The Obesity Bill of Rights: Priorities for government action

Nancy GlickBy Nancy Glick, Director of Food and Nutrition Policy

Americans need and now have an Obesity Bill of Rights for a reason: People with obesity do not receive the same concern, level of attention, and quality care as those with any other serious chronic disease.  

Put into real-life terms: Though the adult obesity rate now exceeds 42 percent – the highest level ever recorded – obesity is still viewed as a problem of lack of willpower; too many health professionals act in discriminatory ways based on people’s size; and those seeking obesity care often face exclusions in insurance plans, restrictive practices that delay or deny treatment, or are not factored into decisions regarding medicine use.   

The consequence is that only 10 percent of people with obesity get help from medical professionals and only 2 percent of those eligible for treatment with Food and Drug Administration (FDA)-approved anti-obesity medicines (AOMs) have been prescribed these drugs, meaning the disease remains undiagnosed and undertreated. Compounding the impact, untreated obesity worsens the outcomes of more than 230 other chronic diseases, which is why obesity is responsible for as many as 400,000 Americans dying from obesity annually and costs the nation $1.72 trillion a year  in direct and indirect health expenditures – more than what Social Security paid in retirement benefits in 2022. 

It does not have to be this way. 

And this is where the Obesity Bill of Rights enters the picture. Developed by the National Consumers League (NCL) and the National Council on Aging, in consultation with leading obesity specialists, the bill of rights establishes eight essential rights with the core requirements so adults will receive the same person-centered, quality care for obesity as those with other chronic conditions. As such, the bill of rights serves as a blueprint for necessary changes in medical practice and government policy, starting with actions that can happen now. 

One immediate action item is pressing Congress to pass the Treat and Reduce Obesity Act (TROA), an important legislation that will allow more seniors to be treated with FDA-approved anti-obesity medications under the Medicare program. This matter is a high priority because obesity rates have nearly doubled among older adults to include two in every five Americans ages 65 and older. 

Another priority is ensuring that health professionals have the prescribing information to effectively treat people with obesity when they are taking drugs for other conditions, such as depression, schizophrenia, infections, and cancer. The simple fact is that certain drugs work differently in people with obesity and the consequences can be underdosing, a delay in response time, or the drug remaining in the body too long, potentially causing side effects. For example, studies show the drug brexpiprazole (Rexulti®), which treats depression and schizophrenia, takes significantly longer to reach effective levels in people with obesity – and some patients never reach these levels. Fortunately, the same research provides an improved dosing regimen so all patients with obesity can achieve efficacy. 

A different challenge involves drugs like posaconazole (Noxafil®), an antifungal often prescribed by oncologists to prevent infections. Two separate clinical trials show that obesity significantly increases posaconazole’s “half-life” – a term reflecting the amount of time it takes to rid the drug from the body. Half-life is an issue with posaconazole because many oncology medications must be delayed until the drug is out of the body’s system. Thus, if the package insert does not flag this matter when patients have obesity, doctors prescribing posaconazole may not know about the increase in half-life and start using oncology medicines too soon.  

These problems are not rare, but drug labels to guide safe and effective prescribing are dismissing people with obesity. For this reason, the Obesity Bill of Rights includes language to make accurate prescribing a requirement for receiving person-centered obesity care. Moreover, because increasing research validates the consequences of “flying blind” when drugs behave differently in the bodies of people with obesity, the obesity community is raising alarm bells, supported by a position statement from the American College of Clinical Pharmacology (ACCP), which urges FDA to close gaps in the testing and approval process for new drugs intended for use by people with obesity.  

However, because more immediate action is needed, five leading obesity organizations – American Society for Metabolic and Bariatric Surgery, the Obesity Action Coalition, the Obesity Medicine Association, the STOP Obesity Alliance, and The Obesity Society – issued a joint statement calling on drug manufacturers to update their labeling immediately to provide correct usage instructions for people with obesity when there should be a difference in dosing.  

