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<![CDATA[ - Blog]]>Sun, 28 Apr 2024 06:22:31 -0700Weebly<![CDATA[FDA warnS against For-Profit Plasma Infusions]]>Wed, 27 Feb 2019 08:00:00 GMThttp://youngbloodinstitute.org/blog/fda-warns-against-for-profit-plasma-infusionsWe wholeheartedly support the FDA’s recent warning against receiving plasma infusions from young donors by For-Profit companies. In fact, as a 501 (c) (3) non-profit corporation who studies transfusions (not infusions), we ourselves have privately warned about the risks associated with these For-Profit Plasma infusion treatments for years. To summarize the FDA (and YBI) position, we’ve highlighted below 4 key concerns from the FDA announcement, annotated with additional context:

Infusions. Medically, infusions differ significantly from transfusions. Infusions add volume without taking anything away, creating risk of circulatory overload, swelling, and potential difficulty breathing. It’s like adding water to an already full water balloon: the balloon will swell until…something else gives. Transfusions, also known as “apheresis,” exchange blood components by taking away an old or damaged blood component and replacing it with a new donor blood component. In fact, the very term “apheresis” comes from the Greek language and means “to take away.” During transfusions, highly skilled nurses program the apheresis machines to control patient’s blood volume to maintain the same volume while simultaneously removing old components and adding new components, thus minimizing risk of circulatory overload more probable in the case of an infusion.
For-Profit. With some exceptions, For-Profit entities typically do not yield new research benefitting humanity. Rather, they seek to benefit shareholders through return on investment, dividends, and/or the sale of the entity to an acquirer. And sometimes this private research may also benefit humanity, as in the case of the Grifols AMBAR studies on Alzheimer’s disorders over the last 10 years. A For-Profit company does not typically qualify for humanitarian research grants to benefit society, instead choosing to fund research on its own in order to develop new lines of business. Most of the For-Profit companies, doctors, and initiatives we know of who conduct infusionsseek to either sell plasma or sell procedures… but seem to do or care little to advance scientific understanding by evidencing or intending to evidence the results.
Plasma. As a human biologic, plasma donations vary significantly. While Stanford and others have demonstrated safety in well-controlled, albeit small-scale, plasma infusion studies, data from the American Society For Apheresis (ASFA) suggests that use of Fresh Frozen Plasma (FFP) has historically resulted in a 57% incidence of transfusion reaction, as compared with a 4% incidence of transfusion reaction using 5% albumin as a replacement fluid. We will post more on possible root causes for this disparity later, in a separate blog post.
Non-Studies. The FDA cited lack of well-controlled studies to demonstrate efficacy and safety and inferred the For-Profit companies they warned of did not actually conduct clinical trials, instead offering “off-label” treatments not associated with any study. Aside from some of the young plasma infusion studies at Stanford on Alzheimer’s and Parkinson’s disorders, this would appear to be largely true. Even the Stanford plasma infusion studies have been limited to small pilot studies designed largely to prove safety. In reality, it cost more to conduct a study than provide “off-label” treatments: clinical trials require much more extensive and costly blood testing to document evidence of changes, particularly prophylactic changes that require early detection and more sophisticated equipment to prove a negative outcome or trend might have been prevented or mitigated; additionally, costs of pedigreed investigators, institutional review boards, and administrative overhead result in clinical trial costs which often range from $75,000 to $150,000 per subject. Some biohackers and MD's alike often attempt to avoid the cost of clinical trial rigor to "fix" problems with no evidence or outcome to society.

