publication date: Apr. 3, 2020

COVID-19 Updates

AACR to Congress: Act on PPE, ventilator and testing shortages

The American Association for Cancer Research board of directors sent the following letter to congressional leadership March 30.

“Dear Speaker Pelosi, House Majority Leader Hoyer, House Minority Leader McCarthy, Senate Majority Leader McConnell, and Senate Minority Leader Schumer:

“As members of the Board of Directors of the American Association for Cancer Research, on behalf of the more than 47,000 laboratory, translational, and clinical researchers; physicians and other healthcare professionals; population scientists; and patient advocates who constitute our national and international membership, we applaud your tireless efforts to address the COVID-19 national health emergency, which include your recent passage of the historic $2 trillion ‘Coronavirus Aid, Relief, and Economic Security Act’ (the ‘relief, recovery, and stimulus’ bill) to address the economic fallout from the COVID-19 pandemic and provide vital emergency funding for hospitals and other essential elements of our nation’s healthcare infrastructure.

“Cancer researchers are at the forefront of biomedical research in the development of molecular diagnostics and therapeutics, and there is a convergence of coronavirus biology with cancer research that will have clinical importance. As the first and largest organization dedicated to the prevention and cure of all cancers through research and patient care, the AACR has the ability to marshal its members’ expertise and broad experience to aid the national COVID-19 response.

‘The scientific and clinical knowledge of AACR members positions us to contribute in a major way to the deployment of resources and the advancement of research to overcome this pandemic. Time is of the essence, and we call on you and your colleagues in Congress to move swiftly forward to take the following steps to alleviate the COVID-19 public health emergency, while also ensuring patients with cancer are protected and the cancer workforce remains vibrant.

“Urge President Trump to use his powers to immediately and fully implement the Defense Production Act to direct industries to accelerate the manufacture of all the crucial medical equipment desperately needed to protect our frontline healthcare providers and to save the lives of those suffering from COVID-19.

‘It is absolutely critical that we equip our healthcare providers currently entrenched in a ‘medical war zone’ with the personal protective equipment that is necessary to keep them, their families, and others safe, such as surgical and N95 masks, gloves, gowns and face shields.

“In addition, we implore you to take steps that provide critically ill patients with access to advanced life support systems, such as ventilators and ECMO devices. To this end, we strongly support the Medical Supply Chain Emergency Act, which was introduced on Monday, March 23, 2020, by Senators Chris Murphy (D-CN) and Brian Schatz (D-HI), as it calls on President Trump to use his powers to fully implement the DPA and produce 500 million masks as well as 200,000 ventilators and other desperately needed supplies including nasal swabs.

“Implement widespread testing of symptomatic individuals immediately, as well as asymptomatic individuals who have been exposed to infection or those in high-risk patient groups such as patients with cancer. Testing and tracking the novel coronavirus are vital measures to understanding the spread of COVID-19 in our communities, which will allow us to better isolate identified cases and contain the infection clusters that are present.

“Overly restrictive testing criteria, such as testing only those who had contact with an already infected individual or traveled to a specific foreign country, will not allow us to adequately assess and combat this rapidly advancing health crisis. Our healthcare providers should be able to access testing because they are on the front lines combatting this pandemic and are at increased risk of contracting and spreading this virus. It is also crucial to recognize that cancer treatment leaves many patients with compromised immune systems, placing them at increased risk for a severe, life-threatening case of COVID-19.

“Therefore, patients with cancer should be tested for COVID-19 whenever their oncologists or other healthcare providers deem it appropriate. Testing alone is not sufficient; a de-identified, national central database should be established immediately to track novel coronavirus positive cases and those who are antibody positive, i.e., who have been exposed to the virus and developed immunity.

“Continue a nationwide social distancing policy for as long as necessary to reduce COVID-19 disease incidence and overall death toll, effectively protecting our frontline healthcare providers. Pulling back or even pausing our social distancing efforts prematurely would likely result in tens of thousands of additional cases and overwhelm our healthcare system. It is imperative that current social distancing policies be extended as required to end this national emergency.

“Uphold the rigorous, science-based approach of the U.S. Food and Drug Administration in its approval of all COVID-19 therapies. It is essential that the administration protect the agency’s high standards of safety and efficacy when approving COVID-19 therapies. We appreciate the rapid issue of guidance to industry, ‘Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials,’ which prioritizes the safety of patients enrolled in clinical trials and provides insight into how to move forward with clinical trials already underway. The agency should continue to be open to well-designed, collaborative, innovative clinical trial strategies that will expedite the prevention, detection, and treatment of COVID-19.

