Friday, November 16, 2012

Human Gene Therapy Gets the Nod

The Lancet, Volume 380, Issue 9855, Page e10, 17 November 2012
doi:10.1016/S0140-6736(12)61992-8Cite or Link Using DOI
Europe officially approved its first gene therapy earlier this month for a rare metabolic disorder. Could this mark a turning point for a technique that has struggled to take off? Karl Gruber reports.
On Nov 2, the European Commission announced the official approval of Glybera, a gene therapy for treating lipoprotein lipase deficiency (LPLD), devised by the Dutch company uniQure. The approval is the first of its kind in the Western world and may herald the beginning of a new era for gene therapy, a field plagued by unfulfilled promises and weary investors, all of which has until now overshadowed its progress.
LPLD is an extremely rare and incurable disorder that affects 1—2 people per million, where a defective lipoprotein lipase (LPL) gene leads to a non-functional LPL enzyme. The LPL enzyme is a key player in fat metabolism and people with LPLD are unable to process fats. They suffer from severe abdominal pain during childhood and several other conditions during adulthood, including recurrent acute pancreatitis
Glybera (alipogene tiparvovec) is a recombinant, non-integrating, non-replicating adeno-associated viral vector expressing Ser447X, a naturally occurring functional variant of the LPL gene associated with lower rates of cardiovascular disease and increased efficiency in fat metabolism. The basic principle of Glybera is to compensate for the defective LPL gene by introducing functional copies of this gene into muscle cells lacking active LPL. Patients receive a single treatment that, according to clinical data, results in long-term improvement of the conditions associated with LPLD, including a reduction in pancreatitis incidence up to 2 years after treatment.
The road to Glybera's approval was not simple, being hurdled by three rejections before success. The first two rejections, back when uniQure was Amsterdam Molecular Therapeutics, were due to the low number of patients studied. The third rejection happened by a very tight vote (16 to 15) and one absentee that tipped the balance against them. However, the safety of the treatment was never in question, the European Medicine Agency acknowledged that Glybera met all safety standards.
A spokesperson for uniQure tells The Lancet that the big problem was to answer the question: is it effective? “We said yes, but the Agency was not certain.” Part of the difficulty was establishing statistically significant efficacy with the low number of patients studied. “With 1000s of patients that are treated in clinical trials for large indications that is much more straightforward; but with 27, it becomes a very different equation. And regulators need to come to terms with that when faced with orphan drugs.” It seems “good will” came after the fourth application, with a request that uniQure keeps a record following up the wellbeing of their patients.

Autism Treatment Guide

Nov 13, 2012 by DAVE MIHALOVIC
Cures To Autism Do Exist

Far too many medical professionals swiftly encourage the route of standard (yet outdated) medications for autism and ignore the abundance of science and research that currently supports effective recovery protocols. Such protocols do lead to cures for many children with autistic spectrum disorders (ASDs) and as healers, we must embrace them at all levels if we're to ever unleash reliable methods of treatment to the over one million children with autism.

For the entire article please visit:

The first perception we must eliminate from our discourse on this subject is that vaccines are the primary cause of autism. There are few advocates more against vaccinations than myself. I have asserted repetitively over the years that when it comes to vaccines, don't sit on the fence and that most of the evidence now suggests that the healthiest children in the future will be unvaccinated

However, after years of researching studies and filtering through piles of scientific data, it has been impossible to conclusively link vaccines as the primary cause of autism. That doesn't mean vaccines are not a contributor or that there is no correlation with the incidence of children with ASDs, because there is. What it means is that there is no basis for causation without considering the multitudes of other factors involved, such as the abundance of toxins and pollutants in our foods, environment and the obvious genetic predisposition which can no longer be denied. If vaccines were scientifically defined as primary causation for ASDs, then every child vaccinated would be diagnosed with some form of autism. This simply is not the case.

Once we have relieved ourselves of the confusion on that very controversial issue, we can then remove the guilt and anger associated with what we term vaccine-injured children and focus on recovery and treatment protocols that actually work. 

Making Strides To Help Children With Autism 

According to the Journal of the American Association of Pediatrics, mothers of autistic children maintain remarkable strengths in creating parent-child relationships and social support. I've known many parents who have austistic children and always reflect on the same thought, "they picked the right parents." The strength of these parents and the determination in their character to rid the disease is really something quite incredible. Look at the video above if you doubt that.

