FDA Pertussis Vaccine Study Shatters Illusion of Vaccine-Induced Immunity

Bordetella pertussis on Charcoal Agar - detail (Photo credit: Nathan Reading)

By Dr. Mercola

Recent vaccine research again reveals the gulf between what you’re told about vaccines—how they work and how effective they are at preventing infectious disease—versus what is truly known about naturally acquired and vaccine acquired immunity.

Nearly a century after the release of the whooping cough (B. pertussis) vaccine, mounting evidence suggests that widespread mandated use of the vaccine could potentially be doing more harm than good in the long term—in addition to having been found lacking in the effectiveness department. As reported by The Washington Post:1

“The research suggests that while the vaccine may keep people from getting sick, it doesn’t prevent them from spreading whooping cough — also known as pertussis — to others.

‘It could explain the increase in pertussis that we’re seeing in the US,’ said one of the researchers, Tod Merkel of the Food and Drug Administration...

Last year was the nation’s worst year for whooping cough in six decades— US health officials received reports of more than 48,000 cases, including 18 deaths... Some studies have concluded the newer vaccine doesn’t last as long as the old one. But the study by Merkel and his colleagues offers a new wrinkle.”

New ‘Wrinkle’ Busts Major Hole in Pro-Mandatory Vaccination Argument

The “new wrinkle” revealed in the featured FDA baboon study is that while the vaccine can cut down on serious clinical disease symptoms, it doesn’t eliminatetransmission of the disease.2 This busts a major hole in the entire argument that vaccines achieve herd immunity, which is used as justification for mandatory vaccination campaigns.

According to the Washington Post:3

“'[I]t was thought that people only spread the disease when they had coughs and other symptoms,' said Dr. Erik Hewlett, a University of Virginia whooping cough researcher who was not involved in the FDA study but has collaborated with Merkel.

Health officials have sought to protect small children by vaccinating the people who are in contact with them such as grandparents and baby sitters— a strategy called ‘cocooning.’ But that may not work as well as hoped if infected people who don’t show any symptoms can still spread it, the research suggests. ‘This is a whole new way of thinking of the problem,’ Hewlett said.”

Whooping Cough Vaccination Makes You an ‘Asymptomatic Carrier’

The study, titled: “Acellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model,”4 used infant baboons to test the hypothesis that "current acellular pertussis vaccines fail to prevent colonization and transmission" of B. pertussis.

The acellular pertussis vaccines that were licensed in 1996 for infants to replace reactive whole-cell pertussis vaccines contain lower levels of certain toxins (such as endotoxin) as well as purified antigens instead of all the components of whole killed B. pertussis bacteria.

The study concluded that infant baboons given Sanofi DTaP (Daptacel) vaccine at two, four, and six months of age were protected against developing outward clinical symptoms of pertussis after being exposed to B. pertussis at seven months of age, but they were still able colonize and transmit B. pertussis to other baboons.

The baboons that were vaccinated with whole cell pertussis (GlaxoSmithKline's Infanrix) also colonized B. pertussis upon exposure to B. pertussis, but they cleared the infection much faster than the acellular pertussis vaccinated baboons—in 18 days compared to 35 days.

Now, the researchers did not say that DTaP vaccine causes vaccine strain pertussis infection. B. pertussis vaccines (both whole cell DPT and acellular DTaP/Tdap) are inactivated vaccines and do not cause vaccine strain infection the way some attenuated live virus vaccines can—such as live oral polio (OPV) and varicella zoster (chickenpox) vaccines.

However, the lead author Tod Merkel did comment to the New York Times5 that when exposed to B. pertussis after recently getting vaccinated, you could be an asymptomatic carrier and infect others, saying:

“When you’re newly vaccinated, you are an asymptomatic carrier, which is good for you, but not for the population.”

Pertussis Vaccine May Not Curb Transmission of Illness

According to the researchers, acellular pertussis vaccine (Daptacel) induces high antibody titers, which is used to measure efficacy. Whole cell DPT (Infanrix) and natural B. pertussis infection also induce high antibody titers.

But, while acellular pertussis vaccinated baboons did not develop serious clinical disease symptoms—such as loss of appetite and cough—when they were directly challenged with B. pertussis (meaning exposed to the B. pertussis bacteria), they still colonized B. pertussis in their throats and were capable of transmitting the infection to other baboons.

Since acellular pertussis (DTaP) vaccines are the only type of pertussis vaccines now given to American children at the ages of two, four, six and 15-18 months, as well as between the ages of four and six years and at 11-12 years, the researchers said:

"These data suggest that cocooning is unlikely to be an effective strategy to reduce the burden of pertussis in infants. However, it is important to note that our data in combination with human data show that vaccination with acellular pertussis provides excellent protection from severe pertussis.

Therefore, any short-term plan for addressing the resurgence of pertussis should include continued efforts to enhance acellular pertussis immunization. However, to protect the most vulnerable members of the population and achieve optimal herd immunity, it will be necessary to develop a vaccination strategy that effectively blocks pertussis infection and transmission."

What You Need to Know About ‘Herd Immunity’

The issue of “herd immunity” as it pertains to vaccinations is a widely misunderstood subject. The National Institute of Allergy and Infectious Diseases describes vaccine-induced herd immunity (also labeled “community immunity” by public health doctors) as follows:6

“When a critical portion of a community is immunized against a contagious disease, most members of the community are protected against that disease because there is little opportunity for an outbreak. Even those who are not eligible for certain vaccines—such as infants, pregnant women, or immunocompromised individuals—get some protection because the spread of contagious disease is contained. This is known as ‘community immunity.’"

What many people don’t realize is that there is such a thing as natural herd immunity. The problem is that public health officialsassume that vaccines will work the same way. However, vaccines do not confer the same kind of immunity as experiencing and recovering from the natural disease.

The science clearly shows that there's a big difference between naturally acquired herd immunity and vaccine-acquired herd immunity, even as scientific knowledge about the biological mechanisms involved in naturally acquired and vaccine acquired immunity is incomplete. These facts are usually ignored because to openly acknowledge them opens the door to some very unwelcome questions about the overall effectiveness of mandatory vaccination programs.

