In America, any supplements must be accompanied by the disclaimer that they are not intended to diagnose or treat any diseases. But why? Let's face it! In reality we are trying to accomplish what the regular medical doctors cannot achieve yet! And that is a very good thing because otherwise regulations would deprive us of any chances to feel better regardless by which exact means any kind of improvement can be accomplished. My research has shown that humans are far too genetically and phenotypically diverse for us to succeed in developing a single drug or any other kind of standardized pre-defined and FDA-approved medical interventions, which will work for each and every patient.
Unfortunately, since most medical diagnostic definitions are so inflexible, we MUST take matters into our own hands. And The Little Yellow Pills seem to be one very effective way to accomplish this. My unpublished research also shows that as people age, they need different combinations of medical interventions. It seems to me that a teenager is a completely different kind of patient, almost like another species, as a patient in his/her 60s. Unfortunately, I cannot prove and publish this important insight because all my research is based on yeast but not on human trials.
The boarders, which divide consumables into either medications or foods, are very fuzzy and conceptually incorrect. There are foods, which can replace the functions of drugs and there are drugs that can serve as foods. It is also wrong to take the same drug dosages at the same time every day because changes in food intake can often affect the efficacy of drugs. Unfortunately, most patients are not aware of it yet and hence, leave it up to their physicians to make such kind of decisions, i.e. what's really best for them, even though they are in a much better position to decide for themselves how much of any drug is best for them, because they can feel its impact much better than any doctor ever can!
I knew a lady, who claimed to be able to treat cancer much better than oncologists only by prescribing food and using it like drugs. I tried her in the summer of 2009. With very crazy-seeming food regiments, such as eating raw liver and the bone marrow from cow bones, she could generate for me almost the same kind of benefits for which my doctor prescribed me Adrenal, Vyvance and Ritalin. My only problem was that I lacked the funds to keep adhering to her prescribed food regiments, because I had to buy everything at the Wholefoods Heath Food store whereas my health insurance covered almost all the costs of my drugs.
It is practically totally impossible to clearly define any set of criteria based on which it would be possible to clearly distinguish between foods and drugs. Therefore, most people seem to have implicitly adopted the misconception that all consumables, which can only be obtained with a doctor's prescription, must be a drug and consequently, all the rest must be foods. Unfortunately, nothing can be further from the truth! But, for whatever reason, only very few people seem to be aware of this implicitly shared wide-spread misconception. I am not a medical doctor. But I know my yeast’s biology of aging, its cell-, and molecular biology, and the way its lipodomics, glycoproteomics, metabolomics, enzymology, genomics, transcriptomics, proteomics affect its overall aging process. I have researched extensively the aging induced changes in its cell cycle durations and regulations.
My adviser has published extensively on the adverse effects of rising membrane permeability because they cause the membrane potentials to decline as the yeast ages; thus driving the aging process forward, especially by raising the toxic concentrations of reactive oxygen species through the aging accelerating rise in mitochondrial dysfunction; thus, interfering with proper ATP synthesis as the yeast reaches the end of its replicative lifespan generally after 25 replications. My PI discovered that the decline of its vacuolar acidity is driving the aging process. It is already starting as early as the fourth replication, i.e. long before any physiological sign of aging can be detected. The age-induced rise in its unfolded protein-response, due to the aging-induced decline of overall chaperon-aided protein folding assistance contribute to the gradually overwhelming of the yeast’s peroxisome and organelle-dependent metabolic detoxification capacities, which eventually cause the yeast to die. A big portion of my dissertation is based on a new discovery, which was first postulated in 2015, that the divergence between the yeast’s transcriptome and proteome is the driver of replicative aging in yeast. Moreover, like the little yellow wonder-pills, the yeast’s growth medium, i.e. its foods or drugs (however you want to look at it) also affects its replicative lifespan.
Apparently or even evidently, your truth is not the truth of many other people.
The disclaimer is used in order to be regulated as a dietary supplement rather than as a drug. You can make the claim - and be regulated as a drug proving efficacy and safety via the NDA process. If you're so sure of your products), suggest you do so.
Mind sharing your "unpublished research" - or is it the attached file?
Thomas, your attitude to the law is very concerning. I dont doubt that there are cases where seemingly incurable conditions are reversed with non-mainstream approaches; I too have seen them. However, the risk is that newly-diagnosed cancer patients who are very vulnerable to false promises and hype may adopt an untested 'treatment' over one that has some efficacy data. I have practised as a clinician in Nutrition-based therapies for decades and I remain ever mindful that we still need clinical evidence to substantiate a response. As with mainstream medicine, we start with a hypothesis, test it at the cellular level, test in on animals and then ultimately - if all the indicators are in order - conduct one or more human clinical trials.
