Oral argument for ACA case will determine the fate of millions

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Nissa ShaffiOn Tuesday, July 9, the U.S. Court of Appeals for the 5th Circuit will hear oral arguments that will determine whether or not the Affordable Care Act (ACA) may be overturned. Throughout the course of its life, the ACA has been under the specter of possible repeal. While there have been piecemeal attempts to strike down the legislation over time, none have been as concerning as the most recent Texas v. United States case, which argues that since the individual mandate is no longer enforced, ACA  would be unconstitutional.

The individual mandate requires that most people maintain a minimum level of health insurance or be subject a financial penalty. In 2017 however, the Tax Cuts and Jobs Act (TCJA), set the individual mandate to $0 as of 2019. As a result of this ruling, the Texas v. United States case was filed by 20 Republican state attorneys general and governors. The plaintiffs argue that the ruling rendered the individual mandate futile, as it no longer produces revenue for the federal government, and since Congress declared the individual mandate to be “essential” when enacting the ACA, this would now make the entire law invalid.

In an ideal situation, the court would maintain the ACA as it exists today, absent the individual mandate. If the ACA is repealed along with the protections that come with it, close to 20 million people would lose their health coverage. Those affected will include mostly low-income adults and children with chronic or pre-existing conditions, dependent adult children ages 26 and younger, Medicare and Medicaid enrollees, employer and employee groups, and more.

Repealing the ACA would jeopardize Medicaid expansion, further burdening uncompensated care and provider reimbursement. In addition, repealing the ACA would increase health care costs among the uninsured by $50.2 billion, result in more than 9 million people losing federal subsidies to purchase health insurance via the marketplace, and would endanger consumers’ ability to obtain essential health benefits.

California’s Attorney General, Xavier Beccerra, is leading a coalition of 21 Democratic attorneys general who have intervened to defend the ACA. Advocates interested in joining these efforts can contact izzy@xavierbecerra.com – please do so and sign the petition by July 14. In addition, organizations can participate in the TXvUS Tweetstorm to express their concerns regarding this case, using the hashtags #TXvUS and #WhatsAtStake, on July 9th at 2 pm EST/ 11 am PST.

NCL is a zealous supporter of the ACA and notes that it is still the law of the land. We are following the developments of this case closely and will continue to fight for access to affordable healthcare for all Americans. For more information on developments of this case, please click here.

FDA acts to protect women’s health

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Nissa Shaffi

Last April, the U.S. Food and Drug Administration (FDA) issued a ban on all sales of pelvic surgical mesh products after determining that the manufacturers, Boston Scientific and Coloplast, failed to “demonstrate [a] reasonable assurance of safety and effectiveness.”

The ban comes on the heels of a 2016 reclassification of the product by the FDA, resulting in a class III (high-risk) designation. As a result, the manufacturers were required to undergo meticulous review and obtain premarket approval by the FDA in order to continue sales of their products in the United States.

A surgical mesh is a medical device used to treat urogynecological or pelvic organ issues. Most commonly, surgical mesh has been used to treat pelvic organ prolapse (POP). POP is a type of pelvic floor disorder that occurs when the muscles and tissues supporting pelvic organs become weakened–often resulting in urinary incontinence typically seen as a result of childbirth or advanced age.

A transvaginal surgical mesh is intended to provide additional support to the pelvic floor muscles to reinforce a weakened vaginal wall for treatment of POP. A urethral sling surgical mesh is supposed to provide support to the urethra or bladder to address urinary incontinence. Surgical mesh comes in two forms: synthetic and animal derived. Synthetic surgical mesh remains in the body indefinitely and acts as a permanent implant. Animal derived mesh, made from the intestine or skin of pig or cow, are absorbable and lose durability over time.

The most frequent complications from these devices include vaginal scarring, mesh erosion, increased risk of infection, and painful urination. Nearly 10 million women worldwide have received mesh implants, with about 10 to 15 percent of these women suffering from complications. Following the ban, there are currently no FDA-approved pelvic surgical mesh products available for sale in the United States.