“Encourage the use of the FDA’s expanded access program, sometimes referred to as ‘compassionate use’ as the primary pathway for patients to access investigational medical products and urge the agency to immediately deploy a COVID-19 focused version of Project Facilitate. Project Facilitate is an innovative, common sense, single point of contact program that helps healthcare providers navigate expanded access for oncology therapeutics administered by the FDA Oncology Center of Excellence. Importantly, expanded access allows us to learn from the experience of every patient treated with investigational drugs, knowledge that will be vital for the conquest of COVID-19.

“Provide the telehealth digital infrastructure and technology needed to ensure continuity of care for patients with cancer. During the COVID-19 pandemic, telehealth technology will be especially valuable to enable vulnerable patients to receive some of their care at home and avoid exposure to the novel coronavirus when visiting the clinic. The survival of patients with cancer depends on the continuity of access to care.

“Although patients with cancer are immune-compromised and at high risk of severe COVID-19 disease, their cancer treatment cannot be interrupted indefinitely without dire health consequences. The expansion of telehealth programs will help patients with cancer by facilitating regular communication with providers and enabling access to timely information about their care. As telehealth is implemented more broadly, we urge you to incorporate patient privacy safeguards into any associated policies.

“Leverage the brain trust of cancer researchers and oncology healthcare providers who are contributing to our national capacity to address COVID-19. Cancer researchers are serving the global and national interest by lending their scientific and clinical expertise to address the COVID-19 pandemic.

“AACR members have the ability to drastically impact current efforts in diagnostic and treatment strategies. They are already working to address coronavirus testing shortages by repurposing their laboratory space to make COVID-19 testing kits and are collecting and analyzing data on patients with cancer and COVID-19 through initiatives such as the COVID-19 and Cancer Consortium.

“Cancer researchers are able to leverage their laboratory expertise and capacity in numerous ways including to: aid in drug screening, development, and repurposing; develop antibody tests; investigate the efficacy of convalescent serum from recovered COVID-19 infected persons as treatment; and conduct vaccine research for COVID-19. Clinical cancer researchers are also well positioned to help manage aspects of care for COVID-19 patients.

“Through the study and use of new immunotherapies, including CAR T-cell therapies, cancer researchers have gained experience using immune-modulating therapies and managing severe immune-mediated side effects also seen in COVID-19. Serious consideration should be given to engaging cancer researchers from various disciplines, oncology healthcare providers, and laboratory professionals in a call to action to study, detect, and defeat COVID-19. The AACR is prepared to survey its constituents to identify volunteers who are willing to help conduct COVID-19 testing during this time when research laboratories are not functioning.

“Continue your exceptional support and steadfast commitment to cancer and medical research. During the past five years, you have prioritized funding for NIH to the point that the agency’s budget has increased by $11.6 billion or 39%. The COVID-19 pandemic highlights the importance and value of the NIH portfolio, and emphasizes that this generous support must be sustained, even more so during this period when our nation is facing a national health emergency.

“The support you have shown for cancer and medical research has contributed to a substantial reduction in cancer incidence and mortality. The age-adjusted U.S. cancer death rate declined by 29% from 1991 to 2017, a reduction that translates into 2.9 million cancer deaths avoided. Therefore, during the fiscal year 2021 appropriations process, we will be calling on you to help make sure this scientific progress continues.

“The future of cancer and medical research depends on ensuring career continuity for researchers despite the adverse influences of COVID-19. Diminished research time and output due to the COVID-19 crisis will unduly harm less-established investigators when they apply for grants.

“This professional uncertainty is compounded by financial insecurity, as many early-career scientists struggle with considerable student loan debt. We appreciate the support you have shown in the passage of the relief, recovery, and stimulus bill to help Americans who are struggling to repay their student loans. We ask that you consider additional measures that will encourage these vulnerable scientists to persist in their research careers, such as directing the NIH to extend the duration of grants to accommodate research disruptions caused by COVID-19 and modifying eligibility windows for special career stage designations (e.g., postdoc and early-stage investigator).

“Sustain scientific innovation and progress for the benefit of patients and cancer survivors. We have serious concerns about the toll that economic stress resulting from the COVID-19 public health challenge is taking on scientific innovation. Assurances from NIH Deputy Director for Extramural Research Michael Lauer and NCI Director Ned Sharpless that NIH and NCI peer review and grants administration will continue as previously scheduled are encouraging.

