Tocilizumab in Critical COVID-19 Patients

A new study by scientists at Metro Infectious Disease Consultants and published on the preprint server medRxiv* in June 2020 reports that the cytokine blocker tocilizumab is a useful adjunct to supportive medical care in severe COVID-19, with increased survival and a lower requirement for mechanical ventilation.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel coronavirus that emerged in China towards the end of the year 2019 but rapidly spread worldwide to become a pandemic. As many as 20% of patients progress to severe disease, and up to 10% may die of terminal respiratory failure secondary to acute respiratory distress syndrome (ARDS). This percentage varies with the population segment affected, with the highest risk being seen among older adults and those with other medical conditions such as type 2 diabetes, obesity, and hypertension.

Study: Tocilizumab as a Therapeutic Agent for Critically Ill Patients Infected with SARS-CoV-2. Image Credit: Wirestock Images / Shutterstock

Wide Range of Symptoms

The spectrum of illness with COVID-19 varies from asymptomatic or mild symptomatic infection in the majority of cases to progressive pulmonary impairment with a pneumonia-like picture, and finally to rapid multi-organ dysfunction with ARDS and cardiovascular collapse. During this stage, the levels of multiple inflammatory cytokines and markers are raised, including IL-2, IL-6, C-reactive protein (CRP), ferritin, D-dimer, and lactate dehydrogenase (LDH).

Tocilizumab – Possible Immunomodulator in COVID-19

There is no specific treatment or vaccine strategy as of now that is effective against SARS-CoV-2. However, the IL-6 blocker tocilizumab has been explored as a possible therapy for immunomodulation, to mute the so-called cytokine storm, the excessive and damaging rise in pro-inflammatory cytokines, in the final stage of severe COVID-19.

This drug is already approved for the treatment of rheumatoid arthritis and the cytokine release syndrome associated with the CAR-T cell treatment of cancer patients. This last condition is very similar to the pathogenesis of the cytokine storm in severe COVID-19 and justifies the experimental use of tocilizumab in the latter stage.

At present, tocilizumab is used at 4-8 mg/kg (max: 800mg per dose) intravenous infusion, repeated once if necessary. The current study was designed to find the actual benefit and the optimal regimen for this drug in COVID-19 patients with the most severe illness.

Study on Tocilizumab Timing and Benefits

The study was made up of 157 patients who were admitted to hospital between March 13, 2020, and April 16, 2020. A retrospective study was done using medical records from multiple practices to retrieve the age, sex, duration of hospital stay, need for mechanical ventilation, the use of steroids and other drugs, and remdesivir. The presence and type of comorbidity were also analyzed, including risk factors like age above 60 years, diabetes, chronic obstructive pulmonary disease, bronchospasm, chronic cardiac or renal disease, immunodeficiency, and cancer.

The dose of tocilizumab was registered as early or late, depending on whether it was given before or within a day after intubation, or later than this, respectively. If the patient was not intubated, the dose was related to the date of admission. The patient outcomes included discharge from hospital, death, or continued hospitalization.

Related Stories

The average patient age was 58 years, and 65% were male. About 40% and 30% were White and Black, respectively, with 22% being Hispanic and a small percentage of Asians. 69% had other illnesses. All patients had raised inflammatory markers on admission.

Steroids were given to 60%, and 99% received hydroxychloroquine and azithromycin. About 85% of patients were given one dose of tocilizumab, and 15% had two doses 12 hours apart. The majority received 4 mg/kg, up to 400 mg in total, while nine patients received 600 or 800 mg.

56% of patients required mechanical ventilation, with 37 receiving tocilizumab early and 44 late.

Among discharged patients (48%), the hospital stay lasted about 15 days. In those who died (28%), it was 16 days and 29 days for those still in hospital at the end of the study period (24%). The highest mortality was among Blacks, at about 44%.

Early Tocilizumab Helps More Patients Recover Faster

Analysis of the use of ventilators in relation to the timing of tocilizumab from the date of admission, the use of steroids, and demographic factors, showed that with each day of delay from the day of admission, the chances of requiring mechanical ventilation went up by a fifth.

In patients who required mechanical ventilation, the timing of tocilizumab was related to the mortality, with a lower mortality rate among those who received the tocilizumab earlier, compared to later dosing (14% v 868%) after accounting for demographic differences. The rate of discharge was also significantly higher in the early-tocilizumab group, at 60%, compared to 18% in the late tocilizumab group of patients.