The FDA advises that women who have already received a transvaginal mesh for the surgical repair of POP should continue their routine follow-up care with their provider and need not take any additional action if they are satisfied with their procedure. Patients should notify their provider if they experience any adverse reactions, such as bleeding or pain, following the procedure.

Given the grave injury these devices have caused in women patients, the National Consumers League questions how they ever received FDA approval in the first place. Nevertheless, banning the devices now is better than keeping them on the market. We must expect better from our healthcare regulators. Thankfully, we now have stronger safety standards that have brought an immediate halt to the sale of these unsafe medical devices.

To read the FDA’s full report on transvaginal mesh, click here.

NCL Health Policy Intern Alexa Beeson contributed to this blog.

NCL statement on ACIP pneumococcal vaccine recommendation decision

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June 26, 2019

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC—The National Consumers League (NCL) presented testimony at the Centers for Disease Control’s (CDC) vaccine committee today in Atlanta, GA in support of keeping an important vaccine to prevent pneumococcal disease on the schedule of recommended vaccines.

“We commend the Advisory Committee on Immunization Practices (ACIP)’s 2014 recommendation for coverage of the pneumococcal vaccine. However, we are disappointed with ACIP’s decision today that the vaccine should be administered ‘based on shared clinical decision-making’ in adults 65 years or older who do not have an immunocompromising condition. We think that ACIP’s failing to positively recommend the vaccine is a disservice to patients and is confusing to healthcare providers who administer these vaccines.” 

Nearly one million adult cases of pneumococcal disease are reported in the U.S. each year, resulting in 400,000 hospitalizations. Even in this era of multiple treatment modalities, five to seven percent of those hospitalized will die, and a large percentage of them will be seniors.

“We should strive to keep adult immunizations simple and accessible to ensure increased protection. This decision by the committee could negatively impact the perceived importance of vaccines and could compromise vaccine uptake, in turn posing a greater risk of infection amongst older Americans and those they come into contact with.”

NCL will continue to educate consumers about the importance of vaccines in protecting the public health and work to dispel the myths about the safety of vaccines.

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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.

National Consumers League to testify at CDC ACIP in support of pneumococcal and other vaccines

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June 25, 2019

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC—The National Consumers League (NCL) will present testimony at the Centers for Disease Control’s (CDC) vaccine committee on June 26 in support of keeping an important vaccine to prevent pneumococcus disease on the schedule of recommended vaccines.

The Advisory Committee on Immunization Practices (ACIP) is revisiting their 2014 recommendation for the pneumococcal vaccine. NCL’s Executive Director Sally Greenberg will present testimony before the committee of vaccine experts in the defense of maintaining the current recommendation of keeping the vaccine, Pneumococcal Conjugate Vaccine 13 (PCV13), on the schedule for adults. NCL also recently joined a letter to ACIP with other health advocates urging the committee not changing the existing recommendation for coverage of the pneumococcal vaccine.

“…[n]early one million adult cases of pneumococcal disease are reported in the U.S. each year, resulting in 400,000 hospitalizations. Five to seven percent of those hospitalized will die, and a large percentage of them will be seniors…..Saving these costs is entirely feasible given that we have a safe and effective vaccine to prevent the pneumococcal illness.”

NCL has a long history of supporting childhood and adult vaccines as enormously safe and effective in reducing illness and death. NCL has sounded alarms about the outbreak of measles across the country, with 1,044 cases this year in the U.S.– the largest since 1992. NCL points out that communities of color and other lower-income Americans are particularly benefitted by keeping important lifesaving vaccines on the schedule.

The group letter noted, “We also recognize that many Americans, especially seniors, will not be able to afford vaccination if it is not provided by Medicare. Cutting back or eliminating Medicare coverage will affect older adults, especially in underserved populations that already see lower rates of vaccination.”

NCL strongly encourages the committee to maintain coverage for the pneumococcal vaccines to prevent disease and save lives.