“However, while a focus must be maintained on conquering COVID-19, a prolonged halting of our national cancer research efforts will slow the recent rate of progress in providing patients with new therapies for cancer. Unfortunately, the current COVID-19 crisis is resulting in cancer clinical trials grinding to a halt, and healthcare and PPE shortages have a deleterious effect on all areas of cancer research and patient care. When this global pandemic is behind us, Congress must provide the necessary resources to maximize the potential for future advances in cancer and medical research and treatment.

“Promoting innovation through the dissemination of new cancer research findings among scientists and other stakeholders is at the core of the AACR mission, and rapid communication of the latest developments in science and medicine is now more important than ever. Therefore, effective immediately, the AACR is making any journal article containing information directly relevant to advancing our understanding of COVID-19 open access and available online. Further, we are already hard at work conducting web-based conferences, and we will organize sessions at our scientific meetings that address the biologic and clinical intersection of COVID-19 and cancer.

“In conclusion, your leadership and support over the past several decades have ensured the development of a highly effective National Cancer Program that can now apply its unique and substantive knowledge and skills to help society defeat this virulent pathogen. We recognize the need to take action immediately to vanquish this virus that threatens the lives of millions of Americans, ravages our economy, and derails scientific progress. Otherwise, our healthcare system will fail and our most vulnerable patients, including those with cancer, will disproportionately suffer. The AACR and its members stand ready to work with you and other members of Congress to achieve the vital recommendations set forth herein. Thank you in advance for your consideration.”

 

Advocacy organizations: Stop threatening health care workers who speak out about lack of PPE

In a public letter to the American Hospital Association, 54 health care organizations condemned attempts by hospital administrators to muzzle health care workers who speak out against coronavirus caseloads and supply shortages.

The letter, dated March 27, follows:

“We were appalled to read recent media reports about hospital administrators across the U.S. muzzling doctors, nurses, and other healthcare professionals with threats of disciplinary action for speaking out about coronavirus patient caseloads and dwindling hospital supplies needed to care for such patients.

“It is critical that the public and local, state, and federal government officials fully comprehend the scope of shortages of personal protective equipment, mechanical ventilators, intensive care unit beds, and other medical supplies so that appropriate steps can be taken to mitigate shortages of these essential medical resources, appropriately and fairly allocate limited resources, and thus protect the safety and welfare of health care workers and patients alike. Attempts to cover up these shortages by muzzling health care workers who are on the front lines of fighting the COVID-19 pandemic are reprehensible and reckless and endanger public health.

“Although such actions may be commonplace in countries with authoritarian regimes, they are not acceptable in the U.S. The undersigned consumer advocacy, workers’ rights, science, research, public health, civil rights, human rights, and grassroots political organizations, labor unions, and individuals therefore demand that the American Hospital Association publicly denounce any such efforts to muzzle health care professionals and call on its member hospitals and health care systems to encourage their doctors, nurses, and other health care professionals to speak freely about coronavirus patient caseloads, dwindling hospital supplies, and any other challenges that should be immediately addressed.

“Thank you for your prompt attention to this urgent public health matter. Please contact Dr. Michael Carome, Director of Public Citizen’s Health Research Group, at mcarome@citizen.org with your response.”

 

American College of Surgeons: Health care workers need PPE

The following is a statement from the American College of Surgeons.

“The American College of Surgeons recognizes that many healthcare facilities are facing shortages of personal protective equipment, including face masks, gowns, and respirators. The ACS believes it is essential that surgeons, nurses, anesthesiologists, and other health care personnel be able to speak freely, without fear of retribution, as they seek to find a solution to accessing PPE. We advise surgeons to speak with their institutional leadership on these matters and to be able to direct any concerns to the ACS, with the goal of protecting themselves and their colleagues.

“The Joint Commission has released a statement supporting the use of standard face masks and respirators provided from home when health care facilities cannot provide access to PPE that is commensurate with the risk to which health care personnel are exposed during the COVID-19 pandemic. Where masks or respirators are recommended, the ACS maintains that surgeons should have access to and latitude to wear these masks at their sole discretion. The Centers for Disease Control and Prevention also has released a document that offers a series of strategies or options to optimize supplies of disposable N95 filtering facepiece respirators.

“The ACS strongly supports the ability of surgeons to use their own masks or other PPE, but this option does not obviate the hospital’s responsibility to provide adequate PPE to all their health care workers. In these extraordinary times, the ACS encourages institutions to adapt and be flexible so that health care personnel continue to feel safe; The Joint Commission guidelines are a reasonable starting point.”

 

CPRIT suspends first cycle of awards for FY21

Cancer Prevention and Research Institute of Texas has suspended its first cycle of grant applications for fiscal year 2021 for Academic Research, Product Development Research and Prevention Program awards.

