Our work to preserve America’s treatment option to fight premature birth

You may never have heard of hydroxyprogesterone caproate or “17P”—it’s a mouthful, but the role it has played in the lives of thousands of pregnant mothers and babies is easy to understand.

National Consumers League statement urging FDA to make patient-centered decision on only available treatment option for pregnant mothers at risk for recurrent preterm birth

Oct. 7, 2020

Removing FDA-approved 17P could put countless pregnancies at risk even as COVID-19 adds new barriers for mothers with a history of spontaneous preterm birth

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC—The National Consumers League is urging the U.S. Food and Drug Administration (FDA) to protect patient access to the only approved treatment to reduce the risk of preterm birth in women with a history of spontaneous preterm birth, following this week’s proposal that all approved treatment options be withdrawn. We maintain that it is not in the best interests of patients, nor their healthcare providers, to deprive pregnant women of access—especially as there are no other approved treatment options—without considering alternative methods to better understand which patients benefit the most from 17P.

Hydroxyprogesterone caproate or “17P” has been the only available FDA-approved treatment option for nearly a decade to reduce the risk of recurrent preterm birth. Patients and the healthcare providers who serve them currently have access to one branded and five generic versions of the prescription product.

Since last year, the FDA has considered whether to remove FDA-approved formulations of 17P due to conflicting data from two clinical trials with notably different patient populations: one of which included a majority of African American women (59 percent) from the United States, and another where African American women represented 7 percent of a predominantly international patient population.

Despite the strengths of the original clinical trial and experiences of thousands of women to whom 17P was administered over the past decade, the strong safety profile of 17P, and the fact that 15 leading patient advocates and providers urged them to carefully consider all of the data and recognize the needs of women of color, the Center for Drug Evaluation and Research (CDER) within the FDA recently proposed that approval for all versions of 17P (branded, generics, and compounded for this indication) be withdrawn from the market.

CDER made this recommendation without meeting with advocates or providers who have personal experience of the positive impact 17P can have on the lives of mothers and babies at risk of being born prematurely.

We strongly urge CDER and the FDA to commit to a transparent and patient-centered process before making a decision about the fate of this vital treatment. Removal of 17P from the market would leave at-risk pregnant women and their providers without a recommended standard of care, and in the interim, extends a period of uncertainty that has already lasted too long.

Appreciating the importance of continued access to FDA-approved treatment options for at-risk pregnant women, including those that reduce their risk of early delivery, several months ago, we led a joint effort to urge the FDA to maintain and protect patient access to 17P. An array of leading consumer, women’s health, and maternal health organizations and thought-leading healthcare providers joined our efforts, together expressing serious concerns that a regulatory decision could be based on a single study that was largely conducted outside of the U.S., in a predominantly white population of women.

In our outreach to the FDA, we urged the agency to consider alternative ways to further evaluate and define the patient populations that most benefit from 17P, without depriving women of access. We regret to state that the agency did not respond to our letter, nor two separate requests to meet with stakeholders who have stood ready to discuss these concerns for months.

Moreover, the company that makes the branded version of 17P reported that it submitted a proposal to the FDA earlier this year with a plan to generate additional data and predictors of benefit in women with a history of recurrent preterm birth. Despite the company’s effort to proactively initiate the first part of a retrospective study, it has indicated that it was not provided an opportunity to discuss this research with the agency before its recent response.

While we recognize there is no single solution that will improve maternal and infant health outcomes, only one proven intervention exists to help pregnant women prevent recurrent preterm birth. Especially during this pandemic, pregnant women and their unborn babies are under extreme stress, yet providers have few therapeutic options to help at-risk mothers. There may be an increased risk of preterm birth and pregnancy loss among pregnant women with COVID-19, and even under normal circumstances, preterm birth places mothers and babies at significant risk—particularly among pregnant women of color.

Access to FDA-approved treatment options should not be compromised without substantial evidence that there is a lack of benefit in the appropriate population—which we don’t believe we have today. Instead, it is our belief that findings from a study where the majority of participants resided outside the U.S. in countries with different health systems and different rates of preterm birth shouldn’t be generalized and that it is reasonable to pursue real-world data sources to help us better understand the overall benefits in a patient population where there are no other options.