You can read the full Statement below from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., cautioning consumers against receiving young donor plasma infusions that are promoted as unproven treatment for varying conditions.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631568.htm]]><![CDATA["Measure twice, cut once"]]>Thu, 16 Aug 2018 07:00:00 GMThttp://youngbloodinstitute.org/blog/measure-twice-cut-onceWe have taken a judicious amount of time to settle on what may well be one of the most comprehensive biomarker panels in clinical trial history, using some of the most advanced, state-of-the-art testing technologies available today.  You can read more detail in our Biomarkers page.  Some clinical trials may use one or two of these advanced technologies, but we don’t know of any or many that use them all. In addition to the standard physician physical exams and lab tests, the combination of scientific biomarkers including CyTOF (Time-of-Flight Mass Cytometry), Digital ELISA, Mass Spectrometry, DNA Methylation, Genetic Sequencing, and Continuous Digital Biomarkers all combined may provide one of the most comprehensive insights into the human body ever shown.
]]><![CDATA[Intellectual property & Aging]]>Tue, 28 Mar 2017 22:19:51 GMThttp://youngbloodinstitute.org/blog/intellectual-property-agingThe good news for patients: medical procedures can’t be patented anywhere in the world, except the U.S.

The bad news for inventors: medical procedure patents can’t be enforced in the U.S.

Funny that intellectual property often becomes the first thing many people think about when hearing of the potential to save mankind from the agonies of aging.   In my travels, I’ve met at least two doctors and “inventors” who claimed to have a patent or patent application on “young blood” – and, apparently, one of them actually had his patent accepted by the U.S. Patent and Trademark Office.

I’m not a patent attorney, but I have created and run intellectual property licensing companies that licensed technology to many, many multi-billion companies around the world. I’ve developed hardware and software products built on a foundation of intellectual property. I have reviewed, overseen, processed, and paid for over 200 patent applications…authored individually and collaboratively by some of the most talented scientists, engineers, chemists, and physicists in the world.

So when I met these two unrelated doctors, neither of whom knows the other, at different points in time, they seemed surprised to learn that medical procedures (or phenomena of nature) can't be patented.

I have nothing against intellectual property protections, or intellectual property attorneys -- I've employed or engaged many of them, obtained many patents. But the prohibition against patenting medical procedures (or enforcing them, as in the U.S.) has strong basis in humanitarian concerns, significantly different than a better smartphone or tablet computer.

Over 80 countries prohibit medical procedure patents.   General Agreements on Tariffs and Trade Agreement on Trade Related Aspects of International Property Rights (GATT-TRIPs) exclude medical procedures from patentability: "Members may also exclude from patentability: (a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals" (Article 27).

In the US, current law does not prohibit the patenting of medical methods, but it provides an exception for medical professionals in cases where medical method patents are infringed, thereby limiting the enforcement of patent rights on medical methods. Further, US case law is moving even further away from broad medical procedure patents. In Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. — (2012), the Court invalidated Prometheus's patent on a diagnostic method that involved administering thiopurines and observing chemical reactions in the body as a basis for dosing advice, stating that the patent improperly claimed a natural law. In 2013, a federal court invalidated a patent held by Sequenom covering the detection of cell-free DNA in the bloodstream of pregnant women. 2013 – Oct.   the US District Court for the Northern District of California granted Ariosa Diagnostics summary judgment and invalidated US Patent No. 6,258,540, saying the patent covers a phenomenon of nature, which is “unpatentable.” I would expect these trends to continue as they have, despite many researchers' devoted attention to discovering and patenting the inner workings of nature itself.

Of course, medical devices and other inventions of people themselves can be patented. We could almost consider the difference to be like inventing a tool (patentable) v. using a tool (not patentable/enforceable).

Plenty of health care businesses created success without patents. Red Cross stands out, and Kaiser Permanente has made many meaningful business model and health care delivery innovations, both as non-profit corporations. With 7 billion people in the world, all of whom will reach an elderly age, we all have plenty of opportunity for many to both help mankind and run a successful healthcare business...without excluding others from doing the same.
]]><![CDATA[Predicting potential for problems]]>Mon, 13 Feb 2017 03:28:07 GMThttp://youngbloodinstitute.org/blog/predicting-potential-for-problemsMedicine today focuses largely on diagnosing existent medical conditions and remediating them, typically with surgery, drugs, chemicals, radiation, or some combination thereof.

Why wait for a problem to happen that you know will happen? Most people don't die of old age or one disease or condition: most people die of multiple diseases or chronic conditions stemming from or exacerbated by the confluence of common root causes: decline of immune system function, oxidative stress, and chronic inflammation.