Vaccines are designed to trick your body's immune system into producing an immune response that includes making protective antibodies that are needed to resist future exposure to the infectious viral or bacterial microorganism. However, your body is smarter than that. The artificial manipulation of your immune system by vaccines containing lab altered bacteria and viruses, as well as chemicals and other ingredients, simply does not exactly replicate the response that your immune system mounts when naturally encountering the infectious microorganism. This is one reason why vaccine policymakers say you need to get “booster” shots because vaccine acquired immunity is only temporary and wears off, sometimes rather quickly.

The featured study also provides evidence of this fact, showing that a vaccine-induced immune response differs from the immune response when naturally encountering the B. pertussis organism. The FDA researchers further suggested that there are also differences in immune responses to whole cell DPT vaccine, which contains the whole B. pertussis bacteria, and acellular pertussis vaccine, which contains lower levels of toxins and uses purified antigens. They said “Vaccination with wP [whole cell pertussis vaccine] and previous infection induced a more rapid clearance compared with naïve and aP[acelullar pertussis[-vaccinated animals.”

As reported by Medical Daily:7

“The researchers also found something revealing when they looked at the specific immune response of each group of monkeys. 'Although all vaccinated and previously infected animals had robust serum antibody responses, we found key differences in T-cell immunity,' the authors wrote in PNAS.

Specifically, previously infected animals and whole-cell-vaccinated animals both exhibited the same kind of boost in immune response while the acellular pertussis vaccination elicited a response that was slightly different. 'The observation that acellular pertussis, which induces an immune response mismatched to that induced by natural infection, fails to prevent colonization or transmission, provides a plausible explanation for the resurgence of pertussis...'"

Although the FDA researchers say they found differences between immune responses to the whole cell DPT vaccine acellular DTaP vaccine, they also admit that “neither vaccine was able to prevent colonization as well as immunity from a previous infection” and that “relative protection afforded by Th17 or Th1 responses in vaccinated or convalescent baboons or humans is not known.”

Bottom line: there are huge gaps in scientific knowledge about both B. pertussis vaccination and B. pertussis infections.

Which Is More Ideal—Permanent or Temporary Immunity?

To learn more, I urge you to listen to the following video, in which Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC), discusses the concept of herd immunity. In it, she brings up some very important questions that need to be seriously considered and answered through rigorous scientific investigation—investigation that has so far been largely ignored:

" In most cases natural exposure to disease would give you a longer lasting more robust qualitatively superior immunity because it gives you both cell mediated immunity and humoral immunity... The fact that manmade vaccines cannot replicate the body's natural experience with the disease is one of the key points of contention between those who insist that mankind cannot live without mass use of multiple vaccines and those who believe that mankind's biological integrity will be severely compromised by their continued use.

The fact that manmade vaccines cannot replicate the body's natural experience with the disease is one of the key points of contention between those who insist that mankind cannot live without mass use of multiple vaccines and those who believe that mankind's biological integrity will be severely compromised by their continued use.

... [I]s it better to protect children against infectious disease early in life through temporary immunity from a vaccine, or are they better off contracting certain contagious infections in childhood and attaining permanent immunity? Do vaccine complications ultimately cause more chronic illness and death than infectious diseases do? These questions essentially pit trust in human intervention against trust in nature and the natural order, which existed long before vaccines were created by man."

Download Interview Transcript

What We Don’t Understand Can Hurt Us

My main point of contention with those who insist that vaccines are the best answer for disease prevention, without regard for constitutional differences between people, is that the science is still grossly lacking when it comes to safety. We simply do not know if vaccination is an ideal choice for all people, all the time—even though that’s what public health officials and others promoting one-size-fits all mandatory vaccination policies would like you to believe. The evidence weighs rather heavily againstsuch a blanket position, in my opinion.

Take the recent news of healthy teenagers dying following flu vaccination for example. In January of this year, a 14-year old Carly Christenson passed away from complications from influenza type-A, despite being vaccinated against the flu.8

Most recently, healthy 19-year old Chandler Webb became violently ill the day after receiving a flu shot—the first flu shot he had ever received.9, 10 His symptoms included violent shaking, headache and vomiting. He was hospitalized with encephalitis (brain inflammation). As the swelling of his brain progressed, Chandler’s doctors frantically tested him for various infectious diseases and treated him with broad spectrum antibiotics. Apparently, they did not think to consider whether he’d been recently vaccinated. His brain became so inflamed that doctors told his mother the massive swelling crushed his brain stem. He died 28 days after his first and last dose of influenza vaccine.

Chandler’s mother wants to raise awareness about the potential of vaccines to cause serious complications like brain inflammation and is urging medical personnel to consider vaccine reactions when searching for potential causes and treating encephalitis and other possible vaccine-related health problems. In this case, the doctors are now claiming they were not able to confirm the cause of Chandler’s death, and are declining to comment because they say they are legally prohibited from making any statements about the case.11

Main Take-Home Points and Limitations of the Latest Pertussis Vaccine Study

To recap, FDA researchers conducting the featured baboon study found that the whole cell pertussis vaccine (GSK's Infanrix DPT), the acellular pertussis vaccine (Sanofi's Daptacel DTaP), and natural pertussis infection all induced high antibody titers in infant baboons. High antibody titer after vaccination is currently the gold standard for proving that a vaccine confers “immunity” and inability to colonize or transmit infection.

However in this study, high B. pertussis antibody titers after vaccination did NOT correlate with immunity and inability to colonize or transmit B. pertussis infection to other baboons—effectively challenging the idea that high antibody titer following vaccination is evidence that vaccination will prevent infection in the vaccine recipient and the recipient will not be able to infect others. Furthermore, the study authors found that:

• Baboons vaccinated with a whole cell pertussis vaccine (DPT) colonized B. pertussis upon direct challenge but cleared infection almost twice as fast as animals vaccinated with an acellular pertussis vaccine (DTaP)—which is the type used by American children since 1996. This suggests that children recently given DTaP vaccine, who are exposed to B. pertussis may be astymptomatic carriers and transmitters of the infection for a longer period of time compared to children who get the older, more reactive whole cell DPT vaccine and clear infection more quickly.
• Previous B. pertussis infection prevented colonization with B. pertussis in baboons better than having received either whole cell pertussis (Infanrix) or acelullar pertussis vaccine (Daptacel). In short, natural immunity offered greater protection against the ability to become infected and transmit infection after exposure to B. pertussis than either of the two vaccines.

