Congressional briefing: The path forward for a safe cannabis marketplace

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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

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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

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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.

It is time to give Medicare beneficiaries effective obesity care

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Sally Greenberg

By Sally Greenberg, Chief Executive Officer

“What we’ve got here is a failure to communicate.”

As one of the most recognized quotes of all time, this line from the 1967 movie, Cool Hand Luke, originally addressed the struggle of a person’s will over government control.

Now the line is applicable to another and equally intractable struggle: ending outdated Medicare rules that leave millions of seniors with diagnosed obesity – particularly members of Black and Latino communities – vulnerable to disability, disease and premature death due to lack of access to the full range of treatment options.

The struggle is not new. As documented in a 2010 report from the US Surgeon General, the prevalence of obesity began to increase sharply in the 1980s and by the 1990s, public health leaders were calling obesity a national emergency. Now, the obesity rate among adult Americans exceeds 40 percent but is even higher among communities of color: virtually half of African Americans (49.6 percent) and 44.8 percent of Hispanics are living with obesity. Moreover, because obesity is directly linked to over 230 medical conditions, the disease is responsible for an estimated 400,000 deaths a year, costing the nation over $1.72 trillion annually in direct and indirect health costs.

Confronting this growing crisis, in 2012, the United States Preventive Services Task Force (USPSTF) issued guidelines recommending screening all U.S. adults aged 18 and above for overweight and obesity and encouraging clinicians to treat or refer adults with obesity for treatment. Then, in 2013, the American Medical Association officially recognized obesity as “a disease state” on a par with other serious chronic diseases, like type 2 diabetes and hypertension, so healthcare professionals (HCPs) would be motivated to diagnose, counsel and treat obesity. These actions were the impetus for most private insurers, state health plans and state Medicaid programs to cover obesity care to some degree. Moreover, the Office of Personnel Management, which oversees health coverage for federal employees, now requires that insurers cover the full range of obesity treatment options, including intensive behavioral therapy (IBT), prescription weight loss drugs, and bariatric surgery. Additionally. Tri-Care, which covers military personnel and their families, and the Veterans Administration cover AOMs for adults who do not achieve weight loss goals through diet and exercise alone.

This leaves the Medicare program, which today represents the biggest obstacle impeding access to quality obesity care. Outdated Medicare Part B policy places undue restrictions on intensive behavioral therapy by allowing only primary care providers to deliver IBT and severely restricting the physical locations where this care can occur. Equally troubling, new FDA-approved anti-obesity medications (AOMs) are excluded from Medicare coverage based on a statutory prohibition tracing back to the start of the Part D program. This was in 2003 when fen-phen (the drug combination of fenfluramine and phentermine) controversy raised questions about the safety of weight loss drugs, leading the Centers for Medicare and Medicaid Services (CMS) to classify these medicines as “cosmetic” treatments not eligible for coverage, just like hair loss drugs and cold and flu treatments.

But obesity medicine has improved substantially since 2003. Due to the latest science on obesity as a serious chronic disease, there have been major advances in drug development, including new anti-obesity medications that achieve meaningful weight loss. Yet, while science has moved forward, CMS policy is stuck in the past.

To change this situation, advocates have gone to both Congress and CMS for help. In Congress, public health and aging organizations have been working to pass bipartisan legislation called the Treat and Reduce Obesity Act (TROA) that would end the exclusion under Medicare Part D prohibiting coverage for AOMs and change Medicare Part B rules to permit all qualified health practitioners to provide Intensive Behavioral Therapy (IBT) to Medicare beneficiaries. With CMS, advocates have written to and met with key staffers on several occasions, urging the agency to use its inherent authority to allow flexibility to include drugs under Part D that might otherwise be excluded. One key argument is that CMS has already done this on multiple occasions, ending exclusions for treatments for AIDS wasting and other medical conditions when it is urgent to do so.   And yet, ten years have passed since AMA classified obesity as a chronic disease with no action from either Congress or CMS. In Congress, TROA did not receive a floor vote in the House of Representatives in 2022 despite having 154 co-sponsors and widespread support from medical societies, public health organizations and the aging community. Similarly, CMS has kept the exclusion on coverage for anti-obesity medications, even though the Biden Administration has asked for ways to address systemic racial inequity and obesity is a throughline to better health outcomes.

