- Dr. Anthony Fauci said Wednesday that a recent study into remdesivir had shown positive results in decreasing the time to recovery in COVID-19 patients, though he also noted that it hadn’t shown an ability to decrease the mortality rate.
- Following the release of this information, it’s now being reported that the Food and Drug Administration will likely grant emergency use of the drug.
- Still, health officials are warning that remdesivir is not a miracle drug, though they are optimistic that it can eventually be used in combination with other drugs to create even more efficacious treatments.
FDA Likely To Approve Remdesivir for Emergency Use
White House health advisor Dr. Anthony Fauci announced Wednesday that a clinical trial of the antiviral drug remdesivir showed a “clear-cut positive effect in diminishing time to recovery” for coronavirus patients.
Speaking from the oval office, Fauci said a trial conducted by the National Institutes of Health showed that patients recovered in an average of 11 days if they were on the drug. By contrast, he said it took 15 days for those in the placebo group to recover.
It is also being reported that the Food and Drug Administration is now likely to grant emergency use authorization for remdesivir, which is manufactured by Gilead Sciences.
“As part of the FDA’s commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in… discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate,” FDA spokesperson Michael Felberbaum said in statement.
Though the drug has not yet shown statistically significant decreases in the mortality rate for COVID-19 patients, results from the NIH do suggest survival benefits. According to the NIH, people receiving the drug also saw a mortality rate of 8% as opposed to 11.6% in the placebo group.
As such, health officials aren’t calling remdesivir a miracle treatment; however, it is a hopeful sign that patients might not have to spend as long in the hospital. As Fauci noted, it will also become a standard of care and will guide clinicians in their approach on how to best treat COVID-19, especially since no other treatments have been approved for the disease.
“Although a 31% improvement doesn’t seem like a knockout 100%, it is very important proof of concept,” Fauci said. “What it has proven is that a drug can block this virus.”
Specifically, remdesivir works by blocking enzymes that the SARS-CoV-2 virus needs to be able to replicate. Because of that, future treatments could include a combination of remdesivir and another drug. In fact, the NIH is already moving forward on testing remdesivir with anti-inflammatory drugs.
Fauci called the study “the first truly high-powered randomized placebo controlled trial” and said about 1,090 participated in it internationally.
During his announcement, Fauci noted that the final analyses for this trial have not yet been completed. While he said he would usually hold off on releasing results of such a trial for several more days, he emphasized the importance of shifting placebo groups to the actual drug as quickly as possible.
“Whenever you have clear-cut evidence that a drug works, you have an ethical obligation to immediately let the people who are in the placebo group know so that they can have access,” Fauci said.
The trial was launched in February after the U.S. evacuated and recruited an American patient from the Diamond Princess cruise ship docked in Japan. From there, the NIH expanded the trial by recruiting other COVID-19 patients. For each of those patients, the process involved giving them either the drug or a placebo for five to 10 days.
WHO Says It’s Too Early to Comment on Remdesivir
The World Health Organization seemed to restrain some of the expectations of remdesivir’s success on Wednesday.
“Typically, you don’t have one study that will come out that will be a game changer,” said Dr. Maria Van Kerkhove, the WHO’s technical lead for the coronavirus response.
Kerkhove then explained that the WHO will generally look at multiple studies before reviewing evidence on a drug’s effectiveness.
“It can sometimes take a number of publications to determine (what) the ultimate impact of a drug is,” Dr. Mike Ryan, executive director of the WHO’s health emergencies program, said.
Other researchers have echoed similar explanations that more research will still need to be conducted with remdesivir as well as other drugs.
“We have work to do. We are looking for other therapies. This trial is going to continue,” said Dr. Andre Kalil told CNN.
Still, Kalli noted that even with that, remdesivir’s currently known benefits are quite significant, especially if patients need a ventilator.
“Four days (fewer) in a hospital is, for me as a clinician—as a clinical practitioner—it is not only significant but very meaningful,” he said.
According to The Washington Post, Eric Topol, director of the Scripps Research Translational Institute, said remdesivir “isn’t a breakthrough drug” and that it has offered a mix of good and bad results that paints a “confusing picture.” Still, he noted that it is a “good start,” calling it efficacious and safe.
Gilead’s Smaller Trial
Also on Wednesday, Gilead released the results of its own study of remdesivir. In it, the company said patients who took remdisivir for five days did just as well as those who took it for 10 days.
Notably, if found to be accurate, that would mean people would not need to receive as much of the drug, making more of it available to a wider group of patients.
“The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir,” Merdad Parsey, Gilead’s chief medical officer, said. “This is particularly important in the setting of a pandemic, to help hospitals and health care workers treat more patients in urgent need of care. ”
Gilead’s study, however, was much smaller than the NIH trial as it looked at 397 patients all with “severe” cases of COVID-19. It also didn’t use a control group, a criticism that several international studies into the potential vaccines chloroquine and hydroxychloroquine have also faced.
