Reading about Andrew Wakefield gets old and tiring. I’m sure that isn’t news to readers here. Writing about Andew Wakefield gets very tiring. Who wants to keep reminding him/her self about a man who has caused so much harm to both the autism communities and public health in general? Who wants to read about dishonesty and unethical behavior?

I can only imagine that Brian Deer must want to put his award on a shelf and move on.

Which all begs the question: why do I think people reading Left Brain/Right Brain might want to read about him again? Because in this case it isn’t about Mr. Wakefield. Rather it is about his supporters. People who put aside the proved charges of dishonesty and unethical behavior. People such as Kent Heckenlively of the Age of Autism blog who are looking for The Wakefield Rehabilitation. It’s about how and why authors cite previous literature, and not reading too much into citations.

Beyond the hopes of those supporting Andrew Wakefield, there is some good research here and a bit of information about how and why people cite certain papers in the scientific literature.

First, how is Mr. Wakefield being “rehabilitated”? Answer: his papers were recently cited in a recent study. Seriously, something that small. That’s how hard people have to look for validation for Mr. Wakefield. A few citations and he’s on the road to rehabilitation.

The new paper isn’t by just any team, though. The study, recently out in PLoS One is Impaired Carbohydrate Digestion and Transport and Mucosal Dysbiosis in the Intestines of Children with Autism and Gastrointestinal Disturbances. The study is a follow-on to the PLoS One paper by Hornig et al., Lack of association between measles virus vaccine and autism with enteropathy: a case-control study.

Why is that important? “Lack of association…” is the paper which definitively put an end to the Wakefield MMR hypothesis. The team tried, with meticulous attention to detail, to replicate the most important factors of various Wakefield MMR-autism papers. They studied children with autism and gastro-intestinal complaints. They restricted their study to children who had demonstrated clear need for endoscopy (one major difference from the Wakefield studies). They were very careful about correctly reporting the patient histories (another major difference). They tested intestinal biopsy samples for measles virus (similar to as study by the Wakefield team), but were very careful to avoid contamination (unlike the Wakefield studies). The recent study used multiple laboratories to test for measles virus (Wakefield used two: his own and the O’Leary laboratory). Unlike Mr. Wakefield, the recent study reported on results from all the laboratories (Mr. Wakefield neglected to mention the results from his own laboratory which were contradictory to his theory).

Hornig et al. wrote:

The work reported here eliminates the remaining support for the hypothesis that ASD with GI complaints is related to MMR exposure. We found no relationship between the timing of MMR and the onset of either GI complaints or autism. We also could not confirm previous work linking the presence of MV RNA in GI tract to ASD with GI complaints.

About as clear a conclusion as I’ve ever seen. “The work reported here eliminates the remaining support for the hypothesis that ASD with GI complaints is related to MMR exposure.”

So, what about the new paper and the citations? Well, members of the team that produced the Hornig et al. study did further research on the tissue samples taken. Brent L. Williams heads up the author list on the new study.

Here is the (highly technical) abstract from the new study by Williams et al.:

Gastrointestinal disturbances are commonly reported in children with autism, complicate clinical management, and may contribute to behavioral impairment. Reports of deficiencies in disaccharidase enzymatic activity and of beneficial responses to probiotic and dietary therapies led us to survey gene expression and the mucoepithelial microbiota in intestinal biopsies from children with autism and gastrointestinal disease and children with gastrointestinal disease alone. Ileal transcripts encoding disaccharidases and hexose transporters were deficient in children with autism, indicating impairment of the primary pathway for carbohydrate digestion and transport in enterocytes. Deficient expression of these enzymes and transporters was associated with expression of the intestinal transcription factor, CDX2. Metagenomic analysis of intestinal bacteria revealed compositional dysbiosis manifest as decreases in Bacteroidetes, increases in the ratio of Firmicutes to Bacteroidetes, and increases in Betaproteobacteria. Expression levels of disaccharidases and transporters were associated with the abundance of affected bacterial phylotypes. These results indicate a relationship between human intestinal gene expression and bacterial community structure and may provide insights into the pathophysiology of gastrointestinal disturbances in children with autism.

If this were really about the autistics and not about Andrew Wakefield, those claiming that there is something different about the GI disturbances in autistics should be extatic. Here is a top notch team pointing to a possible real difference. In the kids tested, the genes were expressing enzymes and transporters—i.e. the genes are performing differently—for autistic kids. Also, they are seeing differences in the bacteria in the autistic kids.

Not only that, but these kids benefited from dietary intervention, although it isn’t specific to the autistic kids: “Beneficial effects of dietary intervention on GI disturbances were reported for all AUT-GI and Control-GI subjects with FA.”

But, it apparently isn’t about the autistics or the research when it comes to the Age of Autism. It’s about rehabilitating Andrew Wakefield’s reputation. (With apologies in advance—the image that comes to mind is a team that has been performing CPR on his reputation for years now. It’s time to move on.)

The important piece of this study, according to Mr. Heckenlively, is that they cite some of Andrew Wakefield’s papers. In particular:

Wakefield AJ, Anthony A, Murch SH, Thomson M, Montgomery SM, et al. (2000) Enterocolitis in children with developmental disorders. Am J Gastroenterol 95: 2285–2295.

Wakefield AJ, Ashwood P, Limb K, Anthony A (2005) The significance of ileo-colonic lymphoid nodular hyperplasia in children with autistic spectrum disorder. Eur J Gastroenterol Hepatol 17: 827–836

Ashwood P, Anthony A, Torrente F, Wakefield AJ (2004) Spontaneous mucosal lymphocyte cytokine profiles in children with autism and gastrointestinal symptoms: mucosal immune activation and reduced counter regulatory interleukin-10. J Clin Immunol 24: 664–673.

