FDA acts to protect women’s health

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 applauds USP for new and revised compounding standards

Every day, thousands of consumers in the United States—including those with rare diseases or allergies to commercially available drugs—rely on specially and individually made medicines known as compounded drugs. Compounding is critically important for patients but, if done improperly, this process can pose significant risks to patients and healthcare workers alike. Patients could—and have—received contaminated drugs or preparations that are subpotent, contaminated, or super-potent. Healthcare workers, in turn, can face risks of exposure to hazardous drugs.

A stark example is the 2012 series of medical errors that resulted in the contamination of compounded medicines, which in turn caused a deadly fungal meningitis outbreak in the United States—killing more than 70 people and causing more than 750 cases of infection in 20 states.

To reduce these public health risks, Congress and other policymakers have swung into action. Today, compounding requires universal standards that advance public health and patient safety priorities. A key player in this is the United States Pharmacopeia (USP), a scientific non-governmental standards-setting organization, which recently published new and revised compounding standards to help produce consistent quality compounded medicines and ensure that patients receive medicines that are the right strength, quality, and free of contaminants.

These updated standards reflect the latest advancements in science and clinical practice, and incorporate input from thousands of stakeholders in the medical and public health community—patients, healthcare practitioners, policymakers, academicians, and industry. The standards complement robust implementation of existing laws intended to ensure quality compounded products with the goal of protecting the safety of patients.

Consumers have an important role to play as we roll out the new guidelines for quality compounding and implementation of the new USP standards:

  • If you receive compounded medicines through your pharmacist or healthcare provider, report any resulting adverse events to your healthcare provider.
  • Sign up for FDA email alerts on safe compounding.
  • Remember to always contact your healthcare provider if you have questions or concerns about your health.

NCL is encouraged to see that the revised USP standards are consistent with FDA guidances. We applaud the efforts of FDA and USP to collaborate with the public health community to help protect patient safety.

Alabama’s abortion ban is an assault on reproductive freedom

Nissa Shaffi

On May 14, 25 white male legislators in Alabama decided the fate of reproductive health for millions of women in their state. This astonishingly homogeneous group supported the Human Rights Protection Act [SB 314] 25-6. Although women make up 51 percent of Alabama’s population, only 15 percent of women serve in Alabama’s state legislature. A mere three women were present for the vote.

The measure is draconian. It will prohibit abortion in all cases, even in instances of rape or incest, and will only permit the procedure in situations where the mother’s life is in danger or if the child presents a “lethal anomaly.” Physicians convicted of performing abortions could face Class A felony charges–carrying a punishment of up to 99 years. To put this into perspective, if a woman is raped and impregnated, her rapist would face less time in prison than would the provider who aborted the pregnancy.

In addition to Alabama’s extreme measure, five other states are considering so-called “Heartbeat Bills” prohibiting an abortion beyond six to eight weeks of pregnancy if a fetal cardiac activity is detected. Semantics matter because, at six weeks, a fetus technically only consists of “a group of cells with electrical activity.” This time frame is crucial because most women are not even aware that they are pregnant and therefore cannot make a timely decision.

We’ve been here before. Before Roe v Wade–the 1973 landmark case that declared the criminalization of abortion to be unconstitutional, thus securing a woman’s right to choose–200 women died annually because they could not access abortions legally.

Banning abortions will not prevent women from getting them. Indeed, shunning women and their healthcare providers only creates an environment where women must seek dangerous methods to end their pregnancies. An estimated 30,000 maternal deaths occur worldwide as a result of clandestine abortions in countries where the procedure is illegal. Restrictive abortion laws threaten reproductive freedom and endanger lives.

Statistically, abortion rates drop in countries where contraception is easily accessible and where the procedure is legal. For example, in countries like Israel and New Zealand, abortion is subsidized by the government. Additionally, creating social infrastructures that support motherhood–such as paid maternity leave and offering affordable childcare–reduce the incidence of abortion.

