You Can Help Bring Major Reform to Vaccine Safety Research

IF YOU HAVE been paying attention to the vaccine safety research controversies, you will know the following names:

Dr. Brian Hooker

Dr. William Thompson

Dr. Frank DeStefano

You may even know the names Dr. Coleen Boyle, and Dr. Julie Gerberding – and you will know the role that Senator Bill Posey (R, FL) has played.

You will know what Skyhorse Publishing is, and why the books they publish are vital to the very foundation of science in America.

If you don’t know anything about these issues – about how Bill Thompson disclosed research fraud at the CDC, involving key studies that the CDC still cites as evidence of no link between autism and vaccine – and about how these revelations have been confirmed by independent scrutiny of the publications involved – and about how former CDC Director Julie Gerberding left the CDC to work for Merck after overseeing the CDC during the period of time when the fraudulent research was alleged to have occurred, browse around my blog a while, or read the Chapter on Vaccines in Cures vs. Profits, or better yet get Kevin Barry’s book.

If you DO know about these issues, then you may not know what you can do to help bring about true reform in vaccine safety research.

Skyhorse Publishing has donated 40 copies each of “Thimerosal: Let the Science Speak” and “Vaccine Whistleblower: Exposing Autism Research Fraud at the CDC”  to the Institute for Pure and Applied Knowledge (IPAK, ipaknowledge.org). IPAK is sending one copy of each book, along with a Statement of Concern, to the Editors or Editors-in-Chief of 40 peer-reviewed journals in which those involved in the shady vaccine safety research practices have published.  We have the books, and the Statements of Concern printed, and ready to go. Here’s the countdown:

UPDATE!

17 of 40 packages sent as of December 4, 2015.

IPAK is a registered 501(c)3 pure public charity. No one working in IPAK is allowed to have any financial interest in the research we conduct. Your donation will allow IPAK to send the next package.  This is an extremely important event in the history of vaccine research, and you can help turn the tide.  Our efforts do not stop at sending letters and packages. IPAK seeks to reform vaccine research to bring about objective, transparent, and, most importantly, peer-accountable practices for vaccine safety & efficacy studies. One of the most disturbing revelations by Bill Thompson was that the research teams at the CDC would change the study design, and the approach to analysis, without oversight by an Institutional Review Board (IRB) until they found a way to make associations between vaccination and autism appear to be non-significant. When they could not dissolve the associations they found via over-analysis, they simply left results out.

HOW YOU CAN SEND AN IPAK “CARE” PACKAGE TO AN EDITOR TODAY.

Visit ipaknowledge.org and donate for this special IPAK Issue Focus Fundraiser. Your donation is tax-deductible. Then also please accept my invitation to consider joining The Society for Pure and Applied Knowledge.  There is much work to do. Let’s go!

James Lyons-Weiler, PhD

Allison Park, PA

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Dr. Paul Offit: The Bible is Irrelevant Today

AFTER WORKING ON THE VACCINE BOARD to get rotavirus vaccine approved, Dr. Paul Offit sold his patent on a rotavirus vaccine for millions. Now, after ignoring nearly fifty years of research pointing to toxicity, and specifically, neurotoxicity of aluminum (an adjuvant used in most vaccines), Dr. Paul Offit has now enraged the faithful.  vaccquote

Before we look at this statement in detail, I must confess that as an evolutionary biologist, I have always let the Constitution be my guide for religious rights. I would die for my country if anyone tried to take away the faithful’s right to express their beliefs. I am a scientist, and also a parent.

Paul Offit and Dr. Pan have decided that it’s a good idea to try to take away parent’s rights and try to make the issue one of ‘children’s rights’.  Unfortunately for them, they do not know the power of the parental instinct to protect one’s children.

Children have a right to have parental protection from the state.

Here is his Offit’s statement:

“Hi. My name is Paul Offit. I am talking to you from the Vaccine Education Center at The Children’s Hospital of Philadelphia. Today I want to talk about an article that recently came out in the journal Pediatrics, titled ‘Frequency of Alternative Immunization Schedule Use in a Metropolitan Area,’ by Steve Robison and colleagues in Portland, Oregon.[1] These authors looked at the choice by parents to separate, delay, withhold, or space out vaccinations in the Portland metropolitan area from 2003-2009. They found a 4-fold increase, from about 2.5% to 10% of parents, who made this choice during those years. The parents were making this choice because they could. With this article as background, I thought we would talk about vaccine exemptions.

