renegadetribune--2019-09-20--Chamomile Proven to Fight Anxiety and Clinical Depression

Recent clinical and laboratory research has determined that chamomile is not only relaxing, but it can significantly decrease anxiety and even fight depression.  The most recent study, from the UK’s University of Nottingham Medical School, found that chamomile significantly relaxed blood vessels and smooth muscle fibers. This effect was indicated specifically with the application of three of chamomile’s central constituents, apigenin, luteolin and bisabolol – all hydroxylates.  This effect of chamomile to soothe and calm the system was also showed in a recent study from the Eulji University Hospital in South Korea. Here 56 patients undergoing coronary treatment and surgery were given aromatherapy with a combination of lavender, chamomile and neroli. A control group was given only nursing care.  The researchers found that the aromatherapy group had significantly lower anxiety and improved sleep compared to the control group.  The fact that chamomile is an anti-anxiety and anti-depression herb was cemented by a clinical study at the University of Pennsylvania School of Medicine. This study was done in 2009, but its data and findings were re-investigated and confirmed last year.  The researchers enlisted 19 people diagnosed with anxiety with comorbid depression, along with 16 people who were diagnosed as having a history of anxiety and depression. These groups were studied along with a control group of 22 people who had no anxiety or depression – past or present.  The study was randomized, double-blind and placebo-controlled. The researchers gave the subjects either 220 milligrams of chamomile extract (standardized to 1.2% apigenin) or a placebo study, both in capsules.  The treatment period spanned eight weeks. During the first week the subjects were given one capsule a day, and for those receiving less benefit on their anxiety scores, this was increased to two capsules the second week, three capsules the third week, four the fourth week and five for the remainder of the eight weeks.  The primary means for judging the success of the treatment was the Hamilton Anxiety Rating (HAM-A) scoring system – which utilizes questionnaires to determine ones level of anxiety. The researchers also used the Beck Anxiety Inventory system and the Psychological Well Being system, as well as the Clinical Global Impression Severity system to confirm their findings.  The researchers found that 57% of the group using the chamomile extract had significantly reduced (greater than 50%) anxiety scores using the HAM-A system.  Three years later, the University of Pennsylvania researchers undertook another review of the data in this study to determine whether or not treatment with chamomile for the clinically anxious and clinically depressed could be considered “clinically meaningful.” This of course enables medical peers to gauge whether or not chamomile could be used as a prescriptive treatment for diagnosed patients.  After reviewing the study and research data in depth, the researchers concluded that the results were “clinically meaningful” and they pointed out that,  This of course means that the improvement in their HAM-D scores – taken only over an eight-week period – short for an herbal therapy – continued to increase over the period of the trial.  The study not only confirms chamomile’s usefulness for anxiety and depression, but that its effects can increase over a longer duration. Traditional herbalists will typically recommend the use of anti-anxiety herbs such as chamomile, lavender, St. John’s wort and others over a period of three months to a year in order for them to reach their full effectiveness. After that, they are often recommended to be continued at least periodically or as needed.  The good news about chamomile, as evidenced by this and other studies, is that it has no known adverse side effects and is non-addictive. This is in stark contrast to anti-depressant pharmaceuticals, some of which are known for being significantly addictive in addition to having numerous other adverse effects.  Roberts RE, Allen S, Chang AP, Henderson H, Hobson GC, Karania B, Morgan KN, Pek AS, Raghvani K, Shee CY, Shikotra J, Street E, Abbas Z, Ellis K, Heer JK, Alexander SP. Distinct mechanisms of relaxation to bioactive components from chamomile species in porcine isolated blood vessels. Toxicol Appl Pharmacol. 2013 Jul 8.  Cho MY, Min ES, Hur MH, Lee MS. Effects of aromatherapy on the anxiety, vital signs, and sleep quality of percutaneous coronary intervention patients in intensive care units. Evid Based Complement Alternat Med. 2013;2013:381381.  Amsterdam JD, Shults J, Soeller I, Mao JJ, Rockwell K, Newberg AB. Chamomile (Matricaria recutita) may provide antidepressant activity in anxious, depressed humans: an exploratory study. Altern Ther Health Med. 2012 Sep-Oct;18(5):44-9.


renegadetribune--2019-03-28--Pennies Worth of Magnesium Daily Puts Antidepressant Drugs to Shame in Clinical Trial

Pennies’ Worth of Magnesium Daily Puts Antidepressant Drugs to Shame in Clinical Trial

A powerful clinical study shows that pennies worth of magnesium a day provides an effective, safe, affordable alternative to dangerous and relatively ineffective pharmaceutical antidepressants.  Depression is one of the most widely diagnosed conditions of our time, with over 3 million cases in the U.S. every year, and 350 million believed affected worldwide.1 Conventional medicine considers antidepressant drugs first-line treatments, including the newly approved injected postpartum drug costing $34,000 a treatment, to the tune of a 16 billion dollars in global sales by 2023. Despite their widespread use, these drugs are fraught with a battery of serious side effects, including suicidal ideation and completion — the last two things you would hope to see in a condition that already has suicidality as a co-morbidity. For this reason alone, natural, safe, and effective alternatives are needed more than ever before.  While research into natural alternatives for depression is growing daily — GreenMedInfo.com’s Depression database contains 647 studies on over 100 natural substances that have been studied to prevent or treat depression — it is rare to find quality human clinical research on the topic published in well-respected journals. That’s why a powerful study published in PLOS One titled, “Role of magnesium supplementation in the treatment of depression: A randomized clinical trial,” is so promising. Not only is magnesium safe, affordable, and easily accessible, but according to this recent study, effective in treating mild-to moderate symptoms of depression.  While previous studies have looked at the association between magnesium and depression,2-7 this is the first placebo-controlled clinical study to evaluate whether the use of over-the-counter magnesium chloride (248 mg elemental magnesium a day for 6 weeks) improves symptoms of depression.  The study design was a follows:  An open-label, blocked, randomized, cross-over trial was carried out in outpatient primary care clinics on 126 adults (mean age 52; 38% male) diagnosed with and currently experiencing mild-to-moderate symptoms with Patient Health Questionnaire-9 (PHQ-9) scores of 5–19. The intervention was 6 weeks of active treatment (248 mg of elemental magnesium per day) compared to 6 weeks of control (no treatment). Assessments of depression symptoms were completed at bi-weekly phone calls. The primary outcome was the net difference in the change in depression symptoms from baseline to the end of each treatment period. Secondary outcomes included changes in anxiety symptoms as well as adherence to the supplement regimen, appearance of adverse effects, and intention to use magnesium supplements in the future. Between June 2015 and May 2016, 112 participants provided analyzable data.”  The study results were as follows:  For perspective, conventional antidepressant drugs are considering to generate an “adequate or complete treatment response” with a PHQ-9 score “decrease of 5 points or more from baseline.” At this level of efficacy, their recommended action is: “Do not change treatment; conduct periodic follow-up.” The magnesium’s score of -6.0 therefore represents the height of success within conventional expectations for a complete response, which is sometimes termed “remission.” In contradistinction, conventional antidepressant drugs result in nearly half of patients discontinuing treatment during the first month, usually due to their powerful and sometimes debilitating side effects.8  Magnesium is a central player in your body’s energy production, as its found within 300 enzymes in the human body, including within the biologically active form of ATP known as MG-ATP. In fact, there have been over 3,751 magnesium binding sites identified within human proteins, indicating that it’s central nutritional importance has been greatly underappreciated.  Research relevant to magnesium has been accumulating for the past 40 years at a steady rate of approximately 2,000 new studies a year. Our database project has indexed well over 100 health benefits of magnesium thus far.  For the sake of brevity, we will address seven key therapeutic applications for magnesium as follows:  It is quite amazing to consider the afformentioned side benefits of magnesium consumption or supplementation within the context of the well-known side effects of pharmaceutical approaches to symptom  management of disease. On average, conventional drugs have 75 side effects associated with their use, including lethal ones (albeit sometimes rare). When considering magnesium’s many side benefits  and extremely low toxicity, clearly this fundamental mineral intervention (and dietary requirement) puts pharmaceutical approaches to depression to shame.  The best source of magnesium is from food, and one way to identify magnesium-containing foods are those which are green, i.e. chlorophyll rich. Chlorophyll, which enable plants to capture solar energy and convert it into metabolic energy, has a magnesium atom at its center. Without magnesium, in fact, plants could not utilize the sun’s light energy.  Magnesium, however, in its elemental form is colorless, and many foods that are not green contain it as well. The point is that when found complexed with food cofactors, it is absorbed and utilized more efficiently than in its elemental form, say, extracted from limestone in the form of magnesium oxide.  The following foods contain exceptionally high amounts of magnesium. The portions described are 100 grams, or a little over three ounces.  Fortunately, for those who need higher doses, or are not inclined to consume magnesium rich foods, there are supplemental forms commonly available on the market. Keep in mind, for those who wish to take advantage of the side benefit of magnesium therapy, namely, its stool softening and laxative properties, magnesium citrate or oxide will provide this additional feature.  For those looking to maximize absorption and bioavailability magnesium glycinate is ideal, as glycine is the smallest amino acid commonly found chelated to magnesium, and therefore highly absorbable.  1) World Health Organization. Depression fact sheet no. 369 2012 [cited 2016 December 20]. Available from: http://www.who.int/mediacentre/factsheets/fs369/en/.  2) Jacka FN, Overland S, Stewart R, Tell GS, Bjelland I, Mykletun A. Association between magnesium intake and depression and anxiety in community-dwelling adults: the Hordaland Health Study. Aust N Z J Psychiatry. 2009;43(1):45–52. Pmid:19085527.  3) Huang JH, Lu YF, Cheng FC, Lee JN, Tsai LC. Correlation of magnesium intake with metabolic parameters, depression and physical activity in elderly type 2 diabetes patients: a cross-sectional study. Nutrition J. 2012;11(1):41. pmid:22695027; PubMed Central PMCID: PMC3439347.  4) Tarleton EK, Littenberg B. Magnesium intake and depression in adults. J Am Board Fam Med. 2015;28(2):249–56. Pmid:25748766  5) Yary T, Lehto SM, Tolmunen T, Tuomainen T-P, Kauhanen J, Voutilainen S, et al. Dietary magnesium intake and the incidence of depression: a 20-year follow-up study. J Affect Disord. 2016;193:94–8. Pmid:26771950  8)  Damiano Piovesan, Giuseppe Profiti, Pier Luigi Martelli, Rita Casadio. 3,751 magnesium binding sites have been detected on human proteins. BMC Bioinformatics. 2012 ;13 Suppl 14:S10. Epub 2012 Sep 7. PMID: 23095498  9) G Moorkens, B Manuel y Keenoy, J Vertommen, S Meludu, M Noe, I De Leeuw. Magnesium deficit in a sample of the Belgian population presenting with chronic fatigue. Magnes Res. 1997 Dec;10(4):329-37. PMID: 9513929  13)  Phuong-Chi T Pham, Phuong-Mai T Pham, Son V Pham, Jeffrey M Miller, Phuong-Thu T Pham . Hypomagnesemia in patients with type 2 diabetes. Clin J Am Soc Nephrol. 2007 Mar;2(2):366-73. Epub 2007 Jan 3. PMID: 17699436  14)  M de Lordes Lima, T Cruz, J C Pousada, L E Rodrigues, K Barbosa, V Canguçu. The effect of magnesium supplementation in increasing doses on the control of type 2 diabetes. Diabetes Care. 1998 May;21(5):682-6. PMID: 9589224  15) Y Song, K He, E B Levitan, J E Manson, S Liu. Effects of oral magnesium supplementation on glycaemic control in Type 2 diabetes: a meta-analysis of randomized double-blind controlled trials. Cardiovasc Toxicol. 2008;8(3):115-25. Epub 2008 Jul 8. PMID: 16978367  19)  S Quaranta, M A Buscaglia, M G Meroni, E Colombo, S Cella. Pilot study of the efficacy and safety of a modified-release magnesium 250 mg tablet (Sincromag) for the treatment of premenstrual syndrome. Am J Gastroenterol. 2008 Dec;103(12):2972-6. PMID: 17177579  20) M C De Souza, A F Walker, P A Robinson, K Bolland. A synergistic effect of a daily supplement for 1 month of 200 mg magnesium plus 50 mg vitamin B6 for the relief of anxiety-related premenstrual symptoms: a randomized, double-blind, crossover study. J Womens Health Gend Based Med. 2000 Mar;9(2):131-9. PMID: 10746516  22) Andrea Rosanoff, Mildred S Seelig. Comparison of mechanism and functional effects of magnesium and statin pharmaceuticals. J Am Coll Nutr. 2004 Oct;23(5):501S-505S. PMID: 15466951  25) Joen R Sheu, George Hsiao, Ming Y Shen, Yen M Lee, Mao H Yen . Antithrombotic effects of magnesium sulfate in in vivo experiments. Int J Hematol. 2003 May;77(4):414-9. PMID: 12774935  26) Afshin Samaie, Nabiollah Asghari, Raheb Ghorbani, Jafar Arda. Blood Magnesium levels in migraineurs within and between the headache attacks: a case control study. Pan Afr Med J. 2012 ;11:46. Epub 2012 Mar 15. PMID: 22593782  28) Alexander Mauskop, Jasmine Varughese. Why all migraine patients should be treated with magnesium. J Neural Transm. 2012 May ;119(5):575-9. Epub 2012 Mar 18. PMID: 22426836  30) Ali Tarighat Esfanjani, Reza Mahdavi, Mehrangiz Ebrahimi Mameghani, Mahnaz Talebi, Zeinab Nikniaz, Abdolrasool Safaiyan. The effects of magnesium, L-carnitine, and concurrent magnesium-L-carnitine supplementation in migraine prophylaxis. Biol Trace Elem Res. 2012 Dec ;150(1-3):42-8. Epub 2012 Aug 17. PMID: 22895810  31) David W Killilea, Jeanette A M Maier. A connection between magnesium deficiency and aging: new insights from cellular studies. Magnes Res. 2008 Jun;21(2):77-82. PMID: 18705534  32) GreenMedInfo.com, What We Learned From The Accelerated Aging of Astronauts  33) Katja Held, I A Antonijevic, H Künzel, M Uhr, T C Wetter, I C Golly, A Steiger, H Murck. Oral Mg(2+) supplementation reverses age-related neuroendocrine and sleep EEG changes in humans. Pharmacopsychiatry. 2002 Jul;35(4):135-43. PMID: 12163983  © 2019 GreenMedInfo LLC. This work is reproduced and distributed with the permission of GreenMedInfo LLC. Want to learn more from GreenMedInfo? Sign up for the newsletter here http://www.greenmedinfo.com/greenmed/newsletter. Here is the original article.


