The first official sounding of the death knell for the ‘hidden horde’ hypothesis of autism (it must be vaccines because there aren’t 1 in 160/150/100 adult autistics) was recently sounded (as reported by Anthony) when an NHS study announced that the rate of autism amongst adults was 1% – exactly the same as for kids.
Fully aware of the implications for their beloved anti-vaccine hypothesis John Stone and Polly Tommey write/star in a recent post on that repository of all things bullshitty – Age of Autism.
NHS Autism Report suggests the increase in autism in recent years was all down to an oversight
Says John Stone, trying to reassure his readership theres still life in the terminal old dog of the hidden horde hypothesis. And why does he say this?
“Are we really able to believe all that we hear on such important subjects, or is there a stronger hand with adifferent agenda behind it?”
Ahhhh, of course! When a piece of science/news story doesn’t support your point of view then it _must_ be the work of….oh, whoever – Illuminati? Out of control government? GAVI? Take your pick.
But surely Stone and Tommey have better reasons than that…? Don’t they?
Well no, not really. They didn’t like the perfectly valid Autism Diagnostic Observation Schedule that was used. Although they don’t refer to it by name, instead they cherry pick questions to try and demean the validity of the test.
The report was based on adults living in households throughout England and the assessments were done in two stages. Stage One asked individuals to rate how well they agreed with 20 statements about their likes, dislikes and abilities – such as whether they preferred going to ‘libraries’ or ‘parties’.
…If the full range of ability had been included in the NHS report, alongside the verbally fluent, high functioning adults living at home, there would surely be far more than 1 in 100. So, either there are more adults than children with an ASD and autism is on the decline(!?) or there is something wrong with the report.
A quick glance at many mainstream autism orgs claim on prevalence would show Stone that yes, there are more autistic adults than children. This report could indeed be interpreted to show a decline in autism.
People will claim that thats counter intuitive but it really isn’t. As autism has become more recognised, better diagnosed and there are more centers worldwide for its early detection, child numbers have not risen but have become more apparent. This is true across the whole ‘spectrum’.
Taking the NAS numbers on prevalence They say that at a rate of 1 in 100 children gives a total of around 133,500 kids with an ASD. This leaves 366,500 adults. A rate of 0.8%.
So the estimate prior to the new report was 0.2% out. But Stone was right, there are now (and always were) more ASD adults than kids. Thats because there are more adults in the general population than kids. In terms of whether the _rate_ of autism has decreased there’s no research to compare this to but an estimate of 0.8% is pretty damn close to 1%. In real terms the NAS were only out by 733 adults. So I would say that this report reflects reality – with no doubt regional variance and other factors, the adult rate is (and always was) around 1%.
But the stoopid continues apace:
One thing is clear, however, the report has no relevance to children withautism like my son Billy and the many thousands like him.
Quoth Polly Toomey who somehow missed the point that this was a study of adults and thus was never going to have much relevance to her children.
We’re then treated to the science of Carol ‘try me shithead‘ Stott who personally received over £100,000 of legal aid money to prop up the dead MMR hypothesis. She claims (after further digs at ADOS) that a ‘further detailed critique’ will be appearing in that robust science journal AutismFile….owned and operated by one Polly Tommey.
So there we have it. This new study, which whilst far from 100% perfect is also far from the dead dog portrayed by the purveyors of science at The Autism File and Age of Autism. They think theres a conspiracy to ‘big it up’ and refuse to see the statistical truth. ASD hasn’t ever been in epidemic, theres been a stable rate for a long time. These dealers in anti-vaccinationism will just have to deal with that.
Autistic spectrum disorders encompass etiologically heterogeneous persons, with many genetic causes. A subgroup of these individuals has mitochondrial disease. Because a variety of metabolic disorders, including mitochondrial disease show regression with fever, a retrospective chart review was performed and identified 28 patients who met diagnostic criteria for autistic spectrum disorders and mitochondrial disease. Autistic regression occurred in 60.7% (17 of 28), a statistically significant increase over the general autistic spectrum disorder population (P < .0001). Of the 17 individuals with autistic regression, 70.6% (12 of 17) regressed with fever and 29.4% (5 of 17) regressed without identifiable linkage to fever or vaccinations. None showed regression with vaccination unless a febrile response was present. Although the study is small, a subgroup of patients with mitochondrial disease may be at risk of autistic regression with fever. Although recommended vaccinations schedules are appropriate in mitochondrial disease, fever management appears important for decreasing regression risk.
The authors note neurologic regression in general (not just autistic regression) is observed with patients who have metabolic diseases:
Patients with mitochondrial diseases, like many patients with metabolic diseases, are at increased risk of neurologic regression in conjunction with stressors such as fever, infection, and dehydration.
They studied 28 patients who met DSM-IV criteria for autism and diagnostic criteria for mitochondrial disease.
They define regression and whether it is related to fever thusly:
Autistic regression was defined as loss of developmental skills that included speech, receptive skills, eye contact, and social interests in individuals ❤ years of age. A relationship between fever and autistic regression is defined as regression beginning within 2 weeks of a febrile episode without the suggestion of infectious meningitis or encephalitis.
One comment–the definition of regression is somewhat vague to me. What is also critically important in this discussion is whether there were any signs of autism before the regression. Or, as some may put it, is this regression into autism or autistics undergoing regression? Is there a mix of pathways?
They state that 17 of the 28 patients studied underwent an autistic regression. This is higher than the roughly 25% value for autistic regression they assumed for the general autism population, and statistically significant.
