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What We Found in a Boston Children’s Hospital Policy Manual About Research on ‘Wards of the State’
The Blaze ^ | 2/1420/ | Liz Klimas

Posted on 02/24/2014 8:12:51 PM PST by 1 spark

“Children who are Wards of the state may be included in research that presents minimal risk…or greater than minimal risk with a prospect of direct benefit.”

That’s a line from Boston Children’s Hospital’s “Clinical Investigations Policy and Procedure Manual. It’s the same facility that took over the care of 15-year-old Justina Pelletier against her parents’ wishes last year and they continue to wonder why.

The parents of the teen from West Hartford, Conn., at the center of a custody, patient’s rights and medical diagnosis battle have questioned the motives as to why Boston Children’s Hospital countered the medical diagnosis and recommended treatment set by a Tufts Medical Center physician years earlier.

Justina was taken as a ward of the state by the Massachusetts Department of Children & Families on Feb. 14, 2013, and remains in the child services department’s custody still.

The hospital’s clinical investigations policy continues (emphasis added):

Children who are Wards of the state may be included in research that presents greater than minimal risk with no prospect of direct benefit (46.406 (50.53) or 46.407 ( 50.54) only if the [institutional review board] determines and documents that such research is

Related to their status as wards; or

Conducted in schools, camps, hospital, institutions, or similar settings in which the majority of children involved as participants are not wards.

In such cases, the patient is represented by at least one advocate, appointed by the institutional review board, who will act on their behalf and in the patient’s best interest.

Any time research would involve a ward of the state, the document says a proposal must be presented in detail to the institutional review board and be approved by DCF’s Research Proposal Review Committee. Boston Children’s Hospital declined to comment about the case and about the policy to TheBlaze.

Dr. Richard Boles, a pediatrician in the Los Angeles area and the medical director of Courtagen Life Sciences, a biotechnology and DNA sequencing company specializing in metabolic disorders, told TheBlaze it wouldn’t be out of the ordinary for Boston Children’s Hospital to conduct medical research.

“They’re a research facility,” he said.

Boles told TheBlaze that any research involves ethics committees and is “up front.” He said the system is so procedural now that if he wanted to survey his own patients for something as simple asking where they bought their vitamins, so he could advise his other patients accordingly, he would have to go through a whole protocol and a wealth of paperwork.

BCH’s clinical investigation policy echoes language in regulations set by the federal Department of Health and Human Services. According to HHS, for children to be involved in research, parental or guardian permission must be given. A “guardian,” is defined as the “individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care,” which, in the case of Justina Pelletier, would be DCF.

Other institutions, like Johns Hopkins Medicine and Duke University Health System to name a couple, have similar guidelines for research involving children, including those who are under care of the state.

But an article published in the journal Pediatrics in 2008 argued that the protections for wards of the state in research might not go far enough.

“Current federal regulations mandate additional safeguards, beyond those that apply to all pediatric research, for some research with wards of the state. Although these additional requirements are attentive to the concerns research with wards of the state raises, we argue that they do not go far enough,” the authors wrote.

“Society is obligated to ensure the harms wards of the state have already experienced due to parental mistreatment or abandonment are not compounded by further harm from inappropriate clinical research enrollment,” they continued. “This means wards of the state must be appropriately protected from risk and from being unfairly selected to bear burdens in clinical research. To these ends, additional safeguards and modifications to existing guidelines are needed.”

On its website, BCH describes itself as “home to the world’s largest research enterprise based at a pediatric hospital” with “$225 million in annual funding, including more federal funding than any other pediatric facility.”

It is unknown if Justina Pelletier is involved in a research program. The teen was diagnosed in 2011 with mitochondrial disease, a disease where the mitochondria (the energy-producing organelle in cells) does not function properly leading to a variety of symptoms including pain, fatigue and gastrointestinal issues. While being treated for this disease, her parents, Linda and Lou, said she was doing well.

