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5 posts from November 2019


190th Podcast Interview: the FDA's Captain Valerie Jensen Discusses Remedying the Drug Shortage Problem (November 20th)

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On October 31st, the FDA released the agency's Congressionally-mandated report titled, “Drug Shortages: Root Causes and Potential Solutions.”  The 124-pg report found drug shortages are increasing, persistent, i.e., the duration longer, with both the intensity and public health impact high.  These shortages can, the FDA found, “have a devastating effect,” by prolonging patient suffering, contributing to disease progression & increased morbidity.  Concerning root causes, the FDA found market consolidation has caused current contracting practices to constitute in sum a “race to the bottom.”   The FDA also found the market also fails to recognize or reward manufacturers for mature quality management systems and found a market that is unable to quickly recover after a disruption in either manufacturing or supply chain distribution.  Despite the worsening drug shortage problem, and the Congress’ considerable focus on drug pricing legislation this year, not a single drug shortage committee hearing was held this Congressional session or this year.  (Listeners may recall I posted in August a related essay I wrote on this topic for STAT).  

During this 28 minute conversation Captain Jensen begins by providing an overview of her day to day efforts managing the FDA's drug shortage efforts.  She moreover discusses the details of the FDA's report to the Congress, principally the report's recommendations, potential other related solutions including improving risk management planning, stockpiling and lengthen expiration dates, efforts by Civica Rx and Provide GX,  forthcoming FDA drug shortage guidances and potential for Congressional action. 

Captain Valerie Jensen is the Associate Director of the Drug Shortage Staff at the Food and Drug Administration.  She previously worked as a clinical pharmacist for Indian Health 13489989994_17efe0a9d4_o
Service hospitals in Arizona and New Mexico for nine years before joining FDA.  She has been with the FDA for the past 19 years leading FDA efforts to work with manufacturers to mitigate and resolve shortages of medications for the patients who depend on them.  Captain Jensen received a B.S. degree in Pharmacy from the University of Iowa in 1990 and upon graduation was commissioned as an officer in the U.S. Public Health Service.  She completed an American Society of Health-System Pharmacists Specialized Residency in Ambulatory Care at the White River Indian Health Service hospital in White River, Arizona in 1991. 

The FDA's report is at: https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions

A related and recent Civica Rx report is at: https://civicarx.org/wp-content/uploads/2019/10/Civica-Rx-White-Paper-FINAL-10.01.19-1.pdf

Again, my related August STAT essay is at: https://www.statnews.com/2019/08/09/drug-shortages-presidential-candidates-policy/

(In my opening statement, I misspoke.  The drug shortage problem adds at least approximately over half a billion (not half a million), dollars annually to healthcare spending.)  


Chris Palmieri Discusses CCA's Efforts to Provide Its Patients Social Service Supports (November 14th)

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As has been widely reported the US spends upwards of twice what other OCED countries on medical care however with worse or similar outcomes.  What explains this is in part the fact the US spends about one-third of what other OECD countries spend on social services such as food aid, housing assistance and transportation.  This despite knowing research shows basic measures of health are more closely and positively associated with social service spending.  “It’s hard to escape the conclusion,” a 2016 Brookings Institute op-ed concluded, “that we should gradually be redirecting a lot of money from medical series to so-called upstream factors [or social factors] that are associated with health.”  This was precisely the same conclusion drawn by a recent/September National Academies of Science’s (NAS) consensus study titled, “Integrating Social Care Into the Delivery of Health Care.”  The NAS report concluded health care be redesigned to integrate social care into health care and that financing of health care integrate social care spending. 

