Unveiling the flaws in the 340B Drug Pricing Program: Hospitals, medical debt, and consumer struggles

Sally Greenberg

By Sally Greenberg, Chief Executive Officer

In 1992, Congress created the 340B Drug Pricing Program to help ensure vulnerable patients would be able to access medications they need but may not be able to afford. This program provides steeply discounted drugs to health care providers – mostly hospitals – serving low-income patients with the intent that the providers would pass those discounts along to patients. Unfortunately, that is not what is happening. The National Consumers League (NCL) is increasingly concerned about this program, especially as it relates to hospitals’ abusive and aggressive debt collection practices, and how those practices lead to consumer medical debt. A recent letter from a bipartisan group of Senators underscores hospitals’ role in this growing problem.

We find it particularly troubling that many hospitals benefiting from 340B are not only nonprofit entities but are designated as charity hospitals – supposedly caring for low income and indigent patients. A 2022 report by the Alliance for Integrity and Reform of 340B found that charity care spending for nearly two-thirds of 340B hospitals was less than the national average for similar hospitals. Further, a December 2019 Government Accountability Office (GAO) report found that “some nongovernmental hospitals that do not appear to meet the statutory requirements for program eligibility are participating in the 340B program and receiving discounted prices for drugs for which they may not be eligible.” One report found that 82% of nonprofit hospitals spent less on community programs than the value of their tax exemptions.

Consumers are not benefiting from the 340B program in the way Congress intended. A patient whose income is above 200 percent of the Federal Poverty Level (FPL) is expected to pay full price for a drug they receive at the hospital, even though the care center from which they are “buying” the drug did not pay full price for it. Hospitals participating in the 340B program saved an average of $11.8 million per year, according to a 2019 report from Beckers Hospital Review, and multiple studies have found that a majority of hospitals markup medicines between 200-500 percent. Under the current program, an individual who makes $29,200 per year has to pay that price.

What is even more alarming is the fact that if a patient can’t pay, the hospitals that have benefited enormously from discounted drugs intended for vulnerable patients are aggressively suing these same patients. This illustrates a major disconnect between the intent of the 340B program and the way it is operating today.

While estimates differ, medical debt is believed to cause more than 60 percent of bankruptcies in America. Most consumers facing medical debt did not end up in that situation because of bad decisions or profligate spending. Most have had some kind of injury or unexpected illness and don’t have insurance – or don’t have sufficient insurance – to cover their medical and hospital costs. Patients who need financial assistance should be processed when entering the hospital for medical care. Many are not given the chance to do so and as a result, can be sued for debt after services are rendered. Medical debt collection practices are debilitating for low-income consumers and can destroy their credit ratings, subjecting them to subprime rates and a never-ending spiral of debt.

Even if patients don’t start out poor, because of excessive fees, penalties, and other costs added onto what may or may not be actual medical debt on the part of patients, aggressive debt-collection practices can leave them destitute. Many don’t have funds to hire a lawyer, and if summoned, they often don’t know they need to actually go to court; in fact, sometimes debt collectors advise them not to show up in court. As a result, default judgments are filed against them, leading to garnishments of wages, and liens on homes, cars, and other properties. In 2019, the Journal of the American Medical Association studied the garnishment of wages by hospitals in the state of Virginia and found that 71% of the hospitals were nonprofit and the gross mean annual revenue of hospitals engaged in garnishments was $806 million, with 8,399 patients having wages garnished.

Below are just a few stories illustrating hospitals’ medical debt collection practices playing out in communities throughout the nation.

  • A woman in Knoxville, Tennessee, was diagnosed with cancer and underwent surgery and chemotherapy. Even though she had health insurance, she was left with almost $10,000 in medical bills that she couldn’t pay. Financial counselors told her she couldn’t schedule cancer checkup appointments with her doctor until she has a plan to pay her bills, according to a December 2022 story by NPR.
  • As reported by the Washington Post in May 2019, an investigation by the Baltimore Sun found that 46 hospitals in Maryland filed more than 132,000 lawsuits for unpaid medical bills from 2003 to 2008 and won at least $100 million in judgments. In some cases, hospitals added annual interest at twice the rate permitted for other types of debts or placed liens against patients’ homes.
  • The Washington Post reported in 2019 that the University of Virginia (UVA) Health System sued former patients more than 36,000 times for over $106 million over a six-year period. During that time, UVA’s Medical Center earned a $554 million profit and held stocks and other investments worth $1 billion. One of the patients the UVA Health System sued was Heather Waldron. Following emergency surgery and other treatment in 2017 to address an intestinal malformation, Waldron received a bill from the University of Virginia Health System for $164,000, more than twice what a commercial insurer would have paid for the care. When she was unable to pay, the UVA Health System pursued her with a lawsuit and a lien on the home she shared with her then-husband and five children. In the fall of 2019, the family lost their home, and the “financial disaster” contributed to Waldron and her husband divorcing earlier that year.

