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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.

Prevalence Rates of Autism Spectrum Disorders Among the Old Order Amish

17 May

One of the topics that comes up over and over online is “The Amish don’t vaccinate” and “the Amish don’t have autism”. Both statements are incorrect. The Amish have no religious prohibition against vaccination and they do have autism.

The question of autism amongst the Amish has been studied and is being presented at the IMFAR autism conference this week. The paper,
Prevalence Rates of Autism Spectrum Disorders Among the Old Order Amish, demonstrates a preliminary prevalence of 1 in 271 as the prevalence of autism amongst Amish children in two Amish communities: Holmes County, Ohio and Elkhart-Lagrange County, Indiana.

J. L. Robinson , Hussman Institute for Human Genomics, University of Miami Miller School of Medicine, Miami, FL
L. Nations , Hussman Institute for Human Genomics, University of Miami Miller School of Medicine, Miami, FL
N. Suslowitz , Center for Human Genetics Research, Vanderbilt University, Nashville, TN
M. L. Cuccaro , Human Genetics, University of Miami School of Medicine, Miami, FL
J. Haines , Center for Human Genetics Research, Vanderbilt University, Nashville, TN
M. Pericak-Vance , Hussman Institute for Human Genomics, University of Miami Miller School of Medicine, Miami, FL
Background:

The prevalence rate of Autism Spectrum Disorders (ASD) appears to be steadily increasing. The latest report from the Center for Disease Control estimates the rate of ASD is 1 in 91 children (Kogan, 2009), up from 1 in 150 in 2007. Understanding the seeming changes in ASD prevalence require careful exploration of genetic and environmental factors. A method that has proven useful in dissecting the etiology of complex diseases is the study of isolated populations. One population isolate that has been studied extensively is the Amish, with well over 250 genetic studies. Expanding studies of autism to the Amish may provide important information about etiology. A crucial first step in this process is a feasibility study to determine ASD prevalence rates in this population.

Objectives:

This study presents preliminary data on the estimated prevalence of ASD among the Amish in two Amish dominant counties as part of a larger epidemiological study. All children between ages 3 to 21 in those counties will be screened for the presence of an ASD.

Methods:

Screening occurred in, two of the largest Amish communities in the United States. Trained clinicians ascertained door to door using a published Amish Directory as a guide. Families were approached and asked to participate in a brief interview regarding their children. Two primary screening instruments were used: the Social Communication Questionnaire (SCQ) and the DSM-IV-TR Checklist (a tool created by the authors). A Vaccination History and a brief family history including questions specific to the ASD phenotype were also taken. Children screening positive on either the SCQ or DSM-IV-TR Checklist were seen for a more comprehensive clinical evaluation by two licensed psychologists. This evaluation included the Autism Diagnostic Observational Schedule (ADOS) and Autism Diagnostic Interview (ADI).

Results:

From September 2008 to October 2009, 1899 Amish children were screened in the two Amish communities. A total of 25 children screened positive for ASD on either the SCQ or the DSM-IV-TR checklist. A total of 14 screened positive for ASD on both screeners. Of those 25 children, 14 were evaluated and seven children were confirmed as having a diagnosis of ASD using the ADI and/or ADOS, and clinical judgment. Interestingly, four of the seven only met ASD criteria on the ADOS but not the ADI. Three of the four who were not diagnosed by the ADI only missed criteria on the Behavioral Domain, which may be attributable to the reporting style of Amish caregivers.

Conclusions:

Preliminary data have identified the presence of ASD in the Amish community at a rate of approximately 1 in 271 children using standard ASD screening and diagnostic tools although some modifications may be in order. Further studies are underway to address the cultural norms and customs that may be playing a role in the reporting style of caregivers, as observed by the ADI. Accurate determination of the ASD phenotype in the Amish is a first step in the design of genetic studies of ASD in this population.

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 Rotateq® licensing revenue, that he may already have earned $10 million from Rotateq® 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 Rotateq®. “

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 Rotateq® 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 Rotateq® 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 ® 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 Rotateq® 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 Rotateq® 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 Rotateq® 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 Rotateq® 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 Rotateq® revenue above $300 million If Rotateq® 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

The war on Tom Insel and the IACC

23 Oct

Tom Insel is director of the National Institute of Mental Health (NIMH) but he is better known to readers of this blog as the chair of the Interagency Autism Coordinating Committee. If you read other autism blogs, he’s probably very well known to you, as he has been the target of a concerted attack from the vaccines-cause-autism groups for a few months now. They even got the publicist, David Kirby, to take their battle to the public in a CBS interview.