CPRIT is taking this action in response to the unexpected impact to the budget from the COVID-19 pandemic and a projected decrease in oil and gas revenues. CPRIT continues to evaluate releasing Requests for Applications for fiscal year 2021 and is committed to doing so if circumstances support it.

CPRIT has closed the FY 21.1 Academic Research Program RFAs listed below (originally due June 3). CPRIT will not accept applications responding to these RFAs and will withdraw any FY 21.1 applications already submitted.

Applications for the second cycle of fiscal year 2020 (FY 20.2) are undergoing peer review. CPRIT is not withdrawing the FY 20.2 applications and expects to announce awards in August or early fall.

  • RFA R-21.1 – RTA Research Training Awards

  • RFA R-21.1 – IIRA Individual Investigator Research Awards

  • RFA R-21.1 – IIRACCA Individual Investigator Research Awards for Cancer in Children and Adolescents

  • RFA R-21.1 – IIRACT Individual Investigator Research Awards for Clinical Translation

  • RFA R-21.1 – IIRACSBC Individual Investigator Research Awards for Computational Systems Biology of Cancer

  • RFA R-21.1 – IIRAP Individual Investigator Research Awards for Prevention and Early Detection

 

Scott Gottlieb: A road map for navigating COVID-19 in the U.S.

In a report published by the American Enterprise Institute, former FDA Commissioner Scott Gottlieb proposes a road map for navigating COVID-19 in the United States.

Gottlieb’s report identifies four phases and the related actions which need to be taken by those overseeing America’s public health strategy to bring the spread of COVID-19 under control and to transition slowly to next steps leading to reopening the country.

Gottlieb co-authored the report with the following public health experts: Mark McClellan, MD, PhD; Caitlin Rivers, PhD, MPH; Lauren Silvis, JD; and Crystal Watson, DrPH, MPH.

Read the full report here.

The authors outline the following four phases:

Phase I: Slow the Spread – Break off the chain of epidemic transmission

  • Measures like social distancing will need to be in place nationally until transmission has slowed down and health infrastructure can be scaled up to safely manage the outbreak.

Phase II: Reopen, State by State – Gradually shift to a focus on individual cases versus entire populations

  • States can move to phase II when they are able to safely diagnose, treat, and isolate COVID-19 cases and their contact

  • Self-distancing measures will still need to be in place to prevent transmission from accelerating again (such as increased distancing in lines, elevators, and indoor spaces).

  • Deep cleaning (sanitizing) of shared spaces should become routine.

  • Initially the public will be asked to limit their gatherings, and people will initially be asked to wear face masks while in the community in order to reduce their risk of asymptomatic spread

Phase III: Establish Protection Then Lift All Restrictions- Effective therapeutics, widespread screening and surveillance, and a vaccine

  • Physical distancing restrictions and other Phase II measures can be lifted only when we have available to us safe and effective technology for mitigating the risk of COVID-19.

  • This technology includes: broad based surveillance, therapeutics that can rescue patients with significant disease, or prevent serious illness in those most at risk, and/or a safe and effective vaccine

Phase IV: Rebuild Our Readiness for the Next Pandemic

  • We must build the tools and systems to ensure that we are never again unprepared to face a new infectious disease threat as soon as we successfully defeat COVID-19.

  • Preparedness for public health emergencies should be elevated as a function in the White House, with a coordinating function equivalent to the Director of National Intelligence

 

CMS addresses surge of COVID-19 patients

The Centers for Medicare & Medicaid Services March 30 issued regulatory waivers and new rules to respond to the 2019 novel coronavirus pandemic.

These temporary changes will apply immediately across the U.S. healthcare system for the duration of the emergency declaration. This allows hospitals and health systems to deliver services at other locations to make room for COVID-19 patients needing acute care in their main facility.

The changes allow local hospitals and healthcare systems to expand treatment capacity that allows them to separate patients infected with COVID-19 from those who are not affected.

CMS recently approved hundreds of waiver requests from healthcare providers, state governments, and state hospital associations in the following states: Ohio; Tennessee; Virginia; Missouri; Michigan; New Hampshire; Oregon; California; Washington; Illinois; Iowa; South Dakota; Texas; New Jersey; and North Carolina. Other states and providers do not need to apply for these waivers and can begin using the flexibilities immediately.

CMS’s temporary actions allow local hospitals and healthcare systems to:

Increase hospital capacity:

  • Communities can use local ambulatory surgery centers that have canceled elective surgeries, per federal recommendations. Surgery centers can contract with local healthcare systems to provide hospital services, or they can enroll and bill as hospitals during the emergency declaration as long as they are not inconsistent with their state’s Emergency Preparedness or Pandemic Plan. The new flexibilities will also leverage these types of sites to decant services typically provided by hospitals such as cancer procedures, trauma surgeries and other essential surgeries.

