Birch Bark Derivative Effective for Epidermolysis Bullosa

A gel derived from birch bark is the first topical medication ever tested in the treatment of epidermolysis bullosa (EB) to heal wounds faster than placebo. The results come from the largest double-blind, randomized trial performed in this patient population.

More than 41% of EB target wounds that were treated with Oleogel-S10 healed within 45 days, compared to about 29% of target wounds treated with placebo, in the EASE phase 3 trial, conducted at 58 sites in 28 countries.

Dr Dedee Murrell

A group of rare genetic disorders, EB “is described as the worst disease you’ve never heard of,” explained lead investigator Dedee Murrell, MD, from St. George Hospital at the University of New South Wales, Sydney, Australia. “It starts in children and is like having burns that heal with scars, and no treatment has been approved for it” by the US Food and Drug Administration (FDA).

“This is the first large clinical trial with placebo of a topical treatment that’s worked for this terrible disease,” Murrell told Medscape Medical News. She noted that standard EB treatment currently consists of applying nonstick dressings to wounds to protect skin from trauma and infection.

Murrell, who has focused her work on EB patients since 1990, presented the findings at the virtual European Academy of Dermatology and Venereology (EADV) Congress 2020.

The trial enrolled 223 patients (average age, 12 years, but ages ranged to 81 years) with three types of EB, including dystrophic and junctional EB and Kindler syndrome. For each participant, a target wound was selected for use as the primary efficacy endpoint. Those wounds had a partial thickness of between 10 cm2 and 50 cm2 and lasted between 21 days and 9 months. Patients were stratified into groups depending on type of EB and size of target wound.

Participants were randomly assigned to receive either Oleogel-S10 (n = 109) or placebo (n = 114). All applied the blinded study gel to all their wounds at least every 4 days at the time dressings were changed.

The primary endpoint was the percentage of patients whose target wounds completely closed within 45 days. Key secondary endpoints included time to wound healing and percentage of target wounds that healed within 90 days of treatment; incidence and severity of target wound infection; change in total body wound burden, as measured by the Epidermolysis Bullosa Disease Activity and Scarring Index skin activity subscore; change in itching, as measured by the Itch Man Scale and the Leuven Itch Scale; and adverse events.

Nearly 92% of patients who were treated with Oleogel-S10 completed the double-blind phase of the trial, compared with nearly 87% who received placebo. As noted, the primary endpoint was met, with 41.3% of Oleogel-S10 patients achieving target wound closure within 45 days, compared to 28.9% of the patients who received placebo (P = .013).

But the difference in time to wound healing by day 90 between the two patient groups was not statistically significant (P = .302), with 50.5% of

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Any ‘Natural’ Products Effective for Migraine?

Butterbur for Migraine Prophylaxis

Use of butterbur is more controversial than riboflavin. A randomized, parallel-group study involving over 200 patients found that the group given butterbur had a response rate of 45%, three times better than the response found with placebo. Another randomized controlled trial, this one involving only 33 patients, examined efficacy of butterbur as prophylaxis. Similarly, this study concluded that butterbur reduced the frequency of migraines by 48% in the experimental group, almost double the reduction found in the control group.

A multicenter, open-label trial in just over 100 kids aged 6-17 years found similar results. About three quarters of participants experienced at least a 50% reduction in headache frequency. No serious adverse events were reported.

The most common side effect, reported by 7%, was eructation.

That does not mean that these products are risk-free. Some butterbur products may contain pyrrolizidine alkaloids (PAs) — a major safety concern. According to the National Center for Complementary and Integrative Health (NCCIH), PAs can damage the liver and lungs, and possibly cause thrombosis and cancer. Patients should be counseled to look for products that are PA-free. One caveat, however: The NCCIH notes that those products may not, in fact, really be PA-free. Butterbur should not be taken by pregnant or breast-feeding women.

The 2012 American Headache Society and the American Academy of Neurology guideline stated that the product had level A evidence for use and was a valid option for patients with migraine. However, the recommendation was questioned owing to reported safety concerns and has now been retracted.

Vitamin E for Menstrual Migraine

Although the woman in this case did not report that her headaches were triggered by menstruation, menstrual migraine is another common variant often seen in primary care. Menstrual migraine is associated with increased prostaglandin levels in the endometrium. Does that mean there is a role for vitamin E, an antiprostaglandin, in prophylaxis?

