Child labor’s public perception problem

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Reid Maki is the director of child labor advocacy at the National Consumers League and he coordinates the Child Labor Coalition.

There are a lot of obstacles to ending child labor that the Child Labor Coalition (CLC) and its nearly 40 members confront on a daily basis. Poverty, governmental indifference, educational access, and a lack of awareness of the long-term impact of child labor on children are all big factors, but another is lack of knowledge of the scope or prevalence of the problem. The average American consumer doesn’t understand that child labor is a pervasive problem affecting an estimated 152 million children in the world—and that’s an estimate developed before the pandemic started. We think the number has grown significantly since COVID started throwing hundreds of millions of families into deeper poverty.

We became aware of the gap between the public’s perception of the problem and the reality of the situation seven years ago when the group Child Fund International commissioned a survey of over 1,000 consumers. Only one percent knew that roughly 150 million children were trapped in child labor globally. Even more disturbing: 73 percent of respondents—essentially three out of four—incorrectly guessed that the global total was less the one million. They were off by a factor of 150!

It’s hard to galvanize public and political opinion to confront a pressing social problem when few people realize the massive scope of the problem and instead misperceive it as a tiny, moribund problem. If we want corporations that benefit from child labor to take serious action, we need a better understanding of the problem’s prevalence. Governments are not likely to act or expend financial resources on programs to fix a problem perceived as affecting very few children.

We’ve been wondering if the Internet and Twitter have helped close the perception gap in the several years since Child Fund’s polling. Surveys are expensive and our budget didn’t allow us to conduct a phone-based survey like the 2013 poll. So, we decided to use a Survey Monkey internet poll to see where the public’s perception levels were at. We conducted the poll before COVID struck.

We gave respondents the opportunity to guess how many children were impacted by child labor and offered the following choices:

  • 1 in 10
  • 1 in 100
  • 1 in 500
  • 1 in 1,000
  • 1 in 5,000
  • 1 in 50,000

The most popular answer was the correct one: “1 in 10.” Thirty-five percent guessed correctly that 10 percent of the world’s children toil in child labor. However, that means that roughly two out of three respondents were off by a factor of 10 or more.

We think the answers in our informal internet poll may have skewed toward a better knowledge of the problem because we advertised the survey on our Twitter (@ChildLaborCLC), meaning it was being seen by people who presumably had better knowledge about child labor than the random public. With two-thirds of the public off by a factor of 100 or more, we know we still have a lot of work to do to close the perception gap.

In the last decade, the CLC has posted nearly 11,000 tweets to increase public understanding that child labor is a widespread and pernicious problem. We’re also active on Facebook (@ChildLaborCoalition) and our website (stopchildlabor.org) generates about 100,000 visits a year.

Those efforts don’t seem to be enough and we could use your help in the fight to end child labor. Please follow our posts and share them. Be a warrior in the fight to end child labor!

Remember that Child Fund International poll in 2013 we started with? The good news revealed in that survey was that more than half (55 percent) of the respondents said they would pay more for clothing made without child labor. They said they would pay 34 percent more on average for clothing untainted by child labor! According to cleanclothes.org, labor costs are typically less than 3 percent of clothing costs. Ending child labor would not raise prices significantly.

Garments are just one of 150 products identified by the U.S. Department of Labor “Sweat and Toil” app as being produced with child labor. If consumers are willing to pay more for child labor free clothing, they are likely to pay more for all products without child exploitation. That’s very encouraging.

The Child Labor Coalition is co-chaired by the National Consumers League and the American Federation of Teachers. Consumers who wish to donate to help reduce child labor can do so here.

Throwing COVID-19-related cautions to the wind

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

Over the past nine months, we’ve lived in a state of hypervigilance. The meticulous precautions we’ve observed throughout the pandemic have taken a toll on us. At worse, we’ve lost a loved one, friend, or coworker to this incessant virus. At best, we’ve been forced to recalibrate our routines and our lives. This collective weariness, to which experts have coined “COVID-19 Caution Fatigue“ is a prevailing factor in the current spike in cases.

