Born too soon; the difference a day makes
Dr. Joia Adele Crear-Perry of the National Birth Equity Collaborative…
Dr. Joia Adele Crear-Perry of the National Birth Equity Collaborative…
By Sally Greenberg, NCL Executive Director
During this Covid pandemic, Americans have been incredibly patient and observant of guidelines for social distancing and staying home. But it can’t last forever. Where the heck is the universal testing for Covid-19? We’ve been talking about it for more than two months and yet you can’t get access to Covid-19 testing unless you’re showing symptoms of the virus. If, as experts believe, 25-50 percent of us might be carrying the virus without symptoms, what does that say?
It says we could be spreading the virus without knowing it! And yet we can’t get tested? We need greater accessibility to testing to know where we stand. If everyone could be tested each day to know if we do or don’t have the disease, or be tested for antibodies to Covid-19 to learn that we can fight the disease, we’d be better equipped to know what we’re dealing with and make smart decisions. Such universal testing can get the country back to work, especially at a time when the economy is in even worst shape since the Great Depression with the retail, restaurant, airline, entertainment, film and hotel industries ground to a halt and millions of workers across the economy out of jobs.
And take note: this kind of testing is possible because testing does not need to require a site visit. A study funded by UnitedHealth Group shows people can self-administer a diagnostic test with a much smaller swab, a process that should save potentially thousands of clinicians from being exposed to the virus while at the same time making the testing simpler. The study, which used data from 500 OptumCare patients, comes amid a parade of diagnostic test approvals for Coronavirus following weeks of criticism of the Trump administration and federal agencies for the lack of testing.
On March 24, the “White House Coronavirus Task Force reported in a briefing that “self-swabbing” options were going to be available that week, so the study supports what the federal government is pursuing.” That’s almost a month ago – so where are they?
What’s worse is that the United States is considered well behind other countries when it comes to the availability of testing generally. Why can’t we figure out this solution?
NCL friend and brilliant inventor of the SawStop, a safe table saw, Steve Gass, came up with a novel approach to employ universal testing that would get most of us back to work. His proposal is below. I’ll end with it, because it says it all:
A cure for the coronavirus pandemic already exists. Contrary to our expectation that cures manifest exclusively as biological agents – medicine for the sick or vaccines for the healthy – the cure for this outbreak is technological. From the Oval Office to Kansas kitchens we’re already talking about it, even while failing to recognize its true potential. Those elusive Covid-19 tests, if utilized daily, by every American, have the power to save our lives and our economy within the month.
To date, the U.S. has only employed testing reactively — to diagnosis a disease after symptoms indicate probable infection — which wins us no real advantage when epidemiological evidence indicates up to 40 percent of transmissions occur covertly, days before symptoms appear, and CDC director Dr. Robert Redfield estimates that 25 percent of carriers (and spreaders) may never manifest symptoms at all. We can continue to hide out at home indefinitely, banking on a vaccine in 12-18 months, but public health expert Dr. David Katz calls that a recipe for “ineffectively fighting the contagion even as we are causing economic collapse.”
Instead, we must deploy tests offensively. They must become our mass-produced instruments of war.
Here’s the plan of attack: one month from today, each of us is tested daily for Covid-19, obtaining immediate results. If positive, you isolate at home and instantaneously eliminate the virus’s prime advantage: its ability to stealthily propagate from “people out there shedding the virus who don’t know that they’re infected,” according to infectious diseases expert Dr. Jeffery Shaman. Meanwhile, the healthy among us freely move back out into our communities, flashing our daily health certificates like boarding passes to gain admittance to workplaces, schools, and stores, certain we won’t harm or be harmed by the people with whom we interact. We’ll have immediately shifted, as economists Dr. Paul Romer and Dr. Alan M. Garber insist we must, to a “targeted approach that limits the spread of the virus but still lets most people go back to work.” The very first day we implement universal daily testing and selective isolation commerce resumes, the viral transmission rate plummets, and the virus exponentially decays. The crisis ends.
The challenge in this crisis of scarcity, when too few can access masks let alone diagnostic devices, is to build enough testing units, now, so that all 330 million Americans can be tested daily. This will require at least 1 million community-based machines adapted for parallel processing of multiple tests simultaneously. If we begin tomorrow and labor 24 hours per day it will take just under 12 days to produce and deploy a million machines at a production rate of one unit every second. That’s not just daunting. It’s mind-boggling.
But it’s not impossible.
In May of 1940 the Greatest Generation listened incredulously as President Roosevelt challenged them to “harness the efficient machinery of America’s manufacturers” to produce 50,000 combat aircraft in 12 months to confront the “approaching storm” of a global war – a goal exceeding the total of all planes built in the U.S. since the Wright brothers’ initial 1903 flight. No one believed an 18-ton plane with 450,000 parts and 360,000 rivets in 550 different sizes could be mass produced, let alone efficiently. But our repurposed auto factories did just that, with Ford Motor Co. churning out one bomber per hour at peak production to secure our safety and win the war.
