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

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

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

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

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

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

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

Zicam Recall Information

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

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

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

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

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

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

©2012 An Inconvenient Woman. All Rights Reserved.

This weekend The Philadelphia Inquirer examined how Sen. Chuck Grassley (R-Iowa) has “found a congressional calling” in “creating uproars that often transform public opinion and policy” and “in recent years … has repeatedly turned his sights on wrongdoing by the pharmaceutical industry and its overseer,” FDA. Grassley held Senate hearings that contributed to the decision by Merck to withdraw the COX-2 inhibitor Vioxx from the market in 2004, and his “revelations about prominent psychiatrists who failed to disclose large payments from drug companies have fueled investigations into conflicts of interest,” according to the Inquirer. In addition, research conducted by his staff in 2007 found that GlaxoSmithKline allegedly “bullied” scientists who identified heart problems associated with the diabetes medication Avandia, the Inquirer reports.

According to the Inquirer, his “doggedness has won him praise,” but “some experts warn that Grassley has oversimplified challenging science.” However, Grassley believes that he is “simply providing a forum for competing scientific ideas, not deciding which ones prevail,” and that the legislation he has proposed is “aimed at bringing more information into the open,” the Inquirer reports (Hill [1], Philadelphia Inquirer, 2/8).

For those of us who want more transparency in the Big Phama Lobby/FDA Approval process, a note of thanks to both Representative Grassley and to the Philadelphia Inquirer editorial staff would be a good thing.

Source Documentation: Philadelphia Inquirer, 02.11.2009
Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

©2012 An Inconvenient Woman. All Rights Reserved.

Dr. Dan Roden is professor of medicine and pharmacology, director of the Oates Institute for Experimental Therapeutics, and assistant vice chancellor for personalized medicine at Vanderbilt University School of Medicine.

The Food and Drug Administration recently announced a public Web site listing potential drug side effects it is investigating. This move does seem to be in the public interest; after all, shouldn’t we know about drug side effects that are concerning enough to warrant an FDA investigation?

On further reflection, this turns out to be a pretty complicated question, and raises important issues about how doctors and patients should evaluate new information about the risks and benefits of drugs we use.

Before a drug is approved for marketing, it is tested in several thousand patients, and common side effects are identified. However, some side effects are only discovered after a drug is marketed. Some of these are so rare they just didn’t happen before a drug was approved. Others don’t turn up until they are identified in large, carefully conducted trials: An increase in heart-attack risk with Vioxx is a recent example.

There is no organized system in the United States, or elsewhere, to systematically examine the safety of marketed drugs. For many years, the FDA has run a voluntary adverse-events reporting system (AERS) that allows health-care providers and patients to describe possible side effects.

While AERS may generate clues to new side effects, the reports are often incomplete and may raise more questions than they answer. Is the rare effect really caused by the drug? What happens if a few people report something common, like an ulcer or a heart attack? How many people would have to report something before the FDA should get interested?

More reports often help

What is clear is that some of the 400,000 AERS reports submitted each year may represent real side effects, and others do not. One argument says that until further studies understand whether a drug actually causes a side effect, making a suspicion public would be counter-productive; for example, patients benefiting from the drug might stop needlessly.

I see a potential benefit to publicizing AERS reports that the FDA is investigating. Suggesting tenuous relationships between drugs and unusual side effects may prompt other physicians or consumers to recognize that they, too, may have seen (or been) similar cases. More reports do not establish cause and effect, but have helped in the past.

I also see an opportunity for coupling this kind of reporting to increasing public awareness of the risks vs. the benefits of treatment with any drug. An aware public will understand that because the FDA is investigating a potential relationship does not establish that a relationship even exists.

There is no drug that is 100 percent effective and never causes side effects. What we don’t want are drugs where the risks are much greater than the potential benefits, or where we can’t pick out the people at high risk for serious side effects. The new reporting system may, therefore, be one small step toward identifying unsafe drugs.

©2012 An Inconvenient Woman. All Rights Reserved.

