New York, NY – January 19, 2023 – The National Advertising Division (NAD) of BBB National Programs determined that Novartis Pharmaceutical provided a reasonable basis for the claim that its Kisqali breast cancer treatment drug is “The only CDK4/6 inhibitor with statistically significant overall survival proven across 3 phase III trials” when directed to an audience of health care professionals (HCPs).
However, NAD recommended that a substantially similar claim in consumer-facing advertising, along with several implied comparative superiority claims, be discontinued.
Eli Lilly, manufacturer of the competing Verzenio drug to treat metastatic breast cancer, challenged survival benefit claims made in Novartis’ advertising campaign for Kisqali.
Metastatic breast cancer is presently incurable, however, current treatments can reduce the spread of cancer to other parts of the body, consequently extending time without disease progression (known as progression-free survival) and enabling patients to live longer—an outcome referred to as “overall survival.” Treatments include blocking the estrogen pathway (hormonal therapy), chemotherapy, and targeted treatments, including treatments that function as CDK4/6 inhibitors.
At issue before NAD was whether Novartis’ claims about Kisqali’s overall survival outcomes in clinical trials convey a message of superior survival benefits over other CDK4/6 inhibitors and imply that patients will live longer with Kisqali than when taking any other competitor’s drug in class.
HCP-Directed Advertising
NAD considered the claim that Kisqali is “The only CDK4/6 inhibitor with statistically significant overall survival proven across 3 phase III trials” that appears in HCP-directed advertising. NAD has long recognized that health care providers and specialists are a sophisticated audience and are better equipped to decipher the advertised results of clinical data than the general consumer, especially when provided with appropriate context and detail.
NAD concluded that clinical experience and the context provided in the advertiser’s HCP-directed brochures would both inform the physician’s takeaway of the claim and limit it to the recited facts, and that this audience would interpret the comparative claim here simply as reporting that Kisqali is unique in achieving a statistically significant overall survival benefit across Novartis’ three phase III clinical trials.
After assessing the results of the advertiser’s three clinical trials published in the New England Journal of Medicine, NAD determined that the advertiser had provided a reasonable basis for the HCP-directed claim.
Consumer-Directed Advertising
With respect to the consumer-directed claim, “Only drug in class with consistently proven survival benefit in HR+/HER2- metastatic breast cancer”* *“across three Phase III trials,” NAD determined that the claim was inherently comparative. NAD therefore concluded that one message reasonably conveyed to consumers, who NAD determined lack the medical knowledge or experience to understand nuances in clinical trial design or outcomes, is that Kisqali is more effective and provides superior survival benefits.
Further, NAD determined that due to the numerous variations in trial design and other key metrics across clinical trials, the studies submitted are not similar enough to compare the overall survival data or other results. NAD noted that where express or implied comparative performance claims are being made, head-to-head studies of the products at issue constitute the most reliable and persuasive substantiation.
NAD therefore recommended that in consumer-facing advertising, the advertiser discontinue the claim “Only drug in class with consistently proven survival benefit in HR+/HER2- metastatic breast cancer” * *“across three Phase III trials” as well as the implied claims that:
- Kisqali provides superior survival benefits as compared to any other available treatment in the CDK4/6 inhibitor class generally and to Verzenio specifically.
- Patients will live longer with Kisqali as compared to any other available treatment in the CDK4/6 inhibitor class generally and to Verzenio specifically.
During the proceeding, the advertiser permanently discontinued several challenged express and implied survival benefit claims. Therefore, NAD did not review these claims on the merits.
In its advertiser statement, Novartis stated that although it respectfully disagrees with NAD’s findings, pursuant to NAD’s recommendation, Novartis plans to discontinue the claim in consumer-facing advertising.
All BBB National Programs case decision summaries can be found in the case decision library. For the full text of NAD, NARB, and CARU decisions, subscribe to the online archive.
