12
Cookies policy Search BMJ Group Journals Jobs Education Decision support Quality improvement Community BMJ Helping doctors make better decisions Libel The United Kingdom has very strict libel laws. You can be sued for libel “if you lower someone’s standing in the eyes of his or her peers.” To defend itself against an accusation of libel, a publication has to prove that the statement it published was true, that it was published “without malice,” and, where possible, was in the public interest. If an allegation turns out to be false (ie based on incorrect facts), we will find it hard to defend, so fact checking is imperative. But we may have a small chance of defending ourselves, if the allegation has been shared fully with the “accused”, and that he or she has had a chance to respond, and if that response has been forwarded unedited to us. So here are a few “musts” for authors. Ensure that you check all your facts Ensure that all articles are balanced. If you are publishing an allegation against someone, you must give the accused a chance to reply. When you approach the accused, you must reveal in detail what your allegations are, so that he or she can have a chance to answer them in full. If, for example, you are going to claim that a hospital employed a doctor who was not properly qualified, and it did not investigate complaints against that doctor, you must put all the allegations in full to the hospital management, so that it has the chance to answer each and every one of the allegations. It is no defence to say that an allegation has already been published elsewhere. If an allegation about a doctor or a drug company has appeared in a newspaper in Spain, Italy, or the US, for example, we cannot rely on that fact to defend ourselves. Firstly, that local newspaper might have got the facts wrong; secondly, the libel laws might be different in that country. So although the doctor/company might not have sued in that location, he or she could come after the BMJ in the UK, because our libel laws are so tight. If you are worried about an article please alert the editor to any doubts you have, so that we can discuss it and, if necessary, can seek advice from the BMJ's libel lawyer. If you think that an issue is complicated and requires more investigation than you originally thought please ask the editor for more time (and - if we have commissioned the article from you - possibly for more money). Wherever possible, please obtain documentary evidence for your claim. Libel | BMJ http://www.bmj.com/about-bmj/resources-authors/forms-policies-and-che... 1 of 2 7/3/2012 1:43 PM

SABA AFF EXHIBITS

Embed Size (px)

DESCRIPTION

SABA AFF EXHIBITS

Citation preview

Page 1: SABA AFF EXHIBITS

Cookies policy

Search BMJ Group

Journals

Jobs

Education

Decision support

Quality improvement

Community

BMJHelping doctors make better decisions

LibelThe United Kingdom has very strict libel laws. You can be sued for libel “if you lower someone’s standing in the eyes of his or her peers.”

To defend itself against an accusation of libel, a publication has to prove that the statement it published was true, that it was published “without

malice,” and, where possible, was in the public interest.

If an allegation turns out to be false (ie based on incorrect facts), we will find it hard to defend, so fact checking is imperative. But we may have a

small chance of defending ourselves, if the allegation has been shared fully with the “accused”, and that he or she has had a chance to respond,

and if that response has been forwarded unedited to us. So here are a few “musts” for authors.

Ensure that you check all your facts

Ensure that all articles are balanced. If you are publishing an allegation against someone, you must give the accused a chance to reply.

When you approach the accused, you must reveal in detail what your allegations are, so that he or she can have a chance to answer them in full. If,

for example, you are going to claim that a hospital employed a doctor who was not properly qualified, and it did not investigate complaints against

that doctor, you must put all the allegations in full to the hospital management, so that it has the chance to answer each and every one of the

allegations.

It is no defence to say that an allegation has already been published elsewhere. If an allegation about a doctor or a drug company has appeared in

a newspaper in Spain, Italy, or the US, for example, we cannot rely on that fact to defend ourselves. Firstly, that local newspaper might have got the

facts wrong; secondly, the libel laws might be different in that country. So although the doctor/company might not have sued in that location, he or

she could come after the BMJ in the UK, because our libel laws are so tight.

If you are worried about an article please alert the editor to any doubts you have, so that we can discuss it and, if necessary, can seek advice from

the BMJ's libel lawyer.

If you think that an issue is complicated and requires more investigation than you originally thought please ask the editor for more time (and - if we

have commissioned the article from you - possibly for more money).

Wherever possible, please obtain documentary evidence for your claim.

Libel | BMJ http://www.bmj.com/about-bmj/resources-authors/forms-policies-and-che...

1 of 2 7/3/2012 1:43 PM

lgentry
Typewritten Text
EXHIBIT 1
Page 2: SABA AFF EXHIBITS

It is also important to remember that words can be interpreted in different ways. You may think that your article is harmless because you have not

laid an allegation clearly at one person’s door (you might have just alleged that something dubious “occurred”), but it is not “you” that matters here,

it is how an ordinary, disinterested member of the public would interpret it. If an ordinary person would infer from the story that someone in the story

was responsible for the dubious occurrence, you can be considered to have libelled them.

If in doubt, please ask a BMJ editor for advice.

< Title pageup

Articles which criticise health professionals >

BMJ Group

Privacy policy

Website T & Cs

Revenue Sources

Highwire Press

Feedback

Help© 2012 BMJ Publishing Group Ltd

Given URL is not allowed by the Application configuration.: One or more of the given

URLs is not allowed by the Application configuration. It must match one of the

Connect or Canvas URLs or domain must be the same as or a subdomain of one of the

Application's base domains.

Libel | BMJ http://www.bmj.com/about-bmj/resources-authors/forms-policies-and-che...

2 of 2 7/3/2012 1:43 PM

Page 3: SABA AFF EXHIBITS

OBSERVATIONS

What will become of the man at the centre of the GMC’s longest running fitness to practise case?

It was the longest General Medical

Council fitness to practise hearing ever:

three gastroenterologists hit with a

Chinese menu of charges.