Our nation still has the know-how, the manufacturing infrastructure, and the industrial resources to save ourselves again by building and deploying a million Covid-19 testing units by the end of the month if we make it our highest national priority starting today. We have men and women yearning to go back to work and we must employ them to optimize established supply chains, man assembly lines, and reinvigorate distribution channels. No single state’s factories can meet the one-unit-per-second output required, but pooled national resources can. The cost and effort will be substantial, certainly, but pale in comparison to the misery wreaked if we let a quarter million Americans die instead.
Make no mistake: World War III is upon us. We must once again wake the sleeping giant, mustering America’s industrial might to save ourselves and the whole world with us by rallying resources to test each of us, over and over again, as if our livelihoods and lives depend on it.
Because they do.
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Stephen Gass, PhD, J.D., is a physicist, a patent attorney, and the retired President and founder of SawStop, LLC, the nation’s foremost supplier of premium table saws and the world leader in table saw safety. He is the principal inventor on over 100 patents covering electrical and mechanical innovations in power tools.
By Nailah John, Linda Golodner Food Safety and Nutrition Fellow
The way we get food now has totally changed due to the Covid-19 virus. Most us around the nation no longer go to our favorite bar or restaurant or stop at the local coffee shop for a bite to eat or to socialize and have a drink. The mandatory closure shutdown of restaurants with the exception of takeout or delivery is our only option of enjoying a meal not cooked at home. Beyond that, we may ask the questions: first is it safe? Second: is it ethical to potentially expose a delivery worker to what we are all trying to avoid the risk of Covid-19?
The answer to the first question is yes, with some caveats. Currently food is not associated with the transmission of Covid-19, according to the *CDC and the *Food and Drug Administration. However, Vox reports that there is growing evidence of fecal/oral transmission, which means you can ingest the virus shed in feces through inadequate handwashing or contaminated food and water. Therefore, handlers of food who carry the virus can spread the virus to food items. In theory, all restaurants have to follow *food safety rules, and there are extra measures that have been put in place due to Covid-19. However, we have seen Chipotle and other restaurants spread infections by poor food handling.
The second question is complicated, but here are some thoughts. Currently delivery workers are in the middle of a pandemic but still have to work to support their families and pay bills. Eater suggests that if customers forego take-out food, delivery workers and restaurants struggling to provide during the crisis could be put out of business.
We recommend ordering take-away food from your favorite restaurants and, even better, support them by buying gift cards for post-pandemic future meals when restaurants re-open.
Your first option is to is use the in-house restaurant delivery option, since third-party apps take commission fees, which reduce the profit for restaurants. Here are some apps that are taking the necessary measures in protecting their workers and helping out the restaurant industry.
It is important that we minimize contact with others since daily things are changing in relation to Covid-19. However, delivery services are really stepping up to keep customers safe and, for that, we should all be grateful. Remember to support your local restaurants by requesting non-contact delivery!
*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings
By Nissa Shaffi, NCL Associate Director of Health Policy
Ten years ago, the United States Congress adopted the Affordable Care Act (ACA), after many decades of unsuccessful attempts at achieving universal health care by advocates. For the first time, the ACA provided coverage options for every American across the economic spectrum, expanding Medicaid in many states and offering the self-employed access to insurance on the open exchange. For NCL, the ACA is the safety net program the founders of the League sought to see put in place from the organization’s inception at the turn of the 20th Century.
Today with the rapid spread of the COVID-19 virus across America, patients’ access to health care is more critical than ever. Yet despite the clear need we all have for health care coverage, over the past decade, the ACA has been under attack by conservatives in Congress and survived multiple attempts at repeal. The latest came from the Texas v. United States case – and now it threatens to render the entire ACA unconstitutional, following the repeal of the ACA’s individual mandate provision. Why conservatives wish to deprive people of health care escapes us at the NCL. In fact, the ACA has transformed the way Americans interact with the healthcare system.
Throughout its short life, the ACA has cemented into law numerous consumer health protections and has expanded access to health coverage for over 20 million people. 37 states have expanded Medicaid, the health care program for low-income Americans. Prioritizing preventive care, the ACA mandated that health insurance providers cover preventive services for all adults, women, and children – free of cost to the patient. The ACA also made it unlawful for insurers to deny or reduce benefits based on preexisting conditions. These include diagnostic included screenings, vaccines, birth control, and access to certain medications. For the first time, those 26 under could retain their health coverage through their parents’ insurance plans.