renegadetribune--2019-02-12--Magnesium The Safe First Line of Defense for Clinical Depression

Magnesium: The Safe First Line of Defense for Clinical Depression

The science supporting the efficacy of magnesium for major depression and other psychiatric disorders, testing for magnesium deficiency, and which forms and dosages are most effective.  Depression, a life-threatening psychiatric disorder, lies at the confluence of biochemical, hormonal, immunological, and neurodegenerative variables, which intersect to generate the pro-inflammatory state with which depression is associated. A major public health issue, depression is estimated to become one of the top three contributors to the global burden of diseases within a few years. Not only does depression consume a sizable portion of health care expenditures, but it is considered to be an independent risk factor for metabolic, cardiovascular, and neuropsychiatric disorders (1).  Current treatments are predicated upon a misguided serotonin theory of depression, and are accompanied by a laundry list of deleterious side effects ranging from sexual dysfunction to homicidality (2, 3, 4). Antidepressant medications likewise significantly increase the risk of all-cause mortality, or death from any cause, as well as heart disease, leading researchers to deem this class of pharmaceuticals as harmful to the general population (5). This, in combination with data indicating that antidepressants are clinically equivalent to placebo, render them an unfavorable option (6), especially considering that they offer little in the way of resolving the root cause.  Rather than resorting to psychotropic drugs, it would be prudent to explore whether magnesium (Mg) supplementation improves depression, since this essential mineral is implicated in the pathophysiology of this disorder. Magnesium may be indeed branded as miraculous given its essentiality as a cofactor to over three hundred enzymatic reactions (7). It is second only to potassium in terms of the predominant intracellular cations, or ions residing in cells that harbor a positive charge (7).  Magnesium is fundamentally involved in protein production, synthesis of nucleic acids, cell growth and division, and maintenance of the delicate electrolyte composition of our cells (7). It also imparts stability to the membranes of the energy factories of our cells called mitochondria (7). As articulated by researchers, “The physiological consequences of these biochemical activities include Mg’s central roles in the control of neuronal activity, cardiac excitability, neuromuscular transmission, muscular contraction, vasomotor tone, and blood pressure” (7).  The biological effects of magnesium are widespread. When deficient, magnesium is correlated with systemic inflammation. Not only does magnesium sufficiency promote cardiovascular health, relaxing the smooth muscles that comprise blood vessels and preventing high levels of vascular resistance that cause hypertension, but it also plays a role in musculoskeletal health and prevents sarcopenia, osteoporosis, and fractures (8). Magnesium is essential to regulation of sleep (9) and vitamin D metabolism (10) as well as neural plasticity and cognitive function.  However, food processing and industrial agriculture, including monoculture crop practices and the use of magnesium-devoid fertilizers, have led to soil erosion and depletion of magnesium content in our food (7). Magnesium is likewise removed from most drinking water supplies, rendering magnesium deficiency an inevitability (11). As such, our daily intake of magnesium has steadily declined from 500 milligrams (mg) per day to 175 mg per day (7). The nutrient-poor, energy-dense dietary patterns which have come to dominate the industrialized landscape are also insufficient in the fiber-rich fruits and vegetables which contain magnesium.  Preliminary animal studies pointed to a role of magnesium in depression, as depletion of magnesium in the diet of mice lead to enhanced depression- and anxiety-related behavior such as increased immobility time in the forced swim test (12). In the forced swim test, a common assay for examining depression-like behavior in rodents, the animal is confined to a container filled with water and observed as it attempts to escape. The time in which the animal exhibits immobility is used as a barometer of despair, indicating that the animal has succumbed to a fate of drowning (1).  This model is confirmed by studies showing that administering substances with antidepressant properties such as Hypericum perforatum, also known as St. John’s Wort, can significantly decrease the time the animal spends without locomotor activity (12). In addition, the time the animal spends immobilized is influenced by many of the factors that are changed as a consequence of depression in humans, such as drug-withdrawal-induced anhedonia, impaired sleep, and altered food consumption (1).  Human Studies Confirm the Role of Magnesium in Depression  There is a paucity of research on the influence of specific micronutrients in depression and results are inconsistent, but several studies have revealed low serum magnesium in this mood disorder. It is well-documented, for example, that dietary magnesium deficiency in conjunction with stress can lead to neuropathologies and symptoms of psychiatric disorders. Researchers echo this sentiment, stating that, “Dietary deficiencies of magnesium, coupled with excess calcium and stress may cause many cases of other related symptoms including agitation, anxiety, irritability, confusion, asthenia, sleeplessness, headache, delirium, hallucinations and hyperexcitability” (11, p. 362).  The Hordaland Health study in Western Norway illustrated an inverse association between standardized energy-adjusted magnesium intake and depression scores, meaning that people who consumed less magnesium had higher rates of depression (13). When the serum and cerebrospinal fluid of acutely depressed patients diagnosed with major depressive disorder or bipolar patients in a depressive episode were compared to healthy controls, the calcium to magnesium ratio was found to be elevated in the former (14). Calcium and magnesium are minerals which antagonize one another and compete for absorption, since each of these minerals is a divalent cation (a positive ion with a valence of two). Suicidality, one of the primary manifestations of severe depression, is accompanied by low cerebrospinal fluid levels of magnesium despite normal calcium levels, lending credence to the role of magnesium in positive emotionality (15).  A formulation of magnesium aspartate hydrochloride known as Magnesiocard has been shown to invoke mood-stabilizing effects in patients with severe rapid cycling bipolar disorder in one open study label (16). In half of the patients treated, this magnesium preparation had results equivalent to lithium, the standard of care for this patient population, such that the researchers suggested: “The possibility that Magnesiocard could replace or improve the efficacy of lithium as a preventive treatment of manic-depressive illness merits further clinical investigation” (16, p. 171). When used as an adjunctive therapy in severe, therapy-resistant mania, magnesium sulphate infusions significantly reduced the use of lithium, benzodiazepines and neuroleptics, so much so that the researchers concluded that it “may be a useful supplementary therapy for the clinical management of severe manic agitation” (17, p. 239).  In another randomized trial of elderly patients with type 2 diabetes and magnesium deficiency, elemental magnesium administered at 450 mg per day was found to have equivalent efficacy to 50 mg of the antidepressant drug Imipramine in treating depressive symptoms (18). Magnesium citrate taken at 300 mg per day has likewise been shown to decrease depression and other symptoms in patients with fibromyalgia as indicated by significant decreases in the fibromyalgia impact questionnaire (FIQ) and Beck depression scores (19).  Data also indicate that supplementation with 360 mg of magnesium administered to women with premenstrual syndrome (PMS) three times a day in the second half of the cycle is effective for so-called negative affect and other premenstrual-related mood symptoms (20). Lastly, intramuscular magnesium sulphate administered every week for six weeks has been proven to be effective in improving emotional state and other parameters in chronic fatigue syndrome (CFS) (21).  Mechanism of Action for Antidepressant Effects of Magnesium  According to researchers, “Biological systems discussed to be involved in the pathophysiology of affective disorders and the action of mood stabilizing drugs are affected by Mg, such as the activity of the hypothalamus–pituitary–adrenocortical (HPA) system, corticotropin releasing factor (CRF)-, GABA- and glutamatergic (via NMDA receptors) neurotransmission and several transduction pathways including protein kinase C” (12). Not only that, but magnesium elicits similar effects on nocturnal hormonal secretion and sleep brain waves to lithium salts, which are used as a treatment modality for bipolar disorder, supporting the role of magnesium as a mood stabilizer (22).  Magnesium operates as an agonist, or a stimulatory molecule, for γ-aminobutyric acid (GABA) receptors (22). GABA is the main inhibitory neurotransmitter in the central nervous system. By binding to the GABA receptor and replicating the effects of GABA, magnesium may alleviate anxiety. Magnesium may also elicit its antidepressant effects by acting as an inorganic antagonist of N-methyl-d-aspartic acid (NMDA) receptor function (Poleszak et al., 2007). Receptor antagonists are ligands, or substances, which bind to a receptor but inhibit its activity rather than activating it. NMDA receptors, which occur on the surface of nerve cells, are activated in part by glutamate, one of the excitatory amino acids in the brain.  Researchers state that, “Dysfunction of NMDA receptors seems to play a crucial role in the neurobiology of disorders such as Parkinson’s disease, Alzheimer’s disease, epilepsy, ischemic stroke, anxiety and depression,” such that, “ligands interacting with different sites of NMDA receptor complex are widely investigated as potential agents for the treatment of a variety of neuropsychiatric disorders” (22). In fact, drug inhibitors at the NMDA receptor complex, such as ketamine, demonstrate antidepressant effects (23, 24), but also induce such severe side effects that their clinical utility is limited (31). Magnesium, on the other hand, may have a similar mechanism of action by interfering with NMDA receptor activation without the adverse consequences of drug-induced NMDA receptor blockade (25).  A recent open-label, randomized, cross-over trial was conducted in outpatient primary care clinics on 126 adults diagnosed with depression (26). During the intervention, 248 mg of elemental magnesium chloride per day, obtained from four 500 mg tablets, was administered for six weeks and compared to six weeks of no treatment, and subjects were evaluated for changes in depressive symptoms (26).  Magnesium administration results in clinically significant improvements in scores on both the Patient Health Questionnaire-9 (PHQ-9), a validated measure of the severity of depression and response to treatment, as well as the Generalized Anxiety Disorders-7 (GAD-7), a sensitive self-reported screening tool for severity of anxiety disorders (26). Impressively, results appeared in as little as two weeks, representing the dramatic improvement that nutrient restoration can facilitate (26). Impressively, however, magnesium exerted anti-depressant effects regardless of baseline magnesium level. It also exhibited efficacy independent of the gender, age, or baseline severity of depression of subjects, as well as their use of antidepressant medications (26). The authors of the study conclude, “Magnesium is effective for mild-to-moderate depression in adults. It works quickly and is well tolerated without the need for close monitoring for toxicity” (26).  