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Thursday, November 29, 2012

Six steps to fighting non-compliant cell therapy treatments. --- The stuff of grey shades, spades, ivory towers and (ahem) balls.

 

Today an article entitled "Professors Critique Stem Cell Medical Tourism" appeared in the online version of The Harvard Crimson summarizing a recent panel discussion hosted in least in part by Harvard Law School assistant professor I. Glenn Cohen and University of Alberta law professor Timothy Caulfield.  The article concludes thusly:
The panelists emphasized that more accurate information should be provided to the public regarding stem cell treatments.
Certainly what Cohen and Caulfield concluded is true.  It has now been true for several years.  We keep saying it.  But are we listening to ourselves?  Are we doing anything meaningful to address this?  If so, is it enough?

Sadly (in my opinion, of course) the answer is 'not nearly enough'.*

For several years now, experts and organizations in the cell therapy sector have been saying that more must be done to educate and assist patients who are seeking stem cell or other cell-based treatments which do not comply with existing regulation and/or widely accepted medical or clinical research practices (hereafter called "non-compliant cell therapies").  

In my opinion, attempts to address this need by the sector's professional organizations, while important, have been unnecessarily feeble, not gone nearly far enough, and legitimately appear by many to be high-minded and pedantic. 


Almost all efforts to-date to address this issue by ISSCR, CIRM, ISCT and others including authors such as Caufield - as laudable and needed as they are - have been focused on helping distinguish between compliant and non-compliant treatments (and providers).  This is certainly much needed.  But what is left, I submit, is an even greater unmet need.


What almost all efforts to-date have failed to recognize or address is that where real help is needed is in helping patients distinguish between the many shades of grey among non-compliant treatments (and providers).

Emerging organizations like ICMS (now in partnership with AABB) have recognized and attempted to address this unmet need through a commitment to create some level of certification, accreditation or standardization of clinics participating in this business of selling non-compliant cell therapies.

While their intentions appear on-target as one meaningful way to address this unmet need and certainly their willingness to tackle this issue in a bold way is to be lauded, the ICMS is inexperienced and underfunded.  I remain hopeful that now through their new partnership with AABB they will be able to provide something that really addresses this unmet need but the jury remains out on whether they will succeed.

Anyone who has followed this blog and/or my threads on LinkedIn know I have been thinking about and discussing this issue for some time. In a desire to move to very concrete suggestions, I want to recommend the following 6 steps to my industry colleagues and professional organizations:

1.  50 shades of grey. Let's admit that this issue is not black-and-white but, as is almost always, involves a broad spectrum of grey in the middle.  

In addition to helping patients distinguish between compliant and non-compliant treatments (and providers) there are a lot of ways to help patients distinguish between non-compliant cell therapy  treatments (and providers) which are more or less risky.  

Let me use examples.  

On the one end of the non-compliant spectrum I would put forward a clinical like Okyanos Heart Institute which (as I understand it) intends to provide cell therapy treatments in the Bahamas to US patients using the Cytori system for cardiac conditions as soon as such treatments are perfectly legal and available to European patients but years before such treatments will be available in the US.  

Non-compliant?  Yes.  But certainly no evidence I'm aware of to support a belief that seeking treatment from them would be any more risky than travelling to Europe to receive the same treatment in a manner perfectly compliant with European regulations.

On the other end of the spectrum are the kinds of clinics highlighted recently by 60 minutes or which are the subject of ongoing lawsuits.

In between - in my opinion - are clinics like Stem Cell Institute and StemCellMD.

2.  Step out of the ivory tower.  Let's recognize that in certain circumstances patients are going to go pay for non-compliant cell therapies and we must do more to help these patients than simply shake our finger and tell them they mustn't.

For some, helping patients distinguish between the better and worst non-compliant clinics might involve a fair amount of nose-pinching but this is the equivalent of the methadone clinic for heroine addicts.  By supporting the better of two evils we are not endorsing it as 'good', we are simply recognizing it is better.

