NCL issues statement on New York Times health article on Alzheimer’s trials

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October 29, 2024

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

WASHINGTON, DC – NCL’s Health Director, Robin Strongin, released the following statement regarding Walt Bogdanich and Carson Kessler’s October 23 article, Health Section, New York Times, “What Drugmakers Did Not Tell Volunteers in Alzheimer’s Trials,” which reported that pharmaceutical companies withheld genetic testing information from volunteers in Alzheimer’s trials putting them at risk for brain bleeds.

“Medical research is complex and by its very nature involves risk. For a devastating disease like Alzheimer’s, consumers may be willing to take more of a risk in the hope of finding a treatment or a cure – if not for themselves, then for future generations.

We appreciate that researchers don’t know the full risk of a drug until tested, we are aware that genetic information can lead to certain types of discrimination, and we also understand that standards of care to disclose and not disclose information depend on multi-faceted decision points. Consumers have an absolute right to know what risks they face, including what information may be withheld, so they can make an informed decision before participating in a clinical trial—including when to opt out.

The scientific advances we witness today bring hope. Along with that hope comes the responsibility to be vigilant and assess and reassess what these advances mean for those willing to participate in clinical trials. It is imperative that we balance the integrity of clinical trials with the safety and protection of research participants.

NCL is increasingly concerned about the outsized role private equity plays in the sacred trust relationship between the research subject and the researcher. Institutional Review Boards must strive to regularly revisit their practices to reassure consumers that they, and the institutions in which research is conducted, are ethical and safe and provide all the information necessary to make truly informed decisions. It is never acceptable to put profits before safety. Clinical trials require numerous parties to come together and tackle the most vexing research challenges.

NCL calls upon all of those involved, including journalists, to provide balanced information that genuinely educate, and not terrify, the public. The last thing we want to happen is to further erode the public’s trust in science. We must all work together to safely, and ethically, find cures to dreaded diseases.”

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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.

As election looms, regulators can act now to help consumers save at the pharmacy counter

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By Sally Greenberg, Chief Executive Officer, National Consumers League

Now that we are a mere 15 days away from the election, all attention is unsurprisingly laser-focused on the outcome of the general election. Surprisingly, however, both candidates have made it clear that one of the leading healthcare issues on the ballot is the future of the Affordable Care Act (ACA). Ten years after its enactment, the ACA has become intertwined with the very fabric of the healthcare landscape in the US and thus requires federal agencies to regularly revisit the statutes to ensure it is fulfilling its original intent.

Now that the current administration has released proposed rulemaking on core provisions of the ACA, it has become more important than ever to add statutes to address a loophole in the essential health benefits (EHB) provision of the ACA. There is no better time for three federal agencies – the Department of Treasury, Department of Labor, and Department of Health and Human Services – to change language in the ACA that is constantly exploited by profit-seeking insurers, producing severe access and affordability barriers for patients and undermining the original intent of the ACA.

The loophole goes something like this: Essential health benefits are a central pillar of the ACA and provide affordability protections to Americans by ensuring that everyone in the individual and small group health insurance markets has access to coverage that actually covers the services they need. These essential health benefits fall into ten categories, one of which is prescription drugs.

If a patient pays out-of-pocket for their prescription (an essential health benefit), that dollar amount counts towards their out-of-pocket maximum. Once they hit the out-of-pocket cost maximum set by the ACA, insurance kicks in and covers the remainder of their out-of-pocket costs. However, insurers and pharmacy benefit managers (PBMs) are designating some specialty prescriptions to be “non-essential” – regardless of whether a patient needs them to stay alive. Once labeled “non-essential,” the patient is no longer protected by the out-of-pocket maximum set by the ACA.

