A U.S. Food and Drug Administration (FDA) advisory committee has recommended that the agency take a new look at updated data on mercury amalgam dental fillings that may indicate medical problems for patients.
The committee also said that more information on amalgam fillings should be posted for both for patients and dentists.
According to CNN:
“Public pressure prompted the panel’s review, initiated less than 18 months after the agency’s decision. Committee members listened to testimony by consumer and dental groups claiming the FDA used flawed science when it set the current guidelines for mercury safety levels.”Sources:
Dr. Mercola’s Comments:
Thanks to a massive response from grassroots America to the U.S. Food and Drug Administration’s (FDA) abysmal 2009 amalgam rule, the FDA agreed to re-examine its pro-mercury fillings position at a hearing earlier this month.
Well, the hearing was a major success!
A government panel of scientists, after two days of hearings before its Dental Products Panel, has determined that the FDA is failing to protect children, pregnant women, hypersensitive persons — and the rest of us — from the dangers of mercury fillings.
Charlie Brown, the national counsel for Consumers for Dental Choice and the president of the new World Alliance for Mercury Free Dentistry, says:
“[This] decision is a resounding defeat of FDA and its policy of protecting dentists’ profits instead of protecting children’s health.”
We’re Making Progress, but the Fight is Not Over
For the last year we have been working alongside Charlie Brown to help eliminate the use of mercury in U.S. dentistry — and we’ve made some major strides.
Most recently, Costa Mesa, California has set the precedent by becoming the first city in the United States to pass a resolution to immediately ban the use of mercury amalgams in dentistry.
This success story was made possible by a trio of Orange County, California activists who distributed flyers explaining the hazards of amalgam (unfortunately, most people are still not even aware that “silver fillings” contain mercury!). They allied with health professionals and green businesses for support.
They organized an extensive petition drive, collecting signatures from individuals asking city council to ban amalgam — both by asking people directly to sign, and by enlisting friendly health professionals and businesspeople to keep the petitions in their front offices.
They surveyed all the city’s dentists, and presented certificates to dentists who are mercury-free.
Then, they sought out Councilman Gary Monahan, who agreed to sponsor a resolution calling on the federal and state governments to “eliminate the use of mercury in dental practices …immediately,” and, at the local level, requesting that every dentist cease using this poisonous material.
Thanks to the testimony of an array of dentists, a dental hygienist, chiropractors, victims of mercury toxicity, businesspeople, a scientist, a Navy veteran, and a lawyer at the City Council meeting reviewing the Monahan resolution, it passed unanimously — and Costa Mesa became the first locality in the United States to call for a ban on mercury fillings.
The FDA hearing earlier this month also made some favorable strides for this movement.
The scientists told the FDA to tell U.S. dental patients, starting right now, that amalgam is mainly mercury, and to tell U.S. dentists to stop giving amalgam to children. They also recommended that the FDA come up with models that show the effects of mercury vapor exposure from dental fillings, as well as review more data on the impact of these fillings on children and fetuses.
The bad news, however, is that the entire matter will now be returned to FDA’s board for consideration, which, Brown notes, is “notoriously pro-mercury and pro-American Dental Association.”
The FDA does NOT have to follow its committee’s recommendations, and, unfortunately, the FDA has a history of ignoring its panelists’ advice if it doesn’t uphold the pro-industry position — even to the point of disagreeing with their own FDA scientific experts.
This is precisely what happened in 2009 with their disappointing “final rule.”
The FDA is STILL Protecting Industry Over the U.S. Public
The FDA has long been the world’s number one protector of mercury fillings, and the U.S. is lagging behind the rest of the world, and even behind some third world countries, in protecting its citizens from this toxic product:
- Canada advised dentists to stop placing amalgam in children and pregnant women in 1996!
- Denmark, Norway and Sweden have essentially banned amalgams.
- There are 5,636 hospitals in developing countries that are committed to or already mercury-free. The majority of these are in the Philippines, India and Argentina.
Yet, in the United States four out of five dental specialists still use amalgams, and the material is still endorsed by the American Dental Association.
FDA Commissioner Margaret Hamburg even has an egregious conflict of interest on amalgam, yet participated in the rule making. Hamburg entered the FDA through the revolving door after making millions as the director of Henry Schein Inc., the largest seller of amalgam.