The highlights, I suppose, were the

panel’s conclusions last week and the

Lancet’s retraction five days later of the

controversial paper. Andrew Wakefield,

the “MMR research doctor,” stood

exposed, in disgrace, and the paper

that caused the mischief is no more.

“The allegations against me and my

colleagues are both unfounded and

unjust,” he declared to the cameras on

28 January. “I repeat: unfounded and

unjust.”

As the journalist whose

investigations led to the charges

and the retraction, I sometimes

wondered whether we would ever see

a result from the GMC. This was the

Jarndyce versus Jarndyce of medical

proceedings. The five member panel

sat for 197 days.

For me the story started with a lunch.

So many do. “I need something big,”

said a Sunday Times section editor.

“About what?” I replied. Him: “MMR?”

But I didn’t fancy that one at all.

This was September 2003, and

litigation was pending in the High Court

over alleged damage to children from

the MMR vaccine. Better to hang on and

cover that, I suggested. But the next

week that trial was cancelled. Expert

reports had been swapped, and the

claimants’ lawyers said they couldn’t

make the case.

So I took an empty notebook

and made my own inquiries. It was

the largest Sunday Times medical

investigation since thalidomide.

No media have yet itemised the

verdicts produced last week, and I’ve

space only for those found proved

against Wakefield: dishonesty (four

counts); research on developmentally

disordered children without ethical

approval (11 counts); contrary to

their clinical interests (nine counts);

causing a child to undergo lumbar

puncture without clinical reason (three

counts); ordering medical tests without

appropriate qualifications and in

breach of a non-clinical employment

contract (three counts).

Then we get the birthday party.

Wakefield paid children £5 each for

blood samples. Also, the now retracted

1998 Lancet paper: the original focus

of my interest. This, the GMC panel

confirmed, included a false claim of

ethical approval and a “dishonest”

description of inclusion criteria.

You don’t need to ask Confucius to

know what will happen at the hearing’s

next stage, to run between April and

June: the panel will undoubtedly decide

that serious professional misconduct

occurred and that Wakefield should be

struck off.

“It’s a case about breaches of some

of the most fundamental rules in

medicine,” Sally Smith QC, for the GMC,

told the panel: a GP, a psychiatrist, a

geriatrician, and two lay members.

But let’s not forget the two doctors

left in the shadows: John Walker-Smith,

73, and Simon Murch, 53. They were

also last week walloped with a raft of

proved charges, although neither was

found to be dishonest.

What they were found to have done

was to collaborate with Wakefield in

his bid to make a case against the

vaccine. Together, in the late 1990s,

they brought a dozen brain disordered

children, aged 2 to 9, to the Royal Free

Hospital, north London.

There, in stays of six days, those

kids endured batteries of tests that in

many cases, the panel found, weren’t

indicated. Ileocolonoscopy: 12.

Lumbar puncture: 9. Barium

meal: 10. Magnetic resonance

imaging: 10. Electroencephalography:

9. Upper endoscopy: 2. Blood tests:

12. Some of the kids, moreover, had

general anaesthetics, while others were

bowel prepped through nasogastric

tubes.

The point of this exercise: to hunt

for measles virus in guts and spines.

Wakefield’s theory was that the

virus—live in the MMR vaccine—caused

Crohn’s disease and autism. He failed

to prove it.

At the time a lawyer was paying

Wakefield £150 (€170; $240) an hour

as the claimants’ expert for the MMR

lawsuit I had planned to report on. So,

the longer the show stayed on the road,

the more money he made. I say: nice

work if you can get it .

In the end he grossed £435 643,

plus expenses: eight times his reported

annual salary. But the real sting was

his call for the triple vaccine to be

suspended in favour of single shots.

Remember that?

As the chief expert in a lawsuit,

he had to say that the triple vaccine

was unfit for marketing, or the case

would have collapsed, the vaccine

scare wouldn’t have happened, and

the shedloads of money would have

stopped.

This underbelly wasn’t known until I

brought it to light. I ought to feel proud.

And I do. So many people have told me

that to nail a baseless health scare is, in

itself, justification for a life.

But I also think about the chief

clinician: Professor Walker-Smith. A

tragedy. He’d been warned time and

again about Wakefield. “Prof” surely

hadn’t qualified, 50 years ago last

month, to act against the interests of

children.

I’ve seen a photo of Walker-Smith as

a student in 1958, at the King George

V Memorial Hospital, Sydney. He’s

washing a baby that he’d just delivered,

and his face betrays the tension you

sometimes see in young doctors. He

was trying to look professional while

amazed.

That he should be brought down by

a man who I say is a charlatan is part

of the legacy of the MMR scandal. The

epidemics of fear, guilt, and disease

are now passing. But I hope that the

lessons for medicine endure.

Brian Deer is a journalist, London

Cite this as: BMJ 2010;340:c672

See also EDITORIAL, p 271, NEWS, p 281

BMJ | 6 FEBRUARY 2010 | VOLUME 340 295

Reflections on investigating WakefieldGMC WAKEFIELD VERDICT Brian Deer

You don’t need to ask Confucius to know what will happen at the hearing’s next stage, to run between April and June: the panel will undoubtedly decide that serious professional misconduct occurred and that Wakefield should be struck off

lgentry
Typewritten Text
EXHIBIT 2
Page 4: SABA AFF EXHIBITS

| briandeer.com | "RIGHTING OF A WRONG"

| Part 1 | Part 2 | Part 3 | BMJ series | British Press Award | Harris Poll |

Exposed: Andrew Wakefield

and the MMR-autism fraud

Brian Deer's award-winning investigation

With revelations spread over more than seven years, between late2003 and early 2011 Brian Deer pursued a landmark public interestinvestigation for The Sunday Times of London, the United Kingdom'sChannel 4 Television network and BMJ, the British Medical Journal,into allegations linking the three-in-one measles, mumps and rubellavaccine (MMR) with claims of a terrifying new syndrome of bowel andbrain damage in children. These allegations led to a decade-longhealth crisis in the UK, and sparked epidemics of fear, guilt andinfectious disease, which would be exported to the United States andother developed countries, spawning every kind of concern overvaccinations.

