Dear American Press: Enough with the Rhetoric. Tell the Full Autism/Vaccine Safety Research Story

PRESIDENTIAL HOPEFULS on the GOP ticket touched a bit of a third rail in the debates on Wednesday night.JLW1

The ANTI-VACCINE SAFETY PRESS (how do you like it?) ran into overdrive to perform damage control on their favorite, most-run story on vaccines and autism: that, again, for (sigh, when will people ever understand, I suffer so!) the BILLIONTH time, “Vaccines Do Not Cause Autism”. They are no doubt trying to save countless lives by teaching people that vaccines save lives.

In support of their positions, each story used well-worn tactics of argumentation. They cited “dozens” of studies that have been published.

Where is the Fourth Estate?

The Washington Post went back in time to 1998 to the Wakefield affair.

But The Post they did not go back to August, 2014 to the news that Dr. William Thompson confessed that the CDC fudged data on vaccine safety, nor did they mention Thompson’s statement via his lawyer’s website that verified that yes, they omitted results. And that he regretted doing harm to people.

The Post also cited the 2004 by the National Academy of Sciences/Institute of Medicine review that concluded that “the evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism.”

Oddly, they neglected to reference the updated (2012) National Academy of Science/IOM report that rejected 17/22 studies that had been touted as “evidence” that autism is not linked to vaccines.

The New York Times went so far as to tell the candidates (and the American public) that vaccines are “not up for debate”.

Excuse me?

Since when does a news organization, which is supposed to objectively report the news, determine the issues that are “open to debate”? They should go back to reporting, and not creating, the news.

The same article cited the outlandish (and irresponsible) statement by Dr. Paul Offit that vaccines are so safe that they could tolerate 100,000 shots at the same time. Really?

Is that rational debate? Each 100,000 shots of just about ANYTHING would likely kill any child. They are not even taking safety seriously. At all.

I take it seriously. Here is the text from the NAS/IOM 2012 report:

The committee reviewed 22 studies to evaluate the risk of autism after the administration of MMR vaccine. Twelve studies (Chen et al., 2004; Dales et al., 2001; Fombonne and Chakrabarti, 2001; Fombonne et al., 2006; Geier and Geier, 2004; Honda et al., 2005; Kaye et al., 2001; Makela et al., 2002; Mrozek-Budzyn and Kieltyka, 2008; Steffenburg et al., 2003; Takahashi et al., 2001, 2003) were not considered in the weight of epidemiologic evidence because they provided data from a passive surveillance system lacking an unvaccinated comparison population or an ecological comparison study lacking individual-level data. Five controlled studies (DeStefano et al., 2004; Richler et al., 2006; Schultz et al., 2008; Taylor et al., 2002; Uchiyama et al., 2007) had very serious methodological limitations that precluded their inclusion in this assessment. Taylor et al. (2002) inadequately described the data analysis used to compare autism compounded by serious bowel problems or regression (cases) with autism free of such problems (controls). DeStefano et al. (2004) and Uchiyama et al. (2007) did not provide sufficient data on whether autism onset or diagnosis preceded or followed MMR vaccination. The study by Richler et al. (2006) had the potential for recall bias since the age at autism onset was determined using parental interviews, and their data analysis appeared to ignore pair-matching of cases and controls, which could have biased their findings toward the null. Schultz et al. (2008) conducted an Internet-based case-control study and excluded many participants due to missing survey data, which increased the potential for selection and information bias. The five remaining controlled studies (Farrington et al., 2001; Madsen et al., 2002; Mrozek-Budzyn et al., 2010; Smeeth et al., 2004; Taylor et al., 1999) contributed to the weight of epidemiologic evidence and are described below.

What’s that? DeStefano et al., (2004) – one of the very studies that Thompson reported that he and colleagues had strong preliminary association results in co-morbid free autism cases, and in African American males – both results which were omitted from the study.

Yahoo! Health tapped an expert in Infectious disease, who claimed that sudden onset of autism is an “odd statement”:

“It’s an odd statement because the diagnosis of autism is made over months and years, not right after a child has a fever,” he says. “It’s a behavioral neurological disorder.”

