Lumi's Batshit Insane Thread

“That’s not true.”

Child 11 was among the eight whose parents apparently blamed MMR. The interval between his vaccination and the first “behavioural symptom” was reported as 1 week. This symptom was said to have appeared at age 15 months. But his father, whom I had tracked down, said this was wrong.

“From the information you provided me on our son, who I was shocked to hear had been included in their published study,” he wrote to me, after we met again in California, “the data clearly appeared to be distorted.”

He backed his concerns with medical records, including a Royal Free discharge summary.5 Although the family lived 5000 miles from the hospital, in February 1997 the boy (then aged 5) had been flown to London and admitted for Wakefield’s project, the undisclosed goal of which was to help sue the vaccine’s manufacturers.6

Wakefield’s “syndrome”
Unknown to Mr 11, Wakefield was working on a lawsuit,7 for which he sought a bowel-brain “syndrome” as its centrepiece. Claiming an undisclosed £150 (€180, $230) an hour through a Norfolk solicitor named Richard Barr, he had been confidentially 8 put on the payroll two years before the paper was published, eventually grossing him £435 643, plus expenses.9

Curiously, however, Wakefield had already identified such a syndrome before the project which would reputedly discover it. “Children with enteritis/disintegrative disorder [an expression he used for bowel inflammation and regressive autism10] form part of a new syndrome,” he and Barr explained in a confidential grant application to the UK government’s Legal Aid Board11 before any of the children were investigated.12 “Nonetheless the evidence is undeniably in favour of a specific vaccine induced pathology.”

The two men also aimed to show a sudden-onset “temporal association”—strong evidence in product liability. “Dr Wakefield feels that if we can show a clear time link between the vaccination and onset of symptoms,” Barr told the legal board, “we should be able to dispose of the suggestion that it’s simply a chance encounter.”13

But child 11’s case must have proved a disappointment. Records show his behavioural symptoms started too soon. “His developmental milestones were normal until 13 months of age,” notes the discharge summary. “In the period 13-18 months he developed slow speech patterns and repetitive hand movements. Over this period his parents remarked on his slow gradual deterioration.”

That put the first symptom two months earlier than reported in the Lancet, and a month before the boy received the MMR vaccination. And this was not the only anomaly to catch the father’s eye. What the paper reported as a “behavioural symptom” was noted in the records as a chest infection.

“Please let me know if Andrew W has his doctor’s license revoked,” wrote Mr 11, who is convinced that many vaccines and environmental pollutants may be responsible for childhood brain disorders. “His misrepresentation of my son in his research paper is inexcusable. His motives for this I may never know.”

The father need not have worried. My investigation of the MMR issue exposed the frauds behind Wakefield’s research. Triggering the longest ever UK General Medical Council fitness to practise hearing, and forcing the Lancetto retract the paper, last May it led to Wakefield and Walker-Smith being struck off the medical register.14 15 16

Wakefield, now 54, who called no witnesses, was branded “dishonest,” “unethical,” and “callous.”14 15 16 Walker-Smith, now 74, the senior clinician in the project, was found to have presided over “high risk”17 research without clinical indication or ethical approval. The developmentally challenged children of often vulnerable parents were discovered to have been treated like the doctors’ guinea pigs.18

Lawsuit test case
But Mr 11 was not the first parent with a child in the study whom I interviewed during my inquiries. That was Mrs 2: the first of the parents to approach Wakefield. She was sent to him by an anti-vaccine campaign called JABS.19 Her son had regressive autism,20 longstanding problems with diarrhoea,21 and was the prime example of the purported bowel and brain syndrome—still unsubstantiated 14 years later.22 This boy would appear in countless media reports, and was one of the four “best” cases in Barr’s lawsuit.

I travelled to the family home, 80 miles northeast of London, to hear about child 2 from his mother. That was in September 2003, when the lawsuit fell apart after counsel representing 1500 families said that, on the evidence, Barr’s autism claims would fail.23 By that time, Mrs 2 had seen her son’s medical records and expert reports written for her case at trial.

Her concerns about MMR had been noted by her general practitioner when her son was 6 years old.24 But she told me the boy’s troubles began after his vaccination, which he received at 15 months.25 “He’d scream all night, and he started head banging, which he’d never done before,” she explained.

“When did that begin, do you think?” I asked.

“That began after a couple of months, a few months afterward, but it was still, it was concerning me enough, I remember going back . . .”

“Sorry. I don’t want to be, like, massively pernickety, but was it a few months, or a couple of months?”

“It was more like a few months because he’d had this, kind of, you know, slide down. He wasn’t right. He wasn’t right. Before he started.”

“Not quicker than two months, but not longer than how many months? What are we talking about here?”

“From memory, about six months, I think.”

The next day, she complained to my editors. She said my methods “seemed more akin to the gutter press.” But I was perplexed by her story, since there was no case in the Lancet that matched her careful account.