The National Consumers League strongly opposes punitive and cruel bills like the one in Alabama. Abortion is not a decision women enter into lightly. These are often excruciating decisions, which ultimately must be at the discretion of a woman and her doctor. These bills strip women of their agency to make safe and informed choices about their body, health, and lives. Alabama’s laws and their ilk are regressive and endanger the health of women, especially those of limited means. We call on all state legislators to recognize this fact and lift these terrible restrictions.

Amazon and other retailers launch program allowing SNAP beneficiaries to order food online

Shaunice Wall is NCL’s Linda Golodner Food Safety and Nutrition Fellow

On April 18, 2018, Amazon and other retailers launched a two-year test (pilot) program to boost food access to some of New York’s 2.7 million Supplemental Nutrition Assistance Program (SNAP) participants. Beneficiaries will be able to use their SNAP benefits to order groceries online and have them delivered directly to their door.

photo of supermarket produceSNAP is one of the most efficient and important public benefit programs,” said Shaunice Wall, NCL’s Linda Golodner Food Safety and Nutrition Fellow. “SNAP helps reduce food insecurity and improves the nutrition of millions, especially among the most vulnerable Americans. For many Americans living in food deserts, online food retailers are sometimes the only way to stock refrigerators,” NCL supports this collaboration between USDA and Amazon.

“People who receive SNAP benefits should have the opportunity to shop for food the same way more and more Americans shop for food–by ordering and paying for groceries online,” said U.S. Secretary of Agriculture Sonny Perdue. As technology advances, it is important for SNAP to advance too, so we can ensure the same shopping options are available for both non-SNAP and SNAP recipients.

Stats on the rise of e-commerce sales in America in 2017

The pilot will test both online ordering and payment. It will also work to ensure that orders are processed safely and securely, according to the United States Department of Agriculture (USDA). SNAP participants will be able to use their benefits to purchase eligible food items, but not pay for service or delivery charges. 

The program will also add a new SNAP redemption option, with broad selection, low prices, and the convenience of home delivery without requiring a membership fee. As Amazon expands participating areas throughout the life of the pilot, they believe the program will dramatically increase access to food for customers living in rural and remote locations.

The USDA defines food deserts as communities where one-third of the population lives at least one mile away from a supermarket in an urban area and 10 miles away in a rural area. For SNAP beneficiaries, it is often the simplest – or sometimes the only – option to use their electronic benefit transfer (EBT) card at convenience stores or gas stations, which often have only a sparse supply of produce and fresh protein.

The pilot will start with SNAP households with EBT cards issued by New York. Online retailers will only be able to deliver in New York. The plan is for the pilot to eventually expand to other areas of New York as well as Alabama, Iowa, Maryland, Nebraska, New Jersey, Oregon, and Washington. Lessons learned will then allow expansion of online purchasing in SNAP.

“The ultimate goal of this pilot is to pave the way for a national rollout once the USDA identifies the best path to large-scale implementation,” says Amazon. NCL recognizes that the advancement of SNAP takes on a larger significance because of the argument by conservatives that the program “costs too much, has grown too quickly, encourages government dependency and discourages work.” NCL supports SNAP and this exciting online system, if it works, well, will address the dearth of healthy food options for millions of Americans in food desserts or who cannot, for lack of transportation, health or disability reasons, get to a supermarket and choose from healthier options.

For more information, please visit the SNAP Online Purchasing pilot webpage.

The troubling rise of maternal deaths in America

Nissa Shaffi

According to the Centers for Disease Control and Prevention (CDC), 700 women die annually from complications related to pregnancy or childbirth. The World Health Organization (WHO) estimates that 45 percent of maternal deaths occur approximately six weeks postpartum, and nearly 60 percent of all maternal deaths are preventable. These deaths have doubled in the past 20 years, which prompted the passage of the Preventing Maternal Deaths Act (H.R. 1318) in December 2018.