A placebo-controlled, double-blind, crossover trial involving 72 women with headache associated with menses evaluated the efficacy of vitamin E. The women received placebo for 5 days around menses for two cycles. After a washout period, they were then given vitamin E, 400 units daily, for an additional two cycles. During the vitamin E phase, the women reported a decline in pain severity and functional disability (P < .001). Less phonophobia, photophobia, and nausea were reported during the time taking vitamin E.

Vitamin E is generally safe at dosages up to 5500 IU/d. It is also well-tolerated, particularly when taken short term, as would be the case with menstrual migraine.

Douglas S. Paauw, MD, is the Rathmann Family Foundation Endowed Chair in Patient-Centered Clinical Education and a professor of general internal medicine at the University of Washington. He was elected to Mastership in the American College of Physicians (ACP) in 2009. He is a frequent lecturer at the ACP annual meeting, presenting yearly standing-room-only lectures on drug interactions and medical myths.

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Milwaukee’s New Order Effective Thursday

MILWAUKEE,WI— The Milwaukee Health Department is revising its COVID-19 orders, putting additional restrictions on gatherings, bars and restaurants, sports, and activities that can play a role in the spread of the disease, according to a media release from the city.

“As we evaluate the metrics the Milwaukee Health Department monitors, it is clear we have entered a more dangerous period of COVID-19 infections,” Interim Health Commissioner Marlaina Jackson said. “It is important that we take additional steps to protect the people of Milwaukee. Our goal is to get the indicators and gating criteria to head back in the right direction so we can move forward with reopening and moving Milwaukee forward.”

Significant changes in the order include the following:
 Public gathering limits will reduce occupancy to 25% of a site’s capacity and reduce the maximum number of people at an indoor event to 10 people, not including employees. Seating is required. The maximum number for outdoor events is 25 people. Religious and political events are subject to gathering limits of 100 people who are required to be seated.
 Restaurant and bar occupancy is restricted to 25% for those without a COVID Safety plan approved by the City of Milwaukee Health Department, and all patrons must be seated except when arriving, departing or walking to restrooms. Dance floors are prohibited.
 Team sports are restricted to intra-squad or intra-school events unless a Milwaukee Health Department approved safety plan is in place. A safety plan requires COVID-19 testing at least once every three days. If a plan has been previously submitted, it must be resubmitted with details related to the testing procedures.
 City of Milwaukee school’s COVID Safety will continue to be monitored by the City of Milwaukee
Health Department. Movement between instructional models will be made on an individual school
basis by the Health Department.

The new order is effective Thursday, October 29, 2020.

This article originally appeared on the Milwaukee Patch

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Pandemic may be making it harder for pregnant women who use opioids to get effective treatment

Opioid use in pregnancy has prompted new guidance from the American Academy of Pediatrics aimed at improving care for women and for newborns affected by their mothers’ drug use.

The number of affected women and infants has increased in recent years but they often don’t get effective treatment, and the coronavirus pandemic may be worsening that problem, said Dr. Stephen Patrick, lead author of the academy report released Monday.

“While we have been talking about the opioid crisis for years, pregnant women and their newborns seldom make it to the top of the heap. Infants are receiving variable care and not getting connected to services,” said Patrick, a Vanderbilt University pediatrician.

The academy’s report says pregnant women should have access to opioid medication to treat opioid misuse. Two opioids, buprenorphine and methadone, are effective treatments but pregnant women often face stigma in using them and doctors who prescribe them are scarce.

The academy says hospitals should have written protocols for assessing and treating opioid-affected newborns. Many don’t and practices vary widely.

Breastfeeding and other practices that promote bonding should be encouraged, and parent education and referral to services for affected newborns should be provided, the academy says. Its recommendations echo guidance from other medical groups and the U.S. government.

“This is a substantial public health problem that is still lacking solutions,” Patrick said.

According to the federal Centers for Disease Control and Prevention, 7% of U.S. women reported in 2019 that they had used prescription opioids during pregnancy. One-in-five of those women reported misusing the drugs while pregnant.