The FDA is so much in the pocket of corporate America that it not only allows mercury-based dental filling to be implanted in children and pregnant women, but it covers up the very fact that these fillings contain mercury, which is a known toxic substance.
And the FDA’s rule ignores the fact that Americans are getting mercury from so many other sources (vaccines, fish and seafood, household products, paints, pesticides, etc.) that many teenagers and adults are saturated with these neurotoxins.
Another Call to Action: We’re So Close, Help Keep the Momentum Going!
Even the FDA is finally starting to realize it has become a pariah in the world by covering up the massive harm being done by the continued use of mercury fillings.
Now that the tide is turning, pro-mercury dentists, the FDA, and the world need to know that consumers like you will not tolerate dental mercury — a neurotoxin and a pollutant — any longer. Just like Costa Mesans have made it clear that the use of amalgam is no longer acceptable in their community, it’s time to get this substance OUT of U.S. dentistry.
I urge all of you reading this to tell Jeff Shuren, director, FDA Center for Devices (Jeff.email@example.com or 301-796-5900), that we have waited long enough — and that it’s time, this month, for FDA to:
- Tell Americans amalgam is mainly mercury
- Protect Americans from mercury amalgam, starting with a ban on amalgam for children and pregnant women.
Tell Dr. Shuren, too, that Canada gave these warnings 15 years ago — which means that an entire generation of U.S. children has grown up unprotected from amalgam’s mercury, and that we will not stand for any more harm to be done to future generations to come.
You can also ask Dr. Shuren:
- Why does the FDA approve of dentists telling parents amalgams are “silver fillings”?
- Why does the FDA ban mercury for treating the legs of race horses but say it’s fine implanted in a human child?
- Does the FDA say increased amalgam use is a “positive health outcome” in order to pump up the sales for Henry Schein Inc., Commissioner Margaret Hamburg’s company?
Together we are making a real difference and with continued passion and support on your part we can WIN! Let’s protect the health of Americans, including that of future generations, from toxic amalgam by getting “silver fillings” banned from U.S. dentistry once and for all.
Related Articles:The Hazardous Gas in Your Mouth: Is This the First Crack in the ADA’s Corrupt Cover-up?
The Liquor Control Board of Washington state is contemplating a ban on alcoholic energy drinks. Not long ago, nine college students in Washington were hospitalized after drinking the beverages at a party.
The students were drinking the caffeinated malt liquor beverage Four Loko.
ABC News reports:
“The makers of Four Loko … point out the partygoers may have been drinking other types of alcohol. Washington is one of several states considering outlawing high-alcohol energy drinks while the Food and Drug Administration reviews their safety.”Sources:
Dr. Mercola’s Comments:
Alcoholic energy drinks have already been banned in at least four states, and the U.S. Food and Drug Administration (FDA) has also issued warning letters to four manufacturers, stating that caffeine is an “unsafe food additive” when mixed with alcohol.
Major brands of the caffeinated alcohol drinks are expected to be off store shelves by mid-December, a move that has many critics stating the FDA has gone too far.
But have they?
Health Risks of Alcoholic Energy Drinks
Alcoholic energy drinks have become popular not only in bars and nightclubs but also on college campuses. They can either be mixed at a bar (combining a regular energy drink with alcohol) or purchased pre-made under brand names like “Four Loko.”
These drinks are proving to be dangerous, perhaps even more so than regular drinks, because the caffeine provides an energy boost that can lead to, as the FDA put it, “wide-awake drunk.”
Not being able to fully feel the depressing effects of the alcohol, people who drink alcoholic energy drinks may be more likely to suffer from alcohol poisoning, be involved in car accidents or commit assaults.
In fact, mixing alcohol with energy drinks doubles your risk of being harmed compared with drinking just alcohol, according to researchers from Wake Forest University in North Carolina.
After surveying more than 4,000 U.S. students, the researchers found that compared with students who did not drink “energy drink cocktails,” those who did were twice as likely to:
- Get injured
- Require medical attention
- Travel with a drunk driver
- Take sexual advantage of someone
- Be taken advantage of sexually
Quite simply, the caffeine masks the feeling that you’re drunk, even though your motor skills, visual reaction times and judgment are still impaired. This can lead you to not only engage in behaviors you should not be doing while intoxicated, but also allows you to drink more than you would ordinarily.