Testimony will take place on June 26-27, 2019 at the CDC Tom Harkin Global Communication Center at the CDC’s main campus at 1600 Clifton Road NE, Atlanta, GA 30329.

To view NCL’s official statement to the ACIP panel, click the following link: bit.ly/2XAIok2.

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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.

Imposters, information theft, and internet scams: the dangers of unregulated online pharmacies – National Consumers League

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By NCL Food Policy and LifeSmarts Caleigh Bartash

With technology improving rapidly over the past few decades, online retailers have proved more convenient, reducing the market share of brick-and-mortar retailers. However, the convenience of purchasing prescription medication online or over the phone can inadvertently trap consumers in internet scams.Countless issues can arise from ordering prescription medication online. Unapproved internet dealers often evade government recognition or detection, failing to comply with drug safety regulations. Consumers can receive counterfeit, contaminated, or expired drugs. In some cases, these drugs may contain deadly opioids like fentanyl. Unauthorized medications can also have varying amounts of a medicine’s active ingredient — if they contain the correct ingredient at all.

Consumers may be attempting to access medications that they have previously been prescribed. However, they face security threats as soon as they give their personal details to an illegitimate pharmacy. These sellers have poor security protections, with leaks of sensitive customer information all too common. Illegitimate online sellers may even outright sell consumer data to scammers. Moreover, these websites can trick unsuspecting consumers into downloading viruses which further risk personal property and information.

Counterfeit drugs, unauthorized data sharing, and cyber attacks are dangerous, but now, a new threat has emerged involving counterfeit letters from the U.S. Food and Drug Administration.

Last week, the FDA released a press announcement alerting consumers to fraudulent warning letters claiming to be sent from the government. They advised that any consumer who received a warning message is likely the victim of a scam.

The July 2018 FDA press announcement is unique in that it is targeted directly to consumers. Commonly, these warning letters are used as a tool to inform the public about drug safety issues and are typically sent exclusively to manufacturers and companies creating products under their jurisdiction. FDA commissioner Dr. Scott Gottlieb summarized the FDA’s policy, stating “we generally don’t take action against individuals for purchasing a medicine online, though we regularly take action against the owners and operators of illegal websites.”

What’s next for those that received a warning letter? The FDA requests that potential victims contact them with information, including pictures and scanned documents if possible, in an effort to help them investigate the scams. Consumers can use the email address FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov as the primary channel for communicating with the agency about suspicious warnings.

The best way to avoid falling victim to any scam involving illegal internet pharmacies is to abstain from suspicious websites. How do you distinguish fake internet pharmacies from safe ones? The FDA offers guidance with their BeSafeRx campaign. Asking a few simple questions at the doctor’s office or calling a certified pharmacist can help consumers protect themselves. Safe online pharmacies usually offer information including address, contact information, and state license. Consumers should be wary if the pharmacy does not require prescriptions to access pharmaceutical drugs. Other warning signs include international addresses, clear spam messages, and unreasonably low prices.

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Have more questions about fraud? NCL’s Fraud.org site has prevention tips, an outlet for consumer complaints, and an experienced fraud counselor to teach you how to avoid common scams. And for those wanting to learn more about proper medication consumption, our Script Your Future initiative has helpful advice and information so you can navigate your prescriptions with the utmost confidence.

Regulations Can Save Lives, Like Ted’s – National Consumers League

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Sarah Aillon, NCL internWritten by National Consumers League Intern Sarah Aillon

The Trump administration is waging war against regulations. In January, President Trump announced in his State of the Union address that “in our drive to make Washington accountable, we have eliminated more regulations in our first year than any administration in history.” Since entering Office, the Trump administration rolled back many environmental, and economic regulations which secure the health, safety, and security of the American people. While the Trump Administration boastfully describes these rollbacks as progress, many public protection advocates have sounded their alarms.

