Endocrine Insider: January 28, 2016

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Past Issues


Advocacy News

Endocrine Society Launches Centennial Celebration; January is Thyroid Health and Thyroid Cancer Month
What’s Next for NIH? Bipartisan Support is Key
Senate Committee Scraps House Version of 21st Century Cures and Releases First Medical Innovations Bill

Clinical News

January 29 Deadline Approaching for the 2016 Harold Vigersky Practicing Physician Travel Award
Society Comments on Senate Working Group Report on Chronic Care

Research News

NIH Seeks Expertise in Prevention Research
Endocrine Society Participates in NACHHD Meeting
FASEB Releases Report on Reproducibility in Research

Media News

The Today Show Investigates Natural Makeup, Skin Care Products


Advocacy News

Endocrine Society Launches Centennial Celebration; January is Thyroid Health and Thyroid Cancer Month

Throughout its Centennial year in 2016, the Endocrine Society will celebrate endocrinology’s contributions to science and public health – while keeping an eye on today’s promising research which will lead to the discoveries of tomorrow. Nobel Prize winners in the field (including four Society Past-Presidents) and historic breakthroughs such as the 1921 discovery of insulin are highlighted on the Society’s new interactive “Century of Endocrinology Timeline.” Each month, this new site will offer a wealth of content on some of the most pressing endocrine-related health conditions of our time, starting with thyroid health and thyroid cancer in January.

To engage patients in the celebration, the Hormone Health Network has developed a thyroid health and thyroid cancer toolkit. The toolkit features a whiteboard animation video on the difference between hypothyroidism and hyperthyroidism, as well as quizzes, infographics, and fact sheets to educate the public about thyroid health.

The Society and the Hormone Health Network will continue to launch new Centennial resources throughout the year. Share your suggestions for Centennial content on the website.

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What’s Next for NIH? Bipartisan Support is Key

The Atlantic recently published an article by Nora Kelly reviewing the successful constituent-lead campaign to increase funding for the National Institutes of Health (NIH) this year and future opportunities for increased funding.

As Kelly notes, NIH and the research programs it supports tend to have support from both Democrats and Republicans. While funding for NIH programs dipped in the past decade due to focus on other priorities and fiscal constraints, 2016 marked a turnaround in support for the agency.

The question now is whether the agency will continue to receive broad bipartisan support for increased funding. If lawmakers continue on this trajectory, the flat nondefense discretionary spending levels established in the Bipartisan Budget Act of 2015 will necessitate cuts elsewhere. The hope seems to be that biomedical research will be seen by conservative lawmakers as a fiscally responsible investment, because of its relevance in all strata of American society. NIH Director Francis Collins is pleased with House support, and hopeful that the agency will see continued support for research and the scientific community...

"It'll be even more wonderful if this actually begins a trend to get us back on a stable, predictable, upward trajectory."

Kelly's full article is available online.

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Senate Committee Scraps House Version of 21st Century Cures and Releases First Medical Innovations Bill

The leaders of the Senate Health, Education, Labor and Pensions Committee have released the first of several bills designed to spur new biomedical cures and make the delivery of health care more efficient.

The measure released by Chairman Lamar Alexander (R-TN) and top panel member Patty Murray (D-WA) aims to ease the documentation required of providers that participate in federal electronic health records programs. Among the changes is a provision to allow non-physician members of health care teams, such as nurses, to document information instead.

The bipartisan bill also would establish a rating system for health information technology to help doctors and hospitals choose the best products. And, the measure would establish a set of common data elements and formats for certain data, such as birthdates, to help facilitate information sharing between providers.

The Department of Health and Human Services inspector general would gain authority to investigate health care providers and any health IT developers who appear to be blocking the sharing of electronic health information.

The bill also aims to support the certification and development of technology so that patients could tap into secure software.

Alexander and Murray emphasized that the draft will likely be tweaked. “The committee has been working for months on legislation to help improve electronic health records, and it involves especially technical work to get this right, which is why our committee looks forward to feedback on today’s draft from doctors, hospitals, health IT developers, and other experts in this area of health care,” said Alexander.

The release of the bill comes a day after Alexander said the committee will consider a set of narrower bills rather than one comprehensive bill designed to spur innovation.

Following House passage of the so-called 21st Century Cures Initiative (HR 6) last summer, Alexander maintained that his goal was to have a Senate companion measure marked up by the end of 2015. But by early January it became clear that the committee was unable to come to a bipartisan agreement on a comprehensive package.

Instead, the committee will hold three markups in the coming months to consider targeted legislation that would tweak the Food and Drug Administration’s approval processes for drugs and medical devices and strengthen the research muscle of the National Institutes of Health.