To start a dialogue that could lead to meaningful action, the National Consumers League and the National Council on Aging decided to change the dynamic. In September 2022, our organizations sent an urgent letter to CMS Administrator Chiquita Brooks-LaSure requesting a meeting so we could speak to her directly on behalf of  about 18 million traditional Medicare beneficiaries whose diagnosis of obesity puts them at risk of other serious conditions. Our letter was well received and on January 17, this meeting took place.

Recognizing that there has been a “failure to communicate” the urgency of the moment, our purpose was to put a human face on seniors with obesity and to convey that bureaucracy and intransigence cannot be the reason that 18 million older adults are denied effective obesity care. As such, we asked Administrator Brooks-LaSure to end the impasse in Part D coverage of FDA-approved AOMs by making access to obesity treatment an agency priority. This action could be the catalyst empowering CMS staff to think differently about obesity and be more open to interpreting the statutory exclusion provision in a way that would permit coverage for anti-obesity medications.

It is too soon to know what the outcome of the meeting will be. We opened a door and pledged to maintain a frank and constructive dialogue with Administrator Brooks-LaSure and staff she designates on the needs of Medicare beneficiaries living with obesity. Our hope is to elevate obesity as a priority for CMS policy and to work with CMS and other stakeholders to remove the access barriers that keep too many Americans from seeking obesity care.

Nancy Glick

Alcohol labeling: We’re in it to win it

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Nancy GlickBy Nancy Glick, Director of Food and Nutrition Policy

For historians, 2003 will be remembered as the year that the space shuttle Columbia crashed, scientists finished sequencing the human genome, and the U.S. launched war against Iraq.

But 2003 also marks an important milestone for American consumers. In December of that year, three national consumer organizations – the National Consumers League (NCL), Center for Science in the Public Interest (CSPI), and the Consumer Federation of America (CFA) – first petitioned the federal government to require an easy to read, standardized “Alcohol Facts” label on all beer, wine and distilled spirits products. This sparked a 19-year battle that is finally paying off for the estimated 67 percent of Americans[1] who drink alcoholic beverages.

In 2003, the Nutrition Facts label on processed foods and non-alcoholic beverages had been in use for almost a decade (1994) and many consumers said they frequently or almost always read the label. Thus, public acceptance and use of the Nutrition Facts label created built-in public support for an Alcohol Facts label. In fact, polling NCL commissioned in both 2005 and 2007 showed overwhelming public support for comprehensive alcohol labeling. Now, polling consistently shows that 75 percent of Americans think alcoholic beverages should have standardized alcohol content labels and 72 percent say this labeling will encourage responsible alcohol use.

Even more significantly, not knowing what is in a beer, wine or distilled spirits drink increases the risk for overconsumption of alcohol, a serious and costly public health problem. According to the latest research findings, alcohol is a source of empty calories that contribute to obesity,[2] and can impact blood sugar control in people with diabetes.[3] Additionally, alcohol is a roadway killer accounting for about 30 percent of all traffic crash fatalities in the U.S.,[4] and excessive drinking increases the risk of liver disease, hypertension, cardiovascular disease, alcohol use disorders, certain cancers and severe injuries.[5] Consequently, an estimated 140,000 people in the United States die annually from alcohol- related causes,[6] which is why the cost of excessive alcohol use reached $249 billion in 2010 and is likely higher today..[7]

Based on this documented evidence, the 2003 petition, which was also signed by 73 nutrition/public health organizations and experts, called for a label that gives consumers the needed information to make responsible drinking decisions, such as the serving size, amount of alcohol and calories per serving, the percent alcohol by volume, and the number of standard drinks per container. And yet, the lead federal agency that regulates alcoholic beverages – the Alcohol and Tobacco Tax and Trade Bureau (TTB) – deliberated but failed to take meaningful action for almost two decades.