We support the critical role hospitals play in communities across the country and understand many dutifully provide charity care to those who cannot pay. However, we believe that if hospitals are designated charity entities and are receiving 340B discounts, they should be required to prove that those discounts have been passed along to patients. The current situation is unacceptable and merits an in-depth investigation and tightening up of the 340B rules. Charity hospitals should not be able to both claim 340B status and drag the very populations they are pledged to serve into debt collection proceedings, taking their homes, their cars, and their possessions in the process. Changes need to be made to ensure that only eligible hospitals are allowed to participate in the 340B program and that the deep discounts for medicines are passed along to patients, as Congress intended.

NCL mourns the passing of Rhoda Karpatkin

Sally Greenberg

By Sally Greenberg, Chief Executive Officer

The National Consumers League mourns the passing of consumer icon and President of Consumer Reports Rhoda Karpatkin.

Rhoda, who died last week, served as President of Consumer Reports (CR) and Consumers Union (CU)—having served for 26 years from 1974 to 2000.

I had the honor of working under Rhoda when I was hired in 1998 as Senior Product Safety Counsel in CU’s Washington office. I would use two nouns to describe Rhoda – fierceness and integrity. Rhoda maintained an unbending commitment to CR’s absolute independence from any outside influence or outside money, and that included corporations, individuals, labor unions, politicians, or media.

A visionary, Rhoda held to an unwavering moral compass. We all looked to her for ideas and guidance. She oversaw the work of Consumer Reports magazine in tumultuous times.

When I was hired, CR was being sued by two automakers whose cars did not pass CU’s rigorous safety testing. Consumer Reports won the lawsuit and neither auto company sells cars today.

Rhoda believed in a global consumer movement. She served two terms as president of Consumers International, a membership organization for consumer activist groups. She also helped to launch the Transatlantic Consumer Dialogue, which continues to this day. This past summer I represented NCL at the TACD meeting in Brussels. An inspiring organization, TACD brings together consumer groups from the U.S. and Europe to share strategies and collective initiatives.

In the name of Esther Peterson, the beloved and powerful consumer advisor to three presidents, Rhoda created a fellowship at CU’s Washington office. Gene Kimmelman, the director of the DC office, and I worked closely with Rhoda to bring candidates in for interviews and Rhoda loved the process and enjoyed coming to Washington from her Yonkers headquarters to participate in the interviews. She often asked candidates, “What are you reading?”—a question I have incorporated into my interviewing repertoire.

A central figure in the consumer movement of the 1970s, Rhoda nearly doubled the circulation of Consumer Reports to 4.2 million. By the time she left, its website was one of the largest paid subscription sites on the internet, with approximately 475,000 subscribers, according to the magazine. Rhoda grew the magazine’s operating budget and oversaw the redesign of the auto-test track and new research laboratories. She also supported the work of Dr. R. David Pittle, CU’s technical director, as we worked with Congress when product safety hazards made the headlines. Together we all tried to ensure that pro-consumer leaders had a place at federal safety agencies like the Consumer Product Safety Commission and the National Highway Traffic Safety Administration.

The consumer movement has had many great leaders, but Rhoda Karpatkin stands out for her kindness, integrity, and vision. I know I share the views of many of my colleagues who are deeply saddened to lose Rhoda. Her indelible influence lives on in all of us lucky enough to have worked with her.

Thank you, Rhoda. We will miss you.

New insurance schemes to carve out specialty drugs deserve skepticism and scrutiny

Sally Greenberg

By Sally Greenberg, Chief Executive Officer

Employers seeking to cut healthcare costs should remember this simple rule of thumb: If an offer to save money seems too good to be true, it usually is. That seems to be the case with offers to try “Alternative Funding Programs” or AFPs.  This is a devious but growing cottage industry, which promises to cut employer costs for specialty medicines.

Specialty medicines are used to treat complex, chronic conditions like cancer and rheumatoid arthritis; they are drugs often offered to some of the sickest patients. While they represent a mere 2 percent of prescriptions, they add up to half of the estimated $500 billion spent each year in the U.S. on drugs. Thus, specialty drugs are hefty contributors to self-funded employers’ health plan costs. (Source: optum.com)

One “solution” offered by third party vendors peddling AFPs is to remove coverage of specialty drugs from the employer’s formulary. This immediately renders those employees “uninsured” as far as coverage for their needed drugs goes. The AFP vendor then matches the newly uninsured employee with a patient assistance program offered by drug manufacturers and other charitable foundations. The patient’s co-pay is fully covered by the assistance program, the employer saves money, and the vendor takes a cut of the savings.

We think this so-called solution is underhanded and dangerous for patients.  It is also unethical and possibly illegal.

First, the charitable programs being mined by the AFP vendors are meant for the truly needy—those who are uninsured or underinsured. If these sources of funding are being drained by the AFPs, they won’t be available for patients who really need the assistance.

These programs are having a predictable effect:  drug manufacturers are starting to tighten the eligibility criteria for their charitable programs, limiting them to patients who are truly uninsured. That means the AFPs won’t be able to fulfill their promise to find alternative sources to pay for the medicine. The inevitable will happen:  patients will be forced to go back to their employers’ insurance, causing dangerous delays in treatment and eliminating any savings.