Some infants born to these women develop symptoms of opioid withdrawal, including tremors, fussiness and diarrhea.

By some U.S. estimates, nearly 80 affected infants are diagnosed every day and the numbers have tripled in recent years.

Patrick has done research suggesting that these infants may be at risk for developmental delays but says it’s possible those findings reflect use of alcohol or other drugs during pregnancy, poor prenatal care or stress.

“Getting into treatment may be getting even harder” because of the pandemic, he said. “There’s so much going on in the world that that issues involving opioid use are flying under the radar.”

Source Article

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How Effective Will Uber South Africa’s New Medicine Delivery Service Actually Be?

Why Global Citizens Should Care

Global Citizen campaigns on the UN Global Goals, including Goal 3 for good health and well-being, which is aimed at promoting access to quality health care for all people. This goal cannot be achieved if medication and health care remains out of reach for so many around the world. Join us and take action on this issue here. 

Uber South Africa recently announced a partnership with Medicare, a health care and pharmacy group, to launch the delivery of over-the-counter medication using the Uber Eats app. 

But as groundbreaking as this announcement may sound, the service may well leave a lot of South Africans out of the picture. 

Because of the partnership, South Africans can now order schedule 1 and 2 medicines (meaning medication that is available for purchase without a prescription) for delivery to their door. This comes after the success that Uber Eats has had with its grocery delivery service that was launched during the national COVID-19 lockdown.  

Medicare CEO Tim Knapp went on to say in a statement that the partnership is just the beginning and the company would continue to find ways to prioritise convenience. “We strongly believe in reinventing pharmacy, and thanks to this partnership with Uber Eats this is made possible,” he said. 

Access to medicine is an obstacle for many South Africans. While the government has worked to make essential medicines more affordable, the poorest citizens live the furthest away from health care facilities. This means that a lot of their time and money is spent on transport to get to clinics and pharmacies, or they simply cannot afford the transport in the first place. 

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While safe access to medication is crucial in a time when South Africans have been encouraged to limit their movements, the introduction of this new delivery service may not make that big of a difference in most South Africans’ lives. Here’s why: 

Medicine delivery services already exists

The delivery of medicine is not a new concept in South Africa. Retail pharmacy giants Clicks and Dischem have been delivering medicine long before the pandemic. The difference is that both pharmacies administer prescribed chronic medication for delivery rather than the over-the-counter medicine Uber Eats will be looking to provide. 

Clicks and Dischem also work to provide patients with reminders that their medication will be delivered at a certain date or that they require a new prescription. 

In contrast, the purpose of the Uber Eats service is for South Africans to order medicine on the app as and when they need it, which works within the context of the company whose main service is to deliver food to people as and when they are hungry. 

Uber Eats is also not the first food delivery app to offer the service in South Africa. Mr Delivery teamed up with retail grocery store Checkers earlier this year to offer the delivery of medicine from

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A Manatt Health Report Analyzing Effective Strategies from Medicaid Managed Care States

Comprehensive review of state managed care contracts and 1115 waivers detail effective SDOH integration strategies

Manatt, Phelps & Phillips, LLP, a multidisciplinary, integrated professional services firm, announced today the release of its latest survey, which provides a comprehensive review of states’ social determinants of health (SDOH) initiatives through Medicaid managed care contracts and 1115 waivers. The report, titled “In Pursuit of Whole Person Health: A Review of Social Determinants of Health (SDOH) Initiatives in Medicaid Managed Care Contracts and 1115 Waivers,” was conducted by Manatt Health, the firm’s healthcare legal and consulting group. With Medicaid being the largest payer of healthcare for the low-income populations that are disproportionately impacted by social and economic challenges, this report takes a deep dive into the ways states can effectively integrate SDOH into the Medicaid delivery system and leverage 1115 waivers to foster innovation.

“This pandemic—and its disproportionate impact on low-income communities and communities of color—has brought the need to address SDOH into sharp focus,” said Melinda Dutton, partner with Manatt Health, who coauthored the report alongside director Naomi Newman, manager Mandy Ferguson and partner Cindy Mann. Newman added: “Our report serves as a resource for states, health plans, provider organizations and other stakeholders looking to improve overall health for their most vulnerable populations.”