  • CMS will now temporarily permit non-hospital buildings and spaces to be used for patient care and quarantine sites, provided that the location is approved by the State and ensures the safety and comfort of patients and staff. This will expand the capacity of communities to develop a system of care that safely treats patients without COVID-19, and isolate and treat patients with COVID-19.

  • CMS will also allow hospitals, laboratories, and other entities to perform tests for COVID-19 on people at home and in other community-based settings outside of the hospital. The new guidance allows healthcare systems, hospitals, and communities to set up testing sites exclusively for the purpose of identifying COVID-19-positive patients in a safe environment.

  • CMS will allow hospital emergency departments to test and screen patients for COVID-19 at drive-through and off-campus test sites.

  • During the public health emergency, ambulances can transport patients to a wider range of locations when other transportation is not medically appropriate. These destinations include community mental health centers, federally qualified health centers, physician’s offices, urgent care facilities, ambulatory surgery centers, and any locations furnishing dialysis services when an ESRD facility is not available.

  • Physician-owned hospitals can temporarily increase the number of their licensed beds, operating rooms, and procedure rooms. For example, a physician-owned hospital may temporarily convert observation beds to inpatient beds to accommodate patient surge during the public health emergency.

  • Hospitals can bill for services provided outside their four walls. Emergency departments of hospitals can use telehealth services to quickly assess patients to determine the most appropriate site of care, freeing emergency space for those that need it most. New rules ensure that patients can be screened at alternate treatment and testing sites which are not subject to the Emergency Medical Labor and Treatment Act as long as the national emergency remains in force. This will allow hospitals, psychiatric hospitals, and critical access hospitals to screen patients at a location offsite from the hospital’s campus to prevent the spread of COVID-19.

Expand the healthcare workforce:

  • Local private practice clinicians and their trained staff may be available for temporary employment because nonessential medical and surgical services are postponed during the public health emergency. CMS’s temporary requirements allow hospitals and healthcare systems to increase their workforce capacity by removing barriers for physicians, nurses, and other clinicians to be readily hired from the local community as well as those licensed from other states without violating Medicare rules.

  • These healthcare workers can then perform the functions they are qualified and licensed for, while awaiting completion of federal paperwork requirements.

  • CMS is issuing waivers so that hospitals can use other practitioners, such as physician assistants and nurse practitioners, to the fullest extent possible, in accordance with a state’s emergency preparedness or pandemic plan. These clinicians can perform services such as order tests and medications that may have previously required a physician’s order where this is permitted under state law.

  • CMS is waiving the requirements that a certified registered nurse anesthetist is under the supervision of a physician. This will allow CRNAs to function to the fullest extent allowed by the state, and free up physicians from the supervisory requirement and expand the capacity of both CRNAs and physicians.

  • CMS also is issuing a blanket waiver to allow hospitals to provide benefits and support to their medical staff, such as multiple daily meals, laundry service for personal clothing, or child care services while the physicians and other staff are at the hospital and engaging in activities that benefit the hospital and its patients.

  • CMS will also allow healthcare providers (clinicians, hospitals and other institutional providers, and suppliers) to enroll in Medicare temporarily to provide care during the public health emergency.

Reducing paperwork:

  • CMS is temporarily eliminating paperwork requirements and allowing clinicians to spend more time with patients. Medicare will now cover respiratory-related devices and equipment for any medical reason determined by clinicians so that patients can get the care they need; previously Medicare only covered them under certain circumstances.

  • During the public health emergency, hospitals will not be required to have written policies on processes and visitation of patients who are in COVID-19 isolation. Hospitals will also have more time to provide patients a copy of their medical record.

  • CMS is providing temporary relief from many audit and reporting requirements so that providers, healthcare facilities, Medicare Advantage health plans, Medicare Part D prescription drug plans, and states can focus on providing needed care to Medicare and Medicaid beneficiaries affected by COVID-19.

  • This is being done by extending reporting deadlines and suspending documentation requests which would take time away from patient care.

Promote telehealth in Medicare:

  • Building on prior action to expand reimbursement for telehealth services to Medicare beneficiaries, CMS will now allow for more than 80 additional services to be furnished via telehealth. During the public health emergencies, individuals can use interactive apps with audio and video capabilities to visit with their clinician for an even broader range of services. Providers also can evaluate beneficiaries who have audio phones only.

