Read the labels before you put the food in your shopping cart. Dried fruit that looks as if it would be a great nutritious snack is most likely contaminated with sulfites, which keep the fruit from getting discolored, but can cause adverse reactions in people with asthma. You're better off buying fresh or frozen organic fruit, like these (http://www.cascadianfarm.com/products/product_detail.aspx?cat=9) from Cascadian Farm.
... keep foods from becoming rancid, browning, or developing black spots. Antioxidants also minimize the damage to some essential amino acids and the loss of some vitamins
Requirements:
Preservatives must be listed by their common names on ingredient labels of all foods that contain them.
Why are carcinogenic food additives allowed in food?
The risk of adverse health effects from botulism is much greater than the risk of developing cancer from small amounts of nitrites, therefore nitrites are allowed.
A food manufacturer wanting to use sodium nitrites must show that nitrosamines will not form in hazardous amounts in the product under the additive's intended conditions of use. For example, regulations specify that sodium nitrite, used as an antimicrobial against the formation of botulinum toxin in smoked fish, must be present in 100 to 200 parts per million. In addition, other antioxidants, such as sodium ascorbate or sodium erythorbate, may be added to inhibit the formation of nitrosamines.
Butylated hydroxyanisole (BHA) is a phenolic antioxidant Phenolic antioxidants prevent rancidity of fats and oils in food by protecting against lipid oxidation.
When the food additives amendment was enacted (1958), BHA and BHT were listed as common preservatives considered generally recognized as safe (GRAS). GRAS regulations limit BHA and BHT to 0.02 percent or 200 parts per million (ppm) of the fat or oil content of the food product.
Both BHT and BHA have been removed from the GRAS list and subjected to tolerances.
BHA is also used as a preservative for dry foods, such as cereals. The FDA set limits for each type of food. On cereals, for example, FDA limited BHA to 50 ppm of the total product.
Studies have suggested that at very high levels in the diets of laboratory animals, BHA could cause tumors in the forestomach of rats, mice and hamsters, and liver tumors in fish. The importance of this in humans is unknown, because humans do not have forestomachs. BHA did not cause cancer in experimental dogs, pigs, and monkeys, species which do not have forestomachs.
Other studies have shown that BHA protects against some chemical carcinogens, depending on the conditions of the tests.
Butylated hydroxytoluene (BHT) is a phenolic antioxidant
Phenolic antioxidants prevent rancidity of fats and oils in food by protecting against lipid oxidation.
Although not toxic itself, BHT may interact with other substances:
Protects against toxicity in some cases
Potentiates toxicity in others
For example, in animal studies BHT was demonstrated to be protective against mutagens such as benzo(a)pyrene and carcinogens when given during or before exposure to benzo(a)pyrene, but enhances toxicity when given after exposure.
Some beneficial health effects of BHT:
There are reports that BHT inhibits formations of some types of tumors.
Protective against carbon tetrachloride poisoning.
There is some evidence that it slows aging in mice.
From "A Fresh Look at Food Preservatives" by Judith E. Foulke, staff writer for FDA Consumer Magazine
Sulfites are used as antioxidants to prevent discoloration of light-colored fruits and vegetables, such as dried apples and dehydrated potatoes. They are also used in wine-making because they inhibit bacterial growth but do not interfere with the desired development of yeast.
FDA prohibits the use of sulfites in foods that are important sources of thiamin (vitamin B1), such as enriched flour, because sulfites destroy the nutrient.
Most people don't have a problem with sulfites. However, since 1985, when the agency started reporting on sulfites through the Adverse Reaction Monitoring System, over 1,000 adverse reactions have been recorded. FDA estimated that more than 1 million asthmatics are sensitive or allergic to sulfites.
In 1986, FDA ruled that sulfites used specifically as preservatives must be listed on the label, regardless of the amount in the finished product. Sulfites used in food processing but not serving as preservatives in the final food must be listed on the label if present at levels of 10 parts per million (ppm) or higher. Regulations issued in 1990 extended these required listings to standardized foods.
Also in 1986, FDA banned the use of sulfites on fruits and vegetables intended to be eaten raw, such as in salad bars and grocery store produce sections. Please the FDA site Sulfites: Safe for Most, Dangerous for Some
The symptom most reported by sulfite-sensitive people is difficulty breathing. Other problems range from stomach ache and hives to anaphylactic shock. In addition to knowing which food preservatives are sulfites and which foods are likely to contain them, sulfite-sensitive consumers can help themselves avoid health problems by following these suggestions:
Be aware that foods served in restaurants, especially potato products and some canned foods, could contain sulfites. Ask the waiter if sulfites are used in what you plan to order.
... so basically, you can't trust anything they've said about how safe thimerosal is, or vaccines are. They've been doing the bidding of Big Pharma all along, in addition to their own pathological quest to vaccinate everyone against everything as soon after birth as possible (as if there is no other way to prevent diseases, and as if vaccines are harmless).
Click through the link to read David Kirby's piece on the Huffington Post.
CDC Director Dr. Julie Gerberding has delivered a potentially explosive report to the powerful House Appropriations Committee, in which she admits to a startling string of errors in the design and methods used in the CDC's landmark 2003 study that found no link between mercury in vaccines and autism, ADHD, speech delay or tics.
Gerberding was responding to a 2006 report from the National Institute of Environmental Health Sciences (NIEHS), which concluded that the CDC's flagship thimerosal safety study was riddled with "several areas of weaknesses" that combined to "reduce the usefulness" of the study.
"CDC concurs," Dr. Gerberding wrote in an undated mea culpa to Congress, (provided to me through a Capitol Hill staffer) adding that her agency "does not plan to use" the database in question, the Vaccine Safety Datalink, (VSD) for any future "ecological studies" of autism.
In fact, Gerberding's report said, any continued use of the VSD for similar ecological studies of vaccines and autism "would be uninformative and potentially misleading."
Ecological vaccine studies are large, epidemiological analyses of risks and trends using computerized data from large populations -- in this case children enrolled at several big HMOs -- without ever examining a single patient in person.
CDC officials conducted at least five separate analyses of the data over a four-year period from 1999-2003. The first analysis showed that children exposed to the most thimerosal by one month of age had extremely high relative risks for a number of outcomes, compared with children who got little or no mercury: The relative risk for ADHD was 8.29 times higher, for autism, it was 7.62 times higher, ADD, 6.38 times higher, tics, 5.65 times, and speech and language delays were 2.09 more likely among kids who got the most mercury.
Over time, however, all of these risks declined into statistical insignificance, statistical inconsistency or else outright oblivion: The relative risk for autism plummeted from 7.62 in the first analysis, to 2.48 in the second version, to 1.69 in the third round, to 1.52 in the fourth, and down to nothing at all in the fifth, final, and published analysis printed in the Journal Pediatrics in November of 2003.
Vaccine officials attributed the steady drop to the elimination of "statistical noise" from the data through due diligence and the endeavor for excellence in governmental statistical analysis.
Indeed, the VSD study was the main pillar of a hugely influential 2004 report by the Institute of Medicine, which also concluded that there was no evidence of link between mercury, vaccines and autism.
