2005 chloroquine study had nothing to do with COVID-19 and the drug wasn’t given to humans

https://www.politifact.com/factchecks/2020/jul/29/facebook-posts/2005-chloroquine-study-had-nothing-do-covid-19-and/?fbclid=IwAR2e4j_lb10FWa5Cyuokzo3pbjlty_ffvwsEfVT_2iQ6ki8a9z-TpzDm9DQ

PolitiFact | 2005 chloroquine study had nothing to do with COVID ...

IF YOUR TIME IS SHORT

  • The 2005 study wasn’t published by the NIH and didn’t prove chloroquine was effective against “COVID-1” because that’s not a real disease.
  • The study found that chloroquine could inhibit the spread of Severe Acute Respiratory Syndrome in animal cell culture, and the authors said more research was needed.
  • There are currently no approved medications or treatments for COVID-19.

 

Chloroquine is back.

The anti-malarial drug first showed up as a possible COVID-19 treatment around May 2020, when President Donald Trump said he had been taking its chemical cousin, hydroxychloroquine, to prevent getting infected with the virus.

Since then, some studies have found that the drugs could help alleviate symptoms associated with COVID-19, but the research is not conclusive. There are currently no FDA-approved medicines specifically for COVID-19. (Chloroquine is chemically similar to hydroxychloroquine, but it is a different drug that’s primarily used to treat malaria. Both carry a particular risk for people with heart problems, plus other possible side effects.)

Now, hydroxychloroquine and chloroquine have been thrust back into the spotlight as misinformation about the drugs’ effectiveness and safety recently reappeared online.

One such post on Facebook falsely claims that Americans have been deceived because health officials at the National Institutes of Health have known all along that chloroquine is effective against “COVID.”

The post reads:

“N.I.H. 15 years ago published a study on chloroquine. It is effective against COVID-(1). We are being lied to America!”

The post was flagged as part of Facebook’s efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Facebook.) 

 

This is flawed. 

First, there’s no such thing as “COVID-1.” COVID-19 was named for the year it was discovered, not because it’s the 19th iteration. 

Second, the 2005 study found that chloroquine was effective on primate cells infected with severe acute respiratory syndrome, known as SARS, which is caused by a coronavirus. But while the two share similarities, SARS-CoV and COVID-19 are different diseases, and primate cells are far from human patients.

Third, the study was indexed by the NIH’s National Library of Medicine, but the NIH was not involved. It was published in the peer-reviewed Virology Journal and conducted by researchers from the Centers for Disease Control and Prevention and the Montreal Clinical Research Institute.

 

What the study says

The study was published in August 2005 and found that chloroquine has “strong antiviral effects on SARS-CoV infection of primate cells” and that it was effective on cells treated with the drug before and after exposure to the virus.

The drug was not administered to actual SARS patients, and the study’s authors wrote that more research was needed on how the drug interacts with SARS in animal test subjects.

“Cell culture testing of an antiviral drug against the virus is only the first step, of many steps, necessary to develop an antiviral drug,” Kate Fowlie, a spokesperson for the CDC previously told PolitiFact in an email. “It is important to realize that most antivirals that pass this cell culture test hurdle fail at later steps in the development process.”

Dr. Alex Greninger, assistant director of clinical virology at the University of Washington School of Medicine, told us that a problem in virology is trying to determine the difference of how drugs work in cell culture in comparison to humans.

“Data on chloroquine is largely taken from these cell culture studies, but we now have trials in people on hydroxychloroquine that show it’s not as effective,” Greninger said, “and there’s new data out in the last week that suggests that some of the reasons could be because of the cell types that SARS coronaviruses grow in, and this original experiment was done on African green monkey kidney cells, which is not the tissue we are really worried about.”

 

What officials say about the drugs now

The Food and Drug Administration granted emergency use authorizations for some medicines to be used for certain patients hospitalized with COVID-19, but it revoked the authorization for hydroxychloroquine and chloroquine in mid-June due to concerns over the drugs’ serious side effects. There are currently no FDA-approved medicines for COVID-19.

“It is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks,” FDA Chief Scientist Denise M. Hinton wrote.

The NIH’s COVID-19 treatment guidelines, which were developed to inform clinicians on how to care for patients with COVID-19, also currently recommend against the use of chloroquine or hydroxychloroquine for COVID-19 treatment, except in a clinical trial.

But even those trials have been halted. The World Health Organization and the NIH announced in mid-June that they would stop hydroxychloroquine patient trials, citing safety concerns that include serious heart rhythm problems, blood and lymph system disorders, kidney injuries, and liver problems and failure.

 

Our ruling

A Facebook post says that the NIH published a study 15 years ago that showed chloroquine was effective against “COVID-(1)” and that health officials have been lying to the American people.

