Is Nevada turning the corner on the coronavirus?

By Emma Cauthorn, Staff Writer

Thursday, April 16, 2020 | 2 a.m.

As we continue to adapt to life in the time of the novel coronavirus, researchers project that Nevada might have reached a significant turning point this past week. As of late Wednesday, the state had recorded 3,211 positive tests for COVID-19 and 137 deaths, a trajectory that the Institute for Health Metrics and Evaluation says is beginning to decrease, assuming the United States continues to stay home through the end of May.

The IHME reports there were 26 deaths in Nevada on April 7, a number the organization projects was the peak for the state. On a national level, IHME’s projected peak was April 13, with 2,150 deaths within that 24-hour period. While those numbers are grim, they’re thought to represent the worst, and IHME is forecasting a declining slope from here. Social distancing and responsible social stewardship have been paramount to slowing the spread of the virus, but it’s not over. The projections rely on us staying home until June 1 at the earliest; otherwise it’s possible we’ll see hot spots pop up across the country once again. Without a vaccine or reliable treatment modalities, getting back to normal might look different than imagined.

Vaccine

Despite the length of time it takes to create a vaccine and widely distribute it—a year or more—researchers and public health professionals warn that it’s essential.

“If ‘back to normal,’ means acting like there never was a coronavirus problem, I don’t think that’s going to happen until we do have a situation where you can completely protect the population [with a vaccine],” Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said during a White House press briefing.

So what makes it so crucial?

A vaccine would change the course of coronavirus and lessen the ongoing threat by protecting everyone, especially high-risk populations such as the elderly and immunocompromised.

It can also prevent reinfection. Contracting and surviving the disease might not guarantee immunity as it does with other viral illnesses. Instances of reinfection are being reported in countries such as China and South Korea, making a vaccine the only reliable method of protecting the general population.

Vaccines work by familiarizing the immune system with a disabled version of a virus, bacteria or parasite, allowing the body to develop an immune response to fight the foreign invader.

There is no proven vaccine for any kind of human coronavirus, so researchers must develop something from scratch. And because vaccines work by triggering your immune system’s response, proper safety testing must be followed—bad vaccines can make some germs more dangerous.

The process of vaccine approval is similar to FDA drug approval and includes lab development, preclinical trials, animal testing, three-stage clinical testing on humans and post-market monitoring.

Dr. Fauci has estimated a vaccine could be ready anywhere between 12 to 18 months, and scientists are working to accelerate the timeline under these unprecedented circumstances. The World Health Organization reports that there are 62 vaccine efforts in development across the globe, two of which are already in clinical trials. As with any medication, proving a vaccine is safe and effective is paramount before it is administered to such a large number of people.

Challenges in finding a treatment

Viruses can be notoriously difficult to treat, because there’s no true “cure.” When fighting bacterial infections, antibiotics work by attacking the bacterial invader. Unlike bacteria, viruses aren’t alive—a virus depends on the human cell it invades to reproduce, grow and “come to life.” Generally, viruses are eradicated by vaccines, and symptoms are treated with supportive care. Antivirals aren’t comparable to antibiotics, because they’re not actually able to kill the germ; antivirals only keep the virus from spreading to other cells.

For instance, the flu is often treated with an antiviral, and if detected soon enough the antiviral can help lessen flu symptoms and the length of the illness. Those who must be hospitalized for the flu are usually treated with fluids and fever reducers, but there is no cure. HIV is treated similarly: Medications help slow the viral spread, regulate the immune response and lessen symptoms, but there is no cure.

So when researchers scramble to find effective treatment modalities against severe COVID-19 cases, what they’re looking for are options to slow the virus within the body and/or regulate the inflammatory immune response to the virus.

This is especially important since some evidence suggests that an overreactive immune response might be the cause of some COVID-19 deaths, particularly in young and otherwise healthy people.

The New York Times reported that cytokine storms are becoming a common occurrence in COVID-19 patients. Cytokines are molecules produced by the immune system to fight off invaders, and typically, the stronger this response, the more likely the body is to fend off infection.

Once the virus is no longer a threat, the immune system should shut down the production of cytokines. In some cases, however, the immune system doesn’t automatically shut down this response, and the “cytokine storm” continues on, possibly attacking healthy organs and causing death.

Acute respiratory distress, as observed in COVID-19 cases, is a common result of a cytokine storm. For this reason, some of the drugs researchers are testing work by regulating the immune response and reducing inflammation.

Coronavirus antibody testing

Antibody testing is becoming an important part of the coronavirus discussion, particularly as it pertains to getting back to work. Antibody testing describes a blood test that would determine if an individual has ever been infected with coronavirus, whether or not they exhibited symptoms. The idea is that those who have been infected have a certain level of immunity and could safely return to work or other daily activities.