In February 2013, she came down with the flu, which for mitochondrial patients can be more severe, her older sister Jessica told TheBlaze, and was recommended by a Connecticut hospital to be transferred to Boston Children’s Hospital where she was supposed to see a gastrointestinal specialist. Instead, Lou Pelletier told TheBlaze Monday she was seen by a neurologist as she came through the hospital’s emergency room who said she didn’t have mitochondrial disease but somatoform disorder, a psychological disorder that said the symptoms she experienced originated in her head.

Boston doctors wanted to take a different approach with Justina’s treatment, something which Lou said they were initially on board with until they found out it meant taking her off her treatments for mitochondrial disease.

When they arrived at Boston Children’s on Feb. 14, 2013, to discharge Justina and take her to Tufts instead, they were accused of over-medicalizing their child, a form of abuse, and DCF took custody. Since then the Pelletiers have been in and out of court fighting to get Justina back and treated for mitochondrial disease. Without treatment for this disease for more than a year, Lou said his daughter is failing.

“If she’s not in the proper facility, she will die,” Lou told TheBlaze earlier this week.

“I am trying to save my daughter’s life,” he said, breaking a court-imposed gag order, something which DCF filed that he be held in contempt of court for doing.


TOPICS: Miscellaneous; News/Current Events
KEYWORDS: freejustina; justinapelletier
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1 posted on 02/24/2014 8:12:51 PM PST by 1 spark
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To: 1 spark

The Cradle of the Revolution has become the Cradle of Repression,
Thanks Harvard Colledge now University with an endowment worthy of George Soros.

No…I did not Mis spell Colledge as it was originated.


2 posted on 02/24/2014 8:22:53 PM PST by acapesket
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To: acapesket

Dr. Mengele would be pleased.


3 posted on 02/24/2014 8:37:39 PM PST by bicyclerepair (TERM LIMITS .......... TERM LIMITS .......... TERM LIMITS)
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To: 1 spark

This whole thing is unreal and sickening. So glad The Blaze is following it. Prayers up for this family.


4 posted on 02/24/2014 8:41:43 PM PST by Jane Long (While Marxists continue the fundamental transformation of the USA, progressive RINOs assist!)
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To: 1 spark

I did a search on foster children as research subjects and found this:

http://www.ahrp.org/ahrpspeaks/HIVkids0304.php

http://www.infowars.com/articles/ps/feds_tested_aids_drugs_on_foster_kids.htm (yes I know crazy alex’s site)

http://www.nbcnews.com/id/7736157/ns/health-aids/t/government-tested-aids-drugs-foster-kids/

http://www.nytimes.com/2011/11/21/health/research/study-finds-foster-children-often-given-antipsychosis-drugs.html

If they teach foster kids like this, a kid they have “Taken possession of” is going to be in bad shape too.

Reminds me of a Quote from the great Ike:

“Yet, in holding scientific research and discovery in respect, as we should, we must also be alert to the equal and opposite danger that public policy could itself become the captive of a scientific technological elite. “

~ General and President Dwight D Eisenhower


5 posted on 02/24/2014 8:44:49 PM PST by GraceG
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To: 1 spark

I know that this is Glenn’s cause célèbre, but I am not able to make any kind of a judgment on this case. Has the girl been examined by independent physicians, and have they performed the proper diagnostic tests?

A parent committing Munchausen by proxy can appear to be very loving and concerned about his or her gravely ill child, even though he or she is causing the illness. Often, the spouse is unaware of the situation and believes the child to be genuinely ill.

The research rules involving children seem pretty standard. Children cannot legally consent to being research subjects, but they must be able to agree with being part of research if they are capable of speech. Without their cooperation, the research cannot be done. The laws are pretty clear on this point.


6 posted on 02/24/2014 9:06:29 PM PST by exDemMom (Current visual of the hole the US continues to dig itself into: http://www.usdebtclock.org/)
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To: GraceG
After all the poor little things have gone through, now they get to be guinea pigs for the almighty State!

