Archive | Legal RSS feed for this section

L.A. authorities find first victim in videotaped sexual assaults

13 Jan

The LA Times recently had a story about sexual abuse of disabled women. Ken brought the story here to LeftBrainRightBrain in Videos show rape of disabled women, police seek help to ID attackers. CNN is now reporting that one of the victims has been identified and one suspect is in custody: L.A. authorities find first victim in videotaped sexual assaults.

Investigators have found the first victim in the videotaped sexual assaults of severely disabled women, and the woman alleges a suspect already in custody had raped her in a Los Angeles care home, authorities said.

The woman, 25, now resides in another Los Angeles County residential care facility. Her medical condition causes her to be physically defenseless, Los Angeles County sheriff’s investigators said.

Having found one of the victims, they were able to obtain information on an alleged attacker:

The woman, found by state investigators Monday, made the sexual assault allegation against Ernie Lloyd, 27, who had turned himself in Saturday following widespread media coverage of the videotaped sexual assaults and a manhunt for four suspects depicted in police sketches. Lloyd was charged with rape of a person with disabilities Saturday after he “implicated himself,” authorities said.

Once again, here are the sketches of the attackers:

Secrets of the MMR scare: How the vaccine crisis was meant to make money

11 Jan

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.

Timeline of MMR scare

11 Jan

From Brian Deer’s latest article in the BMJ“:

Timeline of MMR scare

October 1988: The three in one measles, mumps, and rubella vaccine is introduced to the UK after successful use in the US since 1971. Previously, single measles and rubella vaccines were used, and there was no licensed mumps vaccine

September 1992: The UK Departments of Health withdraw two brands of MMR vaccine after research shows them to be associated with a raised incidence of transient mumps meningitis, although much lower than with natural disease

January 1994: A campaign group, JABS, is launched in Wigan, Lancashire, alleging that MMR causes brain damage and other problems in children. Autism and inflammatory bowel disease are not initially claimed

March 1995: Andrew Wakefield, a researcher at the Royal Free medical school, files for a patent claiming that Crohn’s disease and ulcerative colitis may be diagnosed by detecting measles virus in bowel tissue and body fluids

September 1995: Paediatric gastroenterologist John Walker-Smith moves with most of his team from Bart’s hospital, London, to set up a service at the Royal Free

February 1996: JABS solicitor, Richard Barr, retains Wakefield, at £150 an hour, plus expenses, to support a speculative legal attack on MMR manufacturers. This contract is not publicly disclosed

July 1996: The first child is admitted to the Royal Free for research to try to show a link with MMR. The research is commissioned by, and supported with a £55000 grant from, the UK Legal Aid Board, but this is not publicly disclosed

September 1996: Wakefield and his mentor Roy Pounder meet medical school managers to discuss market projections for a new business based on purportedly diagnosing Crohn’s disease from the presence of measles virus

June 1997: Claiming that the measles virus in MMR causes problems, Wakefield files for a patent on a “safer” single measles vaccine and for products to treat both autism and inflammatory bowel disease. This, too, is not publicly disclosed

February 1998: The Lancet publishes a 12 patient case series by Wakefield and 12 others, proposing a link between MMR and a “new syndrome” of autism and bowel disease. At a press conference, he urges the use of single vaccines instead of MMR

February 1998: Just days after the press conference, Wakefield and business partners meet Royal Free medical school managers to discuss a joint company to develop products based on his MMR claims, including “a replacement for attenuated viral vaccines”

February 1999: Unigenetics is incorporated, with Wakefield and a Dublin pathologist, John O’Leary, as directors. The company is awarded £800000 by the Legal Aid Board to perform tests on samples from children seen at Walker-Smith’s Royal Free unit

December 1999: Mark Pepys, new head of medicine at the medical school, challenges Wakefield about his business scheme and puts him on notice that he must replicate his research

January 2001: The Daily Mail and other newspapers launch campaigns backing Wakefield, working with JABS, after he publishes a purported review of his evidence and repeats his calls for single vaccines

October 2001: Wakefield is asked to leave the Royal Free after failing to mount a large scale controlled study to confirm or refute his claims about MMR

December 2001: Prime Minister Tony Blair is ambushed by Wakefield supporters, who claim that his youngest son, Leo, did not have MMR. The Blairs initially decline to comment but much later deny the claim

