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  1. The Flu Vaccine, Inflammatory Arthritis, and COVID-19: What You Need to Know This year, the flu vaccine is more important than ever. Here’s what you need to know about getting vaccinated safely when you have inflammatory arthritis like rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis. Learn more about our FREE COVID-19 Patient Support Program for chronic illness patients and their loved ones. Getting a flu vaccine is important every single flu season, especially if you have a form of inflammatory arthritis such a rheumatoid arthritis (RA), psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA) — but in the midst of the COVID-19 pandemic, it’s even more critical. While experts are hoping that COVID-related prevention practices like mask wearing, social distancing, and ramped-up hygiene will translate into less influenza spread this season, rheumatology experts are still urging patients to get vaccinated. The good news is that many people with chronic illness don’t need convincing. According to a recent survey of members of the CreakyJoints and Global Healthy Living Foundation’s COVID-19 Patient Support Program (a free program that provides information, advice, and support to help people with underlying health issues navigate the pandemic), 85 percent of 780 respondents said they were planning to get a flu vaccine this fall. About 10 percent said they did not plan to, and 5 percent did not know if they would get the flu vaccine this fall. “As we are getting ready to enter flu season, and with COVID-19 continuing to spread throughout our communities, I think it is extremely important for people to get the flu vaccine this year,” says Justin Owensby, PharmD, PhD, a research pharmacist in the division of clinical immunology and rheumatology at the University of Alabama at Birmingham (UAB). “As the novel coronavirus has severely stressed our health care system/resources, having even a mild flu season will further tax the system,” which may lead to even more strain on the hospitals and health care workers who will help you if you end up needing emergency care because of flu complications such as pneumonia. Here’s more about why, when, and how to get your flu vaccine safely this year. Why You Need the Flu Vaccine, Period First, simply having inflammatory arthritis increases your chances of getting the flu — and, if you do catch it, your risk of serious infection and severe complications is greater. “Compared to the general population, people living with inflammatory arthritis are at substantially higher risk of getting a vaccine-preventable infection, such as the flu or pneumonia, and consequently more complications and hospitalizations from those infections,” explains Dr. Owensby. For example, RA patients have nearly a three times greater risk of getting the flu than healthy patients in the same age group, according to a 2012 analysis of 46,030 RA patients and an equal number of healthy controls, published in the journal BMC Musculoskeletal Diseases. Yet another study, presented as an abstract at the American College of Rheumatology conference in 2018, found that RA patients who get influenza experience increased hospital stays as well as higher costs compared to healthy controls. Inflammatory arthritis decreases your body’s natural immune defenses and some disease-modifying medications used to manage your condition can also weaken your immune response. “The flu shot is designed to strengthen your immune system by allowing it to recognize and fight off an influenza infection,” says Owensby. “Flu vaccines have been shown to reduce the risk of flu illness, hospitalization, and death.” COVID-19 and Flu Coinfection As if that’s not convincing enough, here’s yet another reason to roll up your sleeve: “People can get coinfected with influenza and COVID-19, says Jeffrey Curtis, MD, MS, MPH, professor of Medicine in the Division of Clinical Immunology and Rheumatology at the University of Alabama at Birmingham (UAB). “You can have both infections at the same time, and if that happens, the severity will be much worse.” While the flu shot won’t protect you from getting COVID-19, it may help reduce the risk of spreading COVID. “If you have the flu, and you’re coughing and sneezing, common sense says you’re more likely to transmit COVID,” says Dr. Curtis, “so if you can decrease the incidence and transmission of influenza, then you it’s possible that you can decrease the transmission to COVID.” More research is needed to confirm this effect, however. When Should I Get the Flu Vaccine? The CDC recommends getting your flu shot before influenza spreads within your area; ideally by the end of October. However, getting vaccinated anytime during the flu season, even in January or later, can protect you. Dr. Curtis says it’s important to remember that it takes about two weeks after vaccination for antibodies that protect against flu to develop in the body — and that immunity doesn’t always last the entire season. “There is some temporariness to the duration of protection of the flu