According to the paper, child 2 had his “first behavioural symptom” two weeks, not six months, after MMR. This was derived from a Royal Free history (citing “headbanging” and “screaming” as the start26) taken by Mark Berelowitz, a child psychiatrist and a coauthor of the paper.27 He saw Mrs 2 during the boy’s admission, at age 8, after she had discussed her son’s story with Wakefield.28

As I later discovered, each family in the project was involved in such discussions before they saw the hospital’s clinicians.29 Wakefield phoned them at home, and must have at least suggestively questioned them, potentially impacting on later history taking. But I knew little of such things then, and shared my confusion with Walker-Smith, whom I met shortly after Mrs 2.

“There is no case in the paper that is consistent with the case history [Mrs 2] has given me,” I told him. “There just isn’t one.”

“Well that could be true,” the former professor of paediatric gastroenterology replied, disarmingly. He knew the case well, having admitted the boy for the project and written reports for Barr, who paid him £23 000.30

“Well, so either what she is telling me is not accurate, or the paper’s not accurate.”

“Well I can’t really comment,” he said. “You really touch on an area which I don’t think should be debated like this. And I think these parents are wrong to discuss such details, where you could be put in a position of having a lot of medical details and then try to match it with this, because it is a confidential matter.”

It was not merely medically confidential, it was also legally protected: a double screen against public scrutiny. But responding to my first MMR reports, in the Sunday Times in February 2004,31 the GMC decided to investigate the cases and requisitioned the children’s records.32

The regulator’s main focus was whether the research was ethical. Mine was whether it was true. So as a five member disciplinary panel33 trawled through the records, with five Queen’s counsel34 and three defendant doctors,35 I compared them with what was published in the journal.36

Multiple discrepancies
The paper gave the impression that the authors had been scrupulous in documenting the patients’ cases. “Children underwent gastroenterological, neurological, and developmental assessment and review of developmental records,” it explained, specifying that Diagnostic and Statistical Manual of Mental Disorders IV37 criteria were used for neuropsychiatric diagnoses. “Developmental histories included a review of prospective developmental records from parents, health visitors, and general practitioners.”

But, when the details were dissected before the GMC panel, multiple discrepancies emerged. A syndrome necessarily requires at least some consistency, but, as the records were laid out, Wakefield’s crumbled.

First to crack was “regressive autism,” the bedrock of his allegations.38 39 “Bear in mind that we are dealing with regressive autism in these children, not of classical autism where the child is not right from the beginning,” he later explained, for example, to a United States congressional committee.40

But only one—child 2—clearly had regressive autism.41 Three of nine so described clearly did not. None of these three even had autism diagnoses, either at admission or on discharge from the Royal Free.

The paper did not reveal that two of this trio were brothers, living 60 miles south of the hospital. Both had histories of fits and bowel problems42 recorded before their MMR vaccinations.43 44 The elder, child 6, aged 4 years at admission, had Asperger’s syndrome,45 which is distinct from autism under DSM-IV, is not regressive,46 and was confirmed on discharge.47 His brother, child 7, was admitted at nearly 3 years of age without a diagnosis,48 and a post-discharge letter from senior paediatric registrar and Lancet coauthor David Casson49 summarised: “He is not thought to have features of autism.”50

The third in the trio, child 12, was enrolled on the advice of the brothers’ mother—reported in media to be a JABS activist, and who had herself “only relatively recently”51 blamed the vaccine. Child 12 was aged 6 at admission and had previously been assessed for possible Asperger’s syndrome at Guy’s Hospital, London, by a renowned developmental paediatrician.52 53 She diagnosed “an impairment in respect of language”—an opinion left undisturbed by Berelowitz.54 55

Mrs 12 was a GMC witness at its mammoth hearing, which between July 2007 and May 2010 ran for 217 days. She explained that the brothers’ mother had made her suspicious of MMR and had given her Barr’s and Wakefield’s names.56 Mrs 12 then approached them and filed a statement for legal aid before her son was referred.57

“It was like a jigsaw puzzle—it suddenly seemed to fit into place,” she told the panel, describing how she concluded, four years after the boy was vaccinated, that MMR was to blame for his problems. “I had this perfectly normal child who, as I could see, for no apparent reason started to not be normal.”

The 12 children were admitted between July 1996 and February 1997, and others had connections not revealed in the paper, almost as striking as the trio’s. The parents of child 9 and child 10 were contacts of Mrs 2, who ran a group that campaigned against MMR. 58 And child 4 and child 8 were admitted—without outpatient appointments59—for ileocolonoscopy and other invasive procedures, from one Tyneside general practice, 280 miles from the Royal Free, after advice from anti-MMR campaigners.60

Pre-existing problems
Both child 4 and child 8 were among the eight whose parents were reported to have blamed the vaccine. But although the paper specified that all 12 children were “previously normal,”61 both had developmental delays, and also facial dysmorphisms, noted before MMR vaccination.

In the case of child 4, who received the vaccine at age 4 years, Wakefield played down problems, suggesting that early issues had resolved. “Child four was kept under review for the first year of life because of wide bridging of the nose,” he reported in the paper. “He was discharged from follow-up as developmentally normal at age 1 year.”

