Installment 58 - Dr. Doug Broeska/Regenetek Cellular Technologies,Inc.
About Dr Doug Broeska
Dr. Doug Broeska is a medical researcher and Director of Neuroscience Development at Regenetek Cellular Technologies Inc. His research group performs data analysis on translational work being done in regenerative medicine using existing trial evidence that take these discoveries from the bench to the bedside, or what Max Planck referred to as `from molecule to man`. Their methods include analyzing large amounts of data, discover what’s working in clinical research techniques, and transfer basic research insights into evidence-based clinical therapies using a vertically integrated approach. The mission of Regenetek is to provide study evidence from therapeutic models from around the world to improve upon the current ineffective methods of treating neurodegenerative diseases.
Q & A
Q: While we patients are grateful to have access to offshore stem cell clinics where we can receive "high dose" or culture expanded stem cell therapy, what do you see as the future of access to this therapy in the U.S., now that the FDA has slammed the door on this?
A: That’s a great question. The answer is obviously complex and there are important issues before the US courts even now, which is a clue to the conclusion I will draw later on. But I think everyone agrees that long-term, offshore stem cell clinics are not the solution to American health issues. Why should Americans have to go overseas for stem cell treatments that are offered to other nationalities under regulation of well-controlled guidelines in those countries with different approaches to the definition of a stem cell?
Consider the now landmark Regenerative Sciences (Broomfield, Colorado) case. In 2008, the FDA alleged that Regenerative Sciences was practicing medicine without the medical license necessary to introduce a new drug to the US market. It was stunning news to everyone that human tissue could be contorted into a legal definition of a ‘drug’, but the FDA indeed followed up this accusation in 2010 by suing Regenerative to stop the clinic from performing their degenerative joint cartilage replacement therapy. At the time in 2008, what the FDA considered a ‘drug’ was the culture-expanded bone marrow derived mesenchymal stem cells (MSCs) with autologous platelet lysate. By the time the FDA finished their definition of a ‘cell drug’ a few years later, they expanded it to also include a simple stromal vascular fraction (SVF) aspirated from the patient’s own bone marrow and re-infused back into the same patient without any changes made to the cell samples (no growth expansion techniques, etc used). Regulators have ruled and the courts have now upheld that even the infusion back into the patient of centrifugally separated and washed cells as performed in Regenerative Sciences’ protocol is comparable to the administration of a drug because adult autologous stem cells that are re-infused into patients represent an ‘article that is intended to treat, cure, and mitigate diseases and to affect the structure and function of the patient’s body’ therefore conforming to the definition of “drug” (or at least ‘drug’ as interpreted within the cultural belief structure of the FDA). Furthermore, the FDA contends that stem cell therapies as practised by Regenerative Sciences are not based on evidence, and certainly not proven as safe. In fact, Regenerative Sciences was practising a safe therapy that had been used effectively for many patients, and they were following those patients for a 5-year period as part of their research.
In a sense, withholding effective medical therapy makes this a civil rights issue in the US, which I will touch on later. The FDA has ruled that stem cells are in the nature of drugs but in doing so, they certainly seem to have exceeded their mandate. Firstly, stem cells aren’t cultured and distributed to the public like drugs. Each patient is treated separately in the manner of an intervention, probably more appropriately described as a ‘graft’ with their own cell tissue. Questions arise as a result. Does the government have the right to regulate our own blood and cells, and especially when we have informed consent? Is this really a public health issue if FDA regulations were intended to manage the public health risk for mass-produced drugs? How can a patient-specific, protocol-specific, DNA-specific intervention (even minimally invasive) at many thousands of dollars per procedure, be in any way analogous to the injection or oral ingestion of mass-produced pills (manufactured in batches at a few cents each) taken in the same formulation by thousands of people? In taking this seemingly illogical stance, is the FDA only driven by a fierce and jealous desire to protect the health of Americans or are there other motivators?
