At a press conference on Thursday, March 19th, President Trump referred to the drug known as chloroquine as a potential “game-changer” when it comes to treating the coronavirus. In fact, the drug has been around for almost 70 years. It has long been approved by the Food and Drug Administration for treating and preventing malaria and arthritis, but it’s not clear if it can treat COVID-19, the disease caused by the coronavirus.
The Trump Administration is currently working with the FDA to provide chloroquine to large swaths of the population in order to stem the spread of the virus. While the drug has yet to be approved for treating COVID-19, the FDA is rolling it out under the “Expanded Use” Testing Program, which fast-tracks certain treatment methods during public health emergencies. The FDA will then use additional patient information to determine if chloroquine is the cure we’ve been looking for.
Learn more about this classic drug and how it could turn the tide against the spread of the virus.
The Story of Chloroquine
Chloroquine dates back to 1934. It was first discovered by Bayer AG, one of the largest pharmaceutical companies in the world. It’s been used to treat and prevent the spread of malaria and arthritis for decades, and doctors all over the country regularly prescribe it to their patients. The drug essentially blocks those viruses from entering the body, and researchers have been anxious to find out if it can be used to treat the coronavirus, as well.
The drug was recently featured in a limited clinical trial involving 36 patients with COVID-19. Six of these patients were asymptomatic, 22 had upper respiratory tract infection symptoms, and eight had lower respiratory tract infection symptoms. 20 patients received 600 milligrams of hydroxychloroquine daily in a hospital setting. Some patients also received an antibiotic called azithromycin, depending on their symptoms, which has been shown to be effective in treating bacterial lung disease. The remaining 16 patients served as the control group.
After just six days, 70% of treated patients saw significant improvements, compared to just 12% of control patients. These patients then tested negative for the virus, a promising sign that chloroquine may work as a cure.
The Benefits of Relying on Existing Drugs
Health officials and researchers have a history of looking to existing drugs when combating a public health pandemic such as the coronavirus. Time is of the essence, and existing drugs can help speed up the approval and testing process.
For one, researchers and providers know that existing drugs, such as chloroquine, won’t hurt patients. Doctors have been prescribing it for years, so the risks are inherently lower than they would be if researchers were testing a novel drug that has never been used on patients. As President Trump said at the press conference on Thursday, “The nice part is, it’s been around for a long time, so we know that if things don’t go as planned, it’s not going to kill anybody. When you go with a brand-new drug, you don’t know if that’s going to happen. It’s shown very encouraging early results and we’re going to be able to make that drug available almost immediately.”
Secondly, existing drugs are much easier to produce and distribute than newer drugs. Chloroquine is already embedded in the U.S. healthcare system, which means if it is eventually approved for treating COVID-19, doctors may already have access to the drug. They will already be familiar with its properties and how it can affect patients, thus accelerating the entire treatment process.
Chloroquine is also relatively inexpensive compared to other possible treatment methods. In Canada, the drug can cost as little as 30 cents per pill. According to the consumer pharmaceutical website Drugs.com, the pill currently sells for just $6.63 per tablet here in the U.S.
Bayer AG recently announced that it will be donating around 3 million doses of the drug to the U.S. to help streamline the testing process.
Unrandom, Unblinded, and Under-studied
Despite the initial success of chloroquine when it comes to treating COVID-19, more testing is necessary. The original clinical trial, which has yet to be published in a peer-reviewed scientific journal, featured just 36 patients, a relatively small sample size for such an important medical study. The drug needs to be tested on more infected patients before it can be approved.
The study raises concerns for several additional reasons. The sample group was not random, unlike many clinical trials. Choosing participants at random helps purify the results of the study. If patients are selected from the same source, they may develop unconscious bias throughout the testing process.
The study was also considered unblinded, which means that both patients and providers were aware of the clinical trial and the treatments being given. Unblinded studies can also lead to unconscious bias and inaccurate results. Keeping studies blind ensures that patients and providers stay focused on the results, not the potential implications.
As the Trump Administration begins distributing chloroquine to more providers, the FDA should soon know whether it can effectively treat COVID-19. The medical community has been optimistic, but more information is needed. If chloroquine is the drug we’ve been looking for, it may soon be available in every hospital in America.