Half of the population of the United States was found to consume less than the recommended amount of magnesium when estimated a decade ago (27). Not only is magnesium lost with certain medical conditions, but this mineral is excreted as a consequence of biological activities such as sweating, urinating, and defecating as well as excess production of stress hormones (7, 11). In addition, because low magnesium has been correlated with various disease states, increasing magnesium status may mitigate risk of these diseases.  For instance, researchers note that, “Low magnesium intakes and blood levels have been associated with type 2 diabetes, metabolic syndrome, elevated C-reactive protein, hypertension, atherosclerotic vascular disease, sudden cardiac death, osteoporosis, migraine headache, asthma, and colon cancer” (27, p. 153). In addition, magnesium deficiency at a cellular level “elicits calcium-activated inflammatory cascades independent of injury or pathogens” (27, p. 153). Low magnesium is associated with systemic inflammation, and inflammation is at the root of most chronic and degenerative diseases.  Testing for Magnesium and Food Sources of Magnesium  While the first inclination of some physicians may be to test magnesium levels for an objective parameter of deficiency, the widely used serum or plasma magnesium does not accurately reflect magnesium levels stored in other tissues (28, 29). In addition, both this hematological index of magnesium status, referred to as total magnesium, and the erythrocyte magnesium level, indicative of the levels of magnesium inside red blood cells, are not negatively affected until severe magnesium deprivation has occurred (7). Therefore, these testing methodologies are not accurate enough to catch preliminary or subclinical magnesium deficiency.  Good food sources of magnesium include pumpkin and squash seed kernels, Brazil nuts, almonds, cashews, peanuts, pine nuts, quinoa, spinach, Swiss chard, beet greens, potatoes, artichoke hearts, dates, bananas, coconut milk, prickly pear, black beans, lima beans, soybeans, and seafood sources including halibut, abalone, anchovy, caviar, conch, crab, oyster, scallop, snail, and pollock. However, it is important to note that magnesium can be leeched from vegetables when food is boiled, and that fiber in excess can decrease magnesium absorption by increasing gastrointestinal motility (7).  As elucidated by the researchers, “Over-the-counter magnesium can be offered as an alternative therapy to those patients hesitant to begin antidepressant treatment and is easily accessible without a prescription” (26). Because the soil is no longer enriched in magnesium, supplementation may be warranted. Organic salts of magnesium, including the acetate, ascorbate, aspartate, bicitrate, gluconate, and lactate forms are more soluble and biologically active over the magnesium mineral salts such as magnesium oxide, magnesium carbonate, magnesium chloride, and magnesium sulfate (7).  However, case studies have shown remarkably rapid recovery from major depression, in less than seven days, when magnesium glycinate and magnesium taurinate are administered at dosages of 125 to 300 mg with each meal and at bedtime (11). Magnesium threonate may also be explored as a therapeutic option, as it may have better penetrance of the blood brain barrier and restore neurological levels of magnesium. This form, which is delivered directly to the brain, may improve cerebral signaling pathways and synaptic connections between nerve cells as well as support learning and memory, although the studies have been conducted in animal models (30).  Researchers report that magnesium is usually effective for treating depression in general use, and that comorbid conditions occurring in these case studies, including “traumatic brain injury, headache, suicidal ideation, anxiety, irritability, insomnia, postpartum depression, cocaine, alcohol and tobacco abuse, hypersensitivity to calcium, short-term memory loss and IQ loss were also benefited” by magnesium supplementation (11, p. 362). Barring abnormal kidney function, the Institute of Medicine sets the upper tolerable limit for intake at 350 mg of elemental magnesium per day, but there are few adverse side effects documented unless consumed in inordinate doses (26).  Before changing your medication or nutraceutical regimen, always consult a functional or integrative medical doctor for contraindications. However, given the benign nature of magnesium supplementation and the ubiquity of magnesium insufficiency, depressedpatients should be offered this as a first line strategy alongside a holistic root-cause resolution approach to treating depression (26).  For additional research on magnesium, visit our database on the subject.  1. Yankelevitch-Yahav, R. et al. (2015). The Forced Swim Test as a Model of Depressive-like Behavior. Journal of Visualized Experiments,  97, 52587.  2. Srilakshmi, P., & Versi, L. (2012). Review of sexual dysfunction due to selective serotonin repute inhibitors. AP Journal of Psychological Medicine, 13(1), 28-31.  3. Dording, C.M. et al. (2002). The pharmacologic management of SSRI-induced side effects: a survey of psychiatrists. Annals of Clinical Psychiatry, 14(3), 143-147.  4. Moore, T.J., Glenmullen, J., & Furberg, C.D. (2010). Prescription drugs associated with reports of violence towards others. PLoS One, 5, e15337.  5. Maslej, M.M. et al. (2017). The Mortality and Myocardial Effects of Antidepressants Are Moderated by Preexisting Cardiovascular Disease: A Meta-Analysis. Psychotherapy and Psychosomatics, 86, 268-282.  6. Antonuccio, D.O., Burns, D.D., & Danton, W.G. (2002). Antidepressants: A Triumph of Marketing Over Science? Prevention & Treatment, Volume 5(25).  7. Newhouse, I., & Finstad, E.W. (2000). The Effects of Magnesium Supplementation on Exercise Performance. Journal of Sports Medicine, 10(3), 195-200.  8. Welch, A.A., Skinner, J., & Hickson, M. (2017). Dietary Magnesium May Be Protective for Aging of Bone and Skeletal Muscle in Middle and Younger Older Age Men and Women: Cross-Sectional Findings from the UK Biobank Cohort. Nutrients, 9(11), E1189. doi: 10.3390/nu9111189.  9. Abbasi, B. et al. (2012). The effect of magnesium supplementation on primary insomnia in elderly: A double-blind placebo-controlled clinical trial. Journal of Research in Medical Science, 17(12), 1161-1169.  10. Mursu, J. et al. (2015). The association between serum 25-hydroxyvitamin D3 concentration and risk of disease death in men: modification by magnesium intake. European Journal of Epidemiology, 30(4), 343-347.  doi: 10.1007/s10654-015-0006-9.  12. Singewald, N. et al. (2004). Magnesium-deficient diet alters depression- and anxiety-related behavior in mice–influence of desipramine and Hypericum perforatum extract. Neuropharmacology, 47(8), 1189-1197.  13. Jacka, F.N. et al. (2009). Association between magnesium intake and depression and anxiety in community-dwelling adults: the Hordaland Health Study. Australian and New Zealand Journal of Psychiatry, 43(1), 45-52. doi: 10.1080/00048670802534408.  14. Levine, J. et al. (1999). High serum and cerebrospinal fluid Ca/Mg ratio in recently hospitalized acutely depressed patients. Neuropsychobiology, 39(2), 63-70.  15. Banki, C.M. et al. (1995). Cerebrospinal fluid magnesium and calcium related to amine metabolites, diagnosis, and suicide attempts. Biological Psychiatry, 20, 163-171.  16. Chouinard, D. et al. (1990). A pilot study of magnesium aspartate hydrochloride (Magnesiocard) as a mood stabilizer for rapid cycling bipolar affective disorder patients. Progress in Neuro-Psychopharmacology, Biology, and Psychiatry, 14, 171-180.  17. Heiden, A. et al. (1999). Treatment of severe mania with intravenous magnesium sulphate as a supplementary therapy. Psychiatry Research, 3, 239-246.  18. Barragán-Rodríguez, L., Rodríguez-Morán, M., & Guerrero-Romero, F. (2008). Efficacy and safety of oral magnesium supplementation in the treatment of depression in the elderly with type 2 diabetes: a randomized, equivalent trial. Magnesium Research, 21(4), 218-223.  19. Bagis, S. et al. (2013). Is magnesium citrate treatment effective on pain, clinical parameters and functional status in patients with fibromyalgia? Rheumatology International, 33(1), 167-172. doi: 10.1007/s00296-011-2334-8.  20. Facchinetti, F. et al. (1991). Oral magnesium successfully relieves premenstrual mood changes. Obstetrics and Gynecology, 78(2), 177-181.  21. Cox, I.M. et al. (1991). Red blood cell magnesium and chronic fatigue syndrome. The Lancet, 337(8744), 757-760.  22. Held, K. et al. (2002). Oral Mg(2+) supplementation reverses age-related neuroendocrine and sleep EEG changes in humans. Pharmacopsychiatry, 35(4), 135-143.  23. Zarate, C.A. Jr. et al. (2006). A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Archives of General Psychiatry, 63, 856-864.  24. Berman, R.M. et al. (2000). Antidepressant effect of ketamine in depressed patients. Biological Psychiatry, 47, 351-354.  25. Poleszak, E. et al. (2007). NMDA/glutamate mechanism of antidepressant-like action of magnesium in forced swim test in mice. Elsevier Pharmacology Biochemistry and Behavior, 88(2).  26. Tarleton, E.K. et al. (2017). Role of magnesium supplementation in the treatment of depression: A randomized clinical trial. PLoS One, 12(6), e0180067. doi: 10.1371/journal.pone.0180067.  27. Rosanoff, A., Weaver, C.M., & Rude, R.K. (2012). Suboptimal magnesium status in the United States: are the health consequences underestimated? Nutrition Reviews, 70(3), 153-164. doi: 10.1111/j.1753-4887.2011.00465.x.  28. Altura, B.T. et al. (1994). Characterization of a new ion selective electrode for ionized magnesium in whole blood, plasma, serum, and aqueous samples. Scandinavian Journal of Clinical Lab Investigations, 54(Suppl. 217), 21–36.  29. Weller, E. et al. (1998). Lack of effect of oral Mg-supplementation on Mg in serum, blood cells and calf muscle. Medical Science Sports Exercise, 30, 1584–1591.  30. Slutsky, I. et al. (2010). Enhancement of learning and memory by elevating brain magnesium. Neuron, 65(2), 165-177. doi: 10.1016/j.neuron.2009.12.026.  31. Willetts, J., Balster, R.L., & Leander, J.D. (1990). The behavioral pharmacology of NMDA receptor antagonists. Trends in Pharmacological Science, 11, 423-428.  Ali Le Vere holds dual Bachelor of Science degrees in Human Biology and Psychology, minors in Health Promotion and in Bioethics, Humanities, and Society, and is a Master of Science in Human Nutrition and Functional Medicine candidate. Having contended with chronic illness, her mission is to educate the public about the transformative potential of therapeutic nutrition and to disseminate information on evidence-based, empirically rooted holistic healing modalities. Read more at @empoweredautoimmune on Instagram and at www.EmpoweredAutoimmune.com: Science-based natural remedies for autoimmune disease, dysautonomia, Lyme disease, and other chronic, inflammatory illnesses.  © 2017 GreenMedInfo LLC. This work is reproduced and distributed with the permission of GreenMedInfo LLC. Want to learn more from GreenMedInfo? Sign up for the newsletter here http://www.greenmedinfo.com/greenmed/newsletter.” Original article.