“Senators and staff on our committee have been working together throughout 2015 to produce a number of bipartisan pieces of legislation that are ready for the full committee to consider,” Alexander said.

Murray has said that she was pleased the committee will hold the markups. But a Democratic aide said there is no agreement on the path forward beyond the first markup, and Murray's statement hinted at the areas where the parties couldn't agree.

"I've made clear I believe this progress should include addressing the burden that high drug costs impose on patients, as well as critical mandatory investments in research and development at NIH and the FDA," Murray said.

The first markup will be held February 9, during which lawmakers will take up at least seven bipartisan bills.

Besides the electronic records measure, the other bills that the committee will consider include one (S 2030) that would make it easier for companies working on treatments for rare diseases to win FDA approval, a measure (S 1622) that would seek less burdensome FDA reviews of medical devices and a bill (S 2014) that aims to enhance the abilities of younger researchers at the NIH.

A second markup to be held March 9 will focus on legislation that Alexander said would support President Barack Obama’s precision medicine initiative. A third markup will be held April 6.

The Endocrine Society continues to work with the Senate to include language into the legislative package that recognizes sex as a biological variable. In addition, the Society is urging the HELP Committee to incorporate the National Diabetes Clinical Care Commission legislation (S. 586) we have supported for several years.

Even though the Senate is taking a different path than the House did, the members behind 21st Century Cures, Representative Fred Upton (R-MI) and Diana DeGette (D-CO) appeared to view Alexander's announcement as good news.

"The Senate announcement is just the latest positive milestone in the effort to give patients and their loved ones more hope," the lawmakers said in a joint statement. "But we have much work left to do to make 21st Century Cures a reality. The vice president is working on a ‘moon shot’ to cure cancer, and we’ve got a rocket ship ready to go."

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Clinical News

January 29 Deadline Approaching for the 2016 Harold Vigersky Practicing Physician Travel Award

Apply now for the 2016 Harold Vigersky Practicing Physician Travel Award. Named for Past-president Robert Vigersky’s father, the award assists clinical practitioners operating in private practice by offsetting the cost associated with attending the Endocrine Society’s annual meeting (ENDO) or Clinical Endocrinology Update (CEU).

The award recipient will receive complimentary registration to either ENDO or CEU and a $1,500 allowance for travel and lost productivity. Physicians working in private practice who are not reimbursed for travel to clinical meetings or CME conferences are encouraged to apply. Specific eligibility requirements apply and can be found with the online application form on the Society’s website.

Applications are due Friday, January 29.

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Society Comments on Senate Working Group Report on Chronic Care

The Endocrine Society submitted comments this week on potential policy changes outlined in a report from the Senate Finance Committee Bipartisan Working Group on Chronic Care.

The Working Group was formed in response to a series of hearings held by the Finance Committee in 2015 to learn about the challenges faced by people with multiple chronic conditions and the health care providers who care for them. Based on what the Working Group learned during these hearings and from feedback from relevant stakeholders, a series of policy proposals were released for comment. The working group outlined three main bipartisan goals that each policy under consideration should strive to meet:

  1. The proposed policy increases care coordination among individual providers across care settings who are treating individuals living with chronic diseases;
  2. The proposed policy streamlines Medicare’s current payment systems to incentivize the appropriate level of care for beneficiaries living with chronic diseases; and
  3. The proposed policy facilitates the delivery of high quality care, improves care transitions, produces stronger patient outcomes, increases program efficiency, and contributes to an overall effort that will reduce the growth in Medicare spending.

The proposals ranged from providing greater access to telehealth services, providing payment to providers for extended counseling sessions after a patient is diagnosed with specific conditions, and implementing a medication synchronization system for patients with chronic conditions that require multiple medications.

The Society’s comments focused primarily on improving care and offering targeted services to people with diabetes, as over 70 percent of these individuals have 3 or more chronic conditions, complicating health care providers’ ability to coordinate and manage the myriad of health issues that they face. The Society is committed to supporting the Working Group’s efforts to further define these policy proposals to ensure that providers have the resources needed to manage the care of these patients, and patients have the support that they need to avoid further complications.

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Research News

NIH Seeks Expertise in Prevention Research

The Office of Disease Prevention (ODP) at the National Institutes of Health (NIH) is seeking grant reviewers with methodological and content expertise in five areas closely aligned with prevention research:

  • Study Design Topics
  • Research Methods
  • Content Topics
  • Settings
  • Populations

As disease and disability due to chronic diseases become more prevalent, prevention research is increasingly necessary to reduce or mitigate disease-related harms before they occur. Many endocrine researchers are actively engaged in basic and clinical research projects that are closely related to prevention research efforts. For example, Endocrine Society members are at the leading edge of integrative efforts in neuroscience and endocrinology to understand the drivers of obesity in order to target developmental pubertal effects in children and lifelong consequences, such as metabolic syndrome and cardiovascular disease in adults.

