Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Experts Question FDA Approval of Remdesivir for COVID-19

By Sravya Chary

Experts are calling into question the recent decision of the U.S. Food and Drug Administration (FDA) to approve remdesivir (sold under the brand name Veklury) for the treatment of COVID-19 and casting scrutiny as to whether the decision is truly in the public’s interest.

Evaluating and approving an effective treatment for SARS-CoV-2 virus has been a top priority for regulatory authorities, especially in the absence of a viable vaccine. On October 22, 2020, the FDA approved Veklury for the treatment of COVID-19 in adult and pediatric patients requiring hospitalization.

The FDA cited three randomized, controlled clinical trials as the evidence supporting its decision to approve Veklury. The findings from the three studies were as follows: first, that the median time to recovery from COVID-19 was 5 days sooner in the Veklury group compared to the placebo group. Second, that the odds of a research subject’s COVID-19 symptoms improving were statistically significantly higher in the five-day treatment group than the standard of care group (the 10-day treatment group did not show a statistically significant difference from the standard of care group). Third, that there were no statistically significant differences in recovery or mortality rates between subjects in the five-day Veklury group versus the ten-day Veklury group.

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Pile of colorful pills in blister packs

Duplicate Discounts Threaten the 340B Program During COVID-19

By Sravya Chary

The 340B program, which provides discount drugs to safety-net hospitals, faces an uncertain future due to revenue leakage faced by pharmaceutical manufacturers and increased demand spurred by the COVID-19 pandemic.

Over the last few months, growing demand for 340B drugs and hard-to-monitor billing issues have placed an immense and unforeseen financial burden on pharmaceutical manufacturers. In response, some pharmaceutical manufacturers have threatened to withhold 340B drugs from contract pharmacies, thus limiting access to steeply discounted drugs for eligible patients.

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Empty classroom.

Who’s to Blame for COVID-19 Outbreaks at Colleges and Universities?

By Sravya Chary

For many U.S. colleges and universities that opted for in-person instruction this fall, the return to campus during the COVID-19 pandemic has proven disastrous, and prompted the question: who’s to blame for these new outbreaks?

Although administrators are quick to blame student behavior, in this post, I will argue that the administrations are ultimately at fault – their negligence has put students’ health at risk and exacerbated the public health catastrophe.

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U.S.-Mexico border wall in Texas near a dirt road

Targeting Health: How Anti-Immigrant Policies Threaten Our Health & Our Humanity

By Patricia Illingworth and Wendy E. Parmet

On May 19th of last year, Carlos Gregorio Hernandez Vasquez died of the flu while being held in a cell by U.S. Customs and Border Protection (CBP) in south Texas. He was just 16, a migrant from Guatemala. Hours before his death, when his fever spiked to 103, a nurse suggested that he be checked again in a few hours and taken to the emergency room if he got any worse. Instead, Carlos was moved to a cell and isolated. By morning, he was dead.

Sadly, Carlos’s substandard medical treatment was not an isolated case. Between December 2018 and May 20, 2019, five migrant children died while in federal custody. All of them were from Guatemala. Their deaths were not accidental. Rather, they died as a consequence of harsh policies that are designed to deter immigration, in part, by making life itself precarious for migrants.

Since taking office, the Trump administration has instituted a wide-ranging crackdown on immigration. A surprising number of the policies the administration has instituted as part of that crackdown relate directly or indirectly to health. For example, in addition to providing inadequate treatment to sick migrants, CBP has refused to provide flu shots to detainees, despite the fact that influenza, like other infectious diseases, can spread rapidly in overcrowded detention facilities. In dismissing a CDC recommendation to provide the vaccines, CBP cited the complexity of administering vaccines and the fact that most migrants spend less than 72 hours in its custody before being transferred to other agencies, or returned to Mexico. These explanations lack credibility given how easy it is to administer flu vaccines. Read More

First-person perspective photograph of a health care worker holding up a mask used to prevent the spread of germs

The Big Winner in Trump’s Newest Immigration Policies: The Flu

By Robert Field

The influenza virus gained an important ally during the past few weeks: the Trump Administration. If you have been rooting for a widespread and virulent flu epidemic this winter, several of its new immigration policies should give you reason to cheer.

The first bit of good news for flu fans is a decision to withhold vaccination from children held in Customs and Border Protection detention centers. These facilities are supposed to hold migrants for no longer than three days, but many remain much longer, and the centers are often severely overcrowded. Since the flu can be quite serious, this puts the thousands of children held in them at increased risk of major illness or death.

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