Letter to HHS and NIH relating to clinical trial cost transparency

TO:

Eric Lander, Director, Office of Science and Technology Policy (OSTP) and Science Advisor to the President

Carrie Wolinetz, Principal Assistant Director for Health and Life Sciences, OSTP

Xavier Becerra, Secretary of Health and Human Services

Lawrence A. Tabak, Acting Director, National Institutes of Health (NIH)

Deb Tucci, Director, National Institute on Deafness and Other Communication Disorders, NIH

Lyric Jorgenson, Acting Associate Director for Science Policy & Acting Director of the Office of Science Policy,   NIH

John Gallin, Chief Scientific Officer and the Scientific Director of the NIH Clinical Center, Associate Director for Clinical Research in the Office of Clinical Research, Office of the Director, NIH

Michael Lauer, Deputy Director for Extramural Research, NIH

Gary Disbrow, Director, Biomedical Advanced Research and Development Authority

Date: January 31, 2022

RE:  The US Government Should Disclose the Costs of Clinical Trials it Funds to Make Medical Tools Affordable, Accessible, and Suited to Public Health Needs

Dear OSTP, HHS, NIH, and BARDA colleagues:

We read with interest the recent piece in JAMA “Incentivizing a New Culture of Data Stewardship” and welcome the intention that authors Drs. Jorgenson, Wolinetz, and Collins express to use the National Institutes of Health (NIH) Policy for Data Management and Sharing to integrate effective data management and sharing practices into the process of scientific discovery, “not as an afterthought… but rather as an integral part of how to conduct science.”[1]  We share the authors’ perspective  that data sharing is essential – not only for biomedical research to fulfill “its mission to improve human health but also in leading the enterprise toward a culture that maximizes the public’s investment in research.”

As non-profit organizations and individuals concerned with public health and the affordability of drugs and other medical tools, the undersigned are similarly committed to these two key objectives of improving human health and maximizing the benefits that flow from public investment in research.  In our view, however, neither objective can be achieved if such transparency does not extend to data on the costs of research. The prevailing model of biomedical discovery, development, and delivery fails to control exorbitant prices and make medical tools accessible to all who need them, despite the significant public investment made to bring these health technologies into being.  This happens, in large part, because pharmaceutical and biotechnology companies are able to claim that the high costs of research and development (R&D), clinical trials in particular, justify high prices for drugs and other medical tools – yet they do not disclose these costs in any detail.  What limited information is available indicates that R&D expenditures are far outpaced by revenues.[2]    

As the largest funder of biomedical research in the world, the US government can and must begin lifting the veil on clinical trial costs.  The Department of Health and Human Services (HHS) and its agencies and offices, especially the NIH and the Biomedical Advanced Research and Development Authority (BARDA), should disclose the costs of all clinical trials they fund or conduct in full, disaggregated detail.

Making clinical trial cost information public would allow governments and other purchasers of medical tools to:  interrogate claims about the need to recoup R&D costs through high prices; estimate more accurately the true cost of late-stage clinical research; and ultimately – when such transparency is expanded and coupled with the capability to negotiate prices – negotiate more effectively, less hobbled by information asymmetry.  It would also allow the public and independent experts to determine whether NIH may conduct certain kinds of research more efficiently than industry and should play an even bigger role in the research ecosystem.  

We recognize that uniform disclosure of disaggregated trial costs would not be an effortless undertaking.  As we describe in greater detail in the attached addendum, however, there are no legal barriers to disclosure, the administrative obstacles are surmountable, and the benefits of disclosure and the government’s responsibility to the public warrant the resources that would be required for implementation.

Cognizant of the need for public access to cost data, lawmakers and civil society groups in the US and globally have made a number of efforts to achieve greater R&D cost transparency in recent years.[3]  In 2019, the US government agreed to a resolution at the World Health Assembly, committing to take the necessary steps to make available the costs of clinical trials when publicly available or voluntarily provided, and the actions we are proposing would give effect to that commitment.[4]

We believe that right now is the moment for action.  Amidst the global pandemic, the US government is investing tens of billions of dollars to develop tools to fight COVID-19 and future infectious threats, atop the multiples of this that it normally spends on biomedical R&D – $40 billion annually from NIH alone.  This massive infusion of public resources only intensifies a longstanding need for greater transparency and, ultimately, a more effective and equitable approach to biomedical R&D that answers the most pressing public health needs and also ensures equitable access to the fruits of scientific progress. 

