Gardasil® Deaths, Gardasil® Side Effects, Gardasil® Paralysis -

Is the HPV Vaccine Given to Prevent Cervical Cancer Causing More Medical Problems?

A vaccine designed to prevent cervical cancer is coming under fresh scrutiny amid thousands of complaints linking it to a range of health problems.

Gardasil® has been the subject of 7,802 “adverse event” reports from the time the Food and Drug Administration approved its use two years ago, according to the Centers for Disease Control and Prevention.

Girls and women have blamed the vaccine for causing ailments from nausea to paralysis — even death. Fifteen deaths were reported to the FDA, and 10 were confirmed, but the CDC says none of the 10 were linked to the vaccine. The CDC says it continues to study the reports of illness.

Gardasil prevents the spread of human papillomavirus, known as HPV — a sexually transmitted virus that can cause cervical cancer in a relatively small number of girls and women.

The vaccine’s manufacturer, Merck & Co. Inc., says it has distributed more than 26 million Gardasil® vaccines worldwide, including nearly 16 million in the United States. It estimates that 8 million girls and women have received the vaccine in the United States since June 2006. V

Two girls allege in court that the vaccine made them sick.

One — Jesalee Parsons of Broken Bow, Oklahoma — got the shot at age 13.

Jesalee’s lawyer, Michael McLaren, said she got the shot on February 27, 2007 and soon developed a fever and felt pain. The next day, he said, Jesalee felt pain in her chest and abdomen.

Her mother, Laura Parsons, said Jesalee spent weeks in the hospital and underwent two surgeries after developing pancreatitis. She says the federal government should have studied the drug more before approving its use.

“I just feel let down by the government,” Parsons said.

Merck says it could be a coincidence that the girls got sick after receiving the vaccine.

The company said in a statement that an adverse event report “does not mean that a causal relationship between an event and vaccination has been established — just that the event occurred after vaccination.”

Merck said it would continue to evaluate reports of adverse reactions. It said it “updates product labels with new safety information as appropriate.”

Watch more on complications linked to Gardasil »

For Full Article and more video go to:

http://www.cnn.com/2008/HEALTH/conditions/07/07/cervical.cancer.vaccine/

A sincere thank you to major media outlets, CNN, the Washington Post and the New York Times, for following and reporting the Gardasil® adverse events and asking probing questions about the safety and effectiveness of this aggressively-marketed Merck product.

©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.

I was doing some research for a fiend whose child had just been “diagnosed” Deficit Hyperactivity Disorder (ADHD) by a school nurse who suggested drug therapy. My first thought was a Kindergarten version of ‘One Flew Over the Cuckoo’s Nest’…dazed and compliant preschoolers.

In the past decade, ADHD, ”Deficit Hyperactivity Disorder, a neurobehavioral developmental disorder has become one of the most commonly diagnosed conditions of childhood, and is being increasingly diagnosed in adults. ADHD is characterized by a persistent pattern of inattention and/or hyperactivity, as well as forgetfulness, poor impulse control or impulsivity, and distractibility. The pharmaceutical medical industrial complex currently considers ADHD a “persistent and chronic condition for which no medical cure is available. Methods of treatment usually involve some combination of medications, behavior modifications, life style changes, and counseling. (BTW side effects aside, MEDICAL TREATMENT is spelled with two-cha-chings!)

So how do most ‘school nurses’, Physicians’ assistants and doctors come up with the very common ADHD diagnosis? Most medical professions use the “Desk Reference to the Diagnostic Criteria From DSM-IV-TR®”, compiled by American Psychiatric Association. Available in a spiral-bound book, and online accessible by computer, or PDA, the diagnostic criteria from DSM-IV-TR® is one of the most commonly used tools used by Physicians and other “prescribing” health care professions. Another ‘tool’, Desk Reference (PDR), which includes every prescription drug package insert. The guides serve as ‘medical cliff notes’, listing symptoms, probably diagnosis, suggested drug protocols, prescription drug side effect information and possible drug interactions.

Guidelines issued by the American Academy of Pediatrics recommend medications like CONCERTA® among first-line therapies for children with ADHD as part of a comprehensive treatment program. Go to the CONCERTA® website(1), READ the SIDE EFFECTS.

What rational person would suggest a little kid’s developing brain be put at risk, to assure social compliance? I knew there had to be a better way to deal with “the fidgets” so I did what Inconvenient Women do best, I looked stuff up, and sent the results out to a few thousand of my closets friends.

