EZ Relaxin Discoveries Plus Abilify Report with Diagrams

Given that it is now known that relaxin can and does impact many areas of the brain and body, New Life Health Ventures sees the manipulation of relaxin through pharmaceuticals (non-natural means) for mental health purposes as unduly risky and irresponsible and can and has resulted in physical alteration and damage as well as compulsive thoughts and behavior, suicidal ideation, suicide and even school shootings with no systematic steps in place to track the role of the pharmaceuticals.  This is the case with Abilify. 

As relaxin is known to impact the heart, contribute to metabolic syndrome and impact the brain and its stress response and alter the skeletal, care should be exercised when it is altered with pharmaceuticals- which was not the case with Abilify and perhaps also with other medications, particularly mental health pharmaceuticals.  The potential for undesirable and uncontrollable thought patterns and the propensity for weight gain, diabetes and cholesterol issues resulting from the daily mental health pharmaceuticals have largely been deemed acceptable untalked about outcomes by the FDA and the entire mental health eco-system whose only solution is more pharmaceuticals.

In the U.S. today and for the past 40 years, mental health has been pharmalogically driven and is the third leading costliest area of healthcare and growing.  In the mental health ecosystem there is very little interaction between researchers, mental health providers, physicians and patients and even little acknowledgement on the part of many mental health providers for the need.  Physical complications go unacknowledged and there is no systematic tracking of dangerous thoughts or behaviors of those medicated.  Many anti-psychotics as well as the blood pressure Lisinopril masque the organ damage done by pharmaceuticals that alter relaxin suggesting a dynamic relationship that has been neglected yet has mighty implications and may be part of the reason that psychiatric patients have a life expectancy 20 years lower than normal. 

Unlike European counterparts which err on the side of safety, the U.S. FDA approves drugs it deems to have benefits that exceed the risks and once approved, the risks tend to be buried.  A return to the Hippocratic Oath- “First, do no harm” should be reflected as the gold standard and prevailing attitude and criteria for drug acceptance by the FDA.  Doing so- where only truly safe and truly effective drugs will be approved will dramatically cut the cost of drug approval and the cost of health care and present the true possibility of informed consent and safe help. Inappropriate drugs known to cause damage will no longer be allowed to be forced through as is largely the case today.  Natural supplements and nutrition, exercise, the arts, prayer, and community involvement should all be on parity if not lead pharmaceutical treatment in mental health and thus should be reflected in the FDA’s drug acceptance process.

Studies have shown that relaxin intertwines with 5-HTP and GABA- both of which are available as supplements from plants as a gentler, less risky, more targeted approach for addressing anxiety, depression, and calmness and potentially redirecting relaxin to a more stable state. 

5-HTP and GABA are both known to naturally break the blood-brain barrier.  The blood-brain barrier is a network of blood vessels and tissue that is made up of closely spaced cells and helps keep harmful substances from reaching the brain.  The blood-brain barrier lets some substances, such as water, oxygen, carbon dioxide and general anesthetics pass into the brain.  It is hypothesized that given the intercellular communication capabilities of relaxin,5-HTP and GABA take the safety of the body into consideration by virtue of being a part of the body. Aripiprazole, the main ingredient of Abilify is known to be an analgesic and many mental health pharmalogicals are known to be enhanced with analgesics so as to force a break in the blood-brain barrier.  This type of break is not well understood and may contribute to unintended adverse conditions and harmful thought patterns known to be consequences of these medications.

As 5-HTP and GABA are known to safely promote serotonin and repair neurotransmitters, New Life Health Ventures advocates that they be included as alternatives to all tested mental health pharmaceuticals when testing the efficacy of mental health pharmaceuticals for all currently medicated conditions.  An assortment of studies have shown 5-HTP’s efficacy to be equal to SSRIs and it is much safer, cheaper and readily understood.  The preference for and prevalence of SSRIs is more a result of indoctrination, propaganda and heavy marketing, even to the point of breaking the law than any scientific merit.

5 HTP (5-Hydroxytryptophan) is a clinically effective serotonin precursor.  5-HTP is an intermediate in serotonin synthesis.  It can easily cross the blood-brain barrier and increase serotonin levels found in the central nervous system.  5-HTP suppresses inflammation and arthritis through decreasing the production of inflammatory mediators.  Numerous overviews of 5-HTP can be found on various websites and at one time 5-HTP which is plant based as a supplement suffered from contamination.  Highly credible overviews can be found at the National Library of Medicine, Mount Sinai Hospital’s website and even the U.S. Department of Defense Dietary supplement Resource- in conjunction with its “Operation Supplement Safety”.

GABA (Gamma-Aminobutyric Acid) also has many varying overviews with credible overviews provided by McGill University of Canada, The Cleveland Clinic and the book Physiology, GABA by Jewett BE and Sharma S.

According to the Cleveland Clinic, “Gamma-aminobutyric acid (GABA) is the most common inhibitory neurotransmitter in your central nervous system. GABA lessens the ability of a nerve cell to receive, create or send chemical messages to other nerve cells. GABA is known for producing a calming effect. It’s thought to play a major role in controlling anxiety, stress and fear. Decreased GABA levels are associated with several neurological and mental health conditions, as well as other medical conditions. Increasing GABA levels may help treat high blood pressure, diabetes and insomnia. Because of the abundance of GABA in your brain, the GABA receptor is a major target of drug development by pharmaceutical manufacturers. The effectiveness of GABA supplements and GABA-containing foods to prevent and treat medical conditions needs to be studied in a larger number of people.”

New Life Health Ventures hypothesizes that relaxin may “run in a circuit” and require feedback loops to properly align and modify the areas of the body it encounters coupled with the bodies “state”.  Post-partum depression may be due in part to an unmitigated run of relaxin which may impact other areas of the body, including the heart, brain and adrenal glands.  Compression is known promote pregnancy weight and help promote belly reduction for those with metabolic syndrome weight gain caused by metal health pharmaceuticals like Abilify.

The U.S. government’s National Institute of Mental Health (NIMH) is the largest funder of mental health research in the world with a multibillion dollar budget for studies that are conducted myopically with very little interest in building a body of knowledge and that have virtually no impact on clinical treatment.  THE NIMH is unresponsive to patient input or requests for help regarding pharmaceuticals and essentially has turned a blind eye to the realities of the known dangers and dangerous or damaging outcomes of psychiatric medications and their ability to permanently alter the mind and body in undesirable ways.

The recent discoveries of relaxin are a major paradigm shift regarding the body and human person and its safe care. The fact that very few healthcare providers are aware of the reality of the extensive role relaxin plays in the body mentally and physically and with interaction severely limits their capability to understand and diagnose let alone treat what is really going on and perpetuates inaccurate broad sweeping lifelong diagnoses like bi polar and Schizoaffective disorder and has perpetuated and encouraged the false notion of immediate relief from emotion pain by pharmaceuticals as the ultimate goal when it is highly likely that treatments like GABA and 5 HTP are equally effective and significantly safer for what in reality may be temporal conditions.  Prior to the advent of numerous daily mental health pharmaceuticals, mental health conditions were frequently viewed as neurosis and more temporal in contrast to today’s self-serving view of a lifetime condition requiring dangerous medications.