Coinciding with this unprecedented pandemic is a historic transition in leadership at the NIH – which dispenses most of this grant money – as Dr. Francis Collins concludes more than ten years of service as Director.  In nominating the next NIH Director, the Biden administration must heed the lessons of COVID-19 and reflect upon the mission of this public medical research agency, particularly its goal to “exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.”[5] Shedding light on the significant contribution American taxpayers make to biomedical innovation and facilitating access to resulting tools by making publicly available the costs of clinical trials falls squarely within NIH’s mission and should be made a priority for whoever steps into this role.

Sincerely,

Doctors Without Borders/Médecins Sans Frontières (MSF) USA

Doctors for America

Drugs for Neglected Diseases initiative (DNDi), North America

Knowledge Ecology International

Christopher Morten, Associate Clinical Professor of Law, Columbia Law School 

Co-signatories: 

• Adrian Dominican Sisters, Portfolio Advisory Board 

• Center for Policy Analysis on Trade and Health (CPATH)

• Center for Popular Democracy 

• Chronic Illness Advocacy & Awareness Group 

• Consumer Action 

• Foundation for Integrative AIDS Research (FIAR) 

• Health Care Voices 

• Health Global Access Project 

• Interfaith Center on Corporate Responsibility (ICCR) 

• Justice is Global

•  Lower Drug Prices Now 

• Maryknoll Sisters 

• Mercy Investment Services, Inc. 

• Network Lobby for Catholic Social Justice 

• Northwest Coalition for Responsible Investment 

• Oxfam America 

• Patients for Affordable Drugs Now 

• PrEP4All 

• Prescription Justice 

• Public Citizen 

• Right to Health Action 

• Salud y Farmacos 

• Sisters of Charity of Saint Elizabeth 

• Sisters of St. Francis of Philadelphia 

• Social Security Works 

• Socially Responsible Investment Coalition 

• T1International 

• Trade Justice Education Fund 

• Treatment Action Group 

• U.S. PIRG (Public Interest Research Group) 

• Seventh Generation Interfaith Coalition for Responsible Investment 

• Dr. Luca Li Bassi, MD, Dip Mgt, DPH; Global Health Adviser; Geneva, Switzerland; Former Director General of the Italian Medicine Agency (AIFA) 2018-2019 Chair of the Negotiating Group for WHA Resolution 72.8

• ————-

1 Jorgenson LA, Wolinetz CD, Collins FS.  Incentivizing a new culture of data stewardship:  the NIH policy for data management and sharing. JAMA. Published online November 04, 2021. https://doi.org/10.1001/jama.2021.20489

2 US Congress House Committee on Oversight and Reform. Drug Pricing Investigation: Majority Staff Report. 117th Cong. 2021. https://oversight.house.gov/sites/democrats.oversight.house.gov/files/DRUG%20PRICING%20REPORT%20WITH%20APPENDIX%20v3.pdf

3 US Congress. Transparent Drug Pricing Act of 2017, H.R. 4116, 115th Cong. https://www.congress.gov/bill/115th-congress/house-bill/4116/text; US Congress. Prescription Drug Affordability Act, H.R. 3513, 114th Cong. § 601(a). 2015. https://www.congress.gov/bill/114th-congress/house-bill/3513/text?q=%7B%22search%22%3A%5B%22Medicare+%22%5D%7D&resultIndex=7; US Congress. Prescription Drug Affordability Act, S. 2023, 114th Cong. § 601(a). 2015. https://www.congress.gov/bill/114th-congress/senate-bill/2023/text; US Congress. Fair Accountability and Innovative Research Drug Pricing Act, H.R. 2439, 115th Cong. § 39900(c). 2017. https://www.congress.gov/bill/115th-congress/house-bill/2439; US Congress. Fair Accountability and Innovative Research Drug Pricing Act, S. 1131, 115th Cong. § 39900(c). 2017.

4 WHO. Improving the transparency of markets for medicines, vaccines, and other health products. WHA Resolution A72/A/CONF./2 Rev.1. 2019 May 28. https://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_R8-en.pdf

5 NIH.  Mission and goals. https://www.nih.gov/about-nih/what-we-do/mission-goals