May 2002: Amid continuing media campaigns over MMR, particularly by the Mail and Telegraph groups, the magazine Private Eye issues a special edition, written in collaboration with families that are suing vaccine manufacturers

January 2003: Vaccination among 2 year olds falls to 78.9%: below the 92% the Department of Health says is needed to maintain herd immunity. Figures in parts of inner London are half the national rates

September 2003: The Legal Services Commission stops funding for Barr’s lawsuit after barristers for the claimants report to the commission that, on the evidence, they cannot make a case that MMR causes autism

February 2004: The Sunday Times reveals that the Legal Aid Board funded the Lancet research and that many of the children were litigants. Richard Horton, the journal’s editor, rejects more serious charges against the authors, later proved by the GMC

March 2004: Ten of the 1998 paper’s 13 authors, excluding Wakefield, retract its “interpretation” section, which claimed an association in time between MMR, enterocolitis, and regressive developmental disorders

November 2004: Channel 4’s Dispatches reveals Wakefield’s single vaccine patent and that, despite Wakefield’s claims that the culprit for the disorders is measles in MMR, molecular tests in his laboratory found no trace of the virus

January 2005: Wakefield initiates libel lawsuits, funded by the Medical Protection Society, against the Sunday Times, Channel 4, and Brian Deer over Deer’s website, claiming that all allegations are false and defamatory

March 2005: Among much research rejecting any link with developmental disorders and bowel disease, research is published showing that, after MMR was discontinued in Japan, the incidence of autism diagnoses continued to rise

October 2005: In the London High Court, Mr Justice Eady refuses an application from Wakefield to freeze his libel actions and orders him to proceed to trial of Deer’s allegations against his “honesty and professional integrity”

April 2006: As measles outbreaks are reported across Britain, the first death in the UK from the disease in 14 years is reported—a 13 year old boy from the traveller community

December 2006: The Sunday Times reveals Wakefield’s personal funding from Barr to support the lawsuit over MMR: £435643 plus expenses, from the legal aid fund. Some other Royal Free doctors were also paid

January 2007: Two days after the payments from Barr are revealed, the Medical Protection Society stops funding for Wakefield’s libel actions and through him agrees to pay the defendants’ costs of about £800000 on top of its own legal bills

July 2007: At a fitness to practise hearing in London, the General Medical Council opens its case alleging serious professional misconduct by the Lancet paper’s three senior authors, Wakefield, Walker-Smith, and endoscopist Simon Murch

February 2009: The Sunday Times alleges that Wakefield “fixed” the appearance of a link between MMR and autism. He denies fraud and files a complaint with the UK Press Complaints Commission, which he later abandons

February 2009: In the United States, three test case judgments for 5000 claims based on Wakefield’s theories are handed down in federal court, rejecting the allegation that MMR can cause autism. They are upheld on appeal in August 2010

January 2010: A panel comprising three doctors and two lay members gives findings of fact on the GMC’s case, upholding dozens of charges against Wakefield, Walker-Smith, and Murch and sending all three forward for sentencing

February 2010: Six years after the matters were raised with the Lancet, the journal fully retracts the 1998 paper. Horton describes aspects of it as “utterly false” and says he “felt deceived”

May 2010: After a 217 day inquiry, the GMC panel orders Wakefield and Walker-Smith to be erased from the medical register, but notes that Murch had shown “insight” and finds him not guilty of serious professional misconduct

Fact checking Brian Deer on Andrew Wakefield

11 Jan

As Kev recently wrote here on LeftBrainRightBrain, the main defense of Andrew Wakefield is not a defense at all, but an attack on Brian Deer. Rather than look at the facts laid out in the BMJ article, people are claiming that Andrew Wakefield couldn’t possibly have “fixed” the data (lead authors can and have do this, see our recent post). Also, that Andrew Wakefield didn’t have access to the full records of the children, so that he couldn’t have known that there were contradictory data in those records.

It is an odd argument in that it concedes that yes, indeed, the “facts” in the Lancet article do not match the children’s medical records.

It is also an odd argument because it ignores the citations that Brian Deer makes in his article. Mr. Deer cites where he gets the information that contradicts Andrew Wakefield’s reports. Many of which are not hidden in the child’s records but were available to Mr. Wakefield at the time he wrote his article for the Lancet.

