Tag: JB Handley

Alleged Fraud in the Vaccine Court Omnibus Autism Proceedings

Have you heard about the alleged fraud in the Vaccine Court Omnibus Proceedings?

Alleged by who?

Guess?

Alleged Fraud in the Vaccine Court Omnibus Autism Proceedings

Yup. The usual suspects.

The usual suspects are alleging fraud during the in the Vaccine Court Omnibus Proceedings.

Most folks remember that the Vaccine Court Omnibus Autism Proceedings were a series of cases that were used to test theories that vaccines could contribute to or cause autism.

The conclusion?

Vaccines are not associated with autism.

So what’s the problem?

“Robert F. Kennedy Jr., Chairman of Children’s Health Defense (CHD), and Rolf Hazlehurst, parent of a vaccine-injured child, petitioned the Department of Justice (DOJ) Office of Inspector General (OIG), and the Senate and House Judiciary Committees today to investigate actions taken by federal personnel during the “Vaccine Court” Omnibus Autism Proceedings (OAP).”

Kennedy and Hazlehurst claim to have evidence of “obstruction of justice and appallingly consequential fraud by two DOJ lawyers who represented the Department of Health and Human Services (HHS) in 2007.”

What evidence?

Kennedy and Hazlehurst claim that “that the leading HHS expert, whose written report was used to deny compensation to over 5,000 petitioners in the OAP, provided clarification to the DOJ lawyers that vaccines could, in fact, cause autism in children with underlying and otherwise benign mitochondrial disorders.”

Who is this expert?

It is Andrew Zimmerman, MD, a pediatric neurologist.

There is also a claim that Dr. Zimmerman, along with Dr. Richard Kelley, who was also an expert witness in the Vaccine Court Omnibus Autism Proceedings, served as expert witnesses in a medical malpractice case against a pediatrician who vaccinated a child, supposedly causing him to become autistic.

Which child?

Yates Hazlehurst, who was the second test case in the Vaccine Court Omnibus Proceedings.

Confused?

Dr. Zimmerman settles any fraud issue when he answers this clear question in his deposition in a malpractice against Yates Hazlehurt's pediatrician.
Dr. Zimmerman settles any fraud issue when he answers this clear question in his deposition in a malpractice against Yates Hazlehurt’s pediatrician.

Dr. Zimmerman admits that there is no evidence that vaccines cause autism, but also believes that there are some exceptions, and that vaccines can cause regressive autism in some kids with mitochondrial disorders.

Dr. Zimmerman also clarified that it is not just immunizations, but infections, fever, and other inflammatory responses that can lead to regressive autism.

Dr. Zimmerman clarified that infections can lead to regressive autism too - not just vaccines.
Dr. Zimmerman clarified that infections can lead to regressive autism too – not just vaccines.

And Dr. Zimmerman would have testified to it in the Cedillo case (the first test case in the Vaccine Court Omnibus Proceedings), if he had been allowed to.

Except that upon review of the Cedillo case, Dr. Zimmerman had concluded that “there is no evidence of an association between autism and the alleged reaction to MMR and Hg, and it is more likely than not, that there is a genetic basis for autism in this child.”

Apparently, he had changed his mind later, even though he continues to say that all evidence points to the fact that vaccines don’t cause autism.

“Dr. Zimmerman subsequently submitted a second expert opinion on behalf of Hannah Poling, which in effect states that she suffers autism as a result of a vaccine injury. The same government officials, who submitted and relied upon Dr. Zimmerman’s first expert opinion as evidence in the O.A.P., secretly conceded the case of Hannah Poling and placed it under seal so that the evidence in the case could not be used in the O.A.P. or known by the public.”

Memorandum Regarding Misconduct By The United States Department Of Justice And The United States Department Of Health And Human Services During The Omnibus Autism Proceeding As To The Expert Opinions Of Dr. Andrew Zimmerman

But what about the “second expert opinion” from Dr. Zimmerman?

Zimmerman deposition on Hannah Poling.