From a protocol perspective, the treatments known to be least harmful yet effective should always be given first and viewed as the standard for comparison when testing new treatment candidates and given that it is now possible to study and find out the genetic ramifications of medications, this too should be standard procedure and form a method for ranking drugs by their safeness. At present virtually all mental health pharmaceuticals carry the FDA Black Box warning- it’s highest warning yet the justification and comprehensive findings of their possible damage are procedureless and not readily available for consideration.

From an information science’s management perspective, there should be known ground sources of information, a function jointly shared by the manufacturer and the FDA that should be comprehensive, objective and promulgated.  This gross failure- for Abilify and really all medications at a micro patient level creates excessive danger and limited understanding necessary for appropriate help and is a sign of blatant neglect.  This is particularly problematic in mental health where the providers are not interested in physical maladies and most physicians are ignorant of, ill equipped for, or do not want to get involved with the complications due to psychiatric medications.   It is also increasingly problematic as the medical profession continues to specialize on given areas to the point of neglect of other areas that may be impacted. 

Now that Abilify is generic, the information  provided by pharmacies, the Mayo Clinic and other popular websites neglects to mention the very real dangerous body and mind damage disclosed in the FDA Animal Studies, the RNA Study and information provided to them and to the manufacturer, Bristol Myers Squibb and the FDA as very real known outcomes of taking Abilify.  There is no accountability or designated authority regarding this information and mistakenly and in ignorance the belief that there impact is highly targeted and safe is presumed.

Private sector analysis of pharmaceuticals and their impact on the body is largely viewed opportunistically as potential new applications for an already approved drug with little thought of the very real insights about the drug and its potential consequences as revealed by the analysis.  This is morally wrong and dangerous.

The failure to build a body of knowledge on both the human body and areas impacted by medications and on the realities of the medications is a common major failure is a dangerous and unnecessary source of confusion and unwarranted subjectivity that probably plays the largest role of unmitigated costs and poor outcomes in the U.S. Health System. 

There are the means to build a universal body of knowledge with truth and a commitment to learning, understanding and use of scientific principles of information management but the sense of opportunism and the notion of blockbusters may cause those so misdirected to fail to see the need.  The lack of direction in this area by Federal Health Agencies- HHS, NIH, FDA, NIMH promotes an environment of unsubstantiated authorative/forcing approaches to healthcare that is inappropriate, stifles learning, leads to dangerous outcomes and is insulting. Like any subject, healthcare is understandable if presented properly.  The propaganda, oversimplification, chaos level of subjectivity that largely dictate today’s health care can be displaced with safer, more natural, less expensive and more complete means of restoration and healing when and if the is focus on human dignity, the human person, and reverence for God’s creation and when the open faucet of endless government money for healthcare comes to a close and the abhorrent practices that big money employs are restricted. The NIH spends over $42 billion in grants and most grant money in the U.S. is government money which is highly problematic, as it inhibits thoughtful criticism of government officials and agencies in that you don’t bight the hand that feeds you and it creates a spirit of selfishness.

That the U.S. Department of Defense would orchestrate a mission to review supplement safety is a reflection of a no vote of confidence and need for change in U.S. health agencies, including the National Institute of Health, Department of Health and Human Services and the FDA . Given the known lack of prioritization of safety and scientific approach to information management and inexcusably poor communication skills, it should surprise no one that there were divergent opinions and beliefs amongst the general public regarding Covid 19 and ensuing treatments and vaccines.

In reality, more care is given to proper information management with respect to automobiles and their defects than to patients and the very real known or foreseeable yet not disclosed nor promulgated ramifications of pharmaceuticals coupled with ignorant providers and in mental health, where blaming the patient and labeling them with a major deficiency is a likely outcome is indeed really a crime against humanity.  As the rush toward “artificial intelligence”/sophisticated programing is upon us and even embraced, the level of negligence and recklessness in healthcare will likely grow exponentially unless there is a change in direction.

As 5 HTP and GABA as well as proper nutrition, exercise, the arts, community service, prayer and meditation are known to naturally and safely promote serotonin, New Life Health Ventures advocates that they be included as alternatives for comparison when testing the efficacy of all mental health pharmaceuticals and be promoted as the first/safest treatment for most mental health conditions, which historically were not considered lifelong conditions until the advent of pharmaceutical emphasis when treating emotional pain and trauma.

The Veterans Admiration has found documented success by promoting these means with its “Whole Health” program.  In the United Kingdom, “Social Prescriptions”now play a role in mental health treatment and in impoverished nations, success has been found with semi-uniformed “grandmothers” sitting on park benches can be approached as listeners.

Ground source repositories of complete data and information on pharmaceuticals should be established and maintained as a required safety element for all concerned.  Physicians, patients and pharmacies should be surveyed in manners guaranteeing privacy to monitor drugs for potential damage or other intelligence and periodic overviews should be provided to the entire ecosystem in a push manner to facilitate learning and safety.  This should be a joint responsibility of the drug manufacturer and the FDA and paid for by the drug manufacturer.

Organizations that push drugs later shown to be unsafe through the FDA or on the market for off label applications should be banned from seeking approval for new drugs for 10 years.  Capitalism and Safety must meet.  Truth and Safety must prevail. The human person and human body warrant care and extreme caution.

Prepare to be amazed and marvel at the human body as you learn that something thought to have a very limited role in the body is so much more profound in its role and impact and it “talks”!- and suggests safe ways of natural correction from problematic mental states and manifests the necessitation of building a body of knowledge.

Methodology:

New Life Health Ventures (NLHV) started learning about relaxin in 2015 from a website for pregnant women that promoted compression to help lose pregnancy weight and from the book 30-Second Anatomy Edited by Gabrielle M. Finn.  This was after a thorough review of studies and medical text books on adrenal glands.  The adrenal glands, like relaxin, are known to be an under studied and not well understood area of the body.

A thorough search of studies on Abilify was undertaken including the FDA animal studies which showed a wide variety of organ damage and the reality of withdrawal and a diabetes study which showed a change in glucose independent/before weight gain from Abilify and a 2014 RNA study on the top 100 drugs by revenue.

A 2014 PNAS (RNA) Study by The National Academy of Sciences showed the following:

It was also hypothesized that the drug Abilify impacts/alters the peptide relaxin.  This is now viewed with certainty.

In 2020 a literature/study search was done on Relaxin.  Several studies were screened and three studies were summarized by excerpts- direct quotes from the studies.  The researchers of the three studies were sent copies of the summary of excerpts and the studies were sent to a broad audience as it was hypothesized that relaxin plays a role in fibromyalgia, autism, hypervigilance/alertness, insomnia, deterioration on the lower spine and perhaps much more.

The studies varied in objectivity of orientation in that some were more oriented/motivated to find a pharmological use for the findings verses promoting an understanding of the human body and its dynamic relationships.

The study of relaxin necessitates the building of a body of knowledge.  An alarming reality was observed in that studies were done in silos and from a myopic/narrow perspective, that is to say focusing only on a given part of the body and neglecting to acknowledge or site an overview of the reality of the total areas of the body impacted and with the expressed goal of developing new pharmaceuticals to alter relaxin.   This is in fact dangerous, especially in view of the fact that the discoveries are new and profound.  Relaxin plays a communication role in the body and is balancing act in that too much relaxin in some cases can play a role in fibrosis and even cancer metastasizing and too little can be problematic as well.  Relaxin issues are known to manifest depression, anxiety, vigilance, orientation, working memory and locomotor skills as well as play a role in metabolic syndrome, including diabetes.