During this 30 minute conversation Mr. Palmieri briefly discusses CCA's business lines, moreover its One Care its Senior Care Options health plans that serve Medicaid-Medicare  beneficiaries (so called "Duals") and Medicare beneficiaries under a a Special Need Plan (SNP) designation.  He discusses how his patient population is recruited and moreover CCA's  whole person care approach, accomplished in part via care navigators, that includes providing CCA's patients with social service supports, e.g., CCA's medically tailored meals plan and its mobile integrated health program.  He also discusses how CCA care is financed and the spending efficiency CCA care achieves.  He concludes with a brief description of CCA's WinterStreet Ventures, a CCA affiliate that pilots/develops innovations in care delivery. 

Mr. Chris Palmieri has served since 2015 as President and Chief Executive Officer of the Massachusetts' Commonwealth Care Alliance (CCA).  Immediately prior, Mr. Palmieri served Palmieri_Christopher_circleas the CEO of Remedy Partners, a bundled payment organization.  Prior still, Mr. Palmieri worked for ten years with Visiting Nurse Service of New York (VNSNY), as President and Chief Executive Officer of VNSNY Health Plans where he developed a $2 billion safety-net insurance organization.   Mr. Palmieri has also held senior positions with Amerigroup Corporation, Metropolitan Jewish Health System, Inc., and Faxton-St. Luke’s Health Care/Mohawk Valley Network.  In 2012, Chris was named one of Crain’s New York “40 Under 40,” a distinction for the top business leaders.  Mr. Palmieri currently serves as the Chair of the Association for Community Affiliated Plans (ACAP), and the Vice Chair of the national Managed Long-Term Services and Supports (MLTSS) Association.

For more information on CCA go to: http://www.commonwealthcarealliance.org/

The Brookings' op-ed is at: https://www.brookings.edu/opinions/social-spending-not-medical-spending-is-key-to-health/.

The National Academy of Science report, again titled, "Integrating Social Care in to the Delivery of Health Care," is at: http://nationalacademies.org/hmd/Reports/2019/integrating-social-care-into-the-delivery-of-health-care


CMS' Dr. Kate Goodrich Discusses Measuring and Rewarding for Value (or Spending Efficiency) Under Medicare's Forthcoming MVPs Program (November 13th)

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On November 1st, the Centers for Medicare and Medicaid Services (CMS) published the agency's final 2020 Quality Payment Program (QPP) rule that announced beginning in 2021 CMS will begin instituting MVPs, or Merit-based Incentive Payment System Value Pathways.  These value pathways will be created to financially incent and reward, as CMS states, “high value clinicians.”  This means CMS will begin to measure and financially reward Medicare physician performance based on value or spending efficiency defined as outcomes achieved relative to spending.  MVPs may prove to be a significant Medicare payment policy reform.   This is because while Medicare program officials have implemented numerous "value-based payment" programs and demonstrations since the passage of the 2010 Affordable Care Act, these arrangements financially reward either quality - or - reduced spending growth, they do not reward “value” or spending efficiency.  In addition, as recently noted by Harvard’s Ashish Jha and his colleagues in a October 9th JAMA "Viewpoint" essay, these current "value-based payment" programs have not had large effects on quality improvement.   (Listeners may recall I discussed measuring for health care value or spending efficiency with University of Michigan Professor Andrew Ryan this past May 11th and in later May posted on the podcast website a related essay I wrote for Bloomberg Law.)

During this 30 minute conversation Dr. Goodrich discusses in sum CMS' proposal to implement beginning in 2021 Merit-based Incentive Payment System Value Pathways (MVPs).  She explains the rationale for using of global and population health measures and patient-reported outcome measures (PROMs) and how the agency will measure or evolve its MVP-related cost measures.  She discusses MVPs potential to increase provider productivity, the potential MVPs have in helping to harmonize Medicare three payment silos: fee for service, Accountable Care Organizations (ACOs); and, the Medicare Advantage (Part C) program, in influencing commercial insurance plans' payment policies through CMS' HCPLAN (the Health Care Payment Learning Action Network), and discusses the relevance or importance of social determinates or measures thereof in driving Medicare value. 