About BBB National Programs: BBB National Programs, a non-profit organization, is the home of U.S. independent industry self-regulation, currently operating more than a dozen globally recognized programs that have been helping enhance consumer trust in business for more than 50 years. These programs provide third-party accountability and dispute resolution services that address existing and emerging industry issues, create a fairer playing field for businesses, and a better experience for consumers. BBB National Programs continues to evolve its work and grow its impact by providing business guidance and fostering best practices in arenas such as advertising, child-and-teen-directed marketing, data privacy, dispute resolution, automobile warranty, technology, and emerging areas. To learn more, visit bbbprograms.org.
About the National Advertising Division: The National Advertising Division (NAD) of BBB National Programs provides independent self-regulation and dispute resolution services, guiding the truthfulness of advertising across the U.S. NAD reviews national advertising in all media and its decisions set consistent standards for advertising truth and accuracy, delivering meaningful protection to consumers and leveling the playing field for business.
Contact Information
Name: Abby Hills
Email: press@bbbnp.org
Job Title: Director of Communications
New York, NY – January 12, 2023 – The National Advertising Division (NAD) of BBB National Programs examined a number of challenged health-related claims by RhinoSystems, Inc. and found that the challenged packaging claims and many website claims did not convey virus prevention claims. However, NAD recommended that RhinoSystems discontinue certain other health-related claims that appeared in one television and two radio commercials or on the Naväge website, including:
- The express virus prevention claim on the Naväge website “using products such as Naväge Nasal Care not only avoids steroids and pills, but helps to avoid allergies, post-nasal drip, and a cold or flu.”
- Any implied virus prevention claims in its 2022 television commercial, the two challenged radio commercials and on Naväge’s website.
- The claim on the Naväge website “doctors love nasal irrigation.”
The claims at issue were challenged by competitor NeilMed Pharmaceuticals, manufacturer and supplier of competing nasal irrigation systems.
The parties to the challenge did not dispute that saline nasal irrigation “flushes out” viruses or that it provides symptom relief and mitigation. At issue before NAD was whether the advertiser’s express and implied claims convey a message that the use of Naväge or nasal irrigation prevents or reduces the risk of contracting a cold, flu, or other virus and if so, whether those claims are supported.
Virus Prevention Claims
In reviewing the RhinoSystems claims for Naväge, NAD found that certain of the challenged website claims and all challenged packaging claims generally refer to flushing out germ and virus particles and do not rise to the level of virus prevention claims. For example, while some language goes so far as to say after flushing out the germs consumers will feel healthier, there is nothing indicating that use of the product will prevent contraction of the flu or other viral illness.
However, NAD determined that an implied virus prevention message is conveyed in Naväge’s 2022 television commercial, two challenged radio commercials, and by two claims on Naväge’s website which mention flushing out “infectious” germs and/or bacteria.
Cold and flu prevention claims are impactful to consumers and should be supported by competent and reliable scientific evidence that fits the claim. NAD reviewed the evidence provided by the advertiser for claims that the use of Naväge or nasal irrigation can help consumers avoid or prevent the contraction of infectious diseases like the cold and flu and found that the advertiser’s support for its claims included studies with methodological flaws with respect to the populations, controls, and different methods of delivery that were not a good fit for the broad prevention claims. Accordingly, NAD recommended that such claims be discontinued.
“Doctors Love Nasal Irrigation” Claim
NeilMed objected to claims on Naväge’s website that state, “Doctors Love Nasal Irrigation. Why? Because it’s clinically proven to relieve sinus congestion safely and effectively by flushing out allergens, mucus, and infectious airborne germs. And it does this completely naturally without drugs.”
While NAD did not agree with NeilMed that the “doctors love” claim indicates a doctor preference for Naväge specifically, NAD did conclude that it conveys the message that a significant number of doctors have come to a consensus; therefore, such a claim requires a well-conducted, random, and statistically significant survey of doctors as substantiation.
NAD determined that the evidence in the record regarding recommendations by medical associations and institutions of nasal irrigation is not a good fit to substantiate the more general claim at issue, and recommended that the claim be discontinued. NAD noted that nothing in its decision prevents the advertiser from making a more limited claim based on the specific recommendations of medical associations and institutions in the record.
