VT Advance Directive Registry Launches Email Submission Option and New Combined Form
The Vermont Advance Directive Registry (VADR) and VEN have been working closely for the past year to bring two new features to Vermonters using the VADR. Beginning July 2021, the VADR will now accept new registrations and updates to existing accounts via email. While mail-in and fax submission options will remain in place, both organizations have taken this stride forward in hopes of improving registrant experience and continuing the project of modernizing the VADR for all users.
Along with the launch of email submissions, VEN and the VADR are unveiling a new and improved administrative form to streamline the submission process for all registrants. Now, new and existing users need only one administrative form, the combined Registration Agreement/Authorization to Change form to make submissions, updates and revisions to their VADR accounts. Detailed instructions are available within the form and on the VEN website. Please note that all submissions must still be accompanied by a copy of the most current version of the advance directive document.
If you haven't already, we encourage you to take some time to share your hopes and fears for the future with those closest to you. Review your advance directive if you have one to make sure it represents your preferences and priorities. If you’ve never completed an advance directive, now is the perfect time to:
- Name the individual(s) who know you best and could speak on your behalf if you become ill and cannot speak for yourself.
- Share details about your goals and values so that your family, friends and the health care team can provide the best care possible for you.
- Give copies of your document to your loved ones, doctor, hospital, and the Vermont Advance Directive Registry.
A wide range of resources are available on our website to support advance care planning, including forms, answers to frequently asked questions, conversation guides, and much more.
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New Resource: Vermont Advance Directive Registry Guide
We are pleased to announce a newly published resource that serves as a guide to the Vermont Advance Directive Registry (VADR). This printable brochure answers commonly asked questions about what the Registry is, benefits of registering your advance directive, how to register, and how to update your existing advance directive in the Registry. Health care facilities and providers are invited to utilize this brochure when explaining the Registry to patients and clients, and individuals are encouraged to review this brochure prior to registering or updating their advance directive.
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Remote Witnessing & Explaining of Advance Directives Extended to June 2022
Last summer we shared that a bill (H.950) addressing remote witnessing and explaining of advance directives passed and was signed by Governor Scott on June 15, 2020 as Act Number 107. This Act addressed the legal status of advance directives completed using remote witnesses and/or explainers during two time-frames:
- Documents completed between February 15, 2020 and June 15, 2020 (the period 30 days prior to the declared COVID state of emergency until the effective date of H.950)
- Documents completed between June 15, 2020 and June 30, 2021 (the period after the effective date of H.950)
Remote witnessing has now been extended until June, 30 2022 to permit individuals to complete advance directive documents with remote witnessing for another year. Documents completed after June 30, 2022 will need to be completed with in-person witnessing, barring another extension.
For detailed instructions on how to complete an advance directive using remote witnessing, please visit the link below.
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Stem Cell Regulation Bill Signed into Law
Legitimate research in the use of cellular based therapies remains a rapidly advancing and promising field. However, the proliferation of clinics marketing unregulated and unapproved stem cell products with claims of efficacy and safety that are not evidence-based is concerning. Particularly problematic is the growing practice of promoting unproven and expensive “treatments” of unknown benefit that may pose significant risks to the health and welfare of sick and vulnerable patients.
In October of 2018, the VEN Board had a presentation from a pulmonologist on the topic of stem cell medical tourism. This, along with a series of ads appearing in the Times Argus in November of 2018, prompted the organization to send letters to the Attorney General, The Board of Medical Practice and the Office of Professional Regulation requesting investigation into the advertising practices of these clinics. Specifically that the ads may:
- Falsely imply that stem cell therapy is effective for all of the conditions listed in the ads;
- Falsely imply that the stem cell process is regulated by the FDA;
- Fail to give adequate informed consent of downside risks compared to lack of proven efficacy;
- Fail to disclose weak or non-existent scientific rationale for the treatment and the lack of knowledge of any known mechanism of “healing”;
- Fail to disclose that the experimental nature of the treatment is not subject to standardized experimental protocols.
VEN was concerned that the advertisement and practice may constitute unauthorized medical or naturopathic practice; may constitute false advertising; may be offering false hope to vulnerable persons desperate for any treatment, regardless of proven effectiveness; and may, as has been previously reported, cause serious harm.