vaccinations, so if you get the flu shot in September, it might not offer the same protection in March,” he says. Yet if putting it off until November means you might just put it off forever, Dr. Curtis urges patients to get it done and over with it when it’s top of mind. If you suspect you may have been exposed to COVID-19 or have a confirmed diagnosis of COVID-19, the CDC suggests delaying the flu shot until you’re no longer showing signs and symptoms, adds Owensby. This isn’t because there’s evidence that having COVID affects the effectiveness of the flu vaccination, but rather because you don’t want to unnecessarily expose others to COVID-19. What’s the Best Place to Get the Flu Vaccine? For people with inflammatory arthritis who have been staying at home as much as possible and limiting their outings to minimize exposure to COVID-19, the idea of heading to a doctor or pharmacy to get a flu shot may seem scary. You can find reassurance in the fact that the CDC has given guidance to local pharmacies, grocery stores, and doctor’s offices for safe vaccination practice during the COVID-19 pandemic, including: Screening patients for COVID-19 symptoms or exposure to COVID-19 prior to arrival Limiting the overall number of patients at any given time Providing specific appointment times to manage patient flow and avoid crowding Ensuring staff wear medical face masks and use eye protection Limiting and monitoring points of entry to the facility and installing barriers, such as clear plastic sneeze guards, to limit physical contact with patients Implementing policies for wearing cloth face coverings and practicing respiratory hygiene, cough etiquette, and hand hygiene Setting up a one-way flow through the site and using measures to direct patient traffic and ensure physical distancing Arranging a separate vaccination area or separate hours for persons at increased risk for severe illness from COVID-19, when feasible Ensuring a minimum distance of 6 feet between patients in line, in waiting areas for vaccination, between vaccination stations, and in postvaccination monitoring areas Other safe places to get your flu shot this year may include: Drive-through immunization services Curbside clinics Mobile outreach units Home visits “It doesn’t matter where as long as you get one,” says Dr. Owensby. He recommends using VaccineFinder.org to find where flu vaccines are available near you. “[And] when going to get a flu vaccine, be sure to practice everyday preventive actions.” If you’re not sure whether a local pharmacy or clinic is following COVID-19-related precautions, ask around and get feedback and recommendations from family and friends. You can also call ahead to ask about how crowded the facility is and find out the times of day when it’s likely to be emptiest. What Type of Flu Shot Is Best? Dr. Curtis says there are three considerations for people with inflammatory arthritis: Is it a live vaccine? A live vaccine, such as the nasal spray, can cause side effects in people with inflammatory arthritis who have weakened immune systems. Instead, opt for the flu shot, which is made from inactivated (or killed) influenza virus, which cannot cause illness. Is it quadrivalent? This means that it’s a four-component vaccine, which this year protect against the following four flu strains: A/Hawaii/70/2019 (H1N1) pdm09-like virus; A/Hong Kong/45/2019 (H3N2)-like virus (updated); B/Washington/02/2019; (B/Victoria lineage)-like virus (updated), plus B/Phuket/3073/2013-like (Yamagata lineage) virus. The trivalent vaccine, which offers protection against three strains, does not include the fourth virus, B/Phuket/3073/2013-like (Yamagata lineage) virus. Is it high-dose? This is a more potent type of flu vaccine, and while it’s generally reserved for adults 65 and older, it is beneficial for people with inflammatory arthritis who may have a weaker response to the flu vaccine than people without these health conditions. In fact, research published in The Lancet Rheumatology reported that the high-dose flu shot (Fluzone) substantially improved the immune response in seropositive RA patients compared to the standard-dose flu shot. However, many high-dose vaccines are trivalent, and don’t protect against B/Phuket/3073/2013-like (Yamagata lineage) virus. Talk with your rheumatologist about the best type of flu vaccine for you, and be sure to check with your insurance to see if it’s covered, says Dr. Curtis. If you’re under 65, the high-dose shot may not be covered. Do I Need to Adjust My Arthritis Medications? While the decision to adjust your medications should be between you and your rheumatologist, there are studies showing that some medications, including high doses of steroids, methotrexate, and the biologic rituximab, reduce the body’s immune response to flu vaccine, says Dr. Owensby. Rituximab Treatment with the infused drug rituximab has been shown to decrease the response to the flu shot, says Dr. Owensby, so your doctor may recommend delaying the time between vaccine and your next infusion. Methotrexate Recent studies have shown that a brief, two-week