We know diet and exercise can help mitigate these conditions. But even people with good diets and exercise die of diseases medicine cannot cure because they lack immune system functionality to combat the disease, and medicine or drugs often impair the body's ability to fight for itself. Jack Lalanne died of pneumonia at age 95, in nearly perfect health until a fatal moment. He wanted to live to 120, and believed he could through good exercise and diet. Diet and exercise matter but have limitations. Medicine helps but makes trade offs that further weaken the body's own immune functions.

What if we could better predict predisposition for disease? What if we could address systemic issues that form the root cause of many symptoms we call diseases? Heart disease, cancer, Parkinson's, dementia, Alzheimer's, Rheumatoid arthritis, sclerosis -- all inextricably linked to inflammation and aging of other tissues effected by declining immune function -- could be better predicted and better prevented from developing in the first place.

We hope in our study to develop indicators to predict potential for disease states before they occur, and treatment therapies to prevent those diseases from occurring at all. Many of the blood tests we perform have predictive potential, and we hope to extend our test suite as we accumulate data and discover patterns of commonality with rich, big data sets.
]]><![CDATA[clinical trials in age research]]>Tue, 07 Feb 2017 18:23:59 GMThttp://youngbloodinstitute.org/blog/testFor many interventional studies, a randomized clinical trial takes little to no incremental effort at all: in the case of TPE, we simply gather random blood samples from people over 50 for 6 treatments, and subsequently, compare the results with subjects receiving the intervention therapy.

Nearly 8 years worth of data and study from the AMBAR pilot and follow-on studies demonstrate beneficial effects of TPE on a majority of subjects, for example. However, undocumented insights from medical practitioners in that study suggest other potentially beneficial effects that might provide interesting biomarkers in the future.

Therapeutic Plasma Exchange has decades ago been approved by the U.S. F.D.A. as well as numerous international regulatory bodies; and TPE may be one of the lowest risk medical procedures available today. We conduct clinical trials that intend to prove up (or not) beneficial effects we likely suspect to be the case, but that have not been measured and documented for our study group demographic comprehensively. We do have data on improvements in Alzheimer's, and we have select data on accepted autoimmune conditions in older patients. But more comprehensive measurement of systemic root causes of age-associated disorders hasn't been treated with TPE and measured comprehensively. We believe that many if not most age associated disorders have common root cause in immune system decline, oxidative stress, and chronic inflammation -- all conditions which can be addressed and improved by TPE in the application to systemic decline of aging immune systems. With supporting data, this treatment therapy might become broadly available as a medically insured prophylactic (preventive) treatment therapy for age-associated disorders.

]]><![CDATA[will it work?]]>Sun, 15 Jan 2017 08:00:00 GMThttp://youngbloodinstitute.org/blog/will-it-workIn light of the frenzy of activity and many failures surrounding anti-aging research over the last two decades, the obvious question that anyone should ask comes down to viability.

I’ll address the litany of failures in anti-aging research in a later post – it’s a big topic in need of its own commentary – but let's say the search for "magic bullets" has been futile.

As for our approach, the practical application of medically established treatment therapies to a new understanding of the aging process, here’s what we know and what we don’t know.

We know Therapeutic Plasma Exchange (TPE) is a safe and well-established therapy for a number of medical conditions with powerful immunomodulatory effects not requiring the use of drugs or artificial substances. (Technically speaking the FDA regulates blood products like drugs for safety reasons, but they are not synthetic, man-made drugs, they are real blood products from real humans). TPE removes pathogenic and proinflammatory factors accumulated in our blood via extracorporeal (outside of the body) processing. Further, plasmapheresis leads to normalization of key immune system indicators (e.g., CD4/CD8 ratio) that become abnormal, a condition that afflicts people with old blood, which exhibits immune function ratios similar to patients with autoimmune conditions. So, putting aside “anti-aging” or other beneficial possibilities per se, we know that the TPE removes inhibitory factors negatively effecting and contributing to the slow decline of the immune system, a naturally occurring phenomena of aging blood as it oxidizes over time. And, we know that patients with Alzheimer’s have stopped their decline or improved their condition as a result of TPE treatments. Generally, we know that prevention outweighs remediation; better to bolster the immune system early than wait for the onset of more complicated conditions. And we know that the procedure risk remains relatively low.