Since then, a coalition of stakeholders with similar concerns coalesced to offer education and additional resources about stem cells. Last spring, we reported that Vermont’s Senate Health & Welfare Committee was working on a bill that would require appropriate notice and disclosure about stem cell products from clinics and practitioners who administer them. While initially delayed, that bill has now been passed by both chambers and was enacted on June 7th, 2021. VT Act 61 "require[s] health care practitioners who administer stem cell products that are not approved by the U.S. Food and Drug Administration (FDA) to provide notice of this fact to their patients and in their advertisements and to provide a disclosure form to each patient prior to administering any non-FDA-approved stem cell product. It would also direct the Department of Health to amend its rules on advance directives to further clarify the scope of experimental treatments to which an agent may and may not provide consent on behalf of a principal" ( Sec. 1. 18 V.S.A. chapter 87) .
Act 61 mandates the disclosure of stem cell "therapies" that do not hold FDA approval. The law took effect on July 1, 2021.
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Professional Associations Add to Growing Support for COVID Vaccine Mandate in Health Care Settings
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On July 26th, 2021, the American Public Health Association (APHA) joined the growing list of clinical and professional health care associations calling for all health care and long-term care employers to mandate vaccination for employees. The APHA cites the risk that unvaccinated staff pose to public and patient health as the driving principles behind its recommendation.
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Aducanumab: Controversial FDA Approval Raises Questions
Controversy continues to swirl around the FDA's fast-tracked approval of the highly-anticipated Alzheimer's medication, aducanumab (Aduhelm), as the administration walks back its initial approval. When the initial approval was announced in June 2021, many groups rejoiced at the hope of a possibly effective new treatment. Less than one month later, the FDA narrowed its approval of the drug as a treatment option only for those with mild symptoms and criticism of the speedy approval process has not relented. Now the biggest question of all rests with providers: should I prescribe this to my patients?
Further Reading
We are aware of conversations around the accelerated approval process taking place across the country and would like to spotlight a few articles worth reading on this topic:
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Ethicist: Why a New Alzheimer's Drug Isn't A No-Brainer (NBC News): "Bioethicist Art Caplan gives five reasons why good news is not all good news when it comes to a promising drug for Alzheimer’s disease."
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My head just exploded, now what? Aducanumab (Journal of the American Geriatrics Society): "From the perspective of someone who has wandered in the wilderness in search of a diagnosis and (hopefully) a cure for any number of ailments, I cannot get past the fact that there are insufficient data to determine whether aducanumab actually slows the progression of the disease."
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Ethics Talk: Could Trusting Science Mean Not Trusting Some FDA Decisions? (AMA Journal of Ethics): "In this video and audio edition of Ethics Talk, journal editor in chief, Dr. Audiey Kao, talks with Dr. Caleb Alexander about the US Food and Drug Administration's controversial decision to approve aducanumab for the treatment of Alzheimer's Disease."
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In Reversal, F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug (NY Times): "The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. Now it recommends that the drug be given only to those with mild symptoms."
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How Biogen’s Aduhelm Approval Marks a Precipitous Turning Point for the FDA (American Journal of Managed Care): "A string of controversies surrounding the approval of Biogen's Alzheimer disease drug aducanumab (Aduhelm) has not only called into question the independent nature of the FDA, but puts both providers and patients in a challenging position when it comes to deciding whether or not to prescribe or take the treatment."
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Health Inequities Brought to Light by COVID-19
COVID-19 has revealed countless inequities that have been deeply embedded in the structures of our healthcare system for centuries. Since justice is a core principle of medical ethics, it is important to pay attention to these structural inequities and work toward solutions that get at the root of the institutional problems that lead to unfair treatment. To that end, here are a few articles worth exploring:
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HEALTH DECISIONS is a publication of the Vermont Ethics Network.
The mission of the Vermont Ethics Network is to advance ethics in health care.
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Board of Directors
Geraldine Amori, PhD
E. Tobias Balivet, Esq.
Linda Cohen, JD, MHCDS
Linda Hurley, RN, MS
Alden Launer, MDiv
Peg Maffitt
Tim McAdoo, LNHA, FACHCA
Kier Olsen DeVries, MA
Martha Richardson
Hilary Ryder, MD, MS, FACP, FHM
Michelle Tavares
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Staff
Cindy Bruzzese, MPA, MSB, HEC-C
Executive Director and Clinical Ethicist
Honorary Board Members
James L. Bernat, MD
Michelle Champoux, LICSW
Jean Mallary, RN
Robert Macauley, MD
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