Food and Drug Administration coronavirus update: May 1, 2020

May 1, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:

  • Today, the FDA issued an Emergency Use Authorization (EUA) for the investigational antiviral drug remdesivir. The EUA allows for remdesivir to be distributed in the U.S. and administered by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator. Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use. For more information see: news releaseHealth Care Provider Fact Sheet and Patient Fact Sheet.
  • Today, the FDA updated its guidance on convalescent plasma and associated web page. The updated guidance provides clarification for investigators on how to submit investigational applications for COVID-19 convalescent plasma. In addition, the guidance includes updated information regarding potential donors. Previously, the FDA’s guidance noted that to qualify, individuals should have complete resolution of symptoms for 28 days or resolution for 14 and a negative diagnostic test. The revised guidance recommends that individuals  have complete resolution of symptoms for at least 14 days prior to donation A negative lab test for COVID-19 disease is not necessary to qualify for donation. The revised guidance also clarifies that FDA does not recommend storing a retention sample from the convalescent plasma donation for single patient emergency INDs.
  • To help address shortages of continuous renal replacement therapy (CRRT) products during the COVID-19 public health emergency, today the FDA issued an EUA to Fresenius Medical Care for emergency use of the multiFiltrate PRO System and multiBic/multiPlus Solutions. CRRT is a type of dialysis therapy used to filter and clean the blood when the kidneys are damaged or are not functioning normally. The Fresenius multiFiltrate PRO System and multiBic/multiPlus Solutions have been authorized to provide CRRT to treat patients in an acute care environment during the COVID-19 public health emergency.
  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 380 test developers who have said they will be submitting EUA requests to the FDA for tests that detect the virus.
    • To date, the FDA has issued 54 individual EUAs for test kit manufacturers and laboratories. In addition, 23 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
    • The FDA has been notified that more than 235 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
    • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.
  • The FDA included, under the ventilator emergency use authorization (EUA), a ventilator developed by the National Aeronautics and Space Administration (NASA), which is tailored to treat patients with COVID-19. The ventilator was added to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator EUA that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic. The NASA VITAL (Ventilator Intervention Technology Accessible Locally) is intended to last three to four months and is specifically tailored for patients with COVID-19, by providing respiratory support for patients that are experiencing respiratory failure or insufficiency. The device is designed to be built with components outside the current medical device supply chain and therefore does not impact the existing supply chain of currently made ventilators.
  • The FDA issued a Consumer Update, Helpful Questions and Answers about Coronavirus (COVID-19) and Your Pets, that provides answers to frequently asked questions. Based on the limited information available to date, the risk of pets spreading the virus that causes COVID-19 in people is considered to be low. At this time, there is no evidence that animals play a significant role in spreading the virus that causes COVID-19. There is a small number of animals around the world reported to be infected with the virus that causes COVID-19, mostly after having close contact with a person with COVID-19.
  • Today, the FDA issued a guidance highlighting flexibility under the Drug Supply Chain Security Act (DSCSA). This guidance is intended to facilitate the distribution of prescription drug products needed to respond to COVID-19, including drugs to treat symptoms of COVID-19. During the COVID-19 emergency, the DSCSA requirements related to certain product tracing and product identification activities, and wholesale distribution, do not apply to qualifying distribution activities. This flexibility balances the need for effective distribution of products under emergency conditions with protecting consumers from exposure to products that may be counterfeit, stolen or otherwise harmful.

Additional Resources:

Food and Drug Administration coronavirus update: April 20, 2020

April 20, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • The FDA issued information on the use of serological (antibody) tests to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. This information includes:
  • The FDA issued a face mask emergency use authorization (EUA) in response to concerns relating to insufficient supply and availability of face masks for use by members of the general public, including health care personnel in healthcare settings as personal protective equipment (PPE), to cover their noses and mouths, in accordance with Centers for Disease Control and Prevention (CDC) recommendations, to prevent the spread of the SARS-CoV-2 virus during the pandemic. Manufacturers of face masks that are used as described in the EUA and meet the requirements in the EUA, do not need to take any action, other than complying with the Conditions of Authorization in the EUA, to be authorized under this EUA.

  • Today, the FDA issued a guidance explaining a temporary policy regarding state-licensed pharmacies and federal facilities, that are not outsourcing facilities, compounding certain human drugs for hospitalized patients during the COVID-19 public health emergency. This guidance explains the agency’s policy to help address reported issues with accessing certain FDA-approved drugs used for hospitalized patients with COVID-19. As a temporary measure, with regard to certain drugs, under the circumstances outlined in the guidance, FDA does not intend to take action against state-licensed pharmacies and federal facilities for compounding a drug that is essentially a copy of a commercially available drug, or for providing a drug to a hospital without obtaining a patient-specific prescription. When a hospital is unable to access FDA-approved drug products and is considering the use of compounded drugs for hospitalized patients, outsourcing facilities may be able to offer a supply of compounded drugs that are subject to more robust quality standards than are drugs produced by State-licensed pharmacies or Federal facilities that are not required to comply with CGMP requirements.

  • A new FDA Voices was issued, The Path Forward: Coronavirus Treatment Acceleration Programdescribing a new program that aims to move new treatments to patients as soon as possible, while at the same time finding out whether they are helpful or harmful. So far, 72 clinical trials of potential therapies for COVID-19 are underway with FDA oversight. Both the pharmaceutical industry and academic researchers have submitted many innovative and well-designed studies for prevention and treatment of COVID-19. The FDA has streamlined its review and advice process to get studies started as quickly as possible.