That expert, Dr. Martin Hirsch, MD, professor of medicine at Harvard Medical School and a senior physician in the Infectious Disease Unit at Massachusetts General Hospital, might have done well also to read the 2012 IOM report:

Because the timing of diagnosis or recognition of autism coincides with
the administration of many vaccines, questions have been raised regarding potential etiologic relationship(s) between the two. There are several challenges in interpreting existing data. Establishing a temporal relationship
between a potential inciting event (such as vaccine administration) and
the onset of autism is difficult because dating the onset of the syndrome in most cases is imprecise (although there is a subset of children with acute regression from reportedly normal development). Rechallenge data are not available, since most children do not rapidly (if ever) recover a normal developmental pattern following the onset of their symptoms.

Perhaps Dr. Hirsch should have consulted case reports, such as that of Hannah Poling, who, after receiving vaccinations on July 19, 2000, regressed within a few days into classic and severe infantile autism (Oller and Oller, 2010). Hanah’s case is consider ‘typical’ of regressive autism.

Regressive autism used to be rarer than natal autism; however, these news outlets failed to report that over the time period that the vaccine schedule was expanded, the percentage of total cases of autism that were of the regressive form increased:

“By 1985 the incidence of regressive autism had equalled that from birth. By 1997 both types had increased although the regressive form was now >75% of the total occurrence. This suggests that an acquired condition was overtaking birth defects or purely genetic conditions.” (Ewing, 2009).

News outlets need to stop playing bait-and-switch on the issue of vaccine safety and do their job. When someone brings up questions about the validity of vaccine safety research, they go right to efficacy. Those questioning safety are chastised and minimized. Check out the post’s “news” article – (they puts quotes around the word ‘debate’, so I put quotes around ‘news’):

The GOP’s dangerous ‘debate’ on vaccines and autism.

It is abjectly ridiculous to think that Americans should not discuss or learn about vaccine safety. Or the lack thereof. And it is intolerable for the American Press to ignore one of the largest stories in the history of medicine in the US, and perhaps in the history of the world.

Yahoo! Health’s focus is on the “horror” of doctors. Take the excerpt:

““These politicians are making everybody anxious about an issue and then potentially harming the general population,” Lawrence Michael Dell, MD, primary care specialist at Internal Medicine & Primary Care Specialists in West Bloomfield, Mich., tells Yahoo Health. “If the average American doesn’t look into the efficacy of vaccines, they may say ‘I’m not going to vaccinate my child’ based on these comments.”

No, Dr. Dell, we were not discussing efficacy. That’s not the discussion the we were having. Let’s try this re-focus back on safety:

“When the average American looks into the sorry state of vaccine safety research, they may say ‘I’m not going to vaccinate my child’ based on the reports that the research was reported to be fraudulent by a senior scientist at the CDC.”

Now there’s a focused discussion point.

Concerns over safety cannot be effectively addressed by brow-beating the American public with efficacy.

It is highly irrational for anyone to change the topic from safety to efficacy. Imagine someone who was exceptionally good at walking a tight-rope who became so enamored with their high skill level who decided that they no longer needed a safety net. Is that a reasonable thing to do? They can be good at walking a tight-rope, AND have a safety net. Just in case.

Or imagine car seats that were observed, by some percentage of parents, to give children permanent brain damage. There would be an uproar. To counter with “But car seats save lives!” would convince very few people that the design flaw in the car seats should not be fixed.

We are told that if we only understood the utility function properly that the adverse events associated with pediatric vaccines, then we would see that the suffering of the small percentage of kids who might undergo serious, debilitating reactions are worth it. Really?

What percentage of children should the American people tolerate receiving permanent brain injuries due to car seat manufacturing flaws?

“But car seats save lives!  So don’t talk about their safety, it’s not up for debate.”

Yes, ok. That’s not going to happen.

Vaccines, like car seats, are manufactured. They are man-made. The risks that we are asked to endure for our children in terms of adverse events may be rare, but they are not trivial. Because they are man-made, they can be changed. Improved. Updated. Made more safe.

Or, at least we should look into why some people have adverse reactions, and some do not. In any other medical research setting, the public would be hearing about, with fanfare heralding a new era of medical science:

Individualized medicine. Biomarkers. Big Data.