Let me take a moment to make a side point. The vaccines-cause-autism groups (SafeMinds, Generation Rescue, the National Autism Association, Talk About Curing Autism (TACA)…I’m probably missing one or two), are basically a single consortium as evidenced by their single blog and their shared membership. I don’t see the need to treat them as separate entities. I really don’t see that they should be given multiple representations on the IACC.

I’ve been watching the IACC pretty closely for some time. I’ve also been watching the vaccines-cause-autism consortium. I’ve been watching the consortium build pressure against Dr. Insel.

One thing I’ve noticed: this level of pressure directed at Dr. Insel wasn’t always the case. Less than a year ago, Dr. Insel was not their target.

Take a look at one of the classic pieces of IACC intimidation: a piece called “Grinkers Stinker“. This is dated January, 2008. It was timed to coincide with a 4-day workshop that was the kick-off for the Strategic Plan process.

“Grinker’s Stinker” was a piece about the Dr. Joyce Chung, the former IACC coordinator. She is the wife of Prof. Roy Richard Grinker, anthropologist and author of the book Unstrange Minds. Dr. Grinker has publicly stated that he accepts the scientific consensus that vaccines did not cause an epidemic of autism. Dr. Chung has made no public statements (at least that I can find), but the lack of actual information about her or her opinions didn’t stop a blog post decrying her position on the IACC. From the blog post:

Does Joyce Chung agree with her husband? Did they ask her this question before she took the job?

Oddly, the last comment to that blog piece, by Generation Rescue’s “DC Liason” Kelli Ann Davis, starts with the question, “Can I suggest that we try and put an end to all the mudslinging?”

History has proven that, no, the Age of Autism can’t put an end to the mudslinging. Unfortunate, that.

Take a look at the blog post. There is no mention of Dr. Insel. No one decrying his “lack of leadership”, no one claiming “collusion” or “malfeasance”. None of the mudslinging terms currently used against members of the IACC, especially Dr. Insel. In fact, the first mention of Dr. Insel is in the comment by Ms. Davis. In her comment Ms. Davis suggests that Dr. Insel will be watching out for conflicts of interest.

Times certainly have changed. The Age of Autism likes to demonize those it disagrees with, and Dr. Insel certainly has been a recent target.

What happened?

Dr. Insel (a) had the IACC reconsider an initiative to call for a vaccine-autism study to be included in the Strategic Plan and (b) spoke before a congressional hearing about why vaccine/autism studies are not a high priority.

Not surprising to many of the readers here, I am sure, the vaccines-cause-autism consortium have a single issue (vaccines). As long as Dr. Insel’s position on vaccine/autism research, there was hope for the consortium and they left him alone. Once his current opinion formed and was public, he was public enemy number one. Yes, Dr. Paul Offit (vaccinologist and outspoken critic of the notion that vaccines cause autism) has been superseded.

Recently, Dan Olmsted (owner of the Age of Autism website) called for Dr. Insel to resign. Again, it boils down to the single issue: vaccines.

So, here we are. The vaccines-cause-autism consortium has declared war on Tom Insel for opposing their single-item agenda. If you think “war” is too strong a word, take it up with Mr. Olmsted. In referring to the recent incident where notes from an IACC member were made public:

…notes dropped on the floor (see the notes here) at the IACC, recovered by friendly forces and reported on our blog…

Yes, the Age of Autism people are “friendly forces”.

Here’s my perspective on Dr. Insel, for whatever it may be worth. He is the chair of the IACC. In my opinion, his role is to run the meetings and manage the staff. He should be getting good people in to serve on the IACC and the subcommittees and good people to consult on the topics that are discussed. Basically, his role is that of a facilitator–get good people together with the tools they need to do their job. He needs to be knowledgeable enough on the subject (autism) to do this.

You know what? Given the fact that his full time job is director of the NIMH, he’s actually done a pretty good job.

Is there room for improvement? Heck yeah. How about putting a greater emphasis on research into the needs of autistic adults? The majority of autistics are adults. And yet only 5% of the funding is being applied to this critical area.