Critically, the AFP process interrupts and delays care for patients. One of the AFP vendors, aptly named SHARx, with a logo shaped like the predatory creature its name invokes, admits the process can take 2 to 6 weeks. While trying to enroll the previously insured patient in an assistance plan, they’ll “do as much as they can” to help a patient access their medicine, sometimes demanding they sign over power-of-attorney to their company. In practice, that means patients can be left in limbo with no coverage for a period of time.

How can an employer ethically expose their employees with serious health conditions to that risk? (Source: sharxplan.com)

There are also ERISA and IRS legal and compliance risks to self-insured employers, too, according to an analysis by Vivio, a Public Benefits Corporation (Source: viviohealth.com)

And by some accounts, the AFP vendors are taking a huge cut of any savings, as much as 25 percent, on top of the administrative costs employers must pay to implement the program. (Source: drugchannels.net)

Nonetheless, according to a 2022 survey, 10 percent of self-insured employers with at least 5,000 U.S. employees are using alternative funding vendors. Some 8 percent said they were planning to use them within two years and 19 percent are considering their use in three to five years. (Source: optum.com)

It is easy to initially discount AFP critics as defenders of unfettered drug pricing. However, even Optum, a subsidiary of leading health plan provider United Health Care, has sounded the alarm. They advise their clients “to look past the short-term sales pitch and consider longer-term financial implications, compliance risk and ethics of alternative funding programs.” (Source: optum.com)

We are raising the voice of consumers in support of efforts in Congress to rein in other dubious co-pay assistance schemes deployed by Pharmacy Benefit Managers such as co-pay maximizers and accumulators.  In this case, employers should take the lead in standing up for their employees’ health by refusing to open the door when third party AFP vendors come calling.

Guest Blog: The FABRIC act will address garment industry workplace concerns

By Rebecca Ballard

Last year the first ever federal fashion bill, The FABRIC Act, was introduced in Congress, and it will be reintroduced this September. However, the intersection between labor rights, legislation, and the garment industry is far from new. The industry has been tied to labor abuses since before our country’s founding; it was cotton that enabled the United States to reach global economic prominence, and issues with forced labor in fashion continue to this day. And it is not just labor concerns linked to fashion, but key labor achievements as well. Many of the labor laws that govern our lives and workplaces took root in the garment industry.

As a guest blogger for NCL and a longtime partner with the organization, I am excited to briefly share the fascinating history linking the garment industry and labor movements, some of the present-day issues in the industry, and even an opportunity to advocate for change this year.

The Industrial Revolution and the U.S. Fashion Industry

The industrial revolution gave rise to the fashion industry as we know it today, bringing innovation and affordable mass-produced items as well as widespread workplace labor abuses, sweatshop conditions, and pollution. In fact, the beginning of the U.S. industrial revolution is often cited as the opening of a textile mill in Pawtucket, Rhode Island, in 1793. During the Industrial Revolution we saw women, including recent immigrants, and children take jobs in textile mills to supplement family income. Many of these workers were exploited, toiling sometimes for 16 hours a day during high demand periods, for a subsistence income; all too often they were subject to wage theft.

But through this work, many women garment workers also achieved a measure of independence, leaving homes and families, and some used that newfound independence to join social activist movements and advocate for improved labor conditions. Female workers in Lowell, Massachusetts, for example, formed America’s first women’s union in the 1830s, which focused on maximum hours laws, including a 10 hour work day and higher wages, and they conducted one of the first major labor strikes in this nation’s history. Workers in New York’s sweatshops were victims of harassment, wage theft, and terrible conditions, and the International Ladies Garment Workers Union and Amalgamated Clothing Workers of America unions formed to demand labor reforms there in the early 1900s.

The Triangle Shirtwaist Factory Fire and Subsequent Labor Reforms 

Just as unions were gaining strength, the United States saw a devastating example of the incredible harms that can take place in the garment industry. Near closing time on March 25, 1911, the factory fire that broke out at the Triangle Shirtwaist Factory killed 146 workers, many of whom were immigrant women and girls. The building’s only fire escape building had collapsed during the rescue effort. Machinery and tables crushed workers, while locked doors trapped them, and there were only a few buckets of water to douse the flames. Firefighter ladders were too short to reach the 9th floor and safety nets ripped. The survivors from the 500-plus Triangle Shirtwaist Factory recounted the horrors they witnessed, including their fellow workers leaping to their deaths from the 9th floor rather than being burned alive. Some victims were as young as 14 years old.

In New York state, this tragedy prompted the transformation of the state’s labor and fire codes, thirty-six new state laws, and increased labor funding. The New Deal era under President Franklin Roosevelt saw adoption of similar legislation at the federal level nearly 20 years later with the support of some of these same reformers, like Frances Perkins who witnessed the Triangle Shirtwaist Factory fire herself and later became the Secretary of Labor under President Roosevelt. The Occupational Safety and Health Administration, country-wise fire and safety laws, and the Fair Labor Standards Act could be said to have arisen from laws enacted in New York after the Triangle Shirtwaist Factory fire.