In other words, they are saying that autistic regression may occur more often with kids with mitochondrial diseases.
They note that some of the fevers could be linked to vaccination:
The 17 individuals with autistic regression could be divided into 2 groups, those who regressed with fever (70.6%, 12 of 17) and those who regressed without identifiable linkage to fever or vaccinations (29.4%, 5 of 17).
And,
No individual showed regression with vaccination unless a febrile response was present.
They discuss the concerns with vaccination in the conclusion, noting that vaccination is still recommended for children with mitochondrial diseases. My experience in discussing this issue with mitochondrial disease experts is that they find vaccination to be extremely important. If, for some reason, they decide to not vaccinate a child with mitochondrial disease, they insure that all family members are vaccinated to protect the child.
Children with identified mitochondrial diseases are routinely managed carefully by their physicians with aggressive fever control and hydration. In this context, vaccination of children with mitochondrial diseases is recommended. In our experience, the vast majority of patients with mitochondrial diseases receives a full vaccination schedule according to American Academy of Pediatric guidelines without consequences, particularly when physicians are sensitive to fever control and hydration. In our patients with mitochondrial disease and autistic spectrum disorders, the vaccines did not appear related to the neurologic regression.
I will note again that I feel autistic regression as defined is too vague. Were the patients on the spectrum before the regression? Were they typically developing before the regression?
At least two children were noted to have multiple regressions (a sibling pair). That indicates that at least in some cases, regressions occurred in people already autistic. There just isn’t other information on this.
Another area I would like to see discussed further is on siblings:
Affected siblings were identified in 35.7% (10 of 28).
Affected how? Mitochondrial disease. But, are they also autistic? It would seem not since they included one sibling pair.
This is a big question to me. While the spotlight has been shown on the possibility of mitochondrial disorders being linked to autistic regression, the more general question is more important: could fevers induced by vaccination result in any regression (autistic or otherwise) in people with mitochondrial disorders.
Another question in my mind in this study. Are there patients who underwent regression from non-autistic to autistic) after age 3? According to the Johns Hopkins group, this doesn’t happen. According to them, there is an age window where the regressions could result in autism. This is a very important question in how these patients might fit in to the broader spectrum of autism.
Using the recommended threshold of a score of 10 or more on the Autism Diagnostic Observation Schedule, 1.0 per cent of the adult population had ASD. Published childhood population studies show the prevalence rate among children is also approximately 1.0 per cent.
The ASD prevalence rate was higher in men (1.8 per cent) than women (0.2 per cent). This fits with the gender profile found in childhood population studies.
There is no indication of any increased use of treatment or services for mental or emotional problems among adults with ASD. This is borne out by the recent National Audit Office publication “Supporting People with Autism Through Adulthood”.
A greater proportion of single people were assessed with ASD than people of other marital statuses combined. This was particularly evident among men.
Prevalence of ASD was associated with educational qualification, particularly among men. The rate for men was lowest among those with a degree level qualification and highest among those with no qualifications.
Understandably, the BBC have focused on an aspect not covered by these key points. The fact that the existence of a similar proportion of autistic adults to the proportion of children who are autistic undermines the idea that MMR vaccine has led to an increase in autism.
Latest autism figures should dispel any fears about the MMR jab being linked to the condition, say experts.
The NHS Information Centre found one in every hundred adults living in England has autism, which is identical to the rate in children.
If the vaccine was to blame, autism rates among children should be higher because the MMR has only been available since the early 1990s, the centre says.
Rather strangely the BBC provides a link on that news story to the JABS website, which continues to scaremonger about MMR and other vaccines. That editorial decision shows just how difficult it is going to be to ever disentangle vaccine conspiracy theories from autism.
I am constantly amazed at the low level of proof people use to demonstrate that vaccines cause autism.
Case in point, David Kirby and his recent post on the Age of Autism blog (and, a I write this, The Huffington Post).
He takes an abstract from a poster session and declares victory in the war to prove vaccines cause autism.
Here’s the abstract:
HEPATITIS B VACCINATION OF MALE NEONATES
AND AUTISM
CM Gallagher, MS Goodman, Graduate Program in Public
Health, Stony Brook University Medical Center, Stony Brook, NY
PURPOSE: Universal newborn immunization with hepatitis
B vaccine was recommended in 1991; however, safety
findings are mixed. The Vaccine Safety Datalink Workgroup
reported no association between hepatitis B vaccination
at birth and febrile episodes or neurological adverse
events. Other studies found positive associations between
hepatitis B vaccination and ear infection, pharyngitis, and
chronic arthritis; as well as receipt of early intervention/
special education services (EIS); in probability samples of
U.S. children. Children with autistic spectrum disorder
(ASD) comprise a growing caseload for EIS. We evaluated
the association between hepatitis B vaccination of male
neonates and parental report of ASD.
METHODS: This cross-sectional study used U.S. probability
samples obtained from National Health Interview Survey
1997–2002 datasets. Logistic regression modeling was used to
estimate the effect of neonatal hepatitis B vaccination on
ASDrisk amongboys age 3–17 years with shot records, adjusted
for race, maternal education, and two-parent household.
RESULTS:Boyswho received the hepatitis B vaccine during
the first month of life had 2.94 greater odds for ASD (nZ31
of 7,486; OR Z 2.94; p Z 0.03; 95% CI Z 1.10, 7.90)
compared to later- or unvaccinated boys.Non-Hispanicwhite
boys were 61%less likely to haveASD(ORZ0.39; pZ0.04;
95% CIZ0.16, 0.94) relative to non-white boys.