This is a recognition that we cannot just abandon people because they made (or are going to make) decisions with which we ultimately disapprove.   It is a recognition that sometimes the most righteous thing to do is not only to help people do what we would ideally want them to do but to help them do the best they can in their circumstances and on their terms - even terms with which we may ultimately disagree.

3.  A risk-based strategy.  Let's recognize that even the FDA triages their response to non-compliance and we would do well to do the same.  As a regulated industry we are perfectly comfortable with risk-based assessments and it should be applied here.  

Rather than treating all non-compliance as equally evil, let's apply some risk-based analysis to the situation and develop a strategy to root out the worst (highest-risk) offenders.  

4.  This is not just about tourism anymore - the problem has come home to roost. Let's recognize that this is no longer just a problem of patients leaving a regulated jurisdiction seeking a non-compliant treatment in a jurisdiction with no or more permissive regulation.  

Non-compliant treatments are growing rapidly even in the most highly regulated jurisdictions.  No where is this more true than in the United States.

5. Take responsibility.  Let's recognize that we cannot expect our regulatory enforcement agencies to do it all.  They are under-staffed and under-funded.  They - and the people we all serve - need our active participation in dealing with offenders and those risking patient safety.  

From a self-interested perspective, we owe it to our industry to help crack down on those who put the credibility and legitimacy of cell therapies at highest risk.

6.  Let's grow a pair and call a spade a spade.  If a non-compliant clinic is providing treatments that we believe represent a high-risk to patient safety and the industry's credibility, let's have the b*lls to call them on it.  They can't sue everyone.  

ISSCR backed down on their stem cell tourism initiative after being threatened by lawsuits. Who has stepped up in their absence?  Individual bloggers and authors like Paul Knoeplfer, Alexey Bresenev, Leigh Turner, and myself all who have been threatened with litigation several times for having the audacity to call certain non-compliant clinics out for what we deem - in our own risk-based analysis - to be the worst offenders.  

By way of example, several of my colleagues have recently committed to doing all they can do to call out David Steenblock and his non-compliant cell therapy treatments, many of which are provided at his clinic in California for a plethora of conditions.  In their opinion, many of his treatments represent some of worst examples of non-compliance in the United States right now.  There are many faces or fronts to his practice including www.davidsteenblock.comwww.stemcellmd.org, www.strokedoctor.com, www.davidsteenblock.net, etc.

If, as an industry, we act with more cohesion (collaboratively applying a risk-based assessment of non-compliant clinics) and speak with a more cohesive voice in terms of calling out those clinics and treatments which we conclude pose the greatest risk based on an objective set of criterion, this will present a multi-pronged, formidable and existential threat to clinics that they can't ignore or threaten away.

___

I will be taking these 6 recommendations to any organization who will listen.  I hope you will consider doing the same.


In the meantime - as always - I welcome your comments.

___

* This is my opinion not necessarily the opinion of any clients I represent or organizations I serve. Judge me - not them - accordingly.



19 comments:

Alex Moffett said...

Dear Lee,

I think this is an extremely good discussion topic and that the first step is basically to initiate that, an open discussion.

Hopefully there will be significant interest in discussing the many complex and interrelated issues, facts, operational motives, regulatory flaws and biased opinions at play. In addition, we need to review the emerging cell technologies and our newfound abilities to utilize these technologies for optimal safety and efficacy in the translation of innovative and rational cell therapies.

Personally I can contribute a great deal of information based on my own experiences and observations as the former CEO of Beike Holdings and my many unique experiences while both studying and attempting to reform and optimized their business model. My goal was to move this toward accepted international standards of good cell practice, acquire appropriate certifications, operational transparency and the integration of evidence based scientific documentation to support and elucidate the truth, risks and real clinical benefits. I am happy to do so and hopefully also clarify a number of misperceptions or intentional misrepresentations that have been left unaddressed.

Since separating from Shenzhen Beike in 2010, we have moved on to study the other major players in cell-centric medical tourism. Beginning with the motives, specific business models, sophistication of the cell technologies, clinical practise, oversight and documentation. Next to the ethics pertaining to commercialization and patient ROI and expectation management.