For an overwhelmed parent looking for answers, the amount of scientific and medical information about autism is staggering. In fact, if you Google “autism”, you’ll get over 76 million links to weed through! Thanks to the efforts of many talented and dedicated scientists, critical discoveries have been made that help understand the decline into and recovery from autism. This information is being used to recover autistics of all ages.

Autism is a complex biological disorder involving simultaneous and interrelated dysfunction of the detoxification, immune, digestive and neurological systems.

Gluten-Free, Casein Free Diets 

While dietary strategies may not appear to be doing much in the short-term, the long-term benefits can be outstanding. Many parents have claimed a high degree of success from dietary strategies to reduce the symptoms of ASD. According to researchers from Penn State a gluten-free, casein-free diet may lead to improvements in behavior and physiological symptoms in children diagnosed with ASD.

"Research has shown that children with ASD commonly have GI [gastrointestinal] symptoms," said Christine Pennesi, medical student at Penn State College of Medicine. "Notably, a greater proportion of our study population reported GI and allergy symptoms than what is seen in the general pediatric population. Some experts have suggested that gluten- and casein-derived peptides cause an immune response in children with ASD, and others have proposed that the peptides could trigger GI symptoms and behavioral problems."

"Gluten and casein seem to be the most immunoreactive," Klein said. "A child's skin and blood tests for gluten and casein allergies can be negative, but the child still can have a localized immune response in the gut that can lead to behavioral and psychological symptoms. When you add that in with autism you can get an exacerbation of effects."

"If parents are going to try a gluten-free, casein-free diet with their children, they really need to stick to it in order to receive the possible benefits," she said.

Detoxification and Immune Systems

In the body of an autistic individual, portions of the detoxification system, as well as specific metabolic processes become dysfunctional, leading to a diminished ability to completely break down certain foods. When analyzed by sophisticated scientific instruments, a portion of these partially digested substances are shown to resemble morphine (yes, morphine). These neurotoxins (opioid substances) leak out of the digestive tract, into the blood stream and attack the brain/nervous system, producing the symptoms and complications associated with autism. Diminished levels of critical substances such as glutathione (resulting in oxidative stress) keep this process in place.
Recovery of autism requires:
- Stop the production of neurotoxins (opioid substances)
- Reduce or eliminate oxidative stress
- Heal the nervous system
In October of 2001, a team of clinicians and researchers led by William Walsh, Ph.D. then at the Pheiffer Treatment Center, affiliated with the Health Research Institute now of Warrenville, IL, made available a scientific study entitled “Metallothionein and Autism”. Metallothionein is a protein that is critical to the process of detoxification of harmful substances, particularly heavy metals and toxic chemicals.
The paper describes a study of 503 patients on the autism spectrum vs. aged-matched non-autistic patients. The conclusion of this study was that “most autistic patients exhibit evidence of metallothionein (MT) dysfunction and this dysfunction may be a universal characteristic of autism-spectrum disorders”.
Translation: the detox systems of autistics are impaired.
Walsh also concluded that “MT dysfunction and autism may result from the intersection of two factors: (a) a genetic defect involving marginal or defective MT functioning, followed by (b) an environmental insult during early development which disables MT.”
According to Walsh’s paper, once MT becomes compromised, a host of other dysfunctions occur, including:
-Detoxification of mercury and other toxic metals
-Development and functioning of the immune system
-Development and paring of brain neurons
-Regulation of zinc and copper levels in blood
-Prevention of yeast overgrowth in the intestines
-Production of enzymes that break down casein and gluten
-Response to intestinal inflammation
-Production of stomach acid
-Taste and texture discrimination of tongue epithelia
-Hippocampus function and behavior control
-Development of emotional memory
Walsh’s paper continues: “Examples of biochemical factors which can disable MT proteins include (a) severe zinc depletion, (b) abnormalities in the glutathione redox system, (c) cysteine deficiency, and (d) malfunction of metal regulating elements (MRE’s).”