According to Gilead, the company actively prioritized remdesivir’s manufacturing over that of a placebo early in the pandemic.
“Our goal with these studies was to answer the question of treatment duration, comparing safety and efficacy with five or 10 days of remdesivir treatment,” the company said in a statement. “A placebo control was not necessary to answer this question. The open-label study design was necessary to understand whether shortening the duration of therapy can lead to earlier discharge from the hospital.”
Gilead said it has now expanded its study to be conducted at 180 locations internationally.
See what others are saying: (CNN) (CNBC) (The Washington Post)
At Least 130,000 Covid-19 Deaths Were Avoidable, Columbia Study Finds
- A report from the National Center for Disaster Preparedness at Columbia University estimates that between 130,000 and 210,000 coronavirus deaths were avoidable in the United States.
- While the U.S. accounts for just 4% of the global population, the country makes up 20% of the world’s coronavirus cases and fatalities. The country’s proportional death rate is twice as high as Canada’s and 50 times higher than Japan’s.
- The report largely blamed the Trump administration for ignoring warning signs and scientists, arguing that he has been downplaying the issue, peddling misinformation, and turning the pandemic into a political game.
- It also criticized the Trump administration and other federal leaders for not responding quickly enough in terms of testing and social distancing measures, which could have saved lives if implemented sooner.
Preventable Deaths in the U.S.
The National Center for Disaster Preparedness at Columbia University released a report on Wednesday estimating that at somewhere between 130,000 and 210,000 coronavirus deaths in the United States were avoidable.
At the time the report was made, the county had lost 217,000 thousand lives to the virus. As of Thursday morning, the U.S. death toll stands at 222,000. While the U.S. accounts for just 4% of the global population, the country makes up 20% of the world’s coronavirus cases and fatalities.
According to the report, the U.S. has the ninth highest proportional death rate in the world behind Peru, Belgium, Bolivia, Brazil, Ecuador, Chile, Spain, and Mexico. The country’s proportional death rate is twice as high as Canada’s and 50 times higher than Japan’s.
The report estimated how many deaths may have been preventable by seeing what the U.S. death toll may have been if it had mirrored the strategies of more proactive and high-income countries.
For example, it says that if the U.S. had followed policies similar to those in Canada, the country may have seen just 85,192 fatalities, making more than 132,500 American deaths “avoidable.” If the States had mirrored Germany the death toll may have been 38,457, leaving 179,260 avoidable losses. If the U.S. modeled after South Korea’s robust intervention, Americans may have seen around 2,799 deaths, leaving nearly 215,000 deaths avoidable.
The researchers do acknowledge that other various factors could contribute to a country having a higher mortality rate, including demographics, distribution of population, health risk factors like obesity, and health care access in general. Still they do not believe this would explain the magnitude of the COVID-19 deaths in the U.S. According to the report, even if the U.S. had implemented an “averaged” response, the virus may have only claimed between 38,000 to 85,000 lives, meaning that at least 130,000 COVID-19 deaths might have been avoidable.
Failures of the Trump Administration
Many, including the researchers behind this report, largely blamed state and federal governments as well as President Donald Trump’s Administration for the catastrophic death toll in the nation. Criticism has come from leaders all over, including former president Barack Obama. During a speech on Thursday, Obama said that he handed Trump’s White House a “pandemic playbook” that got thrown out the window.
“Other countries are still struggling with the pandemic but they’re not doing as bad as we are because they’ve got a government that’s actually been paying attention,” Obama added. “And that means lives lost. And that means an economy that doesn’t work. And just yesterday, when asked if he’d do anything differently, Trump said, ‘Not much.’ Really? Not much? Nothing you can think of that could have helped some people keep their loved ones alive?”
Because the U.S. has been repeatedly condemned for its reckless mishandling of the virus, the idea that thousands of deaths could have been prevented is not surprising. Still, seeing the staggering numbers and lives that did not need to be taken is a sobering reminder of the tragedy the country is currently facing. The report said this tragedy falls on Trump’s hands and specifically criticized the president for ignoring science and instead spreading misinformation and turning the pandemic into a political game.
“Many nations facing the pandemic crisis have put politics aside and orchestrated a response led by public health experts and global coordination,” the report stated.
“Unfortunately, the Trump Administration has shown hostility to much of the critical guidance and recommendations put forth by its own health agencies, with the President at times misleading the public on the scope of the threat, attempting to ‘downplay’ the extent of the crisis, and advocating for unproven therapeutical or unsafe treatments.”
A Delayed Response From the U.S.
