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 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.
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.
In preparation for the workshop, each of the five workshop panels will be holding pre-workshop planning conference calls from September 14, 2009 to September 25, 2009. These phone calls will be open to the public via conference call lines. Members of the public who call-in will be able to listen, but will not be heard.
The Contact Person for this meeting is:
Ms. Lina Perez
Office of Autism Research Coordination
National Institute of Mental Health, NIH
6001 Executive Boulevard, NSC
Room 8200
Rockville, MD 20852
Phone: 301-443-6040
IACCPublicInquiries@mail.nih.gov
How real is the “epidemic” of autism? How much of the increase in the number of diagnoses have to do with factors other than a real increase in the number?
I am going to take some time with this paper. If you want the short version of this post–about 26% of the increase in autism counts in California can be attributed to changes in diagnositic practices leading to people being classified autistic (or autistic plus MR) who were classified with mental retardation by pre-1992 standards.
Perhaps the most used dataset for exploring the increase in autism, especially by amateur epidemiologists, is that of the California Department of Developmental Services, or CDDS. The CDDS serves people with developmental disabilities (not just autism) within the state of California. The CDDS made much of its data freely available. While the CDDS data show a large increase in the number of people getting services for autism as a developmental disability, it is difficult to ascertain how much (if any) of this is due to a real increase in the number of people who actually are autistic. This is because it is very hard to know how important external factors are in changing the administrative prevalence of autism.
Many factors influence the prevalence of autism. These include broadening of the criteria for what is called “autism”, such as the change in the 1990’s to include PDD-NOS and Asperger Syndrome in the Autism Spectrum Disorders.
Recently, Hertz-Picciotto and Delwiche found that “three artefacts—younger age at diagnosis, change in the accepted criteria and inclusion of milder cases—accounted for about one-third of a 12-year rise in incidence in California.”
Many people have misrepresented Hertz-Picciotto and Delwiche as showing that there has been a “true” increase in the autism prevalence when, in fact, they state quite clearly “Other artifacts have yet to be quantified, and as a result, the extent to which the continued rise represents a true increase in the occurrence of autism remains unclear.”
One of the artifacts that was not quantified by Hertz-Picciotto and Delwiche was the possibility of diagnostic change and accretion. When diagnostic practices change, a person who would have one diagnosis in one time period might get a different diagnosis in another.
For example, a common question that comes up is this: how many people diagnosed with autism today would have been given a diagnosis of mental retardation 20 years ago?
This has the possibility to be a very important paper. I don’t think I am stretching when I state this as this paper was published together with commentary from no fewer than five four well known research groups.
Here’s the abstract:
Background Increased autism prevalence rates have generated considerable concern. However, the contribution of changes in diagnostic practices to increased prevalence rates has not been thoroughly examined. Debates over the role of diagnostic substitution also continue. California has been an important test case in these controversies. The objective of this study was to determine the extent to which the increased prevalence of autism in California has been driven by changes in diagnostic practices, diagnostic substitution and diagnostic accretion.
Methods Retrospective case record examination of 7003 patients born before 1987 with autism who were enrolled with the California Department of Developmental Services between 1992 and 2005 was carried out. Of principal interest were 631 patients with a sole diagnosis of mental retardation (MR) who subsequently acquired a diagnosis of autism. The outcome of interest was the probability of acquiring a diagnosis of autism as a result of changes in diagnostic practices was calculated. The probability of diagnostic change is then used to model the proportion of the autism caseload arising from changing diagnostic practices.
Results The odds of a patient acquiring an autism diagnosis were elevated in periods in which the practices for diagnosing autism changed. The odds of change in years in which diagnostic practices changed were 1.68 [95% confidence interval (CI) 1.11–2.54], 1.55 (95% CI 1.03–2.34), 1.58 (95% CI 1.05–2.39), 1.82 (95% CI 1.23–2.7) and 1.61 (95% CI 1.09–2.39). Using the probability of change between 1992 and 2005 to generalize to the population with autism, it is estimated that 26.4% (95% CI 16.25–36.48) of the increased autism caseload in California is uniquely associated with diagnostic change through a single pathway—individuals previously diagnosed with MR.
Conclusion Changes in practices for diagnosing autism have had a substantial effect on autism caseloads, accounting for one-quarter of the observed increase in prevalence in California between 1992 and 2005.
The authors started by looking at the individual records for the 7003 clients of the CDDS born before 1987 who had diagnoses of autism at any time in their CDDS records. These individuals would be at least 8 years old by the time the DSM-IV criteria for autism came out in 1994, so they should have already been diagnosed with autism by that time.
What they found was that 631 individuals started out with a diagnosis of mental retardation and later received a diagnosis of autism. 95% of these individuals retained the MR diagnosis. I.e. most moved from “autism” to a dual diagnoses of autism+MR.
They also found that 89 individuals “lost” their autism diagnosis. They are not discussed in detail, so we can’t tell if they held other diagnoses after “losing” their autism diagnosis.