This brings forth the question: Exactly how many and what experiments have been performed from all sources on wards of the State thus far and who protected the rights of the children in those cases.

If the State is willing to do that to little orphans and children from broken homes, imagine how much worse it'll be for us under Obamascare!

I'll just bet the court put a gag order on this. One branch of the iron-fisted State protecting another.

7 posted on 02/24/2014 9:07:37 PM PST by HeartlandOfAmerica (GOP = Gathering of Pussies!)
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To: 1 spark

I seem to recall a portion of history, a little over a half century ago, where a polity made a practice of seizing children as well as adults and subjecting them to experiments.


8 posted on 02/24/2014 9:17:44 PM PST by Grimmy (equivocation is but the first step along the road to capitulation)
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To: exDemMom
Megan Kelly has been following the story for a week. There is nothing wrong with the parents. It's a pissing contest between 2 hospitals. The original hospital that diagnosed and treated her was Tufts. The genius ER doctor at Boston Childrens’, that claimed she was misdiagnosed, had gotten out of medical school 7 months earlier.

When a child is taken away from an abusive parent they should get better. This child is deteriorating because the Boston Children's took her of all her meds. She went into the hospital walking and is now in a wheel chair.

It's insanity. Which makes sense since it's taking place in Boston.

9 posted on 02/24/2014 9:20:33 PM PST by CaptainK (...please make it stop. Shake a can of pennies at it.)
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To: 1 spark

Cases like this are very tricky, because there are three parties: the parents, the state, and the child, and the child is the one everybody thinks they know all about.

Boston Children’s Hospital is very well thought of. Another in Philadelphia, also. I hope things haven’t changed.

Not going to pass judgment on this one. It’s impossible to know who’s right.


10 posted on 02/24/2014 9:27:13 PM PST by firebrand
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To: GraceG

Anything that is allowed to supplant God will, ipso facto, become an idol.

This does not mean we should reject good things with awesome capabilities.

This does mean we should always give God the glory in the way we use those things.

It doesn’t give God any glory to do what has been done to this child. But people who have factored God out of their world view have allowed just the kind of vacuum that makes it possible for such tragedies to occur.


11 posted on 02/24/2014 9:27:32 PM PST by HiTech RedNeck (Embrace the Lion of Judah and He will roar for you and teach you to roar too. See my page.)
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To: firebrand

Well there sure does not seem to be any kind of ombudsman office in the picture, who could try to bring some sense to it. Instead the girl is subjected to being yanked to and fro in a taut legal battle. Very dehumanizing to her.


12 posted on 02/24/2014 9:29:05 PM PST by HiTech RedNeck (Embrace the Lion of Judah and He will roar for you and teach you to roar too. See my page.)
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To: exDemMom

I’m tending towards ‘Something else isn’t being said. The situation is clearly obnoxiously cruel to the child and the parents. Public outcry and the attention this must have gotten in the news media over the last several weeks. There must be some higher form of government interference here.


13 posted on 02/24/2014 9:32:52 PM PST by Usagi_yo (Standardization is an Evolutionary dead end.)
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To: 1 spark

i posted it a couple of hours ago. plz do so also.


14 posted on 02/24/2014 9:33:51 PM PST by Donnafrflorida (Thru HIM all things are possible.)
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To: HiTech RedNeck

Dehumanizing and, I wager, traumatizing. She has been ripped away from her family and likely feels very isolated and alone. I pray that He is with her.


15 posted on 02/24/2014 9:43:57 PM PST by Army Air Corps (Four Fried Chickens and a Coke)
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To: Usagi_yo

LOL—there is no high form of government involvement beyond the CPS and the wonderful court appointee and most likely this child has both the atty ad litem and the guardian ad litem WHO CAN DO WHAT THEY WANT and by now the parents should have contacted the parents rights groups,fight CPS groups and found a knOwledgeable attorney to initiate a law suit on the federal level where these court appointees etc have no immunity and prove their cause.
they have a case,their daughter was under the care of state licensed physicians,diagnosed etc went to boston and....