My plan has always been to design the most complaint and effective business model possible in order to accelerate Ministry of Health level approvals for new cell therapies and to do so much faster and for far less money than the process being promoted by the US FDA. Many aspects of which are out dated and not appropriately applied to cells as compared to Pharmaceutical drugs or other therapeutic agents subject to FDA regulation.

The discussion needs to be focused and broken down into a list of relevant issues that can be addressed one at a time and then in combination as they affect one another. Clearly this is the really one of the most complex parts of the industry’s analysis of this global phenomenon, as it developed, and now exists at the end of 2012.

In relation to Dr. David Steenblock, who you specifically targeted in your blog, I would like to inform you that after over 40 years of pioneering the “wellness paradigm” and integrating numerous new advances into conventional medicine, he is retiring this month and closing his clinic.

I believe he will continue to run is prolific Steenblock Research Foundation (which I have visited and was left speechless by of the amount of peer reviewed data and world renowned journals and text books he had on file- and had read!), he will lecture and help teach the next generation of “Regenerative Medicine Doctors and Nurses”. Consequently, there is really nothing to do in relation to his practice.

But his experience and knowledge is unique and at some point I will open a discussion of CFR 1271.XX and specifically 361 & 351 and how this FDA concession is really more of a “Trojan Horse” strategy designed to confuse and delay the coming age of cell based Regenerative Medicine in the United States.

I am very interested in hearing the opinions and proposed topics from the other readers of your blog and its associated Linked-In discussion groups.

Alex Moffett, CEO
SiriCell Technologies, Inc.






Amy Price said...

I like the risk based assessment approach and triaging this . Lets move far away from personalities and profits and simply present the math. In a few years the Steenblocks, people that mistreated me and Bieke too will be retired, dead or out of the picture but in the meantime the problem remains unsolved and we are accountable. Science, people and health are more important than this.

Even in FDA letters there are massive differences like one place gets cited for putting the cells in an unlabelled blood bag and misbranding but the other has clear contamination like insects in their product and bad medicine. I think the public is harmed when we do not have standards to discriminate.

Barbara Hanson said...

One thing that is apparent is that you may lack information that would be needed to keep up with the ever changing landscape of stem cell clinics that are operating in the U.S. and offshore. While you mention going after Dr. Steenblock, you didn't know he was retiring.

BioRegenesis is another example. The company is still operating under a different name. Until the lawsuit, I don't think there was awareness except from patients about the clinic. There are also other clinics/doctors doing treatments who simply do not advertise, but they are out there and they are treating patients.

I am glad to see that there is finally recognition however that strict prohibition is impossible and that patients may appreciate some guidance, not judgment and "protection". Guidance can't just pop up though every time a clinic makes the news, however. I personally don't see how you would keep up with clinics or individual doctors that you don't know about who are treating patients with stem cells.

Patients want safety, but they also mistrust those that quickly condemn any effort to help them. Celltex is a good example. In record time, this clinic was pounced upon by some in the industry and the FDA then got involved. Some patients were cut off in the middle of treatment. One such patient became suicidal because of it. Patients liked the idea of an IRB and the way Celltex was tracking them. Many were reporting improvements. They hope the clinic can resume treating them in the U.S., but would not hesitate in the least bit going offshore if Celltex should decide to open a clinic in Mexico for instance. To me this says, that closing this clinic instilled no fear in those wanting to get the treatment they were offering. Why this is, is what you will need to figure out when you want to come up with a program to guide patients. While it may sound like a noble venture to try to guide patients, I'm not sure how great an impact it would have. Patients can sue for medical malpractice in the U.S. Doctors must be licensed in the states they practice in. This protection is already available.

I do agree with Alex Moffett that accepted international standards would be advantageous. It would be nice to have something like the Good HouseKeeping seal of approval when deciding where to get treatment, however, if the program is too complicated, individual doctors may just ignore it.

Joel Lesser said...