According to Poling’s mother, “Dr. Zimmerman was not an expert nor was he asked to be an expert on Poling’s case. The government conceded her case before ANY opinion was rendered or given.”

What about Dr. Richard Kelley?

“As noted above, an important consideration for treatment of AMD is that “normal” inflammation can impair mitochondrial function. Although most infections cannot be avoided, certain measures can limit the risk of injury during infection or other causes of inflammation… We believe it is much better to immunize with DTaP than risk infection with highly inflammatory and potentially damaging community-acquired pertussis.”

Dr. Richard Kelley on Evaluation and Treatment of Patients with Autism and Mitochondrial Disease

While he seems to believe that vaccines can trigger regressive autism in some kids with mitochondrial disease, he admits that other kinds of inflammation can do it too, including vaccine-preventable diseases.

“We believe it is much better to immunize with DTaP than risk infection with highly inflammatory and potentially damaging community-acquired pertussis.”

Andrew Zimmerman

And again, so does Dr. Zimmerman, to the point that in many cases, he thinks that even kids with mitochondrial disorders should be vaccinated.

“…the MMR vaccine has been temporally associated, if rarely, with regressions — with regression in AMD and other mitochondrial disease when given in the second year. Doubtless some of these regressions are coincidental, since the usual age for giving the MMR falls within the typical window of vulnerability for AMD regression.”

Andrew Zimmerman

If rarely associated…

Coincidental…

That doesn’t sound very convincing.

Although a lot of Dr. Zimmerman’s deposition makes it into J.B. Handley’s new autism book. What’s missing is that there were many other experts that testified against the idea that vaccines could be associated with autism during the Vaccine Court Omnibus Proceedings and that their testimony and their reports were relied upon more than Zimmerman’s.

“The undersigned has reviewed and considered the filed reports from these experts and finds that the opinions of the experts lend support to the conclusions reached in this decision. In reaching the conclusions set forth in this decision, however, the undersigned relies more heavily on the testimony and reports of the experts who were observed and heard during the hearings.”

Hazlehurst v. Secretary of HHS

So where is the fraud in the Vaccine Court Omnibus Proceedings?

Is it that the Poling case files have been kept under seal and hidden from public view?

“Finally, and perhaps for purposes of Rolf’s request that Poling’s records be released to the public, Jon and I have not allowed the release of Hxxxx’s records nor will we ever willingly allow third parties to tear apart her medical history which includes other close family members as well as things that should have never been in the record to begin with.”

Terry Poling

While we should all care about fraud in our court system, we should all also care about folks who push misinformation about vaccines and try to scare parents away from vaccinating and protecting their kids, especially when they use autistic kids to do it.

Don’t believe them.

It is telling that Dr. Zimmerman, the hero in this story, discredits the other heroes of the anti-vaccine movement, from the Geiers to Andrew Wakefield.

“I do think that — that there was much information — misinformation brought about by Dr. Wakefield and it’s — this has set the field back. I think that — that we — we have worked very hard to try to reassure the public  and I agree with doing that because I am very supportive of vaccinations, immunizations in general.”

Andrew Zimmerman

While Dr. Zimmerman truly believes that future research might find a way to identify a very small subset of kids with mitochondrial disorders that worsen after they get their vaccines (or infections or other types of inflammation), this doesn’t apply to the great majority of autistic kids or even the great majority of kids with regressive autism.

Different answers to a very similar question? They are from different lawyers in the Zimmerman deposition...
Different answers to a very similar question? They are from different lawyers in the Zimmerman deposition…

Even Dr. Zimmerman only seems to speak of an “uncommon relationship” that “is not evident in studies that have been done to date.”

And none of the researchers he mentions, including Richard Frye, Shannon Rose, Joe (Jill?) James, or Dmitriy Niyazov seem to have actually studied vaccines, only possible relationships between autism and mitochondrial conditions.

“The claims by RFK Jr. and Handley draw on something that was not, in fact, a fraud, that is misrepresented as having a dramatic impact on the Omnibus Autism Proceedings when it had little to no effect.”