To this day, public health officials routinely point to five "large epidemiological studies" representing the "highest quality science," none of which found any link to thimerosal.
In fact, the American VSD study has long been held up as the best and brightest of them all (the others were in Sweden, the UK, and two in Denmark). And this reputation has stuck in the minds of medicine and the media.
Curiously though, even the study's lead author -- Dr. Thomas Verstraeten, an employee of vaccine maker GlaxoSmithKline -- protested that the VSD study "found no evidence against an association, as a negative study would. In fact, he said that additional study was needed, which "is the conclusion to which a neutral study must come."
That's when Congress stepped in.
In 2005, a group of Senators and Representatives headed by Sen. Joe Lieberman wrote to the NIEHS (an agency of the National Institutes of Health) saying that many parents no longer trusted the CDC to conduct independent minded studies of its own vaccine program. Lieberman et al asked NIEHS to review the CDC's work on the vaccine database and report back with critiques and suggestions.
The final NIEHS report was a serious and thoughtful critique of where the CDC went wrong in its design, conduct and analysis of the study. The NIEHS panel "identified several serious problems," with the CDC's effort, criticism to which the agency had not responded -- until now.
In her letter to the House Appropriations Committee, the CDC Director responded directly to many -- though not all -- of the most important criticisms and recommendations contained in the NIEHS panel report.
For example, the NIEHS had criticized CDC for failing to account for other mercury exposures, including maternal sources from flu shots and immune globulin, as well as mercury in food and the environment.
"CDC acknowledges this concern and recognizes this limitation," the Gerberding reply says.
The NIEHS also took CDC to task for eliminating 25% of the study population for a variety of reasons, even though this represented, "a susceptible population whose removal from the analysis might unintentionally reduce the ability to detect an effect of thimerosal." This strict entry criteria likely led to an "under-ascertainment" of autism cases, the NIEHS reported.
"CDC concurs," Gerberding wrote, again noting that its study design was "not appropriate for studying this vaccine safety topic. The data are intended for administrative purposes and may not be predictive of the outcomes studied."
Another serious problem was that the HMOs changed the way they tracked and recorded autism diagnoses over time, including during the period when vaccine mercury levels were in decline. Such changes could "affect the observed rate of autism and could confound or distort trends in autism rates," the NIEHS warned.
"CDC concurs," Dr. Gerberding wrote again, "that conducting an ecologic analysis using VSD administrative data to address potential associations between thimerosal exposure and risk of ASD is not useful."
Read that sentence one more time. The head of the CDC is saying that its most powerful and convincing piece of exonerating evidence for thimerosal is, in effect, "useless."
I hope everyone will read it, including the recommendations to make the VSD better, and the CDC's agreement with all of the suggestions.
As questionable at the US thimerosal study was, "it was an improvement on other studies, including the two in Denmark, both of which had serious weaknesses in their designs," Dr. Irva Hertz-Picciotto, Professor of Public Health at UC Davis Medical School and Chair of the NIEHS panel, told reporter Dan Olmsted at UPI.
That leaves very little for the CDC to go on in terms of proving that thimerosal and autism are not associated in any way.
Yes, there is always the study of disability services data from California -- which seem to be rising among the youngest cohorts of kids, who presumably received little or no mercury because thimerosal was largely removed from childhood shots.
But California is an "ecological study" with problems of its own.
"Although (this) information is often used by media and research entities to develop statistics and draw conclusions, some of these findings may misrepresent the quarterly figures," cautions the website of the California Department of Developmental Services (DDS). "Increases in the number of persons reported from one quarter to the next do not necessarily represent persons who are new to the DDS system."
Even the CDC admits that "there are several limitations" with linking a VSD study design with the California data, Gerberding wrote to Congress, because, among other things, California only counts "persons who were referred to and/or voluntarily entered" the disability system."
It will be interesting to see how the House Committee -- and the mainstream media -- react to this rather breathtaking confession by the CDC, which does seem to want to conduct the best vaccine-autism science possible (see Gerberding's replies to NIEHS recommendations for improving the VSD: CDC officials are currently conducting in- depth follow up studies with VSD patients).
As the waning months of the Bush administration get underway, I can't help but wonder if a little housecleaning might be going on at some of our top health agencies.
Yes, it fosters the growth of antibiotic-resistant bacteria.
Yes, it bioaccumulates.
Yes, it's probably an endocrine disruptor.
So, why is it in your toothpaste? (Colgate Total, I'm looking at you!) When they tell you a product "fights germs for 12 hours!" it's probably not a good thing to put into your mouth. If "morning breath" really bothers you, brush your teeth (with Tom's of Maine) as soon as you wake up.
Triclosan is an antimicrobial agent found in a broad variety of products, ranging from hospital and household liquid hand soap, detergents, and other sanitizing products, to toothpaste and hair products, pesticides, and plastic and foam products like cutting boards and shoe insoles. The popularity of antibacterial consumer products has led to increased consumer use of triclosan (Perencevich 2001; Tan 2002). This antimicrobial agent is marketed under a variety of trademarked names as well, including Microban, Irgasan DP-300, Lexol 300, Ster-Zac, Cloxifenolum, Biofresh, and others.
Triclosan has been detected in human breast milk and blood samples from the general population (Adolfsson-Erici 2002; TNO 2005), and in the urine of 61 percent of 90 girls ages 6 to 8 tested in a recent study spearheaded by Mount Sinai School of Medicine (Wolff 2007). EWG-led biomonitoring studies have detected triclosan in 17 of 21 people tested (EWG 2007a). Scientists recently found triclosan in 58 percent of 85 streams across the U.S. (Kolpin 2002), the likely result of its presence in discharges of treated wastewater.
The amount of triclosan in the wastwater stream is estimated to be as much as 3 to 5 milligrams per person per day from residences alone (McAvoy 2002); in addition, substantial discharges of this antimicrobial agent are expected from laundries, hair salons, medical facilities, and many other commercial and industrial sites. Optimal water treatment can result in degradation and removal of 95 percent of triclosan (Samsoe-Petersen 2003); however, small amounts may pass through the treatment plants to receiving waters.
Triclosan kills microbes by disrupting protein production, and also by binding to the active site of a critical carrier protein reductase that is essential for fatty acid synthesis. This target enzyme is present in microbes but not in humans. Though triclosan is known to be acutely toxic to certain types of aquatic organisms (Orvos 2002), available studies do not indicate it causes cancer or birth defects in humans (Bhargava 1996). Products containing triclosan may occasionally cause skin irritation in people with a specific sensitivity (Bhargava 1996).
Triclosan has the tendency to bioaccumulate (Samsoe-Petersen 2003), or become more concentrated in the fatty tissues of humans and other animals that are exposed to this chemical. The chemical structure of triclosan is similar to that of DES, a non-steroidal estrogen linked to cancer development in those exposed in utero, raising concerns about its potential to act as an endocrine disruptor. A recent study on fish showed that triclosan had weakly androgenic effects, but no estrogenic effects (Foran 2000).