NCL stands with the obesity community in calling for this sensible action and urges FDA to be a catalyst in ensuring that health professionals have the prescribing information needed for their patients with obesity to take important therapeutics safely and achieve the maximum benefit. For more information, visit right2obesitycare.org.

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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.

What we need now isn’t just abortion access; it’s time for a reproductive justice framework

By Sam Sears, Health Policy Associate, National Consumers League

For two years now reproductive justice – as a term, a framework, and an ideal – has been thrust into the mainstream. While those who work in reproductive healthcare access and advocacy, particularly abortion access and rights, are familiar with the term, not many people knew about it before the Supreme Court of the United States handed down its decision in Dobbs v. Jackson Women’s Health Organization. Given the most recent rulings from the Court this past month, and what’s been happening in the states in the two years since Dobbs, reproductive justice is all that more important.

So, what is reproductive justice?

It’s actually a very simple concept and framework from which advocacy work stems. Coined by Black women in 1994 before the International Conference on Population and Development in Cairo, the term mashes together reproductive rights and social justice. These women recognized that the pro-choice movement at that time was not accomplishing enough for women of color. Expanding upon the human right to maintain personal bodily autonomy, reproductive justice is often defined as the right to have children, the right to not have children, and the right to parent the children in safe and sustainable communities and environments. Thus, reproductive justice not only includes access to reproductive healthcare, such as birth control and abortions, but it also encompasses economic factors, such as pay equity, childcare costs, and more.

Since the Dobbs decision, there has been an influx of state bans on abortion at various points of gestation and with ever-varying limitations. The most common in the mainstream knowledge base would be Idaho’s ban, one of the nation’s strictest which went into effect in August 2022 (not long after Dobbs). Idaho bans abortion at 6 weeks, with minimal exceptions for the life of the mother and in cases of reported rape or incest, making it one of the most restrictive bans in the country. However, there are 15 other states with some of the most restrictive abortion bans as well.

Anti-abortion conservatives have also begun attacking other aspects of reproduction, further bringing the need for reproductive justice to the forefront. In the last two years, there has been an increase in the dis- and misinformation being spread regarding birth control – calling them abortifacients.

Now, I want to be explicitly clear here. Birth control, be it intrauterine devices (IUDs), the standard pill, or a Plan B emergency contraceptive are NOT abortion-inducing drugs. Contraception prevents pregnancy; it does not end it. Because of this misinformation, attempts to secure the right to birth control or attempts to increase access are not passing within state legislatures. And in Idaho, state elected officials are seeing are being pushed to ban access to emergency contraception and IUDs.

Let’s not forget the chaos surrounding in-vitro fertilization (IVF) because of Alabama and this state’s Supreme Court. As a reminder, in February the Alabama State Supreme Court ruled that frozen embryos are recognized as children under state law. Now the big question is whether, because of this decision, IVF is banned within the state given that not all embryos are viable after being frozen and thawed for placement. So many of the state bans on abortion also include fetuses within the definition of personhood. The impact of the Alabama IVF decision is further-reaching than just the state, especially with the nation’s patchwork web of definitions of personhood because of these bans.

Federal lawmakers have begun trying to clarify and codify access to birth control and IVF. Earlier in June, Senate Democrats hoped to bring a floor vote forward to establish the right to IVF as a method of conceiving. However, the bill, which was authored by Sen. Tammy Duckworth (D-IL), who conceived her children with the help of IVF, was blocked by the GOP because of claims of religious freedom and states’ rights concerns. Senate Democrats have also seen the Right to Contraception Act be blocked by the GOP around the same time. Missouri Sen. Hawley states that his concerns regarding the Right to Contraception Act are regarding state laws and how the bill could lead to mifepristone, one of two medications used in the abortion pill, being available in states regardless of their laws.