  • These temporary changes will ensure that patients have access to physicians and other providers while remaining safely at home.

  • Providers can bill for telehealth visits at the same rate as in-person visits. Telehealth visits include emergency department visits, initial nursing facility and discharge visits, home visits, and therapy services, which must be provided by a clinician that is allowed to provide telehealth. New as well as established patients now may stay at home and have a telehealth visit with their provider.

  • CMS is allowing telehealth to fulfill many face-to-face visit requirements for clinicians to see their patients in inpatient rehabilitation facilities, hospice and home health.

  • CMS is making it clear that clinicians can provide remote patient monitoring services to patients with acute and chronic conditions, and can be provided for patients with only one disease. For example, remote patient monitoring can be used to monitor a patient’s oxygen saturation levels using pulse oximetry.

  • In addition, CMS is allowing physicians to supervise their clinical staff using virtual technologies when appropriate, instead of requiring in-person presence.

 

COA thanks CMS for telehealth expansion

The following is a statement from Ted Okon, executive director of the Community Oncology Alliance, on recent CMS expansions in light of COVID-19.

“The Community Oncology Alliance applauds the Centers for Medicare & Medicaid Services for new flexibilities to telehealth regulations and rules that will allow community oncology providers to dramatically expand safe cancer treatment during the COVID-19 global pandemic. This major expansion of telehealth services and relaxation of regulations provides a huge boost to the ability of community practices to care for patients with cancer whose treatment cannot stop.

“The new regulatory relief and rules from CMS are extensive and include the ability for providers to furnish 80 more services via telehealth and to bill for telehealth visits at the same rate as in-person visits. Additionally, CMS has made it clear that providers can now evaluate patients who have audio-only phone systems, an immense easing of burdens for those patients who might not have access to, or are not comfortable with, advanced technology.

“The COVID-19 pandemic has forced a major reorganization and restructuring of cancer care in America. CMS’ rapid response to the crisis in recent weeks means that patients with cancer, many of whom are Medicare seniors with compromised immune systems that are most at risk of infection, can continue to receive cancer treatments while staying safe.

“For example, thanks to telehealth, a community oncology practice in Oregon has been able to treat an 81-year-old patient with a new diagnosis of acute myeloid leukemia. That person is being managed remotely, with labs drawn at the patient’s residence center. Weekly virtual telehealth meetings allow the physician to track how the patient is doing, ensuring they receive needed cancer care in a safe, cost-efficient setting.

“A community oncology practice in North Texas also reports that telemedicine is allowing it to spare rural patients with long drives into urban areas that have seen COVID-19 outbreaks. This is not only reducing lengthy travel times but also greatly reduces their risk of exposure to the virus. Just this week, because of the new Medicare telehealth policies, the practice has been able to help a new patient with liver disease avoid a 133-mile drive as well as coordinate with other specialists for their cancer care.

“Community oncology can’t thank CMS and Administrator Seema Verma enough for quickly moving these changes forward that will dramatically help oncology providers diagnose and monitor their patients safely during the COVID-19 pandemic. CMS has demonstrated an amazing ability to cut through the red tape of Medicare bureaucracy and speed up these critically important changes. They are right on target in providing a veritable lifeline to Americans who are struggling with cancer in the midst of crisis.

“Across the country, independent community oncology practices have risen to the challenge of the COVID-19 pandemic and continue to serve as cancer care providers for millions of patients. As the providers of cancer care to the majority of patients in America, now more than ever, it is crucial that community oncology practices stay open and active for patients as cancer and cancer care do not stop during times of national emergencies. The expansion of telehealth options and reduction of regulatory burdens are important steps that allow practices to do that while also keeping patients safe and healthy.”

 

LLS, partners commit $4.5M for blood cancer patients impacted by COVID-19

The Leukemia & Lymphoma Society and its partners developed the LLS COVID-19 Patient Financial Aid Program to provide $250 for eligible blood cancer patients struggling with the economic hardship because of COVID-19.

Amgen, Inc., Bristol Myers Squibb Foundation, Foundation Medicine, Inc., Genentech, a member of the Roche Group, Incyte, MorphoSys Foundation, Servier Pharmaceuticals, Subaru of America, Inc., and Takeda Oncology are contributing to the program.

“Along with our partners, we anticipated that blood cancer patients would need help with non-medical expenses such as food and other household needs, and housing and transportation,” Louis J. DeGennaro, LLS president and CEO, said in a statement. “And we aim to raise up to $10 million to help even more patients during this crisis.”

LLS is providing free educational resources and support to patients through a series of blogs, webinars and chats led by medical professionals.

