The FDA is stepping in to suspend the use of a cultured skin substitute developed at the Shriners Burn Hospital in Cincinatti because of a previous inspection report that itemized hundreds of violations in the product's clinical research study. Prior to the FDA's warning letter, the same study had received a warning letter from the Office of Human Research Protection (OHRP) due to wrong informed consent. The OHRP required the doctors audit the patient files to make sure that the correct forms were being used but the FDA found the same violations in their inspection that led to the warning letter and subsequent denial of this particular burn treatment.
FDA Protects 8 Year Old Burn Victim From Skin Substitute Cited in Warning Letter Due to Hundreds of Clinical Study Violations
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It might take a while for other news outlets to report that the FDA is actually doing its job by protecting this young burn victim from a burn treatment that may have been developed under what could be considered "fraudulent" conditions. Some news reports have characterized the FDA's denial as being based on a "paperwork problem" instead of writing about how the integrity of the clinical study was questioned in warning letters sent to both the University of Cincinatti and Shriners Hospital from both the Office of Human Research Protection and the FDA. Then there is the matter of the FDA inspection report that details hundreds of violations in this product's clinical study.
The child you are referring to is a boy named Al Real. And he is just that: REAL. A real 8 year old boy fighting the battle of a lifetime because of a split-second childhood decision. I was alerted to your campaign against the Shriners by a family member of Al Real, and I have taken the past hour to peruse your site and read your columns. I do not doubt the facts of these numerous cases of criminal behaviour by the men in question. Your research appears to be thorough and well-presented as you document the habitual fraud, waste and abuse perpetrated by these men in the name of "mirth, merriment and the good of the children". You state that "The real criminals here are those 'pillars of the community' who have hijacked the IRS and taken advantage of us, all of us, so they can party with prostitutes at tax payer expense." And you could not have stated the facts more truthfully or succinctly. But to assert that the FDA was "protecting" Al Real by denying him a medical procedure simply because it "may have been developed under what could be considered 'fraudulent' conditions" is absurd bordering on ignorant. I would invite you to stand by that child's bed as the smell of his burned flesh fills your nose. Listen to him cry. Watch his Mama and Daddy feign hope as they silently crumble under the gravity of the situation...as they wonder if he will live another day...as they stand helpless to alleviate his fear...as they grieve his painful future. I know this family. I grew up with Al's aunts and Mama and Daddy. They are as decent and as down to earth and as truly American as any family in this country. I am bawling as I write this, furious that you would have the audacity to censure a severely damaged child with life threatening injuries because of the actions of a group of pathetic, overweight, aging has-beens with performance issues. I would support the family's decision to turn to the Devil himself to procure the treatment that Al eventually received - a treatment that doctors agreed would lower his chance of rejection and infection and increase his chances at a meaningful recovery. You ought to be ashamed of yourself. I am with you 100% on your investigation of the ROJ, but don't you dare throw out the (burned) baby with the bathwater. At least not until you have looked that child and his family in the eye. Shame on you.
Thank you for your comments.
Please tell me more about the Real family and what Alfred went through.
Thanks again,
Sandy
There are bad apples in every organization. I have no doubt this is the case with the Shriners. I also have no doubt there are bad apples in the field of journalism. I work with and personally know men who are Masons. These are kind, decent men who are genuine in their efforts. I know these men's wives and children and I've seen lives changed for the good by their efforts. I've also known the Father and Mother of this precious boy since I was a child. Alfred Real would not be here today were it not for the care he received at the Shriners' Hospital in Cincinnati. I'm horrified to learn of the things you allege against the Shriners and, if true, would want the guilty parties punished accordingly. I'm also equally horrified by your efforts to seemingly label this entire group of people as corrupt and without any redeeming value. I pray no one you know will ever require this type of care, as I could never imagine the fear, pain and suffering that has accompanied them along this incredibly difficult road to recovery. What I do know is that the doctors, nurses and the rest of the staff at this hospital saved this boy's life. The care Alfred received, including the treatment you allege has been developed under what you categorize as "fraudulent conditions" along with the kindness, generosity and compassion shown to the rest of the family by the Shriners hospital was not available anywhere else. The stories from the family members who spent time at this hospital are what I'll always know to be truth. It's an amazing place where children's lives are saved and families are cared for. I encourage you to continue your investigation into the things you allege but leave the kids out of it. This boy and the life saving treatment he received doesn't need to be a part of your crusade in any way shape of form.
Dear Todd Cliatt,
Thank you for your comments. Of course Alfred Real got top notch treatment. The FDA was monitoring his progress through reports that were sent in every two weeks by the doctors overseeing his care.
Yes, this is the Shriners at their best. But what if I'm right? How many more children could be helped if the Shriners followed the rules, nonprofit, scientific and/or otherwise?
My allegations are documented. Feel free to read "Let's Make a Deal, Five Categories of Shriner Corruption" then get back to me.
Thank you,
Sandy
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