Among the 81 patients who were put on mechanical ventilation and then discharged, tocilizumab was given early, about 4.2 days from admission, and within a day of intubation. Those who died received the drug about 4 days from intubation and about 5.5 days from admission.

The time from intubation to dosing was the only predictor for discharge following intubation. Again, later tocilizumab administration increased the odds of death in mechanically ventilated patients by 18-fold compared to earlier administration. Among early-tocilizumab patients, non-whites were 6 times more likely to die than whites.

Among those on steroids, 44% were discharged, and 35% expired. There were 25 patients on steroids and mechanical ventilation who died, compared to 15 who were discharged.

Among those who had two doses of tocilizumab, half were intubated. Half were discharged, 23% died, and 32% were still in hospital at the time of analysis. When those who chose not to be put on ventilation via living wills, about 14% of whites and 32% of non-whites died, focusing attention on the continuing but little understood tendency for non-whites to have higher mortality.

Implications

Despite the observational nature of the study, some conclusions were arrived at. Severe drug reactions were rare. However, the use of multiple drugs made it almost impossible to disentangle the effects of any individual drug. This mandates further research with randomized studies.

The study sums up: “While the optimal time to dose tocilizumab has not been previously established, our data strongly support a mortality benefit of dosing tocilizumab early and within 1 day of intubation. Accordingly, we strongly encourage the use of this agent earlier in the COVID-19 treatment spectrum.”

*Important Notice

medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.

Journal reference:

Visit the Source Site

Powered by WPeMatico

U.S. coronavirus cases now over 2 million: Reuters tally

FILE PHOTO: Gavin Roberts wears his father’s police hat as he looks at the flag-draped casket of his father, Glen Ridge Police Department officer Charles Roberts, at his funeral service, after the 45-year-old father of three died of the coronavirus disease (COVID-19) in Glen Ridge, New Jersey, U.S., May 14, 2020. REUTERS/Mike Segar/File Photo

(Reuters) – Total U.S. coronavirus cases surpassed 2 million on Wednesday, according to a Reuters tally, as health officials urge anyone who took part in massive protests for racial justice to get tested.

Nationally, new infections are rising slightly after five weeks of declines, according to a Reuters analysis. Part of the increase is due to more testing, which hit a record high on June 5 of 545,690 tests in a single day but has since fallen, according to the COVID-Tracking Project https://covidtracking.com.

Recent increases in cases are likely a result of more people moving about and resuming some business and pleasure activities as all 50 states gradually reopen. Huge nationwide protests with no social distancing after the May 25 the death of George Floyd at the hands of Minneapolis police could lead to another spike in cases in coming weeks.

Health officials believe the first U.S. coronavirus cases appeared in January, and the nation recorded 1 million cases by April 28. So far in June, there have been an average of 21,000 new cases a day compared with an average of 30,000 a day in April and 23,000 a day in May, according to a Reuters tally.

Total U.S. coronavirus-related deaths have surpassed 112,000, also the most in the world.

On May 12, the World Health Organization (WHO) advised governments that before reopening, the rate of people testing positive for the coronavirus should remain at 5% or lower for at least 14 days.

U.S. rates of positive test results have fluctuated between 4% and 7% nationally and have not met those guidelines, although many individual states have. (Open tmsnrt.rs/2WTOZDR in an external browser for a Reuters interactive)

Some states were still reporting positive rates above the WHO threshold last week, with Maryland at 8%, Utah at 9%, Nebraska at 9%, Virginia at 9%, Massachusetts at 11% and Arizona at 12%.

At the peak of the outbreak in April, 25% to 50% of tests came back positive.

Writing by Lisa Shumaker; Editing by Bill Berkrot

Our Standards:The Thomson Reuters Trust Principles.

Visit the Source Site

Powered by WPeMatico

Exclusive: Lilly COVID-19 treatment could be authorized for use as soon as September – chief scientist

(Reuters) – Eli Lilly and Co could have a drug specifically designed to treat COVID-19 authorized for use as early as September if all goes well with either of two antibody therapies it is testing, its chief scientist told Reuters on Wednesday.

Lilly is also doing preclinical studies of a third antibody treatment for the illness caused by the new coronavirus that could enter human clinical trials in the coming weeks, Chief Scientific Officer Daniel Skovronsky said in an interview.

