3rd article in BMJ on MMR and autism

[Guest guest]

FYI, 3rd article in series of 3 in the British Medical Journal on MMR vaccine,

Dr Wakefield, and lack of linkage to autism.

     These articles have been a fascinating read.  In my opinion, it's nice

to

see the medical establishment step up and admit they have been part of the

problem.  I know others may think this is part of an attempt to smear Dr

Wakefield.  My point is not to stir controversy, this is too heated a topic for

this list serve.  I think it's more important to preserve unity on this list

serve.  Our lives are hard enough trying to support our precious kids.  The

support we give each other here is more important than your views on

vaccination.  However, this is an important set of articles in shaping future

vaccination policy for the government and insurers.  Whatever your views,

you SHOULD be aware of them.  These articles are receiving a LOT of attention

in

the medical community.  Hopefully, the medical establishment has learned some

important lessons.  Hopefully, years of feuding between doctors and families of

children with autism can come to a close.  We need to move on with treatment

and

identification of individuals with autism.  I believe that we are on the

verge

of some significant breakthroughs in understanding the complex genetic factors

and environmental triggers that make our kids autistic.

 

Shane Avery

father of , age 10

 

Medical Establishment Buried Concerns About MMR/Autism Study, BMJ Charges

The Lancet Says It Never Claimed the Study Proved a Link Between the Vaccine and

Autism

Information from Industry

January 20, 2011 — The medical establishment " closed ranks " to protect

Wakefield, the researcher whose 1998 study linked the measles-mumps-rubella

(MMR) vaccine to autism, according to a third and final article of a special

investigative series published online January 18 in the BMJ.

 

UK journalist Deer alleges that when he approached The Lancet editor

Horton in 2004 with concerns about potential issues of research fraud,

conflicts of interest, and unethical treatment of children discovered while

researching an article about the study for the Sunday Times,The Lancet failed to

ensure that a formal, independent investigation was conducted.

 

Dr. Fiona Godlee

In his most recent BMJ article, Mr. Deer writes that failure to conduct such an

investigation and the series of denials issued by Mr. Wakefield, his coauthors,

and the Royal Free Hospital led to the public being " misled for 6 years " about

the credibility of the article before The Lancet finally retracted it in

February 2010.

 

" That's really the nubbin of this story — the failing of The Lancet and the

Royal Free to investigate adequately when questions were raised back in 2004, "

Fiona Godlee, MD, BMJ editor-in-chief, told Medscape Medical News.

 

" Although it was discredited in some ways, this damaging article still sat in

the literature for 6 years. And the GMC [General Medical Council] went through

this incredibly lengthy and expensive investigation, which potentially might

have been avoided to some extent, " added Dr. Godlee.

 

The Lancet Responds

 

Although it was discredited in some ways, this damaging article still sat in the

literature for 6 years. And the GMC went through this incredibly lengthy and

expensive investigation, which potentially might have been avoided to some

extent.

In a statement, The Lancet disputes Mr. Deer's " portrayal of events " in 2004.

" We strongly disagree with his assessment and firmly stand by our actions and

decisions, " they write.

The Lancet also notes that the original 1998 article did not assert that MMR

caused autism and that it was at a separate press conference where Mr. Wakefield

suggested this association.

 

" It is the role of medical journals to foster debate, even disagreeable debate,

and we took this role seriously and responsibly, " says The Lancet release.

 

What none of us knew at the time, including many of his coauthors, was the

extraordinary part that Wakefield had been playing in this affair and the

part that he was about to play. At no point did we actively defend [his] public

statements about the link between MMR and autism. "

 

No matter how the events unfolded, Dr. Godlee writes in her Editor's Choice

editorial this week that a new process is needed in the United Kingdom to ensure

research integrity. Although the UK Research Integrity Office was established in

2006, it lacks mandatory powers and is running out of funding.

 

" Other countries have models we could adapt, [such as] the US Office of Research

Integrity, which has a mandate to oversee institutional investigations of

publicly funded research, " she writes.

 

" In America, you've got a process set up that could possibly be improved, but in

Britain we haven't got a good set-up at all. I think this case should be used as

a springboard for really improving and raising our game on that score, " she

added.

 

In the first article in the BMJ series, as reported by Medscape Medical News,

Mr. Deer wrote that the investigators altered and falsified medical records of

the 12 children involved.

