Category Archives: Policy

Our Comments on Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination FDA Draft Guidance

Environmental Exposures, Policy

September 11, 2023

We appreciate the opportunity to comment and support FDA’s proposed rule regarding: “Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry Draft Guidance.”

We are a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

Due to the growing rate of Americans getting tattoos and increased reports of infections related to contaminated tattoo ink, we agree this is an important public health issue that needs to be addressed. Microbial contamination of tattoo inks can occur in nearly 50% of inks on the market in the United States, which can include organisms that are known to cause serious infection and are highly resistant to antibiotics.1  We support the FDA’s objectives of ensuring that ink products are unadulterated and holding manufacturers accountable for contaminated products.

While the act of tattooing is primarily regulated by state, local, and tribal public health authorities, the FDA has the authority to regulate tattoo ink. In addition to microbial contamination, pigments have been found to contain potentially toxic chemicals, heavy metals, degradants, printer toner, car paint, and other substances that were not intended to be used on the human body.2  We agree that the FDA needs to provide guidance that will better support state, local, and tribal public health agencies to help address the growing public health burden of unsafe tattoo ink. This is especially relevant as many local tattooing regulations have recently been found to be outdated as well as inconsistent.

Accordingly, we recommend that the FDA provides explicit guidance regarding the labeling of tattoo inks. While tattoo ink manufacturers are required to include ingredient and safety risks as part of the labeling requirements under the Fair Packaging and Labeling Act, these labels are rarely seen by consumers since the ink is often purchased in bulk by tattoo studios.3 We strongly urges the FDA to require that user-friendly labels for tattoo ink be made available online to consumers prior to getting tattoos; preferably, in a consumer checklist that they must sign, so that they have the information they need to make informed decisions on the risks of tattooing.

We also recommend that the FDA include clear, understandable guidance regarding the water and dilution techniques that should be used to achieve color variation in tattoo studios. This is of particular importance as non-sterile dilution techniques were a primary cause of the nontuberculous mycobacterial skin infection outbreak that was referenced in FDA’s draft guidance. A common practice for tattoo studios is to use distilled or reverse osmosis water for dilution. However, these are non-sterile techniques, and the FDA should prohibit such techniques and instead require and explain the importance of sterile dilution techniques.

We are also concerned about the voluntary reporting system of contaminated ink products, which primarily relies on consumers. This places the burden of contamination identification and reporting on the consumer rather than the manufacturer, and also undermines the responsibility of the manufacturer to ensure that their products are unadulterated. In addition, since consumers are rarely aware of existing reporting mechanisms, the FDA should require that tattoo studios educate consumers on how to report adverse events caused by contaminated ink. We also agree with the FDA’s recommendation that tattoo ink and ink components be tested for microbial contamination and that tattoo establishments be required to discard contaminated products. Although we are concerned that the lack of proposed manufacture accountability and enforcement mechanisms, traceability, and regulatory incentives will lead to noncompliance, having such requirements will increase the risk of lawsuits for noncompliance, and that will serve as an incentive to comply with FDA requirements.

It is estimated that nearly one-third of Americans have a tattoo with reports of microbial contamination at a staggering 49%1,4 Thus, there is a great need to better regulate tattoo ink and raise awareness among the public about the risks of unsafe tattoo ink. We support the objective of the FDA in helping manufacturers to identify and discard adulterated ink to better protect public health. However, we recommend that ink labels be made readily available to consumers and sterile dilution techniques are included in the final guidance. We also strongly recommend that the FDA develop an information toolkit to increase consumer awareness regarding contamination reporting systems in tattoo studios, while working to build robust mechanisms for manufacturer reporting, traceability, and accountability.

As noted above, in addition to microbial contamination, pigments have been found to contain potentially toxic chemicals, heavy metals, degradants, printer toner, car paint, and other substances that were not intended to be used on the human body. The rate of ink contamination with unsafe substances that include but are not limited to microbial contamination has been reported as high as 67%.5 Therefore, we strongly urge the FDA to expand the regulation of all types of dangerous substances in this draft guidance or develop a similar draft guidance specifically to reduce the risks caused by these other dangerous substances.

References:

  1. Nho, SW et al. “Microbiological Survey of Commercial Tattoo and Permanent Makeup Inks Available in the United States.” Journal of Applied Microbiology, 124: 1294-1302 (2018).
  2. “NEHA Response to Request from FDA for Good Manufacturing Practices on Tattooing Inks and Pigments.” 2023.
  3. Association of Food and Drug Officials, Body Art Committee. “Tattoo Ink and Permanent Makeup Labeling Guide.” 2019.
  4. Pew Research Center. “32% of Americans have a tattoo, including 22% who have more than one.” 2023.
  5. Bonadonna, Lucia. “Survey of Studies on Contamination of Marketed Tattoo Inks.” Karger. 2015.

