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Mark Blaxill promotes bad science

8 Sep

[wags finger]…and don’t you ever forget it 😉

Basically, the story is that The Blax wrote a blog post in which he said:

Despite the relentless drumbeat of propaganda from the CDC, public health authorities and the thuggish on-line goons of the medical industry, there’s a funny thing going on. The evidence of a connection between mercury exposure and autism keeps growing.

It does? Really? Such as what science exactly?

Well The Blax has the answer to that in that he quotes from a study which according to The Blax:

They found that thimerosal at the same concentrations received in human infants had clearly measurable effects on opioid receptor development in the infant rats.

Huh. Well imagine my surprise when I read two blog posts, one from Emily in which she says:

Their starting dose is at least 3.2 times the relevant exposure of Hg. But they’re not finished. They don’t use that dose once. They use it four times, injecting the newborn rats on days 7, 9, 11, and 15 of life, each time with 3.2 times the actual relevant exposure of Hg, for a total of 48 mcg of Hg/kg in a little over a week. Indeed, even if 12 mcg were the relevant exposure, they’re dosing their animals with it four times within a week, give or take, giving us ~13 fold the relevant exposure.

and another from Orac in which _he_ says:

…the minimum dose received was 48 ?g Hg/kg, and the maximum dose received was a whopping 12,000 ?g Hg/kg, or 12 mg Hg/kg!

So when The Blax states that this paper is a like for like comparison between infant vaccines and their dosage, I think its clear to see that this is incorrect. What these researchers have in fact done, is massively overdose their test subjects.

And thats not the only problem with this paper that The Blax is so in love with. Geier, Haley, Bernard…recognise these names? Of course you do! They’re the names that this paper relies on to support its underlying ‘science’.

I think the only real question that needs answering here is – how in heck did this paper get past peer review??

Age of Autism – Amazon file wisely

8 Sep

We all know the new Age of Autism book is coming soon. Its stocked at Amazon for example where pre-orders for the book have placed the books ranking at the heady heights of the top 100,000.

However, whats most interesting is the cover art that Messers Blaxill and Olmsted have chosen for the Kindle edition of the book. In a refreshing turn of honesty, they selected the below (click for bigger) as the cover art.

You can also see it in situ at Amazon US store.

A brave and refreshingly intellectually honest move by Blaxill and Olmsted, I think you’ll agree.

Review of the Introduction of Age of Autism – the book.

23 Aug

So begins the Olmsted/Blaxill upcoming book ‘Age of Autism’.

…instead of taking Kanner’s word for it, [we decided] to learn about these previously anonymous families ourselves. We took clues from his extensive case descriptions and started uncovering the identities of the original families. Time and again, we connected the occupations of the parents to plausible toxic exposures and especially to a new mercury compound first used in the 1930s as a disinfectant for seeds, a treatment for lumber, and a preservative in vaccines. Yes, the parents’ professions were clues— but not to their obsessions or their marriages or their parenting or their genetic oddities; instead, they pointed to a strikingly consistent pattern of familial exposures to the same toxic substance.

(emphasis authors, inserts mine)

This is the paragraph that sets the authors hypothesis out. When we look at it carefully, we can see exactly what its purpose is – its purpose is to fit a set of preconceived ideas that revolve around one central disproven hypothesis – that mercury in vaccines (thiomersal/thimerosal) causes autism.

I haven’t yet read the rest of the book but I’m pretty sure what I’m going to find. To talk about that now would just be conjecture however, so lets stick to what we have here.

According to Olmsted and Blaxill, syphilis treatment, hysteria, mental illness and a variety of modern illnesses are all caused by mercury. I’m very much looking forward to reading this section too. Olmsted & Blaxill use Pink disease (a definite form of mercury poisoning which looks nothing like autism to ‘justify’ the inclusion of these illnesses in the Introduction.

Blaxill and Omsted detail how they went on to meet “Donald T.” one of Kanner’s original cases:

By any mea sure, he has fared astonishingly well. President of his college fraternity and later the Forest Kiwanis Club, a pillar of his Presbyterian church, he had a long career at the local bank, plays a competitive game of golf, and regularly travels the world. We learned how “Donald T.” went from being the first unmistakable case of autism to the first unmistakable case of recovery.

So on one hand we have the doom and gloom of Pink disease (a foreshadow of autism according to Blaxill & Olmsted) which killed hundreds and then actual autism which doesn’t seem that bad. I’ll be very interested to see how Blaxill & Olmsted narrate Donald T.’s ‘recovery’…or could it have been that Donald T. was in fact one of the first cases of autism who also either moved ‘off the spectrum’ (as a certain percentage of autistic people do) or…y’know…he simply progressed as he got older. My guess is that Blaxill & Olmsted will reveal that Donald T. had some kind of miraculous exposure to a chelating agent or multi vitamins or some form of extreme biomed. Lets see.

The whole Introduction is about 6,000 words long. I can’t possibly attempt to review the whole thing and I won’t attempt to review the whole book either. These are the sections of the Intro that caught my eye particularly. Maybe others who have access to the Intro will tackle more. One thing you can be sure of, LBRB will be here to catch and expose the errors.

Finding common ground at the IACC

1 May

The Interagency Autism Coordinating Committee (IACC) met Friday. New members were introduced, including Ari Ne’eman of the Autistic Self Advocacy Network.

The autism communities are far from unanimous in goals and methods. Given the makeup of the IACC, consisting as it does of governmental agencies plus public members of organizations that have been highly critical of each other, one might wonder if it anything could get accomplished.