But medical records, presented by the GMC, give a different picture for this child. Reports from his pre-MMR years were peppered with “concerns over his head and appearance,”62 “recurrent” diarrhoea,63 “developmental delay,”64“general delay,” and restricted vocabulary.65 And although before his referral to Wakefield his mother had inquired about vaccine damage compensation,66 his files include a report of a “very small deletion within the fragile X gene,”67 and a note of the mother’s view that her concerns about his development had begun when he was 18 months old.68

“In general, his mother thinks he developed normally initially and subsequently his problems worsened, and he lost some of his milestones, but he subsequently improved on a restrictive exclusion diet,” wrote his general practitioner, William Tapsfield, referring the boy, then aged 9, after a phone conversation with Wakefield. “The professionals who have known [child 4] since birth don’t entirely agree with this, however, and there is a suggestion that some of his problems may have started before vaccination.”69

Similarly with child 8, who was also described in the Lancet as having overcome problems recorded before vaccination. “The only girl . . . was noted to be a slow developer compared with her older sister,” the paper said. “She was subsequently found to have coarctation of the aorta. After surgical repair of the aorta at the age of 14 months, she progressed rapidly, and learnt to talk. Speech was lost later.”

But Wakefield was not a paediatrician. He was a former trainee gastrointestinal surgeon with a non-clinical medical school contract.70 And his interpretation differed from that of local consultants (including a developmental paediatrician and a geneticist) who had actually looked after the girl. Her doctors put the coarctation side by side with the delay and dysmorphism,71 and noted of her vocabulary that, before MMR at 18 months, she vocalised only 72 “two or three words.” 73

“[Child 8’s] mother has been to see me and said you need a referral letter from me in order to accept [child 8] into your investigation programme,” the general practitioner, Diana Jelley, wrote to Wakefield at referral, when the girl was aged 3 and a half years. “I would simply re-iterate . . . 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.”74

The girl’s general practice notes also provide insight into the background to the 12 children’s referrals. After person(s) unknown told Mrs 8 that her daughter may have inflammatory bowel disease, Jelley wrote: “Mum taking her to Dr Wakefield, Royal Free Hospital for CT scans/gut biopsies ?Crohn’s—will need ref letter—Dr W to phone me. Funded through legal aid.”75

The child was “pale”
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.77 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.”78

Child 1 was vaccinated at 12 months of age, however. 79 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.

Step 1 to achieve this: two and a half years after the child was vaccinated, Walker-Smith took an outpatient history. Although the mother apparently had no worries following her son’s vaccination,80 the professor elicited that the boy was “pale” 7-10 days after the shot. He also elicited that the child “possibly” had a fever, and “may” have been delirious, as well as pale.81

“It’s difficult to associate a clear historical link with the MMR and the answer to autism,” Walker-Smith wrote to the general practitioner,82 with a similar letter to Wakefield, “although [Mrs 1] does believe that [child 1] had an illness 7-10 days after MMR when he was pale, ?fever, ?delirious, but wasn’t actually seen by a doctor.”

Step 2: for the Lancet, Wakefield dropped the question marks, turning Walker-Smith’s queries into assertions. And, although Royal Free admission83 and discharge84 records refer to “classical” autism, step 3, the former surgeon reported “delirium” as the first “behavioural symptom” of regressive autism, with, step 4, a “time to onset” of 7 days.

So here—behind the paper—is how Wakefield evidenced his “syndrome” for the lawsuit, and built his platform to launch the vaccine scare.

“It is significant that this syndrome only appeared with the introduction of the polyvalent MMR vaccine in 1988 rather than with the monovalent measles vaccine introduced in 1968,” he claimed in one of a string of patents he filed for businesses to be spun from the research.85 “This indicates that MMR is responsible for this condition rather than just the measles virus.”

Three of the four remaining children were seen in outpatients on the same day—in November 1996. None of their families were reported in the paper as blaming the vaccine. Child 5, from Berkshire, aged 7 at admission, had received MMR at 16 months.86 The paper reported concerns at 18 months, but the medical records noted fits87 and parental worries88 at 11 months. Child 9, aged 6, from Jersey, also had MMR at 16 months.89 His mother dated problems from 18-20 months.90 Child 10, aged 4, from south Wales, contracted a viral infection, which was suspected by parents and doctors to have caused his disorder, four months after his vaccination.91

“Behavioural changes included repetitive behaviour, disinterest in play or head banging,” said a question and answer statement issued by the medical school, concerning the Lancet 12, on the day of the paper’s publication.

Another discrepancy to emerge during the GMC hearing concerned the number of families who blamed MMR. The paper said that eight (1, 2, 3, 4, 6, 7, 8, and 11) linked developmental issues with the vaccine. But the total in the records was actually 11. The parents of child 5,92 9,93 and 1294 were also noted at the hospital as blaming the vaccine, but their stated beliefs were omitted from the journal.

Burnem is 100% correct though. You're an idiot and may the non-existent gods have mercy on your child murdering soul.