As the pharmamedia projects to the public the perspective that there is no need to concern ourselves with the safety of vaccines, we’re left with the sense that no vaccine safety research need ever be conducted again. After all, vaccines save lives, right?

The discussion is not on whether vaccines save lives. We all know that they do. The discussion is whether they harm people, and whether the research conducted to date is reliable, and whether the CDC committed scientific misconduct, fraud, and whether they continue to mislead the American public on the accuracy of Dr. Thompson’s revelations of same?

I would not be involved in this ‘debate’ were it not for the egregious handling of public education by the CDC on Ebola. When Direct Tom Frieden testified there were no mutations in the virus to the House Select Committee hearings, I was so moved by the attendant risks of that level of ignorance, or misinformation, about a disease so deadly, that I wrote a book to help set the record straight. Medical practitioners, including nurses, need accurate information to know how to care for Ebola patients. They also need to know the reality of the risks they ask their patients to endure when they vaccinate them.

The CDC markedly and repeatedly assured us that we are all going to be OK, even with an outbreak of a disease as deadly as Ebola in the US, due to our advanced medical infrastructure (that claim, by the way, is almost certainly false. Ten cases in one city would exhaust the resources available for handling the infectious liquid waste). And yet we told that anyone questioning vaccine safety is risking, it would seem, the entire population of the US with certain death – just by holding discussions on what we really, truly know about whether vaccines are safe?

I would also not be involved in this topic were it not for Dr. William Thompson’s confessions. He did not merely allege that OTHERS at the CDC fudged and omitted data in numerous studies; he stepped forward to say that he himself participated in these activities. The man was risking, for all he knew, jail time and fines for defrauding the American government of research funds.

So, by all means, let’s sweep the New York Times aside, and let’s continue the debate.

In the Yahoo! Health article,  Dr. Danelle Fisher, MD, vice chair of pediatrics at Providence Saint John’s Health Center in Santa Monica, Calif., says there is a “huge amount of medical evidence” that supports the safety of the vaccine schedule, published by the Advisory Committee on Immunization Practices in conjunction with the American Academy of Pediatrics and the Centers for Disease Control and Prevention.

And then, she follows with the chronic non-sequitur statement:

“The vaccine schedule is there for a reason.”

Really. Vaccines exist for a reason. Well thank you, Dr. Obvious!

The American Press also does not report on financial conflicts of interest among members of the Advisory Committee on Immunization Practices.  Well, CBS News did run an article on this issue. Back in 2008. Fourteen Studies did an excellent job reporting on these organizations:

  1. The American Academy of Pediatrics The American Academy of Pediatrics, a private, non-profit organization, is perhaps one of the few organizations powerful enough to put and end to the autism epidemic. Ostensibly, their focus should be the health of American children. Instead, the interests of the vaccine program and pharmaceutical companies always seems to come first. Here’s a great article from CBS Evening News: How Independent Are Vaccine Defenders?Among the many sins the AAP has committed:
    • Of the 19 actual studies we critique on this website, 50% were published in Pediatrics, the trade journal of the AAP.
    • The AAP has actively lobbied in states to keep mercury in children’s vaccines and against state bans
    • The AAP has yet to acknowledge there is an actual rise in the number of cases of children with autism and instead continues to imply that rising autism levels may solely be due to “better diagnosis”
    • The AAP does not acknowledge, nor have they been known to pursue, any of the hundreds of reported cases of recovery from autism through biomedical intervention
  2. The Advisory Committee on Immunization Practices (ACIP)
    Centers for Disease Control According to the CDC’s website, “the ACIP consists of 15 ‘experts‘ in fields associated with immunization who have been selected by the Secretary of the U. S. Department of Health and Human Services to provide advice and guidance to the Secretary, the Assistant Secretary for Health, and the Centers for Disease Control and Prevention (CDC) on the most effective means to prevent vaccine-preventable diseases.”The ACIP is responsible for expanding the number of required vaccines for children from 10 in 1983 to 36 in 2007 (see a comparison here), without ever ensuring that the schedule was tested in combination or that appropriate monitoring took place for delayed onset conditions.The ACIP was the topic of a document titled Conflicts of Interest in Vaccine Policy Making written by the U.S. Congressional Subcommittee on Government Reform which highlighted the conflicts of interest present between ACIP members and pharmaceutical companies manufacturing vaccines.
  3. Paul Offit, M.D.
    Chief of the Division of Infectious Diseases, Children’s Hospital of Philadelphia Mr. Offit appears to be the pharmaceutical industry’s go to Doctor to speak to the press about the safety of the current vaccine program. He is also the patent holder for the new rotavirus vaccine, recently added to the Immunization Schedule, and a past member of the ACIP (See #1). Among his many outrageous statements, Mr. Offit wrote in the journal of Pediatrics that a child’s immune system could handle 10,000 vaccines:“A more practical way to determine the diversity of the immune response would be to estimate the number of vaccines to which a child could respond at one time…then each infant would have the theoretical capacity to respond to about 10,000 vaccines at any one time.”Regarding Thimerosal in vaccines:“In some instances I think full disclosure can be harmful. Is it safe to say there is zero risk with thimerosal, when it is remotely possible that one child would get sick? Well, since we say that mercury is a neurotoxin, we have to do everything we can to get rid of it. But I would argue that removing thimerosal didn’t make vaccines safer — it only made them perceptibly safer.”On potential conflicts of interest as a vaccine patent-holder:“I am a co-holder of a patent for a (rotavirus) vaccine. If this vaccine were to become a routinely recommended vaccine, I would make money off of that. When I review safety data, am I biased? That answer is really easy: absolutely not.”Speaking to a journalist:

    “You did more harm than good in sort of quote/unquote allowing the parent to be fully informed [regarding the presence of mercury in vaccines]. There’s no politically correct way to say this, but being fully informed is not always the best thing. You can take that out of context and make me look like a jerk, but you know what I’m saying.”‘

It’s not out of context to report a conflict of interest. And the existence of a conflict of interest are not excused by one’s claim that they are not influenced by profit motives. And the American Press stays eerily silent on this side of the issue.

Why do 2015 press articles cite a 2002 IOM review, but not the more recent, updated 2012 review? If these publications include any rejected by the IOM in 2012, then we have not only selective reporting by the Press, but selective citation of the scientific literature. That alone is a form of bias.

The Yahoo! Health article then say that Fisher claims that “it can be potentially dangerous to spread out a vaccination schedule because nearly all of the vaccinations given are not 100 percent effective with the first dose. Spreading out the schedule has ‘no scientific merit,’ she says, and can leave children more susceptible to contracting the diseases you’re trying to protect against until the schedule is complete.”

What she didn’t say is that the effects of wholescale changes to the pediatric schedule that have occurred over the last 15 years have never been studied at all. Instead, vaccines are studied, one at a time, with research funds provided by the manufacturers of vaccines, who, by the way, are completely indemnified from lawsuits for damages or liability for injuries. There are over 250 vaccines in the pipeline – a profiteer’s dream.

The American Press also does not report on the assault on personal liberties that the choice about vaccines embodies. Two words sum it up: Informed Consent.

As for me, I believe that vaccines save lives. I also believe it is a fundamental human right to refuse a particular form of medical care and opt for others. I believe that the CDC has failed to demonstrate the safety of vaccines (re: Dr. William Thompson’s confession of his and others’ scientific misconduct during vaccine safety studies during the 2000’s, which help set the current pediatric schedule. I’ll say it again: I believe vaccines save lives. But informed consent laws required that we are informed with accurate information about the state of knowledge of the safety of the food and drugs we are given.

This is not longer about vaccines. It’s about whether we still have a free and independent press in America. Or do we know live in a Pharmatopia? It’s about whether conflicts of interest still matter. And it’s about whether faked science still matters.

Do we really want to be a country that forces specific medical care upon patients without consent? Consent by coercion is not recognized as consent under any setting. The Universal Code of Human Rights – and the Nuremberg Code – both say that forced medical treatment is unethical. Ask yourself why would anyone want to force this medical, when they also know about the scientific misconduct  – it’s entered into the Congressional Record thanks to Rep. Bill Posey (FL-R).