Earlier this June, the Coalition for Sensible Safeguards and Georgetown Law organized a symposium which addressed the threat deregulation poses in the Trump era. Titled, The War on Regulation: Good for Corporations, Bad for the Public, the event featured a wide range of public protection advocates, including the mother of an accident victim, professors, and Senator Elizabeth Warren (D-Mass.) Their stories prove just how critical many regulations are for individual well-being and what happens when regulations do not monitor dangerous products.

Janet McGee, an advocate on the event’s second panel, and described the harrowing death of her 22-month-old son, Ted. In 2016, the toddler was in his room napping. When Janet went in to check on him, she found Ted under a dresser that had fallen on him. Ted was unresponsive and cold but had a faint heartbeat. McGee started CPR and then rushed him to the hospital. Tragically, the boy passed away four short hours after she first found him.

McGee’s story is not outstanding: every 17 minutes someone in the United States is injured by falling furniture, televisions or appliances. These furniture tip-overs kill a child every two weeks.

Voluntary safety standards in the American furniture industry perpetuate the high risk of furniture tip-overs. Voluntary safety standards threaten the consumer’s safety and security. A Consumer Reports investigation tested 24 dressers against the industry’s voluntary safety standards and found only six dressers met the industry’s standards. In response to their findings, Consumer Reports suggested raising the test weight for furniture tip-overs from 50 pounds to 60 pounds and to apply tests to dressers that are 30 inches high and higher. Anchoring dressers to walls with brackets and straps is an effective strategy to prevent the problem, but few consumers are aware of the need to secure their furniture from tip-overs.

Voluntary safety standards make enforcement of furniture safety difficult. Companies can pick and choose what standards they comply with. Voluntary safety standards allow product design to remain poor and increase the threat of injury and death.

The Ikea dresser responsible for the death of Janet McGee’s son did not meet safety standards. McGee’s Ikea dresser is not the only one from the company to fail their consumers. Over the course of 19 years, 8 children have died from Ikea dressers. As stated by McGee, the longstanding effects of furniture tip-over represent an industry-wide problem. However, with voluntary safety standards, little enforcement or change occurs.

Despite the danger many dressers on the market hold, little has been done to resolve the threat. Safety standards remain voluntary instead of mandatory. “Parents should worry about their children for many reasons, but furniture falling on them should not be one of them,” said McGee. Eventually, Ikea offered to take back 29 million chests and dressers in the Malm line, but very few consumers knew about the recall. Tens of millions of the Malm dressers are thought to still be in use and unsecured today.

McGee’s tragic, cautionary tale is just one example of why consumer regulations are necessary. President Trump’s focus on slashing regulations endanger everyday people, favoring big business at consumers’ expense. Regulatory safeguards enable people to live and work safely. “Strong government rules matter. We cannot, we must not accept a government that works only for a privileged few,” Warren said.

To learn more about furniture tip-over and Janet McGee’s story, click here.

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Sarah Aillon is a rising senior at Dickinson College pursuing dual degrees in Political Science and History. She is passionate about the National Consumers League’s work and is a child labor policy intern with them this summer.

National Consumers League statement on US opposition to breastfeeding at World Health Assembly – National Consumers League

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July 9, 2018

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC–The National Consumers League (NCL), the nation’s pioneering consumer organization, is expressing its disappointment at reports of actions taken by the U.S. delegation to the United Nations’ World Health Assembly opposing a resolution meant to promote breastfeeding worldwide. According to reporting by the New York Times and others, the U.S. delegation demanded that language encouraging governments to “protect, promote and support breastfeeding” be removed from a resolution – introduced by Ecuador — that had been expected to pass without issue.

The resolution, based on established research about the significant health advantages of breastfeeding to both mother and baby,  encouraged countries to promote breastfeeding and “strive to limit the inaccurate or misleading marketing of breast milk substitutes.”

“The United States delegation, embracing the interests of infant formula manufacturers, upended the deliberations,” reported The Times.

The National Consumers League (NCL) has long advocated for the promotion of breastfeeding for health and economic reasons, as well as for policies that support women’s ability to breastfeed, including in public places.