Mr. Heckenlively appears to have built a nice straw man argument in which every thing Mr. Wakefield has done is now discredited. Somehow citing a paper by Mr. Wakefield then becomes some sort of a statement that everything he did was actually right. Both sides of that argument are false. The authors should cite what is in the literature. By citing, say, the Ashwood (2004) paper, they aren’t saying that, say, the 1998 Wakefield Lancet paper is now “rehabilitated’.

Notice that the authors didn’t cite the 1998 Lancet paper. One big reason: it’s been retracted. Which begs the question, why are the authors citing Wakefield et al. (2000)? The paper in the American Journal of Gastroenterology has also been been retracted:

On 28 January 2010, the UK General Medical Council’s Fitness to Practice Panel raised concerns about a paper published in the Lancet by Dr Wakefi eld et al. (1). The main issues were that the patient sample collected was likely to be biased and that the statement in the paper, that the study had local ethics committee approval, was false. Th ere was also the possibility of a serious conflict of interest in the interpretation of the data. Th e Lancet has now retracted this paper (1). Th is paper in the American Journal of Gastroenterology (AJG) (2) also includes the 12 patients in the original Lancet article and therefore we retract this AJG paper from the public record.

One really shouldn’t cite things that have been retracted from the public record. So, is there some message that Williams et al. are trying to send us? Are they saying that Andrew Wakefield was correct all along? Hardly. That paper was retracted in May of 2011, the same time that Impaired Carbohydrate Digestion and Transport and Mucosal Dysbiosis in the Intestines of Children with Autism and Gastrointestinal Disturbances was submitted to PLoS One. The authors weren’t aware of the retraction. Says a lot about how closely they follow Andrew Wakefield, don’t it?

Apparently, the authors have contacted PLoS about the citation, and it will be corrected to notify readers of the retraction. That is the right thing to do. It isn’t a statement about Mr. Wakefield’s research, other than this paper was retracted.

Authors can’t control the message bloggers may try to create from their research (heck, one of the authors, Ian Lipkin, consulted on the recent movie “Contagion”, a main character is a blogger whose message is unscientific and irresponsible). From what I’ve heard, the authors are still very clear on the message of their first PLoS paper: “The work reported here eliminates the remaining support for the hypothesis that ASD with GI complaints is related to MMR exposure. ”

I think the point was made pretty clearly. Mr. Heckenlively in his excitement read way too much into this new paper. Not surprisingly, he just goes on and on making more mistakes. Consider this paragraph:

Isn’t Dr. Wakefield supposed to be some super-villain, leading all of us gullible parents to believe that vaccines aren’t quite as safe as sugar water? Didn’t he make up fake diseases? So, after being stripped of his license to practice medicine in the U. K., it turns out there really is something called autistic entercolitis and ileo-colonic lymphoid nodular hyperplasia in children with autism. At least Dr. W. Ian Lipkin seems to think so.

Wow. All this is extrapolated from a single sentence in the introduction of the paper: “Macroscopic and histological observations in ASD include findings of ileo-colonic lymphoid nodular hyperplasia, enterocolitis, gastritis, and esophagitis [2], [3], [4], [5], [6], [7].”

What does that sentence mean? Simple interpretation: others have reported these findings. Not “we confirm that these findings are real”. Given that reference [3] (a retracted Wakefield paper) may be removed or noted to be retracted, the only support for “enterocolitis” will be gone from the paper.

Mr. Heckenlively wrote “Although this study used a relatively small sample of gut biopsies from children with autism (Hey, isn’t that what Wakefield got in trouble for? Or is my memory failing me?),”

Mr. Heckenlively, your memory is failing you. The findings of the General Medical Council are easily found online.

Let me remind you of some of that document:

The Panel concluded that Dr Wakefield’s shortcomings and the aggravating factors in this case including in broad terms the wide-ranging transgressions relating to every aspect of his research; his disregard for the clinical interests of vulnerable patients; his failure to heed the warnings he received in relation to the potential conflicts of interest associated with his Legal Aid Board funding; his failure to disclose the patent; his dishonesty and the compounding of that dishonesty in relation to the drafting of the Lancet paper; and his subsequent representations about it, all played out against a background of research involving such major public health implications, could not be addressed by any conditions on his registration. In addition, the Panel considered that his actions relating to the taking of blood at the party exemplifies a fundamental failure in the ethical standards expected of a medical practitioner. It concluded that conditional registration would not mark the seriousness of such fundamental failings in his duty as a doctor

and

The Panel made findings of transgressions in many aspects of Dr Wakefield’s research. It made findings of dishonesty in regard to his writing of a scientific paper that had major implications for public health, and with regard to his subsequent representations to a scientific body and to colleagues. He was dishonest in respect of the LAB funds secured for research as well as being misleading. Furthermore he was in breach of his duty to manage finances as well as to account for funds that he did not need to the donor of those funds. In causing blood samples to be taken from children at a birthday party, he callously disregarded the pain and distress young children might suffer and behaved in a way which brought the profession into disrepute.

Mr. Heckelively also poses the question: “Didn’t he [Andrew Wakefield] make up fake diseases?”

That would be “autistic enterocolitis”, a term Andrew Wakefield coined and a condition which still, 13 years later, doesn’t have support. Autistic enterocolitis is not just any and all GI disturbances in autistics. Enterocolitis is “...an inflammation of the colon and small intestine”. Note the “and”, there. Even more important, the PLoSOne paper is not about inflammation at all.

Mr. Heckenlively finishes with the rather hopeful, wishful thinking statement: “But if a big shot scientist like Dr. W. Ian Lipkin is quoting Dr. Andrew Wakefield as a reliable source, maybe the rest of the world will soon be doing the same thing.”