discontinuation of methotrexate after receiving the flu shot can boost your immune response to it, says Dr. Owensby. Although researchers have also found that people taking methotrexate or TNF inhibitor biologics — like etanercept (Enbrel), adalimumab (Humira), and infliximab (Remicade) — do have an acceptable response to the flu vaccine, the response isn’t as strong as it is in healthy individuals who are not taking immunosuppressants. Your best bet is talk to your doctor about the the pros and cons of skipping a dose of your medication around the time you get your flu shot. Dr. Curtis emphasizes that people should not “stop taking medication prematurely,” without consulting their doctors. Can the Flu Shot Increase My Risk of Getting Sick? “To my knowledge, there is no evidence suggesting getting a flu shot will make you more susceptible to COVID-19,” says Owensby. “Although they are both contagious respiratory illnesses, they are caused by different viruses.” COVID-19 is caused by SARS-CoV-2 and flu is caused by different strains of influenza viruses. Similarly, getting the flu shot will not give you the flu, says Dr. Curtis. In fact, those mild flu-like symptoms you may experience after the shot — headache, achiness, malaise, low-grade fever — are all signs of your immune system revving up to protect against the flu, he explains. Keep Practicing Mask Wearing, Social Distancing, and Good Hygiene While experts agree that you need to get a flu shot, it doesn’t mean you should stop taking other precautions to stay healthy this flu season. “Even after receiving the flu shot, it’s still important to take all the steps you can to avoid getting the flu,” says Owensby. So, get vaccinated, amp up your efforts to eat well and exercise, prioritize sleep, manage stress, and of course, practice a whole lot of hand washing and sanitizing. https://creakyjoints.org/living-with-arthritis/coronavirus/daily-living/flu-vaccine-inflammatory-arthritis-covid-19/?utm_source=CreakyJoints&utm_campaign=d589052654-cj-list_september-2020-newsletter_non-psp&utm_medium=email&utm_term=0_2a31b3d2f0-d589052654-232962794
  2. Turning Points in Research for Systemic Lupus in 2019 December 24, 2019 2019's Top Treatmen Advances in Lupus: 2019 was a significant year for new developments in the treatment of systemic lupus. These include new treatment options for systemic lupus and updated treatment guidelines for established treatments. In this slideshow, we highlight a few of the achievements made throughout the year. https://www.rheumatologynetwork.com/lupus/turning-points-research-systemic-lupus-2019
  3. DECEMBER 18, 2019 Breakthrough science provides hope for lupus patients by Monash University Credit: CC0 Public Domain Today the prestigious New England Journal of Medicine (NEJM) publishes research led by Monash University Professor Eric Morand that offers the first real hope for the treatment of lupus, a disease which affects 1.5 million people in the US and more than 5 million globally, 90% women and for which there is no cure. The results are of an international, three-year, Phase 3 trial of a potential new drug that treats this autoimmune disease (also known as systemic lupus erythematosus (SLE)). Lupus is an autoimmune disease in which the immune system attacks healthy parts of the body. It is particularly insidious disease as it has a ten-year mortality of 10%, "which if you are diagnosed in your early twenties is a terrible outcome," according to Professor Morand, who oversaw the global trial in over 360 people with SLE. The trial, called TULIP 2, evaluated AstraZeneca's anifrolumab and achieved a statistically-significant and clinically-meaningful reduction in disease activity versus placebo, with both arms receiving standard of care. Professor Morand has also been key in developing new lupus assessment criteria—which because the disease involves a number of organs in the body—can be difficult to both diagnose and monitor. According to Professor Morand, there has only been one new treatment approved for the disease in the last 60 years, which is not available on the Pharmaceutical Benefits Scheme in Australia. Between 60% and 80% of adults with SLE show increased interferon-induced genes, which reflect overproduction of the immune protein Type 1 interferon. While previous attempts to block this protein in lupus have failed, the potential new treatment, anifrolumab, works by blocking the receptor on all cells in the body, aiming to reverse the triggering of lupus symptoms. Professor Morand said that interferon is associated with other autoimmune diseases such as Scleroderma and Sjogren's disease "so there may be potential for using anifrolumab in the treatment of other interferon related diseases as well." In the TULIP 2 trial, eligible patients received a fixed-dose intravenous infusion of anifrolumab or placebo every four weeks. TULIP 2 assessed the effect of anifrolumab in reducing disease activity—noting a significant effect in global disease activity measures. The trial, from 2015 to 2018, involved 362 patients receiving either 300 mg of the drug or a