Based on new knowledge, the original three studies were re-reviewed and more information was excerpted.

The study of relaxin was resumed in 2022 and a dedicated search service was paid to provide publications.  50-100 additional studies were scanned or read and 4 were selected to be summarized with excerpts.

The subsequent research findings from the studies verified many of our original hypotheses and suggested additional ones which can be found in the readings.

New Life Health Ventures hypothesized that relaxin:

• Play a role in reproduction/heredity
• Play a role in obesity
• Play a role in diabetes and metabolic disorder/syndrome
• Plays a part in fibromyalgia
• Plays a role in certain types of autism
• Can cause renal damage
• Can cause curvature of the lower spine
• Can cause an aggravated/revved up state that can last for extended period of times and can impact the senses

All of these hypotheses are found to have merit!

This report is organized with the summaries of the initial three studies first, each summarized individually followed by a summary of the four more recently reviewed studies.

The findings of the seven studies are presented in a mix of conceptual level findings and technical findings.  This presentation is designed to be approachable to those without formal medical training.

Links to the studies are provided in the electronic copy of the report and all of the studies could be found at the U.S. National Institute of Health Library of Medicine.  Note that none of the studies were found from the U.S. National Institute of Health Library of Medicine, indicating that little effort is made by the U.S. National Institute of Health Library of Medicine to assure pertinent information shows up in searches.

Frequently there is a relationship between mental health states/conditions, cardiac conditions and metabolic disorders that can now and should be explained by altered states of relaxin.  It is both hypothesized and in some cases known that psychiatric medications can cause metabolic disorders and metabolic syndrome.  Metabolic syndrome is so commonplace with those taking daily psychiatric medications that it is deemed acceptable and is largely dismissed and in reality its root cause may also contribute to depression or other thought maladies.

Most of the studies are foreign with Australia playing a lead role.

The report concludes with a summary of the drug Abilify which is a manifestation of the dangers and damage to the body that can and do occur when the nature of potential harm is ignored- as manifested in the FDA animal studies and supported by studies of the drug after introduction by an approval system that violates the Hippocratic Oath, puts people in harm’s way, is none responsive and does not strive to build a body of knowledge.  The approval and patent process allow for pharmaceuticals to be approved even though it is known that they do not know how they work- and when shown how- ignore and bury truth.

Starting in 2012, requests for studies and help were made to Bristol Myer Squibb (BMY) top management and Board of directors.  The requests were denied.  As findings were uncovered in subsequent years they were sent to BMY , the FDA Director and the author of the animal studies, the National Institute of Mental Health, Insurance Companies, and several legislators and cabinet members with a request for help.  There was no help.  There was no acknowledgment. Information regarding the known potential damage of the drug has actively been removed from warnings and websites and the false notion that the drug is safe escalated after it went generic.  Despite being fined over $500,000,000, no money or help was made available to those suffering complications.  Subsequent learning has shown that Abilify is not alone- it follows the boiler plate strategy common to “blockbusters”.

LIST OF  STUDIES

Part 1

 Relaxin Family Peptides and Their Receptors

The Effect of Relaxin on the Musculoskeletal System

Relaxin-3/RXFP3 Networks, An Emerging Target for the Treatment of Depression and Other Neuropsychiatric Diseases?

Part 2

Four additional key studies:

Relaxin-3 is Associated with Metabolic Syndrome and its Component Traits in Women

The Actions of Relaxin on the Human Cardiovascular System

Talking Receptors May Affect Relaxin at Work

Investigation of Relaxin-3 Serum Levels in terms of Social Interaction, Communication, and Appetite as a Biomarker in Children with Autism

Key Findings:

Relaxin Family of Peptides and their Receptors:

 “Relaxin-3 is the most recently identified relaxin family peptide and was discovered following a search of the human genomic database.  Functions likely to be associated with relaxin-3 include stress, memory and appetite regulation.”

“RXFP1 is the cognate receptor for human relaxin-2 in humans that is found in a wide range of reproductive tissues including ovary, uterus, placenta, mammary gland, prostate and testis.  The receptor is also found in heart, kidney, lung, liver and blood cells as well as in a number of areas of brain such as cortex, organum, vasculosum of the lamina terminals (OVLT) and subfornical organs (SFO).  Thus relaxin not only has autocrine and paracrine roles but also acts as a neuropeptide.”

“There are seven relaxin family peptides that are all structurally related to insulin.”

“Relaxin has many roles in female and male reproduction, as a neuropeptide in the central nervous system, as a vasodilator and cardiac stimulant in the cardiovascular system and as an antifibrotic agent.”

“The relaxin 3-RXFP3 system is clearly implicated in the regulation of stress response.”

“Although the evidence for a role for relaxin-3 in the body is equivocal, there are indications that the peptide may influence food intake.”

“There is much information regarding RXFP1 expression, both in terms of the variety of approaches used and the tissues examined (TABLE 1), with receptor expression being identified in both female and male reproductive tissues, the brain and numerous nonreproductive tissues such as the kidney, heart, and lung. Less information is available for RXFP2, RXFP3, and RXFP4, although more detailed evidence is now emerging for RXFP3 expression in the brain, suggesting that this receptor may have promise as a therapeutic target.”

Similarly, “relaxin-3 expression is highest in the human brain, although substantial expression is also found in the testis, where its role remains to be demonstrated (314). The high levels of relaxin-3 expression in the brain of numerous species have led to a focus on the role of the peptide in the CNS.”

“In humans, relatively few studies have been conducted; however, they do suggest similar effects of relaxin on the cardiovascular system. In the clinical trial for scleroderma, long-term (6 mo) infusion of relaxin increased creatinine clearance and produced a modest decrease in blood pressure (149, 527). More recent trials of relaxin for the treatment of cardiac failure have shown that a short (24 h) infusion of relaxin is associated with decreased systemic vascular resistance, serum creatinine, pulmonary wedge pressure, and a small decrease in systolic blood pressure.”

“Relaxin also acts directly on the heart. The presence of relaxin receptors (RXFP1) in the heart was first suggested by the demonstration of high-affinity binding sites for relaxin in rat atria (401, 402).”

“The effects of relaxin on collagen synthesis and breakdown in reproductive tissues were the first biological effects of relaxin to be recorded (220). Since then it has become evident that relaxin has more general antifibrotic properties (47, 181), and a number of attempts have been made to put these to therapeutic use (462, 526–528, 538). One of the interesting aspects that has emerged is that the antifibrotic properties of relaxin are clearly seen only in disease conditions associated with excessive collagen deposition.”

“There is also now increasing evidence that relaxin is produced by cancer cells and can act in an autocrine manner on RXFP1 receptors expressed on these cells. To date, relaxin has been shown to be expressed by endometrial (273), mammary (522), thyroid (226), and prostate tumors (157, 532). There has long been an association of relaxin with breast cancer (reviewed in Refs. 26, 479), and relaxin treatment of breast cancer cells increases their invasive potential (59). Furthermore, elevated serum relaxin levels have been reported in breast cancer patients and in patients with metastases (60). It is possible that the relaxin produced by breast cancer cells is involved in tissue remodeling during breast cancer progression (60). Relaxin has also been associated with prostate cancer progression, and blocking the actions of relaxin or RXFP1 in rodent models of prostate cancer results in decreased cancer growth.”