But, of course, the squeaky wheels (the vaccines-cause-autism consortium in this case) get the grease. The squeaky wheels have been calling for research into environmental causes of autism. Tens of millions of dollars are being focused on this. Why are the squeaky wheels unhappy? Because the squeaky wheels didn’t really mean “environmental causes”. That was only a code word for vaccines.

This level of tension is not just sad. It is detrimental to the progress of the IACC. There are a lot of autistics, parents, professionals and organizations who are interested in working with the IACC. Why spend any more effort on the groups that have declared war?

(note, I made a number of changes in this piece shortly after publishing it)

Autism rate of 1 percent, and the embargo that wasn’t

7 Oct

Someone at the CDC screwed up. There, I said it.

That’s the bottom line of the story, in case you don’t want to plow through this rather messy story.

Two stories out today are discussing how the 1% autism prevalence story has been handled by the government, the AAP and the media. An emphasis is being placed on how the information embargo was handled and, possibly, mishandled.

One at the Covering Health blog is titled, Autism news raises question: When is an embargo not an embargo?. The second story, at National Public Radio, is titled When News Breaks On Autism, Who Gets It Out First?

Let’s go through the history of this story to unravel a bit of what happened.

This past summer, two studies were in press discussing the autism prevalence in the United States. The first study, based on data from the National Children’s Health Survey, was to be published in the Journal Pediatrics. (This is the one just published) The second study is a CDC report, in the Morbidity and Mortality Weekly Report (MMWR) series. Previous MMWR’s have given us prevalence numbers of 1 in 166 (based on data taken in 2000) and 1 in 150 (based on data taken in 2002).

Someone at the CDC leaked information about these studies to Lee Grossman. Whether Mr. Grossman approached the CDC employee or the other way around is unknown. There also isn’t any information on whether Mr. Grossman was supposed to keep this information confidential.

What is known is that Mr. Grossman publicly discussed this information at an Autism Society of America meeting in July.

Mr. Grossman also discussed this information with Mr. Kirby. How exactly that exchange came about we don’t know. Mr. Kirby has given a version of the story on his blog, but he has also shown himself willing to lie in order to protect a source.

Mr. Kirby blogged information about the two studies on August 11th. He did not name pediatrics as the journal, but he did note that the study would involve the NCHS data.

The pediatrics study was scheduled to come out this week (Monday, October 5). As is usual, the American Academy of Pediatrics released information to the press the week prior. These releases are made so that the press can prepare well researched stories to be published coincident with the paper. The press are not allowed to disscuss the story until the “embargo” was lifted at 12:01 eastern time, Monday Oct. 5.

The embargo system is actually a quite good one. This insures that the press has the time to put together well researched, thoughtful stories on a given topic. The writer who spends a lot of time on a story isn’t penalized by some guy slapping together a quick story to make a scoop. It’s a win-win: the press get to write better stories, and groups like the AAP get good press coverage.

But what do you do when someone has already leaked part of the story? To make it even more complicated, there were really two stories here: the Pediatrics paper published on Monday and the MMWR that isn’t published yet.

Understanding the high level of interest in the story, the U.S. Government decided to hold a conference call with the press. They planned their own data–the MMWR. In this way, journalists covering the Pediatrics story could include the MMWR without having to rely on the bits and pieces leaked by Mr. Kirby.

This call was scheduled for last Friday (Oct. 2) at 3pm.

The information from this call was embargoed. From the NPR story:

“Both the CDC overview and the HRSA study [in Pediatrics] were embargoed, because the subject nature was obviously so similar,” a spokesman for the National Institute of Mental Health told Covering Health. “It just wouldn’t be appropriate to not have the CDC following the same set of guidelines as the HRSA study as it relates to the embargo.”

This call was at 3pm.

The U.S. Government decided early Friday morning to hold a second conference call for autism advocacy organizations. This call was scheduled for 2pm, and did not include embargoed information. They didn’t discuss the details of the papers, just the new prevalence numbers (about 1%).

The Age of Autism blog posted the announcement and call in number.

According to Andrew Van Dam at Covering Health:

CDC spokeswoman Artealia Gilliard told AHCJ on Tuesday afternoon that everything in the 3 p.m. press call was under embargo, while nothing that would have been covered by that embargo was mentioned in the earlier call with the autism community. In particular, Gilliard said, no specific prevalence rate numbers were given out on the call.

