FDA/SHC News & Unanswered Questions about PermaDerm (tm)

I'm still tracing out business relationships through nonprofit tissue banks that pays certain board members about half a million. Quite a sum for a nonprofit group. Then there's the same doctors at the same company, one of which is overseeing his partner's research. Or maybe he's protecting it.

Thanks for being here,

Sandy

2 votes

#1 - Mon Oct 4, 2010 3:37 AM EDT

Well done. Congratulations. Keep your head down.

2 votes

#2 - Mon Oct 4, 2010 10:21 AM EDT

Dear Paul Andrew,

Thank you! I'm not sure congratulations on what but after LordCobalt ragged on and on and whined loudly about documentation and the questions I ask sources, it turns out that publishing the unanswered questions provided an interesting way to tell this story.

I think that those I'm investigating need to keep their heads down. They're the ones being investigated by the FDA and who knows who else. The good thing is that the fiscal year just started so there's enough money to fund any investigation to its logical conclusion.

It's looking like doctors from SHC and U of C formed a nonprofit skin and tissue bank so they can sell their products to the places they work. One SHC doctor and one U of C doctor both got about half a million from this nonprofit skin and tissue bank that they started. The problem right now is that the U of C doctor who got the half a million is the same one overseeing the recent compassionate use case at Shriners. Turns out both doctors work for the skin and tissue bank and U of C.

I wonder if they turned in the proper conflict of interest statements.

I kind of doubt it because the skin and tissue lab at SHC doesn't appear to be registered w/the FDA. How does that happen? The focus doesn't seem to be on good research or patient safety but on the billions that could be generated if PermaDerm (tm) is approved by the FDA. If it's approved, then they can produce the product that they buy to heal the little burned kids. I'm sure there's some similar deal w/the military market. Someone will certainly benefit by producing the product that the Army would buy to help the burned soldiers.

I've always suspected insider trading. That's why I asked those questions to Shriner HQ but, as usual, no one ever responds.

From what I've found so far, it's a pretty slick deal, passing money back and forth through these nonprofit groups, most likely selling skin and tissue to the same places they work, then getting half a million dollars from the skin and tissue company.

How is that nonprofit? How is any of this nonprofit when it's clear that doctors hide how much they're making on the side from the product they developed through the University of Cincinnati and SHC?

I just hope that those investigating this do so without compromise.

Thanks,

Sandy

#2.1 - Mon Oct 4, 2010 3:58 PM EDT

I did a bit of poking after reading your story. It seems, the firm Lonza (owners of PermaDerm) and Regenicin are attempting to do what the Shriners SHC were apparently unable to do. They have managed to pull in some top notch talent for their advisory board and are planning for new trials to make a new effort in getting FDA approval.

I looked and could find no negative results from the use of the skin. Is it mostly paper work issues? Or has the skin failed in its application?

I look forward to your response. TY, plcombs

1 vote

#3 - Thu Oct 28, 2010 12:47 AM EDT

Reg Queen

Mr. Combs: I've been a clinical research nurse for over 15 years with experience working alongside investigators in major academic medical centers conducting trials sponsored device companies, pharma, NIH, the DOD and investigator-initiated trials and currently working in the regulatory field including conducting on-site regulatory audits. The clearly documented mismanagement and violations associated with the research performed by Dr. Boyce & his co-horts defy logic and display nothing less than sheer arrogance.

If an investigator's primary interest is in bringing effective new treatments to suffering patients, he/she does everything possible to comply with Good Clinical Practice (GCP) standards, federal & FDA regulations as well as state, IRB & other research compliance policies - not only to (#1) ensure subject safety but also to ensure CLEAN DATA. The continous violations despite ample and numerous warnings speaks volumes. These violations were NOT just matters of "paperwork," but serious very serious violations bringing into question the validity of signed Informed Consent documents and the consent process itself, unreported adverse events (serious & non-serious), failure to document & report re-grafting, lost or failed grafts, required tests & procedures not performed, lack of staff training AND NO SAFETY MONITORING BOARD OR PLAN IMPLEMENTED. And the list goes on & on. Overall complete failure of the lead investator to follow his very own protocol - then protest that all these violations weren't "clinically significant" -- if not significant, why were they put in the protocol? If not significant & you can't comply, why not do the right thing & revise the protocol?

These weren't just "paperwork" issues. This was the work of an arrogant investigator who feels he has to answer to no one, runs a sloppy study resulting in "dirty data," who then goes on to present & publish "dirty data" authorized or not & when his study gets shut down moves on to another company, funding source & whatever else it takes after selling this & that then marching to the bank with a big fat smile on his face. Would patients potentially benefit from this potentially valuable treatment? Yes. Then why would an investigator (PhD not MD by the way) put it at risk for what?? The freedom to conduct sloppy, unethical, unmonitored research & scoff in the face of the IRB & the FDA whose job it is to protect human subjects & to ensure the highest quality of research data resulting from a trial?

How this has gone on this long without more intense publicity I don't know but Ms. Frost has the spine of a steel post. I hope this guy goes down in flames. He is an embarassment to the research community & certainly to the UC IRB who I previously thought as one of the best IRBs in the country. I don't know what went down at that institution but something smells rotten in the state of Denmark.