When we are subjected to high levels of stress (e.g., high alert related to COVID-19), it can activate the stress hormone, cortisol. High levels of this hormone can cause us to become desensitized to the stimuli that triggered the stress hormone in the first place. Meaning, we start to ease up on our vigilance because the threat feels less real. These factors compounded—by feelings of isolation due to limited social contact‑—may have caused us to lose the motivation to maintain safe practices.

We see evidence of this as people are increasingly dining indoors, gathering for weddings, going to rallies, and are boarding flights nationwide. These behaviors are considered responsible for “superspreader events,” where COVID positive people expose multiple others. On average, every person with COVID-19 can potentially transmit the virus to two to three additional people. This has a multiplier effect with people spreading it, in turn, to another two to three people, and, well, you get the picture.

Dr. Fauci has warned that large gatherings during the holiday season could lead to “a surge superimposed upon that surge that we’re already in.” The pandemic demands personal sacrifices—which in turn leads to COVID induced malaise. I’ve personally RSVP’d “No” to a couple of family weddings—because the health and safety of my family matters more than joining them for a round of the “Cha Cha Slide.”

We must listen to public health experts. As I write this, the United States has more than 14.2 million COVID-19 cases and 275,000 deaths. These sad statistics will increase throughout the holiday season. Here are some ways you can combat COVID-19 Caution Fatigue:

  • Build a new routine. Find new and safe ways to move, interact with people, and entertain.
  • Healthy behaviors: focus on nutrient dense food, get adequate sleep, and limit alcohol use.
  • Journal: reflect on all that you’ve endured this year. A lot of us have been pushed to grow, expand, and adjust in unexpected ways. Focus on how far you’ve come, how resilient you are, and keep pushing.
  • Limit sreen time: For those of us working from home, it’s become increasingly tricky to maintain a work-life balance. Try to log off at a set time every day and take a break from screens in general (phone, TV, computer) and find ways to decompress from your day.
  • Personal improvement: Use time that would’ve been spent socializing on cultivating a new hobby. Take a free online course to learn a new concept. I personally like Coursera. Or learn a new language through mobile apps like Duolingo.
  • Prioritize self-care. Practice guided meditations via mobile apps like Headspace, read, or even start virtual therapy to process your emotions, through services like Talkspace.

In recognition of the emotional toll of social distancing, the CDC has issued guidelines on how to cope during the holidays. There’s light at the end of the tunnel. Perhaps several COVID-19 vaccines will be available in the coming months. That said, we have a long way to go, as the demand for the vaccine will far exceed its supply for many months. Remain vigilant and continue to adhere to pandemic-related safety guidelines. Our collective efforts will keep us safe while the vaccines become available across many demographics. Let’s continue to keep ourselves, our loved ones, and our communities safe through care and precautions against COVID-19. Mask up, stay 6 feet apart, wash your hands frequently, and avoid large gatherings. Happy and safe holidays to all!

For patients’ safety, it’s time Congress updated rules governing the $10 billion contact lens industry

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Contact lenses have come a long way since they were first introduced around 70 years ago.  Today, roughly 45 million Americans rely on them for safe, affordable vision correction each year.  But along the way, federal regulation of the contact lens market has not kept pace with the changing way Americans purchase and rely on these medical devices.  The result is that thousands of American consumers are at risk each year of adverse eye health outcomes including keratitis, corneal scarring, corneal ulcers, and infection.

Under federal law, online contact lens retailers do not require patients to provide their prescriptions before ordering contact lenses.  Patients can simply tell the retailer the lenses the doctor prescribed for them and the retailer then must verify the prescription with the prescribing doctor.  As required by the Federal Trade Commission’s Contact Lens Rule (“Rule”), contact lens-prescribing doctors have eight hours to respond to an online sellers’ verification communication before the contact lenses are sent to patients. If they don’t respond, the online contact lens seller can ship the products, regardless of the fact that prescription accuracy hasn’t yet been verified. Since the Rule was implemented in the mid-1990s, before the adoption of email, many sellers used automated telephone calls, or so-called “robocalls,” to fulfill the verification requirement of the Rule.