Almost incredibly, the trigger for what became a worldwidecontroversy over vaccine safety was a single scientific research paperpublished in a medical journal - the Lancet - in February 1998. Writtenby a then-41-year-old academic researcher, Andrew Wakefield, andco-authored by a dozen associates, it reported on the cases of 12anonymous children with brain disorders who had been admitted to apaediatric bowel unit at the Royal Free hospital in Hampstead, northLondon, between July 1996 and February 1997.

Backed by an extraordinary video news-release and press conference,the five-page paper’s claims provoked substantial media interest, andwere followed by a sustained onslaught against the vaccine. Thisincluded further publications by Wakefield criticising MMR, and led toan unprecedented collapse in public confidence in the shot, which,since the late 1980s in the UK and the early 1970s in the US, forexamples, has been routinely given to children soon after they areone year old, almost eradicating measles and rubella from developedcountries.

The prime cause of the alarm was findings in the paper claiming thatthe parents of two thirds of the 12 children blamed MMR for thesudden onset of what was described as a combination of both aninflammatory bowel disease and what Wakefield called "regressiveautism", in which language and basic skills were said to have beenlost. Most disturbingly, the first behavioural symptoms were reportedto have appeared within only 14 days of the shot.

Although the research involved only a dozen children, and its resultshave never been replicated, many medical breakthroughs have begunwith small-scale observations, and, if true, Wakefield's findings mighthave been the first snapshot of a hidden epidemic of devastatinginjuries. "It's a moral issue for me," he announced at the 1998 pressconference, where he called for a boycott of the triple MMR in favourof breaking it up into single measles, mumps and rubella shots, to begiven at yearly intervals. "I can't support the continued use of thesethree vaccines, given in combination," he said, "until this issue hasbeen resolved."

As the doctor campaigned, UK vaccination rates slumped: below thelevel needed to keep measles at bay. Even Tony Blair becameembroiled in the controversy when Wakefield supporters suggested -the Blairs say wrongly - that the prime minister’s youngest son wasnot vaccinated with MMR. Meanwhile in America, a ferocious

A selection of BrianDeer's storieswhich exposedAndrew Wakefieldand shattered adecade-long scare

Left & first below:22 February 2004Second below: 14November 2004

Andrew Wakefield - the fraud investigation http://briandeer.com/mmr/lancet-summary.htm

1 of 6 12/22/2011 3:04 PM

lgentry
Typewritten Text
lgentry
Typewritten Text
EXHIBIT 3
Page 5: SABA AFF EXHIBITS

anti-vaccine movement took off after Wakefield toured US autismconferences and, in November 2000, appeared on the CBS network's60 Minutes programme linking MMR with what he called an "epidemicof autism". This was followed by campaigners' claims that all vaccinesare suspect: either due to their content, or because of the numbergiven to children.

"In 1983 the shot schedule was ten. That's when autism was one in10,000. Now there's 36, and autism is one in 150," argued Americanactress Jenny McCarthy, who blamed MMR for her own son’s autism,and gained the highest profile in the US movement. "All arrows pointto one direction."

Andrew Wakefield's role unmasked

But as journalists queued to report on parents' fears, Brian Deer wasassigned to investigate the crisis, and unearthed a scandal ofastounding proportions. He discovered that, far from being based onany findings, the public alarm had no scientific basis whatsoever.Rather, Wakefield had been secretly payrolled to create evidenceagainst the shot and, while planning extraordinary business schemesmeant to profit from the scare, he had concealed, misreported andchanged information about the children to rig the results published inthe journal.

Before Deer’s inquiries, Wakefield had appeared to all the world to bean independent, if controversial, researcher. Tall and square-headed,with hooded eyes and a booming voice, he was the son of doctors (aneurologist and a family practitioner), had grown up in Bath, aprosperous west-of-England spa town, and joined the Royal Free inNovember 1988 after training in Toronto, Canada. His demeanour waslanguid - he was privately educated - and, born in 1956, he was alingering example of the presumed honour of the upper middle class.

But Deer's investigation - nominated in February 2011 for two BritishPress Awards - discovered that, while Wakefield held himself out to bea dispassionate scientist, two years before the Lancet paper waspublished - and before any of the 12 children were even referred tothe hospital - he had been hired to attack MMR by a lawyer, RichardBarr: a jobbing solicitor in the small eastern English town of King'sLynn, who hoped to raise a speculative class action lawsuit againstdrug companies which manufactured the triple shot.

Unlike expert witnesses, who give professional advice and opinions,Wakefield had negotiated an unprecedented contract with Barr, thenaged 48, to conduct clinical and scientific research. The goal was tofind evidence of what the two men claimed to be a "new syndrome",intended to be the centrepiece of (later failed) litigation on behalf ofan eventual 1,600 British families, recruited through media stories.This publicly undisclosed role for Wakefield created the grossestconflict of interest, and the exposure of it by Deer, in February 2004,led to public uproar in Britain, the retraction of the Lancet report'sconclusions section, and, from July 2007 to May 2010, thelongest-ever professional misconduct hearing by the UK's GeneralMedical Council (GMC).

Barr [audio] paid the doctor with money from the UK legal aid fund:run by the government to give poorer people access to justice.Wakefield charged at the extraordinary rate of £150 an hour - billedthrough a company of his wife's - eventually totalling, for generic workalone, what the UK Legal Services Commission, pressed by Deerunder the freedom of information act, said was £435,643 (then about$750,000 US), plus expenses. These hourly fees - revealed in TheSunday Times in December 2006 - gave the doctor a direct personal,but undeclared, financial interest in his research claims: totalling morethan eight times his reported annual salary and creating an incentivenot only for him to launch the alarm, but to keep it going for as longas possible.