Again, wow. Here we have Ian Lipkin, one of the team that just put an end to the Wakefield-MMR hypothesis. Again, let’s remind ourselves, Ian Lipkin is part of the team which wrote: “The work reported here eliminates the remaining support for the hypothesis that ASD with GI complaints is related to MMR exposure.” There is such a major disconnect between that statement (which, yes, Dr. Lipkin stands by) and what Mr. Heckenlively wrote that I am just left in amazement.

This isn’t a story about rehabilitation. This is a story about diversion. Diversion of attention away from important subjects in autism. These include the medical treatment of major health problems. How does one treat something like bowel problems in individuals with communication and/or sensory difficulties? That’s a big question that gets lost in this whole “Andrew Wakefield” discussion. Research like this new paper is important in that respect: is there something specific to kids with autism, regression and GI disease? Leave aside any discussion about GI being linked to the regression, how do you treat it? I, for one, am glad to see something come out of this research project than just the “MMR doesn’t cause autism and GI disease” conclusion. Instead of trying to read the tea leaves of this paper and try to recoup the damage Andrew Wakefield did to his reputation, why don’t we just read the paper in the context of what this might tell us about the health problems of autistics?

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Gastrointesintal problems are a common topic of discussion and debate in the online autism communities. Much of the discussion involves causation: do GI problems cause autism? A recent study looks at a tangent of this argument. Considering the general population, do GI problems early in life predict autistic traits later in life? The methodology isn’t the strongest: they use parent reports of GI complaints and the self-report questionaire Autism Quotient. They also asked about whether the individuals were immunized with the MMR vaccine.

The results:

There was no statistically significant difference in AQ scores between those who had (n=133) and those who had not (n=671) experienced early gastrointestinal symptoms. (2) analyses revealed that the children with early gastrointestinal problems were no more likely to be represented in the upper quintile of scores on any of the AQ scales. The measles, mumps, and rubella vaccination was unrelated to gastrointestinal symptoms or AQ scores.

The abstract is quoted below:

No association between early gastrointestinal problems and autistic-like traits in the general population

Aim
The aim of this study was to determine whether gastrointestinal problems in early childhood relate to autistic-like traits in a general population sample.

Method
The parents of 804 children (442 females; 362 males) reported at 1-, 2-, 3-, and 5-year follow-ups whether their child had been taken to a hospital, general practitioner, or health clinic for any of five gastrointestinal symptoms: (1) constipation; (2) diarrhoea; (3) abdominal bloating, discomfort, or irritability; (4) gastro-oesophageal reflux or vomiting; and (5) feeding issues or food selectivity. Parents also reported whether their child had received the measles, mumps, and rubella vaccination. Autistic-like traits were measured when the children had reached early adulthood (mean age 19y 7mo; SD 0.63y) using a self-report questionnaire, the Autism Spectrum Quotient (AQ).

Results

There was no statistically significant difference in AQ scores between those who had (n=133) and those who had not (n=671) experienced early gastrointestinal symptoms. (2) analyses revealed that the children with early gastrointestinal problems were no more likely to be represented in the upper quintile of scores on any of the AQ scales. The measles, mumps, and rubella vaccination was unrelated to gastrointestinal symptoms or AQ scores.

Interpretation

Parent-reported gastrointestinal problems in early childhood are unrelated to self-reported autistic-like traits in the general population.

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A new paper is due out soon looking at the available literature on GI and autism.

The significance of the association between many gastrointestinal (GI) pathologies and autism has yet to be discovered. The aim of the present study was to review available evidence documenting any link between autism and GI histopathology in children

I’ve only got the abstract to go by but even that is fairly damning.

Eight studies have reported the histopathological features of the GI tract in children with autism and fulfilled inclusion criteria. In general, none of these trials appeared to be of high quality. Apart from intestinal lymphonodular hyperplasia, the majority of these findings were not consistent….GI pathological findings in children with autism have been inconsistent. The present available evidence does not support or refute a link between GI histopathology and autism in children. The significance of intestinal lymphonodular hyperplasia in these children is unknown.

I’m hoping to get the full paper soon. It would be interesting to know what these eight studies were.

Update

Here’s the eight papers of low quality:

Furlano RI, Anthony A, Day R, et al. Colonic CD8 and gamma delta Tcell
infiltration with epithelial damage in children with autism. J Pediatr
2001;138:366–72.

Wakefield AJ, Anthony A, Murch SH, et al. Enterocolitis in children
with developmental disorders. Am J Gastroenterol 2000;95:2285–95.

Torrente F, Ashwood P, Day R, et al. Small intestinal enteropathy with
epithelial IgG and complement deposition in children with regressive
autism. Mol Psychiatry 2002;7:375–82. 34.

Ashwood P, Anthony A, Pellicer AA, et al. Intestinal lymphocyte
populations in children with regressive autism: evidence for extensive
mucosal immunopathology. J Clin Immunol 2003;23:504–17.

Ashwood P, Anthony A, Torrente F, et al. Spontaneous mucosal
lymphocyte cytokine profiles in children with autism and gastrointestinal
symptoms: mucosal immune activation and reduced counter regulatory
interleukin-10. J Clin Immunol 2004;24:664–73.

Wakefield AJ, Ashwood P, Limb K, et al. The significance of ileocolonic
lymphoid nodular hyperplasia in children with autistic spectrum
disorder. Eur J Gastroenterol Hepatol 2005;17:827–36.

Torrente F, Anthony A, Heuschkel RB, et al. Focal-enhanced gastritis in
regressive autism with features distinct from Crohn’s and Helicobacter
pylori gastritis. Am J Gastroenterol 2004;99:598–605.

14. DeFelice ML, Ruchelli ED, Markowitz JE, et al. Intestinal cytokines in
children with pervasive developmental disorders. Am J Gastroenterol
2003;98:1777–82.

No surprises there.

