8-year-old burn victim denied medical procedure by FDA

[RamboLiberal]

Source: Atlanta Journal Constitution

Family members of a Gwinnett County boy with third-degree burns covering 80 percent of his body are angry because they say he’s been denied a medical procedure by the U.S. Food and Drug Administration.

Alfred Real, 8, a rising third-grader at Arcado Elementary, is being treated at Shriners Hospital for Children in Cincinnati after suffering extensive burns in a June 7 fire in a wooded area not far from his Roe Hampton Lane home, near Stone Mountain.

-----

The Real family traveled to Cincinnati, where they were told a “cultured skin” procedure used to treat burns like Alfred’s was denied by the FDA. The procedure involves taking unburned skin from a person’s body and growing more of it in a lab. The procedure can replace burned skin more quickly and reduces the chance of infection, according to burnsurvivor.com, a Web site for burn victims.

-----

Alfred’s aunt, Michelle Brethaur, told the AJC the boy’s body is rejecting the foreign skin and her nephew needs skin cultured from his own body.

Read more: http://www.ajc.com/news/atlanta/8-year-old-burn-558429.html

---

This is the kind of stupidity that pisses me off - why not let this child have the procedure? What harm can it do?

[napi21]

1. I heard this on our news at 5PM today. At that time they said

something about the procedure being denied because of paperowrk. That didn't make sense to me either. I don't know how to find out what's really the truth. If they're blaming the FDA, it sounds to me like it might be an experimental procedure. There has to be something we're not hearing about this story.

[JanusAscending]

5. No.... they have been doing this successfully

for a number of years now. My Dad had a wound on his heel that WOULD NOT heal, no matter what they tried. He had Medicare as well as a private policy with Aetna. Insurance refused to pay for it, and we could have had it done at our own expense if we could have afforded it! I don't recall the exact amount, but it was up in the 5,000 range.

[Better Today]

8. A small heal wound on an adult does not compare to 80% of a child's body.

[dencol]

29. Actually, it does.

Using one's own cells in both cases. Might want to read the short post twice before posting a snippy remark.

[pnwmom]

41. No, it doesn't. Because anyone with 80% burns is unlikely to survive, no matter

what they do. Using this experimental treatment on this child is unlikely to directly benefit him -- which is a legal requirement for any experimental treatment used on a child.

[Doremus]

45. Nothing experimental about it.

[pnwmom]

46. The treatment proposed for the boy was still in a pre-market, experimental stage.

I can't speak for whatever treatment you are discussing. From the report below:

Officials at the FDA and the University of Cincinnati have confirmed investigations into the clinical study for a burn treatment developed at the Shriners Hospital for Children (SHC) in Cincinnati as it appears to be heading to market (1).

A 2006 FDA inspection, categorized as “high priority” and “for cause,” led to this 41 page report. It itemizes hundreds of violations found in the Shriners Hospital study of “Burn Wound Repair with Cultured Skin Substitutes” as SHC doctors experimented on badly burned children while trying to get a cultured skin substitute to market for commercial and military applications.

This list of observations resulted in the FDA sending a warning letter to Dr. Richard Kagan, Chief of Staff at SHC Cincinnati on January 12, 2007. This means that the study’s results could be invalid or even fraudulent if it can be proven that the patient’s charts were intentionally left incomplete, that adverse effects were intentionally and repeatedly not reported or if invalid informed consent forms were knowingly used on patients enrolled in the study.

Details about the unresolved warning letter can be read here.

The violations are organized according to six main categories of observation, including:

1. Not preparing and submitting complete and accurate reports of unanticipated device effects to sponsors. “Specifically, the subjects listed below, in which cultured skin substitute (CSS) was regrafted, was not reported as graft failures to the sponsor or the IRB and the case report forms do not reflect these losses.

SNIP

[Liberty Belle]

50. Not true. There are many burn victims from the CA wildfires who had

burns over the vast majority of their body, and they survived.

[Liberty Belle]

51. Here's an article showing increasing survival rates in people with burns over 80% of their body:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1190795/

This was published in 1997, and things have only improved since then. I personally have known people burned over 65% who survived and lead good, productive lives.

[Scairp]

42. I didn't think this was experimental

I thought that this procedure had been done for at least a decade, or am I wrong? At any rate, this child is burned as badly as a human being can be and still be alive, so why not do it? The odds of survival are not in his favor.