That said, the researchers acknowledged the baboon study had limitations and among them were the fact that:

• Baboons are not humans and the study authors admitted that "relative protection afforded by Th17 and Th1 responses in vaccinated or convalescent baboons or humans is not known."
• Only one type of whole cell DPT and one type of acellular DTaP vaccine was used in this study but there are many different kinds of DPT and DTaP containing different components. Considering the known variability of measured efficacy and effectiveness of DPT and DTaP vaccines in clinical studies, the FDA study conclusions can only be limited to those two specific DPT and DTaP vaccines.

The Illusion of Vaccine-Acquired Immunity

The concept of vaccine induced herd immunity is built on the assumption that vaccination does protect the vast majority of vaccinated persons in a population from becoming infected with- and transmitting infection to others in the same way that naturally acquired immunity in a population protects acquisition and transmission of infection. The featured FDA research suggests this is not the case and offers a clue as to why whooping cough outbreaks have been occurring and spreading primarilywithin the vaccinated population. To quote NVIC’s Barbara Loe Fisher:

“In my opinion, this study in infant baboons suggests that pertussis vaccine-acquired immunity has been an illusion. Although the vaccines may protect against severe B. pertussis clinical symptoms of the disease—such as paroxysmal coughing—they do not prevent colonization of B. pertussis bacteria and transmission of the infection to others.

In this study at least, recovery from previous B. pertussis infection was more effective in preventing colonization with B.pertussis upon direct challenge than either whole cell DPT (Infanrix) or acellular DTaP (Daptacel) and that suggests transmission of the infection to others after exposure to B pertussis would also be less likely when there is a history of naturally acquired immunity.”

Protect Your Right to Informed Consent and Defend Vaccine Exemptions

With all the uncertainty surrounding the safety and efficacy of vaccines, it's critical to protect your right to make independent health choices and exercise voluntary informed consent to vaccination. It is urgent that everyone in America stand up and fight to protect and expand vaccine informed consent protections in state public health and employment laws. The best way to do this is to get personally involved with your state legislators and educating the leaders in your community.

THINK GLOBALLY, ACT LOCALLY.

National vaccine policy recommendations are made at the federal level but vaccine laws are made at the state level. It is at the state level where your action to protect your vaccine choice rights can have the greatest impact. It is critical for EVERYONE to get involved now in standing up for the legal right to make voluntary vaccine choices in America because those choices are being threatened by lobbyists representing drug companies, medical trade associations and public health officials, who are trying to persuade legislators to strip all vaccine exemptions from public health laws.

Signing up for NVIC's free Advocacy Portal at www.NVICAdvocacy.org gives you immediate, easy access to your own state legislators on your Smart Phone or computer so you can make your voice heard. You will be kept up-to-date on the latest state bills threatening your vaccine choice rights and get practical, useful information to help you become an effective vaccine choice advocate in your own community. Also, when national vaccine issues come up, you will have the up-to-date information and call to action items you need at your fingertips.

So please, as your first step, sign up for the NVIC Advocacy Portal.

Share Your Story with the Media and People You Know

If you or a family member has suffered a serious vaccine reaction, injury or death, please talk about it. If we don't share information and experiences with each other, everybody feels alone and afraid to speak up. Write a letter to the editor if you have a different perspective on a vaccine story that appears in your local newspaper. Make a call in to a radio talk show that is only presenting one side of the vaccine story.

I must be frank with you; you have to be brave because you might be strongly criticized for daring to talk about the "other side" of the vaccine story. Be prepared for it and have the courage to not back down. Only by sharing our perspective and what we know to be true about vaccination will the public conversation about vaccination open up so people are not afraid to talk about it.

We cannot allow the drug companies and medical trade associations funded by drug companies or public health officials promoting forced use of a growing list of vaccines to dominate the conversation about vaccination. The vaccine injured cannot be swept under the carpet and treated like nothing more than "statistically acceptable collateral damage" of national one-size-fits-all mandatory vaccination policies that put way too many people at risk for injury and death. We shouldn't be treating people like guinea pigs instead of human beings.

Internet Resources Where You Can Learn More

I encourage you to visit the website of the non-profit charity, the National Vaccine Information Center (NVIC), at www.NVIC.org:

• NVIC Memorial for Vaccine Victims: View descriptions and photos of children and adults, who have suffered vaccine reactions, injuries and deaths. If you or your child experiences an adverse vaccine event, please consider posting and sharing your story here.
• If You Vaccinate, Ask 8 Questions: Learn how to recognize vaccine reaction symptoms and prevent vaccine injuries.
• Vaccine Freedom Wall: View or post descriptions of harassment and sanctions by doctors, employers, school and health officials for making independent vaccine choices.

Connect with Your Doctor or Find a New One That Will Listen and Care

If your pediatrician or doctor refuses to provide medical care to you or your child unless you agree to get vaccines you don't want, I strongly encourage you to have the courage to find another doctor. Harassment, intimidation, and refusal of medical care is becoming the modus operandi of the medical establishment in an effort to stop the change in attitude of many parents about vaccinations after they become truly educated about health and vaccination.

However, there is hope.

At least 15 percent of young doctors recently polled admit that they're starting to adopt a more individualized approach to vaccinations in direct response to the vaccine safety concerns of parents. It is good news that there is a growing number of smart young doctors who prefer to work as partners with parents in making personalized vaccine decisions for children, including delaying vaccinations or giving children fewer vaccines on the same day or continuing to provide medical care for those families who decline use of one or more vaccines.

So take the time to locate a doctor who treats you with compassion and respect, and is willing to work with you to do what is right for your child.

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• FDA Sued, Forced to Remove Safety Status on Trans Fats

FDA Sued, Forced to Remove Safety Status on Trans Fats

English: Logo of the . (Photo credit: Wikipedia)

By Dr. Mercola

For the past 60 years, saturated animal fats have been wrongfully accused of causing heart disease, despite mounting evidence showing that saturated fat is actually critical for optimal health while trans fat is the dietary fat causing heart disease.

Trans fat, found in margarine, vegetable shortening, and partially hydrogenated vegetable oils became widely popularized as a “healthier alternative” to saturated animal fats like butter and lard around the mid-1950’s. Its beginnings go back 100 years though, to Proctor & Gamble’s creation of Crisco in 1911.1

In 1961, the American Heart Association began encouraging Americans to limit dietary fat, particularly animal fats, in order to reduce their risk of heart disease. In the decades since, despite low-fat diets becoming increasingly part of the norm, heart disease rates have soared.

