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THIS FDA PRESS RELEASE WAS REMOVED IN 2013.

FDA NEWS RELEASE

For Immediate Release: Nov. 27, 2013

Media Inquiries: FDA- Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov
NIH- Nalini Padmanabhan, 301-402-1663, padmanabhannm@niaid.nih.gov

Consumer Inquiries: 888-INFO-FDA,OCOD@fda.hhs.gov

FDA study helps provide an understanding of rising rates of whooping cough and response to vaccination

A new study is helping to provide a better understanding of vaccines for whooping cough, the common name for the disease pertussis. Based on an animal model, the study conducted by the U.S. Food and Drug Administration (FDA) and published November 25, 2013, in The Proceedings of the National Academy of Sciences, shows that acellular pertussis vaccines licensed by the FDA are effective in preventing the disease among those vaccinated, but suggests that they may not prevent infection from the bacteria that causes whooping cough in those vaccinated or its spread to other people, including those who may not be vaccinated.

Whooping cough rates in the United States have been increasing since the 1980s and reached a 50-year high in 2012. Whooping cough is a contagious respiratory disease caused by Bordetella pertussis bacteria. Initial symptoms include runny nose, sneezing, and a mild cough, which may seem like a typical cold. Usually, the cough slowly becomes more severe, and eventually the patient may experience bouts of rapid, violent coughing followed by the “whooping” sound that gives the disease its common name, when trying to take a breath. Whooping cough can cause serious and sometimes life-threatening complications, permanent disability, and even death, especially in infants and young children.

There are two types of pertussis vaccines, whole-cell and acellular. Whole-cell pertussis vaccines contain a whole-cell preparation, which means they contain killed, but complete, B. pertussis bacteria. The acellular pertussis vaccine is more purified and uses only selected portions of the pertussis bacteria to stimulate an immune response in an individual. In response to concerns about the side effects of the whole cell pertussis vaccine, acellular vaccines were developed and replaced the use of whole-cell pertussis vaccines in the U.S. and other countries in the 1990s; however, whole-cell pertussis vaccines are still used in many other countries.

“This study is critically important to understanding some of the reasons for the rising rates of pertussis and informing potential strategies to address this public health concern,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research, where the study was conducted. “This research is a valuable contribution and brings us one step closer to understanding the problem. We are optimistic that more research on pertussis will lead to the identification of new and improved methods for preventing the disease.”

While the reasons for the increase in cases of whooping cough are not fully understood, multiple factors are likely involved, including diminished immunity from childhood pertussis vaccines, improved diagnostic testing, and increased reporting. With its own funds plus support from the National Institutes of Health (NIH), the FDA conducted the study to explore the possibility that acellular pertussis vaccines, while protecting against disease, might not prevent infection.

“There were 48,000 cases reported last year despite high rates of vaccination,” said Anthony S. Fauci, M.D., director of the NIH’s National Institute of Allergy and Infectious Diseases. “This resurgence suggests a need for research into the causes behind the increase in infections and improved ways to prevent the disease from spreading.”

The FDA conducted the study in baboons, an animal model that closely reproduces the way whooping cough affects people. The scientists vaccinated two groups of baboons – one group with a whole-cell pertussis vaccine and the other group with an acellular pertussis vaccine currently used in the U. S. The animals were vaccinated at ages two, four, and six months, simulating the infant immunization schedule. The results of the FDA study found that both types of vaccines generated robust antibody responses in the animals, and none of the vaccinated animals developed outward signs of pertussis disease after being exposed to B. pertussis. However, there were differences in other aspects of the immune response. Animals that received an acellular pertussis vaccine had the bacteria in their airways for up to six weeks and were able to spread the infection to unvaccinated animals. In contrast, animals that received whole-cell vaccine cleared the bacteria within three weeks.

This research suggests that although individuals immunized with an acellular pertussis vaccine may be protected from disease, they may still become infected with the bacteria without always getting sick and are able to spread infection to others, including young infants who are susceptible to pertussis disease.

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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THIS POST APPEARED AND DISAPPEARED ON 04/02/2017

Seeing as today is Autism Awareness Day, I thought it would be an opportune time to publish a post by my close friend, Dr. Michael J. Goldberg, MD - a Los Angeles-based pediatrician who specializes in treating children mistakenly diagnosed with Autism. His findings run counter to the mainstream views of the American Medical Association and society as a whole, and are so novel that I offered to publish something on the Huffington Post on his behalf. Below please find a blog post written entirely byDr. Michael J. Goldberg, MD.