For many years the FDA drug approval process was well-understood, accepted, and until stem cells came along, they did a reasonable job of maintaining the appearance of neutrality in contending that their regulations and rules of how they approved new drugs protected the public. I don’t believe that anyone is under the impression that the FDA does not have their own biases toward accepting evidence from pharmaceutical company trial data in the licensing of new drugs; both past and recent failures speak for themselves. The fact that the FDA has recently shortened the path and the cost burden to pharmaceutical companies in the licensing of record numbers of new drugs is also clear evidence of this.
Furthermore, many of these new drugs are designed to directly compete with stem cell therapies. And there’s no denying the serious financial risk to pharmaceutical companies if they are ‘locked out’ of the ability to sell stem cell ‘products’ that now just happen to align with the FDA’s manipulated definition of a ‘drug’. But just suppose it takes ten or fifteen years to determine if these cells may produce cancer? That certainly gives the drug companies enough time to recover investments from their current new licences.
I submit that there is a far more appropriate and cost-effective way to perform ethical research that will confirm safety and efficacy much quicker. What our company, Regenetek Research has developed, is more suitable to following patients treated with their own stem cells. Basically, it’s a long-term registry with unique web-based tracking features for all patients who have been treated with autologous cells. The tracking features and ability to load patient data into a secure database both retrospectively and prospectively by either the clinic or the patient turn each patient’s therapeutic outcomes into a Case Study. The types of data that can be loaded also produce a robust record for each patient. Should Adverse Events (AEs) of any kind occur during the 5-years or even much later, the patient can immediately make reports for adjudication. Although this type of case-controlled research isn’t currently recognized as part of the FDA process, it’s really the only one that makes sense since we aren’t talking about treating thousands of people with one person’s DNA (therefore Double-Blind RCTs are not appropriate). Using this research methodology, every person who has had autologous SC therapy can be tracked through surveys and by including other clinical tests in the data collected at intervals to identify the changes over time. Once we aggregate the patient data we can then compare patient outcomes to cohort populations such as those patients who suffer through the natural history of the disease. This type of study also conforms to well-known methods of performing medical research and rationalizes the current system as it struggles to find an effective way to produce evidence.
While we cannot by ourselves influence what would pass for ‘acceptable evidence’ in creating such an extended-registry tool that follows patients long-term and compiles data, we ardently believe that our research methodology offers the FDA a way to be more flexible in their approach to therapeutic research by using a method known as Case Study; but other respected oversight and governance societies such as the ICMS and the ISCT that approve of the use of registry information to produce credible evidence, do have the ear of the FDA and they are also given voice within the FDA. After all, these organizations exist to review the field and recommend policies. Whether the FDA is too conflicted by political and economic interests to change their policy or accept different study methodology is really the question.
Personally, I think that it may take many years and several court decisions to move the FDA from their current intransigent stance. Given that the FDA refuses to acknowledge the evidence already produced from breakthrough clinical trials and instead warns the American public that ONLY scams exist when it comes to therapeutic strategies involving stem cell intervention for many diseases, it does not auger well for policy change anytime soon and imposes a considerable bias on the American public. In the meantime, we will keep on producing the data demonstrating safety and efficacy through our case studies on therapeutic stem cell interventions for various diseases. This data does represent evidence.
So to your point, fortunate patients who can afford stem cell therapies that are seen as safe and effective under other medical systems will for now, simply continue to leave the US to access these therapies in other jurisdictions. I do not see this changing anytime soon. However, the inherent danger in regulating human stem cells in the US for the ultimate benefit of the pharmaceutical industry (whether by design or unintentional) will also effectively deny these therapies to seriously needy patients who cannot afford it. This not only entrenches a two-tier medical system based on class, but denies basic human rights to patients of less fortunate means. Whether this angle represents a twist in the road ahead through the courts that will lead to quicker approval of stem cell therapies in the US is anyone’s guess. Anything is possible where both stem cell research and its clinical application have become politicized, socialized, and polarized with every facet and interest group in society, lay and professional alike, having their own recognized and vocal opinions.