Take Action: We encourage members of the Endocrine Society with expertise in the five areas mentioned above to consider completing the survey and serve as reviewers for prevention-related research grants. To create an account on the NIH website, fill out the survey, and share your information with the ODP and the Center for Scientific Review, please examine the instructions on the NIH ODP website.

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Endocrine Society Participates in NACHHD Meeting

On January 21, Endocrine Society participated in a meeting of the National Advisory Child Health and Human Development Council (NACHHD). The Council advises the Acting Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on research, support activities, and functions of the institute.

During the open session, Acting Director Catherine Spong, MD, gave the Advisory Council an update on the new Environmental influences on Child Health Outcomes (ECHO) program and plans for archiving data from ECHO studies so that it can be used by other researchers. Dr. Spong also described how NICHD plans to allocate funds from the Fiscal Year (FY) 2016 budget increase, of which NICHD will receive nearly $51.4 million. Of this total, nearly $20.5 million will go to required increases in trans-NIH initiatives such as the BRAIN initiative. Additionally, NICHD plans to use funds to support additional FY 2015 grants that were at the published payline for the institute. After accounting for these and other expenditures, NICHD will have nearly $6.7 million in additional available funds for FY2016.

NICHD Associate Director for Extramural Research, Della Hann, PhD, then gave a report to the Advisory Council. Dr. Hann that the NICHD received a significant increase in grant applications in FY2015, and that this increase is roughly in alignment with a trend of increasing numbers of applications requesting more funds on average. The Advisory Council then discussed the implementation of recommendations from the review of the research training programs at NICHD, these included shifting support from institutional K awards to individual K awards, increasing the success rate for K99/R00 grants, and modifying the salaries for K08 and K23 awardees.

Dr. Spong also led the Advisory Council in a discussion about “Funding the Best Science”, beginning with a presentation that compared NICHD grants with those at other ICs. Specifically, NICHD grants:

  • Have more focus on human research, as opposed to animal research;
  • Have higher total requested direct costs of $1.6 million, as opposed to $1.2 million for other ICs, and that this disparity is increasing over time.

NICHD expressed interest in ideas and suggestions from the Advisory Council about how to improve the payline for NICHD grant applicants. Ideas included stricter methods for accepting large grants, funding more clinical trials through Funding Opportunity Announcements, and examining larger programs to find savings. Council members suggested that NICHD carefully evaluate “ROI” for grants to guide decision-making and closely examining why NICHD direct cost requests are so much higher than other institutes.

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FASEB Releases Report on Reproducibility in Research

As a member of the Federation of American Societies for Experimental Biology (FASEB), the Endocrine Society contributes to FASEB’s advocacy initiatives and projects in support of biomedical researchers. On Thursday, January 14 FASEB issued a report titled Enhancing Research Reproducibility. The report includes “a set of recommendations aimed to promote the reproducibility and transparency of biomedical and biological research.” The report reflects the increasing emphasis on ensuring that new discoveries and potential breakthrough treatments and therapeutics are based on a robust foundation on reproducible research.

During the development of the report, FASEB held a series of roundtable discussions with a variety of stakeholders to identify key issues and suggestions for recommendations. Endocrine Society representatives Ursula Kaiser, MD; Daniel Bernard, PhD; and Alan Schneyer, PhD; participated in the roundtables. The report focuses on issues specific to mouse and animal models, as well as issues related to the use of antibodies in research. The report also identifies potential strategies that professional organizations, scientific societies, and other stakeholders could pursue to help maintain and strengthen rigor and reproducibility in biomedical research.

We encourage interested members of the Endocrine Society to examine the final report on the FASEB website.

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Media News

The Today Show Investigates Natural Makeup, Skin Care Products

With input from the Endocrine Society, the Today Show Online investigated the “natural skin care movement,” including the ingredients in natural makeup and skin care products, as well as government regulation. The Today Show highlighted the major debate over ingredients like phthalates and parabens, which are considered endocrine disruptors. The Endocrine Society has reported that emerging evidence ties endocrine-disrupting chemical (EDCs) exposure to two of the biggest public health threats facing society – diabetes and obesity. Mounting evidence also indicates EDC exposure is connected to infertility, hormone-related cancers, neurological issues and other disorders. Endocrine Society member Heather Patisaul, PhD, Professor at North Carolina State University was quoted in the report saying, there is “abundant evidence” that even low doses are cause for “significant concern,” especially if the exposure is long term. View the Endocrine Society’s Scientific Statement on EDCs.

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