“We basically said ‘On Monday, two studies will come out. They will update the prevalence estimate we previously had.’ … It didn’t actually have any of the information that was embargoed.”

Gilliard, who was on both calls, specified further: “I know they didn’t put out numbers in the advocacy call. I know we didn’t say 1 in 100. What we’ve been saying is ‘approximately 1 percent of children.’”

So, we have two conference calls, discussing much the same information (about 1% prevalence). One was embargoed and the other was not.

David Kirby blogged the story right away on Friday. Mr. Kirby starts his post with:

Washington loves to dump its bad news on a Friday afternoon, and on October 2 it confirmed that 1 percent of American children (and by extension, perhaps 1-in-58 boys) has an autism spectrum disorder.

It is possible that Mr. Kirby didn’t know that the Pediatrics study was to be published on Monday. It is possible that he didn’t know about the second, embargoed conference call.

Possible, but very unlikely.

If he knew (and I believe he did), his introduction is highly irresponsible. It fans the flames of the idea that the government tries to bury autism information. No surprises there, as Mr. Kirby has made a career out of fanning those flames.

Mr. Kirby further fans the flames by indicating that the 2pm call was short:

There was no alarm, and little time for questions from the community that was invited to “visit.” After about 15 minutes, questioning was cut off, and the call abruptly ended. I tried three times to ask a question (via a telephone switching system) and so did many other people on the call, which lasted a total of 39 minutes.

As we now know, the government had to prepare for the 3pm call. Perhaps Mr. Kirby didn’t know about that call. Again, that seems highly unlikely.

Mr. Kirby complains of not being able to pose his question. You can go read it if you want, I am not copying it here. The question, in classic Kirby style, is really a lecture putting out the current talking points of the vaccines-cause-autism groups.

Dan Olmsted at the Age of Autism blog mentioned the conference call as well, but his post was brief and not filled with the leading comments Mr. Kirby chose.

Lisa Jo Rudy at autism.about.com read the Kirby and Olmsted pieces (she mentioned this in her piece) and decided to blog the story herself. Unfortunately, she was a bit confused by what was embargoed and what was not–she discussed the Pediatrics paper (which was embargoed). This was reported to the AAP, who contacted Ms. Rudy and Mr. Rudy pulled the piece. The AAP decided that the embargo breach wasn’t so big as to pull the embargo entirely. In other words, they went ahead and kept the rest of the press to the Monday morning embargo date.

On Sunday, 7 hours before the embargo was lifted, Mr. Kirby ran a copy of his Age of Autism blog piece on the Huffington post.

The Age of Autism blog is still trying to fan the flames, pushing the idea that the mainstream media doesn’t want to cover this story. Mark Blaxill posted a piece today, Autism News: Pathetic Non Coverage, discussing how his home-town newspaper (The Boston Globe) didn’t cover the story when the embargo lifted on Monday. He states that “In the meantime, on Tuesday the Globe posted a link to an abbreviated form of the Associated Press story. A day late and a dollar short.”

I don’t profess to know what methods Mr. Blaxill used when he couldn’t unearth the story on the globe.com webiste. I know that I used “autism” as the search term and quickly found this story, which came out Monday, October 5. There is also the abbreviated AP story that the Globe put out on Tuesday, which Mr. Blaxill references.

What can we say about the whole debacle? It is a big mess. It is a big mess that started when someone at the CDC told Lee Grossman of the Autsim Society of America some confidential information. That person at the CDC screwed up.

Isn’t that just a bit sad? Trusting a prominent representative of a major autism organization has been shown, in this case, to be a mistake.

I won’t say that Mr. Grossman made a mistake by talking to David Kirby. An error in judgment, yes. Mistake, no. Mr. Kirby’s track record of presenting any data in a very biased mode to promote vaccines-causing-autism is quite well established.

I didn’t see any mainstream press coverage that included any of Mr. Kirby’s talking points. He was able to get a prominent spot in the google news searches on autism with his Huffington Post piece.

The main fallout seems to be (a) the CDC will probably clamp down on giving out information and (b) the press has an impression that autism advocates are irresponsible with information.