CONCLUSION: Findings suggest that U.S. male neonates
vaccinated with hepatitis B vaccine had a 3-fold greater risk
of ASD; risk was greatest for non-white boys.
What did they do? They looked at data from the National Health Interview Studies, and looked at autism and hepatitis B vaccination. They used surveys from 1997 to 2002, with children aged from 3 to 17.
Mr. Kirby was kind enough to post an image of the poster to the EOHarm group.
The autism group had 33 kids total. Of these, 9 of 31 (29%) were given the HepB vaccine. Compare this to 1,258 of 7,455 (17%) of the non-autism group who were given the HepB.
9 out of 31.
Are the red flags up yet? They should be.
Take for example kids aged 17 in the 1997 survey. When were they born? That’s right, 1980.
When was the Hepatitis B vaccine introduced? 1991. According to Mr. Kirby himself, the HepB vaccine didn’t get fully implemented until about 1996.
A lot of the kids were born before the “epidemic” of autism. No one disputes that the number of people identified with autism has gone up significantly in the last 30 years.
So, pretty much anything that changed in that time would “correlate” with autism.
This is how we get studies that “show” that Cable TV causes autism. And, now, the Hepatitis B vaccine causes autism.
Dr. Andrew Wakefield, not of Thoughtful House in the U.S., has recently been called before the General Medical Council for a “fitness to practice hearing”. The allegations stem from activities related to his research of about 10 years ago on children (many autistic).
I recently discussed two of incidents being investigated: a birthday party where blood was drawn from typically developing children (for controls) and activities related to his invention and the subsequent patent his hospital (the Royal Free) applied for. I found it interesting to see these layed out, so I decided to post them here for others to read as well.
These are allegations. The process has not concluded, nor has any decision been reached.
This is a short version. A detailed list (93 pages) can be found on Brian Deer’s website. Note that these 93 pages include allegations against Doctors Murch and Walker-Smith.
Dr Andrew WAKEFIELD GMC Reference number: 2733564
Professor John WALKER-SMITH GMC Reference number: 1700583
Professor Simon MURCH GMC Reference number: 2540201
The GMC’s statutory purpose is to protect, promote and maintain the health and safety of the public by ensuring proper standards in the practice of medicine.
We investigate complaints about individual doctors in order to establish whether their fitness to practise is impaired and whether to remove or restrict a doctor’s registration.
The GMC does not regard its remit as extending to arbitrating between competing scientific theories generated in the course of medical research.
The following is a summary only of the allegations which will be made before the Panel at the forthcoming hearing.
The Panel will inquire into allegations of serious professional misconduct by Dr Wakefield, Professor Walker-Smith and Professor Murch, in relation to the conduct of a research study involving young children from 1996-98.
Dr Wakefield, Professor Walker-Smith and Professor Murch, were at the relevant times employed by the Royal Free Hospital School of Medicine with Honorary Clinical contracts at the Royal Free Hospital.
It is alleged that the three practitioners were named as Responsible Consultants on an application made to the Ethical Practices Committee of the Royal Free Hospital NHS Trust (“the ethics committee”) in 1996 to undertake a research study involving children who suffered from gastrointestinal symptoms and a rare behavioural condition called disintegrative disorder. The title of the study was “A new paediatric syndrome: enteritis and disintegrative disorder following measles/rubella vaccination”. The Panel will inquire into allegations that the three practitioners undertook research during the period 1996-98 without proper ethical approval, failed to conduct the research in accordance with the application submitted to the ethics committee, and failed to treat the children admitted into the study in accordance with the terms of the approval given by the ethics committee. For example, it will be alleged that some of the children did not qualify for the study on the basis of their behavioural symptoms.
It is further alleged that the three practitioners permitted a programme of investigations to be carried out on a number of children as part of the research study, some of which were not clinically indicated when the Ethics Committee had been assured that they were all clinically indicated. These investigations included colonoscopies and lumbar punctures. It is alleged that the performance of these investigations was contrary to the clinical interests of the children.
The research undertaken by the three practitioners was subsequently written up in a paper published in the Lancet in February 1998 entitled “Ileal-Lymphoid-Nodular Hyperplasia, Non-Specific Colitis and Pervasive Developmental Disorder in Children” (“the Lancet paper”).
It is alleged that the three practitioners inaccurately stated in the Lancet paper that the investigations reported in it were approved by the ethics committee.
The Panel will inquire into allegations that Dr Wakefield and Professor Walker-Smith acted dishonestly and irresponsibly in failing to disclose in the Lancet paper the method by which they recruited patients for inclusion in the research which resulted in a misleading description of the patient population in the Lancet paper. It is further alleged that Dr Wakefield gave a dishonest description of the patient population to the Medical Research Council.
The Panel will inquire into allegations that Dr Wakefield and Professor Walker-Smith administered a purportedly therapeutic substance to a child for experimental reasons prior to obtaining information about the safety of the substance. It is alleged that such actions were irresponsible and contrary to the clinical interests of the child.
The Panel will inquire into allegations that Dr Wakefield was involved in advising solicitors acting for persons alleged to have suffered harm by the administration of the MMR vaccine. It is alleged that Dr Wakefield’s conduct in relation to research funds obtained from the Legal Aid Board (“LAB”) was dishonest and misleading. It will be alleged that Dr Wakefield ought to have disclosed his funding from the LAB to the Ethics Committee but did not.