We believe it is possible for the FDA to continue to uphold its strong history of regulatory integrity while listening to perspectives from patient advocates and providers that are rooted in years of clinical use. What we can’t believe is the alternative, which leaves providers and pregnant women without a path forward in the middle of a pandemic.

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Be wary of bad hand sanitizers

By NCL Executive Assistant Adrienne Archer

Hand sanitizers help protect and prevent the spread of COVID-19 when soap and water are not readily available. When the coronavirus first emerged, demand for hand sanitizers soared. Stores were unable to maintain ample inventory, resulting in rampant hoarding and price gouging. Essential workers that desperately needed hand sanitizer couldn’t get them, prompting some companies to start making sanitizers that originally did not produce them (i.e. distilleries, cosmetic companies, etc.)

Guidelines from the Centers for Disease Control and Prevention (CDC) require hand sanitizer to have at least 60 percent ethanol (ethyl alcohol) in order for it to be effective. The CDC does not encourage members of the public to make hand sanitizer for individual use.

The Food and Drug Administration (FDA) has observed a sharp increase in those that, in addition to ethanol, also contain methanol—an ingredient that can be toxic when absorbed through the skin and can be fatal when ingested. Children and adults ingesting certain sanitizers led to blindness, hospitalizations, and even death.

Extended exposure to methanol can cause nausea, vomiting, seizures, permanent blindness, or death. The FDA has also found sanitizers with 1-propanol are also harmful. Accidental ingestions can cause central nervous system depression or death. Consumers that may have been exposed to hand sanitizers containing methanol or 1-propanol should seek medical attention immediately.

The FDA recently updated its guidelines on temporary policies about testing hand sanitizers to determine methanol levels. As companies produce hand sanitizers, they should frequently test to ensure that methanol is not created as a byproduct of either ethanol or isopropyl alcohol. The testing should be performed by an FDA inspected lab to ensure that it has met current good manufacturing practice (CGMP) standards. CGMP ensures the proper design, monitoring, and control of manufacturing processes and facilities. If alcohol (ethanol) has been found to contain more than 630 parts per million of methanol, it is contaminated and should be disposed of in hazardous waste containers. This guidance serves to help state-licensed pharmacies and outsourcing facilities report any incidents. The FDA has guidelines for an additional deterrent formula of alcohol to prevent children from ingesting them.

Consumers should also be cautious of false claims that hand sanitizers provide prolonged protection against COVID-19. Carefully inspect any purchased hand sanitizers to see if methanol or 1-propanol is listed.

FDA maintains a current list of hand sanitizers that are not recommended. As consumers review the list, they should compare the manufacturer name, product name, and National Drug Code (NDC) # on the hand sanitizer. If you find a product on the list, dispose of it immediately in a hazardous waste container and NOT down the drain.

The FDA encourages health professionals, consumers, and patients to report adverse effects and problems to the FDA’s MedWatch Adverse Event Reporting Program. Questions can be emailed to COVID-19-HandSanitizers@FHA.nns.gov. The FDA has also created a quiz to test consumer’s knowledge about hand sanitizers and a Q&A section on hand sanitizers and COVID-19 to keep consumers informed.

‘Should I stay or should I go?’ How the pandemic has affected higher education

By NCL Health Policy intern Talia Zitner

Every morning, I wake up with a new decision to make. Am I going back to campus? Or am I spending the Fall semester taking online classes from the comfort of my childhood bedroom? I’m a rising sophomore at Wesleyan University, and to add insult to injury, I’m also an incoming transfer student. My internal debate about going back to school is near-constant, and despite weighing the pros and cons of each, I still can’t seem to come to a comfortable conclusion.

Around the country, colleges and students are faced with this same, nearly impossible challenge. If schools can’t or won’t open in the fall, they risk closing forever without tuition money. If they do allow students to come back to campus, and an outbreak occurs, they put students, professors, faculty, staff, their families, and the greater community at risk. Students rely on colleges to be their home away from home, a place where they can work and learn in a structured, safe, and healthy environment, not to mention the social benefits.

Consequently, coming back to campus poses a serious financial and ethical question. Like anything else, college and higher education is a business. Consumers want to get the most for their money, and the colleges and universities need consumers to engage to have a sustainable business model. The pandemic has shifted the conversation in many areas of life, higher education included.