During the proceeding, RhinoSystems voluntarily discontinued certain pandemic-related challenged claims, that appeared in a television commercial on the Naväge website therefore, NAD did not review these claims on the merits.
In its advertiser statement, RhinoSystems stated that it “will comply with NAD’s recommendations.” The advertiser further stated that while it respectfully disagrees with NAD’s conclusions regarding the lack of fit between its studies and the challenged claims and continues to believe that its claims are supported, “RhinoSystems is a supporter of the self-regulatory process and will take NAD’s recommendations into account in future advertising.”
All BBB National Programs case decision summaries can be found in the case decision library. For the full text of NAD, NARB, and CARU decisions, subscribe to the online archive.
About BBB National Programs: BBB National Programs, a non-profit organization, is the home of U.S. independent industry self-regulation, currently operating more than a dozen globally recognized programs that have been helping enhance consumer trust in business for more than 50 years. These programs provide third-party accountability and dispute resolution services that address existing and emerging industry issues, create a fairer playing field for businesses, and a better experience for consumers. BBB National Programs continues to evolve its work and grow its impact by providing business guidance and fostering best practices in arenas such as advertising, child-and-teen-directed marketing, data privacy, dispute resolution, automobile warranty, technology, and emerging areas. To learn more, visit bbbprograms.org.
About the National Advertising Division: The National Advertising Division (NAD) of BBB National Programs provides independent self-regulation and dispute resolution services, guiding the truthfulness of advertising across the U.S. NAD reviews national advertising in all media and its decisions set consistent standards for advertising truth and accuracy, delivering meaningful protection to consumers and leveling the playing field for business.
Contact Information
Name: Abby Hills
Email: press@bbbnp.org
Job Title: Director of Communications
Private Student Loan Originations Rebounding, Use of Forbearance Decreases, and Default Rates are Normalizing to Pre-Pandemic Levels
January 11, 2023 – Enterval Analytics, LLC., has released the 19th edition of the bi-annual Private Student Loan Report which confirms that the majority of private student loan borrowers are effectively managing their payments.
Private student loans are fully underwritten to assess creditworthiness, ability to repay, and are certified by the school with 90.78% of undergraduate loans cosigned. Approximately 7.22% of total student loans outstanding as of Q3 2022 are Private Student Loans. The remaining 92.78% of the $1.76 trillion in student loans are federal loans owned or guaranteed by the U.S. Department of Education. The Private Student Loan Report (“Report”) reflects data as of Q3 2022 for private student loans and does not include federal student loan data.
The latest Q3 2022 Private Student Loan Report highlights two additional quarters of generally strong private student loan repayment. Borrower forbearance utilization remains near record lows at 1.30% for Q3, down 82% from its peak of 7.04% when disaster relief programs were made available across the industry in response to the pandemic. As expected, early-stage delinquencies have been elevated and show signs of stabilizing over the last year in the historically normal range of 2.5% to 3.3%.
At the end of Q3 2022, late-stage delinquencies and gross charge-offs are at 1.58% and 2.86%, respectively. Late-stage delinquencies are in-line with pre-pandemic levels that hovered between 1.32% and 1.88% going back to 2017. Annualized gross charge-offs are about 80bps higher than average over the same pre-pandemic period. However, the average charge-off rate since the pandemic is 1.64%, well in-line with historical norms. We expect these repayment trends to continue to normalize.
“The pandemic disaster relief more than doubled the forbearance rates across the private student loan industry but most of the disaster relief programs have ended and forbearance has dropped to near historic lows. Current elevated late-stage delinquencies and charge-offs are in-line with historical norms especially when taken in the context of the significantly reduced charge-offs during the last 3 years,” said John Falb, CEO of Enterval Analytics. “While we are now starting to expect some consumer economic pressure on the horizon, the job market is healthy, and higher education is vital to the U.S. economy.”
The total outstanding balance for private student loans represented in the Report was $ 127.24 billion (including in-school loans but excluding consolidation, refinance and parent loans). Undergraduate loans accounted for 88.44% and graduate loans 11.56% of loans originated in AYTD 2021/22.
