The FDA must create a win-win path leading to new data on 17P and protect access for pregnant mothers

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By Sally Greenberg, NCL Executive Director

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. For nearly a decade, it has been the only FDA-approved therapy to reduce the risk of recurrent preterm birth. It is available to women and their healthcare providers in both branded and generic prescription versions.

I have personally spoken with healthcare providers whose patients have had longer pregnancies thanks to 17P and a longer pregnancy can be a very good thing. As we noted in a letter we signed, along with 15 leading women’s and children’s health advocates, and sent to the FDA a few months ago, premature birth is the leading cause of infant death in the U.S. and has devastating effects on families and is very costly to our health care system. Among those babies who do survive, short and long-term complications can accompany preterm birth.

Prematurity also has a very significantly disproportionate impact on women of color. It is not something to take lightly. In fact, the preterm birth rate among U.S. black women is 49 percent higher than the rate among all other women. Factors associated with being African American—including experiencing institutional racism, racial health inequities, and higher psychosocial stress—contribute to prematurity.

One would think that preserving access to the one branded and five generic forms of 17P would be a priority for the FDA. Yet shockingly, earlier this week, the FDA proposed that all versions of 17P (branded, generics, and compounded for this indication) be withdrawn from the market.

The Center for Drug Evaluation and Research (CDER) within the FDA made this recommendation despite the fact that 17P has a very strong safety profile (two trials and a decade of use by U.S. women and their providers bear that out). It also made its recommendation without meeting with affected women or providers who have personal experience with the benefits of 17P, without comprehensively considering alternative methods to assess which patients benefit most, and without, in our view, fully accounting for the unique needs of black women, who face a rate of preterm birth in the U.S. that is about 50 percent higher than the rate of preterm birth among white women.

To be fully transparent, 17P does have conflicting efficacy data from two clinical trials with markedly different patient populations: the first of which included a majority of U.S.-based African American women (59 percent). This was the trial that led the FDA to approve 17P for use in the U.S. in 2011, and another which included data of a population of women, most of whom lived in the Ukraine and Russia, and few of whom (7 percent) where African American.

There are questions on the table about who specifically benefits most from 17P and those questions do need to be answered. But access to 17P should not be compromised without substantial evidence that there is lack of benefit in the appropriate population and we don’t believe that evidence exists today. We strongly believe that the FDA should accept any request for a hearing in order to allow providers and patients an opportunity to discuss these concerns in more detail.

The FDA was provided with a proposal to keep 17P on the market and gather data to determine which populations of pregnant women benefit most from the therapy. The company that makes the branded version of 17P provided a detailed plan for generating additional data and predictors of benefit in women with a history of recurrent preterm birth.

Utilizing alternate ways to evaluate and define the patient populations that benefit most from 17P while allowing continued access to those in need seems like a win-win approach, especially considering the fact that the second, predominantly international based clinical trial was conducted outside of the U.S. because U.S. healthcare facilities refused to give their patients a placebo rather than 17P, and the same would undoubtedly happen if another clinical trial was attempted on American soil.

We’re talking about pregnant women and babies, not just ‘clinical trial participants.’

As our nation continues to grapple with the effects of the pandemic on our health and lives, evidence has shown that there may be an increased risk of preterm birth and pregnancy loss among pregnant women with COVID-19, particularly pregnant women of color. And while no single solution will improve maternal and infant health outcomes, only one proven intervention currently exists to help pregnant women prevent a recurrent preterm birth.

By factoring in the experiences of mothers and providers, the FDA can continue upholding its strong history of regulatory integrity while taking a necessary, comprehensive view of 17P’s real-world clinical implications on pregnant women and their newborn babies. We urge the FDA not to leave at-risk pregnant women and their healthcare teams without a path forward in the middle of a pandemic.
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Hispanic Heritage Month: Focus on the importance of participating in research through clinical trials

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Hispanic Heritage Month: Focus on the importance of participating in research through clinical trials
by Elena Rios, MD, MSPH, FACP
President & CEO, National Hispanic Medical Association

The COVID-19 pandemic has impacted the world and the United States with a double threat: decreasing health and function of many, especially older patients with underlying diseases (obesity, asthma, diabetes, hypertension, etc.) that decrease the body’s immune response to fight off the virus; and millions left jobless as businesses downsize or close. In the healthcare arena, scientists and physicians are learning about the disease and how to treat it: We now know to limit ventilators to avoid high air pressures that can hurt damaged lungs; to place infected patients on their stomachs to allow lungs to expand; to use dexamethasone to decrease inflammation; and to use new antiviral therapies like Remdesivir and monoclonal antibodies. While there is no vaccine to prevent COVID-19, vaccine developers, researchers, and manufacturers are expediting the development of one.