“Much of the evidence for a role for relaxin-3 in behavioral activation and arousal comes from the parallel study of the neuroanatomy of relaxin-3 projections and sites of RXFP3 expression. Structures in the septohippocampal pathway of rodents are heavily innervated by relaxin-3-positive projections from the NI (FIGURE 6). One of the major functions of this pathway is the generation of hippocampal theta rhythm, which has oscillations at 4–12 Hz. Theta rhythm is controlled by pacemaker neurons of the medial septum (MS) and is involved in behaviors such as vigilance, exploration, orientation, navigation, locomotor control, and working memory. The NI has an important role in theta rhythm, and electrical stimulation of the nucleus causes theta rhythm in the hippocampus.”

“Serotonin (5-hydroxytryptamine, 5-HT) has well-established roles in cognitive, emotional, and behavioral control (reviewed in Ref. 106). Since the NI is located close to the dorsal raphé, a region enriched in 5-HT neurons, studies have been carried out examining the effects of 5-HT on relaxin-3 expression (367) and showed that most relaxin-3-containing neurons of the NI coexpress 5-HT1A receptors. Inhibition of 5-HT synthesis for 3 days increased relaxin-3 mRNA in the NI. More studies are needed to determine the relationship between changes in 5-HT levels and relaxin-3 expression.”

5-HT or Serotonin is biosynthesized from tryptophan amino acid. Tryptophan is converted to 5 hydroxy tryptophan by tryptophan hydroxylase which by action of dopa decarboxylase converted into serotonin.  5-HTP 5-Hydroxytryptophan, also known as oxitriptan, is a naturally occurring amino acid and chemical precursor as well as a metabolic intermediate in the biosynthesis of the neurotransmitter serotonin.  It is sold as a supplement.

“Thus the relaxin-3-RXFP3 system has a role in feeding, metabolism, stress, arousal, learning, and memory.”

“From a therapeutic viewpoint, relaxin decreases excess collagen deposition in fibrotic lesions, with a conservation of endogenous connective tissue structure (181, 542). Relaxin also exerts anti-inflammatory effects, can inhibit the activation of human neutrophils by pro-inflammatory agents (345), and prevents histamine and granule release by activated basophils (29) and mast cells.”

“Relaxin appears to be recruited in many types of cancer cells as an endogenous factor for tissue remodeling. In particular, relaxin is associated with prostate cancer progression, and increased expression of relaxin (but not RXFP1) occurs in prostate carcinomas and prostate cancer cell lines (157, 532, 549). Importantly, downregulation of either relaxin or RXFP1 caused significant inhibition of growth (549) and invasiveness, in addition to increased apoptosis (157) in rodent prostate cancer models.  Furthermore, relaxin is associated with increased invasiveness of endometrial (273), breast (59, 60), and thyroid (226) carcinomas, suggesting that agents blocking relaxin action may be used for the possible treatment of multiple cancers.”

“Since relaxin-3 is produced in GABAergic neurons of the nucleus incertus, it likely acts in concert with GABA signaling. In this way, it may be possible to fine-tune the GABAergic system by targeting RXFP3. This section focuses on the physiological functions of the relaxin-3 and RXFP3 system and how this may be manipulated for therapeutic purposes.”

“γ-Aminobutyric acid, or GABA, is the chief inhibitory neurotransmitter in the developmentally mature mammalian central nervous system. Its principal role is reducing neuronal excitability throughout the nervous system. GABA is sold as a dietary supplement in many countries, including the U.S.”

The Effect of Relaxin on the Musculoskeletal System

“Relaxin is a hormone structurally related to insulin and insulin-like growth factor, which exerts its regulatory effect on the musculoskeletal and other systems through binding to its receptor in various tissues, mediated by different signaling pathways.”

“Several studies have highlighted the therapeutic potential of relaxin for ectopic pregnancy, male infertility, and heart failure, cardiovascular and musculoskeletal diseases.”

“Relaxin1 and 2 reconcile the hemodynamic changes occurring during pregnancy such as cardiac output, renal blood flow, and arterial compliance (Conrad, 2011), as well as weakening the pelvic ligaments for parturition in species such as guinea pigs and mice (Sherwood et al., 1993).

“Relaxin 3 (RLN3) is a highly conserved neuropeptide in vertebrates, and is involved in a wide range of neuroactivities such as response to stress and cognition, as well as in neurological disease (Smith et al., 2011).”

“Evidence also suggests that the functional domains of Relaxin 1 (RXFP1), the cell type in which it is expressed, and the ligand used to activate the receptor all have important roles in the musculoskeletal system (Fig. 2). Relaxin alters cartilage and tendon stiffness by activating collagenase (Hashem et al., 2006; Pearson et al., 2011). Relaxin is also involved in bone remodeling process and in healing of injured ligaments and skeletal muscles (Li et al., 2005; Dragoo et al., 2009). The soft tissue healing cascade is composed of three phases, inflammation, regeneration, and fibrosis, and relaxin is a regulator of both inflammation and fibrosis (Mu et al., 2010).”

“A competition exists between fibrosis and regeneration during healing of damage tissue. Relaxin and transforming growth factor-beta1 (TGF-β1) make imbalance between regeneration and fibrosis process. Increased relaxin and decreased TGF- β1 result in regeneration and consequently healing, while decreased relaxin and increased TGF- β1 lead to fibrosis.”

“Relaxin in combination with estrogens may also have therapeutic value in the treatment of rheumatoid arthritis (RA) (Santora et al., 2005; Ho et al., 2011).  Relaxin exerts its anti-inflammatory effect through down-regulation of neutrophil function (Bani et al., 1998) and stimulates leukocyte adhesion and migration in human mononuclear cells (Figueiredo et al., 2006).”

“A prospective study of elite female athletes illustrated that players with increased serum relaxin levels had an increased risk of an ACL tear compared with females with lower relaxin levels (Dragoo et al., 2011a). Players having a relaxin concentration of greater than 6.0 pg/mL had more than four times greater risk of ACL injury. Other studies have collaborated these findings (Schauberger et al., 1996; Wojtys et al., 2002; Beynnon et al., 2006; Dragoo et al., 2011a).”

Relaxin-3/RXFP3 Networks, An Emerging Target for the Treatment of Depression and Other Neuropsychiatric Diseases?

“Animal and clinical studies of gene-environment interactions have helped elucidate the mechanisms involved in the pathophysiology of several mental illnesses including anxiety, depression, and schizophrenia; and have led to the discovery of improved treatments. The study of neuropeptides and their receptors is a parallel frontier of neuropsychopharmacology research and has revealed the involvement of several peptide systems in mental illnesses and identified novel targets for their treatment. “

“Since the early discovery of “substance P” (von Euler and Gaddum, 1931), a plethora of neuropeptide-receptor systems have been identified and characterized (see Hoyer and Bartfai, 2012)”. Substance P's most well-known function is as a neurotransmitter and a modulator of pain perception by altering cellular signaling pathways. Additionally, substance P plays a role in gastrointestinal functioning, memory processing, angiogenesis, vasodilation, and cell growth and proliferation.

