Former Chief Scientific Officer, DoH, concerned about MMR - Page 3

[WildKingdom]

Originally Posted by kathymuggle 

The parents did agree, though.  Is consent in question?

I am not going to speculate on their reasons for allowing it.  I hardly know - nor am I in their shoes.  The bottom line is the parents did allow it.

Yes, consent is absolutely in question. They did not give informed consent.  Informed consent is not saying, "Sure, I'll let you draw my kid's blood for $5" which is basically what happened.  The blood was used for research.  The parents needed to be informed about the research protocols and what the sample would be used for.  That has to go through and IRB process.

Let's say, for example, that his research was looking at the kid's DNA for future use in a human cloning project.  Would you still say what he did was OK, since the parents agreed to the blood draw?  Of course not, because what parent would agree on the spur of the moment at a birthday party to allow their child's genetic material to be cloned?  These parents had no idea what he was going to do with those samples.

I suggest you read The Immortal Life of Henrietta Lacks if you need a real-life scenario of how things played out before these safeguards were put in place.  The 2 second summary of the book is this- a woman with an agressive cervical cancer was treated at Johns Hopkins in the 1950's.  A sample of her tumor cells was taken with her knowledge, but not her "consent," as she had no understanding of what the ultimate research use of them would be.  Those cells remain in use today as the HeLa cell line.

[purslaine]

Originally Posted by WildKingdom 

.

I suggest you read The Immortal Life of Henrietta Lacks if you need a real-life scenario of how things played out before these safeguards were put in place.  Te.

I have read it.  Good book.

Do you have a link on Wakefield's "invasive procedures" other than collecting blood samples with consent?

[purslaine]

Originally Posted by WildKingdom 

Yes, consent is absolutely in question. They did not give informed consent.  Informed consent is not saying, "Sure, I'll let you draw my kid's blood for $5" which is basically what happened.  The blood was used for research.  The parents needed to be informed about the research protocols and what the sample would be used for.  That has to go through and IRB process.

Ah, informed consent.  Many doctors (at least anecdotally) do not practice informed consent.  MDC is full of stories of women who got the info sheet on vaxxes after the vaccine.   Those doctors names are not dragged through the mud (although perhaps they should be!)  I had one myself - my daughter was prescribed an antibiotic that carries a risk of future deafness.  I learned this after she had been on the drip for a few hours.  I was quite upset.  I do not know if I would have agreed to that particular antibiotic usage (perhaps another antibiotic would have sufficed) but I very much would have liked to discuss it first.

Italics mine.  How do you know that informed consent did not take place?   Link please.

[WildKingdom]

It's in the GMC's charges against wakefield.  Children were subjected to colonoscopies, colon biopsies and lumbar punctures.  Here's a BBC story about it- http://news.bbc.co.uk/2/hi/health/6289166.stm

The charges were upheld.

[WildKingdom]

Originally Posted by kathymuggle 

Ah, informed consent.  Many doctors (at least anecdotally) do not practice informed consent.  MDC is full of stories of women who got the info sheet on vaxxes after the vaccine.   Those doctors names are not dragged through the mud (although perhaps they should be!)  I had one myself - my daughter was prescribed an antibiotic that carries a risk of future deafness.  I learned this after she had been on the drip for a few hours.  I was quite upset.  I do not know if I would have agreed to that particular antibiotic usage (perhaps another antibiotic would have sufficed) but I very much would have liked to discuss it first.

Italics mine.  How do you know they did not give informed consent?  Link please.

 Exactly.  MDC is full of stories like this.  So, knowing that, I am truly at a loss as to how you can feel that Wakefield's actions are OK. 

[Rrrrrachel]

Informed consent in clinical practice and informed consent in research are different. The bar for research is much higher. It's a major pillar of ethical research.

[Dar]

My research involves talking with people. That's it. No invasive procedures. They speak English and are adults. It's pretty much the research project with the least amount of risk to human subjects possible.

My IRB application is around 50 pages at the moment (and still growing), plus I had to go through their 4 hour research procedures course online. I'll probably have to revise it before our IRB board finally approves it, too. I tend to think it's kind of overkill for a project like mine, but I'm a lot more comfortable with overkill than with basically no informed consent at all...

[ma2two]

Originally Posted by WildKingdom 

Yes, consent is absolutely in question. They did not give informed consent.  Informed consent is not saying, "Sure, I'll let you draw my kid's blood for $5" which is basically what happened.  The blood was used for research.  The parents needed to be informed about the research protocols and what the sample would be used for.  