Our Comments on the FDA Proposed Guidance Regarding the Registration and Listing of Cosmetic Product Facilities and Products

Policy

September 7, 2023

We appreciate the opportunity to comment on the Food and Drug Administration proposed guidance: Registration and Listing of Cosmetic Product Facilities and Products; Draft Guidance for Industry.

We are a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We strongly support the purpose and requirements included in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which was part of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328) related to the regulation of cosmetic products. These regulations are long overdue and an essential first step toward protecting public health through the disclosure of the ingredients in these ubiquitous products and the registration of the facilities that make these products. Research has documented scientific concerns about the presence of endocrine disrupting chemicals in cosmetics and their effect on consumers’ health.[1],[2],[3] Some hormone disruptors such as phthalates and parabens are found in a wide range of cosmetic products. Other hormone disrupting substances are used in specific cosmetics, such as triclosan in toothpaste and mouthwash; this chemical ingredient was previously banned from soap products by the FDA in 2016. It is essential that the public be made aware of the potential for cumulative exposure to substances in many different makeups, creams, and other cosmetic products used every day.

We are very supportive of the requirements included in MoCRA, but have four recommendations to improve the proposed guidance:

  • We are concerned that the FDA does not plan to transfer the voluntary cosmetics registration program to this new system. We agree that previous submissions to the voluntary cosmetics registration program fail to satisfy the registration and listing requirements, since that information differs from the information required to be submitted under MoCRA. However, there is likely to be substantial overlap of information. We recommend that these entities should be required to register their facilities and submit product listings even if they voluntarily provided similar information previously. If information is not transferred, where will previously submitted voluntary information be stored? Will it be available to the public?
  • Regarding the requirements set for a product listing, we strongly urge that all fragrance ingredients be required to be listed. Fragrance ingredients in self-care products such as shower gels, shampoos, body lotions, and shaving creams are often labeled “unscented.” This is because manufacturers are not obligated to label the fragrance in the ingredient list if the amount added is just enough to cover the scent of other ingredients versus giving the product a noticeable scent.[4] This is not an appropriate justification. All fragrance ingredients added to the product, no matter how minimal, should be included in the product listing. It is not enough to simply list the product as containing “fragrance” or “flavor” as is required under section 701.3 of title 21, Code of Federal Regulations. A more detailed ingredient list is essential and would not jeopardize trade secrets since according to the guidance document, brand names will not be disclosed publicly.
  • Regarding the requirements set for a facility registration, we support the requirements listed in the guidance but also recommend the disclosure of the amount of the product manufactured or processed in each facility in the year prior to the initial registration. Production levels should also be included in each renewal of registration biennially.
  • According to the guidance, the “FDA requests that individuals submitting registration and listing information to attest to the accuracy and veracity of the information submitted.” The guidance does not specify how violations or inaccuracies in the registrations and product listings will be enforced.  It is essential the manufacturers comply with the requirements in order to ensure transparency, and enforcement is necessary to achieve that goal.

1. Ejaredar, M., Nyanza, E., Eycke, K., Dewey, D. (2015). Phthalate Exposure and Childrens Neurodevelopment: A Systematic Review. Environ Res 142:51-60.

2. Diamanti-Kandarakis, E., Bourquioqnon, J., Giudice, L., et al. (2009). Endocrine-Disrupting Chemicals: An Endocrine Society Scientific Statement. Endocr Rev 30(4):293-342.

3. Harley, K., Kogut, K., Madrigal, D., Cardenas, M., et al. (2016) Reducing Phthalate, Paraben, and Phenol Exposure from Personal Care Products in Adolescent Girls: Findings from the HERMOSA Intervention Study. Environ Health Perspect In Press.

4. Sun, A. (2023) Everything you need to know to choose safe cosmetic products. National Center for Health Research. https://www.center4research.org/cosmetics-safety-regulations-law-tips/

Our Comments on the FDA Notice Regarding Changes to Third-Party Vendors for Risk Evaluation and Mitigation Strategies (REMS)

Policy

July 19, 2023

We are pleased to have the opportunity to share our views with the Food and Drug Administration (FDA) on their notice regarding Changes to Third-Party Vendors for Risk Evaluation and Mitigation Strategies (REMS).