Following the lead of women’s suffrage groups, and often in concert with women’s rights leaders, a number of trade unions formed to support the rights of garment workers. Roosevelt’s New Deal offered legal protection to unions, and through union gains and New Deal programs sweatshop conditions lessened and wages increased. However this brief period of reforms for workers in the US garment industry did not continue when the industry expanded and much of the industry moved abroad.

In addition to labor issues, the modern garment industry continues the environmental degradation that started during the industrial revolution. The industry today is playing a role in climate change and not on track to meet key climate goals and operate within planetary boundaries in its current form. Overproduction as well as over-purchasing are both extreme, and there are presently enough clothes on our planet to clothe six generations of people. Waste is often exported to other countries, hurting local economies and climates through waste colonialism. The industry continues to be powered by coal and uses toxic chemicals that are dangerous for workers, wearers, and our planet. Water usage is also highly problematic. For example, it takes over 2,000 liters of water to make just one t-shirt, around as much as one person drinks in three years. The water used in clothing creation, as well as clothing use, is often filled with microfibers that reach even the depths of our oceans and cause great harm to planetary ecosystems.

California Legislation

Sweatshops reemerged in the 1960s due to a range of forces in the U.S. and abroad: the changing retail industry, the growing global economy, increased contracting, and a large number of immigrant workers in the U.S. In the 1970s, manufacturers began outsourcing production to other countries to lower labor costs and employ a more compliant, non-union worker base. Despite increased consumption and a growing population, the number of U.S.-based garment workers dropped 37 percent, from 1.2 million in 1970 to 760,000 in 1995.

When sweatshops reemerged on U.S. soil they brought with them many horrific practices.  In California in the 1990s, the El Monte sweatshop, was subject to a raid that uncovered workers held behind fences surrounded by razor wire. These modern-day sweatshops exposed brutal conditions, with many tricked into accepting U.S. employment while living in other countries and once here being subject to debt bondage, threats of harm to them or their families, and violations of wage and hour codes. 

The 2021 California’s Garment Worker Protection Act (SB 62) enacted many statewide reforms for the industry in the state with the greatest number of garment workers. This landmark law aims to end wage theft and the payment of less than a minimum wage to garment workers by ending the piece rate of payment and creating liability for contractors for the full amount of unpaid wages and reimbursement of expenses, no matter how many layers of contracting are used. It also aims to enhance workplace safety by having garment workers no longer need to work at unsafe speeds to complete as many items as possible each day to reach a fair rate of pay.

The FABRIC Act

On the federal level, promising reforms include the first federal fashion industry bill, The Fashioning Accountability and Building Real Institution Change (FABRIC) Act, which was introduced in 2022 and will be reintroduced this September. A federal Lobby Day on September 12th is planned in partnership with national worker rights and sustainable fashion NGOs. The FABRIC Act follows in the footsteps of California’s SB62 by eliminating the piece rate and creating joint and several liability for violations of the law.  The FABRIC Act also creates a national garment manufacturing registry and incentivizes domestic production through a $40 million garment manufacturing grant program and reshoring tax credits. Anyone is welcome to be a part of the Lobby Day, and can sign up to volunteer here.

National Consumers League Live Event Ticketing Principles

By John Breyault, Vice President, Public Policy, Telecommunications, and Fraud

The ticketing industry is the gatekeeper to much of our nation’s arts, sports and culture. What should be an exciting moment—securing a seat for your favorite event —has become exceedingly frustrating for many consumers as they navigate a confusing ticket-buying process laden with hidden fees.

NCL works on behalf of fans for all live events to ensure that consumers get the best possible experience, the best bargain for their hard earned dollars and don’t feel they’ve been ripped off with gotcha added costs, like mandatory “convenience fees” “processing fees” “venue fees” or the like when purchasing live event tickets.

Consumers are at the mercy of a rigged ticket marketplace. One company – Live Nation Entertainment (LNE) — dominates the marketplace. The company was created after Ticketmaster and Live Nation were given the green light to merge by the Department of Justice in 2009, despite strong consumer and business opposition.  LNE today controls around 80% of primary ticketing services, owns or has exclusive rights to operate many venues, and has major positions in artist management and event promotion. In 2022, LNE reported $4.5 billion in revenue from ticket resale, more than double what it earned in 2019, making it one of the largest players in the secondary ticket market.

Not surprisingly, LNE engages in practices typical of monopolies, working to drive out competitors. NCL and other consumer groups are leading the charge to unwind the ill-advised 2009 merger of Live Nation and Ticketmaster and restore healthy competition to the marketplace.

NCL believes that ticket resale has a legitimate place in the live event marketplace. The availability of ticket resale services provides a hedge for consumers who buy season tickets or non-refundable tickets, and is also a source for ticket buyers to get bargains when supply outpaces demand, allowing them to save money on below-face value tickets.

Below are some general principles on ticketing that NCL supports.