“Neuropeptides are commonly co-released with GABA/glutamate and monoamine transmitters, and generally signal through G-protein coupled receptors to modulate a broad range of neural processes and behaviors. The potential attractiveness of neuropeptide-receptor systems as therapeutic drug targets is enhanced by their high level of signaling specificity. For example, expression of neuropeptides is often restricted to small populations of neurons within a small number of brain nuclei (e.g., orexin, MCH, and neuropeptide S; Xu et al., 2004; Sakurai, 2007; Saito and Nagasaki, 2008), and neuropeptides frequently bind to their receptors with high affinity and specificity due to their generally large allosteric binding sites (Hoyer and Bartfai, 2012). Neuropeptides are also often preferentially released under states of high neuronal firing frequency in response to the nervous system being challenged, as can occur during acute or chronic environmental stress and/or in association with neuropsychiatric disorders (Hökfelt et al., 2000, 2003; Holmes et al., 2003).”

“These characteristics suggest that therapeutic drugs which target neuropeptide systems may be less prone to unwanted “non-specific” side-effects compared to current drug treatments. For example, although tricyclic antidepressants are relatively effective at increasing 5-hydroxytrypamine (5-HT) and noradrenaline signaling to reduce the symptoms of major depression, they are hampered by cross-reactivity with other transmitter systems and reduce histamine and cholinergic signaling, which contributes to unwanted side effects (Westenberg, 1999). Even their “replacement” drugs (selective serotonin reuptake inhibitors, SSRIs) are associated with shortcomings such as slow onset of action and patient resistance, and side effects including sexual dysfunction, and weight gain (Nestler, 1998). Similar problems have been encountered in the development of antipsychotics to treat schizophrenia (Tandon, 2011), suggesting that more selective drugs that target relevant peptide receptors could have broad therapeutic applications (Hökfelt et al., 2003; Holmes et al., 2003; Hoyer and Bartfai, 2012).”

“Relaxin-3 is involved in regulating aspects of physiological and behavior stress response and the integration of sensory inputs.”

“Relaxin promotes wakefulness”.

Relaxin-3 is associated with Metabolic Syndrome and its Component Traits in Women

Metabolic syndrome is a group of conditions that together raise your risk of coronary heart disease, diabetes, stroke, and other serious health problems. Metabolic syndrome is also called insulin resistance syndrome.  The cluster of metabolic factors include abdominal obesity, high blood pressure, impaired fasting glucose, high triglyceride levels, and low HDL cholesterol levels.

“Relaxin-3 was found to play a role in appetite regulation, increasing food intake and body weight.”

“Serum relaxin-3 level was significantly higher in the metabolic syndrome patients than in the healthy control group. It was also significantly correlated with all the component traits of metabolic syndrome.”

“The results suggest that metabolic syndrome is associated with increased serum relaxin-3 levels in women. Relaxin-3 might be considered as a potential biomarker of metabolic syndrome.”

“The receptor for relaxin-3 is called relaxin family peptide 3 receptor (RXFP3) [4]. Relaxin-3 was found to play a role in appetite regulation [5], increasing food intake [6] and increasing body weight in rats [7]. It was also suggested that relaxin-3 may act as a central signal linking nutritional status and reproductive function [8].”

Graphical abstract

“The metabolic syndrome is a complex of interrelated risk factors for cardiovascular disease (CVD) and diabetes. These factors include dysglycemia, raised blood pressure, elevated triglyceride levels (TG), decreased high density lipoprotein cholesterol level (HDL-C), and obesity (particularly central adiposity). The associations and clustering of these factors have been known for decades.”

“There is widespread agreement that atherosclerotic cardiovascular disease (ASCVD) is the major clinical outcome of the metabolic syndrome; all the metabolic risk factors seemingly predispose to the development of ASCVD. The metabolic syndrome is also strongly associated with the development of type 2 diabetes [9], [10]. When diabetes develops, it becomes a powerful risk factor for the development of ASCVD in itself. Many authorities list type 2 diabetes as a second major outcome of the metabolic syndrome, because diabetes is a disease that has complications other than ASCVD [11].”

“The constellation of metabolic abnormalities includes glucose intolerance, insulin resistance, central obesity, dyslipidemia, and hypertension, all well documented risk factors for CVD. These conditions co-occur in an individual more often than might be expected by chance.”

The Actions of Relaxin on the Human Cardiovascular System

“The insulin‐like peptide relaxin, originally identified as a hormone of pregnancy, is now known to exert a range of pleiotropic effects including vasodilatory, anti‐fibrotic, angiogenic, anti‐apoptotic and anti‐inflammatory effects in both males and females. Relaxin produces these effects by binding to a cognate receptor RXFP1 and activating a variety of signalling pathways including cAMP, cGMP and MAPKs as well as by altering gene expression of TGF‐β, MMPs, angiogenic growth factors and endothelin receptors. The peptide has been shown to be effective in halting or reversing many of the adverse effects including fibrosis in animal models of cardiovascular disease including ischaemia/reperfusion injury, myocardial infarction, hypertensive heart disease and cardiomyopathy.”

“Relaxin given to humans is safe and produces favourable haemodynamic changes.”

“Serelaxin, the recombinant form of relaxin, is now in extended phase III clinical trials for the treatment of acute heart failure. Previous clinical studies indicated that a 48 h infusion of relaxin improved 180 day mortality, yet the mechanism underlying this effect is not clear.”

“In mice, relaxin increases circulating levels of bone marrow-derived endothelial cells (BMDECs) that facilitate angiogenesis and contribute to repair of vascular endothelium. BMDECs are recruited to the site of angiogenesis where relaxin promotes vasculogenesis by RXFP1 receptor activation, leading to NO generation and PI3K and Akt signalling (Segal et al., 2012; Ma et al., 2013b). This may explain the healing properties of relaxin because chronic administration in diabetic mice increases VEGF levels in the wound area and promotes skin recovery, an effect reversed by administration of VEGF antibodies (Bitto et al., 2013).”

Relaxin promotes vascular cell crosstalk

“A research team investigating the promising anti-fibrotic effects of a drug version of the hormone, relaxin, has discovered that the receptor through which it mediates its therapeutic actions can communicate and/or interact with other receptors in cells that contribute to fibrosis progression. This research may have implications for the design of clinical trials involving relaxin and its concomitant use with other drugs that act on these receptors.”

“Fibrosis, the damaging build-up of hardened or scarred tissue in the body, is a hallmark of various diseases and can lead to the dysfunction and failure of organs such as the heart and kidney. Fibrosis-related diseases in various organs contribute to around 45 per cent of deaths in developed countries.”

“A Monash Biomedicine Discovery Institute (BDI) researcher leading a team investigating the promising anti-fibrotic effects of a drug version of the hormone, relaxin, has discovered that the receptor through which it mediates its therapeutic actions can communicate and/or interact with other receptors in cells that contribute to fibrosis progression. Receptors are protein structures that transmit signals to other parts of the body when triggered by a stimulus.”

"We've shown that because these receptors have the ability to communicate, they have the ability to either promote or negate the actions of various drugs that act on each receptor. For example, our findings suggest that the effects of relaxin may be compromised as a treatment for heart failure when administered to patients who are already receiving angiotensin receptor blockers as frontline treatments."

"What we need to do now is better understand how these receptors communicate, not just in myofibroblasts, but in other cells in which they are co-localised. With an improved understanding of how these receptors interact, they may represent a previously unrecognised target for treating organ fibrosis."