But, in the end, most groups have more than a single goal. And, if you remember back to your set theory lessons, that leads to intersections–overlap–common ground.

I was reminded of this watching the IACC meeting. I could only watch bits and pieces during the day. One standout part of the morning came when Jim Moody of the National Autism Association gave a public comment talking about issues of safety, elopement, drownings–preventable deaths of autistics young and old.

Towards the end of the meeting I listened to a number of people refer back to this presentation. Amongst these commenters was Ari Ne’eman. Mr. Ne’eman obviously took the idea seriously and was calling for serious consideration of how this could be implemented into the Strategic Plan, calling for input from the services subcommittee.

I know the idea of safety are not new to Mr. Ne’eman. I contacted him recently when I was preparing a piece, Search and Rescue and autistics.

The members of the IACC span a wide diversity of ideas and viewpoints. Diversity, that’s a good thing.

But, working together for the common good: that’s common ground. Ideas that span diverse organizations and viewpoints. That is a very good thing.

Andrew Wakefield’s Autism Organization?

22 Feb

There has been a major push to show support for Dr. Andrew Wakefield following the clear and decisive ruling against him in by the General Medical Council and the retraction of his flagship paper in The Lancet and his departure from Thoughtful House.

I have some advice for those who are supporting Dr. Wakefield. I realize advice from me is about as welcome to them as me seeing Dr. Wakefield in my pediatricians’ office, but here goes:

If you want to show real support, add him to your board of directors. Add him to your Science Advisory Boards. Call yourselves “Andrew Wakefield’s Autism Organization”. When big donors call, have them speak with Dr. Wakefield. When you lobby the legislature, bring Dr. Wakefield.

Don’t keep him at arm’s length while trying to rehabilitate his reputation.

The way I see it, right now Dr. Wakefield is a liability. It is one thing to write blog posts or letters to newspapers. It is quite another to spend your organizations reputation.

Between the time I started a draft of this post and it now, Dr. Wakefield has made his first public statement about his departure from Thoughtful House. He mentions that he has an “entirely new sort of opportunity that will allow me to continue my work on behalf of autism families”. Who knows, maybe one or more of the existing orgs will take him on.

Mark Blaxill attempts to support Andrew Wakefield?

20 Feb

As most have now gathered, Andrew Wakefield’s career in the UK is finished. However, the PR machine keeps spinning in the USA as a new fascinating web piece from Brian Deer reveals.

Brian tells the story of how Max Clifford’s daughter – who works for her father – had apparently been ready to take on Andrew Wakefield as a client:

They are looking to take us on for a few months…

However, her father – who previously refused to work with Michael Jackson – had other ideas:

It’s my company, and my daughter works for me, he said

We are not involved, and we will not get involved unless they are backed by top medical experts…

Heh. Not much chance of _that_ happening.

During the piece Brian discovers who might be financing Andrew Wakefield’s about-face in the public eye. He suggests a couple of names to Clifford’s daughter who confirms the participation of one Mark Blaxill:

…she appeared to take the bait over Blaxill. “Right, Mark. Okay. Mark is…” But then she paused to ask: “Brian, what’s your background?

Amazing that someone who was preparing to work with Brian Deer didn’t know who Brian Deer was but more interesting to me was the possibility that Mark Blaxill was preparing to fund Max Clifford’s PR firm to try and rehabilitate Andrew Wakefield’s public image. Go read the whole thing, its pretty interesting.

IACC calls for $175 million in autism and the environment research

5 Feb

The Interagency Autism Coordinating Committee has posted the revised Strategic Plan. I blogged it recently here on LeftBrainRightBrain. I made a note of the large commitment to environmental causation research. I thought it worthwhile to highlight that section, since this is the cause of so much criticism of the IACC.

Strangely, the criticism doesn’t come from those who are supposedly “It’s all genetic” types. No, the “it’s all environmental” groups seem to be very loud in complaining that all the research funding is going into genetics.

The Plan is divided by a number of questions. Research into causation is listed in Question 3: “What Caused This To Happen And Can This Be Prevented?”

Under that category, there are seven projects on environmental or gene-environment research. Seven out of 10 projects. The estimated budget for all these projects? $175,900,000.

In other words, 70% of the projects and, if I did my math right, nearly 70% of the funding for causation is estimated to be going to environment and gene-environment projects.

This would seem like a great victory for those who have lobbied for more environmental research. I have yet to see anyone from that group even mention the new Strategic Plan, much less the large commitment to environmental research. Where are the statements from SafeMinds (who have a very vocal member who sits on the IACC proper and another who is on a working group)? How about Generation Rescue? The National Autism Association?

In my opinion, these groups really don’t care much about environmental causation unless it is either mercury or vaccines. Hey, I could be wrong. Let’s see if they surprise me with some acknowledgment of this effort by the US Government.

Here are the objectives if you would like to read for yourself.

Short-Term Objectives

1. Coordinate and implement the inclusion of approximately 20,000 subjects for genome-wide association studies, as well as a sample of 1,200 for sequencing studies to examine more than 50 candidate genes by 2011. Studies should investigate factors contributing to phenotypic variation across individuals that share an identified genetic variant and stratify subjects according to behavioral, cognitive, and clinical features. IACC Recommended Budget: $43,700,000 over 4 years.
2. Within the highest priority categories of exposures for ASD, identify and standardize at least three measures for identifying markers of environmental exposure in biospecimens by 2011. IACC Recommended Budget: $3,500,000 over 3 years.