Lilly has already launched human trials with two of the experimental therapies.

The drugs belong to a class of biotech medicines called monoclonal antibodies widely used to treat cancer, rheumatoid arthritis and many other conditions. A monoclonal antibody drug developed against COVID-19 is likely to be more effective than repurposed medicines currently being tested against the virus.

Skovronsky said the therapies – which may also be used to prevent the disease – could beat a vaccine to widespread use as a COVID-19 treatment, if they prove effective.

“For the treatment indication, particularly, this could go pretty fast,” he said in an interview. “If in August or September we’re seeing the people who got treated are not progressing to hospitalization, that would be powerful data and could lead to emergency use authorization.”

“So that puts you in the fall time: September, October, November is not unreasonable,” he said.

Coronavirus vaccines being developed and tested at unprecedented speed are not likely to be ready before the end of the year at the earliest.

Earlier this month, Lilly announced it had initiated patient testing for two separate antibody treatments. One currently designated LY-CoV555 is being developed in partnership with Canadian biotech AbCellera. The other, JS016, it being developed with Chinese drugmaker Shanghai Junshi Biosciences.

Both work by blocking part of the virus’ so-called spike protein that it uses to enter human cells and replicate.

Lilly’s third antibody treatment candidate acts on a different part of the virus and will most likely be tested in combination with one or both of the others, Skovronsky said.

The drugmaker, however, said it has a strong preference to develop a treatment that can work well in COVID-19 patients as a stand alone, as manufacturing these type of drugs, which are typically administered by infusion, is a complex process and capacity is limited.

“It’s good to have two antibodies. The downside is that manufacturing is precious. We have limited manufacturing capacity. If two antibodies are required, half as many people will get treated,” Skovronsky said. “So our goal is to see if we can do one antibody at as low a dose as possible.”

Lilly is continuing to screen for antibodies through its partnership with AbCellera, which is working with the U.S. National Institutes of Health to identify promising compounds, he added.

Reporting by Michael Erman and Carl O’Donnell; Editing by Bill Berkrot

Our Standards:The Thomson Reuters Trust Principles.

Visit the Source Site

Powered by WPeMatico

Immuno-oncology may accelerate the development of treatments for COVID-19

Researchers at Roswell Park Comprehensive Cancer Center have been actively engaged in the effort to develop treatments or other control strategies that can help communities worldwide to address the impacts of the COVID-19 pandemic.

Because viruses such as SARS-CoV-2 and tumors both interact with the immune system, trying to evade both innate and adaptive immunity, expertise in immunotherapy of cancer is deeply relevant in fighting COVID-19.

“For decades, some of the most important and influential advances in treating cancer came from our understanding of infectious diseases and in particular from virology, the study of viruses,” notes Roswell Park’s Pawel Kalinski, MD, Ph.D., Vice-Chair for Translational Research and Rustum Family Professor for Molecular Therapeutics and Translational Research, lead developer of one of these new COVID-19 treatment strategies.

“Now, those of us working in immuno-oncology may have the opportunity to return the favor and to accelerate the development of treatments for COVID-19 and other infectious diseases.”

The opportunity to apply what we know about cancer as we seek a way to treat COVID-19 hinges on the tools that help our bodies to find and destroy cancer.

“The defense mechanisms that allow cancer cells to go undetected sometimes are similar to how viruses hide from the immune system. So applying what we know from virology can help us to identify and exploit weaknesses in SARS CoV-2, the virus that causes COVID-19,” says Igor Puzanov, MD, MSci, FACP, Professor of Medicine, Director of Early Phase Clinical Trials, Co-Leader of the Developmental Therapeutics Program and Chief of the Melanoma Section in the Department of Medicine.

Dr. Puzanov, who has been working closely with doctors from Catholic Health and the University at Buffalo (UB) as well as colleagues from Italy and China to make some of the most promising COVID-19 therapies available to patients in and around Western New York, catches us up on these various research efforts.

Sarilumab: New role for anti-inflammatory?

The first investigational treatment for COVID-19 to become available in the Buffalo area was the anti-inflammatory agent sarilumab (also known as Kevzara).

Doctors believe the drug, approved for use by the FDA for moderate to severe rheumatoid arthritis and also as a treatment for lupus, might also help fight inflammation in the lungs -; like that experienced by people suffering from COVID-19 infections.