The authors plotted the number of individuals who changed from MR to autism or autism+MR by year. They claim that the number is higher in years when significant changes in diagnostic practices were introduced.
Figure 1 from King and Bearman paper
A peak is fairly clear for 1994, when the DSM-IV was issued. Whether this peak and the others are real is a matter for discussion (as in Dr. Hertz-Picciotto’s commentaruy)
Some of the findings the authors reported are very interesting.
Examining the control variables, we see that the level of intellectual impairment of clients had a significant effect on the likelihood of observing diagnostic change. The relationship between severity and the odds of change appears to be non-linear with moderate and profound severity to be at greatest risk for diagnostic change.
The CDDS lists intellectual impairment by the categories mild, moderate, severe and profound. It strikes me as strange that mild ID is not the area with the highest odds of change. It is very strange that there is no clear trend that the odds of change/accretion go up (or down) with severity of intellectual disability.
Another interesting observation:
Changes in evaluation scores, which capture many of the requirements for an autism diagnosis, surprisingly had little discernable effect on the likelihood of diagnostic change [OR 1.02; 95% confidence interval (CI) 1.00–1.04].
This is quite strange to me as well. One would think, perhaps, that the lower the evaluation score, the more likely that someone would have been undiagnosed.
Or, to put it another way, why weren’t the more “obviously” autistic individuals identified before the diagnostic changes?
Finally, race and year of birth were also significantly associated with the odds of change. Persons born in later years, who were younger, were more likely to experience diagnostic accretion or substitution. Finally, African–Americans
were considerably less likely than Caucasians to have a change in diagnostic status.
To me, this speaks to the idea that not everyone who qualifies for an autism diagnosis under the changes is getting one. I.e. the CDDS still has a clients in this older cohort who are misclassified as MR instead of autism. For example, 0lder clients are less likely to have a family member to advocate for them, and are less likely to see a change in services under autism vs. MR classifications.
The authors then take this “micro level” data (looking at individuals) and apply their findings on a “macro level” (looking at groups of people). In other words, the usethese data to predict how much of the increase in CDDS caseload is due to this one pathway–shift from MR to autism. The results are shown in Figure 4, copied below.
Figure 4 from King an Bearman paper
They find that by 2005, 26% of the increase in the CDDS caseload can be attributed to the shift from MR to autism.
One important point the authors make is the difference between diagnostic substitution and diagnostic accretion. An example of substitution is an individual having his/her diagnosis change from MR to autism. An example of accretion is when an individual has autism added to the already existing MR diagnosis.
Accretion is harder to discern on a group (macro) level, since one would not see the MR count drop coincident with the autism increase. The authors have included both in their definition of diagnostic change.
The authors note that the MR to autism pathway is not the only possibility.
Diagnostic substitution and diagnostic accretion along other pathways, such as developmental language disorder or other learning disabilities, may be contributing to an increase in higher functioning cases. In a study applying contemporary diagnostic standards and practices to persons with a history of developmental language disorder 21% (8/38) of the individuals met the criteria for autism and 11% (4/38) met the criteria for milder forms of ASD. Thus, there are multiple pathways to an autism diagnosis from multiple disorders that contribute to increases along various parts of the spectrum. In this article, we have considered only one pathway and one part of the spectrum
In other words, more of the increase in the CDDS caseload may be due to diagnostic changes, but in ways not covered by this paper.
One factor the authors do not appear to be taking into account is the large regional disparities within California. The administrative prevalence in the CDDS system varies wildly depending on which part of the stat one looks at. In general, rural areas have much lower administrative prevalence values than urban areas, for example.
The authors’ concluding paragraph:
We have estimated that one in four children who are diagnosed with autism today would not have been diagnosed with autism in 1993. This finding does not rule out the possible contributions of other etiological factors, including environmental toxins, genetics or their interaction to the increased prevalence of autism. In fact, it helps us to recognize that such factors surely play an important role in increasing prevalence. There is no reason to believe that any of these frameworks are wrong and many reasons to believe that the increase in autism prevalence is in fact the outcome of multiple self-reinforcing processes. However, this study demonstrates that subsequent explanations for the increased prevalence of autism must take into account the effect of diagnostic change.
I think this is quite good–the paper does not rule out a true increase in autism prevalence. It does demonstrate that factors like diagnositic change and accretion are real and significant.
Many factors are involved with the increase in autism prevalence, including that in the CDDS data. Just because the number of people identified with autism went up doesn’t mean that all of that number is due to a real increase in the number of people who are autistic.
King, M., & Bearman, P. (2009). Diagnostic change and the increased prevalence of autism International Journal of Epidemiology DOI: 10.1093/ije/dyp261
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?
Many do. But often only in the case of high risk pregnancies or amniocentesis. If you want a diagnosis for your self or your already born child, it’s on your dime.