3. Initiate efforts to expand existing large case-control and other studies to enhance capabilities for targeted gene – environment research by 2011. IACC Recommended Budget: $27,800,000 over 5 years.
4. Enhance existing case-control studies to enroll racially and ethnically diverse populations affected by ASD by 2011. IACC Recommended Budget: $3,300,000 over 5 years.
5. New objective
Support at least two studies to determine if there are subpopulations that are more susceptible to environmental exposures (e.g., immune challenges related to infections, vaccinations, or underlying autoimmune problems) by 2012. IACC Recommended Budget: $8,000,000 over 2 years.

6. New objective
Initiate studies on at least 10 environmental factors identified in the recommendations from the 2007 IOM report “Autism and the Environment: Challenges and Opportunities for Research” as potential causes of ASD by 2012. Estimated cost $56,000,000 over 2 years.

Long-Term Objectives

1. Conduct a multi-site study of the subsequent pregnancies of 1,000 women with a child with ASD to assess the impact of environmental factors in a period most relevant to the progression of ASD by 2014. IACC Recommended Budget: $11,100,000 over 5 years.
2. Identify genetic risk factors in at least 50% of people with ASD by 2014. IACC Recommended Budget: $33,900,000 over 6 years.
3. Determine the effect of at least five environmental factors on the risk for subtypes of ASD in the pre- and early postnatal period of development by 2015. IACC Recommended Budget: $25,100,000 over 7 years.
4. Support ancillary studies within one or more large-scale, population-based surveillance and epidemiological studies, including U.S. populations, to collect data on environmental factors during preconception, and during prenatal and early postnatal development, as well as genetic data, that could be pooled (as needed), to analyze targets for potential gene/environment interactions by 2015. IACC Recommended Budget: $44,400,000 over 5 years.

Read more: https://leftbrainrightbrain.co.uk/2010/02/iacc-strategic-plan-is-up/#ixzz0edI3Pe8h

With the facts against them Dr. Wakefield’s supporters appeal to emotion

3 Feb

I should stop being shocked and amazed at how little groups like the Age of Autism blog think of their readership. Sorry to put it so bluntly, but it is pretty clear that they expect us all to just read what they have to say and never go to the original sources and think for ourselves.

Case in point, the GMC hearing on Dr. Andrew Wakefield. Dr. Wakefield was guilty of ethical violations in the treatment of his disabled patients. Not once, not twice but many many times. But you wouldn’t know that to read some of the reports on the blogs and even a couple in newspapers.

We have the NAA SafeMinds and TACA telling us all about how bad this ruling is. We have been told that there was “false testimony”.

OK, take a look at the actual charges. Just for a moment. Here are a few examples

1) Dr. Wakefield took money from the Legal Aid Board (LAB) for procedures paid by the NHS. He then diverted some of the LAB money to other projects.

2) Dr. Wakefield got ethical permission to do his study in December 1996, only on patients enrolled after that date. However, he had already started research on children. Here are two examples:

Child 2 had an MRI, colonoscopy and lumbar puncture in September of 1996.

Child 1 was also a research subject without ethical approval. Tests were performed which were not in the clinical interests of the child.

3) For people who promote the myth that “the only thing he did was start early”, note that Dr. Wakefield’s team did invasive tests that were not called for. For example:

Child 3 was also a research subject without ethical approval, having started before the approval. He underwent a lumbar puncture even though: “The Panel has taken into account the fact that there is no evidence in Child 3’s clinical notes to indicate that a lumbar puncture was required.”

Was this the result of some “false testimony? According to the GMC ruling, experts on both sides stated that the lumbar puncture was not clinically indicated.

Experts on both sides, Professor Rutter and Dr Thomas both considered that such a test was not clinically indicated.

Dr. Thomas is not accused by the defenders of Wakefield as “giving false testimony”.

The above are only a few of the examples of clear misconduct on the part of Dr. Wakefield.

How many times must a man be found guilty of not doing what was in his patients’ clinical interests before we are allowed to consider him as, well, someone who doesn’t always put his patient’s clinical interests first?

Kim Stagliano has taken to the Huffington Post with “The Censorship of Autism Treatment“. No mention of the actual charges. No mention of the fact that Andrew Wakefield was guilty. No mention of the fact that Andrew Wakefield’s research efforts for the past 12 years have centered on repairing his own damaged reputation, not on autism treatment.

Can you find a single mention of the word “ethics” in her post? How about any comment about the actual charges levied against Dr. Wakefield?

You know you are in trouble just with the title from this story: MMR doc’s just guilty of caring . At least that article makes one clear statement:

It [the GMC ruling] focused on the methods of research used, some of which were undoubtedly questionable, but which were performed in the name of finding solace for desperate parents convinced their children had changed for ever following their one-size-fits-all MMR injection.

Yes, you can be unethical if you are “finding solace for desperate parents”.

A blog post by the National Autism Association stated:

“Many parents of children with autism view the GMC investigation as little more than character assassination of a physician brave enough to investigate controversial issues”

Well, not this parent. Anyone who paints the GMC investigation as “character assassination” didn’t read the ruling. Seriously, trying to dismiss this fact-filled ruling as “character assassination” is just plain bizarre.

another post comments, discussing the work Dr. Wakefield’s team performed on his study subjects:

the procedures involved were routine

and

No children were harmed and no parent or guardian has complained about the care these three men provided.

Lumbar punctures are hardly “routine”. Further, there is no reason to do them if not clinically indicated. Colonoscopies are not routine, especially in patients whose symptoms don’t warrant them. Say, as in Child 1.