 

In the second article, reported last week, Mr. Deer " followed the money. " He

found that while the first study patient was still in the hospital, Mr.

Wakefield met with managers from the Royal Free Medical School to discuss

forming a joint business.

 

In this last piece, Mr. Deer writes that he first approached The Lancet in

assumed confidence on advice from his editor at the Sunday Times for comment and

" to be sure we were getting it right. "

 

False Reassurance

 

We were falsely reassured. We were told by authoritative sources...that an

investigation had been done and cleared Wakefield of most charges. But as shown

by documents obtained under the Freedom of Information Act, there was no proper

investigation, merely a 48-hour 'scramble' to protect reputations and discredit

the story.

 

According to the BMJ article, within 48 hours of this meeting, an editor from

The Lancet met with the study's 3 senior authors and the journal published " a

5000-word avalanche of denials in statements unretracted to this day. "

 

Further statements reported that an investigation was undertaken by the Royal

Free Hospital that " cleared Wakefield of wrongdoing. "

 

However, according to documents obtained under the Freedom of Information Act,

the investigation was actually conducted internally by the coauthors themselves.

Both the Royal Free Hospital and Medical School have now confirmed that no

formal investigation was performed, no physicians were ever interviewed, and no

documents generated.

 

" We were falsely reassured, " writes Dr. Godlee. " We were told by authoritative

sources...that an investigation had been done and cleared Wakefield of most

charges. But as shown by documents obtained under the Freedom of Information

Act, there was no proper investigation, merely a 48-hour 'scramble' to protect

reputations and discredit the story. "

 

The Lancet statement also says that it followed the guidelines by the Committee

on Publication Ethics when speaking to the study authors after Mr. Deer brought

his concerns to them in 2004 and published a partial retraction by 10 of the

study's coauthors soon after.

 

Major Flaws in Peer Review Process

 

According to the BMJ article, the GMC became involved soon after the allegations

were made, but it took the panel 6 years to substantiate the allegations.

 

" Were it not for the GMC case, which cost a rumored 6 million pounds, the fraud

by which Wakefield concocted fear of MMR would forever have been denied and

covered up, " writes Mr. Deer.

 

" It is hard to escape the conclusion that this represents institutional and

editorial misconduct, and its impact has been substantial. The international

damage might have been lessened by earlier definitive action, " adds Dr. Godlee.

 

" This case reveals major flaws in pre- and postpublication peer review, " said

Dr. Godlee in a release. " Allegations of research misconduct must be

independently investigated in the public interest. But it's still too easy for

institutions to avoid external scrutiny, and editors can fail to adequately

distance themselves from work they have published and then defended. "

She noted that " this is where coauthors become crucially important. If coauthors

are going to sign their names to a paper, I think they need to have real

knowledge and understanding of the entire study. "

 

Dr. Godlee added that " it was interesting " that the Wakefield study had case

reports on just 12 children but had 13 authors. " One would think it would be

difficult to be fraudulent with so many coauthors, but he's obviously a person

who is very compelling and persuasive and managed to achieve this without them

being alerted to it. "

 

Need for Healthy Skepticism

 

In an accompanying article, clinicians from Seattle, Washington, write that

there is an urgent need to fix a research system that failed to protect its

subjects and the public from the consequences of fraudulent science.

 

Dr. Doug Opel

" So much has been written about Wakefield himself, but we felt that, especially

in light of Deer's articles, there were a lot of unindicted coconspirators

here, " J. Opel, MD, MPH, acting assistant professor at the Treuman Katz

Center for Pediatric Bioethics at Seattle Children's Research Institute,

Washington, told Medscape Medical News.

 

" I think it's important...to look into and investigate why these existing

safeguards that are meant to protect research subjects didn't do their job.

Wakefield was able to circumvent them and conduct unethical and fraudulent

research. We need to understand what those defects are, fix them, and prevent

situations like this from happening again, " added Dr. Opel.

 

The editorialists offer several suggestions for preventing future " research

adverse events " including the following:

* Empower everyone in research to raise questions throughout the process;

* Train research leaders to manage inquiries once raised;

* Not allow journal editors to " take the word " of researchers after allegations

are made against them; and

* Train research leaders to recognize that they may have conflicts of interest

in looking into allegations.

I think it's important...to look into and investigate why these existing

safeguards that are meant to protect research subjects didn't do their job.