There are 3 ways to exempt yourself from vaccines. The first way is a medical exemption. For example, a person may have a contraindication to getting a vaccine. Some people are allergic to gelatin. Gelatin is used as a stabilizer in the chickenpox vaccine and in the nasal spray influenza vaccine. That would be a reasonable reason not to get a vaccine.

If Dr Offit would take time to actually read the literature on aluminum neurotoxicity, as assigned to him, he would realize that medical exemptions may apply to all people. There is a medical basis for concern over acute,  dose-dependent aluminum neurotoxity. Low-dose, chronic exposure also causes neurotoxicity. In fact, parents, here is your medical exemption:

“Numerous studies in the biomedical literature has shown that aluminum is a serious neurotoxicant, and I am concerned that the increase in the number of vaccines over the years in the pediatric schedule have made the total dose of aluminum for my child unsafe. There are times in the schedule where the dose exceeds the FDA’s limit. I refuse to accept your recommendation of this vaccine for my child based on a medical exemption.“.

A second way people can exempt themselves from vaccines are the so-called philosophical or personal belief exemptions. Twenty states allow that kind of exemption. I would argue that these exemptions are misnamed. First of all, the notion that vaccines are a ‘philosophy’ is inaccurate. Philo means love, sophos means wisdom. Exactly where is the wisdom in saying that it is better not to get vaccines than to get them?

Well, Dr. Offit, since you asked, here are your two reading lists from last week. Please do try to do your homework before coming to class next time.

The term ‘personal belief’ is also incorrect in that vaccines are not a belief system. Religion is a belief system. Religion is a faithbased system. Science and medicine are evidence-based systems. They are data-based systems, not beliefs. If you want to feel better about vaccine use, I think one needs only to look at the roughly 20,000 studies that have evaluated the safety or efficacy of vaccines, or the hundreds of studies that have looked at what happens when you combine vaccines and give them at the same time to feel confident that, in fact, there are data to support that choice.

Here, he is misinformed and thereby misleading the public. There are not 20,000 studies that show vaccines are safe. Among those that have been conducted, the National Academy of Sciences Institute of Medicine rejected 17/22 as fatally flawed. There are current four major controversies involving fraud in vaccine safety research, including the revelation of fraud in hiding results showing association between vaccines and autism. And no, Dr. Offit, there not “hundreds” that have studied combination effects. In fact, one of the papers assigned to you has called for such research, and the research that has been done points to compounds that interact with unknown biological effects.

He is also playing fast and loose with words here. “Have evaluated” does not mean “Have concluded”, and “Looked at what happens” does not mean “no findings of toxic synergy”.

The third way one can exempt oneself from vaccines are so-called religious exemptions. Forty-eight states have them. I would argue this also does not make a lot of sense. The first vaccine was Edward Jenner’s vaccine in 1796. The New Testament was written around 100 AD, the Old Testament between 1400 and 400 BC, and the Qur’an around 600 AD. All those texts were written well before vaccines existed, so not surprisingly, they never mention or predict them. I also would argue that it does not make sense to say, ‘It is my religious belief that a child not get a vaccine,’ and therefore a child should be left with less protection under the law.

He is about to become an expert in Constitutional Law, which he is not:

The 14th Amendment of the Constitution, the so-called Equal Protection Clause, states that a child or anyone should be equally protected and implies that this is independent of a parent’s belief system. If the child is exposed to harm, that child should have equal protection. For example, if a Jehovah’s Witness parent says, ‘I do not want my child to get a lifesaving blood transfusion,’ the parent does not have the freedom of religion to practice that because of the 14th Amendment.

No, the 14th Amendment states that individuals are entitled to equal protection from the state. The courts that decided Equal Protection and took away Religious Exemptions are not the final word – the parents can always home school.  Further, vaccines against childhood diseases are not life-saving treatment.

