- Since last week, President Donald Trump has lauded chloroquine and hydroxychloroquine as potential treatment options for COVID-19.
- While there is some evidence that supports their effectiveness against the virus, health officials warn that not enough testing has been done to approve their widespread use.
- Still, people have begun trying to acquire the potential antiviral, leading to shortages for people who need it for it’s already approved treatments for lupus and rheumatoid arthritis.
Shortages of Hydroxychloroquine for People Who Need It
While panic buying has to lead to toilet paper and cleaning supplies shortages across the nation, it’s now also making it harder for some people to get their hands on medicine they’ve taken for years.
An influx of worried Americans are rushing to get ahold of hydroxychloroquine, a drug that treats diseases and disorders such as malaria, rheumatoid arthritis, and lupus. It’s also been hailed by President Donald Trump as an effective drug against COVID-19.
But that’s still unknown.
While there is evidence to support hydroxychloroquine or the similarly-touted chloroquine’s effectiveness against the pandemic, there is currently still not enough evidence to prove it should be used as a widespread treatment against COVID-19.
Even though both drugs have received approval from the Food and Drug Administration, the approvals are not for COVID-19. To be used on a widespread basis, the drugs would need approval following clinical trials.
Still, that hasn’t stopped some people from trying to acquire the potential antiviral by any means possible.
“Well it finally happened to me,” pharmacist Katherine Rowland said on Twitter. “A dentist just tried to call in scripts for hydroxychloroquine + azithromycin for himself, his wife, & another couple (friends). NOPE. I have patients with lupus that have been on [hydroxychloroquine] for YEARS and now can’t get it because it’s on backorder.”
According to the University of Utah, several doctors tried writing prescriptions for both themselves and for family friends to hoard in case they contracted the virus. The university refused to fill their prescriptions.
Because of stories like that, however, many people who need the drug for other conditions are finding themselves without.
According to The New York Times, 47-year-old Toni Grimes was told on Monday that she would have to wait until March 30 to refill her chloroquine prescription meant to treat her lupus. She said this is the first time she hasn’t been able to get her prescription refilled in the 13 years she’s been on it.
Grimes also runs a Phoenix-area Lupus Foundation support group and said another member also has yet to receive their refill, as well.
Such shortages have spurred the Lupus Foundation to release a statement, reading:
“The Foundation applauds the commitment of pharmaceutical companies that have pledged to increase production and supply of [vital] medications. We call on all manufacturers of hydroxychloroquine and chloroquine to do the same. However, increased production must not solely be done for the purpose of responding to COVID-19, but also to meet the existing needs of people with lupus.”
In fact, the scramble to obtain these drugs has grown so rapidly that four of the seven companies that make generic hydroxychloroquine are facing shortages. While the other three could have provided some cushion, they previously stopped making the drug altogether.
Because of the shortages, the Ohio Board of Pharmacy has banned the hoarding of these drugs. Now, people in Ohio can’t buy it unless they have lupus, rheumatoid arthritis, or a confirmed case of COVID-19.
People Are Dying Because They’re Self-Medicating
Ultimately, that may prove to be a beneficial move not only for people in Ohio who need these drugs but also for the people who don’t.
While not in the United States, reportedly, three people in Nigeria have all overdosed on the drug after self-medicating.
Because of that, Nigeria’s Centre for Disease Control issued a statement urgently warning people not to self-medicate, as such a move could lead to harm or even potential death.
In the U.S, an Arizona man died after reportedly ingesting chloroquine; however, instead of using the medical form of chloroquine, both this man and his wife took chloroquine that was supposed to be used to treat parasite infections for fish.
That woman is still alive, but she’s in critical care.
In an interview with NBC News, she said she and her husband—both of whom were in their 60’s—took it after watching several reports on television, including watching Trump laud the drug from the White House Press Room.
“I saw it sitting on the back shelf and thought, ‘Hey, isn’t that the stuff they’re talking about on TV?'” she said. “We were afraid of getting sick.”
Unfortunately, this couple’s goals were flawed from the start. Neither hydroxychloroquine nor chloroquine are being used as vaccines; rather, they are being investigated as potential antivirals. The difference here is that while vaccines prevent a person from getting the disease, antivirals are only meant to treat the disease after you already get it.