We are a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

Implementing changes in REMS has the potential to cause significant disruptions in the operations of any REMS program, including the ability for prescribers and patients to interact with the tools necessary to fulfill the various REMS requirements. These disruptions can undermine patients’ ability to access a drug in ways that minimize risks. Since the FDA does not approve third-party REMS administrators, or play a major role in the initial development of REMS with elements to assure safe use (ETASU), it is essential that the FDA closely monitors any changes in REMS plans to make sure they are appropriate and yield beneficial outcomes.

We strongly urge that the FDA require drug sponsors and their REMS administrators to test proposed changes to REMS systems prior to implementation with those that actively engage with the system, including but not limited to physicians, patients, and pharmacists. This will ensure that the REMS program will have the intended impact. A less-than-rigorous approach to studying the efficacy of REMS defeats the purpose of REMS and fails to protect patients from predictable harm. The FDA REMS for Transmucosal immediate-release fentanyl (TIRF) drugs and the REMS for Extended Release/Long Acting (ER/LA) opioids provide important examples of how improper implementation of REMS can harm patients. The HHS IG found numerous failures for both these REMS programs, at a time when these REMS were especially important because of the opioid epidemic.1 For example, manufacturers consistently missed the REMS’ targets for training ER/LA prescribers, and the FDA was blamed for not giving manufacturers sufficient time to respond to FDA’s requests for better data before their next assessments were due. As a result, the REMS for ER/LA opioids was changed to primarily measure voluntary prescriber training to educate about risks, a decision that also failed to adequately protect patients.

We also strongly recommend that the sponsor and/or the REMS administrator conduct a Failure Modes and Effects Analysis (FMEA) to identify and plan for system failures. This includes providing for adequate support services in the event that the system fails to work as intended following full implementation of an altered REMS system. Part of the planning should include provisions for an emergency suspension of the REMS or specific parts of the REMS.

Additionally, beyond testing a REMS modification with stakeholders, FDA should require stakeholder input from prescribers in all stages of developing, implementing, and tracking a REMS modification related to changes to third party vendors. This will require greater transparency between drug sponsors, REMS administrators, and stakeholders.

In numerous REMS, the FDA has faced measurement challenges, such as a lack of baseline data and limited surveillance data. These metrics are essential for the sponsor to include when evaluating whether a REMS system was successfully and efficiently implemented. It is also essential to collect data on which types of health professionals are involved in implementing a specific REMS. For REMS that involve training of health professionals, there must be a record of the percentage of prescribers being trained, the percentage who start training who complete it, and what percentage that complete the training will answer training questions correctly.

Finally, we strongly recommend that all future REMS agreements that the FDA enters into with manufacturers and their vendors, require that deidentified REMS data be made available to appropriate outside stakeholders. The availability of this data will reassure the public, patients, and health care providers that each REMS is accomplishing its intended outcomes and promoting the safe use of drugs while minimizing harm, especially serious harm.

  1. U.S. Department of Health and Human Services Office of Inspector General. (2020). FDA’s Risk Evaluation and Mitigation Strategies: Uncertain Effectiveness in Addressing the Opioid Crisis. https://oig.hhs.gov/oei/reports/OEI-01-17-00510.pdf

Our Comments on the FDA’s Use of Generally Accepted Medical Knowledge Draft Guidance

Policy

July 24, 2023

We are pleased to have the opportunity to share our views with the Food and Drug Administration (FDA) on their Guidance: Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information.

We are a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We support the efforts of the FDA to remain flexible and provide a more open application of scientific and regulatory judgment when conducting nonclinical studies that determine in vitro safety and efficacy. We recognize that this has the potential to streamline product development as well as avoid unnecessary animal testing, decrease costs, and hasten new drug approval time.  However, we predict that this will result in some sponsors providing insufficient data to show the safety, toxicology, and efficacy profile of a drug.

For that reason, we do not recommend using Generally Accepted Scientific Knowledge (GASK) as the sole source of nonclinical data in New Drug Applications (NDAs) or Biologic License Applications (BLAs). Instead, GASK should only be used to support sponsor data and should not replace the vital research that is needed to create a robust safety and efficacious drug profile.

Permitting GASK as the sole or primary evidence would often create a level of ambiguity regarding a drug’s true pharmacologic, distributive, and toxicologic effects. We support sponsor communication that is clear and data that are unequivocal, so that potential harms are minimized. We strongly encourage that the GASK used be: 1) long-standing, 2) uncontroversial, and 3) scientifically robust.  However, we note that even when the generally accepted scientific knowledge being relied upon is uncontroversial, long-standing, and scientifically robust, the external application of that information by the sponsor may be inappropriate. For example, even when a drug’s mechanism of action or the biologic pathway that a drug acts on is well understood, the drug should still be tested to assure that there are no downstream or unanticipated effects when in vitro to the full extent possible, and not solely rely on GASK.