In addition to the personal payments, Wakefield was awarded aninitial £55,000, which he had applied for in June 1996, but which, likethe hourly fees, he never declared to the Lancet as he should havedone, for the express purpose of conducting the research latersubmitted to the journal. This start-up funding was part of astaggering £18m of taxpayers' money eventually shared among asmall group of doctors and lawyers, working under Barr's andWakefield's direction, trying to prove that MMR caused the previouslyunheard-of "syndrome". Yet more surprising, Wakefield had assertedthe existence of such a syndrome - which allegedly included what hewould dub "autistic enterocolitis" - before he performed the researchwhich purportedly discovered it.

Above left: 18 June 2006Above right: 31 December 2006

Left & below: 8 February 2009

10 April 2011: The Sunday Times announces Deer's second Press Award

January 2011: BMJ special series"Secrets of the MMR scare"

Concluding Deer's investigation of Andrew Wakefieldand the MMR crisis, BMJ, the British Medical Journal,published a special series of major reports over threeweeks in January 2011.

The series, titled "Secrets of the MMR scare", led tointense worldwide media reporting and discussion asthe editors of the journal dubbed the origins of thevaccine scare to be "an elaborate fraud".

Go to Secrets of the MMR scare

5 April 2011: Deer isnamed specialistjournalist of the year inthe British PressAwards. He ispresented with theaward by Sky Newsanchor Anna Botting atthe Savoy Hotel,London. The judgescommended "atremendous righting ofa wrong". More details

Andrew Wakefield - the fraud investigation http://briandeer.com/mmr/lancet-summary.htm

2 of 6 12/22/2011 3:04 PM

Page 6: SABA AFF EXHIBITS

This Barr-Wakefield deal was the foundation of the vaccine crisis, bothin Britain and throughout the world. "I have mentioned to you beforethat the prime objective is to produce unassailable evidence in courtso as to convince a court that these vaccines are dangerous," thelawyer reminded the doctor in a confidential letter, six months beforethe Lancet report.

And, if this was not enough to cast doubt on the research's objectivity,The Sunday Times investigation unearthed another shocking conflictof interest. In June 1997 - nearly nine months before the pressconference at which Wakefield called for single vaccines - he had fileda patent on products, including his own supposedly "safer" singlemeasles vaccine, which only stood any prospect of success ifconfidence in MMR was damaged. Although Wakefield denied any suchplans, his proposed shot, and a network of companies intended toraise venture capital for purported inventions - including "areplacement for attenuated viral vaccines", commercial testing kitsand what he claimed to be a possible "complete cure" for autism -were set out in confidential documents.

One Wakefield business was awarded £800,000 from the legal aidfund on the strength of (later discredited) data which he had supplied.And, even as the Lancet paper was being prepared, behind the sceneshe was negotiating extraordinary plans to exploit the public alarmwith secret schemes that would line his pockets. "Disgraced doctorAndrew Wakefield plotted to make £28 million a year from the MMRjab panic he triggered," was how the British tabloid newspaper TheSun, for example, reported in January 2011 on this late disclosurefrom Deer.

Behind the veil of confidentiality

As with the researcher, so too with his subjects. They also were notwhat they appeared to be. In the Lancet, the 12 children (11 boys andone girl) had been held out as merely a routine series of kids withdevelopmental disorders and digestive symptoms, needing care fromthe London hospital. That so many of their parents blamed problemson one common vaccine, understandably, caused public concern. ButDeer discovered that nearly all the children (aged between 2½ and9½) had been pre-selected through MMR campaign groups, and that,at the time of their admission, most of their parents were clients andcontacts of the lawyer, Barr. None of the 12 lived in London. Twowere brothers. Two attended the same doctor's office, 280 miles fromthe Royal Free. Three were patients at another clinic. One was flownin from the United States.

The investigation revealed, moreover, that the paper's incrediblepurported finding - of a sudden onset of autism within days ofvaccination - was a sham: laundering into medical literature, asapparent facts, the unverified, vague - and sometimes altered -memories and assertions of a group of unnamed parents who,unknown to the journal and its readers, were bound to blame MMRwhen they came to the hospital because that was why they had beenbrought there. Wakefield, a former trainee gut surgeon, denied this.But the true number of families accusing MMR wasn't eight, as thepaper said: it was 11 of the 12 (later all 12) and in most cases recordsnoted parents' compensation claims before the children were referred.

"Mum taking her to Dr Wakefield, Royal Free Hospital for CT scans/gutbiopsies," wrote one family doctor in the north-east of England, forexample, before referring the only little girl in the project (who did nothave inflammatory bowel disease). "?Crohn’s—will need ref letter—DrW to phone me. Funded through legal aid."

In the light of such discoveries, the case was overwhelming to digdeeper into Wakefield's findings. In an exercise never beforeaccomplished by a journalist, Deer was able to exploit the GMChearing to go behind the face of the 1998 paper, identify the subjects,and access patient data. Penetrating veils of medical and legalconfidentiality, he discovered that the hospital's clinicians andpathology service had found nothing to implicate MMR, but thatWakefield had repeatedly changed, misreported and misrepresenteddiagnoses, histories and descriptions of the children, which made itappear that the syndrome had been discovered.

As first revealed in The Sunday Times in February 2009, the effectwas to give the impression of a link between MMR, bowel disease andthe sudden onset of autism when otherwise none was evident.Standard, but unreported, blood tests for inflammation in the childrenwere normal. And what the hospital's clinicians and pathology serviceactually found in the children's guts was severe constipation, with

Nailed: Upon publicationof Deer's first report in theBMJ series "Secrets of theMMR scare", on 5 January2011, CNN's AndersonCooper leads the US mediain the biggest-ever storyabout the vaccine. Trackedto a $550-a-night villaresort in Montego Bay,Jamaica, Wakefield skulksbehind a barrage ofextraordinary lies.