A study from the journal Pediatrics found that breastfeeding could save 900 lives a year and billions of dollars if 90 percent of women breast-fed their babies for the first six months of life. Research has determined that breastfeeding could prevent hundreds of deaths and many more illnesses such as asthma, diabetes, ear infections, stomach viruses, or even childhood leukemia.

The following statement is attributable to Sally Greenberg, NCL Executive Director:

Breastfeeding has long been hailed as the best source of nourishment for infants, providing the perfect mix of nutrition in an easily digestible form and lowering the risk of certain syndromes, diseases, and allergies.

That the United States delegation to the World Health Assembly would be compromised by the interests of infant formula manufacturers is a disgrace – and going so far as to threaten Ecuador with retaliation for introducing this fundamental resolution is an utter embarrassment.

It is troubling that corporate or other interests might be undermining America’s policy stances on basic health issues such as this. We are disappointed at the U.S. delegation’s void in leadership but pleased that the World Health Organization’s long-standing policy of encouraging breastfeeding prevailed.

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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 https://nclnet.org.

Endometriosis: In need of attention! – National Consumers League

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Zoe PharoZoe Pharo is a rising sophomore at Carleton College in Northfield, MN and is excited to be a health policy intern with the National Consumers League this summer.

Endometriosis is estimated to affect close to 200 million women worldwide, but we often hear very little about its prevalence.

 

On behalf of the National Consumers League, I attended a June 19 panel on endometriosis, hosted by the Society for Women’s Health Research. Panelists included Linda G. Griffiths, PhD, Professor of Biological and Mechanical Engineering at the Massachusetts Institute of Technology; Stacey Missmer, ScD, Scientific Director of the Boston Center for Endometriosis; and Robert N. Taylor, MD, PhD, Professor of Obstetrics and Gynecology at the University of Utah. The panel was moderated by the Society for Women’s Health Research’s President and CEO, Amy Miller, PhD.

What is endometriosis? 

Endometriosis is a condition where tissue that is typically only located inside the uterus is found elsewhere in the body. While it is estimated that close to 200 million women worldwide will experience endometriosis, we often hear little about its prevalence. Even as awareness of endometriosis increases—thanks to Lena Dunham and other celebrities sharing their struggles with the disease—numerous challenges still remain, including the following:

  • Many women face delays in diagnosis or misdiagnosis;
  • Funding for research has been slashed and continues to decrease under the Trump Administration;
  • Subtypes of the disease have yet to be identified;
  • Data on the prevalence of endometriosis does not exist; and
  • There is no standardized way to measure the amount of pain felt by women with endometriosis, often resulting in upsetting and discouraging interactions when women try to talk to their clinician, family members, colleagues, spouse, or others about their experiences.

What are the symptoms of endometriosis? 

Common symptoms of endometriosis include infertility, back and pelvic pain, digestive problems, painful sex, and painful menstrual cramps. The most visible symptoms of endometriosis are the lesions that often accompany the disease. However, there is no conclusive research on the relationship between lesions and pain or infertility. It is important to note that many women with endometriosis never present with any outwardly visible symptoms. Further, medical professionals do not have a standard way to measure pain. As Dr. Robert N. Taylor said, “Pain is a highly complex behavior” and is therefore hard to study and model.

Additionally, a patient diagnosed with endometriosis may present with comorbidities. Endometriosis has been found to lead to an increased risk of cancer, cardiovascular disease, and other autoimmune diseases.

Why the delay in diagnosis?

Diagnosis of endometriosis is delayed an average of six to seven years, partly because, as Dr. Taylor said, “American medicine has lagged behind in the teaching of sexuality.” Healthcare providers and women’s health advocates need to create spaces where women are comfortable discussing their sexual health and any painful symptoms that may point towards a diagnosis of endometriosis.