Among the many oversights, the report claimed the administration was responsible for was a lack of testing. From the start of the pandemic, the U.S. was far behind on testing efforts, which are essential in fighting a pandemic. Both the U.S. and South Korea had their first confirmed cases on the same day. South Korea began rapid widespread testing and had conducted 250,000 by March 16. At this time in the United States, Trump was still peddling the idea that the virus was like a flu and might fade away.
The report also noted that a lack of mask mandates and delayed responses in other areas like social distancing likely contributed to the spread of the coronavirus. If major cities in the country had introduced social distancing measures just one or two weeks earlier, it is estimated that 62% of cases and 55% of deaths could have been avoided.
Deaths and case counts are not the only things that could have been avoided. The report noted that in New York State alone 325,000 children have been pushed to poverty because of the pandemic and 4,200 children have lost a parent to COVID-19. If policies had been implemented earlier, there could be at least 1.5 million less people grieving across the country right now.
“The U.S. should have – and could have – done better to protect the nation, and particularly its most vulnerable populations, from a threat that was identified and recognized early in 2020,” the report said in its conclusion.
“The weight of this enormous failure ultimately falls to the leadership at the White House – and among a number of state governments – which consistently undercut the efforts of top officials at the CDC and HHS…a pandemic is not a time for a decentralized and combative national response.”
Purdue Pharma Agrees To Plead Guilty To 3 Opioid-Related Charges in $8B Settlement, But Don’t Expect Them To Pay the Full Amount
- As part of a more than $8 billion settlement with the U.S. Department of Justice, Purdue Pharma will plead guilty to one count of conspiracy to defraud the U.S. government and two counts of violating anti-kickback, or bribery, laws.
- Because Purdue filed for bankruptcy last year, that full figure likely won’t be collected by the government.
- Under the settlement, which will need approval in bankruptcy court, Purdue would become a public benefit corporation that is controlled by the government, with revenue from opioid sales being used to fund treatment options and programs.
- A number of state attorneys generals and Democratic lawmakers have said the settlement does not hold Purdue or its owners fully accountable and could derail thousands of other cases against the company.
- They have also argued that the government should “avoid having special ties to an opioid company… that caused a national crisis.”
Purdue to Plead Guilty to 3 Criminal Charges
The Justice Department announced Wednesday that Purdue Pharma has agreed to plead guilty to three criminal charges related to fueling the country’s opioid epidemic.
Notably, those guilty pleas come as part of a massive settlement worth more than $8 billion, though Purdue will likely only pay a fraction of that amount to the government.
Purdue is the manufacturer of oxycontin, which is a powerful and addictive painkiller that’s believed to have driven the opioid crisis. Since 2000, opioid addiction and overdoses have been linked to more than 470,000 deaths.
As part of the settlement, Purdue will plead guilty to one count of conspiracy to defraud the United States. There, it will admit that it lied to the Drug Enforcement Administration by claiming that it had maintained an effective program to avoid opioid misuse. It will also admit to reporting misleading information to the DEA in order to increase its manufacturing quotas.
While Purdue originally told the DEA that it had “robust controls” to avoid opioid misuse, according to the Justice Department, it had “disregard[ed] red flags their own systems were sending up.”
Along with that guilty plea, Purdue will also plead guilty to two anti-kickback, or bribery, related charges. In one charge, it will admit to violating federal law by paying doctors to write more opioid prescriptions. In the other, it will admit to using electronic health records software to increase opioid prescriptions.
According to a copy of the plea deal obtained by the Associated Press, Purdue “knowingly and intentionally conspired and agreed with others to aid and abet” the distribution of opioids from doctors “without a legitimate medical purpose and outside the usual course of professional practice.”
The $8 billion in settlements will be split several different ways.
In one deal, the Sackler family — which owns Purdue — will pay $225 million to resolve civil fines.
As part of the main deal, another $225 million will go directly to the federal government in a larger $2 billion criminal forfeiture; however, the government is actually expected to forego the rest of that figure.
In addition to that, $2.8 billion will go to resolving Purdue’s civil liability. Another $3.54 billion will go to criminal fines, but because Purdue filed bankruptcy last year, these figures also likely won’t be fully collected — largely because the government will now have to compete with other claims against Purdue in bankruptcy court.”
Purdue Will Become a “Public Benefit Company”
Since Purdue is in the middle of bankruptcy proceedings, a bankruptcy court will also need to approve the settlement.
“The agreed resolution, if approved by the courts, will require that the company be dissolved and no longer exist in its present form,” Deputy Attorney General Jeffrey Rosen said.
However, that doesn’t mean that Purdue’s fully gone or that it will even stop making oxycontin. In fact, as part of this settlement, the Sacklers would relinquish ownership of Purdue, and it would then transform into what’s known as a public benefit company.