I’m a demoncrat (that’s a joke, son), and I love Posey for bringing this issue forward. Don’t let them do this with vaccines – what else will they force on us in the name of easily justified profits from mass vaccinations?

We should be overhauling our vaccine safety research programs instead.

Appreciation is extended to my son Zach for the word “Pharmatopia”. I had been using the awkward term “Pharmacocracy”. 

What do you think? Should the press tell the whole story? Or should they just be ‘responsible’ and report in a manner that is designed to get people to adhere to the CDC’s vaccination schedule?  Does a Fourth Estate even exist in this country? Do ethics still matter in vaccine medicine? Feel free to comment. Detractors welcome!


Top 10 Things You Must Know About the Autism/Vaccination Question

Emotional, disparaging comments from those who believe they know the science that appears to show that there is no causal link between thimerosal in vaccines and the increased rates of autism include name-calling “Anti-vaxxers”, charges of “over-emotionalizing” the issue, and,  “distracting” the families who should be focused on caring for their autistic child or children.

During my research for my second book, “Cures vs. Profits: Success Stories in Translational Research”, I have found wonderful advances in the care of cancer, in brain surgery, in robotic surgery, and forthcoming advances in early Alzheimer’s diagnosis. My approach was unbiased: I wanted to find bona fide advances in medical care made possible via biomedical and clinical research.

I also uncovered a number of accounts of unsavory and illegal activities undertaken by researchers and by medical doctors. This led to four chapters covering such acts, two of which I wrote intentionally to provide a framework of contract of clear evil-doers (Abuses in Medicine, and Outrageous Acts of Pseudoscience). The third and fourth chapters surprised me: They involve Overdiagnosis in ADHD and Vaccinations.

I will blog on the the problem of ADHD Overdiagnosis at a later date: for now, the story of how Pharma reached into academic clinical research center activity is not pretty. I went into the Vaccine chapter to advocate for Vaccines, to review some of this history of this most clear of all translational successes. How could vaccines be bad? They stop the spread of disease, after all. No one gets polio anymore. Practically no one dies from measles in the US anymore. Most of my colleagues clearly stand on the side of protecting the population from diseases with vaccines.

In taking the time to really look at the published data on the possible links between Autism and Vaccines, I have become convinced not only that there is a likely direct cause of Autism, but that the US CDC has repeatedly acted in a manner that is as egregious, if not more, than those actors in the  Abuses in Medicine and Outrageous Acts of Pseudoscience chapters.

So, to help others who, like me, had extolled the virtues of vaccines over the possible, but apparently unlikely risk of adverse events such as brain damage leading to autism, understand the reality that our society is experiencing, and will experience for some time, I decided to share the Top 10 Things You Must Know about the Autism/Vaccination Question.

(1) The science behind the causal link between thiomerosal and neurological damage is both strong, and vast.  We know precisely how ethyl mercury harms neurological development. In brief, nerve cells grow at the tips of their axons via extension of tubulin proteins. Ethyl mercury robs the energy molecule for that extension, thus the growth does not occur.

(2) Ethyl mercury is more, not less toxic than methyl mercury. Studies in monkeys have shown that ethyl mercury is deposited in the brain at a greater rate, and remains in the brain, far longer than methyl mercury. Forget everything you thought you knew about the relevance of EPA guidelines for methyl mercury exposure: they are irrelevant as the mechanisms of damage of the two forms, and the metabolism of the two forms, are significantly different.

(3) Wholescale changes to the vaccination schedule are not subject to testing by the FDA. Between 2003 and 2013, the dosage of ethyl mercury to children via the national vaccination program increased from 75 ug to 575 ug due to additions of new vaccines to the schedule, and to accelerations of the rate of vaccination to fit new vaccines into the schedule. This increase in dosage should be a cause for concern by the FDA even if the question of autism did not exist.

(4) The rates of autism have increased from 1 in 2500 in 1970 to 1 in 68 in 2010. The CDC reports 1 in 50. That’s 2% of the population diagnosed with frank autism. The CDC has argued that the rates reflect an expansion of autism into a spectrum that include Aspberger’s. However, those factors do not account for the exponential increase in the rates of autism.