  1. We want the DOJ and Congress to unwind the Ticketmaster-Live Nation merger.
  2. Hidden ticket fees, deceptive dark patterns, and other anticompetitive ticketing practices should be prohibited. “All in” ticket pricing should be required so that consumers can compare prices from one site to another.
  3. Ticket holdbacks (also known as allocations) should be disclosed to ticket buyers prior to purchase.
  4. Secondary ticket exchanges should be required to disclose the face value of tickets offered for sale on their platforms.
  5. Ticket resellers should be prohibited from engaging in deceptive practices that are deliberately intended to confuse consumers into believing they are buying tickets from the primary seller. Deceptive design practices such as using URLs or other indicia of affiliation with a venue, team, or artist and by paying for search engine optimization that results in resale websites appearing higher in search results than the official box offices should be prohibited.
  6. Secondary ticket exchanges should be required to closely monitor their ticket inventory to ensure that they are not listing tickets obtained in violation of federal or state laws.
  7. All stakeholders in the live event industry should be required to assist enforcement agency’s efforts to stop illegal automated ticket buying and resale.
  8. Federal or state law enforcement agencies should investigate how tickets appear on the secondary ticket market at prices far above face value before offered for sale by primary ticket sellers and whether such sales violate applicable laws.

To these ends, NCL has endorsed legislative reforms to protect ticket buyers and promote competition in the live event industry, such as the BOSS and SWIFT Act and the TICKET Act.

What’s going on with student debt cancellation?

By Eden Iscil, Public Policy Manager

A few weeks ago, the US Supreme Court ignored the facts of the case in front of them and wrongfully ruled that President Biden’s first attempt at cancelling student debt was illegal. While the Court was misguided and seemingly hellbent on making life worse for millions of Americans, debt cancellation is not dead. Earning much less media coverage than the Court’s ruling, President Biden announced on that same day that his Department of Education had initiated a plan B for debt cancellation. Additionally, he revealed a 12-month “on-ramp” to repayment. Here’s what we know so far about these two programs. 

Plan B for cancelling student debt 

Over the past 60 years, Congress passed two laws giving the secretary of education the authority to cancel student debts—the Supreme Court’s ruling last month only applied to one of them. While there is still one more legal avenue available for the Education Department to broadly cancel student debt, the law requires a lengthy regulatory process to get there. Specifically, the department must initiate a negotiated rulemaking, seeking input from various stakeholders involved in student debt. From nominating and appointing negotiators to reaching a final recommendation for the Department, this stage will likely finish around the end of the year. 

Next, the Department will have to publish a proposed rule outlining the parameters of the debt cancellation plan. Currently, the administration has not spoken to how much debt will be cancelled under plan B and who will be eligible beyond an intention to deliver “debt relief for as many borrowers as possible.” This means that we shouldn’t expect to see the details of plan B until early 2024. And once the Department publishes its proposal, there will be a 60-90 day comment period for the public to submit their thoughts on the plan. Only after this comment period is finished (and the Department has read the public’s thoughts) can the program go into effect. Once all of these steps are completed, it will likely be around springtime next year at the very earliest. 

A 12-month “on ramp” to repayment 

Congress set September 30 as the last day of the federal loan payment pause. Without some form of debt cancellation, it is estimated that repayment will put over 9 million borrowers into default. Recognizing this reality and its legal inability to extend the current payment pause thanks to Congress, the Department will waive certain repayment related penalties from October 1, 2023 through September 30, 2024. 

Specifically, during this year-long period, missing a monthly federal loan payment: 

  • Will not result in default or delinquency 
  • Will not be reported to credit bureaus 
  • And will not be referred to debt collection agencies 

While both plan B and the 12-month on ramp are imperfect, the Department is taking steps to minimize harm and is still working to deliver debt relief. It’s important that we continue to show our support for debt cancellation, especially during the public comment period. We should not tolerate an educational system that results in lifelong debt and average monthly payments of $500. 

Safety in question: The alarming disparities between cannabis product health claims and research, and the magnified risks for women

By Health Policy Intern Grace Lassila

July 27, 2023

When I started my National Consumers League (NCL) internship in May 2023, I quickly dove into NCL’s health policy work. NCL is leading on several efforts to protect consumers –one area of focus that stood out to me is their work in the cannabis policy space. NCL is a founding member of Cannabis Consumer Watch (CCW), which educates consumers on cannabinoids, their effects, the risks related to the unregulated marketplace, and the ways policymakers and regulators can help protect consumers. NCL is also a part of the Collaborative for Cannabinoid Science and Safety (CCSS), which also works to educate people about cannabinoids and policy in the interest of public health.

CCW’s “test your cannabis knowledge” quiz was shocking for me. Going into the quiz, I was fairly confident about my knowledge, but as I started getting wrong answer after wrong answer, I realized I had no idea that not only are these products under-researched, but they may pose serious public health risks for consumers. Products can be sold, without having gained FDA approval, making false claims about their medicinal abilities.  And side effects are not adequately researched or revealed to consumers.