In conclusion, we appreciate the opportunity to comment and support the efforts of the FDA to streamline product development and avoid unnecessary animal testing, decrease costs, and hasten new drug approval time. However, this must be better balanced with the need for sponsors to provide clear, unambiguous data regarding the pharmacologic, safety, and effectiveness profile of new drugs and not use GASK as a means of replacing vital research. To that end, we strongly urge the FDA to revise the proposed GASK guidance to require comprehensive and precise language on when using GASK by the sponsor is appropriate.

Testimony of Diana Zuckerman at the CMS Meeting Regarding Transitional Coverage for Emerging Technologies

Policy

August 1, 2023

I’m Dr. Diana Zuckerman, president of the National Center for Health Research and Cancer Prevention and Treatment Fund.  Our Center is a public health think tank that focuses on policies and programs that increase the safety and effectiveness of medical products.

We support the goals of the TCET program, but we see an enormous disconnect between the types of evidence that FDA requires for breakthrough devices, especially for 510k devices, and the CED standards that CMS requires for coverage.  We hear a lot about flexibility from FDA and industry but not enough about scientific evidence of safety or effectiveness.  Innovation should be defined to require that a device is proven to be better, not just newer.  We urge CMS to work with industry to make it clear that CMS evidence standards of clinical benefit are very different from the standards required by CDRH.  And we urge CMS to urge companies to provide the evidence needed to be worthy of CMS coverage.

Let’s remember that the standards for FDA for devices are not proof of safety or effectiveness, but rather the “reasonable assurance of safety and effectiveness.”  And often that “reasonable assurance” is not so reassuring.

I want to reiterate the previous comment that even when the FDA requires clinical data, many types of Medicare beneficiaries are under-represented:  older patients, people of color, and women.

I want to thank CMS for this effort to improve access to safe and effective medical products and urge CMS to hold firm to its standard for coverage based on scientific evidence that all medical products are proven to be reasonable and necessary for Medicare patients.

Our Comments on FDA Guidance Regarding Decentralized Clinical Trials for Drugs, Biological Products, and Devices

Policy

August 1, 2023

We are pleased to have the opportunity to share our views with the Food and Drug Administration (FDA) on their draft guidance regarding Decentralized Clinical Trials (DCTs) for Drugs, Biological Products, and Devices.

We are a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

DCTs have the potential to increase inclusion of underserved or rural communities and patients who are home-bound. It reduces geographic barriers by enabling patients to participate in clinical trials even if they do not live near a study site. This is much more convenient than traveling to a conventional study for medical interventions, data collection, assessments, and follow-up visits. However, the FDA and those conducting DCTs must also recognize how they could inadvertently reduce the enrollment of diverse populations when relying on digital health technologies (DHTs). The inability to access DHTs or lack of familiarity or comfort with DHTs could limit or prevent enrollment of older adults and children, participants living in rural areas, people who speak a language other than English, and people who have lower literacy skills or lower income. We recommend that FDA revise the guidance to incorporate the following strategies when implementing DCTs, including those that use DHTs:

  1. The guidance should incorporate information on how patients who decide to use their own DHTs during DCTs differ from those individuals who are provided a DHT during the study. Patients who regularly use these tools before study participation may differ in terms of several baseline health characteristics, vary in socioeconomic status, or have different health habits than those who do not have DHTs. Data recorded during a trial should include information on a participant’s prior device experience, as well as reasons for use, and include these variables in study analysis, as prior experience with a device could affect outcomes.
  2. DCTs using DHTs should consider and plan for the consistent availability and use of the same DHTs over time, even if newer versions of a device are introduced, as these updates could affect trial performance. Additionally, DHTs that require software on a participant’s phone or computer could undergo multiple app updates over the course of the study, with the potential to add new features that affect data input. Investigators must plan to follow-up with participants whenever major software updates occur.
  3. The FDA guidance mentions that sponsors should consider syncing information recorded by DHTs across different platforms. Digital health sources such as electronic health record (EHR) portals or portals linking data from personal digital devices, can be disconnected during the course of the DCT and require significant additional effort to reconnect. These disconnections can come from password changes and security issues which can result in the loss of data, which may be temporary or permanent depending on the willingness or ability of the participant to reconnect. Planning for this possibility is essential to ensure comprehensive data capture. Study teams should regularly review the completeness and quality of the DHT data over the course of the study to reduce missing data.
  4. The guidance mentions that, “training should be provided to all parties (e.g., trial personnel, local HCPs, and trial participants)” related to the software used in DCTs. This should apply to all DHTs and, as appropriate, should include caregivers who may assist study participants during DCTs.
  5. Although FDA states that researchers “should attempt” to collect data regarding healthcare services provided outside the study site. This does not adequately provide explicit directions on how to provide information regarding unexpected or routine visits to non-study sites, such as an ER visit for an adverse event that may or may not be obviously related to the clinical trial. The FDA guidance recommended that providers outside of the clinical trial not be included in the task log, which tracks health care providers that perform trial-related activities. However, if that information is not collected and evaluated, then significant information about safety issues would inevitably be missed. FDA should explicitly address how potentially important information should be included in the task log and re-evaluate the need to include these data points.