The National Institutes of Health (NIH) and several pharmaceutical companies are conducting research through clinical trials that have found potential vaccines to be safe. This summer they started to enroll people and closely follow them for any adverse effects. Historically, Hispanics, Blacks, and Native Americans have been underrepresented in clinical trial research for a variety of factors, chief among them, a distrust of research and the concept of fatalism (leaving life’s challenges in God’s hands). But it is crucially important to have diversity in clinical trials to have information on the vaccine impact for Hispanics, for example. I encourage all persons over the age of 18 to enroll in the important COVID-19 clinical trials — and recommend websites for two ongoing clinical trials: the CoronaVirusPreventionNetwork.org from the NIH and Moderna, and the CovidVaccineStudy1.com

from Pfizer Inc. Each site provides consumers with information on the locations and how to enroll.

The National Hispanic Medical Association (NHMA) was established in 1994 to represent trusted Hispanic physicians and to improve the health of Hispanics and underserved populations. Given that, by 2042, one out of four people living in our nation will be Latino, NHMA has joined as a partner to encourage the Latino community to join the NIH All of Us Research Program. In May 2018, the NIH opened national enrollment for the All of Us Research Program—a momentous effort to advance individualized prevention, treatment, and care for people of all backgrounds—in collaboration with NHMA and other national partners. People ages 18 and older who reside in the United States, regardless of health status, are eligible to enroll. The overall aim is to enroll 1 million or more volunteers and to oversample communities that have historically been underrepresented in research to make the program the largest, most diverse resource of its kind. Our participation will provide information on how to better develop health care prevention and treatment programs for generations to come.

Precision medicine is an emerging approach to disease treatment and prevention that considers differences in people’s lifestyles, environments and biological makeup, including genes. By partnering with 1 million diverse people who share information about themselves over a 10-year period, the All of Us Research Program will enable research to more precisely prevent and treat a variety of health conditions.

Participants can access their own health information, including genetics information, summary data about the entire participant community, and information about studies and findings, that come from All of Us. Participants are asked to share different types of health and lifestyle information, through online surveys and electronic health records (EHRs), which will continue to be collected over the course of the program. At different times over the coming months and years, some participants will be asked to visit a local partner site to provide blood and urine samples and to have basic physical measurements taken, such as height and weight, to ensure that the program gathers information fromall types of people. This program is especially focused on those who have been underrepresented in research, but not everyone will be asked to give physical measures and samples. In the future, participants may be invited to share data through wearable devices and to join follow-up research studies, including clinical trials.

In addition, data from the program will be broadly accessible for research purposes. Ultimately, the All of Us Research program will be a rich and open data resource for traditional academic researchers as well as citizen scientists—and everyone in between. To learn more about the program and how to join, please visit https://www.JoinAllofUs.org.

About NHMA

NHMA is a nonprofit association representing the interests of 50,000 Hispanic physicians with the mission to improve the health of Hispanics in the U.S. For more information, please visit www.NHMAmd.org

Vitaminwater making bold claims

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Since its founding in 1899, NCL has been on the look-out for product claims that may be deceptive or misleading. So when we came across a few advertisements about vitaminwater recently, we were shocked to see that the company that manufactures vitaminwater, Glaceau (a Coca-Cola company), is suggesting that its products can keep you healthy or pre-empt the need for flu shots!

*In a formal complaint filed with the Federal Trade Commission in February 2011, NCL is pointing to print and television advertisements that suggest vitaminwater can replace flu shots or prevent illness and prey on consumers’ health concerns to sell a high-calorie product:

“These advertising claims are not only untrue; they constitute a public health menace. Stopping these vitaminwater claims, which contradict information by the Centers for Disease Control and other public health authorities, should be a top FTC priority,” stated Sally Greenberg, Executive Director of NCL.

The NCL complaint also urged the FTC to halt deceptive label statements for vitaminwater that describe the product as:

According to NCL, the statements are deceptive because the products on which they appear are not simply made from vitamins and water, but are made with crystalline fructose or other forms of sugar, and contain 125 calories per bottle.