The Panel will inquire into allegations that Dr Wakefield ordered investigations on some children as part of the research carried out at the Royal Free Hospital from 1996-98 without the requisite paediatric qualifications to do so and in contravention of his Honorary Consultant appointment.
The Panel will inquire into allegations that Dr Wakefield failed to disclose his involvement in the MMR litigation, his receipt of funding from the LAB and his involvement in a Patent relating to a new vaccine to the Editor of the Lancet which was contrary to his duties as a senior author of the Lancet paper.
The Panel will inquire into allegations that Dr Wakefield acted unethically and abused his position of trust as a medical practitioner by taking blood from children at a birthday party to use for research purposes without ethics committee approval, in an inappropriate social setting, and whilst offering financial inducement.
We cannot guarantee that all those wishing to attend the hearing will be able to do so, as seating is limited. If you plan to attend the hearing please email the GMC press office press@gmc-uk.org. In the event that we have to allocate seats those people who have notified the press office will be seated before others.
-Ends-
Greater detail can be found in this document, hosted on Brian Deer’s website. It is 93 pages of details of the allegations against Dr. Wakefield, Dr. Walker-Smith and Dr. Murch.
As a bit of background: before Dr. Wakefield’s 1998 Lancet article was published, his hospital, the Royal Free, had submitted a patent application for an invention of Dr. Wakefield’s. The application was titled, “PHARMACEUTICAL COMPOSITION FOR TREATMENT OF IBD AND RBD”
IBD is “inflammatory bowel disease”
RBD is “regressive behavioural disease” “(also referred to as pervasive developmental disorder)”
(definitions taken from Dr. Wakefield’s Great Britain patent application 2,325,856)
As you might assume from the title, the patent has as a main thrust the idea that certain transfer factors could be used therapeutically. In other words, the main point appears to be to use this as a treatment. This does not exclude the fact that the patent also includes a claim for a classic, preventive vaccine.
The original patent application, filed June 6 1997 (before Dr. Wakefield’s first autism paper in The Lancet), is shown on Brian Deer’s website.
There are nine claims to the patent. Eight of which relate to the proposed treatment. Claim two, however, states:
The composition according to claim 1 adapted for use as a vaccine for the prophylaxis of measles virus.
The existence of such a patent application raises the obvious question of conflict of interest. In other words, was there the possibility that Dr. Wakefield’s invention could result in royalty payments to Dr. Wakefield for a vaccine? Could he profit from what amounts to a single vaccine for measles (as opposed to the combination virus MMR vaccine)?
Dr. Wakefield in a previous statement (again hosted on Brian Deer’s website):
The reference to the possible use of TF [transfer factor] to protect children against measles infection – the thrust of the Sunday Times’ conspiracy theory – was put in as an afterthought in the patent. It was entirely speculative and never pursued in any shape, manner or form.
The provisional patent filing was entirely speculative and was for a possible therapy; as such, it had no bearing on the 1998 Lancet paper.
Note that Dr. Wakefield acknowledges that his invention was claimed to be able to protect against measles infection. As we will see below, this is in direct contrast to his statements on Dateline.
Before we delve into that, I must strongly disagree with Dr. Wakefield as to whether this had bearing on the 1998 Lancet article. Part of the patent application clearly claims the use of the invention as a vaccine. Whether the invention was speculative or that the main use was as a therapy is immaterial. The appearance of a financial conflict of interest should have been reported to The Lancet, the referees, and to the press, in my opinion.
In his statement, Dr. Wakefield goes on to say:
It constituted no potential conflict until the patent was awarded.
Again, I strongly disagree. If the patent was a potential conflict of interest, so was the application. Both are a potential to profit.
Also, if the patent itself is a potential for profit, how can one justify the previous argument that the application was not a conflict since it was merely “for a possible therapy”? Again, if the language of the patent was a potential conflict due to the inclusion of the vaccine, the application was a potential conflict as well.
So, after that long introduction, what did Dr. Wakefield have to say to Matt Lauer?
Dr. Wakefield is back to denying that the invention was for a vaccine to prevent measles and is claiming it as merely a therapeutic agent.
But as we have already seen above, this is not what the patent states. This isn’t even consistent with Dr. Wakfield’s own previous comments.
Here is the section where Matt Lauer of Dateline interviewed Brian Deer on the topic:
First impression: Matt Lauer’s team messed up with the statement that the vaccine was “for the elimination of MMR”. I heard that statement as though the purpose of the Wakefield vaccine was to eliminate the MMR as a vaccine. The wording of the first sentence of the patent application is:
The present invention relates to a new vaccine for the elimination of MMR and measles virus and to a pharmaceutical composition…
I read this as the vaccine for the elimination of the MMR viruses from someone with a persistent infection of one or more of measles/mumps/rubella, not as for the elimination of the MMR vaccine itself.
It is not well worded.
The statement from the patent application that most clearly shows that it covers the invention as a vaccine is claim 2. It is short, clear and direct to the point.
The composition according to claim 1 adapted for use as a vaccine for the prophylaxis of measles virus.
This is what Dateline should have used, in my opinion.
I think the segment below clearly shows that part of the intention of the invention was as a vaccine for the prevention of measles which is purported to be safer.
fragment of Dr. Wakefield's original patent application
Back to the interview, I think that Mr. Deer makes a key point in stressing that the patent application discussed the invention as a “safer” vaccine. This makes it more clearly a possible contender to replace the MMR vaccine as a product.