What is interesting — and I do not think most people know this — is that the 2 states that do not have religious exemptions are Mississippi and West Virginia, states you would not necessarily pick. The reason these states do not have a religious exemption is because both states’ Supreme Courts said that it was a violation of the Equal Protection Clause of the 14th Amendment. I think we should call these exemptions what they really are. Let’s not sugarcoat this choice. We should call them the ‘I do not want to get vaccines because I have read a lot of scary things about vaccines and I am afraid that they might hurt my child, and I am not so sure I believe in pharmaceutical companies or the medical establishment or the government, so I do not want my child to get them’ vaccine exemption. That would be, I think, more honest. Thanks for your attention.’

Dr. Offit, your condescension to the parents of the United States will be your undoing. Many of these parents are better informed on the scientific literature than you know.  And they know their legal rights: Even laws that require mandatory vaccines do not supercede parental consent laws.

Here, Dr. Offit, is another reading assignment for you, from 51 authors on the Committee on Pediatric Emergency Medicine and Committee on Bioethics (2011):

“Under US law, minors are generally considered incompetent to provide legally binding consent regarding their health care; parents or legal guardians are empowered to make those decisions on their behalf, and those decisions are considered legally binding.”  

Take it up with your colleagues, Dr. Offit, and quit picking on the parents and children who expect you to “First, do not harm”.

Plain and simple, children have the right to have parental consent, Dr. Offit. This is a children’s right issue for protection from the State. History has proven that the state will neglect and abuse the individual in the name of “the greater good”. My research in the vast literature on the genetics of autism and on vaccine safety has led me to conclude that some people – a larger percentage than we are aware – are susceptible to injury from vaccines, and have mutations that make preservatives and adjuvants particularly unsafe for them. We should be spending time and money finding biomarkers of susceptibility, not arguing and shoving medical practices down people’s throats.

Reference

Committee on Pediatric Emergency Medicine and Committee on Bioethics (51 authors).  2011. Consent for emergency medical services for children and adolescents. Pediatrics. 128(2):427-33. doi: 10.1542/peds.2011-1166.

Dr. James Lyons-Weiler is author of “Ebola: An Evolving Story” and “Cures vs. Profits: Successes in Translational Research“, and “The Environmental and Genetic Causes of Autism“. He is also President, CEO and Chairman of the Board of the Institute for Pure and Applied Knowledge (IPAK).  IPAK is a pure public charity dedicated to providing impartial interpretation of research results without the influence of profit pressures. You can support IPAK with donations via the web. Your generous support will help Dr. Lyons-Weiler and his colleagues continue their efforts to keep the public, including Dr. Offit, informed.

Sing up for our mailing list to receive updates and news about Progressive Science:

Books and Publications by James Lyons-Weiler

Take Back Your TV – Help End Direct-to-Consumer Advertising in the United States

MOST AMERICANS do not know that there are only two countries in the world where direct-to-consumer (DTC) advertising is allowed. Those two countries are the United States, and New Zealand.

During research for my upcoming book, “Cures vs. Profits: Successes in Translational Research” (World Scientific), I ran into the issue of DTC in a rather big way. In writing the chapter on Vaccines, I discovered the CDC Whistleblower, the cover-up by the CDC, and unimaginably infuriating facts such as a National Academy of Science/Institute of Medicine Report that rejected 17/22 scientific studies showing no link between autism and vaccines as fundamentally flawed.

I’m a scientist, and scientists learn by observing things.

I observed the abject refusal of nearly every media outlet – from newspapers to television companies – to even touch the story of Dr. William Thompson’s confessions and revelations regarding scientific fraud on vaccine safety research (see Thompson’s letter via his lawyer’s site in which he confirms his claims..

I observed Rep. William Posey’s pitch for Congressional hearings on the matter of scientific fraud conducted at the CDC – and observed the entire legislative branch fall silent on the issue.

How could the media, and our elected officials, be so complacent so as to become complicit in the perpetuation of the myth of no evidence of links between autism and vaccines?

Let me introduce you to some of the players acting behind the scenes. they go by the names of Jefferson. And Franklin.  In fact, here is a photo of one of them (Courtesy Wikipedia).

hundo

DTC marketing is the #1 source of advertising revenue to these media outlets.

