FDA PRESS RELEASE

The U.S. Food and Drug Administration (FDA) has approved four vaccines for use against the 2009 H1N1 influenza virus.

The vaccines—made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc.—will be distributed nationally after the initial lots become available. This is expected to occur within the next four weeks.

Commissioner of Food and Drugs Margaret A. Hamburg, M.D., says the approval is good news for the nation’s response to the 2009 H1N1 influenza virus. “The vaccine will help protect individuals from serious illness and death from influenza,” she says.

Vaccines against three seasonal virus strains are already available and should be used. However, they do not protect against the 2009 H1N1 virus.

What have studies of the H1N1 vaccines shown?
Based on preliminary data, the approved vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine.

Clinical studies under way will provide more information about the optimal dose in children. Recommendations for dosing will be updated if indicated by findings from those studies. The findings are expected in the near future.

What are the warnings and potential side effects?
In the ongoing clinical studies, the 2009 H1N1 vaccines have been well tolerated. However, consumers need to be aware of the following:

• People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

• Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines. For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects may include mild fever, body aches, and fatigue for a few days after the inoculation. For the nasal spray vaccine, the most common side effects include runny nose or nasal congestion for all ages, sore throats in adults, and—in children 2 to 6 years old—fever. (Also see seasonal flu information in the “For More Information” section below.)

• As with any medical product, unexpected or rare serious adverse events may occur.

FDA is working closely with other agencies to enhance adverse-event monitoring, information sharing, and analysis during and after the 2009 H1N1 vaccination program. In the U.S. Department of Health and Human Services, these agencies include the Centers for Disease Control and Prevention (CDC).

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

FDA Date Posted: September 16, 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.

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.

by The HPV Vaccine, Gardasil

Malia Obama celebrated her 11th birthday over the Fourth of July weekend. The  festivities included a Camp David birthday party with about 20 of her friends and as part of America’s first family, hosting 1,200 military families for a Fourth of July barbecue on the White House South Lawn.

As I looked at the happy images of Malia, Sasha and their mom, the formidable Michelle Obama, I still wonder WWMOD, What Will Michelle Obama DO? I first ask the question a few months ago as additional states seemed poised to mandate the HPV vaccine Gardasil for all school girls, some legislation targeting girls as young as the age of ten.  In 2007, Virginia, the District of Columbia’s very close southern neighbor passed House Bill 2035 requiring that 12 year-olds girls be vaccinated for the sexually transmitted disease Human papillomavirus (HPV). So as Malia, and soon Sasha enter the targeted demographic, I again ask the question,  WWMOD —What Will Michelle Obama Do?

No matter where you stand within the American, political color-spectrum, Reds and Blues all agree: Michelle Obama is a fiercely protective Momma. To my mind that is a very good thing. However as the Adverse Reactions to the HPV vaccine Garasil continue to mount, I find myself asking WWMOD? What Will Michelle Obama DO?

Like many moms out there she wants what is best for her girls. At 7 and 11years old, Sasha and Malia are in Merck’s TARGETED demographic. Thanks to some well-spent lobby-bucks several States mandated Gardasil vaccinations. The parents of those public school girls might not have the choices available to Mrs. Obama.

Several months ago, President Obama stated that his youngest liked PB&J sandwiches and she has a right to expect a safe sandwich. Sasha, Malia and every other American girl have a right to expect safe vaccines. MERCK is experimenting with the reproductive systems of an entire generation of young woman… so what, if anything with President Obama do to insure the safety of his as well as all the other girls of this nation?

NVIC Petitions White House and Congress to Investigate Gardasil

On February 9, the NVIC launched a petition and issued a national press release calling on President Barack Obama, his Administration and Congress, to investigate the fast track licensure and universal use recommendation of Gardasil in 2006, and the dismissal of more than 10,000 reports of Gardasil-related reactions, injuries and deaths to the Vaccine Adverse Events Reporting System as a “coincidence” by federal health officials.