This issue is especially complicated because it can be broken down from multiple perspectives. For example, an economic point of view argues that colleges are only re-opening because they need the money. Like many other businesses, they stay open because they have no other choice. Without the money generated through tuition and other forms of revenue like donation and state funding, it would take years for schools to recover from the impact of COVID. But college is a substantial investment for families. Why should consumers be expected to pay full (or reduced) tuition for an experience that is more like a monastery than college? Will the investment really be worth it if schools are simply shut down again because of an outbreak at a campus party?

On the other hand, if students aren’t in school come fall semester, what else would they be doing? Most students are hard-pressed to find a job or internship that’s worth taking a semester off for in this environment. And time off may push back a student’s graduation time, putting them behind the rest of their peers. For very legitimate reasons, students want to come to campus and keep their college experience intact.

This seems to be where my own expectations fall. I have no idea if the situation will improve between now and the spring semester. To me, the only course of action is to enjoy the experience that I will have, even if it means wearing a mask.

Talia is a Washington, DC native and a rising sophomore at Wesleyan University, where she is studying English. Beyond health policy, Talia’s interests are in journalism, law, and social justice.

Reopening the economy prematurely has dire consequences for states

By NCL Health Policy intern Talia Zitner

The past month has seen a serious surge in reported coronavirus cases in the United States. It seems the virus is going to be with us for a while. Of states where COVID is spiking, the majority are in the South, many of which had ambitious reopening plans that are now being reconsidered.

Three of these states—Texas, Florida, and Arizona—have current surges. All three pushed to reopen their economies early in an attempt to “return to normal.” The current deluge in cases that resulted was due to a lack of continuing stay-at-home order and a failure to require masks.

Texas officially started Phase 1 of its reopening plan on May 1, but—as of June 26—had to retract much of the opening that it had started. In total, Texas was only able to reopen the state for 55 days. As of July 27, Texas has seen an average of 8,089 new cases of the coronavirus over a seven-day period. Compared to cases in April, when there were 814, this is astounding. Texas Governor Greg Abbott (R) has since ordered everyone to start wearing face masks and has limited the size of public gatherings.

It does not appear that Texas will shut down again, however. As the governor said, “we need to refocus on slowing the spread, but this time we want to do it without closing down Texas again.” Although it is an issue of public health, the issuance of a statewide masking policy and the staggered re-opening of the economy has become a matter of contention across party lines. Some residents find the Governor’s actions to be inadequate, and others feel as if the newly implemented precautions impede their personal liberties.

Florida and Arizona are not faring much better. As of April, Florida had 1,027 cases reported. In July, it was 6,563. Florida started its reopening plan on May 4 and entered into Phase 2 on June 5. Clearly, cases have surged.

Earlier this week, Florida reported 8,892 new COVID-19 cases. Like Texas, there seems to be a mixed reaction among Florida representatives to slow the spread of the virus. Senator Rick Scott (R) has been vocal about his intentions for Florida, and it appears the state will not roll back any of its reopening course. As Senator Scott put it a couple of months ago, “wearing a mask is a choice you get to make.”

Like Texas and Florida, Arizona is hurting badly, with only 115 in April surging to 4,753 cases in July. Arizona’s stay-at-home order lasted until May 15, and was replaced by the new Stay Healthy, Return Smarter, Return Stronger Executive Order, on May 16. When Arizona first reopened, Governor Doug Ducey did not require residents to wear face masks, but as the case numbers increased, he allowed local governments to set their own masking policies. As of July 1, officials said that Arizona saw the highest rate of new cases in the entire country.

Many public officials are starting to realize opening too soon was foolhardy and has spread the virus. New revelations by scientists show the virus can actually be airborne, urging those to take indoor transmission more seriously. The virus is also proving to be more of a blood vessel disease than solely a respiratory one, which may lead to long-term impacts that doctors are still learning about.

There’s one takeaway here: following the example of states like Texas, Florida, and Arizona is not recommended. The more seriously states take this crisis the better, and the sooner the entire country will be able to move towards a newer, safer “normal”.

Talia is a Washington, DC native and a rising sophomore at Wesleyan University, where she is studying English. Beyond health policy, Talia’s interests are in journalism, law, and social justice.

Meet the winners of this year’s Script Your Future Medication Adherence Team Challenge

The 2020 Medication Adherence Team Challenge is part of the national Script Your Future public awareness campaign coordinated by NCL with support from its partners and the Challenge sponsors—the American Association of Colleges of Pharmacy (AACP), the National Association of Chain Drug Stores (NACDS) Foundation, the National Community Pharmacists Association (NCPA) and the American Pharmacists Association (APhA).