Investigation of Relaxin-3 Serum Levels in terms of Social Interaction, Communication, and Appetite as a Biomarker in Children with Autism

“Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by a restricted and repetitive pattern of behaviors, interests, or activities, as well as limitations in mutual communication and social interaction [1]. ASD prevalence has been reported to have increased, especially in the last 30 years, affecting approximately 2% of children [2]. Despite the increasing number of studies that investigate this disorder, which negatively affects a significant part of society, its etiology remains unclear, and there is no definitive treatment for ASD yet. In addition, one of the important limitations that we face when diagnosing ASD is the fact that the diagnostic process is based on observations and the history provided by the caregiver. Therefore, objective measurements (blood test or radiologic screening) are of importance for elucidating the etiology of ASD, as well as its diagnosis, and/or follow-up. Yet, numerous studies report that there are biologic abnormalities associated with ASD [3]. Biomarkers to be developed to accurately measure these abnormal biological processes may be of importance in the diagnosis, follow-up, and treatment of ASD.”

“Especially in the study of psychiatric disorders, there is increasing interest in the study of neuropeptides such as orexin, neuropeptide Y, and substance P. Substance P's most well-known function is as a neurotransmitter and a modulator of pain perception by altering cellular signaling pathways. Additionally, substance P plays a role in gastrointestinal functioning, memory processing, angiogenesis, vasodilation, and cell growth and proliferation.”

“In this context, a review of studies investigating relaxin-3, which is a neuropeptide, highlights that relaxin-3 may be associated with depression, schizophrenia, eating disorders, and ASD, and that it offers hope in the treatment of these disorders [4]. Relaxin-3 was found to be mostly expressed from GABAergic (g-aminobutyric acid) neurons in the nucleus incertus (NI) [5] of the brain stem in mammals, and transmitted to the midbrain, hypothalamus, amygdala, basal forebrain, hippocampus, and prefrontal cortex, which contains neurons that express the peptide receptor 3 (RXFP3), and that this signalization was found to promote excitation [6]. Existing studies have shown that relaxin-3 plays a role in the integration of sensory inputs and regulation of behavioral responses to environmental and physiologic stimuli [7], memory and learning processes associated with the hippocampus [8], feeding, and control of the neuroendocrine axis [9].”

“Restrictions in social behavior are the main symptoms of ASD. The roles of the hippocampus and amygdala in ASD are often investigated because they are involved in the basic functions of the social brain. Human imaging studies in this area have shown that there are structural abnormalities in ASD in limbic structures, such as the hippocampus and amygdala [10]. In addition, decreased activity of the anterior cingulate cortex (control of attention and executive functions) was also found in individuals with ASD [11]. The paraventricular nucleus (PVN), which plays a role in regulating social behavior, is another important limbic structure frequently investigated in ASD due to the presence of oxytocin neurons [12]. Moreover, oxytocin neuron loss in PVN has been reported in animal models of ASD [13]. Considering the animal studies investigating the effect of the relaxin-3/RXFP3 system on social behavior, one study found that chronic activation of RXFP3 in the ventral hippocampus increased social avoidance [14]. In another study, it was stated that central relaxin-3/RXFP3 activation disrupted social recognition, and that as a result of this activation there was a functional interaction between RXFP3 and oxytocin receptors in the amygdala, where this interaction might be effective in modulating social memory [15]. These results, showing the link between relaxin-3 and oxytocin, suggest that relaxin-3 may also play a role in ASD.”

“RXFP3 is also found in hypothalamic regions closely related to appetite control and hormonal balance [16]. Acute RXFP3 activation has been shown to consistently increase food intake in satiated adult male rats [17]. Sub-chronic intracerebroventricular (ICV) administration of relaxin-3 resulted in a significant increase in average daily food intake and a cumulative increase in body weight [18]. Oxytocin and arginine vasopressin are the hormones that strongly affect nutritional behavior. In both animals and humans, oxytocin has been shown to act as an anorexigenic signal [19,20] and deficiencies in oxytocin synthesis have been shown to lead to hyperphagia and obesity [21].”

“Given that relaxin-3 projections reach out RXFP3 in the limbic hippocampus, amygdala, anterior cingulate cortex, and PVN, and considering that these areas modulate social interaction and communication [17], it is clear that the possible relationship between ASD and relaxin-3/RXFP3 systems should be investigated in more detail. According to a literature review of this association, no study was found investigating the relationship between ASD and relaxin-3 in humans. Given all these facts, the aim of this study was to investigate the possible relationship between relaxin-3 and ASD. In this study, differences between serum relaxin-3 levels were investigated between children diagnosed as having ASD and control children, matched in terms of age, sex, and socioeconomic level. A nutritional scale was also given to investigate the effects of relaxin-3 on nutrition. Given the animal studies that reported that chronic activation of relaxin-3 disrupted social behavior, it was assumed that the serum relaxin-3 levels of children with ASD in our study would be higher than those of the control group.”

“Given that relaxin-3 projections reach out RXFP3 in the limbic hippocampus, amygdala, anterior cingulate cortex, and PVN, and considering that these areas modulate social interaction and communication [17], it is clear that the possible relationship between ASD and relaxin-3/RXFP3 systems should be investigated in more detail.”

“The study included 50 children with ASD and 30 children as a control group. There were no significant differences between the two groups in terms of age and sex. Sociodemographic data and clinical characteristics are presented in Table 1. Serum relaxin-3 levels were found to be statistically significantly higher in the group with ASD (p < 0.05)

Table 1  Characteristics of patients and control groups and relaxin-3 level

The study included 50 children with ASD and 30 children as a control group. There were no significant differences between the two groups in terms of age and sex. Sociodemographic data and clinical characteristics are presented in Table 1. Serum relaxin-3 levels were found to be statistically significantly higher in the group with ASD (p < 0.05)

In this study, serum levels of relaxin-3 were compared between children with ASD and control group of similar age, sex, and socioeconomic level. In support of the hypothesis, our findings found that serum relaxin-3 levels were higher in children with ASD than in the controls. No statistically significant correlation was found between relaxin-3 levels and CARS total scores in the group with ASD, but the listening response sub-scale score of CARS was found to negatively correlated with the level of relaxin-3. Furthermore, as relaxin-3 levels increased in children with ASD, it was found that the speech problem sub-scale score on the ABC scale and the desire to drink score on the CEBQ scale increased, but the satiety responsiveness and food fussiness scores decreased. These results showed that levels of relaxin-3 were associated with listening, speech difficulties, and appetite problems in children with ASD as reported by their parents.”

“We found no statistically significant correlation between serum relaxin-3 levels and CARS total scores, which indicates the severity of ASD. However, the level of relaxin-3 was found to increase with the decreased listening response score of the CARS scale. These results suggest that there may be more difficulties with listening skills in children with low levels of relaxin-3. Neuroanatomic evidence suggests that relaxin-3 should be considered as an arousal neurotransmitter. Relaxin-3 neurons have been shown to be distributed similarly to monoamine and other peptide stimulation systems.”