Mr. Wakefield has reported in his Lancet article (now retracted) that “We identified associated gastrointestinal disease and developmental regression in a group of previously normal children, which was generally associated in time with possible environmental triggers. ”

Emphasis added.

As Brian Deer has noted in his article in the BMJ, this is not the case. Many of the children reported upon were not “previously normal”. We here at LeftBrainRightBrain have the luxury of more space than did Mr. Deer, so let’s check a few of Mr. Deer’s statements, shall we? Let’s look at the children that Mr. Deer commented upon in his article.

Early on in his article, Mr. Deer refers to Child 8. Child 8 was noted as having facial dysmorphisms. Further, the doctors treating Child 8 “…had significant concerns about her development some months before she had her MMR Vaccination”.

Here is a letter sent to Andrew Wakefield on 3 October, 1996. The Lancet article wasn’t published until 1998:

“ Dear Dr Wakefield

[Child 8’s] mother has been into see me and said that you need a referral letter from me in order to accept Child 8 into your investigation programme. I gather this is a specific area of expertise relating to the possible effects of vaccine damage and her ongoing GI Tract symptoms. As far as I am concerned, if [Mrs 8] is happy to proceed with this and it gives her any further information and peace of mind, I am sure it would be beneficial for both her and for [Child 8]. I enclose photocopies of some recent correspondence which gives a fair idea of [Child 8’s] current state. I would simply reiterate Dr Houlsby’s recent comment that both the hospital and members of the Primary Care Team involved with [Child 8] had significant concerns about her development some months before she had her MMR Vaccination. I take Mum’s point that she has video evidence of [Child 8] saying a few words prior to this vaccination being given and her vocal abilities are now nil but I do not think we can be entirely convinced as yet that the vaccine is the central cause of her current difficulties. However, I am quite prepared to support [Mrs 8] in her quest for further information and I hope some useful results come from these tests.

Best wishes.”

emphasis added.

This was presented to the GMC on Day 29 of the hearing. Mr. Wakefield knew Child 8’s physicians questioned whether child 8 was “previously normal” when he wrote the article in the Lancet. It is unclear if Mr. Wakefield sought out those physicians, or if the “recent correspondence” also noted those early signs. But we do know that Andrew Wakefield had more than just the parent’s report on the child’s history and that the physicians disagreed with the parent’s impression. Given the contradiction between the two sources, at the very least, Mr. Wakefield should have sought out the child’s records.

As an aside here, Child 8 was already funded by legal aid at the time of referral. Mr. Wakefield has claimed that children were not already a part of litigation when they were seen by him at the Royal Free. This is also noted in an doctor’s note in the transcripts:

“Mum taking her to Dr Wakefield, Royal Free hospital for CT scan and gut biopsies.
? Crohn’s – will need a letter.
Dr Wakefield to phone me.
Funded through legal aid.”

Again, the child was “funded through legal aide” before referral to Mr. Wakefield.

Here is how Child 4 is reported in The Lancet paper:

One child (child four) had received monovalent measles vaccine at 15 months, after which his development slowed (confirmed by professional assessors). No association was made with the vaccine at this time. He received a dose of measles, mumps, and rubella vaccine at age 4·5 years, the day after which his mother described a striking deterioration in his behaviour that she did link with the immunisation.

“Confirmed by professional assessors”. I find this interesting. One of the defenses of Mr. Wakefield is that “he was just reporting what parents told him”. But, there it is, “confirmed by professional assessors”. Andrew Wakfield had “professional assessors” check the validity of the claims. Have Andrew Wakefield’s supporters actually read the paper?

Was there anything in this child’s records that a “professional assessor” might flag as possibly showing signs of delay before vaccination? Here is the letter from Child 4’s doctor to Mr. Wakefield dated 1 July 1996.

“Following our recent telephone conversation I would be grateful if you could arrange an appropriate ECR appointment for [4] to undergo assessment regarding his possible autism and his bowel problems.

[Child 4] has had long standing difficulties and shows severe learning difficulties and also bowel disturbance and his mother has always found it difficult to accept that there was no known cause for [Child 4]’s disorder. A few years ago she was chasing the idea that he might have a metabolic disorder and I enclose a copy of a letter I wrote to Dr Wraith in Manchester at that time although his reply was he did not see any value in further tests along these lines. I’m aware that you are looking at the possible links between measles vaccine and various difficulties and [Child 4] certainly had MMR in 1988. In general [Child 4]’s mother thinks that he developed normally initially and then subsequently his problems worsened and he lost some of the milestones he had achieved but that he has subsequently improved on something of a restrictive exclusion diet. The professionals who have known [Child 4] since birth do not entirely agree with this however and there is a suggestion that some of [Child 4]’s problems may have started before vaccination.