Phenotype: A collection of symptoms that reflects how a disease or illness presents, yet does not tell you the cause of the disease.

Epidemic: The outbreak of a disease, that spreads quickly and affects many individuals at the same time.

Autism Spectrum Disorder (ASD): The expanding psychological label assigned to a collection of behaviors and/or mannerisms exhibited in more than 2% (1:48) of children.

Tens of thousands families now have children psychiatrically “labeled” as Autistic / PDD, ADD, ADHD, OCD and now even CDD (Childhood Disintegrative Disorder). Psychiatric and Developmental disorders like this have reached epidemic levels in children: Autism alone is now 1:48 (2.1%) and rising. Polio, at its worse, was 1:1500 (.07%) children. Basic medical science teaches there cannot be an epidemic of a developmental or genetic disorder.

The assumption that ASD behaviors and mannerisms of 2.1% of our children (and climbing) is the result of a mental condition is scientifically untenable. When analyzed from a medical perspective, the presenting dysfunctions/symptoms of most of these children can be explained far more appropriately by the concept of a ‘Phenotype’, that is part of a complex immune, complex viral disease presenting with secondary “Autistic, ADHD, OCD, Anxiety or ODD” symptoms.

As a practicing pediatrician I have devoted the last 25 years working with ASD labeled children. I have identified through years of observation, blood tests and brain scans, an understandable Phenotype of a medical disease process (complex immune, complex viral), that logically and scientifically explains the mixed collection of symptoms manifested in ASD children including: Chronic “ill” appearance, abnormal sleep patterns, chronic allergies, fine motor issues, coordination issues, hypo/hyper profusion in the temporal and frontal lobes of the brain, and abnormally elevated viral titers including HHV6, Epstein Barr, and CMV. These and other markers, in my professional opinion, are indicative of a medically treatable disease process and not a psychological and/or developmental dysfunction.

When this disease and it’s secondary symptoms identified above are medically treated with FDA approved meds and diet modifications, approximately 75% of my parents report the behaviors and mannerisms of the ASD labeled Phenotype either disappear or significantly abate. The parents and therapists report “it is as though a fog has lifted” or “this is not the same child”. These children are placed in a position to be taught, not trained. They can and do learn; they progress, complete their education (some through college) and become productive members of society. A sense of “Normalcy” is returned to the family. Two different retrospective reviews have confirmed an over 75% clinical success rate with medical treatment!! This success rate is possible and expected because these children suffer from an underlying medical disease and not a mental or developmental disorder. A developmental disorder would not respond, could not respond to antiviral and other medical therapies.

Talking recently with an ex-Los Angeles County public health official, he was completely baffled when asked if he had he ever studied anything 1:50 (not 1:1000, 1:5000, or less), anything 2% of the population - and there was no answer. The silence was deafening. Nothing of this magnitude had been looked at in any past training, because it was beyond comprehension.

We have 2% of children being affected, and it is not considered a public health crisis – IMPOSSIBLE.

To the reader I ask: If an ASD rate of 1:48 (2.1%) is not alarming today, how about 1:20 (5%) in five years or 1:5 (20%) in 10 years or 1:1 (100%) in 20 years? To deny that we are in the midst of a true medical worldwide pandemic is unconscionable. Science does not change; it can be ignored, or twisted to fit a popular mindset, but science does not change: you cannot have an epidemic without an underlying disease process.

The current diagnostic mistakes are so obvious and go against basic medical and psychiatric principals. In a recent interview I emphasized that, historically, “autism” was a diagnosis of exclusion. If there was no medical or organic explanation for the child’s problem then a psychiatric referral was appropriate. Children today are labeled “Autistic” or “GDD” (Global Developmental Delay) without an appropriate full medical work up to discover any underlying etiologies/medical causation related to the symptoms described above. In the past, (40 – 70 years ago) this would have been impossible and scientifically incompatible. GDD used to imply an organic underlying medical issue with a child. Today, when a GDD/ ASD labeled child is overcome by “sensory” issues, that child’s obvious medical and physical suffering is currently ignored and left medically untreated. That our present system fails to medically investigate the reasons for that suffering (i.e. complex immune-complex viral) does not give them the right to abandon the child and condemn them to a life of no hope with a psychiatric label of Autism.

In my professional and clinically observed opinion, ideas of “Autism” as a permanent, unfixable mental condition/disorder is mistaken. If ASD were approached as the epidemic/pandemic that it is - much like Polio 1:1500 (.07%) of the 1950s - then medical pediatricians and specialists can and would begin to treat this disease. Medical treatment would help mitigate or even eliminate ASD symptoms/behaviors, and provide real relief for children and their families. We would begin talking about treatment and potential recovery - not long term care: an impossible burden for families, the medical system, our society.

