National Institutes of Health

The National Institutes of Health (NIH) is part of the United States Department of Health and Human Services.

NIH.gov

The NIH gives away enormous amounts of money for scientific research over a wide range of fields.

Grants and funding page.¹⁾

March 2006 Harper’s Magazine— “Out of Control; AIDS and the Corruption of Medical Science” by Celia Farber August 8, 2003, Jonathan Fishbein, who had recently taken a job as the director of the Office for Policy in Clinical Research Operations at DAIDS, wrote an email to his boss, DAIDS director Ed Tramont, alerting him that “there was a fulminant liver failure resulting in death” in a DAIDS trial and that it looked like “nevirapine was the likely culprit.” He said that the FDA was being informed. He was referring to Joyce Ann Hafford.

Tramont emailed him back, “Ouch. Not much we can do about dumd docs!” This email exchange came to light in December 2004, when AP reporter John Solomon broke the story that Fishbein was seeking whistle-blower protection, in part because he had refused to sign off on the reprimand of an NIH officer who had sent the FDA a safety report concerning the DAIDS trial that launched the worldwide use of nevirapine for pregnant women.

The study was called HIVNET 012, and it began in Uganda in 1997. The internal communiqués from DAIDS around the time of Hafford’s death made it clear that doctors knew she had died of nevirapine toxicity. ²⁾³⁾

Last Updated; July 8, 2021 ⁴⁾

The COVID-19 Treatment Guidelines have been developed to provide clinicians with guidance on how to care for patients with COVID-19. Because clinical information about the optimal management of COVID-19 is evolving quickly, these Guidelines will be updated frequently as published data and other authoritative information become available.

February 2022

Currently, remdesivir, an antiviral agent, is the only Food and Drug Administration-approved drug for the treatment of COVID-19. An array of drugs approved for other indications and multiple investigational agents are being studied for the treatment of COVID-19 in clinical trials around the globe.

These trials can be accessed at ClinicalTrials.gov. In addition, providers can access and prescribe investigational drugs or agents that are approved or licensed for other indications through various mechanisms, including Emergency Use Authorizations EUA, Emergency Investigational New Drug (EIND) applications, compassionate use or expanded access programs with drug manufacturers, and/or off-label use.

Whenever possible, the Panel recommends that promising, unapproved, or unlicensed treatments for COVID-19 be studied in well-designed, controlled clinical trials. This recommendation also applies to drugs that have been approved or licensed for indications other than the treatment of COVID-19.

Image p 62 Page 157 concludes NO evidence of Ivermectin efficacy for coronavirus. ⁵⁾

Members of the COVID-19 Treatment Guidelines Panel (the Panel) are appointed by the Panel co-chairs based on their clinical experience and expertise in patient management, translational and clinical science, and/or development of treatment guidelines. Panel members include representatives from federal agencies, health care and academic organizations, and professional societies. Federal agencies and professional societies represented on the Panel includel;

• American Association of Critical-Care Nurses
• American Association for Respiratory Care
• American College of Chest Physicians
• American College of Clinical Pharmacy
• American College of Emergency Physicians
• American College of Obstetricians and Gynecologists
• American Society of Hematology
• American Thoracic Society
• Biomedical Advanced Research and Development Authority
• Centers for Disease Control and Prevention
• Department of Defense
• Department of Veterans Affairs
• Food and Drug Administration
• Infectious Diseases Society of America
• National Institutes of Health
• Pediatric Infectious Diseases Society
• Society of Critical Care Medicine
• Society of Infectious Diseases Pharmacists

The inclusion of representatives from professional societies does not imply that their societies have endorsed all elements of these Guidelines.

The names, affiliations, and financial disclosures of the Panel members and ex officio members, as well as members of the Guidelines support team, are provided in the Panel Roster and Financial Disclosure sections of the Guidelines.

Last Updated December 16, 2021⁶⁾

Co-Chairs

• Roy M. Gulick, MD, MPH Weill Cornell Medicine, New York, NY
• H. Clifford Lane, MD National Institutes of Health, Bethesda, MD
• Henry Masur, MD National Institutes of Health, Bethesda, MD