Prior to the Preventing Maternal Deaths Act, we lacked data necessary to help providers mitigate the risk of maternal deaths. This critical law aims to increase transparency regarding maternal death rates in states and will provide federal grants to investigate the deaths of women who died within a year of being pregnant.  

Medically unnecessary C-sections

One of the factors responsible for the rising rate of maternal deaths is complications resulting from unnecessary cesarean sections (C-sections). Since the 1970s, there has been a 500 percent increase in the utilization of C-sections, making it the most commonly performed surgical procedure in the U.S.

C-sections are an important and effective life-saving measure for mothers and infants, but only when there is an explicit medical need. When performed without established need, they can increase patients’ risk for life-threatening adverse events. Dr. Neel Shah, Assistant Professor at Harvard Medical School, states that unnecessary C-sections may be responsible for up to 20,000 major surgical complications a year, some of which include:

  • increased risk of infections;
  • increased risk of sepsis resulting from infections;
  • excessive postpartum bleeding;
  • blood clots;
  • complications with future births;
  • and maternal death.

A 2017 Consumer Reports investigation discovered that C-section rates for low-risk deliveries vary dramatically from hospital to hospital, ranging from 7 percent to 70 percent across America. Factors from hospital location, convenience, or reimbursement rates are all responsible for the rise in medically unnecessary C-sections. Dr. Shah believes these factors have created a culture that places less value on maternal and child health, and instead prioritizes the hospital and providers where the delivery occurs.

Medically unnecessary C-sections have become a matter of contention among health professionals across the country, as well as a critical blind spot for patients. While patients can take measures to avoid unnecessary C-sections, many simply do not have the option to make changes in their birth plan.

Black maternal death is more than just a statistic

The most sobering reality of the maternal death crisis is that black women are 243 percent more likely to die from pregnancy or childbirth-related causes than women from any other racial or socioeconomic category.

In California, black women undergo C-sections at five percentage points higher than any other racial or ethnic group. In addition to higher C-section rates, black women often fall victim to bias when receiving medical care, where their symptoms are often treated less seriously and with less urgency.

In the case of Kira Johnson, racial bias and negligent postpartum care are believed to have played a critical role in her tragic death. After a routine C-section at Cedars-Sinai Hospital, Johnson experienced severe internal bleeding for over 10 hours before receiving medical attention. Since Johnson’s passing, her husband Charles has advocated on Capitol Hill urging Congress to address the maternal healthcare crisis.

From 2014 to 2016, the District of Columbia had the highest maternal mortality rate in the countryand 75 percent were black women. These staggering figures prompted healthcare providers in the city to create the Maternal Mortality Review Committee (MMRC). Before the MMRC, there was no data available explaining how these women died or the symptoms they presented that could have alerted physicians to their compromised state. The MMRC will work with multiple stakeholders in the city to establish transparency for maternal mortality trends and create interdisciplinary solutions to foster change and accountability.

The call for increased data collection and dissemination

In the United States, maternal death statistics are currently collected by states independently, but in most countries, the federal government assumes that role. The Preventing Maternal Deaths Act will provide the U.S. with data on practices that contribute to maternal deaths throughout the country.

The National Consumers League applauds Congress’ continued efforts to help mitigate the troubling increase in maternal mortality across the country.

Senate HELP Committee’s hearing on vaccines

Nissa Shaffi

On March 5, 2019, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on vaccines and their critical role in halting preventable disease outbreaks. The hearing featured a witness panel consisting of experts from various disciplines, such as public health officials, specialists in pediatric medicine, epidemiology, and the primary immunodeficiency space, as well as Ethan Lindenberger, a high school student who recently obtained vaccinations against the wishes of his parents.

The hearing was noteworthy in that every member of the HELP committee–both liberal Democratic and conservative Republican–supports routine vaccinations. The only hesitation came from Senator Rand Paul (R-KY)–who supports other vaccinations and vaccinates his kids and himself–on flu vaccinations. He was roundly corrected by a doctor-Member of the HELP Committee, Senator Bill Cassidy (R-LA), who said that while flu vaccines aren’t always hitting the right strain, they always lessen the symptoms. 