16 posted on 02/24/2014 11:37:42 PM PST by catroina54
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To: exDemMom
Megyn Kelly is following this story too.

The daughter was diagnosed with mitochondrial disease at Tufts. The daughter then got sick with the flu last year and had to go to Boston Childrens. Tufts and Boston Childrens disagreed on the diagnosis and Boston Childrens accused the parents of medical abuse and got the DFC (that's what its called in Illinois). The DFC took the child away and the court instituted a gag order.

17 posted on 02/24/2014 11:54:01 PM PST by Chgogal (Obama "hung the SEALs out to dry, basically exposed them like a set of dog balls..." CMH)
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To: exDemMom
The daughter is doing much worse at Boston Childrens. This supports Tufts diagnosis of the disease. Last year she could figure skate, now she is in a wheelchair and paralyzed from the waist down. If there was medical abuse she should have shown some improvement.
18 posted on 02/24/2014 11:59:19 PM PST by Chgogal (Obama "hung the SEALs out to dry, basically exposed them like a set of dog balls..." CMH)
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To: firebrand
Boston Children’s Hospital is very well thought of.

Justice in this case requires that Justina Pelletier end up owning BCH.

Of course, the sad fact is, by the time that happens, she may not be in any condition to enjoy her new-found riches, nor even be alive.

The people behind this are fascists of the lowest order.

19 posted on 02/25/2014 12:17:06 AM PST by cynwoody
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To: catroina54

Yea but this has been playing out for more than 3 weeks now. Wouldn’t it attract the governor or Federal Attorney?


20 posted on 02/25/2014 12:44:28 AM PST by Usagi_yo (Standardization is an Evolutionary dead end.)
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To: Usagi_yo
Wouldn’t it attract the governor or Federal Attorney?

Actually, it's the governor's fault. That would be Deval "Together we can" Patrick. It's his fault because fish rot from the head down (as pointed out by another Massachusetts governor). Thus, whatever DCF commits is Deval's fault!

As for federal lawyer pukes, there is, of course, US AG Eric Holder, appointed by third-rate Illinois lawyer Barack Hussein "Yes we can" Obama. It's Obama's fault because he is scum whose Party believes the government should be executing the role it is executing in this case.

21 posted on 02/25/2014 1:02:18 AM PST by cynwoody
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To: firebrand

Boston Children’s Hospital’s psychology wing is at the leading edge of promoting drug remedies for children against parental wishes. Dr. Joseph Biederman is the chief practitioner who was exposed 6 years ago for getting kickbacks from the drug companies.


22 posted on 02/25/2014 3:08:41 AM PST by mongrel
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To: 1 spark

I wonder who the judge is.


23 posted on 02/25/2014 3:41:56 AM PST by savedbygrace (But God!)
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To: savedbygrace

The REAL question is which LawFirms nominated the Judge
and are THOSE lawyers now practicing, secretly, before him.


24 posted on 02/25/2014 3:48:27 AM PST by Diogenesis
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To: Usagi_yo; Chgogal

I am very aware of the public side of the story. But it is not the whole story.

Until more is known—for instance, what kinds of diagnostic tests have been run and what did they show—there is simply not enough information to determine if a child really has been removed from her family by uncaring bureaucrats, or if she is a victim of Munchausen by proxy.


25 posted on 02/25/2014 4:43:03 AM PST by exDemMom (Current visual of the hole the US continues to dig itself into: http://www.usdebtclock.org/)
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To: Diogenesis

Has the name of the judge been released?


26 posted on 02/25/2014 5:28:21 AM PST by snowrip (Liberal? You are a socialist idiot with no rational argument.)
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To: mongrel

and he’s not sitting in a federal pen now, why?


27 posted on 02/25/2014 7:55:04 AM PST by darkangel82
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To: exDemMom

There is plenty of information. You just haven’t read it.