In September of 2007, William Atkins did a brillant, if little noted, piece on hyperactivity in children. I found it on IWIRE one of my favorite obscure resource sources. For the full article go to: http://www.itwire.com/content/view/14399/1066/

Study links hyper kids with artificial preservatives and colorings

Sodium benzoate and other food preservatives and colorings have been linked with hyperactivity in children. Although such ingredients have been thought in the past to produce adverse behavior in children, this study is considered the first scientific evidence of its kind.

The British study from researchers at the University of Southampton, England, has found that the food preservative sodium benzoate (also called benzoate of soda, with chemical formula C₆H₅COONa), when found with food dyes and colorings, can increase hyperactive behavior in children. Jim Stevenson, psychologist at the University of Southampton, and lead researcher of the study states, “We now have clear evidence that mixtures of certain food colors and benzoate preservative can adversely influence the behavior of children. We have now shown that for a large group of children in the general population, consumption of certain mixtures of artificial food colors and benzoate preservative can influence their hyperactive behavior.”

Food colorings and preservatives–which are often found in sweets such as ice cream, candy, and soda, what children love to eat–were studied. For six weeks over one hundred fifty randomly three-year-olds and over one hundred forty randomly eight-year-olds, in Southampton, England, were studied as to their diet.

The children displayed behaviors previous to the study ranging from normal to hyperactive.

They were provided food that was free of additives. Each day they were given one drink, either fruit juice or one of two mixtures of sodium benzoate preservative and food colorings. One mixture contained sodium benzoate and sunset yellow, tartrazine, carmoisine, and ponceau. The other mixture contained sunset yellow quinoline yellow, carmoisine, and allura red. They were not told which they were given, the fruit juice or one of the two mixtures.

The children who were given the benzoate preservative and food coloring mixtures showed, in some cases, more hyperactive behavior than the children given fruit juice. However, the increases in hyperactive behavior were not consistent between the two mixtures. The researchers contend that the hyperactive behavior may be linked to sodium benzoate and one or more of the specific artificial colorings, rather than to all of the colorings.

The U.S.$1.5 million study was funded by the British Food Standards Agency (FSA) and written up on September 6, 2007, in the journal The Lancet.

From the website of the Food Standards Agency comes this advise, “Parents of children showing signs of hyperactivity are being advised that cutting certain artificial colours from their diets might have some beneficial effects. The colours – Sunset yellow (E110), Quinoline yellow (E104), Carmoisine (E122), Allura red (E129), Tartrazine (E102) Ponceau 4R (E124), and Sodium benzonate (E211) – were studied as part of new FSA-commissioned research.”

Within the Friday, September 7, 2007, FSA article “Agency revises advice on certain artificial colours”, Andrew Wadge, the FSA’s Chief Scientist, said: “This study is a helpful additional contribution to our knowledge of the possible effects of artificial food colours on children’s behaviour.”

“After considering the COT’s [Committee on Toxicity (COT)] opinion on the research findings we have revised our advice to consumers: if a child shows signs of hyperactivity or Attention Deficit Hyperactivity Disorder (ADHD) then eliminating the colours used in the Southampton study from their diet might have some beneficial effects.”

“However, we need to remember that there are many factors associated with hyperactive behaviour in children. These are thought to include genetic factors, being born prematurely, or environment and upbringing.”

“The Agency has shared these research findings with the European Food Safety Authority (EFSA), which is currently conducting a review of the safety of all food colours that are approved for use in the European Union, at the request of the European Commission. This review is being undertaken because of the amount of time that has elapsed since these colours were first evaluated.”

“If parents are concerned about any additives they should remember that, by law, food additives must be listed on the label so they can make the choice to avoid the product if they want to.”

[William Atkins' note: When buying foods, always LOOK at the labels. What you don’t read may hurt you and your loved ones when you consume such foods.]

Inconvenient Women take action. If you know a mom who is drugging their child at the suggestion of a school nurse or family doctor, ask her to take this or other nutritional research to them and at least try to change their child’s diet before resorting to the BIG PHARM option.

If the child is a little girl, get her to a female pediatrician, specializing in precocious puberty. Girls as young as four and five years old are experiencing what their moms dealt with at twelve and thirteen. (See precocious puberty in IconicWoman article archive and go to: http://www.HolyHormones.com)

Explore every option before “medicating” compliant behavior.

(1) CONCERTA® and OROS® are registered trademarks of ALZA Corporation

This site and its contents are intended for USA audiences only.

©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.

©2012 An Inconvenient Woman. All Rights Reserved.

Since when has natural health been a crime?