Dr. Puzanov is the Principal Investigator of a local collaborative group of Roswell Park and UB researchers participating in a national phase 2/3 trial with sarilumab, enrolling close to 2,000 patients to determine how effective sarilumab may be as a treatment for patients with severe or critical COVID-19.

“This treatment builds on work conducted in China and Italy, where doctors used a similar drug, tocilizumab, with positive results,” says Dr. Puzanov, co-author of a recent editorial in the journal Translational Medicine on the potential for using tocilizumab and sarliumab as a treatment for COVID-19.

We need more data before we can draw firm conclusions, but we’re hopeful that anti-inflammatory drugs like these can help minimize the possibility of long-term lung damage and reduce the amount of time a person may need to be on a ventilator.”

Igor Puzanov, MD, MSci, FACP, Study Co-Author, Professor of Medicine, Director of Early Phase Clinical Trials

Repurposing cancer drugs in fight against COVID

One of the most innovative approaches being explored as a possible treatment for COVID-19 originated from Roswell Park.

Dr. Kalinski championed the idea of combining two drugs -; rintatolimod (also known as Ampligen) and interferon alfa-2b (also known as interferon A) -; as a combination approach for cancer immunotherapy.

He has several studies of this two-drug combination underway at Roswell Park in some solid-tumor cancers and, working closely with Brahm Segal, MD, got FDA authorization to assess this combination in patients with both cancer and COVID-19.

“This is an exciting idea. We know these two immune modulators can stimulate the immune system in patients with cancer, and now we want to take it a step forward and see if this combination can also stimulate the immune system of people with COVID,” says Dr. Puzanov.

Related Stories

This study is also notable as one of the relatively few investigational approaches targeted toward patients with mild or moderate COVID-19.

“We are conducting our first study of this approach in patients who have both cancer and COVID-19 because they are at higher risk of severe illness,” he adds.

“The hope is that, given early, this combination could prevent the virus from taking hold and causing long-term damage, decreasing the severity of the infection and how long it takes people to recover.”

Remdesivir Approved for Emergency Use

Antiviral drugs first developed for use in treating other infectious diseases were some of the first therapies to be given to patients with COVID-19.

In early May 2020, the FDA authorized the use of the Ebola drug remdesivir as an emergency option for treating COVID-19 in adults and children hospitalized with severe disease. A small number of patients locally have been treated with this drug.

“Early tests have shown that patients treated with remdesivir spend one-third less time in the hospital for their illnesses. So this is a promising therapy we are eager to see more data on,” notes Dr. Puzanov.

Convalescent plasma: All about the antibodies

Roswell Park has also been a regional collection center supporting several hospitals offering patients with COVID-19 a treatment known as convalescent plasma -; plasma infusions from the blood of people who have been treated and cured of their COVID-19 infections, in the hopes that antibodies in their plasma might help others to fight the virus.

George Chen, MD, and Joanne Becker, MD, have been leading this work. They’re encouraging people who have successfully been treated for the virus to consider donating their plasma to help others.

“Convalescent plasma has actually been used for decades as a treatment for viral infections. It can be very important in helping us to manage a brand-new disease like COVID-19, and early evidence suggests that it is helping many patients to improve,” says Dr. Puzanov.

A search for biomarkers

Roswell Park teams are also hard at work analyzing how the SARS CoV-2 virus affects us in order to give clinical teams and vaccine developers a deeper knowledge of how best to manage and possibly prevent this disease. Kunle Odunsi, MD, Ph.D., FRCOG, FACOG, and Carl Morrison, MD, DVM, are leading an important effort to understand the body’s response to COVID-19 infections.

They’re applying their expertise in cancer immunotherapy and precision medicine to identify biomarkers that would allow us to identify early those patients who are more likely to progress to a severe case and to require more intensive treatment.

It’s a first-of-its-kind effort involving regional and industry partners: Catholic Health, UB, and Thermo Fisher Scientific.

“This is a very creative way to learn more about this virus and this disease using cutting-edge gene-sequencing technology, something that’s never been done before with any previous pandemic,” says Dr. Puzanov.

“And it could ultimately prove very important as a way to not only improve clinical outcomes for those with COVID-19 but also to make sure that we apply precious medical resources where they are most needed.”

