AADR Participates in “Raise the Caps Thank You Day”

Last Friday, the House and Senate passed the Bipartisan Budget Act of 2018 (BBA). Among the provisions in the bill, the law raises the austere spending caps for non-defense discretionary programs – which covers virtually everything outside of national defense (e.g., scientific research, education, infrastructure) – by more than $130 billion over two years – the largest single increase to domestic spending since the American Recovery and Reinvestment Act of 2009 (ARRA).

The new spending limits were critical for Congress to provide increased funding for domestic programs, such as research at the National Institutes of Health (NIH) and the National Institute of Dental and Craniofacial Research (NIDCR). While lawmakers will still need to go through the process of allocating funds to the various appropriations subcommittees, including Labor-HHS, the new budget allows for greater certainty through fiscal year 2019 since the top-line levels have now been agreed upon.

In government affairs, equally important to educating members of Congress about our work is thanking them for advancing priorities of importance to our field. Therefore, NDD United, a coalition of which AADR is a member, has coordinated the #BBAValentines campaign to thank members of Congress who voted YES on the Bipartisan Budget Act of 2018 and to let them know their support is appreciated.

On this Valentine’s Day, view the list of lawmakers who voted YES on the BBA, and reach out to your elected officials to thank them for their vote via Twitter or email. Below is a collection of sample Tweets, but feel free to create your own:

  • Thank you [TWITTER HANDLE] for voting to #RaiseTheCaps and protect domestic funding for dental research. Your support is truly appreciated. #BBAValentines
  • On this Valentine’s Day, I extend a heartfelt thanks to [TWITTER HANDLE] for providing a much-needed funding increase for non-defense programs. Thanks for voting to #RaiseTheCaps! #BBAValentines
  • We couldn’t do what we do without you! Thanks [TWITTER HANDLE] for voting to #RaiseTheCaps, which will support important dental research. #BBAValentines

Finally, AADR would be remiss if we didn’t thank you, our members, who participated in the initial #RaiseTheCaps campaign. This campaign played an important role in expressing to members of Congress why raising the caps was important for the public health and health research communities, so thank you!

If you have any questions, please contact AADR Assistant Director of Government Affairs Lindsey Horan.

Following Brief Shutdown, Congress Passes Budget Deal and Continuing Resolution

The federal government experienced a roughly five hour shutdown last night, the second in 2018, after Kentucky Senator Rand Paul filibustered the sweeping budget deal and continuing resolution package (on the grounds of how much it would cost taxpayers) and refused to allow action on it before the midnight deadline.

However, passage of the Bipartisan Budget Act of 2018 in the Senate was inevitable, and around 1:30 a.m., the chamber voted 71-28 in favor of the spending package (a summary of the bill can be accessed here). The House, in a 240-186 vote, followed suit and passed the bill around 5:30 a.m., after which time it went to and was signed into law by the president.

The measure includes a deal to raise the spending caps by roughly $300 billion over two years, increasing the caps on non-defense discretionary spending by $63 billion in FY 2018 and $68 billion in FY 2019 and raising the defense caps by $80 billion in FY 2018 and $85 billion in FY 2019. By lifting the federal debt limit until March 2019, lawmakers will push off future confrontations over the spending caps until after the midterm elections.

In addition to identifying the top-line numbers, the package also includes a stopgap spending measure that will keep the government funded at current levels through March 23, 2018, giving appropriators six weeks to finalize final omnibus legislation for fiscal year (FY) 2018. Other significant provisions in the bill include:

  • An additional $2 billion for research at the National Institutes of Health (NIH);
  • A funding extension for the Children’s Health Insurance Program (CHIP) for an additional four years, lengthening the six-year extension that Congress passed last month;
  • $7 billion over two years for community health centers;
  • $6 billion for new grants and prevention programs to combat the mental health and opioid crises; and
  • A $1.35 billion cut to the Prevention and Public Health Fund over 10 years (significantly less than the $2.85 billion proposed in the House’s CR).