As if the present war on natural health alternatives wasn’t enough, GlaxoSmithKline Consumer Healthcare (GSK), is now petitioning the FDA to determine that dietary supplements claiming to promote, assist or otherwise help with any aspect of weight loss are “disease claims,” and thereby unlawful. U.K. based GSK is conveniently the manufacturer of Alli, the OTC version of the drug orlistat.

Alli, whose website advises consumers: “until you have a sense of any treatment effects, it’s probably a smart idea to wear dark pants and bring a change of clothes with you to work,” exhibits ghastly side effects which include “oily spotting on underwear” and “inability to control stool (incontinence)”. Despite its promising $153.5 million profit during its first two weeks on the market, only a year after its release, excitement is dwindling and sales have slowed. “We know it’s selling very well,” said Brian Jones, a GlaxoSmithKline spokesman who declined to share any specific numbers. “But we don’t know if it’s going to last” (MSNBC 7-07).

Clearly GSK’s “Citizen” Petition Requesting FDA to Treat Weight Loss Claims for Dietary Supplements as Disease Claims is nothing more than a desperate attempt to make it last, by virtually monopolizing the non-prescription weight management products market. Evidently GSK is attempting to make its brainchild, Alli, the sole non-prescription product available to help with weight management. Individuals need to become aware of this debilitating and blatant abuse of power.

For the past several decades, the FDA has correctly viewed claims referencing weight loss as permissible structure/function claims, resting on the sound logic that the body’s ability to gain and lose weight is not a disease. According to GSK’s logic, however, sound scientific structure/function claims should now be interpreted as disease claims. The GSK mistakenly argues that current structure/function claims are misleading consumers into believing these products will both prevent and cure diseases, and that they are FDA approved. The truth of the matter is that the vast majority of supplement manufacturers are well in keeping with the numerous regulations that govern the dietary supplements market, many of which include the statement “This product is not intended to treat, cure, prevent or diagnose any disease” on all labels.

Part of GSK’s argument is that being overweight is a risk factor for disease. They then point to precedents whereby the FDA regards cholesterol level, blood pressure and glucose level related structure/function claims as disease claims. However, this analogy is inapplicable. Consumers taking products to control cholesterol, blood pressure and blood sugar are predominantly concerned with affecting specific diseases, namely heart disease, hypertension and diabetes. On the other hand, people seeking to lose weight primarily wish to improve overall health and appear more attractive. In fact, according to a new survey by Cancer Research UK, the vast majority of people rate looking good over reducing the risk of body fat as a reason to maintain a healthy weight.

While some studies suggest that many people attempt to lose weight for health reasons, those studies that have specifically investigated ‘prevention of a disease’ as a motive for dieting or weight loss have all found disease prevention to be a minor motivation as compared with improvement of general health and cosmetic appearance. Promoting general health is not equivalent to the treatment of a disease. And clearly, neither is improving cosmetic appearance. Every applicable study published on the subject is consistent with the fact that these two motivations for weight loss account for over 80% of the reasons people have for attempting to lose or control body weight. Thus, disease prevention or treatment, is clearly not a major motivator for weight loss or weight management.

Obviously, very few people are interested in losing weight to prevent or treat a disease. So who are these citizens behind GSK’s so-called “Citizen’s” petition? Where are the people who feel they’re being misled by safe and ethical foods and supplements, intended to support or assist weight loss efforts? Who feels misled that weight loss supplements should have prevented or treated their diseases? The answer is nobody. Nobody sees dietary supplements as a cure or treatment for heart disease, diabetes, obesity or any disease for that matter. The petition is brought to the FDA by the might of GlaxoSmithKlein, and not by misled consumers or citizens. Its sole purpose is to improve Alli sales.

Even simple observation shows us that weight loss supplements appeal to consumers’ personal vanity, not to their desire to prevent a disease. What’s more, none of the studies cited in the GSK petition address actual consumer perceptions or expectations of weight loss products. Therefore, while consumers may very well feel that a weight loss related supplement may help to reduce body weight, it has yet to be shown that consumers expect such supplements to mitigate, treat, cure or prevent any disease.

Ever since the Dietary Supplement Health Education Act (DSHEA) passed in 1994, the American people have insisted in no uncertain terms, that they demand their God-given right to buy dietary supplements. Though the GSK petition suggests that individuals are incapable of making the decisions necessary for their own health and well-being, belittling consumer intelligence, people know that good health requires individuals to be fully informed. Long before profit-driven pharmaceutical companies with vested interests even existed, human beings were using herbal remedies and other natural products to supplement their health. Now, because major pharmaceutical companies are putting a price tag where integrity should exist, basic health freedoms are once again in jeopardy.