NVIC’s latest Gardasil risk report, which compares the number and severity of adverse events reported to VAERS through November 30, 2008, reveals that death and serious health problems such as stroke, blood clots, cardiac arrest, seizures, fainting, lupus and rechallenge cases are reported three to 30 times more frequently after Gardasil vaccination than after meningococcal (Menactra) vaccination.
Barbara Loe Fisher explains the significance of this fact:

“If the deaths and serious injuries reported after Gardasil were only a “coincidence,” there would be little or no difference between the frequency and severity of vaccine-related adverse events between two vaccines, if the vaccines were equally reactive, and the number of doses were roughly the same.

Gardasil and Menactra vaccines were licensed within a year of each other and recommended by the CDC for universal use in 11-12 year olds.

Although Menactra is given to boys and girls and has already been mandated in many states for high school and college entry, Gardasil is only given to girls and is not yet mandated.

Menatra is given as a one-dose series and, by February 25, 2008, the CDC reported that about 15.5 million doses of Menactra had been distributed in the U.S.. Gardasil is given in a three dose series and the CDC reported that, by July 2008, about 16 million doses had been distributed in the U.S.

This means that about 15 million doses of Menactra were given to about 15 million boys and/or girls and about 16 million doses of Gardasil – if every girl got three doses – were given to about five million girls.

It is individuals – not doses of vaccine – who collapse, convulse, become paralyzed, have heart attacks, develop lupus and other chronic health problems after being vaccinated. The fact that death and serious health problems are reported 3 to 30 times more frequently after Gardasil than after Menactra is highly significant and it is irresponsible for federal health officials and Merck to blow it off as unimportant.”

What Does Merck Have to Say About it?

It’s incomprehensible that the CDC, FDA, and Merck — the makers of Gardasil – cannot see the facts presented in this VAERS analysis, and choose instead to cling to worn-out propaganda slogans and pre-written advertising messages that fly in the face of reason.

In the hours before a resent CBS News broadcast, Merck addressed the differences between adverse events associated with Gardasil and Menactra as follows:

“It’s important to remember that the proven benefit of GARDASIL is that it helps prevent cervical cancer caused by the two virus types responsible for most cases of cervical cancer.

Nothing is more important to Merck than the safety of our products and we carefully monitor the safety of GARDASIL on a routine basis. Experts at the FDA and CDC also continue to review data and, as recently as four months ago, said “GARDASIL continues to be safe and effective, and its benefits continue to outweigh its risks.”

NVIC is not a medical organization and has a long history of raising concerns about vaccines that are in direct conflict with the opinion of leading medical experts. We encourage consumers to get reliable information about the safety of vaccines from www.cdc.gov.”

Spain Already Removed the Vaccine

Spain has, recently withdrawn 75, 000 doses of the HPV vaccine from their market, after two teenagers who received the shots were hospitalized.

Seems  they weren’t as influenced by the drug company’s rhetoric as U.S. authorities, and are more concerned about the safety of their citizens.

Get Involved and Help Save the Daughters of This Nation

Says Fisher:

“In the past 27 years, the stories of death and brain damage that have been reported to the NVIC have never changed. Whether the vaccine victims are 15 months old or 15 years old, the stories are the same: a trusting parent took a bright, healthy child to a doctor for a routine vaccination and the child was never the same again.

The Gardasil vaccine was inappropriately fast tracked and licensed by the FDA and recommended by the CDC with too little attention paid to the reports of brain and immune system dysfunction that developed after vaccination in pre-licensure clinical trials.

That same cavalier attitude toward Gardasil-related deaths and serious health problems, which have been experienced by many girls and young women after licensure, is inexcusable.”

Most Americans have blindly placed their trust in the vaccine makers and in federal health agencies, whose responsibility is to ensure that drugs and vaccines licensed for public use are safe, effective and necessary.

However, over the years it has become very clear that those responsible for protecting your health are not looking out for your best interest and that of your children.

And if they won’t do it, then it is up to you and me to do it.

I urge you to sign the Investigate Gardasil Vaccine Risks Now! petition available on the http://www.NVIC.org web site that my team helped create for them.

