October 2020 - The American Society for Clinical Investigation

An open letter to the US Food and Drug Administration urging politics-free review of COVID-19 vaccines and new drugs

Posted on October 29, 2020 by John Hawley

October 29, 2020

Stephen M. Hahn, MD
Commissioner
Food and Drug Administration

We, the undersigned, representing the American Society for Clinical Investigation (ASCI), write to endorse and support our colleagues at the FDA in following established procedures of review for all new COVID-19 drug applications, including vaccines, as detailed in “Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry” (FDA, October 2020, docket 2020-D-1137-0019).

Researchers across the world from diverse fields of basic and clinical science have come together in record time to make critical advances aimed at ending the COVID-19 pandemic. These advances have been facilitated by the active engagement of government funding agencies and key regulatory bodies. This work must move forward expeditiously but without cutting corners. Processes have been created and tested to ensure that scientific standards across the continuum of drug development are upheld, and these should be respected. To do otherwise would jeopardize the safety, rigor, and integrity of these studies.

The ASCI is a nonprofit organization of physician-scientist leaders founded in 1908. The Society has more than 3,200 members active in academic medical centers and industry who are committed to science and patient care. The ASCI has full confidence in the FDA’s career scientists and advisory bodies to evaluate forthcoming new drugs and vaccines with impeccable, science-based scrutiny, free of all political pressures. Such scrutiny is key to maintaining the public’s trust in the FDA to ensure that drugs and vaccines made available to our nation’s population are safe and effective.

The 2020-2021 American Society for Clinical Investigation Council:

Lorraine B. Ware, MD (President)
Vanderbilt University School of Medicine

Hossein Ardehali, MD, PhD (President-Elect)
Northwestern University Medical Center

Sohail F. Tavazoie, MD, PhD (Vice President)
Rockefeller University

Benjamin D. Humphreys, MD, PhD (Secretary-Treasurer)
Washington University School of Medicine in St. Louis

Rexford S. Ahima, MD, PhD (Editor, The Journal of Clinical Investigation)
Johns Hopkins University

Kathleen L. Collins, MD, PhD (Editor, JCI Insight)
University of Michigan

W. Kimryn Rathmell, MD, PhD (Immediate Past President)
Vanderbilt University School of Medicine

Anna Greka, MD, PhD (Councilor)
Brigham and Women’s Hospital, Harvard Medical School

Priscilla Y. Hsue, MD (Councilor)
University of California, San Francisco

Sophie Paczesny, MD, PhD (Councilor)
Medical University of South Carolina

Doris A. Stoffers, MD, PhD (Councilor)
University of Pennsylvania

Jennifer A. Wargo, MD, MMSc (Councilor)
University of Texas MD Anderson Cancer Center

Voters approve Diversity, Inclusion, and Equity Committee for addition to bylaws

Posted on October 28, 2020June 23, 2023 by John Hawley

In June, the ASCI Council issued a statement on diversity, inclusion, and equity. In August, further detail was provided in a Journal of Clinical Investigation Viewpoint, A deliberate path toward diversity, equity, and inclusion within the ASCI. Within these, a plan was described to establish a permanent Diversity, Inclusion, and Equity Committee through proposed amendment of the ASCI bylaws.

A ballot was issued to Active voters on September 29, 2020, proposing the following addition to the organization’s bylaws under “Article VII – Committees”:

Diversity, Inclusion, and Equity Committee. This committee ensures that the organization, its programs, and its mentoring mechanisms promote and recognize diversity, inclusion, and equity. The President, Vice President, and President Elect are standing members of the committee; in the event the Chair role is vacant, the President appoints the Chair, who serves a single 3-year term, from among all Council members. Other committee members may be drawn from across the membership and are added by simple majority vote of the committee; these members serve up to 3-year terms that conclude at the start of the Society’s annual meeting or May 1, whichever is earlier.

By the October 5, 2020, deadline, 52% of voters responded. The results were:

Response	Votes, n	% of total
Yes	424	96.80%
No	8	1.83%
Abstain	6	1.37%

Following the bylaw’s Ballot Review Committee section, these results were received, reviewed, and verified by Benjamin Humphreys (2020-2021 ASCI Secretary-Treasurer) and two Active members identified by random selection from ballots submitted and who agreed to audit the results. Thank you to Christopher E. Barbieri, MD, PhD (Weill Cornell Medical College) and Daniel J. Brat, MD, PhD (Northwestern University Feinberg School of Medicine) for their service.

ASCI members elected to the National Academy of Medicine, 2020

Posted on October 28, 2020September 26, 2023 by John Hawley

The ASCI congratulates its members who have been elected to the National Academy of Medicine for 2020. Twenty-two members are represented among the 100 members elected for 2020 (full list). (Citation information following each member as given by the National Academy of Medicine.)

Rexford S. Ahima, MD, PhD (elected to ASCI in 2005)

For innovative laboratory and translational studies that have elucidated the pathophysiology and potential therapies for obesity, diabetes, and related diseases.

Mark S. Anderson, MD, PhD (elected to ASCI in 2009)

For being a leader in the study of autoimmune diseases and the mechanisms that control immune tolerance. He was involved in the seminal discovery of the function of AIRE, a key transcriptional regulator that operates in the thymus to promote the display of a broad array of self-antigens.

Dan H. Barouch, MD, PhD (elected to ASCI in 2009)

For being an international leader in virology and immunology and developing novel vaccines and cure strategies for viruses of global importance, including working on one of the first COVID-19 vaccine candidates, the first Zika virus vaccine, and the first global mosaic HIV-1 vaccine, as well as defining immunotherapeutic HIV-1 cure strategies.

