FDA issues advisory on off-label use of hydroxychloroquine and chloroquine

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FDA has issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19, for which they are not approved by the FDA.

These risks, which are in the drug labels for their approved uses, may be mitigated when health care professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial, as indicated in the Emergency Use Authorization for these drugs to treat COVID-19.

“We understand that health care professionals are looking for every possible treatment option for their patients and we want to ensure we’re providing them with the appropriate information needed for them to make the best medical decisions,” FDA Commissioner Stephen M. Hahn said in a statement. “While clinical trials are ongoing to determine the safety and effectiveness of these drugs for COVID-19, there are known side effects of these medications that should be considered. We encourage health care professionals making individual patient decisions closely screen and monitor those patients to help mitigate these risks. The FDA will continue to monitor and investigate these potential risks and will communicate publicly when more information is available.”

The FDA has issued an EUA to allow hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile to be distributed and used in limited circumstances, such as for certain hospitalized patients with COVID-19.

These drugs are able to be distributed from the SNS to states for doctors to prescribe to adolescent and adult patients hospitalized with COVID-19, as appropriate, when a clinical trial is not available or feasible. The EUA requires that fact sheets with important information about using these drugs in treating COVID-19, including the known risks and drug interactions, as well as appropriate screening and monitoring, be made available to health care providers and patients.

Hydroxychloroquine and chloroquine are FDA-approved to treat or prevent malaria. Hydroxychloroquine sulfate is also FDA-approved to treat lupus and rheumatoid arthritis. These medicines have not been proven safe or effective for treating COVID-19.

However, clinical trials are underway and additional trials are being planned to determine if these drugs can benefit patients with COVID-19. These trials are also examining whether the drugs can prevent COVID-19 among health care workers, first responders or people who have been in close contact with someone with COVID-19.

AACI’s CRI annual meeting goes virtual

The Association of American Cancer Institutes’ Clinical Research Innovation program has moved its July 7-8 annual meeting to a virtual format.

“The health and well-being of AACI meeting attendees, exhibitors, and cancer center patients is our top priority,” AACI said in a statement. “As we plan our 2020 meetings, we are closely monitoring the coronavirus pandemic—particularly the impact of COVID-19 on travel and professional conferences.

“We believe this decision will allow us to deliver the innovative, quality education our members expect from the CRI annual meeting, while prioritizing the health and safety of attendees.”

The association said it plans to announce information on registration and virtual sessions in the coming weeks.

Reagan-Udall Foundation and Friends of Cancer Research form COVID-19 Evidence Accelerator focused on RWE

The Reagan-Udall Foundation for the FDA and Friends of Cancer Research, created the Evidence Accelerator, a public-private partnership combining the efforts of academic, government, and private sector organizations applying data analytics to accelerate the understanding of COVID-19.

Mobilizing major data organizations, government and academic researchers, and health systems, the Evidence Accelerator builds on the work of its partners to maximize the use of real-world data. Contributing researchers will engage in weekly meetings to present and critically discuss findings from different data sources. In addition, the Evidence Accelerator will facilitate parallel analyses of questions to identify patient characteristics, treatment patterns, and management strategies for COVID-19.

Western NY researchers study COVID-19 using NGS to identify immune response biomarkers

Western New York health care and medical researchers are conducting a study that will use next-generation sequencing to identify biomarkers of immune response to COVID-19 that could be used to predict which patients are likely to progress to severe infection that would require more intensive care.

The goal is to provide medical professionals with a blood test that will help them to better prognose and triage patients with COVID-19. The study, the Western New York Immunogenomic COVID-19 Study, is conducted by Roswell Park Comprehensive Cancer Center, Catholic Health and the University at Buffalo.

The WNY Immunogenomic COVID-19 study originated from an exchange between two senior leaders at Roswell Park: Kunle Odunsi, and Carl Morrison.

“We believe we can limit COVID-19’s deadly impact by marrying thoughtful strategy to next-generation sequencing technology—an opportunity that we never had before with any previous pandemic, using technology that in a few short years has changed the way we detect, diagnose and treat cancer,” Odunsi, deputy director, the Robert, Anne & Lew Wallace Endowed Chair in Cancer Immunotherapy, and chair of Gynecologic Oncology at Roswell Park, said in a statement.

“We’ve seen a huge variation in how COVID-19 affects people. Some are not sick at all, some get flu-like symptoms for a few days, and some become very sick and develop symptoms that can become life-threatening,” Morrison, who is senior vice president of Scientific Development and Integrative Medicine at the cancer center, said in a statement.

Three collaborating organizations will work with Roswell Park:

  • Catholic Health will join Roswell Park as a clinical site for the study, providing blood from consenting patients who test positive for COVID-19 to be sequenced and analyzed.