The New York Times reported that other countries, such as China and Italy, are experimenting with antibody testing. The FDA also recently granted an emergency use authorization to one antibody test option in the U.S.

While antibody testing might be valuable for getting the first wave of individuals back to work, it’s not a foolproof system, and its reliability is not yet known. False positives are a concern and could be fatal—if individuals receive false positives, they might think they have a coronavirus immunity when they don’t.

Researchers also don’t know how long immunity to the virus lasts. Reinfection rates and timelines are unclear with diseases in their infancy.

Nevada’s success

Nevada’s quick and effective response, and more specifically the Valley’s #VegasStrong attitude, might be responsible for saving countless lives.

Unacast, a data company that collects and provides cellphone location data analysis, created a Social Distancing Scoreboard. This tool analyzes coronavirus response data, including change in average mobility (based on distance traveled), change in nonessential visits and difference in encounter density.

The goal is to identify the states and counties that are the most successful in their social distancing efforts. At press time, Nevada and Montana were ranked highest in the U.S., each with a B score. Unacast ranked the national average a C.

Nevada’s score is significant because it speaks directly to the strength of the state’s response, along with the continued effort to keep our community safe. Nevada routinely attracts millions of global visitors each month and ranked the highest in the U.S. for effective social distancing.

In comparison, Louisiana was given a D+ score, and Florida received a C. Both states faced scrutiny for their slow response times to the spread of COVID-19, waiting until after Mardi Gras and spring break to announce social distancing measures.

We might never know the quantifiable effect of Nevada’s actions, but Nevadans can be proud of their hard work and sacrifice in the face of a mounting global death toll.

Cure claims: How close are we to finding a treatment for COVID-19?

Since the start of the novel coronavirus pandemic, cure claims have run rampant. Shortly after COVID-19 was confirmed in the United States, televangelist Jim Bakker touted “Silver Solution” as a 12-hour cure for the virus. He was then sued by the state of Missouri for misleading consumers. Separately, the Federal Trade Commission and U.S. Food and Drug Administration issued The Jim Bakker Show and six other companies warnings that required them to stop selling unapproved products and treatments, according to CBS News on March 12. There have been countless other cure claims since—some credible, some not—from medical researchers, cured patients, fraudsters and some from President Donald Trump himself. It begs the question: Which claims have the potential to help treat COVID-19? Will these drugs work for everyone? What does it take to get a medication approved?

Worldwide race to find a treatment

Scientists and researchers worldwide are working tirelessly to find a drug that will treat, lessen the effects or slow the progression of COVID-19.

The Quantitative Biosciences Institute at the University of California, San Francisco has identified 69 FDA-approved drugs in clinical trials and/or preclinical compounds that might be able to fight the novel coronavirus. Nevan Krogan, a systems biologist for the institute, said 27 of the 69 are already FDA-approved. Each is being carefully evaluated in the race for an effective treatment.

More than 100 clinical trials have been launched in China, The Washington Post reported. Other countries, including South Korea and Thailand, have also announced trials. The World Health Organization has identified an experimental treatment called remdesivir, originally used against Ebola, as an especially promising prospect. On April 15, however, China announced that it has suspended remdesivir clinical trials for COVID-19 patients, because it was not able to enroll enough participants. Experts continue to be hopeful about the drug, but more research is necessary. There are other possible antiviral medications that could have an effect, along with some anti-inflammatories that might aid COVID-19 patients with pneumonia.

Chloroquine and hydroxychloroquine

Chloroquine and hydroxychloroquine have been prescribed by doctors for decades after chloroquine was approved by the FDA in the 1940s.

Historically, these drugs have been used to treat and prevent malaria, and in some cases, inflammatory diseases such as rheumatoid arthritis and lupus. However, they were recently discovered to have antiviral effects, too.

Though chloroquine and hydroxychloroquine are generally considered safe for most people and are a recommended treatment for COVID-19 in some other countries, they can cause overdoses and must be prescribed by a doctor.

The two drugs are molecularly related, though hydroxychloroquine is more commonly used today and is generally considered safer.

Cardiotoxicity is the main concern when taking the drugs; they may be especially dangerous for people with preexisting heart rhythm conditions, including long QT syndrome, a congenital cardiac condition that can cause erratic heartbeat and death.

The Los Angeles Times reports that in addition to the 3 million people worldwide with long QT syndrome, millions of people in the U.S. take medications that prolong the heart’s “QT internal,” a measure of the time it takes the heart’s electrical system to recharge between beats.

Other medications that cause this extension include antidepressants, antipsychotics and many antibiotics. People who take these medications could be at risk for developing a dangerous heart arrythmia if they are combined with chloroquine or hydroxychloroquine.