Randall J. Bateman, MD (elected to ASCI in 2012)

For discovering the causes of Alzheimer’s disease (AD), the first highly specific blood test for AD, and initiating the first prevention trial in AD with a public-private clinical trial platform.

Myles A. Brown, MD (elected to ASCI in 1997)

For his leadership in oncology and endocrinology, whose seminal contributions have fundamentally reformulated the mechanistic understanding of hormone dependence of breast and prostate cancers, enabling the development of new therapies for these diseases.

Judy H. Cho, MD (elected to ASCI in 2005)

For establishing that uncommon, loss-of-function variants in the microbial-sensing domain of NOD2 confer risk for Crohn’s disease, and identifying a loss-of-function allele in the IL-23 receptor that protects against Crohn’s disease and ulcerative colitis, leading to new, approved therapies.

Augustine M.K. Choi, MD (elected to ASCI in 2001)

For pioneering the field of gaseous molecules to develop novel therapies to treat lung and non-pulmonary diseases, and making a transformative impact to improve mentorship, diversity and financial equity in medical education.

Wendy K. Chung, MD, PhD (elected to ASCI in 2015)

For identifying the genetic basis for over 45 monogenic conditions (two of which bear her name) across a wide range of diseases, and leading the pivotal study of newborn screening for spinal muscular atrophy. She was the original plaintiff in the Supreme Court case on gene patents.

David W Clapp, MD (elected to ASCI in 2001)

For his work that has led to fundamental new insights into the pathogenesis of NF-1 and improved lives for children and adults with this disorder, and for developing robust career development programs for trainees and faculty to become leaders themselves.

Ralph J. DeBerardinis, MD, PhD (elected to ASCI in 2013)

For fundamentally changing the understanding of cancer metabolism. His work emphasized the importance of mitochondria in tumor growth and identified metabolic vulnerabilities imposed by tumor genetics.

Ronald P. DeMatteo, MD (elected to ASCI in 2015)

For his work establishing the standard of care for combining surgery and targeted therapy (imatinib) for gastrointestinal stromal tumor (GIST), and defining the immune response to GIST and its modulation by targeted therapy.

Justin B. Dimick, MD, MPH (elected to ASCI in 2017)

For his leadership in elevating the science of health care policy evaluation, quality measurement, and comparative effectiveness research within surgical populations.

Cynthia E. Dunbar, MD (elected to ASCI in 2003)

For leading pioneering genetic marking and therapy trials targeting hematopoietic stem cells, and developing uniquely predictive non-human primate models to successfully improve the safety and efficiency of various gene therapies as well as gain insights into hematopoiesis and immunology.

B. Mark Evers, MD (elected to ASCI in 2002)

For his expertise on intestinal hormones and hormonal arcades in oncogenesis. His seminal insights defined the role of gut hormones on normal physiology and metabolism, pioneering innovative understanding of neuroendocrine cell biology and the role of neurohormonal pathways in the development and progression of neuroendocrine tumors.

Toren Finkel, MD, PhD (elected to ASCI in 2002)

For providing the first demonstration that reactive oxygen species (ROS) function as endogenous signaling molecules, thus establishing the field of redox signaling. He has delineated how mitochondrial and cytosolic ROS are regulated, identified cellular redox targets, and defined how ROS-regulated pathways contribute to human disease and normal aging.

David E. Fisher, MD, PhD (elected to ASCI in 1999)

For elucidating the ultraviolet (UV) pigmentation pathway, UV-seeking endorphin response, skin cancer prevention strategies, and hair graying mechanism; discovering melanoma and sarcoma oncogenes; and developing a routinely used melanoma diagnostic.

Levi Garraway, MD, PhD (elected to ASCI in 2009)

For the discovery of genetic drivers of melanoma, prostate cancer, and other malignancies, the discovery of mechanisms of response and resistance to anticancer therapies in melanoma and other cancer types, pioneering platforms and approaches to cancer precision medicine, and incorporating precision medicine principles in therapeutic development.

Jeffrey Louis Goldberg (elected to ASCI in 2011)

For his contribution to the understanding of the regeneration of retinal ganglion cells and axonal growth, and for being a driving force behind vision restoration clinical trials in glaucoma therapeutics and biomarker development.

Joel N. Hirschhorn, MD, PhD (elected to ASCI in 2006)

For his development of methods and standards for performing and interpreting genome-wide association studies. He leads the Genetic Investigation of ANthropometric Traits (GIANT) consortium, which identified most currently known loci associated with stature and obesity.

Aleksandar Rajkovic, MD, PhD (elected to ASCI in 2014)

For leading, mentoring, and being a role model for physician-scientists in reproductive sciences. He discovered numerous genes that play critical roles in reproductive tract development, male and female infertility, and reproductive tract tumors. He has been at the forefront of innovative technologies in the discovery of mechanisms and diagnostics in reproductive pathologies.

Antoni Ribas, MD, PhD (elected to ASCI in 2009)

For defining the mechanistic basis of response and acquired resistance to immune checkpoint blockade cancer immunotherapies, and leading multicenter clinical trials that have provided transformative treatments for patients with advanced melanoma, changing it from a fatal disease to one that is often cured.

Paul M. Ridker, MD (elected to ASCI in 1999)

For his paradigm-shifting work that has not only provided proof-of-principle for the inflammation hypothesis of atherothrombosis but also provided clinicians with the first Food and Drug Administration-approved diagnostic test for vascular inflammation and the first proven anti-inflammatory treatment for atherosclerosis.