In contrast, another study found that low levels of triclosan in combination with thyroid hormones triggered rapid transformation of tadpoles into frogs (Veldhoen 2006). Rather than mimicking the thyroid hormone, triclosan, in concentrations of less than 1 part per billion commonly measured in U.S. streams, appeared to make thyroid hormones more potent. This hormone signaling mechanism is similar in frogs and humans, suggesting that triclosan could potentially disrupt the human thyroid system.
The evolving interaction between microbes and antiseptic agents has led to concern that use of specific antimicrobial ingredients may provoke the development of strains of bacteria that are resistant to disinfection. Studies have described strains of bacteria that have acquired reduced susceptibility to triclosan (McMurry 1998; Chuanchuen 2001). The identification of a triclosan-resistant bacterial enzyme suggests that resistance to this antiseptic ingredient may develop more readily than to other agents (Heath 2000). In addition, exposing specific bacterial strains to triclosan appears to result in selection favoring bacteria that are resistant to multiple antibiotics (Chuanchuen 2001).
The American Medical Association has advanced an official recommendation against using antibacterial products in the home due to concern about antimicrobial resistance (Tan 2002). A Food and Drug Administration panel reviewed the existing research and found no evidence that households that use antibacterial products are healthier than households that use soap and water and other typical cleansing products (FDA 2005).
Studies indicate that in surface waters, triclosan can interact with sunlight and microbes to form methyl triclosan, a chemical that may bioacummulate in wildlife and humans (Adolfsson-Erici 2002; Lindstrom 2002). A recent European study found methyl triclosan in fish, especially concentrated in fatty tissue (Balmer 2004). Triclosan also can degrade into a form of dioxin, a class of chemicals linked to a broad range of toxicities including cancer (Lores 2005). New research shows that triclosan in tap water can react with residual chlorine from standard water disinfecting procedures to form a variety of chlorinated byproducts at low levels, including chloroform, a suspected human carcinogen (Fiss 2007).
Gardasil has been implicated in the deaths of two more young women, the European Medicines Agency (EMEA) has reported. Though no official cause of death has been listed, the young women apparently died shortly after receiving Gardasil, and the EMEA is characterizing their deaths as “sudden and unexpected.”
The two deaths bring the total number of fatalities possibly linked to the Merck cervical cancer vaccine to five. In the U.S., three young women have reportedly died after receiving Gardasil. However, there could be more such incidents, as health officials believe that adverse effects of medication are widely underreported.
Gardasil was approved by the U.S. Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of HPV that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers.
Just weeks after its approval, the U.S. Centers for Disease Control (CDC) recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Merck was more than happy to echo the CDC recommendations, and actually began an intensive lobbying effort to convince state health authorities to make Gardasil vaccinations mandatory for young girls. Merck has made similar efforts in Europe. Merck’s heavy promotion of Gardasil has been effective, as some analysts estimate that Gardasil could net the company as much as $1.4 billion in its first full year on the market.
But Gardasil may not be as safe as Merck claims. A 2007 analysis by Judicial Watch of Gardasil adverse event reports revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. According to Judicial Watch, in several instances, blood clots were reported to have occurred after the administration of Gardasil. The Gardasil side effect reports also included 28 women who miscarried after receiving Gardasil. Other side effects reported to the FDA included paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported. Oddly, Judicial Watch was only able to obtain the FDA’s reports on Gardasil after it filed a Freedom of Information Act request with the agency. As some have pointed out, Judicial Watch is a conservative organization with an agenda. But Judicial Watch did not fabricate these adverse event reports, and the seriousness of some of them indicate a need for further investigation.
In May, Dr. Diane Harper, a top expert on the HPV who, while working as a professor at Dartmouth College, served as a researcher on study trials for Gardasil, questioned efforts to make the vaccine mandatory. In an interview with a Florida TV station, Dr. Harper said that there has not been enough post-marketing surveillance of Gardasil to insure that it is free of side effects that could prove particularly dangerous to young girls. “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in place a process that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.” she said.
Big Pharma is still allowed to ship its poisoning mercury-containing vaccines to kids in the developing world, because the powers that be (including WHO) have deemed these kids not worth the expense of cleaner vaccines. Peruvian scientists did a study using hamsters and thimerosal (ethylmercury) and found that the hamsters were terribly damaged. It's too bad the government (ours and theirs) and Big Pharma don't care.
LAURENTE, Jonny, REMUZGO, Fany, AVALOS, Betthina et al. Neurotoxic effects of thimerosal at vaccines doses on the encephalon and development in 7 day-old hamsters. An. Fac. med., Sept. 2007, vol.68, no.3, p.222-237. ISSN 1025-5583.
Objectives: To determine if thimerosal administration in amounts equivalent to vaccines content produces neurotoxic effects on the encephalon in postnatal hamsters and on experimentation animals' development. Design: Experimental, prospective, bietapic study. Setting: San Fernando Faculty of Medicine, Universidad Nacional Mayor de San Marcos. Biologic material: Seven-day old hamsters. Material: We divided 45 postnatal hamsters in three groups: group A (n = 15), group B (n = 15) and group C (n = 15). We administered three intramuscular equivalent doses of sucrose and thimerosal in 20 µL of physiological serum respectively to groups B and C on birth-days 7 (0,227 µg), 9 (0,216 µg) and 11 (0,220 µg). Group A received only 20 µL of saline solution. Main outcome measures: Body weight, encephalon weight, hamster's stature and encephalon histopathological alterations. Results: Anova and student t tests showed statistical significance in favor of low body weight, low encephalon weight and smaller stature in group C with respect to groups A and B hamsters (p<0,000). χ2 statistical significance in relation to the presence of histopathological alterations in group C was also obtained (p<0,000). We observed greater relative risk of encephalic alterations in group C. Conclusions: The administration of thimerosal in doses equivalent to vaccines content was associated with low corporal weight, low encephalon weight and smaller stature in postnatal hamsters. Neurotoxic effects were also produced at encephalic level, at hippocampus (regions CA1, CA3, DG), cerebral cortex and cerebellum (Purkinje cells and granuloses cells) with decrease in neuronal density, neuronal necrosis, axonal dismyelinization and gliosis. In addition, risk increase in developing any of these alterations was high in the animal group receiving thimerosal.
Update: I received this book this week, and I read it in one sitting. It is that gripping. A quick review...
The foreword, by Dr. Jay Gordon, assistant clinical professor of pediatrics at UCLA Medical Center, grounds the book in medical facts--for example, that the CDC-recommended "birth dose" of Hepatitis B vaccine contains 10 times the amount of aluminum acknowledged as toxic by the EPA. Dr. Gordon states unequivocally, "Vaccines can cause autism. Diet and supplements and other alternatives to doing nothing can lead to recovery from autism. Period."