Brian Deer notes on his website:
A letter from his lawyers dated Jan 31 2005 said: “Dr Wakefield did not plan a rival vaccine.”
It is very difficult to ascertain intentions. At a very real level, what Dr. Wakefield planned is immaterial. The fact of the matter is that there was a possibility (however remote) that Dr. Wakefield could profit if the combination MMR vaccine were removed. The appearance (at least) of a potential conflict of interest was there and should have been disclosed in the paper and press conference, in my opinion.
The information I would like to see on this would be Dr. Wakefield’s lab books (or notes, as the case may be). In particular, he is reported to have applied his “transfer factor” on at least one child. Were there any tests performed (say, measles titers?) that could have been used to justify development as a vaccine? For example, measles titers?
It is also worth noting that as far as I can see, all of the patents on this potential vaccine have been abandoned. In other words, Dr. Wakefield and/or the Royal Free Hospital do not appear to have continuing financial interests in the proposed measles vaccine, or the IBD/autism therapy.
As a final word–I find it interesting that in one of the patents Dr. Wakefield states that that the autism prevalence is about 1%. This from a document dated 1998, 10 years ago. So much for that epidemic, eh?
One of the strangest parts of the story of Dr. Wakefield’s research is the birthday party where blood was drawn from his child’s friends who were given five pounds each.
Dateline NBC included this in their recent story, A Dose of Controversy. Here are two clips from that show, spliced together:
The first thing that struck me was the explanation of the money. If I understand Dr. Wakefield correctly, he didn’t “pay” the children, they were “rewarded” at the end of the party. That makes it a different situation “in ethical terms”.
I’d like to have one of the kids at the party explain the ethical differences, as I am confused.
I guess if the kids gave the blood of their own free will, and only later the were “rewarded”…they didn’t know they would get money…in that case the money wasn’t an incentive or a coercion? Is that what is being said?
Again for those who’ve heard the story, you can put your hands over and you can take time out here, but this is again my son’s birthday party, 32 healthy controls. And you line them up – with parental informed consent, of course. They all get paid £5, which doesn’t translate into many dollars I’m afraid.
So, were they were paid? I thought we just heard that they were “rewarded”, which is different in an ethical sense.
And, what about that “at the end of the party” statement? Again, a quote attributed to Dr. Wakefield:
“One child, who’s my son’s best friend, Ollie, he put his arm out, very bold, had the tourniquet put on, and then went very pale and sort of … wait till next year. He was nine at the time, and his four year old sister came up, stuck her arm out, had the blood taken, took her five pounds and went off.
Is it important that the children were rewarded at the end of the party? My guess is that makes it less of a coercion. But, that little girl got her money right away, didn’t she?
I guess if she was the last child to have blood drawn, and this was the end of the party, this could fit in with Dr. Wakefield’s description of “end of the party.” Possible, I guess, but that is not how I saw this playing out when I first read that quote.
“And (NAME) burst into tears. Ruined his birthday party. But people said to me, Andrew, look, you know, you can’t do this, people, children won’t come back to you. [laughter]. I said you’re wrong, I said: ‘Listen, we live in a market economy. Next year they’ll want ten pounds!'”
I am having trouble figuring out how to reconcile “rewards” with “a market economy” and the children wanting a higher amount the next time.
I gather that at least part of the problem Dr. Wakefield is facing is that blood is not bought or sold in the UK (at least, there is a statement to this effect on Brian Deer’s website). As a U.S. citizen, I am used to the idea that blood is bought and sold. Paying people for blood is still a bit strange to me, but not unheard of. But from my perspective, I would have greater respect for Dr. Wakefield if he had just said (assuming it is true) that he had made a mistake.
Just in case Dr. Wakefield’s comments in print seem a bit too surreal to be true, Here is a video with a bit more of Dr. Wakefield discussing the birthday party:
note–I made a number of clarifications after this post was published.
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.
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.
The press release has the header: “Doctor Who Made Millions Off MMR Manufacturer Does Not Tell Public of His Financial Relationship during NBC Dateline Broadcast”
The NAA state further,
Dr. Paul Offit of Children’s Hospital of Philadelphia (CHOP), who was interviewed for a Dateline NBC television special, failed to tell millions of viewers that while he was promoting MMR as safe he had also made tens of millions of dollars from selling another vaccine patent to Merck, which is the manufacturer of MMR.
Let’s take a look at what was actually said, shall we?
Matt Lauer states (about 1:45 into the video clip), “Dr. Offit is a target. Not just for supporting vaccine safety, but because he himself made millions of dollars for inventing a vaccine.”
Quite frankly, the NAA is lying. Matt Lauer knew that Dr. Offit invented a vaccine and made money from his vaccine and Matt Lauer informed his audience of this. My guess if pressed the NAA will likely hide behind the Merck connection. Yeah. Like Matt Lauer and his producer didn’t know that RotaTeq is sold by Merck. (if so, that Merck logo on the RotaTeq box should have been a big clue, don’t you think?)
A minor point: Dr. Offit did not sell a vaccine patent to Merck. He assigned the rights to his invention the Children’s Hospital of Philadelphia (CHOP), a standard arrangement for an academic or industry employee. CHOP then applied for and was granted patents. CHOP (not Dr. Offit) licensed the patent to Merck, and then sold the license rights to a third party for a lump sum. Out of that sum, CHOP payed Dr. Offit, Dr. Plotkin and Dr. Clark.