Medication non-adherence can lead to devastating health outcomes. Research shows that nearly one in five prescriptions go unfilled and half of all patients with chronic illnesses do not take their medication as prescribed. Improved medication adherence leads to better health outcomes and reduced total healthcare costs, and it was for these reasons that NCL launched the Script Your Future awareness campaign in 2011.

The Team Challenge was established to extend campaign messages into medical and other schools of health professions, and to nurture adherence-minded values in future generations of professionals entering the workplace. Each year, top performing teams are honored with a National Award for overall outstanding team achievement, or a Focused Award, which recognizes outstanding team achievement in the specific areas of health disparity/under-represented community outreach, media/communications outreach, or creative interprofessional team event. This year, we introduced a new focused award category, with the inclusion of a Technology Innovation Focused Award – a category that evaluates creative outreach with a focus on technology-based interventions.

In 2020, our Team Challenge student health professionals were met with unique challenges as they navigated the historic COVID-19 pandemic, which resulted in school closures, event cancelations, and a host of other obstacles. To adhere to social distancing guidelines, our dedicated teams pivoted their campaigns and made an impact in other ways. This year, the Team Challenge observed engagement from nearly 2,900 future healthcare professionals and volunteers, who all together hosted over 250 events in 14 states. Collectively, the teams directly counseled close to 12,000 patients and introduced Script Your Future messaging to over 430,000 consumers, nationwide.  Since the Team Challenge began in 2011, more than 21, 000 future healthcare professionals have directly counseled nearly 87,000 patients and nearly 26 million consumers.

The recognized schools, selected from dozens of applications and 82 participating educational institutions, are listed below.

National Award | University of the Sciences: Philadelphia College of Pharmacy, PA

University of the Sciences (USciences) interdisciplinary medication adherence outreach centered around individuals across all ages, from children to older adults. USciences’ team structure included students of pharmacy, occupational and physical therapies, medicine, and social work. Throughout the Team Challenge, USciences directly counseled 455 patients, reaching a total of 805 people. During their outreach, USciences introduced a new campaign theme – “A future of ______ begins with me”, to personalize medication adherence through each patient interaction. USciences’ campaign also placed a great emphasis on addressing racial disparities, reducing stigma surrounding mental health, and tangential issues like vaccine confidence and proper nutrition.

National Award Finalists

The following schools were named Finalists under the National Award category:
Pacific University School of Pharmacy, West Virginia University School of Pharmacy, Western University College of Pharmacy, Northeast Ohio Medical University (NEOMED), University of Charleston School of Pharmacy, Touro University College of Pharmacy, St. Louis College of Pharmacy.

Rookie Award | Howard University College of Pharmacy – Washington, DC

NCL is thrilled to announce that DC HBCU, Howard University College of Pharmacy, was the recipient of the 2020 Rookie Award. Howard University’s team included students of pharmacy, medicine, social work, and dentistry. Howard University’s target population included homeless or displaced minorities, children and parents, and adults with behavioral issues. The team tailored its disease focus to diabetes and heart disease, as they are chronic conditions that plague the region. Throughout the Challenge, Howard University directly counseled close to 400 patients and reached over 1,000 people with the help of 169 students and volunteers and distributed nearly 1,000 Script Your Future medication adherence resources.

Rookie Award Finalist: University of Arizona College of Pharmacy– AZ

The University of Arizona College of Pharmacy in Tucson, AZ also made a strong showing in the Team Challenge as a first-time competitor.

Focused Awards

Health Disparities Community Outreach Award | St. Louis College of Pharmacy – MO

Pharmacy students from St. Louis College of Pharmacy and nursing students from St. Louis University, joined forces to strategically and intentionally identify their target population – residents of a region of St. Louis known as the “Delmar Divide.” St. Louis College of Pharmacy chose this target population due to the stark disparities observed in the residents directly north and south of the Delmar Divide. For their outreach, St. Louis College of Pharmacy focused their interventions on communities north of the Delmar Divide, which predominantly consists of people of color of lower socioeconomic means. The team chose to focus on chronic conditions like diabetes and hypertension. Together, 60 students and volunteers directly counseled 350 patients and reached nearly 400 people. Through numerous events and newly fostered community partnerships, St. Louis College of Pharmacy disseminated nearly 400 Script Your Future medication adherence resources within the community.