Also, I read the entire article and it doesn't say what happened to this child, how he was burned so badly. Does anyone know the story?

[pnwmom]

47. The procedure proposed for the boy has not gone to market,

and might never make it unless serious questions are resolved about the study.

[RamboLiberal]

60. Boys playing with gasoline was how he was burned

A Gwinnett County boy is fighting for his life after a gasoline fire burned him over 80-percent of his body.

Fire officials said 8-year-old Alfred Real and another boy were playing with gas in a Gwinnett County neighborhood on June 7. They apparently lit a toy plane on fire, when the fumes caught, burning Real.

The family has set up a website to keep the community updated on Alfred Real's progress. You can register at http://www.caringbridge.org/visit/alfredreal.

http://www.cbsatlanta.com/news/23937609/detail.html

[GFmuse]

53. "experimental" status

You are right that this is labeled as an experimental procedure. However it has been in use for over 20 years. For the last 5 years the only hospital that has been performing these cultured skin procedures is the very hospital Alfred is in. Until this procedure is formally approved for use by the FDA, doctors have been getting approval on a case by case basis. As I understand it the FDA disagrees with some of the paperwork and record keeping that has been done in some recent cases and they are disallowing use of the procedure on that basis. The family is only asking that their son/grandson not be subjected to a less successful procedure because of paperwork issues.

Thanks for your time.
-a friend of the Real family

[midnight]

2. Health Care reform should of cut off these criminals who

block children and their parents from their health care treatment that they and their doctors want to try.

[pnwmom]

12. The "criminals" at the FDA are investigating this Shriner's study for not reporting

extremely serious adverse effects, including cases of pneumonia, sepsis, and necrotic (dead) muscle tissue.

This "treatment" doesn't appear to be a miracle cure.

[GFmuse]

54. Not a miracle cure

You are right that the treatment the doctors have recommended is not a "miracle cure." However there are some dramatic differences between it and the more conventional treatments. The experimental procedure (that has had some wonderful results during its 20 year run) comes with about a 20% chance of serious infection. Remember here, we're talking about a child who has 3rd degree burns on 80% of his body. The more conventional procedure, which doctors compare to driving a yugo, is accompanied by a 40% chance of infection. We know it isn't a guarantee or a miracle cure - we just want the chance to try the most successful treatment available.

Thanks for your time!
-a friend of the Real family

www.faretheewellfoundation.org

[truedelphi]

3. Why, they are being scientific. There are protocols to follow,

Don't you know?

Reminds me of when this one ebola outbreak occurred.

Some of the young doctors native to the country (nation in Africa, I forget which one) decided after accidental exposure to the virus, to create a vaccine using the blood from one of the few survivors. All the Western doctors were, "You can't do that! You should only vaccinate yourself if the vaccine comes from a standard laboratory, and has been tested for quality control, and all that goes along with those protocols."

The African medical people thought, "You gotta be kidding. We are dead unless we do something, so do we even have a choice?" They went ahead and prepared the new vaccine and all of them ended up surviving their exposure to the plague.

[Zoeisright]

17. Don't know much about the scientific process, do you?

Being sarcastic about protocols is a dead giveaway.

[truedelphi]

43. I know enough about it to be writing a book.

One article's worth will be up on Daily Kos in about a day.

And I don't mean to be sarcastic about "real, independent" protocol. Only about the mindless, corporate sponsored protocols and thought patternings that Big Corporate Science has convinced its University laboratory trained people to believe.

Most university labs in this nation are now owned by one of the Big Pharma or big Agro people, like Novartis and Monsanto. Over five years ago, Novartis gave the Univ of California at Berkeley some fifty million bucks. So will the University of California come up with anything implicating any of Corporate science's industrial strength chems in our personal products. I doubt that highly. Personal products are not well regulated - many hair mousses, shampoos and what not contain formaldehyde, called Quaternuium something or other on most labels, and benzene.