Biden’s Crackdown on ‘Junk’ Plans: Minimal Impact on Payers

In the News, Policy, We're In the News

Jesus Mesal, Health Payer Specialist, July 14, 2023

The Biden administration’s proposed restrictions on short-term private health plans aim to protect consumers, but they raise questions about the future value potential of a thriving market segment and do little to quell the controversy about insurance criticized by some as “junk.”

Short-term plans offer flexible coverage periods, such as 30 days or three years, and cost 50% to 80% less than individual market coverage. They are not regulated to the same extent as plans offered in the Affordable Care Act insurance marketplaces and can, for example, exclude pre-existing conditions or limit the number of visits or coverage amounts.

The proposal from the Department of Health and Human Services, the Labor Department’s Employee Benefits Security Administration, and the Internal Revenue Service would restrict them to three months, or to four months at a maximum.

These “misleading insurance products” can “trick consumers into buying products that provide little or no coverage when they need it most,” says a joint statement from the agencies.

[….]

The plans, devised as a way for consumers to plug short-term gaps in coverage, have remained a source of political contention since the ACA was enacted in 2010. In 2016, the Obama administration limited their coverage period to three months to address concerns that consumers might choose these plans over comprehensive coverage under the ACA.

Two years later, former President Donald Trump reversed the rule, arguing that consumers should have choice. He extended the allowable duration of short-term plans to a year, with option for consumers to renew them for up to three years. Unlike the ACA’s once-a-year open-enrollment period, these plans are accessible at any time during the year.

Growing market

Since the policy swing, the short-term health insurance market has emerged as a thriving segment experiencing significant growth. The firm Persistence Market Research reports that its value reached $41.1billion in 2022, with the Trump administration rule change playing a substantial role in this expansion.

Mixed opinions

Democratic lawmakers have long advocated for measures to limit the impact of short-term plans. They argue that these lower-cost plans provide minimal coverage and have the potential to lure Americans away from more-comprehensive ACA plans.

The proposed rule could increase ACA marketplace enrollment by an estimated 60,000 individuals in the years2026, 2027, and 2028. Enrollment in ACA plans hit 16.3 million people this year, according to HHS.

“They are called ‘junk’ plans for a reason,” said Diana Zuckerman, president of the National Center for Health Research. Zuckerman questioned why the Biden administration took so long to take this step and does not agree with the argument that having one of these plans is better than having no coverage at all. Short-term plans end up being more expensive for Americans because many people cannot afford the bills they receive when they do not have coverage for emergencies, she said.

“When more people have high-quality health insurance, we are all better protected. These plans do not provide the 10 essential health benefits required by the ACA,” she told Health Payer Specialist. “People claim they have a choice, but what we have observed is that due to misleading marketing, many customers do not fully understand what they are purchasing, and it ends up costing millions of dollars for all Americans.”

[….]

Our Public Comment on HHS Draft Framework to Support and Accelerate Smoking Cessation

Policy

We appreciate the opportunity to submit public comments to the Department of Health and Human Services (HHS) regarding their Draft HHS 2023 Framework to Support and Accelerate Smoking Cessation.

This is an incredibly important issue and we understand that this framework, and its goals, will guide HHS cessation efforts moving forward. We are a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest. Below are recommendations for HHS to consider as the smoking cessation framework is developed.

BACKGROUND INFORMATION

Cigarette smoking is the leading cause of preventable death and illness in the United States. More than 480,000 die annually from smoke-related illnesses and approximately $240 billion was spent on healthcare for smokers in 2018.[1] Safe and effective cessation treatments and techniques are needed to improve the health and longevity of individuals living in the United States. A 2015 study from the Centers for Disease Control and Prevention (CDC) found that 68% of people want to quit smoking, but that desire alone is not enough to maintain a change in the behavior. Research has shown it can take 30 or more tries before a smoker quits successfully.[2],[3] The most common method of quitting for people in the United States is to set a quit deadline and attempt to stop cold turkey on that day. Evidence-based interventions that help assist in quitting have been developed, with some being more successful than others.