1 vote

#3.1 - Thu Nov 11, 2010 11:13 AM EST

Dear Peter Combs,

Thank you for your comments. I am working on a story right now about two audits that essentially say that those involved in the research and those overseeing were clueless. Yes, top notch talent is joining the board.

But no board member or company CEO can retroactivate the skin lab's registration w/the FDA.

In otherwords, all the market activity can take place but the clinical research was done in an unregistered lab. Kinda makes it not valid.

Well, and the FDA shut the study down.

The audits showed that hundreds of adverse effects were not reported, a serious lack of procedures and no safety monitoring.

On and on and on.

Then there are interwoven financial relationships that should have been disclosed.

Same stuff, different day.

I'm working on it and will have more information for you soon.

Thank you,

Sandy

1 vote

#4 - Thu Oct 28, 2010 5:17 AM EDT

I understand that previous studies have problems and are invalid. My interest is in the product and its future in the market for military and other medical uses.

I asked an employee of mine to do some looking on this today. His impression was, Regenicin will be doing its own trials independantly of under all new guidlines , following the rules etc. A co-founder of Amgen and others are on the board who, with other folks to guide the process. From our standpoint the medical future of this technology is more important than the mistakes made in the past and seem to pale against the good this product could do.

Kindly let us know what you learn. I'll look back from time to time.

#5 - Thu Oct 28, 2010 10:52 PM EDT

Dear Peter Combs,

Who is "us"?

Sure, the technology is necessary and will make a handful of people rich. But at what cost? Ignoring the FDA, OHRP and bioethics? Pediatric bioethics at that.

The audits tell another story. I think you are right that Regenicinand Lonza will have to start from ground zero because the FDA rejected the research done by the primary investigators.

It's just too bad that the little burned kids were used as guinea pigs, as if their poverty was taken advantage of. What kind of study has no safety oversight? What kind of a study has a history of noncompliance letters dating back to 1999? What kind of study is shut down by the FDA?

So you think that the previous study was done with disregard to the rules? It sure looks like that to me. Over and over. It's mind boggling.

It will be interesting if those bio-pharma heavy hitters will be able to "influence" the FDA to approve PermaDerm or if the FDA will put it's collective foot down so someone conducts reliable research.

And I've not even begun to write about the possible fraud perpetuated on the Army as UC and SHC Cincinnati somehow convinced someone to keep funding this study that uses an unregistered skin and tissue lab.

Too much wrong. Too much disregard for the kids. Too many people investing in what appears to be clinical research fraud to get a questionable product to market. Who knows if it works? Even the examples submitted as evidence to the Army were cited for FDA violations so their data is invalid.

Thanks and keep coming back.

Sandy

1 vote

#5.1 - Fri Oct 29, 2010 2:41 AM EDT

plcombs

Hello Sandy,

From what we've seen, the results, despite the poor record keeping has been quite good at the end of the day. The lab was unregistered, which is not at all unusual in academic environments, but I've seen nothing to indicate it was subpar in it's performance.

My interest is in wanting to see this product perfected and brought to market. The possibilities are simply too important regardless of past mistakes. The FDA's cumbersome and at times absurd procedural policys have done I think as much harm as good over the years, when compared to the Swiss, France, England, Germany etc..

You seem to imply children were harmed by the research physically, is this so? Or are we talking about paperwork ? Was the reseach really fraud or labelled as such because the paperwork was poorly kept track of?

I also believe we will learn the US Military and some Political figures are pushing hard to get this thing done. Perhaps DARPA might be looking into it, to offer a helping hand.

My feeling is the FDA will fast track the product with some new research and grafting results , I believe they need a test group of Adults and Children. After going to the Regenicin site and checking the backgrounds of the board members they are assembling, my impression is, this is a very serious and well qualified group of professionals, not that kind that attach themselves to things without serious thought.

Once again, thanks for your reply, I look forward to hearing more.

Peter

1 vote

#6 - Sat Oct 30, 2010 12:42 AM EDT

plcombs,

I'd appreciate it if you came out from your anonymous identity and let the readers here know who you are and what you are doing here? Again, who is "we"? Are you an investor? Because if you are, I'd be quite concerned at this point that these problems ie hundreds of unreported adverse effects and unexpected events, to include patient deaths, were hidden from the University of Cincinnati, the FDA, the OHRP and NIH. The pattern follows as these problems and material facts may not have been disclosed not only to the investors but to the SEC.

You seem to know quite a bit about the FDA. Does the FDA issue three warning letters and shut down studies over paperwork? Did the FDA reject the last compassionate use request over paperwork?

No. The rejection was based on a decade of noncompliance and two audits that show patterns of repeat FDA violations, even after being warned by the OHRP and the FDA.

Not only did the agency reject the request, it excluded the CSS research done by the principal investigators. If you want to find out about product performance, let the FDA do their job to make sure that the public is protected from a burn treatment that may have been and could have been developed under fraudulent conditions.

And glossing over the lab not being registered as if it's an afterthought is most curious. The lab was not part of an academic system. The unregistered skin and tissue lab at SHC Cincinnati is part of a hospital, not an educational facility. Please provide examples of how work done at unregistered hospital labs, skin and tissue and/or otherwise, have been accepted as valid by the FDA.

And please elaborate on the military members and political figures anxious for FDA approval. Who are they and what do they stand to gain? And what do you stand to gain?