placebo intravenously once every four weeks for 48 weeks. Benefit was measured using a defined clinical assessment of improvement in all organs as well as the number of flare ups (which see the patient experiencing fever, painful or swollen joints, fatigue, rashes or sores or ulcers in the mouth or nose). The volunteers were aged between 18 and 70 and had moderate to severe disease despite standard treatments. Patients with SLE typically die of organ failure. The study found that—52 weeks after the trial started—significantly more patients on the drug than the placebo had: A reduction in overall disease activity in all active organs improvement in lupus skin disease A reduction in steroid drug doses Reduced annual rate of flares The TULIP 2 trial followed on from the TULIP 1 trial which failed to meet its primary outcome. The second trial, published in the NEJM, used a different endpoint. "Measurement of treatment response in SLE has been very problematic and this represents a kind of second breakthrough of this trial," Professor Morand said. AstraZeneca will now work with regulators, to bring anifrolumab, a potential new medicine, to patients. The study was done in collaboration with colleagues in Japan, the UK, the US, France and South Korea. https://medicalxpress.com/news/2019-12-breakthrough-science-lupus-patients.html
  4. Lupus Survival Much Improved, But Plateaued September 25, 2017 | Lupus By Gregory M. Weiss, M.D. Survival rates for patients with systemic lupus erythematosus have plateaued since the middle of the 1990s after a period of major improvement starting in the 1950s. It has been thought that survival in systemic lupus erythematosus has continued to improve over the years, with reports of survival in adults increasing from 50% in the 1950s to more than 95% in the 1990s. Data with regard to survival trends in low- and middle-income countries and at 10- and 15-year periods are limited, so Maria Tektonidou and fellow researchers in Greece sought to describe mortality trends for children and adults with systemic lupus erythematosus and presented their findings in a recent Annals of the Rheumatic Diseases article. The study The authors performed a systematic review of the literature, looking at children and adults with systemic lupus erythematosus. Ultimately included in the final analysis were 171 studies; 125 looked at adult survival rates, 51 at pediatric survival, and 5 at both. Results • Studies in high-income countries showed a steady increase in survival from the middle of the 1950s to 1990. Survival rates have remained stable since then. • Five-year survival in high-income countries is greater than 95% in both adults and children who have systemic lupus erythematosus. • Five- and 10 year survival was lower for children than adults in low- to middle-income countries. Adults • Survival in adults with systemic lupus erythematosus has not continued to improve through the 2000s. • From 2008 to 2016, survival rates for adults with systemic lupus erythematosus in high-income countries at 5, 10, and 15 years were 0.95, 0.89, and 0.82, respectively (95% confidence intervals [CIs], 0.94-0.96, 0.88-0.90, and 0.81-0.83, respectively). • From 2008 to 2016, survival rates for adults with systemic lupus erythematosus in low- to middle-income countries at 5, 10, and 15 years were 0.92, 0.85, and 0.79, respectively (95% CIs, 0.91-0.93, 0.84-0.87, and 0.78-0.81, respectively). Children • From 2008 to 2016, survival rates for children with systemic lupus erythematosus in high-income countries at 5 and 10 years were 0.99 and 0.97, respectively (95% CIs, 0.98-1.0 and 0.96-0.98, respectively). • From 1980 to 2000, survival rates for children with systemic lupus erythematosus in low- to middle-income countries at 5 and 10 years were 0.85 and 0.79, respectively (95% CIs, 0.83-0.88 and 0.76-0.82, respectively). • Listing of systemic lupus erythematosus as the cause of death in all cohorts decreased over time. Implications for physicians • Although survival in adults and children with systemic lupus erythematosus both in high-income and in low/middle-income countries has improved dramatically since the 1950s, further gains have not been realized in the 2000s. • A decreased frequency of deaths attributed to systemic lupus erythematosus may be the result of new immunosuppressive drugs and combination therapies. • No increase in death resulting from cardiovascular events or cancer was seen in adults with systemic lupus erythematosus. • The authors suggested that strides need to be made in determining why survival rates are lower in children than in adults in low- and middle-income countries. http://www.rheumatologynetwork.com/lupus/lupus-survival-much-improved-plateaued?GUID=&rememberme=1&ts=26092017
  5. Israeli autoimmune disease treatment with parasitic worms has ‘marvelous’ results Professor Yehuda Schoenfeld of Tel-Aviv University, co-founder of medical startup TPCera, uses parasitic worms to treat autoimmune diseases, and the results have been “marvellous.” An expert in SLE & autoimmune diseases, such as MS & Rheumatoid Arthritis.