  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 340 test developers who have said they will be submitting emergency use authorization (EUA) requests to FDA for tests that detect the virus.
    • To date, the FDA has issued 41 individual emergency use authorizations for test kit manufacturers and laboratories. In addition, 16 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
    • The FDA has been notified that more than 210 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
    • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

Additional Resources:

Food and Drug Administration coronavirus update: April 10, 2020

April 10, 2020

The following is a press release from the U.S. Food and Drug Administration:

 

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • The FDA recently issued an emergency use authorization (EUA) for a blood purification system to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit with confirmed or imminent respiratory failure. The FDA issued the EUA to Terumo BCT Inc. and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices.
  • The FDA recently issued an EUA to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. The FDA issued the EUA to STERIS Corporation for the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems using the STERIS N95 Decontamination Cycle (non-lumen cycle), which uses vaporized hydrogen peroxide. This EUA will support decontamination of approximately 750,000 N95 respirators per day in the U.S.
  • The FDA issued a guidance for immediate implementation for pharmacy compounders that experience shortages of the personal protective equipment (PPE) they typically use to compound human drugs that are intended or expected to be sterile. PPE shortages have the potential to significantly impact the quality, purity and availability of drugs that are compounded for patients, including those in critical need. The guidance discusses how pharmacies may be able to preserve PPE if supplies are limited. Further, as a temporary measure to address the public health emergency posed by COVID-19, the agency is providing limited regulatory flexibility for compounders that cannot obtain sufficient supplies of PPE for sterile compounding, provided they adopt risk mitigation strategies as described in the guidance. FDA adopted this policy to help assure patient access to needed medicines and to reduce the risks of compounding when standard PPE are not available.
  • Yesterday, the FDA and Federal Trade Commission issued a warning letter to one company for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. The seller warned, Earthley Wellness DBA Modern Alternative Mama LLC., offers unapproved and misbranded herbal tinctures and herbal remedy products for the prevention or treatment of COVID-19. There are currently no approved preventatives or treatments for COVID-19. Consumers should not purchase or take any product to prevent or treat COVID-19 unless it is prescribed by their health care provider and acquired from a legitimate source.
  • FDA Voices: A Perspective on the FDA’s COVID-19 Response by Mitch Zeller, director of the FDA’s Center for Tobacco Products, was issued. It provides a perspective of the FDA’s “all-hands-on-deck” approach to tackling this pandemic. The FDA is integral in the fight against the coronavirus, using science and innovative approaches to take a broad range of actions that advance our nation’s response.
  • The FDA issued a Letter to Stakeholders advising people not use ivermectin intended for animals as a treatment for COVID-19 in humans. People should never take animal drugs, as the FDA has only evaluated their safety and effectiveness in the particular animal species for which they are labeled. These animal drugs can cause serious harm in people. People should not take any form of ivermectin unless it has been prescribed to them by a licensed health care provider and is obtained through a legitimate source.
  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 300 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
    • To date, 33 emergency use authorizations have been issued for diagnostic tests.
    • The FDA has been notified that more than 170 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
    • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

Additional Resources:

Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

One World: Together at Home worldwide TV event honoring coronavirus health workers will include appearances by Elton John, Paul McCartney, John Legend, Lady Gaga, Chris Martin, Lizzo and more

April 6, 2020

Updated April 14, 2020

Lady Gaga (Photo by Erik Voake/Coachella)

The following is a press release from ABC:

Building on the success of the digital series “One World: Together at Home,” Global Citizen and the World Health Organization (WHO) are partnering for a special one-night event of the same name to air across NBC, ABC, CBS and other global networks and platforms on  Saturday, April 18, 2020 (8:00-10:00 p.m. PT/ET).

“One World: Together at Home” is not a telethon – but rather a global broad entertainment special to celebrate the heroic efforts of community health workers and support the World Health Organization and the global fight to end COVID-19. The event is curated by Lady Gaga and will feature exclusive appearances by Alanis Morissette, Andrea Bocelli, Billie Eilish, Billie Joe Armstrong of Green Day, Burna Boy, Chris Martin, David Beckham, Eddie Vedder, Elton John, FINNEAS, Idris and Sabrina Elba, Alanis Morissette, Andrea Bocelli, Billie Eilish, Billie Joe Armstrong, J Balvin, John Legend, Kacey Musgraves, Keith Urban, Kerry Washington, Lang Lang, Lizzo, Maluma, Paul McCartney, Priyanka Chopra Jonas, Shah Rukh Khan and Stevie Wonder. Friends of Sesame Street will also be on hand to help unify and inspire people around the world.

The two-hour program will be hosted by a trio of network late-night hosts: Jimmy Fallon, Jimmy Kimmel and Stephen Colbert and will include performances from the world’s biggest artists with multimillion-dollar pledges to the WHO’s Solidarity Response Fund. Audrey Morrissey (“The Voice,” “Songland”) and Live Animals will produce the special in partnership with Global Citizen.

The show will lift viewer’s spirits with exclusive, special cameos from the worlds of music and arts, sports superstars, and comedic sketches, while always drawing back to its core purpose – to educate and inform on COVID-19 risks, prevention and response. The broadcast will feature interviews with experts from WHO as well as stories of frontline healthcare workers from around the world – their courage and sacrifice a reminder of the urgency of this moment.

The special will connect artists with audiences on a global scale, airing on the following networks and platforms:

· NBCUniversal: NBC, Bravo, E!, MSNBC, MSNBC.com, NBCSN, NBC News, NBCNews.com, NBC News on YouTube, Peacock, SYFY and USA.

· Walt Disney Television: ABC, ABC News, ABC News Live, Freeform and Nat Geo.