Wakefield was able to circumvent them and conduct unethical and fraudulent

research. We need to understand what those defects are, fix them, and prevent

situations like this from happening again.

 

" We perhaps need a paradigm shift in the research world. We need to look to what

we're doing in the clinical world with respect to quality improvement and

patient safety and determine whether some of those can be applied to the

research realm to protect human subjects, " said Dr. Opel.

 

" We...need to rethink and reform our customs and culture. The disastrous impact

that Wakefield's study has had on vaccine coverage, recrudescence of disease,

public trust, and, most of all, science requires that we do so in haste, " write

the editorial authors.

Dr. Godlee added that when it comes to medical journals, clinicians should also

maintain a healthy skepticism.

 

" We work hard to make sure that what we publish is accurate, and I'm sure the

same is true with The Lancet. One is aware that clinicians are going to be

reading this and using the information to treat and advise their patients. Yes,

there can be inaccuracies, and we know that there will be fraud. But how often

that happens is almost impossible to judge, " she said.

" So physicians need to, one hopes, not be cynical but absolutely question. The

whole scientific enterprise is organized skepticism, where we all are meant to

look at what's put in front of us and submit it to a process of questioning

internally in terms of whether this is valid and relevant, " she concluded.

 

Mr. Deer's original investigation was funded by the Sunday Timesof London and

the Channel 4television network. The current articles were funded by the BMJ. He

reported receiving no other funding except for legal costs from the Medical

Protection Society on behalf of Mr. Wakefield. The editorial authors have

disclosed no relevant financial relationships.

 

BMJ. Article and editorial published online January 18, 2011.

BMJ. Editor's Choice published online January 19, 2011.

[Guest guest]

Rational conversation as you say Shane beats heated rehtoric.

On Fri, Jan 21, 2011 at 11:53 PM, Shane Avery MD wrote:

>

>

> FYI, 3rd article in series of 3 in the British Medical Journal on MMR

> vaccine,

> Dr Wakefield, and lack of linkage to autism.

> These articles have been a fascinating read. In my opinion, it's nice

> to

> see the medical establishment step up and admit they have been part of the

> problem. I know others may think this is part of an attempt to smear Dr

> Wakefield. My point is not to stir controversy, this is too heated a topic

> for

> this list serve. I think it's more important to preserve unity on this

> list

> serve. Our lives are hard enough trying to support our precious kids. The

>

> support we give each other here is more important than your views on

> vaccination. However, this is an important set of articles in shaping

> future

> vaccination policy for the government and insurers. Whatever your views,

> you SHOULD be aware of them. These articles are receiving a LOT of

> attention in

> the medical community. Hopefully, the medical establishment has learned

> some

> important lessons. Hopefully, years of feuding between doctors and

> families of

> children with autism can come to a close. We need to move on with

> treatment and

> identification of individuals with autism. I believe that we are on the

> verge

> of some significant breakthroughs in understanding the complex genetic

> factors

> and environmental triggers that make our kids autistic.

>

> Shane Avery

> father of , age 10

>

> Medical Establishment Buried Concerns About MMR/Autism Study, BMJ Charges

> The Lancet Says It Never Claimed the Study Proved a Link Between the

> Vaccine and

> Autism

> Information from Industry

> January 20, 2011 — The medical establishment " closed ranks " to protect

>

> Wakefield, the researcher whose 1998 study linked the measles-mumps-rubella

>

> (MMR) vaccine to autism, according to a third and final article of a

> special

> investigative series published online January 18 in the BMJ.

>

> UK journalist Deer alleges that when he approached The Lancet editor

> Horton in 2004 with concerns about potential issues of research

> fraud,

> conflicts of interest, and unethical treatment of children discovered while

>

> researching an article about the study for the Sunday Times,The Lancet

> failed to

> ensure that a formal, independent investigation was conducted.

>

>

> Dr. Fiona Godlee

> In his most recent BMJ article, Mr. Deer writes that failure to conduct

> such an

> investigation and the series of denials issued by Mr. Wakefield, his

> coauthors,

> and the Royal Free Hospital led to the public being " misled for 6 years "

> about

> the credibility of the article before The Lancet finally retracted it in

> February 2010.

>

> " That's really the nubbin of this story — the failing of The Lancet and the

>

> Royal Free to investigate adequately when questions were raised back in

> 2004, "

> Fiona Godlee, MD, BMJ editor-in-chief, told Medscape Medical News.

