NEW YORK, FEBRUARY 22, 2021—The US Department of Health and Human Services (HHS) must mandate the disclosure of clinical trial costs funded through its offices and agencies in order to shed light on where public funding is going and to ensure that new vaccines, medicines, and diagnostics—including those for COVID-19—are priced fairly, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) on Monday.
“Disclosing what these companies and other drug developers are spending on clinical trials as part of the research and development (R&D) process would help people and governments better determine and negotiate what a fair price should be for urgently needed medical products,” said Dana Gill, US policy advisor for MSF’s Access Campaign.
It’s critical to know the cost of these clinical trials because pharmaceutical corporations justify high drug costs by pointing to the cost of R&D to bring a drug to market.
“In reality, much of the research relied upon for drug development is funded by taxpayers, and pharmaceutical corporations incur much of their R&D costs during the clinical trial process,” said Gill. “The development of COVID-19 vaccines has shown the world how public funding is the actual driver of medical breakthroughs.”
US taxpayers fund approximately $40 billion for health-related R&D annually. Just for COVID-19, more than $10 billion has been directed to pharmaceutical companies through the publicly funded initiative formerly known as Operation Warp Speed that includes HHS’ National Institutes of Health (NIH), the Biomedical Advanced Research and Development Authority (BARDA), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC), as well as the Department of Defense.
MSF, which ran COVID-19 programs in the US and is currently responding to COVID-19 in more than 60 countries, has been directly involved in the clinical trial process for the Ebola vaccine made by Merck in the Democratic Republic of Congo, as well as trials involving a tuberculosis (TB) medicine made by Johnson & Johnson in various sites across the globe.
“MSF knows what happens when pharma doesn’t have to disclose how much their clinical trials actually cost or agree to charge a fair price,” Gill said. “After stepping in to support these trials, many of our patients still end up with unaffordable treatments or vaccines once they are approved for wider use.”
To ensure the public knows how their money is being spent by pharmaceutical companies during clinical trials, ClinicalTrials.gov should be updated to require HHS agencies and offices to post, going forward, the costs associated with HHS-funded clinical trials—for COVID-19 and R&D on products for other illnesses—to the federal website that currently tracks globally all privately and publicly funded clinical trials. If HHS refuses to make these changes, lawmakers could make this improvement through legislative action or President Biden could demand the public disclosure through executive action.
“There is no legitimate reason for secrecy around research and the cost of clinical trials funded by US taxpayers,” said Gill. “The public has a right to know what it’s paying for. Failing to demand disclosure of this information protects pharmaceutical industry profits at the expense of everyone in the world who needs fairly priced medicines and vaccines.”