One child suffered a perforated bowel (in 12 places!). His family won a lawsuit against the Royal Free hospital.

High Court papers alleged that the colonoscopy procedure performed on Jack in 1998 was ‘not clinically indicated or justified’. They also claimed the ‘principal reason’ for the surgery was to further research into links between autism and bowel conditions rather than Jack’s clinical needs.

How does that not count as not “harmed”? Is it because he wasn’t one of the original 12 from the study in The Lancet?

The behavior of the Wakefield supporters is totally predictable. They have no science. They have no first (or second) tier researchers. They rely heavily on Dr. Wakefield. Who else has the perceived stature of Dr. Wakefield for them? When Brian Deer broke the story that Dr. Wakefield may have “fixed” data in his study last year, there was an immediate reaction from the Wakefield supporters: give him faux awards! Make him the keynote speaker at their conventions!

For the past year the message has been “Dr. Wakefield has not been discredited”. They’ve lost that now.

We’ve been warned that they are bringing out their big guns. Yes, David Kirby will blog about this on the Huffington Post. With apologies to Mr. Kirby, but when he’s their “ace in the hole”, you know they don’t have much.

As I finished this, David Kirby came up with his post: “The Lancet Retraction Changes Nothing”. Joining in the style of the times, Mr. Kirby also ignores the actual GMC ruling. Nothing that actually defends Dr. Wakefield against the real charges.

Seriously, go read for yourself. It’s David Kirby with his usual talking points and straw men.

I hope David Kirby is wrong. I hope that things have changed. I hope that the future is a world where the loudest voices in the autism communities fight for a better life for autistics, rather than for a political goal of recognition for bad science, badly done.

I hope.

My “hostile” or “threatening” messages to the Age of Autism editors

23 Dec

I’m critical of the Age of Autism blog and their so called “editors”. That comes as no news to anyone who has read this blog, I’m sure. But I found an odd bit in David N. Brown’s recent piece, Paul Offit’s Mythical Millions (v. 2), when he noted that Mr. Mark Blaxill and Mr. Dan Olmsted wrote in a recent Age of Autism piece:

Most notably, we have received hostile (and in one case threatening) messages from readers who take issue with our estimates

I sent email messages to Mr. Blaxill and Mr. Olmsted, pointing out their mistakes. Hostile and threatening were not the way I would characterize the emails, so I emailed Mr. Blaxill and Mr. Olmsted with my request for clarification of their comments. They have not responded, which I am taking as confirmation that they considered my communications “hostile” and/or “threatening”. I thought I would let the readers decide whether based on the actual messages below.

As a bit of a backstory, Mr. Olmsted and Mr. Blaxill wrote a piece where they estimated the amount of money Dr. Paul Offit earned from his share of his vaccine patents. In this piece, they made a number of errors. I pointed out some of the errors, errors that were easily confirmed with publicly available information, via email.

I thought I had phrased this in a non “threatening” and non “hostile” manner. Again, I leave it to you, the reader, to decide.

Here is my initial letter to Mark Blaxill and Dan Olmsted, editors at the Age of Autism blog.

Mr. Olmsted, Mr. Blaxill,

I am sure you are interested in accuracy whenever possible in your blog posts. I assume you want to know and want to correct errors.

In a recent post of yours, you estimated the royalty payment for Dr. Paul Offit from CHOP’s sale of it’s rights to the rotavirus vaccine Dr. Offit, Dr. Plotkin and Dr. Clark invented.

Your post makes an estimate that is markedly higher than the real number. This is in large part to two errors you made.

First, the Patent and Intellectual Property Policy you used is incorrect. You rightly note that this is a new policy and that the rotavirus patent was likely covered by a previous policy.

The details of the previous policy are included in this document (http://stokes.chop.edu/forms/btob/Jan07BtoB.pdf) , which can be easily found with the following google search:

Patent and Intellectual Property Policy site:chop.edu

Using the older policy and the $182M reported as the payment CHOP received for their patent, you can calculate an inventors share of $18,550,000.

The second mistake in your estimation is in assuming that Dr. Plotkin and Dr. Clark. did not share in the CHOP inventor share. This is incorrect. Again, a quick google search will demonstrate that Dr. Plotkin and Dr. Clark were, indeed, CHOP faculty. Therefore, the $18,550,000 is divided by 3, resulting in an inventor share of $6,183,333.

The CHOP 2006 annual report (http://stokes.chop.edu/publications/annual_report/pdf/annual_report_2006.pdf page 42) clearly states that Dr. Plotkin and Dr. Plotkin were part of the CHOP team that invented the vaccine. Other pages on the CHOP site note that Doctors Plotkin and Clark were, indeed, faculty there.

I have already emailed Dr. Offit to check that this is an accurate representation of the facts, and he confirmed this.

I look forward to seeing how you make use of these corrections.

Mr. Blaxill reponds:

Dear Sullivan,

Please identify yourself. I do not respond to unsigned communications.

Sincerely,

Mark Blaxill

Sullivan:

Mr. Blaxill,

I realize that this is your policy and I respect that. I apologize for contacting you like this, but I felt it important that you have accurate information in this case. The links I supplied confirm this. That information is independent of whether I sign or do not sign my email.

I believe your mistake to be an honest one. At the same time I believe it was easily avoided as accurate information is readily and publicly available. Note that I made a conservative estimate, using the full $182M of the Royalty Pharma payment, not the $153M you report as net income from CHOP’s sale.

I respect your policy and I was not and am not looking for a response. I do hope that you will act on the information provided.