The NAA press release further states:
According to CHOP documents, Offit’s share of a royalty sale for the Rotateq vaccine to Merck is a minimum of $29 million and may approach $50 million.
This is wrong. This is wrong on two counts. First, there are no CHOP documents which state that Dr. Offit’s share of the sale of the patent rights for $29 to $50M. There can’t be documents that say this because Dr. Offit’s share was about 1/10 of this amount.
How did the NAA get such incorrect information? There is a blog post, written by Dan Olmsted and Mark Blaxill which estimates this based on information they gleaned from the CHOP website. Their misinformation has been spread far since that post.
The only problem is, Dan Olmsted and Mark Blaxill were wrong. They made some big (and easily avoided) mistakes.
First mistake is that they used the incorrect Patent and Intellectual Property Policy in their calculation. That agreement wasn’t in effect when Dr. Offit and his co-inventors invented what became RotaTeq. Even Misters Blaxill and Olmsted acknowledged this in their post.
payment to inventors was based on gross income, with 50 percent distribution on the first $250,000, 30 percent on the next $250,000, 15 percent on the next $4.5 million and 10 percent on the remainder.
The bulk of the payout was 10% of net income. Not 30% as Misters Blaxill and Olmsted assumed.
The second mistake is that Misters Olmsted and Blaxill neglected the fact that Dr. Offit shared the CHOP payment with his co-inventors, Dr. Stanley Plotkin and Dr. Fred Clark.
As part of its distinguished legacy of developing vaccines to improve the lives of children, Children’s Hospital investigators Paul Offit, M.D., chief, Division of Infectious Diseases; H Fred Clark, D.V.M., Ph.D.; Stanley Plotkin, M.D.; and The Wistar Institute developed RotaTeq®, the oral rotavirus vaccine that was licensed and further developed by Merck & Co. Inc.
Dr. Plotkin is the former chief of infectious diseases at CHOP, and Dr. Clark was a research professor of Pediatrics at CHOP. Both easily confirmed through the CHOP website.
It is unequivocal that CHOP considered Dr. Clark and Dr. Plotkin to be a part of the CHOP team. The Intellectual property policy (and all standard IP policies) divide the inventors’ share amongst all inventors.
Sorry to go into such detail, but I can not figure out why Misters Blaxill and Olmsted have not corrected their mistake. One commenter to their blog pointed out that Doctors Clark and Plotkin were CHOP faculty, only to have Mr. Blaxill respond that “…Offit would have received the entirety of the CHOP inventor’s share”. I’d be interested what Mr. Blaxill based that statement upon.
CHOP is reported to have sold their rights to RotaTeq for $182M. Using the correct information, this leads to an estimated payout of about $6M. (Note, Mr. Blaxill and Mr. Olmsted report that the net income to CHOP was $153M. This would lead to about $5M payment for each inventor).
Using the correct CHOP policy, one can calculate (based on $182M):
Inventor share
50% of first $250k is $125,000
30% of the next $250k is $75,000
15% of the next $4.5M is is $675,000
10% of the remainder ($176,750,000) is $17,675,000
Total inventor share $18,550,000
This is split amongst the three inventors, leading to:
each inventor getting $6,183,333
I have confirmed that this is is an accurate estimate with Dr. Offit.
I post this calculation not as an estimate, but as a demonstration that the accurate amount could have been calculated by Misters Olmsted and Blaxill with publicly available information at the time they did their blog post Misters Blaxill and Olmsted took great efforts to find information about the inventor policies at multiple other institutions–much more effort than was required to find the accurate information on CHOP’s own website.
$6M is a lot of money, don’t get me wrong. Dr. Offit has acknowledged this in his statements. But, it is much lower than the estimate that Mark Blaxill and Dan Olmsted have publicized. The honorable thing for these two gentlemen to do now is to correct their mistake.
The real honorable thing to do is to not only correct their error, but to correct the error wherever it has propagated.
What is more important than the amount of the sale is the fact that CHOP sold its interest in the patent. Why is that important? Because that means that the amount of money CHOP can make from this patent will be unaffected by just about anything Dr. Offit does or say.
But, I’ve strayed a bit on this post, away from the NAA. The source of the misinformation is the Age of Autism blog and Misters Blaxill and Olmsted. Perhaps the NAA could use the argument that they didn’t create the misinformation, they were just passing it along? Except that the NAA sponsors the Age of Autism blog.
Back to the rest of the press release. It is an amazing piece of work. I found it especially odd when the NAA interview themselves and make it sound like news. They don’t try to hide it, they give quotes from Wendy Founier and Jim Moody…and then list themselves as the contact people for the press release.
They also interview Dr. Wakefield, who calls Dr. Offit “disingenuous” at the beginning of the paragraph, and finishes the paragraph showing concern for how people like Dr. Offit might impact the integrity of the swine flu vaccine.
Anyone detect the irony there? Dr. Wakefield (and the NAA) are so concerned about the swine flu vaccine program that they worry about Dr. Offit impacting the integrity of the program?
Talk about disingenuous.
The press release repeats one of the stranger of the accusations against Dr. Offit–the claim that he does not treat patients with autism:
Beyond Offit’s financial conflicts, autism advocates are also dismayed about the physician’s credibility on speaking about autism in general, as he does not treat patients with autism.
Unless the NAA wants to state that autistics in Philadelphia do not get infectious diseases, it is pretty certain that Dr. Offit has treated a number of autistics in his long career.