Chloroquine and Hydroxychloroquine in Clinical Trials
For widespread use, scientists need to prove that these drugs are not only effective against COVID-19 but also that the benefits outweigh the risks.
While this is a normal goal for any drug, scientists are playing especially close attention to these drugs as governments try to rapidly push them through clinical testing.
“Chloroquine is an extremely toxic drug with a terrible side effect profile,” Meghan May, a microbiologist at the University of New England College of Osteopathic Medicine, said in a written email to The New York Times. “Hydroxychloroquine is far safer, but its side effects are still significant. If it is not abundantly clear that it is beneficial, giving this drug to a critically ill patient feels risky.”
Those side effects include heart rhythm problems, severely low blood pressure, as well as muscle or nerve damage.
As reported in the journal Nature Medicine, researchers found evidence that hydroxychloroquine impedes the coronavirus’ ability to enter cells; however, that alone doesn’t mean it would do the same thing in a person or that a person could tolerate the doses used in the lab.
In a clinical trial conducted in February, scientists in China reported that chloroquine helped more than 100 patients at 10 hospitals. Because of that, the drug reportedly saw widespread use both there and in South Korea.
Still, this trial is also not enough to prove chloroquine’s effectiveness against COVID-19. Reportedly, with this study, the treated patients all had various degrees of the illness and were all treated with different doses for different amounts of time.
The trial also didn’t contain any control groups, which means that it’s also possible people could have just recovered on their own without the drug.
Another study from France has also captured many eager ears, including Trump’s. There, doctors gave hydroxychloroquine to 26 people who had been infected with the coronavirus.
Of those 26 people, six were also given an antibiotic called azithromycin, but before that study was completed, six other people dropped out. Of those, three people wound up in intensive care and one died. That’s not necessarily to say chloroquine killed them, because like that study from China, there was a lot of variation between each case. Some had been asymptomatic while others were symptomatic.
At the end of the trial, none of the six patients who had received both hydroxychloroquine and azithromycin had detectable levels of the virus. Meanwhile, over half who had received only hydroxychloroquine had no detectable levels, and only 12.5% of people who received neither drug had no detectable levels.
Once again, this single trial or even all three studies together are not enough to prove the effectiveness of these two drugs. National Institute of Allergy and Infectious Diseases Director Anthony Fauci has called such trials only anecdotal at the moment. In fact, clinical trials could take months.
Trump’s Calls for Chloroquine and Hydroxyquine
Scientists have been eyeing these drugs as potential treatments for most of the outbreak’s lifespan, but their names gained household usage after Trump announced last week that he was asking the FDA to cut “red tape” around their usage.
“It’s very powerful, but the nice part is that it’s been around for a long time so we know that if things don’t go as planned, it’s not going to kill anybody,” Trump said of chloroquine on Thursday.
Over the weekend, Trump continued to prop up those drugs, saying on Twitter, “HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine… Hopefully they will….be put in use IMMEDIATELY. PEOPLE ARE DYING, MOVE FAST, and GOD BLESS EVERYONE!”
Trump announced Monday that the federal government was working to obtain large quantities of chloroquine. It has already received 3 million doses from Bayer.
On Tuesday, New York state began two trials, one focusing on chloroquine and another focusing on hydroxychloroquine with the azithromycin.
See what others are saying: (The New York Times) (NBC News) (Politico)
Trump Signs Order Allowing Former Troops to Be Called Upon for Coronavirus Fight
- President Trump signed an executive order that allows for former troops to be brought back to active duty to help fight the coronavirus pandemic.
- This is not an immediate order to call former service members back, but it is typically used when the military is in need of specific skill sets, like persons with high demand medical capabilities.
- Officials are still reviewing who might be activated.
- The order comes just days after the Army called upon former service members to voluntarily rejoin and help in the military’s response efforts. Over 14,000 have expressed interest as of Friday.
Trump Signs Executive Order
President Donald Trump signed an executive order Friday that allows the Pentagon to bring former U.S. troops and members of the National Gaurd and reserve back to active duty to help those already battling the county’s coronavirus outbreaks.