Essentially, that means it would be run by the government. Under that setup, money from limited oxycontin sales, as well as from sales of several overdose-reversing medications, would be pumped back into treatment initiatives and other drug programs aimed at combating the opioid crisis.
For its part, the Justice Department has endorsed this model.
Should Purdue Be Punished More?
There has been strong opposition to this deal, mainly from state attorneys general and Democratic members of Congress who say it doesn’t go far enough.
Those critics argue that the settlements don’t hold Purdue or the Sackler family fully accountable, especially the Sacklers since — unlike Purdue — they didn’t have to admit any wrongdoing.
“[W]hile our country continues to recover from the pain and destruction left by the Sacklers’ greed,” New York Attorney General Letitia James said, “this family has attempted to evade responsibility and lowball the millions of victims of the opioid crisis. Today’s deal doesn’t account for the hundreds of thousands of deaths or millions of addictions caused by Purdue Pharma and the Sackler family.”
“If the only practical consequence of your Department’s investigation is that a handful of billionaires are made slightly less rich, we fear that the American people will lose faith in the ability of the Department to provide accountability and equal justice under the law,” A coalition of 38 Democratic members of Congress said in a statement to Attorney General Bill Barr last week.
While this settlement doesn’t include any convictions against the Sacklers specifically, as the Justice Department noted, it also doesn’t release them from criminal liability and a separate criminal investigation is ongoing.
Still, last week, 25 state attorneys general asked Barr not to make a deal that includes converting Purdue into a public benefit company, urging the Justice Department to “avoid having special ties to an opioid company, conflicts of interest, or mixed motives in an industry that caused a national crisis.”
Part of their concern is that the government would essentially run this new company while also holding the original one accountable. Those attorneys general instead argued that Purdue should be run privately but with government oversight.
See what others are saying: (Associated Press) (The New York Times) (Fox Business)
Parents of 545 Children Separated at U.S. Border Still Can’t Be Found
- A Tuesday filing update from the ACLU and Department of Justice revealed that a Steering Committee in charge of reuniting families that were separated at the U.S.-Mexico border has not been able to find parents of 545 separated children.
- Efforts to reach these parents via telephone have been unsuccessful and those involved are not hopeful that will change. Two-thirds of these parents are believed to be in their respective countries of origin.
- So far, parents for 485 kids have been reached.
- Finding these parents is an already complicated process made even more strenuous by the coronavirus pandemic. On-the-ground searches were suspended because of COVID-19 but have now picked up in limited capacity.
Parents of 545 Children Remain Unfound
A Tuesday court filing from the U.S. Department of Justice and American Civil Liberties Union revealed that the parents of 545 children who had been separated at the U.S.-Mexico border have not been found or contacted.
Two thirds of those parents are expected to be in their respective country of origin. While there have been efforts to reach these families via phone, they have not been successful. Other efforts to reach these parents are in the works.
Thousands of families were separated in 2018 under President Donald Trump’s zero tolerance policy, but a federal judge ordered that those families should be reunited. Soon after, many were, but in reality many more families had actually been separated. It was later revealed that the Trump Administration had been separating families back in 2017 under a pilot program. A court order reuniting those families was not issued until last year.
A Steering Committee, of which the ACLU and other organizations are members, is now searching for these parents. According to the filing, the government provided a list of 1,556 children. The current focus on reaching children whose membership in this case is not contested and who have available contact information for a sponsor or parent. The Steering Committee has attempted to reach the families of all 1,030 children who fit that bill, and have successfully reached the parents, or their attorneys, for 485 kids.
“There is so much more work to be done to find these families, Lee Gelernt, the deputy director of the ACLU Immigrants’ Rights Project, told NBC News, which broke the story.
“People ask when we will find all of these families, and sadly, I can’t give an answer. I just don’t know,” he continued. “But we will not stop looking until we have found every one of the families, no matter how long it takes. The tragic reality is that hundreds of parents were deported to Central America without their children, who remain here with foster families or distant relatives.”
Efforts to Find Parents
Because so much time has passed between family separation practices and today, initiatives to find those parents are difficult. They are also further complicated by the fact that during the pilot program, U.S. officials did not collect thorough information from these parents, and many were deported before courts ordered they be reunited with their kids.
Nan Schivone, the legal director for Justice in Motion, which carries out on-the-ground searches for parents, told The Washington Post that attorneys “take the minimal, often inaccurate or out-of-date information provided by the government and do in-person investigations to find these parents.”
Schivone said it is an “an arduous and time-consuming process on a good day.” Sometimes, these lawyers might find themselves in remote villages where outsiders are suspect and language barriers can slow down communication.
The pandemic halted these efforts as lockdowns and curfews made it impossible for Justice in Motion to look for parents abroad. Though, Tuesday’s filing revealed that “limited physical on-the-ground searches for separated parents has now resumed where possible to do so.”