These automated robocalls use computer-generated voices.  They are often inaudible.  They frequently contain incomplete patient information, and, in practice, these robocalls are sent via computer at all hours of the day and night without noting any call back number to correct errors. This cumbersome process makes it nearly impossible for eye doctors to properly verify contact lens prescriptions.  In fact, this prescription verification system can lead to the shipment of incorrect contact lenses to patients with potentially dangerous consequences for patient vision health and safety.

As many consumers can attest from being bombarded with marketing robocalls, making sense of them is a nightmare. Using robocalls to verify important patient information, for the reasons previously outlined, is unsafe.

Current technology is capable of far better than this robocall system, especially due to the various forms of electronic communication we use today. These technologies can produce receipts, notify consumers of product shipments, and share product alerts and updates. Electronic communication is far more reliable and effective because it’s inexpensive, easy to understand, accessible.  It also creates a verifiable paper trail.  Therefore, we believe sellers of contact lenses should be required to use email or other forms of electronic communication, not automated robocalls, to keep consumers safe.

The FTC’s revised Contact Lens Rule also adds a cumbersome paperwork requirement that consumers and eye doctors need to complete at the end of a contact lens exam and fitting. Under this rule, prescribers must collect and store a so-called signed acknowledgment form in which a patient verifies that they received a copy of their prescription, as is already required under federal law.

That’s all well and good, but we believe a far better system to inform contact lens patients of their rights would be to require prescribers to post a sign in their offices, which is clear and conspicuous, noting that patients have a right to a copy of their contact lens prescription at the completion of their contact lens fitting. This type of posted signage is already mandatory in California, seems to be working well there, and we think it should be emulated on the federal level.

That’s a better solution because like many other forms consumers and patients are asked to sign, consumers probably won’t take time to read the form and thus won’t understand what they are signing; this is an ineffective exercise, in our view, and will result in more paperwork without necessarily ensuring patients have access to their prescriptions as the law intends.

In short, it’s time for Congress to update the rules governing this important, $10 billion industry.  It should start by requiring the use of the latest technologies—not robocalls—to get consumers the information they need about their eye prescriptions and that those prescriptions are verified as accurate by their eye professionals.

Jeanette Contreras portrait

Low-income essential workers lack adequate COVID-19 testing

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By NCL Director of Health Policy Jeanette Contreras

As the United States enters the third wave of COVID-19, low-income and minority communities hit hardest by the virus continue to disproportionately lack access to testing. The pandemic is shining a spotlight on the underlying health disparities that have long persisted within these medically underserved communities. Racial and ethnic minorities experience more severe COVID-related illness requiring hospitalization and are at higher risk for death from COVID-19. This is due largely to the prevalence of chronic conditions such as diabetes, asthma, heart disease, and chronic obstructive pulmonary disease (COPD).

In addition, racial and ethnic minorities make up a significant portion of the low-wage essential workers on farms, in grocery stores and warehouses, and in truck shipping. The essential workforce is composed of  64 percent women and 41.2 percent people of color. This translates to a higher risk of exposure to the virus among minorities because their employment involves interacting with the general public or co-workers in an unsafe environment. According to an August 2020 report from the U.S. Department of Health and Human Services (HHS), Hispanic/Latino persons were the largest demographic living in counties identified as coronavirus hotspots (3.5 million persons), followed by Black/African American persons (2 million).

HHS released a comprehensive strategy to address the lack of access to COVID-19 testing in vulnerable communities, which included expanded testing at federally qualified health centers (FQHCs) and partnerships with retail pharmacies. However, the very social determinants of health that these communities face, such as lack of transportation, child care, and paid sick leave, create significant barriers to getting to a community health clinic or a drive-through testing site. Despite higher demand in minority communities, there are fewer testing sites available to them when compared to access in predominantly white, more affluent areas. Researchers of the COVID Tracking Project found that zip codes with white populations of 75 percent had significantly more testing sites per capita than zip codes that were 75 percent minority.

