Hydroxychloroquine pills. (AP Photo/John Locher)
(CN) — The National Institutes of Health released treatment guidelines for Covid-19 Tuesday and notably, the health agency did not recommend the use of remdesivir, which has shown some early promise, or hydroxychloroquine, a malaria drug touted by President Donald Trump.
Both drugs, as well as a bevy of other treatments, are currently being studied in clinical trials, and the NIH urged patience while asserting that scientifically rigorous methods are the most effective way to find a safe and effective treatment for a global pandemic that continues to rage in the U.S. and throughout the world.
“The panel recognizes the critical importance of clinical research in generating evidence to address unanswered questions regarding the safety and efficacy of potential treatments for COVID-19,” the NIH said in its treatment guidelines released Tuesday.
The NIH panel is composed of representatives from a diverse body of organizations including the Centers for Disease Control, the Food and Drug Administration and the Infectious Diseases Society of America, among others.
The purpose of the panel’s conclusions is to caution doctors and patients to not seek drugs that are rumored to be effective when the science is not settled.
Hydroxychloroquine provides the clearest example.
Touted by Trump and others as a possible treatment, the drug has so far disappointed and a recent trial run in a Veterans Affairs hospital found that patients who were given the drug actually died at a higher rate than patients who were not given the treatment.
“In this study, we found no evidence that use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with COVID-19,” said a group of doctors in a study published Tuesday. “An association of increased overall mortality was identified in patients treated with hydroxychloroquine alone.”
The study has not been peer-reviewed, but the collection of doctors behind the study said the preliminary results are an indicator of the importance of waiting to amass scientific evidence before applying treatments with dubious efficacy.
“These findings highlight the importance of awaiting the results of ongoing prospective, randomized, controlled studies before widespread adoption of these drugs,” the study authors wrote.
Urging patience is an arduous task as deaths from the coronavirus pandemic continue to mount in the U.S. and around the world. Approximately 45,000 people have died from Covid-19 in the United States.
Other drug trials have been more promising. Remdesivir, an antiviral medication manufactured by Gilead Sciences, has prompted a sense of guarded optimism after a majority of patients who used the drug under a compassionate use protocol demonstrated signs of clinical improvement.
There are also reports out of a clinical trial that has entered phase 3 showing promise both in Chicago and Houston.
“The best news is that most of our patients have already been discharged, which is great,” daid Dr. Kathleen Mullane, an infectious disease specialist at the University of Chicago, who is in charge of a clinical trial. “We’ve only had two patients perish.”
But experts caution that preliminary results are just that — preliminary.
“There needs to be more evidence that it is actually remdesivir that is driving these outcomes rather than some other factors,” said Dr. Bruce Y. Lee, a professor at the CUNY Graduate School of Public Health & Health Policy.
In light of this, the NIH reminded doctors that no approved treatment is available and some drugs are only to be used in situations where the patient is in grave danger.
“It is important to stress that the rated treatment recommendations in these Guidelines should not be considered mandates,” the NIH said. “The choice of what to do or not to do for an individual patient is ultimately decided by the patient together with their provider.”
The NIH also noted that many clinical trials are underway, analyzing drug treatments like remdesivir and hydroxychloroquine and other alternatives such as experimenting with having patients lay supine (on their bellies) or immersion in hyperbaric oxygen chambers to help improve breathing.
The National Laboratory of Medicine shows about 750 clinical trials related to Covid-19 are already underway.