publication date: Mar. 27, 2020
ASCO 2020 annual meeting goes virtual
The annual meeting of the American Society of Clinical Oncology will go virtual this year, the society announced March 24.
“As public health safety measures related to COVID-19 extend, the ASCO board has concluded that the annual meeting, scheduled for May 29-June 2 in Chicago, cannot occur in person as planned,” ASCO said in a statement.
“That is why we still intend to deliver the latest cancer science to the global community during the annual meeting timeframe using a virtual format that respects the contributions of the authors and the work of the Scientific Program Committee,” the statement said. “Information on the format, dates, specific content, registration, refunds, and many other details will be available in the coming weeks and posted on am.asco.org.”
Abstracts will be published online and in the Journal of Clinical Oncology, though ASCO’s educational program will not take place within the virtual annual meeting setting.
“As we confront this extraordinary situation, the health and safety of members, staff, and individuals with cancer—in fact, the entire cancer community—is ASCO’s highest priority,” Richard L. Schilsky, executive vice president and chief medical officer of ASCO, wrote a guest editorial in The Cancer Letter March 18 (The Cancer Letter, March 18).
ASCO’s statement on its virtual annual meeting is posted here.
Congress passes coronavirus relief bill, slating $4.3B for CDC, $3.5B for BARDA, $945M for NIH, $80M for FDA
The House of Representatives March 27 passed a $2 trillion coronavirus relief package to “prevent, prepare for, and respond to coronavirus, domestically or internationally.” The bill appropriates pandemic response funds in the following amounts: $4.3 billion for CDC, $945.4 million for NIH, $80 million for FDA, and $200 million for CMS.
The Senate voted to approve the legislation 96-0 on March 25. President Donald Trump is expected to sign the bill immediately. The Coronavirus Aid, Relief and Economic Security (CARES) Act is the largest economic stimulus measure to date in U.S. history.
The bill provides $3.5 billion to the Biomedical Advanced Research and Development Authority “for necessary expenses of manufacturing, production, and purchase … of vaccines, therapeutics, diagnostics, and small molecule active pharmaceutical ingredients, including the development, translation, and demonstration at scale of innovations in manufacturing platforms.”
Here’s a breakdown of the allocations by agency, institute, and program:
Centers for Disease Control and Prevention: $4.3 billion
$1.5 billion for states etc. to “carry out surveillance, epidemiology, laboratory capacity, infection control, mitigation, communications, and other preparedness and response activities”
$500 million for “global disease detection and emergency response”
$500 million for “public health data surveillance and analytics infrastructure modernization”
$300 million for the Infectious Disease Rapid Response Reserve Fund
National Institutes of Health: $945.4 million
National Institute of Allergy and Infectious Diseases: $706 million, of which $156 million is allocated for “vaccine and infectious diseases research”
National Heart, Lung, and Blood Institute: $103.4 million
National Institute of Biomedical Imaging and Bioengineering: $60 million
National Center for Advancing Translational Sciences: $36 million
Office of the Director: $30 million
National Library of Medicine: $10 million
Food and Drug Administration: $80 million
Salaries and Expenses: $80 million, including funds “for the development of necessary medical countermeasures and vaccines, advanced manufacturing for medical products, the monitoring of medical product supply chains, and related administrative activities.”
Centers for Medicare and Medicaid Services: $200 million
Substance Abuse and Mental Health Services Administration: $425 million
NCI on the state of clinical trials, funding
The following are statements from NCI on the state of clinical trials and funding during the COVID-19 pandemic.
“Cancer patients are particularly vulnerable to infectious diseases such as COVID-19, both because of their underlying health condition and because cancer treatments can suppress the immune system. At this time, we do not know how the COVID-19 pandemic will evolve or the extent to which it will place stress on cancer patients, their families, and their caregivers.
“The Centers for Disease Control and Prevention and other public health experts have provided authoritative advice on how individuals can protect themselves. Patients should seek advice from their health care providers regarding their individual care and whether they should be tested for COVID-19.
“A patient’s health care team is best suited to evaluate that individual’s unique situation and advise on the safest course of action. As more information becomes available on mitigation strategies from physicians caring directly for cancer patients, that information will be shared broadly in the oncology community. For example, researchers at the Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center, and the University of Washington have published information about managing cancer care during the COVID-19 pandemic, and NCI is closely monitoring the clinical experience of cancer caregivers across the world.
“For individuals undergoing treatment for cancer, the spectrum of acute need for cancer treatment is broad. In some situations, it is essential that patients receive treatment immediately for their cancer. In other situations, such as for patients who are not receiving active treatment, visits for follow-up cancer care may be safely delayed. Patients should discuss individual treatment plans with their health care team.
“During the challenging situation of the COVID-19 pandemic, we understand that health care system resources will be limited, and this may affect cancer clinical trial operations. We do, however, believe that there are circumstances (e.g., in order to access potentially life-saving therapy) where patients with cancer should enroll or continue to participate in a clinical trial. Advice given to patients participating in clinical trials should be tailored to the individual patient based on their clinical circumstances.