This is wrong. There’s no such thing as “COVID-1” and the study cited was not published by the NIH and had to do with animal cells infected with SARS, not COVID-19. The drug was not given to human patients and the study’s authors said more research was needed.

Health officials caution against the use of chloroquine or hydroxychloroquine to treat COVID-19 patients, citing the possibility of serious side effects. There are currently no approved treatments for the virus.

We rate this False. 

 

 

 

 

FDA ends emergency use authorization for hydroxychloroquine

https://www.axios.com/hydroxychloroquine-fda-ends-emergency-use-authorization-f5353a2c-115a-4a57-b8e2-360b735b4937.html?stream=health-care&utm_source=alert&utm_medium=email&utm_campaign=alerts_healthcare

FDA withdraws emergency use authorization for hydroxychloroquine ...

The FDA ended Monday its emergency use authorizations for two controversial drugs, hydroxychloroquine and chloroquine, as a potential coronavirus treatment.

Why it matters: Despite gaining President Trump’s adamant support and use, the drugs have failed in several clinical trials and have been found to possibly cause serious heart problems.

What they’re saying: The FDA said it believes the drugs “are unlikely to be effective in treating COVID-19” under the emergency use authorization.

  • It also said that “in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of [the drugs] no longer outweigh the known and potential risks for the authorized use.”

Read the letter and memo regarding the revocation:

 

 

 

Huge Study Throws Cold Water on Antimalarials for COVID-19

https://www.medpagetoday.com/infectiousdisease/covid19/86642?xid=nl_mpt_DHE_2020-05-23&eun=g885344d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%202020-05-23&utm_term=NL_Daily_DHE_dual-gmail-definition

Huge Study Throws Cold Water on Antimalarials for COVID-19 ...

— No support for continued use seen in analysis of 15,000 patients who got controversial drugs

Chloroquine or hydroxychloroquine (HCQ), with or without an antibiotic, in hospitalized COVID-19 patients were associated with increased risk of death in the hospital and higher rates of arrhythmias, analysis of outcomes in nearly 100,000 patients indicated.

The 15,000 patients who received HCQ or chloroquine were about twice as likely to die compared to controls who did not receive these agents after adjusting for covariates (18.o% for hydroxychloroquine and 16% for chloroquine versus 9.3% for controls), reported Mandeep Mehra, MD, of Brigham and Women’s Hospital in Boston, and colleagues.

The drug was also associated with a higher risk of ventricular arrhythmia during hospitalization (6.1% for hydroxychloroquine, 4.3% for chloroquine versus 0.3% for controls), the authors wrote in The Lancet.

Moreover, risks for both in-hospital mortality and ventricular arrhythmia were even higher compared to controls when either drug was combined with a macrolide antibiotic, they noted.

Mehra said in a statement these drugs should not be used as treatments for COVID-19 outside of clinical trials.

“This is the first large scale study to find statistically robust evidence that treatment with chloroquine or hydroxychloroquine does not benefit patients with COVID-19,” he said. “Instead, our findings suggest it may be associated with an increased risk of serious heart problems and increased risk of death. Randomised clinical trials are essential to confirm any harms or benefits associated with these agents.”

Mehra’s group analyzed some 96,000 patients from 671 hospitals on six continents with COVID-19 infection, from Dec. 20 to April 14, all of whom had either died or been discharged from the hospital by April 21.

Overall, 14,888 patients were treated with hydroxychloroquine, chloroquine, hydroxychloroquine with a macrolide antibiotic or chloroquine with an antibiotic, and their results were compared to 81,144 controls who did not receive these drugs.

Authors adjusted for demographic factors, as well as cardiovascular disease, diabetes, lung disease, smoking, immunosuppressed conditions and baseline disease severity.

The estimated excess risk attributable to the drug regimen rather than other factors, such as comorbidities, ranged from 34% to 35%.

Arrhythmia’s greatest risk was in the group who received hydroxychloroquine and a macrolide antibiotic such as azithromycin (8% versus 0.3% of controls), and this regimen was associated with a more than five-fold risk of developing an arrhythmia while hospitalized, though cause and effect cannot be inferred, the group noted.

“Previous small-scale studies have failed to identify robust evidence of a benefit and larger, randomised controlled trials are not yet completed,” said co-author Frank Ruschitzka, MD, Director of the Heart Center at University Hospital Zurich in a statement. “However, we now know from our study that the chance that these medications improve outcomes in COVID-19 is quite low.”

An accompanying editorial by Christian Funck-Brentano, MD, PhD, and Joe-Elie Salem, MD, PhD, of Sorbonne Université in Paris, noted limitations of the observational data, but said the authors “should be commended for providing results from a well designed and controlled study … in a very large sample of hospitalized patients.”