One particularly concerning aspect of the cannabis marketplace is that while CBD or Delta-8 or other cannabis products are often marketed to women, there is a concerning lack of research into the safety of these products for women. Historically, misogyny and sex discrimination have made women’s health severely under-researched and underfunded. More research on diseases, disorders, and medication is conducted on men, not women. Women are misdiagnosed far greater than men are, and experience dangerous health outcomes because of it (Greenhalgh). And without sufficient research and data on women’s health, it is incredibly difficult for legislators to write policy (Adams). Overall, for women’s health to improve, more resources need to be devoted to this issue.

Despite cannabis companies’ marketing efforts that claim their products can help with anything from menstrual cycle-related pain to morning sickness, there is little insight into the effects of cannabis or cannabis derivatives on women, pregnant people, nursing parents, and newborns. What we do know is that the risks are very real – a recent study found that THC use during pregnancy was linked to changes in fetal development and several studies have shown that CBD can be transferred to a baby via breast milk. The FDA strongly advises against THC or CBD usage while pregnant or breastfeeding. And, given the evidence currently available, I would caution any women from using these products for medical benefit.

The lack of regulation, as well as research, is very concerning. Because the FDA currently does not regulate these products, consumers have no way of knowing whether the dosage, ingredients, or claims on the label are accurate and no way of knowing whether or not they are contaminated. Though some products may acknowledge they are ‘Not Approved by FDA,’ many consumers may not see this fine print – and assume that anything they can buy at their local grocery store must be safe for consumption. While the risks of an unregulated cannabis marketplace affects all consumers, women who need medical health and relief and turn to cannabis products may be more at risk.

The good news is that in January of this year, the FDA recognized this grey area for regulation – particularly for CBD – and stated that CBD would not be regulated as a food and dietary supplement anymore, because of the unknown safety risks, and requesting that Congress act quickly to protect public health and the consumers involved.

While cannabis products are often marketed as a miracle drug, they are not. While there may be some health benefits, without comprehensive research and regulation of these products, the risks outweigh the potential good. Consumers remain responsible for making their health decisions, and women in particular should be vigilant. The FDA is heading in the right direction but more must be done to protect consumers – and women in particular. I encourage you to learn more about a safe path forward here and help NCL raise awareness of this important issue.

Sources:

Adams, Katie. “Women’s Health Is Suffering Due to Lack of Research and Funding, Experts Say.” MedCity News, 9 Dec. 2022, medcitynews.com/2022/12/womens-health-is-suffering-due-to-lack-of-research-and-funding-experts-say/#:~:text=Women’s%20health%20has%20been%20historically,healthcare%20conference%20in%20Washington%2C%20D.C.

Eversheds Sutherland. “FDA Says ‘No’ to CBD: Now What?” FDA Says “No” to CBD: Now What? – Eversheds Sutherland, us.eversheds-sutherland.com/mobile/NewsCommentary/Legal-Alerts/256713/FDA-says-no-to-CBD-Now-what#:~:text=Since%202018%2C%20the%20FDA%20has,%2Dapproved%20drug%20(Epidiolex). Accessed 6 July 2023.

Greenhalgh, Ally. “Medicine and Misogyny: The Misdiagnosis of Women.” Confluence, 5 Dec. 2022, confluence.gallatin.nyu.edu/sections/research/medicine-and-misogyny-the-misdiagnosis-of-women.

Grinspoon, Peter. “Cannabidiol (CBD): What We Know and What We Don’t.” Harvard Health, 24 Sept. 2021, www.health.harvard.edu/blog/cannabidiol-cbd-what-we-know-and-what-we-dont-2018082414476.

“What You Should Know about Using CBD When Pregnant or Breastfeeding.” U.S. Food and Drug Administration, www.fda.gov/consumers/consumer-updates/what-you-should-know-about-using-cannabis-including-cbd-when-pregnant-or-breastfeeding#:~:text=FDA%20strongly%20advises%20against%20the,during%20pregnancy%20or%20while%20breastfeeding.&text=Cannabis%20and%20Cannabis-derived%20products,products%20appearing%20all%20the%20time. Accessed 6 July 2023.

Growing up in fields

By Child Labor Coalition Intern Jacqueline Aguilar

July 20, 2023

I grew up in a small rural area named Center, Colorado which has a population of about 2,000 people. Growing up my parents were always working in the fields, I remember my father coming home from work, and I would feel how raspy his hands were on my face. I would always ask myself, “Why are his hands so rough?” Eventually, I realized it was because of the hard work he did every day.

In middle school, buying school clothes was difficult for my parents. I started working in the lettuce fields at the age of eleven with many of my friends. We would go in at 5:00 am and get out around 2:00 pm, my parents couldn’t take me to work because they had their own job to get to, so I would have to catch a ride with my supervisor at 4:30am and get home around 3:00 pm.

Walking down those lettuce fields was draining physically, and mentally. It consisted of tired feet walking down the field with my blistered hands holding a bulky hoe and keeping an eye out on the lettuce heads making sure they grew the right way. Most days would start with the fields cold and wet with dew. I was often drenched in mud. By the time the sun rose, it was boiling outside. I would still wear layers of clothes to avoid getting sunburnt and wrap bandanas around my head and neck.