While we have strong empirical data to support what we know, we don't necessarily know how long the treatment therapy will last. And the answer may vary by individual based on environment, lifestyle, diet, and genetic history. If someone works 80 hours per week, never exercises, eats junk food, drinks heavily, smokes, takes drugs, and parties the rest of the time…those negative inputs may outweigh any benefits of any treatment therapy, of course. In the case of autoimmune disorders, frequency of treatment therapies varies by specific disease, as well as individual. While aging blood bears a similar profile to the blood of autoimmune patients, aging blood typically takes much longer to reach that state, an inexorable decline over time rather than a more acute condition. We don’t know how profound possible benefits may be, or if we’ll observe what has been observed in mice – growth in muscle cells, liver cells, and brain cells.   Hence, the basis for our clinical trial, and, given the tremendous diversity of individual conditions, the reason we chose to conduct a trial at a greater scale, initially up to 1,000 patients.]]><![CDATA[Why not make a profit?]]>Mon, 28 Nov 2016 21:03:46 GMThttp://youngbloodinstitute.org/blog/why-not-make-a-profitA lot of people I've met have asked me why a non-profit corporation.... "Why not set up a for-profit operation?" they ask.

First, and foremost, we hope we can do something to help humanity, an intrinsic reward unto itself. Much of modern medicine unfortunately concerns itself with profits first, patients second, hoping to find a "magic bullet" to patent. Medical procedures, particularly a decades-old medical procedure, can't be patented or, in the U.S, enforced. Nor should they, in my opinion, and I've run companies that developed 100's of commercial patents. We have a unique opportunity in history to take a relatively low-risk approach and develop or refine a highly impactful anti-aging treatment therapy which could alter the course of mankind by preventatively mitigating age-associated disease extending life and/or extending well lived life. We plan to "open source" our findings, and like any open source initiative, we may spawn 100 or more for-profit entities which commercialize best practices and procedures that we develop. Good luck to all of them, and all of the world. Many good reasons exist to form for-profit companies, but making a profit may not always be one of them (more on this later). But before that can happen, we need to better data on the beneficial effects and best practices associated with aging.

Second, even though we begin with a fairly benign, low-risk procedure and significant upside for human health in aging states, we have much to learn. We can build from the experience and knowledge of the last several decades of immunology, and we have positive results with at least one age-associated condition, Alzheimer's disease, since 2009. But within this experience, protocols, treatment frequencies, and other nuances can vary by individual, disease, and actual condition. This treatment therapy works best to prevent negative outcomes; once a disease state has progressed to a highly degenerative condition, odds of improvement decline rapidly; hence, the Alzheimer's studies have focused on mild to moderate Alzheimer's, not severe cases.

Third, a nonprofit can purse objectives for the benefit of humanity without regard to investor interests and return expectations, other than the social benefit and humanitarian return of making a significant difference in the lives of many, possibly including those closest to you. Everyone has friends and family who will ultimately suffer from age-associated conditions. That said, donations to a non-profit organization provides a tax benefit, whereas payments to a for-profit organization come from savings after tax. Simply put, a $10 donation to a non-profit could result in a $3 deduction where a $10 payment to a for-profit requires $13 in income to make a $10 after tax payment. And while we depend on direct donations and grants, as a non-profit we can be more flexible and focused to plow all available resources into our product and humanitarian objectives, rather than worry about investor dividends, ultimately lowering cost of service well below what a for-profit operation could possibly achieve.

Finally, we have a lot of folks volunteering, working pro bono, and/or deferring compensation who have intrinsic motivation that we're doing something good for friends, family, and the world. Why not?]]><![CDATA[What I learned from one prominent research scientist ]]>Wed, 19 Oct 2016 23:04:26 GMThttp://youngbloodinstitute.org/blog/defy-aging-and-prevent-diseases

A few years back, when I first began investigating University findings that "young blood rejuvenated mice, I met with a prominent scientist at a prominent university, who shall remain unnamed so as not to personalize this commentary. In the privacy of his office, I learned two interesting and salient things through the course of his Powerpoint presentation to me.

