Mary Anne Schmitt-Carey

FDA Oncology Center staff worked with other FDA offices and Centers, and OHRP to lead the development of this guidance. “Tissue biopsies in clinical trials are often needed to determine eligibility or to understand the effect of the medical product being studied in the trial,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “This new draft guidance builds on the agency’s ongoing efforts to enhance clinical trials by providing recommendations to improve participant safety and further clinical research.”

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For the better part of the past year, I have had the honor of co-chairing a NASEM study committee charged with assessing women’s health research at the NIH. I have had the privilege of working with and learning from a remarkable committee and staff. This report, A New Vision for Women's Health Research, Transformative Change at the National Institutes of Health, finds that while the NIH has made important contributions in women’s health research, there has been a persistent underinvestment in women’s health research and as result there are still many gaps. The committee is recommending a greater investment and a new women’s health research structure for NIH including: ·        A new Institute for women’s health, on female physiology and chromosomal differences, reproductive life course, and female-specific conditions not under purview of other ICs ·        A new fund to foster interdisciplinary and sex differences research ·       New and enhanced approaches to grow, support, and retain the women’s health workforce ·        Increased funding to support these efforts. We make recommendations for priority areas across the research continuum, with the goal of sparking breakthroughs to either prevent, treat, or reduce the amount of time women live with painful or debilitating conditions, as well as conditions that cause early mortality, such as cardiovascular disease, female-specific cancers, and maternal morbidity and mortality. The persistent lack of investments and resultant gaps have consequences on women’s lives, their families, and society as a whole. The committee concludes that if no change is made, slow and stagnant progress will continue to undermine the health and wellbeing of women and girls in this country.  Sheila Burke; Sherita Golden; Robert Kaplan; Angeles Alvarez Secord; Neelum T. Aggarwal, MD; Chloe Bird, PhD, FAAAS, FAAHBHolly Ingraham; Nancy Lane; Jane Salmon; Crystal Schiller; Methodius Tuuli, MD, MPH, MBA; Bianca Wilson; Felina Cordova-Marks; Amy Geller

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I’m proud to “Go Blue For AMR” this week in honor of World #AMR Awareness Week (#WAAW). This year’s observance comes on the heels of recent progress that global leaders made at the UNGA High-Level Meeting on AMR. The High-Level Meeting resulted in a commitment to a clear set of targets and actions which included establishing a structure to support sustained global progress through the Independent Panel for Evidence for Action on AMR. This can help us build on the momentum generated by the meeting and continue working together, with a One Health approach, to combat this pressing global health crisis. As we think about this year’s theme for World AMR Awareness Week (Educate. Advocate. Act Now.), I want to reinforce how important it is that we all come together to slow the spread of AMR. At Merck, we know that industry has a critical role to play. We are doing our part and have a longstanding commitment to addressing antimicrobial resistance, including prioritizing AMR education and advocating for policies aimed to improve antimicrobial stewardship and access. The time is now for the Quadripartite organizations to begin to establish the independent panel to support Member States in their efforts to combat AMR. #MerckProud

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Check out this new Mathematica blog on improving postpartum care in Medicaid and CHIP. Very timely and actionable. #Medicaid, #CHIP, #maternalhealth, #Mathematica

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More evidence that it pays for #hospitals to merge and dominate local markets. To be clear, they are not merging to succeed at "value-based care"; they are merging to succeed at extracting more--significantly more--value from us.

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It’s been two years since the Supreme Court overturned Roe v. Wade. While we don’t yet know the full extent of the consequences, our latest state scorecard provides an important baseline for assessing the impacts of policy changes that result from the rulings.  Looking at data from all 50 states and the District of Columbia, Commonwealth Fund’s new scorecard examines how women’s health and reproductive care are faring in the U.S. The research reveals alarming results: States with abortion restrictions often have fewer maternity care providers, and maternal death rates are highest in states with full abortion bans. The findings indicate that gaps in women’s health and reproductive care could widen further in post-Roe America, especially for women of color and those with low incomes in states that have restricted access to reproductive health care. https://buff.ly/3WswPsU  

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A recent report has unsurprising findings about the challenges in accessing and assessing Medicaid HCBS, and includes a necessary call for improving how Medicaid HCBS is delivered! "A maze of federal legal authorities has resulted in inconsistent and inequitable access to [long-term] care among [Medicaid] beneficiaries and across geographies. The many programs are difficult to understand, even for researchers and regulators trying to measure outcomes." #Medicaid #longtermcare #caregiving #HCBS