To cap this all off, the Age of Autism blog, sponsored by the NAA, ran a post advertising the NAA press release. However, instead of calling it what it is, a press release, they framed it as being “reported by Reuters”.
Yeah. They tried to make it sound like news reporting by a major outlet rather than a press release.
David Brown, please read the article before making incorrect statements. The payment to CHOP was $182 million (Wistar received a separate and earlier $45 million dollar payment). From this, Offit would have received the entirety of the CHOP inventor’s share. Benchmarks show the inventor’s distribution can range from 15-35% of royalty income, with the current CHOP policy set at 30% (a share we didn’t feature in our calculations because it is a new standard and may not have been the relevant one for Offit’s distribution). In other words, our estimate is conservative and uses a percentage that is at the very low end of the relevant range.
I informed Mr. Blaxill and Mr. Olmsted ahead of publishing this post of this information, specifically that (a) Dr. Offit did not receive the entirety of the CHOP payout and that (b) their calculation of the CHOP inventors’ share was incorrect and not even a conservative estimate. I included links they could use to confirm the information. I encouraged them to make the correction. Mr. Blaxill and Mr. Olmsted have declined.
Since there is next to zero chance that Dateline will act on them, I thought I would take a look at the talking points:
A. There has been extensive replication of the finding of bowel disease in children with autism (ASD) from five different countries. These findings have been published in peer-reviewed journals or presented at scientific meetings. It is therefore incorrect and misleading of Matt Lauer to have stated that every aspect of my original hypothesis has been disproved. On the contrary, the main findings of the original Lancet paper, that is, bowel disease in autistic children, has been repeatedly confirmed. This obvious inaccuracy requires clarification by NBC.
One of my many failings is that I am a sloppy writer and, yet, I key in on imprecise language in the work of others. Case in point:
“On the contrary, the main findings of the original Lancet paper, that is, bowel disease in autistic children, has been repeatedly confirmed. ”
“…the main point of the Lancet paper, bowel disease in autistic children…”
Very imprecise. What about bowel disease in autistic children is the finding of the Lancet article that Dr. Wakefield wants us to know? The statement is so vague that all we are left with is the fact that some autistic children have bowel disease.
This is misdirection on Dr. Wakefield’s part. It isn’t even good misdirection. The Dateline story wasn’t “the career of Andrew Wakefield, what he got right and wrong”. It was about the assertions that MMR cause autism.
Dr. Wakefield makes it appear that this statement was Matt Lauer’s. It is a fine point, but Matt Lauer didn’t state that “…every aspect of my original hypothesis has been disproved”. The statement was from the American Academy of Pediatrics, which Matt Lauer quoted with attribution.
We have identified a chronic enterocolitis in children that may be related to neuropsychiatric dysfunction. In most cases, onset of symptoms was after measles, mumps, and rubella immunisation. Further investigations are needed to examine this syndrome and its possible relation to this vaccine.
Had Dr. Wakefield himself distanced himself from the MMR-causation theory in the last 10 years, even a little, I’d think it reasonable for him to emphasize the the idea that he brought to light GI disturbances in autistic kids. But he hasn’t. It isn’t what the Dateline story was about.
The big question, if he thought this was important, why didn’t Dr. Wakefield himself emphasize that in the interview?
Dr. Wakefield’s second point:
B. The shortcomings and the flaws of the studies quoted by Dr. Offit, claiming to disprove an association between vaccines and autism, were not discussed in the program. In my interview with Mr. Lauer I took as an example a paper from Dr. DeStefano from the CDC claiming to exonerate MMR that actually showed that a younger age of vaccination with MMR is associated with a greater risk of autism. This study confirms the association and has been falsely portrayed as vindicating the vaccine. This should have been included in order to provide balance to the program.
Can someone tell me what DeStefano paper and what analysis he is talking about?
C. Reference was made to an autistic child in the vaccine court whose claim for MMR damage was overturned by the judge. No reference was made to the successful vaccine court case on behalf of the child Bailey Banks, coming just one week after the unsuccessful claim described by Mr. Lauer, in which the judge ruled that MMR vaccine can cause autism. Therefore, in the view of vaccine court, it is not a question of whether or not MMR can cause autism, but rather how many children are affected.
The case referred to in the Dateline episode was that of Michelle Cedillo. Her’s was the first “test case” to be heard by the Autism Omnibus Proceeding.
Her case was first heard by a “special master”, who denied compensation. The case then was appealed, and the judge didn’t “overturn” anything. The judge upheld the original decision.
The Bailey Banks case is one that gets debated a lot on the net. Rather than go into that again, let’s ask: how does this relate to Dr. Wakefield’s research? Perhaps I missed it as I did some very quick searches, but I didn’t find anything in the Bailey Banks decision that had anything to do with digestion/inflamation/enterocolitis/constipation/diarrhea… I think you get the idea–the case has nothing to do with Dr. Wakefield’s ideas about autism and the gut.
I.e. Wakefield’s point C is another diversionary tactic.
D. There was a complete absence of comment on the lack of any adequate safety studies of childhood vaccines and the vaccine schedule in particular. There was no mention of the admission by vaccine regulators that there is no data on the long-term safety of vaccines, the chronic disease burden caused by vaccines, and the likely potentially harmful interactions between various vaccines in the routine schedule.