“The fact that the CARS scaleʼs listening response sub-scale score and the ABC scaleʼs speech problem sub-scale score were associated with relaxin-3 suggests that relaxin-3 may be associated with communication skills. There is no study showing the relationship between relaxin-3 and communication skills. Understanding the connections between relaxin-3 and communication skills areas in the brain in future studies will enable us to better understand the role of relaxin-3. Relaxin-3 serum levels, which are believed to function in stress, excitation, and memory, were investigated in our study [6]. According to these results, relaxin-3 may have an effect on speaking from verbal communication skills and listening from non-verbal communication skills.”

The Reality of Abilify-Its Capability of Altering the Peptide Relaxin and Life Threatening and Life Altering Dangers and Damage Known to Occur but No Longer Disclosed

Abilify is a new generation antipsychotic initially approved by the FDA in 2002 for treatment of schizophrenia.   Approved initially for the rare condition of adult schizophrenia, it then was approved for adult bipolar then for a second drug for depression and then for schizophrenic children and finally for autism in children.  A review of the FDA approval documents showed no reference to the findings of the animal studies and a rubber stamp approval process.  For schizophrenic children, no schizophrenic children were found to test the drug, yet it was approved anyway, even when deaths were noted.  Children in Europe and Australia are protected from being prescribed Abilify, unlike the United States.   Abilify was developed by Otsuka Pharmaceutical of Japan and distributed in the U.S. starting in 2002 by Bristol Myers Squibb. 

As sited from “Reformulation Focused Life Cycle Management of the FDA –Approved Drugs, Journal of Biology and Today’s World Research (2020) Volume 9, Issue 3

“Abilify has high affinity for dopamine D2 and D3, serotonin 5-HT1A and 5-HT2A receptors (Ki values of 0.34 nM, 0.8 nM, 1.7 nM, and 3.4 nM, respectively), moderate affinity for dopamine D4, serotonin 5-HT2C and 5-HT7, alpha1-adrenergic and histamine H1 receptors (Ki values of 44 nM, 15 nM, 39 nM, 57 nM, and 61 nM, respectively), and moderate affinity for the serotonin reuptake site (Ki=98 nM) [8].”

Abilify Timeline and Product History:

Bristol Myers Squibb and Otsuka Revenue from Abilify

While on Abilify I experienced weight gain and early menopause, uncontrollable thyroid and very high blood pressure, none  of which I attributed to the drug as I was told you don’t gain weight on Abilify and I knew nothing about medications and presumed they were safe. After 5 years I experienced level 3 kidney damage and insomnia and my diagnoses was changed to PTSD and my provider tapered me off Abilify.

At the time, 2011, the Bristol Myers Squibb (BMY) website on Abilify said 30 days in detox for withdrawal from the drug, yet no provisions were made with detox centers.   In mid 2012, perhaps in response to my letters to the BMY Board of directors, the warning was removed from their website.  At that time, I cited their corporate mission to the BMY Board of Directors which included “patient trust”.  They subsequently changed their mission and removed “patient trust”.  Note BMY has 150 staff attorneys!-There Corporate Counsel- who signs off on the FDA approved drugs at approval time is a former NYC prosecutor.

I learned about Relaxin because when I suffered Abilify withdrawal, I could do the splits both ways for the first and only time in my life.  At the time, in 2011, Relaxin was thought to be a protein facilitates the spreading of the hips in pregnant women and little more than its role in pregnancy was known about relaxin although it was known to be in males and females and in all mammals.  Less formal research indicated that it played a role in pregnancy weight gain that could be offset with compression “belly bandits”.  Although I could do the splits, I was in severe pain throughout my body and could not lift objects over my head- No upper arm strength.  I suffered temporary learning disabilities in reading, sever adrenal rushes that lasted for weeks, chronic insomnia, and chronic pain throughout my body.  My body took on new shape and I had a protruding belly and looked pregnant.  Prior to ceasing Abilify, level 3 kidney damage was detected.  After ceasing Abilify I developed severely concaved lower spine and suffered severe pain in the breast area which I learned to be adrenal glands.  Uterine cysts, occasional lung issues and times when my skin and senses were on high alert also occurred.

I suffered Abilify withdrawal 3 times, once untapered and twice tapered and under provider supervision.  Untapered I suffered light flashing headaches and severe body pains and my provider, an internist was the person who discovered the warning on the Bristol Myer Squibb website stated 30 days in detox.

The two times I was taken off tapered I experienced identical symptoms all over my body 28 days after ceases- which correlates with Abilify’s half-life, including dangerous adrenal rushes that would last for weeks. All of my senses were acute.  I was very alert and could not sleep and my body suffered phantom limb pain as I went through withdrawal.  My symptoms were documented by keeping pain journals which were virtually identical and in reality is a perfect experience with 1 degree of freedom and no real variability.

As I suffered a severe and dangerous withdrawal followed by chronic pain in the abdomen and back 2012-2016 and first wrote Bristol Myers Squibb Senior Management and Board of Directors asking for help and copies of the studies for myself and my providers.  The MN Attorney General’s Office also contacted BMY on my behalf and all requests were denied.  Note I am a highly trained and published statistician.

Between 2012-present, there was no help from BMY.  Bristol Myers Squibb only provided me with the labeling including the receptors.  Most providers did not want to get involved.  I found a collection of studies which can be found at https://abilifysurvivorsguide.com/.  One study showed that Abilify can cause diabetes, one study showed the areas of the body impacted by Abilify and one study showed how Abilify is processed by the body and a physician that read the study said there was a stray molecule.

In 2014, when I learned that my pain might be adrenal glands from an endocrinologist, I did a Hail Mary search on Abilify’s impact on the adrenal glands and found the FDA monkey studies.  As I said in my letter to BMY Board, “I am a female monkey”- my injuries corresponded with what happened to the monkeys and some female monkeys died.  It was shown that the drug caused dependence and babies could be born addicted through the placenta.  The drug never should have been approved.  For links to the studies and more detailed information go to AbilifySurvivorsGuide.com

An RNA analysis published in 2014 is consistent with the findings in the Abilify animal studies.

The Abilify FDA animal studies showed polymorphism: that the drug impacted different monkeys in different ways, some had kidney damage, some had adrenal gland damage, organ damage: testis, prostate, uterus, ovary, liver, gut,  lung, heart, brain, and skin as well as breast, vasculature, bone, and diabetes and fibrosis,  and a known and potentially fatal withdrawal were all evident.  Female monkeys suffered more than male monkeys.

Abilify is also known to be an analgesic with a long half- life, so the pain may start about after the last dose of the drug, as was the case with me, multiple times.  Chronic insomnia, a protruding abdomen and severely concaved lower back also resulted.  These areas of damage correspond to the 2013 diagram of the now known areas of impact of the peptide relaxin to a remarkable degree.  Abilify was also known to “give a lift” in the morning and require a sleeping remedy at night and it is now known that relaxin causes “awakeness”.

A 2014 PNAS (RNA) Study by The National Academy of Sciences showed the following:

The website AbilifySurvivorsGuide  hosts links to the animal and other studies on Abilify and presents supplements for successful detoxing.  It is now believed that the physical pain and body damage from Abilify were largely due to fibrosis as well as renal damage and skeletal damage of the lower back likely due to relaxin..  Abilify anesthetizes the organs while it damages them.

