NCL announces new action center to help patients steer clear of deadly counterfeit drug websites

December 5, 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), America’s pioneering consumer advocacy organization, today launched Fraud.org/FakeRx, a new digital consumer education campaign to address the growing global crisis of harmful counterfeit medications. The World Health Organization estimates that one in every 10 medical products circulating in developed countries is either substandard or fake, and nearly $83 billion in counterfeit drugs are sold annually. Counterfeit drugs can be, at best, a waste of money and, at worst, fatal.  The Partnership for Safe Medicines has found counterfeit pills made with fentanyl in 48 states, with deaths attributed in 33.

“Counterfeit drugs are everywhere, and they are dangerous. Going to the Internet to buy medicines is a bad idea if you don’t know how to protect yourself from illegal pharmacies selling counterfeit drugs. Consumers do not realize how common counterfeits are; our campaign aims to provide the tools and resources to help consumers steer clear of illegal products and protect themselves and their families,” said NCL Executive Director Sally Greenberg. “NCL is launching Fraud.org/FakeRx to serve as a hub for reliable information for consumers and law enforcement.  Our action center helps consumers learn how to spot the red flags of counterfeit drugs and report issues to law enforcement.”

With the growth of Internet sales of medications, the problem of illegal pharmacies hawking counterfeit drugs is a growing risk to consumers. Visitors to Fraud.org/FakeRx can arm themselves with information to:

  • Reduce the chances they’ll encounter counterfeit drugs and shop safely for medications online
  • Learn to spot harmful counterfeit drugs if they do; and
  • Report counterfeit drugs and the websites offering them to the authorities fighting the problem.

“Criminals posing as legitimate online pharmacies are a serious threat to our nation’s drug supply and to unsuspecting consumers who purchase contaminated or potentially deadly counterfeit medications,” said George Karavetsos, former director of the U.S. Food and Drug Administration’s Office of Criminal Investigations. “Policymakers, regulators, and manufacturers have clear roles for doing their part to protect our drug supply, but having informed consumers is essential to shutting down this illegal online market. This campaign gives consumers the tools they need to stay safe and keep criminals from lining their pockets with consumers’ money.”

NCL has worked with victims of suspected and confirmed counterfeit drugs to capture their experiences and report them to authorities. Two mothers who each lost their adult children to tainted counterfeit medications have lent their stories to the new campaign in hopes of helping others avoid falling to the same fate.

“I lost my son, Jerome, himself a loving big brother and father of three beautiful children, to a counterfeit drug laced with fentanyl. It took one single pill to take Jerome away from us,” said Natasha Butler, whose son was one of a wave of victims of counterfeit drug deaths in Sacramento in 2016. “We had no idea that these dangerous drugs, manufactured to look exactly like the real thing, are out there and could be the last drug someone ever takes. Anyone who takes medication or fills prescriptions needs to be aware of the risks of counterfeits, and that where you get drugs is so crucial for your safety and health. Everyone should visit Fraud.org/FakeRx to learn about the risks and how to avoid being the next victim.”

 “On June 11, 2018 my phone rang at 7:24 am. The voice on the other line told me that my beautiful daughter, Ashley, was dead. Ashley had been given a counterfeit pill laced with fentanyl. I was told by the coroner that she probably died instantly,” said Andrea Thomas, a Colorado mother who, since her daughter’s death from a counterfeit drug, co-founded Voices for Awareness Foundation. “The deadly pill Ashley took looked just like her normal medication. This is an epidemic in our country that I previously knew nothing about. It is time to take action. The National Consumers League’s new resources for consumers will help spread awareness and will make a difference to many.”

To hear from additional victims who know the issue firsthand, visit the new Fraud.org/FakeRx. The site also includes tips for consumers about ways to save on prescription drugs without increasing their risks of purchasing counterfeits. 

NCL thanks its partners for providing support for the new campaign: Allergan, Celgene, Eli Lilly, Gilead Sciences, Pfizer, and PhRMA.

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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.

AAOA and National Consumers League Raise Awareness About Prescription Opioid Abuse Safety

October 16, 2019

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

Alexandria, VA—Allied Against Opioid Abuse (AAOA) and the National Consumers League (NCL) released a new suite of resources to help educate consumers about prescription opioid safety. The AAOA-NCL Consumer Toolkit provides materials to help reinforce the need for patients, caregivers, parents and others to understand their rights, risks and responsibilities associated with prescription opioid use.

Education plays a crucial role in helping consumers understand the importance of safely using, storing and disposing of prescription opioids,” said Sally Greenberg, Executive Director, NCL. “We are pleased to partner with AAOA on this important set of resources, which will provide individuals with actionable steps that they can take to keep prescription opioids secure and prevent misuse and abuse of these medicines among family and friends.”  

The AAOA-NCL Consumer Toolkit addresses common questions that patients may have about their rights, risks and responsibilities associated with prescription opioids, and highlights facts about opioid medications to fill a knowledge gap and prevent misuse before it occurs. The toolkit includes the following resources:

AAOA has taken a leading role in sharing information and fostering communication between patients, consumers and the medical community to help reduce prescription opioid abuse,” said John Parker, Senior Vice President of Communications for the Healthcare Distribution Alliance, the founding member of AAOA. “By leveraging NCL’s expertise, our goal is to communicate directly with consumers about the important role everyone has to play in ensuring the appropriate use, storage and disposal of prescription opioids.”  

In August, the AAOA-HealthyWomen Toolkit was released to help educate women, in their role as consumers and caregivers, about what they can do to prevent the misuse and abuse of prescription opioids in the home. To learn more about AAOA’s resources, including a series of videos that raise awareness about prescription opioid safety, visit www.AgainstOpioidAbuse.org/Act.

For press inquiries, contact press@againstopioidabuse.org

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About Allied Against Opioid Abuse
Allied Against Opioid Abuse is a national education and awareness initiative to help prevent abuse and misuse of prescription opioids. Founded by the Healthcare Distribution Alliance, the initiative is a collaborative effort with diverse partners across the pharmaceutical supply chain, as well as organizations that are experts in public health and healthcare, including Alliance for Aging Research, American Pharmacists Association, American Physical Therapy Association, BeMedWise, Caregiver Action Network, Gerontological Society of America, Healthcare Leadership Council, HealthyWomen, Men’s Health Network, Mental Health America, National Alliance of State Pharmacy Associations, National Association of Directors of Nursing Administration, National Association of States United for Aging and Disabilities, National Community Pharmacists Association, National Consumers League, National Transitions of Care Coalition, Pharmacy Technician Certification Board, and the PA Foundation. Our goal is to contribute to solving the opioid crisis in a meaningful way by educating patients about their rights, risks and responsibilities. To learn more, visit www.AgainstOpioidAbuse.org or follow us on Twitter: @AAOA_Tweets.

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.

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 statement on ACIP pneumococcal vaccine recommendation decision

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

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

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.