The kids were healthy children of Wakefield's colleagues who were medical doctors. They were aware of what the blood was going to be used for.

[ma2two]

Originally Posted by WildKingdom 

It's in the GMC's charges against wakefield.  Children were subjected to colonoscopies, colon biopsies and lumbar punctures.  Here's a BBC story about it- http://news.bbc.co.uk/2/hi/health/6289166.stm

The charges were upheld.

Can you give a link showing that the charge of ordering lumbar punctures was upheld?

This is Wakefield's explanation of the false charge of ordering lumbar punctures, so I doubt it was upheld.

http://www.youtube.com/watch?v=nEKghCUUlZg&feature=relmfu

[WildKingdom]

Originally Posted by ma2two 

Can you give a link showing that the charge of ordering lumbar punctures was upheld?

This is Wakefield's explanation of the false charge of ordering lumbar punctures, so I doubt it was upheld.

http://www.youtube.com/watch?v=nEKghCUUlZg&feature=relmfu

http://www.scribd.com/doc/25983372/FACTS-WWSM-280110-Final-Complete-Corrected

Also in this article http://news.bbc.co.uk/2/hi/health/8483865.stm under the heading "Callous Disregard"

[purslaine]

Originally Posted by WildKingdom 

 Exactly.  MDC is full of stories like this.  So, knowing that, I am truly at a loss as to how you can feel that Wakefield's actions are OK. 

Italics mine.  I did not say that.

I said I did not think a blood draw at home was horrible with a capital H, if the parents consented.

If it turns out there was a lack of informed consent, then no, I am not Ok with it.

Up until today I was unaware of the backstory on Wakefield - I simply knew his study (which only had 12 people and is hardly the basis for not -vaccinating among any non-vaxxers I know).  At this point in time I am still in research mode and have not concluded anything on him.  I will read differing  POV and then make up my mind.

[ma2two]

In response to my post #52 in which I wrote, "Can you give a link showing that the charge of ordering lumbar punctures was upheld?"

Originally Posted by WildKingdom 
http://www.scribd.com/doc/25983372/FACTS-WWSM-280110-Final-Complete-Corrected

Thanks. "Found not proved in respect of lumbar puncture." (page 8)

[AbbyGrant]

      Quote:

Originally Posted by ma2two 

In response to my post #52 in which I wrote, "Can you give a link showing that the charge of ordering lumbar punctures was upheld?"

Thanks. "Found not proved in respect of lumbar puncture." (page 8)

That was in response to "Indicating that you would be responsible for arranging a number of  those  procedures  including  MRI,  lumbar puncture and EEG" in a section about the application. If you read further you will see Wakefield was found to cause children to undergo lumbar punctures which were not clinically indicated. Page 20 has an example in regard to child 3.  

[Taximom5]

Originally Posted by kathymuggle 

Oh, I get why researchers are annoyed over it.  It might be a big deal to researchers.

I am not sure it is worth dragging his name through the mud for, though, for the rest of us.  It (getting blood from children whose parents agreed) hardly makes him EVIL, even if it is against protocal.

_____________

If anyone has a link to the "invasive  tests" he submitted children to, particularly beyond a blood test, I would be interested in reading it.  TIA!

I don't have a link (yet), but just wanted to chime in to say, I think the issue was lumbar punctures (which Wakefield was NOT the clinician who ordered them) and colonoscopies (not sure who ordered them, but my impression was that it was the clinician who ordered the colonoscopies, not the researcher).  Colonoscopies back then WERE the standard of care for diagnosing inflammatory bowel disorders in non-autistic kids, but not in autistic kids, because parents were always told that there couldn't possibly be a medical problem involving the intestines, autistic children were just "like that," blah blah blah.

At least 3 things have changed since then.  

1) endoscopies rather than colonoscopies are the preferred diagnostic tool for inflammatory bowel disorders

2) celiac disease/gluten intolerance are now recognized as being realtively common diagnoses even amongst NON-autistic people

3) most mainstream doctors specializing in autism care accept as common knowledge that autistic people are at increased risk for inflammatory bowel disorders, including celiac disease and/or gluten intolerance.

That said, there seems to be a concerted effort to deny the autism/intestinal trouble link.  

A study published in the January, 2010 issue of Pediatrics found no such link--but they were looking back at medical records from a time when doctors routinely pooh-poohed parents who brought up their children's obvious intestinal issues.

In other words, they were looking to NOT find the problem.

There are many, many comments across the internet from parents of autistic children, who commented on the report that there was no link.  Most of those comments were along the lines of, "How can I send my teenage autistic child's severe diarrhea or severely constipated stool directly to the doctors who insist that there is not link beteween autism and bowel disorders?"