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Last week, Brian Deer published an article in the BMJ How the case against the MMR vaccine was fixed. In it he lays out how data were misreported in Andrew Wakefield’s now retracted 1998 article in The Lancet. The BMJ editors published an editorial coincident with the Deer article, Wakefield’s article linking MMR vaccine and autism was fraudulent.

In his latest article in the BMJ, Brian Deer lays out: Secrets of the MMR scare How the vaccine crisis was meant to make money

Andrew Wakefield had plans to make money. A lot of money. He created a business to produce diagnostic testing kits. He applied for a patent for a therapeutic agent and a proposed vaccine to prevent measles infections. This in addition to the money he was collecting as a paid expert to the MMR litigation in the UK.

On the diagnostic testing kit. Mr. Deer obtained the prospectus for the company that was formed to develop and market it:

“It is estimated that the initial market for the diagnostic will be litigation driven testing of patients with AE [autistic enterocolitis] from both the UK and the USA,” said a 35 page “private and confidential” prospectus, which was passed to me [Brian Deer] by a recipient.

He predicted £28,000,000 in revenue from the therapeutic and diagnostic products from his company.

Mr. Wakefield used a laboratory in Ireland, Unigenetics, headed by John O’Leary, to test tissue samples for measles virus. This is well known. Mr. Wakefield was a director of that laboratory.

The work by Unigenetics was key to the company’s success. Mr. Wakefield predicted—apparently in September 1996, before the research was completed—that Unigenetics would provide “unequivocal evidence for the presence of the vaccine derived measles virus in biopsy samples”

“Once the work of Professor O’Leary and Dr Wakefield is published, either late in 1999 or early in 2000, which will provide unequivocal evidence for the presence of the vaccine derived measles virus in biopsy samples,” the prospectus said, “the public and political pressure for a thorough, wide ranging investigation into the aetiology of the bowel conditions will be overwhelming.

“As a consequence of the public, political and legal pressures brought to bear, the demand for a diagnostic able to discriminate between wild type and vaccine derived measles strains will be enormous.”

That paper has since been discredited. First, a major attempt to replicate it failed. More importantly, Stephen Bustin, perhaps the world’s foremost expert on the methodology used (PCR), found that the Unigenetics laboratory’s methods were so seriously flawed as to make any results worthless (good summary here). Also, it was found that PCR data from Mr. Wakefield’s own research group were negative for measles virus, and that Mr. Wakefield buried those negative results.

It was because of these (and more) conflicts of interest that he was let go from the Royal Free Hospital (long before the Brian Deer investigation). Mr. Wakefield’s claim that his departure from the Royal Free was because his “research was unpopular”. Contrary to this position, the Royal Free had offered Mr. Wakefield the opportunity to prove his hypothesis.

But the paperwork does not show this. Despite all that had happened, UCL volunteered to support his work. It offered him continuation on the staff, or a year’s paid absence, to test his MMR theories. He was promised help for a study of 150 children (to try to replicate his Lancet claims from just 12) and, in return for withdrawing from the January London conference, he would be given the intellectual property free.

“Good scientific practice,” the provost’s letter stressed, “now demands that you and others seek to confirm or refute robustly, reliably, and above all reproducibly, the possible causal relationships between MMR vaccination and autism/“autistic enterocolitis”/inflammatory bowel disease that you have postulated.”

Yes, Mr. Wakefield had an offer on the table to take a year to prove his hypothesis. The Royal Free already had their doubts, and even more doubts about Mr. Wakefield’s conflicts of interest. And, yet, it would take a few more years before Brian Deer would make this public.

At first Mr. Wakefield agreed to the Royal Free’s proposal. But he never put the plan into action. When it became clear that he had no intent to follow through, he was let go from the Royal Free.

One defintion I found (the top definition at dictionary.com) defines fraud thus:

deceit, trickery, sharp practice, or breach of confidence, perpetrated for profit or to gain some unfair or dishonest advantage.

As presented last week by Mr. Deer, data were manipulated to “fix” the results of Mr. Wakefield’s research. This week’s installment discloses how Mr. Wakefield sought to profit from this work. Pretty clear to this reader that this meets the definition of fraud.

Here is how the BMJ summarized the article:

Andrew Wakefield, the disgraced doctor who claimed a link between MMR and autism, planned secret businesses intended to make huge sums of money, in Britain and America, from his now-discredited allegations.

The Wakefield scheme is exposed today in the second part of a BMJ series of special reports, “Secrets of the MMR scare”, by investigative journalist Brian Deer. Last week we revealed the scientific fraud behind the appearance of a link between the vaccine and autism. Now Deer follows the money.

Drawing on investigations and documents obtained under the Freedom of Information Act, the report shows how Wakefield’s institution, the Royal Free Medical School in London, supported him as he sought to exploit the MMR scare for financial gain.

It reveals how Wakefield met with medical school managers to discuss a joint business even while the first child to be fully investigated in his research was still in the hospital, and how just days after publication of that research, which triggered the health crisis in 1998, he brought business associates to the Royal Free to continue negotiations.

One business, named after Wakefield’s wife, intended to develop Wakefield’s own “replacement” vaccines, diagnostic testing kits and other products which only stood any real chance of success if public confidence in MMR was damaged.

Documents reveal the planned shareholdings of Wakefield and his collaborators, and how much Wakefield expected to receive personally. Financial forecasts made available for the first time today show Wakefield and his associates predicting they could make up to £28 million ($43,367,082; €33,290,350) a year from the diagnostic kits alone.

“It is estimated that the initial market for the diagnostic will be litigation driven testing of patients with AE [autistic enterocolitis] from both the UK and the USA,” said a 35 page “private and confidential” prospectus obtained by Deer, aimed at raising an initial £700,000 from investors. “It is estimated that by year 3, income from this testing could be about £3,300,000 rising to about £28,000,000 as diagnostic testing in support of therapeutic regimes come on stream.”

