Americans now have an Obesity Bill of Rights

January 31, 2024

Media contact: Nancy Glick, 202-320-5579, nancyg@nclnet.org; Simona Combi, 571-527-3982, simona.combi@ncoa.org

Washington, DC – Because obesity – the most prevalent and costly chronic disease in the United States –remains largely undiagnosed and untreated a decade after the American Medical Association (AMA) classified it as a serious disease requiring comprehensive care,[1] the National Consumers League (NCL) and National Council on Aging (NCOA) today introduced the nation’s first Obesity Bill of Rights and launched a grassroots movement – Right2ObesityCare – to advance changes in federal, state, and employer policies that will ensure these rights are incorporated into medical practice.

Developed in consultation with leading obesity specialists and endorsed by nearly 40 national obesity and chronic disease organizations, the Obesity Bill of Rights establishes eight essential rights, so people with obesity will be screened, diagnosed, counseled, and treated according to medical guidelines and no longer face widespread weight bias and ageism within the health care system or exclusionary coverage policies by insurers and government agencies.

“Our goal with the Obesity Bill of Rights is to define quality obesity care as the right of all adults and empower those with the disease to ask questions and demand treatment without discrimination or bias regardless of their size or weight” said Sally Greenberg, Chief Executive Officer of the National Consumers League. “For too long, adults with obesity have encountered a health care system that is working against them. They have been stigmatized, discriminated against, not treated with respect by their health providers, and have faced significant hurdles and burdensome requirements to receive obesity care.”

As described by Patricia Nece, J.D., Immediate Past Chair of the Obesity Action Coalition, “For my entire life, I’ve been a target of ridicule simply because of my weight. People rarely take time to look beyond my weight to see me.”

Currently, only 30 million[2] of the estimated 108 million adults living with obesity[3] have been diagnosed with the condition, and only about 2% of those eligible for anti-obesity medications have been prescribed these treatments.[4] The consequence of untreated obesity for the nation is worsening outcomes for over 230 obesity-related chronic diseases,[5] approximately 400,000 premature deaths a year,[6] and an estimated $1.72 trillion in direct and indirect costs to the U.S. economy.[7]

Defining Quality Obesity Care for All
The Obesity Bill of Rights establishes and promotes eight essential rights to drive transformational change and define the core requirements for people with obesity to receive person-centered, quality care:

  1. The Right to Accurate, Clear, Trusted, and Accessible Information on obesity as a treatable chronic disease
  2. The Right to Respect by all members of the integrated care team when screening, counseling, and providing treatment
  3. The Right to Make Treatment Decisions about one’s health goals and obesity care in consultation with the individual’s health providers
  4. The Right to Treatment from Qualified Health Providers including counseling and ongoing care from health providers with expertise in obesity care
  5. The Right to Person-Centered Care that is personalized, respects the individual’s cultural beliefs, meets their specific health goals, and considers the person’s whole health and not just their weight status
  6. The Right to Accessible Obesity Treatment from Health Systems, so those with severe obesity receive care in settings that allow for privacy, using size and weight-accessible equipment and diagnostic scans
  7. The Right for Older Adults to Receive Quality Obesity Care that comprises a respectful, comprehensive care approach consistent with their personalized medical needs
  8. The Right to Coverage for Treatment with access to the full range of treatment options for the person’s disease as prescribed by the individual’s health provider

“Collectively, these rights will ensure that adults with obesity have trusted, accurate information about their disease, respectful and nondiscriminatory care from medical professionals, and insurance that provides access to all treatments deemed appropriate by their health providers,” said Ramsey Alwin, NCOA President and CEO. “In town halls across the country, older adults told us they often feel invisible when seeking obesity care. The Obesity Bill of Rights recognizes and aims to address their unique challenges.”

Putting the Bill of Rights into practice

With the goal of reversing the trajectory of the nation’s obesity epidemic, NCL and NCOA will spearhead Right2ObesityCare, a new grassroots movement to engage people with obesity, their caregivers, health professionals, community leaders, employers, and a network of obesity and chronic disease organizations to drive adoption of the Obesity Bill of Rights in clinical settings.

Using the online hub www.right2obesitycare.org to mobilize stakeholders, Right2ObesityCare will focus on national and state policy efforts, including developing a set of national “obesity goals” for full implementation of the Obesity Bill of Rights by December 31, 2029. Plans include hosting regional town halls, workshops, and advocacy forums across the country; scheduling meetings with federal and state legislators and regulators; and arming interested citizens and advocacy leaders with materials and tools to advocate for implementation of the Obesity Bill of Rights in their communities and workplaces. NCL and NCOA also will pursue development of a model law that stakeholders can use to incorporate the Obesity Bill of Rights into state law.