Though adequate testing is only one of the prongs in confronting the pandemic, followed by contact tracing and isolation, it provides critical data needed to provide resources in the communities hardest hit by this pandemic. The World Health Organization (WHO) recommends conducting around 10–30 tests per confirmed case as a general benchmark–less than 5 percent positivity rate suggests the pandemic is under control. The U.S. currently has a positivity rate of 6 percent, and many states are not testing at a rate needed to contain the spread. Further adding to the disproportionate burden, there is no federal guidance for routine testing of essential workers. To provide adequate testing in low-income and minority communities, we need to address the underlying social determinants of health that place them at greater risk.

What you should know about the Healthcare.gov Open Enrollment

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

From November 1, 2020 to December 15, 2020, consumers will be able to enroll in health coverage through the health insurance marketplace, Healthcare.gov. Choosing the right health plan involves thoughtful decision-making, with careful consideration of your needs and your budget. COVID-19 testing and treatment, telehealth, and mental health services have been vital pandemic necessities, and consumers are advised to pay attention to any changes in their current health plans to account for any adjustments in health needs.

It is estimated that annually consumers typically spend 17 minutes when selecting plan options during open enrollment, most simply sticking with their plans from the previous year. If you need assistance navigating the health insurance marketplace, you can consult a healthcare navigator to help in comparing the coverage options that make sense for you. Healthcare navigators provide free, unbiased advice and offer services in a number of languages. To find a navigator in your area, please click here.

Even with the election and looming challenge to the ACA coming before the Supreme Court, California v. Texas, consumers should know that the federal health insurance marketplace, also known as Obamacare, is still available. The Supreme Court will hear oral arguments on November 10, but the ultimate decision can come as late as June 2021. We’ve written more about the implications of California v. Texas here. Despite multiple attempts by opponents to repeal the ACA, over 20 million people have gained coverage through the marketplace in the past decade.

The Centers for Medicare & Medicaid Services (CMS) recently announced that marketplace premiums have dropped by 2 percent nationally. Additionally, as a result of the pandemic, the marketplace has seen greater insurer participation – in turn, offering consumers with more robust options for coverage. Plans offered via Healthcare.gov are required to cover a set of essential health benefits mandated by the ACA, ensuring that you have access to comprehensive care – a provision that is of chief importance during this time. The ACA has afforded consumers with a host of health protections and prohibits insurance plans from discriminating against enrollees based on health status, including pre-existing conditions. To learn more about the marketplace, click here.

The National Consumers League encourages consumers to seek coverage via ACA compliant plans offered on the marketplace. If you miss the deadline to apply for coverage within the open enrollment period, you may be able to qualify for a Special Enrollment Period (SEP). Applying during a SEP is contingent upon meeting certain criteria, such as life events like having a child or losing health coverage. If you qualify for Medicaid or the Children’s Health Insurance Program (CHIP), you can apply at any time. Most importantly, in order to have coverage that is effective by January 1, 2021, you must sign up by December 15, 2020.

CMS Proposed Rule Ignores Data & Bipartisan Support for the Value of Copay Assistance Programs

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By NCL Director of Health Policy Jeanette Contreras

Americans love getting a discount. As consumers, we like to shop to save without compromising the quality of the products we buy. But in healthcare, the stakes are higher at the checkout counter. Patients not only want a discount, they depend on it to afford necessary, sometimes lifesaving, medication to treat their health condition.

Despite what we know about the value and impact of copay assistance programs, a new policy from the Centers for Medicare & Medicaid Services (CMS) could put a barrier between these critical programs and the patients who need them most.