Q: You have mentioned that you have a data based platform for a registry - has it been started?
A: Yes, we are in early stages. Regenetek Research has launched a beta test of the Registry with patients from a single clinic to deal with technical issues. We are ready to launch the first version and have a number of hospital and Registry clients now lined up. I cannot disclose who they are at the moment until agreements are signed as NDAs are still in effect, but I am confident that we will have a global presence within the next 90 days. I have intentionally addressed most of my answer in the next question, number 3.
Q: Can you address any possible solutions for organized follow-up for stem cell patients being treated at various clinics around the world?
A: I have just returned from the BIO-TECH convention in Chicago (April 22-25) where we had meetings with groups that ranged from large hospitals, to major drug companies, to the FDA. Our company, Regenetek Research has launched a web-based tool designed to track and follow patients from a world-wide population. The enthusiastic response we received from seemingly far flung interests in the medical industry exceeded our expectations. It seems we have developed a service whose time has come.
With patients seeking cell-based therapies having to travel so far for treatment, it’s obviously not cost-effective for clinics to attempt to follow each one from a distance. Even if clinics attempted to case study these patients, the ‘lost-to-follow-up’ would be staggering and the study wouldn’t be worth pursuing. As these therapies are now happening world-wide in hundreds of clinics, potentially rich data sets are being lost with every patient who isn’t being tracked and followed by some method of data capture. Stem cell therapeutic clinics’ claims of efficacy are baseless even with video demonstration of success because the data isn’t captured within a study; evidence is lost or not credible and stories of success are anecdotal.
We are currently working with the International Cellular Medicine Society to extend functionality of their patient registry by creating applications that allow long-term tracking, reporting of adverse events and the collection of much more rich data than a simple patient registry is designed to do. We do this by giving every patient a web-based dashboard that allows them to answer survey questions at intervals, communicate with their clinic doctors, report adverse events immediately, upload ancillary data such as MRIs, and even see their health-related changes plotted over time as they complete their surveys. The networked infrastructure can be configured to wide variety of protocols for many diseases. It’s available through a single gateway for a population of patients who may have been treated at one clinic but come from different global regions. Adding other medically related data such as change in medication over time or prospective imaging related to the condition that is being treated and studied expands the opportunity to create better study data. Ultimately improving knowledge of safety and efficacy within the structure of a case study series will benefit clinicians and patients.
I referred to our extended patient registry case study trial model in the first forum question because it offers regulatory agencies like the FDA a more appropriate methodology for reviewing outcomes of patients treated with their own stem cells. In fact where the cells being transplanted are unique to the patient, I don’t really see how it’s appropriate to do it any other way. A randomized control trial (RCT) process such as the FDA is suggesting, is not applicable where the results cannot be generalized to patients; in fact, heterogeneity of patient tissue would be cited as the reason for an alternative to the RCT. The summation of results from a series of case studies provides reliable data in proportion to the number of responders, particularly if qualification criteria, therapies, and outcome measurements are standardized. A good case can be made for the type of case study models we are promoting to register the results of ‘n-of-1’ stem cell trials, linked to the certain diseases of the subject population.