I find your cavalier approach reprehensible - and it seems from your comments that your hypothesis is a long way from being able to provide evidence for either safety or efficacy. In the meantime, whether we like them or not, the laws are in place to protect citizens.
What is the alternative? Doing nothing? What is potassium? A drug or a supplement? You can get it in the ER or buy it in a Health Food Store, but at too low dosages for making a real difference. Why do most people's brains seem to function like a mutually exclusive binary classifier? Why does it need to be either or?
If I'd relied only on what's available in the ER, I could not even do any work. The hospital discharged me today without being able to help. So I only have alternatives, which are still better than nothing.
Foods and drugs are a continuum like differential equations in calculus.
We still have very little understanding about many medical problems. In such cases trail and error is often better than doing nothing.
Learning about medicine from books and lectures and experiencing medicine are 2 different stories.
Medicine works for most patients most of the time. But what about the remaining few patients for whom our medicine cannot provide any improvements?
If genomic testing would be mandatory so we could exclude allergically reacting patients from taking drugs that could otherwise not get approved, it would help so many other patient, who would benefit a lot from taking them.
Humans are far too diverse genetically to have good chances for developing a drug that works all the time for everybody.
Have you ever heard of drug repositioning? The law does not change human physiology or medical problems according to its regulations.
The alternative is for those of us working in the field of phytochemical research to continue to research and publish with a view to providing the clinical trial data need to establish a safe dose-response for a supplement just as we do for a drug. It's unfortunate that you used potassium as your example because as a supplement, it is restricted at certain doses, given that it can be life -threatening to take more than required. Regulations that prohibit the use of high-dose potassium are there to protect people from risk.
As for asking what is a drug and what is a supplement, that is a good question. Why do some people think that ingesting doses of supplements in excess of any amount one could reasonably ingest from food is beneficial to human cells? Why is this a better solution to ingesting drugs with their non-specific effects?
Modern biochemistry is providing answers to many of the upstream causes of disease. Much of this is due to an ever-expanding understanding of cellular signalling processes; other aspects are addressed by gene expression studies.
What's most interesting is that high dose vitamin C which was promoted in the 1970s by Linus Pauling and others is now found to mask some of the essential signals cells use to activate their endogenous defence mechanisms. (I would expect that if Pauling were here now, he too would see that his theory did not stand the test of time). Other direct-acting antioxidant vitamins have been shown to exhibit negative effects when ingested at supra-physiological doses.
In summary, mainstream medicine does not typically address the upstream causes of disease, especially chronic disease. But that does NOT give licence to abuse supplements and the laws in place to govern them. The idea that supplements are necessarily safe is erroneous and modern biochemistry and genomics is proving that.
Bottom Line: Eat real food and use supplements judiciously!
For me cancer is an exciting fascinating, but simultaneously fear-inducing phenomenon, similar to playing with fire, because it is nature’s proof that immortality is not only possible, but wide-spread evolved biological reality. This gives us plenty of opportunities to observe options for delaying and eventually stopping all adverse effects of aging while simultaneously claiming the lives of far too many patients every single day. If we want to cure cancer, we must reverse aging into physiological, metabolic cellular rejuvenation, because otherwise, if no action is taken, the aging immune system can eventually no longer maintain its comprehensive anti-cancer surveillance.
However, the cancerous tissue is only one of the at least two major variables affecting treatment outcome, because the specific physiological and metabolic constitution of the still non-cancerous somatic cells is at least equally important. If we cannot yet maximize the benefits of anti-aging and rejuvenating interventions extending lifespan and health-span due to their unfortunately still way too little acceptance by the general public, healthcare providers and even research professionals, we must live with the inevitable consequence that with advancing age cancer cannot be cured permanently yet, because it keeps evolving until initially very effective interventions gradually fail. The thus induced evolutionary race between cancer, medical interventions, physiological and immunological conditions, which deviate widely even among patients suffering from genetically identical tumors, will challenge medical providers to discover unique very patient-specific interventions faster than the cancer can kill. E.g. younger and otherwise still healthy patients can tolerate much higher dosage of toxic anti-cancer drugs than fragile older patients who therefore need completely different medical interventions.