Researchers found that students who drank energy drink cocktails drank nearly 40 percent more than other students, and had twice as many episodes of “weekly drunkenness.”
Energy Drink Cocktails Can Even be Deadly
There is a major problem that occurs when you mix a powerful stimulant (an energy drink) with a powerful depressant (alcohol): some people’s bodies simply can’t take it.
The combination can, in fact, cause cardiopulmonary or heart failure, which can be deadly. Countries like France and Denmark have already banned sales of Red Bull following several reported deaths of people who mixed it with alcohol.
Even on their own these caffeine-loaded beverages may cause your blood to become sticky, a pre-cursor to cardiovascular problems such as stroke.
One hour after drinking the popular energy drink Red Bull, researchers found your blood system becomes abnormal, as might be expected from a patient with cardiovascular disease.
Further, a study in the journal Addictive Behaviors found that people who drank alcoholic energy drinks were at a 3-fold increased risk of leaving a bar highly intoxicated, as well as a 4-fold increased risk of intending to drive upon leaving the bar — a move that could easily be deadly for that person as well as others — compared to people who drank alcohol only.
You Don’t Need Energy Drinks to Get Energized
If you’re an energy-drink junkie, it is important to make a commitment to give up this habit.
Some energy drinks contain the equivalent caffeine of 14 cans of Coca-Cola!
It is very possible to suffer from caffeine intoxication when you drink caffeine at this level, which includes symptoms that mimic those of anxiety and other mood disorders, such as:
- Gastrointestinal upset
- Rapid heartbeat (tachycardia)
- Psychomotor agitation (restlessness and pacing)
- In rare cases: death
Needless to say, when you drink large amounts of caffeine, or even an amount similar to that of drinking a cup or three of coffee, when the effect wears off you’ll also start feeling lethargic and will likely crave another can (or cup) to boost your energy once again.
As many of you likely know, it can become a vicious cycle of jolting and crashing.
It is fairly self-evident that children should never consume energy drinks, but due to the detrimental health impact of their contents, it would definitely be wise to avoid energy drinks if you:
- Are pregnant or lactating
- Are sensitive to caffeine
- Suffer from anxiety
- Suffer from high stress
- Suffer from chronic fatigue syndrome
- Have high blood pressure
- Are predisposed to cardiovascular disease
- Have any kind of blood clotting disorder
Anyway, in reality caffeine does not create real energy or alleviate tiredness. It is only a strong stimulant that provides a sudden, temporary jolt to your system, hence the feeling of alertness. For a real health boost, you’ll want to focus on the lifestyle habits that will raise your energy level for many hours, and include:
- Eating right for your nutritional type
- Releasing emotional stress and negativity with the Emotional Freedom Technique (EFT)
- Sleeping when you’re tired
Really, when you read through all the risks, does it still sound like fun to toast your friends with an energy drink cocktail? I should think not.
While I don’t recommend drinking alcohol at all, if you do choose to at least turn down any caffeinated versions for the sake of your health, and use these tips to increase your energy levels naturally, without a dangerous dose of caffeine.
Related Articles:The Painful Consequences of Energy Drink Cocktails
By Dr. Mercola
If you have been reading this newsletter for awhile you will know that it is very unusual for me to request anyone to contact their legislators, but if you live in the US, there are two issues that now need your urgent attention and involvement:
- The upcoming US FDA hearings before its Dental Products Panel on December 14 and 15, to determine whether to stop amalgam use for children and pregnant women, and
- The final vote on bill S.510, which takes place on Monday, November 29
I will review both of these issues below, and I urge you to take action on both by contacting your legislators. I’ve summarized the action items for each, to make this as quick and easy as possible.
Banning Mercury in Dentistry – A Battle We CAN Win!
If you or a loved one has suffered grievous harm from dental mercury, the U.S. Food and Drug Administration (FDA) says you don’t exist! Because according to FDA’s propaganda machine, dental mercury doesn’t hurt anyone.
As America’s chief protector of profits for “drill-fill-and-bill” dentistry, the FDA is no doubt hoping you’ll stay silent when it holds its hearings on December 14 and 15, which is why I’m issuing this urgent action request.
