard T. Clark, that states FDA inspectors determined manufacturing rules are not being followed at the plant in West Point, Pa. The plant, which recalled two vaccines in December over sterility problems, makes a number of children’s vaccines and four for adults.

The nine-page letter states FDA found “significant objectionable conditions” in the manufacture of vaccines and drug ingredients during repeated inspections from Nov. 26 to Jan. 17.

In a separate posting on its website, the agency said it issued the warning letter because Merck’s response to the FDA report sent after the inspections was “inadequate to address the serious deviations noted.”

According to the heavily redacted warning letter, Merck officials didn’t thoroughly investigate when vaccine batches inexplicably failed to meet specifications, even if batches had been distributed, and some combination measles-mumps-rubella shots that failed “visual inspection for critical defects” were distributed anyway.

The letter also said the plant didn’t have written procedures, tests, or other laboratory controls to ensure “identity, strength, quality, and purity” of products.

However, the FDA said it “does not believe that the issues identified will affect the safety of the vaccines” made at West Point, or their availability.

“We’re committed to working with the FDA to ensure that all these issues are addressed to their full satisfaction,” said Merck spokeswoman Amy Rose, who added that the company does not distribute contaminated products.

“We are confident in the quality, effectiveness, and safety of our medicines and vaccines,” she said.

Rose said Merck would be submitting additional information to the FDA and discussing it in a meeting.

The warning letter gives Merck 15 days to tell the FDA how it will correct the violations. If Merck does not comply, the letter states the FDA can take actions including suspending or revoking the plant’s manufacturing license, seizing products.

©2012 An Inconvenient Woman. All Rights Reserved.

The Food and Drug Administration (FDA) is warning people not to use or buy Mommy’s Bliss Nipple Cream because the product contains potentially harmful ingredients that may cause respiratory problems or vomiting and diarrhea in infants.

Marketed by MOM Enterprises Inc. in San Rafael, Calif., the product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. The product labeling specifically states that there is no need for mothers to remove the cream prior to nursing. However, FDA is alerting the public because of the potential harm this product could have on nursing infants. To date, no injuries to infants have been reported to FDA.

Potentially Harmful Ingredients

The two potentially harmful ingredients in Mommy’s Bliss Nipple Cream are chlorphenesin and phenoxyethanol, which may interact with one another to further increase the risk of slow or shallow breathing (respiratory depression) in nursing infants.

Chlorphenesin

• relaxes skeletal muscle
• can depress the central nervous system and cause respiratory depression in infants
• can cause a skin condition that can worsen the drying and cracking of nipple skin (dermatitis) in mothers

Phenoxyethanol

• is a preservative that is primarily used in cosmetics and medications
• can depress the central nervous system
• may cause vomiting and diarrhea, which can lead to dehydration in infants

Signs to Watch For

Get immediate medical attention if your child is showing the following signs and symptoms or if you are having difficulty awakening the child:

• decrease in appetite
• limpness of extremities or decrease in strength of grip and
• a change in skin color

What Consumers Should Do

• Discontinue use of Mommy’s Bliss Nipple Cream.
• Consult a health care professional if you experience problems or believe your infant may have experienced problems due to the product.
• Speak with your health care professional or certified lactation consultant if your nipples are cracked or painful.
• Report adverse events related to the product to MedWatch at www.fda.gov/medwatch/report.htm or by calling 800-332-1088.

For More Information

FDA Press Release

www.fda.gov/bbs/topics/NEWS/2008/NEW01839.html

FDA MedWatch Web site

www.fda.gov/medwatch/

Date Posted: May 30, 2008

©2012 An Inconvenient Woman. All Rights Reserved.