  6. When gender makes a difference Men and women tend to have different diseases and are affected differently when treated, largely because of hormones. DR. AVITAL Porter and patient. (photo credit:BINYAMIN ADAM) By JUDY SIEGEL-ITZKOVICH When neurobiologist Anat Biegon was studying depression in females 40 years ago at the Weizmann Institute of Science in Rehovot, she asked a colleague what drug dosage was needed to safely anesthetize rats before experimenting on them. Biegon recognized than that women were much more likely than men to suffer from chronically low moods. She gave the female rodents the recommended amount – and all of them died. The colleague had given the dosage accepted for use on male rats; no special dose had been calculated for female rats because they were considered to be the same as the male gender. Today, as a professor of neurology and radiology at Stony Brook University in New York (part of the State University of New York), Biegon has established a center for the study of gender, hormones and health at her university. She delivered a solo lecture last month at Hadassah University Medical Center in Jerusalem’s Ein Kerem on “Sex Differences in Medicine? Why Should We Care?,” and has gone far to study the implications of differences between females in males. Biegon, who at Tel Aviv University studied chemistry for a bachelor’s degree and biochemistry for her master’s degree, branched out into neurobiology in Rehovot and then completed post-doctoral work at Rockefeller University in Manhattan. Since 1990, she has remained in the US, and her main research interests have included brain response to traumatic, ischemic or inflammatory insults; gonadal hormone modulation of brain function in health and disease; and radiopharmaceuticals for non-invasive imaging of neurotransmitter and hormone markers in the brain – all the while keeping an eye on gender differences in these subjects. “Gender, biological sex and sex hormones affect everything in medicine, including prevalence, disease presentation and outcome, the safety of medical devices and procedures, drug response, metabolism and safety and efficacy,” she said in the English-language speech. Her lecture was based on American statistics but, she said, “the situation in Israel shouldn’t be much different.” “As many as 66 percent of visits to doctors are by women,” she noted. This is not because women are more fearful of being ill or like to spend their time in health fund clinics. “It’s due to the fact that women live considerably more years than men and they are thus more likely to suffer from age-related, chronic and incurable diseases. In addition, pregnancy, birth, breastfeeding and taking care of children can have adverse effects on women’s health.” While victims of attention-deficit/hyperactivity disorder (ADHD), autism and traumatic brain injury are predominantly boys/men (75 percent versus 25% in females), autoimmune diseases (in which the immune system attacks bodily tissue or cells because it mistakenly regards them as “foreign”) and others affect mostly females. While ADHD is more common in boys, and girls have lower ratings on hyperactivity inattention and impulsivity, they tend to have more intellectual impairment in this condition. “About 90% of sufferers of lupus erythematosus [a complex inflammatory disease causing scaly red patches on the skin, and sometimes affecting connective tissue in the internal organs] are women,” said Biegon. In addition to depression, women suffer more from Alzheimer’s disease, multiple sclerosis, cluster headaches, osteoporosis, fibromyalgia and osteoarthritis. Hip, forearm, spinal and humerus bone fractures occur more in women. “These are generally not killer diseases, but they make life miserable for a long time,” she noted. “During the course of a woman’s life, affected by reproductive hormones the risk of disease can rise and ebb: For example, during her fertile years a woman is at higher risk of depression; this declines at menopause and then increases when she becomes old-old.” Even when a woman undergoes a sex change operation, the “liability” of disease can follow her on her path through the other gender. “Robert Eads, a twice-divorced man with two children who became a transsexual at the age of 45, died of ovarian cancer,” Biegon reported, showing her/his photo. She/he had her breasts removed and took testosterone supplements, but the ovaries were never removed because they were not functional at that age. But he nevertheless succumbed to ovarian cancer at 53. Transgender women who become men