Losing weight is one of the most basic and prevalent of modern human desires–so many of us wish to look and feel better, healthfully. If GSK’s flawed prerogative is accepted by the FDA, the state of natural health will become alarmingly vulnerable. And, if this callous attempt to usurp our intrinsic right to take control of our own health is permitted, what’s next? Where will the line be drawn? Will citizens be forced to buy expensive prescriptions where they would once have purchased a simple herb, food or vitamin? And what of the hard-working citizens without the benefits of health insurance? How, then, will these people afford to supplement their health?

Every human being has the right to live a healthy life, and a responsibility to create that health for him- or herself. This heinous petition suggests that individuals should not be in charge of their own health—rather, that health decisions should rest solely in the hands of profit-driven megaliths. It implyies that only those who can afford to purchase costly prescriptions and potentially hazardous OTC drugs have the right to a healthy life. It has never been more important to protect your health freedom rights from the greedy activities of Big Pharma.

Consumers must become conscious of this gross violation of their health freedoms. Help protect your own health rights, and the rights of your fellow citizens by writing to the FDA and telling them why you think GSK’s ‘Citizen’ Petition to Treat Weight Loss Claims for Dietary Supplements as Disease Claims is an offensive violation of your health freedoms. It’s time to fight for your health. After all, if you don’t do it—who will?

To join with other people who feel as you do, become a member of the Nutritional Health Alliance (NHA) health freedom advocacy group. For the sake of health freedom, join the NHA today!

• Sign up here for free weekly updates from NHA!

Reprinted with permission: Nutritional Health Alliance (NHA)

©2012 An Inconvenient Woman. All Rights Reserved.

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

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

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

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

Click here to view updated FDA consumer advice on amalgams.

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

Sources: FDA, PR Newswire, JAMA April 2006.

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

Questions and Answers on Dental Amalgam

1. What is dental amalgam?

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

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

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

3. What are the safety concerns about dental amalgam?

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

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

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

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

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

Yes, there are several other types of dental fillings.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

7. What is the next step for FDA?

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

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

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

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

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

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

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

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

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

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

©2012 An Inconvenient Woman. All Rights Reserved.

en Espanol

• Introductory Message

• Parents Dos and Don’ts

• Refusing Vaccines — Doctors Speak Out (Off-site video)

Introductory Message

If you are trying to make a decision about whether to vaccinate yourself or your child we hope you find the information on our website helpful in making an informed decision. We recommend that you not only use NVIC’s information in making a decision but also talk to trusted health professionals and consider browsing through other vaccine information web sites, many of which are linked directly from this web site.

If you or your child has suffered a serious health problem following receipt of a vaccine, it is very important that you make a vaccine adverse event report to NVIC (click here to report a reaction). Since 1982, NVIC has operated a vaccine adverse event database which is helping to stimulate independent research into vaccine adverse events. A record of what happened to you or your child could help identify common factors which pre-dispose individuals to reacting to vaccines; find ways to prevent others from suffering the same kind of vaccine-related health problems you or your child are suffering; and may well contribute to future development of therapies to help repair vaccine damage.

You should also make a vaccine adverse event report to the federal government’s Vaccine Adverse Event Reporting System (VAERS). The health professional that administered the vaccine has a duty under the law to report all serious health problems which develop within 30 days of vaccination to VAERS. If that person refuses to make the report, contact NVIC and we will help you make the vaccine adverse event report to VAERS yourself.

We encourage you to continue to seek information and ask questions. This is not an easy subject and it is not an easy decision to make. You are in charge of your own health and that of your child(ren). You must live with the consequences of the decision that you make. Look at all sources of information including sources that describe how the different diseases are contracted and how they are spread. Without this information you cannot make an informed decision.

The following articles on this website may be helpful to you:

In the Wake of Vaccines

Are We Over Vaccinating Our Children?

We hope you will become a member of NVIC so we can continue our mission of preventing vaccine injuries and deaths through public education. As a member you will receive e-mail reports and that will keep you up-to-date on the latest developments in vaccine research, development, policymaking and legislation.

~ Barbara Loe Fisher

VACCINATION DECISIONS FOR PARENTS

Vaccination is a medical procedure which carries a risk of injury or death. As a parent, it is your responsibility to become educated about the benefits and risks of vaccines in order to make the most informed, responsible vaccination decisions.