Research has shown that ACA Medicaid Expansion has improved access to care, financial security, health outcomes, economic mobility, and have reduced uncompensated care. Despite the progress made by the ACA, there are still 29 million uninsured people in the United States. If the ACA is repealed, 25 million Americans may lose their coverage overnight, without the promise of its replacement. Perhaps the COVID-19 outbreak will change the calculus and bring home how devasting it would be to repeal the ACA. Insurers would no longer be obligated to provide protections offered by the law, allowing plans to deny coverage indiscriminately, leaving millions of families along with low-income and high-risk individuals without care.
The true impact of the ACA will be even more apparent as the national continues to grapple with the COVID-19 pandemic in the coming months. COVID-19 has upended the economy and affected virtually every industry and has caused unemployment to soar. On March 21, unemployment claims reached a record 3.3 million – the highest level of jobless claims in history (the Great Depression saw levels of 24 percent unemployment at its peak but there was no unemployment insurance safety net during the 1930s and thus no jobless claims, just breadlines). Economist Heidi Shierholz of the Economic Policy Institute estimates that by summer, approximately “14 million workers will lose their jobs due to the coronavirus shock.”
A report by FAIR Health estimates that potential treatment for COVID-19, resulting in an average six-day hospital stay, could total to a whopping $73,300 for the uninsured: a devastating prospect in the middle of a global financial collapse. With the increased loss of employer-based health insurance, the ACA proves to be more crucial than ever as individuals and families may turn to the health insurance marketplace to secure coverage. NCL is backing legislation – and the health plans support this too – to move workers losing jobs and health insurance to the COBRA program with heavy subsidies so they can ride out the pandemic – COVID-19 has exposed so many severe deficiencies in the healthcare system. To learn more about statewide efforts to mitigate the impact of COVID-19, click here.
While the fate of the ACA remains uncertain, it is still the law of the land. If you are concerned about loss of coverage during this time, several state-run health plans have enacted Special Enrollment Periods (SEPs) in response to the COVID-19 outbreak, click here to learn more. NCL believes that healthcare is a right and that protections offered by the ACA make this country a far stronger, more robust nation. We will continue to work diligently to protect universal access affordable and reliable health coverage. To learn more about what’s at stake and how you can help prevent the potential repeal of the ACA, click here.
March 27, 2020: A message to our online community about how we are working hard to ensure crucial protections for consumers and workers in this time of uncertainty.
In this critical time, as our nation is gripped by the COVID-19 virus, we want you to know that we remain 100% committed to doing everything we can to help stop the spread of the virus and to fight for consumer and worker protections in this rapidly changing economy.
Although we are now doing so remotely in order to maintain our safety and the safety of our loved ones, NCL staff continues to work behind the scenes to ensure that the interests of consumers and workers are not forgotten in the rush to pass legislation and make executive branch decisions.
Below we’ve highlighted what’s happening and hope that you agree that our work – and your support – are more important than ever.
The pandemic has reduced passenger air traffic to a trickle, putting the airlines in deep economic distress. A strong, well-functioning, and safe airline industry is essential to our country. That said, NCL does not believe that giving a blank check to the industry is in consumers’ best interest. That’s why NCL led a coalition of consumer and air passenger advocates to call on Congress to include strong passenger protections in the COVID-19 relief bill. We will continue to advocate for reforms to the airline’s business practices, like excessive fees and shrinking seats, in the weeks and months to come.
We are actively reaching out to consumers to educate them about how to spot coronavirus-related scams. We are already seeing reports of scammers using this moment of national emergency to sell bogus coronavirus “cures” and target seniors with phony investment scams. That’s why we issued a statement applauding Attorney General William Barr’s order to all U.S. Attorneys to ramp up efforts to shut down COVID-19 scams and are continuing to alert our readers about emerging trends.
We are also using our Consumers for Safe CBD platform (4safeCBD.org) to highlight false product claims made by unscrupulous CBD manufacturers who are using the crisis to promote their products .
In response to a request for help from FDA, NCL is supporting the agency’s efforts to expose bogus coronavirus tests, treatments, and cures. In addition, we signed onto a letter as part of our adult vaccine coalition to ask for ZERO CO-PAYs for all Medicare Part D vaccines, which could include COVID-19 vaccines when they become available. With safety as a paramount concern, NCL is supporting the American Nurses Association’s *call to action to increase Personal Protective Equipment (PPE) for nurses.
NCL persists in its fight for worker protections and joined a letter opposing the exclusion of immigrants from the omnibus relief package. We also signed onto an effort to ensure the Postal Service can remain fully functional during this crisis and beyond. The USPS is predicting that an economic recession could pose a “serious threat to the near-term viability of the Postal Service,” and has asked Congress to give USPS more than $7 billion each year for the next two years.