The first ten chapters, from the portion of the book entitled "The Time Is Now," describe Jenny's involvement in the autism-recovery movement, from the time when her son Evan was diagnosed to her current public appearances and her efforts to get the CDC and the American Academy of Pediatrics to create and support a safer vaccine schedule, and to support efforts by Defeat Autism Now! (DAN!) doctors to heal children who have been diagnosed with autism. In addition to catching up the readers who haven't read Louder Than Words, Ms. McCarthy's previous book, this first section gives readers an insight into Ms. McCarthy's motivations in writing this new book. Primarily, she wants to share the stories of parents who have healed their children's autism--as the subtitle says, "against all odds"--so that other parents of children who have been diagnosed can find inspiration and take the important step of finding a DAN! doctor to begin treating their children. She also wants to give these women a public forum--to let them have their moment, as she did at the Green Our Vaccines rally in DC in June--to let them tell the stories that have consumed their lives since their children's diagnoses. I couldn't stop thinking what a tremendous burden it must be for Ms. McCarthy--who could have quietly continued her career as a comedian, actress, and model instead of speaking out for vaccine safety and autism treatment protocols--to be the mouthpiece for all autism-recovery families. She tells us that she is frequently stopped in airports and other public places by mothers who are working on healing their children, and the emotional toll of these conversations--and the neverending battle with the CDC and the AAP, which continue to recommend an unsafe and untested vaccine schedule--must be nearly overwhelming. Thus, one other motivation for writing the book must have been to unburden Ms. McCarthy from some of the stories that she has been carrying around in her head and her heart for so long. I hope it works. She is a tireless advocate for children and families, and the world needs her to keep up her strength.
The second portion of the book contains stories from "mother warriors" (and one father warrior) who have healed their children, to varying degrees, from the myriad of health issues involved in autism. Ms. McCarthy intersperses her own thoughts with the narratives of these parents, recalling moments along her journey with Evan and offering her views on issues raised by the parents. The stories are inspirational and heartbreaking, but mostly, they are hopeful. They show that recovery is possible, and they highlight the importance of spreading the word about DAN! treatment protocols. The content of the stories is enough to keep you reading, but there are also some remarkable turns of phrase that will bring tears to your eyes and a tightness to your chest. I offer one example: Coral Bergmann, who is healing her son Branson, and says, "Although I am a single parent, I am not alone. I have had a chance to be reacquainted with God. Not the God you meet in your Sunday best in church, but the God you meet on your kitchen floor at three in the morning."
The book concludes with a directory of DAN! doctors and information on Generation Rescue, a parent-founded and parent-funded autism advocacy group.
* * *
I've pre-ordered it, and I'll be reviewing it when I receive it in September. I'm looking forward to Ms. McCarthy's counterpoint to the psychological profession's decades of "refrigerator mother" lies.
Did you know that most people (something like 90%) are immune after three shots in a series, and more than half (around 70%) are immune after two shots? Half of people don't need more than the first shot in a series. The way to find out if your kid already has serological immunity is to ask for an antibody titer test after the first or second shot. Any time your doctor wants to give your kid a booster shot, ask for an antibody titer test first. If there are enough antibodies present in your child's blood, no boosters are required at present. I'm not a doctor, but if you ask your doctor (or check Medline, referenced below), they'll tell you the same thing. Why pay Big Pharma for an unnecessary shot? Why put more formaldehyde and aluminum into your kid's body if he already has immunity? A blood test isn't fun for a little kid, but neither is an injection, and the blood test doesn't involve any heavy metals or chicken embryos--sounds better to me!
Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood. The antibody level in the blood is a reflection of your past exposure to an antigen or to something that the body does not recognize as belonging to itself. The body uses antibodies to attack and remove foreign substances.
Blood is drawn from a vein, usually from the inside of the elbow or the back of the hand. The site is cleaned with germ-killing medicine (antiseptic). The health care provider wraps an elastic band around the upper arm to apply pressure to the area and make the vein swell with blood.
Next, the health care provider gently inserts a needle into the vein. The blood collects into an airtight vial or tube attached to the needle. The elastic band is removed from your arm.
Once the blood has been collected, the needle is removed, and the puncture site is covered to stop any bleeding.
In infants or young children, a sharp tool called a lancet may be used to puncture the skin and make it bleed. The blood collects into a small glass tube called a pipette, or onto a slide or test strip. A bandage may be placed over the area if there is any bleeding.
When the needle is inserted to draw blood, some people feel moderate pain, while others feel only a prick or stinging sensation. Afterward, there may be some throbbing.
In some situations, your health care provider may check your antibody titer to see if you had a infection in the past (for example, chickenpox) or to decide which immunizations you need.
The antibody titer is used to determine:
The strength of an immune response to the body's own tissue in diseases such as systemic lupus erythematosus (SLE) and other autoimmune disorders.
Your need for a booster immunization
Whether a recent vaccine caused a strong enough response from your immune system so that you are protected against the specific disease
Normal values depend on the antibody being tested. If your health care provider is testing for antibodies against your own tissue, then the normal value would be zero or negative.
If your health care provider is testing to see if your immunization brought your antibody titer up to a preventive level, then the normal result depends on the specific value for that immunization.
If your health care provider is testing for antibodies against your own tissue, abnormal results would show a positive antibody titer. This means that your immune system is fighting its own tissue, cells, or substances.
If your health care provider is testing to see if your immunization brought your antibody titer up to a preventive level, an abnormal result would indicate that your body has not mounted an adequate response against the immunization, and you are not adequately protected from the disease.
Low levels may also occur if you have an immune deficiency.
Veins and arteries vary in size from one patient to another and from one side of the body to the other. Obtaining a blood sample from some people may be more difficult than from others.
Risks associated with having blood drawn are slight by may include:
Please click through the link to access the www.MyKidsMyChoice.com website and resources. You have the power to give your child a healthy life or a compromised one.
You’ve researched. You’ve considered the risks and benefits and you want to make your own decision regarding vaccinations.
There are three exemptions in the US—medical, religious and philosophical. All states have medical. A medical exemption to all of the vaccines is difficult to obtain, though you may be able to get an exemption for one or two. Understand also, the Department of Health can override your doctor.
The law (PHL 2164) provides, “(the law) shall not apply to children whose parent, parents or guardian holds genuine and sincere religious beliefs which are contrary to the practices herein required (immunizations), and no certificate shall be required as a prerequisite to such children being admitted or received into school or attending school.”
Most of the time, you will need to include a personal letter with the form.
Your beliefs have to be truly religious and they have to be sincerely held. This is a ‘two-tier’ test. The first one is genuinely religious in nature.
Most people I talk with hear "religious exemption" and panic, “I haven’t been to church in six years. And I have an issue with the Catholic Church.”
First, you do not have to be a member of an organized religion. Second, the above can be true and you can still believe in religious principles that directly connect to the rejection of vaccines.
In fact, I believe it’s impossible to have a conversation about rejecting vaccines without mentioning God and Faith.
You just need to find the correct words to express religious thoughts and concepts that connect to refusing vaccinations.
The Bible states, “Praise the Lord who forgives all sins and heals all diseases.” Psalm 103: David
This line of scripture expresses a simple idea; placing Faith in the healing power of God can cure disease. I believe the immune system is a gift from God. Inviting disease into a gift from God disrespects His divine gift to us, corrupts the body and consequently the soul. It separates from a Faith we have in God that he can cure all diseases.