· ViacomCBS: CBS, Channel 5 in the UK, Network 10 in Australia, and Telefe in Argentina; BET and MTV globally across 180+ countries; and CMT, Comedy Central, Logo, MTV2, Paramount Network, Pop, TV Land and VH1 in the U.S.

· Bell Media platforms in Canada, MultiChoice, and RTE.

· BBC One will broadcast an edited version of the event for UK audiences on Sunday, April 19.

“One World: Together At Home” will also be a multi-hour digital broadcast streaming online on multiple global platforms, including Alibaba, Amazon Prime Video, Apple, Facebook, Hulu, Instagram, LiveXLive, Tencent, Tencent Music Entertainment Group, TIDAL, TuneIn, Twitch, Twitter, Yahoo and YouTube. This digital special will include additional artists and performances from all over the globe as well as unique stories from the world’s healthcare heroes. For information about how to tune in and take action, visit www.globalcitizen.org/togetherathome.

Commitments from supporters and corporate partners will go to the COVID-19 Solidarity Response Fund, powered by the UN Foundation, to support and equip healthcare workers around the world, and to local charities that provide food, shelter, and healthcare to those that need it most. These local groups have been vetted to ensure they are helping communities impacted by COVID-19.

April 14, 2020 UPDATE: International advocacy organization Global Citizen today announced an expanded list of artists that will appear in the “One World: Together at Home” global broadcast special, being held in support of the global response to the COVID-19 pandemic being led by the World Health Organization.

The newly announced artists include Alicia Keys, Amy Poehler, Awkwafina, Camila Cabello, Celine Dion, Ellen DeGeneres, Jennifer Lopez, LL COOL J, Lupita Nyong’o, Matthew McConaughey, Oprah Winfrey, Pharrell Williams, Sam Smith, Shawn Mendes, Taylor Swift, Usher and Victoria Beckham. Curated in collaboration with Lady Gaga, the artists announced today join a lineup of entertainers who were unveiled last week that includes Andrea Bocelli, Billie Eilish, Billie Joe Armstrong of Green Day, Burna Boy, Chris Martin, David Beckham, Eddie Vedder, Elton John, FINNEAS, Idris and Sabrina Elba, J Balvin, John Legend, Kacey Musgraves, Keith Urban, Kerry Washington, Lang Lang, Lizzo, Maluma, Paul McCartney, Priyanka Chopra Jonas, Shah Rukh Khan and Stevie Wonder.

“One World: Together at Home” will be hosted by Jimmy Fallon of “The Tonight Show Starring Jimmy Fallon,” Jimmy Kimmel of “Jimmy Kimmel Live!” and Stephen Colbert of “The Late Show with Stephen Colbert.” Friends from Sesame Street will also be on hand to help unify and inspire people around the world to take meaningful actions that increase support for the global COVID-19 response.

Leading up to the global broadcast special, there will be a six-hour streamed event, curated from around the world, to support brave healthcare workers doing life-saving work on the front lines. The “One World: Together at Home” streamed event will reach millions around the world digitally and will include performances and appearances from Adam Lambert, Andra Day, Angèle, Anitta, Annie Lennox, Becky G, Ben Platt, Billy Ray Cyrus, Black Coffee, Bridget Moynahan, Burna Boy, Cassper Nyovest, Charlie Puth, Christine and the Queens, Common, Connie Britton, Danai Gurira, Delta Goodrem, Don Cheadle, Eason Chan, Ellie Goulding, Erin Richards, FINNEAS, Heidi Klum, Hozier, Hussain Al Jasmi, Jack Black, Jacky Cheung, Jack Johnson, Jameela Jamil, James McAvoy, Jason Segel, Jennifer Hudson, Jess Glynne, Jessie J, Jessie Reyez, John Legend, Juanes, Kesha, Lady Antebellum, Lang Lang, Leslie Odom Jr., Lewis Hamilton, Liam Payne, Lili Reinhart, Lilly Singh, Lindsey Vonn, Lisa Mishra, Lola Lennox, Luis Fonsi, Maren Morris, Matt Bomer, Megan Rapinoe, Michael Bublé, Milky Chance, Naomi Osaka, Natti Natasha, Niall Horan, Nomzamo Mbatha, P.K. Subban, Picture This, Rita Ora, Samuel L. Jackson, Sarah Jessica Parker, Sebastián Yatra, Sheryl Crow, Sho Madjozi, SOFI TUKKER, SuperM, The Killers, Tim Gunn, Vishal Mishra and Zucchero. The digital stream will be available on Alibaba, Amazon Prime Video, Apple, Facebook, Instagram, LiveXLive, Tencent, Tencent Music Entertainment Group, TIDAL, TuneIn, Twitch, Twitter, Yahoo and YouTube.

As part of the “One World: Together at Home” campaign, brands including Analog Devices, Cisco, Citi, The Coca-Cola Company, GlaxoSmithKline, IBM, Johnson & Johnson, PepsiCo, Procter & Gamble, State Farm(R), Target, Teneo, Verizon, Vodafone and WW International, Inc. have supported the COVID-19 Solidarity Response Fund for WHO and regional charities that are working to meet immediate COVID-19-related needs locally.

“We are grateful to the private sector who have listened to the public’s call for action and come together to support the global response to COVID19. This pandemic is too large for governments to tackle alone,” said Hugh Evans, co-founder and CEO of Global Citizen. “We are also incredibly grateful for the continued support from the artist community to make ‘One World: Together at Home’ a moment of global unity. Our hope for the special is that everyone will come away believing that we, as a shared humanity, can emerge from this moment forever grateful for the work of doctors, nurses, teachers, grocery store workers and all those who are the backbone of our communities.”