For the last year we have been working alongside Charlie G. Brown, who is the national counsel for Consumers for Dental Choice and the president of the new World Alliance for Mercury Free Dentistry, to help eliminate the use of mercury in U.S. dentistry.
In the past year I have had several calls to action and to date your responses have been nothing short of extraordinary; you are clearly making a real difference!
We ran an article in early September, calling for volunteers to get involved to organize a grassroots project, and the results were phenomenal. Some of you responded and took action, and as a result, Costa Mesa, CA has set the precedent by becoming the first city in the United States to pass a resolution to immediately ban the use of mercury amalgams in dentistry.
If you missed that latest update, please do take a moment to read this inspirational story.
Thanks to your efforts at making your voices heard, on July 15, 2010 the United States Food and Drug Administration (FDA) also chose a mercury-free dentist by the name of Michael Fleming to be on the Dental Products Panel, which will be the group to reassess the safety of mercury fillings for high-risk groups by way of a hearing this December.
Now, your efforts are needed once again in the fight against mercury fillings.
Major Mercury Hearings Coming Up in December
Thanks to a massive response from grassroots America to the FDA’s abysmal 2009 amalgam rule, the FDA has agreed to re-examine its pro-mercury fillings position and, this December, will convene hearings before its Dental Products Panel to determine whether to stop amalgam use for children and pregnant women.
Again, in a major victory, and largely thanks to your efforts at making your voices heard, the FDA chose a mercury-free dentist by the name of Michael Fleming to sit on this Panel.
But as we move toward the December hearing, we need your continuing letters and phone calls to the FDA and I’ll give details shortly to help you do so.
The FDA Refuses to Protect Your Health – Tell Them You Won’t Stand for It Any Longer!
Did you know that the FDA’s Commissioner, Margaret Hamburg, came to the FDA from the board of Henry Schein Inc., the nation’s number one seller of amalgam?
In the rule issued right after Hamburg’s arrival, the FDA spares no effort to pump up amalgam sales — actually claiming that greater amalgam use equates to “positive public health outcomes!”
How convenient for Henry Schein Inc.
As for the scientific backing for their claim, it simply does not exist. Mercury is a well-documented toxic hazard to human health, and it doesn’t get any safer when placed in your mouth, where it releases toxic gases with every bite of food.
Instead of protecting you from a well-known, potent neurotoxin, the FDA gave the green light to the deceptive technique of marketing amalgam as “silver fillings,” knowing full well that sales plummet when consumers learn that dental amalgams actually contain toxic mercury.
Urgent Action Steps to Ban Mercury from Dentistry in the US
Faced with unprecedented consumer-level pressure, the FDA has been forced to hold a new round of hearings on amalgam, scheduled for December 14 and 15, and to accept public comment on changing its rule.
For those seeking to protect children from brain injury related to mercury amalgam exposure, and for those who want to share how mercury harmed them, the time to act is now.
Here are three ways to make your voice heard at the FDA:
- Submit a comment online to FDA by December 3
Tell them how you were deceived by the term “silver fillings” and subjected to mercury fillings without your knowledge, and/or the story of how you were injured by amalgam- all because the FDA puts corporate profits first.
Comments can involve telling the FDA about your injuries, your children’s exposure to mercury, how your mercury fillings were implanted without your informed consent, how deceptive the FDA’s dental amalgam website is, how mercury hurts our environment, or any other concerns relating to mercury fillings.
- Write the FDA official in charge of amalgam.
Jeff Shuren, M.D. is the director of the FDA’s Center for Devices. Contact him at:
Dr. Jeffrey Shuren
Ask Dr. Shuren:
- Why does FDA approve of dentists telling parents amalgams are “silver fillings”?
- Why does FDA ban mercury for treating the legs of race horses but say it’s fine implanted in a human child?
- Does FDA say increased amalgam use is a “positive health outcome” in order to pump up the sales for Henry Schein Inc., Commissioner Margaret Hamburg’s company?
- Come to the FDA hearings in person.
The hearings are December 14 and 15, 2010, 8am-6 pm, just outside of Washington DC at:
The Holiday Inn-Gaithersburg, Main Ballroom
2 Montgomery Village Ave.
Gaithersburg, MD 20879
If you want to testify, you must write firstname.lastname@example.org by November 29 to let her know.