The following further illustrates this point:
“As for God, his way is perfect; the word of the Lord is flawless. He is a shield for all who take refuge in him. For I have kept the ways of the Lord, I have not done evil by turning from God.”
Additionally, vaccinations are fear-based and founded on a threatening principle. Mankind says that if I do not vaccinate, my child may get sick/die and may cause others to get sick/die. This idea is far away from the peace that God represents for me and the love He encourages us to feel for humankind. The pessimistic principle of vaccinations contradicts the love I feel for my fellowman as an instrument of Jesus Christ. Participating in the spiritually dark (and diseased) process of vaccines disconnects me from my mission to connect with God. To participate in this dark and diseased process gives energy and credence to harm and disease and offends my faith. For me, Jesus is about hope, love, optimism, peace and contentment.
Scripture that illustrates my feelings:
“The Lord turns my darkness into light.”
God said, “I am the light of the world. Whoever, follows me will never walk in darkness but will have the light of life.” “There is no fear in love, but the perfect love (I have for my God and my children) drives out fear.” John 4:18 “Such love has no fear, because perfect love expels all fear. If we are afraid, it is for fear of punishment, and this shows that we have not fully experienced his perfect love.”
“God has not given us a spirit of fear and timidity but of power, love and self-discipline.” The Bible states, “As within, so without.”
To me, the above states that what I invite into my spirit will be manifested in my body and vice-versa. If I invite/ allow disease into my body, my soul will be corrupted. To accept vaccinations is to invite disease into the body and the soul; only disease will result.
“Blessed is the man who perseveres under trial because when he has stood the test, he will receive the crown of life promised to those who love him.”
To me, this means that God needs us to persevere through disease, have Faith in His Supreme healing powers and know that addressing sickness will make us grow stronger.
“What if I am asked if I give my children medicine when they are sick? Or I give them vitamins?”
First, if they start asking you questions, make sure you have legal representation. Do not go into a taped meeting without an attorney or an advocate. Second, explain to school officials that injecting disease into a healthy body and helping a body in crisis are two very different actions.
Medicine helps a body in crisis; medicine is an optimistic hope for restored health. Medicine and vitamins work for the goal of maintenance/restoration of health and vitality.
Vaccinations are diseases injected into the blood anticipating sickness. Accepting disease into a healthy body turns your back on the gift of the immune system that God has blessed you with; inviting this disease will only bring more disease. Hope for, and pursuit of, good health is different from accepting and preventing disease.
The foundations of these principles are completely different. Medicine and vitamins do not disrespect the gift God has given us.
Helping a body in crisis has nothing to do with "interference, " and "substituting man's power," with the healing power of God. Sometimes school district attorneys will try to trip you up by using these words and altering your presentation of your belief system. This is so they can claim your objections to vaccinations are based on medical or philosophical grounds. DO NOT let them lead you down that road.
They may claim that it is illogical to use medicines and vitamins if God can heal all diseases. Repeat, "Restoring health to a body in crisis is different from injecting disease into a healthy body." If they repeat the question, offer the same answer, over and over again. We found the need to repeat ourselves numerous times during our interview.
The attorney who interviewed me and my husband claimed we used the words, "substitute" and, "interference," during our meeting. Upon review of the tape, it was evident we did not.
“But my kids have already had some vaccinations.”
Society puts a tremendous amount of pressure to vaccinate. Doctors pressure, even threaten, parents who refuse to vaccinate. Some pediatricians will not take unvaccinated children as patients.
Parents may ostracize others who do not vaccinate. Family members will also tell parents who want to follow their Faith, they’re “crazy.” Many parents understandably give in to the pressure.
Parents have told me that God sent them signs for years that vaccinations were not part of God’s plan. These parents did not listen until, in a conversation with God at a deceased loved one’s grave, they felt compelled by the spirit of God to follow the signs and their faith. They explained to the school that it took a long time to follow the signs from God and their true Faith, but their resolve is now strong and they will not turn their back on God. "Many parents ask Jesus Christ for forgiveness for not following what they knew in their heart to be His word to them."
“I don’t think my religious beliefs are anyone’s business.”
Schools have the legal power to compel you to prove to them your beliefs are sincere and genuine. When determining your sincerity, they are permitted to consider your forthrightness and demeanor. That means you must COOPERATE. It does not help you to be defiant or righteous, it actually harms you. They have all the power.
If they deny you, you can appeal the decision through the Commissioner of Education (he usually sides with the school) and/or the State and Federal Court Systems. The Courts consider the attitude and overall demeanor and the forthrightness of the complainant. It helps you to be completely cooperative because it can make you look like David and them Goliath. The school has virtually unlimited funds- your tax dollars and those of your community members. Most taxpayers do not.
“My first school accepted a letter. Don’t all schools do that?”
No. The law is broad and schools have the power to interpret it in any way they see fit. I was denied my waiver, yet in the next town over, religious waivers are no more than a letter in the nurse’s office. Most schools accept a letter. If they do not stop at the letter, it is imperative to set the proper groundwork so you will ultimately prevail in higher courts of law.
“What if I get called in for an interview?”
Find an attorney or I will accompany parents on a “sincerity interview” for a fee. I would suggest you bring your own tape recorder and set aside several hours beforehand to prepare yourself for the questions that may be asked. I will help prepare you as part of the interview fee.
“What happens if I get denied?”
You can appeal to the Commissioner of Education, the State Court and/or the Federal Court system. The Commissioner of Education usually upholds the school district’s decision. You have the best chance with Federal Court, as they will most likely adhere to the Federal Supremacy Rule, but that is also an expensive route.
You may select an attorney or pursue an organization that helps with civil rights and/or religious freedom issues, i.e. the ACLU or Liberty Counsel to name two resources. If I have helped you write your letter, I will also help you interest the ACLU or Liberty Counsel in your case. If they will not help, I have other attorneys that can help you.
This is from the blog of K Krasnow Waterman, who writes about law and technology and issues caught between them. Please do click through the link and read the comments posted on K's blog--they're even scarier than the blog post. Let's just teach our daughters to keep their pants on or practice safe sex, rather than giving them this risky, risky shot!
Gardasil causing seizure, numbness, "temporary paralysis" is being reported in Australia. Tom Grant has shared with me this information from a television news show in Australia (from the Seven network's Today Tonight show):
"More than 17 girls a week around Australia are experiencing adverse reactions, such as seizures and numbness after having the cervical cancer vaccine. The Dept Of Health while revealing the number of reactions is refusing to release the exact details despite growing controversy overseas including links to at least 7 deaths! There have been previous reports in Australia of young girls fainting and experiencing seizures, dizzy spells and paralysis including 20 students at a Melbourne private school who reported being sick after having the injection in late May."
From what I can see in the materials, the show seems to have included an interview with a 12 year-old girl who sent an email to the network describing suffering hallucinations and partial paralysis after receiving the shot. In her email she describes that so many girls were sick after receiving the shot at her school that she was mostly ignored by school nurses and only taken seriously when she called her mother and her mother came and took her to a physician. She is apparently recovered, though it's unclear whether she was treated when she went to her own doctor or if the symptoms abated on their own. She also describes having seen a tv show that said other girls in Melbourne had also suffered a temporary paralysis after receiving the shot.