If you believe strongly in NVIC’s effort to inform the  public about these types of issues, you can support their cause by making a donation of $25 or more to NVIC and receive a gift of Barbara’s 2008 book Vaccines, Autism & Chronic Inflammation: The New Epidemic. Click HERE to make a donation.

You may also print out this NVIC flyer detailing how to recognize a vaccine reaction.

Says Fisher:

“In 2009, I have a sense of déjà vu as the story of Gardasil vaccine plays out real time. There are striking parallels between how those operating the mass vaccination system reacted in the 1980′s to persistent reports that the DPT vaccine was harming more children than originally assumed, and the way they are reacting now to persistent reports that Gardasil is more reactive than it was originally assumed.

Assumption of safety is no substitute for proof of safety.

And turning away from human suffering in order to protect the status quo is not the way to run a government that needs the trust and support of the people.

In the 18th century, Queen Marie Antoinette looked down at a starving people pleading for bread to stay alive and said “Let them eat cake.” It is time for everyone in government, industry and medicine to take a different approach to persistent reports of vaccine injuries and deaths or risk metaphorically suffering the same fate that ended the monarchy in France.

In the 21st century, today’s peasants don’t have pitchforks – they have laptops, desktops, smartphones and the internet.”

I strongly urge you to join in petitioning our new U.S. administration and Congress to take a close, hard look at the HPV vaccine, to end the needless suffering of tens of thousands of young, bright, innocent girls.

To read the full article, Please click on: http://articles.mercola.com/sites/articles/archive/2009/02/19/Katie-Couric-Reports-on-Serious-Vaccine-Issues.aspx

©2012 An Inconvenient Woman. All Rights Reserved.

During
this public health emergency, the FDA has issued Emergency Use
Authorizations that expand access to medical products that may become
necessary.

Two antiviral treatments covered by Emergency Use Authorizations,
Tamiflu (oseltamavir) and Relenza (zanamivir), may already be included
in many emergency stockpiles.

All companies, U.S. states and localities, and other organizations
with Tamiflu and Relenza that are approaching, or past, the labeled
expiration date, are urged to consider keeping it while the U.S.
Department of Health and Human Services evaluates options, including
those that may allow for their use if needed during this 2009 H1N1 flu
virus outbreak.

If the stockpiling entity decides to retain expired or
soon-to-expire Tamiflu and Relenza, it should be maintained and
monitored under the product’s labeled storage conditions.

These organizations are also urged to contact the FDA’s Emergency
Operations Center with information on how much Tamiflu and Relenza in
their stockpiles is at or approaching expiration.

This information should be reported to:

FDA’s Emergency Operations Center
301-443-1240.

This statement is not directed to individual patients who already
have these two products in their homes. Individuals with these products
should continue to follow the directions from their doctor, pharmacist
or other health care professional.

©2012 An Inconvenient Woman. All Rights Reserved.

2009 H1N1 Flu Virus and Antivirals Questions and Answers

Q: Do the FDA’s Emergency Use Authorizations for antiviral drugs (Tamiflu and Relenza) cover their use for both prevention and treatment?
The EUAs for Tamiflu and Relenza cover the emergency use of the drugs, subject to the terms and conditions of the EUAs. Tamiflu and Relenza are also approved by the FDA for treatment and prevention under certain circumstances. Specifically:

Tamiflu is approved:

to treat uncomplicated acute illness due to influenza infections in patients 1 year of age and older who have been symptomatic for no more than 2 days, and
to prevent influenza in patients 1 year and older.

Relenza is approved:

to treat uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients 7 years of age and older who have been symptomatic for no more than two days, and
to prevent influenza in adults and pediatric patients 5 years of age and older.

The EUA for Tamiflu authorizes, under certain circumstances, Tamiflu to be used to treat and prevent influenza in children under 1 year of age, and provides alternative dosing recommendations for children older than 1 year (based on age instead of weight). (We note that because of limited experience, use of Tamiflu for prevention of 2009 H1N1 flu in infants less than 3 months of age is not routinely recommended but may be considered if the need is considered critical.) The EUA also authorizes distribution of Tamiflu deployed from the Strategic National Stockpile and that has had its expiration date extended under the federal government’s Shelf Life Extension Program (SLEP).