Dear Lee,
I like your initiative, but I have some disagrees about the manner.
Some people are arguing that to try to guide patients could be a noble venture without any great impact, reminding the following:
- Patients can sue for medical malpractice in the U.S.
- Doctors must be licensed in the states they practice in.
- Some protection is already available.
But this protection can unfortunatly arrive too late. To sue for medical malpractice does not get you out of your tomb!
And SC therapies is a new, rapidly evolving field, requiring frequent updates.
The availability of Guidelines would give the opportunity to the doctors and the patients to be more aware and involved about the safety of the procedures.
I am convinced that self-care is the only way to evolve, but information is a prerequisite.
Do not ask unaware people to be responsible....
So, Yes, guidelines are necessary. Information is also the best way to fight risky therapy treatments.
Because I have to re focuse the debate.
The concern is not compliance or no compliance. The real concern is safety. What is your intend by entitling fighting non-compliant: to be the judge of SC industry?
Is it why you are giving names instead to talk about the malpractices? Sentencing people and companies without trial.
If I can give you a tip, is to avoid to name, the best way to just get ennemies. So better to explain, describe and expose the facts. Just let the FDA, and other Health organisations take their reponsabilities and do their job. It would be enough to inform the patients about what are the bad practices and associated risks.
I stay at your disposal for further discussion on this subject, as well as to bring my help to your initiative.
Joel Lesser

Henry E. Young PhD said...

I have always believed that any person or clinic offering stem cell therapy should be under an objective oversight committee, such as a hospital institutional review board (IRB) or an industrial institutional review board. And any entity that does not abide by that precedence should be advertised by such to current and future clients.

Lee Buckler said...

Henry aren't you the same Henry Young being sued for administering a non-compliant cell therapy allegedly without any of the "objective oversight" you are here espousing?

Medical Malpractice Lawsuit Following Death of Stem Cell Recipient

Lee Buckler said...

I certainly agree with the tenor of many of the posts so far that this is a multi-pronged effort. This certainly has to be much less about naming names and much more about providing guidance, tools, resources that will allow patients themselves to distinguish between those non-compliant providers which are truly risky and those which appear to be following many of the safeguards we associate with good clinical practice.

Henry E. Young PhD said...

Lee,
To give you the correct perspective: I was requested by Barbara Hanson to formulate a list of recommendations, utilizing my adult stem cell technology, to be utilized for the treatment of participants with COPD. I did just that and gave Barbara the list. Four items on that list which I emphasized over and over were #1 IRB oversight, #2 Explaining risks versus benefits of the procedure(s)to the participants; #3 use of a Class-II BioSafety hood to process the stem cells, and #4 Post-treatment followup of the participants. The owner of the company, Barbara Hanson, and the attending physician chose to ignore those particular recommendations, along with a few others of lesser importance when they treated their patients. I was never a member of the company, but rather an unpaid consultant. I had two additional separate interactions with BioRegenesis - three times as a patient getting treatment myself, I am stage-IV SLE, and running an IRB-approved clinical trial for Parkinson's disease, which finished last year. I submitted the results recently for publication " Adult stem cells: bench-top to bedside". The results were not what I would call stellar, but they were promising. Enough so that my collaborator wants to apply for an IND FDA IRB-approved Phase-I placebo controlled clinical trial. Now you have the REST of the story.

Lee Buckler said...

I do appreciate hearing your side of the story Henry. I want to make it very clear that it is not my intent to make accusations. We'll leave that to the regulators and litigants. A mere reporting of alleged accusations does not equal their endorsement. Similarly, an observation of non-compliance is not an accusation it is simply an opinion about whether or not a particular action or product complies with applicable laws and regulations.

For example, if I were to opine that the treatment of COPD patients in the United States with autologous apheresis-derived 'stem cells' of any type is a treatment that must be under IND/BLA or it is non-compliant....that is not an accusation that is a statement of legal opinion. It is my opinion that if you were involved in any way in the provision of this kind of treatment without it being under IND than you were involved in the provision of a non-compliant treatment.