I agree the product is important. It could have been to market already, most probably, if the research had been done correctly the first time. If this is such a great product, why not do it right the first time? Why not take the time and care to make sure that all aspects of the study are duplicatable and reliable instead of having auditors and inspectors come through and find things wrong for over ten years. Even after being warned, the investigator/s and/or staff kept violating FDA regulations.

If you knew that the study included knowingly applying the CSS to an infected site and you were a burn patient and you discovered more about the repeated OHRP and FDA violations, would you want this product used on you or one of your loved ones?

I do hope the FDA fast tracks this product to market because it has the potential to help many burn victims but only if the research is done correctly. At this point, I hope the FDA is going through the audit results to determine if fraud occurred. One auditor wrote that there was not enough time to determine if backdating patient records constituted investigator misconduct.

These problems should not be swept under the rug. It is up to these high profile board members to stand united and demand that all the problems be disclosed to the public, SEC, the U.S. Army and who ever else needs to know.

The board members and advisory committee have a duty to provide all information to the public as well as to all agencies involved. This will establish a solid foundation for future studies because the disqualified research done at Shriners in Cincinnati under the lack of oversight by University of Cincinnati should be thrown out and disregarded, because this is just what the FDA did.

Finally, please address the all important issue of pediatric bioethics. Is it ethical to use little burned kids in a clinical research study so messed up that the FDA shut it down? And please address the charitable and ethical implications for the Shriners, a group allegedly dedicated to helping the children when, in fact, these burn victims were used and, per the lack of informed consent and lack of safety oversight, endangered in the rush to get this questionable burn treatment to market.

Thank you,

Sandy

1 vote

#6.1 - Sat Oct 30, 2010 9:48 PM EDT

plcombs

Hi Sandy,

Are you saying that this product Killed patients and was not reported to anyone? If this is so, to whom was it reported as the cause or determined to be the cause of deaths?

these problems ie hundreds of unreported adverse effects and unexpected events, to include patient deaths, were hidden from the University of Cincinnati, the FDA, the OHRP and NIH. The pattern follows as these problems and material facts may not have been disclosed not only to the investors but to the SEC.

As for the past history of the product and the research issues, its of little interest to me other than it's been a colossal waste of time. I doub't much can be done about it one way or another. As you so correctly noted, the product is important and should be put into the market once the trials provide satisfactory data to the FDA.

You had asked, I assume rhetorically

You seem to know quite a bit about the FDA. Does the FDA issue three warning letters and shut down studies over paperwork? Did the FDA reject the last compassionate use request over paperwork?

The answer is YES they do...shut down things over paperwork. Many projects have had rejection of paperwork because it was doen in a foreign lab competting with American labs. Look back through the AIDES Cocktail fiasco years ago. Thousands of people died because the FDA and US Medical Industry got into a panic over the advances in France, stalling approval for a couple years. That French product became the first standard in treatment.

Regardless, you have been around and know the FDA's behavior, historically, has been anything but consistant or professional. A few years ago, we learned several drug companies were virtually approving their own products.

I caught notice of your postings from a research print out done my a staffer of mine and found myself with a few questions. Our interest in this topic and this product along with other regenerative technological developements is confidential. As I am asking reasonable questions and making no assertions, other than common knowledge comments, I feel whatever our motivations are pertaining to my questions about this issue are unimportant.

Please post more about the patients who's deaths were shown to have been caused by this product. That is a startling thing to hear and would be something to persue.

Many thanks again for sharing.

Peter Combs

#7 - Sun Oct 31, 2010 11:37 PM EDT

plcombs,

Thank you for your comments.

I won't play word games with you. Patient deaths were not reported, along with hundreds of other advere effects. It's up to the FDA and/or other regulators to determine if these deaths were product related. This entire evolution need to just stop and got back to ground zero, no matter how long it takes and commercialize PermaDerm (tm) correctly.

You know.

Follow the rules.

And this includes disclosing all the problems to investors, the SEC and whoever else needs to know.

It looks like those who launched the PermaDerm (tm) PR campaign and enticed investors may have shot their wad prematurely. Once all this comes to light and the FDA decides to further investigate past irregularities, it will obviously take more time. This will also put increased scrutiny on Lonza and Regenicin as well as on the University of Cincinnati and the Shriners.

Once the research is done correctly, there should be no problem getting FDA approval.

I appreciate that you want this product commercialized as many have much to gain if it hits the market. My focus is on different things including serious, if not show stopping, conflicts of interest and an apparent disregard for bioethics, especially pediatric bioethics.

I think the disasterous development history does matter, especially when it comes to defrauding the government. False claims and all that. It's clear that PermaDerm's developers hid adverse effects, unexpected results, wrong informed consent and much more from the regulators.

One auditor reported that FDA violations were still going on during the actual audit.

Then what about the nonprofit group who claims to help these kids but is instead experiments on them in clinical research so bad the FDA shuts it down?

The rush to develop this burn product illustrates what happens when researchers work in their own or others' best interest instead of that of the public.