The EUA for Tamiflu and Relenza authorize the drugs to be used at later time points (i.e., in patients who are symptomatic for more than 2 days) and/or in patients sick enough to require hospitalization (i.e., patients who do not have “uncomplicated acute illness” per se). The EUAs for Tamiflu and Relenza authorize the drugs to be distributed or dispensed without all of the FDA-required prescription label information. The EUAs for Tamiflu and Relenza authorize the drugs to be accompanied by certain written emergency use information. The EUAs also note that public health officials or other volunteers may distribute Tamiflu and Relenza to recipients in accordance with applicable state and local law and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction.

Q: Do the Emergency Use Authorizations for the antiviral drug products Relenza and Tamiflu cover only products in the Strategic National Stockpile (SNS) or do they cover the state and local stockpiles and private sector stockpiles?
The EUAs for Relenza and Tamiflu are not limited to Tamiflu and Relenza held in the Strategic National Stockpile. However, the EUAs are limited to Tamiflu and Relenza distributed under the authority of the Centers for Disease Control and Prevention (CDC) and/or the appropriate local state and local public health authorities, and impose conditions on CDC and the state and local public health authorities for doing so. To the extent that private entities are part of state and local emergency response plans for distributing drugs in an emergency in compliance with the terms and conditions contained in the EUAs, they would be covered by the EUAs. However, private entities simply distributing product outside of the emergency response plans of the Authority Having Jurisdiction (a term from the Public Readiness and Emergency Preparedness Act declaration for antivirals) would not be within the scope of the EUAs.

Q: Do the Emergency Use Authorizations for Tamiflu and Relenza cover regular pharmacy prescriptions?
The EUAs are limited to Tamiflu and Relenza distributed under the authority of the U.S. Centers for Disease Control and Prevention and/or the appropriate state and local public health authorities, and impose conditions on CDC and the state and local public health authorities for doing so. To the extent that pharmacies are part of state and local emergency response plans for distributing drugs in an emergency in compliance with the terms and conditions contained in the EUAs, they would be covered by the EUAs.

Q: Do the Emergency Use Authorizations for antivirals allow hospitals without outpatient pharmacies to dispense Tamiflu and Relenza?
The EUAs are limited to Tamiflu and Relenza distributed under the authority of the U.S. Centers for Disease Control and Prevention and/or the appropriate state and local public health authorities, and impose conditions on CDC and the state and local public health authorities for doing so. To the extent that hospitals without outpatient pharmacies are part of state and local emergency response plans for dispensing drugs in an emergency in compliance with the terms and conditions contained in the EUAs, they would be covered by the EUAs.

Q: Under the FDA’s Emergency Use Authorizations for Tamiflu and Relenza, what information should be given to a patient?
The Fact Sheet for Patients and Parents authorized under the Tamiflu and Relenza EUAs must be made available to the patient or recipient of the product through appropriate means, which may include distribution of the Fact Sheets with the product.

Q: Under the FDA’s Emergency Use Authorizations for Tamiflu and Relenza, what does it mean to make available medication information “through appropriate means?”
A condition of the EUAs for Tamiflu and Relenza provides that state and/or local health authorities make available “through appropriate means” fact sheets developed for recipients and for health care providers for this emergency use. Making these fact sheets available “through appropriate means” can include (but is not limited to) handing that information to the recipient with the product, or otherwise making it available for reference at the location where medications are being distributed, depending on the circumstances of the emergency.

Q: In the Emergency Use Authorizations for Tamiflu and Relenza, what kind of “additional information,” which is consistent with the fact sheets, can be provided by the CDC and state or local authorities?
Examples of “additional information” include direct translations of the fact sheets into other languages, a poster display, and DVD or television announcements that relay the information contained in the fact sheets.