NCL joined allies at farmworker organizations in expressing concerns related to exposure of the largely uninsured, financially fragile farmworker community to COVID-19 and asking political leaders to be mindful of the unique concerns, considerations, and risks confronting farmworkers.
*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings
NCL remains actively engaged in working to properly ensure that relief packages address the interests of consumers and workers. We are very pleased that Congress will be providing cash assistance to our most vulnerable, and we continue to push for salary and benefit protections, particularly for those workers in the most seriously impacted industries.
In the coming days, stay tuned for news of our Trumpeter Awards Dinner, which we will host in October. We will be sending out a Save the Date and announcing our award recipients shortly.
Best wishes for staying safe and healthy, from all of us at NCL.
Sally Greenberg
Executive Director
National Consumers League
NCL: #NeverMoreRelevant
By Nailah John, Linda Golodner Food Safety and Nutrition Fellow
Perhaps some of the only good news about the Covid-19 is that food is not the primary way that the virus can be spread. According to Harvard Medical School, “We are still learning about transmission of COVID-19. It’s not clear if this is possible, but if so, it would be more likely to be the exception than the rule. That said, COVID-19 and other coronaviruses have been detected in the stool of certain patients, so we currently cannot rule out the possibility of occasional transmission from infected food handlers. The virus would likely be killed by cooking.”
Great, but not all foods can or are intended to be cooked – think of deli meats, cole slaw, potato salad, cheeses, salads, fresh fruits and vegetables, breads, pastry, butter, cream cheese; so if the mainstay of a deli or restaurant is “fresh” foods, spreading the virus is a real threat if the right precautions are taken.
And COVID-19 has made us all keenly aware of the importance of wiping surfaces and washing hands frequently, especially when handling food. We also know that COVID-19 can’t typically be transmitted from food or from food packaging. But we do have suggestions.
Food safety measures one should take:
Food safety is paramount in our day-to-day lives – it’s so important that we take the necessary steps not to expose ourselves – whether eating in a restaurant or cooking at home, to COVID-19. Remember eat healthy, nutritious foods and take all the steps needed in preparing a safe meal for you and your family.
I spent a week last month in Boise with two members of the staff of Melaleuca—a company that makes more than 400 nutritional, cleaning, personal care, and cosmetic products—making lobbying visits to the Idaho legislature. Katie Hart and Jay Cobb work for Frank Vandersloot, CEO of Melaleuca. Vandersloot is a highly successful, conservative businessman who is committed to protecting Idaho residents from abusive medical debt collection practices after discovering that one of his employees was hit with thousands of dollars in bills—including hefty lawyers’ fees and court costs—based on a $294 medical debt that she couldn’t even identify. The stark reality is that 50 percent of bankruptcies in America are caused by medical debt. He was championing a bill called the Idaho Patient Act, House Bill 515.
Many people believe federal law provides broad protections for people in debt. While the federal Fair Debt Collection Practices Act (FDCPA), enforced by Federal Trade Commission, makes it illegal for debt collectors to use abusive, unfair, or deceptive practices when they collect debts, it doesn’t address how debts are calculated or curb predatory fees, penalties and court costs.
NCL has worked with Melaleuca for several years, first to fight a bill in Congress that would have essentially legalized pyramid scheme activity. Last October, I flew to Melaleuca headquarters in Idaho Falls to meet nearly half of the state’s legislators who came to town as part of their tour of businesses in Idaho. At that gathering, Vandersloot discussed his hope to pass a bill to address these predatory collection practices, aiming his fire at the practice of ginning up the cost to patients of medical debts with thousands in lawyers’ and court fees; often patients have no idea where the debt is from and debt collectors aren’t required to provide that information to them. The Idaho Patient Act addresses that issue.
Vandersloot also puts his money where his mouth is: not only did he propose a legislative remedy, he and his wife Belinda created a $1 million fund to provide legal counsel to Idahoans who have been hit with these attorney bills. Consumer advocates like NCL have been working for decades to curb the excesses of this industry. But to see a conservative CEO take on this issue gives the effort a new push.
Sticking up for the little guy is not out of character for Vandersloot. He spoke with the same fervor when we worked together fighting a bill that would have legalized pyramid schemes. In neither case was there any financial reward coming to Melaleuca—Vandersloot took a stand on this issue because he felt it was the right thing to do. Though we may disagree on a host of other matters, on this we are aligned and that is a good thing for vulnerable consumers. Strange bedfellows are a big advantage when it comes to getting things done in the political arena.