(5) People in charge of the vaccination schedules have had serious conflicts of interest and have personally profited from the decisions they helped make in terms of which vaccines to add to the schedule. The committee that makes the decisions about the health of our entire country has serious financial conflicts of interest. Watch Robert F. Kennedy Jr’s testimony on this in Vermont earlier this year, arguing why parents should still have say over what goes into their children’s bodies:

(6) The press has a conflict of interest as well. As Kennedy points out, Pharmaceutical industry now represents the number one source of advertising revenue for major media outlets. Direct to consumer market is legal in two countries in the world: the US and New Zealand. Thus, the things you may read or hear about Robert F. Kennedy Jr’s presence of mind are ruthless, irresponsible pandering, and are likely a direct consequence of this influence.

(7) Parents can easily request thimerosal-free vaccines. The CDC is quick to say that thimerosal has been removed from all vaccines except one (the flu vaccine, for pregnant women, of all people!). This is not true. Thimerosal is included at doses of at least 24.5 ug of mercury in the following:

Tdap (Boostrix)

Influenza (Affluria, Fluvirin)

Meningococcal (Menomune)

these brands about be avoided by anyone concerned about exposing their children the mercury. There are thiomerosal-free alternatives for each of these vaccines listed by Vaccine Safety.

Nevertheless, the FDA reports that many vaccines still use thiomerosal early in the production process, leaving behind “trace amounts”. They also report that vaccines now include aluminum (another known neurotoxin, which can act synergistically with thimerosal), and, of all things, MSG. Some people (like myself) are highly sensitive to MSG (it, like nitrates, can cause migraines).

(8) Most so-called “Anti-Vaxxers” are not against vaccines. Rather, they for vaccines, they just want safe ones. They are castigated, ridiculed, called crazy, all for wanting to protect their own, and others’ children, from being poisoned by mercury and other neurotoxins.  They should be referred to as “Pro-Safe Vaccineers”, or “Anti-Toxins”.

(9) Certain state governments want to take the Parent’s right to say “No” out of the equation. California just passed a law that only allows religious exemption for refusal of vaccines. (CORRECTION BY READER: California just passed a law that dispensed with the “Personal Beliefs Exemption. Now only Medical Exemptions are allowed with the recent passage of SB 277. This law did away with the Personal Beliefs Exemption if you want your children to be able to attend both public and private schools. Home-schooled children will not have to comply with the new law.” The measles outbreak of 2014 has helped bouy the sense that parents who refuse vaccines are irresponsible hacks who need a paternalistic government intervention in their lives. As I wrote my chapter on vaccines, I advocated for the CDC, and medical doctors, to outline the risk that parents place others at by choosing to not vaccinate their child. I stand by that recommendation. There are young (6 mos), the elderly, and those with weakened immune systems whose lives could be devastated by an outbreak of childhood diseases.  However, I also emphasize that the vaccines should be safe.

(10) Which side your choose as a scientist, a doctor, a parent, a lawyer, and a citizen matters. The Autism movement does not trust the government. This mistrust is well-earned. Until there is an other hearing on the CDC cover-ups, including their manipulation of the data via repeated analyses, and their hiding results that showed potential significant association, it is up to the public to communicate our concerns to our law makers, and our doctors.

Listen to (part) of Dr. William Thompson’s admission. If you find it distateful, you may choose to ignore Dr. Wakefield’s dramatic linking of this issue to Tuskegee. The issue, for me, stands on its own. if you cannot understand that Wakefield was trying to study to problem of whether the age of vaccination increased the risk of autism – the very question of whether the accelerated vaccine schedule – the CDC’s schedule – increased the risk of autism.

I am appealing to my colleagues in science, and in medicine. If you are so moved by Dr. Thompson’s admissions of fraud by the CDC, contact your Congressional representative, and demand that Congress subpoena Dr. Thompson for a new hearing (as of July 14, thousands of pages have been sent to the Congressional Science Committee). Dr. Thompson has released a statement via his lawyer [UPDATED LINK] (one of the best Whistle-Blower lawyers in the country) in which he further admits wrong-doing by the CDC.

To learn more, I strongly recommend Robert F. Kennedy’s Jr.’s book, “Thimerosal: Let the Science Speak for Itself” (173 pp, Skyhorse Publishing) on Amazon.