On this page:

• Genetic Engineering
• Benefits of GE Animals
• GE Animals Regulated Under New Animal Drug Provisions

The Food and Drug Administration (FDA) is inviting the public to comment on draft guidance that discusses FDA’s approach to regulating genetically engineered (GE) animals.

Although the guidance, released Sept. 18, 2008, is aimed at industry, FDA believes it may also help the public gain a better understanding of this important and developing area. The guidance explains the process by which FDA is regulating GE animals.

Genetic Engineering

Genetic engineering is a process in which scientists use recombinant DNA (rDNA) technology to introduce desirable traits into an organism. DNA is the chemical inside the nucleus of a cell that carries the genetic instructions for making living organisms. Scientists use rDNA techniques to manipulate DNA molecules.

Genetic engineering involves producing and introducing a piece of DNA (the rDNA construct) into an organism so new or changed traits can be given to that organism. The rDNA construct can either come from another existing organism, or be synthesized in a laboratory. Although conventional breeding methods have been used for a long time to select for desirable traits in animals, genetic engineering is a much more targeted and powerful method of actually introducing specific desirable traits into animals.

Genetic engineering is not a new technology. It has been widely used in agriculture, for example, to make crops like corn and soy resistant to pests or tolerant to herbicides. In medicine, genetic engineering is used to develop microbes that can produce pharmaceuticals. And in food, genetic engineering is used to produce enzymes that aid in baking, brewing, and cheese making.

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Benefits of GE Animals

GE animals hold great promise for human and animal health, the environment, and agriculture.

• Health protection of animals – Animals are under development to be more resistant to very painful and harmful diseases, such as infection of the udder (mastitis) in dairy cows and bovine spongiform encephalopathy (widely referred to as “mad cow” disease) in all cattle.
• New source of medicines – Animals can be engineered to produce particular substances, such as human antibodies, to make infection-fighting drugs for people. These “biopharm” animals can change the way we treat chronic diseases, such as bleeding disorders, by providing large quantities of safe, health-restoring proteins that previously were available only from human cadavers.
• Transplantation – Pigs are being engineered so that their cells, tissues, or organs could be transplanted into humans with a reduced risk of immune rejection.
• Less environmental impact – Food animals are being engineered to grow more quickly, require less feed, or leave behind less environmentally damaging waste.
• Healthier food – Food animals, such as pigs, are under development to contain increased levels of omega-3 fatty acids, providing a more healthful product. Livestock can also be engineered to provide leaner meat or more milk.

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GE Animals Regulated Under New Animal Drug Provisions

FDA regulates GE animals under the new animal drug provisions of the law, and the agency must approve them before they are allowed on the market. Food and animal feed from GE animals will undergo FDA review before the food or feed can be marketed. The Federal Food, Drug, and Cosmetic Act defines a drug as “an article (other than food) intended to affect the structure or any function of the body of man or other animals.” Therefore, the rDNA construct intended to change the structure or function of the body of the GE animal is a drug.

FDA may exercise “enforcement discretion” over some GE animals, based on their potential risk and on a case-by-case basis. This means that the agency may not require premarket approval for a low-risk animal. For example, the agency is not requiring premarket approval for GE lab animals used for research, and did not require approval of a GE aquarium fish that glows in the dark. FDA does not expect to exercise enforcement discretion for animal species traditionally consumed as food.

This guidance will help industry comply with FDA’s requirements and will help the public understand FDA’s oversight of GE animals and food from such animals.

This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

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For More Information

FDA welcomes comments on its 25-page draft guidance document at www.fda.gov/dockets/ecomments or www.regulations.gov. Once on this Internet site, select Docket No. FDA-2008-D-0394 and follow the directions. All written comments should be identified with Docket No. FDA-2008-D-0394. The comment period runs for 60 days and closes Nov. 18, 2008.

FDA has developed a number of publications to help inform consumers about the technology of GE animals and the agency’s regulation of these animals. Please visit www.fda.gov/cvm/GEAnimals.htm.

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Date Posted: September 18, 2008Science

©2012 An Inconvenient Woman. All Rights Reserved.