There was no cold water available for us during working hours, or even on our lunch break. We normally worked a 12-hour shift with a 30-minute lunch—typically just cold food or snacks since we didn’t have enough time to go home and make something.

I found the work exhausting, so I started working a food service job. But soon found myself back in the fields when my father got diagnosed with lung cancer. My father had migrated to the U.S. when he was 19 and had been working in the fields ever since. The cancer could have been caused from the fertilizer, dust, and pesticides that he breathed in the fields.

My mother is now disabled with torn ligaments in her shoulder, which can also be from her field work and the movements of sorting the potatoes for so many years.

My parents were unable to provide for me financially and had to move three hours from home for my dad’s cancer treatment, so I worked the potato harvest while attending high school. I juggled a lot of responsibilities during this time, and it was difficult to still be a child with so much on my plate.

I recall one morning it began to snow, we didn’t know any better, so we kept working in the heavy weather. My fingers and feet grew ice-cold as I sorted potatoes, and I wished they would tell us to go home for the day. At that moment, I knew I wanted more for myself.

I am trying to give back to my community. I dedicate two days of my week tutoring ESL students at Center Middle School, where I previously attended. I want to help Spanish-speaking students continue school without the language barrier.

I have also been connected to the Migrant and Seasonal Head Start Program since youth. For the past three years, I have been the Otero Migrant and Seasonal Head Start Recruiter in the San Luis Valley in Colorado which allows me to promote a good program that benefits farmworker children and parents. I am an active member of the College Assistance Migrant Program at Adams State University where I’ve learned the value of an educational community and the power of coming together to work toward a common goal.

I am now a rising junior at Adams State University working toward a major in sociology with an emphasis in social work and a minor in Spanish. I hope to receive my Master’s degree at Colorado State University-Pueblo to become a medical social worker. I want to stay close to my community to help families that face barriers to medical services—just as mine did when my father had cancer.

Financing the healthcare of tomorrow playlist: Tracks for consumers and policymakers

By Robin Strongin, Health Policy Director

July 12, 2023

My husband has advanced Lewy Body Dementia and one of the few things we can still enjoy together is listening to music. We used to curate playlists for all kinds of music. We even put together playlists to mark special occasions (like our daughter’s wedding). Really, any topic became fair game for a playlist.

I was invited to speak at the Patients Rising Disrupting Healthcare Summit summer conference in Washington DC. My panel topic was Financing the Healthcare of Tomorrow. As I was preparing my presentation, I spoke with Michael Capaldi, Executive Director, the Institute for Gene Therapies. Mike is an expert on gene and cell therapies, and these therapies are definitely the healthcare of tomorrow, although thankfully, we are beginning to see the promise of these therapies today. When we talked about my presentation, he said, “you know, Robin, patients are really at a crossroads:  on the one hand, they are much more educated and empowered about their care, but some of the new therapies on the horizon are so complex, the cost and time commitments to innovate in these areas are so high, that groups like the National Consumers League [i]are in position to help patients and caregivers understand these complexities.”

And that’s when it hit me. A playlist. My colleague had me at Crossroads. If you’re a fan of delta blues, like my husband and me, then you know Robert Johnson and his classic, Crossroads.  The rest of my remarks rounded out my Financing the Healthcare of Tomorrow Playlist: Tracks for Consumers and Policymakers, which include:

Crossroads (Robert Johnson)—Robert Johnson’s haunting work reminds me of the difficult choices health policymakers have to make when it comes to healthcare financing—of course research and innovation are expensive—the diseases for which there are no cures, the conditions crying out for prevention, are complex and require decades of research, a deep understanding of basic science, and navigating an unpredictable regulatory path. Too many diseases and too few resources lead to heartbreaking trade-offs. Patients also have difficult choices to make when it comes to paying for their care. We shouldn’t have to be making deals with the devil—as Robert Johnson sings about in Crossroads. Instead, we need to reframe the questions we ask, review how we prioritize funding streams, and think creatively about financing mechanisms. Rather than question if society spends too much on healthcare, we should be asking how can we spend it more efficiently? How do we adequately incentivize all involved in funding transformational innovation? How do we make sure patients can afford and access the treatment they need?

I Am Woman (Helen Redding)—it gets really old but here we are, still talking about, and working on, closing the gender gap—in raising capital for venture funding for women-lead innovation teams; and in awarding grants to women lead research teams. Did you know, that according to the NIH Database monitoring NIH grants, grants awarded to women lead teams in 2022 numbered 19,028 and in the same year men won 31, 560 NIH grants? Progress yes, but not good enough. Not even close. Why is this important?  Because the teams with funding ask the research questions. The more diverse the research teams, the broader the array of diseases that are studied. More cures for more people.