This is why financial disclosures are so important, especially in the last case of compassionate use at SHC Cincinnati. The University of Cincinnati doctor overseeing the latest case is on the same board of directors as the doctor at SHC. They're on the board of a skin and tissue bank and it looks like they get the skin and sell it to themselves at work. One of the skin and tissue bank's tax return shows that the previous SHC chief of staff was paid over $500,000, same as the doctor overseeing the last compassionate use case. That's quite a salary for a nonprofit group.

Sounds complicated but these are the types of disclosures that must be made to the FDA and others so they can track how the money flows.

Follow the money.

I understand that the money won't flow if the FDA holds up PermaDerm (tm). It will be interesting to see what happens as I expect that there is much pressure bearing down on an agency constantly under fire for cozy relationships and convenient decisions.

Will the FDA take the time to protect the public from a product they once deemed to be as dangerous as the patient's condition or will the agency just fold to policitical, military and financial pressures to rush this product to market inspite of known problems?

The outrage is, again, how we taxpayers subsidize these corruptions repeatedly asssociated with the Shriners. This case illustrates the quality of clinical research conducted at five out of 22 Shriners' hospitals.

Makes all the prostitution/sex trafficking/child sex tourism stuff nearly pale in comparison.

There seems to be those of you holding your breath to see if PermaDerm (tm) will somehow be approved by the FDA and perform for investors.

You write that the FDA is not consistent or professional. What about those surrounding the nearly criminal development of this product?

We'll see if all the media hoopla and dog and pony shows are premature and if ABC will really run that story on PermaDerm (tm) Monday night or anytime soon.

Nice way to bump up stock prices.

I'm getting back to work here to catch everyone up on what I've found about these audits.

Thanks again for your comments and keep coming back,

Sandy

1 vote

#8 - Mon Nov 1, 2010 3:04 AM EDT

Hello Sandy,

I just checked, the stock price hasn't changed much in weeks up or down 20 cents. Though the volume has increased significantly. As investment, it looks like a fairly long term deal, which all of these things are.

In the future I would suggest you be a bit more cautious about accusing people of causing deaths, when you have nothing to support the accusation. I understand fully, you interest in having the research done properly. I think with Lonza (one of most important and well respected medical labs on the planet) doing the work, they will cross ALL the "T's" and see to it that paperwork is handled properly. Which is all laudable ..

As an FYI, their is an event comming along hosted by Lonza regarding Permaderm and Regenicin: Speakiong on behalf of Regenicin will be Dr. Craig Eagle Head of Oncology for Pfizer Worldwide and a Board Member of Regenicin. Also scheduled to participate is the Armed FOrces Insitute of Regenerative Medicine, the U.S. Department of Defense Office of Technology Transition a couple of Congressmen and doctors involed with burn treatments.

I suspect they have put together a good game plan for how to proceed, without causing the creation of obstacles for getting this product into hospitals as soon as possible.

Keep posting...Best regards, Peter Combs

#9 - Tue Nov 2, 2010 4:50 PM EDT

Peter Combs,

Thank you for the opportunity to again clear up your misunderstanding and point out that deaths occurred but were not reported. The problem is that the unreliable data and system wide failures makes it nearly impossible to duplicate any of PermaDerm’s successes or failures.

How can anyone determine if the unreported deaths associated with the suspended PermaDerm ™ study were product related?

From page 144 of the Morley Audit:

"Adverse Event Reporting has improved with this annual report, however neither the site or the sponsor seems to understand the FDA’s constant notifications (Warning letter of January 12, 2007 or the Integrity Hold letter of February 2, 2007) in addition to the warning letter issued to the Sacramento site in March of 2006, regarding the failure to report and accurately document unanticipated and anticipated adverse device events. The third party audit has identified 695 adverse events and the site/sponsor reported eight (8) for the year 2007…

The adverse events reported for 2008 were 36 UADE reports by Dr. Boyce, whereas the auditors recorded 760 events. While this number of events reported increased over last year, the reporting is still not as complete as the auditors identified additional events which should have been reported.”

Even after the study was shut down, only 44 out of 1,455 adverse events were reported.

Why would anyone not report things like deaths or over a thousand of other adverse events, especially after being warned over and over?

This is the kind of thing that investors, the SEC and other regulators need to know.

As far as Lonza goes, it looks like they need to work w/SHC Cincinnati to get that skin and tissue lab registered before any more research can be done.

Thank you,

Sandy

1 vote

#9.1 - Wed Nov 3, 2010 2:29 PM EDT

Hello SAndy,

I doubt Lonza will do anything with the SHC/Cincinnati, Lonza has its own lab here in the US which the FDA is familiar with and will I suspect work with a hospital in their own area which satisfys their needs. You perhaps could call them and ask what their plans are.

I still don't see anything mentioning DEATHS in the report you cited. Did someone tell you their were deaths? or is it your assumption?

At this point Lonza and Regenicin are taking this work on their own for the most part it seems. Lonza BOUGHT the Patent..and Regenicine owns the distribution and marketing rights. The way it looks, people previously involved are no longer in the loop. Which is, based on your writings, a good thing.

Regards, Peter

#10 - Wed Nov 3, 2010 5:40 PM EDT

Peter Combs,

If you go to my latest article, you will see how this grant application to the U.S. Army links Lonza to SHC Cincinnati in terms of duplicating results to obtain FDA approval for PermaDerm (tm). The grant application to the Army shows the there is no way to disconnect Lonza, the Army, SHC Cincinnati and the University of Cincinnati prior to any future FDA approval.