Merck has a growing economic interest in Virginia. In December 2006, Merck announced it would invest $57 million to expand its Elkton, Va., plant to make Gardasil, helped by a $700,000 grant from a state economic development agency that is part of the executive branch. Two months later, Gov. Tim Kaine, who has been mentioned as a possible Democratic vice presidential candidate, signed legislation requiring Gardasil for schoolgirls. Four months after that, Merck pledged to invest $193 million more in the plant to make drugs and vaccines, helped by a state grant of $1.5 million.

Source: New York Times

©2012 An Inconvenient Woman. All Rights Reserved.

“Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now.”

— Dr. Diane Harper, a professor of medicine at Dartmouth Medical School

Those who follow BIG PHARM have noticed some interesting trend-lines lurking in the infamous ‘9-point Helvetica, grey ink’ Corporate 10-K, Annual Reports. Over the past several years, research budgets trended downward, while “Marketing” expenditures accelerated.

What would be considered a BIG PHARMA marketing expense?

Marketing expenses would include clever print and electronic media ads, along with brochures for health professionals. This print material is usually given to Doctors at “Sponsored” events, “Educational” resort-based retreats, private dinners, and that basic and most appreciated pharmaceutical freebee, the “Free Lunch”! On any given day an army of pharmaceutical reps drop off Lunches and other “Goodie packages” to busy practices with free drug samples and good cheer.

Speaking of “good cheer” Marketing expenses also include BIG PHARMA lobbyists spending largest amongst the very representatives “we the people” sent to our local, state, and federal to look after our interest. The amount of cash laid down by MERCK in 2005-2006 to grease the skids for one of the fastest new drug roll outs yet witnessed is staggering. Whoever said you couldn’t buy happiness, hasn’t talked to a MERCK stockholder.

Go to: THE EVIDENCE GAP; Drug Makers’ Push Leads to Cancer Vaccines’ Rise

August 20, 2008 – By ELISABETH ROSENTHAL (NYT) – Front Page –

… DRUG MAKERS’ BIG PUSH A marketing campaign in the United States and Europe by Merck has made Gardasil, its cervical cancer vaccine, a best seller. Cervarix, a similar vaccine from GlaxoSmithKline, has also proved popular, and profitable.

Read the full article and send the link out to anyone who cares about the health issues of women and girls!

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

The lobbyist/legislator ‘hook-up’ only works if no one is looking. Make sure your representatives know you are watching them and are holding them accountable for the health and wellfare of the nations’ women and girls.

©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.

In the July 20, 2008 edition of the, New York Post, SUSAN EDELMAN told Jessica Ericzon’s story. It serves as a cautionary tale for girls, their mothers and guardians. In my opinion it should be required reading for every state official who controls public health policy, every school nurse and every pediatrician, gynecologist and family practice physician. Email it to your local, state and congressional representatives. Bring it to PTA meetings. Send it to anyone who loves his or her daughters, sister, mother, and wife. Jessica’s chance to be a wife, a mom, and a grandmother has been taken from her by a system more focused on profi,t than patient safety. It is past time we stand up to the lobbyist that grease the wheels of government with cash and favors and the representatives more concerned with the next campaign donation than the health and welfare of their most vulnerable constituents.

TRAGIC: Jessica Ericzon collapsed dead days after receiving a shot of the cervical-cancer vaccine Gardasil.

She loved SpaghettiO’s, pepperoni, lilies, listening to her iPod and making her pals laugh.

In her senior yearbook, she wrote, “The best things in life aren’t things, they’re friends.”

Now that’s the quote chiseled into her gravestone.

Jessica Ericzon, 17, was “an all-American teenager,” as described by one of her upstate LaFargeville teachers.

Last February, she was working on her softball pitches, getting ready for a class trip to Universal Studios in Florida and hitting the slopes to snowboard with her older brother.

Then one day, the blond, blue-eyed honors student collapsed dead in her bathroom.