Katie Hart has been wisely deployed to live and work in Boise while the legislature is in session and navigate this important bill through the complicated legislative process. She’s a smart and charismatic lawyer—she and Jay Cobb, an expert strategist, could teach Lobbying 101: they’ve met with the Idaho Hospital Association, Idaho doctors, insurance companies, and the Idaho trial lawyers and revised the bill to address their concerns.
Specifically, the Idaho Patient Act proposes the following:
In Boise, my first order of business was to register in the Idaho capitol building as a lobbyist, even though I was only going to be there for the day. We wanted to do everything by the book! For $11 the Secretary of State’s office put me into the system and off we went.
Jay Cobb explained that Idaho is very conservative where rules or regulations are frowned upon. Of the 70 members of the Idaho House, 56 are Republican and some of those lean far right. 14 are Democrats. Of the 35 members of the Senate, only 7 are Democrat. The Governor is Republican, as is the Secretary of State and the Attorney General.
Katie and Jay have been working for months with elected officials, revising the bill without compromising its impact, and last week the measure was reported favorably from the House Business Committee by a 15-2 vote (after a 5 hour hearing with many witnesses and terribly sad stories). Adding to the challenge of getting this bill enacted the second Vice Chair of the Republican Party in Idaho, and a member of the Idaho legislature were adamantly opposed to the legislation because as their egregious medical debt collection practices were epicenter of the problem. Now the bill goes to the full House and over to the Senate.
While in the state house, we met with Senator Grant Burgoyne, a democrat who has provided legal representation to the collections industry. His observation? this bill would rein in “bad actors,” and the collections industry as a whole doesn’t oppose it. Senator Michelle Stennett, a democrat from Ketchum, told us about the challenges of getting what she thought were reasonable measures out of committee in Idaho because members are so loathe to pass any laws. The longest serving Democratic House member told us she believes the bill will pass, and the very smart and entertaining newly elected Boise Representative Steve Berch, who ran five times as a democrat in a red district and finally got elected, also predicts a positive outcome for this bill.
To cap off the day, both U.S. Senators were in the State House and I had the chance to say hello to one of them, Senator James Risch (R-ID) and meet his DC staff.
The calculus changes when a conservative CEO with political clout backs a bill to offer protections to consumers who -through no fault of their own -have medical debt. Thanks to Frank Vandersloot, Katie Hart and Jay Cobb and the whole team at Melaleuca for making their case to the Idaho legislature so persuasively.
We hope this bill gets enacted in Idaho. If it does, the law will become a template for other states to put reasonable guardrails around collection of medical debt and offer some much-needed consumer protections. And maybe we can even hope that Vandersloot’s willingness to use his clout and bully pulpit to speak out on behalf of those who have no voice will be emulated by other CEOs.
Postscript
On March 9, the Idaho Senate passed the Idaho Patient Act 32-1. On March 16 Idaho Governor Brad Little signed the bill into law.
Congratulations to Frank Vandersloot, Melaleuca’s CEO, to his talented team of Katie Hart and Jay Cobb, and to all the members of the Idaho state legislature, who stood up for consumers and understood that one in seven Idahoans struggle with medical debt.
To quote the words on the Hanukkah dreidel, “A great miracle happened there.”
By Nailah John, Linda Golodner Food Safety and Nutrition Fellow
Social distancing, isolation, and general uncertainty about the coronavirus have made many rightly concerned about feeding their families during this historic pandemic. Food is very much top-of-mind for most Americans at this critical time. Here are some tips we can offer consumers.
Some of us haven’t stocked our pantry, and we don’t cook much at home. This is a good time to start doing both. My pantry at home is always stocked because I have a toddler who always wants food and snacks. But it’s a good practice generally, and now we are reminded of that more than ever.
From The Washington Post, here are some tips for keeping the pantry stocked so that, in the event of an emergency, you have some options without having to leave the house:
Chef Ortega also hopes that this forced hibernation will encourage people to cultivate fresh food themselves: fresh rosemary that you can grown near a your window or a tomato plant at your back door or on a balcony.
So make a trip to the grocery store—but consider doing so at an off-peak time, and follow the CDC’s advice for going into public safely—and stock up your pantry, cook your family’s favorite dishes, and store them in your freezer. There’s never been a time where we needed to be more prepared, and you’re sure to enjoy the experience with family!
March 18, 2020
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 joins with our fellow Americans, friends, colleagues, and families in as we adapt our lives to address the health crisis caused by COVID-19. NCL has long been a consumer and patient advocate and we strongly support research, scientific programs, and policy solutions to address diseases across the board.
We want to take this moment to say “thank you” to the thousands of public health servants going into the hospitals, doctors offices and clinics and working on the frontlines to save millions of lives. We rely and depend on their vast knowledge, dedication and commitment to treating sick patients, and we want to specially thank them during this unprecedented national health crisis.