Dr. Kate Goodrich is currently the Director of the Center for Clinical Standards and Quality (CCSQ) and CMS Chief Medical Officer (CMO).   This Center is responsible for 18 quality KateGoodrichmeasurement and value-based purchasing programs including the Quality Payment Program, quality improvement programs in all 50 states, clinical standards and survey and certification of all providers across the nation, and coverage decisions for treatments and services for CMS.  The Center budget exceeds $1.2 billion annually. Prior to being CCSQ director and CMO, Dr. Goodrich served as the director of the Quality Measurement and Value-based Incentives Group in CCSQ from 2012 through 2015. She graduated from the Robert Wood Johnson Clinical Scholars Program at Yale University in 2010.  From 1998 to 2008, Dr. Goodrich was on the faculty at the George Washington University Medical Center (GWUMC) and served as division director for Hospital Medicine from 2005 to 2008.  She went to medical school at Louisiana State University in Shreveport, Louisiana, and completed her internal medicine residency and chief medical resident year at GWUMC.  She continues to practice clinical medicine as a hospitalist and professor of medicine at GWUMC.

The Quality Payment Program final 2020 rule that discusses MVPs is at: https://www.federalregister.gov/documents/2019/11/15/2019-24086/medicare-program-cy-2020-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other

Information on the HCPLAN is at: https://hcp-lan.org/

The Bloomberg Law essay is, again, at: https://news.bloomberglaw.com/health-law-and-business/insight-containing-health-costs-requires-measuring-rewarding-spending-efficiency


Dr. Azra Raza Discusses Her Recently Published Book, "The First Cell and the Human Costs of Pursing Cancer to the Last" (November 1st)

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Dr. Azra Raza's recently published book, The First Cell and the Human Costs of Pursing Cancer to the Last, has been described as a "searing account of how both medicine and our society (mis)treat cancer, how we can do better, and why we must."  It has been termed "a clarion call . . . [that] repudiates the approach . . . that biomedical science has taken to attempt to find new treatments and curers."  The lack of progress in treating cancer is "an embarrassment" and "equally embarrassing is the arrogant denial of that embarrassment."  We spend over $150 billion annually on treating cancer and a patient diagnosed today is as likely to die from the diagnosis as a patient diagnosed 50 years ago.   

During this 35 minute conversation Dr Raza begins by discussing what causes cancer (we do not know or know completely).  She moreover discusses the urgent need for a new cancer research paradigm, i.e., the current use of tissue culture cell lines and mouse models have proven to be inadequate.  She also argues cancer researchers need to spend less time chasing the last cancer cell and instead ID the first cancer cell, i.e., we should place greater emphasis on early detection.  She explains her criticisms of the pharmaceutical industry and the federal government funding in researching effective cancer treatments.  Dr Raza also explains her relationship with her patients, her belief treating oncologists need to develop empathic relationships with their patients and she notes her view regarding palliative sedation. 

Dr. Raza is the Chan Soon-Shiong Professor of Medicine and Director of the MDS Center at Columbia University in New York.  She started her research in Myelodisplastic Syndromes (MDS) in 1982 and moved to Rush University, Chicago, Illinois in 1992, where she was the Charles Arthur Weaver Professor in Oncology and Director, Division of Myeloid Diseases.  The MDS ArazaProgram, along with a Tissue Repository containing more than 50,000 samples from MDS and acute leukemia patients was successfully relocated to the University of Massachusetts in 2004 and to Columbia University in 2010.  Before moving to New York, Dr. Raza was the Chief of Hematology Oncology and the Gladys Smith Martin Professor of Oncology at the University of Massachussetts in Worcester.  She has published the results of her research and clinical trials in numerous, peer reviewed journals such as The New England Journal of Medicine, Nature, Blood, Cancer, Cancer Research, British Journal of Hematology, Leukemia, and Leukemia Research. Dr. Raza serves on numerous national and international panels as a reviewer, consultant and adviser and is the recipient of a numerous of awards including the First Lifetime Achievement Award from APPNA, Award in Academic Excellence twice (2007 and 2010) from Dogana and The Hope Award in Cancer Research. 