This report details how states are using their Medicaid managed care contracts and 1115 waivers to address unmet social needs and drive innovation in this space. Through an in-depth review of the contracts of each state and territory with Medicaid managed care (41 in total), Manatt identified the provisions and subsequent intervention methods related to SDOH, and categorized them by type of service or intervention (e.g., screening and referral requirements, quality metrics); targeted populations (e.g., pregnant women, children, people experiencing homelessness); and targeted domains (e.g., housing, food/nutrition, employment).

An infographic to help illustrate the findings can be found here. The full report, including detailed state profiles with contract language, can be located through a subscription to [email protected] Health, an original content information service providing a wide range of premium analysis and data on breaking industry news and trends; in-depth evaluation of state and federal health policy changes; detailed summaries of Medicaid, Medicare and Marketplace regulatory and sub-regulatory guidance; and 50-state surveys on critical industry issues.

This report was compiled through an analysis of the contracts and 1115 waivers of each of the 41 states and territories with Medicaid managed care conducted between October 2019 and June 2020. In certain instances when states’ managed care organization (MCO) model was not released, Manatt utilized the state’s MCO “request for proposals” to understand the scope of SDOH-related requirements on plans. Of the 41 states and territories, two requested that their profiles be withheld from this publication due to ongoing MCO procurements and contract amendments.

About Manatt, Phelps & Phillips, LLP

Manatt, Phelps & Phillips, LLP, is a leading professional services firm, providing integrated legal and consulting services to a global client base. With offices strategically located in California (Los Angeles, Orange

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Relugolix Combo Effective for Uterine Fibroids Through 1 Year

A combination therapy using the experimental drug relugolix was effective in treating pain and heavy bleeding from uterine fibroids for a full year, according to findings from a long-term extension study of the phase 3, open-label LIBERTY trials.

Dr Ayman Al-Hendy

The drug was also well tolerated, with retention of bone mineral density and no new adverse events, said Ayman Al-Hendy, MD, PhD, who presented the results October 17 at the virtual American Society for Reproductive Medicine (ASRM) 2020 Scientific Congress.

“Relugolix combination therapy represents a potential long-term treatment for women with heavy menstrual bleeding associated with uterine fibroids,” said Al-Hendy, a gynecologist and endoscopic surgeon at the University of Chicago, in Illinois.

Al-Hendy, who consults for the company that makes the drug, on October 20 presented results showing improvement in quality of life with relugolix therapy.

“The fact that this longer-term study shows continued, persistent results at a year really gives us confidence that we’ll be able to use these drugs as a long-term therapy to treat fibroids,” Hugh S. Taylor, MD, president-elect of ASRM, told Medscape Medical News. Taylor, a professor and chair of ob-gyn and reproductive sciences at the Yale School of Medicine, New Haven, Connecticut, was not involved in the study.

“A drug like this is so necessary,” Taylor continued. “We don’t have any other drugs on the market approved for long-term use.”

Relugolix is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist under investigation for long-term management of uterine fibroids. The once-daily combination therapy includes 40 mg relugolix, 1 mg estradiol, and 0.5 mg norethindrone acetate.

Extension Study Shows Prolonged Benefits

The extension trial enrolled women aged 18 to 50 years who were experiencing heavy menstrual bleeding from uterine fibroids and who completed the 24-week phase 3, double-blind, placebo-controlled LIBERTY 1 or 2 trials. Heavy menstrual bleeding was defined as bleeding in which at least 80 mL of blood was lost per cycle for two cycles or 160 mL was lost during one cycle. Ultrasound imaging was used to confirm the presence of fibroids.

In LIBERTY 1 and 2, women were randomly assigned to receive relugolix combination therapy, placebo, or relugolix alone for 12 weeks followed by combination therapy for the remaining 12 weeks (delayed group). Those trials found that relugolix combination therapy was effective through 6 months in reducing menstrual blood loss and pain in women with uterine fibroids without loss of bone mineral density.

LIBERTY 3 extended the trial to 52 weeks, with all participants receiving relugolix combination therapy.

As in the earlier trials, the primary endpoint was reduced menstrual blood loss. By the end of the study, women needed to have at least a 50% reduction in blood loss from the initial study’s baseline while maintaining a blood loss of <80 mL. The investigators also evaluated the mean percentage of menstrual blood loss reduction, amenorrhea rate, and improvements in anemia as secondary endpoints and assessed changes in bone mineral density.