We also thank so many other workers – those in drug stores, grocery stores, Post Offices, the food delivery drivers, taxi, bus and subway drivers, utility workers keeping our electricity, gas, and water systems intact. We owe all of them a debt of gratitude as so many of us are able to work from home; we depend on all of you and thank you for your service to the nation.
We also join with colleagues in the healthcare advocacy community to thank infectious disease specialist Dr. Anthony Fauci for his extraordinary and selfless leadership in this battle against the spread of the coronavirus.
Join us on social to say #ThankYouDrFauci.
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About the National Consumers League
The National Consumers League, founded in 1899, is America’s pioneering 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.
March 17, 2020
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 (NCL), America’s pioneering consumer and worker advocacy organization, today applauded the Federal Trade Commission (FTC) and Food and Drug Administration (FDA) for cracking down on vendors selling purported “cures” for the deadly coronavirus. In letters sent to seven companies, the agencies rightly warned that companies seeking to profit off of the “high level of anxiety” consumers are experiencing due to the coronavirus outbreak may be violating federal consumer protection statutes.
The following statement is attributable to Sally Greenberg, Executive Director of the National Consumers League:
“Americans are right to be concerned about the spread of the COVID-19 coronavirus. Unfortunately, there are charlatans out there seeking to make a buck selling snake oil ‘cures’ for this deadly virus. These scammers are defrauding consumers of money they will need to weather the coming economic storm. Even worse, consumers who believe these fake cures will ward off or cure the coronavirus may delay obtaining needed medical care with potentially deadly results for themselves and those around them. That is why we are so grateful to the leadership shown by FTC Chairman Simons and FDA Commissioner Hahn in putting these purveyors of false hope on notice.”
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About the National Consumers League
The National Consumers League, founded in 1899, is America’s pioneering 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.
The work of the National Consumers League is making a difference in people’s lives across the country. Meet some of the consumers touched by our programs.
Read about NCL’s impact
Paige, 55, a Nashville wife and mother of two, answered an employment ad for secret shoppers. Before sending payment to the scammers, she reached out to NCL.
Read about NCL’s impact
A grease fire flared up in Decklan’s kitchen. As his family scrambled and panicked, fearing that the whole house might erupt in flames, Decklan remained calm. He hurried over to the pantry, grabbed some baking soda, and dumped it on the fire quickly extinguishing the blaze.
Read about NCL’s impact
Cincinnati resident Charles, 45, lost his computer business — and health insurance— during a time of economic downturn. A diabetic, Charles was now unable to afford his medication. He stopped taking it which made him seriously ill and put his life at risk.
Read about NCL’s impact
Jeremy is a fast-food worker who has been employed at a number of Chipotle restaurants in New York City. When he was just 20 years old, he took part in an NCL research project that revealed that management practices within the fast food chain were putting workers—and food safety for customers—at risk.
Read about NCL’s impact
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PBPA Commends HHS Funding to Support Maternal and Infant Health
The Preterm Birth Prevention Alliance (PBPA), a coalition of maternal and women’s health advocates dedicated to improving preterm birth outcomes in the United States and addressing its disproportionate impact on women of color, applauds the U.S. Department of Health and Human Services (HHS) for awarding nearly $350 million to states across the country to improve support for safe pregnancies and healthy babies.
“For far too long, U.S. maternal health care has lagged behind that of other developed countries, particularly for women of color,” noted Sally Greenberg, Executive Director of the National Consumers League. “This additional funding will enable local health departments and nonprofits to better address the health care needs of the most vulnerable mothers and their babies.”
The funding, awarded by HHS’ Health Resources and Services Administration (HRSA), will support home visiting services, increase access to doulas, address infant mortality and maternal illness, and improve data reporting on maternal mortality.
“Maternal health care in the U.S. has consistently failed women of color,” Greenberg continued. “We applaud HHS for this additional funding that will help to improve the maternal health for all mothers and babies, especially women of color and those most at-risk.”
The funding announcement follows the release of a report by the U.S. Commission on Civil Rights which found that Native American women are more than two times more likely to die from pregnancy-related complications than white women in the U.S. This disparity was further exacerbated for Black women in the U.S., who are three to four times more likely to die from pregnancy-related complications than white women.
“In addition to expanding programs to support maternal health, we must increase representation from racially and ethnically diverse groups in research and clinical trials, particularly those studying treatment options to prevent maternal morbidity and mortality,” said Greenberg. “The need for the additional HHS funding and the report from the Commission on Civil Rights clearly illustrate how critical representative research and real world evidence are to ensuring all mothers and their babies have the same opportunity for the best possible health outcomes.”