Part of ongoing global effort

As the first wave of COVID-19 cases in our region begins to subside, Dr. Puzanov takes stock of the collaborative efforts that have made this diverse collection of research efforts possible.

“We’re proud to contribute our knowledge and our expertise in getting new therapies safely to patients through this global effort,” he says. “We are helping to advance the world’s understanding of this disease and how best to treat it, and we hope that this will translate to greater peace of mind for everyone.”

Source:

Roswell Park Comprehensive Cancer Center

Visit the Source Site

Powered by WPeMatico

Deployment of health care professionals can improve inflammatory-rheumatic disorders

Inflammatory-rheumatic disorders are a widespread ailment, affecting at least 1.5 million people in Germany alone. Because there is a shortage of rheumatologists, however, only half of the patients in this country are adequately treated.

The use of other health care professionals, as is the case in Denmark and the UK, could help to improve the situation. A study in Germany has shown for the first time that the care of patients with inflammatory-rheumatic diseases by ‘rheumatological assistants’ (RFA) is just as effective as treatment by specialist rheumatologists.

To reduce waiting times and prevent damage to health, the European League Against Rheumatism (EULAR) strongly recommends the use of RFAs in Germany, which will be announced at a press conference on 3 June 2020 held for its annual congress.

Around two percent of the adult population in Germany is affected by chronic inflammatory rheumatic diseases, such as rheumatoid arthritis (RA), axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA). “These patients have a considerable medical condition,” explains Dr. Kirsten Hoeper from the Clinic for Rheumatology and Immunology at the Hanover Medical School in Germany.

Missed opportunities for treating patients due to long waiting times

Severe pain, extreme fatigue, lack of strength, stiffness and physical deformity can have a significant impact on activities, education and career, partnership and family and can lead to occupational disability. Early diagnosis and therapy are essential to prevent as far as possible such serious consequences of damage to the joints.

But the existing medical resources do not suffice to provide early, patient-centred and guideline-based care. The waiting times are far too long,this is despite the fact that new drugs could almost completely force the disease back into so-called remission for the majority of patients – provided that treatment is administered in good time.”

Dr Kirsten Hoeper, Clinic for Rheumatology and Immunology, Hanover Medical School, European League Against Rheumatism

The deployment of RFAs could improve the situation, as is already well-established in some Northern European countries.

RFAs are members of related medical professions such as paramedic, nurse, student nurse or road traffic/motor traffic accidents, who have acquired additional theoretical and practical knowledge about the care of patients suffering from rheumatic and musculoskeletal diseases (RMDs). Such a delegation of medical care in rheumatology is recommended worldwide.

“The legal framework for this also exists in Germany,” says Hoeper. “In addition, the curriculum for the RFA degree exists since 2006, which is currently available to the German Medical Association for certification in an extended form.

Related Stories

In order to examine whether and how RFAs can also be used in the German health care system, a prospective, randomised, controlled and multi-centre study was conducted, which was completed in December 2019.

“A total of 236 patients from eight German centres participated in the study, where a blood test had confirmed the diagnosis of rheumatoid arthritis,” explains the author of the study Hoeper.

Study involvement of RFAs produces the same treatment results

On average, the patients were 58 years of age, over 70 percent were female and suffered from rheumatic complaints for a period of 130 (ranging from 12 to 144) months on average.

While one study group was exclusively treated by rheumatologists during the twelve-month study period, the other study group RFAs temporarily took over the care at three fixed intervals with only brief contact to the physicians.

The patients’ condition was measured using the standard assessment form DAS28 (Disease Activity Score at 28 joints), which assesses the activity of the disease on an ascending scale from 2.0 to 10.0. Values between 3.2 and 5.1 are considered moderate.

Result of the study: The structured delegation of medical tasks to an RFA does not undermine the current standard of care. While the disease activity for the group co-treated by RFAs was on average DAS28 2.43, the value for the group with continuous rheumatologist consultation was on average DAS28 2.29.

“This difference is not clinically or statistically significant”, concludes EULAR President Professor Dr. Iain B. McInnes from Glasgow, Scotland, UK. “For the first time it can be shown for Germany that an RFA consultation is a safe way to complement the care of patients suffering from rheumatoid arthritis”, says Professor Dr. med. John Isaacs from Newcastle, Great Britain, EULAR Scientific Programme Committee Chair.