If you want to come and watch — and yes, we need a crowd there — you may simply show up. If you have questions, write the consumer coordinator working for mercury-free dentistry, Freya Koss at email@example.com
The FDA will not be expecting a forceful turnout, especially from ordinary citizens, so we can surprise them with a show of force and dogged determination.
We have made significant steps so far, and much of it is due to your continued efforts and support.
Please continue to join in on this important cause to get this toxic element out of U.S. dentistry. We are making a difference and the momentum is strong — together, we can WIN, and protect the health of Americans, including that of future generations, from this archaic and toxic dentistry practice.
Tell Your Senators to KEEP the Tester-Hagan amendment of Bill S.510
If you live in the US this is another urgent action you can take during this holiday weekend that will impact the quality of the food you are able to secure.
Last week, the US Senate voted 74-25 to move to consideration of S.510, the Food Safety Modernization Act – which will amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply.
If you’re unfamiliar with this bill, this LewRockwell article provides a nice summary, including “12 reasons why S. 510 could be absolutely disastrous for small food producers and for the U.S. economy.”
“If accepted [S 510] would preclude the public’s right to grow, own, trade, transport, share, feed and eat each and every food that nature makes.
It will become the most offensive authority against the cultivation, trade and consumption of food and agricultural products of one’s choice.
It will be unconstitutional and contrary to natural law or, if you like, the will of God.”
Judith McGeary with the farmandranchfreedom.org provided me with the following update on this potentially devastating bill, along with an urgent action request.
Agribusiness has Shown Its True Colors!
After 30 hours of debate and behind-the-scenes negotiations, the US Senators released a final Manager’s Amendment that includes a compromise version of the Tester-Hagan amendment. But even though an agreement was reached on the Tester-Hagan amendment last week, the issue is still not over.
The final vote on the bill has been delayed until Monday, November 29, due to disagreements over amendments relating to the health care bill and a ban on earmarks.
In the meantime, Agribusiness has shown its true colors.
For over a year, the big Agribusiness trade organizations have supported passage of S.510. From Agribusiness’s perspective, the bill was a win-win: they could absorb the costs of the regulations because of their size; they’d gain good PR for supposedly improving food safety practices; and the competition created by small, local food producers, which are rapidly growing, would be crushed by the regulatory burdens.
This was only speculation until now.
But when the Senators agreed to include the Tester-Hagan amendment in the bill, to exempt small-scale direct-marketing producers from some of the most burdensome provisions, 20 Agribusiness trade organizations fired off a letter stating that they would now oppose the bill!
“[B]y incorporating the Tester amendment in the bill, consumers will be left vulnerable to the gaping holes and uneven application of the law created by these exemptions.
In addition, it sets an unfortunate precedent for future action on food safety policy by Congress that science and risk based standards can be ignored. And most importantly, this amendment rejects the fundamental purpose of S. 510 that requires FDA to develop standards and set requirements that are based on science and risk.”
What science and risk?
No one has produced any data or evidence of any widespread problems caused by local producers and marketed directly to consumers. All of the major foodborne illness outbreaks have been caused by products that went through the long supply chains of Agribusiness.
Agribusiness’s real concern about the Tester-Hagan amendment isn’t food safety, but the precedent set by having Congress recognize that small, direct-marketing producers are different, and should be regulated differently, from the large Agribusinesses.
Agribusiness is now trying to convince the Senators to pull the Tester-Hagan amendment back out.
While the amendment is currently part of the “Managers’ Package” – the amended version of the bill agreed to by six bipartisan sponsors – nothing is certain until the actual vote.
This Thanksgiving week, please take a moment to call or email your Senators to tell them to hold firm on KEEPING the Tester-Hagan amendment part of the bill!
Take Action NOW!
Your voice needs to be heard on this issue, and time is running out. The vote on this dangerous legislation takes place on Monday, November 29.
So take action now!
- Call the Capitol Switchboard: 202-224-3121, and ask to be directly connected to your Senator’s office. Tell your Senator to keep the Tester-Hagan amendment in the bill.
- You can find additional contact information for your US Senator at http://senate.gov/general/contact_information/senators_cfm.cfm
Related Articles:Why 80% of U.S. Dentists are 150 Years BEHIND the Times.
