Great America

The FDA Can Reduce The Horrific Racial Disparities in COVID-19 Deaths

We need to get the Trump Administration to cut through the red tape to get an important advancement in Sickle Cell Anemia approved that has the potential to help alleviate some of the disparate impact of COVID-19 on African Americans.

With over 60,000 deaths, the COVID-19 pandemic is one of the greatest challenges our country has faced in decades. No group in this country has been hit harder by the coronavirus than African-Americans.

According to the Centers for Disease Control and Prevention (CDC), there are 1.05 million COVID-19 cases in the United States as of April 29th. Of the states releasing racial data, African-Americans represent 13 percent of the population but 29.2 percent of the deaths, according to the CDC

No state has been hit harder by the COVID-19 virus than New York. Of the 62 counties in New York State, 57 of them are outside of New York City. In those 57 counties, African-Americans are 9 percent of the population and 18 percent of the fatalities. In New York City, African-Americans were 28 percent of the COVID-19 deaths compared to only 22 percent of the population. 

New York state has lost 18,015 people to the coronavirus. This is more than any other state. Approximately 71 percent of New Yorkers killed were residents of New York City. 

According to the New York State Health Department, 89.2 percent of those 18,015 people had at least one comorbidity, including hypertension, diabetes, and strokes.

While social distancing has reduced the spread of the disease, we cannot close the racial disparities in COVID-19 deaths unless we address the underlying factors that make African-Americans more vulnerable to this disease. 

For example, sickle cell disease is far more prevalent among blacks than whites. According to the CDC, sickle cell disease (SCD) affects approximately 100,000 Americans. SCD occurs in 1 out of 365 African-American births. Among Hispanics, it is 1 out of every 16,300 births. Among whites, the chances of having this genetic disease are miniscule. 

Sickle cell disease patients have weakened immune systems, which makes them more vulnerable to COVID-19. One pharmaceutical company, Micelle BioPharma, Inc., is leading the effort to help African-Americans in the COVID-19 crisis.

Micelle Biopharma is developing a drug called Altemia for sickle cell patients. According to the company’s chief medical officer, Dr. Uche Sampson, “The development of Altemia™ is based on the FDA’s findings of safety for Lovaza®, a marketed omega-3 fatty acid product that was approved by the FDA for the treatment of hypertriglyceridemia.”

In other words, Altemia™ is similar to Lovaza®. Both drugs are derived from fish oil, but, Altemia™ is at a lower dosage. 

This drug was already successful from the blinded period of the Phase 2 clinical trial. In response, the FDA supported an Open-Label Extension period of the Phase 2 clinical trial to provide the benefits of the drug to subjects in the placebo arm.

We need to get this drug to the market as quickly as possible through a Phase 3 trial waiver. Such an action is not unprecedented. In 2015, the FDA approved a Phase 3 waiver for Intellipharmaceutics. This company produced a drug called Rexista™ XR, which is the  bioequivalent of OxyContin. If the company was forced to conduct a Phase 3 study, it would have cost almost $20 million dollars. A Phase 3 trial can last as long as three to four years. 

  • In 2017,  Dr. Sarfaraz K. Niazi, an expert in biopharmaceutical manufacturing, wrote a citizen petition to the FDA about how to make their clinical trials less costly by knowing when to provide waivers to Phase 3 trials when the drugs tested are similar to the drugs already in the market. Most of Dr. Niazi recommendations on biosimilars were approved by the FDA in 2018. 

Now we need the Trump administration to cut through the bureaucratic red tape one more time and get Altemia™ to save lives from COVID-19. Furthermore, our government needs to develop further treatments to reduce the racial disparities in COVID-19 deaths.