Last month there were two small wins within the reproductive justice space. SCOTUS had two cases before it that were related to abortion – Alliance for Hippocratic Medicine v FDA and Idaho v. United States. For the first case, the suit took aim at the Food and Drug Administration (FDA) challenging the agency’s approval of mifepristone, arguing that the FDA did not adequately consider the evidence back in 2000. SCOTUS unanimously ruled that the Alliance for Hippocratic Medicine and the other plaintiffs in the case did not have the standing to challenge the FDA. SCOTUS ruled to dismiss Idaho v. United States thus leaving in place the order that blocks Idaho from enforcing its current abortion ban, described above. In this case, the Department of Justice (DOJ) filed against Idaho, arguing that the state’s abortion ban violates the Emergency Medical Treatment and Labor Act (EMTALA).

Overall, the anti-abortion groups are expanding their work well beyond simply abortion. Thirty years ago, the Women of African Descent for Reproductive Justice recognized that the then-pro-choice movement was not enough; it left women of color and other disenfranchised women behind and out of the conversation. These women expanded their work to also include childbirth and child-rearing. With the current attacks against contraception, as well as the uncertainty and expected attacks against IVF, the pro-choice movement must expand as well. It is time for the nation to begin working toward reproductive justice.

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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.

The Pain Project: Pain management doesn’t just mean opioids*

By Sam Sears, Health Policy Associate, National Consumers League

Earlier this year, the National Consumers League (NCL) produced, as part of its health series, an episode of the “We Can Do This!” podcast focused on alternatives to opioids for pain control. In this podcast, listeners were able to hear directly from those with lived experience with opioid use disorder, both personally and as the loved one of someone with the disorder. You can listen to the podcast here. Each of the speakers on this episode was brought together, through the creation and launch of “The Painful Truth” campaign.

The campaign features a three-minute film, which features real individuals looking for pain control, discussing their options and the complications that can come with opioids. Matt Robinson, who is featured in the film and one of the speakers on our podcast, discusses his experience with opioid use disorder, and shares with NCL that his first experience with opioids for pain control was when he was 12; the result of a sports injury. Former Congresswoman Mary Bono discusses the founding of Mothers Against Prescription Drug Abuse, and her experience with a loved one who experienced opioid use disorder. Our final guest, Charlene Ng, Vice President of US Medical Affairs at Bayer, shares how recently her teenage son was offered a prescription for opioids for pain management after wisdom teeth removal.

I think it’s really important to highlight how in two of the stories the speakers shared on this episode how they or their loved one were first offered a prescription for opioids as young adults and as teens. We know we’re in a mental health, and, specifically a substance use disorder, crisis within the States, and while the overall national dispensing rate for opioids has declined between 2019 and 2022, our nation still consumes over four-fifths of the world’s opioids. Given that the US makes up less than 5% of the world’s population, that’s a truly staggering number.

Generally, we trust doctors. They’re highly educated, specialize in their field, and pledge an ethical code of conduct to ‘do no harm’. It’s understandable that when a doctor recommends something, especially a medication for pain management, there isn’t a whole lot of questioning or concern. However, opioids are not the only option for pain management that is out there and available for consumers – especially considering the significant side effects that come with such an addictive substance.

Not too long ago, in 2022, the CDC issued new and updated clinical guidelines for prescribing opioids for pain. There are 12 total recommendations for these guidelines, grouped into four categories, and I think the most important recommendations happen to be the first two related to determining whether or not to initiate opioids for pain. Regardless of the type of pain, be it chronic or acute, the CDC states that nonopioid options, both nonpharmacological and other medications that aren’t opioids, are preferred to opioid use for pain management. What really resonated with me in these is that nonopioid therapies can be as effective, if not more so, for common types of acute pain (which includes wisdom teeth removal and acute musculoskeletal injuries like common sports-related sprains and breaks). These therapies include non-pharmacological options such as heat therapy, massage, acupuncture, chiropractic care, and more, and pharmacological non-opioid options such as NSAIDs, acetaminophen, and more, depending on the cause of the pain.