It’s been a long time coming, but on November 7, 2013, the US Food and Drug Administration (FDA) announced it is now considering removing partially hydrogenated oils—the primary source of trans fats—from the list of "generally recognized as safe" (GRAS) ingredients.2

The FDA will accept comments for 60 days, after which a permanent decision will be made. If finalized, the FDA’s decision means that food manufacturers can no longer use partially hydrogenated oils, i.e. trans fats, in their products without jumping through hoops to get special approval.

The comment period began November 8, 2013. I urge you to submit your comment to the FDA, telling them you want them to finalize its determination that partially hydrogenated oil is no longer general recognized as safe for use in food.

You can submit comments electronically to the FDA docket on regulations.gov. Make sure to use docket number FDA-2013-N-1317. To submit comments by mail, send to FDA at the following address. Again remember to include the agency name and docket number:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

This is the First Step Toward Eliminating Dangerous Trans Fats

This is a remarkable turnaround, and I personally could not be more pleased by this proposed change. This is the first step towards the truth, informing consumers that trans fats are a primary culprit causing premature death. The World Health Organization (WHO) has also called for the elimination of trans fats from the global food supply.3

Unfortunately, the FDA is still holding fast to its ignorant view on saturated animal fats, urging people to “choose products that have the lowest combined amount of saturated fat, cholesterol and trans fat.”4 As I will discuss below, this advice may still cause more harm than good.  You can't expect much from this department, after spending decades spreading misinformation and creating horrible policy - they don't want to look foolish by admitting their faults.

The Hazards of Trans Fats

Trans fats are formed when hydrogen is added to vegetable oil during food processing in order to make it solidify. This process, known as hydrogenation, makes fats less likely to spoil, so foods stay fresh longer, have a longer shelf life and also have a less greasy feel.

However, the end result is a completely unnatural fat that causes cellular dysfunction. According to the FDA, 12 percent of all processed foods contain at least one partially hydrogenated oil, aka trans fat.5

But virtually any food made with or fried in partially hydrogenated oils could potentially contain trans fat, even if it’s not listed on the label. A loophole allows food manufacturers to forgo listing trans fat on the label if it contains less than half a gram per serving. In many cases, this is why some foods have such ridiculously tiny serving sizes.

If you eat a few servings, each containing half a gram of trans fat, you may actually ingest a physiologically significant amount of this deadly fat. So to truly avoid trans fats, you need to read the label and look for more than just 0 grams of trans fat.

Check the ingredients and look for partially hydrogenated oil. If the product lists this ingredient, it likely contains trans fat.

It’s important to keep your intake of trans fat as low as possible, if you eat it at all, as even low amounts can pose grave health risks. In fact, increasing your daily consumption of trans fats from 2 grams to 4.67 grams increases your risk of heart disease by 30 percent!6

Research has also found that trans fats contribute to cancer, bone problems, hormonal imbalance and skin disease; infertility, difficulties in pregnancy and problems with lactation; low birth weight, growth problems, and learning disabilities in children.

Trans Fats May Be Responsible for Up to 20,000 Heart Attacks Annually

According to CDC director Thomas Frieden,7 an estimated 5,000 Americans die from heart disease caused by dietary trans fats each year, and another 15,000 will get heart disease as a result of eating too many trans fats. Other CDC statistics suggest that as many as 20,000 heart attacks could be avoided each year by eliminating trans fats from the food supply.8

Trans fat intake has steadily decreased over the past several years, According to FDA estimates, Americans consumed an average of one gram of trans fat per day in 2012, compared to 4.6 grams per day in 2003. However, according to the Institute of Medicine, trans fat is unsafe at any level.

The Hypocrisy of the CSPI Revealed

Despite scientific evidence, there’s been a lot of controversy surrounding the potential harm of trans fats, and some organizations, such as the Center for Science in the Public Interest (CSPI) has vacillated back and forth on their recommendations. CSPI followed a similar process with aspartame, initially showing no concern but once popularized ends up changing positions.  As recently reported by The Atlantic:9

“In the 1980s, some scientists began to associate heart disease with saturated fats, and in response, groups such as the Center for Science in the Public Interest and the National Heart Savers Association (NHSA) began to hound manufacturers for “poisoning America ... by using saturated fats,” and as a result “nearly all targeted firms responded by replacing saturated fats with trans fats,” as David Schleifer wrote in 2012 for the journal Technology and Culture.10   At the time, many restaurants used beef fat for frying, which groups like CSPI believed was far worse than hydrogenated oils...”

After years of campaigning and pressuring fast food restaurants and food companies to switch from (healthy) animal fat and tropical oils to (far more harmful) vegetable oils,11 the Center for Science in the Public Interest (CSPI) is now applauding the FDA’s decision to revoke trans fats’ GRAS status,12 and has removed information touting the benefits of partially hydrogenated oils from its website.  Before applauding the FDA's decision on trans fats, they were a primary group promoting this dangerous substance.  For these reasons, CSPI is not high on my list of reliable resources.

Ten years ago, the Weston A Price Foundation noted the CSPI’s hypocritical stance on this issue, and questioned whether CSPI might actually be promoting the interests of the soy industry rather than public health:13

“It is impossible to measure the hazards and grief that Liebman and Jacobson--the leaders of the major nutrition "activist" consumer organization--have inflicted on many millions of an unknowing public--because CSPI's campaign was wildly successful. Thanks to CSPI, healthy traditional fats have almost completely disappeared from the food supply, replaced by manufactured trans fats known to cause many diseases.

By 1990, most fast food chains had switched to partially hydrogenated vegetable oil. In 1982, a McDonald's meal of chicken McNuggets, large order of fries and a Danish or pie contained 2.4 grams of trans fat, out of a total of 54 grams of fat. In 1992, that same meal contained 19.2 grams trans fats, a 700 percent increase.

... Who benefits? Soy, or course. Eighty percent of all partially hydrogenated oil used in processed foods in the US comes from soy, as does 70 percent of all liquid oil. CSPI claims that its [financial] support comes from subscribers to its Nutrition Action newsletter... but in fact, in CSPI's January, 1991 newsletter, Jacobson notes that "our effort was ultimately joined. . . by the American Soybean Association."