Case selection
The frequency of these beliefs should not have surprised Wakefield, retained as he was to support a lawsuit. In the month that Barr engaged him—two years before the paper was published—the lawyer touted the doctor in a confidential newsletter to his MMR clients and contacts. “He has deeply depressing views about the effect of vaccines on the nation’s children,” Barr said.95 “He is also anxious to arrange for tests to be carried out on any children . . . who are showing symptoms of possible Crohn’s disease. The following are signs to look for. If your child has suffered from all or any of these symptoms could you please contact us, and it may be appropriate to put you in touch with Dr Wakefield.”

The listed symptoms included pain, weight loss, fever, and mouth ulcers. Clients and contacts were quickly referred.96 Thus, an association between autism, digestive issues, and worries about MMR—the evidence that launched the vaccine scare—was bound to be found by the Royal Free’s clinicians because this was how the children were selected.97

Moreover, through the omission from the paper of some parents’ beliefs that the vaccine was to blame, the time link for the lawsuit sharpened. With concerns logged from 11 of 12 families, the maximum time given to the onset of alleged symptoms was a (forensically unhelpful) four months. But, in a version of the paper circulated at the Royal Free six months before publication, reported concerns fell to nine of 12 families but with a still unhelpful maximum of 56 days.98 Finally, Wakefield settled on 8 of 12 families, with a maximum interval to alleged symptoms of 14 days.

Between the latter two versions, revisions also slashed the mean time to alleged symptoms—from 14 to 6.3 days. “In these children the mean interval from exposure to the MMR vaccine to the development of the first behavioural symptom was six days, indicating a strong temporal association,” he emphasised in a patent for, among other things, his own prophylactic measles vaccine,99 eight months before the Lancet paper.

This leaves child 3. He was 6½ and lived on Merseyside: 200 miles from the hospital. He received MMR at 14 months,100 with the first concerns recorded in the general practitioner’s notes 15 months after that.101 His mother—who 4 years later contacted Wakefield on the advice of JABS102—told me that her son had become aggressive towards a brother, and records say that his vocabulary had not developed.103

“We both felt that the MMR needle had made [child 3] go the way he is today,” the parents wrote to a local paediatric neurologist, Lewis Rosenbloom, 18 months before their son’s referral to London.104 They told him they wanted “justice” from the vaccine’s manufacturer, and that they had been turned down for legal aid.105 “Although it is said that the MMR has never been proven to make children to be autistic, we believe that the injection has made [child 3] to be mentally delayed, which in turn may have triggered off the autism.”

I visited this family twice. Their affected son was now a teenager and a challenge both to himself and to others. His mother said his diagnosis was originally “severe learning difficulties with autistic tendencies” but that she had fought to get it changed to autism.106

As for a connection with MMR, there was only suspicion. I do not think his family was sure, one way or the other.107When I asked why they took him to the Royal Free, his father replied: “We were just vulnerable, we were looking for answers.”

What was unquestionably true was that child 3 had serious bowel trouble: intractable, lifelong, constipation.108 This was the most consistent feature among the 12 children’s symptoms and signs109 but, being the opposite of an expected finding in inflammatory bowel disease,110 111 it was nowhere mentioned in the paper. This young man’s was so severe that he was dosed at his special school, his mother said, with up to five packets of laxative a day.

“You always knew when his stomach was hard,” she told me, in terms echoed over the years by many parents involved with Wakefield. “He would start headbutting, kicking, breaking anything in the house. Then he would go to the toilet and release it.”

For the Royal Free team, however, when reporting on these patients, such motility issues 112 were sidelined in the hunt for Wakefield’s syndrome. In almost all the children, they noted commonly swollen glands in the terminal ileum, and what was reported as “non-specific colitis.”113 114 In fact, as I revealed in the BMJ last April,115 the hospital’s pathology service found the children’s colons to be largely normal, but a medical school “review” changed the results.

In this evolution of the gut pathology noted in the records to what was published in the paper, child 3’s case is a prime example. After ileocolonoscopy (which, GMC prosecution and defence experts agreed, was not clinically indicated116), the hospital’s pathologists found all colonic samples to be “within normal histological limits”.117 But three months after the boy was discharged, Walker-Smith recalled the records and changed the diagnosis to “indeterminate ileocolitis”.118

“I think, sadly, this was the first child who was referred, and the long term help we were able to give in terms of dealing with constipation was not there,” he told the GMC panel. “However, we had excluded Crohn’s disease and we had done our best to try and help this child, but in the end we did not.”

So that is the Lancet 12: the foundation of the vaccine scare. No case was free of misreporting or alteration. Taken together, NHS records cannot be reconciled with what was published, to such devastating effect, in the journal (table⇓).


Comparison of three features of the 12 children in the Lancet paper with features apparent in the NHS records, including those from the Royal Free hospital

• View popup
• View inline

Wakefield, however, denies wrongdoing, in any respect whatsoever.119 He says he never claimed that the children had regressive autism, nor that he said they were previously normal. He never misreported or changed any findings in the study, and never patented a measles vaccine. None of the children were Barr’s clients before referral to the hospital, and he never received huge payments from the lawyer. There were no conflicts of interest. He is the victim of a conspiracy.120 121 He never linked autism with MMR.