March 10, 2016

This post appeared for a few hours on The Huffington (Censored) Post.

Is RFK Jr. ‘Anti-Vaccine’?

Posted on March 8, 2017 by TheFightBack

RFK Jr. at the National Press Club

News that President Trump may tap Robert Kennedy Jr. to head a commission on vaccine safety has not been well-received by the media.

Kennedy is a “conspiracy theorist” wrote the Washington Post; he’s an “Anti-Vaccine Activist” blared the New York Times, which condemned “Kennedy and his fellow travelers”; and on it went.

Kennedy is a leading environmentalist. He’s also the son of the former attorney general and senator, Robert Kennedy; and nephew of former President John F. Kennedy.

Having followed his work for years, I had a difficult time believing he could be on point on so many issues, and completely off-base about vaccines, as media reports suggest.

So I looked into it. I read a 2014 book Kennedy edited on thimerosal, a mercury-based preservative used in some vaccines. I also read his critics.

And here’s my non-medical-expert opinion: the media should stop the name-calling.

Anti-Vax

For starters, it’s a stretch to accuse Kennedy of being anti-vaccine.

“I am pro-vaccine,” Kennedy wrote in Thimerosal: Let the Science Speak:

I had all six of my children vaccinated. I believe that vaccines have saved the lives of hundreds of millions of humans over the past century and that broad vaccine coverage is critical to public health. But I want our vaccines to be as safe as possible.

This begs the question: What’s the definition of this term, “anti-vaccine”? If you question any aspect of any vaccine should you be stuck with this label?

“If patients have concerns, doubts, or suspicions — for example, about the safety of vaccines, this does not mean they are ‘anti-vaccine,’” writes Peter Doshi, associate editor of the British Medical Journal.

The label (or its derogatory derivative “anti-vaxxer”) is a form of attack. It stigmatizes the mere act of even asking an open question about what is known and unknown about the safety of vaccines.

Thimerosal

Multi-dose vaccines, which are less costly to produce and store than single-dose vaccines, require a preservative to keep them sterile. The preservative protects the batch from being contaminated when a syringe is inserted to remove each dose.

For years, thimerosal has been one of the most common vaccine preservatives, although alternatives are increasing (at least in the U.S. – in the developing world vaccines still regularly contain thimerosal).

In the heavily-footnoted Thimerosal, Kennedy calls the preservative “a dangerous neurotoxin” due to its mercury content.

The Food and Drug Administration (FDA), among other health bodies, disagrees. Still the FDA“continues to work with, vaccine manufacturers to reduce or eliminate thimerosal from vaccines.”

Thimerosal has already been removed from U.S. childhood vaccines, except in trace amounts. The removal followed a joint 1999 statement from the American Academy of Pediatrics and the Public Health Service, which includes, among other federal agencies, the FDA and the Centers for Disease Control. The joint statement recommended thimerosal’s removal, but stated its risk, while unknown, was likely slim-to-none.

Subsequently, numerous public health bodies, including the FDA and CDC, have reaffirmedthimerosal’s safety.

But Kennedy says statements from health agencies are not the same as scientific studies. Along with actor Robert De Niro, Kennedy is offering $100,000 to anyone “who can point to a peer-reviewed scientific study demonstrating that thimerosal is safe in the amounts contained in vaccines currently being administered to American children and pregnant women.”

Flu Shot

While no longer in childhood vaccines, thimerosal is still found in some flu vaccines. This flu season, upwards of 35 million doses of the flu vaccine contained thimerosal.

The CDC recommends an annual flu shot for anyone over the age of six months, including pregnant women.

“In effect,” wrote the authors of Thimerosal, “the CDC has switched the main source of American children’s Thimerosal exposure from early childhood vaccines to Thimerosal-preserved flu shots, beginning in utero.”

Public health agencies don’t view this as a threat.

Kennedy does.

That doesn’t make him anti-vaccine.

It’s time for the media to stop the name-calling.

* It’s not a sure thing Kennedy will chair the vaccine commission, if it’s even created. Following Kennedy’s recent, sharp criticism of Trump’s anti-environmental measures, it’s hard to imagine the thin-skinned president appointing him to anything.

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We have 2% of children being affected, and it is not considered a public health crisis – IMPOSSIBLE.

Is RFK Jr. ‘Anti-Vaccine’?

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