I believe that there is another, more acute need for this service at the moment. Just over the past 3 or 4 years, Intervention Radiologists in the US and elsewhere have been performing the ‘liberation procedure’ (expansion of neck veins) on MS patients (with diagnosed CCSVI) by the tens of thousands and have been paid hundreds of millions of dollars for these surgeries without any evidence that the therapies are effective. I am not aware of any IRs who are currently following their patients. I would like to propose the use of our software for any individual IRs or IR groups performing the surgeries so that they can more effectively follow their patients. The per-patient cost to follow a patient for 5 years is minimal and a small fraction of what they take into revenue from each patient. With the help of the clinic, and with informed patient consent, my research group would also go back to the beginning starting with the patient’s medical record and diagnosis, record of the therapy itself, and subsequently contact each patient to capture their data retrospectively. From the outset, we give each patient an internet-based dashboard and the ability to login and chart their progress at intervals over 5 years. With the clinic as the sponsor, we could then build accurate data on the efficacy of the liberation therapy as a strategy for MS management, including charting the adverse events and other complications for 5 years. I believe that in the case of an experimental procedure, the Interventional Radiologists as group who are performing this therapy have a responsibility to follow their patients to chart exactly how they are doing post-therapies, and develop evidence on safety and efficacy from the case study series. Otherwise, all we have is hundreds of millions of dollars spent on anecdotes. We have no registry and no venue for reporting adverse events. As much coverage as there is on social media sites established expressly to cover CCSVI news, there is no clear consensus as to whether this procedure works. Data from a large sample such as this could have far more reach than the small trials that are/were going on in Newfoundland and Albany (now finished, no data or interpretations published yet). Alternatively, if the IRs performing the interventions did not want to participate, Regenetek Research could create a world-wide registry for the patients through an MS Society.
As to the question, Regenetek Research is willing to distribute the tools to clinics and patients to study the data in an organized follow-up of MS patients having had liberation therapy. If anybody out there besides me thinks this is a good idea and of therapeutic value, let me know.
Q: I've recently become aware that companies like Stem Cells, Inc. and institutions like UC Irvine are using stem cells from the brains of aborted fetuses. I've always been secular and pro-choice, but this just seems grotesque and puts a commercialization on fetal remains. Is there any scientific rationale for this, it the diseases being studies like Alzheimer's can be treated with adult stem cells?
A: I am aware of many past studies that have used fetal tissue only and you may be referring to the one on the Stem Cells Inc site entitled ‘Engraftment of Sorted/Expanded Human Central Nervous System Stem Cells from Fetal Brain’ published in the Journal of Neuroscience Research in 2002. Searches of the work currently being done at the two centers that you mention in your question will reveal the use of autologous bone marrow derived stem cell treatments for various clinical trials. Comparing the state of stem cell research in 2002 to 2013 is like comparing a Commodore 64 to an i-pad. But the science had to start somewhere. Scientists had to look through every part of the body to find the richest sources of cells and to characterize the type and number of cells found in each location. We still may be considered to be in an early stage of research but in 2002 it was assumed that allogeneic cord and other fetal parts were the only sources of true stem cells that could be expanded in vitro to provide a therapeutic dose that would continue, in vivo to divide, migrate, differentiate, and specialize into the neural lineages appropriate for treating neurodegenerative diseases. That was also before more sophisticated in vitro expansion techniques were developed. Not that long ago, autologous sources were considered to have limited therapeutic use. Comparisons between allogeneic and autologous purified non-genetically modified human CNS stem cells are still being studied. There are now completed studies showing efficacy of treatment of Alzheimer’s with adult stem cells and a number of new studies underway.
Q: Do you have an opinion, pro or con, on the addition of platelet-rich plasma to a stem cell infusion. Also, is there any benefit to hyperbaric oxygen in promoting cell growth?
A: It depends on the context of the use. Platelet-rich plasma (PRP) is blood plasma enriched with platelets. As a concentrated source of autologous platelets, PRP contains several different growth factors that stimulate and accelerate the healing of bone and soft tissue and has proven efficacy for cartilage regeneration. Studies have also allowed that it relieves pain associated with joint dysfunction. It would not be beneficial to add it to a stem cell infusion for other targeted treatments.
Hyperbaric oxygen has been shown scientifically to promote wound healing by inducing the growth of new blood vessels. To date it has not been shown scientifically to be beneficial to stem cell growth for the treatment of degenerative neurologic disorders. Although it is promoted by many as healing many systemic medical disorders, there is a paucity of scientific evidence to support their claims. My colleague, Dr. Ravi Kamepalli has done a lot of work in the area of wound healing as Medical Director of the Hyperbaric Clinic at St. Rita’s Medical Center in Lima, OH.