Paul Offit explains the money side of the rotavirus vaccine he worked on

14 Sep

Misinformationists love a vacuum. Unfortunately, Dr. Paul Offit left them a big opening by not disclosing how much his hospital, the Childrens Hospital of Philadelphia (CHOP), paid him as his share of the royalties from the sale of the rights to his rotavirus vaccine invention.

Dr. Offit invented a rotavirus vaccine, together with CHOP faculty members Dr. Stanley Plotkin and Dr. Fred Clark. This vaccine was commercialized as RotaTeq. CHOP is reported to have been paid $182M, with a net income of $153M.

From that, Doctors Offit, Plotkin and Clark would have been paid an inventor’s share.

In my opinion, it was sufficient for Dr. Offit to acknowledge that it was a significant amount of money.

Mr. Mark Blaxill and Mr. Dan Olmsted of the Age of Autism blog felt differently. They felt it necessary to put an number to Dr. Offit’s royalty payment from CHOP.

Dr. Offit and CHOP declined to respond to their request for information on this subject.

As a point of interest: CHOP didn’t respond to my request, made at that time, either.

In this information vacuum, Misters Blaxill and Olmsted used public information from a scattering of sources to estimate that Dr. Offit was payed between $29M and $55M.

They were off by about a factor of 10.

As noted in a recent post, I showed how one could easily make an accurate estimate of the royalty payment from that sale, and it was about $6M. Misters Olmsted and Blaxill, who spent a considerable amount of time scouring information from the University of Arkansas to the University of California missed the easily obtainable public information on the CHOP website.

Before I wrote that piece, I contacted Misters Blaxill and Olmsted with the correct information, even including a statement that Dr. Offit had acknowledged that the estimate I came up with was accurate. I was informed that a public statement was necessary by Dr. Offit.

I found this odd because on Sept. 9, a statement by Dr. Offit was reported.

This was originally run on the blog “Countering the Age of Autism” as Paul Offit explains the money side of the rotavirus vaccine he worked on, by David N. Brown, frequent poster to this site and owner of the Evil Possum website.

In an email correspondence with David Brown August 18, 2009, Dr. Paul Offit writes:

David,

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. It was a ridiculous amont of money and certainly far more than any of us needs, but it is also a far cry from what has been claimed.

But the part that hurts the most is the continued claim that we did this for the money. I don’t know any scientist who does it for the money (you certainly don’t make much in salary). You do it because it’s fun and because you think you can contribute. And the reward for creating a vaccine was also never financial. The reward was watching this vaccine dramatically reduce the incidence of rotavirus hospitalizations in the US and now getting to watch the vaccine enter the developing world in countries like Mali, Bangladesh, Vietnam, Ghana, and Nicaragua. That’s why we did it.

It hurts to watch people slander me the way they do. They just don’t know me. Or any of us that work so hard to get a technology like the rotavirus vaccine to the countries where it will save the most lives.

Paul

Reprinted with permission from David Brown and Dr. Paul Offit.

Paul Offit responds to the press release by NAA (and carried by AoA)

14 Sep

The National Autism Association put out a press release last week that was an amazing piece of work. Just not in a good way.

I was not the first to comment on it. Below is a post from the Countering Age of Autism blog that I asked to rerun here.

So, with permission:

On the 8th, NAA sent out a press release rehashing the same misinformation that AoA habitually runs (it’s almost like they got it right from them and Wakefield. They probably did). AoA picked it up and ran with it, and I spent a fair portion of my day trying to figure out who NAA was as well as mount an adequate rebuttal. I don’t know that it’s an adequate rebuttal, but it is what I can do.

I appreciate the researchers who work tirelessly in labs trying to figure out ways to save lives. I admire the diligence and commitment it takes to work for over two decades on one vaccine because you believe in it that strongly. Now, I don’t reach the level of adoring fan like Wakefield’s groupies apparently do (if you saw the Friday morning piece on the Today show before the Sunday Dateline, you know what I’m talking about), but I’m not a groupie kind of gal. Maybe those women are. My point is, this isn’t blind adoration speaking. I’ve read Dr. Offit’s books, all of them, because I wanted to know more about vaccines (read those first), and I read Autism’s False Prophets, as well, because I wanted to see what he’d found out.