The extension study enrolled 78% (n = 477) of the 610 women

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Feinstein Institutes researchers find effective COVID-19 ‘cytokine storm’ treatment

Some immune systems have responded to coronavirus disease 2019 (COVID-19) infections by going into overdrive, resulting in an overzealous inflammatory response referred to as a cytokine storm. In a retrospective study of nearly 6,000 patients, researchers from The Feinstein Institutes for Medical Research and Northwell COVID-19 Research Consortium have identified the most effective immunomodulatory therapies to treat patients with evidence of this cytokine storm and improve patient survival.

This press release features multimedia. View the full release here:

Dr. Negin Hajizadeh and colleagues. (Credit: Feinstein Institutes for Medical Research)

A multidisciplinary team of investigators, led by Negin Hajizadeh, MD, a pulmonary and critical care physician, and associate professor at the Feinstein Institutes, analyzed the electronic health records of hospitalized COVID-19 patients across 12 of Northwell Health hospitals – New York State’s largest health system – between March 1 and April 24, 2020. The results were published today in CHEST, by Sonali Narain, MD, assistant professor at the Feinstein Institutes, corresponding author, and team.

Patients were divided into one of six groups; no immunomodulatory treatment (standard of care), patients who received intravenous corticosteroids, anti-interleukin 6 antibody therapy (tocilizumab) or anti-interleukin-1 therapy (anakinra) alone or in combination with corticosteroids.

The results show that the most effective treatment was the combination of corticosteroids – such as dexamethasone – with tocilizumab when compared to standard of care. Additionally, there was an improvement if corticosteroids were used alone, or in combination with tocilizumab or anakinra when compared with standard of care.

“Cytokine storms are a hallmark for many COVID-19 patients and are associated with the most severe form of this illness,” said Dr. Hajizadeh, associate professor at the Zucker School of Medicine at Hofstra/Northwell and co-senior author on the paper. “Our findings suggest that with the intervention of certain drugs like corticosteroids, we can battle the cytokine storm and improve outcomes to the point that we believe we have found a new standard of care for seriously ill patients.”

Overall, there were twice as many males as females in the cohorts, and more than 65 percent had never smoked. Contradictory to previous reports, the Black population was associated with better survival compared to white patients. Additionally, the most common comorbidities across the groups of patients that experienced a cytokine storm include:

  • Hypertension (44-59 percent);

  • Diabetes (32-46 percent);

  • Cardiovascular disease (5-14 percent);

  • Chronic kidney disease (5-12 percent);

  • Cancer (5-11 percent);

  • Asthma (3-12 percent).

“Dr. Hajizadeh’s major COVID-19 research study gives timely and crucial new knowledge about using currently available anti-inflammatory drugs,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes. “This information will help others save lives.”

The researchers hope that the findings are useful for frontline providers to care for severely ill COVID-19 patients and to aid in the future design of large randomized controlled clinical trials, the gold standard of medical research.

About the Feinstein Institutes

The Feinstein Institutes for Medical Research is the research arm of Northwell Health, the largest health care provider and private employer

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19 | How laughter may be effective medicine for these trying times

a person wearing a costume: COVID-19 | How laughter may be effective medicine for these trying times

© Jocelyn Fernandes
COVID-19 | How laughter may be effective medicine for these trying times

Some enlightened doctors, nurses and therapists have a prescription for helping all of us to get through this seemingly never-ending pandemic: Try a little laughter.

Humor is not just a distraction from the grim reality of the crisis, said Dr. Michael Miller, a cardiologist at the University of Maryland School of Medicine in Baltimore. It’s a winning strategy to stay healthy in the face of it.

“Heightened stress magnifies the risk of cardiovascular events, including heart attacks and strokes,” Miller said. “Having a good sense of humor is an excellent way to relieve stress and anxiety and bring back a sense of normalcy during these turbulent times.”