Astonishing Development

On November 17, 2015, history was made. The American Medical Association called for a ban on DTC marketing in the United States. 

I know, right?  Unbelievable.

I do not wish to debase the entire community of medical doctors: only a subset of them are corrupt.

But many of my colleagues and I fear that this amazing development won’t go anywhere substantial.

So I’m taking off my CEO hat, and my author hat, and putting on my American Citizen hat and I am asking you to act now to tell your Congressional Representatives that you’ve had enough of hearing about drugs on television.

We need to ban the practice, like the rest of world has, and make it illegal for Pharma to put ideas into consumer’s heads. They use this access to manufacture demand, to make less optimal treatments seem more appealing. They misinform the public and often do not meet the legal requirements of disclosures and limits on claims.

Money from Pharma Corrupts and Silences Politicians

Think about it. A senior investigator at the CDC came out and reported that he, and colleagues, conducted scientific fraud as a matter of routine. Worse, that fraud has led to an expansion of the vaccine schedule in term of numbers of vaccines, and in time: 0-2 year olds are now routinely vaccinated. There is much, much more to this (see CDC Whistleblower, published by Skyhorse).

And yet no one except Posey is willing to take a stand and demand hearings.

This is outrageous.

Please sign this petition, and share this post on Facebook and Twitter.

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New Book Released 2016 – Cures vs. Profits: Successes in Translational Research (World Scientific (323 pages). To help support the publicity campaign, click on the book cover, above!

Paging Dr. Offit! Your Aluminum Neurotoxicity Reading Assignments Are Ready

AS COLLEGE PROFESSORS, my colleagues and I have always enjoyed the enthusiastic students who are eager to learn more. Those who stand out in myREADING memory are those who have requested more reading material. I have taught basic introductory biology, genetics, bioinformatics, courses in high-dimensional genomic and proteomic data analysis, and courses in study design and research ethics – and I always loved the gleam in the eye of students who just want to know.

Paging Dr. Offit!

Dr. Paul Offit earned millions of dollars from the sale of his patent for the Rotavirus vaccine after he voted to have it included in the pediatric vaccine schedule. He also appears to not be familiar with the body of peer-reviewed literature that condemns aluminum as a serious neurotoxin with well-characterized mechanisms of neurological damage.

In his book, “Deadly Choices: How the Anti-Vaccine Movement Threatens Us All” (Basic Books, New York), Offit is irresponsibly and recklessly dismissive of aluminum as a serious threat to the health of nearly all people by falsely reporting that:

“aluminum has been found to be harmful in only two groups of people: severely premature infants who receive large quantities of aluminum in intravenous fluids, and people on chronic dialysis (for kidney failure) who receive large quantities of aluminum in antacids”.

People absorb around very little of the aluminum they eat, but they absorb 100% of the aluminum injected in to their blood stream. [GENEROUSLY OFFERED CORRECTION/DETAILS: From Vaccine Papers, Al absorption from food is about 0.3%, typically within a range of 0.1-1%]. Offit claims, without citation, that aluminum in very quickly cleared from the body. He cites “researchers” (without citations) who studied aluminum concentrations in “blood” before and after receipt of aluminum-containing vaccines, and reports “No difference”.

Offit’s book was published in 2011. Unfortunately, it is evident that Offit did not even bother to search of the Pubmed, a wonderful public scientific research literature database at the National Center for Biotechnology Information, the standard resource for researchers who desire to know the latest on research topics in medicine, biology, psychiatry, and many other disciplines. A search reveals over 200 studies or papers on aluminum neurotoxicity before 2011. At the time of this writing (Nov. 2015), there are 393 studies or papers on the neurotoxicity of aluminum.

Some of these studies include direct discussions on the risk of aluminum in adjuvants in vaccines and provide data that demonstrate how aluminum works as a neurotoxin. Others discuss ways to alleviate neurotoxicity of aluminum. Others describe aluminum as a well-known neurotoxin responsible as a causal agent for neurodegenerative diseases.