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My "only good news on Friday" comes from New York City and beyond, where 32BJ SEIU and Building Service 32BJ Benefit Funds have been educating and mobilizing in NYC (the belly of the beast of powerful hospitals) to lower hospital prices and put more money in workers' pay checks. Their "Price of Power: Confronting the Hospital Affordability Crisis" brought powerhouse resisters together to build power for patients, workers, and employers. Site neutral payment, antitrust enforcement, transparent prices, and direct contracting are top agenda items. Zack Cooper showed how hospital consolidation is slowing local job growth and depressing wages of working people. Ryan Danks of USDOJ Antitrust Division described how consolidation, non-competes, and anti-competitive contracting inhibit health care innovation. Newark, NJ Mayor Ras Baraka took the reins to negotiate better deals with hospitals for city workers. Courageous NYC Councilwomen are taking on hospital affordability through transparency and public accountability. Public employers like Miami-Dade Schools are demanding that local hospitals be better civic leaders or else they won't be included in plan networks. And Building Service 32BJ Benefit Funds is sharing their playbook for contracting on better terms to protect hard-earned wages and benefits from price gouging. #antitrust #siteneutralpayment #hospitals Cora Opsahl Claire Brockbank Manny Pastreich Chris Deacon Check out this comprehensive, A to Z game plan to take power back. https://lnkd.in/ec8JWYpw

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AHRQ has released six new files developed by our team at Mathematica supporting the development and updating of the Compendium of U.S. Health Systems. These resources include the 2023 System files, describing the 639 organizations meeting AHRQs definition of a healthcare system. The newly released resources also include the Group Practice linkage files for 2020-22, with information on system affiliation and size for nation’s 35,448 physician group practices. Using these researchers can now conduct practice-level longitudinal analyses from 2016 thru 2022! Other information includes the 2023 Outpatient Site linkage files, providing "street-level information" on 279,446 care delivery sites and their clinical orientation and ownership relationships. For more info go to Comparative Health System Performance Initiative | Agency for Healthcare Research and Quality

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Seamless data is essential for communities to effectively address public health disparities. The past three years have shown us just how important data is to addressing needs in a timely manner, and the lack of data needed to respond to continuous public health threats has shown us why an updated data infrastructure is long overdue.    In their recently updated Public Health Data Strategy for 2024-2025 and a companion 2023 Lookback Report, @The CDC Foundation shares how they intend to continue improving data modernization across all levels of public health.   More here: https://lnkd.in/ehWsk2d9    #PublicHealthData #DataQuality

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If you need a short, smart overview of the #IRA drug law and how to evaluate it (and I do), check out Laura Tollen 's piece at Health Affairs this week. Adding Laura to the drug gurus I follow here. I'm still trying to learn all the drug policy acronyms, like #MFP. #drugpricing William Sarraille Deborah Williams https://lnkd.in/eDWdhmKn

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The terrific team at Brown University School of Public Health has created a very useful tool for employer purchasers--both public and private--based on research done by Roslyn C. Murray, PhD, MPP on the #Oregon public employee plan's limit on #hospital OON prices. #NorthCarolina (no surprise) is a state that could save real money (almost half a billion!) if the SHP put a modest limit on hospital OON prices (200% Medicare), while still preserving robust hospital profit margins. If states are looking for ways to afford coverage for GLP-1s and other health priorities, this is a policy to consider (though it may require legislation). The tool is based on the well-vetted RAND hospital price data. The user can vary the level of the OON limit and exempt rural hospitals, and see hospital specific impacts. Hospital prices faced by public employee plans can be pretty representative of the prices faced by private employers in a state, so this tool could be helpful for them as well. Chris Deacon Marilyn Bartlett NASHP | National Academy for State Health Policy Christopher Whaley Shawn Gremminger Jon Rankin North Carolina Department of State Treasurer National Alliance of Healthcare Purchaser Coalitions Christine Monahan .Dave Chase, Health Rosetta-discovering archaeologist Tom Friedman Kerry Willis MD https://lnkd.in/evpz3cSX

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A 2021 Rutgers study points to the history and implications of inadequate funding of the state's public health infrastructure - https://lnkd.in/dRJ8ukDR. Recent reporting points to the implications of chronic inadequate funding on the state's ability to respond to public health emergencies: https://lnkd.in/e_tmcc9M.

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Policy changes would not be possible if no one spreads the word. Dave Bondy, Digital & Video Manager for the Mackinac Center, makes it his business to inform the public. On the Overton Window podcast, Bondy discusses how the Mackinac Center reaches people looking to learn more about impactful policy. Bondy’s interest in journalism started when he was seven years old. “I would go around the neighborhood with a little fake microphone and interview neighbors,” Bondy says. He got involved with high school and college newspapers, at one point covering college sports for the Detroit Free Press. "Your job is to hold the powerful accountable," a colleague told Bondy when he began his reporting career. This became a guiding principle in his career, pushing him to challenge authority and expose untold stories. Bondy brings deep experience with digital media — particularly short-form videos. “The one-minute short videos do great right now. In a year from now, they may not,” he says. The constantly shifting landscape requires an understanding of the algorithms’ nuances. In the rise of social media, it can be said that every user is a journalist. "I don’t agree with that,” Bondy says, “There are still ethics, there are morals, there are certain rules—you can’t go out and slander or defame someone.” His commitment to fairness and objectivity is central to his work. "I will be critical of Democrats, Republicans, independents. I try just to give the information and not tell people how to think,” he says. Bondy’s career reached a turning point when he faced backlash in the workforce for his criticism of an elected official. He realized he couldn’t work in an industry that compromised the pursuit of truth to maintain access to sources. It was this experience that led Bondy to the Mackinac Center. “I came in wanting to help spread the message not just to people who already know about the Mackinac Center, but to people who don’t,” Bondy says. Through his work, Dave Body strives to bring authenticity and transparency to the digital realm, encapsulated in his brand, "Keeping it Real." The slogan aims to capture “the realness of just being me and some may not like it at times, but I try to be very fair.” There is a growing need for voices like his. In an age where algorithms often trap users in echo chambers, Bondy’s focus remains on filling the knowledge gaps left by legacy media. Jessica Wyeth Dave Bondy