take testosterone, which is a precursor of estrogen. So this hormone treatment can also increase the risk of estrogen- linked diseases.” SYMPTOMS OF the same acute conditions can present themselves differently in men and women, Biegon continued. In men, the first signs of a myocardial infarction (heart attack) in men include sharp pain in the left part of the chest, possibly with the pain radiating down the arm on that side. In women, they could be very different. “Often, there is no chest pain. There could instead be a cough, feeling tired or pain in the jaw or back. So many women may not know they are having a heart attack, and many physicians in the emergency room may not take their symptoms seriously,” Biegon said. The emergency room doctor could think a woman was “hysterical” and just give her a Valium pill and send her home. “This situation costs a large number of women’s lives.” A few weeks ago, the American Heart Association issued an official statement on the matter. “Cardiovascular disease is the leading cause of mortality in American women. Since 1984, the annual cardiovascular disease mortality rate has remained greater for women than men; however, over the last decade, there have been marked reductions in cardiovascular disease mortality in women. The dramatic decline in mortality rates for women is attributed partly to an increase in awareness, a greater focus on women and cardiovascular disease risk and the increased application of evidence-based treatments for established coronary heart disease. This is our first scientific statement from the American Heart Association on acute myocardial infarction in women,” the association declared. “Sex-specific differences exist in the presentation, pathophysiological mechanisms and outcomes in patients with acute myocardial infarction. This statement provides a comprehensive review of the current evidence of the clinical presentation, pathophysiology, treatment, and outcomes of women with acute myocardial infarction.” BIEGON said that although traumatic brain injury is more common in men, the results are usually different in women and men. The injury usually causes the brain to swell. The victim undergoes a CT (computerized tomography) scan and is tested with intracranial pressure-measuring devices. The swelling alone can kill. “But in people with severe brain injury, a quarter of men have swelling that is reduced. In women, the brain swells much more from the same injury. In women in their reproductive years, under the age of 51, swelling in various female organs – the breasts and abdomen – is common during and after menstruation. So brain swelling in such women is also greater due to hormones. Post-menopausal women suffer much less brain swelling after traumatic injury to the head. One can’t ignore age in this matter.” Mortality rates of young girls who suffered traumatic brain injury are more than twice as high as that of boys, she says. “But when they reach puberty, the ratio stabilizes and becomes equal until age 30, but at age 50, men have higher death rates.” Biegon stressed: “The absence of evidence doesn’t mean evidence of absence. If a study shows no sex difference, it doesn’t mean it is true. One always has to look at the interaction with age. One needs large numbers of women to say something about a gender effect, but often many women are not included. Researchers compare older and younger men, but not women to men. When you survive brain injury, you are alive. The question is if life is worth living; one might need constant care for disability and even be in a vegetative state.” AS FOR the safety of medical devices and procedures, coronary angioplasty is claimed to be very safe and effective when arteries in the heart are found to be clogged. “But this is true for men! Death after angioplasty is less than 1% for men but close to 2% in women. This is a significant difference,” Biegon asserted. “This means more hospitalization and complications in women. The female gender is and independent predictor of lower success for angioplasty and a higher risk of death.” Drug response also varies according to whether the patient is male or female. “Women are more likely to suffer adverse effects of drugs than men, and not only because of their average smaller size. ACE inhibitors for treating hypertension have been found to be less effective in women than in men. The use of digitalis, found to be not effective in women in some major studies, has more side effects.” Digitalis, a natural medicine that strengthens the force of the heartbeat by increasing the amount