Thank you,

Sandy

#10.1 - Thu Nov 11, 2010 5:25 PM EST

Peter Combs,

This audit describes the unreported deaths as well as over 1,000 unreported adverse effects, hundreds of protocol deviations, lack of informed consent and refusal to provide conflict of interest statements by the doctor who made millions off this research.

This online document depository has the other audit, reports, tax returns and correpsondence relating to this case.

Please take the time to review these documents and make sure that you have read my other articles about this subject so you know the whole story.

My next article should answer any more of your questions.

Thank you,

Sandy

1 vote

#11 - Wed Nov 3, 2010 6:01 PM EDT

Hi Sandy and Peter,

My note here will be simple, as clearly I am not as well versed on this subject as you two. I am a family friend of the patient who was the last one to receive the treatment this summer. Personally I have never heard of you, Sandy, and have no idea for whom you work as a journalist. However, I find it a travesty to try to block a television appearance on the national news which is highlighting the incredible journey of this little boy on his road to recovery.

I also was under the impression (from the boy's family) that it is a paperwork issue - by the way, people die all the time from supposedly FDA regulated drugs i.e. Ephedra, PhenFen, certain heart and blood pressure meds, etc. that were put out there with the belief that they were considered safe. If you were burned, wouldn't you want to try anything at all that might help you have some sort of enhanced quality of life? Not that I want anyone to die, but please, put yourself in the burn victims' place (or AIDS patient) and tell me that you would not try anything at all to get better. No one EVER fully recovers from a burn, but if you could regrow your own skin even with a chance for a negative side effect, it could be nothing but positive!! And don't go after the Shriner's for Heaven's sake - they are offering FREE medical care to thousands of children for many families that would be put out on the doorstep otherwise.

That's my two cents for now,

Kirsten

#12 - Thu Nov 4, 2010 11:37 AM EDT

Dear Kirsten,

Thank you for your comments.

FYI, Newsvine is a subsidiary of MSNBC.

Where did you hear that I'm blocking a television appearance about any little boy because you are giving me way too much power. As if I could do anything like that. The mainstream media has not pursued my findings except when I scooped the New York Times on a story about Shriner corruption. FOX News Atlanta reported on "Brazil Sex Tourism," used my work as a resource then went on to win an Emmy for it. ABC News with Diane Sawyer confirmed part of my coverage of Brazil child sex tourism and ran pictures of Jesters and girls that previously appeared here. And Brazilian news recently confirmed what I'd reported two years ago about those little Indian girls lured into prostitution and the indictment of the former fishing tour operator who allegedly did it.

But that's it.

I'm not sure who is stirring things up in Georgia, but it's clear that you and others are being told that the PermaDerm (tm) study was shut down because of "paperwork."

My next article will detail how the FDA shut the study down because of data integrity and system wide failures. According to an audit, the data reliability issues included "observed deficiencies with respect to (a) investigators compliance with the Study protocol, and (b) the proper maintenance of records, including protocol deviation reports and unanticipated devise adverse reports ): and system wide failures to conduct and monitor the study (including, observed deficiencies with respect to: (a) the implementation of Study monitoring procedures, (b) device accountability, (c) device labelling, and (d) the submission of required IDE progress reports.)"

Kirsten, the data was so unreliable that the FDA shut the study down. Think about how important it is to keep records, especially when doing this type of research. Don't you think it's important to be able to go back and isolate the specifics of any successes and/or failures? Data in clinical research needs to be duplicatable.

When the FDA first rejected the pertinent compassionate use request, the letter stated:

"FDA would welcome the opportunity to learn more about the safety of this product, if you can identify clinicians who are knowledgeable about Autologous Cultured Skin Substitute. Because considerable concern exists about the validity of the data generated under this IDE, we believe that these knowledgeable clinicians should be independent from the two investigators performing this study and their understanding of the product should be derived from experience other than this IDE study or publications by Drs. Kagan or Boyce."

Per conflict of interest disclosure regulations, did anyone tell the Real family that Dr. Boyce made about $2 million so far from his research and stands to make a total of about $4 million if PermaDerm (tm) gets FDA approval? Did anyone tell the Real family that Dr. Kagan also has financial interests but both doctors refused to disclose to the Institutional Review Board how much they stand to make from their research?

There are so many more problems.

Please read "Let's Make A Deal; Five Categories of Shriner Corruption" and let me know what you think. They now take insurance, BTW. It will be interesting to see if any insurance company will pay for an unapproved experimental treatment like PermaDerm (tm).

And about the suffering? I have suffered at the hands of an alcoholic Mom who'd send me to school with hand prints on my face. She'd be in jail today for the mental, emotional and physical abuse I experienced. Today, I try to deal with resultant depression and PTSD but take comfort in the fact t I broke the cycle of abuse by loving my three kids and accepting them no matter what. I have suffered the ravages of alcoholism and have fought one day at a time to stay sober the past 28 years. I suffer from diabetes, arthritis and have ADHD and dyslexia so bad there are days I type entire words backwards. My brain is like a frog in the blender but the frog lives. I have spinal stenosis and cervical compression in my neck that will require a second reconstructive surgery.