Better care in a cost-efficient way

“Integrating a team approach comprising rheumatologists with other health professionals into the treatment of patients with inflammatory rheumatic diseases presents great opportunities,” emphasises McInnes.

“RFAs can complement a physician’s workload, who in turn can use freed-up resources for more complex or new patients,” Hoeper adds. The long waiting times for an appointment with a rheumatologist could thus be cut shorter. Hoeper concludes, “by following the international EULAR Recommendations regarding RFAs, Germany will lead to better patient care in a cost-efficient way”.

Source:

European League Against Rheumatism

Visit the Source Site

Powered by WPeMatico

When A Doctor No Longer Accepts Medicare, Patients Left Holding The Bag

Pneumonia. Heart problems. High cholesterol. Betsy Carrier, 71, and her husband, Don Resnikoff, 79, relied on their primary care doctor in Montgomery County, Maryland, for help managing their ailments.

But after seven years, the couple was surprised when the doctor informed them she was opting out of Medicare, the couple’s insurer.

“It’s a serious loss,” Resnikoff said of their doctor.

Patients can lose doctors for a variety of reasons, including a physician’s retirement or when either patient or doctor moves away. But economic forces are also at play. Many primary care doctors have long argued that Medicare, the federal health insurance program for seniors and people with disabilities, doesn’t reimburse them adequately and requires too much paperwork to get paid.

These frustrations have prompted some physicians to experiment with converting their practices to more lucrative payment models, such as concierge medicine, in which patients pay a fee upfront to retain the doctor. Patients who cannot afford that arrangement may have to search for a new physician.

The exact number of physicians with concierge practices is unknown, health care experts said. One physician consulting company, Concierge Choice Physicians, estimates that roughly 10,000 doctors practice some form of membership medicine, although it may not strictly apply to Medicare patients.

Shawn Martin, senior vice president of the American Academy of Family Physicians, estimated that fewer than 3% of their 134,000 members use this model but the number is slowly growing.

The move to concierge medicine may be more prevalent in wealthier areas.

Travis Singleton, executive vice president for the medical staffing company Merritt Hawkins, said doctors switching to other payment systems or those charging Medicare patients a higher price for care are likely “in more affluent, well-to-do areas where, frankly, they can get fees.”

It is far easier for physicians than hospitals to opt out of taking Medicare patients. Most hospitals have to accept them since they rely on Medicare payments to fund inpatient stays, doctor training and other functions.

The majority of physicians do still accept Medicare, and most people insured by the federal program for seniors and people with disabilities have no problem finding another health care provider. But that transition can be tough, particularly for older adults with multiple medical conditions.

“When transition of care happens, from one provider to another, that trust is often lost and it takes time to build that trust again,” said Dr. Fatima Sheikh, a geriatrician and the chief medical officer of FutureCare, which operates 15 rehabilitation and skilled nursing centers in Maryland.

Shuffling doctors also heightens the risk of mishaps.

A study of at least 2,200 older adults published in 2016 found that nearly 4 in 10 were taking at least five medications at the same time. Fifteen percent of them were at risk of drug-to-drug interaction.

Primary care providers mitigate this risk by coordinating among doctors on behalf of the patient, said Dr. Kellie Flood, a geriatrician at the University of Alabama-Birmingham.

“You really need the primary care physicians to serve as the quarterback of the health care team,” said Flood. “If that’s suddenly lost, there’s really not a written document that can sum all that up and just be sent” to the new doctor.

Finding a physician who accepts Medicare depends partly on workforce demographics. From 2010 to 2017, doctors providing primary care services to Medicare beneficiaries increased by 13%, according to the Medicare Payment Advisory Commission (MedPAC), a nonpartisan group that advises Congress.

However, the swell of seniors who qualify for Medicare has outpaced the number of doctors available to treat them. Every day, an estimated 10,000 Americans turn 65 and become eligible for the government program, the Census Bureau reported.

The impact: In 2010, MedPAC reported, there were 3.8 primary care doctors for every 1,000 Medicare enrollees. In 2017, it was 3.5.

Authors of a MedPAC report out last June suggested that the number of available primary care providers could be an overestimate. Their calculation assumed all internal medicine doctors provided these services when, in reality, many specialize in certain medical conditions, or accept only a limited number of Medicare patients into their practices.