sottnet--2019-08-23--CRISPR enters its first human clinical trials

We don't always fully understand the changes we're making  Since its debut in 2012, CRISPR gene editing has held the promise of curing most of the over 6,000 known genetic diseases. Now it's being put to the test.In the first spate of clinical trials, scientists are using CRISPR/Cas9 to combat cancer and blood disorders in people. In these tests, researchers remove some of a person's cells, edit the DNA and then inject the cells back in, now hopefully armed to fight disease.Researchers are also set to see how CRISPR/Cas9 works inside the human body. In an upcoming trial, people with an inherited blindness will have the molecular scissors injected into their eyes.Those tests, if successful, could spur future trials for Duchenne muscular dystrophy, cystic fibrosis and a wide variety of other genetic diseases, affecting millions of people worldwide."CRISPR is so intriguing," says Laurie Zoloth, a bioethicist at the University of Chicago Divinity School, "and so elegant."But big questions remain about whether CRISPR/Cas9 can live up to the hype.Other previously promising technologies have fallen short. For instance, stem cell injections helped paralyzed rats walk again.Zoloth says.Conventional gene therapies, which insert healthy copies of genes to replace or counteract disease-causing versions, also suffered severe setbacks, says Ronald Conlon, a geneticist at Case Western Reserve University in Cleveland.CRISPR's reputation was tarnished last year after a researcher in China edited a gene in embryos that went on to develop into two baby girls in 2018 (SN: 12/22/18 & 1/5/19, p. 20)., says Alan Regenberg, a bioethicist at Johns Hopkins Berman Institute of Bioethics. Still, he says, there's reason for caution when working with humans.CRISPR/Cas9 is a re-engineered virus-hunter, originally developed by bacteria. In 2012 and 2013, scientists described how the system could be tweaked to cut DNA in precise locations, and then demonstrated how it could be deployed in human and animal cells. A piece of RNA — a single-stranded genetic molecule similar to DNA — is the CRISPR part and guides an enzyme called Cas9 to particular spots in the genetic instruction book, or genome. The enzyme slices through both strands of the DNA double helix. Cuts can be used to disable certain genes, snip out troublesome DNA or even repair a problem.But CRISPR sometimes goes to the wrong spot, resulting in unwanted edits, or "off-target effects " (SN: 9/3/16, p. 22). Even with intended cuts, unwanted errors can arise. "," Regenberg says. "Even if we do make the changes we want to make,."Still, CRISPR is more precise than conventional gene therapy and therefore may have the power to treat some diseases for which gene therapy hasn't worked well, says Conlon, who discussed challenges to gene editing for cystic fibrosis in the June Genes & Diseases. But another big hurdle, he says, is getting CRISPR into the cells where it is needed.Delivery is less of a problem for the gene-editing therapies in trials to treat cancer and blood disorders, Conlon says. That's because, for those trials, researchers don't have to set CRISPR/Cas9 loose in the body. Instead, they take blood-forming stem cells out of participants and edit those cells in lab dishes, where the scientists can check for problems.University of Pennsylvania researchers have given two people with recurring cancers a CRISPR/Cas9 therapy, a university spokesperson said. One person has multiple myeloma; the other, sarcoma. As part of an ongoing trial , both received T cells, a type of immune cell, programmed with CRISPR to go after cancer cells. Similar trials are under way in China Trials are also under way for two blood disorders: sickle-cell disease and beta-thalassemia. Both result from defects in the gene for hemoglobin, the oxygen-carrying protein in red blood cells. The therapy is designed to mimic a fix that nature has already devised, says David Altshuler, chief scientist at Vertex Pharmaceuticals. Usually, a form of hemoglobin that helps fetuses in the womb grab more oxygen from their mother's blood stops being produced after birth. But some people have a harmless genetic variant that causes fetal hemoglobin to be produced throughout life. "People like that who also inherited a sickle-cell mutation or a beta-thalassemia mutation weren't sick," Altshuler says.The fetal hemoglobin compensates for the disease-causing defect, something Vertex, a cystic fibrosis drugmaker headquartered in Boston and London, hopes to use to sickle-cell sufferers' advantage. Vertex and CRISPR Therapeutics, a company in Cambridge, Mass., are testing whether CRISPR/Cas9 cuts can mimic the genetic variant that keeps fetal hemoglobin turned on for life and ease symptoms in people with the blood disorders. "We're very confident that the edits that are being made in the cells are translating into clear and reproducible increases in fetal hemoglobin," Altshuler says.Researchers check for both off-target cuts and mutations at the desired cutting site before giving cells back to the study volunteers via a bone marrow transplant, Altshuler says. The companies announced in February that they had treated one person for beta-thalassemia . Another person has undergone the same type of therapy for sickle-cell disease , researchers said in July. The scientists have not yet announced results from these trials.Still, many genetic diseases affect the whole body or organs that can't be removed and edited in a lab. No one knows whether CRISPR can work well in the human body. But a clinical trial using the gene editor to treat an inherited type of blindness called Leber congenital amaurosis 10 may help answer the question. The disorder is caused by a mutation in the CEP290 gene that leads to a nonfunctional protein. When the protein doesn't work, rod cells in the retina die and light-gathering photoreceptors can't renew themselves, resulting in blindness.There is a gene therapy, approved in 2017 by the U.S. Food and Drug Administration, for a type of Leber congenital amaurosis caused by a mutation in the RPE65 gene. But CEP290 is too big to pack into a virus to do conventional gene therapy, says Charles Albright, chief scientist of Editas Medicine, a company based in Cambridge, Mass., that develops CRISPR gene editing for various genetic diseases.In July, Editas and global pharmaceutical company Allergan opened recruitment for a blindness gene-editing trial. In the trial, two guide RNAs will lead Cas9 to make two cuts that will snip out the troublesome piece of DNA.The first people to get the experimental therapy will be adults who are nearly blind, Albright says. Small amounts of the CRISPR editor will be injected under the retina to test for safety. It's uncertain whether the low doses will improve vision. If the doses prove safe, later volunteers will get higher doses. The researchers may also test the therapy in children."We're going into arguably the most difficult patients to start with and we're going to improve from there," Albright says.scientists reported in the February Nature Medicine.Even if these first trials don't pan out as hoped, CRISPR won't be shelved, Albright thinks. "This is a technology that's here to stay," he says.There's precedence that perseverance — and choosing the right disease to target — can eventually pay off. After setbacks, conventional gene therapy has recently had a big success.In May, the FDA approved a gene therapy for children with spinal muscular atrophy, a debilitating and deadly genetic disease caused by a mutation that disables the SMN1 gene. That gene is needed for specialized nerve cells called motor neurons to survive and function properly. Children with the genetic disease often die because the muscles that control breathing fail. The FDA said August 6 that it had been alerted to problems with data manipulation from animal testing of the therapy. But the agency says that the therapy is working well in humans and should stay on the market."These kids with SMA who otherwise would have died are up and running and talking and learning and progressing," Conlon says. "It is just mind-blowing."When it comes to gene editing, researchers are banking on similar happy endings. "People are so optimistic and so hopeful again," Zoloth says. "I want it to work. Everyone who thinks seriously about human suffering should really be wanting this to happen and should be optimistic ... about medicine's capacity and its power."