From a personal perspective:  our pediatrician told us that "children get tummy aches, don't over-react." (Actually, it wasn't me over-reacting; it was my son's kindergarten teacher who called me asking if she should call 911 because she'd never seen a child in so much pain during a bowel movement.)  

Luckily for us, our pediatrician revised his thoughts after seeing what a gluten-free, casein-free diet did for our son's "tummy aches." (The tummy aches disappeared, and only returned when a friend unwittingly served him chicken broth that contained wheat flour.)

[seaheroine]

Originally Posted by Taximom5 

I don't have a link (yet), but just wanted to chime in to say, I think the issue was lumbar punctures (which Wakefield was NOT the clinician who ordered them) and colonoscopies (not sure who ordered them, but my impression was that it was the clinician who ordered the colonoscopies, not the researcher).  Colonoscopies back then WERE the standard of care for

That said, there seems to be a concerted effort to deny the autism/intestinal trouble link.  

A study published in the January, 2010 issue of Pediatrics found no such link--but they were looking back at medical records from a time when doctors routinely pooh-poohed parents who brought up their children's obvious intestinal issues.

In other words, they were looking to NOT find the problem.

Pretty much.  You know, in research, I've read several of Offit's books, though I disagree with many of his arguments.  I thought it only appropriate to read Wakefield's side of the story.  He addresses many issues, including that of the institutional review board.  His supervisors and the GMC had other motives to thwart/discredit his studies.  Perhaps before passing absolute judgement on the court proceedings and trial, his book might be an interesting read.

[purslaine]

Originally Posted by Taximom5 

I

There are many, many comments across the internet from parents of autistic children, who commented on the report that there was no link.  Most of those comments were along the lines of, "How can I send my teenage autistic child's severe diarrhea or severely constipated stool directly to the doctors who insist that there is not link beteween autism and bowel disorders?"

From a personal perspective:  our pediatrician told us that "children get tummy aches, don't over-react." (Actually, it wasn't me over-reacting; it was my son's kindergarten teacher who called me asking if she should call 911 because she'd never seen a child in so much pain during a bowel movement.)  

As I may have said previously, my sister has 2 kids with autism.

One of them definitely has intestinal issues.  He has many tiny little wet bowel movements throughout the day.  I do believe it goes beyond his (admittedly) limited diet.  He is still in diapers at 9.  While I suspect he would still be in diapers if he he did have bowel issues, it is clearly not helping.  Moreover, we do think his aggression flares up when he is having bowel issues.

[eireann]

Originally Posted by Rrrrrachel 

Nope. He doesn't. He sold his interest in rotateq and no longer makes any money off of it.

No, that's not exactly correct. Selling one's interest and not making money off what the stocks are based on are two vastly different beasts.

He held the patent on Rotateq. Therefore, he will always make (plenty of) money off Rotateq, regardless of "interest." He made about $29 million off the patent alone. That does not include future royalties, which, if the market profit reports on Rotateq are correct, reach into the hundreds of millions.

Regardless, he made millions off this product already, thanks to Merck (they also fully endowed his chair at Children's Philadelphia.) Even if he cut all financial ties, do you think for a moment he'd shut the door on his loyalty to them in any way, shape or form? Of course not. They made him a very rich man; he has PLENTY of incentive. 

http://www.cbsnews.com/stories/2008/07/25/cbsnews_investigates/main4296175.shtml

http://childhealthsafety.wordpress.com/2011/04/19/offit-lying-again/

[Rrrrrachel]

I have read in several interviews that he no longer makes any money off of rotateq. I do not think he has "loyalty" to Merck, no.

[purslaine]

Originally Posted by Rrrrrachel 

I have read in several interviews that he no longer makes any money off of rotateq. I do not think he has "loyalty" to Merck, no.

links?

[Rrrrrachel]

I can't remember where I originally read it, but it took me about two seconds to find this

http://communities.washingtontimes.com/neighborhood/autism-unexpected/2011/jan/7/paul-offit-and-anti-vaccine-movement/

Which links to this.

http://autismsciencefoundation.wordpress.com/2011/01/06/dr-paul-offit-discusses-new-book-deadly-choices-at-national-press-club/

Same google search turned up these

http://lizditz.typepad.com/i_speak_of_dreams/2011/01/a-statement-from-paul-offit-md.html
http://health.usnews.com/health-news/blogs/on-medicine/2009/01/05/why-paul-offit-isnt-flexible-on-vaccines

I stopped looking after that but I'm sure there's more.