But MedPAC concluded seniors are not at a disadvantage finding a doctor.

“We found that beneficiaries have access to clinician services that is largely comparable with (or in some cases better) access for privately insured individuals, although a small number of beneficiaries report problems finding a new primary care doctor,” the MedPAC researchers wrote.

The coronavirus outbreak has complicated the ability for many Americans to access care, regardless of their insurer. However, many older patients now have an opportunity to connect with their doctors virtually after the Centers for Medicare & Medicaid Services (CMS) broadened access to telemedicine services under Medicare.

Experts said the long-term effects of the virus on doctors and Medicare remain unknown. But Martin said the shortage of cash that many doctors are experiencing because of the coronavirus epidemic has revealed the shortcomings of how primary care doctors are paid.

“The COVID crisis really brought to life the challenges of fee for service,” said Martin.
Despite these challenges, the number of doctors choosing to opt out of Medicare has been on the decline, according to data from CMS.

Singleton, of Merritt Hawkins, said concern about doctors leaving the Medicare system is part of larger workforce issues. Those include the need to recruit more medical students to concentrate on primary care.

One estimate predicts the nation will face a shortage of 23,600 primary care physicians by 2025. The majority of residents in internal medicine ― those who care for adults — are choosing a subspecialty such as cardiac care or gastroenterology, MedPAC reported.

In 2017, MedPAC reported, the median compensation for all doctors was $300,000 a year. Among primary care doctors, it was $242,000.

Creative business models can make up that difference. Under the concierge model, the doctor charges patients an annual fee — akin to a gym membership ― to access their practice. The provider still bills the insurer ― including Medicare — for all patient care.

Another model ― called direct primary care — charges the patient an annual fee for access and care; doctors do not bill health insurance plans.

Proponents say that the model enables them to take more time with their patients without dealing with the bureaucracy of getting paid by health insurers.

“I think what is most attractive to direct primary care is that they just practice medicine,” Martin said.

The size of a physician practice can also determine whether it accepts Medicare. Large practices can better offset the lower Medicare payment rates by leveraging their influence with private insurers to raise those reimbursements, said Paul Ginsburg, director of the USC-Brookings Schaeffer Initiative for Health Policy. But small, independent clinics may not have the same clout.

“If you’re a large primary care practice, private insurers are really going to want to have you in their network,” he said. “And they’re willing to pay more than they might pay an individual solo practitioner who they’re not as concerned [with] because it’s only one physician.”

Luckily, after more than a dozen calls to physicians, Carrier and Resnikoff said they found another primary care doctor. They said she accepts Medicare and impressed them during their meet-and-greet with her knowledge of their medical history. She also met their criteria for age and expertise.

“At this point in our lives, I’d be eager to find somebody who’s young enough that they might be in practice for the next 10 years,” Carrier said.

Related Topics

Aging Insurance Medicare

Maryland

Visit the Source Site

Powered by WPeMatico

Gilead’s remdesivir prevents lung damage in COVID-19 study on monkeys

(Reuters) – Gilead Sciences Inc’s (GILD.O) antiviral drug remdesivir prevented lung disease in macaque monkeys infected with the new coronavirus, according to a study published in the journal Nature on Tuesday.

FILE PHOTO: Two ampules of Ebola drug Remdesivir are pictured during a news conference at the University Hospital Eppendorf (UKE) in Hamburg, Germany, April 8, 2020, as the spread of coronavirus disease (COVID-19) continues. Ulrich Perrey/Pool via REUTERS/File Photo

The findings were first reported in April by the U.S. National Institutes of Health (NIH) as a “preprint,” prior to traditional academic validation provided by a medical journal.

Remdesivir is the first drug shown to be effective against COVID-19 in human trials. Other clinical studies involving the drug are being closely watched as nations look for treatments for the disease that has infected more than 7 million people and killed over 400,000 globally.

Remdesivir was approved last month in Japan under the brand name Veklury. It has been cleared for emergency use in severely-ill patients in the United States, India and South Korea. Some European nations are also using it under compassionate programs.

In the study published on Tuesday, 12 monkeys were infected with the new coronavirus, and half of them were given early treatment with remdesivir.

Macaques that received remdesivir did not show signs of respiratory disease and had reduced damage to the lungs. (go.nature.com/2Yj9xq2)

Authors of the study also said the viral load, or amount of virus, in the lungs of remdesivir-treated animals was lower.