It is crucial for HHS to invest in cessation strategies that are safe and effective, including behavioral therapies and nicotine replacement therapies (NRT). Behavioral therapies and nicotine replacement therapies (NRTs) are common, with hundreds of studies looking at which of them are most effective. A 2021 meta-analysis of behavioral therapies found that any form of counseling (e.g., in-person, telephone, self-help, etc.), as well as guaranteed financial incentives, were the most successful forms of therapy.[4] The same study analyzed the economic benefits of behavioral therapies and found that different behavioral therapies were equally cost effective. A 2023 meta-analysis of NRTs looked at 68 studies and found a combination of NRT, such as nicotine gum alongside a nicotine patch, was more effective than using any method individually.[5] The same study also found that higher-dose products are more effective than their lower-dose counterparts and that using NRT prior to quitting smoking can be more effective than starting the NRT after quitting. However, higher-dose products may also have greater risks, and smoking cessation products can have serious psychiatric side effects.[6] Therefore, studies of the efficacy of NRTs compared to each other or to behavioral/counseling treatments need to also consider data on unpleasant or serious side effects.

Some claim that e-cigarettes can be used as a cessation therapy.  This claim has been described as “negligent and misinformed.”[7]  Research in this area needs to be carefully reviewed because despite conflicting findings, there is growing evidence that e-cigarettes are not safe and not effective to aid in smoking cessation.[8],[9] Most of the studies that support e-cigarettes for smoking cessation have flaws making the results questionable (e.g., short term follow up or not randomly assigning participants.) Since vaping is often promoted as a tool to quit smoking, it is essential to have better data to determine whether this is supported by evidence.

ACCESS AND COVERAGE

Increasing access and coverage of cessation treatments is a key step in decreasing the number of deaths related to smoking. A 2018 study examined patients who were offered smoking cessation treatments by their primary care doctor. The results showed fewer than 20% of smokers accepted any type of therapy.[10] This same study found that White patients were more likely to be offered a prescription for a cessation medication whereas Black patients were more likely to be offered cessation counseling. We recommend HHS determine effective strategies to help primary care providers increase patients’ knowledge about effective cessation therapies and willingness to try them. These key providers can give information to patients about how they can stop smoking and what resources are best at helping them to do so. Providing patients with several effective options, will allow them to find which strategy, or perhaps strategies, work best for aiding their smoking cessation.

SURVEILLANCE EXPANSION

Expanding surveillance regarding smoking and cessation behaviors is vital to understand the patterns and trends of the behaviors. Regularly evaluating data from point of sales and compliance with advertising requirements will allow HHS to act on the most up-to-date information and enforce decisions by the court. For example, the FDA banned flavored e-cigarettes after data showed that teenagers used preferred them to traditional tobacco flavors, and that they potentially served as a gateway to nicotine addiction.[11] Similarly, it is important to ensure that advertising restrictions banning the promotion and sales of e-cigarettes aimed at children and teenagers are enforced. We also recommend collecting information about trends in popular cessation therapies such as purchasing trends for NRTs. This will enable HHS to encourage safe and effective cessation methods.

PROMOTING RESEARCH

Promoting well-designed research to support and accelerate smoking cessation will help achieve the Cancer Moonshot’s goal to reduce the cancer death rate by 50% over the next 25 years. Better research is needed comparing the effects of different cessation therapies for different demographic groups.  Across races, people who quit smoking, particularly early in their life, have reduced risk of all-cause mortality.[12] However, there is not enough research on the most effective cessation therapies for specific populations. A small study conducted by researchers at the University of Miami found there were greater decreases in perceived stress for African Americans and Hispanics after receiving behavioral therapy for smoking cessation, but the study did not look at the effectiveness of other cessation therapies.[13]

 

[1] Centers for Disease Control and Prevention. (2022, July 28). Costs and expenditures. Centers for Disease Control and Prevention. https://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/cost-and-expenditures.html

[2] Babb, S., Malarcher, A., Schauer, G., Asman, K., & Jamal, A. (2017). Quitting Smoking Among Adults – United States, 2000-2015. MMWR. Morbidity and mortality weekly report, 65(52), 1457–1464. https://doi.org/10.15585/mmwr.mm6552a1

[3] Chaiton, M., Diemert, L., Cohen, J. E… & Schwartz, R. (2016). Estimating the number of quit attempts it takes to quit smoking successfully in a longitudinal cohort of smokers. BMJ open, 6(6), e011045. https://doi.org/10.1136/bmjopen-2016-011045