With the negotiations on the overall spending caps out of the way, lawmakers will now begin to iron out the final details for FY 2018 funding legislation. While the bill makes a step in the right direction, there is still concern about how Congress will divvy up the 302(b) allocations, the amount of funding given to the respective appropriations subcommittees, such as Labor, Health and Human Services, Education and Related Agencies. The Coalition for Health Funding, of which AADR is a member, recently sent a letter to lawmakers urging them to ensure health-related departments receive a fair share of relief.

As negotiations transpire, the community will encourage lawmakers for proportional relief for the agencies and programs of the Department of Health and Human Services (HHS) and will carefully be monitor for any policy riders in the final FY 2018 omnibus legislation that could undercut public health.

Check back on the blog for updates, and feel free to contact Assistant Director of Government Affairs Lindsey Horan if you have questions.

AADR Provides Dental Research Perspective in Two Strategic Planning Processes

The American Association for Dental Research (AADR) has recently been engaged in the strategic planning process at the National Institutes of Health (NIH) by submitting feedback on two Requests for Information (RFIs): the RFI on the Office of Disease Prevention Strategic Plan for Fiscal Years (FY) 2019-2023 and the RFI Soliciting Input for the Tribal Health Research Office Strategic Plan, FY 2018-2022.

RFIs are one way that AADR elevates the fields of dental, oral and craniofacial research and helps ensure that oral health is represented as being key to overall health. More details on each opportunity and AADR’s response are as follows:

RFI: Office of Disease Prevention Strategic Plan for FY 2019-2023

As part of its charge to improve public health by increasing the scope, quality, dissemination and impact of NIH’s prevention research, the Office of Disease Prevention (ODP) is crafting a new strategic plan on activities related to research in disease prevention and the dissemination of research results. The latest RFI from the ODP sought to gather broad public input on the latest iteration of the Office’s strategic plan, including its five proposed strategic priorities.

AADR responded to the RFI and, throughout its response, stressed oral health research’s role as part of this important conversation. AADR highlighted how much of the progress the United States has made with respect to oral health thus far is a result of effective prevention and treatment efforts, and noted how the  two most common dental diseases – dental caries and periodontal diseases – are thought to be largely preventable.

Read AADR’s full set of comments to the ODP here.

RFI: Soliciting Input for the Tribal Health Research Office Strategic Plan FY 2018-2022

In 2015, the NIH established the Tribal Health Research Office (THRO) “to coordinate tribal health research-related activities across the agency to effectively serve tribal nations and individuals.” The THRO is building upon its charge by working on its first strategic plan, which seeks to “improve, promote and strengthen communication between NIH and American Indian/Alaska Native (AI/AN) communities, as well as communication among its Institutes, Centers and Offices (ICOs), on Indigenous health research and discoveries.”

The THRO’s recent RFI solicited feedback on the five priorities under consideration for the first strategic plan.

AADR’s feedback included commending the THRO for supporting the bidirectional flow of information between NIH ICOs and stakeholders and tribal communities, and made a number of suggestions. Suggestions from AADR included having the NIH pursue direct partnerships with the tribes and tribal Institutional Review Boards, employ incentives for the use of tribal employees and interns in funded research activities or for collaboration with tribal colleagues, and incorporate oral health as a priority area.

Read AADR’s full set of comments to the THRO here.*

*AADR often relies on the subject-matter expertise of our members to help inform responses to Requests for Information/Comment. Given their backgrounds and perspectives, AADR consulted with members Judith Albino, PhD, Colorado School of Public Health, and David Drake, PhD, MS, University of Iowa College of Dentistry and Dental Clinics, on the THRO RFI. AADR would like to thank Drs. Albino and Drake for their comments, which were integral to shaping AADR’s response. 

FDA advisory committee largely rejects modified risk claims for heat-not-burn tobacco products

The Tobacco Product Scientific Advisory Committee (TPSAC) to the Food and Drug Administration (FDA), has voted against allowing Phillip Morris International (PMI) to make certain modified risk claims on its heat-not-burn tobacco product, IQOS.

The IQOS system uses a heating blade to electronically heat reconstituted tobacco inside of a cigarette-like heating stick, creating an aerosol that is inhaled by the user. The temperature is regulated by the device and held beneath the temperature at which tobacco burns. The system also includes a rechargeable battery. PMI claims that heating is a safer way to consume tobacco than burning.