The show also interviewed the inventor, who is Australian. And, it noted that the number of reported reactions is low relative to the number of vaccines given. This appears to be the reason that both US and Australian health authorities have not taken any sort of action. At the time of various publicized reports, the rate of reporting was about 1 adverse reaction in 4,000 in Australia (496 out of 2million) and about 1 in 1,800 (1637 out of nearly 3 million) in the US.
My own research indicates that adverse reactions are generally believed to be underreported, although there is no agreement as to how much.
HHV-6 one of the eight known members of the human herpesvirus family.
Note that HHV-6 is not the virus that causes cold sores, genital herpes, chicken pox, shingles, or infectious mononucleosis.
Primary Infection
HHV-6 was first discovered in 1986 in the United States at the National Cancer Institute. This virus infects human white blood cells, specifically T lymphocytes.
Researchers have identified HHV-6 as the cause of childhood roseola (exanthem subitum). Symptoms of this illness include fever and a distinct type of rash. Most infants are infected with HHV-6 before age two, but many display mild or no symptoms. Some symptoms, such as fever, may be incorrectly attributed to conditions other than roseola. However, a small number of infected infants can develop serious disease including bone marrow infection (decreased production of white blood cells and platelets) and brain infection (seizures).
Serologic testing reveals that more than 95% of the world's population is positive for antibodies to HHV-6, indicating an immune response to an infection by the virus. Transmission of this virus is believed to occur as a result of exposure to saliva.
After this initial infection, HHV-6 viral DNA remains latent, or dormant, within the nuclei of cells.
The Biologic Repertoire of HHV-6
The best data about HHV-6 disease comes from children with roseola. Symptoms noted in infants with roseola include fever, swollen glands, lethargy (fatigue), nervous system complications, and bone marrow suppression.
HHV-6 is also known to infect and destroy the cells that produce myelin, the fatty coating that surrounds and protects nerve cells. Additionally, the virus demonstrates the ability to cause disruption of the normal functioning of the human immune system.
HHV-6: Variants A and B
Two variants of HHV-6 are recognized: HHV-6A and HHV-6B. Primary infection of HHV-6B is the cause of roseola in children and greater than 95% of the population has antibodies to this variant. Primary infection with HHV-6A is believed to occur later in childhood or during adulthood and may occur without symptoms.
Latency and Reactivation
HHV-6 reactivation in adulthood can result in illness. Reactivation means that the virus is no longer dormant and begins to replicate. In most individuals, reactivations are extinguished by the immune system and the virus is forced back into latency. Click diagram below to enlarge.
Reactivations in Persons with Intact Immune Systems
The factors that lead to reactivation in people with intact and functioning immune systems are unclear and probably include genetic and environmental causes (such as hormones, other infections, and exposure to chemicals). Most instances of reactivation will not result in chronic, active infection as the normal immune system will suppress the reactivated virus and return it to a latent state. However, reactivation of HHV-6 in normal adults has been associated with a mononucleosis syndrome, autoimmune disorders, and nervous system diseases.
Recent studies have revealed active HHV-6 infections in single, random blood samples taken from Multiple Sclerosis (MS) patients (56% positive) and Chronic Fatigue Syndrome (CFS) patients (39% positive). Normal, healthy controls were negative for active HHV-6 virus (0% positive). This is a significant finding and demonstrates that active HHV-6 infections are not seen in healthy people without these disease associations.
Reactivations in Persons with Compromised Immune Systems
In individuals whose immune systems have been compromised by disease (e.g. AIDS) or treatment (e.g. chemotherapy for cancer or immunosuppressive drugs after transplantation), a reactivation of HHV-6 can result in suppression of the bone marrow or inflammation of the tissues of the brain, liver or lungs.
Why is the Wisconsin Viral Research Group interested in HHV-6?
Work from several laboratories has strongly implicated HHV-6 as the cause of multiple sclerosis.
Other studies have suggested a role for HHV-6 in many cases of severe, persistent fatigue especially in patients with other signs of systemic disease (fever, swollen lymph nodes, cognitive impairment).
HHV-6 associated disease has been successfully treated with antiviral medications.
Recognition of the presence of active HHV-6 infections in MS, CFS, and other chronic diseases would allow for treatment of these patients.
The problem is that salmonella's "virulence quickly dissipates on Earth." Yes, that's right: salmonella is NOT the kind of rapidly spreading bacterium for which you might think scientists would work on a vaccine. They have to take it to SPACE to get it to be dangerous enough to work on. Just wait until this one gets onto the mandatory childhood vaccination schedule.
Space may be final frontier for Salmonella vaccine
FasterCures SmartBrief | 06/05/2008
Researchers hope microgravity in space will help speed development of a vaccine for Salmonella, work on which has lagged because the bacterium's virulence quickly dissipates on Earth. Earlier research in space shows microgravity triple's Salmonella's potency, giving researchers a greater chance to genetically manipulate a strain for vaccine development.
The age of the blockbuster drug is over. Pharmaceutical firms can't count on huge wins like Viagra anymore, and there is always the problem of what to do when the big drugs go off-patent. The solution: come up with a million new vaccines for diseases that you never thought your kid would get (because he most likely wouldn't). Then get the government to make them mandatory. Brilliant! It's too bad the vaccines are loaded with toxins and prone to giving horrible side effects. Oh, wait, Novartis's shareholders don't care.
Novartis unveiled a promising pipeline of novel vaccines, highlighting vaccine candidates that address significant unmet needs for prevention of fatal diseases such as meningococcal infections and other hospital and community acquired infections. Several vaccine candidates from the Novartis Vaccines research and development portfolio have the potential of being first of its kind.
"Our emerging late and early stage pipeline underscores our commitment to prevention as a means to improve health and address public health challenges," said Dr Joerg Reinhardt, CEO of Novartis Vaccines and Diagnostics. "We are focusing on diseases such as meningococcal meningitis where current vaccines do not protect against all strains that cause this potentially fatal condition which affects up to 500,000 people a year".
Novartis has two meningococcal vaccines in late stage development, Menveo (ACWY-CRM conjugate vaccine) for infants and adolescents and MenB for multiple strains of the meningococcal serogroup B.
Novartis is the only company currently developing vaccines against all five meningococcal serogroups (A, B, C, W-135 and Y) in phase III clinical trials, a Novartis press release said.
Currently, available vaccines do not provide adequate protection against all meningococcal disease serogroups, particularly in young children and adolescents who have the highest rate of disease. The disease is estimated to strike an estimated 500,000 people annually of whom an estimated 50,000 die and up to 20 per cent suffer from serious long-term consequences such as deafness, neurological damage or limb loss.
"Meningococcal meningitis is a potentially vaccine-preventable disease and with new vaccines offering protection across age groups, other families may not have to suffer losing a child as I did to this devastating, yet preventable illness," said Lynn Bozof, executive director and one of the five founding members of The National Meningitis Association".