“Two-thirds of Americans are overweight or obese; the last thing people need is sugar water with vitamins you could get from eating a healthy diet, or by taking a vitamin pill, Greenberg stated.

The FTC should act now, during cold and flu season, to stop vitaminwater’s outlandish claims,” she said.

Read NCL’s letter to the FTC *here, or tell vitaminwater what you think of its ads here.

*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings

Not so sweet: Child labor in banana production

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By Child Labor Coalition intern Ellie Murphy

Americans eat a lot of bananas. The U.S. is the world’s biggest importer of bananas, eating between 28 and 30 bananas per person per year. Worldwide, bananas are the most popular fruit with 100 billion consumed annually. The fruit is nutritious and cheap. Prices generally fluctuate between 30 cents and $1.00 per banana. It’s a great deal for the consumer, but someone is paying a heavy price to produce bananas: exploited farmworkers, including many children.
Stagnating banana prices have put the squeeze on farmers, leading some planters to hire the cheapest workers—children. The work is hard, often dangerous, and not fit for children. Yet they toil in the fields to help their impoverished families.

Countries that use child labor to produce bananas include Ecuador, Belize, Brazil, Nicaragua, and the Philippines, according to the U.S. Department of Labor’s (USDOL) List of Goods Produced by Child Labor or Forced Labor.

Poverty is the main driver of child labor, but children in the developing world face barriers to accessing education that can push them to farm work. Besides the cost of school, uniforms, and books, there are also some countries that don’t have enough schools, classrooms, or teachers. And transportation problems can impact children’s ability to attend school.

Child labor in the banana sector poses significant challenges to children’s health and overall well-being. Child workers employed at these plantations are often forced to handle sharp tools like machetes, carry heavy loads, and face exposure to agrochemicals like pesticides and fungicides without protective clothing or gear. Dizziness, nausea, and negative long-term health conditions can result in child workers, and because child workers often live on banana plantations, escaping these health hazards is nearly impossible.

Let’s take a closer look at Ecuador, the world’s top exporter of bananas.

A Human Rights Watch (HRW) report released in April 2002 found widespread labor and human rights abuses on Ecuadorian banana plantations. Children as young as eight were found performing hazardous work. “The use of harmful child labor is widespread in Ecuador’s banana sector,” concluded HRW. Report authors interviewed 45 child banana workers and found that 41 began working between eight and 13 with most starting at age 10 or 11. “Their average workday lasted twelve hours, and fewer than 40 percent of the children were still in school by the time they turned fourteen,” noted HRW. According to USDOL, almost half of indigenous children in rural areas do not attend school, “which can make them more vulnerable to child labor.

“In the course of their work, [child banana workers] were exposed to toxic pesticides, used sharp knives and machetes, hauled heavy loads of bananas, drank unsanitary water, and some were sexually harassed,” noted HRW.

Roughly 90 percent of the children HRW interviewed reported that they “continued working while toxic fungicides were sprayed from airplanes flying overhead. In an attempt to avoid harmful chemicals, children interviewed about their experience stated that they used various methods to avoid toxic chemicals: “hiding under banana leaves, bowing their heads, covering their faces with their shirts, covering their noses and mouths with their hands, and placing banana cartons on their heads.”

About one in 20 Ecuadorian children in the 5-14 age group work—and four in five of these child workers toil on farms, according to data from USDOL released in its 2019 Findings on the Worst Forms of Child Labor (2019) report.

Clearly, child labor laws in Ecuador are not being adequately enforced. Alarmingly, according to the USDOL, funding for Ecuador’s labor inspectorate fell dramatically from $1.5 million in 2017 to $265,398 in 2018. During that time the number of inspectors increased from 150 to 249. There is no explanation provided for these conflicting numbers but USDOL did note there were fiscal pressures on the Ecuadorian government.

The 2002 HRW report cited many causes of child labor, including discrimination against unionized adult workers who earn higher wages. As a result, many workers who unionize are fired and replaced with children who earn around $3.50 per day, 60 percent of the minimum wage for banana farmers. “Ecuadorian law fails to protect effectively the right to freedom of association, and employers take advantage of the weak law and even weaker enforcement to impede worker organizing,” noted HRW.

Since the 2002 HRW report, Ecuador has raised the minimum age of employment to 15, banned children from hazardous work, and raised fines for employers hiring children.