The bi-annual Report includes continuous contributions from the five largest student loan lenders and holders: Citizens Bank, N.A., Discover Bank, Navient, PNC Bank, N.A., and Sallie Mae Bank. In addition, the report includes data from seven other student lender contributors. In total, these contributors represent the vast majority of in-school originations and a majority of the private student loans outstanding in the U.S.
The full Private Student Loan Report is available for download at https://www.enterval.com/#reports
About Enterval Analytics, LLC.
Enterval Analytics was formed to provide industry leading research, tools, and insights for the private student loan market. Previously, the private student loan report was published by MeasureOne. In 2021, Enterval acquired certain reporting assets of MeasureOne and has assumed the lead in creating this report.
Enterval has a dedicated team of seasoned professionals, with specialized experience in data analysis, finance, student loan portfolio management, higher education policy, public and government relations—Enterval is uniquely positioned to deliver reporting and software tool solutions focused on the higher education space. For more information about Enterval, visit www.enterval.com.
Media Contact:
John Falb
Enterval Analytics, LLC
jfalb@enterval.com
(702) 777-8480
Contact Information
Name: Elaine Rubin
Email: sales@enterval.com
Job Title: Director of Corporate Communications
McLean, VA – January 10, 2023 – BBB National Programs today announced the 91 panel pool members of the 2023 National Advertising Review Board, the appellate body for the U.S. advertising industry’s system of self-regulation.
The National Advertising Review Board panel pool members, selected for their stature and experience in their fields, provide independent peer review to ensure truthfulness and accuracy in national advertising and help promote voluntary compliance with self-regulatory decisions.
Founded in 1971, the National Advertising Review Board provides appellate review of BBB National Programs’ National Advertising Division and Children’s Advertising Review Unit decisions. In more than 90% of case decisions, companies voluntarily comply with any advertising recommendations made. In situations where an advertiser fails to make good-faith efforts to modify or discontinue advertising as recommended, cases are referred to the appropriate regulatory agency. These advertising programs are three of more than a dozen self-regulatory, accountability, and dispute resolution programs of the independent non-profit organization, BBB National Programs.
For 2023, panel pool members include 91 distinguished leaders from three different categories:
- National Advertisers
- Advertising Agencies
- Public Members (academics and other members of the public sector)
A National Advertising Review Board appellate panel generally consists of five members from the pool, with three national advertising representatives, one agency representative, and one public sector representative on each panel.
Nominations for National Advertising Review Board panel pool members are made by the Association of National Advertisers (ANA), American Association of Advertising Agencies (4A’s), American Advertising Federation (AAF), Interactive Advertising Bureau (IAB), and BBB National Programs. The initial term is two years, and each member is eligible to be re-appointed for two additional two-year terms. This year 22 new members join 69 individuals returning to their distinguished roles.
“I am thankful to our industry association partners, which this year also includes the Interactive Advertising Bureau, for nominating our diverse and highly talented 2023 National Advertising Review Board panel pool members,” said Eric D. Reicin, President and CEO, BBB National Programs. “I am honored to welcome our new and returning distinguished panel pool members to their 2023 role of helping resolve truth-in-advertising disputes and enhance consumer trust.”
Following is the list of BBB National Programs’ National Advertising Review Board panel pool members for 2023.
New Panel Pool Members
New Public Members
- Jeffrey J. Maciejewski, PhD, Professor, Department of Computer Science, Design and Journalism, Creighton University
New Agency Members
- Celeste Castle, EVP, Head of Research and Measurement, Amplifi USA
- David Lane, Co-Founder, LevLane
- Peggy Nordeen, CEO, Starmark
- Andy Pray, Founder & CEO, Praytell
- Sharon Tallach Vogelpohl, President & Chief Executive Officer, MHP/Team SI
New Advertising Members
- Lynne Bartron, Vice President, Global Consumer Marketing, Gen Digital Inc.