Plus ça change – anti-vaccine activists revive the Hannah Poling case

So there is nothing really new here.

And while it might be news to folks like Bob Sears, vaccines are safe and necessary and still don’t cause autism.

More on the Alleged Fraud in the Vaccine Court Omnibus Proceedings

VigiAccess Numbers in Context

Most people are familiar with VAERS, the Vaccine Adverse Event Reporting System.

They sometimes forget that it is only the Vaccine Adverse Event Reporting System for the United States.

Other countries have their own vaccine safety systems.

VigiAccess Numbers in Context

One of the biggest is VigiBase, the World Health Organization’s  global database for suspected adverse drug reactions, maintained by the Uppsala Monitoring Centre in Sweden.

“Information on suspected ADR should not be interpreted as meaning that the medicinal product in question, or the active substance(s), generally causes the observed effect or is unsafe to use.”

Not surprisingly, folks misuse VigiBase numbers, just like they misuse VAERS reports.

JB Handley needs help understanding VigiAccess reports.
JB Handley needs help understanding VigiAccess reports.

To look at the VigiBase reports, you can use VigiAccess.

“VigiAccess has a search interface that allows visitors to retrieve summary statistics on suspected adverse reactions to medicines and vaccines.”

Uppsala Monitoring Centre

While VigiBase “is at the heart of UMC’s signal detection and scientific research,” you aren’t going to learn much from VigiAccess.

“Geographically, only continent-level statistics are shown, due to issues relating to patient confidentiality and data protection in individual countries.”

Uppsala Monitoring Centre

The biggest problem?

You don’t know how many vaccines were given to all of those people.

For example, while it might sound like there have been a lot of adverse drug reaction reports for the DTaP vaccine, with 179,447 reports in VigiAccess, since those are worldwide reports since 1968, it is likely among many billions of doses of vaccines being given.

Most importantly though, as with VAERS, “The reports in VigiBase result from suspicions of a relationship between a drug and a reaction. No causal relation has been confirmed.”

So how do you put the numbers from VigiBase and VigiAccess in context?

If you consider that reports and safety signals from VigiBase, VigiMatch, VigiRank, and other tools used by the Uppsala Monitoring Centre continue to find that vaccines are safe, then to put the DTaP numbers in context, they help us know that vaccines are being well monitored for safety.

And since we know that these diseases haven’t disappeared, any further context, if you need it, would be that since vaccines are safe and necessary, then you should get yourself and your family vaccinated and protected.

More on VigiBase and VigiAccess

 

Andrew Wakefield Is Not A Fraud?

Most folks have a good idea of who Andrew Wakefield is and what he did.

Who's to blame for low immunization rates and continuing outbreaks?
Who’s to blame for low immunization rates and continuing outbreaks?

Still, some folks seem to be pathologically optimistic that he didn’t actually do anything wrong.

Andrew Wakefield Is Not A Fraud?

You remember Andrew Wakefield, right?

“To our community, Andrew Wakefield is Nelson Mandela and Jesus Christ rolled up into one.”

J. B. Handley

He is the guy who published the 1998 paper in Lancet in the UK that started folks thinking that the MMR vaccine is somehow associated with autism.

In 1998, a major medical journal based in the UK, The Lancet, published a report headed by Andrew Wakefield, who was at that time a gastroenterological surgeon and medical researcher. The report implied a causal link between the measles, mumps, and rubella (MMR) vaccine and the development of autism combined with IBD in children, which Wakefield described as a new syndrome he named “autistic entercolitis”.

Andrew Wakefield’s Harmful Myth of Vaccine-induced “Autistic Enterocolitis”

But he didn’t actually say that the MMR vaccine caused autism in that paper, did he?

No, he saved that for the press conference for the paper.

If not for the press conference, which in itself was unusual, and all of the media attention over the next few years, his small study, which was “essentially a collection of 12 clinical anecdotes,” would have gone nowhere.