“One World: Together at Home” will air on Saturday, April 18, 2020, at 5:00 p.m. PDT/8:00 p.m. EDT, appearing on ABC, NBC, ViacomCBS Networks, The CW, iHeartMedia and Bell Media networks and platforms in Canada. Internationally, BBC One will run the program on Sunday, April 19, 2020. Additional international broadcasters include AXS TV, beIN Media Group, MultiChoice Group and RTE. The digital stream will begin at 11:00 a.m. PDT/2:00 p.m. EDT and will inspire unity among all people who are affected by COVID-19.

At this critical moment in history, Global Citizen is also calling on individuals, governments and philanthropists to join and support immediate COVID-19 response efforts. Changemakers, investors and foundation leaders are being urged to actualize their giving and invest quickly in related efforts, like stronger health systems and vaccine development.

Last month in response to the global pandemic, Global Citizen launched an urgent campaign in support of the COVID-19 Solidarity Response Fund for WHO. Calling on individuals to take action and asking world leaders and corporations to support the response with sufficient resources, Global Citizens from over 150 countries around the world have taken hundreds of thousands of actions in support of the response fund. For information about how to tune in and take action, visit globalcitizen.org/togetherathome.

For more information about Global Citizen and their campaign to support the WHO’s Solidarity Response Fund, please visit globalcitizen.org and follow @GlblCtzn Twitter, Facebook and Instagram using #GlobalCitizen.

To learn more about WHO’s response to the pandemic and the COVID-19 Solidarity Response Fund, please go to www.who.int/COVID-19 and follow @WHO on Twitter, Facebook, Instagram, LinkedIn and TikTok.

American Nurses Foundation launches coronavirus response fund for nurses

April 1, 2020

The following is a press release from the American Nurses Foundation:

Today, the American Nurses Foundation (the Foundation), the philanthropic arm of the American Nurses Association (ANA), announces the launch of the Coronavirus Response Fund for NursesJohnson & Johnson and the Tylenol brand made a $1.5M commitment to the launch of this fund.  Through this initiative, members of the public can demonstrate their appreciation and support for nurses who are on the frontline caring for patients during this pandemic, despite significant risk to their well-being and safety.

Through this national Coronavirus Response Fund, the public can thank and support nurses by texting THANKS to 20222 to make a $10 donation, which will:

  • Provide direct assistance to nurses serving on the frontlines and across other health care settings.
  • Support the mental health and well-being of nurses given the unprecedented stress of the situation.
  • Ensure all nurses have access to the latest scientific evidence to protect themselves, prevent the spread of the infection, and provide patient care.
  • Drive national advocacy to strengthen public health efforts and deploy critical medical supplies.

“Nurses always answer the call to serve their patients, communities and country during times of crisis. As we confront the new and emerging challenges of this pandemic, nurses are and will continue serving on the frontlines in extraordinary ways. This fund provides a way for members of the public to show appreciation and support for nurses’ commitment and sacrifice,” said the Foundation Chair Tim Porter-O’Grady, DM, EdD, ScD (h), APRN, FAAN, FACCWS. “We encourage like-minded individuals to contribute to this fund as a way to show our appreciation and support for nurses.”

A portion of the donations will help support Nurses House, Inc., a national fund for registered nurses in need. The Foundation is partnering with this organization to help nurses affected by COVID-19. Nurses who are unable to work due to COVID-19 infection, caring for a family member with COVID-19, or are under mandatory quarantine, can submit an application for assistance.

Nurses are reliable and proven responders during infectious disease emergencies, providing safe, quality, compassionate and nondiscriminatory care to their patients and the communities in which they serve. This Coronavirus Response Fund will enable the Foundation to readily assist all nurses who urgently need sufficient support and resources to effectively respond to this global health crisis.

About the American Nurses Foundation
The American Nurses Foundation is the charitable and philanthropic arm of the American Nurses Association (ANA), with the mission to transform the nation’s health through the power of nursing. The Foundation supports research, education, and scholarships, which improve health, wellness, and patient care. For more information visit www.nursingworld.org/foundation

About the American Nurses Association
The American Nurses Association (ANA) is the premier organization representing the interests of the nation’s 4 million registered nurses. ANA advances the nursing profession by fostering high standards of nursing practice, promoting a safe and ethical work environment, bolstering the health and wellness of nurses, and advocating on health care issues that affect nurses and the public. ANA is at the forefront of improving the quality of health care for all. For more information, visit www.nursingworld.org.

Upgraded Points survey shows 1 in 5 Americans won’t travel again until 2021, citing coronavirus concerns

April 1, 2020

The following is a press release from Upgrade Points:

Upgraded Points recently released its newest targeted study featuring a survey based on questions given to airline travelers concerning the recent global pandemic. The study seeks to understand American travelers’ plans and concerns, helping to better illuminate the travel crisis as it unfolds; while also delivering important data about the American airline industry itself—which recently asked for and will receive a reported $50 billion bailout from the U.S. government. Upgraded points is a trusted source for a wide variety of similar in-depth airline studies, as well as advice and pointers for travelers.

1 in 5 Americans said they aren’t going to travel again until 2021. Conversely, from the time of the study, about 20% said they would travel again in the next 6 weeks.

“The airline industry is in a great deal of trouble again,” said Alex Miller, Founder of Upgraded Points. “They’ve certainly seen their share of difficulty over the years: after 9/11, during the 2008 economic downturn, etc. But this is probably the worst crisis the industry has ever faced. Without millions of travelers on planes and in airports, the industry just can’t make the revenue it needs to survive. Whole countries are asking citizens to stay indoors, and that includes enforcing travel restrictions and closing borders. No one knows exactly when this global pandemic will peak and then begin to recede. So all we can do now is wait, and gather valuable data to help understand the situation as it happens. That is the goal of this particular study.”