Since 1994 4 has continued to have intermittent problems with his bowels and diarrhoea that [Mrs 4] relates to food intake; he has had a negative test for celiac disease and has on at least 2 occasions had giardia but he has had no further investigations regarding the cause of these symptoms.

As I say, [Mrs 4] is convinced that both [Child 4]’s behaviour and his diarrhoea are triggered by his diet and she has him on something of a restrictive exclusion diet. He has not gained weight and we have been very concerned about this and [Mrs 4] feels that this is despite him being on a more normal diet. We have therefore not made any assessment as to whether his failure to gain weight might be due to an inadequate diet or to possible malabsorption.

I would be grateful if you could arrange an appropriate appointment and would be very interested if you feel [Child 4] fits into the sort of category of patient that you are interested in looking at further”.

From Day 6 of the GMC hearing. Note that the “…had MMR in 1988” is likely incorrect and that it was the monovalent measles vaccine in 1988.

Again, Mr. Wakefield was alerted to a child having possible problems before MMR administration, but reported the child as “previously normal”. We are left with a question, did Mr. Wakefield just fail to follow up on this possibility or did he know the details and misreport them?

Here is a statement in the child’s records. Whether this was available to Mr. Wakefield at the time of writing the article in The Lancet is unclear:

A delayed development was acknowledged by the health visitor at 1 year of age but at this stage [Mrs 4] did not accept that [Child 4] was slow.

Here is a letter written to Child 4’s physician after his time with the Royal Free team:

“I will write to Dr Wakefield to see if I have any better luck at getting a summary of their investigations and conclusions. [Child 4] had a course of (I think) sulphasalazine after his investigation at the Royal Free Hospital. He became acutely distressed, apparently with abdominal pain and his autism and behaviour did not improve. It was therefore discontinued after a fortnight”.

Apparently, the therapies Mr. Wakefield’s team supplied were not always beneficial.

Let’s move on to Child 1. Mr. Deer reports in the BMJ:

The remaining five children served Wakefield’s claims no better. There was still no convincing MMR syndrome. Child 1, aged 3 years when he was referred to London, lived 100 miles from the Royal Free, and had an older brother who was diagnosed as autistic.76 Child 1’s recorded story began when he was aged 9 months, with a “new patient” note by general practitioner Andrea Barrow. One of the mother’s concerns was that he could not hear properly—which might sound like a hallmark presentation of classical autism, the emergence of which is often insidious. Indeed, a Royal Free history, by neurologist and coauthor Peter Harvey, noted “normal milestones” until “18 months or so.”

Child 1 was vaccinated at 12 months of age, however. Thus neither 9 nor 18 months helped Wakefield’s case. But in the Lancet, the “first behavioural symptom” was reported “1 week” after the injection, holding the evidence for the lawsuit on track.

Here’s the “new patient” note:

“New patient – recently posted from XXXX. Mum worried re hearing/wax in ears/? Discharge left ear … Reassured.” Then “(NB – older brother … ? behaviour probs and ? family dynamics ?)”.

Here’s the statement by Dr. Harvey (of the Royal Free): “after normal milestones a deterioration from 18 months or so”. The referral letter for this child, sent to the Royal Free, states that the child was normal until age 15 months.

Here is a statement from the records at the Royal Free (day 24 of the transcripts):

“Child 1 was admitted for further investigation of his autism and specifically to look into a possible association between his neurological condition and any gastrointestinal disorders. The main problems are a “classical” autism diagnosed a year ago and of diarrhoea.”

On page 50:

“His diarrhoea started approximately 18 months ago. He passes five watery stools a day which contain no blood or mucous. They do contain some undigested food. He appears to have no control over his bowel movements and frequency is increasing. His appetite has always been poor and there has been no obvious change in this. He has only very occasional episodes of vomiting.

He is up-to-date with his immunisations, including his MMR at 12 months of age. There is obvious parental concern that this has some bearing on his subsequent condition.”