In other words, if you would like to consider terminating your pregnancy and not bringing a heavy user of insurance covered medicine into the world, the insurance companies are happy to help. If you might be looking for answers, which may result in greater medical expenses, the insurance company doesn’t want to help.
Accommodations. They don’t have to be big, but they can make a big difference.
Case in point: a 14 year old autistic girl needed help in a dressing room. The store claimed a policy that only one person can be in a dressing room at a time. Surely this policy could be waived in this case?
Such is the case that was recently decided in Minnesota. A local outlet for the Retailer Abercrombie and Fitch refused to allow an autistic girl to bring her sister with her into a fitting room.
According to Minnesota Public Radio, the store wasn’t even following its own policy:
The company’s associate handbook states that only one person is allowed in a fitting room at a time, but adds, “Some exceptions to this rule include parents with their kids and a disabled person’s assistant.” The company designed the policy to reduce theft.
Abercrombie and Fitch has been fined $115,264. Of this, $25,000 will go to the girl for mental anguish. About $41,000 will go to her lawyers.
The National Autism Association has a campaign afoot to raise awareness with the catch-phrase “how much longer”.
As in these quotes from their campaign:
“FDA, HOW MUCH LONGER WILL YOU APPROVE VACCINES THAT AREN’T NEARLY AS SAFE AS THEY COULD BE?”
Or
“HOW MUCH LONGER, NIH, before you adequately fund environmental research?”
I have a question:
How much longer, NAA, before you act like a reasonable member of the autism communities? (substitute Generation Rescue or SafeMinds for NAA, they are all basically the same group).
The NAA quote about NIH shows a lot about the NAA’s intent. “Adequately fund environmental research”. A lot of money is going to environmental research for autism causation at NIH. A lot. But, until it includes vaccine-causation, no amount is going to be considered “adequate” to the NAA.
NIH and most of the medical community doesn’t think that there is a good reason to do vaccine-causation research. But that isn’t the reason why groups like NIH don’t fund research. Let’s face it, NIH have an entire center devoted to spending on money that most of the medical community considers a waste.
The NAA would like to place the blame on everyone. Everyone else, that is. It’s a vast conspiracy, funded by Pharma dollars, with everyone afraid to admit the truth about the damage they caused. Do I have that right, NAA?
The real problem, NAA/Safe-Minds/Generation Rescue, is that you are your own worst enemy.
Ask yourselves a very simple question: if NIH is willing to spend money on projects with little hope of success, if NIH is willing to spend money on questions where the general expectation is that the answer will be no (remember that chelation study?), if they are willing to do that, why not spend money on a vaccine-causation project?
To answer that, you have to ask, what is the cost of a vaccine-causation project?
The real cost isn’t calculated in dollars. The real cost in is the damage to public health that such a study would bring. Yes, funding a do-vaccines-cause-autism project would hurt public health.
How can I say that? Because you guys at NAA (and sister orgs) would use the fact that NIH has funded such a project to attack vaccines. The entire time from the approval of the funds to the time the study results were published, you would be claiming “See, the government thinks vaccines are causing the autism epidemic”. What happens when the project is done? If the research doesn’t agree with your position, you will reject it. That is your clear track record.
Besides, what quality independent researcher would take on such a project? Anyone able to do such a study is is likely smart enough to realize that he/she would be hounded for the rest of his/her life if he/she doesn’t publish results that agree with your preset expectations.
You guys are stuck in the past. A past where you could say “vaccines caused an autism epidemic” and people listened. It’s time to listen to the people who support you. Really listen. Listen and realize that just because someone is supporting you doesn’t mean that he/she supports everything you say. Case in point: Dr. Bernadine Healy. Does she say there has been an epidemic of vaccine-induced autism? Does she say the epidemiology is junk? No. She says there may be small groups. Groups too small to be detected in the epidemiology that’s been done. That’s really, really small, by the way.
Get it? Even your supporters say you haven’t proven anything and that at most you represent a small fraction of the autistic population. You’ve been able to “wag the dog” for a long time, but that time is over. It’s time to realize that at most you would be a small part of the autism communities. It’s time to realize that the autism communities are part of a larger disability community.
If this seems too complicated, here are a few simple steps you can take to rebuild your credibility:
1) admit that thimerosal did not cause an “autism epidemic”
2) admit that MMR did not cause an “autism epidemic”
3) stop discounting all science that disagrees with you.
4) stop smearing people who disagree with you.
5) stop creating misleading faux research.
6) stop trying to discredit fine American institutions.
7) stop denying the existence of a large number of adult autistics.
Oh there’s more. A lot more.
As I said above, NIH is willing to fund research that constituents want even when it is very likely to be fruitless. But you have made it expensive to perform from a public health perspective and won’t accept any answer except the one you want.
How much longer until you get vaccine-autism research? You tell us. You are the ones in the way. Your “how much longer” campaign probably just set you back at least a year.
You probably see this as harsh. In reality it is probably the best advice you have been given all day.
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