Reply: The following night,Cooper, in New York,interviews Deer in London.Deer rebuts Wakefield'sfictions, explains how theinvestigation came aboutand reveals his anxiety: theharm Wakefield caused tofamilies of children withautism.

CNN worldwide: On 6January 2011, Deer isinterviewed by Zain Verjeefor the US news network'sinternational audience,rebutting an extraordinarycampaign of deceitlaunched by Wakefield.

The fraud exposed: selected press comment in January 2011

Autism Fraud

"Now the British Medical Journal has taken the extraordinary step of publishing a lengthyreport by Brian Deer, the British investigative journalist who first brought the paper’s flaws tolight — and has put its own reputation on the line by endorsing his findings.

"After seven years of studying medical records and interviewing parents and doctors, Mr.Deer concluded that the medical histories of all 12 children had been misrepresented to makethe vaccine look culpable. Time lines, for example, were fudged to make it seem as thoughautismlike symptoms developed shortly after vaccination, while in some cases problemsdeveloped before vaccination and in others months after vaccination.

"Dr. Wakefield has accused Mr. Deer of being a hit man. But the medical journal comparedthe claims with evidence compiled in the voluminous transcript of official hearings and declaredthat flaws in the paper were not honest mistakes but rather an 'elaborate fraud.'” [Excerpt]Online: January 12 2011. Print: January 13 2011 (Page A22)

The Autism Vaccine Hoax

NET-A-PORTER.COM www.net-a-porter.com

The world's premier online luxury fashion destination.Shop now

Angie's List Health www.AngiesList.com/Health

Find The Best Doctor In Your Area. Read LocalReviews & Choose!

2012 CNA Classes Near You CNA.CampusCorner.com

Take 2012 CNA Classes Online & Near You - EnterYour Zip & Apply Now!

CNA Nursing Schools www.collegesurfing.com

Find CNA Nursing Schools In Your Area. Search Now!

Andrew Wakefield - the fraud investigation http://briandeer.com/mmr/lancet-summary.htm

3 of 6 12/22/2011 3:04 PM

Page 7: SABA AFF EXHIBITS

predominantly normal [table] biopsies and benign or normal features.When taken together with developmental histories and diagnoses,moreover, not one case was free of critical mismatches between thepaper which launched the vaccine crisis and the kids'contemporaneous records. Some children were a cause for concernbefore vaccination. Some were deemed normal months afterwards.Some did not have autism at all.

"If my son really is Patient 11, then the Lancet article is simply anoutright fabrication," said the father of the penultimate child in theseries - admitted to the Royal Free, at age 5, from northern Californiaand whose history was falsely reported in the paper.

Children's protections sidelined

In addition to finding that the study had been rigged, the investigationuncovered a raft of further issues, including irregularities in ethicalsupervision. Research on patients is governed by national andinternational standards - particularly the Helsinki declaration - and noreputable hospital review board would have endorsed the kind offishing expedition Wakefield embarked on for Barr. Without thatendorsement, moreover, no reputable medical journal would havepublished any resulting paper. Against that background, to satisfy theLancet's patient-protection requirements, but without revealing tohospital authorities what was really going on, Wakefield falselyreported that a gruelling five-day battery of invasive and distressingprocedures performed on the kids - including anaesthesia,ileocolonoscopies, lumbar punctures, MRI brain scans, EEGs,radioactive drinks and x-rays - proposed for the lawsuit, was approvedby the Royal Free's ethics committee.

But Deer revealed that, despite the research being executed on theuniquely vulnerable, developmentally challenged children ofsometimes distraught parents hoping for money, the ethics committeewas not told the truth about the project, and had given no suchapproval. Responding to Deer in 2004, Wakefield and his keyassociates, paediatricians John Walker-Smith and Simon Murch,denied this explosive discovery and issued a formal statement. But,after being confronted with the proof at the GMC hearing, theychanged their story and - despite clear rules - now argued theyneeded no approval.

The investigation also probed Wakefield's basic science. The story wasmuch the same. He had obtained the legal money and planned hisbusiness ventures against a theory of his own that the culprit for bothinflammatory bowel disease and autism was persistent infection withmeasles virus, which is found live as a normal part of MMR. But Deerrevealed on Channel 4 that sophisticated, unreported, molecular testscarried out in Wakefield's own lab had found no trace of measles inthe children's guts and blood. Those tests were among a string whichfound no evidence of the virus. The Sunday Times also disclosedcritical flaws in one apparently positive study, which involvedmaterials supplied by Wakefield. This had misled thousands offamilies affected by autism, both in the UK and the US, ensnared foryears in hopeless litigation based almost entirely on his measlestheory.

Deer (who in April 2006 reported the first British measles death in 14years) took no view on whether vaccines may or may not causeautism, but never found any scientific material which repeated theLancet findings. Although all kinds of children, including those withautism, suffer from digestive issues, he learnt of a mass ofauthoritative research which rebutted Wakefield's claims. "Specifically,numerous studies have refuted Andrew Wakefield’s theory that MMRvaccine is linked to bowel disorders and autism," was how theAmerican Academy of Pediatrics summarised the consensus in anAugust 2009 statement to NBC News for a Dateline programme[video] featuring both Wakefield and Deer. "Every aspect of DrWakefield’s theory has been disproven."

