Connect with us

U.S.

White House Experts Clash Over Promotion of Hydroxychloroquine for COVID-19 Treatment

Published

on

  • Axios reported that presidential trade adviser Peter Navarro heatedly confronted Dr. Anthony Fauci on Saturday over whether or not there has been “clear” evidence showing hydroxychloroquine’s effectiveness against COVID-19.
  • The fiery exchange did little to stifle President Trump’s praise of the drug, as he continued to push it in back-to-back press conferences this weekend.
  • On Sunday, Trump cut off a reporter trying to ask Dr. Fauci about his thoughts on hydroxychloroquine’s effectiveness.

Navarro Clashes With Fauci Over Hydroxychloroquine

The debate within the Trump Administration on how to advertise hydroxychloroquine as a treatment for COVID-19 heated up over the weekend in a fiery exchange between presidential trade adviser Peter Navarro and Dr. Anthony Fauci.

According to an exclusive report by Axios, that confrontation happened Saturday afternoon in the White House Situation Room. It began after Commissioner of Food and Drugs Stephen Hahn began talking about hydroxychloroquine, an anti-malarial drug that’s being investigated to possibly treat COVID-19 patients.

President Trump has frequently touted it at press conferences, calling it a “game-changer” for the United States. Many scientists like Dr. Fauci, however, have been more cautious on how to present the drug to the public since it’s not currently approved to treat COVID-19. This is because hydroxychloroquine has a number of known side effects, including heart and vision problems.

While their argument isn’t to necessarily prevent hydroxychloroquine from ever being used, scientists simply want to make sure the benefits outweigh the risks before it gets widespread use. 

In the meeting, Hahn reportedly started giving updates regarding different hydroxychloroquine trials.

Navarro then got up, and according to an Axios source familiar with the situation, “…the first words out of his mouth are that the studies that he’s seen, I believe they’re mostly overseas, show ‘clear therapeutic efficacy.’ Those are the exact words out of his mouth.”

Fauci then pushed back, saying that at the moment, the evidence for those studies and hydroxychloroquine’s effectiveness is only anecdotal. Notably, that is something he’s repeatedly said in the past weeks. 

Fauci’s comment reportedly set Navarro off. According to Axios’ sources, Navarro then pointed to those studies and said, “That’s science, not anecdote.”

Reportedly, he then started yelling and accused Dr. Fauci of objecting to Trump’s travel restrictions, saying, “You were the one who early on objected to the travel restrictions with China.” 

Dr. Fauci and others then reportedly looked confused, likely because Fauci has praised Trump’s travel restrictions on China.

Following that, Vice President Mike Pence and others reportedly tried to moderate the discussion, a source saying, “It was pretty clear that everyone was just trying to get [Navarro] to sit down and stop being so confrontational.”

Eventually, Jared Kushner reportedly managed to convince Navarro and everyone else to change the conversation to hot zones in the U.S. 

Before they did, they agreed that the administration’s stance should be that the decision to use the drug is between patients and doctors prescribing it off-label.

“There has never been a confrontation in the task force meetings like the one yesterday,” Axios’ sources said. “People speak up and there’s robust debate, but there’s never been a confrontation. Yesterday was the first confrontation.”

Monday morning, Navarro spoke on that disagreement and defended himself on CNN, saying, “Doctors disagree about things all the time. My qualifications in terms of looking at the science is that I’m a social scientist. I have a Ph. D. And I understand how to read statistical studies, whether it’s in medicine, the law, economics or whatever.” 

Trump Continues to Tout Hydroxychloroquine

Despite a notable escalation in tensions over hydroxychloroquine among President Doanld Trump’s advisers, it did not seem to stop Trump from propping up the drug this weekend. 

“What do you have to lose?” Trump said Saturday. “It’s been out there for a long time, and I hope they use it. And they’re going to look at the—with doctors, work with doctors, get what you have to get. 

“And I hope they use it because it’s been used for a long time and therefore, it’s passed the safety tests,” he continued.

“In fact, I might do it anyway,” Trump added on hydroxychloroquine. “I may take it. I’ll have to ask my doctors about that, but I may take it.”

Alongside that, Trump said that the U.S. has stockpiled 29 million pills of hydroxychloroquine.

Trump continued to rush hydroxychloroquine as a treatment on Sunday, saying, “We don’t have time to say, ‘Gee, let’s go and take a couple of years and test it out. And let’s go and test with the test tubes and the laboratories.’ We don’t have time. I’d love to do that, but we have people dying today, as we speak, there are people dying.” 