- Laura Brewick, SVP, Marketing, Serta Simmons Bedding
- Stephen Cassell, Chief Marketing & Brand Officer, Point32Health
- Matt Casselton, VP, Marketing and Consumer Engagement, Trinity Health
- Jill Cress, Chief Marketing and Experience Officer, H&R Block
- Nicolle DuBose, Vice President and Head of Marketing for Schlotzsky’s, Focus Brands
- Rebecca Duke, Head of Portfolio Marketing, Platforms and Partnerships, Mondelez International
- Fernando Herrera, Vice President of Imaginarium & Marketing, Sun-Maid Growers of California
- Ivonne Kinser, Vice President of Marketing and Innovation, Avocados from Mexico
- David Lee, Global Senior Director of Licensing and Cultural Marketing, Kellogg
- Linda Lee, Chief Marketing Officer, Meals & Beverages, Campbell Soup Company
- Phil McWaters, Senior Vice President, Global Personal Health Care, Procter & Gamble
- Kevin L. Miller, Chief Marketing Officer, The Fresh Market
- Brad Moranchek, Head of Global Integrated Media, Kimberly-Clark Corp.
- Dana Paris, Chief Marketing Officer, Canidae Pet Food
- Chris Phillips, VP, Branded Content Sales & Strategy, Realtor.com
Returning Public Members
- Jenny Buschhorn, Assistant Professor of Practice, Advertising Program Head, Texas State University
- Margaret (Meg) C. Campbell, Professor of Marketing, Anderson Presidential Chair in Business Administration, School of Business, University of California, Riverside
- Debra (Debbie) M. Desrochers, B.S., M.B.A., Ph.D., Senior Lecturer, Management, Director of Studies MRes in Management, Marketing, Business & Society, Centre for Business, Organisations and Society (CBOS), University of Bath
- Allen Garcie, Associate Professor of Digital Arts, Sybil T. & J. Frederick Patten Endowed Professor, Director, LaPIXEL Digital Arts & Media Academy, Designer/Facilitator, IdeaSpace, Department of Arts and Media – Digital Arts Program, Louisiana State University Shreveport
- Nancy J. Gray, Clinical Assistant Professor, P. Carey School of Business, Arizona State University
- Timothy Hendrick, Associate Professor, Advertising, School of Journalism & Mass Communication, San Jose State University
- Glynnis M. Johnson, Assistant Professor-Marketing, Morehouse College
- Alice Kendrick, Professor of Advertising, Southern Methodist University
- Peg Murphy, Associate Professor, Communication Dept., AAF AdClub Advisor, Columbia College Chicago
- Joel M. Nichols, M.B.A., Assistant Professor, Department of Journalism and Strategic Media, The University of Memphis
- Daniel John Petek, Education Board of Directors, AAF, Advertising Instructor, Washington State University
- Larry Powell, Professor, Advisor for Lindsey + Asp, Advertising & Public Relations, Gaylord College, University of Oklahoma
- Jan LeBlanc Wicks, Professor & Vice Chair, School of Journalism and Strategic Media, University of Arkansas
Returning Agency Members
- Wendy Aldrich, EVP, Managing Partner, Universal McCann
- Michael Bassik, Founder & CEO, Axel Solutions, LLC
- Brad Bennett, Chief Firestarter, Wildfire
- Scott Bishoff, SVP Client Director, Canvas World Wide
- Allen Bosworth, President, EP+Co
- Laura Jean Bracken, President/COO, Palisades
- Dean Broadhead, CEO, broadhead.