In its 2019 child labor Findings report, USDOL noted that “in 2018, Ecuador made a significant advancement in efforts to eliminate the worst forms of child labor.” One change involved better protecting unionized employees against discrimination so that children are not targeted for cheap labor. Ecuador has also created more social programs for children susceptible to child labor, including the “Lifetime Plan” that provides conditional cash transfers to vulnerable children from birth.

Despite the positive ranking for Ecuador, child labor in the banana sector continues to be prevalent in Ecuador.  Poverty and limited law enforcement make child labor an unfortunate reality for families.

Banana exporting companies often fail to address adequately child labor and hazardous working conditions in their supply chains. The big players –Dole, Del Monte, and Chiquita Fyffes—need to do more if we are to end child labor in banana production. Dole claims to prohibit child labor stating that “[it prohibits] any people younger than 18 from being hired or employed in *any form.” Yet, child labor in the sector flourishes in at least five of the major exporting countries, according to USDOL.

In its Findings report, USDOL makes a number of recommendations to help reduce child labor in Ecuador, including a call for a new national child labor survey, added funding to hire more labor inspectors, and social programs in rural farm areas and informal sectors. USDOL also suggests “removing school-related fees, increasing classroom space, and providing adequate transportation.” These modifications will specifically help children living in rural areas such as migrant children and indigenous children stay in school.

Concerted efforts by the Ecuadorian government and multinational banana exporters are needed if child labor is to be reduced.

Consumers have a part to play in the solution as well. The Food Empowerment Project advises consumers to buy bananas produced with less exploitation. They recommend buying from Equal Exchange. Bananas from small farmer-owned cooperatives are available in some parts of the United States. Look for bananas from Coliman, Earth University, and Organics Unlimited/Grow. “If your grocery stores do not carry these brands of bananas, we encourage you to ask them to,” says the Food Empowerment Project.

Consumers should make their voices heard: the sweetest banana is a child-labor-free banana.

Ellie Murphy is a rising junior at Tufts University, majoring in International Relations and Sociology.

*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings

Mail-in and absentee voting during COVID-19

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By NCL Executive Assistant Adrienne Archer

The National Consumers League (NCL) wants consumers to know that voting by mail or absentee ballot during the COVID-19 pandemic is safe. Due to conflicting information being shared by the media, and federal, state and local governments, it can be difficult to determine how best to vote. During the COVID-19 pandemic, a voter should always focus on keeping themselves and their family safe and healthy. Whether voting by mail-in or absentee ballot, it’s important to have a plan. However, due to the variety of challenges posed by the pandemic, it might be difficult to keep up with the changes or updates to a state’s voting guidelines. Voters should contact their local elections office.

Many states and the District of Columbia have made it easier to vote early by mail or by absentee ballot. In the past, voters needed a reason why they couldn’t vote in person. National Conference of State Legislators (NCSL) has resources for on *state laws governing voting across the U.S. To know exactly when to vote in your state, contact your local elections office. USA.gov also offers information on the time frames for early or absentee voting.

All states will offer a form of mail-in voting and some states will make it more accessible to vote than others. Some states are still crafting legislation to make it easier for people to vote by mail or absentee ballot. The New York state legislature passed three bills allowing voters to request an absentee ballot or mail-in ballot because of COVID-19 fears. One of the bills allows for absentee ballots to be postmarked as late as election day and still be counted.

Government officials have noted possible instances of voter fraud. Some states have voiced concerns that mail-in ballots can easily be stolen, altered, or forged. Voters worry that they will not receive their ballot in time to vote. Congress is worried that the increase in mail will overwhelm the United States Postal Service (USPS) and delay the delivery of ballots. To add to the problems, the U.S. Postmaster General has made budget cuts to the USPS, dismantled machines, collected mailboxes, and reduced mail services causing consumers to worry that the USPS will not be able to process the increase in mail. Disability advocates want to ensure that mail-in voting will not be more difficult for voters with disabilities to exercise their right to vote.

Voting by mail is a safe option: it increases the overall voter response in the election. Even with these challenges to voting, military members and older Americans have been always encouraged to vote absentee. The Centers for Disease Control and Prevention (CDC) has provided *recommendations for people to handle mail-in ballots safely when they are received. In response to consumer requests, the USPS has created a website to help voters ensure that they can receive and return their ballot safely. Also, voters should remember that the main goal of voting during this pandemic is to safely cast their votes.