I make no accusation regarding the product's effectiveness or safety and certainly made no accusations regarding anyone's clinical standards or the propriety of their medical practice. I restricted my opinion to whether or not the treatment was/is, in my opinion, in compliance with current regulations.

Mallory E. McLaren said...

Lee,

As I would expect, this is a thoughtful article and touches on the fundamental concept of trust: something that patients will need to have if the spectrum of regenerative medicine treatments and therapies are to take their rightful place in 21st century medicine.

We need to take a hard look at the motivations that entities like the FDA have. Can we be sure that the compliance standards the FDA et al sets—which set the bar for everyone else—are really the most appropriate? Can we be sure that those standards haven’t been set with the goal of making it difficult-to-impossible for new and novel modalities of medicine to emerge in a meaningful way? The bottom line is that, in the main, novel medical innovations aren't likely to to come in the main from Big PhRMA. Follow my stream of logic.
1. Generally, Big PhRMA’s motivation is to create blockbuster drugs and vanity therapies and pills and drips and devices that merely treat, but not to truly cure patients.
2. Big PhRMA has captivated the focus of the FDA many years paying of PDUFA-related fees for such treatments to receive hasty approvals. Those fees constitute a huge chunk of the FDA’s funding, and the FDA has geared itself in a very fundamental way towards PDUFA-related approvals, at the expense of many other priorities. Why? Because in 2010, for example, the FDA collected around $850M in PDUFA fees. Those fees, on a per-payment basis, are so steep that many innovators are priced right out of the system.
3. Big PhRMA interests instigated the PDUFA legislation.

Ergo-- the effect of the Act has been to exclude smaller players from being validated by the FDA since the fees are so high. Just high enough to keep Big PhRMA’s status quo alive—conventional drugs and devices and biologics that aren’t really transformative in any meaningful way.

This means that we have to be extremely diligent and critical in our thinking about what “compliance” means, and why those standards have to be followed. Lee is right that the sector needs to band together, but we must do so not just for the reason of weeding out the snake oil dealers. There are well-established interests in the biomedical world, that are wrapped around powerful governments like a big snake, and even if all the bunk clinics are put out of the business, our fundamental challenge still lies before us. How the “fourth pillar” global community of cellular and molecular medicine works together to establish its rightful and permanent place in medicine and biology, with the regulators or powerful nations, will be the real measure of our success.

I hope my response doesn’t come across as missing the point entirely, but I hope for the reader to see the forest for the trees.

Mallory E. McLaren
3L - Seton Hall University School of Law
Health/Biotech and Regulatory/Legislation Concentrant
Class of 2013
LinkedIn: http://www.linkedin.com/pub/mallory-e-mclaren/5/a72/89b

Barbara Hanson said...

Dr. Young is being sued by the husband of a patient treated with his protocol. I am not being sued. I am not the owner of BioRegenesis. This is the link to the information from the Nevada Secretary of State. https://nvsos.gov/sosentitysearch/CorpDetails.aspx?lx8nvq=sCcIN4R0vhgRj8TBNFsMvw%253d%253d&nt7=0 The company has changed names from BioRegeneis to Heygen (which was incorporated separately) (HEY being Henry E Young's initials)to PluriGenesis.
I would caution Dr. Young to check his facts before posting erroneous information on the internet.

Barbara Hanson said...

If the link to the Nevada Secretary of State site doesn't work, here is the information. Anyone can do their own research on this as well. The information is available online.

BIOREGENESIS INSTITUTE, LLC


Business Entity Information
Status: Active File Date: 1/7/2011
Type: Domestic Limited-Liability Company Entity Number: E0009532011-9
Qualifying State: NV List of Officers Due: 1/31/2013
Managed By: Managers Expiration Date:
NV Business ID: NV20111018206 Business License Exp: 1/31/2013

Registered Agent Information
Name: GUY MANNING Address 1: 3428 MANZANO CIRCLE
Address 2: City: LAS VEGAS
State: NV Zip Code: 89121
Phone: Fax:
Mailing Address 1: Mailing Address 2:
Mailing City: Mailing State:
Mailing Zip Code:
Agent Type: Noncommercial Registered Agent
View all business entities under this registered agent