Analysis Methodology

The study surveyed 1,250 people in the U.S., asking a variety of questions related to their travel plans, concerns around those plans, and asking them to identify what would make them feel most comfortable about traveling again. The results were compiled into a series of detailed tables and lists that give exact percentages based on the answers received. The makeup of those surveyed include 55% male and 45% female, further broken down into six different age range groups, representing adults aged 18 through 65 and up. By far, the largest group of those surveyed fell into the 26–34 range, representing 39% of the whole.

Biggest Travel Concerns: Questions About Fears

Overall, the majority of Americans questioned clearly stated that their biggest traveling concern was the COVID-19 virus. But the study broke that question down into a variety of other specific concerns to help reveal the nuanced complexities around the topic. When asked what worried them most—contracting the virus personally or passing it on to others—the majority of Americans responded they were most concerned about contracting the virus themselves. Though 32% of those asked did express concerns about passing the disease on to others, while still others expressed concern about becoming part of overall community spread. These results are further categorized into specific age ranges as well. Please see the study for full details.

Unsurprisingly, the biggest fear travelers have is contracting COVID-19 from traveling and then spreading it to family and friends.

How and When Will Americans Feel Comfortable About Traveling Again?

Americans were also asked when they plan to begin traveling again, under what circumstances, and at which airline ticket price. The answers were arranged based on the choices given: an immediate time frame (the next two weeks), then monthly, all the way into 2021. The overwhelming majority stated they had no plans to travel again until 2021, representing 20% of those surveyed.

Americans were also given a series of factors to choose from, representing what would make them feel more comfortable traveling, and at which ticket prices. Factor choices given include: Enough Time Has Passed, No New COVID-19 Cases, and Government or Health Officials Give the “All-Clear” to Travel. The results were compiled into percentages, price ranges and further classified into specific age groups.

To see the exact numbers and percentage breakdowns by age, as well as bar graphs and helpful pie charts used for visual comparison, please visit the full study HERE.

About Upgraded Points LLC

Headquartered in Austin, Texas, Upgraded Points is a travel company that provides insider strategies on maximizing travel points and rewards. Launched in 2016 by Alex Miller, Upgraded Points uses targeted research efforts and in-depth studies to give travelers, as well as those looking to travel a real understanding of how to maximize their points and miles. Learn more at: www.UpgradedPoints.com.

Food and Drug Administration coronavirus update: March 31, 2020

March 31, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • Today, the FDA stood up a new program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.
  • Today, the FDA posted information regarding shortages of hydroxychloroquine and chloroquine to its drug shortages webpage due to a significant surge in demand. The agency is working with manufacturers to assess their supplies and is actively evaluating market demand for patients dependent on hydroxychloroquine and chloroquine for treatment of malaria, lupus and rheumatoid arthritis. All manufacturers are ramping up production, and the agency’s webpage displays current availability. The FDA is working with manufacturers to ensure this can happen expeditiously and safely. The U.S. Department of Health and Human Services (HHS) has also accepted 30 million doses of hydroxychloroquine sulfate to the national stockpile and one million doses of chloroquine phosphate for possible use in treating patients hospitalized with COVID-19 or for use in clinical trials. Use of the donated medications is expected to help ease supply pressures for the drugs. This is a fluctuating and dynamic situation and the FDA is actively engaged. The agency is updating its shortages lists regularly and continuing to communicate in real-time so that patients and healthcare providers have the most current information on product shortages in the U.S.
  • Today, the FDA and FTC issued warning letters to three companies for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure COVID-19. One of the companies warned, Halosense Inc., sells salt therapy products with misleading claims that the products are safe and/or effective for the treatment or prevention of COVID-19. Another company warned, Bioactive C60/FullerLifeC60 LLC, sells an unapproved and unauthorized product, “FullerLifeC60,” with misleading claims that it can build up immunity to help treat or prevent COVID-19 in people. The third company warned, JRB Enterprise Group Inc. DBA Anti Aging Bed, offers colloidal silver products for sale in the U.S. with misleading claims the products are safe and/or effective for the treatment or prevention of COVID-19. With these warning letters, the FDA is exercising its authority to protect consumers from companies selling unapproved products and making false or misleading claims during the COVID-19 pandemic.
  • Diagnostics update to date: During the COVID-19 pandemic, the FDA has worked with more than 220 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. On March 30, FDA issued two additional emergency use authorizations for COVID-19 diagnostics, for a total of 22 authorized tests. Additionally, the FDA has been notified that more than 110 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

Additional Resources:

Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Review: ‘Skin Deep: The Battle Over Morgellons,’ starring Cindy Casey-Holman, Steven Feldman, Edward Hu, Ginger Savely, Kelly Pickens, Marianne Middelveen and Raphael Stricker

March 31, 2020

by Carla Hay

Cindy Casey-Holman in “Skin Deep: The Battle Over Morgellons” (Photo courtesy of Gravitas Ventures)

“Skin Deep: The Battle Over Morgellons”

Directed by Pi Ware

Culture Representation: Taking place in various parts of the United States, this documentary (which interviews mostly white people and a few Asians) examines the controversies over the medical validity of a debilitating skin condition that’s known as Morgellons, featuring commentaries from patients and medical professionals.

Culture Clash: People in the documentary disagree over whether not Morgellons should be officially recognized as a disease by the Centers for Disease Control and the U.S. Department of Health and Human Services.

Culture Audience: “Skin Deep: The Battle Over Morgellons” will appeal mostly to people who want to learn more about what’s being done about Morgellons and will also appeal to people who like watching documentaries about rare medical conditions.