of calcium in the heart’s cells and controls irregular heart rhythms has been found to cause more deaths in women than in men. Aspirin has been recommended for preventing myocardial infarction in older people. “Almost everyone over 60 takes baby aspirin,” said Biegon. “But 32,000 participants studied for the effects of aspirin in preventing the risk of heart attacks were all men. When a different study tested 40,000 women for the same purpose, aspirin made absolutely no difference in preventing MI. Aspirin is Man’s Best Friend but not that of women, who developed only side effects from taking it. Women are often overdosed with medications, and as they tend to suffer from more chronic illnesses at older ages, they are prescribed multiple mediations and suffer from drug-drug interactions.” Liver enzymes, the lecturer continued, “are induced by testosterone and inhibited by estrogen, so men have a faster oxidating metabolism than women. The effects of barbiturates, for example, are modulated by age and gender. Before puberty, boys and girls spend the same amount of time sleeping. After puberty, girls and women receiving barbiturate pills sleep significantly more than men, depending on where they are in their menstrual cycle and the involvement of their sex hormones.” The US Food and Drug Administration, she said, forced a pharmaceutical company to lower the recommended doses of zolpidem (brand names include Ambien, Zonadin, Sanval, Zolsana and Zolfresh), a prescription medication used for the treatment of insomnia and some brain disorders. Younger women need only half the dose as that given to males, as their estrogen affects it, Biegon said. GENDER DISCRIMINATION in the medical establishment has been quite ludicrous for centuries. In 1859, the American Medical Association said that women’s “psychological condition during part of the month disqualifies them from being doctors.” Only in 1945 did the Harvard Medical School remove a ban on accepting female medical students. In 1977, FDA guidelines excluded “women of childbearing potential” (meaning the ability to become pregnant) from taking part in Phase 1 and Phase 2 clinical trials. Sixteen years later, the US National Institutes of Health issued a requirement to include women in all 93, NIH issues requirement to NIH-sponsored clinical trials, but, said Biegon, “many drug companies ignore this. But things are changing: Last year, the NIH issued a mandate to consider sex as a ‘biological variable’ in all research it funds.” Today, there are a growing number of organizations, professional societies, journals and hospital-based centers dedicated to research and sex differences in medicine. Still, said Biegon, the “vast majority of medical research today is on males, except for breast cancer and some multiple sclerosis trials. We still don’t know how various drugs affect the fetus and women in pregnancy. Fertile women suffer from allergic, cardiovascular system, skin, endocrine, immune, infectious, respiratory, pain, urogenital and many other conditions, and automatically, doctors say they are not considered safe in pregnancy. “The drug packages say: ‘Consult your doctor about use in pregnancy,’ but what does the doctor know if there are no clinical trials? Sick women do get pregnant, and pregnant women do get sick. They have no access to evidence-based medical care.” Such women, she continued, “need medications, but they can hardly be given to them due to lack of study. A sick mother is not good for a fetus. If you’re taken off medication because it may harm fetus and then have epileptic seizures, your fetus can suffer from fetal bradycardia [very slow heartbeat] and other serious problems.” But “many women who are pregnant and have epilepsy are, despite warnings, still taking drugs for the condition, so they should be included in randomized clinical trials to compare them with men. One can do MRI scans of infants and see any effects of the drugs on the fetus and identify blood in the brain. You don’t have to wait for the birth to see any effects. If you see a problem, you can deal with it in utero in prenatal surgery; for example, one can operate in the uterus on fetuses with spina bifida, for example.” Biegon concluded that medical schools have to teach students differently so they can appreciate sex differences in medicine. “At my school, we will soon start a course on gender- based medicine for fourth-year students.” http://www.jpost.com/Business-and-Innovation/Health-and-Science/When-gender-makes-a-difference-444090
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