Communication and Media Outreach Award | Lake Erie College of Osteopathic Medicine School of Pharmacy (LECOM) – PA & FL

To illustrate the diversity of their team, LECOM pharmacy and medical students from campuses based in PA and FL produced a public service announcement (PSA) spoken in eight languages, to help amplify the value of medication adherence to numerous populations. The PSA garnered over 2,800 views. LECOM employed social media platforms like Facebook, Instagram, Twitter, and LECOM’s Pulse Newsletter, to help disseminate Script Your Future medication adherence messaging. LECOM students also wrote an original book to present heart health information to the children entitled “Mr. Pumper and the Heart Valves”, which was read to third grade elementary students. Throughout the Challenge, 293 students and volunteers directly counseled over 500 patients, reaching over 1,200 patients, and disseminated over 730 Script Your Future resources in their community.

Creative Inter-Professional Team Event Award | University of Pittsburgh School of Pharmacy – PA

The University of Pittsburgh School of Pharmacy partnered with the Schools of medicine, dentistry, social work, nursing, dietetics, and rehabilitation sciences, to organize a team of over 300 students and volunteers to execute their medication adherence outreach. University of Pittsburgh harnessed the interdisciplinary nature of their team to build a campaign serving older adults in their community, from a holistic treatment perspective. The team addressed issues like hypertension, social isolation, and food insecurity. Throughout the Challenge, University of Pittsburgh directly counseled over 130 patients and reached over 2,200 patients.

Technology Innovation Award| Western University College of Pharmacy – CA

Western University College of Pharmacy made an impressive debut for the inaugural inclusion of the Technology Innovation Award. To foster medication adherence, the team created a dedicated website that directed patients to resources relating to disease areas like COPD, pneumonia, heart failure, and diabetes. The website was geared towards patients recently discharged following a hospital stay and contained features like medication and post-discharge appointment reminders and medication adherence-related infographics in multiple languages.

At-home vision assessments no replacement for in-office visits

With COVID-19 keeping many of us at home, companies claiming to offer at-home vision tests are ramping up their marketing, despite the fact that there is no U.S. Food and Drug Administration-approved at-home device that people can use to self-conduct a vision assessment, let alone a full eye examination. These devices aren’t even proven to provide an accurate vision prescription. NCL has long recommended an annual, in-person eye exam as part of consumers’ annual health and wellness routines.

“Consumers need to be wary of products that mistakenly claim that their at-home devices can provide an eye exam or a vision prescription and should instead consult their eye doctors who are available to help provide safe solutions,” said NCL Associate Director of Health Policy Nissa Shaffi.

NCL leads advocates in urging FDA to protect patient access to critical therapy for preterm birth

By Sally Greenberg, NCL Executive Director

The National Consumers League and 14 leading health organizations and individual providers have collaborated in sending a letter to the Food and Drug Administration (FDA) as the agency considers whether to withdraw the only FDA-approved therapy that reduces the risk of preterm birth in women with a history of preterm birth.

Why did we and our fellow advocates decide to send this letter in the midst of the COVID-19 pandemic? Several important reasons.

First, preventing preterm birth is always a vital cause—during or without a pandemic. The leading cause of infant death in the United States, premature birth has devastating effects on families and is very costly to our health care system. For babies who do survive, short and long-term complications can accompany preterm birth. For mothers, a history of spontaneous preterm birth is a leading risk factor for recurrent preterm birth, yet providers have only one therapeutic option – hydroxyprogesterone caproate or “17P,” in one branded and five generic forms – to prevent recurrent preterm birth for these at-risk mothers.

Taking away these options—especially in the midst of a pandemic—would be concerning for pregnant women who are at high-risk for preterm birth, including those that reduce their risk of being admitted to the hospital for early delivery.

Secondly, as recent events surrounding both COVID-19 and continued fundamental rights injustices have reminded us, a profound and systemic inequity exists in the United States where institutional racism contributes to health disparities—including preterm birth and infant mortality. COVID-19 has disproportionally impacted African American women, the same population that is most likely to experience preterm birth. The preterm birth rate among U.S. black women is 49 percent higher than the rate among all other women, according to the March of Dimes.