For most of my son’s (who will be 20 this year) life, I have been focused on HIM. I homeschooled him for ten years, I spent the years before that often all day in the school system with him. He was the center of my world as I worked with him to help him. I didn’t join support groups; I didn’t talk to a lot of parents with autistic children. My husband and I labored alone for the most part. I wasn’t desperate; I was determined. I read everything I could on autism, mostly the science because I am so not into the woo. If it was woo, I stayed away from it. Until March of this year when I realized how much was out there.

Why did I start looking, now, after all these years? My daughters are on the spectrum as well. They are 12 and 14 years younger than their brother and it seemed like I needed to see what was out there. Especially since I have students who ask about vaccines and autism. I delved deep into the science of it, and then into the woo. Not all the woo, mostly the easy access free stuff at Huff and AoA and like autism organizations. Gods, but there is a frakload of woo out there. And really nasty behavior on the part of the woo-ites. Like the threats that Dr. Offit receives. Not acceptable behavior period.

So, when this stuff hit, I emailed Dr Offit to ask if he’d like to rebut this latest round of trash talk. And, thankfully, he did.

And here is the email that Countering Age of Autism posted:

Run with the permission of Dr. Offit:

Dear Kim,

Thanks for the support. At some point those who believe that vaccines cause autism will realize that I’m not their problem. The data are their problem. But I guess, absent supportive data, it’s easier and more satifying to attack me (I would also like to point out that I didn’t do any of these studies that exonerated vaccines as a cause of autism; I just explain them to the media).

Although it might sound crazy, I take some solace in the fact that those who oppose vaccines continue to get the facts wrong. It’s somewhat reassuring to know that they hate me for the wrong reasons. And the Huffington Post blog by James Moore, a well-respected journalist, is completely off the mark. I would have expected more.

1) I am not a paid consultant to Merck.

2) I never “voted myself rich” while I was on the ACIP. RotaTeq came up for a vote in 2006, three years after I was no longer a voting member. And even if I were a member, I wouldn’t have been allowed to vote. Further, I consistently declared my potential conflict. Although some people may find this hard to believe, I’m actually proud to be the co-inventor of the rotavirus vaccine and was more than happy to declare this at the beginning of every meeting.

3) What (the hell) does being the co-inventor of a vaccine have to do with standing up for the science of vaccine safety. It certainly doesn’t affect my financial position one way or the other. I do it because I think that children are getting hurt by all of this (the same reason I went into pediatrics and worked on vaccines). The logic of the anti-vaccine folks escapes me here. Let me see if I’ve got this right; I invent a vaccine that can save as many as 2,000 lives a day so that I can make money so that I can lie about vaccine safety so I can hurt children.

4) I do not receive salary support or laboratory support from the Hilleman endowed chair. Five percent of that endowment does go to support members of our division, but not me.

5) I never received one penny of the $350,000 claimed in the Burton report. All of that money went to Dr. Fred Clark. I was totally supported by grants to NIH.

I really do appreciate your support, Kim. Few seem to be willing to stand up for me. And it does occasionally get me down. But mostly it just makes me angrier and more determined to hang in there.

Best,

Paul

Circling the Wagons

29 May

The alternative medicine community is certainly loyal to their own. This seems especially true in the world of Autism where no idea is ever abandoned, no practitioner ever criticized.

After the Chicago Tribune published articles on the Geiers (and here), as well as Dr. Mayer Eisenstein, it was a forgone conclusion that the community would close ranks.

These articles were published right before the AutismOne conference–which chose to honor Andrew Wakefield after news was released that he may have altered his data. See what I mean? No quicker way to be a hero than to have really the skeletons in your closet made public.

The most basic response was from Kim Stagliano, who let this tweet on Twitter:

From Kim: Chicago Trib is close to dead. Suddenly launches full frontal attack on autism during Autism One. AAP in backyard. They hear us.

Yes, the Tribune is bad and in the pockets of the AAP and the AAP are evil. Please.

Dan Olmsted came out rather quickly with a piece in the Age of Autism blog in defense of the Geiers and Dr. Eisenstein. Later, Anne Dachel did another piece.

Both use a simple contrivance: avoid the real questions raised by the article. Instead, write about “what the Tribune story should have included”. This is especially true of Anne Dachel, who went on and on over pretty much all the media talking points of the vaccines-cause-autism movement.

For example, both Mr. Olmsted and Ms. Dachel thought the Tribune should have discussed Dr. Bernadine Healy. The connection to the story? None. But, Dr. Healy is vitally important to the story Olmsted and Dachel want to tell. See what I mean?