In general, the most important thing for consumers to know is to talk to their doctor or health professional. Doctors work for and with us. Substance use disorder and addiction are a huge problem within the US currently, and it can be very scary to have to take a medication that can lead to that. But opioids aren’t our only option. If you are getting an opioid prescription, ask why, or ask about nonaddictive options! Make sure your health team talks to you about all the possible side effects and consequences that may develop, and if moving forward with an opioid is the right step for you.

If you or someone you know is struggling, options for treatment and help can be found on SAMHSA’s website.

*Medical Disclaimer: All information in this blog post is strictly for informational and educational purposes only.  Nothing in this post is a substitute for medical advice, diagnosis, or treatment.

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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.

Not so fast, PBMs: You aren’t fooling consumers

By Robin Strongin, Senior Director of Health Policy

A recent op-ed, “It’s Time for Facts in the PBM Debate” by the president of one of the nation’s largest pharmacy benefit managers (PBMs), is at odds with the reality of what consumers are facing when we go to the pharmacy.

In his commentary, David Joyner paints a rosy picture of how the largest PBMs lower drug prices. Meanwhile, consumers across the country are being hit with higher out-of-pocket costs and a lack of understanding about what goes into the costs for their medicines. This opaque system results in consumers running into several issues trying to access more affordable drug options.

The PBMs aren’t fooling anyone.

In Joyner’s own company, a whistleblower brought suit over the PBM’s scheme to keep lower-cost generics off its formularies for Medicare beneficiaries, pushing seniors to more expensive drugs (for which the PBM had negotiated higher profits for itself). The whistleblower said she was told by company executives that the financial benefits of this manipulation outweighed the possibility of getting caught.

More recently, community pharmacies in Iowa filed a lawsuit against CVS Health and its Caremark PBM claiming that they violated antitrust laws and illegally collected fees from pharmacies filling Medicare prescriptions. We’ve seen this behavior often force trusted, and long-established local pharmacies out of business.

What’s most concerning is that such questionable PBM behavior can have tragic results beyond pharmacy closures. In Wisconsin earlier this year, a young man with severe asthma died after he was informed at the pharmacy that his inhaler was no longer covered by insurance and he couldn’t afford the hefty out-of-pocket cost.

We can’t let this happen to another person. Consumers deserve more transparency. They deserve accountability in this middlemen PBM system. Most of all, we all deserve better than to be inundated with large PBM falsehoods.

Even as these mega-PBMs assure us that they are patient advocates, they are fighting tooth and nail in Congress and state legislatures to block measures that would take the necessary steps to ensure that consumers – and not the PBMs themselves – actually benefit.

Those are the facts in the big PBM debate.

Nancy Glick

It’s time to care about obesity care

Nancy GlickBy Nancy Glick, Director of Food and Nutrition Policy

Every year, the calendar is full of national health observances – special months, weeks and days that raise awareness of serious diseases and health issues. While all are valuable to advance the health of the Americans, Obesity Care Week taking place March 4-8 is especially significant.

Why?  Because even though the adult obesity rate now exceeds 42 percent – the highest level ever recorded – obesity is still viewed as a problem of lack of willpower, too many health professionals act in discriminatory ways based on people’s size, and those seeking obesity care often face exclusions in insurance plans or restrictive practices that delay or deny treatment.

The consequence is that that only 10 percent of people with obesity get help from medical professionals, meaning the disease remains largely undiagnosed and undertreated.

It doesn’t have to be this way. There are a variety of safe and effective treatment options. And medical societies, including the American Medical Association (AMA), agree that obesity is a complex disease requiring ongoing quality care. The key is for society – including health professionals, insurers and policymakers – to care about obesity and agree that treatment matters. Here are the reasons why.

It is long past time for health professionals, employers, insurers, policymakers and the American public to care about obesity and work collectively to break down the barriers that prevent people from accessing proper care and treatment. This is the purpose of Obesity Care Week – to shine a light on a disease that no one has wanted to talk or think about and shift the way society views obesity and treats the disease.