Hence, as long as rejuvenation and immortality are not yet actively pursued, we will have lots of cancer patients, who relapse every few years and who therefore, require their own cancer chaser or cancer suppressing scientist, who must develop novel and effective live-saving anti-cancer treatments for each of his/her patients faster than the relapsing cancer can kill, e.g. by taking advantage of the unique differences between tumors and cancer-free tissues. Cancers can only develop by differing from the remaining cells giving them a replicative advantage. Fortunately, this makes cancers more vulnerable to any intervention, which harms the more rapidly dividing tumor faster than cancer-free cells.
In the near future better collaborations between patients and their healthcare providers allows patients to actively choose any combination of interventions offered by their physicians. This makes current FDA approval procedures obsolete, because realistically, the lives of our patients depend much more on timely discovering and exploiting novel distinctive fitness differences between tumor and healthy tissues in the presence of external stressors than on unlikely adverse drug reactions. Most unexpected adverse effects of such kind of rapidly evolving experimental cancer and patient-specific treatment won’t kill immediately and can be stopped on time. Currently, no drug, which harms 10%, but saves the lives of 90%, can get approved despite helping 9 times more people. Soon lots of these rare adverse drug reactions can be much more reliably predicted based on genotypic data.
The pivotal role of our research at Fred Hutchinson is to discover, explore and evaluate the effects of novel interventions, because medical providers can add them to their expanding and cancer-discriminating toolboxes, out of which they can let their patients choose their preferred interventions based on their side-effects and other personal preferences. We at Fred Hutchinson want to give our healthcare providers a head start by supplying them with as many cancer-discriminating techniques far enough in advance to have enough time for discovering the best way to force an aggressively metastasizing tumor back into remission before it kills.
From an economic commercial perspective, this rapid co-evolution between interventions and relapsing metastasizing or rapidly growing tumors is generating life-saving medical demands from which even the privately funded sector can commercially benefit until the effective reversal of aging has become a feasible alternative to chasing cancers for the rest of the patients’ lives.
At Fred Hutchinson we can provide proof-of-principle that above outlined adaptations to develop ever changing cancer-suppressing combinations will allow adding many more years to the lives of cancer victims compared to current health policy practices. We will soon need realistic and goal-oriented - instead of procedure-oriented - healthcare and research policies to save the lives of many more people for much longer. This would cause a new powerful, innovative and self-directed group of professional cancer suppressors to thrive while gradually transitioning to fully cancer-curing anti-aging interventions, which are caused by eliminating the age-dependent and exponentially rising risk for developing cancer, because of the gradual overall metabolic, physiological and cognitive decline due to aging. Aging is the true master disease of all age-related degenerative diseases because it raises susceptibility to its many symptoms, e.g. Alzheimer, Parkinson, Cancer, Diabetes, Macular Degeneration, Depression, Infections, Pneumonia, Dementia, Hearing Loss, Cardiovascular Diseases, Strokes, etc.
I am fascinated by the prospective of true ageless immortality. That is why I used machine learning techniques to predict, model and reverse-engineer aging in yeast. Like yeast, cancer cells are constantly dividing. I expect an even better gene-function-specific time series clustering outcome for cancer because of much more abundant cancer training data. My most extensive time series yeast RNA microarray dataset had only 81 time points, taken in 4 minute intervals spanning only 3 complete cell cycles during 6 hours. Since there is more interest in cancer than in yeast research, I hope to get to analyze high temporal resolution cancer datasets with at least 12 transcriptome, proteome, metabolome, and epigenetic time points per cell cycle over many cell cycles to test my aging hypothesis not only on yeast but also on human cells.
There is no money in researching supplements so we will never see clinical trials that will satisfy those on the conventional side of the fence. Younger medical professionals are starting to realise that the "gold standard" just doesn't work for supplements or "good nutrition".
Add to this "Why Most Published Research Findings Are False” by John P. A. Ioannidis https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1182327/ and you know the "gold standard" is kinda grey.
Older, more entrenched (and often severely arrogant), Doctors cannot cope with their precious pillar having been knocked out from under them. They will become derogatory, angry and vicious and resort to all manner of open and underhand methods to silence anyone in their way. These Drs will be the first to go when robots take over 50% of the diagnosis and treatment of many health problems. (Amazingly they can't see it coming)
While many think that Drs will be preferred over robots, consider this. My current understanding is that Drs get it right 75% of the time. Robots being tested now, get it right at least 85% of the time. If you are in the 25% who are wrongly diagnosed, wouldn't you rather choose robotics. Dr Watson is amazing.
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