Dan Olmsted’s method sidestepping of the real questions was rather poorly done. In his piece, he writes:

The article lumps Lupron — about which I know nothing, and have no opinion — in with alternative approaches like diet, about which I do know something, and do have an opinion.

Frankly, I found this a ridiculous statement. Dan Olmsted was attending the AutismOne conference–a conference which for years has hosted talks by Mark Geier on Lupron and which Dan Olmsted has attended for years. I guess he missed the Geier talks?

It isn’t as though Mr. Olmsted isn’t able to form an opinion on scant data. Mr. Olmsted has shown a particular interest in Kathleen Seidel–to the point where Mr. Olmsted “diagnosed” her kid with mercury poisoning based on a paragraph in the book Autism’s False Prophets. From only a snippet (wrongly interpreted by Mr. Olmsted) about one of Ms. Seidel’s previous jobs, Mr. Olmsted claimed that she had high levels of mercury, and further stated:

Laugh me off if you want, but I have spent a lot of time looking for plausible links between parents’ occupations and autism in their children, and I know them when I see them.

So, he’s willing to go out on a limb based on a few words in a book, but, say, the page after page that Ms. Seidel wrote about the Geiers and Lupron (e.g. here, here and here) left no impression?

Sorry, Mr. Olmsted. I know ’em when I see ’em too. I see you dodging really tough questions about the Geiers in an effort to protect one of the big names in autism psuedoscience.

To further point out how silly the “about which I know nothing, and have no opinion”, one of the readers of that blog piece pointed out:

Dan, last year AoA published a post from Kent Heckenlively entitled “MERCURY, TESTOSTERONE AND AUTISM – A REALLY BIG IDEA!” In the comments, you said that you had gone to the Geiers’ house and witnessed a child receive a Lupron injection and improve immediately. You “just had to put this on the record,” you said.

I take the fact that Mr. Olmsted has gone from Lupron shill to even this weak distancing himself from Lupron (“I know nothing”) as a good sign. Even Dan Olmsted must be seeing the cracks in the Lupron Logic.

Ms. Dachel does her own “two step” around the question of her real opinion on Lupron.

Let me say that I’m not an expert on any of the medical aspects of this; I’m merely an observer. So here’s what I’m seeing.

Since when does not being an expert on the medical aspects stopped anyone at the Age of Autism blog from making very clear opinionated statements?

But, again, I take the clear signal that she is willing to distance herself from Lupron as a small, but positive sign.

So, let me use their contrivance–let me list what Mr. Olmsted and Ms. Dachel should have written about in their blog pieces. Let me list many of the real questions raised by the articles in the Tribune. As you read this list, it will become obvious why the Olmsted/Dachel tag-team avoided these questions: these are serious questions about people possibly harming children with autism and Dan Olmsted and Anne Dachel don’t have answers to these questions.

At least, they don’t have answers which would satisfy their readership.

Here is the list of questions I had after reading the Tribune articles:

1) Are parents still being sold the idea that Lupron will help remove mercury from their autistic children?

2) Are parents still being told that mercury causes autism? (OK, we all know the answer to that one. The answer is yes. No amount of data will convince Mr. Olmsted.)

3) Are the diagnoses of “precocious puberty” valid? Would a real pediatric endocrinologist agree with the Geier’s assessments? From the Tribune, quoting an actual expert in precocious puberty:

None of the data verify or even suggest that any of these patients have precocious puberty.

4) What is the purpose of all the extra lab tests the Geiers are performing? Are they for the Geiers’ research? If so, why should the parents (or their insurance) foot the bill?

5) Why do the Geiers use 10 times the normal dosage of Lupron?

5) Is Lupron being used as a chemical restraint?

6) Does Lupron even work well enough to warrant its use? Given that Dr. Eisenstein is reported to be close to dropping Lupron, it clearly isn’t a “miracle drug”.

7) what are the side effects of extended use of Lupron. Especially, what are the side effects of wrongly delaying puberty? According to the Tribune story:

Experts in childhood hormones warn that Lupron can disrupt normal development, interfering with natural puberty and potentially putting children’s hearts and bones at risk.

8) Why don’t the Geiers recommend patients to see board certified pediatric endocrinologists?