Mr. Blaxill:

Dear “Sullivan”,

Your information is interesting but equivocal. I have information that goes in the other direction. More to the point, we asked both Offit and CHOP to comment on the story before publication and they declined. The only definitive way to resolve the ambiguity is full disclosure of the amounts Offit received from all sources and he has declined to do so. So we have no plans at the moment to act on this or any other new information, which at the most amounts to a distinction without a difference. The conclusion stands: Rotateq made Offit a millionaire.

In the meantime, you continue to hide behind an anonymous email address. You must understand that discredits you as a source.

Sincerely,

Mark Blaxill

Sullivan

Dr. Offit has publicly stated how much he was paid by CHOP.

http://counteringageofautism.blogspot.com/2009/09/paul-offit-explains-money-side-of.html

A blogger contacted Dr. Offit and Dr. Offit responded. The blogger (David N. Brown) used his real name in reporting the information. No different than had he responded to you and you had included that information in your blog under your name.

Were you both unaware of that blog and that post?

Will you make the correction now?

Mr. Olmsted and Mr. Blaxill did not make the correction. The recently admitted their mistakes, but have yet to make the correction.

Upon reading the comment that they had received “hostile” and “threatening” responses, I decided to inquire as to whether they were referring to the exchange above. Below is my final email in this exchange.

Mr. Olmsted, Mr. Blaxill:

In reading David Brown’s discussion of your recent blog post on Dr Offit, I found this comment: ” Most notably, we have received hostile (and in one case threatening) messages from readers who take issue with our estimates. ”

I would like to know if you include this exchange as either hostile or threatening.

I thank you for your time.

This has remained unanswered. I take this as a strong indication that, yes, they considered my discussion “hostile” or “threatening”.

Frankly, I believe either clarification or an apology are in order from Mr. Blaxill and Mr. Olmsted as the above discussion was quite respectful. Do I expect that? No. I don’t expect such behavior from people who would write the passage below:

“The only definitive way to resolve the ambiguity is full disclosure of the amounts Offit received from all sources and he has declined to do so. So we have no plans at the moment to act on this or any other new information, which at the most amounts to a distinction without a difference. “

The message was clear to me: the blog post would remain uncorrected unless Dr. Offit met their demands. The fact that Mr. Olmsted and Mr. Blaxill were clearly mistaken had no bearing on whether the piece would remain. Note that even though they have admitted their mistake, no mention is made in their original post to this day.

I started the above communication with the assumption that Mr. Blaxill and Mr. Olmsted were honorable people who, while we disagree, would put accuracy above smear.

I am willing to admit my mistake.

Paul Offit’s Mythical Millions (v. 2)

22 Dec

This is a PUBLIC DOMAIN document (dated 12/11/09, revised 12/12). It may be copied, forwarded, cited, circulated or posted elsewhere. The author requests only that it not be altered from its current form.

Breaking news: Dan Olmsted and AoA have finally admitted that CHOP paid Paul Offit $6 million, not $29M, $45 or $55M, for the Rotateq patent.
So why isn’t the Evil Possum sneering and laughing a single “HAH!” of contempt as he surveys the smoking wreckage and broken bodies of his enemies?

Because, the “correction” was embedded in another hate piece against Paul Offit, “Counting Offit’s Millions.” Here are some of the things Olmsted has to say to rationalize his earlier incompetence and/or dishonesty, and justify further suspicions against Paul Offit, and what I have to say in reply:

“Our new estimate of Offit’s total profit of $13-35 million through 2019, overlaps the range of our original estimate of $29-55 million. Both those estimates exceed Offit’s recent — and apparently partial — disclosure that he made `about 6 million.'”

I object strongly to the reference to this statement as “recent”. I posted it on “Evil Possum” (See “Offit’s Mythical Millions (v. 2)” back on August 18. I would also remind everyone of Dr. Offit’s statement to me: “CHOP sold its patent for $182 million. This information was made publicly available and was published in the Philadelphia Inquirer at the time. The inventors, Fred Clark, Stan Plotkin, and me split 10 percent of that three ways. This means that we each received about $6 million.” As we shall see, AoA is not trying to dispute this. They are arguing that he received more money from other sources. Fair enough, but that does not make his disclosure “partial”. It should be clear from context that Offit is disclosing the amount he was paid from the CHOP inventor’s share.

“Offit’s recent revelations do little to change our conclusion, that he was `voting himself rich’ while sitting on a government vaccine standards body.”

This “conclusion” would make no sense even if their original “estimate” were correct. From the standpoint of ca. 1999, even in the event of the recommendation of rotavirus vaccination the eventual development of Offit’s own patent into a commercial product was uncertain at best and improbable at worst. So, as long as the charge is intentionally using his position to pursue anticipated monetary gain, accusers don’t have a leg to stand on. It should also be noted that they have not offered any evidence that Offit made a single decisive vote on the issue.

“Based on two crucial new disclosures from Offit, we estimate in a revised and more detailed analysis that Offit has received and will continue to receive multiple payments based on RotateqÂŽ licensing revenue, that he may already have earned $10 million from RotateqÂŽ and that he stands to earn between $13-35 million over the lifetime of Rotateq’s key patents (based on different assumptions regarding the product’s future worldwide sales forecasts).”