[madrchsod]

4. this is why the fda refused.....

http://sandyfrost.newsvine.com/_news/2010/04/09/4134899-fda-report-details-hundreds-of-violations-in-shriners-burn-treatment-study-as-product-heads-to-market

i believe the fda is spot on if these issues are not resolved

[Better Today]

7. OMG, before everyone becomes incensed and irate, read madrchsod's link.

http://sandyfrost.newsvine.com/_news/2010/04/09/4134899-fda-report-details-hundreds-of-violations-in-shriners-burn-treatment-study-as-product-heads-to-market

[momof2]

56. Sandy Frost

Before you put too much weight in this website, note that
Sandy Frost has a serious axe to grind with Shriners (the
fraternal organization more than the hospitals)--she is not an
impartial reporter. She has no medical training, and has
certainly never seen a child with an 80% 3rd degree burn.  She
does not understand that what she (and also the FDA) describes
as "adverse events" are totally normal, daily
occurrences for a patient with such a severe burn. Check out
the refereed peer-reviewed medical literature (pubmed.gov) if
you want to learn more about the kind of skin grafts they are
talking about for this child, NOT the online ramblings of a
self-declared "investigative journalist."

[Sandy Frost]

64. From Sandy Frost

momof2,

You write I have a serious axe to grind with the Shriners. I have investigated their nonprofit status the past four years and for the past two have reported on and have documented their secret sub-group, the Royal Order of Jesters.

I think you'd agree that operating a nationwide network of prostitution, such as the Jesters are doing, while hiding behind burned and crippled children, just like Alfred Real, bears investigation, if not prosecution. Three Jesters were caught in a FBI human trafficking sting out of Buffalo, New York. These included a former NY State Supreme Court Judge, his law clerk and a retired police captain.

Then there are those 19 Jesters who went fishing in Brazil with a tour guide who has been indicted by the Brazilian Federal Police for rape and luring underage Indian girls off their reservations into prostitution aboard his fishing boats. Fishing guides testified the Jesters went to Brazil asking to be called "Masons" and for girls as young as 13.

Maybe you need to spend more time on my site studying the documents for yourself. Maybe you missed my latest article about the former Erie County sheriff deputy who was charged with transporting prostitutes from Buffalo up to a national Jester meeting in Niagara Falls, Ontario.

I am just the messenger writing about that which the FBI, ICE, the FDA and other investigators are finding out about those corrupt Shriner leaders who are using their positions of public trust for private gain and are breaking the law and, according to the FDA, are endangering others through unreliable clinical research.

I reported on these Shriner-related issues before others did so, including the New York Times, Fox News Atlanta, the Dallas Morning News and, most recently, ABC News with Diane Sawyer.

It sounds like you have an axe to grind with me when you should support the FDA's decision to protect Alfred from procedures and products that are based on research that is unduplicatable, lacks integrity and has been under investigation by the FDA since 2006.

Prior to the FDA investigating this clinical research study at Shriners in Cincinatti, the chief of staff received warning letters from the Office of Human Research Protection, asking for patient files to be audited for proper informed consent. When the FDA inspected years later, this had not been done.

Would you want your child to be in the hands of doctors who fail to follow protocals, fail to report adverse effects, fail to maintain informed consent, fail to maintain complete records and fail to report accurate results to the Institutional Review Board overseeing the research?

I didn't think so.

Sandy Frost

[Stargazer09]

18. Thank you for posting that

I agree that the FDA does have cause for concern. Scary to think that maybe the standard treatment would work, if only the doctor would use it instead of pushing his experimental treatment.

Either way, I hope that little boy recovers from his burns.

[boppers]

22. So, the correct response to "what harm could it do" is:

"It could hurt him even more, and possibly kill him."

[D-Lee]

30. Thanks for the link -- FDA report was impessive! nt

[Better Today]

6. The FDA??? The FDA isn't an insurer. This makes little sense. If it's experimental

I could understand but not agree with insurance refusing, but wtf does the FDA have to do with it, unless it is saying it simply cannot be performed on anyone because of some sort of safety issue.

Hang on looks like someone posted above while I was typing, maybe that explains it.

[pnwmom]

10. The FDA is understandably cautious about experimenting on people who cannot

give informed consent, which certainly includes children.

[Better Today]

13. Yes, you'll notice that I went back and read the post above, and now understand the full depth of

legitimate FDA concerns.

[groundloop]

14. FDA puts a hold on a procedure where data has possibly been altered....

and all of a sudden it's a government conspiracy to kill children. I can understand why the parents are upset, but if patient data were altered during a trial the FDA is more than justified in being cautious.