The impact of the investigation has been felt around the world, withmedia coverage from New Zealand [audio] to Canada [video]. In theUK, the revelations prompted a 2004 statement by the prime minister,a collapse in the anti-MMR campaign, and a rebound in vaccinationlevels. In the US - where the Barr-Wakefield deal was joined byallegations marshalled by American attorneys that a mercury-basedvaccine preservative, thimerosal, was also at fault - findings by Deerwere presented by the Department of Justice in federal court,followed in February 2009 by scathing judgments. After hearing a testcase of petitions from some 5,000 families, one presiding judge said:"Therefore, it is a noteworthy point that not only has that 'autisticenterocolitis' theory not been accepted into gastroenterology

A tragic scare campaign is exposed as 'fraud'.

"Twelve years late, the media and medical community may finally be digging a grave for oneof the more damaging medical scares in history. We're speaking of the vaccines-cause-autismpanic, the burial of which cannot come too soon...

"It took the Lancet until last year to offer a full retraction of the 1998 study, and that cameonly after Britain's medical regulator had ruled that Mr. Wakefield had acted "dishonestly andirresponsibly." The British Medical Journal's article is the first in-depth look at Mr. Wakefield'sabuses. By journalist Brian Deer—who has investigated Mr. Wakefield for years—the articlereports that the doctor grossly misrepresented the cases of 12 children to support his theory,and that he worked with plaintiffs attorneys to exploit the panic for financial gain.

"This is a start, but the health community and media have a long way to go to restore publictrust in immunizations. They also bear some responsibility for the dollars that have beendiverted from research into finding the real causes of the terrible affliction that is autism. Let'shope they now broadcast the vaccine truth as much as they encouraged the vaccine panic."[Excerpt] 8 January 2011

Read these editorials and more from 2011 in full

CTV interview: On 6January, Deer talks livefrom London to DanMatheson at the Canadiancommercial network's newsstudios in Toronto.

Fighting fraud: In a 6January discussion onMSNBC's Dylan RatiganShow, Deer debates theissue of scientific fraud withGrant Steen, a doctor whofirmly believes theWakefield case to beextraordinary and not asign of a deeper malaise.

Canadian chat: During atrip by Deer to Toronto,sponsored by the CanadianJournalism Foundation, he'sinterviewed by GeorgeStroumboulopoulos onCBC's Tonight Show. 14March 2011.

Retraction: selected press comment in February 2010

Hippocrates would puke - Doctor hoaxedparents into denying kids vaccine

Paid Clinical TrialsGet paid for clinical research trials inAustin, TX. Join today!www.benchmarkresearch.net

Wireless VulnerabilitiesScan your network for threats. Free OnlineNetwork Vulnerability Scan.vulnerability.scan.qualys.com

Wet AMD Signs & SymptomsGet symptom info about Wet AMD andlearn about a treatment option.www.LivingWithAMD.com

Andrew Wakefield - the fraud investigation http://briandeer.com/mmr/lancet-summary.htm

4 of 6 12/22/2011 3:04 PM

Page 8: SABA AFF EXHIBITS

textbooks, but that theory, and Dr Wakefield’s role in its development,have been strongly criticized as constituting defective or fraudulentscience."

Wakefield campaign denies everything

In response to Deer, Wakefield supporters denied that he took moneyfor research, and, amid a barrage of sometimes paid-for smears andcrank abuse of the journalist, lauded the doctor as a "hero". But thefather-of-four's deceits had not only triggered the resurgence ofsometimes fatal or brain-disabling measles outbreaks, plungedcountless parents into the hell of believing it was their own fault foragreeing to vaccination that a son or daughter had developed autism,and misled an ethics committee over child rights and safety, but itwas discovered that he had gone as far as to betray a vaccine safetywhistleblower whose identity he discovered [video] and had boughtblood from children as young as four years old, attending a birthdayparty, and then joked about them crying, fainting and vomiting.[video]

Meanwhile, Wakefield denied any conflicts of interest and claimed henever even said that MMR caused autism. But documents - includingpatents - evidenced his claims, and he published a string of furtherfalsified reports to undermine the vaccine. Even when he knew thathis allegations had been proven baseless, he was found promotingthem from a controversial business in Austin, Texas, called ThoughtfulHouse, where - after being fired from the Royal Free in October 2001,following his refusal to repeat the Lancet study with a larger numberof children - he held a $280,000-a-year post, spun from his campaign.

Throughout the investigation, Wakefield refused to co-operate, filedbaseless complaints and issued statements denying every aspect. Healso initiated, sought to stall and then abandoned with some £1.3m($2m) costs, a two-year "gagging" libel lawsuit, financed by theMedical Protection Society, which defends doctors against theirpatients. In reply, Deer and Channel 4 pressed for a speedy trial,publicly accusing Wakefield of being "unremittingly evasive anddishonest". His conduct in the litigation was also damned by a HighCourt judge, who said that Wakefield "wished to extract whateveradvantage he could from the existence of the proceedings while notwishing to progress them", and that the doctor was using the lawsuitas "a weapon in his attempts to close down discussion and debateover an important public issue".

Lancet paper retracted and doctor ousted

Faced with overwhelming proof of misconduct, Wakefield wouldconcoct a preposterous conspiracy theory [video] to account for hisexposure, and denied rigging his results. "The notion that anyresearcher can cook such data in any fashion that can be slipped pastthe medical community for his personal benefit is patent nonsense,"he argued in a March 2009 statement. "Scientific rigor requiresrepeatability for verification of any research and Mr Deer's implicationsof fraud against me are claims that a trained physician and researcherof good standing had suddenly decided he was going to fake data forhis own enrichment."

But on 28 January 2010 - after 197 days of evidence, submissions anddeliberations - a panel of three doctors and two lay members hearingthe GMC case handed down verdicts which wholly vindicated Deer.Branding Wakefield "dishonest", "unethical" and "callous", they foundhim guilty (against a criminal standard of proof) of some three dozencharges, including four of counts of dishonesty and 12 involving theabuse of developmentally-challenged children. His research was foundto be dishonest and performed without ethical approval. Five dayslater, the Lancet fully retracted the paper from the scientific literature,prompting international media interest and further retractions.