Officers Include Inactive Officers
Manager - LAWRENCE M HOWARD
Address 1: 1000 NORTH GREEN VALLEY PARKWAY Address 2: SUITE 440-115
City: HENDERSON State: NV
Zip Code: 89074 Country: USA
Status: Active Email:
Manager - ROBERT C MCCLOY
Address 1: 1000 NORTH GREEN VALLEY PARKWAY Address 2: SUITE 440-115
City: HENDERSON State: NV
Zip Code: 89074 Country: USA
Status: Active Email:

Heather said...

Hey Lee,

Do you think there is a way to guide patient's to the least worst treatment without legitimizing it? I feel like any comment by the legitimate stem cell community will be taken by patients as an endorsement. While it may not be possible, it seems like the best way through would be to reform the FDA approval process to allow treatments that may or may not improve someone's life expectancy/quality to be tried under some sort of provisional license. Wouldn't it be better to allow someone with ALS who wants to try an experimental therapy go forward after minor vetting from the FDA?

Heather Scott, PhD
Genea Stem Cells

Lee Buckler said...

Heather,

The concern that by providing patients with useful tools to use in deciding about/between non-compliant cell therapies we will be legitimizing all of them is a real one but I submit the benefits outweigh that cost if done correctly. We have used that excuse as a rationale for inaction for too long.

I agree that like most complex issues the solution is not simple and needs to be multi-pronged. I also think there is more regulatory agencies can and should do to allow enhanced/advanced access to innovative therapies under controlled conditions.

While lobbying the agencies for such change, however, patients are seeking non-complaint therapies and I think there is more we can/should do to help them.

Jennifer Ziegler said...

I like what you are saying Lee, but it appears to be "johnny come lately" as far as patients are concerned. I mean no disrespect whatsoever, but because of the erroneous regulations placed on a patients own cells, and the lack of treatment options for many diseases in the US, we are going to leave the country no matter what the professionals say. Had some of you spoke up 10 years ago, we might not be in the predicament that we are in today. (and maybe you did???) Warnings from stem cell academia go in one ear and out the other. Patients listen to other patients period. We fully understand the risks, the benefits, what clinics are good, what doctors have proven results. We've been to the clinics that you all have not. We've received the treatments that you all haven't, we know the doctors personally that you all do not. We are connected to a network of patients who share everything. So...personal patient experience trumps any warnings that academia might put out, and there in lies the problem. I'm not pointing fingers….just stating patient facts. So, how do we bridge the gap when the FDA won't even hear about something like progressive approval? How do we bridge the gap with a scientists that truly believe MSC's cause cancer? How do we repair the lack of trust patients have in academic opinions? I like all your ideas, but wonder if it's too little too late. The flood gates have been opened, and because of all the positives that patients are experiencing, nothing will stop us from getting treated at an overseas clinic of our choosing. Thanks for the post!

Lee Buckler said...

Hi Jennifer. I like your comments.

Firstly, let me admit where I think I went wrong with this post.

1. Despite the post's title, what I'm trying to propose is not about "fighting" clinics or treatment or patients seeking them but about arming patients with making better decisions about which clinics to go to. I agree that the floodgates are open and there is no stopping so its now about education and helping them make the best decision possible.

2. As I believe I said in my WSCS2013 talk, I NOW believe the right groups to take leadership on this are NOT the industry groups I suggested but rather the patient group like the ones to which you belong. If industry can help in any meaningful way I would like to see that happen as I do believe some industry professionals can help with identifying the right questions for patients to ask and issues to watch for.

This post is NOT about telling patients not to seek treatment wherever they want. This post is about helping patients decipher which are the higher quality and less risky treatment providers out there.

I think that relative to many patients out there you are in a very privileged situation in terms of the information and network you have. I think many patients still don't know where to look for helping them decide how to decide whether or not a clinic or treatment is right for them. I think there are many people out there who do NOT yet understand how to distinguish between the higher quality and credible clinic and the type of guys who end up on 60 minutes -- because all they have to rely on is the advertising hyperbole.