I don't let any of this stop me. I am instead grateful because that which does not kill me makes me stronger. I put one foot in front of the other and try to embrace the gifts that Creator has so generously given me. I am answering my lifelong calling as a journalist which is how I choose to be of service.

Please be open minded and take the time to read more of this four and a half year investigation into the Shriners and their secret sub-group, the Royal Order of Jesters, currently under investigation for sex trafficking, prostitution and child sex tourism.

Thank you,

Sandy

1 vote

#12.1 - Thu Nov 4, 2010 8:41 PM EDT

http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_R/threadview?m=te&bn=100515&tid=3&mid=-1&tof=13&rt=2&frt=2&off=1#-1

Kristen,

I think you are missing the point of Sandy’s reporting. I would highly suggest that you spend some time going through her site and read her reports and the supporting documents. I don’t think anyone (except a parent of one of the burned or sexually exploited kids) feels for these kids as she does.

What I get from her reports is that she is attempting to bring to light how some very unscrupulous men, (under the guise of looking after burned kids) are using the kids as guinea pigs for their own personal gain. She was the first to break the story of the Royal Order of Jesters (Shriners) and their reported sexual exploitation of young girls on “fishing” trips. She has done an incredible of exposing all of this corruption.

There is a very dark side to the Shrine organization, one that has been conveniently covered up over the years and has only begun to be exposed. Sunlight is the only true disinfectant.

As to Alfred Real, I read the news reports and he must have an incredible heart to have gone through what he has. The pictures of him going back to school are very moving. But this does not excuse what the Shriners have done.

What story are you talking about that Sandy is trying to block? Is there another story being done about Alfred? Is there a chance that Alfred is being used in order to promote “PermaDerm” (these kind, loving men would never do that would they?) Thus bringing pressure on the FDA so that all of the shoddy and in my opinion criminal actions on the part of the researchers can be pushed aside? Who stands to gain from this?

I would again ask that you spend some time and read through what Sandy has brought to light. It is not easy to stand against the power wielded by the Shriners.

If you access the link below I think you may start to get a picture of what is really going on behind the scene and what the true objective is ($$$$$$$$$):

Sincerely,

Paul Andrew

1 vote

#13 - Thu Nov 4, 2010 2:30 PM EDT

http://www.benzinga.com/press-releases/10/11/c570594/regenicins-permadermâ-¢-to-be-highlighted-at-armed-forces-media-event

#14 - Thu Nov 4, 2010 2:39 PM EDT

plcombs

Paul and Sandy,

I just finished listening to the presentation by the new owners of PermaDerm which is LONZA of Switzerland and will be marketed after FDA approval by Regenicin. They are doing their OWN new trials which are scheduled for 2011 andit seems the technology is now in better hands than previously. I suggest you go take a look at the staff they have assembled, all of them with loads of experience, one worked as an inspector for many years at the FDA and will see to it that they comply with all the rules.

As for the what went on at Shriners, i know little about it and is something for lawyers to work out, which they no doubt will. As for the Prostitution issue, of course its terrible and disgusting and as someone once said..."their are some folks who just need killin"..the guys involved are bums. Reminds me of the Catholic Church Scandel..which seems never to end.

I had a look at the links on the "unreported deaths", I saw nothing to indicate it was caused by the product....as you know, the fatality rate for severe skin burns is high, especially when large areas are involved. I can however understand your concerns as the exact cause was not recorded properly at the time. Judging from how they managed things previously, it would seem the lack of carefull paperwork more likely the result of poor complaince procedures and not a cover-up.

As an aside, many years ago, in the 1960's my late aunt was one of the first recipients of a pig valve for her heart, done by the pioner in the procedure, a Doctor from Texas. She died a week later. It was her only chance...she took it. From that experience much was learned the by the Doctor and the staff A Massachusetts General Hospital did as much as they could, with what they knew. Medical advances are often done with human Guinea pigs..young and old.

Regards, Peter Combs

#15 - Thu Nov 4, 2010 8:08 PM EDT

Peter Combs,

Great reporting.

Cover up? What cover up?

And again, you don't have the whole story.

Stay tuned,

Sandy

1 vote

#15.1 - Thu Nov 4, 2010 9:27 PM EDT

Reg Queen

Apparently I didn't place my response in the most recent communication from the infamously mysterious Mr. Combs so here it is again (picture all CAPS for the intended affect):

1 vote

#15.2 - Thu Nov 11, 2010 11:18 AM EST

The reason I even know you who are, Sandy, is because my friend (Al's aunt) sent a message on Facebook about you trying to block the story and gave us your name. I googled you, and here I am. If there is indeed a dark side to the Shriner's, then shame on them. I will do more research myself so I can find out more from various sources. All I know is, Al and his family would have done anything to help their little boy and that's precisely what they did.

#16 - Fri Nov 5, 2010 1:03 PM EDT

Dear Kirsten,

Thank you again for your comments.

Please let me know where the Facebook message is? I am curious how this rumour got started.

Thank you,

Sandy

#16.1 - Fri Nov 5, 2010 8:33 PM EDT

Kristen,

I have never in my life seen such evil and greed! I thought that the abuse of the kids in Brazil was bad but this Alfred Real story shows to what lengths these men will go to promote themselves and line their pockets!