Americans voting from abroad, or in the military should be aware of the following: potential delays with sending and receiving mail, possible embassy closures due to COVID-19, and ensuring that their personal address is updated with his or her state. Americans abroad should request a ballot immediately from the Federal Voting Assistance Program’s website and check with their local U.S. polling place for instructions on receiving and returning the ballot. Most states permit Americans abroad to request a ballot via email with the caveat that a completed ballot should be returned by well before the November 3rd deadline via postal mail. Under Federal law, ballots should be requested by overseas military voters by September 19th (at least 45 days before the election). The Military Postal Agency has a list of recommended mailing dates. After individuals have returned their ballot, they should be sure to contact their local elections office to ensure that their ballot was received or if they have any questions.

Voting by mail has always been a good way to ensure access to those with disabilities. The American Civil Liberties Union has guidelines to improve accessibility to persons with disabilities. They suggest voters with a disability should receive ballots electronically so they can vote from the safety of their homes. Voters could indicate their candidate on the ballot by using accessibility features on his or her device. Then the ballot should be printed and mailed to his or her local polling place. Some states require witnesses or notarization on the ballot envelope. The American Civil Liberties Union (ACLU) wants to dispense with this requirement. Election poll workers should receive training on accessible voting options and how to respectfully interact with voters with a disability. Lastly, every state should raise awareness about accessible voting options.

In summary, to effectively vote by mail or absentee ballot during the COVID-19 pandemic, the National Consumers League suggests these steps:

  1. Create a plan for voting by mail or via absentee ballot.
  2. Check your local polling office to ensure that it has your correct mailing address and you are eligible to vote in the upcoming election.
  3. Request your absentee or mail-in ballot NOW, well before the deadline of October 3rd (45 days before the election) from your local polling office.
  4. If voting from abroad or in the military, allow for extra time to request and receive your ballot.
  5. If you have a disability, every state has in place accommodations so you may vote safely and effectively. If you have questions, please contact your local polling place early so they may be resolved.
  6. When you get your ballot, review the instructions for completing and returning it. If you have questions, contact your local polling office for guidance.
  7. Mail-in your ballot immediately, in advance of your state’s deadline, allowing for time for it to be reviewed and counted.

Above all, vote, vote, vote!

*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings

Labor Day 2020 sees highest approval ratings for unions since 2003

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Happy Labor Day everyone! The breaking news about this year’s Labor Day Celebrations is that a cross-section of Americans support labor unions in higher numbers. In fact, a recent Gallup poll found that 65 percent approve of unions, compared to just 49 percent in 2009. Today, 83 percent of Democrats support unions, while 64 percent of independents do and 45 percent of Republicans do. That’s telling news about how Americans perceive the value of labor unions.

Why has support for unions gone up? Because unions provide a voice for workers on health care, workplace safety, economic security, and decent wages—something all Americans want and need. Last week NCL asked our union representatives on our Board of Directors to join us for a discussion on COVID-19 and the importance of unions. You can watch the broadcast here: COVID-19: The inside perspective from frontline workers and their unions.

We are also pleased that State Attorneys General are playing an increasingly important part in protecting workers from wage theft and enforcing the law against errant employers.

NCL’s John Breyault has had four interviews with state AG’s in the past several months, focused on fraud and other related issues. The NCL Board and staff support stronger AG action in the coming months, and our work on this issue truly makes NCL’s mission #NeverMoreRelevant in these changing times.

This 2020 Labor Day, we want to thank the many millions of American workers who have showed up each day for work, risked their health and well-being to do their jobs during this very challenging pandemic. With support for unions on the rise, let us commit to reforming labor laws and allowing workers to organize and join unions without undue influence or scare tactics from employers. The rates of union membership should be far higher and would be but for the barriers in place. Once again, to America’s workers we say: stay safe and stay healthy this 2020 Labor Day.

Jeanette Contreras portrait

FDA Emergency Use Authorizations and public trust for COVID-19 treatments

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By NCL Director of Health Policy Jeanette Contreras

There has never been a more critical time for consumers to have confidence in the Food and Drug Administration (FDA). The FDA is charged with ensuring the safety, efficacy, and security of the drugs, biologic products, and medical devices needed to treat and prevent the spread of COVID-19. The agency has undergone scrutiny from the scientific community for issuing Emergency Use Authorization (EUA) for COVID-19 treatments and diagnostics that appeared to be politically motivated.