[4] Hartmann-Boyce, J., Livingstone-Banks, J., Ordóñez-Mena, J. M… & Aveyard, P. (2021). Behavioural interventions for smoking cessation: an overview and network meta-analysis. The Cochrane database of systematic reviews, 1, CD013229. https://doi.org/10.1002/14651858.CD013229.pub2

[5] Theodoulou, A., Chepkin, S. C., Ye, W… & Lindson, N. (2023). Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. The Cochrane database of systematic reviews, 6(6), CD013308. https://doi.org/10.1002/14651858.CD013308.pub2

[6] Campbell, A. R., & Anderson, K. D. (2010). Mental health stability in veterans with posttraumatic stress disorder receiving varenicline. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 67(21), 1832–1837. https://doi.org/10.2146/ajhp100196

[7] McAlinden, K. D., Eapen, M. S., Lu, W., Sharma, P., & Sohal, S. S. (2020). The rise of electronic nicotine delivery systems and the emergence of electronic-cigarette-driven disease. American journal of physiology. Lung cellular and molecular physiology, 319(4), L585–L595. https://doi.org/10.1152/ajplung.00160.2020

[8] Laucks, P., & Salzman, G. A. (2020). The Dangers of Vaping. Missouri medicine, 117(2), 159–164.

[9] Venkata, A. N., Palagiri, R. D. R., & Vaithilingam, S. (2021). Vaping epidemic in US teens: problem and solutions. Current opinion in pulmonary medicine, 27(2), 88–94. https://doi.org/10.1097/MCP.0000000000000757

[10] Hooks-Anderson, D. R., Salas, J., Secrest, S., Skiöld-Hanlin, S., & Scherrer, J. F. (2018). Association between race and receipt of counselling or medication for smoking cessation in primary care. Family practice, 35(2), 160–165. https://doi.org/10.1093/fampra/cmx099

[11] Leventhal, A. M., Goldenson, N. I., Cho, J., Kirkpatrick, M. G., McConnell, R. S., Stone, M. D., Pang, R. D., Audrain-McGovern, J., & Barrington-Trimis, J. L. (2019). Flavored E-cigarette Use and Progression of Vaping in Adolescents. Pediatrics, 144(5), e20190789. https://doi.org/10.1542/peds.2019-0789

[12] Thomson, B., Emberson, J., Lacey, B… & Islami, F. (2022). Association Between Smoking, Smoking Cessation, and Mortality by Race, Ethnicity, and Sex Among US Adults. JAMA network open, 5(10), e2231480. https://doi.org/10.1001/jamanetworkopen.2022.31480

[13] Webb Hooper, M., & Kolar, S. K. (2015). Distress, race/ethnicity and smoking cessation in treatment-seekers: implications for disparity elimination. Addiction (Abingdon, England), 110(9), 1495–1504. https://doi.org/10.1111/add.12990

NCHR Comments on FDA’s Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising

Legislation, Policy

 

June 26, 2023

The National Center for Health Research (NCHR) appreciates the opportunity to submit public comments on the notice by the Food and Drug Administration regarding their Survey on Quantitative Claims in Direct-to-Consumer (DTC) Prescription Drug Advertising.

NCHR is a non-profit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We strongly support the efforts of the Office of Prescription Drug Promotion (OPDP) to protect public health by conducting research to evaluate patients’ understanding of quantitative information provided in prescription drug advertising. We work closely with patients and consumers and are well aware that many people do not understand quantitative claims made in drug advertisements.1 The information collected in this survey is essential to ensure the public is able to comprehend drug information in order to make informed medical decisions.

We appreciate the clear example provided in the notice regarding the type of information FDA is seeking to collect (i.e. claims describing medians). Some of the statements included were clear and direct (e.g., “People treated with Drug X lived for a median of 8 months” in combination with the explanation that “In people receiving Drug X, this means that about half lived more than 8 months and about half lived less than 8 months”). Research to evaluate patients’ understanding of such explanations will provide crucial information about individuals’ level of comprehension regarding quantitative information.  

We strongly recommend that determining patients’ and consumers’ comprehension of information regarding relative risk, absolute risk, relative benefit, and absolute benefit should also be evaluated by the FDA in this survey. For example, how does the public understand a statement that a drug reduces the relative risk of recurrence by 37% or increases the absolute chances of 5-year survival by 3%? Information about relative risk or relative benefit is often used in advertising because those numbers are inevitably larger and seem more impressive than the absolute difference in risk or benefit. According to the FDA’s own research, 65% of physicians believe DTC ads confuse patients about the relative risks and benefits of prescription drugs.2 Unfortunately, patients are not the only ones confused by these statistics.