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I'm excited to join the Board and be associated with Health Bank One. I've been wondering what to do next, and this feels really good for patients, clinicians, and researchers. Health Bank One integrates disparate medical records into a single app, controlled by us-- patients and our families-- then summarizes those records with AI into patient-understandable and actionable terms. It does all the technical and administrative work for patients. All you have to do is signup and tell it where your records are. For me, my records were spread over six different healthcare systems in Salt Lake City, Chicago, and Asheville. My current primary care doc loves it, too, because now he sees my complete health history in one place. The founder, Bo Holland, is not your stereotype opportunistic tech founder, looking for a big money exit in healthcare. He's a hands-on technology product leader, a successful veteran entrepreneur, with my kind of values. His son, Ford, was diagnosed with a rare brain tumor in 2013. The family was tossed into the mess of navigating Ford's medical records, which planted the seed for doing something about it. My dear friend, teammate, and colleague, Timothy R. Zoph, is also on the Board and introduced me to Bo, about two years ago. It's inevitable that patients possess and control a complete view of our clinical records. Now is the time for this solution in the market, given the laws which require healthcare systems to share your medical records; the adoption of FHIR technology; and the emergence of AI. Keeping fingers crossed that we can make a difference...! https://lnkd.in/gcxVcXzE

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It is time for a transparent robust scientific evaluation of the health risks of cell phone radiation and an assessment of the adequacy of the FCCs 1996 human exposure limits. Common sense public health policies are needed to inform the public and mitigate risk. Industrial solutions exist that can allow internet connections without RF radiation exposure. In a recent meta-analysis published in Environmental Health, researchers found a statistically significant increased risk of brain cancer in people who used cell phones for over 10 years.  As Dr. Joel Moskowitz shared on his blog www.saferemr.com, this is one of seven meta-analyses that has linked higher cell phone use to tumors. They found an increased risk of brain tumors in studies where individuals had cumulative call times of 896 hours or more. Relative Risk 2.89 People who typically held the phone against one side of their head during calls had a higher risk of developing cancer on that side. Relative Risk 3.53 https://lnkd.in/erVpMNXy

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Ahead of #WHA77 next week, GHTC is urging policymakers to prioritize and advance policy reforms on #AMR, maternal and child health, #TB and #NTDs, and #PandemicPreparedness to deliver a more fit-for-purpose, equitable R&D ecosystem. https://lnkd.in/e6QbT_Xu

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Big Applause for Prof. Irene Papanicolas (Harkness Fellow 2015-2016) & the CHeSS Launch at Brown University!!! Thrilled to witness the launch event for Center for Health System Sustainability (CHeSS) at the Brown University School of Public Health. This pioneering initiative is set to revolutionize the academic pursuits of teaching and researching the importance of international data excellence and comparisons. And it is U.S. based! (More trains and less planes for me…) CHeSS harnesses the power of data and global engagement to craft comparative insights and policy recommendations that are not just numbers, but narratives for change from the next generation of international health policy leaders. (We love collaborating with them!) Let's shift the focus from competition to cooperation. It's all not about who's best; it's about what's best for each of us. Through international comparisons, we can transcend boundaries, learn collectively, and tailor healthcare to each countries’ unique needs. We can redefine healthcare and pave the way for a healthier tomorrow. Learn more about CHeSS here: https://lnkd.in/gBTeaBx3.

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The more time I spend reading, writing, and thinking about the impact of replacing in-person community with online community, the more I recognize some of what makes me unusual as a conservative. I place little value on loyalty (except in marriage) and authority. I also value sanctity less than most religious conservatives do. However, I still believe sanctity is incredibly important, just not the sanctity of authority or loyalty. Instead, I place a high sanctity value on Truth and pursuing it. That naturally lends itself to valuing structure and certain kinds of rules. I despise arbritrary rules. I love process rules or guidelines (structure!) that improve and/or expedite reaching well-reasoned/true/correct/best outcomes. I love structure in my life. It keeps me on track, in good shape, and efficient. Without structure, even self-imposed, I tend to be less efficient and less committed to in-person community (even though I’m a massive extrovert). I tend to self-impose high amounts of structure in my life so that I work smarter and harder and stay committed to social engagements (which keeps my mood high and friendships close). This article does a great job of explaining why religious community and structure in particular is a net good for virtually everyone.

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