Q: Why does the Emergency Use Authorization for Tamiflu state that it covers Strategic National Stockpile assets and those authorized under SLEP, but the EUA for Relenza does not make the same statement?
The EUAs for Tamiflu and Relenza cover all Tamiflu and Relenza that is being distributed as part of a government (federal, state or local) emergency response as specified under the EUAs. This can include Tamiflu and Relenza from the Strategic National Stockpile (SNS), but can also include state or local stockpiles of Tamiflu and Relenza, provided it is distributed in accordance with applicable state and local laws and/or in accordance with the public health and medical emergency response plans of the Authority Having Jurisdiction (a term from the Public Readiness and Emergency Preparedness Act declaration for antivirals), subject to the terms and conditions of the EUAs. In addition, it should be noted that while Tamiflu is part of the federal Shelf Life Extension Program (SLEP), Relenza is not. For this reason, reference to SLEP in the Relenza EUA was unnecessary.

Q: Does a physician need a confirmed diagnosis before prescribing Tamiflu?
Tamiflu is approved for both the treatment and prevention of influenza. Health care providers should use their best judgment given the circumstances and extent of exposure when deciding whether prophylaxis and/or treatment is warranted.

Depending on the characteristics of an outbreak, public health officials may provide additional recommendations for prioritization and identification of appropriate recipients. Because testing may require a few days and might have variable accuracy, and the antiviral drugs are most effective when used early in the course of illness, health care providers may choose to begin treatment based on determination of a suspected or probable case. Published CDC recommendations and case definitions should be consulted as appropriate.

Q: Do the Emergency Use Authorizations override state guidelines regarding dispensing and storage of Tamiflu and Relenza in a public health emergency?
Distribution and administration of Tamiflu and Relenza under the EUAs are subject to the terms and conditions of the EUAs. The EUAs require Tamiflu and Relenza to be distributed in accordance with state and local laws and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction (a term from the Public Readiness and Emergency Preparedness Act declaration for antivirals).

Tamiflu and Relenza should be stored consistent with the manufacturer’s storage instructions in the approved labeling. The EUA includes a waiver of good manufacturing practice requirements with respect to the holding of authorized Tamiflu and Relenza by CDC and other public health authority(ies) for a period of 90 days. If a public health authority believes that improper storage of their Tamiflu and Relenza may have occurred, please contact the FDA.

©2012 An Inconvenient Woman. All Rights Reserved.

The United States Attorney’s Office

District of Massachusetts

FOR IMMEDIATE RELEASE
JUNE 18, 2009
WWW.USDOJ.GOV/USAO/MA

CONTACT: CHRISTINA DiIORIO-STERLING
PHONE: (617)748-3356
E-MAIL: USAMA.MEDIA@USDOJ.GOV

PHARMACEUTICAL COMPANY MANAGER SENTENCED FOR OFF-LABEL MARKETING

BOSTON, MA – A Branchburg, NJ, woman was sentenced today for violating the Food, Drug and Cosmetic Act, for marketing the drug Bextra for uses and dosages that were not approved by the Food and Drug Administration.

Acting United States Attorney Michael K. Loucks; Warren T. Bamford, Special Agent in Charge of the Federal Bureau of Investigation, Boston Field Division; Susan J. Waddell, Special Agent in Charge of the Department of Health and Human Services, Office of Inspector General; Leigh-Alistair Barzey, Resident Agent in Charge of the Defense Criminal Investigative Service; Kim A. Rice, Special Agent in Charge of the U.S. Food and Drug Administration, Office of Criminal Investigations, Metro Washington Field Office, Special Prosecution Staff; Jeffrey Hughes, Special Agent in Charge of the U.S. Department of Veterans Affairs, Office of Inspector General, Office of Investigations – Northeast Field Office; and Joseph Finn, Special Agent in Charge of the United States Postal Service, Office of Inspector General, Boston Field Office, announced today that MARY HOLLOWAY, age 47, of Branchburg, New Jersey, has been sentenced by United States Magistrate Judge Judith Dein to pay a $75,000 fine and twenty-four months of probation after pleading guilty to an Information charging her with distribution of a misbranded drug.