It started with a pain in the back of her head. On the advice of her family doctor, Jessie had taken a series of three Gardasil shots. The vaccine, marketed for females ages 9 to 26, is the first found to ward off strains of the sexually transmitted human papillomavirus, or HPV, which can cause cervical cancer.

Jessie got the first injection in July 2007. After her second shot in September, she complained of a pain in the back of her head, fatigue and soreness in some joints, said her mom, Lisa.

On Feb. 20, while on winter break from school, she got her third and final dose of the vaccine.The next night, “she told me the spot on the back of her head was bothering her again,” her mom said. The next morning, Feb. 22, Lisa, a hospital technician, left for work just after 5 a.m., leaving Jessie asleep.

Jessie never showed up for the class she was taking at Jefferson Community College.

When her mom got home at 3:20 p.m., she found Jessie sprawled on her back on the bathroom floor, with blood spots on her head where it had hit a flowerpot.

Jefferson County Medical Examiner Samuel Livingstone is stumped. “She was essentially dead by the time she hit the floor. Whatever it was, it was instantaneous,” Livingstone said. His autopsy found no cause. He speculates she suffered a cardiac arrhythmia, or irregular heartbeat, extremely rare in young people.

Jessie had been on birth-control pills for a year to treat acne, records show.

Livingstone reported Jessie’s death to the federal Vaccine Adverse Events Reporting System. Run by the FDA and the Centers for Disease Control and Prevention, it has collected 8,000 reports of problems after Gardasil shots, including paralysis, seizures and miscarriages.

Seventeen other deaths following the vaccine have been reported since Merck & Co. introduced it in 2006.

Officials have confirmed 11 of the reported deaths so far, said CDC spokesman Curtis Allen.They have found “no pattern or connection” to Gardasil in eight deaths and are still reviewing three, he said.

Lisa Ericzon now feels her daughter was “a guinea pig” for Gardasil, and is urging parents to research the vaccine before letting their daughters get it.

“I want other mothers to know,” said Lisa, the first parent of a girl who died after Gardasil to speak publicly.

“I don’t want them to go through what I went through.”

Jessie planned to major in psychology at SUNY Plattsburgh and pursue her greatest ambition – to become a New York state trooper. Just six days before she died, she got to ride along with a trooper canine unit. She was ecstatic.

The full article can be found at:

http://www.nypost.com/seven/07202008/news/regionalnews/my_girl_died_as_guinea_pig_for_gardasil_120737.htm

Read it. Become an Inconvenient Woman — Don’t Get Angry — Get Active!

Send this article link to every mom you know.

©2012 An Inconvenient Woman. All Rights Reserved.

 Reported by Barbara Loe Fisher

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 buracratic mantra: “It is a coincidence.”

“I just kept thinking about the good outcomes rather than what could actually happen.” What happened to Crystal Olivera was arm pain so severe that it left her unconscious immediately after a Gardasil shot, something she had never experienced with her hepatitis and meningitis vaccines. “The next thing I know I am on the floor in the fetal position.” Had she known more about Gardasil – “I wish I’d waited a little until it was out in the public more and also that they did more research about the negative side effects.” – Jamie Colby, Fox News (July 11, 2008) SEE VIDEO at http://www.foxnews.com/video2/video08.html?maven_referralObject=2233990&maven_referralPlayli