Deer’s investigation also reveals today that Wakefield was offered support to try to replicate his results, gained from just 12 children, with a larger validated study of up to 150 patients, but that he refused to carry out the work, claiming that his academic freedom would be jeopardised. His research claims have never been replicated.

There will be at least one more installment in this series by Brian Deer in the BMJ.

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One of the key things that Brian Deer’s reporting has done is thrown doubt on the oft-repeated claims that

a) The papers subjects nearly all suffered from some form of colitis
b) The papers subjects nearly all suffered from regressive autism
c) The papers subjects nearly all regressed in the days following their MMR jab.

Nowhere is the more apparent than in the data tables supplied by Brian Deer in his report for the BMJ. They are replicated below:

In this first table above, the data shows that contrary to Wakefield’s Lancet data which shows 9 out of 12 having regressive autism, the kids NHS records are either inconclusive or negative, giving a maximum possible amount of kids with regressive autism as 6 out of 12. Wakefield et al were ‘wrong’ about at least 3 kids.

In this second table above, the data shows that Wakefield et al Lancet data shows 11 out of 12 kids having non specific colitis. By comparison their NHS records show that 3 out of 12 have non specific colitis. Wakefield et al were ‘wrong’ about 9 out of 12 kids.

In this last table above, we can see that Wakefield reported in the Lancet that 8 out of 12 kids showed symptoms days after MMR. However, according to these same kids NHS records, a maximum of 2 out of 12 showed symptoms days after receiving their MMR. Wakefield was ‘wrong’ about 6 children.

There is supplementary data on bmj.com

The BMJ claim fraud. It is very difficult to disagree with them.

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Following on from Lisa Jo’s well placed concerns about this study,I also have a few. Namely the references. Not being scientifically qualified to tackle the meat of the paper I look straight at what the researcher uses to support his ideas. So far I’ve found these references the authors base their paper on:

1) Kidd, P. M. Autism, an extreme challenge to integrative medicine. Part: 1: The knowledge base. Altern. Med. Rev. 2002, 7 (4), 292–316.

2) Ashwood, P.; Anthony, A.; Pellicer, A. A.; Torrente, F.; Walker-Smith, J. A.; Wakefield, A. J. Intestinal lymphocyte populations in children with regressive autism: evidence for extensive mucosal immunopathology. J. Clin. Immunol. 2003, 23 (6), 504–17.

3) Bolte, E. R. Autism and Clostridium tetani. Med. Hypotheses 1998, 51 (2), 133–44

4) James, S. J.; Cutler, P.; Melnyk, S.; Jernigan, S.; Janak, L.; Gaylor, D. W.; Neubrander, J. A. Metabolic biomarkers of increased oxidative stress and impaired methylation capacity in children with autism. Am. J. Clin. Nutr. 2004, 80 (6), 1611–7

At the very least, relying on studies from Alternative Medical Review, studies co-authored by Andrew Wakefield, studies from Medical Hypothesis and studies co-authored by Jim Neubrander should give rise to questions over the credibility of this paper. Is it enough to scupper it? Of course not. But when we take Lisa Jo’s questions into the bargain – that autism does not always, if ever, have a distinct GI component, I have to wonder about this paper.

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This post is from Eureka Alert

A popular belief that specific dietary changes can improve the symptoms of children with autism was not supported by a tightly controlled University of Rochester study, which found that eliminating gluten and casein from the diets of children with autism had no impact on their behavior, sleep or bowel patterns.

The study is the most controlled diet research in autism to date. The researchers took on the difficult yet crucial task of ensuring participants received needed nutrients, as children on gluten-free, casein-free diets may eat inadequate amounts of vitamin D, calcium, iron and high quality protein. Unlike previous studies, they also controlled for other interventions, such as what type of behavioral treatments children received, to ensure all observed changes were due to dietary alterations. Past studies did not control for such factors. And although no improvements were demonstrated, the researchers acknowledged that some subgroups of children, particularly those with significant gastrointestinal (GI) symptoms, might receive some benefit from dietary changes.

“It would have been wonderful for children with autism and their families if we found that the GFCF diet could really help, but this small study didn’t show significant benefits,” said Susan Hyman, M.D., associate professor of Pediatrics at Golisano Children’s Hospital at the University of Rochester Medical Center (URMC) and principal investigator of the study which will be presented Saturday (May 22) at the International Meeting for Autism Research in Philadelphia. “However, the study didn’t include children with significant gastrointestinal disease. It’s possible those children and other specific groups might see a benefit.”

In response to widespread parent-reported benefits, URMC initiated the trial in 2003 to scientifically evaluate the effects of the gluten-free and casein-free diet, which eliminates wheat, rye, barley and milk proteins. Parent observation has played an important role in earlier treatment discoveries in children with autism, such as melatonin’s benefits for sleep.

Hyman’s study enrolled 22 children between 2 ½- and 5 ½-years-old. Fourteen children completed the intervention, which was planned for 18 weeks for each family. The families had to strictly adhere to a gluten-free and casein-free diet and participate in early intensive behavioral intervention throughout the study. Children were screened for iron and vitamin D deficiency, milk and wheat allergies and celiac disease. One child was excluded because of a positive test for celiac disease and one was excluded for iron deficiency. Other volunteers who were excluded were unable to adhere to the study requirements. The children’s diets were carefully monitored throughout the study to make sure they were getting enough vitamin D, iron, calcium, protein and other nutrients.