Your Cheatin’ Heart (Hank Williams, Jr.)—I want to be careful and not paint all hospitals with the same brush but I would be remiss not to point out that too many hospitals are behaving badly: taking huge advantage of their nonprofit status, aggressively placing liens on patients who can’t afford their care, engaging in abusive debt collection activities, and worse, denying care; manipulating the 340B program designed 30 years ago to enable true safety-net providers to help low-income and other vulnerable patients access more affordable medicines and healthcare services. Some entities participating in the 340B program have taken advantage of the program’s current lack of clarity at the expense of the patients that the program is meant to serve.

Bad to the Bone (George Thorogood) – When it comes to taking advantage of our healthcare system, one major player in the drug pricing process might be considered “bad to the bone” – pharmacy benefit managers, or PBMs. PBMs continue to find ways to increase their profits while consumers are forced to pay high out-of-pocket costs for the prescription medicines they need. Although they were intended to help negotiate savings on medicines (which would be good), they are not passing along discounts to patients and are actually incentivized to steer patients to higher cost medicines – b-b-b-b-bad to the bone if you ask me!

Party Like It’s 1999 (Prince)—Shakespeare asked, What’s in a name? Fair question. Reminds me to also ask, what’s in a definition and when is it time to update it? How we defined value, quality (as in value of care, quality of care) and other terms in 1999, needs to be reevaluated on an ongoing basis. New innovations, insights, and understandings necessitate we revisit how we define, measure, and update the terms and metrics used to make decisions that affect healthcare financing. A great example comes from another colleague[ii]  who has co-authored and published compelling work on a “paradigm shift in managing high blood pressure.” He and his colleagues make the case that “Abandoning the view that hypertension is a disease in favor of regarding it as a cause of a disease and hence, adopting a population-based preventive approach would encourage the development of simpler guidelines.” Refreshed decades old thinking that could yield the elusive results the status quo has not achieved seems worthy of a party, like its 2023.

I Will Survive (Gloria Gaynor) and Stayin’ Alive (The Bee Gees)—Really, isn’t this what we are all trying to do?

A Change Is Gonna Come (Sam Cooke)—for patients like my husband, for our family, and for all the other patients and caregivers, change cannot come soon enough.  I pledge to do everything possible to advocate for meaningful change and help Patients Rising.

[i] I direct health policy for National Consumers League

[ii] Wald, Nicholas J., Wald, David S., Kellermann, Arthur L., “When Guidelines Cause Hypertension,” Commentary, The American Journal of Medicine, 2018, pp. 1402-4.

From class action to mass arbitration: Exposing corporate evasion in modern commerce

Sally Greenberg

By Sally Greenberg, Chief Executive Officer

July 6, 2023: Several decades ago, clever lawyers for large corporations came up with a scheme to prevent their clients from being held accountable for wrongdoing. They did so by putting “forced arbitration clauses” in consumer and business contracts. The effect was to block consumers and others from getting access to the courts, and instead force them into arbitration, which is a private system for deciding legal cases that is controlled largely by the corporation itself.

It was a sad day for consumers when the Supreme Court gave its blessings to this underhanded scheme; today forced arbitration clauses are put into virtually every contract that we as consumers are forced to sign in exchange for services like cable, cell phone, credit cards, mobile homes, and car sales.

Class action lawsuits have served as a critical safeguard for consumers against powerful corporate interests; they remain an essential pillar of corporate accountability. These collective legal battles help to restore consumer rights and maintain marketplace ethics. Landmark cases such as the Enron scandal, which highlighted fraudulent accounting practices, class actions against the makers of addictive opioids and against those responsible for the Deepwater Horizon oil spill illustrate again the power of collective legal action.

But now, as consumers are fighting back and cleverly using forced arbitration in their favor, corporate America is crying foul. The very companies that championed forced arbitration and blocked class actions don’t much like it when they have a taste of their own medicine.

According to Consumer Reports, for example, a new strategy, mass arbitration, has already had a significant impact. It has pressured several corporate defendants—including Uber, DoorDash, Samsung, Chipotle, and DraftKings—to grapple with accusations they otherwise could have swatted away. And it reportedly led at least one corporate giant, Amazon, to remove mandatory arbitration provisions altogether from its retail website’s terms of use.

According to the magazine, a group of enterprising lawyers representing about 40,000 TurboTax customers employed a kind of legal jiujitsu: They simultaneously filed thousands of arbitration claims, swamping Intuit with fees, prompting the company into a hasty retreat. But it was too late for the company: Several judges have refused to let Intuit out of the arbitrations, with one commenting that the company has been “hoisted by [its] own petard.”

Sadly, the companies are nevertheless employing delaying tactics, exploiting loopholes, and resisting the system they once endorsed and in fact created, all of which points to the need for an overhaul of the system.

Recent arbitration reforms in California offer a glimmer of hope. They champion a justice system built on fairness, transparency, and accountability. Reforms must tackle forced arbitration clauses and corporations from exploiting system vulnerabilities and face strict penalties for stalling or refusing to engage with the system they created.

As consumers, employees, and members of society, we must insist on corporate transparency and accountability; giving consumers a fair shake is more important than ever. Only then can we end corporate evasion, restore balance in our dispute resolution processes, and protect individual consumer rights against corporate wrongdoing.