“On March 18, the Food and Drug Administration issued guidance on the conduct of clinical trials of medical products during the COVID-19 pandemic. In addition, NCI has provided guidance for clinical trials’ activities during the COVID-19 pandemic, with the intent of giving greater flexibility to the patient and their caregiver so that they may more easily be treated on a clinical trial if indicated.
“We continue to closely monitor NCI-supported clinical trials to help address the needs of investigators to implement accommodations so that they can, to the greatest extent possible, maintain continuity of care for their patients who are being treated on trials. If a clinical trials site’s policies and practices vary from the guidance we have outlined, they are encouraged to contact NCI’s Cancer Therapy Evaluation Program.”
NCI’s Sharpless vows to support extramural research through crisis
NCI Director Ned Sharpless issued a statement outlining NCI’s strategy for responding to the COVID-19 pandemic:
“As we understand so well, biomedical research improves public health through scientific discovery. The COVID-19 pandemic only reinforces the importance of our work and the work of so many others who are dedicated to protecting and improving public health. I want to assure you that NCI, in partnership with NIH, is taking affirmative steps to support the extramural cancer research enterprise during this challenging time.
“I encourage you to read the recent post on NIH’s Open Mike blog about NIH operations during this public health emergency. NIH has established a comprehensive resource with guidance for grant applicants and funding recipients on NIH grant operations. I also recommend checking this resource often over the coming weeks, as additional notices will be posted on a regular basis.
“At NCI, we are committed to sustaining progress against cancer, now and always. With this commitment in mind, earlier this month I asked NCI Principal Deputy Director Doug Lowy, M.D., to lead an NCI task force with a broad mandate, which includes maintaining the continuity of NCI operations during this public health emergency, including operations that support NCI extramural research.
“I am also deeply involved, working with other NIH institute directors and our colleagues at the Department of Health and Human Services as we respond to evolving developments related to COVID-19. NCI employees continue to work, many teleworking from home, to sustain our interactions with the extramural community.
“With that background, let me share a few updates on NCI extramural operations given the rapidly evolving situation we are witnessing.
“The NCI Division of Extramural Activities will ensure that all previously scheduled peer review meetings proceed using one of three alternate meeting formats that NIH identified: telephone-assisted, virtual, or video-assisted. Reviewers can find more information on these formats on the NIH Tools and Technology web page.
“If you are participating in the peer review of applications submitted to NCI, we ask you to please be flexible about the scheduling and the meeting format so that incoming applications can continue to be reviewed in a timely way.
“Once peer review is complete and grant applicants have access to summary statements, applicants should contact the appropriate NCI program director. Applicants will find contact information for the program director in the top left corner of the summary statement.
“If you are not sure whom to contact, the appropriate contact for your application can be found on our Grants & Training webpage.
“If you have questions regarding grant applications you submitted, please pose your questions through eRA Commons.
“The NCI Office of Grants Administration continues to issue grant awards, revisions, and post-award actions. NCI staff will be following the NIH guidance on coronavirus administrative flexibilities related to grant awards.
“If you have questions about your awarded grant, please contact the grants management specialist listed on your Notice of Award. If you aren’t sure who your assigned specialist is, please visit Grants Management Contacts on our Grants & Training webpage.
“Although we are facing truly exceptional circumstances, in the United States and globally, I am confident that we will weather this crisis together and grow stronger as an international cancer community. And let me also express my heartfelt gratitude for your continued dedication to your work and our nation’s health during these trying times.”
AACI urges immediate implementation of Defense Production Act
The Association of American Cancer Institutes has urged President Donald Trump to invoke the Defense Production Act to forcefully confront the COVID-19 emergency.
The letter, dated March 23, follows:
“Dear Mr. President:
“As the directors of 97 leading academic cancer centers in the U.S., we are responsible for treating a particularly vulnerable patient population. Many of our patients are immunosuppressed, and most have serious comorbidities. Consequently, they are particularly susceptible to having serious complications and poor outcomes from SARS-CoV2 infection (which causes COVID-19).
“In fact, some of our patients have already contracted this virus and died from respiratory failure. Furthermore, our patients generally require frequent interactions with health care providers, who are being increasingly affected themselves with COVID-19 or are being seconded to assist in the treatment of COVID-19 patients.
“Our physicians and advanced practice personnel are witnessing firsthand the increasing strain on our healthcare systems, most notably the widespread shortage of personal protective equipment, such as surgical and N95 masks, gowns, nasal swabs, and face shields, as well as advanced life support systems, such as ventilators and ECMO devices. In a word, the situation is already desperate in many of our hospitals, and rapidly edging towards utter disaster.
“For this reason, we implore you to immediately invoke and utilize the Defense Production Act to marshal the power of American manufacturing to address the COVID-19 emergency. We also request that you mobilize units of our military, such as the Army Corps of Engineers to aid in rapid construction of temporary hospital facilities and military medical personnel to assist and relieve our front-line emergency room and intensive care unit personnel.
“The full scope of this emergency is only beginning to be apparent, but it is already clear that there is not a second to lose. Failure to act decisively and immediately will undoubtedly result in the tragic, massive, and ultimately avoidable loss of many American lives.