Obesity Care Week is also an opportunity to call attention to the first Obesity Bill of Rights for the nation, developed by NCL and the National Council on Aging in consultation with leading obesity specialists and issued in January 2024. Starting with the recognition that obesity is a treatable disease, the Obesity Bill of Rights establishes eight essential rights so adults will receive the same level of attention and care as those with other chronic conditions and have access to all treatments deemed appropriate by their health providers. Now is the time to advance changes in federal, state, and employer policies that will ensure these rights are incorporated into medical practice.

More information about the Obesity Bill of Rights is available at: www.right2obesitycare.org.

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.

Congressional briefing: The path forward for a safe cannabis marketplace

By Robin Strongin, Senior Director of Health Policy

Cannabis Consumer Watch recently hosted a briefing on Capitol Hill to educate policymakers and staff on the public health risks that exist in the current cannabis marketplace, and to offer policy solutions that would help protect consumer safety and encourage innovation for patients. The briefing was moderated by the Collaborative for Cannabinoid Science and Safety’s Libby Baney, and the panel of experts included:

Robin Stronger, Senior Director of Health Policy, National Consumers League, who explained NCL’s biggest concerns about the current cannabis marketplace. She pointed out, “Out of over 140 CD products studied by the FDA, more than half were mislabeled and nearly 40 of those products had more than 120% of the CBD level listed. Several had pesticides and even toxic mold – we just don’t know what consumers are buying. And consumers aren’t aware of the risks.”

Dale Sutherland, President & Founder, CODE 3, who shared that during his time with DC Metropolitan Police Department, they saw, “how bad distribution efforts can be – product manufacturing and transportation conditions that aren’t heavily regulated present several unique health risks.”

Sue Thau, Public Policy Consultant, CADCA highlighted the negative effects cannabis products have on children in particular, explaining, “Poison control calls related to cannabis digestion are increasing each year – and that’s just the data that we do have – there isn’t an efficient way to track all the issues parents and families face.” She provided examples of THC products that use packaging similar to popular children’s snacks or are in packaging that appeals to kids.

From consumer health to law enforcement, to concerns around youth consumption, the unique backgrounds of the panel made for a robust conversation that included multiple perspectives on the cannabis issue. To learn more about the concerns highlighted during the discussion, visit our Cannabis 101 page here.

 

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.

Nancy Glick

A message for National Minority Health Month: Take obesity seriously

Nancy GlickBy Nancy Glick, Director of Food and Nutrition Policy

As National Minority Health Month in April comes to a close, It is a good time to take stock of the health status of the more than 125 million Americans of color or 38.4 percent of the population now living in this country.

The good news is that improvements in disease prevention are saving lives. For example, more minority women are getting mammogram screenings for breast cancer, getting treatment with antibiotics earlier, and seeking counseling for smoking cessation.  As a consequence, Hispanic, American Indian, and Asian women all have lower death rates from heart disease when compared with white women and breast and lung cancer deaths have been declining steadily among African American women.

But while we can celebrate these advancements, now is the time to be even more mindful of the minority health problems that are often discounted and go untreated. And here, no problem needs our attention more than the disease of obesity, where people of color face an unequal burden of weight-related chronic conditions and premature death due to significant disparities in medical care.

In sheer numbers and its toll on death and disability, obesity has reached crisis proportions in the US. According to the Centers for Disease Control and Prevention, the adult obesity rate now exceeds 40 percent – the highest level ever recorded. And the costs are staggering.  Not only is obesity a serious disease by itself, but it worsens the outcomes of over 230 chronic conditions including type 2 diabetes, heart disease, and certain cancers. Thus, obesity is responsible for 300,000 premature deaths each year and costs the U.S. economy over $1.72 trillion annually in health costs.

But these statistics only begin to document the problem. Obesity disproportionately affects Black and Brown communities and is now one of the most serious health equity issues facing the nation. Due to higher rates of obesity among communities of color, Black adults are 1.5 times as likely to experience stroke, 40 percent are more likely to have high blood pressure and 60 percent are more likely to be diagnosed with diabetes than White adults. Additionally, Hispanics are 1.7 times more likely to have diabetes than Whites, Asian Americans are 40 percent more likely to be diagnosed with diabetes, and Native Hawaiians/Pacific Islanders are 2.5 times more likely to have diabetes and 3.9 times as likely to experience a stroke.