Manufacturer copay assistance programs include discounts, coupon cards, and vouchers which many of our friends, family members, and neighbors use to afford their prescriptions. Studies have shown that without these financial support systems, many patients couldn’t afford their medicines.

The CMS proposal, which has yet to be finalized, would require manufacturers to guarantee that this assistance goes directly to patients—and if manufacturers do not, they would be required to include the value of the copay assistance in Medicaid Best Price and Average Manufacturer Price (AMP) calculations. That would be fine but there’s a  problem.

CMS has a separate policy that was already finalized earlier this year: the Notice of Benefit and Payment Parameters (NBPP) Rule for 2021. In part, the NBPP allows health insurance companies and pharmacy benefit managers (PBMs) to use policies that stop copay assistance from counting towards a patient’s out-of-pocket burden—sometimes called copay accumulator adjustment programs.

NCL criticized HHS for permitting health plans to use these so-called copay accumulator adjustment programs.

“Removing this cost-sharing assistance will force those patients to pay thousands of dollars more in unexpected costs at the pharmacy. These new costs could push some to forego those medications, leading to worsened health outcomes. This could compromise medication adherence and will lead to increased health care costs over time.” – NCL Executive Director Sally Greenberg

Separate studies conducted by the Centers for Disease Control and Prevention (CDC) and IQVIA show that out-of-pocket costs can contribute substantially to reduced adherence or to patients not taking their medication altogether. This is counterproductive because if patients do not take their meds as directed, it means higher costs in other parts of the healthcare system stemming from increased hospitalizations, ER visits, and long-term health issues.

If the data doesn’t convince CMS, voters should. Weeks before the presidential election, we can clearly see widespread support for the value of copay assistance regardless of political affiliation. According to a new National Hemophilia Foundation national survey, more than 80 percent of registered voters believe the government should require copay assistance to be applied to patients’ out-of-pocket costs. Even lawmakers agree that CMS should stop this policy before it launches. A bipartisan group of 36 members of the U.S. House of Representatives sent a letter to CMS urging the agency to not finalize the “contentious line extension section or the Medicaid best price change as currently defined in the notice of proposed rulemaking.”

Clearly, copay assistance is critical to Americans. We hope CMS reevaluates the potentially harmful consequences of this new rule on patients and pulls back this counterproductive proposal.

Equitable allocation of a COVID-19 vaccine

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

As the world waits with bated breath for the release of a safe and effective COVID-19 vaccine, one concern that is paramount is the proper distribution of the vaccine. According to leaders of Operation Warp Speed (OWS)—a coordinated partnership between the Department of Health and Human Services (HHS) and the Department of Defense (DoD)—detailed planning is ongoing to realize OWS’s lofty goal of delivering 300 million doses of a COVID-19 vaccine, with the initial doses available by January 2021.

Implementing a vaccine program of this magnitude is contingent upon precise coordination that traverses federal, state, local, tribal, and territorial governments. The prodigious task ahead is determining who would get the first initial doses of the vaccine upon release. The pandemic has further illustrated that communities most vulnerable to COVID-19 are often rife with systemic racism and socioeconomic factors conducive to higher infection rates. An initial limited supply of a vaccine will only intensify these inequities.

Multiple analyses conducted on the federal, state, and local levels confirm that people of color have experienced a disproportionate burden of COVID-19 cases and deaths. Hispanic or Latinx, and American Indian and Alaskan Native (AI/AN) communities have experienced three times the rate of infection, and Black communities two times the rate of infection, compared to White populations. The CDC warns that this imbalance in morbidity and mortality is begotten by deep-seated disparities that stem from generations of racism and unaddressed social determinants of health.

To mitigate these inequities, the National Academies of Science, Engineering, and Medicine (NASEM) have formed a committee to establish an overarching framework addressing key considerations for the equitable allocation of a COVID-19 vaccine, including at-risk communities, priority populations, geographic distribution, scalable measures, and vaccine hesitancy.