Recommendations from the Centers for Disease Control (CDC), National Institutes of Health (NIH), and National Academies of Sciences, Engineering, and Medicine were confirmed to be “the gold standard” and got kudos from everyone on the panel. In the face of a very anti-science administration, good medicine and good science overwhelmingly prevailed and won the day.

The hearing also drove home the importance of increasing the dissemination of factual, evidence-based research about the safety of vaccines to consumers. Confirming previous research, a new 10-year study conducted in Denmark found that there is no correlation between autism and the measles, mumps, and rubella (MMR) vaccine. Researchers studied 657,461 Danish children between 1999-2010, and discovered that the MMR vaccine did not increase the risk for autism or trigger autism in susceptible children.

Below are some of the highlights of the witnesses’ testimony:   

Public health burden from outbreaks

The resurgence of measles is not only detrimental to affected individuals, but it also presents an incredible burden on public health infrastructure as communities struggle to contain an incredibly infectious disease outbreak.

Dr. John Wiesman, Secretary of Health, Washington State Department of Health, stated that while the MMR vaccine costs $20 per dose, the current outbreak has cost the state of Washington approximately $1 million — as well as the time investment of more than 200 individuals contributing more than 10,000 hours of work to help contain the outbreak and investigate the trajectory and sources of possible contamination. Dr. Wiesman also mentioned that every dollar spent on vaccines generates a cost savings of $10.

Vaccine hesitancy

Officials credit the proliferation of measles across the country to growing anti-vaccine sentiments. HELP Committee Chairman Lamar Alexander (R-TN) stressed that low immunization rates destroy herd immunity and that annual child and adult vaccine schedules help to ensure individual and community safety.

Mr. Lindenberger explained how the Internet was instrumental in both spreading misinformation regarding vaccines to his parents, and conversely, how crucial it was to helping him obtain factual data on the safety of vaccines — and convincing him he needed to get vaccinated. Lindenberger stressed the importance of education to help stem the tide of misinformation surrounding the safety and efficacy of vaccines.

The witnesses also stated that vaccine confidence is built through physician consultation. Parents have been known to reverse their anti-vaccine stance when physicians provide counseling, allowing for an objective, judgment-free space for parents to ask questions. Healthcare provider counseling not only assuages looming doubts regarding vaccine safety but helps to protect the entire community in the process.

Vaccine regulation, research, and funding

Several witnesses from the HELP hearing emphasized the importance of building vaccine confidence through sound research, dissemination of factual information, policy implementation, and funding.

John Boyle, president and CEO of the Immune Deficiency Foundation, expressed how important vaccines have been to his survival as an individual with a primary immunodeficiency disease. For individuals like Boyle, survival is contingent on herd immunity, as he is not able to get vaccinated himself.

Dr. Wiesman joined with other advocacy organizations in calling on Congress to increase the budget of the CDC by 22 percent by 2022. Dr. Wiesman also requested that the federal government launch a national vaccine education campaign, similar to the anti-tobacco Truth campaign.

Dr. Saad B. Omer, professor of epidemiology and pediatrics at Emory University, recommended that Congress make physician vaccine counseling reimbursable, as providers are often overburdened and this could aid in their efforts. Dr. Omer also recommended the continued prioritization of vaccine safety research and greater investment in vaccine acceptance and communication research.

NCL thanks the Senate HELP Committee and other Members of Congress for shining a light on the importance of vaccination, and NCL will continue our work to dispel the myths and educate the public on the safety and effectiveness of vaccines.

National Consumers League renews call for legislation requiring child vaccinations

February 11, 2019

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

Washington, DCAfter a harrowing account in a February 6, 2019 Washington Post article about the galloping rate of measles because of state laws permitting parents to forego – for personal or religious reasons — safe and effective vaccines for their children, the National Consumers League (NCL) is renewing its call for passage of strict vaccination laws.