[Zoeisright]

15. You're absolutely right. The government isn't conspiring to kill children

or make anybody suffer. If protocols weren't followed during a trial, something could really go wrong with that experimental procedure. Then people would be screaming that the FDA isn't doing its job.

[ShockediSay]

20. Parent/s could consent, legally.

And Shriners might go ahead w/out FDA approval {and w/out insurance reimbursement}. If above referenced complications ensue, Shriners would have to accept liability for all consequences
{and someone would lose the money/profits for an 'approved treatment.'

It is a very Republican defense to say I just did what the government said I could.

[pnwmom]

24. I'm not sure what you're getting at. The Shriners should be following the

study as it was approved, including informed consent procedures (which were not consistently followed) and reporting all adverse effects (which wasn't happening). Given the information that is available, I think the FDA did the only correct thing.

[superconnected]

9. Beautiful little boy. I hope he gets his treatment.

[pnwmom]

11. Unreported adverse effects include pneumonia, sepsis, and necrotic muscle tissue.

According to the FDA's report on this experimental "treatment."

I hope the boy survives his burns, but I'm not sure this treatment will save him.

[girl gone mad]

16. With burns on 80% of his body, pneumonia, sepsis, and necrotic muscle tissue..

would be the least of his worries.

I hope the FDA was properly weighing the severity of his injuries against the small risk of an adverse side effect.

[Stargazer09]

19. After reading about the FDA's concerns,

it seems like that experimental treatment might actually kill the child. When I read the article, it mentioned children dying during treatment, without saying whether or not the treatment killed them.

What a tough choice for the parents to make.

[pnwmom]

27. I agree. What a horrible choice for the parents. A key question, however,

is whether there is ANY benefit expected to the individual child for participating in this study -- there might not be, since this child is so sick.

A parent may consent to treatment for his or her child, but a parent may NOT consent for EXPERIMENTAL treatment unless the treatment is hoped to be of direct benefit to that child. (In other words, an adult can agree to participate in any medical research himself, but cannot make that decision for his child unless it is expected to benefit the child.)

One of the criticisms the FDA is making is that informed consent has not been consistently obtained. I'm wondering if the parents in this case are being given the true facts as to the small likelihood that their child will benefit from the treatment.

[Stargazer09]

32. One thing that made me wonder

was the fact that the child's relative said that the traditional treatment wasn't working. Considering the doctor's stake in the "success" of his treatment, I personally would be concerned about a conflict of interest in this case. The lack of honesty during the informed consent process sends up a lot of alarm bells in my mind, and it sounds like the doctor is pushing the parents to consent to something without being completely up front with them about the risks and his stake in the treatment.

[pnwmom]

37. That is my fear, too. The parents are extremely vulnerable to false hopes --

an unfair kind of pressure.

[pnwmom]

25. You don't know that there was a "small risk of an adverse effect" because

very serious adverse effects were not being reported. And informed consent procedures were not being consistently followed.

To add the risk of pneumonia or systemic blood poisoning or tissue death to what this boy was already going through could lead directly to his death. There is no good solution for a child with 80% burned skin.

[girl gone mad]

28. I read the report.

It was one case of pneumonia, one of recurring sepsis. I just don't know if they've made the right decision here. I hope those at the FDA can live with the choice in the event this child doesn't survive his wounds.

[pnwmom]

40. The child is unlikely to survive no matter what is done. Offering the parents

a false hope -- and the child a painful treatment that is unlikely to do anything but prolong death -- is simply cruel.

[momof2]

57. adverse events?

These adverse events are common in burn patients, who are the
sickest of the sick, and are probably not related to the
experimental treatment at all!

[provis99]

21. this kid is essentially already dead.

No one survives 80% 3rd degree burns; they might as well try this treatment despite possible problems, since the kid won't survive without it anyways.

[canetoad]

23. Thank you

Not for being the bearer of bad news, but for realistically pointing out this kid's chances of survival. With or without cultured tissue.

[pnwmom]

26. One of the criticisms of the Shriners is that they weren't following the rules of

informed consent. The parents need to understand that the probability is that this treatment will NOT benefit their child, although the final results of the study may or may not benefit somebody else's child. On the other hand, the study has been so poorly conducted up till now that any conclusions drawn are virtually worthless.