Cindy Casey-Holman (second from right) in “Skin Deep: The Battle Over Morgellons” (Photo courtesy of Gravitas Ventures)

The documentary “Skin Deep: The Battle Over Morgellons” takes an up-close and personal look at what is currently a controversial medical mystery: Morgellons. Is it an undiagnosed skin disease or is it a figment of mentally ill people’s imaginations? The medical community is divided over what is the real answer. This documentary (directed by Pi Ware) responsibly presents both sides of the argument, but the film unquestionably sides with the patients who say that they have Morgellons.

People who say they have Morgellons have similar physical characteristics: They have painful skin lesions and open sores that often have hair or different-colored fibers growing out of these sores. The people with this condition also say that they feel like bugs or small animals are trying to crawl out of their skin. In addition, they also report having memory loss or other signs of neurological degeneration. (These are also characteristics of heavy methamphetamine use, but many of the people who have Morgellons are not meth users.) Because Morgellons seems to be a very rare condition that is not officially recognized by the Centers of Disease Control (CDC), many medical professionals are reluctant to diagnose patients with Morgellons.

Complicating matters is that fact that people with this skin condition often use extreme measures to try and get rid of it, which might or not not be indications of mental instability. In a medical consultation on camera with nurse practitioner Ginger Savely (who’s a Morgellons patient advocate), one Morgellons-stricken man in the documentary tells her that he’s been using a homemade, medically unapproved “remedy” of a topical paste that includes DDT (the main ingredient of insecticide) to treat his skin condition. The patient swears that this home remedy has been working for him. Savely, who is only consulting with him and is not his main medical professional, literally cringes and says that the DDT ingredient is “toxic.”

This inclination to treat the problem with self-remedies is why many medical professionals think that people who say they have Morgellons are really just mentally ill and should not be coming up with their own medical solutions to a problem that isn’t fully understood yet. People who have Morgellons are often accused of causing their skin sores through self-mutilation.

The documentary points out that there are some people who think they have Morgellons, but they actually don’t, and it’s those misinformed people who are giving the “legitimate” Morgellons patients a bad name. But herein lies the problem: Even if doctors believe that Morgellons is a medical condition, they often don’t agree on what would make a “legitimate” Morgellons patient.

Cindy Casey-Holman, a former registered nurse, is one of the leading activists to get medical professionals and health-related government agencies to take Morgellons seriously. In the documentary, she said she first noticed that she had the characteristics of Morgellons in the mid-1990s. In addition to the skin sores, she had a low-grade fever, swollen feet and a lot of anxiety. Betsy Anderson, one of her friends and a former co-worker, is interviewed and confirms this information.

Since no doctor could diagnose what was wrong with her at the time, Casey-Holman said that she did the best she could to try to get better, and the symptoms eventually went away. However, the symptoms returned about seven or eight years later at one of the worst times imaginable: close to her wedding date. She’s had the condition in varying forms ever since, although she says at the end of the film that it’s nowhere near as bad as it was for her back in the 2000s.

Casey-Holman’s husband Charles Holman (who has since passed away) and an advocate named Dr. Greg Smith teamed up to co-found a nonprofit activist organization called the New Morgellons Order. That organization has since morphed into the Charles E. Holman Morgellons Disease Foundation, of which Casey-Holman is the director. She says in the documentary that she is based in Hughes Springs, Texas, after living in San Francisco for many years.

She is also the chief organizer of an annual Morgellons Conference, which gets a lot of screen time in the documentary. The movie doesn’t specify what year that the featured conference took place, but it’s mentioned that the conference was at a hotel in Austin, Texas. It’s a small event. Casey-Holman says in the film that the conference has less than 100 people attending per year. And in a room for panel discussions and speaker presentations, it looks like there are about 50 people or less in the room at any given time.

Casey-Holman says that people who believe they have Morgellons began to find each other through the Internet, beginning in the late 1990s/early 2000s. It was around this time that the media began reporting that people had this skin condition. People who say that they have Morgellons were once relegated to just Internet chat rooms to share their stories with others, but then they were starting to be interviewed on national television in news reports about Morgellons. And that’s when this skin condition started to get even more media attention.

The medical skeptics about Morgellons say that the publicity over Morgellons is one of the reasons why they think Morgellons is a medical hoax. Dr. Timothy Berger, a University of California at San Francisco dermatologist who used to be Casey-Holman’s doctor, comments on Morgellons: “I believe this was an Internet-associated situation. I hadn’t seen patients with the fiber complaint until the fiber story got universally spread.” Berger then compares people who say they have Morgellons to Vietnam War veterans who blamed their sicknesses on Agent Orange.

Another medical skeptic about Morgellons is Dr. Steven R. Feldman, a dermatologist based in Winston-Salem, North Carolina. He gets the most screen time in the documentary’s presentation of anti-Morgellons viewpoints, and he’s the closest thing to a “villain” in this movie. For starters, Feldman comes across as arrogant and condescending. He freely admits that in dealing with patients, what he says isn’t based on the individual but is often pre-rehearsed, canned talk. He also admits that he can appear to have a cheerful demeanor with patients, but it’s actually forced. “It’s for show,” he says.

When commenting on Morgellons, Feldman says, “Doctors can’t find anything objective causing these sensations … Morgellons and delusions of parasitosis, to many physicians, are exactly the same thing.” And to further drive home the point that Feldman is the “jerk” of this story, during his lecture presentation at the Morgellons Conference featured in the documentary, he tells the attendees that they’ll get better results in doctors’ cooperation if they are polite and nice to their doctors.