Thirdly, 17P is the only FDA-approved therapy that reduces the risk of preterm birth and has been used for nearly a decade. We are concerned that removing access to the only FDA-approved therapy may deepen maternal and infant health inequities that exist within the U.S.

It is also troubling that if providers cannot access FDA-approved forms of 17P, this may expose pregnant women to compounded medications, which have no labeling to provide guidance on administration, contraindications, or potential side effects.

Removing 17P products in the absence of suitable alternatives would leave patients and providers significantly disadvantaged in the fight against prematurity. While we recognize the FDA is encountering tremendous challenges in addressing the COVID-19 pandemic, it is important to underscore the public health need for continued access to approved treatment options, and we trust that the agency will consider the patient impact as they evaluate this issue.

To add your voice to the letter to FDA, urging the agency to preserve patient access to the only FDA-approved therapy to reduce the risk of preterm birth, you can sign on here.

Vaccine hesitancy and the unique challenge of COVID-19

headshot of NCL Health Policy intern Talia

By NCL Health Policy intern Talia Zitner

Around the globe, researchers and scientists are racing to find a vaccine for the COVID-19 virus. Developing a safe, effective, and affordable vaccine is already a challenging feat, but vaccine hesitancy presents another unique challenge to scientists, government researchers, and community leaders.

“Vaccine hesitancy” refers to the reluctance or refusal to be vaccinated or have one’s children vaccinated against a disease, even if a vaccine is proven to be safe and effective. Vaccine hesitancy poses dangers to both the individual and their community, since exposure to a contagious disease puts the person at risk, and they are far more likely to spread the disease to others if they won’t get vaccinated. Ironically, these communities may be the most vulnerable to COVID-19, and a serious effort must be made to create a sense of comfort around the COVID-19 vaccine once it’s available to the public.

Not to be confused with the vaccine-hesitant, “anti-vaxxers” represent a movement of people who dispute the safety of vaccinations and challenge laws that mandate vaccinations. This is a more insidious movement funded by dubious sources (reportedly, one New York couple has donated millions of dollars to the movement) that deceptively politicize public health measures under the guise of protecting personal liberties.

Public health agencies are trying to get vaccination levels to 95 percent to guarantee herd immunity. Some concerns that are top of mind for consumers include knowing the timeframe for a vaccine, who will have access to it, what it will cost consumers, if anything, and how states will determine methods of enforcing vaccination. The possibility of a COVID-19 vaccine also begs the question of whether vaccination will be mandatory for public schools and government workers.

Perhaps one of the most important projects right now surrounding vaccine hesitancy is the Vaccine Confidence Project (VCP), which is dedicated to “conducting a global study to track public sentiment and emotions around current and potential measures to contain and treat COVID-19.” Using a mix of population surveys and social media tracking, VCP “will investigate perception and sentiment of COVID-19 social distancing measures and potential medical tools globally.” This project will be essential moving forward, as it will continue to inform understanding on how the global population perceives the eventual vaccine.

As of now, VCP reports that only 25 percent of African Americans—a population that has been disproportionately hit by the virus—plan to get the COVID-19 vaccine. Why is this the case? Due to lack of access to hospitals, pharmacies, doctors and clinics in Black communities, failure to expand Medicaid, and other root causes; the COVID-19 pandemic has laid bare the disparities in our health care system.

To ensure herd immunity—which is somewhere north of 90 percent immunity—much work needs to be done, especially with the Black community, to increase confidence when a COVID-19 vaccine is released. At this time, Black leaders such as former U.S. Surgeon General, Dr. Regina Benjamin, and current U.S. Surgeon General Dr. Jerome Adams, are among those leading the charge to encourage public health efforts such as advocating for face-mask usage and collaborating with the National Newspaper Publishers Association (NNPA) Coronavirus Task Force and Resource Center, which provides expertise on the virus and its impact on the Black community.

Another community that will be crucial to prioritize surrounding vaccine hesitancy is the older Americans. The New York Times reported that of the “241 interventional COVID-19 studies undertaken in the United States and listed on clinicaltrials.gov…37 of these trials—testing drugs, vaccines and devices—set specific age limits and would not enroll participants older than 75, 80 or 85 years old. A few even excluded those over 65.” Why would older Americans trust a vaccine not tested for their age groups? Clinical trials will need to include people across all ages, otherwise, this will only increase vaccine hesitation. The vaccine must be safe and effective, and ample outreach must be conducted to ensure vaccine confidence across all demographics.