sottnet--2019-12-20--New oral polio vaccine to BYPASS key clinical trials as vaccine caused outbreaks overtake wild polio

Instead, key questions about the vaccine's effectiveness will be answered in the field.  those caused by the wild virus-and they continue to spread unchecked  The real of test of nOPV2  may be used in millions of kids beginning in mid-2020  To stem a growing polio crisis, health officials are accelerating the development of a new oral vaccine with plans for emergency approval and deployment in regions with active polio transmission as early as June 2020. The new vaccine, called nOPV2,conclusively end the outbreaks, caused by the live virus in the vaccine reverting to a virulent form. But expedited approval means skipping the real-world testing of large clinical trials.and we do not see reversion to neurovirulence," says Vincent Racaniello , a virologist at Columbia University, "but when they are used for mass immunization of millions of individuals, rare events can become evident.", originally developed by Albert Sabin in the 1950s, can in rare instances revert to virulence . Because the Sabin vaccine had successfully eradicated wild type 2 poliovirus in 2015, health officials across the world quit administering it the following year. However,before the cessation of the type 2 vaccine, which gave an opportunity for un-immunized people to later become infected by the virus that had begun reverting to virulence in people who had gotten the vaccine. With successive transmission through the unvaccinated,Nowadays,, according to the World Health Organization., a virologist at the Centers for Disease Control and Prevention (CDC) told Science earlier this year.nOPV2, the new type 2 oral polio vaccine, has been genetically engineered to avoid the pitfalls of Sabin's vaccine.and coordinated by PATH , a nonprofit developer of public health innovations, with scientific work taking place at the National Institute for Biological Standards and Control (NIBSC) in the UK, the University of California, San Francisco, the CDC, and the Food and Drug Administration.says Andrew Macadam , a principal scientist at NIBSC and a designer of nOPV2. As RNA viruses, polio and polio vaccine strains evolve using mutation and recombination. Polio "has a polymerase that is not very accurate," says Macadam, so mutations occur frequently during replication. More importantly for rapid adaptation, recombination allows the virus to incorporate RNA strands from other C type enteroviruses in human hosts that enable gains in virulence. These partners include all the Sabin strains and Coxsackievirus, for example.nOPV2 obstructs some key genetic routes to pathogenicity, believed to be controlled by "gatekeeper" mutations. In particular, a single point mutation at nucleotide 481 increases neurovirulence and actually occurs in most people soon after immunization. The pivotal change at 481 makes a return to virulence possible, according to Macadam. "The gatekeeper idea," he explains, "is that it needs to revert at 481 before it can do anything else and then you can incorporate these other mutations" that cause the vaccine to become pathogenic.So nOPV2 developers modified 18 nucleotides near 481 in the poliovirus genome so that the well-known single substitution no longer opens the gate to virulence. This safeguard in turn is protected from wholesale replacement via recombination by relocating a gene necessary for replication to another part of the genome so that if the modifications near 481 are lost through recombination, the gene needed for replication will also be lost. As a result, reversion "requires two recombination events instead of one," according to Macadam, one being the acquisition of a second copy of the replication gene and the other being the loss of the 481-related modifications.says Macadam.In addition, Macadam's team outfitted nOPV2 with a higher-fidelity polymerase that introduces fewer errors during replication while another gene received alterations to decrease the virus' propensity for recombination.Testing so far validates the new design. A small, Phase 1 clinical trial in Belgium of 30 adults found nOPV2 completely stable against the main gatekeeper mutation about three weeks after vaccination. Ordinarily, 481 mutates within six days. Macadam and colleagues have also carried out as-yet unpublished studies in cell culture that demonstrate genetic stability.Macadam nevertheless says. Specifically, he is concerned about the recombination risks posed by the Sabin 1 and 3 strains.says Macadam.However, delivering vaccines in separate campaigns creates a significant operational constraint. "This conundrum is real, and is already being seen," says WHO spokesperson, Oliver Rosenbauer . In parts of Nigeria and the Lake Chad region, some vaccination campaigns are conducted with Sabin 1 and 3, others with solely with Sabin 2. "So that needs to be logistically managed appropriately."Also,Rather than tightly circumscribed use of nOPV2 in response to isolated outbreaks, says Temitope Faleye Faleye is a researcher at the Nigerian Institute of Medical Research. "You immunize as many children as possible to ensure that you don't have pockets of people" who can start vaccine viruses back on the path to renewed virulence, which happened before and led to the current outbreaks.Even if nOPV2 is kept away from Sabin 1 and 3, they are not the only available recombination partners. "The real concern out here is these species C [enteroviruses] that are circulating," according to Faleye. "By default," he says,in Nigeria and across sub-Saharan Africa, where most of the world's outbreaks of vaccine-derived polio are occurring.Faleye saysthan the Sabin 2 strain.He describes nOPV2 as "beautiful,on solid science."Racaniello, who wasn't involved in the development of the vaccine, agrees that nOPV2 is "probably going to be better," but with a caveat. "There is nothing like the selection force of millions of human guts." Increased fitness and virulence overlap, so. And because of the compressed approval and deployment timeline , nOPV2, which will pit the vaccine against real-world conditions such as co-infections with other enteroviruses, could finish.A completed Phase 2 trial in Panama sheds little light on recombination with enteroviruses. "Species C enterovirus prevalence was not an endpoint" in the Panama trial, says PATH's John Konz , who leads the nOPV2 project. "We might get some sense of levels from next generation sequencing of virus in stool samples, but those results are not yet available." In addition, according to Macadam, "the actual analysis pipeline won't be as extensive as it might be, if we had unlimited resources."Racaniello commends nOPV2, which "was made using all the fundamental results that we and others have developed over the years." But he questions how airtight nOPV2's architecture is against reversion. The gatekeepers are essential for efficient replication, according to Racaniello, "butClinical trials so far have measured the type 2-specific serum neutralizing antibodies elicited by nOPV2. Protection is believed to result when titres reach certain thresholds. "Can we measure antibody responses in animal models and in limited clinical tests and say, 'This should be OK in people?'" asks Racaniello.he says, naming some of the key partners in the Global Polio Eradication Initiative, which decides and implements the vaccine strategy for polio eradication. "That should be enough . . . but."At PATH, "we don't see any unique risks for nOPV2 over the current vaccine," says Konz. The relative paucity of clinical data is offset by the knowledge from decades of using the Sabin 2 strain from which nOPV2 is derived. "In the end," he says, "it's a relative benefit-risk decision that the WHO, policymakers, and national authorities will have to make."While the polio eradication effort is betting nOPV2 will be a silver bullet, "nothing is off the table," according to WHO's Rosenbauer, "and everything is being explored," including even a possible return to the old vaccine with the three original Sabin strains.


sottnet--2019-12-30--'Ultraprocessed' foods may make you eat more, clinical trial suggests

Something about the industrial processing of food makes us more likely to overeat, according to a new study. Volunteers ate more and gained more weight on a heavily processed diet than an unprocessed one, even when the two diets had the same available calories and nutrients.The study is "a landmark first," and a "shot over the bow" in a debate over the health of processed food, says Steven Heymsfield, an obesity researcher at Louisiana State University's Pennington Biomedical Research Center in Baton Rouge who was not involved with the work. But some experts question whether the study controlled for important differences between the diets.Kevin Hall, a physiologist at the National Institute of Diabetes and Digestive and Kidney Diseases in Bethesda, Maryland, suspected that processed foods were linked to poor health simply because they were likely to contain lots of fat, sugar, and salt. So in the new experiment, he and his team tried to rule out those factors. They recruited 20 healthy people and gave each about $6000 to surrender some freedoms, dietary and otherwise. Participants spent 28 straight days in a National Institutes of Health facility — with no excursions. They wore loose-fitting scrubs to make it harder for them to guess whether their weight was changing. Each was restricted to an "ultraprocessed" diet or a "minimally processed" diet for 2 weeks, and then switched to the other diet for 2 more weeks.The captive participants did enjoy one big freedom: They chose how much to consume. Once they ate their fill, Hall's team calculated their intake by painstakingly weighing the leftovers, down to every dollop of ketchup that didn't make it onto a hot dog."They showed that the effect [of processing] goes beyond nutrients," says Carlos Monteiro, an epidemiologist at the University of São Paulo in São Paulo, Brazil, who helped develop the NOVA classification system and supports government interventions to limit processed food consumption.If participants continued eating those extra 500 calories, they would "gain a lot of weight — a lot — over time," says Heymsfield, though he notes that their gusto for the ultraprocessed diet might have waned if the study had gone on a few weeks longer.Yet on surveys, the participants rated the processed meals as no more pleasant than the unprocessed ones. If they weren't enjoying the food more, why were they eating more of it?One possibility is that industrial processing produces softer foods that are easier to chew and swallow — and thus easier to scarf down.And despite the researchers' efforts to perfectly match the nutrition of the diets, there were some differences that may have influenced how much people ate.Ultraprocessed foods also tend to be more energy-dense — they have many more calories per gram, notes Barbara Rolls, an obesity researcher who studies eating behavior at Pennsylvania State University in State College. (Although Hall's team concluded the two diets were roughly equal in energy density, the measurements included low-energy-density beverages added to the ultraprocessed diet to boost fiber via dissolved supplements.)Hall and his colleagues are now planning a similar-size study with a few tweaks: They'll bump up the protein in the ultraprocessed diet and swap fiber-enriched beverages for soups, which may encourage people to eat more slowly.For now, some researchers aren't convinced that processing itself is a menace. "A lot of ... the ultraprocessed foods in this study are perhaps ones that we [shouldn't] to be eating too often," Rolls says. And most people don't have the time or resources to prepare farm-to-table meals, she adds.doi:10.1126/science.aay0623


sputnik--2019-10-03--Swiss Food Giant Nestle Accused of Violating Indian Clinical Trial Laws on Premature Babies