28 posted on 02/25/2014 8:56:14 AM PST by CaptainK (...please make it stop. Shake a can of pennies at it.)
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To: darkangel82

I’m just beginning to learn more about this man, so I don’t have more information.


29 posted on 02/25/2014 11:18:39 AM PST by mongrel
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To: savedbygrace
I wonder who the judge is.

http://www.mass.gov/courts/courtsandjudges/judgesandjudicialofficers/johnstonj.html

It's a little confusing: Joseph Johnston is listed at Essex County, but this case is in Suffolk County. Martindale does show him in Suffolk. ZabaSearch turns up a Joseph F. Johnston living in West Roxbury, which is in Suffolk County. Intelius indicates the West Roxbury guy is 56. Judge Johnston was admitted to the bar in 1985. Intelius also indicates the West Roxbury guy is related to a Kathleen Johnston. According to this article the judge's wife is named Kathy.

30 posted on 02/25/2014 11:52:24 AM PST by cynwoody
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To: exDemMom
Until more is known—for instance, what kinds of diagnostic tests have been run and what did they show—there is simply not enough information to determine if a child really has been removed from her family by uncaring bureaucrats, or if she is a victim of Munchausen by proxy.

If she were a victim of Münchausen by proxy, her condition should have improved over her 13 months in the Regime's custody. Instead, it has worsened considerably.

31 posted on 02/25/2014 12:05:41 PM PST by cynwoody
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To: darkangel82
and he’s not sitting in a federal pen now, why?

Nope. Biederman and the other two culprits got a wrist slap.

32 posted on 02/25/2014 12:11:19 PM PST by cynwoody
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To: cynwoody

Better than nothing, though still inadequate.


33 posted on 02/25/2014 1:27:59 PM PST by darkangel82
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To: mongrel

Thank you. I’m also hearing more about the guy from the Netherlands who has a career stake in this. It’s now in the Twitterverse, so I think we’ll be hearing more on this story.


34 posted on 02/25/2014 1:49:21 PM PST by firebrand
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To: cynwoody

Good work. TY.


35 posted on 02/25/2014 2:00:39 PM PST by savedbygrace (But God!)
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To: CaptainK
There is plenty of information. You just haven’t read it.

I have read the only available information there is, the information provided by the family. Since theirs is the only story out there, it is hard to know what is the truth.

What I do know is that people with Munchausen syndrome (either primary or by proxy) can be extremely convincing and sound utterly sincere. They have an uncanny ability to convince people that their concerns about their medical condition are not being taken seriously by the medical community.

Having only heard the family's side, I have no evidence to rule out or in Munchausen by proxy. I also have no evidence to rule out or in bureaucratic overreach.

36 posted on 02/25/2014 5:54:38 PM PST by exDemMom (Current visual of the hole the US continues to dig itself into: http://www.usdebtclock.org/)
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To: cynwoody
If she were a victim of Münchausen by proxy, her condition should have improved over her 13 months in the Regime's custody. Instead, it has worsened considerably.

I would say that the fact that she has been moved into a foster home means she is getting better, not worse.

37 posted on 02/25/2014 6:07:33 PM PST by exDemMom (Current visual of the hole the US continues to dig itself into: http://www.usdebtclock.org/)
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To: exDemMom

One year out of her parent’s care and she’s in a wheel chair. The Boston Children’s Hospital put her in that wheel chair, not her parents. That’s the exact opposite of what happens with Munchausen syndrome.


38 posted on 02/25/2014 7:17:39 PM PST by CaptainK (...please make it stop. Shake a can of pennies at it.)
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To: Usagi_yo

They won’t get involved here and to all that have experineced these protective agencies we know it.
When your family is interfered with by these protective agencies you have to get down,learn your rights and then try and find an attorney who will go up against another attorney and that’s the problem. it is extremely difficult and that’s why those violated by these courts are simply filing pro se or in propria persona and taking their cases and learning step by step to get in front of a judge and jury.
Right now under the law,these parents have no rights,their daughter is a ward of the courts,she has no rights,has her ad litems who can dictate who visits and where she will reside,get treatment etc etc .
A convicted prisoner has more rights than their daughter and them.
Believe me,anyone that has been violated and victimized by these kangaroo courts will affirm what I’m saying.
The system is out of control and been out of control and these court appointees have been given too much power and authority under these courts.
Hopefully,due to the publicity,they can retain a high power attorney.