“Mr Deer’s implications of fraud against me are claims that a trained physician and researcher of good standing had suddenly decided he was going to fake data for his own enrichment,” he said in a now abandoned complaint against me to the UK Press Complaints Commission. “The other authors generated and ‘prepared’ all the data that was reported in the Lancet. I merely put their completed data in tables and narrative form for the purpose of submission for publication.”

But, despite signing up to claim credit for a paper in the Lancet, his co-authors Walker-Smith and Murch did not even know which case was which. Walker-Smith said he had “trusted” Wakefield.122 “When I signed that paper, I signed with good intent,” he told the GMC panel. Denying any wrongdoing, he argued that the published report was not even about MMR, but merely described a new “clinico-pathological entity”. He said that the admissions to the Royal Free were “entirely related to gastroenterological illness” and how the children were sourced was “irrelevant” and “immaterial.” His lawyers said that he was appealing against the panel’s decision and on these grounds they had advised him not to respond to my questions.

The journal, meanwhile, took 12 years to retract the paper, by which time its mischief had been exported. As parents’ confidence slowly returned in Britain, the scare took off around the world, unleashing fear, guilt, and infectious diseases—and fuelling suspicion of vaccines in general. In addition to measles outbreaks, other infections are resurgent, with Mr 11’s home state of California last summer seeing 10 babies dead from whooping cough, in the worst outbreak since 1958.123

Wakefield, nevertheless, now apparently self-employed and professionally ruined, remains championed by a sad rump of disciples. “Dr Wakefield is a hero,” is how one mother caught their mood in a recent Dateline NBC TV investigation, featuring the story of the doctor and me.124 “I don’t know where we would be without him.”


How the link was fixed
The Lancet paper was a case series of 12 child patients; it reported a proposed “new syndrome” of enterocolitis and regressive autism and associated this with MMR as an “apparent precipitating event.” But in fact:

• Three of nine children reported with regressive autism did not have autism diagnosed at all. Only one child clearly had regressive autism
  
  
• Despite the paper claiming that all 12 children were “previously normal,” five had documented pre-existing developmental concerns
  
  
• Some children were reported to have experienced first behavioural symptoms within days of MMR, but the records documented these as starting some months after vaccination
  
  
• In nine cases, unremarkable colonic histopathology results—noting no or minimal fluctuations in inflammatory cell populations—were changed after a medical school “research review” to “non-specific colitis”
  
  
• The parents of eight children were reported as blaming MMR, but 11 families made this allegation at the hospital. The exclusion of three allegations—all giving times to onset of problems in months—helped to create the appearance of a 14 day temporal link
  
  
• Patients were recruited through anti-MMR campaigners, and the study was commissioned and funded for planned litigation

And since we know you're going to cry conspiracy theory, the author of the previous article has no support from any organization for his work, no financial ties to any organization that might have an interest in the subject, etc. so get fucked, retard.

"Competing interests: The author has completed the unified competing interest form at www.icmje.org/coi_disclosure.pdf (available on request from him) and declares no support from any organisation for the submitted work; no financial relationships with any organisation that might have an interest in the submitted work in the previous three years; BD’s investigation led to the GMC proceedings referred to in this report, including the charges. He made many submissions of information but was not a party or witness in the case, nor involved in its conduct."

More Proof That Vaccines Don’t Cause Autism


ANTI-VAXXERS ACCIDENTALLY FUND A STUDY SHOWING NO LINK BETWEEN AUTISM AND VACCINES

Most experts today agree the belief that childhood vaccines cause autism is based on bunk science. Even still, some advocacy groups claim immunizations are responsible for raising the risk for this neurodevelopmental condition, despite a growing body of research that shows there isn’t a link. (The study that most anti-vaccination groups point to was retracted after it was found to be based on falsified data.)

Despite the science, organizations involved in the anti-vaccine movement still hope to find some evidence that vaccines threaten children’s health. For example, the autism advocacy organization SafeMinds recently funded research it hoped would prove vaccines cause autism in children. But this effort appears to have backfired for the organization—whose mission is to raise awareness about how certain environmental exposures may be linked to autism—since the study SafeMinds supported showed a link between autism and vaccines does not exist.

Retracted autism study an 'elaborate fraud,' British journal finds - CNN.com


Retracted autism study an 'elaborate fraud,' British journal finds

A now-retracted British study that linked autism to childhood vaccines was an "elaborate fraud" that has done long-lasting damage to public health, a leading medical publication reported Wednesday.

An investigation published by the British medical journal BMJ concludes the study's author, Dr. Andrew Wakefield, misrepresented or altered the medical histories of all 12 of the patients whose cases formed the basis of the 1998 study -- and that there was "no doubt" Wakefield was responsible.

"It's one thing to have a bad study, a study full of error, and for the authors then to admit that they made errors," Fiona Godlee, BMJ's editor-in-chief, told CNN. "But in this case, we have a very different picture of what seems to be a deliberate attempt to create an impression that there was a link by falsifying the data."

Britain stripped Wakefield of his medical license in May. "Meanwhile, the damage to public health continues, fueled by unbalanced media reporting and an ineffective response from government, researchers, journals and the medical profession," BMJ states in an editorial accompanying the work.