FDA Does the Right Thing Once Their Backs are Against the Wall...

Most news agencies are hailing the FDA’s draft decision to revoke trans fats’ GRAS status as a sign that the agency is working (after all). But many of you may be wondering what spurred the FDA to take corrective action now, after decades of research have reiterated just how harmful trans fats are. What prompted an agency best known for corruption and conflicts of interest to act in the best interest of Americans’ health now?

Well, as it turns out, the agency’s decision comes right on the heels of a lawsuit filed by Dr. Fred Kummerow, a 99-year old heart disease researcher who has been studying heart disease for about 60 years. He first wrote about the health hazards of trans fats all the way back in 1957.14 Dr. Kummerow filed a citizen petition with the FDA in August of 2009 to have trans fats banned, based on the scientific evidence of harm. The agency is legally required to respond within 180 days. Four years later, no response had been issued, so Dr. Kummerow resorted to suing the agency.15

The lawsuit, Kummerow vs US Food and Drug Administration et al,16 was filed August 9, 2013 with the Illinois Central District Court. Listed defendants include Kathleen Sebelius, Michael M Landa, US Dept of Health and Human Services, Center for Food Safety and Applied Nutrition, Margaret Hamburg, and the FDA.

According to an August 13, 2013 report by FoodNavigator.com,17 Dr. Kummerow “is seeking a judgment declaring that the FDA’s failure to ban the use of partially hydrogenated oils... and its delay in issuing a final response to his 2009 petition, violate the Administrative Procedure Act and the Food, Drug, and Cosmetics Act.” Dr. Kummerow also sought “an order compelling the FDA to respond to his petition and to ban partially hydrogenated oils ‘unless a complete administrative review finds new evidence for their safety.’”

Considering the fact that evidence of trans fat safety is scant to say the least, it appears the FDA had little choice but to do what it should have done years ago, which is address a well-known toxin in the food supply. It’s just too bad that they have to be sued in order to do their job. According to a report by the St. Louis Dispatch:18

“When asked whether Kummerow’s lawsuit had led to the FDA’s action, a spokeswoman for the agency said she could not comment on pending litigation. But on Thursday, attorneys for the FDA filed the agency’s trans fat determination as an exhibit in Kummerow’s lawsuit, and their proposal for the ban included a mention of Kummerow’s 2009 petition. “There’s no way to know if his petition or the lawsuit was the initiating event (for the ban), but the timing is interesting,” said Diana Yates, life sciences editor at the University of Illinois.”

Chris Masterjohn, PhD has been working with Dr. Kummerow for a number of years, and I recently interviewed him about this issue, and how Dr. Kummerow’s lawsuit may have been the driving force behind the FDA’s decision to finally take action.

Chris Masterjohn, PhD, is creator and author of Cholesterol-and-Health.Com, a web site dedicated to extolling the benefits of traditional, nutrient-dense, cholesterol-rich foods and to elucidating the many fascinating roles that cholesterol plays within the body. Chris is a frequent contributor to Wise Traditions, the quarterly journal of the Weston A. Price Foundation, and is a perennial speaker at the annual Wise Traditions conference, and has published seven first-author, peer-reviewed publications.

He obtained a PhD in Nutritional Sciences from the University of Connecticut and is currently working as a Postdoctoral Research Associate at the University of Illinois where he is studying interactions between vitamins A, D, and K. The opinions he expresses in this interview represent his independent analysis and do not necessarily represent the positions of the University of Illinois.

Don’t Be Fooled—Saturated Fat is Not Associated with Increased Heart Disease Risk

As mentioned earlier, while the hazards of trans fats are now officially recognized, government health agencies and the medical establishment as a whole are still holding on to the outdated hypothesis that saturated animal fats and tropical oils are bad for your health as well. Nothing could be further from the truth, and if you care about your health you’d be wise to reconsider the advice to follow a strict low-fat diet. Mounting scientific evidence supports saturated fat as a necessary part of a heart healthy diet, and firmly debunks the myth that saturated fat promotes heart disease. For example:

• In a 1992 editorial published in the Archives of Internal Medicine,19 Dr. William Castelli, a former director of the Framingham Heart study, stated:
• "In Framingham, Mass., the more saturated fat one ate, the more cholesterol one ate, the more calories one ate, the lower the person’s serum cholesterol. The opposite of what… Keys et al would predict…We found that the people who ate the most cholesterol, ate the most saturated fat, ate the most calories, weighed the least and were the most physically active."
• A 2010 meta-analysis,20 which pooled data from 21 studies and included nearly 348,000 adults, found no difference in the risks of heart disease and stroke between people with the lowest and highest intakes of saturated fat.
• Another 2010 study published in the American Journal of Clinical Nutrition21 found that a reduction in saturated fat intake must be evaluated in the context of replacement by other macronutrients, such as carbohydrates.
When you replace saturated fat with a higher carbohydrate intake, particularly refined carbohydrate, you exacerbate insulin resistance and obesity, increase triglycerides and small LDL particles, and reduce beneficial HDL cholesterol. The authors state that dietary efforts to improve your cardiovascular disease risk should primarily emphasize the limitation of refined carbohydrate intake, and weight reduction.

What Makes for a Heart Healthy Diet?

It’s important to realize that saturated fats from animal and vegetable sources provide a number of important health benefits, and your body requires them for the proper function of your:

Cell membranes	Heart	Bones (to assimilate calcium)
Liver	Lungs	Hormones
Immune system	Satiety (reducing hunger)	Genetic regulation

To prevent heart disease it’s critical to address your insulin- and leptin resistance, which is the result of eating a diet too high in sugars and grains, not fat. As decades of research has shown, dietary fat has very little to do with your heart disease risk—with the exception of trans fats from partially hydrogenated vegetable oils, which have been linked to increased heart disease risk, even in small amounts. So, to safely and effectively reverse insulin and leptin resistance, thereby lowering your heart disease risk, you need to:

1. Avoid sugar, fructose, grains, and processed foods
2. Eat a healthful diet of whole foods, ideally organic, and replace the grain carbs with:
• Large amounts of vegetables
• Low-to-moderate amount of high quality protein (think organically raised, pastured animals)
• As much highly quality healthful fat as you want (saturated and monosaturated from animal- and tropical oil sources). Most people actually need upwards of 50-70 percent fats in their diet for optimal health—a far cry from the 10 percent currently recommended.