Perhaps not consistent, but Andrew Wakefield knew that the child’s records did not place concern until much time had passed since the MMR vaccination.

The “onset of behavioral symptoms” reported in The Lancet does derive from parental report. But not a very strong report. A letter to Andrew Wakefield about child 1 put it like this:

“I saw this interesting child with autism which began some weeks following MMR although there was 7-10 days after the MMR at the age of 1 a brief illness during which he was pale, possibly had fever and his mother said he may have been delirious. [Mrs 1] was keen that you would have a look at a document that she got concerning homeopathic remedies and I am passing this on to you.”

So, Mr. Wakefield reported Child 1 as having first symptom 1 week after MMR. If you include “fever/delirium”. Not exactly an autism symptom. But developmentally the child was noted as being normal until 15 or 18 months? Is that “fixing” data or just something less than accurate?

The Wakefield 1998 Lancet article did not give an accurate picture of these children, based on the records available to Mr. Wakefield at the time. And that is the important fact: Mr. Wakefield had access to information that put his reported findings into question.

The Big Lie – what Andrew Wakefield did was possible and fraudulent

10 Jan

Earlier this week, the blog Child Health Safety published a piece claiming it was impossible for Andrew Wakefield to have acted fraudulently. Earlier today, JB Handley of Age of Autism published a similar piece:

“It was not possible for Wakefield or anyone else to falsify the prior clinical records of the children because no one at the Royal Free Hospital London had them nor is it normal practice for them to have had them. So there could be no fraud over ‘altering’ those histories. It just was not possible.”

Plain English: In Britain, when you are referred from a local doctor to a major hospital, like the one where Andy worked, your previous doctor’s records DO NOT travel with you.

Hmmm. Lets look at the definition of the claim of fraud from the editorial in the BMJ.

The Office of Research Integrity in the United States defines fraud as fabrication, falsification, or plagiarism. Deer unearthed clear evidence of falsification. He found that not one of the 12 cases reported in the 1998 Lancet paper was free of misrepresentation or undisclosed alteration, and that in no single case could the medical records be fully reconciled with the descriptions, diagnoses, or histories published in the journal.

This quite clear – but don’t CHS blog and JB Handley have a point? If Andrew Wakefield couldn’t see the NHS records, how could he have falsified data? He might have been wrong, but fraud? No. If Wakefield couldn’t have seen those NHS records he could not have altered data from them to enhance his Lancet piece.

Except he _did_ see these children’s NHS records. From the very paper itself, we can glean the following:

12 children (mean age 6 years [range 3–10], 11 boys) were referred to a paediatric gastroenterology unit
with a history of normal development followed by loss of acquired skills, including language, together with diarrhoea and abdominal pain. Children underwent gastroenterological, neurological, and developmental assessment and review of developmental records.
Ileocolonoscopy and biopsy sampling, magnetic-resonance imaging (MRI), electroencephalography (EEG), and lumbar puncture were done under sedation. Barium follow-through radiography was done where possible. Biochemical, haematological, and immunological profiles were examined.

Developmental histories included a review of prospective developmental records from parents, health visitors, and general practitioners.

This is quite clear. Wakefield saw the NHS records of the Lancet 12. The claim that he didn’t is incorrect at best.

Videos show rape of disabled women, police seek help to ID attackers

7 Jan

The package left at the LA County Sheriff’s Department sickened even the most jaded detectives – 100 hours of video of men who appear to be sexually assaulting severely disabled women.

From the LA Times:

The attacks appeared to have taken place at residential care centers, authorities said, and most of the attackers are believed to be employees. One suspect appears to be a paraplegic patient, hoisting himself off his wheelchair, before removing his diaper and that of his victim’s, and beginning his assault.

The footage, dropped off in March, has left detectives with few leads. Though authorities are confident the scenes were shot in residential care facilities, it’s unclear if they are located in Los Angeles County. Much of the footage is so grainy that only the faces of four of the estimated 10 men could be made out.

Authorities have released still shots to the public, hoping that someone who recognizes an individual or setting in the video will come forward. You can see those images here.

The package containing the video was left with authorities last March, and it has taken months to enhance and analyze the images. Detectives say the victims appear to be between 20 and 40 years old, and that some appear almost “entirely unresponsive.”

The men appear to also be between 20 and 40. The footage, detectives said, appears to be a collection, with some men appearing in more than one scene. Some of the footage was shot with a handheld camera, with the rest appearing to be captured by a security camera, detectives said.