First, when he came to a certain chart in his presentation which looked something like this...
he said, "here's the problem!" pointing at the oval entitled "young blood" and

"What's the problem?" I asked.

"Young blood cures everything, potentially all or most age-related diseases" he replied.

"Why is that a problem?" I asked

"Because all of the money for funding is inside each one of these silos" he replied, pointing at each age-related disease condition, one for Alzheimer's, one for Cancer, one for Heart Disease, and so on. "You can't fix everything or you'll never get funded."

Epilogue
While a number of efforts researching human plasma and beneficial factors contained within, do focus on one particular silo, we established the Young Blood Institute as a non-profit specifically to avoid this conflict. Why not do one procedure and measure everything? Yes, the blood testing may be more expensive. But the knowledge gained and the comprehensive data gathered, in our view, far outweighs the cost. And, if we do demonstrate that one prophylactic therapy can systemically prevent the onset or degradation of multiple diseases, mankind wins.

]]><![CDATA[RAAD Fest a success]]>Tue, 09 Aug 2016 07:00:00 GMThttp://youngbloodinstitute.org/blog/coming-soonI attended RAAD Fest in San Diego this past August 4-7th. "RAAD" stands for Revolution Against Aging and Death, and brought together an amazing amalgamation of doctors, scientists, sociologists, researchers, authors, business people, entrepreneurs, and corporations dedicated to extending and enhancing life. ]]><![CDATA[back to the beginning...]]>Tue, 02 Aug 2016 07:00:00 GMThttp://youngbloodinstitute.org/blog/second-draftI began my professional career with IBM Biomedical Systems, developer of the 2997 Blood Cell Separator, one of the world's first automated apheresis machines. Originally developed in partnership with the National Cancer Institute (NCI) at the National Institutes of Health (NIH) by an IBM engineer, George Judson, this device spawned a little known renaissance in blood component exchange, blood treatment therapies, and immunology, ultimately contributing to cancer programs, autoimmune disorders, and even AIDS research and treatment therapies. The automation of blood component collection and exchange also fundamentally improved the blood donation/collection industry, before then limited to whole blood collections and manual blood separation techniques. Today, we use the product descendants of the IBM blood cell separator to collect stem cells from bone marrow.

After IBM sold its Biomedical Systems business unit to COBE Laboratories, I went on to work in more traditional IBM marketing and development groups, and later spun some technologies out of IBM to found an imaging technology licensing company, Applied Science Fiction, which developed 100's of patents and licensable software and hardware designs. Since then, I’ve run a number of other tech companies, developed numerous products, licensed and sold technologies worldwide, and managed significant new technology initiatives.

Now that I’m returning to my roots, as it were, I take comfort in the fact that not much has changed with apheresis equipment and procedures in 30 years, other than the natural evolution and refinement of those technical and medical breakthroughs of the 70's and 80's. Why? Because this historical evolution of apheresis equipment medical and best practices significantly reduces both technology risk and health/safety risk when re-focusing these evolutionary developments from rare and often niche conditions such as autoimmune disorders to the most significant challenge and opportunity we face as humankind: the natural autoimmunity of aging blood. We start from a solid foundation of long ago approved FDA (and international regulatory) procedures, decades of medical practice and experience, and an very low safety risk.

In the field of immunology and blood science, progress has been evolutionary and episodic over the last 100 years, beginning with Karl Landsteiner's discovery of ABO blood types in 1900, a discovery which, in the hindsight of a 7 billion person population, may have saved 10's or even 100's of millions of lives over the last century. Now, when the world has begun to cite a new medical buzzword "immunotherapy" -- particularly for age-associated diseases -- we can look to the most natural and historically proven immune system therapy in the world: our own plasma, and a medical practice well honed for many decades.

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