For more on The First Cell go to: https://www.basicbooks.com/titles/azra-raza/the-first-cell/9781541699526/

Dr Raza's related 2006 3 Quarks Daily post, "Rx: Reductionist Vs.. Pluralist Views of Cancer," is at: https://www.3quarksdaily.com/3quarksdaily/2006/01/rx.html.

Per my mention of Thomas Kuhn's seminal, The Structure of Scientific Revolutions, the Wiki overview is at: https://en.wikipedia.org/wiki/The_Structure_of_Scientific_Revolutions


Dr. Rick Doblin Discusses the Potential/Real Therapeutic Benefits of Psychedelic Agents (October 31st)

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Psychedelic agents or drugs, for example Lysergic Acid Diethylamide or LSD (a cereal fungus and first synthesized in 1938), were widely researched for their therapeutic potential through the 1950s.   Among other noted users of these agents was the actor, Cary Grant.  However, when these drugs escaped the research lab in the 1960s, moral panic set in.  America's youth would, it was feared, "turn on, tune in and drop out" (a phrase popularized the Berkeley/Harvard psychologist Timothy Leary) and social upheaval would ensue.  By 1970 LSD, psilocybin and other psychedelic agents were banned for both research and recreational use purposes.  Beginning in the 1990s the FDA began giving limited approval to conduct psychedelic-related efficacy studies.  Two decades later it appears the US has now, finally, turned the corner on researching the potential wide spread therapeutic benefits of psychedelics.  This was again made evident last month when by Johns Hopkins announced opening its Center for Psychedelic and Consciousness Research.  This announcement was preceded in April by the Imperial College in London announcing the opening of its Centre for Psychedelic Research.  

During this 26 minute interview, Dr. Doblin begins by describing what effect these agents have on the brain or what parts of the brain are stimulated to what effect.  He discusses moreover his organization's MDMA (methylenedioxy-methamphetamine) research, currently a Phase 3 trial to study the effects on patients suffering from PTSD (oddly not supported by the DoD or VA), and a wide range of other current research efforts concerning treating, among other diagnoses, addiction, depression, eating disorders, phobias, OCD, schizophrenia and terminal illnesses.  He also weighs in on the future legal status of these drugs, again currently illegal or banned as Schedule I controlled substances. 

Rick Doblin, Ph.D., is the founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS).  He received his doctorate in Public Policy from Rick_doblinHarvard's Kennedy School of Government, where he wrote his dissertation on the regulation of the medical uses of psychedelics and marijuana and his Master's thesis on a survey of oncologists about smoked marijuana vs. the oral THC pill in nausea control for cancer patients.  His undergraduate thesis at New College of Florida was a 25-year follow-up to the classic Good Friday Experiment, which evaluated the potential of psychedelic drugs to catalyze religious experiences.  He also conducted a thirty-four year follow-up study to Timothy Leary's Concord Prison Experiment.  Rick studied with Dr. Stanislav Grof and was among the first to be certified as a Holotropic Breathwork practitioner.  His professional goal is to help develop legal contexts for the beneficial uses of psychedelics and marijuana, primarily as prescription medicines but also for personal growth for otherwise healthy people, and eventually to become a legally licensed psychedelic therapist.  He founded MAPS in 1986.

For information on MAPS go to: https://maps.org/.

Information on Michael Pollen's 2018 work noted during this discussion, How to Change Your Mind,What the New Science of Psychedelics Teaches Us About Consciousness, Dying Addiction, Depression and Transcendence, go to: https://www.penguinrandomhouse.com/books/529343/how-to-change-your-mind-by-michael-pollan/.

For a recent personal account of a psychedelic experience, see, for example, Helen Joyce, "My Adventures in Psychedelia," at: https://www.3quarksdaily.com/3quarksdaily/2019/10/my-adventures-in-psychedelia.html.