US Buys World Supply Of Remdesivir For Coronavirus — What Does That Mean For Public Health And Our Future?
Earlier this week (June 29), the U.S. Department of Health and Human Services (HHS) announced a purchase agreement with Gilead for remdesivir. HHS said they have staked claim to 100 percent of Gilead’s projected production for July (94,200 treatment courses), 90 percent of production in August (174,900 treatment courses), and 90 percent of production in September (232,800 treatment courses), in addition to an allocation for clinical trials. (When asked today, Gilead said 90% of the drug is committed to the U.S. for this period.)
Get started on your Homeland Security degree at American Military University.
HHS Secretary Alex Azar commented that “President Trump has struck an amazing deal to ensure Americans have access to the first authorized therapeutic for COVID-19.”
Where does this leave the rest of the world?
Responding to a question about the U.S. hoarding the world’s supply of remdesivir, Dr. Mike Ryan, WHO executive director of Health Emergencies Program, expressed concern, noting, “Obviously, there are many people around the world who are very sick with this disease and we want to ensure that everybody has access to the necessary lifesaving interventions.”
Gilead has voluntary licensing agreements with generic pharmaceutical manufacturers based in Egypt, India and Pakistan to further expand supply of remdesivir. The agreements allow the companies—including Cipla Ltd., Dr. Reddy’s Laboratories Ltd., and Mylan, among others—to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle income countries. However, these agreements would preclude distribution of the generic in many other countries, including Brazil, Peru, Russia, China, Japan, Mexico and many European nations, even though many of them are struggling with Covid-19.
There have been similar attempts by the US to monopolize access to new medicines before. Sanofi’s CEO, Paul Hudson, appeared to suggest that the U.S. would receive priority access to a vaccine from his company because the U.S. had provided initial research funding.
French President Emmanuel Macron promptly rebutted that claim, saying that any Covid-19 vaccine must be treated as a “public good for the world, and not subject to the laws of the market.”
Canada’s Prime Minister Justin Trudeau also chided the U.S., saying “We know it is in both of our interests to work collaboratively and cooperatively to keep our citizens safe.”
This move by HHS is now being mirrored by the EU, as Stella Kyriakides, health commissioner for the 27-country EU is trying to broker a separate deal and is “currently in negotiations with Gilead to reserve doses of remdesivir for EU member states.”
There is also discussion of whether countries might issue a compulsory license to override Gilead’s intellectual property rights.
A Stat News opinion piece today argues that HHS could decree a “government patent use,” which would allow HHS to control the manufacturing, distribution, and cost of remdesivir, rather than Gilead.
Gilead has come under considerable criticism for its pricing of remdesivir as well. They plan to charge insurers (including Medicare and Medicaid) $3,120 for the five days of treatment and $2,340 for governments.
Yet the drug was largely developed by U.S. research agencies—the CDC and the USAMRIID (U.S. Army Medical Research Institute of Infectious Diseases). The federal government has already spent more than $70 million of its taxpayers’ money to help in remdesivir’s development.
The Institute for Clinical and Economic Review estimates a fair price for remdesivir is $310. The drug has not been shown to cure Covid-19; its benefit has been in slightly reducing the patient’s length of stay in the hospital.
The production cost of remdesivir is estimated as $0.96 per day, or $5 for a typical course of treatment, according to an article by Dr. Andrew Hill of the University of Liverpool’s Pharmacology Department in the Journal of Virus Eradication.
In December, I attended (virtually) Event 201, a pandemic preparedness exercise. Participants included global leaders in public health, industry, and government. The program was a collaboration between the Johns Hopkins Center for Health Security, the World Economic Forum, and the Bill and Melinda Gates Foundation. You can read my assessment of the experience here.
The exercise was modeled after a (fictional) viral illness like previous epidemics caused by SARS or MERS. The lessons of Event 201 were prescient; unfortunately, they were ignored. There was an emphasis on the need for global cooperation if one were to successfully control a pandemic.
We have seen the consequences of nationalism and unilateral decisions before. Previously, Indonesia did not want to share novel (H5N1) bird flu samples. Their complaint was that “samples provided freely by developing countries are used by companies in wealthy countries to develop vaccines and other products that the developing countries can’t afford.” There were similar concerns expressed about Ebola samples being used to develop an Ebola vaccine.
The pandemic preparedness exercises and discussions all include the need to distribute access to treatments globally and equitably. The U.S. cornering the world’s supply of remdesivir sets a bad precedent.
Hill noted, “It actually calls into question the most basic of ethical standards to actually take all the drug back to the United States when it’s been tested in a whole variety of countries. It’s not the way that you deal with a pandemic. If everybody goes into their silo and starts hoarding drugs and equipment and vaccines, then the drugs are not going to be given out fairly.”
Dr. Thomas Inglesby, Director of the Center for Health Security of the Johns Hopkins Bloomberg School of Public Health, chaired last fall’s Event 201 and is a leading expert on pandemic preparedness. He expanded on Hill’s concerns, noting “The clinical trials where remdesivir was studied occurred in many countries where the medicine will now not be available because of this U.S. decision — this will likely complicate international trials in the future.”
Inglesby also echoed the concerns of some, including myself, both about ethics and about potential retaliation in the future.
“I don’t think any one country should claim all of the supply of a highly valuable medicine or a vaccine…Not only is it the ethically right thing to allow a portion of it to be acquired by other countries, but it is also what the U.S. should be doing practically. If the U.S. keeps most or all of the world’s supply of remdesivir, then should the first COVID-19 vaccine ultimately be developed elsewhere in the world first, the U.S. might be denied access to it in response.”
Whether we are talking about the need to share data, samples of emerging pathogens, or new medicines or vaccines, if we don’t have global cooperation, it will come back to bite us. We would do far better if each country recognized that we are one.
Online Degrees & Certificates In Cybersecurity
American Military University's online cybersecurity programs integrate multiple disciplines to ensure you gain the critical skills and management practices needed to effectively lead cybersecurity missions – from government or private industry. Learn from the leader. American Military University is part of American Public University System, which has been designated by the National Security Agency and the Department of Homeland Security as a National Center of Academic Excellence in Cyber Defense Education.