Surely Offit, an expert placed on the National Vaccine Advisory Committee, the body in HHS responsible for making decisions on changes to the pediatric vaccine schedule, would have bothered to check the literature prior to 2011 while writing his book? If he had, he would have found studies with some compelling titles. The abstracts, and the papers themselves, are damning evidence for the use of aluminum as a vaccine adjuvant.

Here are some titles of the studies available at the time of his book-writing that individuals who are serious about vaccine safety might be interested in. Dr. Offit, for your convenience, I have included the links directly to the Pubmed entry:

Long-term persistence of vaccine-derived aluminum hydroxide is associated with chronic cognitive dysfunction.” (2009)

Aluminum hydroxide injections lead to motor deficits and motor neuron degeneration.” (2009)

Aluminum-induced defective mitochondrial metabolism perturbs cytoskeletal dynamics in human astrocytoma cells.“(2009)

Role of metal ions in the abeta oligomerization in Alzheimer’s disease and in other neurological disorders.” (2008)

Aluminum adjuvant linked to Gulf War illness induces motor neuron death in mice.” (2007)

Neurological adverse events of immunization: experience with an aluminum adjuvanted meningococcal B outer membrane vesicle vaccine.” (2007)

Mechanisms of aluminum-induced neurodegeneration in animals: Implications for Alzheimer’s disease.” (2007)

Inflammation, neurodegenerative diseases, and environmental exposures.” (2004)

Chronic exposure to aluminum in drinking water increases inflammatory parameters selectively in the brain.” (2004)

Neurotoxic effects of aluminium among foundry workers and Alzheimer’s disease.” (2004)

Neurological adverse events associated with vaccination.” (2002)

“The potential role of aluminium in Alzheimer’s disease.” (2002)

Just in case Dr. Offit is still involved in vaccine research, development or policy, and since he makes statements that appear in news articles on vaccine safety, I have taken the time to create a second reading list of more recent articles as well that Dr. Offit can add to his first reading list. Medical doctors really should keep abreast of new developments in medical research to stay professionally accredited.

But first, I have a hypothesis to share, which is indicated by past studies of numerous types. It came to me during my research for my forthcoming book, “Genetic and Environmental Causes of Autism”.

Is Macrophagic myofasciitis (MMF) Vaccine-Related Adult-Onset Autism/ASD?
A study in 2001 – a full decade before Offit’s book – reported central nervous system ailments eerily similar to those found in autism in patients diagnosed with macrophagic myofasciitis, symptomatic demyelinating CNS disorder, hemisensory or sensorimotor symptoms, bilateral pyramidal signs, cerebellar signs, visual loss, cognitive and behavioural disorders, and bladder dysfunction, supratentorial white matter hyperintense signals and corpus callosum atrophy (Authier et al., 2001).

Clinical features of MMF as described by Rigolet et al., (2014) are also strongly reminiscent of autism, including marked cognitive deficits (not related to pain, fatigue, or depression) including dysexecutive syndrome and visual memory impairment, and some cognitive deficits can appear unusually severe. Cognitive dysfunction was found to be stable over time. They also report that “classical therapeutic approaches are usually unsatisfactory making patient care difficult”.

Autism also involves cognitive deficits, executive function issues, memory impairment, and can involve severe cognitive deficits that are recalcitrant to treatment.

Additional Findings Support the Hypothesis

Mice injected with aluminum adjuvant doses equivalent to those given to US military service personnel showed both neuroinflammation and cell loss in the spinal cord and motor cortex, with consequent memory deficits (Petrik et al., 2007).

The cause of MMF has since been identified aluminum hydroxide from vaccines lesions (Gherardi et al., 2001; Authier et al., 2006; Gherardi et al., 2012; Rigolet M et al., 2014). Patients with MMF have an unusually long reaction at the site of injection of aluminum-containing vaccines in their muscle, and biospies show infiltration of muscle tissue by macrophages.

Here is chilling description of the effect of aluminum when used as an adjuvant:

“…poorly biodegradable aluminum-coated particles injected into muscle are promptly phagocytosed in muscle and the draining lymph nodes, and can disseminate within phagocytic cells throughout the body and slowly accumulate in the brain” (Gherardi et al., 2015).