Sunday’s press briefing, however, was eclipsed by another moment when Trump cut off a reporter as that reporter tried to ask Dr. Fauci a question regarding his opinion on the use of hydroxychloroquine.

“Would you also weigh in on this issue of hydroxychloroquine? What do you think about this and what is the medical evidence?” a reporter asked Fauci, who was taking questions from the podium

“Do you know how many times he’s answered that question?” Trump asked, stepping forward from the side as Dr. Fauci  “Maybe fifteen. Fifteen times. You don’t have to ask the question.”

“The question is for the doctor,” the reporter said. “He’s your medical expert, correct?”

“He’s answered that question 15 times,” Trump repeated before moving onto the next question.

Where Is the U.S. With Hydroxychloroquine?

Right now, the United States is likely still months away from knowing whether or not hydroxychloroquine will prove to be effective against COVID-19.

That said, clinical trials have already begun in New York. Last week, the Food and Drug Administration also approved hydroxychloroquine for emergency treatment.

On Sunday, Pence announced another clinical trial, a 3,000 person trial set to begin with the Henry Ford Health System in Detroit. Specifically, it will look at whether or not hydroxychloroquine will prevent COVID-19 in healthcare workers battling the virus.

“This is going to be the first major, definitive study in healthcare workers and first responders of hydroxychloroquine as a preventative medication,” said Dr. William O’Neill with the Henry Ford Health System. “There has been a lot of talk about this drug, but only a small, non-blinded study in Europe. We are going to change that in Metro Detroit and produce a scientific answer to the question: Does it work?”

Still, that study will also take at least a few months to conduct. Even then, doctors are warning that timely caution is the best practice for this drug.

“There could be negative side effects,” President of the American Medical Association Dr. Patrice Harris said on CNN. “There could be deaths. This is a new virus, and so we should not be promoting any medication or drug for any disease that has not been proven and approved by the FDA.”

“You could lose your life,” she added after being asked about potential dangers. “It’s unproven. And so certainly there are some limited studies, as Dr. Fauci said. But at this point, we just don’t have the data to suggest that we should be using this medication for COVID-19.”

Se what others are saying: (Axios) (CNN) (Newsweek)

U.S.

Multiple States Crack Down on TikTok With Partial Bans, Lawsuits

Published

on

Nearly half a dozen states have taken some kind of enforcement action against the video-sharing platform in the past two weeks alone.


Texas Bans TikTok for State Agencies

A growing number of U.S. states have been cracking down on TikTok in recent weeks amid growing concerns about security threats posed by the popular video-sharing app.

On Wednesday, Texas Gov. Greg Abbott (R) ordered all state agencies to ban the use of the platform on any government-issued phones and computers. In a letter to state officials, Abbott specifically cited concerns over data security on the Chinese-owned app.

“TikTok harvests vast amounts of data from its users’ devices—including when, where, and how they conduct Internet activity—and offers this trove of potentially sensitive information to the Chinese government,” he wrote.

“While TikTok has claimed that it stores U.S. data within the U.S., the company admitted in a letter to Congress that China-based employees can have access to U.S. data,” the governor continued. “It has also been reported that ByteDance planned to use TikTok location information to surveil individual American citizens.”

Abbott also mentioned that China’s 2017 National Intelligence Law requires businesses to help China with intelligence work, “including data sharing,” noting the algorithm already censors certain topics that are politically sensitive to the Chinese government. 

Additional State-Level Bans

Abbott, however, is just the most recent Republican governor to take similar action against TikTok.

Maryland Gov. Larry Hogan (R) on Tuesday issued an emergency directive banning the use of TikTok and other “Chinese and Russian-influenced products” in the executive branch of the state government. 

On Monday, the governor of South Carolina, Henry McMaster (R), also requested that the state’s department of administration block TikTok on all state government devices that it manages. The week prior, South Dakota Gov. Kristi Noem (R) additionally barred all state employees and contractors from using the app on state-owned devices.

The rapid succession of new policies is notable because, according to the Wall Street Journal, before the last two weeks, Nebraska was the only state to impose these kinds of bans, having done so back in 2020.

The latest actions are likely due in part to a public statement last week from FBI Director Chris Wray, who raised concerns about the app and said its algorithm “allows them to manipulate content, and if they want to, to use it for influence operations.”

More bans could be on the horizon: this week, a group of Wisconsin’s members of Congress asked the state’s Democratic governor to ban the app from state devices, and legislators in Arkansas drafted a similar bill for the next session.

Meanwhile, some states are cracking down on the video-sharing app in a different way. Also on Wednesday, Indiana’s attorney general filed two lawsuits against TikTok. The first accuses the company of misleading users about how safe the app is for children, claiming that it exposes them to inappropriate content despite its 12-plus age rating on the App Store. 