But there was no “Wakefield Factor” on immunization rates in the UK, was there? Didn’t measles cases continue to go down in the 10 years after his Lancet paper was published?

MMR vaccination rates had dropped below 80% by 2003, when the first measles outbreaks in the UK began. They didn't fully recover until 2012.
MMR vaccination rates had dropped below 80% by 2003, when the first measles outbreaks in the UK began. They didn’t fully recover until 2012.

Despite the heroic efforts of some folks to manipulate the data, it is clear that MMR vaccination rates dropped and measles cases jumped in the years after Wakefield’s MMR scare.

But even if his paper scared people away from vaccinating and protecting their kids, he was never really found guilty of fraud, was he?

While the findings of the General Medical Council panel that took away Wakefield's medical license never used the word 'fraud,' they described things that are fraudulent.
While the findings of the General Medical Council panel that took away Wakefield’s medical license never used the word ‘fraud,’ they described things that are fraudulent. The words dishonest and misleading come up a lot too.

How do you define fraud?

“The Office of Research Integrity in the United States defines fraud as fabrication, falsification, or plagiarism.13 Deer unearthed clear evidence of falsification. He found that not one of the 12 cases reported in the 1998 Lancet paper was free of misrepresentation or undisclosed alteration, and that in no single case could the medical records be fully reconciled with the descriptions, diagnoses, or histories published in the journal.

Who perpetrated this fraud? There is no doubt that it was Wakefield. Is it possible that he was wrong, but not dishonest: that he was so incompetent that he was unable to fairly describe the project, or to report even one of the 12 children’s cases accurately? No.”

Fiona Godlee on Wakefield’s article linking MMR vaccine and autism was fraudulent

Brian Deer wasn’t the only one calling Wakefield a fraud.

But those charges from the General Medical Council were later all overturned, weren’t they?

While charges against John Walker-Smith, a co-author of Wakefield’s study, were dropped on appeal, that doesn’t exonerate Wakefield in anyway. Remember, John Walker-Smith was actually against blaming the MMR vaccine and unlike Wakefield, he and another co-author actually published their own press release stating continued support of the use of the MMR vaccine.

But the other coauthors have stood by the results of the paper, haven’t they?

“We wish to make it clear that in this paper no causal link was established between MMR vaccine and autism as the data were insufficient. However, the possibility of such a link was raised and consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed upon these findings in the paper, according to precedent.”

Retraction of an Interpretation

They stood by the idea that it is important that research be done so that gastrointestinal problems in autistic children can be recognized and treated. Almost all of them retracted Wakefield’s interpretation of the paper though.

Yeah, but other studies have proven Wakefield to be right though, haven’t they?

No, they haven’t. In fact, other labs could not even replicate Wakefield’s original study.

Why wasn't Wakefield ever charged in a criminal court?
Why wasn’t Wakefield ever charged in a criminal court?

But Wakefield’s Lancet paper wasn’t retracted because it’s findings were wrong…

Yes it was!

“Following the judgment of the UK General Medical Council’s Fitness to Practise Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al are incorrect, contrary to the findings of an earlier investigation. In particular, the claims in the original paper that children were “consecutively referred” and that investigations were “approved” by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.”

Retraction—Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children

Still think Andrew Wakefield isn’t a fraud?

Every time there is a measles outbreak, anti-vaccine folks pop up to defend Andrew Wakefield. The problem is that they get virtually everything about him wrong!

Their false narratives and myths attempt to rewrite history and make you forget that he doesn’t just scare parents away from vaccinating and protecting their kids, he hurts autistic kids and their families.

More on Andrew Wakefield Myths

How to End the Epidemic of Bad Books About Autism

Looking for a book about autism?

There are a lot of good ones, including NeuroTribes and the Thinking Person’s Guide to Autism.

Unfortunately, there are an awful lot of bad ones too.

How to End the Epidemic of Bad Books About Autism

Why are there so many bad books about autism?

That’s easy.