India’s federal Health and Family Welfare Ministry has rebuked its Medical Research body for laxity in allowing Swiss food and beverage company Nestle to sponsor clinical trials on premature babies illegally using substitutes for breast milk, the National Herald reported.  According to the media outlet, under the research project sponsored by Nestle, clinical trials were carried out on 75 premature babies in five different hospitals in breach of the Infant Milk Substitutes Act.  The Act stipulates that “No producer, supplier or distributor shall offer or give any contribution or pecuniary benefit to a health worker on any association of health workers, including funding of seminar, meeting, conference, educational course, contest, fellowship, research work or sponsorship.”  The Ministry has reprimanded the head of the Indian Council of Medical Research (ICMR) for not adhering to the law, while allowing the research to take place. The trial was reportedly conducted on babies between the age of 28-34 weeks to assess the growth and feeding intolerance in preterm infants. The trial suggested that the infant could be given a milk substitute instead of breast milk.  The Health Ministry has asked ICMR, the main body in India for the formulation, coordination and promotion of biomedical research to ensure that all such clinical trials are first screened for infringements of the Infant Milk Substitutes Act.  Amulya Nidhi, Co-Convenor of Swasth Adhikar Manch (Health Rights Forum), a voluntary body fighting for health rights said the Supreme Court of India had laid down strict rules for the conduct of clinical trials in a 2013 case.  “….clinical trial of new chemical entity shall be conducted strictly in accord with the procedure prescribed in Schedule ‘Y’ of Drugs and Cosmetics Act, 1940 under the direct supervision of the Secretary, Ministry of Health and Family Welfare,” Nidhi said.  Nidhi questioned ICMR, a state-funded body itself for violating the rules made by its parent ministry on breast feeding. “It is illegal on the part of ICMR to approve such a research project,” he added.  Nestle has yet to comment on the accusations.


theguardianuk--2019-07-02--Doctors not prescribing medicinal cannabis due to lack of clinical trials

High expectations among the public of the benefits of medicinal cannabis are being disappointed because doctors are unwilling to prescribe it in the knowledge that there is little evidence to stand up some of the claims, according to MPs.  A House of Commons health select committee inquiry says the hopes of patients and families were raised when the government agreed to reschedule medicinal cannabis to make it more available in the light of “the distressing cases of Alfie Dingley and Billy Caldwell” – two children with severe epilepsy whose parents said only the drug gave them respite from seizures.  But adequate clinical trials to prove the effects of medicinal cannabis in epilepsy and other conditions have not been carried out. Without that evidence, few doctors are willing to write a prescription.  The Royal College of Physicians told the committee that “there is a perception that CBMPs [cannabis-based medicinal products] work in areas where there is little or no evidence and some patients feel they are being denied access to an efficacious drug”.  Dr Sarah Wollaston MP, chair of the health and social care committee, said: “Although the recent changes to government policy were welcomed, there was a failure to communicate what this would mean in practice for the availability of medicinal cannabis.  “Expectations were unfairly raised that these products would become widely and readily available, and there needs to be far clearer communication that this is not the case.”  The rescheduling by government, from schedule 1 to schedule 2 of the Misuse of Drugs Act, makes it far easier to carry out trials into medicinal cannabis. The committee is concerned, however, that some pharmaceutical companies are reluctant to maketheir products available for research.  Trials, said Wollaston, “would build a stronger evidence base so that patients can weigh up any risks and benefits of treatment. At present there are too many gaps in the evidence to allow most forms of medicinal cannabis to be licensed for use and approved by Nice [National Institute for Healthcare Excellence].”  The government-funded National Institute for Health Research has called for research proposals that it could fund. The committee recommends that intractable childhood epilepsy should be a priority.  Dr Amir Englund, researcher in psychopharmacology at King’s College London, said patients who had exhausted other options could be given some medicinal cannabis products as part of a post-licensing trial. But, he warned, “an important issue to address is the one of exaggerated claims of cannabis as a treatment for various conditions which circulate online and in news articles.  “For instance, clinical trials have found that a number of patients with epilepsy become seizure-free on medical grade CBD, however this only happens to roughly 5% of patients – which naturally becomes the focus of news stories. The other side of the coin is that some patients in these trials drop out either because they felt no improvement or were experiencing side-effects.”


theindependent--2019-05-31--Why women HIV patients are now engaging in clinical trials

Inspired by reports of a second patient apparently freed of infection with HIV, the virus that causes Aids, scientists are pursuing dozens of ways to cure the disease.  But now, researchers must reckon with a long-standing obstacle: the lack of women in clinical trials of potential HIV treatments, cures and vaccines.  Women make up just over half the 35 million people living with HIV worldwide, and the virus is the leading cause of death among women of reproductive age. In Africa, parts of South America and even in the southern United States, new infections in young women are helping to sustain the epidemic.  Women and men respond differently to HIV infection, but clinical trials continue to rely heavily on the participation of gay men. Trials of potential cures fare particularly poorly in this regard.  A 2016 analysis by the charity Amfar found that women represented a median of 11 per cent in cure trials. Trials of antiretroviral drugs fared little better; 19 per cent of the participants were women.  Vaccine studies were the closest to equitable participation, at 38 per cent.  “If we’re going to find a cure, it’s important that we find a cure that actually works for everybody,” says Rowena Johnston, Amfar’s director of research.  There are well-known differences in the immune systems of men and women. The flu jab produces a much stronger immune response in women, for example.  The response to HIV infection seems also to differ. The immune system in women initially responds forcefully, maintaining tight control over the virus for five to seven years.  But over the long term, this state of high alert takes a toll. Women progress faster to Aids than infected men, and are more likely to have heart attacks and strokes.  “There are all sorts of differences between men and women, probably mediated partially by hormonal effects,” says Dr Monica Gandhi, professor of medicine at the University of California, San Francisco.  For example, the female hormone oestrogen seems to lull HIV into a dormant state. That may sound like a good thing, but the dormant virus is harder for the immune system, or drugs, to kill.  Some differences may be evident even before puberty: in one study, all but one of the 11 children who were “elite controllers” – people who seem to suppress HIV to undetectable levels without drugs – were girls.  Women also respond differently to some drug treatments.  Dolutegravir may increase the risk of neural tube defects in children born to women taking the drug, researchers have found. Nevirapine is far more likely to cause a severe rash in women than in men – yet men accounted for 85 per cent of the trial subjects in which the drug was tested.  These sex differences are likely to be germane to trials of potential cures, most of which are exploring ways to energise the immune system to kill HIV.  The number of men – and gay men in particular – in HIV trials has always surpassed the number of women. Early on, the epidemic was largely concentrated in gay men, who enrolled to gain access to new drugs as early as possible.  Gay men “were literally dying to get into these trials”, says Jeff Taylor, 56, an HIV advocate in Palm Springs, California, who enrolled in dozens of trials after his diagnosis in 1982.  Now, 30 years later: “It’s the same group of people, who understand the value of clinical trials,” he says.  Gay men have formed strong support networks that alert potential participants to clinical trials, and they often live in cities where the research is conducted.  By contrast, women with HIV tend to be isolated, and may not advocate for themselves. They may need help with child care or transportation, or be more comfortable with female doctors – accommodations few trials offer.  For women of colour, there is an additional hurdle: mistrust resulting from a long history of exploitation by medical researchers. “It’s a lot of stigma still in our community around research,” says Ublanca Adams, 60, who is living with HIV in Concord, California.  Scientists do not seem to know how to gain that trust, she says: “How information is given out to our community and our people is just not in a way to be inclusive, nor is it inviting.”  Adams says she has enrolled in a few observational studies, but does not trust scientists enough to participate in tests of a treatment or cure.  In the rare cases where scientists go the extra mile to enrol women, they face additional scrutiny from the Food and Drug Administration. (The agency has strict rules for including women of childbearing age.)  Most researchers simply opt for the easy way out and enrol men, collecting data from women only after a drug is on the market.  Two recent trials of long-acting antiretroviral drugs – which can be injected monthly instead of taken by mouth daily – have managed to attract significant numbers of women: 33 per cent of participants in one study, and 23 per cent in the other. But because of the promise of less frequent treatment, these trials were hugely popular and so had an easier time recruiting women than most.  “Patients lined up outside the clinic,” says Dr Kimberly Smith, head of research and development at ViiV Healthcare, the company that led the research.  In general, though, Smith says, trials in the United States struggle to enrol women, because about 75 per cent of the infected still are men.  Anticipating the need to test cures in young women, Bruce Walker and his colleagues at the Ragon Institute of MGH, MIT and Harvard have set up a group called Fresh in South Africa. Nearly 2,000 young women in the Umlazi Township check in twice weekly to be tested for HIV.  The researchers provide preventive therapy, but a small proportion of the women still become infected. Walker’s team is tracking their infections from the start and planning to test cures in the group.  Generally, however, it is difficult to get scientists to take the need to enrol women seriously, says Dr Eileen Scully, assistant professor of medicine at Johns Hopkins University.  “Some of the hard scientists dismiss this type of discussion as being more socially determined, or some sort of women’s liberation thing,” she says.  Scully led the only cure trial so far to focus solely on women, testing whether a drug that blocks oestrogen makes it easier to kill HIV. From the start, the investigators had to make some concessions.  To skirt the restrictions limiting participation by women of childbearing age, Scully and her colleagues recruited menopausal women. But these participants have lower levels of circulating oestrogen, which may skew the results.  Still, the team has already made one key discovery.  “We were one of the fastest trials ever to enrol,” Scully says. “Women are ready to be engaged.”


theindependent--2019-07-03--Cannabis companies should be aposnamed and shamedapos if they refuse to subject their products t

Cannabis companies should be 'named and shamed' if they refuse to subject their products to clinical tests, MPs say