“Vaccinations are proven safe and effective. They prevent diseases like measles, polio, smallpox, influenza, and diphtheria which used to terrify parents and send communities into panic. Vaccines should be seen as a gift of modern medicine. When you decide not to vaccinate your child, you’re endangering your child and your community,” said NCL Executive Director Sally Greenberg.  

NCL supports laws that restrict exemptions. Greenberg continued: “Legitimate and well-documented health conditions should be the only reason to not vaccinate your children. The loophole of `personal preference’ or ‘religious exemptions’ has caused the “current epidemic and traffic in fear mongering and unfounded pseudo science. The link between autism and vaccines has been debunked time and again and yet anti-vaxxers persist in spreading bad information and contribute to the dangerous spread of deadly illnesses in their communities.”  

NCL commends California, West Virginia, and Mississippi for allowing only medical exemptions to vaccine requirements. In 2016, NCL honored Dr. Richard Pan, a California State Senator, for his brave leadership on vaccine laws. In 2015, he authored landmark legislation abolishing all non-medical vaccine exemptions, legally requiring vaccines for school-aged children, thereby restoring community immunity from vaccine-preventable diseases. In his acceptance speech, Dr. Pan remarked, “Consumers need accurate guidance on medications that can improve their health, especially vaccines which benefit both patients and the public. NCL has been a strong partner as we strive to combat misinformation about vaccines.”

Unfortunately, most states permit religious exemptions from vaccines, and 17, including Washington, Oregon, and Idaho, currently allow philosophical exemptions. As a result of this policy, 7.9 percent of children in Clark County, WA were unvaccinated. NCL applauds Washington state Representative Paul Harris (R-Vancouver), who has introduced legislation that would ban personal or philosophical exemptions from the measles vaccine. To see where your state stands on non-medical vaccine exemptions, please click here.

NCL’s stance on vaccines

NCL admires the work of health advocates like Dr. Richard Pan and countless others who understand the vital role that vaccines play in protecting our communities. Vaccines are among the safest and most effective public health measures we have. NCL calls on all states to strike non-medical vaccine exemptions. Because of vaccines, we have the luxury of not worrying that our children or our families will contract these once devastating diseases. The measles outbreak is a wake-up call. Our message to parents and adults alike: get vaccinated!

###

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.

Why nutrition labeling on alcoholic beverages can reduce binge drinking – National Consumers League

Shaunice Wall is NCL’s Linda Golodner Food Safety and Nutrition Fellow

Alcohol – like everything else we eat and drink – is best enjoyed in moderation. If consumed to excess, drinking alcoholic beverages can lead to addiction and increased risk of certain chronic diseases, but also weight gain, because these drinks are often dense in calories and devoid of nutrients.

One of the problems consumers face, however, is that there is virtually no information on the nutritional content in the alcoholic beverages they consume. NCL has been working to change this for more than 30 years, but progress on this front has been very disappointing. Does lack of a label cause binge drinking? Of course not, but evidence indicates that caloric and nutritional labeling encourages healthier choices when consumers read and understand the labels.  

What is binge drinking anyway? 
The National Institute on Alcohol Abuse and Alcoholism defines binge drinking as a pattern of drinking that brings a person’s blood alcohol concentration (BAC) to 0.08 grams percent or above. For men, it means consuming 5 or more drinks – and for women – it’s consuming 4 or more drinks in about 2 hours. 

A “drink” defined 
A drink” refers to half an ounce of alcohol (e.g., a 12oz. beer, a 5oz. glass of wine, or a 1.5oz. shot of distilled spirits). 

The impact of alcohol consumption and binge drinking 

In 2015, the National Survey on Drug Use and Health reported that 86.4 percent of people in the United States aged 18 or older drank alcohol at some point in their lifetime. 