Speaking to CNN's "Anderson Cooper 360," Wakefield said his work has been "grossly distorted" and that he was the target of "a ruthless, pragmatic attempt to crush any attempt to investigate valid vaccine safety concerns."

The now-discredited paper panicked many parents and led to a sharp drop in the number of children getting the vaccine that prevents measles, mumps and rubella. Vaccination rates dropped sharply in Britain after its publication, falling as low as 80% by 2004. Measles cases have gone up sharply in the ensuing years.

In the United States, more cases of measles were reported in 2008 than in any other year since 1997, according to the Centers for Disease Control and Prevention. More than 90% of those infected had not been vaccinated or their vaccination status was unknown, the CDC reported.

"But perhaps as important as the scare's effect on infectious disease is the energy, emotion and money that have been diverted away from efforts to understand the real causes of autism and how to help children and families who live with it," the BMJ editorial states.

jayrebb

Still waiting on you to cite one credible study justifying your point of view.

Just one buddy. Let us know when you sack the fuck up and admit you're full of shit and are a garbage person for buying into this shit hook line and sinker.

jayrebb said:

Except the corporation approaches the FDA and requests changes to production methods to save costs, and the FDA rubber stamps without any discussion.

Court protects them from responsibility from vaccine injury. Adjuvants were created to slash costs, as were the big jugs.

Thats called big pharma, child.

Click to expand...

citation required

Neuromancer said:

jayrebb is a mouth breathing, knuckle dragging mouth breather but a broken clock can be right twice a day hodj and delayed vaccination is not inherently stupid or wrong.

Click to expand...

No, it is stupid and wrong because it is unnecessary and was invented as a way to normalize the anti vaxx movement when they started to realize they were looking real retarded with Jenny McCarthy as their face to the world while children were actually dying of a preventable communicable disease as a result.

Here is the actual standards of the FDA for changes to already approved drugs

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm077097.pdf

Other than for editorial changes in previously submitted information (e.g., correction of spelling or typographical errors, reformatting of batch records), an applicant must notify FDA about each change in each condition established in an approved application beyond the variations already provided for in the application (§ 314.70(a)(1)). A supplement or annual report must include a list of all changes contained in the supplement or annual report. On the list, FDA recommends that the applicant describe each change in enough detail to allow FDA to quickly determine whether the appropriate reporting category has been used. For supplements, this list must be provided in the cover letter (§ 314.70(a)(6)). In annual reports, the list should be included in the summary section (§ 314.81(b)(2)(i)).

The applicant must describe each change fully in the supplement or annual report (§ 314.70(a)(1)). An applicant making a change to an approved application under section 506A of the Act must also conform to other applicable laws and regulations, including current good manufacturing practice (CGMP) requirements of the Act (21 U.S.C. 351(a)(2)(B)) and applicable regulations in Title 21 of the Code of Federal Regulations (e.g., 21 CFR parts 210, 211, 314). For example, manufacturers must comply with relevant CGMP validation and recordkeeping requirements and ensure that relevant records are readily available for examination by authorized FDA personnel during an inspection.

A changes-being-effected supplement providing for labeling changes under § 314.70(c)(6)(iii) must include 12 copies of the final printed labeling (§ 314.70(c)(1)). In accordance with § 314.70(a)(4), an applicant also must promptly revise all promotional labeling and drug advertising to make it consistent with any labeling change implemented in accordance with § 314.70(b) or (c). Except for supplements providing only for a change in labeling, an applicant must include in each supplement and amendment to a supplement a statement certifying that a field copy has been provided in accordance with 21 CFR 314.440(a)(4)6 (§ 314.70(a)(5)).

IV. ASSESSING THE EFFECT OF MANUFACTURING CHANGES A. Assessment of the Effects of the Change The holder of an approved application under section 505 of the Act must assess the effects of the change before distributing a drug product made with a manufacturing change (§ 314.70(a)(2)).7 For each change, the supplement or annual report must contain information determined by FDA to be appropriate and must include the information developed by the applicant in assessing the effects of the change (section 506A(b), (c)(1), (d)(2)(A), and (d)(3)(A) of the Act).

The type of information that must be included in a supplemental application or an annual report is specified in § 314.70(b)(3), (c)(4), and (d)(3). 1. Conformance to Specifications An assessment of the effects of a change on the identity, strength, quality, purity, and potency of the drug product should include a determination that the drug substance intermediates, drug substance, in-process materials, and/or drug product affected by the change conform to the approved specifications.8 A specification is a quality standard (i.e., tests, analytical procedures, and acceptance criteria) provided in an approved application to confirm the quality of drug substances, drug products, intermediates, raw materials, reagents, components, in-process materials, container closure systems, and other materials used in the production of a drug substance or drug product. Acceptance criteria are numerical limits, ranges, or other criteria for the tests described (§ 314.3(b)). Conformance to a specification means that the material, when tested according to the analytical procedures listed in the specification, will meet the listed acceptance criteria. 2. Additional Testing In addition to confirming that the material affected by manufacturing changes continues to meet its specification, we recommend that the applicant perform additional testing, when appropriate, to assess whether the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product have been or will be affected.