There are many questions left to be addressed. As we continue to navigate preventive measures for COVID-19, independent researchers and organizations will become increasingly more important to guiding decision making before and after a vaccine is developed.

Vaccine hesitancy is a global problem that will only be compounded by the COVID-19 pandemic. Fostering vaccine confidence will be imperative when the second wave of the virus sweeps the globe, as it inevitably will.

Talia is a Washington, D.C. native, and a rising sophomore at Wesleyan University, where she majors in English. Beyond health, Talia’s interests are in journalism, law, and social justice.

Observing World Food Safety Day: Food safety, foodborne illnesses, and the pandemic.

By Nailah John, Linda Golodner Food Safety and Nutrition Fellow

Happy World Food Safety Day! June 7 is a special day designated by the United Nations to draw global attention to the health consequences of contaminated food and water.

The concept of food safety encompasses all practices that are used to keep our food safe and relies on the joint efforts of everyone involved in our food supply. “Everyone” refers to all actors in the food chain, farmers, manufacturers, wholesalers, retailers, restaurants, caterers, and many more. Laws and regulations are in place to reduce the risk of contamination under the Food Safety Modernization Act, which is transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it.

In the United States, the Centers for Disease Control and Prevention CDC estimates that each year 48 million people get sick from a foodborne illness, 128,000 are hospitalized, and 3,000 die. There are more than 250 types of foodborne diseases, caused by bacteria, viruses, and parasites. Some common foodborne illnesses that are found in our country include:

Norovirus: a contagious virus that causes vomiting and diarrhea. You can get norovirus from:

  • Direct contact with an infected person
  • Consuming contaminated food or water
  • Touching contaminated surfaces, then putting unwashed hands in your mouth

Salmonella: lives in the intestines of people and animals. can come from infection from a variety of sources, including:

  • Eating contaminated food or drinking contaminated water
  • Touching infected animals, their feces, or their environment.
  • The bacteria cause about 1.35 million infections, 26,500 hospitalizations, and 240 deaths in the United States every year.

Clostridium perfringens: a spore-forming bacterium that is found in the environment as well as in the intestines of humans and animals. It is also commonly found in raw meat and poultry, beef, poultry, gravies and dried of pre-cooked foods

  • Infections often occur when foods are prepared in large quantities and kept warm for a long time before serving. Outbreaks often happen in institutions, such as hospitals, school cafeterias, prisons, and nursing homes, or at events with catered food.

Campylobacter: the most common bacterial cause of diarrheal illness in the United States.

  • Causes 1.5 million illnesses each year.
  • caused by eating raw or undercooked poultry or consuming something that has come into contact with raw or undercooked poultry, seafood and untreated drinking water.

Staphylococcus (Staph): a gastrointestinal illness caused by eating foods contaminated with these toxins.

  • symptoms include sudden nausea, vomiting and stomach cramps, diarrhea.
  • Not washing hands if food is contaminated with Staph, the bacteria can multiply in the food
  • Foods that are not cooked after handling, such as sliced meats, puddings, pastries and sandwiches are especially risky if contaminated with Staph.

As we note efforts worldwide to ensure that our human food supply is safe, we would be remiss in 2020 if we did not note the increased food safety concerns during the COVID-19 pandemic.

According to the CDC, there is currently no evidence to support transmission of COVID associated with food. It is important that consumers wash hands with soap and water for 20 seconds when handling food. The CDC highlights that, because of poor survivability of these coronaviruses on many surfaces, there is likely low risk of spread from food products or packaging. The CDC also reinforces the need to avoid cross-contamination of foods in preparing food safely by keeping raw meat separate from other foods, cooking meat to the recommended temperature, which kills harmful bacteria and ensuring that perishable foods are refrigerated.

It is also important to always rinse fresh fruits and vegetables under running water, including melons and other produce with skins and rinds. Scrub the produce firmly with a clean brush, also remember to clean the lids of canned goods before opening them, says the FDA. Washing produce and cooking meats, fish, and poultry thoroughly is key during this pandemic, especially with so many people preparing their meals at home. Our message to consumers and restaurants and anyone who handles food: as we mark World Food Safety Day, follow these important food safety practices to help prevent foodborne illness and stay healthy and safe during these uncertain times.