At this point, any sensible person should be thinking, “Consider the source…” When Olmsted was working from figures and other facts that could easily be established from a few public records, he came up with a “minimum” of $30M for a payment whose actual amount was $6M. He also seems to have overlooked such basic things as the prominent listing of CHOP on Clark’s and Plotkin’s resumes and a clear statement in the CHOP document used as a “source” that a policy was not applicable to patents disclosed before July 1, 2005. So why should anyone put much trust in what he has to say on more complex issues, especially market projections?

“(Paul Offit) has thrust himself into the spotlight as both a vaccine safety authority and an autism expert, spokesman roles that have little to do with his work on RotateqÂŽ. “

This is an entirely frivolous criticism. It cannot seriously be disputed that he is a “vaccine expert”. As for the label of “autism expert”, that is not a label Offit has applied to himself. The only place I personally have seen it applied it to him is in the sarcastic headline of an October 26 AOA post.

“Most notably, we have received hostile (and in one case threatening) messages from readers who take issue with our estimates. Although these threats have concerned us, they have also been a useful source of new information, the full implications of which our critics had clearly not grasped.”

I think it is not improbable that this is directed against me; in another instance, I have been referred to by name as “abusive”. In the interests of completeness, here is the text of a private email sent to Mark Blaxill: “I have attempted several times to post additional comments on article `Voting himself Rich’. I recognize that I have allowed the tone to get overly harsh, and I would rather discuss this in a private discussion, before posting my own work in progress… If you have any response or emendation to offer, I will duly note it in any public posting. But your previous report and response, as such, cannot stand.” So, what in this is “threatening”?

“(W)e have been unable to fully explain the $29 million difference between Royalty Pharma’s reported payment ($182 million) for CHOP’s royalty interest and CHOP’s reported proceeds ($153 million) from the monetization of its royalty rights.”

This is a decidedly frivolous aside, unless Olmsted wishes to imply that Offit’s disclosure regarding the CHOP sale is incomplete. By this point, any remaining “mystery” is on par with “What happened to Jimmy Hoffa?”: What we don’t know, can easily be guessed! It is reasonable to suppose about $18.5M was paid to the inventors. As for the other $10.5M, that could be accounted for by any number of things. Filing a patent costs money. Arranging the sale of a valuable intellectual property costs a lot of money. I attempted to explain the inevitable expenses in one of the few posts that were not censored by AoA: “I’m sure the 29M would include payments to others; for example, a 15% fee is typical from inventors’ royalties.” It should have been clear that I was no longer just discussing the inventor’s share, but also the presumable expenses related to the patent and sale. A reply by Mark Blaxill completely failed to acknowledge the issue: “David Brown, please read the article before making incorrect statements… Offit would have received the entirety of the CHOP inventor’s share.” Olmsted’s continued display of bafflement likewise shows a failure to apprehend (or openly acknowledge) just how far the claims of the original article were from what was known or even plausible.

“Based on the current CHOP policy, it is clear that such private arrangements between inventors are anticipated. `If there is only one such Inventor, Author, or other creator, the total Inventor Share is payable to that person’ reads the `Patent and Intellectual Property Policy” from CHOP’s Administrative Policy Manual. But `where there is more than one such Inventor, Author, or other creator, and all such persons unanimously agree in writing how the Net Income should be distributed among them … then the Net Income will distributed in accordance with such agreement.‘ According to Offit, he, Clark and Plotkin reached a private agreement to share the inventor proceeds, which resulted in a three way split of the inventor distribution.” (Underlining added)

This passage caught my attention because it seemed eerily familiar, and not just because I had read it in the CHOP patent policy manual. Just now, I was checking on my first draft (no longer online) of “Offit’s Mythical Millions”: “CHOP’s manual, cited by Blaxill and Olmstead, makes the following statements: `The Inventor Share… is the total amount payable to all Hospital Personnel who are Inventors, Authors, or other creators of the Intellectual Property… Where there is more than one such Inventor, Author, or other creator, and all such persons unanimously agree in writing how the Net Income should be distributed among them… then the Net Income will distributed in accordance with such agreement… (If) all such persons have not unanimously agreed on the distribution… then the IPA, or his/her designee, will determine an appropriate allocation of Net Income among the Inventors, Authors, or other creators… Each Inventor, Author, or other creator will be entitled to receive his/her Inventor Share of Net Income in accordance with this policy whether or not he/she remains Hospital Personnel. In the event of the death of an Inventor, Author, or other creator, such Net Income will be paid to his/her estate.’ (All italics added.)… It is also clearly the hospital’s intent that coworkers settle the issue among themselves. The implication is that the division of the share among a team would be negotiated among the team as a whole, with a reasonable balance of bargaining power even between a leader and his subordinates.” (Underlining new.)

Given the degree of similarity between their quotes and mine, I think it is very possible (I won’t go so far as to say probable) that their quote of the CHOP document is simply copied and pasted from mine. And that raises some question in my mind whether Olmsted (and Blaxill) have ever gone to the trouble of reading their “source” with any care. Then there is the remark that follows, which looks to me very much like what I suggested in the first draft of “Mythical Millions”. My correspondence with Offit on the matter convinced me otherwise, which was why I replaced that document.

“But if Offit shared the Royalty Pharma proceeds with Plotkin and Clark, then Offit would also stand to receive a share of any RotateqÂŽ related payments made to Wistar, payments we did not attribute to him previously and that he has not disclosed.”

This is a reasonable conclusion, but an unacceptable argument. The reason Plotkin and Clark were eligible for payment from the CHOP share is that they both were present or former employees of the hospital. For the same argument to apply to Offit and the Wistar payment, it must be shown that he is or was a Wistar employee. As it happens, he is (a fact which I was aware of back in August). But, Olmsted has not gone to the minimal effort of establishing this fact, nor has he shown that he understands why he was in error in the first place.