The assessment should include, as appropriate, evaluation of any changes in the chemical, physical, microbiological, biological, bioavailability, and/or stability profiles. This additional assessment could involve testing of the postchange drug product itself or, if appropriate, the material directly affected by the change. The type of additional testing that an applicant should perform would depend on the type of manufacturing change, the type of drug substance and/or drug product, and the effect of the change on the quality of the drug product. For example: • Evaluation of changes in the impurity or degradant profile could first involve profiling using appropriate chromatographic techniques and then, depending on the observed changes in the impurity profile, toxicology tests to qualify a new impurity or degradant or to qualify an impurity that is above a previously qualified level.9 • Evaluation of the hardness or friability of a tablet after certain changes. • Assessment of the effect of a change on bioequivalence when required under 21 CFR part 320 could include, for example, multipoint and/or multimedia dissolution profiling and/or an in vivo bioequivalence study. • Evaluation of extractables from new packaging components or moisture permeability of a new container closure system. An applicant should refer to all relevant CDER guidance documents for recommendations on the information that should be submitted to support a given change. If guidance for information that should be submitted to support a particular change is not available, applicants can consult the appropriate CDER chemistry or microbiology review staff for advice. B. Equivalence When testing is performed, the applicant should usually assess the extent to which the manufacturing change has affected the identity, strength, quality, purity, and potency of the drug product. Typically this is accomplished by comparing test results from pre- and postchange material and determining if the test results are equivalent. Simply stated: Is the drug product made after the change equivalent to the drug product made before the change? An exception to this general approach is that when bioequivalence is redocumented for certain ANDA postapproval changes, FDA recommends that the comparator be the reference listed drug. Equivalence comparisons frequently have a criterion for comparison with calculation of confidence intervals relative to a predetermined equivalence interval. For this, as well as for other reasons, equivalent does not necessarily mean identical. Equivalence may also relate to maintenance of a quality characteristic (e.g., stability) rather than a single performance of a test. C. Adverse Effect Some manufacturing changes have an adverse effect on the identity, strength, quality, purity, or potency of the drug product. In many cases, the applicant chooses not to implement these manufacturing changes, but sometimes the applicant wishes to do so. If an assessment indicates that a change has adversely affected the identity, strength, quality, purity, or potency of the drug product, FDA recommends that the change be submitted in a prior approval supplement regardless of the recommended reporting category for the change. For example, a process change recommended for a changes-being-effected-in-30 days supplement could cause the formation of a new degradant that requires qualification and/or identification.10 The applicant's degradation qualification procedures may indicate that there are no safety concerns relating to the new degradant. Even so, we recommend that the applicant submit this change in a prior approval supplement with appropriate information to support the continued safety and effectiveness of the drug product. During the review of the prior approval supplement, the FDA will assess the impact of any adverse effect on the drug product as this change may relate to the safety or effectiveness of the drug product. Applicants are encouraged to consult with the appropriate CDER chemistry or microbiology review staff if there are any questions on whether a change in a characteristic would be viewed by CDER as adversely affecting the identity, strength, quality, purity, or potency of the drug product.

blah blah blah

Basically, you're full of shit. There are rigorous standards for changing production of already approved drugs.

I'd say you're basically done here Jayrebb. If you can come up with even a fraction of a shred of valid evidence for your world view on this subjet, let me know! It won't happen so I'm not holding my breath.

jayrebb said:

I'm convinced this is all about you getting me to post Dr. Wakefield's studies and/or the peripheral studies he referenced (WHICH HE DID NOT CONDUCT OR HAVE ANYTHING TO DO WITH) that Big Pharm THEMSELVES FUNDED on rhesus monkeys decades ago which proved MMR could cause failure to thrive when given too early.

Click to expand...

All discredited, so I really hope that's not the evidence you would cite.

But clearly you're admitting here it is, so that should be the first wake up call to you. There are no valid studies showing that vaccines cause autism so deal with it.

Neuromancer said:

It wasn't though. My wife gives vaccines every single day to more babies than you have seen in your life.

There is most definitely side effects from injecting anything into a baby whether it is saline or a vaccine. You cannot deny this. There are a lot of things we give at birth +(days) because we can't trust parents. A baby then has events until it comes down from that. It doesn't cause autism. It isn't a bad thing. There is an argument there for delaying though and scheduling IF we could trust parents to come back and actually do it but we cannot.

You are throwing the baby out with the bathwater because you don't want anti-vaxxers to have any ammunition at all. I said you would do that and you did it ....

Nobody that I know that talks about delayed schedule has anything but absolute contempt for the anti-vaxxers. Unlike you they are medical professionals, unlike me they don't post all over the place about it because people like you would grab pitchforks.

Click to expand...

No one said they don't have side effects, or that we should ignore that impact.

The anti vaxx movement actually makes it harder to tackle the real side effects that can affect some people after immunization because the media is afraid of spreading more of the fear mongering that leads to actual disease outbreaks that result in deaths.