This is important: microglial cells are macrophages with dual roles in the brain: they perform routine surveillance and clean-up of cellular debris, viruses and bacteria. Upon infection, or serious brain damage, however, they become activated, change shape, and go on the attack. Microglial overactivation is a leading candidate for increased apoptosis and neurological damage associated with autism.

The neurotoxic effects of aluminum salts are also apparent: it increases levels of glial activation, inflammatory cytokines and amyloid precursor protein within the brain (Bondy, 2010). Amyloid precursor protein is one of the main culprits for Alzheimer’s disease.

The medical community and the public should revisit the issue of whether aluminum is a necessary adjuvant for vaccines. Evidently, for some vaccines that use virus-like particles as opposed to attenuated or live virus vaccines, no adjuvant is needed.

Reading List #2

Here is the rest of Dr. Offit’s reading list of studies and papers published after 2010:

Trace elements in scalp hair samples from patients with relapsing-remitting multiple sclerosis.” (2015)

Correlation of aluminum and manganese concentration in scalp hair samples of patients having neurological disorders.” (2015)

Aluminum-induced entropy in biological systems: implications for neurological disease.” (2014)

Are there negative CNS impacts of aluminum adjuvants used in vaccines and immunotherapy?” (2014)

A sudden onset of a pseudo-neurological syndrome after HPV-16/18 AS04-adjuvated vaccine: might it be an autoimmune/inflammatory syndrome induced by adjuvants (ASIA) presenting as a somatoform disorder?” (2014)

Elevated brain aluminium and early onset Alzheimer’s disease in an individual occupationally exposed to aluminium: a case report.” (2014)

Prolonged exposure to low levels of aluminum leads to changes associated with brain aging and neurodegeneration.” (2014)

Administration of aluminium to neonatal mice in vaccine-relevant amounts is associated with adverse long term neurological outcomes.” (2013)

Aluminum in the central nervous system (CNS): toxicity in humans and animals, vaccine adjuvants, and autoimmunity.” (2013)

Autoimmune/autoinflammatory syndrome induced by adjuvants (ASIA syndrome) in commercial sheep.” (2013)

How aluminum, an intracellular ROS generator promotes hepatic and neurological diseases: the metabolic tale.” (2013)

Aluminum toxicity and astrocyte dysfunction: a metabolic link to neurological disorders.” (2011)

Aluminum vaccine adjuvants: are they safe?” (2011)

Metal ions affecting the neurological system.” (2011)

To be clear, Dr. Offit’s book could not include the references from the second reading list, as his book was published in 2011. But in the page and a half he takes to uses to claim that aluminum is only a problem for people with kidney failure and premature infants is terribly misleading, and is now also woefully out of date. As he and his profit-driven colleagues saw fit to allow vaccinations in babies between the age of 1 day to 2 years, it is of little reassurance that he knew that aluminum was harmful to premature babies.

Perhaps Dr. Offit was also not aware that the WHO Vaccine Safety Advisory Committee had, long before 2011, reported that there may be a subset of predisposed individuals who may be sensitive to aluminum-containing adjuvant (Authier et al., 2001).

Published scientific knowledge does not appear to play a role in the formation of vaccination policy in the United States.

November 16, 2015 (updated 11:22 AM)

Dr. James Lyons-Weiler is author of “Ebola: An Evolving Story” and “Cures vs. Profits: Successes in Translational Research“. He is also President, CEO and Chairman of the Board of the Institute for Pure and Applied Knowledge (IPAK).  IPAK is a pure public charity dedicated to providing impartial interpretation of research results without the influence of profit pressures. You can support IPAK with donations via the web. Your generous support will help Dr. Lyons-Weiler and his colleagues continue their efforts to keep the public, including Dr. Offit, informed.

Sing up for our mailing list to receive updates and news about Progressive Science:

References

Authier FJ et al., 2001. Central nervous system disease in patients with macrophagic myofasciitis. Brain. 124(Pt 5):974-83.

Authier FJ, et al. 2006. AlOH3-adjuvanted vaccine-induced macrophagic myofasciitis in rats is influenced by the genetic background. Neuromuscul Disord 16(5):347–52.10.1016/j.nmd.2006.02.004

Bondy SC. 2010. The neurotoxicity of environmental aluminum is still an issue. Neurotoxicology. 31(5):575-81. doi: 10.1016/j.neuro.2010.05.009.