Q: You have been involved with CCSVI clinic in India on pioneering a three part therapy involving stem cells for treating multiple sclerosis, including extensive case histories. Can you give a quick update on that and how it is working for patients?
A: CCSVI Clinic in India has been able to use the existing clinical research data from well-known clinical trials to develop a therapeutic protocol that includes support strategies for both cervical vein expansion and myelin and neuronal tissue regeneration. I acknowledge that I was involved with Dr. Anand Alurkar in first developing the Combination Therapy protocol for MS that includes treating both cervical veins and the central nervous system (CNS).
I want to expand my answer somewhat by examining why we’ve had such success with the protocol. But firstly, regarding the ‘liberation therapy’ by itself; there is an elephant in the room that should be acknowledged by all MS patients at this point. We are far enough down the road with the liberation therapy and time has shown that venoplasty in MS patients who have occluded cervical veins as a single intervention strategy doesn’t work to improve their long-term health (as a general therapy that will be endorsed by the medical community). That is not to say that it couldn’t if it was supported by another intervention that could keep the veins open. There is clearly an association between occluded neck veins and the disease itself. What’s more, it’s been clearly established that many of the typical symptoms of the disease yield immediately upon successful retrograde pressure relief on the CNS. That was why the ‘liberation’ procedure was so popular in the first place. But it’s also been seen that in most cases the veins restenose rather soon after the procedure. The hopeful early use and promotion of stents quickly disappeared once complications arose in patients (permanent vein occlusion, death) because of their use.
Having looked at over 200 DU studies of neck veins in MS patients, I realized that just statistically, there must be an association and, if the veins could maintain long term patency, proof of efficacy for venoplasty as a therapeutic strategy for MS might stand the scrutiny of a trial. From that hypothesis, I further theorized that stem cells, used in vascular grafts (TEVG) and porcine implants that bound mesenchymal stem cells to a scaffold by way of chemotactic interaction with a cell surface would appropriately serve to fabricate a more stress-resistant vessel that maintained its new shape (by way of balloon expansion) and therefore long-term patency. At this point I’m not sure why anyone suffering with MS would have cervical venoplasty without an additional support intervention if it is known that in virtually all cases the veins return to their anomalous shape within days, weeks or a few months. I know that there are fierce patient-promoters of the current Interventional Radiologists who have built successful businesses around this one unsupported procedural protocol and presumably there is a considerable financial bias involved in continuing to treat and re-treat patients in this way. But that’s a different topic.
Beyond keeping the neck veins open, it is important to treat the areas of the CNS that have been insulted and injured by the demyelinating disease process. The key here would be to turn the disease off and repair the tissue damage that’s been done. Secondary considerations would be to avoid additional interventions.
I have written an article for the CCSVI Clinic’s website describing the early outcomes of the first 16 patients we are studying. The main feature of this investigation is that overall, patients improved by a total of 47% according to an aggregate of the 3 scales (appropriate to MS) used over an average period of 155 days post-therapies, and the average EDSS score dropped from 6.0 to 3.5.
We have also been studying outcomes for patients with ALS, MSA, and Parkinson’s disease. The research is now about a year into the use of the new stem cell line that was first isolated for use in MS patients. The clinic has made some videos on those patients demonstrating safety and efficacy. Most if not all of the patients have seen significant improvements, continue to improve, and none have needed a second intervention indicating that we believe that we have undertaken both the protocol and the stem cell lineage expansion correctly. Importantly, there has not been a single adverse event, significant, minor, unintended or otherwise. Many of the patients have made their outcomes public and also make themselves available to speak with should anyone wish to confirm the data through patient corroboration. We will be following all patients of CCSVI Clinic using the Regenetek software for five years with the further ability to register adverse events for up to 20 years.
Q: I've been in touch with MS patients since 2008 who have had expanded stem cell therapy. It seems there is about a 20% non-response rate. Do you have any guess as to why and what can improve this?