Your line of reasoning here is a strawman.

How anti-vaxxers have scared the media away from covering vaccine side effects

How anti-vaxxers have scared the media away from covering vaccine side effects

"It was the most startling side effect I've ever come across." That's how Elizabeth Miller, head of the immunization department at Public Health England, described some recent vaccine research you've probably never heard about: Pandemrix, a shot designed to stave off swine flu, also appears to be causing narcolepsy in some children.

Public health officials — especially ones that work in the politically fraught field of vaccine safety — don't typically make emotive statements like that.

Then Miller told me about something that shocked her even more: The media didn't pick up on this story at all. In fact, she characterized the reception to her 2013 research about vaccines and narcolepsy as "radio silence."

I told Miller that I didn't find her news all that surprising, because I ignored the Pandemrix story, too. I've sometimes shied away from writing about uncertainty in vaccine science for fear that my stories might have horrible consequences for public health. It seems other reporters may have been doing the same.

Vaccines are one of the single greatest contributors to public health of the past century. And in recent years, whenever anti-vaccine groups or cranks have tried to cast doubt on this fact, the country's best health journalists have sprung into to action, working to present the facts and essentially debunk anti-vaccine pseudoscience. Vaccines, after all, are overwhelmingly safe. And people should know that.

But what happens when credible scientists discover real drawbacks to certain vaccines? How do we report on that responsibly — without giving ammunition to deniers?

One reason the media is reluctant to report on vaccine drawbacks: We've been burned before

Miller is an extremely credible scientist, and her results didn't come in isolation. Previously, researchers in Finland and Sweden had uncovered an association between Pandemrix and narcolepsy, a chronic neurological disorder that messes up the body's ability to regulate sleep-wake cycles. So Miller and her colleagues began to investigate. They combed the health records and sleep tests of patients at British hospitals. In their 2013 study published in the British Medical Journal, they came to a firm conclusion: The swine flu vaccine increased the risk of narcolepsy in children. All told, more than 1,000 people who got the shot developed narcolepsy, an incurable condition.

In the United States, Pandemrix was never licensed, and it was only used during the 2009-'10 H1N1 swine flu pandemic — not before or after. To be clear, some reporters have since picked up on the story, particularly after manufacturer GlaxoSmithKline acknowledged the link and governments agreed to give victims compensation.

Still, there was little coverage of the early research itself. And Miller thinks there may be a reason journalists stayed away: They've been burned in the past.

Back in 1998, a doctor named Andrew Wakefield famously claimed a link between the measles-mumps-rubella vaccine and autism. As it turned out, Wakefield's study was fraudulent. The scientific evidence overwhelmingly suggests that the MMR vaccine is safe. Wakefield had distorted the evidence, and his study has since been retracted; he's also been thoroughly discredited.

But at the time, Wakefield's study received lots of breathless (and uncritical) coverage. And those news reports fueled anti-vaccine scares that drove down rates of immunization coverage in Europe and around the world, helping to bring back entirely preventable diseases like measles. This effect persists today.

You can see the dilemma facing health reporters. Criticisms of vaccines have often come from cranks like Wakefield (and his celebrity sidekick Jenny McCarthy). So the media is understandably skeptical. What's more, the consequences of getting things wrong are severe — stories about vaccine drawbacks run the risk of reducing vaccination rates and creating a genuine public health crisis.

It's not just journalists, either. Many scientists now seem to be extra-skeptical toward anyone pointing out drawbacks in vaccines, according to Hanna Nohynek, a vaccine researcher with the Finnish government. She conducted some of the early research on the narcolepsy finding, and told me she had great difficulty placing her study in scientific journals.

"We went to the New England Journal of Medicine. They did not want to take the paper. TheLancet rejected it. The BMJ rejected it," she said. "Nobody wanted to publish something that might be similar [to the Wakefield paper]."

So how should reporters cover uncertainty in vaccine science?
All this heavy skepticism is understandable. At the same time, scientists and journalists can't just ignore evidence around vaccines — especially if there are real risks involved.

In search of a better way, I reached out to various researchers and reporters to get their views on how we can better cover vaccine uncertainty. They offered up a number of good suggestions that have implications for other politically charged issues in science, too:

1) It's okay to be more skeptical of newer vaccines than older, established ones. Andre Picard, the public health reporter at Canada's Globe and Mail newspaper, has navigated tricky questions around vaccines for more than 30 years. He says he still has trouble with this question. "How do you cover the side effects of vaccines without giving credence to antivax zealots? is a really good question," he wrote in an email.

Theoretically, he said, journalists should report on vaccines like any other drug: communicating both the benefits and risks. "With older childhood vaccines, that’s pretty easy," he says. "Lots of benefits, and negligible risks."

But he puts newer vaccines in a different category. As with all new drugs, there can be unknown side effects. "For example, when the rotavirus vaccine was tied to intussusception, that was an important story to cover even though it killed a vaccine with many benefits. And, thankfully, there is now a better version with fewer side effects," he says. Picard reported that story, and in 2011, the early findings about a potential narcolepsy side effect with the swine flu jab.