“The Obesity Bill of Rights brings us a step closer to creating a society where all individuals are treated with respect and without discrimination or bias regardless of their size or weight. Establishing eight essential rights for people living with obesity strengthens efforts to end such blame, shame and discrimination and give individuals who want and need it, access to safe and effective options to improve their health,” added Joe Nadglowski, President and CEO of the Obesity Action Coalition.

Advocacy on implementing the Obesity Bill of Rights also gives policymakers new impetus to pass legislation that will remove the regulatory and insurance obstacles that keep many people with obesity from getting the care prescribed by their health providers.

According to Rep. Brad Wenstrup, DPM (R-OH), “By tackling obesity head on, we can better prevent numerous additional diseases like type 2 diabetes, high blood pressure, and heart disease. My bill, the Treat and Reduce Obesity Act (TROA), expands Medicare beneficiaries’ access to treatment options to include FDA-approved medications, clinical psychologists, registered dieticians, and nutrition professionals. Not only would this legislation help Americans live healthier and longer lives, but it can also save taxpayer dollars over the long run.”

Added Rep. Gwen Moore (D-WI), “Obesity is a chronic condition – not a personal or moral failing. We need to ensure our health care system treats it as a disease, so that Americans with obesity can access holistic, high-quality care that meets the full spectrum of their needs. I am proud to be a co-lead of the Treat and Reduce Obesity Act, which puts us on a path toward effectively treating obesity, helping create healthier outcomes for Americans and supporting enhanced quality of life for Medicare beneficiaries who need comprehensive care.”

Development of the Obesity Bill of Rights

A year in development, the Obesity Bill of Rights is the product of extensive research combined with four town hall meetings hosted in senior centers and churches in California, Delaware, Mississippi, and Oklahoma between June and August 2023. At these town halls, more than 250 older adults, community leaders, and local clinicians described a health care system that is inhospitable to delivering quality obesity care, and physicians described having limited time for counseling, not enough training in obesity management, and inadequate coverage and reimbursement for obesity care.

After turning this knowledge and the lived experiences of older adults into a first draft, NCL and NCOA hosted a roundtable at The Obesity Society annual meeting in October 2023 where leading obesity experts reviewed the preliminary document and made recommendations. NCL and NCOA then sought feedback from specialists in minority health, aging, and rural health, as well as health professionals and other stakeholders who provided additional guidance. The final step was to circulate the updated Obesity Bill of Rights to a wide group of stakeholder organizations, resulting in initial endorsements from 36 obesity, public health, and chronic disease organizations and medical societies.

Nearly 40 consumer, aging, and public health organizations endorse the Obesity Bill of Rights

To date, the following organizations have endorsed the first-ever Obesity Bill of Rights: 1) the Academy of Nutrition and Dietetics; 2) Alliance for Aging Research; 3) Alliance for Women’s Health & Prevention; 4) American College of Occupational and Environmental Medicine; 5) American Medical Women’s Association; 6) American Nurses Association; 7) American Society on Aging;  8) American Society for Nutrition; 9) Association of Black Cardiologists; 10) Association of Diabetes Care & Education Specialists; 11) Bias180; 12) Black Women’s Health Imperative; 13) Choose Healthy Life; 14) ConscienHealth; 15) Council on Black Health; 16) Defeat Malnutrition Today; 17)  Gerontological Society of America; 18) Global Liver Institute; 19) Health Equity Coalition for Chronic Disease; 20) HealthyWomen; 21) Lupus Foundation of America; 22) MANA; 23) National Asian Pacific Center on Aging; 24) National Black Nurses Association; 25) National Hispanic Council on Aging; 26) National Hispanic Health Foundation; 27) National Kidney Foundation; 28) Noom, Inc.; 29) Nurses Obesity Network; 30) Obesity Action Coalition; 31) Obesity Medicine Society;  32) Patients Rising;  33) Partnership to Advance Cardiovascular Health; 34) Preventive Cardiovascular Nurses Association; 35) The Obesity Society; and 36) WeightWatchers.

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About NCL

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. The organization’s 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.