A: I am unable to comment on that statistic or its source, so I’ll stick with what I do know. Firstly, I guess you would have to define ‘non-response’, and beyond that, specific other parameters that would lead to irregular treatment outcomes (please bear in mind that no medical therapy offers a guarantee of complete success). Things that would affect therapeutic response in a patient with a chronic demyelinating neurological disease would be: the origin of the stem cells, from that source, what cells (are they ‘true’ stem cells?) are isolated and expanded to a clinical dose, how the cells are being characterized and by what measurement parameters have samples been tested prior to in vitro expansion, lab techniques and protocols for population-expansion, cell viability post-expansion, therapeutic protocols and implantation techniques, general health of the patients being treated, consistency of the cell product delivered from the lab over time, variability between labs and clinical facilities (in your generalization of ‘about 20%’), etc, etc. The variables that may affect efficacy of the therapy (the ‘response’), run into the many thousands so without considerably more definition of the question, the answer is also imprecise.
Now I’ll make an assumption that by ‘non-response’ (of therapy) in an MS patient you are referring to the absence of any neurological deficit recovery outcome in patients who have been treated with cellular therapy. For this to occur in the first place, the correct cell lineage that will result in remyelination and neuronal regeneration once the stem cells are implanted must be sourced. True stem cells (Telomerase positive cells that can become any tissue in the body and have near-unlimited potential to divide) exist only in small subpopulations of bone marrow and not at all in adipose tissue which is what most clinics seem to be using for their source of cells for expansion because of the convenience of obtaining a large sample. However, the therapeutic value of adipose-derived cells is highly limited and the International Society for Cellular Therapy (ISCT) is studying new data on efficacy. I wouldn’t expect that there would be a consistent clinical response from beginning the expansion from this source of cells and I understand that many clinics are starting with adipose tissue. As time goes on we will learn about what works and what doesn’t. The knowledge is expanding every day, but probably not as quickly in the US as in other countries. At the risk of sounding self-serving, I will say that the clinic I am working with has a much higher response rate in the treatment of MS which means that they have identified the correct stems to expand from a bone marrow-derived source and are performing the protocol following the science learned on the bench. I particularly note the recent studies of Harris and Connick that validate the science behind the efficacy of this therapeutic research.
Q: My son has a very rare genetic disorder called Pitt Hopkins. It results in severe physical and intellectual disabilities as well as lack of speech. It has been put on the autism spectrum because of the sensory and communication issues, but it is quite a bit different, in fact the kids tend to be very social. I'm wondering about your thoughts on stem cells for single gene disorders. Is this being done or given that it is a genetic disorder would the autologous cells also be compromised and therefore ineffective for stem cell treatment?
A: Yes and no. But let me explain. For those of you who are unaware, Pitt Hopkins (PTHS) is specifically caused by a genetic mutation in the TCF4 gene, or a deletion of the chromosomal region in which TCF4 is located, and is considered to be a single gene disorder. As such, most affected individuals result from a "De Novo" mutation or deletion and are a single occurrence within a family. Treatment of single gene disorders in general and Pitt Hopkins specifically, falls within the domain of Genomics and Gene Therapy. Autologous stem cells in the early research phases have not been generally used to re-program the gene sequencing and fix genetic mutations, even if the stem cells are normal, as they likely would be.
Whereas it is theoretically possible to utilize this treatment approach for single gene mutations such as Pitt Hopkins, the area of research and treatment has focused on the much more common genetic entities where inheritance and prevalence are much higher, such as Down's syndrome. Given that Pitt Hopkins is such a rare and random disease occurrence (one of the so-called ‘orphan diseases’), the research money is most unlikely to be channeled into this area at this time. I note that through the Pitt Hopkins Research Foundation website, the investigations into the disease are very early stage and the research grants are meager.
Basically this type of research is still in the very early phases of Translational Research and in the case of PH more likely to be possible but not probable. To my knowledge there are no regenerative research studies being considered within this area of treatment. Periodic re-evaluation with a medical geneticist regarding current information and recommendations is advised, or you may check on the PTRF site for current status in a number of categories.