"What is indisputable is that vaccines protect children from dangerousdiseases," said The New York Times, in one of a string of editorials inleading newspapers. "We hope that The Lancet’s belated retractionwill finally lay this damaging myth about autism and vaccines to rest."

Three weeks later, on 17 February 2010, Wakefield was ousted by thedirectors of his Texas business, and on 24 May - day 217 of the GMChearing - he was ordered to be erased from the UK doctors' register,ending his career in medicine. On 21 December 2010, that erasurewas confirmed after he abandoned a court appeal against theverdicts.

Medical journal calls the fraud

"It was Wakefield's article, published in 1998 in the premier British medical journal, The Lancet,that gave authority to the proposition that combined inoculations for measles, mumps andrubella were connected to childhood autism. Now, though, the United Kingdom's GeneralMedical Council, which licenses doctors, has concluded that Wakefield cherry-picked thechildren who became his study subjects, including paying kids at his son's birthday party togive blood. The council also found that he subjected children to unnecessary procedures, suchas colonoscopies, for experimental purposes without getting ethical approval. Oh, andWakefield was secretly bankrolled by lawyers who hoped to sue vaccine makers. Oh, and heowned a patent on a competing measles vaccine... Steadfastly defending both his integrityand his science - and backed by supporters who mutter about "show trials" and "witch hunts"- Wakefield has been shamed before the world. He deserves far worse." [Excerpt] February 62010

Dodgy science is bad medicine

"It's a sad fact that the retraction this week of a controversial research paper on the effectsof a common childhood vaccination will not have anything like the impact on public opinion ofthe paper's original publication... The Lancet's online announcement that "we fully retract thispaper from the published record" followed a finding by the General Medical Council, thestatutory regulatory authority of doctors in the UK, that Wakefield had acted "dishonestly andirresponsibly" in reporting his research. The evidence, of conflict of interest, data-fixing andethical breaches, makes grim reading. But grimmer still are the effects of the needless anxietyhis "findings" caused." [Excerpt] February 7 2010

Debunking the link between autism and vaccination

"The real villain here, of course, is Dr Andrew Wakefield.... Meanwhile, science chugged along,as it does. The autism claim was always suspect, because autism 'presents' naturally ataround the same age that children get their vaccine jabs. As any logician will tell you,Correlation Does Not Imply Causation. It's only our natural instinct to see patterns that gets inthe way of this obvious sense... In the US, Hollywood got on board. Comedic actor JimCarrey and Playboy bunny-turned-actress Jenny McCarthy were convinced vaccination causedher son Evan's autism, and they were welcomed with open arms to spruik their views on chatshows across the country. But at the same time, some serious questions were starting toarise about Wakefield's original research. UK investigative journalist Brian Deer produced someexcellent, scathing articles... Those who care about science and reason should not sit backand say ''Wakefield guilty, study retracted, case closed''. Processes have failed here that needserious, ongoing thought." [Excerpt] February 4 2010

Read these editorials and more from 2010 in full

What others say 1: MattLauer talks to NBC chiefmedical editor Dr NancySnyderman on the TodayShow.

What others say 2: GarySchwitzer is interviewed onFox News. He argues thatthe story shows how ajournalist can make adifference.

Selected resources from the Andrew Wakefield investigation

Wakefield's first and second patent claims for a vaccine/immunisation for the "preventionand/or prophylaxis" of measles virus infection - even the existence of which he denies

Some of the many documents which prove that Wakefield's 1998 Lancet research wascommissioned through solicitors funded by the UK government's legal aid board

The agreed meanings of Brian Deer's Channel 4 TV documentary, pleaded in AndrewWakefield's abandoned "gagging writ" lawsuit, Wakefield v Channel 4 & Ors, are here

A High Court judge, Sir David Eady, hammered Wakefield for trying to "close down discussionand debate over an important public issue", as reported by Press Gazette

View the cheque sent to Deer by Wakefield's lawyers in 2007 to cover the costs of defendingthis website, after the research cheat abandoned a baseless "gagging writ" libel action

See how The Washington Post in 2004 reported Deer's early interview with a Wakefield ally,which transformed a routine news assignment into a major public interest investigation

Andrew Wakefield - the fraud investigation http://briandeer.com/mmr/lancet-summary.htm

5 of 6 12/22/2011 3:04 PM

Page 9: SABA AFF EXHIBITS

Finally, in January 2011, BMJ, the British Medical Journal, concludedthe investigation with a three-week package of disclosures andeditorials, including three major reports by Deer: How the caseagainst the MMR vaccine was fixed, How the vaccine crisis was meantto make money and The Lancet's two days to bury bad news. Thepackage (which involved peer-review and separate editorial checkingof key evidence and documents) also included an introduction byDeer, Piltdown medicine, explaining the fraud and comparing it withBritain's most notorious scientific forgery. In editorials, the BMJ calledWakefield's research "an elaborate fraud" and accused the Royal Freemedical school and the Lancet of "institutional and editorialmisconduct".

Among hundreds of media reports worldwide on the BMJ revelations -which were covered by all north American networks and reachedalmost half of Americans surveyed days later in a Harris poll - TheNew York Times said in a second editorial on the affair: "Now theBritish Medical Journal has taken the extraordinary step of publishinga lengthy report by Brian Deer, the British investigative journalist whofirst brought the paper's flaws to light - and has put its own reputationon the line by endorsing his findings."

Three months later, Deer's personal journey found closure when inMay 2011 he was named specialist journalist of the year in the Britishnewspaper industry's annual Pulitzer-style Press Awards. Judges forthe Society of Editors praised what they called his "outstandingperseverance, stamina and revelation on a story of majorimportance". They said of his investigation: "It was a tremendousrighting of a wrong".