To use a kid that has suffered as he has, to use his parents, family and friends to further their (Regenacin/Shriners) goal of selling PermaDerm (a product that would be incredible if the research had been done properly!) is pure evil.

It seems like they could not wait to finally have a poster child who survived their unethical experimentation to promote their unproven/undocumented product so that they could rake in the cash! To blame Sandy for intentionally stopping his story is ludicrous!. To incite the family and friends against her and try to do with her what they did with the FDA, incredible! What type of monsters are they? I think ABC should run his story but that they need to do a much deeper story about what is behind all of this (shoddy research, deaths, corruption, self interest/promotion, lies, deceit, etc.). ABC did an incredible story about exposing Child Sex Tourism as Sandy has reported here. I think they could do an incredible 20/20 piece telling how the Shriners organization, the Drs, PHDs and corporate entities involved used the suffering of a young boy and his family to railroad the FDA and launch their product (that was developed using shoddy research and in an unapproved lab as per the documentation provided by Sandy) with the goal of making Millions! This is pure, unadulterated GREED!

These men must be exposed for what they are.

Sincerely,

Paul Andrew

Note: our family has added Al and the Reals to our prayer list.

2 votes

#17 - Fri Nov 5, 2010 6:42 PM EDT

Dear Paul,

Thank you for your support and for speaking your truth. And thank you for actually taking the time to read the words that I write.

And thank you for offering your prayers as I offer mine.

Thank you,

Sandy

#17.1 - Fri Nov 5, 2010 9:39 PM EDT

Paul,

Amazingly, I agree with you!! Again, I am going to continue to research the extremely deep seeded issues at hand with the Shriner's but I would really like to see both sides of the story on air. Let's show all sides and let the public decide for themselves, so we can all take a stand from an educated point of view. I, of course, want only the best for my friends (thank you for adding them to your prayer list) and believe they are smart people. If they have somehow been duped, then I am angry. I feel that the piece needs to be aired, and it sounds like you guys have the pull to do it. If something needs to be exposed, let's get it done. If indeed you speak the truth, the networks should have no problem with it whatsoever.

#18 - Fri Nov 5, 2010 8:04 PM EDT

Oh and Sandy, would you mind not saying "the little burned kids" anymore - I find it vulgar and offensive. I also had and alcoholic mother who thankfully has rehabilitated herself, also 27 years sober, and have plenty of my own stuff going on. I am trying to respect your journalism and it would be easier to take the the personal parts out of it, so I can form an unbiased opinion in the matter. Am trying to sort through some of the links now....

#19 - Fri Nov 5, 2010 8:28 PM EDT

Kirsten,

Offer suggestions, please. Explain why this combination of terms offends you because I've been using it for years. I think that the image fits the points I am trying to make in relation to how the Shriners exploit and hide behind this image.

And let me invite you and those of your acquaintences involved with this story to start your own Newsvine site. Your feeds will appear on the MSNBC page and it might help you celebrate Alfred's healing.

Just beware of other forces who stand to benefit from his publicity.

Thank you,

Sandy

#19.1 - Fri Nov 5, 2010 9:15 PM EDT

I guess I just prefer something more along the lines of, children who have been severely burned, young burn victims, etc. When you say "little burned kids" it sounds extremely derogatory, as if they are a cult or something. Anyway, I understand your points about those who may want to gain something from the publicity, though I would caution you from using those terms yourself. Take the high road that you are so wanting to take.

I will suggest the family start a Newsvine feed, but I am most certainly not the one to do it. It's simply not my place. I tried to click on several of your links but got blank pages or one patent page that had absolutely nothing to do with Permaderm - it was some sort of engineering patent about dies. I did read a tiny portion from others who feel the stock issue is out of line, and unfortunately this lies far from my field of expertise. It did sound remotely like someone had something to gain from it, for sure.

#20 - Fri Nov 5, 2010 9:33 PM EDT

I just read the response from Zac and Graham, Al's dad and brother - please, edit what you are sending out beforehand and don't make them feel any worse than they already do. You don't realize it, but when you're dealing with immediate family members, you are treating them like members of the press i.e. "please confirm your identity" blah, blah. I don't think anyone would try to trick you into thinking they were the father of a burn victim, so please, mind your P's and Q's.

I looked at one of your other links to rense.com and honestly, all I found there were extremists who believe 9/11 was linked to numerology (I lost a brother-in-law in that horrible tragedy) and people who think Randy Quaid is A-ok!! Huh?? He and his wife have a shared psychosis called folie a deux, so again, let's not mix apples and oranges. I tried to copy my friend's FB message to you, so you could "dispel" the evil rumors but it won't let me copy. Anyway, she is entitled to her feelings so leave it alone.

#21 - Fri Nov 5, 2010 10:44 PM EDT

Kirsten,

What kind of journalism experience do you have? Part of my job is verifying sources. Period. I may or may not be dealing with immediate family members. If they choose to come on my site and make comments in my comment section and want to engage in public dialogue, I want to make sure they are who they say they are.

You brought up the Facebook posting. Please provide the Facebookers name so I can see what she is writing about me.

Thank you,

Sandy

#21.1 - Fri Nov 5, 2010 11:35 PM EDT

Kirsten,

I just found Michelle Schillaci Brethauer's account on Facebook but it's open to only friends and family. I'll contact her directly.