LLS is soliciting donations for the program. All donations contribute to LLS’s mission to find cures for blood cancers and to ensure patient access to care.

 

PharmaMar submits phase II clinical trial of Aplidin treatment of COVID-19 to the Spanish Medicines Agency

The APLICOV clinical trial protocol for Aplidin (plitidepsin) was submitted to the Spanish Medicines and Healthcare Products Agency.

PharmaMar sponsors the multicenter, randomized phase II clinical trial, in which two different doses of plitidepsin will be evaluated for the treatment of patients with COVID-19 pneumonia. The protocol is currently being evaluated.

The protocol includes 160 patients admitted to hospitals in Spain, where it is intended to assess whether plitidepsin, administered intravenously for 5 days to patients with COVD-19 pneumonia, reduces the proportion of patients who progress to Acute Respiratory Distress Syndrome, the main cause of patients requiring mechanical ventilation and/or admission to intensive care units.

Several Spanish centers are due to participate in the study and which is expected to start as soon as the authorization from the health authorities is obtained.

On March 13, PharmaMar announced the results of in vitro studies of plitidepsin in human coronavirus HCoV-229E, with a mechanism of multiplication and propagation that is very similar to that of SARS-CoV-2. The studies were carried out at the National Biotechnology Centre of the Spanish National Research Council by Luis Enjuanes, Sonia Zúñiga and Isabel Solá.

“As soon as we receive authorization from the AEMPS, we will be able to start the clinical trial with plitidepsin and we hope that it can become an effective weapon against COVID-19,” José María Fernández, president of PharmaMar, said in a statement.

Plitidepsin acts by blocking the protein eEF1A, present in human cells, which is used by SARS-CoV-2 to reproduce and infect other cells. By means of this blocking, the reproduction of the virus inside the cell is prevented, making its propagation to the rest of the organism’s cells, not feasible.

 

Study: Patients with new-onset digestive symptoms after possible COVID-19 contact should be suspected for the illness

A unique subgroup of patients who have COVID-19 with low severity disease experienced digestive symptoms, most notably diarrhea, according to a study published in The American Journal of Gastroenterology.

The authors, from Union Hospital and Tongji Medical College in Wuhan, China, report that these digestive ailments presented themselves as early symptoms of COVID-19 in some patients.

“This study is vital because it represents the 80% or more of patients who do not have severe or critical disease,” Brennan M.R. Spiegel, co-editor-in-chief of The American Journal of Gastroenterology, said in a statement. “This is about the more common scenario of people in the community struggling to figure out if they might have COVID-19 because of new-onset diarrhea, nausea, or vomiting.”

The analysis included 206 patients with low severity COVID-19, including 48 presenting with a digestive symptom alone, 69 with both digestive and respiratory symptoms, and 89 with respiratory symptoms alone.

Key Findings:

  • There is a unique subgroup of COVID-19 patients with low severity disease marked by presence of digestive symptoms.

  • These patients are more likely to test positive in stool for COVID-19 RNA, to have a longer delay before viral clearance, and to experience delayed diagnosis compared to patients with respiratory symptoms but no digestive symptoms.

  • In some cases, the digestive symptoms, particularly diarrhea, can be the initial presentation of COVID-19, and may only later or never present with respiratory symptoms or fever.

  • Importantly, only two-thirds of people in this study had a fever, meaning it is not even necessary to have a fever to suspect the diagnosis.

  • These data emphasize that patients with new-onset digestive symptoms after a possible COVID-19 contact must be suspected for the illness, even in the absence of cough, shortness of breath, sore throat, or fever.

 

Convalescent plasma donations to be collected by Versiti Blood Centers to treat COVID-19 patients

Versiti Inc. in early April plans to collect plasma from recovered COVID-19 patients to help treat others with the virus.

The blood-related treatment—approved by the FDA as an Emergency Investigational New Drug —would be used by hospitals for the most severely affected patients.

Versiti blood centers is working with partner hospitals to identify recovered patients. As per the guidelines, hospitals must request FDA approval and work within the EIND guidelines, or other approved IND, in order to treat coronavirus patients with plasma. Donors would be referred to Versiti through hospitals, or the recovered patients’ physicians.

“The potential donors must first be proven to have had a COVID-19 diagnosis through a positive lab test result, and must then have a negative test result 14 days after recovering from symptoms,” Versiti Senior Medical Director Dan A. Waxman said in a statement. “It’s a very collaborative effort with our hospital partners who will be working to identify and verify the donors.”

Versiti hopes to implement the coronavirus plasma collection program in early April. The donated plasma will be provided directly to the hospitals with whom Versiti is partnering.