After at least four weeks on the strict diet, the children were challenged with either gluten, casein, both or placebo in randomized order. They were given a snack once weekly with either 20 grams of wheat flour, 23 grams of non fat dried milk, both, or neither until every child received each snack three times. The type of snack was given in randomized order and presented so that no one observing – including the family, child, research staff and therapy team – knew what it contained. The snacks were carefully engineered to look, taste and feel the same, which was an exercise in innovative cooking. In addition, the nutrition staff worked closely with the families to make a snack that met their child’s preferences. Casein was disguised in pudding, yogurt or smoothies and gluten in banana bread, brownies, or cookies depending on the child’s food preferences.

Parents, teachers and a research assistant filled out standardized surveys about the child’s behavior the day before they received the snack, at two and 24 hours after the snack. (If the child’s behavior wasn’t usual at the scheduled snack time, the snack would be postponed until the child was back to baseline.) In addition, the parents kept a standard diary of food intake, sleep and bowel habits. Social interaction and language were evaluated through videotaped scoring of a standardized play session with a research assistant.

Following the gluten and casein snacks, study participants had no change in attention, activity, sleep or frequency or quality of bowel habits. Children demonstrated a small increase in social language and interest in interaction after the challenges with gluten or casein on the Ritvo Freeman Real Life Rating Scale; however, it did not reach statistical significance. That means because of the small difference and the small number of participants in the study, the finding may be due to chance alone.

The investigators note that this study was not designed to look at more restrictive diets or the effect of nutritional supplements on behavior. This study was designed to look at the effects of the removal of gluten and casein from the diet of children with autism (without celiac disease) and subsequent effect of challenges with these substances in a group of children getting early intensive behavioral intervention.

Hyman said, “This is really just the tip of the iceberg. There are many possible effects of diet including over- and under-nutrition, on behavior in children with ASD that need to be scientifically investigated so families can make informed decisions about the therapies they choose for their children.”

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The piece below is from the blog justthevax, where it ran as “Independent” the Wakefield way (really something for the fail blog). I like this piece because, frankly, I wish I had done it. Catherina takes a look at the exact claims made by Dr. Wakefield’s supporters and shows that they are clearly false.

“Independent” the Wakefield way (really something for the fail blog).

One of the claims that keeps reappearing in the comments sections under articles covering the GMC ruling on Andrew Wakefield and colleagues is that

The key finding (chronic colitis found in ASD children) of Dr. Wakefield’s early case report published in The Lancet in 1998 HAS been independently confirmed by medical researchers in five different countries.

That is a very significant claim. After all, independent confirmation of a recent finding, would make the validity of a finding more likely, and if 6 independent laboratories found the same gut changes in autistic children, then then likelihood that this was a) a fluke or b) made up by Andrew Wakefield would be drastically reduced.

Finally, one of those commenters has posted those ‘independent confirmations’ – so I thought it might be worth having a look at them.

Krigsman, A. (Assistant Professor of Pediatrics, New York University School of Medicine Director of Gastroenterology Services), et al.,Ileocolonoscopy in Children with Autistic spectrum Disorder and Chronic Gastrointestinal symptoms. Autism Insights 2010:2 1-11.

Gonzalez, L., et al., Endoscopic and Histological Characteristics of the Digestive Mucosa in Autistic Children with gastro-Intestinal Symptoms. Arch Venez Pueric Pediatr, 2005;69:19-25.

Balzola, F., et al., Panenteric IBD-like disease in a patient with regressive autism shown for the first time by wireless capsule enteroscopy: Another piece in the jig-saw of the gut-brain syndrome? American Journal of Gastroenterology, 2005. 100(4): p. 979-981.

Balzola, F., et al., Autistic enterocolitis: Confirmation of a new infammatory bowel disease in an Italian cohort of patients. Gastroenterology 2005;128(Suppl. 2);A-303.

Galiatsatos, P., et al., Autistic enterocolitis: Fact or fiction. Canadian Journal of Gastroenterology. 2009;23:95-98.

Let’s look at number 1, Krigsman et al. The name sounds vaguely familiar. In fact, anyone who has read a little about the MMR-autism affair will know Arthur Krigsman as the clinical director of Thoughtful House, which happens to be the same Texas Clinic out of which Andrew Wakefield practises. One editor of “Autism Insight”, the journal in which this “independent confirmation” was published, is Andrew Wakefield (another one the senior author of the study, Carol Stott). Gosh, I bet peer review was harsh for this one.

Gonzales et al, number 2, has been published in “Arch Venez Pueric Pediatr” which stands for Archivos Venezolanos de Puericultura y Pediatría. It was a bit tricky to get my hands on the paper, especially since the citation was not quite right, but I did manage and was not surprised to find that indeed the authors cannot replicate Wakefield’s 1998 “findings” of a distinct autistic enterocolitis, although they do report a higher incidence of gastrointestinal problems in their autistic group.

Balzola et al, number 3, is a case report of one adult autistic patient with inflammed bowel.

Similarly, Balzola et al, number 4, is a meeting abstract (if anyone has access, could they email me that abstract, please) that never saw the light of day as a peer reviewed study.

Finally, number 5, Galiatsatos et al., is a case report, featuring two adult patients with gastrointestinal problems and an ASD diagnosis. The authors call for “more investigations” in their discussion.

So what do we have here? Three (3) genuinely published cases of autistic adults who had consulted a doctor for gastrointestinal problems and were found to have gastrointestinal problems. One conference report from April 2005 that has not gone through peer review and has not appeared in a real journal in the 5 years since the conference. One real study looking at over 50 autistic children which does not confirm Wakefield’s findings. And finally, one study by Wakefield’s buddies in a freshly founded journal run by Andrew Wakefield and his buddies, to say that their buddy Andy was really right all along – how is that for “independent” confirmation?!

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Before the General Medical Council reached a verdict on Dr. Wakefield, Brian Deer was promising that he was going to report on the data Dr. Wakefield used for his now retracted Lancet paper. We were told that he would give a first time ever view of a journalist allowed to check the facts on a scientific research paper.