/in Blog, Health, Prevention Blog Post
By Sally Greenberg, NCL Executive Director
While the COVID-19 pandemic has led to hardship for all Americans, it is clear that people of color have been disproportionately burdened. Across the health care continuum, addressing this disparity has become part of the broader conversation about the history of systemic racism and the underlying social determinants of health that negatively affect the mental, physical, and economic health of individuals and entire communities.
The pandemic has underscored persistent health disparities, and there is growing recognition that representation in research and clinical trials can have a profound impact on health outcomes. A lack of representation from racially and ethnically diverse groups in research and clinical trials have typically led to gaps in data, missing the opportunity to assess the full impact of various treatments and drugs across a range of populations. The collection and use of real-world research and data to inform the potential use, risks, and benefits of medical products and treatments can ultimately lead to better health outcomes, particularly for those who have been underrepresented in the past.
Existing efforts to improve inclusion
Efforts to expand diversity and representation in medical research are underway in Congress. Policymakers are encouraging the incorporation of Real World Evidence (RWE) in drug development through the recent Cures 2.0 draft legislation released by Reps. Diana Degette (D-CO-1) and Fred Upton (D-MI-6). While the status quo limits us from effectively reaching underserved populations, the proposed legislation would allow studies that include RWE for some drugs after they have been approved. At the heart of this issue is a growing appreciation that the same therapy can affect different populations in different ways, which is why Cures 2.0 supports collecting data that more accurately reflects the unique experiences and needs of patients across diverse populations.
Recognizing the potential for RWE in maternal health
The lack of representative research in the field of maternal health is undeniable, and its implications are staggering. The dismal state of maternal care in the United States reflects how our health care system has failed women of color, including by not adequately studying treatment options to prevent maternal morbidity and mortality. The need for RWE is clear when you consider the persistent disparities in health outcomes that plague minority communities.
Preterm birth and its disproportionate impact on women of color is a stark illustration of the need to make progress on representative research in maternal health. Preterm birth is the second-largest contributor to infant death in America today. Despite the tremendous physical, emotional, and financial toll that preterm birth continues to take on our country — disproportionately so on women and families of color — not enough therapeutic tools currently exist to prevent it.
Today, “17P,” the only FDA-approved treatment to help reduce the likelihood of spontaneous, recurrent preterm birth in the United States is at-risk of being withdrawn from the market in all its forms, including the branded product and five generic versions. Unfortunately there is conflicting evidence from two different clinical trials, one representative of a diverse U.S. population and another studied in a largely white population in Europe. It’s not a straightforward comparison. If 17P is withdrawn, the women most affected by preterm birth, predominantly women of color, would be left without an FDA-approved treatment option.
The FDA is considering the path forward, including additional data collection through leveraging RWE from past patient use. The success of the first (approval) trial for 17P in the impacted communities signals the importance of RWE. Continued access to 17P is, at its core, a matter of health equity. Black women must not yet again be left vulnerable to a system that historically has overlooked them.
PRETERM BIRTH PREVENTION ALLIANCE APPLAUDS FDA’S GRANTING OF HEARING FOR THE ONLY FDA-APPROVED THERAPIES TO REDUCE RECURRENT PRETERM BIRTH
WASHINGTON, DC, August 26, 2021 –
Preterm Birth Prevention Alliance a coalition of maternal and women’s health advocates dedicated to improving preterm birth outcomes in the United States and addressing its disproportionate impact on women of color, commends the U.S. Food and Drug Administration (FDA) for granting a public hearing to discuss 17P, the only FDA-approved class of branded and generic treatments to reduce preterm birth in indicated patients.
We appreciate the FDA’s willingness to hear directly from individuals facing prematurity and the providers who treat them about their experiences with 17P,” said National Consumer League’s Executive Director Sally Greenberg. “It is an important step towards better understanding variations in efficacy across diverse populations and ensuring all women have an equal chance at the best possible outcomes.”
Last week, the FDA agreed to grant Covis Pharma, the manufacturer of the branded 17P product Makena its request for a public hearing to discuss 17P. Hydroxyprogesterone caproate—or “17P”—has been approved since 2011 and is the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth in the United States. In 2020, the FDA proposed withdrawing 17P in all its forms, including the branded product and its five generic versions, based on conflicting efficacy data from two studies composed of vastly different populations, one predominantly inclusive of women in the U.S. most vulnerable to preterm birth and one not.
“Mothers and birthing people deserve access to the best possible treatments to prevent preterm birth. We cannot achieve birth equity if we study pregnant women as a monolith,” said Blythe Thomas, Initiative Director of 1,000 Days. “It is only by systematically researching the real-world, post-market impact of 17P on individuals from a variety of racial and ethnic backgrounds, while maintaining access for all affected, that we can reduce disparities in maternal and infant health.”
