Remdesivir Rollout News Round-Up

Remdesivir Rollout News Round-Up

According to a May 7 Washington Post headline, the “Trump administration pushed use of remdesivir, but unequal rollout angers doctors.” This rollout is “confusing, unfair and marred by incomplete medical information” according to many doctors, while the Trump administration has controlled “distribution of the drug, which is in limited supply.” Physicians at several hospitals have said that they can’t get the drug and that they do not understand the process to get it. 

Dr. Benjamin P. Linas, of Boston Medical Center is quoted, “The thing that is upsetting is the process at the federal level. There’s no transparency. We don’t know who made the decision, or how it has been done. The process is just a staggering injustice.” He also pointed out that their center, “treats large numbers of African American and Hispanic patients on Medicaid.” Dr. Linas has tweeted, “Today, the family of a dying patient asked me why we do not have . What am I supposed to say?” The Department of Health and Human Services’ Assistant Secretary for Preparedness and Response (ASPR) is coordinating release of remdesivir, and they hired AmeirsourceBergen to deliver the drug. 

Doctors Forced to Make Decisions Without All the Data

Another issue is that treating doctors still do not have access to the full results of the NIH study that allowed for emergency-use designation of remdesivir, so, “they still don’t know which patients stand to benefit the most from the drug.” This includes data about how different demographic groups respond. The FDA’s authorization only states that it be used “in adults and children hospitalized with severe disease.” Dr. Mark J. Snyder of Massachusetts General says that they expect to get the drug, but not enough for all patients who need it. Doctors are especially frustrated that the unreleased data means they don’t know which patients to prioritize for available supplies.

Gilead is donating enough remdesivir for about 140,000 patients, but it is expected that his will “be used up quickly.” The rush for remdesivir was fueled by an announcement of its success at a White House event by the NIH’s Dr. Fauci. The statement “included only two points of trial data, which critics said were insufficient to gain a full understanding of the drug’s effectiveness and safety.”

Informal Survey, Pricing Debate

The Post tells us that, “Conan MacDougall, an infectious-disease clinical pharmacist at the University of California at San Francisco, has been trying to track the distribution of remdesivir by conducting informal surveys with hospitals. ‘Right now, it’s not clear what criteria are being used to decide allocation—there seems to be more allocation in some areas with a high density of cases (New York, Massachusetts) although there’s also a center in Tennessee on the list.’”  

On another point, with no announcement yet, there has been public debate about the pricing for remdesivir. While Public Citizen says that the drug should cost the $1 per day it costs to produce, the “Institute for Clinical and Economic Review, said Gilead would be justified charging up to $4,500 for a 10-day course of treatment, based on the savings to health systems and other factors.”

Illinois Seeks Equitable Distribution

Another article covering remdesivir distribution is from PBS’s WTTV Illinois, on May 10. They note that 90% of Illinois’ share of the drug will go to Cook County. The state received enough doses to treat about 700 patients. In comparison, “As of Sunday, there are 1,232 patients across Illinois in intensive care units, 709 of whom are on ventilators, with the number of cases continuing to rise.” Public Health Director Dr. Ngozi Ezike has said that the drug distribution will be “equitable, transparent and data-driven.” He calls for prioritizing “hospitals that have seen the most critically ill COVID-19 patients and to safety net hospitals and hospitals treating large communities of color.” At the federal level, DHSS “left it to states to determine how to decide which hospitals would receive the drug ‘because state and local health departments have the greatest insight into community-level needs in the COVID-19 response, including appropriate distribution of a treatment in limited supply.”

US Representative Rosa DeLauro Seeks Answers

Finally, the Connecticut Mirror weighed in on the roll-out in a May 13 article. They report that US Representative Rosa DeLauro, “has asked the Food and Drug Administration to explain its clumsy rollout of remdesivir, the only drug that has shown any effectiveness in curbing the onslaught of the coronavirus. She wants to know why some states are receiving the drug and others are not.” DeLauro is asking DHHS to “create a transparent process for distributing available doses of the anti-viral.” 

Along with other representatives, she argues that the current process is akin to a “lottery.” Next, according to the Mirror, AmerisourceBergen apparently is stepping back from its leading role in distribution, in favor of DHHS, after complaints that virus “hot spots” have been ignored. The essence—people’s lives are on the line.” DeLauro asks why, if 1.5 million vials of remdesivir are available, is the US only getting 607,000? The lawmakers want HHS to disclose, “the formula HHS used to determine which states would receive remdesivir and how many doses each state would receive.” They also want to know information about delivery schedules and price.