Even when women do discuss their symptoms, delayed diagnosis can be due to symptoms that overlap with other gynecologic and gastroenterological processes. For example, a common misdiagnosis is IBS. In addition, for many years, the only way to definitively diagnose endometriosis was by operating, using laparoscopy or excision. Surgical diagnoses come with risks, so we are beginning to move towards alternative methods that do not rely on such invasive procedures. However, even newer medical treatments, such as suppressing hormone production, can have negative consequences in young women.   

What can policymakers, healthcare providers, and advocates do?

Policymakers can appropriate additional funding for endometriosis research. First and foremost, endometriosis is an economic problem, representing an annual $69.4 billion economic burden in the United States. Despite this burden, funding for endometriosis is shrinking, at the same time that endometriosis is becoming more prevalent in the population.  

As Dr. Linda Griffiths pointed out, research on endometriosis is not what is funding many scientists’ careers. Dr. Griffiths described her research on endometriosis as a “hobby,” and advocated for more basic research on the biology of endometriosis and on potential subtypes of the disease. Future research should also look at selective groups that have yet to be studied. In addition, it is important to reconsider how to effectively judge pain. Currently there is no standard algorithm. This is troubling to Dr. Griffiths, as she recounted a time when she vomited from the intensity of her own endometriosis pain.  

Dr. Griffiths also recommended routine and accurate collection of data, which currently does not exist for endometriosis. We need to consistently measure the prevalence of endometriosis in various populations as well as the efficacy of potential treatments.  

Dr. Stacey Missmer recommended the implementation of policies to enable women to report their symptoms and be taken seriously when they do so. Electronic medical records might provide a way to alter clinician-patient interactions. Dr. Missmer said she envisions an electronic drop-down option for immediate entry, perhaps asking patients, “Are you experiencing pelvic pain?”

Finally, we need to talk openly about the physical and psychological effects of endometriosis. NCL is working closely with leading organizations in the women’s health space to consider the most effective ways to bring down barriers to better outcomes in women’s reproductive health.

Vaccine-averse ‘Hotspots’: A danger to all – National Consumers League

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By Melissa Cuddington, NCL public policy intern

Think that measles has been eradicated from the United States? Think again. According to a report published earlier this month by PLOS Medicine, measles is still spread by unvaccinated children and foreign visitors to the United States. This spread is seen in “hotspots,” otherwise known as areas where the risk of disease is higher because parents choose to abstain from getting their children vaccinated. Parents continue to claim non-medical exemptions for issues of philosophy, and that’s dangerous.

A recent Washington Post article shined a light on the growing problem the anti-vaccination movement is creating: 18 states still allow parents to opt their children out of school immunization requirements. These hotspots are located across the country both in urban, metropolitan locations, such as Houston, Austin, and Pittsburgh and in rural areas as well.

In many of these urban centers, too many children are being exempted from immunization requirements, making it easier for vaccine-preventable diseases to spread and infect others. The Post article notes that these urban centers have busy airports, opening up the possibility for diseases to spread to the un-vaccinated.

According to a study conducted by the Centers for Disease Control and Prevention (CDC), people who remain unvaccinated are most likely the cause of the increased occurrence of measles and other contagious diseases being spread throughout the United States. The CDC also predicts the reemergence of these diseases if parents continue to skirt vaccination requirements.

Many of these diseases from the past are easily preventable if parents get their children vaccinated at a young age. Medical research shows that if children do not receive the measles vaccination (MMR) 12 to 15 months after birth, they are at risk of exposure.

Sadly the anti-vaccination movement in the United States has been going strong. At some point, parents need to consider that the decision not to get their child vaccinated is not just personal—it’s a communal one. The choice to abstain from vaccination puts vulnerable adults and children at risk. As the research demonstrates, this decision could expose others to possibly fatal diseases, which are entirely preventable with immunization.

As a consumer advocacy organization that champions vaccinations for all who can safely be vaccinated, NCL pushes against these non-medical exemptions. It is dangerous for parents to be making decisions for their children that can have adverse effects on others. NCL encourages state and federal health officials to support laws that don’t allow personal preference to prevent children from being immunized. California’s law is a good model and would keep us all safe from totally preventable diseases.