According to the U.S. Centers for Disease Control, binge drinking is the most common, costly, and deadly pattern of excessive alcohol use in the United States. More than one in six U.S. adults, or 38 million people, are binge drinkers, and they binge an average of four times a month.

In 2010, alcohol consumption cost America an estimated $249 billion in workplace productivity losses, health care expenditures, criminal justice costs, and other expenses — binge drinking was responsible for 77 percent of these costs, or $191 billion.  

Some nutritional consequences of binge drinking 
In 2018, a study funded by the National Institutes of Health found that young adults who frequently binge drink were more likely to have cardiovascular risk factors, including higher blood pressure, cholesterol, and blood sugar at a younger age than non-bingers. In addition to malabsorption of several nutrients in the gut, binge drinkers are at risk of malnutrition because alcohol contains calories that may substitute for those in more nutritious foods. Another more common consequence of binge drinking is weight gain, which in turn contributes to the nation’s obesity epidemic.   

The link between alcohol and obesity 

Researchers suggest a positive correlation between calories derived from alcohol and obesity. Alcohol also has an effect on hunger levels and food preferences.  

Alcohol cannot be stored in the body, however, its conversion to acetate in the liver and subsequent release into the bloodstream inhibits the amount of fat the body burns.  

The problem with binge drinking and misleading nutrition labels 

pint of beer may contain as much as 200 calories – the same as a doughnut. Yet, in the United Kingdom, one study found that 85 percent of the population is unaware of or underestimates calories from alcohol. This problem is universal, and–in the United States–this is due in part to misleading nutrition labeling proposals by the U.S. Treasury Department’s Tax and Trade Bureau (TTB), which regulates and collects taxes on trade and imports of alcohol. 

Labeling of alcohol can reduce binge drinking 

As noted above, one strategy to increase awareness and reduce the risk of excessive alcohol use is to label alcoholic beverages with serving facts. Listing the ingredients alerts consumers to the presence of any potentially harmful or problematic substances while providing nutritional informationsuch as energy contentallows consumers to monitor their diets and makes it easier to maintain a healthy lifestyle.  

The impact that such a move could have was illustrated by a small experiment conducted in a UK pub, in which customers presented with caloric information consumed on average 400 fewer calories than those who had access to no such information.  

Obstacles for nutrition labeling of alcohol in the United States 

Labeling requirements for alcoholic beverages are woefully inadequate. The proposals offered by TTB are too little, and they don’t support public health.  

In 2003, a petition by several special interest groups (including NCL) to TTB, claimed that there were substantial disparities in the labeling requirements applicable to different kinds of alcoholic beverages. Wine and distilled spirits labels are required to reveal the beverages’ alcohol concentration – expressed as a percentage of alcohol by volume (additional proof-level statements are optional) – but labeling alcohol content on beer and other malt beverages is entirely optional. Only those alcoholic beverages that make nutritional claims, such as “light” or “lite” beers must disclose calorie content and certain nutrition information. 

There has been no rationale published by TTB for these differences.  

The National Consumers League’s petition  
NCL, the Center for Science in the Public Interest (CSPI), and 67 other organizations continue to advocate for mandatory content and nutritional labeling on all alcoholic beverages. While it may not eradicate binge drinking, consumers who want to consume alcohol in moderation deserve to know what’s in that drink. A label like the Nutrition and Supplement Facts on alcoholic beverages is long overdue.

NCL statement on drug importation legislation – National Consumers League

January 14, 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—As the nation’s pioneer consumer organization, the National Consumers League (NCL) strongly supports consumer access to safe, effective, and affordable prescription drugs. 

However, NCL is concerned that new legislation, the Affordable and Safe Prescription Drug Importation Act (S.97/H.R. 447) and the Safe and Affordable Drugs from Canada Act of 2019 (S. 61), which would allow medicines to be imported into the United States from foreign countries, would open the U.S. market to a flood of counterfeit and/or substandard drugs, putting patient health and safety at risk.