See the MMR investigation stories listed | Tables: Lancet paperanalysed

Invite Brian Deer to speak at your event

Hear the story of the vaccine scare, and how an investigativejournalist unmasked the elaborate scientific fraud which lay at its

heart

Contact Brian

The UK General Medical Council's January 2010 findings of fact on the misconduct ofWakefield and two co-defendants, professors John Walker-Smith and Simon Murch

Here is the tabulation, obtained by Deer under the freedom of information act, revealing theenormous payments to Wakefield which began two years before the 1998 Lancet paper

The General Medical Council panel's May 2010 conclusion and sentencing, summarisingWakefield's misconduct and ordering him to be erased from the UK medical register

Read the side-show tale of a paid smear campaigner, Martin J Walker, brought in to plant thefalse Wakefield claim that the drug industry was behind the vaccine investigation

Brian Deer's tabulation of the Lancet paper findings on the 12 children, comparing them withthe NHS records of the same children. Published in a BMJ series in January 2011

See Wakefield threaten, belittle and betray a vaccine safety whistleblower who, in strictconfidence, disclosed what he said was evidence of UK government bungling over MMR

View the histology reports which lay behind Wakefield's claim to have discovered a newinflammatory bowel disease associated with autism. Experts say they are almost all normal

Selected audio interviews with Deer about the investigation

Hear Brian Deer interviewed by Kathryn Ryan of Radio New Zealand in a special 30 minuteconversation about the MMR investigation and Wakefield, broadcast on 10 February 2010

Hear Deer interviewed by Russ Roberts about the investigation's methods and findings in anhour-long podcast from the Library of Economics and Liberty, posted 31 January 2011

In this 30-minute clip, Deer is interviewed by Michael Enright of the Canadian BroadcastingCorporation's Sunday Edition show, heard across North America. 20 February 2011

August 2009: Brian Deer isinterviewed by Matt Lauer on theNBC News Dateline programconcerning the first part of theWakefield investigation.

Another clip includes Wakefield'sreply. He says of the children:"Now let's be clear. They wereadmitted to the Royal Free forinvestigation of their symptoms.Nothing to do with research,nothing to do with class action,nothing to do with vaccines."Documents say otherwise.

Copyright, 2004-2011, Brian Deer.All rights are reserved. No materialat this website may be copied,retransmitted, reposted,duplicated, or lifted to pad blogs.Please read our copyright andplagiarism statement.

Extended summary of the story The whistleblower briandeer.com site homepage Contact Brian Deer MMR part 1: The Lancet scandal

Andrew Wakefield - the fraud investigation http://briandeer.com/mmr/lancet-summary.htm

6 of 6 12/22/2011 3:04 PM

Page 10: SABA AFF EXHIBITS

Exhibits 4-8 – Temporary filed under seal

Page 11: SABA AFF EXHIBITS
lgentry
Typewritten Text
EXHIBIT 9
Page 12: SABA AFF EXHIBITS

T.A. REED

& CO. Day 2 - 6

A

B

C

D

E

F

G

H

There are very clear guidelines that require doctors to apply to ethics committees for

permission to do research on their patients and to give an honest and accurate account and

information to the ethics committee and to abide by the requirements of the committee when

they are carrying out that research. There are particular requirements, as you might expect,

relating to research on young children, because of their vulnerability. Our case quite simply

is that these three doctors did not comply with those guidelines, and, as a result of that, very

vulnerable children were subjected to inappropriate and invasive treatment.

Equally, there are another set of rules. The publication of research is underpinned by

requirements that doctors reporting research projects are accurate, honest and responsible in

the manner of their reporting. Our case is that with regard to Dr Wakefield and

Professor Walker-Smith they did not comply with those requirements when they were writing

up their project for publication in The Lancet medical journal, and, as a result of that, they

were in breach of the trust that both the scientific community and the public at large place in

the integrity of medical practitioners.

Furthermore, there are yet more rules. There are requirements in relation to the declaration of

potential conflicts of interest about which the scientific community and the public are entitled

to know in order to make their own judgements about the significance of a research project,

and our case is that, with regard to Dr Wakefield, he failed to comply with those requirements

in failing to disclose both his deep involvement with the MMR litigation and his receipt of

Legal Aid Board money to fund his research, and by that failure he deprived his readers of

information that they should have had.

So it is a case about the breach of some of the most fundamental rules in medicine, essentially

focused on misconduct in the carrying out of the research on the children by the three

responsible consultants in charge of the research project, and the manner in which two of

those doctors reported the project which was subsequently printed in The Lancet medical

journal.

You will be aware, I know, that the statutory remit of the GMC is to investigate serious

professional misconduct and it is about protecting patients and the public and upholding high

standards of probity and integrity in the medical profession. It is not about stifling scientific

freedom to publish properly conducted research, but the operative words that you should bear

in mind when you are hearing this case are the words “properly conducted”. This Panel

hearing is even less an appropriate forum for the determination of scientific disputes or

debating scientific theories. This case is concerned with events which took place nearly ten

years ago. Much has been said and written on the subject of MMR in that time. We are not

concerned with that. We are concerned with the conduct of the research project and not with

the ensuing controversy over the safety of MMR. So we emphasise at this stage that these are

professional misconduct hearings. They are not some sort of broad-ranging public inquiry.

Now, I am going to, at the risk of tedium, run through the charges quickly in summary. You

have heard them read out, necessarily over rather a long period of time, and of course there is

always a danger when you hear things read out over a long period of time of forgetting, by

the time you get to the end, what the beginning was, and failing to be able to see the wood for

the trees. So I am going to concentrate on the wood, and, as I say, just summarise the charges

that you have heard.

lgentry
Typewritten Text
EXHIBIT 10