The second alleges that the platform deceived customers about China’s ability to access their data, stating it has the ability “to spy on, blackmail, and coerce” users in the name of Chinese national security.

See what others are saying: (The Washington Post) (CBS News) (CNN)

Continue Reading

U.S.

North Carolina County May Be Without Power for Days After Substation Attacks

Published

on

Tens of thousands have been left without power as temperatures drop.


Power Outage Prompts State of Emergency

Two power substations in Moore County, North Carolina were attacked on Saturday and sustained heavy damage from gunfire. The damage has left about 40,000 people without power as the temperatures fall. 

Response to the crisis has been swift. A state of emergency was declared Sunday afternoon, an emergency shelter powered by a generator has been opened, and local schools have canceled classes for Monday. 

Local authorities have partnered with state and federal agencies in an effort to find those responsible for the attack. The North Carolina State Bureau of Investigation as well as the FBI have joined the investigation

The Sheriff of Moore county, Ronnie Fields, said the attack was “targeted” while speaking at a news conference Sunday night.

It wasn’t random,” he told reporters. “The person, or persons, who did this knew exactly what they were doing.”

A representative from Duke Energy, the owner of the substations, informed the public that the damages are significant and will require complete replacement of key parts. Unfortunately, the company will not be able to reroute power as they have during storms. The representative said that, because of this, people in Moore County may be without power until Thursday. 

Investigation Into Perpetrators

As of now, authorities don’t know who is responsible. Sheriff Fields told the press that no group has taken credit for the attack. The investigation is ongoing.

“An attack like this on critical infrastructure is a serious, intentional crime and I expect state and federal authorities to thoroughly investigate and bring those responsible to justice,” Gov. Roy Cooper (D) said in a tweet Sunday night.

On social media, many have speculated that the attack was an effort to stop a local drag show from being performed. The show had reportedly garnered a significant number of protesters and a police presence. The power cut out Saturday evening shortly after the show had started. 

Sheriff Fields reported Sunday night that, so far, no connection has been found between the attack and the drag show. 

See what others are saying: (AP News) (CNN) (Axios)

Continue Reading

U.S.

Adderall Shortage Sparks Fears of Opioid-Like Crisis

Published

on

Experts specifically have expressed concerns that the lack of legal Adderall will force people to turn to black markets as they did when the supply of opioids was cut off.


Ongoing Shortage

Public health experts watching the ongoing Adderall shortage in the U.S. have raised concerns about the possibility that it could cause a major health crisis.

In mid-October, the Food and Drug Administration (FDA) announced that there was a nationwide shortage of immediate-release Adderall. The agency specifically noted that Teva Pharmaceuticals, which is the biggest manufacturer of the drug, was “experiencing ongoing intermittent manufacturing delays.”

Since then, the FDA has also reported that there are other manufacturers experiencing similar problems as well. In statements to the media, Teva has explained that the supply disruptions were triggered by a combination of a since-resolved labor shortage on its packing line this summer, as well as increased demand for the drug.

Adderall prescriptions have skyrocketed over the last two decades. From 2006 to 2016, the prescription of stimulants more than doubled in the U.S., and those numbers have grown since the pandemic. According to figures from the data analytics firm IQVIA, from 2019 to 2021, Adderall prescriptions alone rose by about 16%, surging from 35.5 million to 41.2 million.

Experts say the big spike over the last few years has been driven by the fact that more people are seeking these drugs to help cope with stress and distraction. Telehealth regulations that were relaxed during the pandemic also made it much easier for people to get diagnosed and prescribed in shorter periods of time.

A growing number of new start-ups have been taking advantage of lax rules, flooding social media — and specifically TikTok — with advertisements telling people to get ADHD meds if they feel distracted or tired. Many professionals say these apps pose issues because they are designed for such quick diagnosis so it can be hard to tell if ADHD is actually the problem people who present those symptoms are dealing with.

The resulting effect has been renewed speculation that stimulants are being overprescribed — a factor some believe could also be driving this shortage.

Additionally, Adderall is a Schedule II controlled substance, so it is highly regulated by the Drug Enforcement Administration (DEA), meaning there are caps on how much each company can produce so they can’t just ramp up production to make up for the backlog. It is also difficult for pharmacies to just pivot and start carrying new brands because of the regulations on this drug.

Potential Crisis

Leo Beletsky, a professor of law and health sciences at Northeastern University and faculty director of the Health in Justice Action Lab, worries all these elements could create the perfect storm for a full-blown crisis.

