During the COVID-19 crisis, many people are being forced to make decisions with limited or incomplete information. This is resulting in life-and-death choices sometimes made with only partial knowledge of the possible consequences. Some of these determinations relate to treatment options for the coronavirus. In this case, it is the federal government that is the one making a drastic decision with incomplete information in approving chloroquine for use in the treatment of COVID-19.
The President Has Pushed for the Use of Chloroquine
President Trump has devoted multiple briefings to advocating for the use of an anti-malarial treatment chloroquine to treat COVID-19. The President believes that this drug will be a “game-changer” in spite of limited testing which demonstrates its effectiveness against coronavirus. There have been a few small-scale anecdotal tests that have indicated the possibility of effectiveness as well as some stories of patients who have been given the drug and have recovered from the virus.
At one press briefing, the President said that he would be directing the FDA to fast-track regulatory consideration of these drug treatments for coronavirus. In recent briefings, he has continued to press chloroquine as the answer to the COVID-19 crisis. Now, as a result of the President’s direction, the FDA has expedited its review process and given emergency approval to chloroquine to treat COVID-19. Millions of doses of the drug are being shipped to hospitals across the country.
Chloroquine Still Carries a Number of Risks
Even as it has given an emergency approval to the drug, the FDA still acknowledges the risks that the drug can harm patients. There is very little data about the safety of this drug that has only been used in small amounts since the 1950s. There is some fear that continued use of chloroquine can cause heart trouble. In some cases, this drug can cause irregular heartbeat or even more severe heart damage. In addition, there is other evidence that long-term use of this drug can also cause vision problems. However, what works in the patients’ favor is that patients are not given chloroquine for the long term as the course of treatment to work against COVID-19 is generally a few days.
It Is Not Clear that Chloroquine Will Be Effective
However, whether there are benefits to the drug is still open to question. There is a great deal of controversy about whether this drug actually works in the fight against COVID-19. Even Dr. Fauci has questioned whether chloroquine can actually be effective and has said that there is very little to support its use as a treatment for coronavirus. At the same time, the studies that have claimed that chloroquine could be effective have not necessarily been reflective of real-time conditions. This research has been framed in terms of the possible benefit of the drug as opposed to the actual effectiveness of it. In other words, whether chloroquine actually works is open to a number of different interpretations. Accordingly, using chloroquine as the basis for a national treatment strategy is an incredible gamble at this point.
However, the FDA’s approval of the drug stated that the benefits of the approval outweighed the risks such that emergency approval was warranted. It is important to note that the FDA is a sub-agency of the Department of Health and Human Services. In other words, the FDA is not an independent executive agency. Thus, it could be subject to occasional political pressures that could influence its regulatory decisions. Given that the President has been publicly talking about the effectiveness of this drug, it is likely that the FDA was under considerable pressure to smooth the way for its widespread use across the country. Now, it is an open question whether it will be effective.
The FDA Is Taking a Chance with the Emergency Approval
In effect, what the FDA is saying is that it is willing to give chloroquine a try because there is a crisis and there are no better options available. In other words, the FDA is indicating that anti-malarial drugs are at least worth trying as a possible answer. This is evidenced by the FDA’s approval letter which was devoid of any scientific conclusions and phrased without conclusions. The FDA said that it is “reasonable to believe” that chloroquine would be effective. However, there are definitely risks as we simply do not know whether they are safe. There are indications that some patients have responded well to treatment with the drug. However, the numbers in the study may also be influenced by the fact that a number of patients dropped out of the study either due to being transferred to the ICU, death or other reasons.
Nonetheless, a large part of the treatment strategy is pinning its hopes on a study conducted overseas of less than 20 patients. The study had no testing protocol and little to ensure the quality of the data. This is not to say that chloroquine will not work. However, it is a risky gamble to take with the lives of patients even though treatment options are scarce.
In contrast to the FDA, European regulators will not approve chloroquine to treat COVID-19 without the data to support it. Currently, European patients can receive chloroquine through clinical trials or national emergency programs.
In many ways, the FDA’s emergency approval of chloroquine was superfluous. Doctors have already been prescribing the drug for many patients for a number of weeks since the outbreak of the disease. Moreover, the FDA has not approved long-term usage of the drug. The approval was only for short-term usage to treat serious cases of the virus.
However, given the FDA’s approval of the drug and the known side effects, patients are going to be given a drug and will not have any recourse if they are harmed by it. The emergency approval and the fact that we are in a national crisis would likely mean that patients would have difficulty filing a lawsuit in the event that they suffer any side effects. Doctors will routinely have to make tough decisions throughout the course of this emergency that will need to be assessed afterwards.
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