But what really sets off some of the attendees to respond angrily is when Feldman makes this outrageous statement more than once during his lecture: “I don’t believe that there are any bad doctors.” (Tell that to state medical licensing boards that have revoked numerous medical licenses for doctors due to malpractice or other reasons. There are also many doctors who have been convicted of medical-related crimes.)

Feldman’s statement that there are “no bad doctors” causes one particular conference attendee, Morgellons activist Kelly Pickens, to shout a rant at Feldman before storming out of the room. She later confronts Feldman again in a hallway after the lecture. Pickens has a tragic story that is told in this documentary, but that information won’t be revealed in this review.

Another Morgellons patient who’s featured in the documentary is Edward Hu, a former attorney in San Francisco whose medical condition became so severe that he had to leave his job as a federal public defender. His medical problems led to a falling-out between him and his younger brother Brian, a doctor who’s been skeptical that Morgellons is a real medical condition. The documentary shows Edward Hu in various states of his condition (some better than others) over time, as well as the two brothers’ attempts to reconcile.

Are there any doctors who believe Morgellons is real? Yes. The documentary interviews some of them. One is Raphael Stricker, an internist who considers himself to be a Morgellons specialist. He says that people who believe that they have Morgellons should try to avoid bringing in their own skin samples (often called “matchbox signs”) for doctors to test, unless those samples are specifically requested. As Stricker says in the movie: “Doctors make fun of the matchbox sign, because they see it as proof that they [the patients] are crazy.”

Another advocate for Morgellon patients is veterinary microbiologist Marianne Middelveen, who teamed up with Stricker to test a hypothesis that Morgellons could be caused by bacteria. The study’s results, which are shown in the documentary, suggested a strong correlation between bacteria and this skin condition.

The documentary also covers the long-held belief that Lyme disease could linked to Morgellons, since the symptoms for Lyme disease are similar. Another theory is that Morgellons is caused by a source within the body (such as a genetic defect) and not from a source that was introduced to the body, such as external bacteria. None of these theories has been medically proven.

In the documentary, Harry Quinn Schone, a medical historian and author of “Contested Illness in Context” mentions that for decades, medical professionals thought ulcers were caused by stress until it was proven that ulcers were caused by bacteria. But it took a lot of controversy, skepticism and scientific research before that conclusion was reached by the medical community. Schone suggests that Morgellons is in a similar misunderstood gray zone that ulcers used to be in, when it was believed that the cause for ulcers was more emotional/psychological than physical.

Another medical expert who is an advocate for Morgellons patients is Randy Wymore, an associate professor of pharmacology at Oklahoma State University. He believes that the CDC conducted a very flawed study that concluded in 2012 that Morgellons had no underlying medical condition or no infectious source. Wymore says that the sample size for the study was too small; he claims as little as 12 people actually participated in the study.

And according to Wymore, the long questionnaire that the CDC gave to people who were potential study participants showed a lot of bias in favor of the theory that Morgellons patients had psychiatric problems. The documentary does not mention if the filmmakers made any effort to contact the CDC for comment. The good news, says Wymore, is that because of continued testing, he’s seen that doctors are becoming less skeptical of Morgellons and are becoming more curious about how to treat this condition.

“Skin Deep” is undoubtedly sympathetic toward the patients, but there’s very little investigation into how authentic their stories are. As viewers, we’re supposed to take their word for it that the sores on their skin just mysteriously appeared with no explanation. While it might be true for some, it might not be true for others. The documentary doesn’t really try to prove the credibility of anyone identified in the film as a “Morgellons patient,” except for Casey-Holman, who has the aforementioned friend backing up her story.

“Skin Deep” director Ware also injects some melodrama by including re-enactments using actors. These re-enactments are borderline manipulative/cheesy and don’t seem very appropriate for a documentary about a topic as serious as people’s medical problems. Despite these flaws, “Skin Deep” does make it clear that even though people can disagree on what causes Morgellons, there are physical manifestations clearly showing that something is definitely wrong with these patients. The issue is what is really causing these skin sores and other problems associated with Morgellons.

As shown in the movie, because Morgellons is such a mysterious condition, patients are often not believed not just by medical professionals but also by family, friends and other loved ones. Several of the Morgellons patients in the movie say that Morgellons has ruined their health and ruined the relationships they’ve had with many loved ones. The suicide rate for Morgellons patients is extremely high, says Savely.

Nurse practitioners Savely and Melissa McElroy Felser, who are advocates for Morgellons patients, stress the importance of having compassion for those who are suffering. Whether or not Morgellons is a real disease, the suffering is real. And, as “Skin Deep” concludes, that suffering in and of itself is cause for alarm and for the medical community and other concerned people to do their part to address this problem.

Gravitas Ventures released “Skin Deep: The Battle Over Morgellons” on digital, VOD and DVD on March 31, 2020.

Food and Drug Administration coronavirus update: March 30, 2020

March 30, 2020

by Carla Hay

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed. Moreover, as in previous emergencies, the FDA has been extremely proactive and supportive of test development by all comers—laboratories, and large and small commercial manufacturers—offering our expertise and support to speed development and to quickly authorize tests that the science supports.

It is not the FDA’s role to develop tests or decide what tests a health care professional uses. Our role is to determine if the tests developed by others provide accurate and reliable results, even when some would prefer that we let tests on the market without evidence that they work. It’s critical that the tests used work. False results can also contribute to the spread of COVID-19. We want our treatments to be tested for effectiveness and reviewed by the FDA. We want the same for our tests—assurances that they are accurate and effective.