stId=&sRevUrl=http://www.foxnews.com/health/index.ht ml

“Jessica Ericzon, 17, was “an all- American teenager,” as described by one of her upstate LaFargeville teachers. Last February, she was working on her softball pitches, getting ready for a class trip to Universal Studios in Florida and hitting the slopes to snowboard with her older brother. Then one day, the blond, blue-eyed honors student collapsed dead in her bathroom. It started with a pain in the back of her head. On the advice of her family doctor, Jessie had taken a series of three Gardasil shots. The vaccine, marketed for females ages 9 to 26, is the first found to ward off strains of the sexually transmitted human papillomavirus, or HPV, which can cause cervical cancer. Jessie got the first injection in July 2007. After her second shot in September, she complained of a pain in the back of her head, fatigue and soreness in some joints, said her mom, Lisa. On Feb. 20, while on winter break from school, she got her third and final dose of the vaccine. The next night, “she told me the spot on the back of her head was bothering her again,” her mom said. The next morning, Feb. 22, Lisa, a hospital technician, left for work just after 5 a.m., leaving Jessie asleep. Jessie never showed up for the class she was taking at Jefferson Community College. When her mom got home at 3:20 p.m., she found Jessie sprawled on her back on the bathroom floor, with blood spots on her head where it had hit a flowerpot. Jefferson County Medical Examiner Samuel Livingstone is stumped. “She was essentially dead by the time she hit the floor. Whatever it was, it was instantaneous,” Livingstone said. His autopsy found no cause.” – Susan Edelman, New York Post (July 20, 2008)

http://www.nypost.com/seven/07202008/news/regionalnews/my_girl_died_as_guinea_pig_for_gardasil_120737.htm

” Katherine Kimzey got her first injection of Gardasil along with a Hepatitis-A vaccine and a chicken pox booster. She got the second injection two months later, along with the D-TaP vaccination. Six weeks after the second injection of Gardasil, Katherine passed out. “I tried to get up and my neck was stiff, and I couldn’t move it,” the teenager explained. “I couldn’t move at all.” Katherine spent five days in the hospital.

Shannon Nelson, 18, from the Chicago area, got the Gardasil shot and two other vaccines– at the same time. Within a week the soccer star could barely move. “When I went into the hospital I couldn’t walk at all. I had to have a wheelchair. It just got worse each day,” she explained. Nelson spent 23 days in the hospital and while she’s better now the teenager believes one of the vaccines she received is responsible for her illness and her neurologist says it’s certainly possible.

Katherine Kimzey is back on the soccer field in North Texas. But she still has occasional pain and doesn’t know what the future will hold. Thinking about her past experience she says she still worries and so does her mom. Michelle Kimzey says next time; she won’t be so quick to jump on the new vaccine bandwagon. “I think the connection is huge,” she said.

In a statement to CBS 11 News, Merck — the maker of Gardasil — said it has analyzed the reports of paralysis and death, and believes: no safety issue related to the vaccine has been identified.” – Ginger Allen, CBS News 11 – Dallas (July 21, 2008) http://cbs11tv.com/health/Gardasil.cervical.cancer.2.776277.html

“Consumer concerns over safety have not been assuaged by “reassurances from the government,” said Barbara Loe Fisher, cofounder of the National Vaccine Information Center (NVIC). “We have heard reassurances about safety before – for example, with the whole-cell pertussis (diphtheria- pertussis-tetanus [DPT]) vaccine in the 1980s,” she said, noting that this was subsequently withdrawn and replaced by an acellular version in the United States in the 1990s. Ms. Fisher has a son whom she believes was damaged by the DPT vaccine 28 years ago, and she has worked ever since as an activist in the vaccine safety field in various capacities, including a 4-year stint as a consumer member of the FDA Vaccines and Related Biological Products Advisory Committee.

In addition, the NVIC has been running its own private vaccine reaction registry for the past 26-years, and it currently has about 140 reports on Gardasil, Ms. Fisher said. “These include reports of injury and death, and we are seeing a pattern of what we have termed ‘atypical collapse,’ ” she commented. “These include cases where a girl suddenly passes into unconsciousness either immediately or within 24 hours of vaccination and then revives feeling weak and unable to speak properly or exhibiting other neurological signs. What we are concerned about is that girls are not aware of this possibility and could be crossing the road or driving a car and suddenly pass out.” Ms. Fisher also outlined concerns about how Gardasil has been studied. She pointed out that very few of the participants in the clinical trials were aged 11 to 12 years, which is the recommended target age for the vaccine. The New York Times reported in 2006 that of the 20,000 trial participants, 1200 were younger than 16 years.” – Zosia Chustecka, Medscape Medical News (August 8, 2008) http://www.medscape.com/viewarticle/578110

Sources:

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

http://www.NVIC.org

http://www.StandUpBeCounted.org

©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.