“His claim of a 10% inventor distribution for RotateqÂŽ is supported by a document we received from a critic of our analysis: a January 2007 newsletter from CHOP call `Bench to Bedside.’”

I will add a significant detail: I mentioned this document in the first draft of “Mythical Millions”, and gave Blaxill notice of what I intended to publish on August 10.

“Offit has now publicly disclosed both of these terms (a disclosure that Age of Autism Contributing Editor Jake Crosby confirmed in direct correspondence with Offit).”

This immediately reminded me of one of Crosby’s periodic visits to Left Brain/Right Brain. On September 14, he left this confrontational “comment”: “When did Paul Offit receive the royalty payments for the Rotavirus vaccine? It was added to the schedule in February 2006, but the new patent code went into regulation in November 2006. If Paul Offit’s vaccine was added to the schedule in early 2006, but received payment in late 2006 (either November or December), or beyond, then he would have received inventor’s share of the money according to the current patent policies of CHOP.

Also, how would Drs. Clark and Plotkin receive CHOP inventor’s share of the vaccine when they already received some through Wistar and no longer work at the hospital, and only Paul Offit does? That does not seem to make sense.” He did not offer any further comments or questions in response to detailed explanations. I mention this because it is indicative of how slow and recalcitrant AoA has been in retracting their original article: Nearly a month after I posted Offit’s statement, it appears that even a major member of the AoA staff was either wholly unaware of the correction or not yet fully informed of the extent to which the original story had been shown to be in error.

But even this revised lump sum estimate likely understates Offit’s total return from the CHOP royalty streams. According to the announced payment terms, Royalty Pharma only purchased the rights to CHOP’s royalty stream “from and after October 1, 2007.” Based on its quarterly financial statements, Merck reported Rotateq ÂŽ sales of $537 million before that date. If CHOP retained the royalty rights to Merck revenues before that date, then Offit could have received royalty payments directly from CHOP based on Merck’s early RotateqÂŽ revenues in addition to the lump sum payment he received based on the Royalty Pharma transaction…

This is an odd tangent. If Olmsted thinks that Offit received a significant amount of money from this transaction, why doesn’t he give an amount? For that matter, why doesn’t he mention this after providing some suggestions as to calculate royalties? This immediately raised my suspicion that, as in the inclusion of $55M in the original piece (see “18/3=29”), Olmsted has put forward a claim he knows is improbable at best, to lead readers to draw erroneous conclusions.

As it happens, Olmsted suggests later (see below) that the royalties to the hospital(s) would have been 2.5%. If that is applied here, the hospital would have received $13.5M. Based on the complex policy in place in ca. 2000, the inventor’s share would be $200,000 for the first $500K, $675,000 up to $5M, and $850,000 for the rest, for a total of $1.725M, or $575K per inventor. Or, so it would seem. For 2006, matters seem straightforward. Olmsted reports that there were $163M in sales for Rotateq before the end of the year, which comes out as $4M for the hospital and $242K for each inventor. But what about 2007, which is when the greater part of the royalty would come into play? That would depend on the terms on which payments were made. If CHOP had received a royalty payment for each quarter, then the institution would have pocketed the royalties up to October. But if the royalty was an annual payment, it appears quite possible that, in making the sale, CHOP forfeited all royalties for 2007. Needless to say, I consider the second possibility more likely.

“Wistar’s immediate receipt of $45 million was subject to the same inventor distribution requirements as the CHOP transaction. So just as Offit received a share of the CHOP inventor distribution, the Wistar deal created an occasion for a second lump-sum payment. According to the “Guidelines for Wistar inventors”. Offit would have received 5% of the Paul Capital proceeds, or $2.25 million … In his recent disclosures regarding his CHOP payment of $6 million, Offit has consistently neglected to mention that he received another seven-figure payment from Wistar a few months before. Adding these payments together gives Offit a total of $8.4 million from lump sum payments alone.

I mention this to point out that (contrary to what Olmsted seems to believe) none of this is news to me. As already mentioned, I was aware of Offit’s employment at Wistar around the time I contacted him for comment on his CHOP share. If he didn’t tell me his income from other sources, I will grant that, given the opportunity, I chose not to ask. Also, to the best of my recollection ,I had at that point taken a look at the Wistar policies, and come up with a figure in the neighborhood of of $7M for the inventor’s share. If I had chosen, I could have suggested the same figure Olmsted is presenting now. I had little reason to go to the trouble. For one thing, Olmsted had placed the focus on the CHOP share. For another, he had so preposterously inflated Offit’s income that two million or so either way would make no difference in judging the the credibility of his “reporting”. As far as I’m concerned, it still doesn’t.

“(I)n order for Paul Capital to be willing to pay $45 million for a 13 year royalty stream between 2006 and 2019, we calculate that Wistar’s royalties on the first $300 million in RotateqÂŽ revenues would need to fall somewhere between $6-9 million per year, depending on the discount rate Paul Capital applied to the future royalties… This calculation would mean that Wistar has a royalty rate somewhere in the 2-3% range. For simplicity’s sake, we have assumed that Wistar’s actual royalty is 2.5%, which after adding an equal amount for the CHOP license brings Merck’s total royalty for its RotateqÂŽ patent license to 5%.”