Johnson & Johnson CEO William Weldon testified before the House Committee on Oversight and Government Reform on Thursday, September 30, apologizing for making a mistake and letting the public down with the numerous recalls his company has had lately.
In a report by CNNMoney.com, Weldon also admitted that the company secretly bought up defective drugs without informing regulators and consumers of its actions. The Times reported Weldon as saying in prepared remarks to the Committee on Oversight and Government Reform.
“I know that we let the public down. We did not maintain our high quality standards. Children do not have access to our important medicines. I accept full accountability for the problems and I will take full accountability for fixing them.”
CNN also said that Weldon told the committee that the long delays in issuing product recalls after first becoming aware of adverse event reports and consumer complaints was “an area where we’ve learned a very important lesson.”
“We definitely don’t want to defend our actions there and we don’t want to make any excuses. We have benefited by being here. I can only assure you that we are doing everything in our power to never let this happen again,” he said.
CNN said lawmakers met Weldon’s comments “with skepticism.”
Dr. Mercola’s Comments:
Johnson & Johnson CEO William Weldon has publicly admitted that the company not only hid manufacturing problems but also initiated a “phantom recall” last year involving more than 80,000 Motrin tablets.
Rather than announcing the recall and having stores remove the product from shelves, Johnson & Johnson quietly sent in undercover agents disguised as regular shoppers to buy up the remaining stock.
Amazingly, this is not an illegal practice because the U.S. Food and Drug Administration (FDA) does not have authority to order recalls, or define how they should be conducted. Still, lawmakers cited a “too cozy” relationship between Johnson & Johnson and the FDA, as months apparently passed from when the Agency first learned of J& J’s “recall” plan, and when they eventually sent a message telling them to conduct an official recall.
The FDA further stated that J&J was “hiding the nature of its activities,” which appears to be par for J&J’s course.
More Shady Business from Johnson & Johnson
The Motrin debacle was not the first time Johnson & Johnson took their time in issuing a product recall, and when asked by lawmakers to explain the unsettling pattern, CEO Weldon said:
“This is an area where we’ve learned a very important lesson. We definitely don’t want to defend our actions there and we don’t want to make any excuses . We have benefited by being here. I can only assure you that we are doing everything in our power to never let this happen again.”
Even lawmakers were skeptical about Weldon’s latter promise, CNN reported, given their sordid history and current problems.
Just this month the government of British Columbia, Canada filed a lawsuit against J&J, which claims they aggressively marketed the “Ortho Evra” contraception patch without disclosing serious side effects like blood clots, pulmonary emboli, strokes, heart attacks and deep vein thrombosis. The suit claims J&J did not provide adequate warnings on labels, conduct long-term use risk studies or provide Health Canada with accurate risk information.
And most of you reading this are probably well aware of the recall earlier this year by McNeil Consumer Healthcare, a division of Johnson & Johnson, on all unexpired lots of certain over-the-counter pediatric drugs, including Tylenol, Motrin, Zyrtec and Benadryl products.
That recall was made following the discovery of manufacturing deficiencies that could affect the quality, purity and potency of the drugs. For instance, the recalled products could contain:
- Higher concentration of active ingredient than specified
- Inactive ingredients that may not meet testing requirements
- Tiny particles of unspecified origin
Not surprisingly, an FDA inspection at the company’s Ft. Washington, PA plant revealed 20 manufacturing and quality violations, causing the plant to be shut down.
A separate recall also occurred in September 2009, when 21 children’s and infant’s Tylenol liquid products were deemed potentially unsafe due to bacterial contamination found in one of the inactive ingredients.
One of the Top Corporate Criminals
Johnson & Johnson was named by AllBusiness.com as one of the “Top 100 Corporate Criminals of the 1990s!” for deliberately destroying documents related to a criminal investigation case on one its products.
In keeping with their reputation, in January the U.S. Department of Justice accused Johnson & Johnson of paying tens of millions of dollars in kickbacks to Omnicare Inc to buy and recommend Johnson & Johnson drugs.
This latest scheme is the subject of a federal lawsuit that has 18 states suing not just Omnicare, but 14 other major drug companies, alleging that they ran this scheme together.
In the wake of all this hassle, Omnicare’s CEO Joel Gemunder has quit, but not without remuneration. His parting pay is a record $130 million!