The FDA notice states that survey questions will be informed by consumer feedback elicited in one-on-one interviews. We support this method of data collection but request that the FDA be more specific about how many interviews OPDP plans to conduct to compile this information, and what type of demographic diversity they will require when selecting people to be interviewed. A relatively small or homogeneous selection of individuals to interview one-on-one could result in unintentional bias in the survey, which in turn would have implications for the results of the estimated 1,100 completed surveys.

We urge you to consider our recommendations, which are intended to enhance the quality of the survey. We would be happy to help recruit patients for your survey or interviews.

 

REFERENCES

1. Sullivan, H. W., O’Donoghue, A. C., Lynch, M., Johnson, M., Davis, C., & Rupert, D. J. (2019). The Effect of Including Quantitative Information on Multiple Endpoints in Direct-to-Consumer Prescription Drug Television Advertisements. Medical decision making : an international journal of the Society for Medical Decision Making, 39(8), 975–985. https://doi.org/10.1177/0272989X19875946

2. Food & Drug Administration. (2015). The Impact of Direct-to-Consumer Advertising. https://www.fda.gov/drugs/information-consumers-and-patients-drugs/impact-direct-consumer-advertising 

NCHR Comments on USPSTF Draft Recommendation on Breast Cancer Screening

Breast Cancer, Legislation, Policy, Uncategorized,

June 6, 2023

We are pleased to have the opportunity to express our views regarding the U.S. Preventive Services Task Force Draft Recommendation Statement regarding breast cancer screening.

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

While we support the task’s draft recommendation that women who are at average risk of breast cancer should undergo a screening every other year rather than annually, we are concerned that the task force’s recommendation of lowering the age of screening mammography from 50 years old to 40 years old is broadly applied to all women, rather than directed at groups most at risk. The guidelines are only supposed to be regarding women of average risk of breast cancer, and information is widely available to indicate some women are at higher risk because of genetic predispositions, smoking, obesity, family history, and other factors.  Dense breasts are also a risk factor, but unfortunately breast density also makes mammography less accurate[1] and tends to be especially high for women under the age of 50[2].

It is especially important to note that the most recent research, which may post-date the writing of these draft recommendations, had findings that suggested that Black females should start screening approximately 8 years earlier than White women, and that Hispanic and Asian and Pacific Islander females could start even later[3]. For that reason, we urge the USPSTF to consider whether the recommendation to start at age 40 should only apply to Black women and to other women who also have higher than average risk of breast cancer at a younger age, whereas starting at age 50 or even later is scientifically supported for other racial/ethnic groups that have been studied.

We agree with the USPSTF that there is not enough evidence to recommend screening mammography for women 75 years old or older.

We also agree that biennial mammogram screening has benefits that outweigh the risks for most women between the ages of 50-74 and for women at high risk between the ages of 40-50, there is currently insufficient evidence that using additional screening tools, such as using an MRI following a screening mammogram, is beneficial even for women with dense breasts, unless a diagnosis is needed when abnormalities are shown during the mammogram.

We understand that the USPSTF may be reluctant to suggest different screening schedules for Black women or for any specific group of women, but we urge the Task Force to focus on the scientific data. In this case, that includes different recommendations based on race and ethnicity data. Women are capable of understanding why the age to start mammography screening may be different for women with different risk factors. What is confusing is when some physician groups recommend annual mammograms for all women starting at age 40, even though the data do not support that recommendation. USPSTF should not compromise its standards to be more similar to those recommendations.

NCHR is grateful for the opportunity to comment on this USPSTF draft recommendation. The National Center for Health Research can be reached at info@center4research.org or (202) 223-4000.

 

REFERENCES

1) Kolb TM, Lichy J, Newhouse JH. Comparison of the performance of screening mammography, physical examination, and breast US and evaluation of factors that influence them: an analysis of 27,825 patient evaluations. Radiology. 2002 Oct;225(1):165-75. doi: 10.1148/radiol.2251011667. PMID: 12355001.

2) Barrette, Lori, Breast Density: What Women Should Know” University of Rochester Medical Center. 15 October 2015. <https://www.urmc.rochester.edu/news/publications/health-matters/breast-density-what-women-should-know>

3) Chen T, Kharazmi E, Fallah M. Race and Ethnicity–Adjusted Age Recommendation for Initiating Breast Cancer Screening. JAMA Netw Open. 2023;6(4):e238893. doi:10.1001/jamanetworkopen.2023.8893