About NCOA

The National Council on Aging is the national voice for every person’s right to age well. We believe that how we age should not be determined by gender, color, sexuality, income, or ZIP code. Working with thousands of national and local partners, we provide resources, tools, best practices, and advocacy to ensure every person can age with health and financial security. Founded in 1950, we are the oldest national organization focused on older adults. Learn more at www.ncoa.org.

 

[1] Obesity Medicine Association. June 19, 2013. “AMA House of Delegates Adopts Policy to Recognize Obesity as a Disease. Accessible at https://obesitymedicine.org/blog/ama-adopts-policy-recognize-obesity-disease/:

[2] PharMetrics-Ambulatory EMR database, 2018. Novo Nordisk Inc.

[3] Hales CM, et al. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. Centers for Disease Control and Prevention. NCHS Data Brief. No. 360. February 2020.

[4] PharMetrics-Ambulatory EMR database, 2018. Novo Nordisk Inc.

[5] Obesity Care Advocacy Network. Fact Sheet: Obesity Care Beyond Weight Loss

[6] Hurt Rt, et al. Obesity epidemic: overview, pathophysiology, and the intensive care unit conundrum. J Parenter Enteral Nutr. 2011 Sep;35(5 Suppl):45-135

[7] Milken Institute (October 2018), “America’s Obesity Crisis: The Health and Economic Costs of Excess Weight.”

Copycat versions of expensive drugs may look the same, but the impact on consumer pocketbooks is far from identical

By Sally Greenberg, Chief Executive Officer, National Consumers League

To a scientist, a biosimilar medicine is designed to work like a brand-name medicine, with the molecular structure operating in a highly similar way in both therapies. The biosimilar medicine looks the same to a doctor, too, who can expect similar clinical results.

For many patients, though, the cost of the two medicines hit the pocketbook in hugely different ways. Today, many insurance plans ask patients to pay a percentage of the list price of certain medicines out of pocket – a practice called “coinsurance” – rather than a flat copay.

Even if that coinsurance percentage is the same no matter the drug, patients can pay vastly different amounts if one drug has a higher list price than another.

This has become a quiet crisis for patients using the anti-inflammatory medicine Humira, the best-selling medicine in history. Humira carries a list price of about $7,000 a month, though insurance companies, through savvy negotiation, pay far less.

For patients with coinsurance – the specifics vary by insurer, but it’s usually around 25% of a medicine’s list price, with some plans setting a maximum per-prescription price – that could add up to more than $1,500 a month out of their own pockets to get a medicine they cannot do without. That’s a huge burden, but not a huge surprise to those who have witnessed their health insurance benefits become less and less generous.

Fortunately, there are new options. Biosimilar versions of Humira are now available that have a list price of close to $1,000 a month. For patients with a 25% coinsurance, the medicine costs $250 out of pocket.

That should be a no-brainer for consumers. Who wants to pay six times more?

Unfortunately, due to our ultra-complicated health care system, almost no one uses the cheaper biosimilar. In part, that’s because insurance companies like more expensive medicines because they can make more money from these drugs, and there are few policies in place designed to protect patients from this kind of behavior.

Doctors, too, may miss opportunities to offer patients lower-cost options. After all, when the brand-name product and biosimilar are both technically “covered” by a patient’s insurance, it seems like it shouldn’t matter which product is selected.

The truth is that because insurance benefits are all over the place, it does make a difference for some patients. A huge difference. Thousands of dollars’ worth of difference.

The good news is that there are efforts that can make this easier for consumers and their physicians. Industry, government, and advocates can commit to boosting education so that more Americans can understand their health plan.

Such an educational effort could also include a focus on coinsurance to ensure that no consumer ever gets surprised when they have to pay a percentage of an inflated cost.

But educational efforts only go so far. We cannot rely on solutions based around asking doctors and consumers to assume primary responsibility for navigating a broken system. Fixing this problem for good requires policymakers to act.

First, Congress needs to address the role the pharmacy benefit managers – the middlemen known as “PBMs” that determine how drug benefits are designed – have played in creating the distorted market structure that has led to health plan strategies designed to push costs onto consumers.

Bipartisan legislation has been introduced that would begin to correct this convoluted market and put an end to patients needlessly overpaying to pad the profits of PBMs, but congressional leaders need to prioritize reform. There may be few areas of consensus on Capitol Hill, but this is one of them, and it’s time to turn good ideas into law.

Second, meaningful market incentives need to be established to drive biosimilar uptake. This happened in the generics market decades ago, where clear incentives have driven generic drug penetration to the point where 91% of all prescriptions are for generic drugs.  Unlike biosimilars, patients who take generics see clear cost savings, which is a great motivator.