Glutathione is frequently mentioned in biomedical discussions of autism due to its critical role in the detoxification pathway. Glutathione is produced by a metabolic process known as the methionine cycle. Important work has been performed describing the most vulnerable parts of the methionine cycle. This cycle starts with methionine and is supposed to end with glutathione. However, because this metabolic process has been disrupted in autistics, little or no glutathione is produced. Indeed, oxidative stress, or low levels of glutathione have been described as a hallmark traits of autism. 

Because glutathione is so critical in the detoxification pathway, diminished levels begin to interfere with a variety of other metabolic processes as initially described by Dr. Walsh and borne out via subsequent research. These include the dysfunction of the methylation and sulfation processes. Following is an excerpt from “Autism is Curable. How a Generation Was Poisoned And How To Correct It” by Dr. Stuart H Freedenfeld describing these processes.
“Methylation is an extremely important process that is essential to our health. It activates brain-signaling molecules and inactivates DNA and RNA (it is how liver cells learn to be different from muscle cells and how we inactivate viruses). Impairment of the methylation mechanism impairs another process called sulfation. Sulfation is necessary to produce many substances including the protective coating of the digestive tract and the connective tissues of the body. It is also the source of the most important detoxifying substance in our body, glutathione. This substance is so important that if its level falls below a certain amount in any cell, that cell will self-destruct. Glutathione is also the essential mechanism to remove toxic metals from inside the cells.
For the entire article please visit:

Official: GI Conditions in Children With Autism.


Gastrointestinal Conditions in Children With Autism Spectrum Disorder: Developing a Research Agenda

  1. Nancy E. Jones, PhDi
+Author Affiliations
  1. aDevelopmental/Behavioral Pediatrics, Nationwide Children’s Hospital, Columbus, Ohio;
  2. bDepartment of Medical Microbiology and Immunology, University of California, Davis, Davis, California;
  3. cPediatrics, University of Maryland, School of Medicine, Baltimore, Maryland;
  4. dPediatrics/Pediatric Gastroenterology, University of Arkansas for Medical Sciences, Little Rock, Arkansas;
  5. eMedical Dietetics, Abbott Laboratories, Columbus, Ohio;
  6. fPediatrics, Cincinnati Children’s Hospital, Cincinnati, Ohio;
  7. gAnatomy and Neurobiology, University of Vermont, Burlington, Vermont;
  8. hCalifornia Institute of Technology, Pasadena, California; and
  9. iClinical Programs, Autism Speaks, Los Angeles, California
  1. Drs Ashwood, Fasano, Fuchs, Geraghty, Kaul, Mawe, and Patterson contributed equally to this work.
Key Words:
  • Abbreviations:
    ASD —
    autism spectrum disorder
    GI —
    5-HT —
  • Autism spectrum disorders (ASDs) are a set of complex neurodevelopmental disorders defined behaviorally by impaired social interaction, delayed and disordered language, repetitive or stereotypic behavior, and a restricted range of interests. ASDs represent a significant public health issue with recent estimates indicating that as many as 1% of children in the United States are diagnosed with an ASD.1,2 Many individuals with ASDs have symptoms of associated medical conditions, including seizures, sleep problems, metabolic conditions, and gastrointestinal (GI) disorders, which have significant health, developmental, social, and educational impacts. Gastrointestinal complaints are a commonly reported concern for parents and may be related to problem behaviors and other medical issues such as dysregulated sleep (ATN Annual Registry Report, unpublished data, November 2009).3 Despite the magnitude of these issues, potential GI problems are not routinely considered in ASD evaluations. This likely reflects several factors, including variability in reported rates of GI disorders, controversies regarding the relationship between GI symptoms and the putative causes of autism, the limited verbal capacity of many ASD patients, and the lack of recognition by clinicians that certain behavioral manifestations in children with ASDs are indicators of GI problems (eg, pain, discomfort, or nausea).410
    Whether GI issues in this population are directly related to the pathophysiology of autism, or are strictly a comorbid condition of ASD remains to be determined, but clinical practice and research to date indicate the important role of GI conditions in ASDs and their impact on children as well as their parents and clinicians.9
    On November 15, 2009, a symposium addressing these issues was organized as an adjunct to the annual meeting of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. A panel of international experts presented the latest scientific information on pathophysiology, evaluation, and treatment strategies for GI conditions in children and adolescents with ASDs. One aim of the meeting was to raise awareness among gastroenterologists and GI researchers of GI disorders in the ASD population and to provide clinicians with information to improve their clinical practice for these children. The symposium addressed 4 major areas of concern for children with ASDs: reflux, constipation, diarrhea, and nutrition. Each session reviewed the state of the evidence, the latest findings on issues such as intestinal permeability, inflammatory processes, innervation, motility, nutrition, and the epidemiology, presentation, and clinical management of GI issues.
    The symposium also set the context for a follow-up workshop on November 16 that focused on identifying and prioritizing the key research topics for further investigation. The 1-day workshop brought together a group of symposium participants and speakers with a broad range of expertise in GI and autism clinical practice, and clinical as well as basic science research.
    This report provides an overview of findings in GI and ASDs as presented in the symposium and highlights the key conclusions from the workshop. Specifically, the group identified the following 4 topics as priority areas for further study: epidemiology of GI conditions in ASDs, underlying pathology (gut-brain connection, immune function, animal models and genome-microbiome interaction), treatment and outcome, and nutrition. A recent consensus report on GI conditions in ASDs published in Pediatrics in 20109put forth 23 recommendations for the evaluation and management of GI conditions in ASDs. Although ASDs are behaviorally defined disorders, current thinking suggests multiple “autisms” with varying biological underpinnings. Some of these may eventually be identified as having associated GI symptoms, as has been seen with the MET gene. Pending new evidence on any such relationships, the recommendations in this current article expand upon several of the key recommendations made in the consensus statement highlighting areas in need of new knowledge.
    For full study report please visit:

    Friday, November 09, 2012

    Vaccine Antibody Theory Is False

    New Failed Vax Study Proves Vaccine Antibody Theory Is False


    Vaccination theory is false, never proven but not questioned. A failed new vaccine against MRSA, V710, demonstrates this fact clearly. Increasing antibody titers, the standard measure of a vaccine’s efficacy, is not the same as natural immunity.
    Death in an Eye
    Photo by Doug Wheller
    A study has clearly documented that the basic theory behind vaccinations—that immunity is provided by the development of antibodies—is wrong. Sadly, it was dead wrong, as people died for the presumption.
    The vaccine, V710, is for a disease that was caused by modern medicine: MRSA, methicillin-resistant Staphylococcus aureus, also referred to as the flesh-eating bacteria disease. So, they tried to create a vaccine to fix a problem that the system itself created.
    The V710 vaccine was expected to become a blockbuster, as it was intended for use before surgeries and on people entering hospitals to prevent MRSA. What a system: Create a disease and then try to find a treatment for the disease you’ve created and reap giant profits from it!
    The study’s failure, though, reveals something highly significant about the entire vaccine industry. It’s based on a theory that clearly does not stand up to inspection. If the development of antibodies were the key to “strengthening the immune system”, as is routinely declared by doctors and health agencies, then V710′s failure would not have been possible.
    By all accounts, the vaccine resulted in a “robust immunologic response”, which means that lots of antibodies were created. But when given to people in advance of cardiothoracic surgery, moreinfections happened, and more people died of multiple organ failure.

    The Study

    The study was funded by Merck. The lead researcher, Dr. Fowler, was the chair of Merck’s V710 Adivsory Committee. He also has received grants and research support from Merck, Cerexa, Pfizer, Novartis, Advanced Liquid Logics, and MedImmune, plus has been a paid consultant to Astellas, Cubist, Cerexa, Merck, Pfizer, NovaDigm, Novartis, The Medicines Company, Biosynexus, MedImmune, Galderman, and Inimex, and has received honoraria from Astellas, Cubist, Merck, Pfizer, Theravance, and Novartis.
    We probably shouldn’t be too surprised that Fowler has no idea why the results were so dismal in light of the good antibody responses, saying, according to Medscape:
    I can’t think of a biologically plausible reason for it.
    The study included 3,958 patients who were given the active V710 vaccine and 3,967 who received a saline placebo. 201 people (5.08%) given the vaccine died, compared to 177 (4.46%) who received the placebo. That was 13.9% more deaths in people who were vaccinated.
    NOTE: The results were translated into person-years, a construct that strikes me as meaningless in this context. The issue is how many people undergoing a single instance of specific types of surgery succumbed, not how it looks in terms of person-years.
    Of the vaccinated patients, 22 got MRSA and 7 of those died. Of the unvaccinated control group, 27 got MRSA and 2 of them died.
    Vance Fowler Jr., MD, MPH, study leader and professor of medicine at Duke University, stated:
    V710 was not efficacious in preventing S. aureus bacteremia and/or deep sternal wound infection, despite eliciting a robust antibody response. Overall mortality rates were not significantly different for vaccine and placebo recipients.
    13.9% more people who got the V710 vaccine died. That was 24 more deaths. Considering the size of the market that was being addressed, had the vaccine made it to market, that would have rapidly translated into thousands of extra deaths directly caused by the vaccine. Overall mortality rates weren’t significant?
    Reported here are the MRSA rates only, but Medscape also reports that those who got the V710 vaccine and developed S. aureus were 5 times more likely to die than those in the placebo group.