Laughter releases nitric oxide, a chemical that relaxes blood vessels, reduces blood pressure and decreases clotting, Miller said. An epidemiological study of older men and women in Japan confirmed that those who tend to laugh more have a lower risk of major cardiovascular illness. Possessing a healthy sense of humor is also associated with living longer, an epidemiological study from Norway reported, although the correlation appears to be stronger for women than for men.

Armed with this growing body of research, Miller prescribes “one good belly laugh a day” for his patients. It’s not just going “ha, ha,” he explained, but a “deep physiological laugh that elicits tears of joys and relaxation.”

While the long-term impacts of such a practice remain unknown, Sophie Scott, a neuroscientist at University College London, said that laughter has been shown to reduce the stress hormones cortisol and adrenaline and increases the body’s uptake of the feel-good endorphins.

There also appear to be cognitive benefits. Watching a funny video was tied to improvements in short-term memory in older adults and increased their capacity to learn, research conducted by Dr. Gurinder Singh Bains of Loma Linda University found.

Perhaps most relevant today, possessing a sense of humor also helps people remain resilient in the face of adverse circumstances, said George Bonanno, a professor of clinical psychology at Columbia University.

In one study, Bonanno interviewed young women who had been sexually abused and noted their facial expressions. “Those who managed to laugh or smile at moments during their interview were more likely to be doing better two years later than those who had not,” he said. “Humor keeps negative emotions in check and gives us a different perspective, allowing us to see some of the bad things that happen to us as a challenge rather than a threat.”

Humor and tragedy may be more intimately connected than one would think.

“Charlie Chaplin once said ‘In order to truly laugh you need to be able to take your pain and play with it,’” said Paul Osincup, the president of the Association for Applied and Therapeutic Humor. “Write down all of the most difficult and annoying things about quarantine,” Osincup recommends. “Play with those. See if you can find any humor in your situation.”

Megan Werner, a

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Coronavirus Testing Delays Still Prevent Effective Disease Control, Survey Finds : Shots

People wait in the shade while in line to get Covid-19 tests in Revere, MA.

David L. Ryan/Boston Globe via Getty Images

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David L. Ryan/Boston Globe via Getty Images

People wait in the shade while in line to get Covid-19 tests in Revere, MA.

David L. Ryan/Boston Globe via Getty Images

People are getting the results of coronavirus tests in the U.S. faster than they were in the spring, but testing still takes far too long to help effective disease control measures such as contact tracing and quarantining, according to the results of a large national survey.

The survey, which is conducted monthly by a consortium of researchers from Northeastern, Northwestern, Harvard and Rutgers universities, also finds that Hispanics and African-Americans are waiting about a day longer than whites on average, underscoring yet another way the pandemic is hitting minorities harder.

The researchers also found that a disturbingly high proportion of those testing positive — almost half — are never contacted by a health worker to determine who they may have infected, a crucial step for preventing outbreaks.

“That is how you limit the spread of the disease and limit the number of people who have to socially isolate and avoid lockdowns,” says Dr. David Lazer of Northeastern University, who led the team conducting the survey. “The good news is there has been some improvement. The bad news is everything is still taking far too long.”

The researchers surveyed 52,329 people in all 50 states and the District of Columbia in July, August and September as part of a series of ongoing surveys the team has been conducting since April.

Of those surveyed, 12,911 got a coronavirus test, including 8,843 whose sample was collected with a nasal swab.

Among that group, the average wait time for results was 2.7 days in September, down from four days in April, the researchers found. In addition, the proportion of people getting their results back within 24 hours increased from 23% to 37%.

While that’s an improvement, the turnaround time is still “too slow in most cases to support a successful strategy of contact tracing,” and most people are still waiting far too long, the researchers wrote.

“Despite decreased average wait times, a substantial proportion of Americans still endure long waits,” they added.

They noted that in September, 42% of those tested had to wait at least three days before getting their results.

The average black respondent waited 4.4 days to receive results and the average Hispanic respondent waited 4.1 days. In comparison, white and Asian American respondents respectively waited an average of 3.5 and 3.6 days, the researchers found.

“We know that African-Americans and Hispanics are underserved medically,” Lazer says. “This is reflective of that larger reality. It’s terrible.”

To keep outbreaks from occurring, people who are infected need to be contacted quickly, ideally within 24-36 hours to make sure they don’t infect other people and find out who they may have come into contact with so those people

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