>

>

> " Although it was discredited in some ways, this damaging article still sat

> in

> the literature for 6 years. And the GMC [General Medical Council] went

> through

> this incredibly lengthy and expensive investigation, which potentially

> might

> have been avoided to some extent, " added Dr. Godlee.

>

> The Lancet Responds

>

> Although it was discredited in some ways, this damaging article still sat

> in the

> literature for 6 years. And the GMC went through this incredibly lengthy

> and

> expensive investigation, which potentially might have been avoided to some

> extent.

>

> In a statement, The Lancet disputes Mr. Deer's " portrayal of events " in

> 2004.

> " We strongly disagree with his assessment and firmly stand by our actions

> and

> decisions, " they write.

> The Lancet also notes that the original 1998 article did not assert that

> MMR

> caused autism and that it was at a separate press conference where Mr.

> Wakefield

> suggested this association.

>

> " It is the role of medical journals to foster debate, even disagreeable

> debate,

> and we took this role seriously and responsibly, " says The Lancet release.

>

> What none of us knew at the time, including many of his coauthors, was the

> extraordinary part that Wakefield had been playing in this affair

> and the

> part that he was about to play. At no point did we actively defend [his]

> public

> statements about the link between MMR and autism. "

>

> No matter how the events unfolded, Dr. Godlee writes in her Editor's Choice

>

> editorial this week that a new process is needed in the United Kingdom to

> ensure

> research integrity. Although the UK Research Integrity Office was

> established in

> 2006, it lacks mandatory powers and is running out of funding.

>

> " Other countries have models we could adapt, [such as] the US Office of

> Research

> Integrity, which has a mandate to oversee institutional investigations of

> publicly funded research, " she writes.

>

> " In America, you've got a process set up that could possibly be improved,

> but in

> Britain we haven't got a good set-up at all. I think this case should be

> used as

> a springboard for really improving and raising our game on that score, " she

>

> added.

>

> In the first article in the BMJ series, as reported by Medscape Medical

> News,

> Mr. Deer wrote that the investigators altered and falsified medical records

> of

> the 12 children involved.

>

> In the second article, reported last week, Mr. Deer " followed the money. "

> He

> found that while the first study patient was still in the hospital, Mr.

> Wakefield met with managers from the Royal Free Medical School to discuss

> forming a joint business.

>

> In this last piece, Mr. Deer writes that he first approached The Lancet in

> assumed confidence on advice from his editor at the Sunday Times for

> comment and

> " to be sure we were getting it right. "

>

> False Reassurance

>

> We were falsely reassured. We were told by authoritative sources...that an

> investigation had been done and cleared Wakefield of most charges. But as

> shown

> by documents obtained under the Freedom of Information Act, there was no

> proper

> investigation, merely a 48-hour 'scramble' to protect reputations and

> discredit

> the story.

>

>

> According to the BMJ article, within 48 hours of this meeting, an editor

> from

> The Lancet met with the study's 3 senior authors and the journal published

> " a

> 5000-word avalanche of denials in statements unretracted to this day. "

>

> Further statements reported that an investigation was undertaken by the

> Royal

> Free Hospital that " cleared Wakefield of wrongdoing. "

>

> However, according to documents obtained under the Freedom of Information

> Act,

> the investigation was actually conducted internally by the coauthors

> themselves.

> Both the Royal Free Hospital and Medical School have now confirmed that no

> formal investigation was performed, no physicians were ever interviewed,

> and no

> documents generated.

>

> " We were falsely reassured, " writes Dr. Godlee. " We were told by

> authoritative

> sources...that an investigation had been done and cleared Wakefield of most

>

> charges. But as shown by documents obtained under the Freedom of

> Information

> Act, there was no proper investigation, merely a 48-hour 'scramble' to

> protect

> reputations and discredit the story. "

>

> The Lancet statement also says that it followed the guidelines by the

> Committee

> on Publication Ethics when speaking to the study authors after Mr. Deer

> brought

> his concerns to them in 2004 and published a partial retraction by 10 of

> the

> study's coauthors soon after.

>

> Major Flaws in Peer Review Process

>

> According to the BMJ article, the GMC became involved soon after the

> allegations

> were made, but it took the panel 6 years to substantiate the allegations.

>

> " Were it not for the GMC case, which cost a rumored 6 million pounds, the

> fraud

> by which Wakefield concocted fear of MMR would forever have been denied and

>

> covered up, " writes Mr. Deer.