They also cautioned against attributing the increased risk of hospital deaths to the higher incidence of arrhythmias, noting that “the relationship between death and ventricular tachycardia was not studied and causes of deaths (i.e., arrhythmic vs non-arrhythmic) were not adjudicated.”

The editorialists nevertheless concluded both hydroxychloroquine and chloroquine, with or without azithromycin, “are not useful and could be harmful in hospitalized patients with COVID-19,” and stressed the importance of clinical trials for these drugs.

“The global community awaits the results of ongoing, well powered randomized controlled trials showing the effects of chloroquine and hydroxychloroquine on COVID-19 clinical outcomes,” they wrote.

 

 

 

 

Rick Bright, ousted director of vaccine agency, warns that administration lacks ‘centralized, coordinated plan’

https://www.cnn.com/2020/05/14/politics/coronavirus-whistleblower-testimony/index.html?fbclid=IwAR0KfVp-njw8vqKFdaLbBC4r4NAx3KeS4rFg2vmFbSneW7PcqOwVYult9rc

Virus whistleblower tells lawmakers US lacks vaccine plan | Where ...

Rick Bright, the ousted director of a crucial federal office charged with developing countermeasures to infectious diseases, testified before Congress on Thursday that the US will face an even worse crisis without additional preparations to curb the coronavirus pandemic.

“Our window of opportunity is closing,” Bright said. “Without better planning, 2020 could be the darkest winter in modern history.”
Bright criticized the Trump administration for failing to implement a “standard, centralized, coordinated plan” to combat the virus and questioned its timeline for a vaccine. His testimony came a week after filing a whistleblower complaint alleging he was fired from his job leading the Biomedical Advanced Research and Development Authority for opposing the use of a drug frequently touted by President Donald Trump as a potential coronavirus treatment.
About an hour before Bright’s hearing, Trump tweeted that he had “never met” or “even heard of” Bright, but considers the NIH senior adviser a “disgruntled employee, not liked or respected by people I spoke to and who, with his attitude, should no longer be working for our government!”
Before the House Committee on Energy and Commerce’s health subcommittee, Bright urged the Trump administration to consider a number of actions, including increasing production of essential equipment and establishing both a national test strategy and a national standard of procurement of supplies. He calls on top officials to “lead” through example and wear face coverings and social distance.
Bright claimed that the administration missed “early warning signals” to prevent the spread of the virus. He said that he would “never forget” an email from Mike Bowen, the hearing’s other witness and the vice president of the medical supply company Prestige Ameritech, indicating that the US supply of N95, the respirator masks used by health care professionals, was at a perilous level.
“He said, ‘We’re in deep shit,'” testified Bright. “‘The world is.'”
Bright said he “pushed” that warning “to the highest levels” he could at Health and Human Services but received “no response.”
“From that moment, I knew that we were going to have a crisis for health care workers because we were not taking action,” said Bright. “We were already behind the ball.”
In his written statement, Bright blamed the leadership of HHS for being “dismissive” of his “dire predictions.” Bright wrote that he knew the US had a “critical shortage of necessary supplies” and personal protective equipment during the first three months of the year and prodded HHS to boost production of masks, respirators, syringes and swabs to no avail. He alleged that he faced “hostility and marginalization” from HHS officials after he briefed White House trade adviser Peter Navarro and members of Congress “who better understood the urgency to act.”
And he charged that he was removed from his post at BARDA and transferred to “a more limited and less impactful position” at NIH after he “resisted efforts to promote” the “unproven” drug chloroquine.
A Department of Health and Human Services spokesperson responded that it was “a personnel matter that is currently under review” but said it “strongly disagrees with the allegations and characterizations.”
Bright is seeking to be reinstated to his position as the head of BARDA. The Office of Special Counsel, which is reviewing Bright’s complaint, has determined that was a “substantial likelihood of wrongdoing” in removing him from his post, according to Bright’s attorneys.
Rep. Anna Eshoo, a California Democrat and the panel’s chairwoman, said Bright “was the right person, with the right judgment, at the right time.”
“We can’t have a system where the government fires those who get it right and reward those who get it completely wrong,” added Eshoo.
In his testimony, Bright also cast doubt on the Trump administration’s goal of manufacturing a vaccine in 12 to 18 months as overly optimistic, calling it “an aggressive schedule” and noting that it usually takes up to 10 years to make a vaccine.
“My concern is if we rush too quickly, and consider cutting out critical steps, we may not have a full assessment of the safety of that vaccine,” Bright said. “So, it’s still going to take some time.”
Some Republicans on the subcommittee said that the hearing shouldn’t have been held at all.
Rep. Michael Burgess of Texas, the top Republican on the panel, said “every whistleblower needs to be heard,” but added the hearing was “premature” and a “disservice” to the Special Counsel’s investigation since Bright’s complaint was filed only a week ago.
And Republican Rep. Richard Hudson of North Carolina claimed that the hearing was not about the whistleblower complaint but “undermining the Administration during a national and global crisis.”
Thursday’s subcommittee meeting comes two days after a blockbuster hearing in the Senate that featured Dr. Anthony Fauci, who leads the National Institute of Allergy and Infectious Diseases. Fauci said that access to a vaccine in time for the fall school year would be “a bit of a bridge too far” and warning against some schools opening too soon, which Trump later called “not an acceptable answer.”
Fauci testified from his modified quarantine at home since he had made contact with a White House staffer who tested positive. But Bright appeared masked and in-person for his hearing on Capitol Hill, as did the lawmakers who questioned him. Many members of the House have steered clear of Capitol Hill since the onset of the outbreak, although they are expected to return on Friday to vote on a multi-trillion dollar Democratic bill responding to the crisis.