[momof2]

58. you are so wrong

It's pretty common, particularly at Shriners Burns Hospitals,
for children with very severe burns to survive their initial
injury.  If a patient can be treated by experienced
professionals, even patients with 95% burns can survive.
Without skin grafting though, scarring becomes a real problem.
This is a serious issue for injured soldiers returning from
Iraq and Afghanistan, who face years of rehab and scarring. 

[RamboLiberal]

63. That's bullcrap - odds still against but if kid survived thus far

he has a good chance.

New England Journal of Medicine:

The chances of survival after burn injury have increased steadily during the past 50 years. At the end of World War II, only 50 percent of patients survived burns involving 40 percent of their total body-surface area. Today, over 50 percent of all patients with burns involving 80 percent of their total body-surface area survive, and the survival rate may be even higher for adolescents and young adults, among whom almost no burn is too extensive to preclude recovery. This remarkable success can be attributed to a number of therapeutic developments, including vigorous fluid resuscitation, the early excision of burn .

http://content.nejm.org/cgi/content/extract/338/6/387

[Ian David]

31. They should apply for a Compassionate Use waiver.

IDE Early/Expanded Access
Introduction

An unapproved medical device may normally only be used on human subjects through an approved clinical study in which the subjects meet certain criteria and the device is only used in accordance with the approved protocol by a clinical investigator participating in the clinical trial. However, there may be circumstances under which a health care provider may wish to use an unapproved device to save the life of a patient or to help a patient suffering from a serious disease or condition for which there no other alternative therapy exists. Patients/physicians faced with these circumstances may have access to investigational devices under one of four main mechanisms by which FDA may make an unapproved device available:

* Emergency Use
* Compassionate Use (or Single Patient/Small Group Access)
* Treatment Use
* Continued Access

These mechanisms can be utilized during a certain time-frame in the IDE process if the criteria are met. FDA approval is required except in the case of emergency use. The mechanisms are summarized below followed by an in depth discussion of criteria and requirements.

<snip>

* Device Regulation and Guidance
* > How to Market Your Device

Section Contents Menu

* Device Advice: Device Regulation and Guidance
* How to Market Your Device
* Investigational Device Exemption (IDE)
o IDE Definitions and Acronyms
o IDE Approval Process
o IDE Responsibilities
o IDE Application
o IDE Reports
o IDE Records
o IDE Institutional Review Boards (IRB)
o IDE Informed Consent
o IDE Financial Disclosure
o IDE Early/Expanded Access
o IDE Enforcement of Good Clinical Practices (GCP) Regulations
o Import and Export of Investigational Devices
o FAQs about IDE
o IDE Related Topics
o IDE Guidance
o IDE Regulations
o IDE Links

-
IDE Early/Expanded Access
Introduction

An unapproved medical device may normally only be used on human subjects through an approved clinical study in which the subjects meet certain criteria and the device is only used in accordance with the approved protocol by a clinical investigator participating in the clinical trial. However, there may be circumstances under which a health care provider may wish to use an unapproved device to save the life of a patient or to help a patient suffering from a serious disease or condition for which there no other alternative therapy exists. Patients/physicians faced with these circumstances may have access to investigational devices under one of four main mechanisms by which FDA may make an unapproved device available:

* Emergency Use
* Compassionate Use (or Single Patient/Small Group Access)
* Treatment Use
* Continued Access

These mechanisms can be utilized during a certain time-frame in the IDE process if the criteria are met. FDA approval is required except in the case of emergency use. The mechanisms are summarized below followed by an in depth discussion of criteria and requirements.

This graph compares the Traditional IDE Study with the various timeframes in the device development process in which early access provisions can be utilized. The Traditional IDE Study is conducted after IDE approval until completion of the IDE approved study. Emergency Use can be utilized throughout the device development process, that is, before or after IDE approval up to marketing approval. Single Patient/Small Group Access (or Compassionate Use) can be utilized after IDE approval until marketing approval. Treatment Use can be used during the IDE study after data suggests that the device is effective until marketing approval. Continued Access can be utilized after the IDE approved study is completed until the device receives marketing approval.
Emergency Use

Emergency situations may arise in which there will be a need to use an investigational device in a manner inconsistent with the approved investigational plan or by a physician who is not part of the clinical study. Emergency use of an unapproved device may occur before an IDE is approved.
Criteria:

* Life-threatening or serious disease or condition
* No alternative
* No time to obtain FDA approval

Time-frame:Before or after initiation of the clinical trial

There are special cases under emergency research in which the human subject is in a life-threatening situation and it is not feasible to obtain informed consent. In order to allow such research to proceed, special provisions for exception from informed consent requirements must be met. In addition, the IRB and a physician not participating in the investigation must review and approve the investigation. The sponsor must also submit a separate IDE application to FDA.