Gherardi RK, et al. 2001. Macrophagic myofasciitis lesions assess long-term persistence of vaccine-derived aluminium hydroxide in muscle. Brain 124(Pt 9):1821–31.10.1093/brain/124.9.1821

Gherardi RK et al., 2001. Macrophagic myofasciitis lesions assess long-term persistence of vaccine-derived aluminium hydroxide in muscle. Brain. 124(Pt 9):1821-31.

Gherardi R and Authier FJ. 2012. Macrophagic myofasciitis: characterization and pathophysiology. Lupus 21(2):184–9.10.1177/0961203311429557

Gherardi RK et al., 2015. Biopersistence and brain translocation of aluminum adjuvants of vaccines. Front Neurol. 2015 Feb 5;6:4. doi: 10.3389/fneur.2015.00004. eCollection 2015.

Petrik MS et al., 2007. Aluminum adjuvant linked to Gulf War illness induces motor neuron death in mice. Neuromolecular Med 9:83–100.

Rigolet M et al., 2014. Clinical features in patients with long-lasting macrophagic myofasciitis. Front Neurol. 5:230. doi: 10.3389/fneur.2014.00230. eCollection 2014.

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New Books Released 2016

Cures vs. Profits: Successes in Translational Research (World Scientific (323 pages).

The Environmental and Genetic Causes of Autism (Skyhorse Publishing)

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Books and Publications by James Lyons-Weiler

 

Research Without Profit Motive: Welcome IPAK

DURING MY RESEARCH for my forthcoming book, “Cures vs. Profits: Successes in Translational Research” (World Scientific), I met dozens of people whose passion for the truth in science vastly outweighed the drive for profit.  The topics included dark intrigue in the area of ADHD overdiagnosis. I included recent examples of clearly egregious criminal activities in the area of biomedicine (such as the doctor in Michigan who treated people who had no cancer with chemo, killing some), and in the area of biomedical research. I found bona fide successes in areas such as chemosensitivity assays, breast cancer hormone receptor based targeted treatments, and found absolutely wonderful news in the area of cancer immunotherapy. Of course, any book on translational successes in biomedicine must include vaccines, right?

I writing the chapter on vaccines (which was the last chapter I wrote), it felt half finished. I knew I had to address the Wakefield affair. Unaware of the ensuing controversy over the Thompson affair at the CDC, I blithely told the party-line story of how people who do not vaccinate their children place the very young, the elderly, and those with compromised immune systems at risk.

How naive I was.

After I dug further in the Thompson affair, read the full transcripts of his revelations to Dr. Brian Hooker, I secured and read the research studies from the CDC on vaccines conducted and published during the 1990’s.  What I found in the publications match the accusations of Thompson re: overcooked data analysis (Madsen et al.), omission of critical positive findings of association in African American males and in idiopathic autism (DeStefano et al., 2004). Some of the most damning evidence were copies of emails, secured by Brian Hooker after 10 years of resistance by the CDC (think about that…) due to pressure from US Sen. Bill Posey (R-Florida)… emails with titles such as “it just won’t go away” (meaning the association between vaccination and autism in the Madsen study). The CDC delayed publication of those results for four years, only to then leave out the original positive finding and (get your wonk hat on) only after using redundant covariates as ‘control variables’ (multicollinear variables should not all be used, it can cause spurious findings). They did not seek interaction terms between any of these factors and vaccination. The factors were birth weight, gestational age, income of the mother, and mother’s age.. .all potentially important factors that could make increase the toxicity of adjuvants such as ethyl mercury and aluminum.

The pattern of changing design and analysis protocols to fit the results of these vaccine safety studies to the pre-determined result of no association is outrageous, and every American should be pissed off that we were lied to, mislead, fed misinformation about the role of vaccines and diseases such as autism, ADHD, and others. They lied to us, then they lied about lying to us. If researchers funded by the NIH did this, not only would their papers be retracted from the journal in which they published, they would be fined and potentially jailed for misuse of federal funds to conduct research. A very big No-No.