“Many of our hospital partners have already requested the donations,” Waxman said. “They are anxious to begin the program.”

The plasma treatment would transfer the antibodies that the recovered patient created into critically ill patients currently receiving care. Because of the investigational nature of this treatment, it is difficult to know just how many plasma infusions a COVID-19 patient may require, Waxman said.

Plasma donations take about 30 to 40 minutes and will be collected at Versiti donor centers in Illinois, Indiana, Michigan, Ohio and Wisconsin. The donation process is the same as with other plasma donations, and will be performed using an apheresis machine.

Though blood group AB is the universal plasma donor, any blood type donor who has recovered from the virus is eligible to donate as part of the program.

Versiti is working with Froedtert Hospital and the Medical College of Wisconsin, under the direction of Gilbert White, Versiti executive vice president for research and chief science officer and professor at MCW, who is serving as the primary investigator, and Mary Beth Graham, medical director of Infection Prevention & Control at Froedtert Hospital, and associate chief of the Division of Infectious Disease at MCW, to support a research study related to plasma infusion.

“This is a very important joint effort that we are undertaking which will benefit every hospital system in the state of Wisconsin and beyond,” White said.

The research project involves a clinical trial component with recovered coronavirus patients, who will be referred by hospitals.

 

Metastatic breast cancer patient tests negative for COVID-19

Janice Cowden, a Florida resident who has metastatic breast cancer and symptoms of the novel coronavirus, has tested negative for COVID-19 after a lengthy process that involved being denied testing multiple times—despite her vulnerable status (The Cancer Letter, March 20).

Cowden, 62, was worried about having potentially exposed other patients at a fundraising event in late February. Two weeks ago, on March 21, she finally received a test. To be exact, she received two tests—one at a curbside testing facility, and one at her primary care provider.

It took 13 days for Cowden to receive the results from both tests. “The upside of two negative tests is that MD Anderson might be less likely to reschedule my PET/CT/Onc appointments again,” Cowden said.

Cowden’s symptoms have mostly subsided after a full month of not knowing whether she put others at risk. The delay indicates a nationwide response to COVID-19 that can be best described, in Cowden’s words, as “a total shit show.”

“That’s usually what we call metastatic breast cancer—just a total shit show. It’s very valid to use that term in relation to this virus too, because it truly is that,” Cowden said.

Cowden first developed symptoms of COVID-19 in early March—severe coughing, labored breathing, aches and a high fever of 103. There was a delay in testing, because her primary care physician and the emergency room didn’t have any tests.

“This whole experience has been one of extreme frustration and disappointment for me. There are so many other people who are just at the beginning of this,” Cowen said. “Clearly they’re not going to be getting their results, unless they’re inpatient, any faster—or unless they’re a health care worker at a facility.”

In Florida, where there are upwards of 8,000 confirmed cases of the virus, Gov. Ron DeSantis issued a statewide stay-at-home order April 1. On the day Cowden sought treatment at the ER at the direction of her primary care physician, her community held a St. Patrick’s Day celebration.

“It’s just so widespread in Florida. So, I look at this and I think, why is it so difficult for Americans in general to do what we need to do to lessen the spread of the disease?” Cowden said. “Those of us who’ve been immunocompromised due to disease treatment for breast cancer are used to having to socially isolate. If they could just do it for a short time, then it would change that entire trajectory pattern.”

 

FAQs and Guidances

Federal government:

Professional societies:

  • American Society of Clinical Oncology FAQ: Emerging issues and challenges in caring for patients with cancer during the coronavirus pandemic

  • American Cancer Society FAQ: Common questions about the new coronavirus outbreak

  • Society for Immunotherapy of Cancer Resources: Patient management and basic and translational research

  • Community Oncology Alliance resources: Coronavirus (COVID-19) practice resources and protocols

  • Leukemia & Lymphoma Society FAQ: Resources and what you should know about the coronavirus

  • American Society for Radiation Oncology FAQ: COVID-19 recommendations and information

  • American College of Surgeons resources: For the surgical community

  • Society for Immunotherapy of Cancer resources: Implications for patients, translational research

  • American Society for Transplantation and Cellular Therapy resources

  • European Blood and Marrow Transplantation Society recommendations

  • World Marrow Donor Association resources

Research centers:

  • St. Jude Children’s Research Hospital FAQ: COVID-19 and children with cancer

  • Journal of the National Comprehensive Cancer Network: How to manage cancer care during COVID-19 pandemic

 

This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.

Copyright (c) 2020 The Cancer Letter Inc.