9) If precocious puberty is so prevalent amongst children with autism, why don’t pediatric endocrinologists see it? According to the Geiers:

Mark Geier responded that these are “opinions by people who don’t know what they are talking about,” saying the pediatric endocrinologists interviewed by the Tribune don’t treat autistic children and have not tried the Lupron treatment.

10) What about older kids the Geiers are treating? Are they being correctly diagnosed? From the Tribune story:

David Geier said his father diagnoses high-testosterone teens not with precocious puberty, but with another very rare condition: testicular hyperfunction.

How does “testicular hyperfunction” explain the older girls the Geiers have treated?

11) The effects of Lupron on sex hormones are temporary. Stop the shots, the hormones return. The loss of the beneficial effects of puberty are permanent. Does the trade off make sense?

And that is just the list of questions based on the article on the Geiers. Then there is the story about Dr. Eisenstein. This too raises a number of tricky questions.

1) Is Dr. Eisenstein a credible resource for information? After reading the article, one has to question that.

2) Would people like Anne Dachel, Kim Stagliano and Dan Olmsted recommend people see a physician whose malpractice insurance may be “phony”?

In court records dating back three decades, the families of dead and brain-damaged children repeatedly alleged that doctors who work for Eisenstein made harmful mistakes — sometimes the same error more than once. His practice also has been dogged by accusations in court records that its offshore malpractice policy was phony.

3) Would Is Dr. Eisenstein’s record of selling “illegal” health insurance troublesome?

He also dabbled in group health plan sales to Illinois families but tangled with state insurance regulators in the mid- to late 1990s. Regulators warned consumers in a newsletter that Eisenstein “continued to illegally market” the Homefirst Health Plan, based in the British Virgin Islands, even after they told him the plan was ineligible. Despite this, he continued selling the plan, records show, and they ordered him to “cease and desist.”

4) Dr. Eisenstein seems to be good at blameshifting. In this case he accuses the parents of making a mistake that appears to be clearly that of his colleague at HomeFirst. Is this the sort of doctor parents of autistic kids should be seeing?

A Homefirst doctor took a sample of blood from Na’eem’s umbilical cord that could have been used to diagnose the problem and could have led to prompt treatment, according to court testimony. But instead of dropping off the sample at the lab, the doctor said under oath, he was tired, went home and put the sample in his refrigerator, where it sat the whole weekend.

In an interview, Eisenstein blamed the parents for not taking the baby to the emergency room for a blood test. Na’eem’s parents testified that no one from Homefirst ever told them to go to the emergency room.

5) Dr. Eisenstein appears to make some rather questionable decisions about insuring his own practice. Also, it appears from this quote that perhaps he has gone without malpractice insurance. Again, is this the sort of doctor parents of autistic children should be using?

After Nathan Howey’s death, Weiss Hospital sued Homefirst, Rosi and Eisenstein for fraud, alleging they misrepresented their Caribbean-based malpractice policy. Eisenstein testified that he was in St. Kitts helping one of his daughters, a veterinary student there, buy a condo when the lawyer who helped arrange the sale told Eisenstein he also sold malpractice insurance.

“I was tickled pink to get insurance,” he said under oath.

A Cook County judge called it an “improperly underwritten insurance plan.” Eisenstein, who says the policy is legitimate, agreed to pay Weiss $50,000 after mediation.

6) Dr. Eisenstein appears to have inflated his credentials:

Eisenstein said under oath that he was a faculty member at the Hinsdale Hospital Family Practice Residency Program from 1992 to 2003. A hospital administrator testified that Eisenstein “never was” a faculty member. In a recent interview, Eisenstein said that while he wasn’t a faculty member there, he did teach students from that program and kept snapshots of them.

(anyone else reminded of Vera Byers, witness for the petitioners in the Omnibus, who claimed to be faculty at UCSF? In reality, she used the library and attended parties there.)

7) Lastly, is this the type of doctor we should be taking our kids to?

Reflecting on the $1.275 million malpractice settlement, he appeared unshaken.

“It’s the cost,” he said, “of doing business.”

I’m sure the parents were glad to hear that their kid’s life was “the cost of doing business”.

There are a lot of questions raised by these stories. Hard questions. Questions Mr. Olmsted, Ms. Dachel and Ms. Stagliano should answer if they want to really serve their readership.

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