39 posted on 02/25/2014 10:21:36 PM PST by catroina54
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To: CaptainK
One year out of her parent’s care and she’s in a wheel chair. The Boston Children’s Hospital put her in that wheel chair, not her parents. That’s the exact opposite of what happens with Munchausen syndrome.

As I have pointed out in other posts, a child victim of Munchausen by proxy can learn to very convincingly fake symptoms--including the need for a wheelchair.

Also, what supposedly landed her in the hospital was the flu. Influenza can cause neurological damage, a condition called "Guillain-Barre syndrome" that leaves its victims physically incapacitated.

The fact that she was well enough to be sent into foster care suggests that her physical condition *is* improving.

I continue to maintain that we do not have enough information to judge what is really going on in this case. I reserve judgment until I know more facts on *both* sides of the issue.

40 posted on 02/26/2014 4:11:09 AM PST by exDemMom (Current visual of the hole the US continues to dig itself into: http://www.usdebtclock.org/)
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To: exDemMom

Is Guillain-Barre syndrome a psychological affliction? Because that’s the only problem Boston Children’s says she has. Guillain-Barre syndrome was never a diagnoses.

They are sending her into foster care because the hospital has to release her now. Not because she’s gotten better.

Getting an ER doctor is luck of the draw. If you get a jerk it can disrupt your life. It happened to me when my son was four. I had to get on my hands and knees and beg another doctor on staff to take over. Thankful he did.


41 posted on 02/27/2014 8:29:22 AM PST by CaptainK (...please make it stop. Shake a can of pennies at it.)
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To: CaptainK

Guillain-Barré is a neurological condition that causes weakness and paralysis. It is caused by infectious disease, most often influenza.

Given that they had taken her to Boston Children’s because of the flu, that would be one *possible* explanation of her being wheelchair bound after having been mobile. There are other explanations.

The fact that she was sent to foster care means that her condition is stable, if not improving. No one is released from the hospital if their condition is deteriorating (unless they have a terminal illness and wish to die somewhere else, but that is a different matter).


42 posted on 02/27/2014 7:29:09 PM PST by exDemMom (Current visual of the hole the US continues to dig itself into: http://www.usdebtclock.org/)
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To: exDemMom
I know what Guillain-Barré is. She was never diagnosed with it. Boston Children's is saying it's all in her head.

I don't understand the point of bringing it up, unless you are saying that Boston's Children might have missed that during her ER visit, which would make them doubly incompetent.

43 posted on 02/28/2014 6:37:37 AM PST by CaptainK (...please make it stop. Shake a can of pennies at it.)
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To: CaptainK
I know what Guillain-Barré is. She was never diagnosed with it.

If you know what it is, then why did you ask?

Boston Children's is saying it's all in her head.

I am not aware of anything Boston Children's has said. As I pointed out previously, we are only hearing one side of the story. We do not know the hospital's side, nor do we know the actual diagnoses.

I don't understand the point of bringing it up, unless you are saying that Boston's Children might have missed that during her ER visit, which would make them doubly incompetent.

The point was to suggest one possible explanation for the girl having been ambulatory at some point in the past, while being confined to a wheelchair now. Guillain-Barre syndrome is a known complication of influenza, which she reportedly had.

Unfortunately, the other explanations I can think of are more supportive of Munchausen by proxy.

44 posted on 02/28/2014 6:27:23 PM PST by exDemMom (Current visual of the hole the US continues to dig itself into: http://www.usdebtclock.org/)
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