At the plea hearing, prosecutors told the Court that, had the case proceeded to trial the Government’s evidence would have proven, the following:

From approximately November 2001, through April 2005, HOLLOWAY was employed as a Regional Manager at a pharmaceutical company and was responsible for sales in her region of the drug Bextra. Bextra was a Cox-II inhibitor and had been approved in by the Food and Drug Administration (FDA) in November 2001 for the signs and symptoms of osteoarthritis, adult rheumatoid arthritis, at 10 mgs and primary dysmennorhea at 20 mgs, twice a day as needed. In 2001, the FDA specifically denied the request of the pharmaceutical company to approve it for acute pain, including the pain of surgery. The FDA told the pharmaceutical company that it could not approve it for these other indications because the safety in these other uses had not been established. Specifically, the FDA was concerned about the results of a study in which there was an excess of cardiovascular events in patients who had undergone coronary artery bypass graft surgery and used Bextra.

HOLLOWAY was aware of the FDA’s safety concerns, but that she nonetheless had her sales staff of approximately 100 employees sell Bextra for precisely the uses that the FDA refused to approve. For example, HOLLOWAY trained and encouraged her sales teams to promote Bextra by obtaining protocols from doctors that instructed that Bextra be used for the pain of surgery, an unapproved use, and at 20 mgs, an unapproved dose. HOLLOWAY also instructed her staff to market Bextra for use before, during and after surgery to reduce the risk of deep vein thrombosis, which is a form of life threatening blood clots, even though she knew there were no studies showing that Bextra was safe and effective for this use. Finally, HOLLOWAY encouraged her staff to make false safety claims about Bextra in order to sell the drug.

Acting United States Attorney Michael K. Loucks said, “We will continue to hold individuals responsible for their conduct in promoting pharmaceutical drugs outside of the uses for which they have been found to be safe and effective by the United States FDA. The conduct at issue here undermined the FDA’s regulatory scheme and put patients at risk for the purpose of pursing profits for the individual and the pharmaceutical company.”

Bextra was withdrawn from the market in April 2005.

The case was investigated by the Federal Bureau of Investigation, the Office of Inspector General for the Department of Health and Human Services, Special Prosecutions Staff for the U.S. Food and Drug Administration, Office of Inspector General for the Department of Veterans Affairs, the Defense Criminal Investigative Service, and the Office of Inspector General for the United States Postal Service. It was prosecuted by Assistant U.S. Attorneys Sara Miron Bloom and Susan M. Poswistilo of Loucks’ Health Care Fraud Unit.

©2012 An Inconvenient Woman. All Rights Reserved.

©2012 An Inconvenient Woman. All Rights Reserved.

Products involved include: Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate); Adderall, Adderall XR (mixed salts amphetamine); Cylert (pemoline) and generics.

Audience: Pediatricians, Neuropsychiatric healthcare professionals (but we thought you might want to know too.)

[Posted 06/15/2009] FDA notified healthcare professionals that it is providing its perspective on study data published in the American Journal of Psychiatry on the potential risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children. This study, funded by the FDA and the National Institute of Mental Health (NIMH), compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident.The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children. Given the limitations of this study’s methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. FDA believes that this study should not serve as a basis for parents to stop a child’s stimulant medication. Parents should discuss concerns about the use of these medicines with the prescribing healthcare professional. Any child who develops cardiovascular symptoms (such as chest pain, shortness of breath or fainting) during stimulant medication treatment should immediately be seen by a doctor.

FDA is continuing its review of the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications used to treat ADHD in children. FDA and the Agency for Healthcare Research and Quality are sponsoring a large epidemiological study that will provide further information about the potential risks associated with stimulant medication use in children. The data collection for this study will be complete later in 2009.

[06/15/2009 - Communication About An Ongoing Safety Review - FDA]
[06/15/2009 - News Release - FDA]

[06/15/2009 - Stimulant Medications Prescribing Information, Medication Guides - FDA]

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166667.htm

©2012 An Inconvenient Woman. All Rights Reserved.