- Jeffrey Buntin, Jr., President & CEO, The Buntin Group
- Brad Casper, Chief Executive Officer, Heart and Soul Marketing
- Jason Chebib, GM, The Americas, System1
- Brandon Cooke, Global Partner, Global Chief Marketing & Reputation Officer, FCB
- Stephanie Crockett, President & COO, Mower
- Steve Erich, Founder & President, Erich & Kallman
- Fay Ferguson, Co-Owner & Co-CEO, Burrell Communications
- Marina Filippelli, CEO, Orci
- Cary Hatch, Managing Director, Hart MDB+
- Patrick Kiss, President, BSSP
- Jeff Larson, President/COO, Mediassociates
- Victor Lee, President, Advantage Unified Commerce, Advantage Solutions
- LuisMiguel Messianu, Founder, Creative Chairman & CEO, Alma
- Bob Morrison, CEO, Morrison Agency
- Krista Nicholson, President, Motive
- Ingrid Otero-Smart, President/CEO, Casanova//McCann
- Dave Ronk, Marketing Engineer, The Shipyard
- Tom Stein, Chairman and Chief Client Officer, Stein IAS
- Duff Stewart, CEO, GSD&M
- Meredith Vaughan, CEO, Vladimir Jones
- Aaron Walton, CEO, Walton Isaacson
Returning Advertising Members
- Nicole Apple, ANA Agency Relations Committee Co-Chair, Former Head of Global Strategic Agency Management, Kimberly-Clark Corporation
- Homi Battiwalla, Senior Marketing Director – Global Marketing Excellence, PepsiCo Global
- Maya Battle, Director, Marketing Intelligence, Macmillan Publishers
- Adam Benaroya, Director, Global Media Capabilities & Operations, Johnson & Johnson Consumer Health
- Katrina Bott, Senior Director, Global Strategic Sourcing, Capri Holdings Limited
- Denis Budniewski, Director, Marketing, Agency Strategy and Production Transformation, Verizon
- Amy Bytell, Senior Marketing Manager, Performance Media, Cox Automotive
- Charles Chappell, Vice President, Innovation and R&D, The Hershey Company
- Michael Cruz, VP of Marketing, National Cycling League
- Olivier Fleurot, Ph.D., Global Vice-President, Research, Development & Innovation, S. C. Johnson & Son, Inc.
- John Fredette, Head of Brand and Marketing, Corporate Affairs, Con Edison
- Katherine Freeley, Global Head of Media & Digital, Procurement, Novartis
- Linda Gharib, Director, Brand and Corporate Communications, Wolters Kluwer
- Daniel Glantz, Former Global Head of Sponsorship and Strategic Partnerships, AIG
- Lee Hsieh, Global CRM & Digital Experience Acceleration Lead, Johnson & Johnson Consumer Health
- Alia Kemet, Senior Vice President, Global Creative & Digital Transformation, McCormick & Company, Inc.
- Valerie Light, Former Manager, Broadcast Production, Verizon Communications
- Jim Low, President, Rip Van
- Ian McDonald, Global Category Manager, Marketing Procurement, Edgewell Personal Care Brands
- Renee Milliaressis, Chief Media Officer, Colgate-Palmolive
- Jason Morros, Vice President, Head of Integrated Marketing, Edison Properties
- Gary P. Osifchin, CMO and GM, U.S. Hygiene, Reckitt Benckiser
- Justin Parnell, Vice President, Marketing, Strategy & ESG, Mondelez International, Inc.
- Simona Rabsatt Butler, Director, Global Sourcing – Media, Visa
- Erin Silver, Director, Social Media and Growth Marketing, Exclusive Resorts
- Amy Spiridakis, Vice President, Marketing, Target Corporation
- Kwan Yim, Director, Head of Global Agency Management, Citi
- Doug Zarkin, Vice President, Chief Marketing Officer, Pearle Vision
Learn more about the National Advertising Review Board here.
About BBB National Programs: BBB National Programs is where businesses turn to enhance consumer trust and consumers are heard. The non-profit organization creates a fairer playing field for businesses and a better experience for consumers through the development and delivery of effective third-party accountability and dispute resolution programs. BBB National Programs oversees more than a dozen leading national industry self-regulation programs and continues to evolve its work and grow its impact by providing business guidance and fostering best practices in arenas such as advertising, child-directed marketing, dispute resolution, automobile warranty, privacy, and emerging areas. To learn more, visit bbbprograms.org.
Contact:
Abby Hills, Director of Communications
BBB National Programs
703.247.9330 / press@bbbnp.org