One of the most important fats your body needs for optimal health is animal-based omega-3. Deficiency in this essential fat can cause or contribute to very serious health problems, both mental and physical, and may be a significant underlying factor of up to 96,000 premature deaths each year. For more information about omega-3's and the best sources of this fat, please review this previous article.  Besides animal-based omega-3 fats, other sources of healthful fats to add to your diet include:

Avocados	Butter made from raw grass-fed organic milk	Raw dairy	Organic pastured egg yolks
Coconuts and coconut oil	Unheated organic nut oils	Raw nuts, such as, almonds, pecans, macadamia, and seeds	Grass-fed meats

Healthy Fat Tips to Live By

The most effective prevention strategy against heart disease you’ll likely ever find is your diet—the foods you do and do not eat every day. For example, a Mediterranean-style diet has been shown to be three times more effective than statin drugs at reducing cardiovascular mortality. A Mediterranean-style diet is basically a whole-food diet. And that is indeed key for any healthy diet.  The answer to your heart disease concerns is to EAT REAL FOOD. This change alone will dramatically reduce the amount of refined sugar and processed fructose in your diet. It will also address the issue of healthful versus harmful fats in your diet. Besides eliminating processed foods, the following tips can help ensure you’re eating the right fats for your health:

• Use organic butter made from raw grass-fed milk instead of margarines and vegetable oil spreads.
• Use coconut oil for cooking. It is far superior to any other cooking oil and is loaded with health benefits.
• Use olive oil COLD, drizzled over salad or fish, for example. It is not an ideal cooking oil as it is easily damaged by heat.
• Following my nutrition plan will teach you to focus on healthy whole foods instead of processed junk food.
• To round out your healthy fat intake, be sure to eat raw fats, such as those from avocados, raw dairy products, and olive oil, and also take a high-quality source of animal-based omega-3 fat, such as krill oil.

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• RIP trans fats
• FDA Sued, Forced to Remove Safety Status on Trans Fats
• Oreos Are Found to Be as Addictive as Cocaine
• Organized Crime Ring The Pharmaceutical Drug Cartel

Red Flag for Universal Flu Vaccine

Sailors inspect needles containing influenza vaccine (Photo credit: Official U.S. Navy Imagery)

By Dr. Mercola

Despite powerful evidence to the contrary, the conventional view is that the best way to protect yourself against influenza is to get a seasonal flu shot. This flies in the face of a multitude of studies showing that:

1. The flu vaccine fails to work for many people.
   Case in point: The 2012/2013 flu vaccine contained a very good match to the circulating strains, yet the reported effectiveness of the vaccine was still only slightly over 60 percent.
   According to Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota:1 "A match doesn't tell us how well a vaccine is going to work. It's almost meaningless."
2. Vaccinating against one strain of influenza may actually increase your risk of exposure to related but different strains.

The latter point makes recent vaccine developments particularly troublesome, as vaccine researchers are hard at work developing a “universal” flu vaccine that is supposed to protect against virtually all subtypes of influenza—hypothetically, at least.

As new research shows, this may be a very dangerous hypothesis to pursue in order to promote the idea that universal use of a “universal” flu vaccine is necessary and will be a safe and effective public health policy.

Could Universal Flu Vaccine Result in Universal Poor Health?

Recent research2 on pigs, using whole, killed flu viruses, raises very important questions about the approach taken in the development of a universal flu vaccine. The study in piglets found that getting vaccinated against one strain of influenza raised the risk of severe infection with a related but different influenza strain.

It may be worth noting that the researchers are all with either the US Department of Agriculture’s Research Service or the US Food and Drug Administration, should anyone want to dismiss these findings as propaganda thought up by the vaccine safety and choice movement.

The researchers refer to this effect as “vaccine-associated enhanced respiratory disease.” Wisely enough, they recommend their findings “should be considered during the development and assessment of experimental universal flu vaccines.” According to the senior author Dr. Amy Vincent:3

“We need to ask questions and make sure the appropriate experiments and studies are done to ensure this will or will not happen in different vaccine scenarios.”

The US Food and Drug Administration (FDA) has recently approved several new flu vaccines, including quadrivalent (four strain) vaccines using eggs for production, as well as trivalent vaccines.

These were created using either a baculovirus (army worm) expression system or MDCK (dog kidney) cells and recombinant DNA technology4 for production--the first of its kind. These new influenza vaccines using novel cell substrates may be opening the door to a whole host of potential unknown health effects, both short- and long-term.

This season you will have quite an array of flu vaccines to choose from. As recently reported in Time Magazine,5 available choices this year will include:

1. Standard three-strain flu vaccine. This year’s version includes influenza strains H1N1 and H3N2, and an influenza B virus
2. Quadrivalent, or four-strain vaccine, which includes two A class of viruses and two from the B class, which tends to cause illness primarily in young children
3. Nasal spray, called FluMist. This year it will contain four strains opposed to three, matching the quadrivalent injection
4. Egg-free vaccine (FluBlok), in which the influenza virus were grown in caterpillar cells instead of chicken eggs
5. High-dose vaccines, promoted for seniors aged 65 and over
6. Intradermal vaccine, promoted for those afraid of needles. The vaccine is delivered through a panel of micro-needles rather than a single needle

Will a 'Universal' Flu Vaccine Work?

Typically, most flu vaccines stimulate the production of antibodies to the main protein of the flu virus, called hemagglutinin, which is located on the outer shell of the virus. This protein gives you the “H” designation of a given strain, and it is this protein that attaches to the cell it’s trying to invade. There are 17 known hemagglutinins and the antibodies created to an H1 virus will not protect against an H3 or H5 virus, and so on.

Making matters even more complex, there are also different strains within each of these subtypes, and the artificial immunity you get from a vaccine may or may not extend to all strains of any given hemagglutinin subtype. So the vaccine industry is trying to boost vaccine acquired immunity by targeting “stalk antibodies.”