  • The University at Buffalo, through its Jacobs School of Medicine and Biomedical Sciences and School of Pharmacy and Pharmaceutical Sciences will focus on the interface of virus-cancer-immunology research initiatives that will help facilitate the study.

  • Thermo Fisher Scientific will provide data analysis and defray the costs of the equipment and chemical reagents that are central to this work.

Gene Morse, SUNY Distinguished Professor, UB School of Pharmacy and Pharmaceutical Sciences, and director of the Global Virus Network Center of Excellence at The University of Buffalo, is building scientific collaborations that focus on the interface of virus-cancer-immunology research initiatives that will facilitate the study. He will examine the blood samples of COVID-19 patients for immune-pharmacodynamic markers to quantify antiviral and immune-therapeutics activity in relation to the stages of COVID-19 infection and the development of antibodies following infection.

The team will sequence immune receptors from both T cells and B cells, the two major types of immune cells our bodies enlist in order to fight off viruses like SARS-CoV-2, the particular coronavirus that causes COVID-19.

A fund has been established to support the initiative, with 11 Day Power Play Inc., a nonprofit that raises funds for pressing medical research. It has provided a leadership gift of $150,000 toward the project’s estimated cost of $1 million.

Funds donated to Roswell Park’s COVID-19 Response Fund: give.roswellpark.org/COVID-19.

Invitae develops tools to support telemedicine

Invitae has developed tools to help health care workers order genetic testing via telemedicine for patients with cancer and newly pregnant women.

Invitae’s clinical chatbot, Gia, provides telemedicine genetic testing framework that helps identify patients who need germline genetic testing.

Clinicians are turning to telemedicine for patients who face disruptions to clinic visits, such as women who are newly pregnant or patients with cancer. Adapting to remote care requires tools that make it easier to replace tasks that were previously handled in-person, such as patient education or information gathering. Invitae has added new telehealth workflows to Gia for clinicians.

“Genetic testing plays an important role in clinical care. We’ve expanded Gia’s capabilities to give clinicians a virtual go-between that can handle many elements of patient education, identification and information gathering involved in genetic testing,” Robert Nussbaum, chief medical officer of Invitae, said in a statement. “Coupled with our ability to ship test kits to and from a patient’s home that use saliva and do not require phlebotomy, we can help clinicians continue to provide care from afar.”

Gia stands for “genetic information assistant” and streamlines communication between patients and clinicians. It automates pretest education and genetic testing. Gia is HIPAA-compliant and SOC-2 certified. It also has a 92% satisfaction rate.

Gia includes patient identification, pre-test education, post-test support and automated documentation that is available 24/7. Gia can also help identify patients that may be at increased risk for breast, endometrial, ovarian, pancreatic, colon and prostate cancer and may benefit from genetic testing as a screening tool.

Kennedy, former FDA commissioner and Stanford president, dies of COVID-19

Donald Kennedy, who served as FDA commissioner from 1977 to 1979, died this week of complications resulting from COVID-19. He was 88.

“I am sad to inform you of the passing of former FDA Commissioner Donald Kennedy, Ph.D., who passed away this week from complications resulting from COVID-19,” FDA Commissioner Stephen M. Hahn said in a statement. “Kennedy was a widely-recognized researcher, an admired teacher, an astute administrator, and a firm believer in the importance of public service. He leaves an impressive and inspirational legacy. Words cannot express enough how much we value the contributions Dr. Kennedy made to public health.

“As we all cope with this pandemic, his passing strikes close to home.

“Under his leadership, the agency warned the public about, and seized as an illegal drug, the popular but ineffective cancer treatment, Laetrile. He also led the agency as it faced widespread reaction to the attempted ban of saccharin under the Food Additives Amendment. Among his accomplishments, Dr. Kennedy implemented the 1976 Medical Device Amendments; pursued a concerted—though in the end unsuccessful—effort to pass a comprehensive Drug Regulation Reform Act (though many provisions of that effort eventually found their way into the law); proposed restrictions against the use of antibiotics in animal feed; and removed, under the Secretary’s order, the antidiabetic drug, phenformin, as an imminent hazard under the law—the first time that provision had been applied.”

After he left the FDA, Kennedy returned to Stanford University as vice president for academic affairs and provost and then, from 1980 to 1991, served as president. He served as editor-in-chief of the journal Science from 2000 to 2008.

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 Association for Cancer Research FAQ: Information on virtual annual meetings

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

  • National Coalition for Cancer Survivorship webinar with Otis Brawley

  • 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

  • Joint recommendations for treatment of patients with breast cancer

  • American College of Surgeons resources: For the surgical community

  • Multiple Myeloma Research Foundation resources

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

  • GO2 Foundation for Lung Cancer resources

  • Adolescent and young adult resources

  • American Society for Transplantation and Cellular Therapy resources

  • European Blood and Marrow Transplantation Society recommendations

  • World Marrow Donor Association resources

  • National Institute for Health Care Management Foundation 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


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