>

> " It is hard to escape the conclusion that this represents institutional and

>

> editorial misconduct, and its impact has been substantial. The

> international

> damage might have been lessened by earlier definitive action, " adds Dr.

> Godlee.

>

> " This case reveals major flaws in pre- and postpublication peer review, "

> said

> Dr. Godlee in a release. " Allegations of research misconduct must be

> independently investigated in the public interest. But it's still too easy

> for

> institutions to avoid external scrutiny, and editors can fail to adequately

>

> distance themselves from work they have published and then defended. "

> She noted that " this is where coauthors become crucially important. If

> coauthors

> are going to sign their names to a paper, I think they need to have real

> knowledge and understanding of the entire study. "

>

> Dr. Godlee added that " it was interesting " that the Wakefield study had

> case

> reports on just 12 children but had 13 authors. " One would think it would

> be

> difficult to be fraudulent with so many coauthors, but he's obviously a

> person

> who is very compelling and persuasive and managed to achieve this without

> them

> being alerted to it. "

>

> Need for Healthy Skepticism

>

> In an accompanying article, clinicians from Seattle, Washington, write that

>

> there is an urgent need to fix a research system that failed to protect its

>

> subjects and the public from the consequences of fraudulent science.

>

>

> Dr. Doug Opel

> " So much has been written about Wakefield himself, but we felt that,

> especially

> in light of Deer's articles, there were a lot of unindicted coconspirators

> here, " J. Opel, MD, MPH, acting assistant professor at the Treuman

> Katz

> Center for Pediatric Bioethics at Seattle Children's Research Institute,

> Washington, told Medscape Medical News.

>

>

> " I think it's important...to look into and investigate why these existing

> safeguards that are meant to protect research subjects didn't do their job.

>

> Wakefield was able to circumvent them and conduct unethical and fraudulent

> research. We need to understand what those defects are, fix them, and

> prevent

> situations like this from happening again, " added Dr. Opel.

>

> The editorialists offer several suggestions for preventing future " research

>

> adverse events " including the following:

> * Empower everyone in research to raise questions throughout the process;

> * Train research leaders to manage inquiries once raised;

> * Not allow journal editors to " take the word " of researchers after

> allegations

> are made against them; and

>

> * Train research leaders to recognize that they may have conflicts of

> interest

> in looking into allegations.

>

> I think it's important...to look into and investigate why these existing

> safeguards that are meant to protect research subjects didn't do their job.

>

> Wakefield was able to circumvent them and conduct unethical and fraudulent

> research. We need to understand what those defects are, fix them, and

> prevent

> situations like this from happening again.

>

>

> " We perhaps need a paradigm shift in the research world. We need to look to

> what

> we're doing in the clinical world with respect to quality improvement and

> patient safety and determine whether some of those can be applied to the

> research realm to protect human subjects, " said Dr. Opel.

>

> " We...need to rethink and reform our customs and culture. The disastrous

> impact

> that Wakefield's study has had on vaccine coverage, recrudescence of

> disease,

> public trust, and, most of all, science requires that we do so in haste, "

> write

> the editorial authors.

> Dr. Godlee added that when it comes to medical journals, clinicians should

> also

> maintain a healthy skepticism.

>

> " We work hard to make sure that what we publish is accurate, and I'm sure

> the

> same is true with The Lancet. One is aware that clinicians are going to be

> reading this and using the information to treat and advise their patients.

> Yes,

> there can be inaccuracies, and we know that there will be fraud. But how

> often

> that happens is almost impossible to judge, " she said.

> " So physicians need to, one hopes, not be cynical but absolutely question.

> The

> whole scientific enterprise is organized skepticism, where we all are meant

> to

> look at what's put in front of us and submit it to a process of questioning

>

> internally in terms of whether this is valid and relevant, " she concluded.

>

> Mr. Deer's original investigation was funded by the Sunday Timesof London

> and

> the Channel 4television network. The current articles were funded by the

> BMJ. He

> reported receiving no other funding except for legal costs from the Medical

>

> Protection Society on behalf of Mr. Wakefield. The editorial authors have

> disclosed no relevant financial relationships.

>

>

> BMJ. Article and editorial published online January 18, 2011.

> BMJ. Editor's Choice published online January 19, 2011.

>

>