This whole passage is far from convincing. It is clear that what is “calculated” is based on a series of assumptions, of which the first- “for Paul Capital to be willing to pay $45 million for a 13 year royalty stream… Wistar’s royalties on the first $300 million in RotateqÂŽ revenues would need to fall somewhere between $6-9 million per year”- is clearly the most questionable. How does one know what businessmen would be “willing to pay”, unless either a) one is telepathic or b) the businessman can see the future? It’s not at all clear to me how Olmsted came up with his figure.

Rather than try to sort out his calculations (in which he has given me no reason for confidence), I will do my own math. $45 million divided by 13 is $3.46M, or 1.15% of $300 million. It can be assumed on this basis that royalties were more than 1.15% , because Paul Capital would have had no chance of making a profit otherwise. But, if it were that much more, it is more likely Wistar would not have sold. So, I will settle for 2%, which would have given Paul Capital the chance of almost double return and allowed them to break even by the time sales hit the $150M mark. A 5% inventor’s share (1/3 of 15%) would come out at 0.1% of gross minus $300M.

In this scenario, in 2008, when gross Rotateq sales reached $665M, Offit and associates would have received $365,000. This doesn’t come close to justifying Olmsted’s figures. As noted, his claim at the start was that Offit has made $10M from Rotateq, which since he estimates lump sums to be $8.4M would mean $1.6 million, over 3 years, or on average $533,333 per year. My calculation for 2008 provides only 68%, and that is so far the peak for Rotateq sales. Moving up the percentage is little help: At 2.5%,, the royalties come out at $456,000 for 2008, which is 70K short. Even at 3%, I come up with $547,500 to Offit, which is only barely more than what Olmsted requires. So how is it that Olmsted has arrived at an “average” of $533K per year, when applying the royalties percentage he claims to have used to the highest sales on record falls short by about 14%?

That brings us to the final sentence of the passage, which I can only regard as an outright lie. Now, Olmstead previously suggests that Offit received royalties on Rotateq sales through ca. Q3 2007, on grounds which seem plausible. But that is not what Olmstead appears to be saying. Instead, he gives every indication of saying (briefly and offhandedly) that Offit is receiving ongoing income from both Wistar and CHOP. There is absolutely no chance that this is true, or even what Olmstead believes to be true. He repeatedly states, in this very article, that any current income to Offit can only come from Wistar. That he seems explicitly to say otherwise here cannot be excused as mere “error”. Witness the next item…

“(W)e estimate that Offit receives an eighth of a cent (or .125%) for every dollar of Merck’s RotateqÂŽ revenue above $300 million If RotateqÂŽ performs well, it can generate a large annual income for Offit: a relationship we have illustrated graphically in Figure 1.”

Year Q1 Q2 Q3 Q4 Total/300 Royalty
2007 85 119 171 149 224 $280,000
2008 190 178 134 162 364 $455,000
2009 134 126 127 120* 207 $258,750
Total $993,000

*Estimate by the author, minimum

It is clear from the chart that Olmsted’s “estimate” has no basis even in his own data. Even the 2008 “spike” falls $78K short of the $533K per year necessary to add up to the $1.6M that Olmsted implies. The sum of them all is only 62% of that figure. (Even granting his doubtful claim of CHOP royalty payments through Q3 2007 won’t quite get to $1.6M without rounding.) The only readily apparent means by which Olmsted could have come up with that, based on ongoing royalties alone, is by assuming two sources of such income, ie by adding CHOP payments which he has admitted do not exist. In summary, it is again proved absolutely impossible that Olmstead could have arrived at in the methods he describes. Furthermore, if he did not necessarily lie in producing the first story, it cannot be doubted that he is doing so in this one. I will grant him the benefit of one doubt: It is possible that the untenable figures precede the apparent “miscalculations”, and that the former were foisted onto him by another, possibly with initials of H, B and J, not necessarily in that order.

That brings us to the graph, which can be traced to what appears to be a protected site created by Generation Rescue, and kept disappearing or getting messed up when I tried to include it here. To the extent that I am able to analyze it (a task which required magnification, a printout and a ruler), I must admit its figures are less objectionable than Olmsted’s. At the least, it is clear enough (when the graph is examined closely enough!) that Offit’s annual royalty would not reach or exceed $500K until around $750M in gross sales. (By Olmsted’s math, the royalties on $750M would be $562,500.) But that is more than nullified by the extravagant scale assumed. Based on available fiscal data, it can be predicted reasonably that Rotateq sales will remain stable at around $500M per year. But the anonymous graph maker saw fit to illustrate Offit’s royalties on sales up to $3.5 billion.

After this, the only remaining question is why, after four months of denial, silence, censorship and the occasional insult, AoA is finally making a “correction” now. It certainly is not to convince me or those in the communities of which I am a part. If they cared about what we had to say, they would have issued corrections a long time ago. The only intelligible interpretation is that this is a “rear guard” action, and a sign that even loyal AoA members, perhaps even some of their leaders, are growing tired of this “story” and/or “anti-Offit” tactics in general. I suspect that the role of Olmsted in particular has been to stall, waiting either for criticism to die down or to perfect exactly what he has finally done: create a story which would admit his previous error(s) while allowing himself to “save face” before his loyal followers. In that event, I have only one thing left to say to Olmsted: This is the best you could do??!
And the Possum just says, “HAH!”

David N. Brown is a semipro author, diagnosed with Asperger’s Syndrome as an adult. Previous works include the novels The Worlds of Naughtenny Moore, Walking Dead and Aliens Vs Exotroopers, and the nonfiction ebook The Urban Legend of Vaccine-Caused Autism. This and other articles related to autism are available free of charge at evilpossum.weebly.com