And just this May, a J&J subsidiary pleaded guilty to illegally promoting its epilepsy drug Topamax for psychiatric purposes and submitting alleged false claims to Medicare, and in so doing, settled a civil lawsuit in the case for $75 million. So they’re clearly no stranger to fraud and deception.
A Major Breach of Trust
I remember very clearly in October 1982 when seven people were killed because someone tampered with Tylenol and laced it with cyanide, as I was in my medical internship in a hospital rotation. The sick joke at the time was, “Did you hear of the new Tylenol CN (cyanide)?”
This was a serious problem and Johnson & Johnson handled the crisis so well they are frequently studied in business schools for how to respond to a crisis like this. That instance wasn’t their fault, as they were the victim of tampering, but they have been smack dab in the middle of numerous other breaches of public trust that were their fault since then.
With all these recalls and lawsuits occurring, how can any health-conscious consumer trust the safety or the effectiveness of any of these drugs?
And an even more pressing question, why are drug companies ALLOWED to continue maintaining the status quo despite being caught lying, defrauding, even knowingly killing, time and time again?
As long as the system continues unchallenged, unsafe drugs will continue to enter the marketplace at the hands of unscrupulous manufacturers. If you want to do your part in chipping away at the drug industry while looking out for your safety,
I encourage you to reduce and work toward eliminating your reliance on prescription drugs with the recommendations I provide on this site. Well over 90 percent or more of the drugs being prescribed today are completely unnecessary. You can look them up in our site search engine to find options and also use the free nutritional plan to help.
Related Articles:Johnson & Johnson Recalls Children’s Tylenol and Motrin
The Food and Drug Administration said preliminary results from a study in Mexico involving GlaxoSmithKline’s Rotarix vaccine suggest an increased risk of a serious bowel problem that could be fatal.
A statement posted to the FDA’s website said the study showed an increased risk of intussusception in the 31-day period following the first dose of Rotarix. Intussusception is a twisting or obstruction of the intestine that can be fatal.
The safety of Rotarix and RotaTeq, a similar vaccine made by Merck, have carefully been tracked by regulators since another vaccine by then drug-maker Wyeth was pulled off the market in 1999 after it was linked to an increased rate of intussusception.
Dr. Mercola’s Comments:
GlaxoSmithKline’s Rotarix vaccine has been plagued with problems since its approval in 2008, not the least of which is this alarming link to intussusception, a potentially fatal problem with the intestine in which one portion of the bowel slides into the next.
Preliminary results from a Mexican study found an increased risk of intussusception within 31 days following vaccination with Rotarix, with most cases occurring within the first seven days. Unfortunately, the vaccine will still remain on the market until the U.S. Food and Drug Administration (FDA) has a chance to review the final study results sometime next year.
Yet you only need to look at the past history of rotavirus vaccines to know that this is a disaster in progress .
Similar Rotavirus Vaccine Pulled From Market for This Very Same Problem
Rotarix is intended to prevent rotavirus disease, which causes diarrhea and dehydration. A similar oral rotavirus vaccine was actually pulled from the market in 1999 after nine reports of intussusception occurred within the first 7 months of vaccine use, more than double the cases reported in the previous seven years.
Meanwhile, in 2007, the FDA also issued an advisory warning about RotaTeq (a rotavirus vaccine made by Merck). For what? The risk of intussusception, in which 16 of the 28 reported cases required surgery to repair a baby’s intestinal tract.
Given this track record with rotavirus vaccines, it is appalling that the FDA is not taking urgent action to protect the children, but then this is the same agency that approved Rotarix in the first place — even though there was a higher rate of pneumonia-related deaths and convulsions among vaccinated infants in one of the main studies.
It’s also the same agency that only “recommended” physicians temporarily suspend their use of Rotarix earlier this year after a serious contamination risk was uncovered .
Rotarix Contaminated by Pig Virus
As though the risks of intussusception are not bad enough, a research team revealed that Rotarix was contaminated with “a substantial amount” of DNA from a pig virus.
Somewhat by accident, Dr. Eric Delwart and colleagues, who were intending to “show that live attenuated vaccine only contained the expected viral genomes and no other,” discovered that Rotarix contained “significant levels” of porcine cirovirus 1. Rotateq, Merck’s rotavirus vaccine, was found to contain a virus similar to simian (monkey) retrovirus.
Both the FDA and GlaxoSmithKline spokespeople continue to state that no safety risk has been uncovered from the contamination, at least not yet. But what are they going to say? The vaccine has already been given to 1 million U.S. children, and about 30 million worldwide, who must now live with the consequences of this contaminated vaccine, whatever they may be.
Carefully Research before Getting Your Kids Vaccinated for Rotavirus
Clearly these vaccines, including the two still on the market, are causing a disturbance serious enough that a typically rare bowel problem is becoming all too common.
Before taking this potential risk with your child, you must get informed on the risks of rotavirus . the disease the vaccine is intended to prevent.
Rotavirus is very contagious and does cause more than 500,000 deaths in young children each year, but this is mostly in developing countries. In the United States, rotavirus is responsible for only “several dozen” deaths a year, according to FDA Commissioner Dr. Margaret Hamburg.
Typically, when a child in the United States contracts rotavirus, and most do, only rest and fluids are required to recover. This infection also provides natural immunity that will protect your child for life.
As the National Vaccine Information Center writes:
“The CDC estimates that, by age 3, almost every US child has had a case of rotavirus. Once a child has been infected with a strain of rotavirus, he or she develops antibodies and is either immune for life or has a milder case if infected with that same strain in the future.
Most healthy children, who are infected with several strains of rotavirus in the first few years of life, develop lifelong natural immunity to rotavirus infection.”
So in most cases, if you live in a developed country there is absolutely no need to get the vaccine in the first place. And even now that vaccination is widespread, the vaccine appears to be having virtually NO effect on rotavirus rates. According to NVIC:
“Today, even though almost all US infants receive vaccines for rotavirus, and despite efforts to improve the management of childhood rotavirus-associated diarrhea, hospitalizations of children in the U.S. with the disease have not significantly declined in the past two decades.”
It even states right on GSK’s Web site that “Vaccination with ROTARIX may not provide 100% protection to all recipients.” The site also reveals the fact that safety has not been established for all infants:
“Safety and effectiveness in infants with chronic gastrointestinal disorders, or with known primary or secondary immunodeficiencies, have not been evaluated.”
So with this particular vaccine, children are taking on serious risks with little to no benefit.
The question U.S. parents need to ask is, would I rather risk my child getting a mild disease that requires rest and fluids for recovery — and then affords them lifelong immunity — or risk getting them vaccinated and having them suffer from a potentially fatal intestinal blockage or some other unknown side effect?
With this and all vaccines, it’s necessary to always weigh the risks versus the benefits, as often you’ll find that the risks come out on top.
My Appeal to You
Don’t sit this one out! We’ve got them “on the run.”
Tell everyone. Tell your friends, your family. With a little bit of effort, you can make significant strides toward preserving your freedom to make voluntary health decisions affecting your and your children’s future.
One of the top goals for the National Vaccine Information Center (NVIC) is preserving your freedom of choice about if and when to use vaccines. As part of that mission, this non-profit charity has been fighting for your right to make informed VOLUNTARY vaccine choices since 1982.
During the upcoming Vaccine Awareness Week, NVIC is launching the online NVIC State Advocacy Portal that will give you the tools you need to take action to protect legal medical, religious and conscientious belief exemptions to vaccination in YOUR state.
Mercola.com & NVIC Dedicating November 1-6 Vaccine Awareness Week
In a long-scheduled joint effort to raise public awareness about important vaccination issues during the week of November 1-6, 2010, Mercola.com and NVIC will publish a series of articles and interviews on vaccine topics of interest to Mercola.com newsletter subscribers and NVIC Vaccine E-newsletter readers.
The week-long public awareness program will also raise funds for NVIC, a non-profit charity that has been working for more than two decades to prevent vaccine injuries and deaths through public education and protecting informed consent to vaccination.
The November 1-6 Vaccine Awareness Week hosted by Mercola.com and NVIC will follow a month-long vaccine awareness effort in October that was recently announced on Facebook by parents highlighting Gardasil vaccine risks.
The six-week-long focus this fall on vaccine issues will help raise the consciousness of many more Americans, who may be unaware that they can take an active role in helping to prevent vaccine injuries and deaths and defend the legal right to make voluntary vaccination choices.
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