I spoke just this week with a patient from small-town Canada who had done a fair amount of research but still had made very few contacts or references. I believe an online tool that helped a patient assess the quality of the clinic he is considering would be very useful.

But at the end of the day, I'm just guessing. I don't want to tell patients what would help them. I'm trying to come up with what I believe we all could do that would be more constructive and helpful - in a practical way - then what we are doing now. Because if even what you are doing now is the best way to approach helping patients my guess it is not very scalable. We need something that can education and help hundreds of patients wherever they are around the world.

Jennifer Ziegler said...

I think your title is fine! I've never gotten the impression that you are about fighting clinics or treatments of patients seeking them. I completely understand what your saying Lee, and agree with it wholeheartedly. I'm sure you're right there are many patients who aren't quite sure where to turn. I've never heard you warn about NOT getting a stem cell treatment, in fact I know you've said if put in a similar situation you would probably seek this treatment. I spend most of my day sharing my personal story, informative articles, other patient stories, informative web sites and information on relevant clinics that I know turn out positive results. I don't ever direct anyone to any specific clinic but explain that this is personal decision, and they need to do their homework….then they can make the decision that's best for them, their disease and their family. It's quite literally a full time job for many PFSC members. Then add all of our online advocacy presence and yep, I just have to shut the computer sometimes and read a book! HA! I appreciate your acknowledging that patients groups could quite possible play a vital role in all of this. We have the inside information that most just speculate about. It might be a good idea, if some actually visit the clinics, meet the doctors, familiarize yourself with the process and technology being used. I think then advice offered from academics would be taken to heart. As of now, it all comes across as 2nd or 3rd hand. A patient would rather trust another patient who's been there done that, and seen results. Thanks for your time and attention to this important matter!

Henry Young, PhD said...

Dear Lee,
With respect to the outcome of the lawsuit against Henry Young PhD. "Stipulation and Order for Dismissal with Prejudice was entered in the above action on the 28th of April 2014" by Joanna S. Kishner, District Court Judge, State of Nevada.

Henry E. Young PhD said...

Dear Lee,
As Paul Harvey would say, “… and now for the rest of the story”. The lawsuit against me was finally settled in court in 2014, as stated above. I received a letter from the court explaining the judgment and the reasons for the judgment. This is little consolation for what I was put through for three years. The individual behind the scenes that orchestrated the lawsuit sought to have me fired from my institution. Failing that due to my status as a tenured full professor, they proceeded to make my life as difficult as possible by informing bloggers, my institution, my administration, and clinical colleagues of my perceived transgressions. They attempted to have the IRB-approval for the Parkinson clinical study (subsequently published) revoked on three separate occasions during the study. My institution sought to remove a potential embarrassment (based on hearsay) by taking away my research laboratory, I am not allowed to publish using my institution’s name, my existing grants were terminated, I was not allowed to apply for any new grants, I was mandated to cease attendance of any scientific research conferences, I was stripped of my clinical affiliations, my clinical colleagues shun me, and I was relegated solely to being a teacher. Devastation occurred in my personal life as well. I am financially ruined paying legal fees to keep my good name intact. And my health, such as it is, has suffered. I freely admit that I was SLE Stage-IV, inherited maternally, until receiving autologous and allogeneic endogenous stem cell transplants based on technology emanating from my laboratory. The stress from the lawsuit and its ramifications contributed to the addition of another autoimmune problem to my repertoire, I am now an autoimmune-induced insulin-dependent brittle diabetic. So even though that individual lost their bid in court to have me ruined, in the end they got what they wanted, my destruction by proxy. They have won. My new title at the end of the 2014-2015 academic year will be Professor, MUSM, Retired. Compensation for me was never about money, I never received any monetary compensation from my associations with the companies in question. Rather my compensation was the knowledge that individuals such as myself with chronic diseases could receive a better quality of life. And now you have the rest of the story.