April 24, 2020
Steven Hahn, M.D.
United States Commissioner of Food and Drugs
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Mr. Hahn, M.D.:
The People’s Organization for Progress and the Black Is Back Coalition for Social Justice, Peace and Reparations join the call for the FDA to expedite the review and approval of the Cuban drug, Interferon Alpha 2B (which Newsweek heralded as a wonder drug) and other medications that the Cuban Medical Brigade employs for the treatment of COVID-19 in the United States.
The United States now has the horrific distinction of having the worst numbers of every metric for handling this pandemic, as it leads the world in the total number of infections and the total number of deaths. This is inexcusable as thousands of people in the United States are dying daily, not simply due to the disease, but also due to the politics of this government itself! On March 24, the United States had 778 recorded deaths from COVID-19 and as of the writing of this letter that number has skyrocketed to 51,865! Unfortunately, by the time the FDA gets around to deciding on whether or not to act on this letter, that number will probably have more than doubled.
But contrary to what the US would have its populace believe, this doesn’t have to be the trajectory of this disease and in other countries that were also hit with this pandemic — it is not! When one examines the numbers in other impacted regions, we see a completely different trajectory. For example, when we look at the numbers for China, which was the first country hit with the pandemic (and the only country which had no prior warnings), we see that the total number of deaths as of 4/24 is 4,632 and on March 24th the total number was 3,281. That means that from 3/24 to 4/21 1,351 people died in China, while 51,087 people died in the United States! Now there is an attempt by western powers to undermine China’s numbers by insinuating that China is engaging in deception. But if one examines the whole region of Asia, one will see that the pandemic mirrors China’s trajectory, as the number of deaths for the entirety of Asia as of 4/24 is currently 16,586! Asia has approximately 4.4 billion people, while the United States has approximately 325 million. Something is clearly very wrong!
China and other Asians countries employed a much different approach than the for profit model of healthcare employed by the US. China took an all hands on deck approach, which involved using nutrition, vitamins, Traditional Chinese Medicines, western medicine and working with Cuba’s Interferon Alpha 2B, which is one of the only pharmaceutical medications that has worked with great efficacy thus far. The Chinese National Health Commission in early 2020 publicly called for the use of the medication and subsequently it has been widely used across Asia. While the US in the meantime seems to take a die until a vaccine is discovered approach. This is unconscionable considering Asia’s success rate and the success of other countries using Interferon Alpha 2B. It is currently being used in 37 countries and is reported to have prevented thousands of deaths in S. Korea, which to date only has 237 deaths out of more than 10,000 cases. In fact Germany is currently using that medication and it has one of the lowest rates of death among the top industrialized western nations.
In 2016 the US Office of Foreign Assets Control approved instituted regulations that allowed for scientific collaboration between the US and Cuba and that allowed the FDA to review and approve marketing Cuban pharmaceuticals in the US without OFAC approval. Specifically, sections (b) and (c) of 515.547 of Title 31 of the Code of Regulations states that:
- (b) Persons subject to U.S. jurisdiction are authorized to engage in all transactions incident to obtaining approval from the U.S. Food and Drug Administration (FDA) of Cuban-origin pharmaceuticals, including discovery and development, pre-clinical research, clinical research, regulatory review, regulatory approval and licensing, regulatory post-market activities, and the importation into the United States of Cuban-origin pharmaceuticals.
- (c) Persons subject to U.S. jurisdiction are authorized to engage in all transactions incident to the marketing, sale, or other distribution in the United States of FDA-approved Cuban-origin pharmaceuticals, including the importation into the United States of Cuban-origin pharmaceuticals.
The FDA already has the authority to act to approve this drug for use in the United States and it is reprehensible that it hasn’t done so. Americans continue to die at an alarming rate, with the Black community bearing the brunt of this pandemic. We are putting this office and government on notice that we will not allow this to continue to happen and demand that every viable avenue is deployed to save lives, including working with the global community to provide the best remedies possible, including medications from Cuba!
People’s Organization for Progress
Black Is Back Coalition for Social Justice, Peace and Reparations