Recent phase III trial data for Menveo (MenACWY-CRM) suggest that it has the potential to become the first meningococcal vaccine to protect all age groups from infancy to adulthood against the four vaccine preventable serogroups (A, C, W-135 and Y). A pivotal phase III study compared Menveo head to head with Menactra. The co-primary objectives were lot-to-lot consistency for three Menveo lots and seroresponse non-inferiority of Menveo as compared with Menactra for the 11 to 18 and 19 to 55 years of age groups, followed by a pre-defined superiority analysis after non-inferiority was first demonstrated. Submissions for infants and young children 2 months-10 years of age are planned for 2009. Menveo is expected to fit within standard childhood vaccination schedules.
The Novartis MenB vaccine is a recombinant vaccine that is designed to protect against a majority of global strains of serogroup B for which no vaccine is currently available. In Europe, North America and many other parts of the world the B strain is the most common meningococcal serogroup. In clinical trials completed to date, the Novartis MenB vaccine has shown excellent immunogenicity in infants and strong immunogenicity in adults in early clinical development. A phase III trial in infants and children is currently ongoing as part of a comprehensive phase III development effort for the vaccine. Regulatory submissions for the Novartis MenB vaccine for infants and children are planned for 2010.
Novartis has a strong position in prevention of meningococcal disease achieved via the distribution of more than 26 million doses of Menjugate (MenC-CRM) and the production of MeNZB against a strain of meningococcus B specific to an outbreak in New Zealand.
They say they're making it for developing countries, but we all know that developing countries have little money to pay for drugs. Let's see how long it takes before typhoid is on the US vaccination schedule.
Emergent BioSolutions Initiates U.S. Phase II Trial of Oral Typhoid Vaccine Candidate
Jun 05, 2008 7:41 AM CDT
Study designed to confirm safety and immunogenicity of vaccine manufactured at the large-scale commercial facility planned for launch
Phase III trials are expected to begin next year
ROCKVILLE, Md.-- (BUSINESS WIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that dosing of patients has begun in a U.S. Phase II clinical trial of the company’s single-dose oral typhoid vaccine candidate. This randomized, double-blind, placebo-controlled, single-dose, dose-escalation trial is being conducted in healthy adults. The company anticipates that trial results will be available by year end. This US study will evaluate vaccine manufactured at the large-scale facility planned for commercial launch. This trial is designed to confirm the safety and immunogenicity of the vaccine, and Phase III trials are expected to begin in 2009. If approved, this candidate would be the first single-dose, drinkable typhoid vaccine available for adults and children.
“The commencement of this U.S. Phase II study represents an important milestone in the clinical development of our oral typhoid vaccine candidate,” said Daniel Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “In previous clinical studies, this vaccine candidate has demonstrated promising immunogenicity and safety results in both children and adults. We are pleased with our continued progress in the development of this important vaccine candidate, which is a cornerstone in our company’s mission of protecting life.”
Dr. Stephen Lockhart, senior vice president of product development for Emergent BioSolutions, said, “Typhoid fever continues to be a high disease burden worldwide, claiming over 200,000 lives annually, most notably children living in developing countries where the disease is endemic. In addition, there is increasing incidence of antibiotic resistant strains of the disease which would suggest an even greater need for efficient and effective vaccination. This global health problem affects not only individuals living in endemic regions but also those traveling to typhoid endemic regions. With millions of people traveling globally every year, typhoid fever remains a health concern in industrialized and developing countries. This clinical trial is an important next step in the development of this advanced stage product.”
About the Typhoid Vaccine Candidate
The company’s typhoid vaccine candidate is a live, attenuated strain of Salmonella typhi engineered to eliminate virulence by deletion of two specific genes. The vaccine is intended to be administered in a single, drinkable dose for adults and children residing in typhoid endemic regions as well as individuals traveling to these endemic regions. Currently available typhoid vaccines have limited efficacy in children less than six years of age. In endemic regions, pre-school aged children have the greatest public health risk for contracting typhoid fever. Emergent’s typhoid development program is focused on developing a product that is safe and effective with a patient friendly method of administration, as well as serving a critical unmet need in targeting a product that would be effective in children as young as two.
Previously published studies have shown the vaccine candidate to be immunogenic and well-tolerated in both adults and children as young as 5 years of age. The vaccine candidate has completed various trials, including:
A randomized, placebo-controlled Phase II clinical study conducted among children in Vietnam. Study results showed that 97% of the children administered a single, oral dose of vaccine developed an immune response, defined as an increase in Salmonella typhi anti-LPS IgG and/or IgA antibody levels in the blood. No serious adverse events were reported.
An open-label, non-placebo controlled, pilot study conducted in the United Kingdom in healthy adults in which the vaccine candidate was well tolerated and immunogenic, eliciting both cell mediated and humoral responses.
A double-blind, placebo controlled, single-dose, dose escalating clinical trial conducted in the United States in which 100% of the trial participants in the highest dose group and 56% of the participants in the lowest dose group developed an immune response.
An open-label, non-placebo controlled, single-dose clinical trial conducted in the United States in healthy adults to evaluate the safety and immunogenicity of two different presentations of the vaccine. The vaccine candidate was similarly immunogenic in both presentations and both were well tolerated.
A single-blind, placebo controlled clinical trial in Vietnam in healthy adults. The Wellcome Trust provided funding for the trial. The vaccine met the criterion for immunogenicity and was well tolerated, with no serious adverse events reported.
For the current clinical study, approximately 200 patients will be enrolled across three sites in the U.S. Screening of patients for this study began in early May 2008. Further information on this trial is available on www.clinicaltrials.gov and can be referenced under the trial code NCT00679172.
Additional trials are being designed that would address the needs of adults, children and seniors residing in and traveling to typhoid endemic regions. Emergent is working closely with regulatory agencies in the U.S., Europe and endemic regions to design a development program that meets disease prevention needs and builds upon current disease management programs.
About Typhoid
Typhoid, also known as typhoid fever, is caused by infection with the bacterium Salmonella typhi. Typhoid is characterized by fever, headache, constipation, malaise, stomach pains, anorexia and myalgia. Severe cases of typhoid can result in confusion, delirium, intestinal perforation and death. Typhoid is transmitted by consuming contaminated food or drinks. Contamination usually results from poor hygiene and sanitation. Typhoid is often endemic in developing countries in which there is limited access to treated water supplies and sanitation.
An estimated 22 million cases of typhoid occur every year worldwide. The World Health Organization (WHO) recommends that pre-school aged children living in typhoid endemic regions be immunized to control the disease. In addition, typhoid fever vaccination should be considered for all persons traveling to developing countries, with travelers to Asia, Africa and Latin America deemed to be especially at risk. U.S. military personnel deployed in these areas are also at risk of infection.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a leading biopharmaceutical company dedicated to one simple mission—to protect life. We develop, manufacture and commercialize vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. Our products target infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. Our marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. More information on the company is available at www.emergentbiosolutions.com.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including our expected revenue growth and net earnings for 2008, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including our ongoing and planned development programs, preclinical studies and clinical trials; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s current report on Form 10-Q for the quarter ended March 31, 2008 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
Six weeks later, the 14-year-old Dallas resident became so dizzy she could barely walk. She was hospitalized and missed three weeks of school.
