COVID-19 Drug Remdesivir Approved By FDA for Emergency Hospital Use

FDA Regulation

On Friday, the U.S. Food and Drug Administration authorized Gilead Science’s experimental antiviral drug remdesivir for patients currently in the hospital battling COVID-19. In their official announcement letter, the FDA states that “the remdesivir have not been approved” by the FDA but instead “the remdesivir is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the remdesivir.”

"The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said during a Thursday meeting with President Donald Trump at the White House.

A clinical trial from the U.S. National Institutes of Health published Wednesday found that remdesivir reduced coronavirus fatalities from 11.6% to 8% and reduced the duration of illness from 15 to 11 days. 

In contrast, CNN reported that a small Chinese study published the same day showed no improvement in COVID-19 patients taking remdesivir. Although the Chinese study was cut short by an insufficient number of patients, the study was more carefully and critically constructed than studies conducted by Gilead Science or the National Institutes of Health. Additionally, out of the three studies, only the study from China has been published in a peer-reviewed medical journal, leading some experts to say it’s too early to tell if remdesivir is truly the game changer some would like it to be.

One challenge facing many healthcare officials in determining the effectiveness of the plethora of “cures” promoted by politicians and eager scientists is parsing out the patients who were going to recover anyway from those genuinely affected by the drugs in question. Multiple comprehensive, controlled clinical trials are needed to identify a reliable treatment for COVID-19. In the meantime, remdesivir will join the arsenal of treatments that have been made available for physicians to battle the pandemic.

Brief Relief for Nursing Homes: A Week’s Worth of Protective Equipment on Way

News

One week of much-needed relief is in sight for nursing homes which, like other healthcare facilities across the nation, have been plagued by severe, potentially life-threatening shortages of masks, gowns, gloves and eye protection. 

The Federal Emergency Management Agency (FEMA) is coordinating two deliveries of a 7-day supply of personal protective equipment to more than 15,400 Medicare and Medicaid certified nursing homes across the nation over the next two months on behalf of the Trump administration, as reported by Politico. 

The shipments will begin in early May and are expected to be completed by early July. The first PPE deliveries are headed for particularly hard-hit areas such as New York City, New Jersey, Chicago and Detroit. Assisted living and intermediate care facilities are excluded from the program. To date, the coronavirus has claimed the lives of more than 10,000 nursing home residents and staff, according to KFF.

Nursing Homes Request National Protections For COVID-19

Legal Developments

Nursing homes nationwide are asking for a national blanket of legal immunity for the duration of the coronavirus pandemic. Some states, such as New York, have already implemented an immunity law for health care centers.

If granted, these protections could immunize nursing care facilities and staff from claims of neglect, understaffing or inadequate equipment, as long as the facility is responding to COVID-19. Nursing homes could still be held accountable for deliberate acts of gross or reckless negligence and acts that are determined to be malicious. 

Nursing homes have argued that these measures will allow them to operate without fear. Nursing home resident advocates like Anny Figueroa worry that nursing homes will “continue to neglect and abuse these helpless individuals because now they are not liable,” she told NBC News.

Time will tell whether the government will enact any sweeping immunity policies for nursing homes.

Potential COVID-19 Vaccines By End of 2020

Drug Developments

Pfizer will start human trials on an experimental COVID-19 vaccine in the United States as early as next week, as reported by CNN. 

The American pharmaceutical giant has partnered with German biotech company BioNTech, which began a clinical study in Germany on April 23 with 12 participants. BioNTech researchers will look at close to 200 healthy volunteers, ages 18 to 55, who will be given a range of doses to determine the optimal dose, safety and efficacy of the vaccine.

"The companies estimate that there is potential to supply millions of vaccine doses by the end of 2020, subject to technical success of the development program and approval by regulatory authorities, and the potential to rapidly scale up the capacity to produce hundreds of millions of doses in 2021," according to Pfizer’s first quarter report. 

CNN also reported that Oxford University is testing a vaccine on humans, and at least six vaccine programs are in the clinical trial phase and more than 80 are in preliminary phases.

Daubert Hearing Conclusion Mostly Preserves Talc Expert Testimonies

Legal Developments

After nine months of deliberation, Chief Justice Freda L. Wolfson released a 141-page opinion determining the fate of expert witnesses in the ongoing talc multidistrict litigation (MDL). The 16,000 lawsuit MDL against defendant Johnson & Johnson over the safety of its talcum powder has hinged on the expert testimony of eight witnesses.

In a sharp refutation of Johnson & Johnson’s claims that plaintiff counsel intended to present “junk science,” Judge Wolfson ruled that all five of the plaintiff’s expert witnesses would be permitted to testify. Read the full story here.