Claim that FDA ‘approved’ remdesivir needs context


A claim that the antiviral remdesivir is the first drug the U.S. Food and Drug Administration has approved as treatment for COVID-19 needs context.


The investigational drug produced by California-based Gilead Sciences was issued May 1 only an emergency use authorization (EUA), not an FDA approval or license, after clinical trials showed it helped patients with severe COVID-19 recover faster.


An EUA is issued only for emergency situations. In the case of remdesivir, this would be for the duration of the COVID-19 declaration justifying its use.


Earlier, on March 28, the FDA issued an EUA for the antimalarial hydroxychloroquine sulfate and chloroquine phosphate also to treat COVID-19.


The authorization covers hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile, the U.S. national repository of antibodies, vaccines, chemical antidotes and other critical medical supplies.


Like remdesivir, both drugs have no FDA approval or license to treat COVID-19.


However, hydroxychloroquine sulfate and some versions of chloroquine phosphate are FDA-approved to treat malaria. Hydroxychloroquine sulfate is also FDA-approved to treat lupus and rheumatoid arthritis.


In a Facebook post on May 5, internist-cardiologist Willie Ong said remdesivir became the first drug against COVID-19 to obtain FDA approval:

Good News: Unang Gamot Laban sa Covid Aprubado ng US FDA (First drug against COVID approved by US FDA)

In the accompanying eight-and-15-second video, Ong, who is also a newspaper columnist and senatorial candidate in the 2019 midterm elections, said remdesivir can block the novel coronavirus or SARS-CoV-2:

Finally, mayroon na tayong unang gamut para sa COVID-19… unang pamatay sa COVID… Very good news po: At least meron ng unang gamot na napatunayan na napipigilan ang virus (Finally, we have the first drug against COVID-19…the first to kill COVID…Very good news: At least there is the first drug proved to block the virus).

Ong said the clinical trial on remdesivir has stopped:

…kasi sobra nang panalo na ang remdesivir. Sure win na at hindi na hakahaka lang (because remdesivir is such a sure win and it’s no longer a conjecture).

He then urged the Philippine government to, like Japan and Israel, start ordering remdesivir, saying it has become “standard of care”:

Pakiusap natin sa gobyerno natin proven na, kailangang umorder na tayo ngayon. Kahit hindi tayo makabili, pumila na tayo kasi proven na siya, standard of care (We ask the government to order remdesivir because it’s proven. Even if we can’t buy it now, let’s place an order because it is proven, the standard of care).

The FDA issued remdesivir an EUA after the National Institutes of Health (NIH), the U.S. government’s primary agency responsible for biomedical and public health research, announced April 29 that preliminary results of a randomized controlled trial showed that hospital patients with advanced COVID-19 who were given remdesivir intravenously recovered 31 percent faster than those who received placebo.


The median time to recovery was 11 days for the remdesivir group compared to 15 days for placebo group. The results also suggested a mortality rate of 8 percent for the remdesivir group compared to 11.6 percent for the placebo group.


The trial involved 1,063 patients in 68 sites, 47 in the United States and 21 in countries in Europe and Asia.


In a televised meeting at the White House the day the results were announced, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said: “What this has proven is that a drug can block this virus.”


His statement was Ong’s basis for saying remdesivir can block the virus.


Fauci, however, also said the results from the NIH were still awaiting peer review.


While giving remdesivir an EUA to treat COVID-19 patients, the FDA said the antiviral drug is not FDA-approved to treat or prevent any diseases, including COVID-19.


The FDA acknowledged there is limited information known about the safety and effectiveness of remdesivir as treatment for COVID-19, but said the drug was shown in a clinical trial to shorten the time to recovery in some patients.

It was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use.

It said the possible side effects of the drug include increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating and shivering.


The FDA restricted the use of remdesivir on COVID-19 in adults and children hospitalized with severe disease, or patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.


In its letter to Gilead, the FDA instructed the manufacturer not to promote or advertise the drug as safe or effective.


It also said Gilead should state that remdesivir has not been approved but is only authorized by the FDA under an EUA with a limited duration.