Anyone with information is asked to call Special Victims Bureau detectives at (866) 247-5877. Anonymous tipsters can call (800)222-TIPS.

One of the rooms where attacks took place.




LA Times: Authorities seek identity of men videotaped sexually assaulting disabled women

7 Jan

Ken Reibel has already covered this story here. This is horrific. I am seriously at a loss for words except to say that I want as many of these men prosecuted. To that end, I wanted to put the sketches of the perpetrators on the blog just in case anyone might recognize them.

The LA Times gallery of photos is here. I have copied the sketches below.

Anyone with information is asked to call Special Victims Bureau detectives at (866) 247-5877. Anonymous tipsters can call (800) 222-TIPS.

Mitochondrial Dysfunction in Autism

22 Dec

A recent paper from the MIND Institute, published in the Journal of the American Medical Association (JAMA) entitled Mitochondrial Dysfunction in Autism caused a bit of a stir. One which is far beyond what is supported by the paper’s conclusions or data, I will add.

The study is very small: 10 autistic children and 10 controls. The authors used a very nonstandard methodology. Perhaps the best summary of this study so far can be found on the Simons Foundation blog SFARI (Defects in mitochondria linked to autism). Deborah Rudacille discusses the methodology and brings in quotes from the study’s lead author (Cecilia Giulivi) as well as established experts in the field of mitochondrial disease and autism such as Jay Gargas.

Before I get too far ahead of myself, here is the abstract:

Context Impaired mitochondrial function may influence processes highly dependent on energy, such as neurodevelopment, and contribute to autism. No studies have evaluated mitochondrial dysfunction and mitochondrial DNA (mtDNA) abnormalities in a well-defined population of children with autism.

Objective To evaluate mitochondrial defects in children with autism.

Design, Setting, and Patients Observational study using data collected from patients aged 2 to 5 years who were a subset of children participating in the Childhood Autism Risk From Genes and Environment study in California, which is a population-based, case-control investigation with confirmed autism cases and age-matched, genetically unrelated, typically developing controls, that was launched in 2003 and is still ongoing. Mitochondrial dysfunction and mtDNA abnormalities were evaluated in lymphocytes from 10 children with autism and 10 controls.

Main Outcome Measures Oxidative phosphorylation capacity, mtDNA copy number and deletions, mitochondrial rate of hydrogen peroxide production, and plasma lactate and pyruvate.

Results The reduced nicotinamide adenine dinucleotide (NADH) oxidase activity (normalized to citrate synthase activity) in lymphocytic mitochondria from children with autism was significantly lower compared with controls (mean, 4.4 [95% confidence interval {CI}, 2.8-6.0] vs 12 [95% CI, 8-16], respectively; P = .001). The majority of children with autism (6 of 10) had complex I activity below control range values. Higher plasma pyruvate levels were found in children with autism compared with controls (0.23 mM [95% CI, 0.15-0.31 mM] vs 0.08 mM [95% CI, 0.04-0.12 mM], respectively; P = .02). Eight of 10 cases had higher pyruvate levels but only 2 cases had higher lactate levels compared with controls. These results were consistent with the lower pyruvate dehydrogenase activity observed in children with autism compared with controls (1.0 [95% CI, 0.6-1.4] nmol × [min × mg protein]?1 vs 2.3 [95% CI, 1.7-2.9] nmol × [min × mg protein]?1, respectively; P = .01). Children with autism had higher mitochondrial rates of hydrogen peroxide production compared with controls (0.34 [95% CI, 0.26-0.42] nmol × [min × mg of protein]?1 vs 0.16 [95% CI, 0.12-0.20] nmol × [min × mg protein]?1 by complex III; P = .02). Mitochondrial DNA overreplication was found in 5 cases (mean ratio of mtDNA to nuclear DNA: 239 [95% CI, 217-239] vs 179 [95% CI, 165-193] in controls; P = 10?4). Deletions at the segment of cytochrome b were observed in 2 cases (ratio of cytochrome b to ND1: 0.80 [95% CI, 0.68-0.92] vs 0.99 [95% CI, 0.93-1.05] for controls; P = .01).

Conclusion In this exploratory study, children with autism were more likely to have mitochondrial dysfunction, mtDNA overreplication, and mtDNA deletions than typically developing children.