After the GMC verdict was handed down, I watched the Sunday Times for such an article. I waited. Well, the wait is over. And it isn’t in the Times. Mr. Deer reports his findings in the British Medical Journal (BMJ).

Although much of the attention on Dr. Wakefield’s work has centered on the possible MMR connection, the topic of a “new syndrome” called “autistic enterocolitis” was proposed in that paper. In Wakefield’s “autistic enterocolitis” under the microscope, Mr. Deer takes a closer look at that claim. He does what is very rarely done: he obtained original data used for the study and obtains expert opinions on that data.

In his introduction, he notes the “new syndrome” and the MMR angles of the Lancet paper. Citing the press release from the Lancet paper:

“Researchers at the Royal Free Hospital School of Medicine may have discovered a new syndrome in children involving a new inflammatory bowel disease and autism,” the institution announced in a press release in February 1998. “Their paper . . . also suggests that in a number of cases the onset of behavioural symptoms was associated with MMR vaccination.”

Mr. Deer notes that before any patients were investigated, Dr. Wakefield was already proposing in a submission to the Legal Aid Board that such a new syndrome exists and it is linked to regression in children.

“In contrast to the IBD cases, which have a prima face [sic] gastrointestinal pathology, children with enteritis/disintegrative disorder form part of a new syndrome,” said Wakefield and the lawyer in a confidential submission for legal aid funding for the project in June 1996, before any of the 12 children in the paper had been investigated. “Nonetheless, the evidence is undeniably in favour of a specific vaccine induced pathology.”

For emphasis:

The evidence was “undeniably in favour of a specific vaccine induced pathology”.

Before children were investigated.

That on its own is huge. And, from what I can tell, not consistent with the image Dr. Wakefield is portraying in the alternative media.

That said, was there evidence of this “new syndrome”?

But when the children were brought in to the Royal Free for ileocolonoscopy, between July 1996 and February 1997, a snag in Wakefield’s project emerged. The hospital’s pathology service repeatedly judged colonic biopsy samples to be unexceptional, and thought bowel disease was a possibility in only one child.

The Royal Free’s own pathology service thought that the biopsy samples were unexceptional.

How can Mr. Deer make such a claim? He obtained data from the children’s records from their investigations at the Royal Free. Unfortunately, the actual samples are no longer available, but the reports are, and Mr. Deer submitted these to experts to review:

The biopsy slides are no longer available, according to one of the paper’s authors, Professor Amar Dhillon, but the GMC obtained all but one of the hospital pathology reports, and for the missing case I obtained the discharge summary. I passed the summary and reports to specialists for their reaction. They concluded that most of the 11 children reported as having non-specific colitis in the Lancet paper had been reported by the Royal Free as having normal pathology.

One expert reviewer stated:

“In the present reports and patients, overall, it is my impression that 8 of the 11 [for whom pathology reports were available] were normal,” Karel Geboes, a professor in the gastrointestinal pathology unit of the Catholic University of Leuven, Belgium, told me.

How does this compare to what was reported in the Lancet?

Eleven of the 12 children were said to have “non-specific colitis”: a clinically significant inflammation of the large bowel. In all 11, it was said to be “chronic,” while in four it was reported as both “acute and chronic.”

In other words, the report in the Lancet is not consistent with how experts interpret the pathology reports.

Mr. Deer further notes:

In fact the [Royal Free’s pathology] service identified findings suggestive of possible inflammatory bowel disease in only one of the 12 children. “The mild patchy generalised increase in inflammatory cells with lymphoid aggregates and follicles is not very specific but could be in keeping with low grade quiescent inflammatory bowel disease,” it reported for child 2. But this inflammation resolved after two months’ enteral feeding with a product now marketed as Modulen. A repeat ileocolonoscopy found no abnormality, and a food intolerance was diagnosed.

Yes, it appears that the pathology service, at Dr. Wakefield’s own hospital, at the time of the investigation, didn’t find evidence of abnormalities reported by Dr. Wakefied’s team.

In the GMC hearing, one of the co-authors on the Lancet paper, Dr. Susan Davies, discussed her concerns about the changes in the findings from normal to abnormal at the time of the investigation.

These changes—from normal to abnormal, or from healthy to diseased—had also raised concern in the mind of at least one of the paper’s authors. In September 2007, Davies, the lead histopathologist for the Wakefield project, was examined at length before the panel. “When you were given a draft of the Lancet paper, did you read it?” she was asked by Sally Smith QC, for the doctors’ regulator.
“Yes,” Davies replied.
“What was your overall view of the terminology used in relation to the histology findings in the Lancet paper, just when you read the paper?”
“I was somewhat concerned with the use of the word colitis.”
“First of all, what did you understand that word to mean?”
“I personally use that terminology, ‘colitis,’ when I see active inflammation, or a pattern of changes which suggest a specific diagnosis, and it was not my impression that the children coming through in the spasmodic way that they had, I [sic] had formulated some distinct pattern warranting that terminology.”

If even a co-author was concerned, and the hospital’s pathology reports don’t support the diagnosis of colitis, the obvious question would be: how did the paper reach it’s conclusions?

The answer appears to be that the results underwent a second review. This second review is discussed in the Lancet paper, but there is no mention of the review changing the interpretation of the data,

Mr. Deer poses an important question:

[H]ow many peer reviewers would have felt comfortable approving the paper if they had known that the hospital pathology service reported biopsy specimens as largely normal, but they were then subjected to an unplanned second look and reinterpreted?

Which we are fortunate enough to have answered. Mr. Deer was able to obtain an answer from one of the peer reviewers:

“I’m surprised the GMC didn’t make more of this,” said David Candy, paediatric gastroenterologist at St Richard’s Hospital, Chichester, who reviewed the paper in 1997. “That’s an example of really naughty doing—to exclude the original pathology findings.”