Have you heard the phrase “diversionary tactic” too often yet? What does any of this have to do with whether Dr. Wakefield’s research? This is a favored diversion in online discussions of vaccines/autism. When people run out of real ammunition (and they do quickly), switch to trying to debate general safety of vaccines–and it almost worked. Instead of addressing some of your comments, I’ll move on to your fifth point:
E. Undue credibility was given to Brian Deer, a discredited freelancejournalist, whose false reporting has caused so much misunderstanding and damage to children through the misrepresentation of the doctors and parents who were seeking answers to the vaccine-autism question. Deer has repeatedly misled the public and the medical profession and has been unable to respond to clear evidence of his false reporting in the Sunday Times through the UK’s Press Complaints Commission.
Nice slam, there, Dr. Wakefield. Given the sloppy nature of your previous comments, I am impressed that you pulled this together so well.
You make it seem like it is accepted that Brian Deer is “discredited”. I guess if you don’t get out of Thoughtful House or autism-parent conventions, you might think that.
The “unable to respond…” bit is pretty classic. The Press Complaints Commission isn’t hearing the complaint until after your own GMC hearing, correct? So, I guess he has been unable to respond at the PCC. But, did that really stop him from responding? I seem to recall a pretty sharp worded response that Orac hosted on Respectful Insolence.
Didn’t you, Dr. Wakefield, bring that complaint to the PCC? If so, nice job leaving out the fact. It would come across quite differently had you stated: “…and has yet been unable to respond to clear my claims of his false reporting in the Sunday Times through the UK’s Press Complaints Commission.”
F. It was not disclosed that I have repeatedly invited Dr. Offit to take part in public debate on the safety of MMR vaccine and the false and misleading claims that he has made in the media and his book. He has refused to accept this invitation and has continued to hide from an open and honest debate.
Why would NBC waste time on this? Was it pertinent to the discussion? Answer: no.
I think they did you a favor by not mentioning it. No one looks good with the “So and So won’t debate me” argument. They just don’t. The “please debate me” argument is a staple of the crank. I doubt you wish to appear to be in that category, do you?
Academics “debate” in the literature, not on some stage. If you want to debate Dr. Offit, come up with some good research. Publish it.
Alternatively, if you want to see how a Wakefield/Offit debate comes out, read “autism’s false prophets”. If that is “hiding”, he hasn’t done a very good job of it.
G. NBC alluded briefly to the fact that Richard Horton, editor of The Lancet, was informed of my participation as a medical expert in the MMR litigation almost one year before publication of the Lancet paper in 1998. NBC failed to clarify that when Horton was challenged to respond to the fact that when he so enthusiastically denounced me and the paper in 2004 the Lancet staff was already fully aware of the facts and at that time did not consider them to be relevant. Horton refused to be interviewed by NBC and the interview segment shown was from 2004. This refusal is in sharp contrast to his willingness to denounce me in the media in 2004. NBC also failed to mention that in the light of these facts Horton has been reported to UK’s General Medical Council on an allegation of perjury.
Even if true, this is just more diversions. If you thought it important enough to fax all this information to the Lancet, why didn’t you include a conflict of interest statement in the article itself? The referees would have appreciated that, I believe. Was there any mention of potential conflicts of interest in your cover letter to The Lancet when you submitted the paper? Or in the cover letter for your acceptance? All of those were places where you should have made such statements.
H. It was unfortunate that NBC, having stated their determination to resist external pressure to distort the balance of the program, yielded to such pressure from the American Academy of Pediatrics, allowing them the final word in the program while denying representation from the National Autism Association who put forward to NBC a rational and well reasoned call for further science to resolve this very real issue.
I’m sorry, but are you seriously putting he “National Autism Association” on equal footing with the American Academy of Pediatrics? How many members does the NAA have? (a lot less than the AAP) What is the name of their journal (they don’t have one) What is the impact factor of their journal? (Pediatrics is a very well respected journal).
Given the NAA’s recent childish antics with their attempted slime job against Dr. Offit (which you, Dr. Wakefield, participated in), I think that Dateline has been proven correct for not airing their comments.
I. Dr. Offit cited a large population study of autism and MMR from Denmark in support of his claim to ‘certainty that there is no link.’ This study was so flawed that it was rejected from consideration by the gold standard scientific review by the highly influential Cochrane Collaboration. Dr. Offitt, who is not an epidemiologist, was clearly at a loss to understand the study’s fatal flaws.
“Dr. Offitt, who is not an epidemiologist…” What’s up with that comment? I’m sorry, is Dr. Wakefield an epidemiologist? Answer: no. Do you have to be an epidemiologist to understand the study or it’s strengths or flaws? No.
What fatal flaws is Dr. Wakefield referring to? The big Danish study was by Madsen, et al.. The Cochrane Review lists this study as one of the “cohort studies included in the review”. Not “rejected from consideration”.
That aside, I have the Cochrane Review “Vaccines for measles, mumps and rubella in children (Review)” open. The version I have open is noted: “This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2009, Issue 3”, so I think it is the most recent.
I guess if the Cochrane review is “highly influential” and the “gold standard” it would make sense to see what they think of the autism/MMR hypothesis, eh? The review states:
No credible evidence of an involvement of MMR with either autism or Crohn’s disease was found.
Was this because they didn’t know about Dr. Wakefield’s work? Hardly. Four of Dr. Wakefield’s papers were listed. All were listed in the “excluded studies” section.
So where does this leave us? We have, what, nine talking points which are mostly diversions or misrepresentations. Anyone wonder why I don’t think Matt Lauer will be responding to these soon?
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