The Only COVID-19 FDA-Approved Drug Might Cost Thousands

This article was updated on May 14, 2020.

Since the Food and Drug Administration (FDA) authorized Gilead Sciences’s drug, remdesivir, for emergency use in seriously ill COVID-19 patients, the controversy as to what decision the company would come to for naming the price of remdesivir has been resolved.

The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) announced that Gilead Sciences has come up with an allocation plan for the drug remdesivir. The allocation is from a donation by Gilead Sciences, Inc. to the United States which was finalized on May 3. 

There are 1.5 million vials of the drug ready, which is enough for about 100,000 to 200,000 patients. After widespread criticism, the company continues to manufacture more remdesivir and has donated its entire stockpile of the drug of 607,000 vials to the U.S.

The drug’s benefits are modest, but remdesivir is the first therapy proven to have some effect against COVID-19, shortening a patient’s hospital stay by about four days. 

The donation of remdesivir will be sent to states that have been hit the hardest by COVID-19. Beginning on May 7, the following states will receive cases of remdesivir (each case contains 40 vials of the donated drug):

  • Connecticut – 30 cases
  • Illinois – 140 cases
  • Iowa – 10 cases
  • Maryland – 30 cases
  • Michigan – 40 cases 
  • New Jersey – 110 cases

Who is Gilead Sciences?

Gilead Science is an American biopharmaceutical company that is dedicated to developing innovative medicines for life-threatening illnesses. The company focuses primarily on antiviral drugs, like remdesivir, that are used to treat HIV, hepatitis B, hepatitis C, and influenza. 

“Going forward, we will develop an approach that is guided by the principles of affordability and access,” said CEO Daniel O’Day of Gilead at the company’s annual meeting Wednesday, May 6. The company’s management approach is said to be designed to create a sustainable future that reflects their integrity and commitment to excellence.

Gilead announced that they donated their initial supply of 1.5 million doses, but the company has relayed that they will need to start charging for the drug to make production sustainable. It is currently unclear when that decision will be made public.

Previous ethical controversy

This is not the first time for Gilead Sciences to be in the spotlight. In 2013, Gilead came out with a treatment that essentially cured hepatitis C, named Sovaldi. The company faced ethical controversy when they priced Sovaldi at $1,000 per pill.

In 2018 and carrying  into 2019, Gilead had multiple lawsuits filed against them over their promotion of the HIV medication, Truvada, that caused permanent damage to the kidneys and bones as well as the company’s suppression of a safer version of the drug that is less toxic. Truvada was also priced at $22,000 per year. 

The results have led to public scrutiny, despite the vast improvements in science for life-threatening illnesses that the company has contributed. The controversies have ignited a nationwide debate on fair pricing for prescription medicines.

The backlash subsided in the midst of the coronavirus pandemic, during which the company has made great progress in developing vaccines and treatments considered essential to battling COVID-19 and other prominent viruses. Unfortunately, the question of Gilead’s integrity has created controversy yet again.  

What is remdesivir? 

Among other potential COVID-19 treatments, remdesivir is an intravenous (administered into the veins) drug that was once studied for Ebola.

Remdesivir is not a cure for the coronavirus, but an experimental drug that may speed up recovery. It is currently the most successful drug for the virus globally. 

How does it work?

Once SARS-CoV-2, invades a human cell, it replicates with the help of a viral enzyme called RdRp. Remdesivir is designed to slow or stop the virus from cloning itself by blocking this particular enzyme.

The drug works differently than antibody-based treatments or vaccines, which are designed to help a person’s immune system identify and eliminate pathogens.

Remdesivir is most effective when administered as soon as a patient begins to show symptoms. The challenge is that the drug is administered to the patient for over 10 days through an IV.

Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, suggested that remdesivir could reduce recovery time by a median of four to 11 days compared with 15 days for those who got a placebo.

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