Then, she had a seizure. For weeks, she bounced back and forth between specialists and was eventually diagnosed with epilepsy.
Katherine's mother, Michelle Kimzey, now believes her daughter's symptoms were caused by a new vaccine that was supposed to protect her against cervical cancer.
The symptoms started not long after Katherine had her second shot late last year, she said. And they mirrored many of the 5,000 reports filed by the public through a national database that monitors the safety of vaccines after they are licensed.
"When you read everybody's stories, they're too similar not to be related," Mrs. Kimzey said.
But officials with the Centers for Disease Control and Prevention and doctors nationwide said such concerns about the drug are unfounded and most significant side effects reported are unrelated to the vaccine.
"The safety of the vaccine is being very closely monitored," said John Iskander, acting director for immunization safety at the CDC, which runs the database along with the Food and Drug Administration.
Fainting, he said, has been the strongest negative response to the vaccine.
"There certainly have been high-profile suspected side effects, some reports of deaths," he said, "but those have been investigated and they don't appear to have been causally related."
The recommendations have not changed and the vaccine will remain available, he said.
Jennifer Allen, a spokeswoman for New Jersey-based Merck & Co.'s vaccine division, which makes Gardasil, said Thursday that the company conducted clinical trials for 10 years and that it remains confident in its product.
But this hasn't assuaged Mrs. Kimzey, 41. And Katherine has refused to get her third and final dose of the vaccine.
Approved 2 years ago
Gardasil was approved by the Food and Drug Administration two years ago for females between ages 9 and 26. It protects against sexually transmitted diseases caused by the human papillomavirus, or HPV, responsible for 70 percent of cervical cancers and 90 percent of genital warts. Females are encouraged to get the vaccine before they become sexually active.
Three shots are given over a six-month period. The company said 16 million doses have been administered since its approval. And it lists nausea, vomiting and pain following the shot among the side effects.
The HPV vaccine has generated debate across the country and in Texas. Gov. Rick Perry issued an executive order in February 2007 requiring that all sixth-grade girls get the HPV shot. But angry parents and conservative groups fought the mandate, fearing it condoned premarital sex and took away parental rights. The Legislature defeated the order last April.
The National Vaccine Information Center heralded the decision, saying that testing of the vaccine was not extensive enough in girls under 12. The nonprofit center had already started warning about the possibility of adverse reactions such as extreme fatigue, arthritis and loss of consciousness.
Barbara Loe Fisher, co-founder and president of the center, said she's frustrated that the CDC has "assumed safety" for Gardasil, which has been tested only in conjunction with the vaccine for Hepatitis B.
Today, girls often receive the Gardasil shot at the same time as a meningitis vaccine and another new booster that immunizes against tetanus, diphtheria and pertussis.
The FDA has approved all the vaccines separately, but studies on administering them together are still ongoing.
"Not only was Gardasil put on the fast track and licensed quickly," said Ms. Fisher, "but to say safety is assumed and you can give any vaccine with it is even more shocking."
Enough evidence
Joseph Bocchini, chairman of the Committee on Infectious Diseases for the American Academy of Pediatrics, says there's enough evidence to support mixing the drugs and not enough adverse reactions to stop it.
"From the data, we already know [the vaccines] would not be expected to interfere with each other in terms of antibody or safety," said Dr. Bocchini. "If we look at the number of doses given vs. the reports, it's very clear that there are significant benefits that far outweigh potential risks at this time."
Dr. Bocchini cautioned that reactions that do not occur immediately, like seizures, may actually be caused by something else. So far, he said, there have not been enough verifiable reports of extreme side effects through the Vaccine Adverse Event Reporting System, or VAERS, to generate a study.
Dallas County's Health and Human Services officials said they have received no reports of severe reactions to the vaccine.
The Texas Department of Health and Human Services said it had 210 reports of reactions to Gardasil last year, eight of which required hospitalization.
But officials said this is not an uncommon number for a vaccine. Dr. Jennifer Walsh said she will continue to encourage use of the vaccine where she works, the Adolescent Medical Clinic at Children's Medical Center Dallas.
"I'm still following the standard guidelines," Dr. Walsh said. "I don't have any worries at this point."
I like how the article's author goes out of her way to say that "only" 30% of fillings as of 2003 were mercury. That's great news! Only 30% of fillings were horribly neurotoxic!
WASHINGTON (Reuters) - Silver-colored metal dental fillings contain mercury that may cause health problems in pregnant women, children and fetuses, the Food and Drug Administration said on Wednesday after settling a related lawsuit.
As part of the settlement with several consumer advocacy groups, the FDA agreed to alert consumers about the potential risks on its website and to issue a more specific rule next year for fillings that contain mercury, FDA spokeswoman Peper Long said.
Millions of Americans have the fillings, or amalgams, to patch cavities in their teeth.
"Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses," the FDA said in a notice on its Web site.
"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," the agency said.
The FDA said it did not recommend that people who currently have mercury fillings get them removed.
The FDA must issue the new rules in July 2009, Long said.
Such a rule could impact makers of metal fillings, which include Dentsply International Inc and Danaher Corp unit Kerr.
The new rule will give the agency "special controls (that) can provide reasonable assurance of the safety and effectiveness of the product," Long said.
The lawsuit settlement was reached on Monday with several advocacy groups, including Moms Against Mercury, which had sought to have mercury fillings removed from the U.S. market.
While the FDA previously said various studies showed no harm from mercury fillings, some consumer groups contend the fillings can trigger a range of health problems such as multiple sclerosis and Alzheimer's disease. In 2006, an FDA advisory panel of outside experts said most people would not be harmed by them, but said the agency needed more information.
Mercury has been linked to brain and kidney damage at certain levels. Amalgams contain half mercury and half a combination of other metals.
Charles Brown, a lawyer for one of the groups called Consumers for Dental Choice, said the agency's move represented an about-face. "Gone, gone, gone are all of FDA's claims that no science exists that amalgam is unsafe," he said in a statement.
J.P. Morgan Securities Inc. analyst Ipsita Smolinski said the FDA is not likely to outright ban the fillings next year but will probably call for restrictions.
"We do believe that the agency will ask for the label to indicate that mercury is an ingredient in the filling, and that special populations should be exempt from such fillings, such as: nursing women, pregnant women, young children, and immunocompromised individuals," Smolinski wrote in a research note on Wednesday.
Fewer patients have been opting for mercury fillings in recent years, instead choosing lighter options such as tooth-colored resin composites.
Only 30 percent of fillings given to patients were mercury-filled ones as of 2003, according to the American Dental Association (ADA). Other options include glass cement and porcelain as well as other metals such as gold, but they cost more and are less durable, the group has said.
(Reporting by Susan Heavey; editing by Carol Bishopric)
The video is priceless. Jenny and Jim speak for those who have lost their voices, and for those we hope will never have to live through vaccine injuries.
Outils 
Aide