1. Your doctor is required by law to provide you with vaccine benefit/risk information materials before your child is vaccinated. Consumer groups, including the National Vaccine Information Center, worked with government health agencies to develop parent information booklets on each mandated vaccine. Ask your doctor for the booklet and take time to read it before your child is vaccinated. You may also ask your doctor to show you the information insert provided by the drug company which manufactured the vaccine(s) your child is scheduled to receive.

2. Your doctor is required by law to keep a permanent record of all vaccinations given, including the vaccine manufacturer’s name and lot number. Ask for a copy of the doctor’s record on vaccinations given to your child to keep for your records.

3. Your doctor is required by law to report all adverse events, including injuries and deaths which occur within 30 days after vaccination to federal health authorities. If your doctor refuses to report a reaction following vaccination, you have the right to report to the government yourself.

4. If your child is left permanently brain damaged or dies as a result of a vaccine reaction, you may be entitled to benefits under the National Childhood Vaccine Injury Act of 1986.

DO:

Become educated about childhood diseases and vaccines. You have the ultimate responsibility for your child’s health and well-being and you, not your doctor or state or federal health officials, will live with, and be responsible for the consequences of your decision.

Ask your doctor to give your child a physical exam to make sure your child is healthy before you permit vaccination. A sick child can be at increased risk for having a vaccine reaction.

Write down your child’s personal and family medical history listing major illnesses and diseases or medical conditions, especially previous reactions to vaccinations, and have it included in your child’s permanent medical records. Before permitting vaccination of your child, ask your doctor if any of these conditions will put your child at risk for having a vaccine reaction. A child who has had a previous severe reaction to a vaccination can be especially at risk for even more severe reactions if more vaccine is given. If you are not satisfied with the answers you are given, get a second opinion.

Monitor your child closely after vaccination. Call your doctor if you suspect a reaction. If your doctor is not concerned and you are, take your child to an emergency room.

Obtain a copy of your state mandatory vaccination laws. Become educated about state vaccine requirements, your rights and legal exemptions to vaccination. Click here to review your state law.

Don’t be intimidated by medical personnel and forced into a vaccination decision before you are comfortable with your decision.

Reprinted With Permission.

Source: National Vaccine Information Center

©2012 An Inconvenient Woman. All Rights Reserved.

FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.

Company manufactures and distributes unapproved and adulterated drugs

The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

Scientific Laboratories is a contract manufacturer and distributor of various prescription cough and cold products. The government’s complaint, filed by the U.S. Department of Justice, alleged violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The company failed to seek required FDA approval for some of its products and failed to comply with current good manufacturing practice requirements (CGMP).

“The FDA will not allow a company to put the public’s health at risk,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks.”

The unapproved new drugs manufactured and marketed by Scientific Laboratories as prescription cough and cold products include: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, and Nazarin HC Liquid. Because these drugs have not undergone FDA review nor received approval, their safety and effectiveness have not been established. Additionally, the FDA has not reviewed the adequacy and accuracy of the directions and warnings in their labeling.

The FDA had warned Scientific Laboratories against violating the FD&C Act and about the risk of enforcement action if it failed to take corrective measures.

“The FDA will take action against companies and their executives who violate the law and endanger public health,” said Margaret O’K. Glavin, associate commissioner for Regulatory Affairs. “The FDA will carefully monitor the provisions of this injunction as well as investigate and take action against other marketers of unapproved drugs.”

The consent decree bars the defendants from manufacturing and distributing any drug until they obtain required FDA approval and fully comply with CGMP requirements. The defendants must destroy their illegal drugs. The consent decree also allows the FDA to order the defendants to shut down in the event of future violations. It also subjects the defendants to liquidated damages in the amount of $5,000 per day if they fail to comply with any of the provisions of the decree, and an additional sum of $5,000 for each violation, up to $1 million per year.

If patients have these products in their homes, they should discuss with their health care provider whether to discontinue use of the products and to find alternative therapy. Pharmacies should discontinue dispensing these products.

In June 2006, the FDA issued a guidance document titled, “Marketed Unapproved Drugs—Compliance Policy Guide” (CPG).  This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective. The CPG also explains that FDA may take action against manufacturers and marketers of unapproved drugs that violate other provisions of the FD&C Act, including CGMP requirements.

The decree was signed Thurs., May 8, 2008 by Judge William D. Quarles, Jr., in the U.S. District Court for the District of Maryland.

For more information:

FDA’s ongoing efforts on marketing unapproved drugs

CDER’s Web page on Compliance with Current Good Manufacturing Practices

©2012 An Inconvenient Woman. All Rights Reserved.