In an interview with Rogue Rocket, he outlined two overarching concerns.

 “One is that you have lots of people who had access, sort of regular access to medication that they may not now have access to, and there are individual-level risks that sort of cascade from that,” he said. “Insomnia, depression, in some instances, you could even see suicidal ideation. So all of these are kind of, you know, health risks that result from rapid tapering or discontinuation, discontinuation of taking Adderall.”

“What is an even bigger concern or, an equally important concern, is that lots of people without access to the pharmaceutical supply will turn to the illicit market and counterfeit Adderall is readily available on the illicit market and other forms of unfettered means. Specifically, methamphetamine is available, widely available on the illicit market 24/7. You know, there’s no shortage in that market,” he continued.

Beletsky explained that there are a number of harms that can come as a result of people turning to the black market — and there is first-hand evidence of this from the opioid crisis. As he noted, opioids were also widely criticized as being overprescribed, and so when access was cut for prescription opioids, people turned to illegal markets and there was a massive spike in the use of heroin, counterfeit opioids, and fentanyl contamination.

“The public health, sort of population-level concern is that we might see similar patterns here where lots of folks are being pushed into the market and they’re, you know, it’s the Wild West. Counterfeit Adderall oftentimes does have methamphetamine,” he stated. Counterfeit Adderall can also be cross-contaminated with other dangerous drugs like fentanyl.

“Methamphetamine is even cheaper than counterfeit Adderall pills, and so the concern is that folks might start smoking meth and even injecting meth, which is, you know, increasingly common,” Beletsky continued. “It would be a huge public health disaster if thousands or even millions of people started taking methamphetamine in or trying to replace this pharmaceutical supply.”

Prevention Options

Beletsky pointed out a number of tools the FDA has at its disposal to address the possible crisis and clear up the shortage, including encouraging other competitors to create new sources of production, as well as encouraging the importation of Adderall from abroad.

However, while the agency would have the power to fast-track these actions to skirt regulatory hurdles, so far, they have not taken any of these steps. In response to questions as to whether the FDA will intervene and speed up the process, a spokesperson told Rogue Rocket  that the agency “evaluates all its tools and determines how best to address each shortage situation based on its cause and the public health risk associated with the shortage.”

When asked when the FDA thinks the shortage will be resolved, the spokesperson said it is “expecting the supply issues to resolve in the next 30-60 days.”

But Beletsky said he does not buy that timeline.

“I’m afraid that they may be over overly optimistic given the scale of the problem,” he told Rogue Rocket. “My guess is it’s going to take months to resolve. And I hope that, you know, most folks are able to kind of make do and not start kind of purchasing alternatives from the illicit market.” 

The professor emphasized that the current shortage is a symptom of broader problems with America’s overall system for drug regulation that goes beyond the FDA and centers on the powers granted to the DEA. 

Unlike the FDA, the DEA is a law enforcement agency, and Beletsky notes it has a long history of focusing on controlling the supply of these kinds of drugs rather than ensuring there is adequate access for the people who need them.

As a result, the DEA has very little control over both the legal and illegal markets for controlled substances. Because of this, people lack proper access to the prescriptions they need while the massive, unregulated black market is thriving.

Beletsky argued it is imperative that we use this latest shortage as yet another wake-up call to highlight the need for rethinking how drug access is structured in America.

“I think that it’s really important to highlight the failures of the DEA in this context, because the DEA, much more than the FDA, is responsible for finding that balance between access and control,” he said. “I think that we really need to reevaluate the role of the DEA in our drug regulatory system. And the FDA, on the other hand, probably could use additional authority.” 

“When it comes to essential medicines, we really need much more authority for governmental regulation to step in and sort of help to stabilize access to these particular medications, as well as many others.” 

How to Seek Help

Beletsky noted that there are several steps people who need Adderall can take until the shortage clears up.

“I think it’s important to note that there are other alternatives in the pharmaceutical supply that are not in shortage,” he explained. “And so talk to your provider about what additional tools may be available, you know, other stimulants that you can […] try to kind of bridge the gap.” 

“I think it’s also important to note that if you do turn to, you know, folks are turning to buying Adderall or other alternatives on the illicit market, it’s really important to test that supply, especially for fentanyl.”

For more information on obtaining test strips and other harm reduction tools, Beletsky recommended visiting Next Distro or finding your local harm reduction agency, which can be done on the National Harm Reduction Coalition website.

For those suffering the impact of the Adderall shortage, The Washington Post has a guide with helpful tips and ideas from professionals.

See what others are saying: (WIRED) (The New York Times) (Axios)

Continue Reading