“Really naughty doing”. Not very clinical but I think it tells the story well.

Is it possible that the hospital’s pathology service missed the condition? Apparently at least one author (Dr. Walker-Smith, a co-defendant with Dr. Wakefield in the GMC hearings) noted this in his GMC testimony:

And how bad was this “colitis,” such that the hospital’s pathology service didn’t spot it as the children came through? Walker-Smith told the GMC panel that he had “concerns” about the service and its ability to detect inflammation.

In his report, Mr. Deer counters with:

Yet inflammatory indices that were not reported in the Lancet paper, including serum C reactive protein concentrations and other blood tests, were almost all within normal ranges for the 12 children.6 And as an alternative explanation for any inflammation that was present, nearly all of the children had constipation with megarectum16 (unreported in the paper), which specialists say can cause cellular changes.

Mr. Deer attempted to speak with Dr. Dillhon, a co-author on the Lancet paper. Dr. Dillhon viewed the slides made from the samples taken from the children, and he graded them with Roman numerals to rank the degree of inflammation. At some point, those Roman numerals were translated into “non-specific colitis”.

So who translated these scores on the grading sheet into findings of “non-specific colitis” in the paper? Dhillon says it wasn’t him. He says he would like to see the slides again, but they are missing from the Royal Free laboratory. “He [Dhillon], Andrew Anthony, and Wakefield all looked at them,” I was told, on Dhillon’s behalf, by a senior member of staff at the Royal Free. “Andy [Wakefield] then synthesised their results into what appeared in the paper.”

But still, according to Mr. Deer, “...how the Roman numerical scores, histopathological gradings for a variety of sites in the colon, became the “colitis” findings might, under such circumstances, be anybody’s guess.”

Mr. Deer posits a possible scenario, based on Dr. Wakefield’s complaint to the press complaints commission:

Wakefield wrote: “When the biopsies were reviewed and scored by experts in bowel pathology—namely, Drs Dhillon and Anthony—these doctors determined that there was mild inflammation in the caecum, ascending colon, and rectum,” he said. “This was correctly reported as non-specific colitis in the Lancet.” In other words, it looks like it was Wakefield who translated the scores.

A companion editorial was published in the BMJ by Prof. Sir Nicholas Wright, warden, of Barts and the London School of Medicine and Dentistry, Queen Mary University of London. He lists in his conflict of interest statement: “He has provided expert opinion in the case of Wakefield v GMC and acted as a character witness for Professor John Walker-Smith.”

His editorial:

Does autistic enterocolitis exist?
Despite the retracted Wakefield study, questions remain

His conclusion:

Is autistic enterocolitis a histopathological entity or even an entity at all? In view of the lack of data and the entrenched position of many of the protagonists and antagonists, any firm conclusion would be inadvisable. The expert review, referenced by Deer, concludes that key areas such as the prevalence and best treatment of gastrointestinal disorders in people with autistic spectrum disorders are incompletely understood, and that evidence based recommendations are not yet available. We should remember, as recent experience in several fields has shown, that although science has its defects, it is a self correcting process. Time is, perhaps, the wisest counsellor of all. In the meantime, this case offers a salutary reminder for researchers and journal editors alike that coauthorship means bearing responsibility for what is written.

First, I would submit that Dr. Wright is not being clear on the subject. It is not whether autistics have a greater prevalence of GI issues, or whether there is a difference in the treatment for autistics. The question is whether there is a specific entity which is unique to autistics: autistic enterocolitis. Further, it is also a primary question whether “autistic enterocolitis” is causal in autism. While one can hide behind the “you can’t prove a negative” shield, the answers at present appear to be no to both questions.

Second, the idea that science is a self correcting process is often times true. In this case, it clearly is not. The science, the Lancet paper, was not corrected through science but through investigative journalism. Without the stories in The Sunday Times, Dr. Wakefield’s “science” would likely still be in the official record of The Lancet. Much more, the Lancet study and the presumed expertise of Dr. Wakefield would have likely been key in litigation in the UK and the US. Without Mr. Deer’s continued scrutiny, the facts behind the research into the Lancet paper, specifically that the pathology reports on those children were not consistent with the findings of the paper, would almost certainly not have come to light.

Returning to Mr. Deer’s article, he concludes:

So what should we make of all this? Now the Lancet paper is retracted, its findings don’t officially exist. And, if Dhillon is right in saying the slides can’t be found, the ultimate proof is missing. All we have are the pathology reports, which independent specialists seem to agree are largely unremarkable. “They wanted this bad,” commented Tom MacDonald, dean of research at Barts and the London School of Medicine and coauthor of Immunology and Diseases of the Gut. “If I was the referee and the routine pathologists reported that 8/11 were within normal limits, or had trivial changes, but this was then revised by other people to 11/12 having non-specific colitis, then I would just tell the editor to reject the paper.”

Clearly the Lancet paper should have been rejected. But this isn’t just a scientific paper that made a bad conclusion. This paper impacted multiple families inside the autism communities to believe that their child’s autism was caused by MMR. This paper led many families in the autism communities to apply poorly researched “therapies” to their disabled children. This paper led many families to stop vaccinating their children, leading to outbreaks of measles in the UK and elsewhere.

It is easy to go through Mr. Deer’s paper in the BMJ point by point in a clinical fashion, noting how the research went awry, showing that “autistic enterocolitis” has what appears to be no founding in science. But how does one express the reaction to so much damage caused by Dr. Wakefield’s investigation?

Of course, a further question I have and I bet I share with Dr. Wakefield’s supporters is this: is Brian Deer finished or is there even more yet to be unearthed in this sad tale of research gone awry?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A blog post by the National Autism Association stated:

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

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

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

the procedures involved were routine

and

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

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

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

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

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

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

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

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

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

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

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

I hope.

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