The authors suggested that remdesivir should be considered as a treatment as early as possible to prevent progression to pneumonia in COVID-19 patients.

In a U.S.-run clinical trial released in late April, remdesivir reduced hospitalization stays by 31%, or about four days, compared to a placebo.

Gilead last week reported data from its own trial of remdesivir, showing that the drug provided a modest benefit for patients with moderate COVID-19 given a five-day course of the treatment.

Reporting by Manas Mishra in Bengaluru and Deena Beasley in Los Angeles; Editing by Saumyadeb Chakrabarty and Bill Berkrot

Our Standards:The Thomson Reuters Trust Principles.

Visit the Source Site

Powered by WPeMatico

U.S. CDC reports 1,956,421 coronavirus cases, 110,925 deaths

FILE PHOTO: Commuters ride the subway on the first day of New York City’s phase one reopening during the outbreak of the coronavirus disease (COVID-19) in New York City, New York, U.S., June 8, 2020. REUTERS/Mike Segar/File Photo

(Reuters) – The U.S. Centers for Disease Control and Prevention (CDC) on Tuesday reported 1,956,421 cases of new coronavirus, an increase of 17,598 cases from its previous count, and said the number of deaths rose by 550 to 110,925.

The CDC reported its tally of cases of the respiratory illness known as COVID-19, caused by the new coronavirus, as of 4 pm ET on June 8, versus its previous report released on Monday. (bit.ly/2Uw9aYi)

The CDC figures do not necessarily reflect cases reported by individual states.

Reporting by Trisha Roy in Bengaluru; Editing by Shinjini Ganguli

Our Standards:The Thomson Reuters Trust Principles.

Visit the Source Site

Powered by WPeMatico

Georgia State researcher receives $1.95 million NIH grant to study cause of autoimmunity

Reviewed by Emily Henderson, B.Sc.Jun 8 2020

Dr. Leszek Ignatowicz, a professor in the Institute for Biomedical Sciences at Georgia State University, has received a five-year, $1.95 million federal grant to study what causes autoimmunity in the human body.

Autoimmune diseases, which occur when the immune system mistakenly attacks the body’s own organs, tissues and cells, are the third most common group of diseases in the United States after cancer and heart disease. More than 100 types of autoimmune diseases have been identified, including Type 1 diabetes, rheumatoid arthritis, multiple sclerosis, lupus, psoriasis, thyroid diseases and inflammatory bowel disease.

Most autoimmune diseases have no cure, which results in debilitating symptoms, organ function loss and even death. Despite how common and increasingly prevalent autoimmune diseases have become, they largely remain a mystery.

Related Stories

This grant from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases will fund research to understand why the immune system attacks its own body, referred to as compromised tolerance, and how autoimmunity develops.

All vertebrates, including humans, have two levels of immunity. The first is the innate immune system, which is activated by molecules common in bacteria, parasites or viruses. The second layer of defense is the adaptive immune system, which depends on lymphocytes (B cells or T cells), one of the body’s main types of immune cells. Autoimmunity takes place when lymphocytes become activated by peptides derived from the body’s own proteins rather than those from pathogens, activating an immune response.

Most people don’t get autoimmune diseases because tolerance works properly in their body. With central tolerance, T cells that have a capacity to be pathogenic and autoreactive, or activated by self-antigens, are supposed to be eliminated and die in the thymus gland where they originally developed. This process is not 100 percent reliable, and an unknown percent of potentially autoreactive T cells escape and may cause autoimmunity. Then, a second line of security called peripheral tolerance identifies these remaining T cells that have the potential to be autoreactive and inhibits them.

The goal of this work is to better understand how the natural limitations of thymic selection predispose us to autoimmunity. This research will provide a better understanding of cellular and molecular mechanisms driving autoimmunity and help to develop therapeutic strategies targeting autoreactive T cells that escaped central tolerance. From a clinical perspective, identification of dormant, autoreactive T cells is critically important for saving a new category of autoimmune patients with peripheral tolerance deliberately broken by regulatory T cells that silence treatments to enhance immunity to infection or cancer.”

Dr. Leszek Ignatowicz, Professor, Institute for Biomedical Sciences, Georgia State University

Source:

Georgia State University

Visit the Source Site

Powered by WPeMatico