Here’s what this means, and why their efforts may end up producing the opposite effect they’re seeking: The hemagglutinin is shaped much like a lollipop, with the mutating part making up the head. Researchers have learned that the stem or stalk of the protein, on the other hand, tends to remain fairly unchanged across the various viruses. This is the discovery that has resulted in the current search for a “universal” flu vaccine. Vaccine developers believe that by removing the head portion, namely the stalk—i.e. the dominant protein portion of the virus—they might be able to induce cross-reactive antibodies capable of protecting against virtually any influenza virus, regardless of whether it’s an H1, H3, or H5, and so on.

The recent flu vaccine research in pigs raises a huge red flag calling into question the validity of this hypothesis, however. After giving piglets an H1N2 vaccine, they were then exposed to the H1N1 virus in circulation during 2009. As reported in the featured article:

“Instead of being protected, the H1N2-vaccinated pigs developed more severe disease than exposed pigs that hadn’t been pre-vaccinated. When the researchers tested the blood of the vaccinated pigs, they found high levels of antibodies that attached to the stalk of the H1N1 hemagglutinin, but not to the head of the protein.

Vincent said she and her colleagues are still trying to figure out why this produces more severe disease. But the theory is that while the stalk antibodies can’t neutralize or kill invading viruses, they do bind to them. And that may actually help the viruses enter the cells and multiply to higher levels—the paper calls them 'fusion enhancing.'”[Emphasis mine]

Canadian Results from 2009 Pandemic May Offer Glimpse of Troubles to Come

We saw evidence of this “fusion enhancing” scenario in Canada during the 2009 H1N1 pandemic. The connection between previous flu vaccination and increased risk of disease during the 2009 season was initially spotted by Dr. Danuta Skowronski, a flu expert at the Canadian B.C. Centre for Disease Control.

She noticed that people who had gotten a flu shot the previous fall were MORE likely to succumb to the novel H1N1 strain, compared to those who had not received a flu shot the previous year.6 When blood samples from 27 healthy, unvaccinated children and 14 children who had received an annual flu shot were compared, the former unvaccinated group naturally built upmore antibodies across a wider variety of influenza strains compared to the latter vaccinated group.

Not surprisingly, her findings were promptly dismissed by the influenza community at large. Some dubbed it “the Canadian problem,” although it’s unclear why anyone would think that such consequences would be limited within the confines of the Canadian borders... A similar trend was also noted in data from Hong Kong,7 should anyone be tempted to write off the Canadian data as being an anomaly.

Dr. Skowronski’s team tested the hypothesis on ferrets,8 and found that the ferrets in the vaccine group also became significantly sicker than the unvaccinated animals. As reported in the featured article:9

“Asked about Vincent’s study, Skowronski said she’s been watching results from that group for years, and even cited vaccine-associated enhanced respiratory disease when she was asked by skeptics to describe what might explain her unexpected results in 2009.

'I think... what they’re showing is a biological mechanism that warrants further evaluation in terms of its relevance to the use of seasonal vaccines in human...” Skowronski said. 'It’s concerning, obviously, because if this is the mechanism, then it means there needs to be a lot more... attention paid to these universal vaccine candidates that are targeting that stalk antibody.'

The big question is, are we in fact weakening our overall ability to fight viruses by getting too many vaccines? While this question can apply to any vaccine, it’s particularly pertinent with regards to influenza vaccine, which public health officials say we must get each and every year from the age of six months throughout our lives until death! An even larger question, and one which researchers have only just begun to scratch the surface of, is whether or not universal use of vaccines can have a generational effect.

Infants Born to Vaccinated Mothers May Lose Initial Immunity Sooner

One study offering a glimpse into this question was recently published in the Journal of Infectious Diseases.10 As reported by Medical News Today:11

“Newborns are protected from measles, mumps, and rubella during their first few months of life by antibodies they receive from their mothers. An infant's level of immunity is based, in part, on the mother's blood antibody level. A child's first dose of MMR vaccine is usually administered at around age one. Prior to the first vaccination, however, an infant's immunity begins to wane.

Previous studies have demonstrated that mothers who received MMR vaccination tend to have a lower concentration of measles-specific antibodies compared to mothers who naturally acquired measles infection. As a result, babies born to mothers who received the MMR vaccine have a shorter duration of protection and may remain unprotected for a period of time before they receive the first vaccination.”

The study in question12 found that infants born to mothers who received the measles-mumps-rubella (MMR) vaccine lose natural, passively acquired immunity from their mothers sooner than those born to mothers who’d been naturally infected with measles.

Another study13 published in the same issue of the same journal found that, on average, the duration of passive protection against measles was two months longer for infants born to unvaccinated mothers.

Sadly, the authors use these worrying facts to support recommendations to get infants vaccinated sooner, rather than address the elephant in the room, which is whether or not we’re seriously compromising natural immunity over generations. Contracting a childhood disease naturally creates a positive feedback loop of robust, longer lasting immunity that is then transferred to your baby (if you’re a woman) and kept in place during early infancy.

By mass-vaccinating against childhood diseases that are not deadly for the vast majority of children in the U.S. and other developed countries with good sanitation, nutritous food and health care, are we slowly but surely, one generation at a time, eliminating the body’s natural ability to develop a qualitatively superior immunity to infectious diseases? And if so, where does that leave us? And, more importantly, why are we trading a more robust and longer lasting natural immunity for an artificial more temporary vaccine acquired immunity?

UNICEF Monitors and Defames Health Sites for Reporting Vaccine Research

Getting back to the flu vaccine, a recent review of published research shows flu vaccines are marginally effective at best, and produce neurological complications at worst, while having no effect at all on hospitalizations or working days lost. One of the most recent examples is the devastating side effects of the 2009-2010 flu vaccine, which caused some 800+ cases of narcolepsy in Sweden and other European countries.14

Despite such evidence, vaccine-safety and choice advocates such as myself are being increasingly targeted by the vaccine industry and those associated with that very profitable industry. We’re the “bad guys,” apparently simply because we bring the scientific evidence to the attention of the public and urge that everyone make well-educated vaccine and other health care decisions..

For example, a new report15 by the United Nations Children's Fund (UNICEF) reveals that the organization is tracking "the rise of online anti-vaccination sentiments in Central and Eastern Europe,” and has identified the most influential “anti-vaccine influencers” on the web. This list includes yours truly, along with other independent health websites like GreenMedInfo.com, Mothering.com and NaturalNews.com, just to name a few.

This is indeed a sad state of affairs.