Another concern with chloroquine specifically is the potential to cause hemolytic anemia in individuals with a genetic condition called G6PD deficiency.

Hemolytic anemia can cause jaundice, shortness of breath, tachycardia and, in severe cases, kidney failure. Medpage Today reports that most people with G6PH deficiency are not aware they have it until something triggers an episode of hemolytic anemia—and that one drug commonly associated with this condition is chloroquine.

To date, there’s little clinical evidence that chloroquine or hydroxychloroquine can cause significant improvement in COVID-19 cases, but the president’s declaration that it might has caused a huge surge in demand.

The FDA has recognized a shortage in both drugs, leaving many patients with rheumatoid arthritis, lupus and other diseases unable to get their medication for its intended use.

Developing new treatments can take anywhere from months to decades, typically costing millions or more, and once that treatment is tested, the approval process typically takes at least a year. The FDA’s Center for Drug Evaluation and Research is responsible for ensuring that all drugs on the market are safe and effective. CDER also provides doctors and patients additional information about how to use a drug safely, including possible side effects, how and when to take the drug, contraindications, etc.

The process of receiving approval

1. Discovery: Researchers identify compounds that may be promising and deserve further development.

2. Preclinical research: Pharmaceutical companies must first test their product—whether it be a drug, medical device or biologics, such as vaccines. Testing begins with laboratory animals to find any possible toxicities before they’re tested on humans in “clinical trials.”

3. Clinical research: Once determined safe enough, clinical trials begin with human volunteers and include three phases, each with an increasing number of test subjects.

4. FDA review: When there’s enough documentation and testing, the company will submit an application to have the results reviewed and investigated by CDER. Once submitted, CDER has 60 days to decide if the initial application is sufficient for the review process. CDER begins the review internally with a team of physicians, statisticians, chemists, pharmacologists and other scientists, according to the FDA. If this review finds that the drug’s benefits outweigh its risks, the drug is approved for sales. CDER doesn’t test the drug’s efficacy itself, but conducts limited research to evaluate quality, safety and effectiveness standards are met. They also ensure the drug can be properly and swiftly manufactured, and that the labeling is correct.

5. FDA postmarket safety monitoring:Once approved, the FDA continues to monitor the drug in a process called postmarketing surveillance wherein the company is required to submit safety updates. The company can begin distributing and marketing the treatment.

Can the approval process be expedited?

Depending on the circumstance, the approval timeline can be expedited by the FDA in processes called accelerated approvals and fast track. This can occur in circumstances wherein the treatment fills an unmet need and/or if it’s an option to treat serious or life-threatening illness. COVID-19, and the public health risk associated with it, complies. In an accelerated approval process, the FDA bases the effectiveness on a “surrogate standpoint,” such as a blood test result, rather than waiting on results from a clinical trial. The fast-track program allows drug manufacturers to submit portions of the application as it becomes available, instead of having to wait for it all to be compiled.

According to the FDA, since the accelerated approval pathway was established in 1992, many significant drugs have been brought to market through this process, including antiretroviral drugs used to treat HIV/AIDS, as well as a number of cancer-fighting treatments.

And there’s something else—once a drug is approved for one use, doctors may prescribe it for “off-label” use as well. Off-label use describes the practice of prescribing or using a drug for a disease that it has not been approved to treat. The Manhattan Institute estimates that 21% of commonly used drugs are prescribed for off-label uses, and this practice becomes even more common in emergency settings. Off-label use drugs have not been run through the full FDA approval process for the alternative uses.

There are reportedly a few drugs being used off-label to treat some COVID-19 patients, including chloroquine and hydroxychloroquine, which President Trump erroneously claimed were approved by the FDA to treat coronavirus. This claim was untrue at the time, but the FDA has since issued emergency approval to use hydroxychloroquine in some COVID-19 cases. Hydroxychloroquine is thought to be beneficial in severe COVID-19 cases because it can help regulate the body’s immune response. Because of the FDA’s stringent drug approval process, some argue that off-label uses of medication may be our best bet for fighting the novel coronavirus quickly, but the research is still in the early stages, and the misuse of some drugs can do more harm than good.

Did Nevada turn a corner?

The Institute for Health Metrics and Evaluation created a resource tool that showcases COVID-19 state-by-state projections, assuming full social distancing until June 1. The organization is an independent population health research institute at UW Medicine, part of the University of Washington. Based on the projections, the graphs show when each state is expected to reach its peak number of COVID-19-related deaths before the curve flattens and deaths begin to taper. Nevada is believed to have reached its peak on April 7, with 26 deaths on that day.

This story appeared in Las Vegas Weekly.