How did my medicine get here? Behind the scenes of the healthcare supply chain

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Many of us take for granted that our medicines are available at the pharmacy whenever needed…

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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.

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How to protect consumers from PBM greed

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By NCL Director of Health Policy Jeanette Contreras

The rising cost of health care is a sore point for all consumers and nowhere is it more glaring than at the pharmacy counter. However, consumers are largely unaware that Pharmacy Benefit Managers – or PBMs – are the middlemen working behind the scenes with very little competition and accountability. There are now just three PBMs that account for about 77% of all equivalent prescription claims. This lack of competition allows PBMs to easily manipulate the price and make it impossible for consumers to get a fair deal.

There is plenty of blame to go around when it comes to the rising cost of prescription drugs. But PBMs ultimately control which medicines we get (and don’t get) and how much we pay out of pocket for them. That’s exactly why the Federal Trade Commission (FTC)– whose mission is to protect consumers and competition – has requested public comments on the ways these large, middlemen companies are affecting drug affordability and access.

I recently led a discussion with key experts to discuss this issue. NCL’s Executive Director Sally Greenberg, Former FTC Policy Director David Balto, and HIV + Hepatitis Policy Institute Executive Director Carl Schmid, shared their insights with us.

David Balto explained, “There are three things needed for a market to really function effectively – you need to have choice (competition); second, transparency – that is you know what you’re getting and what the benefit of the bargain is; and third, that there’s no conflict of interest. In the PBM market, PBMs fail on all three grounds.”

PBMs initially came into existence to streamline how consumers get their medicines and were intended to lower costs. However, as Sally Greenberg pointed out, “The fact that PBMs have the influence and decision-making authority they do should be concerning for all consumers. PBMs have the power to negotiate discounts with drug manufacturers, they work with insurance companies to determine which drugs will ultimately be covered, and they work with pharmacists to reimburse them for dispensing drugs. All along the way, they’ve found ways to profit – and all along the way this impedes the savings that should be going to consumers.”

Carl Schmid shared more about how this impacts patients, “We’re now seeing the creation of specialty drugs or specialty tier (on formularies). This is a term created totally by the PBMs…now it’s just any new drug – all HIV drugs, all Hepatitis drugs, all cancer drugs – they’re all specialty drugs these days and they put them in the highest tier. And this not only creates higher out-of-pocket costs for patients, but it’s also discriminatory.”

These unfair PBM practices lead to unnecessarily high out-of-pocket costs for prescriptions while PBMs continue to find ways to game the system to their benefit. The FTC wants to hear from consumers and patients who have been negatively impacted by these PBM practices.

Watch the full discussion here to learn more about the PBM problem. Then share your story with the FTC here.

NCL Briefing: measuring the 340B program’s impact on charitable care and operating profits for covered entities

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Join the National Consumers League for a panel discussion with experts from Health Capital Group, the Community Oncology Alliance, and Johns Hopkins on this new white paper, which analyzes 340B’s impact on hospital profit margins and charitable care spending and attempts to quantify the amount of program benefits accruing to covered entities, contract pharmacies and patients.

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Why we need more Black health professionals in the workforce

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By NCL Health Policy Associate Milena Berhane

A lack of diversity in the health care workforce has been a persistent issue in the United States, posing significant implications to health equity, particularly for the Black or African American community.

An estimated five percent of physicians identify as Black, despite making up 13 percent of the U.S. population. A recent study utilizing U.S. Census Bureau information found that the proportion of Black physicians in the United States has only increased by four percent in more than a century — from 1900-2018. This study also reported that the percent of Black male physicians has remained relatively stagnant since 1940. Diversity issues also exist in other health care professions, with an estimated 7.8 percent of nurses, 3.8 percent of dentists, and 2.5 percent of physical therapists being Black.

The education, testing, application, and interviewing process required to pursue a career in health care is rigorous and costly. In addition to a four-year degree, candidates are also required to take standardized exams, pay expensive application fees, and pay for travel to interview. Most medical students expect to spend up to $10,000 for the application process. Once accepted to a health professional program, the tremendous monetary and time costs of schooling are immense obstacles for many. Medical school attendees accumulate an average $200,000 of student loans by the time they are finished with their programs.

Due to generations of systemic racism in our country, Black Americans are less resourced — financially and in terms of social capital — than their white counterparts. The rigorous process of applying to and remaining in health professional programs creates a pipeline that excludes disadvantaged students from the ability to pursue careers in clinical care.

The barriers to enter the workforce have further negative impact on communities and health equity. Black patients face a variety of issues that can influence their ability to access medical care, including medical mistrust caused by historical unethical medical mistreatment faced by Black Americans, dismissal of health concerns that Black patients express to health care providers, and others. Time and time again, Black patients have shared their experiences of medical providers ignoring their health concerns, and therefore being undertreated and going undiagnosed for their conditions. In addition, research indicates that Black patients report poorer patient-provider communication and shared decision-making. These issues lead to Black patients receiving lower quality care from medical providers, further worsening health conditions that could be treated.

Racial bias and a lack of culturally competent medical care in the healthcare system has led to poorer health outcomes for Black patients. Black Americans of all ages already face higher rates of hypertension, asthma, diabetes, and other health issues due to systemic racism and how it has affected the environments they live in, the food they have access to, their education prospects, income, etc. These inequities compiled with a culturally incompetent and bias medical system leaves Black Americans with little ability to receive proper medical treatment and improve their health and well-being. Although medical schools are attempting to teach the importance of culturally competent care, it is crucial that Black patients are also able to access healthcare providers that look like them and come from their communities.

Clearly, the current make up of racial diversity of the health care workforce has failed to keep up with the demographic shifts in the United States. Although public health efforts are important in addressing and improving health equity, inequities within the medical system must be addressed simultaneously. The COVID-19 pandemic has only highlighted and exacerbated health inequities. Increasing the amount of Black health professionals across the United States is a critical step in ensuring better health outcomes for Black patients and their overall well-being.

Illicit drugs and the digital marketplace

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By NCL Health Policy Associate Milena Berhane

Technology has brought into the homes of millions of consumers many wonderful tools for accessing the drugs and medical products we need. We, as consumers — at the touch of a few buttons — have access to drugs and devices that would have required far more time and effort to acquire in the past. But with that ease of access, we also have millions of tainted or suspect products peddled to consumers, including counterfeit drugs.

At any one time, there are 35,000 active pharmacies online, according to ASOP Global. Ninety-five percent of them do not comply with applicable laws and pharmacy standards. Counterfeit products sold by this 95 percent are manufactured in often unsafe conditions and contain little or no active ingredients.

Those in charge of online registries could better control this. These registries control the websites that can be set up on the Internet, managing domain name extensions such as .com, .gov, and .org, and .pharmacy. It is critical that Internet registries and registrars monitor the activity on their domains and ensure that illegal activity is prevented.

Consumers look for drugs online for both cost and convenience reasons. It’s understandable that consumers are turning to the Internet for cheaper options when the cost of many prescription drug costs is so high. Those who do undoubtedly don’t understand the risk of illegal online pharmacies; research shows only an estimated 37 percent see little danger in ordering from such a pharmacy. In addition, 7 in 10 Americans incorrectly believe that appearing at or near the top of Internet search results legitimizes such a website.

The COVID-19 pandemic has also played a role in these risks, with an increased sale of online goods, including prescription drugs. About 31 percent of consumers who bought prescription medication online did so for the first time in 2020 because of the pandemic. As a result, now more than ever, we need to ensure that illegitimate online pharmacies are far better regulated, and frankly, put out of business.

The examples are stark. In 2021, the Drug Enforcement Administration (DEA) seized more than 9.5 million counterfeit pills, which is more than what was seized in 2020 and 2019 combined. Due to these high numbers, in late 2021, the DEA warned that “fake prescription pills are widely accessible and often sold on social media and e-commerce platforms — making them available to anyone with a smartphone, including minors.”

We believe that online platforms have the responsibility to enforce their terms and conditions. These registries and registrars are choosing profit over safety by allowing online pharmacies to sell fake drugs and products.

For this reason, the National Consumers League is supporting the DRUGS Act (H.R. 6352/S.3399) which aims to holds Internet registries and registrars responsible for any illegal and illegitimate drugs being sold through their online platforms. Modeled after a pilot “trusted notifier” program, this bill would require registries to suspend a website, conduct an investigation, and then shut the platform down if it is found to be selling illegal substances.

In the meantime, NCL will continue to educate consumers about the dangers of counterfeit drugs. NCL’s FakeRx Action Center provides consumers with the tools to protect themselves from fake drugs and illegal online pharmacies — as well as a place to report counterfeits. Consumers have a duty to do their homework, but we have to make it far harder for fakes and counterfeits to be peddled to unwitting consumers. The DRUGS Act will go a long way to make that a reality.

NEW RESEARCH: CBD companies exploiting academic partnerships for marketing purposes

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January 20, 2022

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (412) 945-3242

Washington, DC—The Journal of Studies on Alcohol and Drugs today released new research that reveals the various tactics cannabidiol (CBD) companies use to thwart the Food and Drug Administration (FDA) review process and assert that their therapeutical claims are backed by science.

The study, The Use of Academic Research in Medical-Cannabis Marketing: A Qualitative and Quantitative Review, illuminates the need for FDA regulatory approval and stronger oversight to address the risks to consumers and patients alike when companies exploit that system. The findings reveal nearly 1,000 health claims touting CBD’s ability to mitigate symptoms or treat mental health, autism, pain, sexual health, AIDS, cancer, COVID-19, and more, providing just a snapshot of the current, unregulated marketing tactics being used to mislead the public.

The research was commissioned by Consumers for Safe CBD, a campaign spearheaded by the National Consumers League and conducted by Data Science Solutions. The research took place in the summer of 2020 and was published today in the Journal.

“It’s important that consumers understand what they’re up against when it comes to the current marketplace,” said Sally Greenberg, Executive Director of the National Consumers League. “Day in and day out we see CBD products promoted by celebrities and ‘health experts’ who have no clue what is truly in the products they push. This research helps give a snapshot of just how many misleading claims are out there and will help consumers better understand how to identify — and know to question — marketing red flags.”

“Unfortunately, many CBD manufacturers talk quite a bit about research, but have rarely engaged in the kind of large-scale randomized controlled trials necessary to establish that a drug is safe and effective,” said Theo Caputi, M.P.H, M.SC. author of the study. “CBD products are flooding the retail marketplace — readily available to consumers — and this review shows a serious need for adequate research and testing to ensure safety of these products and effectiveness for the claims companies are making.”

Most of the top medical marijuana companies analyzed:

  • use the existence of academic partnerships and observational relationships in an effort to legitimize health claims, despite having little to no clinical trial activity;
  • routinely use academic research in marketing strategies (“research as marketing”) to mislead the public; and,
  • evade FDA approval process by creating their own pseudo-approval process, making products appear legitimate, safe, effective, and eligible for insurance coverage for a range of health claims through these “research as marketing” tactics.

“It is alarming to see so many companies purposefully evading the FDA process — the gold standard in consumer protection — and making therapeutic claims with little to no real, clinical evidence,” said Greenberg. “Many of these companies have received warning letters from the FDA, yet these harmful and misleading tactics continue. It’s time for Congress to empower FDA to use its full authority to protect consumers. Consumers for Safe CBD will continue to serve as a watchdog to ensure CBD products are safe and effective.”

The CBD market continues to grow despite the FDA stating that CBD cannot be generally regarded as safe (GRAS) for use in food and beverage products. According to a Statista report, CBD sales in the U.S. reached $4.6 billion in 2020. By 2026, the market is expected to grow to $16 billion. Consumers, through these “research as marketing” tactics, have been led to believe that CBD has both medical benefits and health maintenance effects. However, there is only thorough, scientific-backed proof of medical benefits in the one and only FDA-approved CBD prescription drug product available.

“It is arguably unethical and certainly misleading for commercial entities to use the legitimacy of early scientific research — and the announcement of such endeavors — as a marketing tool,” Caputi added, “In fact, this ‘research’ used — or even simply announced in press releases — is not nearly substantial enough to ensure safety and effectiveness of these products for therapeutic use. We must rely on the rigorous FDA approval process to be sure these products meet the gold standard for safety and efficacy.”

Click HERE to read the full study in the Journal of Studies on Alcohol and Drugs.

To  learn more about the risks of unregulated CBD, visit 4safecbd.org.

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About the National Consumers League

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.

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Reason to celebrate: No more surprise medical bills in the new year!

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By NCL Director of Health Policy Jeanette Contreras

Consumers have grown to expect surprise medical bills as a given in the fragmented U.S. healthcare system. Even people with large employer-sponsored health insurance coverage could expect to receive a surprise bill for an out-of-network medical service. A 2021 report from the U.S. Department of Health and Human Services outlined how more than half of U.S. consumers reported recently receiving an unexpected medical bill — many related to essential services like childbirth, elective surgeries, or emergency services. Thanks to the No Surprises Act, signed into law as part of the Consolidated Appropriations Act of 2021, surprise medical bills will be a thing of the past.

Beginning January 1, 2022, federal protections ban surprise medical bills any time a person receives emergency care, including some non-emergency services. For example, the new law bans out-of-network charges for out-of-network providers who work at an in-network facility. It also requires that cost-sharing for emergency services, like co-pays and co-insurance, be based on in-network rates.

Healthcare providers and facilities will be required to give patients easy-to-understand notice regarding out-of-network care, explaining that it could be more expensive. Providers will also need to tell patients whom to contact if they think the provider or facility has violated the surprise billing protections. Patients will be able to dispute a claim if they receive a medical bill that is higher than the estimated cost given in advance of care.

Whether or not a patient has insurance, they can submit a complaint about a medical billing issue if they have a question or are concerned that their provider may not be following the new rules. For more help, consumers can go to the CMS.gov webpage to submit a claim online or call the No Surprises Help Desk at 1-800-985-3059, 8am-8pm ET seven days a week; (TTY: 800-985-3059).