Developing a test:

  • Typically, with an emerging health threat, the Centers for Disease Control and Prevention (CDC) is the first developer of a diagnostic test in the U.S.
  • Samples of the virus are crucial to confirming the accuracy of the test.
  • CDC has first access to viral samples that other test developers do not. CDC also manufactures their own tests for distribution to their national network of public health labs. In this pandemic, CDC encountered problems manufacturing their test. FDA assisted CDC in their work to resolve the issue and utilize a commercial manufacturer to make tests for any laboratory, not only public health labs.
  • Viral samples became commercially available to private sector test developers in later February, when the National Institutes of Health’s partner BEI Resources began selling vials of the virus grown from material provided by CDC.
  • Laboratories have always had the ability to develop their own tests in the U.S.; the COVID-19 outbreak did not change this. Once a developer has a viral sample, they can confirm the accuracy of their test very quickly, usually in two to three days.
  • In the future, making viral samples available earlier to commercial developers will be crucial to deploying tests quickly. Moreover, CDC’s test should be manufactured by a commercial entity with the requisite expertise.

Timeline of FDA support for test developers:

  • Since the beginning of January, the FDA has worked with more than 230 test developers who have or are expected to submit requests for FDA emergency authorization of their tests; to date, 20 authorizations have been granted.
  • In addition, more than 110 laboratories have notified the FDA that they have begun using their own tests.
  • For interested developers, the FDA provided recommendations for how to check a test for accuracy as well as a short form to make it easy to share their test information quickly in support of an Emergency Use Authorization (EUA).

Emergency Use Authorization authorities:

  • An EUA, put into place by Congress, is a relaxed standard that allows tests to be made available based on less data than in non-urgent circumstances and allows for expedited FDA review.
  • In many cases, the FDA can do this review in as little as a day, which it has done repeatedly.
  • EUA authority is not a barrier to test availability.

FDA policy updates:

  • The FDA recognized the urgent need for even faster testing availability. Although laboratories could use the EUA pathway, many were hesitant or didn’t know the pathway was available to them.
  • To respond to this need, the FDA revised the process to allow labs to begin testing prior to FDA review of their validation data. This policy change was an unprecedented action to expand access to testing. Nevertheless, in the first week, only six laboratories took advantage of this further streamlined process because many laboratories did not have a test, or did not have the viral samples to check the accuracy of their test.
  • In addition, the FDA implemented another change to empower states to take responsibility for tests developed and used by laboratories in their states without FDA review.

The FDA has and will continue to play a pivotal role in this emergency response.

Additional Resources:

Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

CDC Foundation launches crowdfunding campaign to extend and accelerate public health coronavirus response

April 12, 2020

 

The following is a press release from the CDC Foundation:

The CDC Foundation today announced the launch of a crowdfunding campaign aimed at raising hundreds of millions dollars needed to bolster public health response efforts to address the novel coronavirus (COVID-19) pandemic, which now has cases in more than 40 U.S. states and in more than 115 countries. This funding will be used to support the CDC Foundation’s Emergency Response Fund to address a wide variety of in-the-moment, on-the-ground needs from public health responders, at the local, state, national and international level.

“This crowdfunding campaign provides an incredible opportunity for individuals, philanthropies and corporations to take part in the response to the expanding coronavirus pandemic,” said Judy Monroe, MD, president and chief executive officer of the CDC Foundation. “When we bring our resources together, we can make a tremendous impact and coordinate our efforts to tackle this dangerous public health threat.”

In the campaign, which is themed “All of Us: Combat Coronavirus,” the CDC Foundation is working with Charidy.com, a global crowdfunding firm with a track record of helping nonprofits fundraise rapidly and successfully. The campaign will involve fundraising, media and social media to raise support for the COVID-19 emergency response. The campaign also has a unique focus on team-based fundraising for organizations to engage their workforces.

Funds raised in the campaign will be used to:

  • help communities prevent, detect and respond to COVID-19
  • deploy emergency staffing with the skills required to meet the needs on the front lines at the state and local level
  • fund and deliver critical home essentials, such as food and medical needs to quarantined and isolated individuals
  • develop education and awareness campaigns to advance prevention and reduce stigma
  • build capacity and infrastructure for global response efforts and other immediate needs as they evolve

The CDC Foundation launched its Emergency Response Fund in late January. To date, the Fund has raised support for a variety of public health efforts, including the purchase of lab equipment and establishment of contracts for overtime pay in 11 public health labs and support for personal care and medical items for individuals who are quarantined as well as transportation and support for delayed travelers.

“Even with the U.S. government emergency funding package that has been signed into law, there are a wide variety of urgent demands where government support will not be available or available in time to meet all the rapidly-changing needs on the ground,” said Monroe. “That’s where donations from individuals, philanthropies and corporations can fill critical gaps and make a tremendous difference. All of us are needed to combat coronavirus.”

Contributions to the CDC Foundation’s Emergency Response Fund are tax deductible to the extent permitted by law and can be made on the crowdfunding site at give4cdcf.org or by phone or mail. To discuss giving opportunities, including an in-kind donation or forming a crowdfunding team through this campaign, contact Advancement at the CDC Foundation: by email at advancement@cdcfoundation.org or 404-523-1873.

About the CDC Foundation

The CDC Foundation helps the Centers for Disease Control and Prevention (CDC) save and improve lives by unleashing the power of collaboration between CDC, philanthropies, corporations, organizations and individuals to protect the health, safety and security of America and the world. The CDC Foundation is the go-to nonprofit authorized by Congress to mobilize philanthropic partners and private-sector resources to support CDC’s critical health protection mission. Since 1995, the CDC Foundation has launched more than 1,000 programs and raised over $900 million. The CDC Foundation managed hundreds of CDC-led programs in the United States and in more than 140 countries last year. For more information, visit www.cdcfoundation.org.  Follow the Foundation on Twitter, FacebookLinkedIn and Instagram.