What does this look like in practice? A patient may spend money on lifesaving medications that don’t count toward their out-of-pocket maximum. All year, a patient could pay out-of-pocket for prescriptions but never reach their maximum and see their insurance kick in. This saves a few bucks for insurers and PBMs but imposes massive financial burdens for patients who would otherwise be protected under the ACA. The EHB loophole forces patients to pay more out-of-pocket, a situation that circumvents the original intent of the law — which, as a reminder, is to keep drug costs affordable for consumers.

How can we close this loophole? The Department of Treasury, Department of Labor, and Department of Health and Human Services could act now. The tri-agencies can integrate language to close the EHB loophole into the Notice of Benefit and Payment Parameters (NBPP) to clarify that any service covered by a health plan is defined as an EHB.

Both of the frontrunners of the 2024 presidential election have signaled their intent to find solutions that lower prescription drug costs for Americans. While the country braces for the ripple effects of a new administration regardless of the results, regulators should close the EHB loophole to protect consumer access to treatments in line with the original intent of the ACA – affordable and accessible care for patients.

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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.

National Consumers League statement on FTC action against Big Three PBMs

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September 20, 2024

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

WASHINGTON, DC – The National Consumers League (NCL), America’s pioneering consumer advocacy organization, today applauds the Federal Trade Commission (FTC) for bringing action against the three largest prescription drug benefit managers (PBMs) and affiliated group purchasing organizations (GPOs). The FTC’s administrative complaint states that PBMs have engaged in anticompetitive and unfair rebate practices, inflating the list prices of insulin, lining their pockets, and transferring the costs to patients.

The following statement is attributable to NCL’s Chief Executive Officer Sally Greenberg:

“We applaud the FTC for its continued actions and investigation into PBMs. This latest action reinforces the role PBMs play in creating consumers high out-of-pocket costs of medicines consumers face. Caremark Rx, Express Scripts, and OptumRX administer four-fifths of all prescriptions within the states, and prioritizing their profits over the patients’ wellbeing directly impact why 25 percent of insulin patients are unable to afford their medication.”

The FTC’s press release about the administrative complaint can be read here.

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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.

Nancy Glick

The Obesity Bill of Rights: Priorities for government action

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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.

NCL and the National Council on Aging worked with health leaders and obesity specialists to establish a set of rights for people with obesity.

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PBMs are driving the increase in out-of-pocket healthcare costs for consumers, says NCL

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July 23, 2024

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

WASHINGTON, DC – The National Consumers League (NCL) today submitted a letter to both the Republican and Democratic chairs of the House Committee on Oversight and Accountability expressing concerns about pharmacy benefit managers (PBMs) driving the increase in out-of-pocket healthcare costs for American consumers. The letter was submitted just as the committee was conducting a hearing with top executives from Express Scripts, CVS Caremark, and Optum Rx.

The following statement is attributable to NCL’s Chief Executive Officer Sally Greenberg:

“We are concerned that these anti-consumer practices are putting the profits of insurance companies and their PBMs before patients, local pharmacies, employers, and state governments. Congress has an opportunity to review these corporate practices and work to ensure a reduced market power, thus minimizing the incentives for PBMs to steer patients towards higher-priced medicines, claim higher and higher rebates to fatten their bottom line, and ultimately driving independent pharmacies out of business.”

The full letter can be accessed here.

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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.

NCL statement on FTC interim report on PBMs

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July 10, 2024

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

WASHINGTON, DC – The National Consumers League (NCL) today applauds the Federal Trade Commission’s (FTC) interim staff report on prescription drug middlemen, pharmacy benefit managers (PBMs). The report details how PBMs profit at the expense of patients, inflating drug costs and squeezing Main Street pharmacies.

The following statement is attributable to NCL’s Robin Strongin, Senior Director of Health Policy:

“The FTC’s continued investigation into PBMs, and this latest report, shows promising momentum in addressing the high out-of-pocket costs of medicines consumers face. Countless investigations such as this, as well as news coverage, patient stories, and pharmacy closures across the country, prove again and again that PBMs are doing more harm than good. As the report shows, the vertical integration of PBMs has allowed them to rake in profits at the expense of patients and independent pharmacies.