Gilead complied with the requirement, announcing in its May 1 press release that:

Remdesivir is an investigational drug that has not been approved by the FDA for any use. It is not yet known if remdesivir is safe and effective for the treatment of COVID-19.

It also explained that an EUA is intended to provide availability of a medicine during an emergency and is not the equivalent of an FDA approval.


In his Facebook status update, Ong said remdesivir may be costly.


Gilead has yet to set a price for remdesivir, but the Institute for Clinical and Economic Review, a drug pricing watchdog, suggested it could be about $4,500 per patient on a 10-day treatment course.


The World Health Organization said in a press conference on May 4 it would discuss with Gilead how to make the drug more widely available “as further data emerges on its effectiveness.”


Remdesivir, chloroquine and hydroxychloroquine are included in the Solidarity Trial, an international clinical trial launched by WHO and its partners to help find an effective treatment for COVID-19. It involves 100 countries.


The drugs are also included in the FDA’s Coronavirus Treatment Acceleration Program.


Ong’s post received 217,000 likes, 22,000 comments and 249,000 shares. His Facebook page has 13.76 million followers.


References


Food and Drug Administration. (2020, May 1). Coronavirus (COVID-19) update: FDA issues emergency use authorization for potential COVID-19 treatment. Retrieved from https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment


Food and Drug Administration. (2020, May 1). Letter to Gilead Sciences Inc. Retrieved from https://www.fda.gov/media/137564/download


Food and Drug Administration. (2020, May 4). FDA combating COVID-19 with therapeutics. Retrieved from https://www.fda.gov/media/136832/download


Food and Drug Administration. (2020, May 6). Emergency use authorization. Retrieved from https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization


Food and Drug Administration. (n.d.) Frequently asked questions on the EUA for chloroquine phosphate and hydroxychloroquine sulfate. Retrieved from https://www.fda.gov/media/136784/download


Food and Drug Administration. (n.d.) Frequently asked questions on the EUA for remdesivir. Retrieved from https://www.fda.gov/media/137574/download


Food and Drug Administration. Fact sheet for patients and parent/caregivers emergency use authorization (EUA) of remdesivir for coronavirus disease 2019 (COVID-19). Retrieved from https://www.fda.gov/media/137565/download?fbclid=IwAR2A6HJ-eI3Q2Q6N6rxYZDyUh9aLH829F_DxJlUcneQb3jQzE_A33fkXF58


Gilead’s investigational antiviral remdesivir receives U.S. Food and Drug Administration emergency use authorization for the treatment of COVID-19. (2020, May 1). Retrieved from https://www.gilead.com/news-and-press/press-room/press-releases/2020/5/gileads-investigational-antiviral-remdesivir-receives-us-food-and-drug-administration-emergency-use-authorization-for-the-treatment-of-covid19


ICER presents alternative pricing models for remdesivir as a treatment for COVID-19. (2020, May 1). Retrieved from https://icer-review.org/announcements/alternative_pricing_models_for_remdesivir/


National Institutes of Health. (2020, April 29). NIH clinical trial shows remdesivir accelerates recovery from advanced COVID-19. Retrieved from https://www.nih.gov/news-events/news-releases/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19


Ong, Willie [DocWillieOngOfficial]. (2020, May 4). Gamot sa Covid, May Tulong sa Paggaling [Facebook status update]. Retrieved from https://www.facebook.com/watch/?v=632820613966644


Public Health Emergency. (n.d.). About the Strategic National Stockpile. Retrieved from https://www.phe.gov/about/sns/Pages/about.aspx


Remdesivir, tested at Stanford Medicine, authorized for emergency use against COVID-19. (2020, May 3). Retrieved from https://med.stanford.edu/news/all-news/2020/05/remdesivir-gets-emergency-approval-from-fda-for-covid-19.html


World Health Organization. (n.d.). ‘Solidarity’ clinical trial for COVID-19 treatments. Retrieved from https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments


World Health Organization. (2020, May 4). Live from WHO Headquarters - COVID-19 daily press briefing 04 May 2020 [Video File]. Retrieved from https://www.youtube.com/watch?v=LFCn0Gp_9aQ

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