Executive Secretary

• Alice K. Pau, PharmD National Institutes of Health, Bethesda, MD

Members

• Judith Aberg, MD Icahn School of Medicine at Mount Sinai, New York, NY
• Adaora Adimora, MD, MPH University of North Carolina School of Medicine, Chapel Hill, NC
• Jason Baker, MD, MS Hennepin Healthcare/University of Minnesota, Minneapolis, MN
• Lisa Baumann Kreuziger, MD, MS Versiti/Medical College of Wisconsin, Milwaukee, WI
• Roger Bedimo, MD, MS University of Texas Southwestern/Veterans Affairs North Texas Health Care System, Dallas, TX
• Pamela S. Belperio, PharmD Department of Veterans Affairs, Los Angeles, CA
• Stephen V. Cantrill, MD Denver Health, Denver, CO
• Kathleen Chiotos, MD, MSCE Children’s Hospital of Philadelphia/University of Pennsylvania, Philadelphia, PA
• Craig Coopersmith, MD Emory University School of Medicine, Atlanta, GA
• Eric Daar, MD Harbor-UCLA Medical Center, Torrance, CA
• Amy L. Dzierba, PharmD New York-Presbyterian Hospital, New York, NY
• Gregory Eschenauer, PharmD University of Michigan, Ann Arbor, MI
• Laura Evans, MD, MSc University of Washington, Seattle, WA
• John J. Gallagher, DNP, RN University of Pittsburgh Medical Center, Pittsburgh, PA
• Rajesh Gandhi, MD Massachusetts General Hospital/Harvard Medical School, Boston, MA
• David V. Glidden, PhD University of California, San Francisco, San Francisco, CA
• Steve Grapentine, PharmD University of California San Francisco, San Francisco, CA
• Birgit Grund, PhD University of Minnesota, Minneapolis, MN
• Erica J. Hardy, MD, MMSc Warren Alpert Medical School of Brown University, Providence, RI
• Carl Hinkson, MSRC Providence Health & Services, Everett, WA
• Lauren Henderson, MD, MMSc Boston Children’s Hospital/Harvard Medical School, Boston, MA
• Brenna L. Hughes, MD, MSc Duke University School of Medicine, Durham, NC
• Steven Johnson, MD University of Colorado School of Medicine, Aurora, CO
• Marla J. Keller, MD Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
• Arthur Kim, MD Massachusetts General Hospital/Harvard Medical School, Boston, MA
• Jeffrey L. Lennox, MD Emory University School of Medicine, Atlanta, GA
• Mitchell M. Levy, MD Warren Alpert Medical School of Brown University, Providence, RI
• Jonathan Li, MD, MMSc Brigham and Women’s Hospital/Harvard Medical School, Boston, MA
• Gregory Martin, MD, MSc Emory University School of Medicine, Atlanta, GA
• Susanna Naggie, MD, MHS Duke University School of Medicine, Durham, NC
• Andrew T. Pavia, MD University of Utah School of Medicine, Salt Lake City, UT
• Grant Schulert, MD, PhD Cincinnati Children’s Hospital Medical Center/University of Cincinnati College of Medicine, Cincinnati, OH
• Nitin Seam, MD National Institutes of Health, Bethesda, MD
• Steven Q. Simpson, MD University of Kansas Medical Center, Kansas City, KS
• Renee Stapleton, MD, PhD University of Vermont Larner College of Medicine, Burlington, VT
• Susan Swindells, MBBS University of Nebraska Medical Center, Omaha, NE
• Pablo Tebas, MD University of Pennsylvania, Philadelphia, PA
• Phyllis Tien, MD, MSc University of California, San Francisco/San Francisco VA Healthcare System, San Francisco, CA
• Alpana A. Waghmare, MD Seattle Children’s Hospital, Seattle, WA
• Kevin C. Wilson, MD Boston University School of Medicine, Boston, MA
• Jinoos Yazdany, MD, MPH University of California, San Francisco, San Francisco, CA
• Community Members
• Danielle M. Campbell, MPH University of California, Los Angeles, Los Angeles, CA
• Carly Harrison LupusChat, New York, NY

Consultants

• Christopher Carpenter, MD, MSC Washington University, St. Louis, MO
• Eric Freedman, MD Department of Veteran Affairs, Cape Coral, FL

Ex Officio Members, U.S. Government Representatives

• Timothy Burgess, MD Department of Defense, Bethesda, MD
• Demetre Daskalakis, MD, MPH Centers for Disease Control and Prevention, Atlanta, GA
• Derek Eisnor, MD Biomedical Advanced Research and Development Authority, Washington, DC
• Joseph Francis, MD, MPH Department of Veterans Affairs, Washington, DC
• Virginia Sheikh, MD, MHS Food and Drug Administration, Silver Spring, MD
• Timothy M. Uyeki, MD, MPH Centers for Disease Control and Prevention, Atlanta, GA