As the abstract states, the MIND Institute study methodology involved: “Mitochondrial dysfunction and mtDNA abnormalities were evaluated in lymphocytes from 10 children with autism and 10 controls”. Lymphocytes (a type of white blood cell). Children were concecutively recruited and genetically unrelated. Mitochondrial function was tested first, and given the results seen, children were brought back for a second blood draw where mitochondrial DNA (mDNA) and nuclear DNA (nDNA) were examined.

As shown in the figure below, they found that the autistic children had different mitochondrial activity levels than their controls. Note that “low” activity is not referenced to any standardized norms, but to the 10 control children.

They also performed genetic testing. Table 3 from the paper is reproduced below:

They show that, by their methodology, 7 of their 10 autistic kids have some form of genetic signature for mitochondrial dysfunction. 2 of 10 of their controls meet their criteria as well.

The Simons blog quotes the study author, Prof. Giulivi on this choice:

“Lymphocytes do not rely as heavily on mitochondria as the brain does,” she says, “so if this is happening in cells that don’t use mitochondria as much, it’s likely to be happening in cells that rely more heavily on mitochondria, like neurons.”

They also quote Dr. Fernando Scaglia, of the Baylor Clinic:

However, the unconventional decision to use lymphocytes should have been validated, says Fernando Scaglia, associate professor of molecular and human genetics at Baylor College of Medicine in Houston. “I’m not saying that studies done in lymphocytes are useless,” says Scaglia, an expert in inherited metabolic disease. “But they should be validated in other tissue.”

and Prof. Gargas of the University of California at Irvine:

“Lymphocytes are fine to study chromosomal DNA, but they are a horrible source for studying mitochondrial DNA,” he says.

Cells have hundreds of mitochondria, each with multiple copies of the DNA. In people with mitochondrial disease, some cells have healthy DNA and others have the mutated copies, he notes. In a blood sample, defective lymphoctyes tend to get lost among rapidly proliferating healthy cells.

“The best source for studying mitochondria are post-mitotic cells such as muscle,” he says. “That way you are sampling the set of cells the child was born with.”

In the end, if we stick to the idea that this is a very preliminary report and relies on a new unproven methodology at that, we can consider the study as posing interesting questions. Is mitochondrial dysfunction more prevalent in autistics than the general population? Are there ways to test this in a faster, less intrusive manner than is often used? If we take this study in context, there may be some value. Unfortunately as Seth Mnookin has already pointed out, this study has already been used to promote ideas that are clearly outside of the study and conclusions. This is the unfortunate world of autism research: it is hard for people to push the boundaries and risk being wrong. Not because it may cause the researchers some embarrassment, but because there are a multitude of people waiting to misuse information and mislead.

Commentary on Mitochondrial Dysfunction in Autism

22 Dec

I recently wrote about the paper Mitochondrial Dysfunction in Autism by the MIND Institute. It is difficult to write about the topic of mitochondrial dysfunction and mitochondrial disorders and autism without discussing vaccines. Even the Simons Foundation blog mentioned vaccines in their treatment of the paper, even though the paper makes no comments about vaccines.

Why? Because the case of Hannah Poling and, especially, the way David Kirby presented it to the public has linked autism–mitochondrial dysfunction–vaccines into one neat package. With posts like “NEW STUDY – “Mitochondrial Autism” is Real; Vaccine Triggers Cannot Be Ruled Out” and “The Vaccine-Autism Story: Trust Your Government, or Be a Patriot and Get on Google”. In the latter post he wrote:

“Google “autism and mitochondria,” (96,900 hits) and then Google “mercury and mitochondria,” (169,000 hits) and draw your own, informed conclusions. “

It was very much in David Kirby’s style. Don’t come out and say something directly (like, “mercury is the cause of mitochondrial disease”) but lead the reader along with a series of, well, leading statements.

A more responsible approach would be that one needn’t trust the government nor seek advice on google. A more responsible approach for Mr. Kirby would be to suggest that perhaps, just perhaps, parents of autistic kids should seek out the advice of experts in mitochondrial medicine. Mr. Kirby clearly had an agenda, and it wasn’t the well being of autistics. He was promoting the idea that vaccines caused an autism epidemic.