During his press conference Friday night, Trump said the decision allows the federal government “to mobilize medical, disaster and emergency response personnel to help wage our battle against the virus by activating thousands of experienced service members including retirees.”
“We have a lot of people, retirees, great military people — they’re coming back in,” Trump added.
What This Means
The executive order released by the White House states that anyone recalled can remain on active duty for up to 24 months straight. It provides the Department of Defense and the Department of Homeland Security the authority to order as many as 1 million individuals at one time, however, it is not an order to do so.
According to Pentagon spokesperson Jonathan Hoffman, the order applies to units and individual members in the National Guard and Reserves and certain Individual Ready Reserve members who are normally in an inactive status.
Hoffman said that decisions about who may be activated are still being reviewed, but he added, “Generally, these members will be persons in Headquarters units and persons with high demand medical capabilities whose call-up would not adversely affect their civilian communities.”
As of now, the Individual Ready Reserve contains 224,841 members, according to the Department of Defense, and nearly 11,000 of those members “have medical capabilities.”
“This is a dynamic situation, we do not currently have a projected number of expected activations, but the Department is now fully authorized to make activations as needed,” Hoffman said.
He also stressed that the departments would consult with state officials before using any National Gaurd Reserve Component units under the executive order.
Earlier this week, the Army called upon former service members to voluntarily rejoin and help in the military’s pandemic response efforts. The Army said the initial response has been positive, with at least 14,6000 people expressing interest as of Friday.
See what others are saying: (Politico) (CNN) (Fox News)
FDA Authorizes Portable Test Kit That Can Detect COVID-19 in 5 Minutes
- The FDA has approved the use of a new coronavirus test kit that can give positive results in as little as 5 minutes and negative results in 13, leaps faster than the hours and sometimes days laboratory tests normally take.
- The tests are run on a lightweight and small portable device that can be used in emergency rooms, urgent care clinics, and even outside hospital walls.
- Abbott, the medical device company that makes the kits, plans to send out 50,000 tests a day starting next week.
New Test Approved
The U.S. Food and Drug Administration gave Emergency Use Authorization to the medical device company Abbott for a new coronavirus test kit that gives results within minutes.
Abbott announced the news in a Friday press release, saying it plans to start delivering 50,000 tests a day beginning next week. The tests run on the company’s ID NOW platform, a portable device about the size of a small toaster than weights only 6.6 pounds.
Its portability means it can be used directly in an emergency room or urgent care clinic and even, “outside the traditional four walls of a hospital in outbreak hotspots.”
The company called it “the fastest available molecular point-of-care test for the detection of novel coronavirus(COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes.”
Second Rapid Test to Be Approved by FDA
The approval from federal health officials means that regulators were satisfied with the test’s validation data and are confident that its benefits outweigh any risk, like false positives or negatives.
The FDA’s approval marks the seconds time it has green-lit a fast working test that could accelerate testing across the country. Last week, it approved a 45-minute rapid point of care test by the molecular diagnostics company Cepheid. However, that test is primarily intended for emergency rooms and hospitals, not doctors’ officers or urgent care clinics.
Still, those turnaround times are leaps faster than the hours to days it takes most laboratory tests to bring results.
Medical Shortages Still Cause Concern
The approval of the Abbott test comes as cities across the nation battle with numbers of potential patients that surpass available tests and resources. Even with insufficient testing, the United States became the country with the largest number of reported cases of coronavirus on Thursday, exceeding China and Italy. By Friday, the U.S. hit more than 100,000 cases.
Many fear that shortages of other critical medical equipment, like masks and swabs, could stifle the new rapid test’s impact. That’s because the kit requires a swab sample collected from patients, and many health care facilities are running desperately low on the tools needed to safely collect those samples.
The Center for Disease Control issued guidance Tuesday that allows some patients to collect their own nasal swabs in health care facilities, in an effort to reduce the amount of protective equipment needed for health care workers.
On the opposite end, however, others note that fast and efficient testing can help medical professionals determine how much protective equipment they actually need to wear when interacting with a patient, as well as what kind of care to provide. Since this test can be done in a doctor’s office, it could even potentially help diagnose patients with mild or asymptomatic cases of the virus and help stop them from unknowingly spreading it.