The threat is real, but hand ringing is not the answer. Obesity is a treatable disease, just like type 2 diabetes and hypertension. Yet obesity remains largely undertreated by healthcare providers.  As documented in a National Consumers League report issued in July 2022, 108 million adult Americans have obesity, but only 30 million adults have been diagnosed with the disease (source:  PharMetrics-Ambulatory EMR database, 2018. Novo Nordisk Inc.).

Compounding the problem, only 2 percent of those eligible for treatment with FDA-approved anti-obesity medicines (AOMs) have been prescribed these drugs. This means that very few Americans with obesity are benefiting from a new class of safe and effective medicines that control appetite and cravings to achieve significant weight loss. According to a study published in the New England Journal of Medicine, use of one of these drugs resulted in more than a 20 percent reduction in obesity when added to lifestyle modification.

While there are many reasons why obesity is going undiagnosed and untreated, the most pernicious are insurance barriers that keep people from getting the care they need. This includes government policy that allows states to define what are the essential health benefits that must be covered under any Affordable Care Act (ACA) marketplace plan sold on state health insurance exchanges. Yet, despite the ACA’s guarantees of providing all essential health benefits to consumers, a 2016 analysis by the Obesity Care Advocacy Network (OCAN) found that 24 states excluded coverage for weight/obesity management services in their benchmark marketplace plans, resulting in blatant discrimination against people with obesity.

An equally troubling situation involves the Medicare program, which prohibits coverage for FDA-approved anti-obesity medicines based on a policy dating back to 2003 when these drugs did not exist. This resistance to change leaves millions of seniors, particularly members of Black and Latino communities, vulnerable to disability, disease and premature death due to lack of treatment. Moreover, the extent of the disparities in obesity care will only get worse in the coming years if the status quo remains. As documented in a March 2023 report from AmerisourceBergen, the total number of Black, Native American, Asian, and Hispanics eligible for Medicare is predicted to more than double by 2038, many of whom will have obesity and a different set of chronic conditions than what Medicare is currently prepared to address.

Then, there is the Medicaid program operated by the states, which covers about three in ten Black, American Indian and Native Hawaiians/Pacific Islanders under age 65 and more than two in ten Hispanic adults. While Medicaid has helped narrow longstanding disparities in health coverage and access to care for people of color, this is not true for those Medicaid beneficiaries living with obesity. Today, only 15 Medicaid programs cover anti-obesity medications in fee-for-service Medicaid, and only four additional programs cover anti-obesity medications under at least one Medicaid managed-care plan. Moreover, only two states cover anti-obesity medications in benchmark Marketplace plans.

Adding to these coverage disparities, 15 million people on Medicaid – 30 percent of whom are Hispanics and 15 percent are African Americans  – could lose access to their health coverage in the coming months. This is due to the end of a federal program that paid states to add more low-income and disabled residents to the Medicaid rolls during the COVID-19 pandemic.

Already, five states – Arizona, Arkansas, Idaho, New Hampshire, and South Dakota – have begun to disenroll people and by the end of June, 34 states and the District of Columbia will cut their Medicaid rolls, either due to their income status or for procedural reasons, such as not completing renewal forms. For this reason, advocates are using all available levers to help enrollees keep their Medicaid coverage and to assist those dropped from the program to find coverage through the Affordable Care Act’s marketplace or other options.

While this is a short-term solution, it is part of the national commitment by the public health community, minority health leaders, clinicians, patient advocates, and consumer organizations to change outdated and discriminatory policies that restrict coverage and access to obesity treatments. Our message is clear: the health of all Americans depends on taking obesity seriously and ensuring that those with the disease receive timely, comprehensive obesity care.