While the hearing date has not yet been set, the Alliance looks forward to sharing the perspectives of affected individuals and their physicians with the agency once the hearing is scheduled and will continue to advocate for at-risk moms and babies of all races and ethnicities.
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ABOUT THE PRETERM BIRTH PREVENTION ALLIANCE
The Preterm Birth Prevention Alliance (PBPA) is a coalition of maternal and women’s health advocates who share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth. Formed in 2021 by the National Consumers League, the 15 partners in the PBPA seek to improve preterm birth outcomes in the United States by maintaining access to safe, FDA-approved treatment options and advocating for more diverse medical research that adequately represents the experiences of women and newborns of color. Women of color need a seat at the table. To learn more, visit www.pretermbirthalliance.org
LEADING PATIENT ADVOCATES LAUNCH PRETERM BIRTH PREVENTION ALLIANCE TO PROTECT CRITICAL ACCESS TO THE SOLE FDA-APPROVED CLASS OF THERAPIES TO REDUCE RECURRENT PRETERM BIRTH
WASHINGTON, DC, April 20, 2021 – Today, the National Consumers League (NCL), along with a coalition of patient advocacy organizations dedicated to advancing the health of mothers and infants, announced the launch of the >Preterm Birth Prevention Alliance.
Members of the Alliance are joining forces in an effort to preserve patient access to the only Food & Drug Administration-approved class of treatments for pregnant women who have previously had an unexpected, or spontaneous, preterm birth. Together, Alliance members seek to ensure that the Food & Drug Administration (FDA) hears concerns from the full range of stakeholders about the potential risks and impact of withdrawal for at-risk pregnant women and their providers.
For the fifth year in a row, the U.S. preterm birth rate has increased (to 10.2 percent of births), and preterm birth and its complications were the second largest contributor to infant death across the country. Preterm birth also represents a significant racial health disparity, with Black women in America experiencing premature delivery at a rate 50 percent higher than other racial groups throughout the country.
However, in 2020, the FDA >proposed withdrawing hydroxyprogesterone caproate, commonly called “17P” or “17-OHPC”, the only FDA-approved class of branded and generic treatments to help prevent the risk of preterm birth in women with a history of spontaneous preterm birth. The FDA is currently determining whether to hold a hearing on the status of 17P, based on conflicting efficacy data from two studies composed of vastly different patient populations, one inclusive of women in the U.S. most vulnerable to preterm birth and one not.
“We’re fighting for a more inclusive healthcare system that gives everyone an equal chance to have the best outcomes possible,” said Sally Greenberg, executive director of the National Consumers League. “We don’t believe that removing 17P from the market without gaining a better understanding of who could benefit the most from its use is in the best interests of patients, nor their healthcare providers, particularly as there are no other approved treatment options available.”
To date, 14 organizations have joined NCL to advocate for the health interests of at-risk pregnant women and infants, including: 1,000 Days; 2020 Mom; American Association of Birth Centers; Black Mamas Matter Alliance; Black Women’s Health Imperative; Expecting Health; Healthy Mothers, Healthy Babies Montana; HealthyWomen; Miracle Babies; National Birth Equity Collaborative; National Black Midwives Alliance; National Partnership for Women & Families; Sidelines High-Risk National Support Network; and SisterReach.
“As a trained obstetrician and gynecologist, I know firsthand the impact of preterm birth on Black women and birthing people. I also know that racism – not race – is the driving factor leading the disproportionate impact of preterm birth on Black women and birthing people thereby exacerbating systemic inequities in maternal and infant health. To achieve birth equity, which is the assurance of the conditions of optimal births for all people with a willingness to address racial and social inequities in a sustained effort, we must work to protect and uphold a standard of care for spontaneous, recurrent preterm births and ensure it remains accessible and affordable for all who stand in need,” added Dr. Joia Crear Perry, founder and president of the National Birth Equity Collaborative.
The Preterm Birth Prevention Alliance is calling for the FDA to grant a public hearing to fully consider all of the data, additional research methods, and stakeholder perspectives before deciding whether to withdraw approval of this critical class of therapies. The health of America’s moms and babies warrants the utmost care and consideration.
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ABOUT THE PRETERM BIRTH PREVENTION ALLIANCE
The Preterm Birth Prevention Alliance is a coalition of maternal and women’s health advocates who share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth. Formed in 2021 by the National Consumers League, we seek to improve preterm birth outcomes in the United States by maintaining access to safe, FDA-approved treatment options and advocating for more diverse medical research that adequately represents the experiences of women and newborns of color. Women of color need a seat at the table. To learn more, visit www.pretermbirthalliance.org.
Initial support for the Preterm Birth Prevention Alliance is provided by Covis Pharma.
MEDIA CONTACT:
Carol McKay, carolm@nclnet.org
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