“Thank you very much for considering our request.”
Nebraska Medicine develops method to reuse personal protective equipment
In light of the national shortage of one-use personal protective equipment, Nebraska Medicine has developed a safe and effective method to decontaminate these items so they can be used multiple times.
A team led by John Lowe, UNMC assistant vice chancellor for inter-professional health security training and education, is using ultraviolet light towers to irradiate high numbers of masks, which were originally designed to only be used once. The strategy will allow Nebraska Medicine to greatly extend its supply of these items during the coronavirus pandemic.
“The shortage of PPE is a nationwide issue—each and every one of these items is increasingly precious,” Mark Rupp, chief of the infectious diseases division at UNMC, said in a statement. “Although we were well prepared, our supplies were beginning to dwindle. We had to find a way to keep our providers and patients safe, and this will definitely help us achieve that goal.”
The decontamination of these items works like this: groups of masks are safely bagged and transported to a room inside the hospital which is equipped with two ultraviolet light towers. The PPE is hung on wires stretching the length of the room and then decontaminated when the lights are powered on. The items are then removed and returned to the original owners for reuse.
“The shortage has forced us to be innovative,” Lowe said. “While these items weren’t meant to be used more than once, this is a 100% safe way to extend their useful life. Other major hospital systems in the U.S. have also started to implement this method for the same reason we are.”
Nebraska Medicine infectious disease experts release open-access book on quarantine and isolation
Four University of Nebraska Medical Center physicians who also have roles in the Global Center for Health Security at UNMC/Nebraska Medicine, recently released an open-access book about quarantine.
The book, published before the onset of the coronavirus pandemic, is available through Amazon and the University of Nebraska Press.
“Nebraska Isolation and Quarantine Manual,” the book, shares practical aspects of why, how and when to apply quarantine and isolation for conditions that warrant care in biocontainment or quarantine. It also includes the history of quarantine and its legal and ethical considerations.
The book was written and edited from lessons learned at UNMC during the West Africa Ebola virus outbreak.
The authors say the book is especially useful for medical, nursing and public health personnel who work in medical centers, clinics and in the community, as well as for students in the health professions.
Ted Cieslak, Mark Kortepeter, Christopher Kratochvil, and James Lawler, co-edited the book. The book covers historical and legal aspects of quarantine and isolation on high-consequence infectious diseases that might be considered for specialized care in a biocontainment unit.
“Given our experience in managing Ebola during the West African outbreak, the fact that we possess the nation’s largest biocontainment unit, and we just opened the nation’s first (and only) federal quarantine facility, we felt that we possessed the unique expertise necessary to produce such a book,” Cieslak, medical director of the National Quarantine Unit at UNMC/Nebraska Medicine, said in a statement. “Despite the voluminous nature of the medical literature, we could find no other text designed to be a practical resource for clinicians, policy makers and public health officials in the field. We felt it was incumbent upon us to write one.”
“We had no idea how timely the book arrival would be, given the current COVID-19 pandemic. We are pleased this might be beneficial for medical personnel across the world in a time of need,” Kortepeter, professor of epidemiology in the UNMC College of Public Health, said in a statement. “There is not a lot of specific information about what diseases quarantine should and should not apply to, which is what makes this document even the more useful.”
NSGC urges Congress to recognize genetic counselors
Patients with Medicare and Medicaid coverage are unable to receive genetic counseling through telehealth, and The National Society of Genetic Counselors is urging Congress to act.
The state of emergency caused by the COVID-19 pandemic is causing genetic counseling clinics to close down and convert to telehealth practices. At the same time, Genetic counselors are not recognized by Centers for Medicare & Medicaid Services, the society said.
NSGC asks that CMS waive the “incident to” requirement for genetic counselors, and allow certified genetic counselors to provide remote services by phone to Medicare and Medicaid beneficiaries.
NSGC is urging Congress to recognize genetic counselors under the Social Security Act, by enacting H.R. 3235. NSGC is requesting a Section 1135 waiver to ensure there isn’t a disruption of these genetic services.
Breast cancer patient featured in The Cancer Letter receives testing for COVID-19, awaits results
Last week, The Cancer Letter spoke with Janice Cowden, a patient with metastatic breast cancer and symptoms of COVID-19—who was denied testing despite being especially vulnerable to the disease (The Cancer Letter, March 20).
Cowden has since received two tests for COVID-19—a nasopharyngeal swab at a curbside clinic, and a throat pharyngeal swab at the office of her primary care physician. She has yet to receive the results of either test.
Prior to developing symptoms, Cowden had attended a fundraiser with about 300 people—including dozens of women with metastatic breast cancer.
NCI Emergency Resources: What people with cancer should know about the coronavirus
NCI guidance: Interim guidance for patients on clinical trials supported by the NCI Cancer Therapy Evaluation Program (CTEP) and the NCI Community Oncology Research Program (NCORP).
FDA guidance: Conduct of clinical trials of medical products during COVID-19 pandemic
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
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.