The government and pharmaceutical industry are leaving patients to suffer without access to medicinal cannabis because of a lack of urgency in addressing prescribing issues and research, MPs have said.  A report by the Commons Health and Social Care Committee (HSCC) has said ministers' failure to explain the realities of its medicinal cannabis legislation has left the NHS managing frustrated patients.  Despite legislation taking effect in November only a handful of prescriptions have been issued and the committee said the government set expectations too high without establishing the evidence for its use.  The HSCC report urges ministers to fund medicinal cannabis in areas like epilepsy where the drug could make the biggest difference.  It also called for a “name and shame” policy for cannabis companies which fail to provide research to back up their products’ claims and for government to stop confiscating prescriptions obtained overseas.  “There needs to be a sense of urgency to explore the potential of medicinal cannabis in these conditions so that there is a robust research base on which to base future clinical decisions,” the report said.  Difficulties in patenting cannabis extracts and the tens of millions required to conduct clinical trials for their approval mean many companies do not try to get their products licensed.  Some companies will not even provide their products for researchers and in these cases the HSCC says the government should take action.  Prior to the law change The Independent revealed a lack of evidence for the products’ safety and effectiveness would be a major barrier to doctors prescribing it.  This has been borne out by the Commons report, which adds that claims by the Home Office have heaped pressure on doctors who have to explain to patients why they cannot access the drug now it’s legal.  “Expectations were unfairly raised that these products would become widely and readily available, and there needs to be far clearer communication that this is not the case,” said Dr Sarah Wollaston, MP and chair of the committee.  While the law changes make it easier to research cannabis, Dr Wollaston added: “At present there are too many gaps in the evidence to allow most forms of medicinal cannabis to be licensed for use and approved by the National Institute for Health and Care Excellence (NICE).”  But charities said the government and industry need to act now to prevent patients living with debilitating symptoms having to wait decades for trials to prove what most patients already know.  “Multiple sclerosis symptoms which are relentless, painful and disabling,” said Genevieve Edwards, from the MS Society. "Yet people with MS are frustrated and disappointed that it’s still easier to buy cannabis on the street than it is to get an NHS prescription.  “A focus on further research can’t become an excuse for inaction for the people with MS who could benefit now.”  Dr David Caldicott, of Australian National University said the research on medicinal cannabis is a century behind other treatments and the growing medicinal cannabis industry needs to prove it can put patients before profits.  “Big Green runs the risk of tarring itself with exactly the same reputation as Big Pharma, or worse,” he said.  Despite the UK having the luxury of following cannabis decriminalisation in the US, Canada Israel and elsewhere, Dr Caldicott said the government “seems determined to avoid learning any of their lessons”.  A government spokesperson said: “We will carefully consider this report and its recommendations alongside the outcome of the NHS England review into the use of cannabis-based products for medicinal use in the NHS.  “In doing so, the government will consider any further action we might take to strengthen the evidence base and improve access to cannabis-based products for medicinal use where specialist doctors determine it is clinically appropriate.”


theirishtimes--2019-09-02--HSE looks to recruit clinical lead for abortion services rollout

The Health Service Executive is seeking to recruit a clinical lead for abortion, nine months after the service was introduced.  The person appointed will be tasked with the rollout of termination of pregnancy services to all 19 maternity units, and nationally in GP surgeries and other community settings.  At present, abortion services are available in only 10 maternity units and through about 350 GPs in the community.  The person to be appointed will be required to provide clinical leadership for the implementation of “safe, evidence-based, quality-assured, woman-centred, accessible services for women who require abortion care”, according to the role description.  The post is a part-time one, open to experienced obstetricians and gynaecologists for a two-year period. The HSE says it may be re-advertised thereafter “if the continuation of the role is deemed necessary”. Among the responsibilities of the post-holder will be the provision of clinical leadership to support implementation of abortion services nationally in acute and community services.  The person, to be seconded to the post for two days a week, will also be responsible for the rollout of the service in all 19 maternity units.  The HSE says it is important that termination of pregnancy services are integrated into general gynaecological and reproductive healthcare services.  Last week, the Medical Council issued revised ethical guidance for doctors following the introduction of abortion services in January. While allowing doctors to opt out on grounds of conscience, the guidance also sets out the obligations the doctor has to the patient in such circumstances.  “If the patient cannot arrange their own transfer of care, you should make these arrangements on their behalf. In an emergency situation, you must provide – as a matter of priority – the care and treatment your patient needs,” it states.  Abortion up to 12 weeks was legalised last January; after 12 weeks, it is allowed only in certain specific circumstances, including where there is a risk to the life or health of the mother.  Separately, all women who give birth to a baby in the State’s maternity units next month are to be surveyed about their experience.  The first national maternity experience survey, which will also take place in smaller units in November, aims to learn from the experiences of women so the safety and quality of care can be improved.  Maternity services have been embroiled in a number of controversies in recent years, including the death of Savita Halappanavar in 2012 and a series of baby deaths at Portlaoise hospital. Earlier this year, dozens of women took to the air, on RTÉ Radio’s Liveline, to complain about their own experience of giving birth in Irish hospitals.  Information sessions for maternity staff about the survey are being held next week and the women will be surveyed in early 2020.


theirishtimes--2019-10-08--Vaccine not tested on teens before ‘de facto’ clinical trial, court told

An anti-swine flu vaccine given to teenagers by the HSE in 2009 had never been tested on that age group, a major case that opened on Tuesday in the High Court has been told.  Aoife Bennett (26), of Naas, Co Kildare, claims she developed narcolepsy and cataplexy disorder as a result of being given the Pandemrix vaccine in school on December 10th, 2009 as part of a nationwide vaccination programme. She was aged 16 at the time.


thesun--2019-11-19--First male birth control injection that is administered into genitals is nearly ready after successf

First male birth control injection that is administered into genitals is nearly ready after successful clinical trial

THE world's first ever male birth control injection that is administered into genitals is nearly ready after the injection successfully passed its clinical trial.  The birth control method, which lasts approximately 13 years, involves injecting a polymer which effectively blocks sperm from leaving the testicles.  The Indian Council of Medical Research, a government-funded biomedical research agency, has successfully completed a clinical trial on an injectable male contraceptive, the Hindustan Times reported.  Dr R.S. Sharma, senior scientist with ICMR, said: "The product is ready, with only regulatory approvals pending (from the government).  "The trials are over, including extended, Phase 3 clinical trials for which 303 candidates were recruited with a 97.3 per cent success rate and no reported side effects.  "The product can safely be called the world’s first male contraceptive.”  The vaccine, preceded by a dose of local anaesthesia, is designed to replace a traditional vasectomy.  Researchers in the US have developed a similar contraceptive, called Vasalgel, which has not yet been brought to market.  A male birth control pill also exists, though researchers anticipate it’ll be about 10 years before it makes it to market.  Drugs such as these can only prevent pregnancy, but do not protect against STDs.  Dr Sharma added: “The polymer was developed by Professor S.K. Guha from the Indian Institute of Technology in the 1970s.  "ICMR has been researching on it to turn it into a product for mass use since 1984, and the final product is ready after exhaustive trials."  Researchers call this reversible inhibition of sperm under guidance.  V.G. Somani, Medicine Controller General of India, said that because of pending regulatory approval, the injection “will still take about six to seven months … before the product can be manufactured."  It comes as Vice asked several Indian men if they were open to the idea of a shot in the groin to prevent pregnancy.  Many agreed that more options would be a boon for men and women, though many weren’t keen on needling their nether regions.  A version of this story originally appeared on New York Post.  We pay for your stories! Do you have a story for The Sun Online news team? Email us at tips@the-sun.co.uk or call 0207 782 4368 . We pay for videos too. Click here to upload yours


thevaccinereaction--2019-10-23--New Herpes Vaccine Nearing Human Clinical Trials

Researchers at the University of Pennsylvania recently reported that they are close to developing a herpes simplex virus 2 (HSV-2) vaccine for humans. HSV-2 primarily causes genital herpes and is contracted through forms of sexual contact with a person who has HSV-2. An estimated 14 percent of Americans between the ages of 15 and 49 are infected with HSV-2. According to Forbes, the goal of is to make the vaccine work in a similar manner to the current human papillomavirus (HPV) vaccine on the market.1 2 3  Previous attempts to develop a herpes vaccine have failed. However, according to a new study published in Science Immunology, an new experimental HSV-2 vaccine has prevented genital lesions in mice and guinea pigs. According to a report in New Scientist, the vaccine prevented low-level “hidden” infections. Other experimental vaccines initially thought to be promising enough to test in humans have failed to prevent these hidden infections in animals.4  Harvey Friedman, MD, who is a coauthor of the study and an immunologist at the University of Pennsylvania, is quoted as saying that, “This degree of protection is better than any other vaccine candidates have achieved in mice. We also had excellent protection in guinea pigs, which is another animal model used to evaluate genital herpes vaccine candidates.” He adds, “but we won’t know if this vaccine will work until it is tested in humans.”4  Dr. Friedman states that the new HSV-2 vaccine takes a genetics-based approach to preventing herpes transmission. It combines the messenger RNA (mRNA) coding for three proteins found in the virus.4  No mRNA-based vaccine has yet been approved for use in the United States. According to PHG Foundation at University of Cambridge, while RNA vaccines are non-infectious and RNA does not integrate itself into the host genome, the mRNA strand in an RNA vaccine “may elicit an unintended immune reaction.”4 5  Amesh Adalja, MD, a senior scholar at Johns Hopkins Center for Health Security, says, “the technology has the potential to totally change the face of vaccine development in terms of speed, ease of manufacture and pursuit of novel targets. The promising results seen with this mRNA vaccine in mouse and guinea pig model will hopefully move into human clinical studies and also further the rise of mRNA vaccine technology.”3  Dr. Friedman and his team are in negotiations with a biotechnology company to begin the first stage of human clinical trials in the next year with 50 to 100 people to first test the vaccine’s safety and its ability to produce an immune response.3  If the vaccine is successful in all stages of the human trials, Dr. Friedman said researchers envision it being recommended for children to the onset of sexual activity similar to recommendations for HPV vaccine routinely administered to pre-adolescents.3


thevaccinereaction--2019-12-15--‘Unethical’ Clinical Trials of Vaccines Pose Threat to Human Lives