PMI was seeking approval to make modified risk claims about three products – IQOS Regular, IQOS Smooth Menthol and IQOS Fresh Menthol. PMI was seeking approval for the following claims:

  • Scientific studies have shown that switching completely from cigarettes to the
    IQOS system can reduce the risks of tobacco-related diseases.
  • Switching completely to IQOS presents less risk of harm than continuing to smoke
    cigarettes.
  • Scientific studies have shown that switching completely from cigarettes to the
    IQOS system significantly reduces your body’s exposure to harmful or potentially
    harmful chemicals.

As part of the modified risk approval process, FDA convenes experts in biomedical, social and behavioral and public health tobacco research to seek their professional opinions about the validity of the claims and the effect on the health of both users and nonusers. PMI was not seeking approval to bring IQOS to market in the US at this meeting. The premarket approval application is a separate process. IQOS is already available in Japan, South Korea and parts of Europe.

The two-day meeting included presentations from scientists and representatives from PMI and the FDA followed by 3-minute comments from about 30 members of the public representing various stakeholders and interests. Committee members peppered PMI and FDA representatives with questions throughout the meeting that hinted at their skepticism and concerns about the products and the modified risk claims.

Scientists and representatives from PMI presented data from chemical, preclinical and human studies on IQOS products in support of their claims. According to PMI data, the IQOS system releases substantially lower levels of the harmful constituents compared to combustible cigarettes, and IQOS use showed less evidence of harm and smoking-related disease. PMI representatives reiterated that this product is targeted at smokers and narrowly focused its modified risk claims on smokers who completely switch from using combustible cigarettes to IQOS.

FDA scientists then presented their evaluation of the scientific data included in PMI’s application. FDA scientists were able to independently verify PMI’s claims that substantially lower levels of harmful or potentially harmful chemicals are released from IQOS products but also noted that based on exposure to harmful ingredients, smoking 10 heatsticks would be equivalent to smoking 1 to 3 combustible cigarettes.

The comments from members of the public were overwhelmingly in favor of approval of these modified risk claims. Supporters strongly believed that IQOS products could help smokers who had failed other cessation methods and that these products were a safer alternative to cigarettes. Some expressed concern about overregulation and stifling innovation.

Ultimately, the committee voted against approving the first two claims but voted in favor of the third. The committee agreed that use of IQOS exposes the user to lower levels of harmful chemicals but voted 5-2 (with one abstention) that PMI did not show that reduced exposure was “reasonably likely to translate to a measurable and substantial reduction” in death or disease.

Some sticking points throughout the meeting included the definition of “complete switching”, which PMI defined as 70-100% use of IQOS and up to 30% combustible cigarette use. Committee members did not believe that there was enough evidence for some of the claims or that the studies were conducted for a sufficient length of time to draw a conclusion. Committee members also found the wording of the claims confusing and worried about implying a benefit from partial – not complete – switching. Committee members were concerned that the limited reduction in biomarkers of potential harm after switching to IQOS was also not sufficient to support the claims of reduced harm. Furthermore, the committee thought that the likelihood of complete switching – the circumstance upon which claims were predicated – was low compared to the higher likelihood of combined combustible cigarette and IQOS use. However, the committee did agree that IQOS would probably not appeal to youth, adults who have never smoked or former smokers. Many of the committee members drew comparisons to e-cigarettes and raised concerns over vulnerable populations and the popularity of menthol tobacco products to African Americans.

The committee’s decisions are non-binding. Instead, the FDA will consider the votes, opinions and discussion of the committee while making its final decision on PMI’s modified risk claims in the coming months.

Additional Resources

2018 TPSAC Meeting Materials and Information

National Academies releases report, “Public Health Consequences of E-Cigarettes”

A long anticipated study by the National Academies of Sciences, Engineering and Medicine on the health effects on e-cigarettes found a substantial level of evidence that youth and young adults who use e-cigarettes are at greater risk of trying combustible cigarettes.

The study, “Public Health Consequences of E-cigarettes”, was commissioned by the Food and Drug Administration to provide information about the health effects of e-cigarettes on individual users as well as the population at large, especially on vulnerable populations such as youth and pregnant women. The resulting report is over 600 pages long and addresses a number of health effects, including impacts on the cardiovascular and respiratory systems and the oral cavity and cancer risk. The committee that issued the report grouped their numerous conclusions by the level of evidence supporting each finding, with conclusive being the highest level of evidence, followed by substantial, moderate, limited, and insufficient at the lowest level. The committee also described health effects for which there were no available data to draw a conclusion.

In addition to finding that e-cigarette use increased the risk of combustible cigarette use among youth and young adults, the committee also found a moderate level of evidence that for youth and young adults who had ever used combustible cigarettes, e-cigarette use increased the intensity (defined as “the number of cigarettes smoked per smoking day”) and frequency (the number days a cigarette was used in the past 30 days) of subsequent combustible cigarette use. There was also limited evidence that in the short-term, e-cigarette use increased the duration of subsequent combustible cigarette use among youth and young adults who had ever tried combustible cigarettes.

The report included a chapter on the available evidence on the oral health effects of e-cigarettes that focused specifically on periodontal disease. The committee noted that because e-cigarettes are such a recent arrival on the tobacco products market, “there is a lack of rigorously designed studies examining the effects of e-cigarettes on oral health”. All conclusions were based on limited evidence. One study showed that certain markers of periodontal disease were elevated in both male e-cigarette users and cigarette smokers compared to non-smokers. (Note: the report incorrectly states: “The men who smoked cigarettes had a significantly higher plaque index and probing depth than group 2 [e-cigarette users] or group 3 [non-smokers].” AADR has notified the committee of the error.) Another study indicated that switching from combustible cigarettes to exclusive e-cigarette use improved oral health. However, yet another study showed that switching from smoking to e-cigarettes increased gingival inflammation in smokers after two weeks. In vitro studies showed that the nicotine and flavoring in e-cigarette vapors may harm oral tissues and that menthol flavoring can cause DNA damage and inflammation. The committee noted a lack of epidemiological studies on the association between e-cigarette use and periodontal disease.

Notably, the committee did not include any information on oral or oropharyngeal cancer or other oral health effects.

On the issue of the efficacy of e-cigarettes as smoking cessation devices, the committee found a moderate level of evidence that more frequent e-cigarette use increased the likelihood that a smoker would be able to successfully quit and that nicotine-containing e-cigarettes were more effective in smoking cessation than non-nicotine e-cigarettes. The conclusions were based on two different types of studies – observational studies versus randomized control trials, respectively – but the level of evidence was rated as moderate for both conclusions. However, due to an insufficient level of evidence, the committee could not say whether e-cigarettes were more or less effective as smoking cessation devices compared to quitting “cold turkey” or using FDA-approved cessation treatments. There was also no evidence for or against the claim that dual use of combustible cigarettes with e-cigarettes is less harmful than exclusive use of combustible cigarettes.

The committee was able to conclusively say that completely switching from combustible cigarettes to e-cigarettes reduced exposure to the harmful chemicals found in combustible cigarettes and that there is a substantial level of evidence that complete switching results in many decreased adverse health effects. However, there was also a substantial level of evidence that e-cigarettes use results in dependence.

Finally, the committee identified a number of research needs to more thoroughly understand the health effects of e-cigarettes, including the need for both short and long-term studies and the need to improve the quality and methods of e-cigarette research.

Additional Resources

National Academies website, “Public Health Consequences of E-Cigarettes” nationalacademies.org/ecighealtheffects

Report release webinar: https://youtu.be/vifAY4YcVbQ

Full report, “Public Health Consequences of E-Cigarettes”

 

HHS Delays Implementation of Common Rule Revisions by Six Months

Last week, the U.S. Department of Health and Human Services (HHS) issued an Interim Final Rule that will delay the implementation of revisions to the Federal Policy for the Protection of Human Subjects (more regularly referred to as the Common Rule) from January 19, 2018 to July 19, 2018. The announcement came just two days before most provisions in the rule were set to go into effect.

Changes to the Common Rule have been in motion since September 2015, when HHS and other Common Rule agencies published a Notice of Proposed Rulemaking (NPRM) that solicited more than 2,000 comments and led to an extensive review process. The final rule was released in January 2017 with an “effective” date of January 19, 2018.

Included in the final rule were changes, such as:

  • The requirement for consent forms “to provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.”
  • The requirement – in several cases – to use a single institutional review board (IRB) for multi-institutional research studies. The original NPRM proposal was revised “to add substantial increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.”
  • New categories and classification of existing categories, including “a new exemption for secondary research involving identifiable private information if the research is regulated by and participants protected under the HIPAA rules.”
  • The new option for researchers conducting studies on stored identifiable data or identifiable data specimens to rely on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement.

– Changes pulled from HHS press release (changes between proposed and final rule also included in release).

According to the latest notice, the implementation delay “both provides additional time to regulated entities for the preparations necessary to implement the 2018 Requirements, and additional time for the departments and agencies listed…to seek input from interested stakeholders through a notice and comment rulemaking process that allows for public engagement on the proposal for a further implementation delay.”

Those wishing to comment on the delay of revisions – and a potential further delay – may do so at regulations.gov (docket number: HHS– OPHS–2017–0001). The Federal Register notice containing more information can be found here.

Federal Government Shuts Down After Senate Unable to Reach Deal

After weeks of negotiations, the Senate rejected a deal on a measure to keep the government funded after the January 19 deadline.

On January 18, the House had approved legislation to keep the government funded through February 16 and extend funding for the Children’s Health Insurance Program (CHIP) through fiscal year (FY) 2023. Congress will reconvene today, January 20, to discuss a tentative deal on a continuing resolution (CR) that would keep the government funded through February 8, with an agreement to hold a vote prior to that date on the status of individuals enrolled in the Deferred Action for Childhood Arrivals (DACA) program.

According to The Washington Post, Office of Management and Budget Director Mick Mulvaney said the conflict has a “really good chance” of being resolved before the government opens on Monday.

In advance of a shutdown, federal agencies have posted contingency staffing plans for a shutdown. Approximately half of the employees at the U.S. Department of Health and Human Services (HHS) will be furloughed. Included in the operations that will continue, the National Institutes of Health “will continue patient care for current NIH Clinical Center patients, minimal support for ongoing protocols, animal care services to protect the care of NIH animals, and minimal staff to safeguard NIH facilities and infrastructure.” Additionally, the Centers for Disease Control and Prevention “will continue minimal support to protect the health and well-being of US citizens here and abroad through a significantly reduced capacity to respond to outbreak investigations, processing of laboratory samples, and maintaining the agency’s 24/7 emergency operations center.”  For more about how HHS may be affected, read more on the HHS contingency plan or from HealthLeaders Media.

AADR Heads to the Hill: What to Expect for the 2018 Advocacy Day

Next month, the American Association for Dental Research (AADR) and the Friends of NIDCR will host the annual Advocacy Day on Capitol Hill. This event, which will be held on Tuesday, February 27, 2018 from 9:00 a.m. – 5:00 p.m. ET, is intended to bring those who support dental, oral and craniofacial research to Washington, D.C. to educate policymakers about the value of this work.

For some, this event may be second nature, but for others, an advocacy day might be an entirely new concept. Whether you’re new to this type of event or simply need a refresher, we have put together some information about what you can expect for the 2018 Advocacy Day and why you should attend:

Why host an Advocacy Day in the first place?

There are many reasons to host an advocacy day. In particular, advocacy days:

  • Amplify causes by having a diverse, compelling group of individuals make their voices heard;
  • Allow individuals to have face time with those who are creating policy and making decisions about how federal dollars are spent;
  • Bring peers and colleagues together to network and share their experiences with one another; and
  • Provide an opportunity for individuals to hear about the latest developments in Washington, D.C. and how it may affect their home states.

What should I expect on the day of the event?

After breakfast, the day’s agenda will begin with a key issues briefing. Over the course of the morning, attendees will hear a legislative and political overview about what’s happening in Washington, receive a scientific update on the activities and research initiatives at the National Institute of Dental and Craniofacial Research (NIDCR) from NIDCR Director Dr. Martha Somerman, and receive a message training about how to navigate the Hill the conduct meetings with staff.

Once we break from the morning’s briefing and lunch, attendees will head to their visits with congressional offices. AADR is aiming to book at least two meetings for each participant. These visits, scheduled with members’ elected official(s), provide a unique opportunity for attendees to share why they care about dental, oral and craniofacial research and why it is important for the government to fund it.

Why should I attend?

For AADR members, the fields of dental, oral and craniofacial research presumably have a large role to play in your life.

As a researcher, this field may be your livelihood.
As a student, this work may be integral to your future path.
As a patient advocate, this research may hold promise for the disease or condition that you and/or your organization are working to tackle.

Regardless of your connection to this field, your voice is central to elevating oral research on the Hill and ensuring that policymakers know why it should be funded. Members of Congress value and listen to constituents. You are the best stewards of this message. By participating in this event, you can help protect funding for dental research and keep it on the minds of policymakers over the course of the year.

Last year, AADR members conducted over 70 meetings with members of Congress and congressional staff. We’re aiming to conduct even more visits this year!

I’m in. Where do I sign up? 

Register by completing the registration form online. *Please note: your registration represents your professional commitment to attend. Last minute cancellations or failure to attend will harm our relationship with members of Congress and their staff. 

If you have any questions or need any additional information, please contact AADR Assistant Director of Government Affairs Lindsey Horan.

All of Us Research Program Seeks Input on Research Priorities

The All of Us Research Program aims to build one of the largest, most diverse datasets of its kind for health research, with one million or more volunteers nationwide, who will sign up to share their information over time. Researchers will be able to access participants’ de-identified information for a variety of studies to learn more about the biological, behavioral, and environmental factors that influence health and disease. Their findings may lead to more individualized health care approaches in the future.

Using IdeaScale, the All of Us Research Program is collecting ideas through a tool known as a “use case” that outlines and describes research questions that the All of Us Research Program could help answer.

The information provided will be used at the All of Us Research Priorities Workshop on March 21–23, 2018, to identify key research priorities and requirements (such as data types and methods) for future versions of the All of Us protocol.

You can ensure that dental, oral and craniofacial research is included in the All of Us Research Program by:

1. Voting for the following ideas submitted by the National Institute of Dental and Craniofacial Research by Friday, February 9:

2. Clicking here to be directed to IdeaScale, where you can see the ideas submitted by others or add your own idea by Friday, February 9.

3. Sending your idea to sajiboye@iadr.org that may be submitted on behalf of AADR by COB Friday, January 26.

Thank you for your engagement in this research initiative.

AADR submits comments to the Opioid Policy Steering Committee

AADR has submitted comments in response to the Food and Drug Administration’s (FDA) request for public comment on additional steps the FDA can take to reverse the opioid abuse epidemic. AADR’s comments strongly emphasized the need for both prescriber and patient training.

The FDA Opioid Policy Steering Committee (OPSC) was established in May 2017 and tasked with developing strategies for fighting the opioid abuse epidemic. The OPSC’s four focus areas are 1) decreasing exposure to opioids and preventing addiction; 2) supporting opioid use disorder treatment; 3) promoting the development of new, less addictive pain therapies and 4) improving enforcement and revisiting the benefit/risk assessment of opioid therapies.

The request for comment was a follow-up to the National Academy of Medicine (NAM) report, “Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use”. AADR member Dr. Eli Eliav, an orofacial pain researcher at the University of Rochester, was a member of the NAM committee.

In comments to the OPSC, AADR stressed the importance of controlling the opioid abuse epidemic while allowing access to opioids for patients who really need them for pain control. AADR supported the NAM committee recommendations for more research to better understand pain and opioid use disorders, the opioid epidemic and public health considerations to inform the regulatory process. AADR supported the recommendation by the American Dental Association that nonsteroidal anti-inflammatory drugs should be the first-line pain medication for acute dental pain and advocated for the implementation of a national, mandatory prescription drug monitoring program. AADR also recommended mandatory provider training on how to prescribe opioids, recognize possible abuse and treat chemically-dependent patients.

For AADR’s full letter to the OPSC, please click here.