On August 23, the FDA issued an EUA for the use of an investigational convalescent plasma to treat patients with COVID-19, touting it as yet another achievement in the Administration’s fight against the pandemic. After just two days of backlash from the scientific community, FDA Commissioner Dr. Stephen Hahn, took to Twitter to concede his mistake, admitting that the criticism was justified. Commissioner Hahn stated that the EUA is not the final FDA approval and that the agency would revoke authorization if needed. Criticism included former FDA Commissioners who stand by randomized clinical trial as the gold standard for evidence-based medicine.

This renowned round of criticism has come not long after the FDA provided EUA for hydroxychloroquine in March which it revoked in July after further review proved that it lacked efficacy.

The Federal Food, Drug, and Cosmetic Act provides the FDA Commissioner with the authority to issue EUAs for unapproved medical products or unapproved uses of medical products in response to a public health emergency, such as the current pandemic. An EUA can be revoked when new evidence emerges and the risk no longer outweighs the benefit of the unapproved use of a drug or product, yet the Trump Administration claimed that it was revoked due to political reasons.

Since February, when the Department of Health and Human Services (HHS) declared the pandemic a public health emergency, the FDA has exercised its authority to issue hundreds of EUAs for diagnostic tests, personal protective equipment, ventilators, and other medical devices to combat COVID-19. In August alone, the FDA revoked EUAs for over 100 diagnostic tests, including antibody and rapid tests. The FDA recognizes that EUA is not intended to replace randomized clinical trials and that clinical trials are critically important for the definitive demonstration of safety and efficacy of a drug, treatment, or product.

Throughout the pandemic, consumers have received conflicting information from the Administration on various COVID-19 treatments, testing products, and safety recommendations. After witnessing the media controversy over EUAs for hydroxychloroquine and convalescent plasma, we are concerned that consumers may believe that the FDA is hastily approving investigational tests and drugs for political gain. The FDA, now more than ever, needs to reestablish public trust as it proceeds to fast track the approval of a COVID-19 vaccine.

Be wary of bad hand sanitizers

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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.

*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings

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

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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.

How you should respond to the security threat likely inside your computer

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Nearly two years ago, researchers revealed flaws in the chips of virtually every computer made since the mid-1990’s. The flaws—primarily found in Intel’s chips—create a vulnerability that can be exploited by allowing hackers to obtain unauthorized access to privileged information.


Since the initial exploits were first exposed, new versions have continued to be discovered—the most recent of which was found this past November. While software “fixes” have been released, they tend to reduce the speed and performance of computers—as much as 40 percent, according to some reports. In addition, since the flaw is hardware-based, the “fix” is only good until the next exploit is discovered.

At the time of the discovery of one of the “worst CPU bugs ever found,” there was significant alarm expressed in the news as well as across the cybersecurity community. Since that time, public attention has waned. Unfortunately, the problem has only grown worse. And while there has been considerable discussion of the impact these flaws have on businesses, the impact on consumers has been somewhat overlooked.

That’s why NCL’s #DataInsecurity Project recently released a paper detailing the threat that these bugs—with scary names like Meltdown, Spectre, and Zombieload—pose to consumers, their data, and the performance of their computers.

Every organization or individual running a server or computer with affected hardware should take action to protect themselves. Unfortunately, consumers are less likely to know what to do or have the resources to do it, leaving them more exposed.

For example, consumers are more likely to be running older or outdated software. Consumers are also likely to keep their computers much longer than a business, making their hardware older as well. The way these flaws work, older hardware generally sees a greater slowdown when the security patches are applied.

Additionally, the small businesses that consumers interact with may also be running “legacy” hardware or software. These businesses may not be able to afford the high cost of additional servers to offset the speed loss from the patches or of entirely replacing old systems. This difficult choice for small businesses could mean that some decide against applying patches – with potentially severe consequences for consumers’ data security.

Google has taken preemptive steps to protect consumers, but it also warned that as a result of these security measures, “some users may notice slower performance with some apps and games.” Apple, conversely, has offered software patches but left other security measures as an “opt-in” for consumers.

So, while consumers may not face the same type of risk as businesses, they do face a lot of challenges when it comes to addressing these exploits. Consumers already live in a heightened threat environment, filled with phishing emails and computer viruses. They shouldn’t have to choose between the security of their data or the performance of their computers.

To learn more about these issues and the best way to protect yourself, you can find NCL’s white paper here.