Counterfeit medications made with deadly ingredients have been found in over 40 states across America, posing a significant public health threat. There is no way to ensure that drugs purporting to come from Canada actually come from Canada. A Food and Drug Administration (FDA) evaluation of non-FDA-approved imported drugs revealed that “while nearly half of imported drugs claimed to be Canadian or from Canadian pharmacies, 85% of such drugs were actually from different countries.” Allowing importation will only serve to exacerbate the challenge of preventing counterfeit drugs from reaching American patients.

Every head of Health and Human Services and the FDA for the last 18 years has refused to certify the safety of drug importation. FDA Commissioner Gottlieb recently stated that 86 percent of the packages FDA inspectors seized in 2017 contained counterfeit or sub-standard drugs. NCL fears that authorizing importation would expose consumers to unknown risks and undermine the security of the U.S. pharmaceutical supply chain.

Rather than considering misguided importation proposals, NCL encourages Congress to strengthen our drug supply chain and pursue other strategies to ensure the affordability and accessibility of safe and effective prescription drugs.

###

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.

Make a New Year’s resolution to get vaccinated against shingles

Nissa Shaffi

Shingles (herpes zoster) is caused by the varicella zoster virus (VZV), the same virus that causes chickenpox. Once a person recovers from chickenpox, the virus lays dormant in the body’s nerve cells, while the host remains asymptomatic. While scientists are not sure what causes the virus to reactivate in the form of shingles, it can present in individuals who are elderly or those who have compromised immune systems in general, due to medication or health conditions.

Shingles is a painful rash that usually develops on one side of the body, often the face or torso. The rash consists of blisters that typically scab over in seven to 10 days and clears up within two to four weeks. Even long after the rash has healed, shingles can lead to long-term complications in the form of postherpetic neuralgia (PHN)—severe nerve pain— at the site of the rash.  Although shingles is not contagious, VZV can spread from a person with active shingles to cause chickenpox in someone who has either never had chickenpox or has never received the chickenpox vaccine. The virus spreads through direct contact with the blisters, and a person is not infectious before the blister phase.

The only way to lower the risk of developing shingles is to get vaccinated. The Centers for Disease Control and Prevention (CDC) recommends that healthy adults 50 years and older get two doses of the new shingles vaccine called Shingrix to protect against the disease. The new vaccine is administered in a two-dose series, and the second dose is administered two to six months following the first dose. According to the CDC, it is imperative that patients complete the vaccine series as it provides greater protection than its predecessor Zostavax, which is a single-shot vaccine.

According to reports, a surge in demand for the shingles vaccine following the recommendations has led to a national shortage, leaving consumers searching far and wide for available doses. While news of the vaccine shortage is certainly unfortunate, the silver lining in this situation is that patients are taking proactive measures to protect themselves from illness.

NCL strongly advocates for the use of vaccines as a safe and effective preventive public health measure to protect against debilitating illnesses. A survey conducted by NCL in 2014 revealed that due to prevalent anti-vaccine rhetoric, nearly 33 percent of American consumers are misinformed about the benefit of vaccines. Vaccines are essential to public health as they protect vulnerable populations with diverse health needs. Adults and children who are not able to receive vaccines due to certain conditions rely on the general population for protection against disease, also known as herd immunity.

Consumers should feel at ease knowing that while shingles is a serious condition, your odds of developing the disease before the shortage ends are low. The CDC recommends that consumers call their local pharmacies or use Vaccine Finder to find their nearest available dose. If Shingrix is unavailable in your area, the CDC recommends that consumers 60 and older get the Zostavax vaccine.

If you have gone more than six months since your initial dose, the CDC states that you do not have to start the vaccine course over, but should instead promptly get the second dose to ensure maximum immunity. If you have already received your first dose of the vaccine, you can sign up for text, voice, or email reminders for your second dose. For more information on the causes and risk factors associated with shingles, please click here.