But no such incentives exist in the U.S. biosimilar market, offering an opportunity for Congress to create similar incentives where both patients and physicians share in the savings available from these lower-cost biosimilars.  Only then will consumers, and the U.S. health care system more broadly, realize the enormous potential of a sustainable biosimilars market.

Our health care system is complicated on purpose. Complexity makes it hard for consumers to see good deals, even when they’re right in front of them. That’s the scenario playing out with biosimilar versions of Humira: even if the drugs may be the same, the impact on patients may not be.

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About the National Consumers League (NCL)

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

PBMs claim new programs will save consumers money. Let’s take a closer look.

By Robin Strongin, Senior Director of Health Policy

Consumers have known for quite some time now that the prescription drug pricing system is essentially a black box. Dealings among drug manufacturers, health insurers and pharmacy benefit managers (PBMs) establish which drugs insurance will cover and make accessible to consumers. What’s more, the prices that consumers pay for those medicines vary wildly – often leading to high out-of-pocket costs for us all.

Two of the three major PBM companies that are in the middle of this drug pricing web recently announced that they are establishing new programs (CVS’s CostVantage and Express Scripts’ ClearNetwork) that set transparent formulas for drugs with a pre-set markup and a flat fee for the PBMs. On paper, this sounds like a great idea.

But consumers would be wise to take these claims with a healthy grain of proverbial salt. We know PBMs continue to find new ways to put themselves over patients (more on that here) and we must demand answers to the issues the PBMs are still skirting. For example:

  • Will these new programs actually make prescription drugs more affordable and reduce out-of-pocket costs at the pharmacy counter? Notably, both Express Scripts and CVS Health have acknowledged that employers and plan sponsors may not save any money from this move. There is no sign either that consumers will be able to get the drugs they need for a fair price.
  • While the companies boast increased transparency, they still have not shared – nor said they will share – how much they are paying to acquire the drugs that will be dispensed to patients. PBM clients have long sought this information, but it appears that data will still be hidden in the black box.
  • In the case of CVS Health, the changes the company announced will only be effective at CVS-owned pharmacies. It will not affect how CVS will reimburse millions of prescriptions at the local and independent pharmacies it doesn’t own. A cynic might say this is just another mechanism by CVS to drive more patients to its own pharmacies.

Most notably, nothing CVS Health and Express Scripts have announced will change one of the pervasive anti-consumer elements of the drug pricing system. In their dealings with drugmakers, they can still cut deals that will determine which medicines get preferential placement. This means PBMs could continue to push consumers toward higher-priced drugs and limit access to more affordable generics and biosimilars.

It’s no coincidence that Congress is getting closer to passing PBM reform legislation that would mandate transparency, force the PBMs to pass their negotiated savings from drugmakers to consumers and remove the incentives for PBMs to push consumers to higher-priced drugs. One might say that these moves by CVS and Express Scripts are cosmetic attempts to ward off legislation by touting their own self-reforms.

But, as with so much that goes on in the drug pricing game, these “reforms” may not be what they seem. We need Congress to step in for consumers to help ensure we’re no longer facing a big disadvantage at the pharmacy counter.

Learn more about the PBM problem at nclnet.org/pbms.

NCL comments regarding Proposed Rule: Medication Guides: Patient Medication Information Docket No. FDA-2019-N-5959

November 21, 2023

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831

The National Consumers League recently submitted comments regarding the Proposed Rule, Medication Guides: Patient Medication Information, that we believe will greatly improve the information patients receive with their prescription medicines.

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About the National Consumers League (NCL)

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

NCL applauds the confirmation of Monica Bertagnolli as next NIH director

November 9, 2023

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831

The National Consumers League (NCL) applauds the U.S. Senate’s decision to confirm Dr. Monica Bertagnolli to be the next director of the National Institutes of Health (NIH).

This past Tuesday, the Senate voted 62-36 for Bertagnolli to take over the leadership role at NIH – a role that has been vacant for nearly two years. Preceding Bertagnolli was 2022 Trumpeter Honoree Dr. Francis Collins, who served as NIH director for more than 12 years.

“Dr. Bertagnolli brings a wealth of knowledge and experience,” said NCL CEO Sally Greenberg. “As a surgical oncologist, former director of the National Cancer Institute, and former president of the American Society of Clinical Oncology, Dr. Bertagnolli is the right person to oversee the NIH as this important agency serves a critical role in advancing public health.”