The arcane process started in 2005 with an advance notice of proposed rulemaking, which produced over 19,000 public comments. In 2006, TTB issued another notice of proposed rulemaking on allergen labeling followed by a notice in 2007 on alcohol and nutrition labeling. Unfortunately, however, TTB allowed these proposed rules to languish, ultimately deciding in 2013 to issue a voluntary rule allowing companies to decide what nutrition and calorie information to disclose – and what to keep hidden. Not surprisingly, many manufacturers opted out of TTB’s program so most alcoholic beverage products on the market remain unlabeled or carry incomplete information.

Even with these setbacks, the consumer community kept up the pressure on TTB because the need for alcohol labeling has only increased. This became apparent during the COVID-19 pandemic when a 2020 RAND study charted a 14 percent increase in alcohol consumption among adults over age 30 in one year.[8] Another national study found that excessive (binge) drinking increased by 21 percent during the pandemic, with the potential for 8,000 additional deaths from alcohol-related liver disease by 2040.[9]

And then, the sand started to shift. Also related to the pandemic, consumer demand skyrocketed for hard ciders, some types of beers, wine coolers and the other low-alcohol drinks sold in supermarkets and convenience stores and what consumers saw were complete alcohol labels on these products. This is because low-alcohol drinks fall under the purview of the Food and Drug Administration, not TTB. Armed with this evidence, NCL leaders met online with Department of Treasury and TTB officials in June 2021 and put TTB in the uncomfortable position of having to explain why often the same manufacturers who must put a standardized content label on brands regulated by FDA don’t bother to do so when their products are under TTB’s jurisdiction.

Not long after this meeting, the Treasury Department conducted its own review and on February 9, 2022, issued a report, Competition in the Markets for Beer, Wine and Spirits, that advanced the importance of labeling information to foster competition within the beverage alcohol industry. The report contains several recommendations, including the recommendation that “TTB should revive or initiate rulemaking proposing ingredient labeling and mandatory information on alcohol content, nutritional content, and appropriate serving sizes.”

This was encouraging news, so NCL doubled down, combining forces with CSPI and the Consumer Federation of America to get TTB to mandate alcohol labeling across the board. Recognizing that public pressure alone will not ensure success, the organizations turned to Congress, hosting briefings for lead staffers of the House and Senate appropriations committees with jurisdiction over TTB’s budget and sending a joint letter to key Congressional leaders from 23 consumer, health/nutrition, and alcohol policy organizations about the need for mandatory alcohol labeling. This led to report language in the draft House and Senate 2023 appropriations bills that encourages TTB to initiate a final rulemaking.

The last step was filing a lawsuit against TTB in the United States District Court for the District of Columbia on October 3, 2022, asking the court to direct TTB to grant or deny the 2003 petition within 60 days. The lawsuit was a gamble, but it worked: on November 17, 2022, TTB accepted the 2003 petition and committed to publish three rulemakings covering mandatory nutrient and alcohol content labeling, mandatory allergen labeling, and mandatory ingredient labeling within the next year.

However, this is not the end of the story. The proposed rules will be accompanied by open public comment periods where we can anticipate that segments of the alcohol industry will be aggressive in fighting robust consumer labeling.  Therefore, NCL will also be actively engaging a wide range of stakeholders to weigh in on behalf of consumers so the American public to have access to standardized and complete labeling information on beer, wine and distilled spirits. It has taken 19 years to get to this point, but our message is clear: alcohol labeling is long past due, consumers overwhelmingly want to see it, and we will stay in the fight until alcohol labeling is a reality.

[1] Gallup. Alcohol & Drinking. July 2022

[2] U.S. Department of Agriculture and U.S Department of Health and Human Services. Dietary Guidelines for Americans, 2020-2025. 9Th Edition. December 2020.

[3] Emanuele NV, et al. Consequences of Alcohol Use in Diabetics. Alcohol Health Res World. 1998; 22(3): 211–219.

[4] National Highway Traffic Safety Administration. Risky Drunk and Drugged Driving Statistics.

[5] U.S. Centers for Disease Control and Prevention. Alcohol and Public Health. Last reviewed April 14, 2022. https://www.cdc.gov/alcohol/fact-sheets/alcohol-use.htm

[6] U.S. Centers for Disease and Control Prevention. Deaths from Excessive Alcohol Use in the U.S. Page last reviewed April 14, 2021. https://www.cdc.gov/alcohol/features/excessive-alcohol-deaths.html . Accessed June 2, 2022.

[7] U.S. Centers for Disease Control and Prevention. Alcohol and Public Health. Page last reviewed April 14, 2022. https://www.cdc.gov/alcohol/features/excessive-drinking.html. Accessed June 2, 2022.

[8] Pollard MS, et al. Changes in Adult Alcohol Use and Consequences During the COVID-19 Pandemic in the US. JAMA Netw Open. 2020;3(9):e2022942.

[9] Julien J, et al. Effect of increased alcohol consumption during COVID-19 pandemic on alcohol-associated lover disease: A modeling study. Hepatology. Vol. 75; Issue 6; June 2022; 1480-1490.

Promising new therapies are giving hope to Alzheimer’s patients and families, so why limit access?

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Sally Greenberg

By Sally Greenberg, Executive Director

For years, Alzheimer’s patients, families, and caregivers have battled a condition with no treatment options. This year alone, an estimated 6.5 million Americans age 65 and older are living with Alzheimer’s.

The good news is, we’ve recently seen remarkable progress in the fight against Alzheimer’s disease as innovative treatments demonstrated the ability to halt disease progression in a major clinical trial and proved to curb cognitive decline. These therapies targeting the buildup of amyloid beta plaque in the brain (one of the telltale signs of Alzheimer’s) have shown promise for so many patients and families facing this fatal diagnosis.

The first such therapy was approved by the U.S. Food and Drug Administration (FDA) in June of last year. This should give us all hope for a brighter future, but this progress may be moot if regulatory barriers hinder patient access.

Rather than ensure broad coverage through the Medicare program – as is the case for nearly every other type of drug that receives FDA approval – the Centers for Medicare and Medicaid (CMS) decided this spring to restrict access to these new Alzheimer’s treatments only to patients participating in approved clinical trials. This puts severe limitations on coverage for an entire class of innovative Alzheimer’s disease treatments, with CMS in direct conflict with the FDA, whose medical experts approved the drug as safe and effective.

In fact, this puts the FDA’s entire accelerated approval pathway in the crossfire, sounding an alarm to millions of patients hoping for medical breakthroughs.

No one is arguing the therapy is a miracle cure, but that’s not how new therapies tend to work. History has shown that when it comes to serious conditions with high unmet medical needs, even small improvements are critical.

Accelerated approval first surfaced during the AIDS crisis, when HIV was a death sentence and there were no treatments. AIDS advocates demanded something – anything — despite minimal benefits “because we have nothing now and no hope.” The first AIDS treatments in the 1980s were grueling regimens with serious side effects, but they had to start somewhere. Today, as medicines have evolved, HIV-positive patients require one pill a day and can live with the disease.

The same is true for Duchenne’s Muscular Dystrophy, a terminal disease that lands young boys in wheelchairs often before they reach 10 years old. Approval of the first drug to treat Duchenne’s met significant controversy in 2016 because it was minimally effective. Yet, the FDA approved it because these patients had no hope. Today there are five treatment options for the disease that slows down the progression and buys time.

And in 2001, a game-changing therapy for chronic myeloid leukemia received approval; the treatment helped to spur innovation in what became targeted therapies for cancers.

The science and medical ecosystem will continue to naturally progress, moving us from zero treatment options to medicines that mitigate symptoms, to treatments that halt disease progression, and eventually, cures. This is true in the Alzheimer’s space, but by limiting access to an entire class of Alzheimer’s treatments, CMS is putting future scientific breakthroughs at risk and creating a ripple effect throughout the entire healthcare system. This new promising drug class will only be available to those with the financial wherewithal to pay thousands of dollars out of their own pockets.

With this precedent, any drug that emerges from the rigorous development pipeline could be deemed too expensive or too early in the discovery phase. CMS acting as the final arbiter on what new treatments will be made available and overriding the scientific judgment of FDA experts should concern all of us.

As we look ahead toward a new Congress, our lawmakers can and should put pressure on CMS to keep pace with the science and give hope to Alzheimer’s patients and families.

Jeanette Contreras portrait

Leaders in Congress support safe OTC hearing aid standards

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By NCL Director of Health Policy Jeanette Contreras

Mild to moderate hearing loss is a difficult reality that millions of Americans struggle with, which is why the availability of over-the-counter (OTC) hearing aids is exciting for those who are impacted by hearing loss. While making OTC hearing aids more accessible is a promising step for consumers, we at NCL would be remiss if we didn’t underscore our concerns around the Food and Drug Administration’s (FDA) proposed OTC hearing regulations as they currently exist.

In December of last year, NCL was one of hundreds of organizations who submitted a comment to FDA’s public docket on the issue; and last month we submitted a letter voicing our concerns to the FDA that was supported by 29 not-for-profit, public health organizations across the country. These organizations collectively represent the concerns of millions of consumers, patients, and individuals impacted by hearing loss.

We want to reiterate our enthusiasm for OTC hearing aids, but as the gold standard of safety in our country, it is imperative that the FDA make sure these devices are safe for consumers and do not worsen a problem they are intended to mitigate. As written, the draft regulations would allow for a maximum sound output level of 120 dBA – equivalent to the volume of a chainsaw or fire engine siren. This is concerning, as exposure to sounds at 120 dB can be dangerous in as little as nine seconds according to the CDC. This is why NCL, along with other leading consumer and healthcare voices, encourage the FDA to follow the recommendations of hearing care professionals, including the American Academy of Otolaryngology–Head and Neck Surgery that recommend a maximum output of 110 dB and a gain limit of 25 dB. Without a limit on gain, OTC hearing aids users will be able to amplify sounds to dangerous levels, and far beyond what Congress authorized when it said these devices must be limited to adults with moderate hearing loss or less.

The safety parameters we are recommending would in no way compromise the efficacy of OTC hearing aids intended for individuals with perceived mild to moderate hearing loss. In fact, a recent study concluded that commercially-available hearing aids programmed according to parameters typical of those used for individuals with mild to moderate hearing loss yield effective output and gain levels and are within the recommended limits specified by leading hearing care organizations and medical experts.

Importantly, the FDA has already cleared several hearing aids for adults with perceived mild to moderate hearing loss that were found to be safe and highly effective during clinical trials. While these devices were authorized under a different category of hearing aids, these devices limit the maximum output to 115 dB or below and gain to 30 dB or less, lower than the amplification limits currently proposed by the FDA. At the very least, the FDA should incorporate these amplification limits in the final OTC hearing aid regulation.

Finally, as we await finalized guidance from the FDA, we applaud leaders in Congress who are standing behind consumers in supporting safe and effective amplification limits. Last month, Congresswoman Betty McCollum (D-MN) and Congresswoman Rosa DeLauro (D-CT) sent a letter to the FDA echoing their safety concerns. The letter states, “[The proposed rule] hurts consumers and patients in two ways. First, it means individuals suffering from greater levels of hearing loss could put off a needed visit with a licensed hearing professional. Doing so could lead to worsening their existing symptoms, delaying an accurate diagnosis and treatment, and even creating irreparable damage to their hearing. Secondly, it means those with perceived mild-to-moderate hearing loss would be exposed to harmful levels of noise that could result in further damage to their long-term hearing. In order to avoid these concerns, FDA should impose a gain limit of 25 dB and an overall output limit of 110 dB.”

Similar to the countless other experts that have also weighed in, we believe that establishing safe amplification limits would not reduce the efficacy of these devices or limit the advancement of innovative technologies. We thank Congresswomen McCollum and DeLauro for being a voice for consumers and patients on this important issue. To learn more about gain and output and how to protect yourself from hearing loss, check out our infographic.

The decline in COVID-19 testing nationwide could derail pandemic response wins

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

COVID-19 testing has been a critical component of the nation’s pandemic response, as health officials monitored the virus’s progression and set policies that supported back-to-school and return-to-work initiatives. Increased testing capacity has enabled our most essential industry sectors to resume activities that continue to carry us through the pandemic. However, as vaccines become more accessible and we surpass initial goals for population-wide immunizations, testing has declined by 35 percent daily since mid-January.

Testing provides a reliable snapshot into the virus’s trajectory that allows for proper allocation of vital resources (e.g., supplies, personal protective equipment (PPE), and medical equipment) and essential personnel. Data from testing rates are also critical for vaccine manufacturers, as they evaluate how the virus is mutating and further efficacy of the vaccine. The uptick in vaccinations, while incredibly promising, may have induced an inflated sense of security and diminished caution towards the virus. However, in the midst of rising variants, the decline in testing may very well be the Trojan horse that derails national efforts to combat the virus.

Testing has also declined in part due to a shift in focus to getting vaccinated. While vaccines are equally important, we need adequate COVID-19 testing for public health surveillance purposes. There needs to be sufficient capacity and public health messaging in place to encourage individuals who have potentially been exposed to SARS-CoV-2, or coronavirus, to get tested immediately.

Dr. Nasia Safdar, Medical Director for Infection Prevention at UW Health, states “we are seeing a decline in testing,” she said. “If we see the numbers continue to decline sharply, at some point then it may not be worthwhile to do widespread testing, but we’re certainly not there yet.” Without these measures, our healthcare system will be rendered unequipped to deal with dormant and emerging threats, like potential outbreaks and continuous mutations of the virus.

There are a couple of strategies that could help us get a hold on precipitous testing rates. It is estimated that a national program for universal mass testing for unvaccinated people would cost a few billion dollars a week—an amount that still presents a cost-benefit when considering potential shutdowns. The American Rescue Plan has appropriated $50 billion for expanded testing, which could help the situation significantly.

Another aspect of the problem is a lack of testing sites. With so many resources currently devoted to expanding vaccination sites at pharmacies and hospitals, people need places to get tested. Greater corporate involvement in the response could be a potential avenue for increasing capacity.

Finally, the Food and Drug Administration (FDA) is working to advance development and approval for over-the-counter (OTC) and point-of-care (POC) tests. Obtaining a greater number of FDA-approved OTC and POC COVID-19 tests could help address issues with logistics and access, and would give schools, workplaces, and communities more options for reliable and accurate screening.

The pandemic is far from over and experts predict that COVID-19 will likely be endemic, meaning it will be detected regularly, even if within small pockets of the population. We need all possible public health interventions at our disposal to ensure that we can effectively limit the spread of the virus and preserve ongoing plans to reopen the economy so that we can start the process to sustainably reintegrate back into society.

Dr. Safdar further emphasized, “the vaccines are great as they are, they’re not 100 percent. There will be a certain number of people that will…contract the illness despite having been vaccinated. It might be a milder condition which is very welcome news, but nonetheless, to make a diagnosis and figure out what treatment is required, you have to get a test.” Testing continues to be a simple, yet powerfully effective measure to prevent the massive spread of COVID-19 and we must persist in our efforts towards early detection.

Addressing health inequity: A critical step towards a successful national vaccine rollout strategy

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

The COVID-19 vaccines have provided much needed doses of hope as consumers eagerly wait for their shots. However — due to competing pressures of managing inadequate supplies, complex state-managed distribution plans, emerging viral variants, and unaddressed health disparities — the national vaccine rollout has fallen short of its intended goals.

To date, more than 40 million have received at least one dose of a COVID-19 vaccine, and 16+ million people are currently fully-vaccinated. On average, providers around the country are administering 1.6 million doses per day. According to experts, 70 to 90 percent of the population will need to be vaccinated if we are to achieve herd immunity and return to normal everyday activities.

The delays in the vaccine rollout have been attributed to variations among states and territories, which have been expected to set their own distribution plans and eligibility criteria. All states have made the vaccine available for healthcare workers, and nearly 43 states and the District of Columbia have expanded their eligibility to include occupation-based vaccination programs. These include members of the non-medical essential workforce, like grocery store employees and police officers.

While vaccine hesitancy among some Americans remains a problem, it’s becoming less of a concern as more and more people are getting vaccinated. COVID-19 has further exposed both vulnerabilities in our infrastructure and social determinants of health — conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect their overall health — that threaten to impede access. Throughout the rollout, vulnerable communities have experienced barriers in booking vaccine appointments due to limited access to broadband, phones, and accessible, affordable transportation.

Vaccine hesitancy and social determinants of health remain the primary obstacles in the rollout process. Going forward, addressing health disparities will be a critical strategy in realizing a successful national response, because — without health equity — the virus will continue to ravage the most vulnerable communities. The National Consumers League supports comprehensive strategies to address the glaring disparities in health and access that COVID-19 has exposed.

What the new COVID-19 variants mean for consumers

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

Viruses mutate, and SARS CoV-2—more commonly known as COVID-19—is no exception to that rule. When a virus evolves and mutates from its predominant virus, all that we know about it changes as well. It may be too soon to glean what impact the variants could have on vaccine rollout and efficacy, but the Centers for Disease Control and Prevention (CDC) have provided the detailed evidence they’ve uncovered thus far.

Three new strains of COVID-19 have been identified presently in four countries: the United Kingdom (B.1.1.7), Japan and Brazil (P.1), and South Africa (B.1.351). These new variants have not been observed to be more deadly, nor have they made people sicker, but one thing they all have in common is that they are more contagious than COVID-19. Cases for these strains have been found in 33 countries, including the United States.

While the variants all differ slightly in their function, they all possess a specific mutation called D614G — a shared trait that allows these new strains to spread more quickly than the predominant virus. The strain found in the United Kingdom, B.1.1.7, has an estimated 50 percent transmissibility rate, or how quickly it spreads from person to person. Considering ongoing efforts to release new vaccines for inclusion in a national rollout to curb this pandemic, a mutating virus presents unique challenges for an already overburdened healthcare system.

So, what does this mean for travel, testing, vaccines, and so on? The CDC has released a helpful questionnaire for individuals to consider before they pursue travel, requesting that people delay non-essential travel whenever possible. For those that plan to travel, the CDC has released guidance which states that individuals traveling via air into the United States must provide proof of a negative test result or documentation of recovery, before boarding their flight. Masks are required on all forms of public transportation, including planes. The CDC has issued travel notices regarding global travel and each country’s corresponding risk-level.

Scientists are continuously gathering data to determine how the variants will impact the efficacy of certain therapies, vaccines, and tests. Until further evidence suggests, states are reluctant to enforce stringent lockdown procedures. According to public health experts, the best way to rein in the transmission of these highly contagious variants and to ensure a successful vaccine rollout, is to practice physical distancing and double masking. Layering two masks, as double masking suggests, provide added layers of protection and a better-fitting face covering. Not all masks are equal. To learn more about how to maximize protection against the coronavirus with masks, click here.

As new information emerges, it is important to adjust our safety measures to successfully navigate an ever evolving situation. Consumers are understandably experiencing pandemic-fatigue. Rest assured that the fruits of our collective efforts are closer than they appear, if only we work together towards protecting ourselves and our communities from unnecessary transmission.