JB Handley is the latest to write a book about vaccines and autism, moving the focus to aluminum, now that it has become obvious that removing thimerosal from vaccines didn't affect autism rates.
JB Handley is the latest to write a book about vaccines and autism, moving the focus to aluminum, now that it has become obvious that removing thimerosal from vaccines didn’t affect autism rates.

Just about every anti-vaccine expert out there also thinks that they are an expert on autism. In fact, they think that they have all of the answers and can even help you cure and prevent autism.

That’s why there are books like:

  • The Autism Book: What Every Parent Needs to Know About Early Detection, Treatment, Recovery, and Prevention by Dr. Bob Sears
  • Preventing Autism: What You Can Do to Protect Your Children Before and After Birth by Dr. Jay Gordon
  • Louder Than Words: A Mother’s Journey in Healing Autism by Jenny McCarthy
  • Callous Disregard: Autism and Vaccines – The Truth Behind a Tragedy by Andrew Wakefield
  • Vaccines, Autism & Chronic Inflammation: The New Epidemic by Barbara Loe Fisher
  • The Age of Autism: Mercury, Medicine, and a Man-Made Epidemic by Dan Olmsted and Mark Blaxill

What do all of these books miss?

“Autism, as I see it, steals the soul from a child…”

Dr. Jerry Kartzinel writing in the introduction to Jenny McCarthy’s first autism book Louder Than Words

Besides the fact that there is no autism epidemic and that vaccines are not associated with autism, they miss that they are actually hurting autistic families.

“Doctors who first worked with children with regressive autism back in the early 1990s found that one of the biggest “wows” came from treating intestinal yeast overgrowth, and this benefit holds true today. Children whose diarrhea doesn’t go away with the GFCF diet usually show resolution with yeast medication.”

Bob Sears, MD on The Autism Book

From restrictive diets and antifungal drugs for yeast infections to bleach enemas and detox therapies, these books often push expensive, often unproven, sometimes disproven, and dangerous  non-evidence based biomedical treatments and cures on hopeful parents of autistic kids.

Don’t help them by buying or promoting their books.

Instead, look for better books by folks who are really helping autistic kids and don’t think they are damaged, or books by someone who is actually autistic.

What to Know About the Epidemic of Bad Autism Books

There are a lot of good books out there with helpful information if you think that your child is autistic, has been  recently diagnosed, or if you simply want to learn more about autism. It’s time to stop the epidemic of bad autism books.

More on the Epidemic of Bad Autism Books

That $3 Million Vaccine Bonus for Pediatricians

The BCBS Michigan PGIP vaccine incentive.
BCBS Michigan offers a Physician Group Incentive Program to improve care to their members.

Have you heard about the bonuses that some pediatricians get for making sure their patients are fully vaccinated?

Depending on who you want to believe, this bonus, kickback, or so-called bribe, could be as high as:

  • $40,000
  • $80,000
  • $600,000
  • $3,000,000

Why the differences?

These anti-vaccine folks are simply reading an insurance company’s provider incentive program and trying to make it fit their narrative that pediatricians push vaccines on kids for profit.

While Blue Cross Blue Shield of Michigan’s Physician Group Incentive Program does use Healthcare Effectiveness Data and Information Set (HEDIS) criteria on completed vaccinations to give members a $400 payout, it isn’t what some people think.

The money used to make the payout or incentive reward comes from “a percentage of the applicable fee schedule on most professional paid claims.” So it is, in effect, money that the pediatrician has earned and should have already been paid. And if they don’t meet HEDIS performance measurements, they don’t get that money.

“All network physicians agree by contract to allocate funds from their fee schedule reimbursement to the PGIP Reward Pool. The current amount of the allocation is 5 percent. This 5 percent allocation goes into a pool to be paid out to physician organizations that meet performance metrics established by Blue Cross Blue Shield of Michigan.”

2016 Physician Group Incentive Program Clinical Quality Initiative: FAQ

Now, if you are creating a pool of money that is going to distributed to all or most of the doctors in the group and it comes from just 5% of reimbursements, how can they be getting bonuses of $40,000 or $80,000 or more?