“That said, we also recognize that this interim report and its findings don’t go far enough. It’s well past time to examine and address the overall corporatization of health care, including the vertical integration of the industry. In the current set-up, the biggest winners are the health insurance corporations that own PBMs, doctors, pharmacies and more. The biggest losers? Consumers.

“While NCL is encouraged that the FTC is working to hold PBMs accountable, we also encourage the need for meaningful reform that helps and doesn’t harm consumers.”

The full report can be accessed here.

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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

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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.

NCL submits letter to CDC urging them to make flu and COVID vaccines available at same time

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June 25, 2024

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

WASHINGTON, DC – Last week, NCL submitted comments to the Centers of Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) in response to their request for public comments in advance of the ACIP meeting being held June 26 – 28, 2024 in Atlanta, Georgia. During this meeting, ACIP will be discussing several vaccines, including but not limited to COVID-19, flu and RSV vaccines. The committee will also be voting on recommendations many of the vaccines discussed, including COVID, flu and RSV for adults.

In the comments, NCL urges that the Committee do all in its power to ensure that both flu and COVID vaccines are made available at the same time, thus allowing patients to receive both vaccinations at the same appointment. NCL also asks that ACIP review the current recommendations for the RSV vaccine, specifically the shared clinical decision-making requirement. To read NCL’s comments in full, click here.

The Advisory Committee on Immunization Practices (ACIP), which is composed of fifteen medical and public health experts and is charged with advising the CDC Director on the use of vaccines and the adult and childhood immunization schedules. ACIP meets regularly to review data, studies and proposals for vaccines, and as needed for emergency cases. Meetings are open to the public, and since COVID they have been streamed online. The June 26 – 28 meeting will be streamed online, via YouTube and is available to watch here.

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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.

Patients can’t afford Congress delaying PBM reform another year

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By Robin Strongin, Senior Director of Health Policy

As the 2024 political campaigns intensify, we’re going to be hearing a lot from candidates about what they’re going to do to make healthcare more affordable. The problem is, we’re dealing with high out-of-pocket costs right now and we shouldn’t have to wait until after another election for something to be done about them, especially when the current Congress has solutions today.

As I navigate my husband’s care through his battle with Lewy body dementia and speak to other patients and their loved ones, I have become all too familiar with the practices certain players in our healthcare system use to boost their already extraordinary profits at our expense. Pharmacy benefit managers, or PBMs, are a prime example of this and we urgently need legislation to rein in their actions that are affecting both the costs we pay for care and access to the medicines our families need.

Several committees in both the U.S. House and Senate have been working on PBM reform legislation for months and there are multiple bills that could be passed now and sent to President Biden for his signature. With the time they will be taking off for campaigning, lawmakers have very few days left that they will be in Washington, D.C. this year. It would be all too easy for them to kick this can down the road and let the next Congress deal with it.

We need to raise our voices to demand that they don’t pass on this opportunity to make a difference.

There are two elements of PBM reform that could have an immediate impact on costs and prescription drug accessibility that Congress should pass without hesitation:

  • Disconnect PBM profits from drug prices. Right now, PBMs generate revenues from the rebates they demand from drug manufacturers. The higher the drug costs, the more they make in rebates and, consequently, they steer patients to medicines that cost more and block access to lower-priced generics and biosimilars. Enough is enough. Pass legislation that will have PBMs paid a flat fee for their services and remove the perverse incentives that are forcing patients to pay more and that place financial interests between patients and their healthcare providers.
  • Mandate that the PBMs pass along those negotiated rebates and discounts to consumers. Currently, these middlemen are moving those dollars into their own pockets. These savings should be going to patients at the pharmacy counter. It’s just common sense.

These are urgent issues that affect the lives and pocketbooks of millions of Americans. Yes, it’s great that politicians are making promises about how they will fix healthcare costs next year, but we need action now. Congress must pass PBM reform legislation before they adjourn this year.