Yeah, it's kind of funny about how my work is picked up by all sorts of conspiracy sites. Must be because the Jesters and Shriners are Master Masons, though I don't focus too much on it. I'm not sure about the others, but I know that millions have read my stuff on Rense's site. I've been interviewed on his show as well.

You might want to check out this other radio interview I did with a show out of Sweden.

No need to shoot the messenger.

Keep coming back,

Sandy

#21.2 - Sat Nov 6, 2010 12:02 AM EDT

Here's Michelle Schillaci Brethauer's Facebook page and comments to date.

So, ABC was doing a story on Alfred? That's news to me.

How quickly these people dismiss four and a half years of work documenting the biggest nonprofit fraud of our time and scoff when I advise them to read my findings before jumping to conclusions.

Sad but typical.

Sandy

#22 - Sat Nov 6, 2010 12:18 AM EDT

It's okay, since Michelle is my friend, you don't have to post the FB status to me, particularly since you probably saw that I was one of the responders in the feed. I ran into her today, and I'm beginning to feel like it's a she said/she said situation. My husband has actually enlightened me to some of the points you are making as being partially true. There probably are groups that are trying to make themselves look good and charitable while doing so in an unethical way. Unfortunately, this happens all the time!!!!!

My whole point in this is to protect my friend and her family and not make them feel like the bad guys. Poor Al did not have enough of his own skin to graft and in fact, they had to scalp him six times in an attempt to get the job done. When they found out about the PermaDerm, it was, in their eyes, their only hope. He needed a way to regrow his own skin and this seemed like a solution. I see that they are now trying to bring to product back to market and hopefully it will be done properly this time.

I also wish that you would get your stories on the news, not regarding Alfred in any way, but simply outing the Shriners, as it were. If this is all indeed true, it needs to be headline news, not tucked away on obscure websites. Not everyone gets their news this way.

I thank you for your responses and for hopefully finding a way to be compassionate to those involved, perhaps thinking of how you word things in the future, while also doing a stand up job of blowing the whistle on those who deserve it. I will look forward to seeing your newspiece on television in the near future.

Regards,

Kirsten

#23 - Sat Nov 6, 2010 6:41 PM EDT

http://www.benzinga.com/press-releases/10/10/c564788/sci-fi-like-tissue-engineered-skin-substitute-may-push-micro-cap-stock-

Kristen,

I would suggest that you go to these sites and spend some time:

http://www.hotstockmarket.com/forums/showthread.php?t=82160

http://www.tradingmarkets.com/news/press-release/stem_stem_wdst_sci-fi-like-tissue-engineered-skin-substitute-may-push-micro-cap-stock-much-higher-1268673.html

http://markets.financialcontent.com/mi.charlotte/news/read?GUID=15355660

http://www.kten.com/Global/story.asp?S=13451937

http://www.kcautv.com/Global/story.asp?S=13427364

You, your friends, and the Real family have been/are being used. Sandy in her research into PermaDerm ran across the announcement of the upcoming ABC story into PermaDerm were it was being used to promote the sale of Regenicin stock. They stated in part "Regenicin is preparing to advance this ground-breaking technology to commercialisation with the full support of the U.S. military. We have confirmed that plans for a press conference to announce this news are underway. In fact, a source sent me a yet to be circulated copy of the invitation to the event- which will be hosted by Lonza in Walkersville, MD. Once publicly announced, the press conference could become a major news catalyst involving grants and/or government orders for technology. That event, according to the invitation we received, is scheduled to take place on Tuesday, November 9 and we would expect that either Lonza or Regenicin will be issuing a press release to soon."

Then they stated "We have been told by several sources that ABC World News with Diane Sawyer will feature a segment about this break-through technology on tonight's (Friday night's news) broadcast. CBS and other networks are expected to join in covering the story in the days ahead.

In July, CBS' 60-Minutes' Morley Safer filed a segment focusing on how U.S. soldiers return from battle horribly maimed. "There is only so much medicine can do," said Safer. "But we may be on the path to a new technology in which quite literally, we will be growing new body parts."

What better way to launch the press conference and Regenicin than an ABC News story on Alfred Real and how his life was saved by PermaDerm?

Nowhere did the reports mention Alfred Real. This is all a big marketing push and that is all it is. Self interest on the part of Regenicin and the exploitation of a poor burned kid and his family. They needed to shut Sandy up and what better way that using the same tactic that worked on the FDA? Make her the bad guy (as all of you posted on Facebook). Change the focus from what Sandy was reporting to her supposedly stopping ABC from presenting Alfred's story. Have the family and friends attack her and call her evil. The true evil are the puppeteers.

I have a question I would like to ask you and that is, who mentioned to the Real family that Sandy Frost was trying to stop ABC from telling Alfred's story? Who sent them to her web site?

Nowhere was Sandy's story linked to Alfred. Not until the family and friends made posts on her site. What was the purpose of telling the family about what Sandy was reporting? She had not targeted Alfred, she was targeting corruption, shoddy research and the use of kids as guinea pigs.

You need to take a long look at the intent in focusing the family's wrath on Sandy.

You answer to these two questions would be greatly appreciated and should help show exactly what/who is behind all of the smoke and mirrors.

Thanks,

Paul Andrew

1 vote

#24 - Sat Nov 6, 2010 6:50 PM EDT