Experts also say drastically increasing testing capacity can help get the economy back on track sooner. With increased testing, measures like keeping everyone at home could be replaced with more targeted identification and isolation of those infected.
EPA Limits Environmental Regulations During Coronavirus Crisis
- The U.S. Environmental Protection Agency announced Thursday that it is scaling back its enforcement of environmental rules during the coronavirus emergency as businesses face challenges like layoffs and accessibility issues.
- The temporary policy allows companies to monitor their own compliance with environmental laws, and the EPA said it will not issue penalties for violations of certain reporting requirements.
- Many critics slammed the move, arguing that it opens doors to excess pollution and does not prioritize the health and safety of people and wildlife.
- The EPA defended the policy, saying it has reserved its authorities for situations other than routine monitoring and reporting and will consider the pandemic’s impacts on a “case-to-case basis.”
The U.S. Environmental Protection Agency (EPA) says it will limit the enforcement of certain regulations as the coronavirus pandemic continues, leaving companies in charge of monitoring their own compliance with environmental laws.
The agency unveiled the temporary policy on Thursday, arguing that businesses are running into obstacles like layoffs and accessibility issues as the virus alters normal life across the nation.
“EPA is committed to protecting human health and the environment, but recognizes challenges resulting from efforts to protect workers and the public from COVID-19 may directly impact the ability of regulated facilities to meet all federal regulatory requirements,” EPA Administrator Andrew Wheeler said in a statement.
Under normal circumstances, companies must report when their facilities release a certain amount of pollution into the air or water. Now, that requirement will be put on hold for the time being.
“In general, the EPA does not expect to seek penalties for violations of routine compliance monitoring, integrity testing, sampling, laboratory analysis, training, and reporting or certification obligations in situations where the EPA agrees that Covid-19 was the cause of the noncompliance and the entity provides supporting documentation to the EPA upon request,” the policy states.
The agency also said it would exercise “discretion” in enforcing other environmental rules. It noted that the policy does not apply to criminal violations or hundreds of the country’s most toxic waste sites that fall under the Superfund act. The EPA also said it expects public water systems to maintain high standards.
“Public water systems have a heightened responsibility to protect public health because unsafe drinking water can lead to serious illnesses and access to clean water for drinking and handwashing is critical during the COVID-19 pandemic,” the policy says.
The memo said that the changes will apply retroactively beginning on March 13, with no set end date indicated.
Criticism of New Policy
Some, including people in the oil industry, had been asking for these regulations to be loosened, but others slammed the EPA’s choice, claiming it is too broad and lax.
Gina McCarthy, who headed the EPA under the Obama administration and is now president of the Natural Resources Defense Council, called the policy an “open license to pollute.”
Some called the changes “outrageous” and “evil,” accusing the EPA of prioritizing businesses over the health of individuals and wildlife.
Prominent figures in the climate change fight slammed the move as well.
“The EPA uses this global pandemic to create loopholes for destroying the environment,” teenage climate activist Greta Thunberg tweeted. “This is a schoolbook example for what we need to start looking out for.”
Others pointed out the irony of suspending rules that preserve air quality while a respiratory disease makes its rounds across the country.
“What part of, ‘air pollution increases our vulnerability to respiratory diseases LIKE CORONAVIRUS,’ is not clear, EPA?” one Twitter user wrote.
Defense of Policy
The EPA stood behind their move and did not agree with its classification as a dismissal of regulations.
“It is not a nationwide waiver of environmental rules,” Andrea Woods, an E.P.A. spokeswoman, told The New York Times. “For situations outside of routine monitoring and reporting, the agency has reserved its authorities and will take the pandemic into account on a case-by-case basis.”
Susan Parker Bodine, the EPA official who issued the policy, said that it does not excuse organizations from consequences if they do committ environmental violations.
“If you do have violations of your permit, you’re still obligated to meet your permit limits, you’re supposed to do everything possible,” Bodine told ABC. “And after the fact the agency will take that all into consideration but there isn’t a promise of no penalties in those kinds of situations.”
“If you have an acute risk, if you have an imminent threat … the facility has to come in and talk to their regulator, their authorized state or come into the agency,” she added. “And the reason for that is that we want to, we want to put all of our resources into keeping these facilities safe keeping communities safe.”