Q: Do we have enough history yet to be able to say there are certain diseases that can be effectively cured with stem cells vs simply improved?
A: If you mean complete absence of the underlying treatment condition so that it will never recur, as opposed to a ‘5 year cure’ (as that length is seen to be the time frame for many disease entities being treated with stem cells and by other interventions), then the answer is yes.
Many of the benign hematologic or blood disorders have been successfully treated with bone marrow transplants, which is essentially the use of stem cells. There are many auto-immune, degenerative neurologic, cardiac, and orthopedic conditions for which stem cells are becoming more prominent in their treatment and there are now genetic conditions where autologous stem cells are able to re-program the genes with effective results. Down's syndrome is one such disease entity.
One of the major issues in attempting to understand whether many of the newer disease conditions being treated with stem cells have been ‘cured’ versus simply ‘improved’ is that there is not an effective method of tracking the conditions/treatment/outcomes and adverse events (AEs) over a long period of time; ie, at least 5 years. A registry with a robust tracking model such as the one Regenetek has developed that can be used world-wide is required.
Q: Many experts quoted by the media about stem cell therapies have conflicts of interest that predispose them to a negative stance on autologous cell therapies. For example, academic researchers with grant money or future patent royalties for embryonic or IPSC approaches. Can you help set a precedent of disclosure by declaring your interests as it relates to the work you are doing with stem cell therapy?
A: I'm not sure that's going to set any kind of precedent but, sure. I've already made my disclosures so I'll repeat them here below. But let me preface your question with a few comments about the state of our industry in 2013.
I really don't think that there's anyone working in any medical field who isn't biased, myself included. If you have a stake in a protocol, patent royalties from a device, a drug licence, research, a medical business, a career position, or grant funding, there's going to be a bias in your behavior. It's an industry-wide issue that affects researchers, pharmaceutical companies, universities and even the regulatory authorities that are supposed to be the oversight. It's ironic that in an industry that demands pure 'evidence' as proof of efficacy, there is bias to the point of corruption.
Much of the problem stems from financial conflicts of interest where the funders of the studies control the research outcomes. There have been many shameful incidents of outright fraud in demonstrating relationships between pharmaceutical industry patronage and study conclusions. And we don't have to look to India or Mexico or Costa Rica to find the worst behaviors. In 2008, it was revealed that GlaxoSmithKline and every other antidepressant (SSRI) manufacturer world-wide conspired to conceal and misrepresent clinical trial data in a pattern of conspiracy that lasted for many years. Hidden and deleted from the trial evidence that led to licencing these drugs was medical information that indicated there was a high risk of suicide with SSRI prescription use. Dozens of well-respected clinicians who knew this signed off on the drug and the FDA was complicit in the cover-up and delays in creating warning labels and requiring informed consent. Antidepressant sales are currently around $25 billion per year.
So if the industry is willing to engage in such a pattern of behavior for a single use drug, I submit that they will do just about anything to keep stem cells (that have the potential to 'cure' so many diseases) under wraps wherever they can for as long as they can. Getting stem cells declared 'a drug' by the FDA is a nice start. It puts stem cells back in to the drug companies' court. Getting the FDA to reduce the requirements for drug licencing is another. You don't even have to be a 'conspiracy theorist' to believe there's a link. Based on the behavior within the industry, it's right there in the open.
As for my personal interests, I am a professional member of the International Cellular Medicine Society and as such, I abide by the rules, regulations and guidelines of the ICMS in the course of my conducting my research. Along with the research, I am also undertaking the distribution of my Registry software, parts of which are protected by patents. I own two companies from which to do both. I am a majority shareholder in The CliniCard Inc. and Regenetek Research Inc. I have no other relevant affiliations or financial involvement with any other organization.
Had UC treatment April 5th, 2007
Had autologous treatment March 19, 2010
Had bone marrow and adipose stem cell treatment (autologous) June 16, 2010