Instead of addressing the scientific evidence showing the potential harm of vaccines, both short- and long-term (perhaps even generational), they’re spending precious time, resources and brain power on public relations schemes to convince you not to pay attention to the available science. After all, many of the referenced articles published in this newsletter and on Mercola.com highlight documented evidence published in peer-reviewed journals! The only reason they’ve tagged me as an “anti-vaccine influencer” charged with the crime of lowering vaccine uptake, is because they’d rather keep that evidence under wraps so the public remains uninformed.

As stated by Sayer Ji, owner of Greenmedinfo.com:

“UNICEF's opening reference to the 'lie' (misinformation) spread by the above-mentioned web-based organizations indicates that while the document purports to be analytical and descriptive, it has proscriptive and defamatory undertones, and only thinly conceals an agenda to discredit opposing views and voices.

UNICEF's derogatory stance is all the more surprising considering that websites such as GreenMedinfo.com aggregate, disseminate and provide open access to peer-reviewed research on vaccine adverse effects and safety concerns extracted directly from the US National Library of Medicine, much of which comes from high-impact journals.”

Flu Vaccines Fail to Work Well According to Independent Research Review

Take the independent study review from the Cochrane Collaboration, for example. As Tom Jefferson, a researcher with the Cochrane Collaboration told Northwestern.edu:16 “There is no evidence that vaccines can prevent deaths or prevent person-to-person spread of infection.”

According to these independent research reviewers:17

“At best, vaccines might be effective against only influenza A and B, which represent about 10 percent of all circulating viruses. Authors of this review assessed all trials that compared vaccinated people with unvaccinated people. The combined results of these trials showed that under ideal conditions (vaccine completely matching circulating viral configuration) 33 healthy adults need to be vaccinated to avoid one set of influenza symptoms. In average conditions (partially matching vaccine) 100 people need to be vaccinated to avoid one set of influenza symptoms.

Vaccine use did not affect the number of people hospitalized or working days lost but caused one case of Guillian-Barré syndrome (a major neurological condition leading to paralysis) for every one million vaccinations.

Fifteen of the 36 trials were funded by vaccine companies and four had no funding declaration. Our results may be an optimistic estimate because company-sponsored influenza vaccines trials tend to produce results favorable to their products and some of the evidence comes from trials carried out in ideal viral circulation and matching conditions and because the harms evidence base is limited.”

Protect Your Right to Informed Consent and Vaccine Exemptions

With all the uncertainty surrounding the safety and efficacy of vaccines, it's critical to protect your right to informed consent to vaccination and fight to protect and expand vaccine exemptions in state public health laws. The best way to do this is to get personally involved with your state legislators and the leaders in your community.

 THINK GLOBALLY, ACT LOCALLY.

Mass vaccination policies are made at the federal level but vaccine laws are made at the state level. It is at the state level where your action to protect your vaccine choice rights can have the greatest impact. It is critical for EVERYONE to get involved now in standing up for the legal right to make vaccine choices in America because those choices are being threatened by lobbyists representing drug companies, medical trade associations and public health officials, who are trying to persuade legislators to strip all vaccine exemptions from public health laws.

Signing up for the National Vaccine Information Center’s free Advocacy Portal at www.NVICAdvocacy.org gives you immediate, easy access to your own state legislators on your Smart Phone or computer so you can make your voice heard. You will be kept up-to-date on the latest state bills threatening your vaccine choices and get practical, useful information to help you become an effective vaccine choice advocate in your own community. Also, when national vaccine issues come up, you will have the up-to-date information and call to action items you need at your fingertips.

So please, as your first step, sign up for the NVIC Advocacy Portal.

Share Your Story with the Media and People You Know

If you or a family member has suffered a serious vaccine reaction, injury or death, please talk about it. If we don't share information and experiences with each other, everybody feels alone and afraid to speak up. Write a letter to the editor if you have a different perspective on a vaccine story that appears in your local newspaper. Make a call in to a radio talk show that is only presenting one side of the vaccine story.

I must be frank with you; you have to be brave because you might be strongly criticized for daring to talk about the "other side" of the vaccine story. Be prepared for it and have the courage to not back down. Only by sharing our perspective and what we know to be true about vaccination will the public conversation about vaccination open up so people are not afraid to talk about it.

We cannot allow the drug companies and medical trade associations funded by drug companies or public health officials promoting forced use of a growing list of vaccines to dominate the conversation about vaccination. The vaccine injured cannot be swept under the carpet and treated like nothing more than "statistically acceptable collateral damage" of national one-size-fits-all mandatory vaccination policies that put way too many people at risk for injury and death. We should be treating people like human beings instead of guinea pigs.

Internet Resources Where You Can Learn More

I encourage you to visit the following web pages on the National Vaccine Information Center (NVIC) website at www.NVIC.org:

• NVIC Memorial for Vaccine Victims: View descriptions and photos of children and adults, who have suffered vaccine reactions, injuries and deaths. If you or your child experiences an adverse vaccine event, please consider posting and sharing your story here.
• If You Vaccinate, Ask 8 Questions: Learn how to recognize vaccine reaction symptoms and prevent vaccine injuries.
• Vaccine Freedom Wall: View or post descriptions of harassment and sanctions by doctors, employers, school and health officials for making independent vaccine choices.

Connect with Your Doctor or Find a New One that Will Listen and Care

If your pediatrician or doctor refuses to provide medical care to you or your child unless you agree to get vaccines you don't want, I strongly encourage you to have the courage to find another doctor. Harassment, intimidation, and refusal of medical care is becoming the modus operandi of the medical establishment in an effort to stop the change in attitude of many parents about vaccinations after they become truly educated about health and vaccination.

However, there is hope.

At least 15 percent of young doctors recently polled admit that they're starting to adopt a more individualized approach to vaccinations in direct response to the vaccine safety concerns of parents. It is good news that there is a growing number of smart young doctors, who prefer to work as partners with parents in making personalized vaccine decisions for children, including delaying vaccinations or giving children fewer vaccines on the same day or continuing to provide medical care for those families, who decline use of one or more vaccines.

So take the time to locate a doctor, who treats you with compassion and respect and is willing to work with you to do what is right for your child.

 http://articles.mercola.com/sites/articles/archive/2013/09/10/universal-flu-vaccine.aspx  Link back to Mercola.com for more information and video.

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