Mr. Kirby thankfully appears to have moved on from focusing his attention on promoting the vaccine-autism hypotheses. And yet, there is obviously a hunger amongst his old readers for this discussion. This can be seen in Mark Hyman’s blog post at the Huffington Post, “Autism Research: Breakthrough Discovery on the Causes of Autism” which has nearly 1,900 comments. Where David Kirby was promoting himself and the interests of groups like SafeMinds and Generation Rescue, Dr. Hyman uses the MIND Institute paper to promote himself and his own business.

What is worse is the way he goes about doing this. Dr. Hyman is even less capable of covering his obvious mistakes than was David Kirby.

Dr. Hyman writes:

While we don’t have all the answers, and more research is needed to identify and validate the causes and treatment of autism, there are new signs of hope. A study just published in The Journal of the American Medical Association by researchers from the University of California, Davis called “Mitochondrial Dysfunction in Autism” (i) discovered a profound and serious biological underpinning of autism — an acquired loss of the ability to produce energy in the cells, damage to mitochondria (the energy factories in your cells), and an increase in oxidative stress (the same chemical reaction that causes cars to rust, apples to turn brown, fat to become rancid, and skin to wrinkle). These disturbances in energy metabolism were not due to genetic mutations, which is often seen in mitochondrial problems, but a condition the children studied acquired in utero or after birth.

The statement is amazing. Not in a good way. It is amazing that someone could write such an irresponsible paragraph and attribute it to a paper which clearly doesn’t make or support these claims.

The very title of Dr. Hyman’s post (Autism Research: Breakthrough Discovery on the Causes of Autism) is in error. The study makes no claims about the causes of autism. Dr. Hyman didn’t have to look any farther than the paper itself which clearly states as one of the limitations:

Sixth, inferences about a cause and effect association between mitochondrial dysfunction and typical autism cannot be made in a cross-sectional study.

Given this, we can also throw out Dr. Hyman’s wild claim that the study’s authors “discovered a profound and serious biological underpinning of autism”.

Since it is already clear that Dr. Hyman is using the paper to promote his own ideas, regardless of the facts in the paper, I won’t posit as to why he claims that the mitochondrial dysfunction is “acquired”, or that this is due to “damage” to mitochondria. The paper does not support either of these conclusions as fact.

He makes the claim that “These disturbances in energy metabolism were not due to genetic mutations, which is often seen in mitochondrial problems, but a condition the children studied acquired in utero or after birth.”

I am unsure how Dr. Hyman reached this conclusion. The paper notes differences in the mtDNA of many of the children studied. It does not provide evidence as to when or how these genetic differences arose.

Table 3 clearly shows the genetic measures the MIND Institute researchers used. Question the method as you may (or some experts have), there are differences in the mtDNA. The methodology doesn’t allow one to state if these difference were present at birth or not.

The MIND Institute hosts an interview with Prof. Giulivi
At about 3:30 into Prof. Giulivi’s interview, she states clearly that they can not conclude if the mitochondrial dysfunction they claim causes autism or is a result of it.

It is hard for me to decide if Dr. Hyman is more irresponsible than David Kirby or if it is the other way around. David Kirby was certainly doing some self promotion, but his impact was largely as a publicist for the autism-as-vaccine-injury groups like SafeMinds and Generation Rescue. Dr. Hyman is clearly focused on promoting his own services as a practitioner of alternative medicine.

The problem is that in the end, rather than being a leader in treatment, as Dr. Hyman presents himself, such irresponsible actions hinder advancement.

The Huffington Post: Featuring bad science, facile reasoning since 2005

14 Dec

That’s the title of a new blog post by Seth Mnookin, author of “The Panic Virus“. The title is spot on (and could be the the title of a book in its own right): The Huffington Post: Featuring bad science, facile reasoning since 2005.

Seth Mnookin took a look at unscientific thinking that can lead to dangerous results. Not surprisingly, he found that the anti-vaccine movement and the autism-vaccine discussion in particular made an excellent core for his book. In his first blog piece related to Panic Virus, Mr. Mnookin takes a look at how the Huffington Post reported a recent study on mitochondrial dysfunction and autism. The Huffington Post piece, authored by Mark Hyman, made claims well beyond those supported by the paper itself.

A brief quote by Mr. Mnookin:

If you’re confused as to why The Huffington Post would run Hyman’s piece — well, I have my theories, but suffice it to say that the site arguably features more scientific quackery than any other mainstream media outlet.