U.S. Government Support Team

• John T. Brooks, MD Centers for Disease Control and Prevention, Atlanta, GA
• Richard T. Davey, Jr., MD National Institutes of Health, Bethesda, MD
• Laurie K. Doepel, BA National Institutes of Health, Bethesda, MD
• Alison Han, MD (Co-Team Coordinator) National Institutes of Health, Bethesda, MD
• Elizabeth S. Higgs, MD, DTM&H, MIA National Institutes of Health, Bethesda, MD
• Martha C. Nason, PhD (Biostatistics Support) National Institutes of Health, Bethesda, MD
• Renee Ridzon, MD National Institutes of Health, Bethesda, MD
• Kanal Singh, MD, MPH (Co-Team Coordinator) National Institutes of Health, Bethesda, MD

Assistant Executive Secretaries

• Page Crew, PharmD, MPH National Institutes of Health, Bethesda, MD
• Safia Kuriakose, PharmD Frederick National Laboratory for Cancer Research, in support of NIAID, Frederick, MD
• Andrea M. Lerner, MD, MS National Institutes of Health, Bethesda, MD ⁷⁾

Appendix A, Table 2. COVID-19 Treatment Guidelines Panel Financial Disclosure for Companies Related to COVID-19 Treatment or Diagnostics

Last Updated: February 24, 2022 - Reporting Period: April 1, 2020, to March 31, 2021 ⁸⁾

Funding database - select “All Years” for payment totals

JUDITH A ABERG collected $7.7 million ⁹⁾

ADAORA A ADIMORA collected $150,000 ¹⁰⁾

JASON V BAKER collected $1.3 million ¹¹⁾

LISA M BAUMANN KREUZIGER collected $120,000 ¹²⁾

ROGER J BEDIMO collected $420,000 ¹³⁾

ERIC S DAAR collected $2 million ¹⁴⁾

JEFFREY L LENNOX collected $100,000 ¹⁵⁾

MITCHELL M LEVY collected $200,000 ¹⁶⁾

GREGORY S MARTIN collected $650,000 ¹⁷⁾

SUSANNA NAGGIE collected $3.8 million ¹⁸⁾

RENEE D STAPLETON collected $146,000 ¹⁹⁾

SUSAN SWINDELLS collected $960,000 ²⁰⁾

PABLO M TEBAS collected $1.8 million ²¹⁾

PHYLLIS C TIEN collected $250,000 ²²⁾

JINOOS YAZDANY collected $550,000 https://openpaymentsdata.cms.gov/physician/1046038

C-19 Advisory Board conflict of interest listings ²³⁾

• Nov 26, 2021 - The NIH, through an NIAID grant, funded research at a hospital that participates in human organ harvesting in China.²⁴⁾

The NIH Office of Technology Transfer evaluates, protects, monitors, and manages the wide range of NIH and FDA discoveries, inventions, and other intellectual property as mandated by the Federal Technology Transfer Act and related legislation.

To accomplish its mission, OTT oversees patent prosecution and negotiates and monitors licensing agreements. OTT performs similar functions for patenting and licensing activities for the Food and Drug Administration (FDA), another component of the Department of Health and Human Services (HHS).

Other major functions within OTT include the development of technology transfer policies for NIH and with the other two major research components of HHS (FDA and the Centers for Disease Control and Prevention [CDC]) and the implementation of decisions by the Technology Transfer Policy Board.

NIH and its Role in Technology Transfer

It is impossible to overstate the untapped potential that technology transfer represents. To understand why, consider the many steps involved in medical breakthroughs.

Today, most important developments in medical science typically begin in laboratories, such as the discovery of specific new biological molecules, processes, or pathways, or innovative applications of existing knowledge. In most cases, these discoveries in and of themselves have limited effect beyond meeting a fairly narrow research goal. Their real impact for public health generally comes after several more significant steps - including further R&D;, testing, approval by appropriate regulatory bodies (such as the FDA), manufacturing, and distribution.

OTT carries out its technology transfer mandate by retaining title to inventions developed in NIH's intramural laboratories and licensing these inventions to private entities to ensure use, commercialization, and public availability. In a similar way, extramural recipients of NIH funds, such as universities, are allowed to seek patent protection for inventions arising from their NIH-funded basic research and license the rights to private entities to promote commercialization.

Over the last 15 years, NIH has executed thousands of license agreements. These licenses transfer NIH and FDA inventions to the private sector for further research and development and potential commercialization that can lead to significant public health benefits.

At OTT, we're always open to ways to make technology transfer a more user-friendly process. We are committed to seeing that the public has ongoing access to newer and more effective health care products and procedures. Please contact us if you have any questions regarding any information provided within our website. ²⁵⁾