Opinion | Primum non nocere—“first, do no harm”—is a basic tenet of medical ethics. That is about to change in India. “Controlled Human Infection Method” (CHIM) studies are planned to be introduced here. Humans are to be deliberately infected with diseases to test the efficiency of experimental vaccines. It will provide a shortcut to vaccine licencing and reduce costs to manufacturers.  At Hotel Taj Palace, from 19 -21 November, under the rubric of the “World Conference on access to medicinal products”, the ICMR and the DBT plan to introduce CHIM studies. According to the Economic Times, even vaccine manufacturers are advising caution before allowing such a radical departure from standard practice.  The Translational Health Science and Technology Institute (THSTI), under the DBT, is spearheading the efforts under the banner of a mysterious “India Volunteer Infection Research Consortium”. Dr Y.K. Gupta, principal advisor, THSTI, has said that “initially, such studies should only be allowed in high-quality academic institutions… Similarly, at least initially, only healthy, educated adults should be included in a CHIM study”. The promoters are clear that such concessions are needed only initially.  So, the “initial” studies are to be done on drug-responsive malaria, typhoid and flu (which is self-limiting). It is claimed that CHIM volunteers are to be infected with a weakened strain of the pathogen. However according to biologics development consultant Dr K.B. Walker “a safe, well characterised strain will lose some semblance to the real “challenge” organism and so weaken the relevance of CHIM in informing further clinical development”. This defeats the main objective of doing such studies.  Also, what is the use of doing studies on easily treated disease? The real need is for vaccines against dangerous diseases like Ebola. After the initial human revulsion against CHIM has been overcome, we can expect trials with Ebola infection and similar plagues. After the “initial” stages, we can expect these studies will not be limited to academic institutions and contract research organisations (CROs) will do these studies more efficiently. This is a slippery slope. Once the Rubicon is crossed, there may be no coming back.  The country remembers what happened when the government tried to encourage the inflow of foreign exchange for clinical trials from abroad with tax cuts and relaxing local laws. The cost of doing clinical trials in India was half of what it cost in other countries in the West, even counting kickbacks to local doctors. There was a spurt in such trials. However, lax governmental regulation had to be tightened after 1,725 deaths among trial participants were reported. Justice R.M. Lodha commented about these trials saying, “human beings are being treated like animals”.  Writing in Hindu Businessline, a group of ethicists and legal experts have raised a number of questions about these CHIM that need to be answered. Who are the industry collaborators? Who are the funders? Who will own patents obtained through CHIM? Will there be disclosure about the incentive paid to volunteers? Will there be an open registry of adverse events and results?  In a country, where adverse events during a government-funded rotavirus trial are yet to be disclosed despite repeated appeals going up to the Supreme Court, open disclosures regarding CHIM trials seems very unlikely.  The poor in India are known to enter studies not for altruism, but for healthcare, better healthcare services for themselves—or for money. Even in developed countries, participants are known to join multiple trials for the high payments, despite the discomfort and the risks posed by repeated infections, according to the article in Hindu Businessline.  The Alliance for Human Research Protection (AHRP) is presided over by Vera Sharav, a survivor from Hitler’s holocaust. The AHRP has called the proposed studies on human volunteers in India, “a vaccine experiment atrocity”.  This article was reprinted with the author’s permission. It was originally published in The Sunday Guardian.  Note: This commentary provides referenced information and perspective on a topic related to vaccine science, policy, law or ethics being discussed in public forums and by U.S. lawmakers. The websites of the U.S. Department of Health and Human Services (DHHS) provide information and perspective of federal agencies responsible for vaccine research, development, regulation and policymaking.


abcnews--2019-10-31--Hearing concludes in Missouri abortion clinic licensing case

An administrative hearing to decide whether the state of Missouri can revoke the abortion license for the state's only abortion clinic has concluded.  The hearing in St. Louis before a commissioner with the Missouri Administrative Hearing Commission was expected to last five days but wrapped up Thursday, a day early. A ruling isn't expected until February at the earliest.  The state health department wants to revoke the license for Planned Parenthood's St. Louis clinic, citing concerns about four instances of what the state called "failed abortions." Planned Parenthood officials say the state is trying to use the licensing process to end abortions in Missouri.  Revocation would make Missouri the first state since 1974, the year after the Supreme Court's Roe v. Wade decision, without a functioning abortion clinic.


abcnews--2019-11-14--Ohio abortion clinic lands license needed to stay open

The Dayton area's last abortion clinic has prevailed in a years-long battle over Ohio’s stringent new licensing requirements and will remain open.  The Ohio Department of Health has granted Women’s Med Center a surgical facility license.  The center in Kettering had postponed surgical abortions as it pursued multiple avenues to stay open, including state and federal court challenges and negotiations with local health systems and doctors.  After being unable to land the legally required emergency patient-transfer agreement, the center secured enough doctor signatures for a variance.  Ohio Right to Life, the state’s largest anti-abortion group, said it’s disappointed the state has licensed a facility that’s skirted laws for years that are intended to protect women.  NARAL Pro-Choice Ohio, an abortion-rights group, said Ohio’s restrictive abortion laws are not medically necessary.


ageofautism--2019-08-13--The Science is Unsettled Spin in psychiatric clinical trial reports is widespread

The Science is Unsettled "Spin in psychiatric clinical trial reports is widespread"

Note: One of the phrases we 0ften hear regarding vaccine safety is that "The science is settled, vaccines do not cause autism." Is science in its pure form ever really settled. And what of science today, in a profit driven system? Here, an article talks about the problem of sweet talking, data changing tweaks in psychiatric clinical trial report summaries that are read instead of the full study in part because few have the time to read actual papers and properly draw their own conclusions.  How can anyone claim the science is settled when we know that studies are spun to present profit-assisting data?  We can't. Why is this understandable and presentable in the media EXCEPT when it comes to vaccinations?  The deluge of information is not necessarily a good thing, especially when doctors are also required to do more administrative paperwork than ever before.  Even those who want to keep up may be unable to do so.    ###  Spin in psychiatric clinical trial reports is widespread   More than half of a sample had flattering tweaks in report summaries    It's not just longform journalism and apoplectic Internet commenters that prompt a "tl;dr" from readers. Research papers trigger it, too, as scientists are so inundated with the volume of new results that just barely keeping up is a struggle. According to University of Oxford psychiatrist Michael Sharpe, "Everyone is deluged with information."  Research papers give a brief summary of their contents in an information-rich "abstract" of the article—it's often the only text that's publicly available from a paywalled journal. Time-pressed researchers may rely on the abstract rather than investing in reading the lengthy paper, but those abstracts are not always reliable. A paper published this week in the journal BMJ Evidence-Based Medicine found that half of the 116 psychiatry and psychology articles they analyzed included some sort of spin that made the results look better than they were.  "These findings raise a major concern," Sharpe told the Science Media Centre, "especially as readers may draw conclusions on the basis of the abstract alone, without critically appraising the full paper."    Read the full article at ArsTechnica. It's troubling and we aren't sure there's any answer to make future reports more accurate.


bbc--2019-02-14--Free clinics The little-known safety net of US healthcare

Free clinics: The little-known safety net of US healthcare

West Virginia's largest free clinic sits on a quiet street in Charleston, the small capital city of a state often called America's unhealthiest. Since 1982, West Virginia Health Right has offered under- and un-insured patients access to healthcare at little to no cost.  "I think free and charitable clinics are the most overlooked jewel of the US," says the clinic's CEO, nurse practitioner Angie Settle.  Most legislation focuses on federally qualified health centres, Mrs Settle says, which receive federal funding to cater to lower-income and private patients alike.  "Well, we're sitting right in the middle of two federally qualified health centres and we have 26,000 patients. So obviously they're not meeting the whole need."  Last year, West Virginia Health Right (WVHR) provided $15m (£11.6m) worth of healthcare and prescription medications to those patients - for an average per person cost of $115 (£90) for a full year of care.  "A lot of people have this misconception about free clinics that it's just a handout for people who don't want to work," Mrs Settle says.  "That can't be further from the truth. Eighty-three percent of our patients are employed in some capacity."  But for many, having a job does not guarantee access to health insurance or care - and government assistance programmes have strict income limits.  "Without us, a lot of the people that we see would have no other alternative but to turn to public assistance, to quit their job so they can get poor enough to be on Medicaid."  Bobbi Morrison, a nurse practitioner at WVHR, used to work in a private clinic, and says the difference is striking.  She could get insured patients there access to specialists in weeks. But for the uninsured or those on federal programmes?  "I've seen people wait for certain specialists six months to a year."  At WVHR, physicians and dentists volunteer their time so that patients can get holistic treatment often in just one visit.  As a part of an initiative to build trust and keep patients on track with their care plans, new WVHR patients join one of three teams and will work with providers on those teams for as long as they come to the clinic.  Mrs Morrison says one of the clinic's main goals is education.  "I have people come in all the time who haven't had a women's health visit in 20 years because they didn't think they could get one anywhere."  "What we take as basic common sense or understanding, a lot of people don't have. That's the hard part of what we try to do."  The newly renovated second floor of the clinic boasts a large kitchen and teaching space for that very purpose.  And WVHR's wellness classes are always packed.  Patients of all ages sign up for free lessons on healthy cooking, diabetes management, exercise - and then volunteer to lead classes themselves.  "It's a support group. It's a community," clinical coordinator Rhonda Francis says.  "Our patients learn and then want to teach others."  WVHR also teaches patients about couponing - using grocery deals to get healthier food - and offers challenges where patients can get cash rewards for losing weight.  "We've tried to add wrap-around services like behavioural health, addiction - making the health education more robust," CEO Mrs Settle says.  She describes patients coming in like Nascar - car racing - drivers to pit stops: Providers try to squeeze every treatment in, "because we don't know when we'll see them again".  Twenty-one-year-old Ricci Shannon says she heard about the free clinic from a co-worker after she mentioned suffering from a serious toothache.  Ms Shannon, who is uninsured, says she had been trying to avoid a trip to a dentist for fear of how much it would cost.  "It just seems expensive," she says of health insurance. "An extra bill to incorporate when you're just getting started."  "I would literally be dead without this clinic," the 57-year-old West Virginian says.  "If you got nothing, you still got something. You got a way to save your life, to get your insulin, your BP medicine, whatever you need.  "You hear people complain - 'I've been sitting here for 20 minutes' - well where in the hell else you gonna go? Where are you gonna get that prescription for nothing?"


bbc--2019-03-19--Egg freezing Behind the scenes of a fertility clinic

Egg freezing: Behind the scenes of a fertility clinic

With more and more women around the world considering freezing their eggs, how does the process work?  BBC Health reporter, Smitha Mundasad, has been behind the scenes of a fertility clinic to find out exactly how eggs are frozen, and has been speaking mum of two Ali about her own egg freezing journey.  You can find out more on the Beyond Today podcast on the BBC Sounds app and online here from 1700 GMT Tuesday March 19.