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About the National Consumers League (NCL)

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

NCL Health Podcast Series: Amy Hinojosa, National CEO of MANA

NCL is excited to present the inaugural podcast episode of our new Health Podcast Series under the “We Can Do This!” podcast umbrella, hosted by our Senior Director of Health Policy Robin Strongin. This month we are celebrating National Hispanic Heritage Month with our esteemed guest Amy Hinojosa, National President & CEO of MANA.

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.

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.

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.

NCL and 36 leading patient organizations urge Congress to protect access to essential laboratory tests

June 7, 2023

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831

Washington, D.C.— June 7, 2023 The National Consumers League (NCL) today sent a letter signed by 37 leading advocacy organizations, including groups that represent patients with common and chronic conditions who depend on laboratory testing to manage their health, urging Senate and House leaders to protect access to clinical laboratory services by enacting the Saving Access to Laboratory Services Act (SALSA / H.R. 2377 / S. 1000) this year.

“Without congressional action this year, Medicare reimbursement cuts scheduled for January 2024 could limit access to essential tests that 65 million American seniors rely on to diagnose and manage disease,” said Sally Greenberg, NCL Chief Executive Officer. “The Saving Access to Laboratory Services Act would help ensure robust access to laboratory services that improve patient health.”

Highlights from the letter include:

  • “Without congressional action, Medicare reimbursement cuts – a fourth round scheduled to begin January 1, 2024 – could jeopardize access to many clinical laboratory tests that are used to diagnose, monitor, prevent, and manage common diseases for Medicare beneficiaries.”
  • “Clinical diagnostic tests play a critical role in health care by informing 70 percent of medical decisions doctors and other health care providers make to care for patients. For example, in 2020 care for Medicare beneficiaries was supported by more than 17 million hemoglobin A1C tests that assessed diabetes risk, 28 million tests that diagnosed and monitored heart disease, and 90,000 tests that diagnosed leukemia and hereditary breast and colon cancer.”
  • “A strong, national laboratory infrastructure is critical to ensuring that testing can be rapidly developed and made widely available when pathogens of concern are identified. Simply put, clinical laboratories strive to be prepared for whatever the next infectious disease outbreak may be and in times of emergency are part of the nation’s critical infrastructure.”
  • “Between 2017 and 2022, payment for some common tests for diseases like diabetes, cancer, and heart disease were cut by 27 percent. The next round of Medicare cuts would lower reimbursement up to another 15 percent for about 800 laboratory tests widely used to screen and manage many serious diseases. It is essential that Congress protect patients by acting this year to fix the Medicare payment model for clinical diagnostic tests.”
  • “Because of the serious implications for patients who rely on routine as well as advanced diagnostic laboratory services, Congress has acted three times to delay these cuts in recent years, but permanent reform is needed now. Fortunately, the Saving Access to Laboratory Services Act would update Medicare’s payment system, which would help protect access to clinical laboratory testing, support investment in innovation, and strengthen America’s clinical laboratory infrastructure.”

Below is the list of signatories:

  • A Breath of Hope Lung Foundation
  • AliveAndKickn
  • Alliance for Aging Research
  • Alliance for Women’s Health and Prevention
  • American Association of Kidney Patients
  • American Sexual Health Association
  • AnCan
  • Black Women’s Health Imperative
  • CancerCare
  • Cancer Support Community
  • Caregiver Action Network
  • Caring Across Generations
  • Cholangiocarcinoma Foundation
  • Chronic Disease Coalition
  • Community Liver Alliance
  • Down Syndrome Association of Orange County
  • FORCE: Facing Our Risk of Cancer Empowered
  • Global Liver Institute
  • GO2 Foundation for Lung Cancer
  • HealthCare Institute of New Jersey (HINJ)
  • Healthcare Leadership Council
  • Healthy Men Inc.
  • HealthyWomen
  • ICAN, International Cancer Advocacy Network
  • International Foundation for Autoimmune & Autoinflammatory Arthritis
  • The Latino Coalition
  • LUNGevity Foundation
  • Lupus and Allied Diseases Association, Inc.
  • Men’s Health Network
  • Minority Health Institute
  • The National Association of Directors of Nursing Administration
  • National Alliance of State Prostate Cancer Coalitions
  • National Consumers League
  • The National Grange
  • RetireSafe
  • Triage Cancer
  • Vasculitis Foundation

Click here to view the full letter.

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