These revelations are verified by Thompson in a statement from his lawyer, and then by DeStefano in interview with Sharyl Attkisson, in which DeStefano admitted that vaccines might cause autism in a minority of people.  Pay no attention to Snopes on this, they have not done their homework. In fact, the credibility of the CDC was on the table for me after researching for my first book, “Ebola: An Evolving Story“, through which I found the CDC refusing to test kits for detection of Ebola because they had their own under development; I witnessed lies about the existence of mutations in Ebola; I heard misleading information from the CDC on how similar the 2013-2015 virus was to the virus from Zaire in 1995. Why?

Digging deeper, I found that profit motives were rampant within the CDC. Such motives, I had already found, skew the results, the type of studies done, and the interpretation of scientific studies. Key scientists at the CDC are not immune to such pressures.

The epiphany I had during this time was that our society needs a research institute in which the profit motive played no role. I envisioned taking on research topics in the public’s interest, with no consideration on whether I could someday make money from my invested time and energy in research.

A “pure public charity” doing research in the public interest, independent of profit pressures.

A few months later, IPAK is a reality. The Institute for Pure and Applied Medicine conducts and promotes research that is based on bona fide best practices in science. The project areas are numerous, and include:

Vaccine Safety Research Reform – Given that adjuvants are not needed, what changes need to be made in vaccine development to insure that they are both safe & effective?

Veteran’s Mental Health – Do soldiers who are deployed to active duty and those with desk jobs really have the same rate of suicide? We will look into that claim.

Reversing ADHD Overdiagnosis –  One in five boys in Georgia are diagnosed with ADHD. How can this be, when the worldwide estimates are from 0.1% to 3%?  What approaches can be used in schools to insure that only children who actually need psychotropic drugs are given them by their government-employed school nurses?

Accuracy in Treatments – It is estimated that inaccuracy in treatments is a cause for over a billion dollars of wasted money on ineffective treatments in the US each year. For cancer patients, they don’t have time for their oncologists to figure out that their current favorite industry-standard chemotherapy does not work. Which chemotherapies will work can in principle be determined before the patient is even treated. IPAK therefore promotes, supports and conducts research aimed at improving the accuracy of the use of cancer treatments. (NO, we don’t do ‘Alternative Medicine’. If it’s useful, run clinical trial and make it ‘medicine’).

Compassionate Use Paperwork Simplification – End-of-life patients and their loved ones sometimes do not have time to sort through the red tape for requesting off-label compassionate use of drugs and the experimental use of new drugs to try to save their or their loved ones’ lives. IPAK will research ways to simplify the process, and will go so far as to file the paperwork on your behalf, acting as a patient advocate.

Colon Cancer Prevention – I once gave a plenary presentation to a large group of pharmaceutial executives and told them that they had it in their power to prevent colon cancer. We know everything we need to know to drastically reduce the rate of colon cancer. I told them that in 10 years time, 1/2 a million people will have died from colon cancer. Fifteen years later, there is still no product that has been developed and received FDA approval to prevent colon cancer in at-risk populations. IPAK is working to popularize the hypothesis that some newly approved FDA drugs may well have the capacity to reduce colon cancer.

Infectious Disease Rapid Assay Development – We need to be able to rapidly and accurately screen for Ebola and other diseases prior to symptoms. IPAK is working with other institutions to bring forward new ways of amplifying weak molecular signals and dampen noise to provide highly sensitive and specific point-of-care diagnostics.

FDA Clinical Trial “Gold Standard” Reform – There are numerous valid ways of defining a robust and generalizable prospective clinical trial. The long-standing randomized, placebo-controlled clinical trial has serious weaknesses – and the FDA does not even accept the result of the most power test available for that designs. We need to re-educated statisticians on the non-exclusivity of the randomized trial.

Please join us and help make IPAK make advances in these important areas. Our November membership drive is on, so visit http://ipaknowledge.org and navigate to the Donate page.  You will receive our quarterly newsletter and membership in the Society for Pure and Applied Knowledge and a thank-you for your donation.

Please be generous, and please invite your friends and colleagues to join IPAK as well.

James Lyons-Weiler, PhD

CEO, President & Chairman of the Board

Institute for Pure and Applied Knowledge

11/4/2015