Detailed information on conditions for exception from informed consent can be found under Informed Consents, Exception from Informed Consent Requirements for Emergency Research.
Compassionate Use(or Single Patient/Small Group Access)

The compassionate use provision allows access for patients who do not meet the requirements for inclusion in the clinical investigation but for whom the treating physician believes the device may provide a benefit in treating and/or diagnosing their disease or condition. This provision is typically approved for individual patients but may be approved to treat a small group.
Criteria:

* Serious disease or condition
* No alternative

More:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm051345.htm

[pnwmom]

38. The problem is that the study has been halted because of deficiencies in how

it has been conducted, including very serious unreported adverse effects and incomplete consent forms.

[burnsei sensei]

33. Why I'm sure it's a good,

market-oriented, cost-cutting measure!
And isn't that the way Americans like health care?
After all, what were all those demonstrations about last year and earlier this year?

[Baalath]

35. This wasn't denied for money reasons. FDA isn't insurance

No one can get this treatment because of problems the FDA has with the treatment and the research. The FDA must do its job and protect people with research protocols and nonproductive research.

[pnwmom]

39. Welcome to DU, Baalath! n/t

[gristy]

34. What harm could it do?

Oh, my.

[Xenotime]

36. Science rules must be followed.

[Haole Girl]

44. How horrible

I will never forget the screams I heard coming from the burn unit, when my mother was in NICU. :-(

[mopinko]

48. yeah, let's torture a dying kid so that we can all feel like

we did everything we could.
it is the job of the fda to get between the hopeless and false hope. may this child be treated for his pain and allowed to make a peaceful exit. this procedure is nowhere near ready to take on a case like this.
of course his parents want to take any shot they can get. but all this is going to do is increase and prolong his agony. and theirs.
peace to them all. including the doctor who probably sincerely wants to help and give hope, even when there is none. may his objectivity return.

[GFmuse]

55. rates of success

Thanks for your time. I wanted to let you know that things have changed enormously in the burn care field. In fact, since Shriners Hospitals entered the burn care field, the survival rate for children with burns over more than 50 percent of their body surface has doubled. In addition, today, patients with burns over 90 percent can survive and go on to lead full, productive lives. This is in no way a pointless fight, and Alfred is not making an exit. He has a great chance, but yes, he is still in critical condition.

[AngryAmish]

49. It is thinking like yours is why Steve mcQueen is making wonderful movies into old age...

[pansyofanotaku]

52. Poor thing...

That little boy must be suffering. There are some rare and pretty bad side-affects to the procedure, but, considering his chances, I'd take the risk. It makes me mad that the insurance companies and FDA both make money off people and then get to pick and choose who gets covered!!! Then again, what to expect from a government created by old, rich, slave-owning, white men. America, home of the free and the neglected...

[momof2]

59. If this child

is at a Shriners Hospital, all of his care will be free of
charge, no insurance needed or accepted!

[Sandy Frost]

65. Shriners Now Bill Insurance

momof2,

This article from the Spokesman Review reports that the Shriner hospitals now bill insurance:

http://www.spokesman.com/stories/2010/jun/26/kids-still-put-first/

From the article:

"The Shriners Hospital for Children in Spokane begins billing insurance companies next week, a major change for a charitable organization that for decades cared for children with crippling bone, joint and muscle problems, and absorbed the expense."

[GlennWRECK]

61. Poor thing :( But that's the procedure

Sometimes you get the shit end of the stick in these sorts of things, unfortunately.

[RamboLiberal]

62. According to CaringBridge Website - FDA has approved!

The FDA has agreed to talk to Zac and Angela today at 2:00pm!!!! We will keep you posted. Keep you prayers going for a change in their decision.

The FDA has approved the procedure for Al! The AJC article helped to change their minds...Pow​er to the people!

http://www.caringbridge.org/visit/alfredreal