 

 

Researchers stop COVID-19 drug trial after 11 patients die

https://bigthink.com/coronavirus/covid-treatment-deaths

COVID-19 chloroquine trial cut short after 11 patients die - Big Think

  • Scientists around the world are currently experimenting with chloroquine and hydroxychloroquine as potential treatments for COVID-19.
  • Despite some early reports suggesting that these antimalarial drugs may help prevent and treat the disease, there’s still no solid evidence showing that they’re a safe and effective treatment.
  • The recent trial in Brazil suggests that high doses of chloroquine are toxic and should be avoided.

A small clinical trial in Brazil suggests that one potential treatment for COVID-19 comes with life-threatening side effects.

As the world searches for effective COVID-19 treatments, some nations have authorized doctors to give patients antimalarial drugs as part of experimental clinical trials. These trials show some indication that the drugs, chloroquine and the closely related hydroxychloroquine, may be effective at treating and preventing COVID-19.

Early reports from China and France, for example, suggested that the drugs may help improve patients’ conditions. But health experts have cautioned against overhyping the results, flagging methodological issues in the research like not including a control group or having a small sample size. To date, there’s no solid evidence showing that these drugs effectively treat COVID-19 or block coronaviruses from infecting cells.

What is clear, based on previous research and the new trial in Brazil, is that these drugs can cause serious side effects, particularly among those with heart conditions.

“The antimalarial medication hydroxychloroquine and the antibiotic azithromycin are currently gaining attention as potential treatments for COVID-19, and each have potential serious implications for people with existing cardiovascular disease,” the American Health Association notes in a statement.

“Complications include severe electrical irregularities in the heart such as arrythmia (irregular heartbeat), polymorphic ventricular tachycardia (including Torsade de Pointes) and long QT syndrome, and increased risk of sudden death.”

In the recent Brazil trial, researchers gave chloroquine to 81 COVID-19 patients in a hospital in Manaus. The study involved two groups: One received a high dose of 12 grams of chloroquine over 10 days, the second group received 2.7 grams over five days. Both groups also received the antibiotic azithromycin, which poses its own heart risks.

By the sixth day of the trial, 11 patients had died, and the researchers decided to stop giving the drug to the high-dose group.

“Preliminary findings suggest that the higher chloroquine dosage (10-day regimen) should not be recommended for COVID-19 treatment because of its potential safety hazards. Such results forced us to prematurely halt patient recruitment to this arm,” the team wrote in a preprint paper.

The high-dose group had an especially high risk of suffering heart arrhythmias, a finding also observed in a separate trial on hydroxychloroquine conducted in a hospital in France, which cut the trial short.

“To me, this study conveys one useful piece of information, which is that chloroquine causes a dose-dependent increase in an abnormality in the ECG that could predispose people to sudden cardiac death,” Dr. David Juurlink, an internist and the head of the division of clinical pharmacology at the University of Toronto, told The New York Times.

Still, it’s possible that some combination of chloroquine, hydroxychloroquine and azithromycin may be effective at preventing and treating COVID-19. The researchers behind the Brazil trial said more research is “urgently needed,” but warned doctors against using high dosages.

“We therefore strongly recommend that this dosage is no longer used anywhere for the treatment of severe COVID-19, especially because in the real world older patients using cardiotoxic drugs should be the rule.”

One major problem in searching for COVID-19 treatments is that it’s currently difficult to conduct clinical trials in a normal and methodologically sound manner. Despite increasing demand for drugs like chloroquine, many health experts are warning that more research is needed to understand their effects and risks.

“The urgency of COVID-19 must not diminish the scientific rigor with which we approach COVID-19 treatment,” Robert A. Harrington, M.D., FAHA, president of the American Heart Association said in a recent statement. “While these medications may work against COVID-19 individually or in combination, we recommend caution with these medications for patients with existing cardiovascular disease.”