With the generic and other versions of the drug today, there is no mention of the known and verified body damage and dangerous withdrawal.  While under patent, Abilify sold for over $1300- $1600 for a 30 day supply.  Now that it is generic it can be had for $12 for a 90 day supply generic version, and $0.55 a pill for brand.  This is over a 99.9% price decrease, meaning a 70% price decrease to $390 still leaves the price/margins extremely exorbitant.

Note Abilify was a purchased Japanese compound from Otsuka.  Presently, Alphabet’s Verily, is starting clinical tests of a Japanese compound from Otsuka for major depression.  In 2017 on NHK (Japanese) television it was reported that Japan had over 350 compounds and also that there were Japanese who were suffering adrenal gland and assorted complications and were encouraged to take a year of rest.

Abilify, in 2017, was the first drug to have a version with a chip implanted so a provider can tell remotely if the drug was digested.  Given this reality, it is not surprising that portions of the general public believe that COVID mNRA vaccines contain and/or implant chips.

High levels of relaxin are now showing promise as a biomarker for Autism, meaning Abilify likely actually makes matters worse for autistic children.

In 2012 Otsuka applied for a patent for aripiprazole, the active ingredient in Abilify as a general analgesic, pain reliever.  Prior to that, Abilify had been proposed for cocaine withdrawal.  Abilify targets the same receptors as Oxycodone.  Oxycodone is known to have a dangerous withdrawal.

In late 2016 I took matters into my own hands and research detoxing and successfully relieved my pain- which was likely scar tissue and fibrosis and at times phantom limb pain.

I have sent Bristol Myers Squibb their own studies and those of others- sent also to FDA, HSS, and virtually every cabinet member of the Obama and Trump administration and several Senators and members of Congress- There was no acknowledgement and no help, save thank you letters from the 2016 Trump Campaign and Vice President Elect Pence and a form letter on mental health from President Barack Obama after the 2016 election- and an unsigned letter from the Federal Trade Commission indicating that my information has been saved in their secure database.

Subsequently, FTC Commissioner Rebecca Kelly Slaughter has responded and all documentation is on file with the FTC.

None of the information can be found when searching on the drug at various pharmacies or the Mayo Clinic- despite my having provided them the information.

Here is an impact diagram of Relaxin from the Relaxin Family Peptides and Their Receptors Study:

Due to my experience with Abilify- altered relaxin was particularly evident after cessation- and really a month after taking the last dose due to Abilify’s unusually long half-life, my entire physique changed- I looked pregnant- my belly protruded, curvature of the lower spine became present and severe pain now known to be fibrosis and neurological pain became unbearable and all senses- sight, hearing, taste, touch were acute.  The fibrosis created constant pain and disfigurement.  The pain lasted for five years and was subdued by extensive detoxing with dandelion tea, garlic, milk weed thistle, Vitamin K, Apple cider vinegar, and baking soda.  The disfigurement of the lower back is permanent. 

New Life Health Ventures advocates viewing relaxin comprehensively with the mindset of marvel and attention to detail to the delicate yet powerful role of balance and communication relaxin exercises throughout the body and bodies of animals and how it changes throughout pregnancy.  One study revealed an adverse impact on rabbit knees- rabbits hop so the role of the knee in a rabbit may require a particular balance, resilience and/or sensitivity!

New Life Health Ventures sees the human body as intelligent and full of life and we believe and have seen that the body parts actively communicate with each other and at times are willing to sub optimize in many cases automatically to aid parts of the body that may be in crisis and we hypothesize relaxin plays a part in this.  We furthermore believe that procreation and all it entails is central to the design of the human person and all of God’s creations. Relaxin plays a significantly larger role in creation and reproduction than originally thought.

New Life Health Ventures sees the manipulation of relaxin for mental health purposes as unduly risky and irresponsible and can even lead to greater future manifestations of stress throughout the mind and body.

Studies have shown that relaxin intertwines with 5-HTP and GABA- both of which are available as supplements from plants as a gentler, less risky, more targeted approach for addressing anxiety, depression, and calmness and potentially redirecting relaxin to a more stable state.

Conclusions

As 5 HTP and GABA are known to naturally and safely promote serotonin, New Life Health Ventures advocates that they be included as alternatives for comparison when testing the efficacy of all mental health pharmaceuticals and be promoted as standard protocol as the first/safest treatment for most mental health conditions, which historically were not considered lifelong conditions until the advent of life long daily pharmaceutical emphasis when treating emotional pain and trauma.  

Ground source repositories of complete data and information on pharmaceuticals should be established and maintained as a required safety element for all concerned.  Standardized efforts to collect non-personalized data and information from patients, pharmacies, and practioners should be formalized, transparent and ongoing and readily available to all, so as to assure informed consent.

A return to the Hippocratic Oath- “First, do no harm” should be reflected as the gold standard and prevailing attitude and criteria for drug acceptance by the FDA.  Doing so- where only truly safe and truly effective drugs will be approved will dramatically cut the cost of drug approval and the cost of health care and present the true possibility of informed consent.  Natural supplements and nutrition, exercise, prayer, and community involvement should all be on parity if not lead pharmaceutical treatment in mental health and formally be seen as treatments for comparison during drug efficacy trials.

Idiosyncratic drug reactions and paradoxical reactions are most typically dismissed by the FDA to the point that few providers or pharmacists even think of the possibility thereby reinforcing a very false, problematic and negligent notion of complete safety through the acceptance of incomplete information.  When people are sick, they are vulnerable and frequently desperate and therefore in need of formalized means of protection from the dangers of pharmaceuticals and counseled on the need for patients.

In mental health, so as to perpetuate drug acceptance, a false hysteria and false notion that suicide, self-harm, or harming others are highly likely outcomes or that depression frequently leads to suicide when in many cases it is simply great sorrow, contributes to the false notion that immediate biochemical relief is required when a cup of tea and a sense of being understood may be what it takes to start the healing process.

Organizations that push drugs shown to be unsafe through the FDA or market should be banned from seeking approval for new drugs for 10 years.  Capitalism and Safety must meet.  Truth and Safety must prevail.

The self-serving barriers to entry ($1 Billion to get a new drug through the FDA) can and must be dismantled as well as the false notion that exorbitant prices/profits should be allowed so as to compensate for costs of the attempted failures- no other industry is given such privileged justification for product management and both these faulty elements contribute to a great deal of harm, confusion, lack of transparency and over complication in treatment and gross irresponsibility.  There is no accountability , transparency or responsibility in healthcare today in the U.S., save some pricing transparency by Mr. Cuban’s Cost Plus Drug Company, which has been noted to play a role in decreasing the price of Eli Lilly insulin.  There is a blanket tolerance for grossly over-priced science experiments that have little merit and get past regulators and government officials who cannot see past the exorbitant money that accompanies many unsafe, damaging and dangerous pharmaceuticals.  Our health system is by far the most expensive in the world with declining life expectancy and failed strategies in mental health, diabetes, blood pressure because it no longer has objectivity, nor a focus on the human person or reverence for God’s creation nor is it governed by science or scientific principles.  It lacks common sense and virtue.

Most true discoveries like “insulin” or the Salk vaccine or now relaxin- naturally through understanding promote relatively simple remedies which for some time now have been commonly overlooked in favor of “blockbusters” and “business opportunities” both of which have benefited by burying knowledge and information by people and organizations that do not have the fidelity to be in healthcare- which in reality is sacred and requires a sense of reverence, learning, truth and patience.