Also keep in mind that in 2006, the pool of money totaled just $4,000,000 to be divided among all of the physicians in the program. Again, you are not going to get very large bonuses from those kinds of numbers.

Although the reward pool is much larger now, it is for dozens of PGIP initiatives and is divided up among over 19,000 doctors in almost 50 physician groups.

Most importantly though, does the simple fact that they do get bonus mean that they are pushing or forcing vaccines on kids just to make their childhood immunization target and get their bonus? If you consider that only 63% of their patients need to be fully vaccinated, which is much lower than vaccine coverage levels in the United States overall and in Michigan, it isn’t very hard to get the “bonus.”

A pediatrician who intentionally doesn’t vaccinate their patients might suffer under this type of program, but most of them don’t seem to take insurance anyway. Their patients usually have to pay cash for the “benefit” of seeing a vaccine-friendly doctor.

In the end, folks try to use these PGIP payments to mislead parents into thinking that something fishy is going on.

This means that a 5-doctor pediatric practice, if they reach 100% compliance on vaccinations, will receive a bonus of just over $3,000,000 (that’s not a typo, my math is right, that’s $3 million bucks!!)*.

JB Handley

Is his math really right?

Think about it. How often do kids have a two year birthday, which triggers the incentive?  Handley mentions that his calculation isn’t annualized, to cover that, but still, no pediatrician is getting a $3 million vaccine bonus.

Or a $40,000 bonus for that matter. You just have to look at the salaries for pediatricians in Michigan to understand why these claims are ridiculous.

The $400 childhood immunization payout.
Pediatricians aren’t making multi-million dollar bonuses to get kids vaccinated on time.

The most obvious error all of these folks make is that is almost unheard of for a doctor to only accept one single type of insurance plan. What percentage of patients does the Blue Cross Blue Shield of Michigan’s Physician Group Incentive Program make up among all of the insurance plans these doctors take?

If it was even 5 or 10%, which would be high, then there would be at most a handful of patients turning two each year to trigger the bonus. The yearly payments, which cover more than just vaccines, are no where close to being as big as anti-vaccine folks make them out to be.

Examples of payouts in the BCN 2017 Medical Services Agreement.
Examples of a yearly payout in the Blue Care Network 2017 Medical Services Agreement.

Again, this is a voluntary program the doctors join and in which the payout or incentive reward comes from “a percentage of the applicable fee schedule on most professional paid claims.”

And remember, this isn’t really extra money they get anyway. They are not bribes or kickbacks. It is money they likely would have gotten if they had not joined the incentive program.

What about the idea that Blue Cross Blue Shield has removed the incentive program pamphlet detailing the $400 payout? No conspiracy. The 2016 program expired. It was replaced with a new one.

Benefits of Pay for Performance Programs

So why do they join? Research from the programs shows that they help provide higher quality care at a lower cost.

That makes sense.

Consider how much it costs to contain a measles outbreak, for example, it is easy to understand why and insurance company would rather encourage doctors to get kids immunized rather than pay a lot more to take care of sick kids with vaccine-preventable diseases in doctor’s offices, ERs, and hospitals.

A recent study in Pediatrics, “Economic evaluation of the routine childhood immunization program in the United States, 2009,” actually used similar HEDIS immunization data as the Blue Cross Blue Shield of Michigan’s Physician Group Incentive Program and found that “routine childhood immunization among members of the 2009 US birth cohort will prevent ∼42,000 early deaths and 20 million cases of disease, with net savings of $13.5 billion in direct costs and $68.8 billion in total societal costs, respectively.”

So why aren’t they used even more often?

They can be expensive to implement, especially if a doctor doesn’t already have electronic medical records. And some experts believe that improvements aren’t necessarily from changing doctors behavior, but rather from better documentation of things that they were already doing.

What To Know About Vaccine Bonuses for Pediatricians

Pediatricians are not getting big bonuses, bribes, or kickbacks to vaccinate kids.

For More Information on Vaccine Bonuses: