What the Tax Reform Legislation Means for Research

The GOP’s move to overhaul the tax system is moving quickly, with the House and Senate working in parallel on tax reform legislation. Before diving into the respective bills’ potential implications for scientific research, let’s first look at where we stand in the legislative process.

On Thursday, November 16, House Republicans passed their tax bill (H.R. 1) along party lines, 227-205, completing the first step in the budget reconciliation process. The bill, which passed with no Democratic support and 13 Republicans in opposition, will now go to the Senate for its consideration. The budget reconciliation instructions are significant because they will allow the Senate to pass the bill without Democratic support, if needed. (If you want to dive deeper, see this article from The New York Times.)

In the other chamber, the Senate is concurrently working on its own bill, one that greatly differs from that of the House. The Senate’s bill, after four days in markup, passed the Senate Finance Committee on Thursday via a party-line vote of 14-12. The full Senate is expected to take up the bill after Thanksgiving. (Read more from POLITICO.)

While the bills vary in terms of their provisions, which will need to be resolved during conference, both have consequences for research:

At the highest level, the first thing to note about both the House and Senate bills is that they are each expected to add roughly $1.5 trillion to the federal debt over the next 10 years. While the provisions within the bills are likely to shift as negotiations continue among and between the two chambers, this figure is unlikely to change. So, what does this have to do with research specifically? Recent history has shown that when there is an increase in the deficit, the subsequent move from Congress is to take steps to cut discretionary spending. Non-defense discretionary spending, which includes health care and health research, would likely take the bulk of that cut.  Continue reading

AADR Provides Input on Trans-NIH Strategic Plan for Women’s Health Research

In September, the Office of Research on Women’s Health (ORWH) at the National Institutes of Health (NIH) released a Request for Information to solicit input from scientists and advocacy and patient communities on the trans-NIH Strategic Plan for Women’s Health Research. Specifically, ORWH was seeking feedback on three proposed cross-cutting themes and goals under consideration for the next iteration of the plan that is intended to promote allocation of NIH resources for conducting and support women’s health research across NIH Institutes and Centers.

For this reason, AADR wanted to stress to the ORWH that the cross-cutting themes and goals can and should be readily applied to oral and craniofacial health and disease research supported by NIH, and specifically by the National Institute of Dental and Craniofacial Research and submitted a set of comments to this effect:

The American Association for Dental Research (AADR) appreciates the opportunity to provide input on the trans-NIH Strategic Plan for Women’s Health Research. We commend the Office of Research on Women’s Health (ORWH) for putting forth the important cross-cutting themes in the Request for Information and believe they are an imperative step in ensuring that women’s health research is conducted and supported across NIH Institutes and Centers.

As such, we would note that the proposed themes and goals can and should be readily applied to oral and craniofacial health and disease research supported by NIH and specifically, the National Institute of Dental and Craniofacial Research. In addition to the manifestations of sex-based differences in dental, oral and craniofacial diseases and conditions, which may be affected by hormonal changes, genetic variations and more, contextual factors and life experiences also play an important role in oral health – an integral component of overall health.

Additionally, as ORWH deliberates its approach to the science of women’s health, we would encourage ORWH to consider that, while the biologic implications of sex are both justified and important in basic or translational disease models, there is also opportunity for clinical investigators – particularly in the multi-dimensional approach to the science of women’s health – to highlight the socioeconomic and behavioral aspects of gender as well as biological sex. As noted by Ioannidou(1), “economic inequality and hardship for women have resulted in limited access to oral care. As a result, gender emerged as a complex socioeconomic and behavioral factor in influencing oral health and outcomes.” Expanding the strategic plan to encompass gender may lead to a greater understanding of the life-course and psychosocial dimensions sought after by ORWH as well as equip our system for better care by considering health disparities, gender bias and therapeutic interventions.

 

(1) Ioannidou, E.: The sex and gender intersection in chronic periodontitis. Frontiers in Public Health 2017 Aug 4;5:189.

AADR Showcases NIDCR-Funded Research at Second Annual Public Health Fair

For the second year, the American Association for Dental Research (AADR) was a proud co-sponsor and exhibitor at the Coalition for Health Funding’s (CHF) Public Health Fair, an event aimed at educating members of Congress and their staff about the value and importance of public health, including federally-funded public health research and programs. Representative Rob Wittman (R-VA) kicked off the event, stressing the importance of public health research in our society and sharing his belief that prevention efforts are the wisest way to use public health dollars.

  

During this event, held in the Rayburn House Office Building Foyer on November 8, organizations – ranging from professional associations to federal agencies – convened on Capitol Hill to demonstrate how they are collectively working to improve the health and well-being of the American people. Whether through promoting preventive care and community health initiatives, conducting surveillance to prevent and respond to disease, or collaborating with researchers to determine how to make health care safer and more effective for all, each of these groups has a role to play in our nation’s health.

This year, AADR and the Friends of National Institute of Dental and Craniofacial

The finished product of the 3-D printing technology displayed at the Public Health Fair.

Research (FNIDCR) were joined at our booth by Mr. Walter Zimbeck and Mr. Mark Kauf, two researchers from Technology Assessment & Transfer, Inc., a Maryland-based research and development company, who received an NIDCR grant to develop 3-D printing technology for the production of high performance ceramic dental crowns, which has the potential to lower material and processing costs as well as improve restoration aesthetics and performance.

In addition to a display of some ceramic dental crowns they had produced, Mr. Zimbeck and Kauf set up a 3-D printer at the AADR booth so attendees could see the printing technology in action. To learn how the technology works, check out CHF’s Facebook live video.

AADR was proud to be a part of this event and enjoyed learning about other organizations’ public health initiatives. For more insight into the Public Health Fair, view the Facebook live recaps here, and scroll through the day’s Twitter stream by searching the hashtag #PublicHealthFair.

To learn more about the Coalition for Health Funding, visit the CHF website. For more information about AADR’s advocacy and government affairs work, visit our website or contact Lindsey Horan at lhoran@aadr.org.

 

 

 

 

Prevention Fund Remains a Target in Revised CHAMPION Act

Earlier this month, Rep. Walden introduced H.R. 3922, the “Community Health and Medical Professionals Improve Our Nation Act of 2017,” or the “CHAMPION Act,” to extend funding for community health centers, the National Health Service Corps, teaching health centers and other primary care programs. While federal funding extensions for these programs are critical, the CHAMPION Act proposed to fund them at the expense of the Prevention and Public Health Fund, the nation’s only dedicated investment in prevention and public health programs. In response, AADR sent a letter to House Energy and Commerce Committee leadership opposing the use of the Prevention Fund as an offset.

The House has now released a revised version of the CHAMPION Act, which folds in reauthorization for the Children’s Health Insurance Program (CHIP). Unfortunately, the Prevention Fund fares worse in the revised legislation, the CHAMPIONING HEALTHY KIDS Act, than in the original version passed by the Energy and Commerce Committee: a proposed $10.5 billion (or 75 percent) cut over the next eight years as opposed to the initial $6.35 billion proposed cut. Importantly, the revised bill would phase the Fund out after two years.

As a reminder, the Prevention Fund accounts for roughly 12 percent of the Centers for Disease Control and Prevention’s (CDC) budget, which includes funding for the Preventive Health and Health Services Block Grant. Among the grant dollars, nearly $4 million is provided for state oral health programs. The Fund also supports community prevention programs, such as tobacco cessation programs.

UPDATE: On Friday, November 3, the House of Representatives passed H.R. 3922 by a vote of 242 to 174. The bill included cutting the Prevention Fund by $6.35 billion, back to the Committee-approved level.

A number of organizations in the health funding community are speaking to members of Congress about the importance of the Prevention Fund, but ultimately, members of Congress want to hear from their constituents — you! We encourage those who support the Prevention Fund to reach out to their elected officials to educate them about the Prevention Fund and the harmful effect these cuts could have on public health, including public health research.

AADR has created an action alert to make contacting your elected officials easy.

Trust for America’s Health has also compiled a number of resources that may be helpful for your outreach:

If you have any questions about the Prevention Fund or about additional ways you can take action, please contact AADR Assistant Director of Government Affairs Lindsey Horan.

AADR Comments on Draft HHS Strategic Plan Call Attention to Oral Research

This week, the American Association for Dental Research (AADR) submitted feedback to the U.S. Department of Health and Human Services (HHS) on its draft strategic plan for fiscal years (FY) 2018-2022.

The newest version of the strategic plan takes important steps to achieve its aim to “address complex, multifaceted, and evolving health and human services issues.” Importantly, this included an emphasis on the promotion of evidence-based prevention and practices to achieve better health outcomes – a core component to achieving safer and more efficient, effective and equitable care.

AADR was also pleased, in particular, to see HHS reference oral health throughout its framework. As we think about how best to treat patients and improve health care outcomes, we must ensure that oral health is considered as an integral part of medical and other types of care.

Our comments both commend HHS for its calls to support research, improve access for vulnerable and under-served populations and promote healthy behaviors that have a direct impact on oral health as well as offer suggestions to bring greater representation to oral health issues throughout the plan.

Read AADR’s full comments on the HHS Strategic Plan FY 2018-2022 here.

Status Update: Fiscal Year 2018 Appropriations

Under regular order in the annual budget and appropriations process, the president would release the president’s budget submission in February and Congress would complete its budget resolution, which sets the top-line budget totals and divides spending into categories, by mid-April. However, as we have seen over the past several years, ‘regular order’ has become more of the exception than the rule as continuing resolutions (CRs) are passed to keep the government afloat (until budget deals can be reached), and appropriations deadlines are continually pushed back.

In this year’s case, the public didn’t see movement with respect to fiscal year 2018 budget resolutions until the House Budget Committee unveiled its budget blueprint in July and the Senate Budget Committee unveiled its version late last month. Among the biggest takeaways in both the House and Senate versions are the cuts to non-defense spending, which covers everything outside of the defense portfolio, including scientific research, education, etc.:

“The Senate’s resolution keeps defense spending at the budget cap levels outlined by the Budget Control Act. It hacks away at non-defense spending starting in 2019, cutting it by as much as $106 billion by 2027. The House, on the other hand, cuts into non-defense spending right away, but includes a $70 billion increase in defense spending in 2018 alone” (The Hill).

The full House narrowly passed its $4.1 trillion budget resolution last Thursday, October 5, creating a pathway through which members could pass tax reform via the budget reconciliation process. The full Senate is expected to consider its budget resolution in mid-October.

Drilling down further into fiscal 2018 spending, the House and Senate are also working to finalize their respective spending bills, including appropriations for the Departments of Labor, Health and Human Services, Education and Related Agencies (Labor-HHS). The House, which in mid-September voted along party lines to approve a package of 12 spending bills, is farther ahead in the process than the Senate, whose Labor-HHS bill for fiscal 2018 was approved by the Senate Appropriations Committee just last month.

Relevant for AADR members, the House and Senate bills call for a $1.1 and $2 billion increase, respectively, for the National Institutes of Health (NIH). The two spending bills also call for increases to the budget of the National Institute of Dental and Craniofacial Research (NIDCR). The House bill provides roughly $432.36 million for NIDCR, and the Senate bill provides just under $439.74 million, compared with the fiscal 2017 level of $425.75 million.

The House and Senate bills will ultimately have to be reconciled, and in anticipation of the end of the fiscal year on September 30, lawmakers voted to extend 2017 spending levels until December 8, 2017 to give them more time to reach an agreement. However, it is not clear whether Congress and the White House will be able to make a deal by that time.

AADR will continue to keep its members apprised of the budget process and how developments unfold in the weeks to come.

Fiscal Year 2018 Resources:

AADR sends letter to House leadership opposing CHAMPION Act’s reliance on Prevention Fund dollars

The American Association for Dental Research (AADR) this week sent a letter to House Energy and Commerce Committee leadership expressing AADR’s opposition to using money from the Prevention and Public Health Fund (Prevention Fund) as an offset to pay for the Community Health and Medical Professionals Improve our Nation Act of 2017, or CHAMPION Act.

The CHAMPION Act, proposed by Representative Greg Walden (R-OR), calls for critical federal funding extensions for programs such as Community Health Centers and the National Health Service Corps. While it is critical that Congress fund these programs, the CHAMPION Act proposes to do so at the expense of the Prevention Fund (specifically by cutting $6.35 billion from the Fund over the next eight years) and the agencies and essential public health programs it supports. The Prevention Fund, as the nation’s only dedicated investment in prevention and public health programs, works in concert with the programs included in the CHAMPION Act to collectively improve the health of all Americans.

In addition to the Prevention Fund’s roles in supporting community prevention programs, such as tobacco cessation programs, and expanding public health research and tracking efforts, it also accounts for roughly 12 percent of the budget for the Centers for Disease Control and Prevention (CDC), including funding for the Preventive Health and Health Services Block Grant. This program provides nearly $4 million for state oral health programs and plays a key role in supporting preventive dental care.

Therefore, AADR asked that while policymakers work to extend funding for these primary care programs that they find solutions that do not cut or divert current or future funding allocations from the Prevention Fund. As AADR noted in its letter, “The Prevention Fund and its initiatives would benefit these programs, resulting in better care at the state level and healthier families across the nation.”

Read AADR’s letter here.

Administration Issues Proclamation Revising Executive Order “Protecting the Nation from Foreign Terrorist Entry into the United States”

Earlier this year, shortly after its term began, the administration issued the executive order (EO) “Protecting the Nation from Foreign Terrorist Entry into the United States,” which among other provisions, suspended entry into the United States for immigrants and nonimmigrants from Iran, Iraq, Syria, Yemen, Sudan, Somalia and Libya for a 90-day period. The International and American Associations for Dental Research (IADR/AADR) strongly opposed that EO, citing its potential chilling effect on the global scientific community and on our mission to advance research and increase knowledge for the improvement of oral health worldwide.

This past Sunday, September 24, President Trump issued a presidential proclamation revising the restrictions and limitations set forth by the previous EO. Per the proclamation, beginning on October 18, entry restrictions and limitations are to be put into effect for the following countries (countries not included in the earlier EO are bolded): Chad, Somalia, Iran, Libya, North Korea, Syria, Venezuela, and Yemen. Venezuela’s restrictions are narrower, with the order’s attention focused predominately on government officials and their families, and Sudan is no longer included in the list.

Beyond the countries included in the proclamation, there are a few notable differences between the orders issued in January and September. First, unlike the previous order, which had a specified 90-day time frame, the new restrictions are intended to be indefinite, though a senior administration official referred to them as “conditions- based, not time-based.” The new proclamation also eases restrictions on individuals who hold visas and states that no immigrant or nonimmigrant visa issued before October 18 will be revoked, though once student or work visas expire, their renewal is not guaranteed. Yet, while there are various exemptions and waivers included within the new text, as was noted in The New York Times, “most [citizens of the countries] will be barred from coming to work, study or vacation in America.”

In the coming months, AADR will we be monitoring this policy’s potential impact on the scientific enterprise (including, but not limited to, faculty and students’ ability to research, teach, or attend international scientific conferences) and take action to safeguard research and champion those who conduct it. Collaboration and the free flow of ideas is core to scientific progress and the advancement of our nation as a whole.

IADR has a global reach, with members and student members from all over the world, including those countries identified above. We remain committed to our diverse membership and will continue to partner with the broader scientific and health care communities in advocating for policies that allow not only our members – but also other students, scientists, and international peers – to partner, study and learn from one another both at home and abroad.

AADR submits comments on inclusion of pediatric research in All of Us Research Program

AADR has submitted comments in response to request for public input on the inclusion of pediatric research in the All of Us Research Program, formerly the Precision Medicine Initiative. Currently, children are excluded from the All of Us Research Program, along with prisoners and adults who are unable to give consent. The Child Enrollment Scientific Vision Working Group of All of Us requested input on the types of research questions that could be answered with the enrollment of children. AADR submitted the following comments in response:

Question 1
What are the most critical short-, medium-, and long-term precision medicine research questions that could be addressed by the inclusion of pediatric populations in the All of Us Research Program?

Short term (0-5 years)

Orofacial clefts affect 1/700 live births and are associated with environmental, dietary and genetic factors. Future studies should integrate genetics with cleft phenotypes, identify and describe the contribution of candidate genes and describe the interaction between genetic and environmental risk factors (Parker SE et al. 2010. Birth Defects Res A Clin Mol Teratol. 88(12):1008-16; Dixon MJ et. 2011. Nat Rev Genet. 12(3): 167-178; Li C et al. 2017. JDR 96(11): 1184 – 1191). Childhood dental caries remain a public health concern marked by pronounced health disparities. There is evidence of heritability of dental caries but few known associated loci (e.g., ACTN2) and polymorphisms (Stanley BO. 2014. JDR 93(7):626-32). The strength of the evidence supporting these associations is limited due to small sample sizes and reliance on candidate-gene study designs. Researchers currently do not understand the magnitude and the mode of influence of these loci and polymorphisms on caries risk in children (Divaris K. 2017. Dent Clin N Am. 619-625), especially in the context of environmental factors like fluoride exposure (Shaffer JR et al. 2015. Hum Genet. 134(2):159-67). Understanding the composition and function of the oral microbiome in health and disease will also help investigators precisely dissect the etiology of caries on an individual level and lead to more effective preventive and therapeutic modalities.

Medium (5-10 years)

In 5-10 years, All of Us could help scientists understand the genetic, lifestyle and environmental factors that contribute to oral health disparities in children and that are not completely explained by differences in socioeconomic status. A better understanding of the biological underpinning of oral and craniofacial conditions in children can help explain how social deprivation and other upstream factors can have such profound impact on multiple, clinical oral health endpoints. For example, All of Us could help elucidate the impact of genetics and epigenetics (a mechanism that may illuminate previously uncharacterized links between social factors, environmental exposures and biological or clinical outcomes) on intermediate oral and craniofacial phenotypes such as tooth anatomy, salivary factors, the oral microbiome as well as directly on oral disease susceptibility (Divaris K. 2016. JDR 95(3):248-254).

Long (more than 10 years)

Understanding how oral health and disease develop over time requires longer follow-up periods than what is typically feasible with a research project grant. The inclusion of pediatric research in All of Us will enable longitudinal studies of oral and craniofacial health among large, population-based samples. Gaps in knowledge that need to be addressed include the impact of craniofacial developmental diseases, such as cleft lip/palate and enamel hypomineralization and hypoplasia, on susceptibility to or exacerbation of other diseases; common risk factors between oral and other diseases leading to common prevention and treatment strategies; the quantification of risk for certain oral diseases like dental caries (Divaris K. 2016. JDR 95(3):248-254); caries progression from ages 0-18; and oral health across the lifespan. The health of children with complex medical conditions or with cancer can be further compromised when they have untreated caries lesions. The development of effective means for the prevention or management dental caries among this and other pediatric populations with special health care needs is critical.

All of Us should collect and bank saliva and other biological specimens (e.g., plaque) to enable genetic and microbiome analyses, as well as studies on how salivary factors change from infancy over the life course. Saliva collection methods for valid downstream omics (e.g., genomics, microbiomics and proteomics) analyses in very young children need to be studied.

Question 2

What are the key gaps in current pediatric study designs that might be appropriate for All of Us to address through the enrollment of children (for example, preconception studies, sibling studies)? 

All of Us should enroll families and follow these family cohorts over time. Children are subject to the behaviors, environment and resources of their caregivers, e.g., caregiver oral health literacy is associated with the oral health status of the child (Vann WF et al. JDR. 89(12):1395-400).  Maternal periodontitis treatment may improve low birth weight, but the evidence is low quality (Iheozor-Ejiofor Z et al. 2017. Cochrane. (6)) due to study sizes and possibly treatment intervention at the end of the first trimester versus preconception.

All of US should include community-based participants, i.e., individuals enrolled regardless of health or disease status. Oral and craniofacial research has relied on case-control study designs or clinic-based samples, but these designs are subject to numerous biases.

All of Us should enroll racially/ethnically diverse children from younger age groups. Precision oral health studies (e.g., genome-wide association studies) have been mostly conducted in children of European decent and have included few children under the age of 6, the cutoff age for early childhood caries. Many studies of oral diseases have also been conducted in small cohorts or clinical (care-seeking) samples. A larger, diverse pool of community-based (not necessarily care-seeking or clinic-attending) participants can alleviate previous challenges with low statistical power, validity, reproducibility and generalizability (Divaris. 2017. Dent Clin N Am. 619-625).

Question 3
What are the research resources that the inclusion of children into the All of Us Research Program could potentially generate (for example: registries, databases, or innovative methods)?

The data generated from All of Us will enable the refinement, validation and ultimately improvement of current caries risk assessment tools (Divaris K. 2016. JDR 95(3):248-254) and the generation of more precise algorithms for the prediction of disease occurrence, time to disease development, and disease severity as well as methodologies in genetics and social and behavioral research. The dental research community will greatly benefit from using samples stored in biobanks for future research. The inclusion of pediatric research in All of Us will enable hypothesis generation and testing for future research. It is expected that the availability of such rich biorepositories (offering opportunities for ‘deep phenotyping’) and other big data sources (allowing ‘wide’ research explorations) will accelerate scientific discovery and the potential for translation of research findings to meaningful, individual and population health-improving solutions in the oral and craniofacial domain.

 

AADR Comment on Prenatal Fluoride Exposure Study in Mexico

AADR Comment on “Prenatal Fluoride Exposure and Cognitive Outcomes in Children at 4 and 6–12 Years of Age in Mexico” by Bashash, M. et al. in Environmental Health Perspectives published online September 19, 2017

The findings reported by Bashash et al. add to the scientific literature on associations between fluoride exposure and cognitive outcomes. Their epidemiologic study using 299 mother-child pairs in Mexico examined maternal urinary fluoride levels, as a proxy measure of pre-natal fluoride exposure, and two measures of cognitive outcomes in their children at age 4 and 6 -12 years. Their findings must be taken into context with previous studies, including the New Zealand Dunedin longitudinal study that did not find an association between fluoridated water and IQ.

It is also important to note that Bashash et al. used data from a longitudinal birth cohort study in Mexico (ELEMENT) originally designed to examine how environmental exposures to metals and other chemicals affect pregnant women and children, and not to examine the specific relationship between fluoride exposure and cognitive development. The current study is examining samples of urine from two cohorts, the first to investigate prenatal lead exposure (1997-2001) and the second, the effect of calcium supplementation (2001-2006). As an examination of fluoride was not part of the original study design, there are no data on total fluoride intake by the pregnant mothers or their children, other than the fact that Mexico does not have community water fluoridation. Exposure to fluoride would be from naturally occurring in water supplies, fluoridated salt, and other dietary and environmental sources.

Some places in Mexico with high concentrations of naturally-occurring fluoride in water also have high concentrations of arsenic, a known neurotoxin. As the authors noted, information regarding the study population’s exposure to arsenic or other environmental toxins was not available, and therefore, could not be ruled out as a confounding variable. Given such lack of exposure data, among other limitations clearly cited by the authors, the results should not alter current policy recommendations on the use of fluorides for caries prevention.

The AADR concurs with Bashash et al. that the ability to extrapolate their findings to how exposures may impact general populations is limited given the lack of data on fluoride exposure and fluoride pharmacokinetics during pregnancy. The authors conclude that their findings must be confirmed in other populations. The AADR agrees with the authors that these findings reinforce the need for additional research.

AADR notes that fluoride has been an important tool in reducing the prevalence of dental caries in the United States. Specifically, the Centers for Disease Control and Prevention named community water fluoridation one of the top 10 public health achievements of the 20th century. Other fluoride interventions include the application of topical fluorides including fluoride varnish, the use of fluoride supplements and fluorides in toothpaste. As a result, caries prevalence in children has been reduced dramatically as has the number of older adults with total tooth loss in the United States.