    Implications on Vaccine Theory

    What we need to take home from all of this is that the basic theory behind vaccinations isn’t based on reality. It’s based on assumptions. It assumes that triggering the immune system unnaturally to create antibodies is equivalent to developing them from a natural disease process. The fact is that it’s not. It’s a method of circumventing nature, not duplicating it.
    Titers Are Not Immunity
    The reality is that no consideration has been given to what happens to the immune system as a whole after vaccination. The only thing of interest has been getting the titers up as high as possible, that is, making the concentration of antibodies as high as they can. That’s used as the definition of a vaccine’s success. It’s used in spite of the fact that titers resulting from vaccines are often far higher than titers that result from natural infections. Yet, natural immunity is usually 100% and lifelong, while vaccine-induced immunity is virtually never anywhere close to 100%, nor does it last more than a few years.
    There’s obviously a lot more involved in disease immunity than how high the titers can be driven. But you’d never know that. The only thing that’s considered is whether an arbitrary titer is reached, not the overall effect of a vaccine.
    Antibodies Are Just Part of the Immune System
    In the rush to vaccinate, no one considers the effects on the body as a whole, or even on the rest of the immune system. Resistance to disease is far more than antibodies.
    The immune system is divided into two parts: humoral and cell-mediated. The humoral immune system is the one that vaccines address. It produces antibodies to infectious agents. When overactivated, it can also create antibodies to the self, resulting in autoimmune disorders, such as rheumatoid arthritis and lupus erythematosus. As is clearly shown by the V710 fiasco, vaccines are not able to duplicate what the body does naturally in fighting an infectious agent—and no one knows exactly what’s wrong or has the slightest idea of how to duplicate nature.
    The cell-mediated part of the immune system is managed by T-lymphocytes, the T-cells that HIV patients focus on. The T-cells mediate, that is, they manage and control macrophages, natural killer (NK) cells, and antigen-specific cytotoxic lymphocytes and cytokines in response to antigens. The cell-mediated portion of the immune system is the part that you cannot do without. This is the standing part that’s ready to respond to virtually any sort of infectious attack or cancer. Yet, vaccine makers pay little attention to it when addressing infectious diseases.
    In once respect, it’s probably a good thing that cell-mediated immunity is ignored. At least, there’s little attempt to manipulate it, although—Alas! it’s becoming the focus of some of the newer vaccines that aim at targets other than infectious diseases. However, no consideration is given to whether vaccinations may be harming it, just as virtually all harms done by vaccines are handled by pretending they don’t exist.
    The fact is that measuring titers is clearly not an adequate way to determine immune system health or strength. The claim that vaccines “strengthen the immune system” is just that—a claim. It has no basis in fact. There is no reason to believe, and every reason to disbelieve, that forcing the increase of titers is equivalent to immunity from disease. It’s equally clear that the injection of toxic materials along with antigens is a dangerous practice. We surely don’t need to prove that! Nonetheless, the vaccine industry and its minions are injecting heavy metals, deadly chemicals, and substances like squalene that are virtually guaranteed to cause system toxicity and autoimmune disorders.
    Perhaps one good thing can come of the failed V710 MRSA vaccine. Perhaps sane heads will pop up and say:
    Stop this madness. 
    Let’s look at what we’re doing. 
    Let’s ask why more than half our children are systemically sick and will never enjoy good health.
    Surely a bit of temporary easing of risk against infectious disease is not worth the results that we can see all around us!
    Surely we can stop this madness.