The framework proposes four phases of vaccine distribution and their corresponding priority populations, as follows:

[Source: NASEM]

The above proposal will inform CDC’s Advisory Committee on Immunization Practices’ (ACIP) recommendations in advance of a COVID-19 vaccine release; and it was developed through careful consideration of CDC’s Social Vulnerability Index (CDC SVI), and the apropos, COVID-19 Community Vulnerability Index (CCVI). To elucidate, these phases were designed with people of color in mind, as they experience heightened risk of exposure working in essential roles in society, and therefore succumb to higher rates of infection.

Another key component of the vaccine plan is addressing vaccine hesitancy. People of Color are significantly underrepresented in clinical trials and undertreated in medical settings. This phenomenon, compounded by a general mistrust of medical establishments by minorities, will prove to be a challenge when encouraging vaccine uptake. Community engagement will be essential in building trust among the vaccine hesitant and messaging should be delivered by community leaders, or healthcare providers that resemble the population they treat. Culturally competent care has proven to have favorable effects on health outcomes and it is critical in encouraging vaccine confidence.

Once a vaccine becomes available, health officials across the country will need to deploy resources and personnel to ensure access to the vaccine among our most vulnerable. As affirmed by U.S. Army Lt. Gen. Paul Ostrowski (OWS), “We have to be able to go beyond the pharmacies, the hospitals and so forth to get after nursing homes; to get after meatpacking facilities; to get after those that are sheltered [at home]. We have to get this out to all four corners of this nation.” Getting to a vaccine is a challenge in itself, but once its released, it’s all hands-on deck.

COVID-19 increasing health concerns about obesity

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COVID-19 increasing health concerns about obesity
By Nailah John, Program Associate

The pandemic has brought many countries to a standstill, restricting movement, necessitating social distancing, and impeding economic activities across a broad spectrum of nonessential occupations. It’s also resulted in many people changing their habits, including changes in food consumption, physical activity, and an increase in people working from home, which may exacerbate current levels of obesity.

Obesity is a major concern here in the United States and worldwide. The World Health Organization defines obesity as “abnormal or excessive fat accumulation that may impair health.” In 2016, the World Health Organization released data that showed 650 million adults were obese, and in 2019, an estimated 38.2 million children under the age of 5 were overweight and obese. In the United States, the Center for Disease Control and Prevention indicates that, in 2019, the obesity rate surpassed the 40 percent mark and reached 42.4 percent.

Since the pandemic began, there have been dozens of studies reported that many patients who become sick with COVID-19 are obese. In an article in the journal Obesity Reviews, an international team of researchers compiled data from scores of peer-reviewed papers capturing 399,000 patients. The findings indicated that individuals with obesity suffer from metabolic dysfunction and low-grade inflammation, which are considerable factors in the manifestation of severe lung diseases. The primary cause of COVID-19 mortality is susceptibility to acute respiratory distress syndrome (ARDS) which is more likely in obese individuals. The review goes on further to state that “being an individual with obesity independently increases the risk of influenza morbidity and mortality, most likely through impairments in innate and adaptive immune responses. Potentially the vaccines developed to address COVID-19 will be less effective for individuals with obesity due to a weakened immune response.”

The Wiley Public Health Emergency Collection found that obesity increases vulnerability to infections and is a risk factor to COVID-19-related mortality. Body mass index (BMI) was significantly higher in patients with a severe form of Covid-19 infections. Being obese increases the odds of COVID-19 patients being hospitalized. The Wiley Public Health Emergency Collection highlighted that COVID-19 patients with obesity were hospitalized more than those without obesity. According to a report that looked at 5,700 COVID-19 patients with obesity in New York City, whereas 22 percent of the population is obese, they make up 41.7 percent of hospitalized patients.

Prevalence of obesity in the United States is increasing yearly, and there is a dire need for this health issue to be curbed. It will take efforts at the federal, state, and local level. Therefore, it is paramount that each individual engages in healthy eating habits, eats the right portion sizes, engages in physical activity, and encourages others.

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