Category Archives: Misleading

Huge Study Throws Cold Water on Antimalarials for COVID-19

Posted on by • Posted in 2020 Election Issues, Chloroquine, Clinical Research, Clinical Trials, Coronavirus, Credibility, False Hope, Food and Drug Administration (FDA), Health Policy, Hydroxychloroquine, Mislead, Misleading, Mortality, Pandemic, Public Health, Public Safety, Trust, Truth, Wishful Thinking • Leave a comment

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.

 

 

 

 

Cartoon – Blinded by Science

Posted on by • Posted in 2020 Election Issues, Blind, Cartoon, Centers for Disease Control & Prevention (CDC), Coronavirus, Credibility, Crisis, Crisis Management, False Hope, False Narrative, Hydroxychloroquine, Misinformation, Mislead, Misleading, Mistake, Mistrust, Pandemic, Public Health, Public Safety, Scientists, Wishful Thinking • Leave a comment

A Politician Delivers A Campaign Speech Acrylic Print by Paul Noth

Cartoon – Coronavirus Recovery Plan

Posted on by • Posted in 2020 Election Issues, Cartoon, Coronavirus, Crisis, Crisis Management, Economic Crisis, Economic Stimulus, Economy, Employee Furlough, Employee Hiring Freeze, Employee Layoffs, Employee Pay Cuts, Employee Protections, False Hope, Health Policy, Job, Job Market, Job Search, Job Security, Leadership Decentralized, Miracle, Misinformation, Mislead, Misleading, Mortality, Pandemic, Public Health, Public Safety, Quarantine, Social Distancing, Wishful Thinking • Leave a comment

Then a Miracle Occurs | HENRY KOTULA

Whistleblower alleges Trump administration ignored coronavirus warnings

Posted on by • Posted in 2020 Election Issues, Clinical Research, Clinical Research Funding, Clinical Testing, Clinical Trials, Conflicts of Interest, Coronavirus, Credibility, Crisis, Crisis Management, Dept of Health and Human Services (HHS), Food and Drug Administration (FDA), Health Policy, Hydroxychloroquine, Misinformation, Mislead, Misleading, Mistake, Mistrust, Scientists, Transparency, Trust, Truth, U.S. Biomedical Advanced Research and Development Authority (BARDA) • Leave a comment

https://www.axios.com/coronavirus-rick-bright-whistleblower-f48cc9c6-8e6e-4662-a127-03e51f323288.html?stream=health-care&utm_source=alert&utm_medium=email&utm_campaign=alerts_healthcare

Whistleblower alleges Trump administration ignored coronavirus ...

Rick Bright, the former director of the U.S. Biomedical Advanced Research and Development Authority (BARDA), filed a whistleblower complaint Tuesday alleging that the Department of Health and Human Services failed to take early action to mitigate the threat of the novel coronavirus.

Flashback: Bright said last month he believes he was ousted after clashing with HHS leadership over his attempts to limit the use of hydroxychloroquine to treat the coronavirus.

What’s new: In his complaint, Bright claims he was excluded from an HHS meeting on the coronavirus in late January after he “pressed for urgent access to funding, personnel, and clinical specimens, including viruses” to develop treatments for the coronavirus should it spread outside of Asia.

  • Bright alleges it “became increasingly clear” in late January that “HHS leadership was doing nothing to prepare for the imminent mask shortage.”
  • Bright claims he “resisted efforts to fall into line with the Administration’s directive to promote the broad use of chloroquine and hydroxychloroquine and to award lucrative contracts for these and other drugs even though they lacked scientific merit and had not received prior scientific vetting.”
  • He adds that “even as HHS leadership began to acknowledge the imminent shortages in critical medical supplies, they failed to recognize the magnitude of the problem, and they failed to take the necessary urgent action.”

The White House declined to comment. HHS did not immediately respond to a request for comment.

https://www.documentcloud.org/documents/6882494-NEW-R-Bright-OSC-Complaint-Redacted.html

 

 

 

 

White House plans to scale back coronavirus task force

Posted on by • Posted in 2020 Election Issues, Clinical Research, Clinical Testing, Coronavirus, Credibility, Crisis, Crisis Management, Denial, Economic Crisis, Economy, False Hope, Health Policy, Infection Control, Infectious Virus, Misinformation, Mislead, Misleading, Mortality, Pandemic, Partisanship, Public Health, Public Safety, Quarantine, Social Distancing, Vaccination, Vaccine, Wishful Thinking • Leave a comment

https://thehill.com/homenews/administration/496211-white-house-signals-it-will-wind-down-coronavirus-task-force

Anthony Fauci - Axios

The White House is in the early stages of winding down its coronavirus task force, Vice President Pence’s office confirmed Tuesday.

The surprise decision comes as most states are preparing to loosen restrictions meant to slow the spread of the virus, while a number of areas continue to see increases in new COVID-19 cases and deaths.

Pence’s office confirmed to The Hill that the vice president told reporters at a limited briefing that his plan is to scale back the task force’s role by Memorial Day. Pence has been leading the task force since late February.

Members are likely to return to their respective departments and manage the coronavirus response from there.

Dr. Deborah Birx, who was brought in from the State Department to coordinate the White House virus response, will “continue to review and analyze data and work with the departments in agencies to help that data inform their decision making processes,” a spokesman for Pence’s office said.

The New York Times first reported on the expected demise of the task force.

The task force, which includes nearly two dozen officials from various government agencies, held near-daily press briefings for more than a month but has been less visible in recent weeks as President Trump and others transition their focus to the economic consequences of the pandemic.

There have been no coronavirus task force briefings in more than a week, and the daily meetings have become less frequent. The group was scheduled to meet Tuesday afternoon.

But the decision to formally disband the task force is sure to raise concern among public health experts who have warned the coronavirus will likely be part of life in the U.S. until there is a widely available vaccine, which could take a year or longer to develop.

 

 

The Health 202: Social distancing hasn’t been as effective in stemming U.S. coronavirus deaths as policymakers had hoped.

Posted on by • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Coronavirus, Crisis, Crisis Management, Expectations, Food and Drug Administration (FDA), Health Policy, Infection Control, Infectious Virus, Leadership Decentralized, Mislead, Misleading, Mortality, Pandemic, Public Health, Public Safety, Quarantine, Social Distancing, Uncertainty, Vaccination, Vaccine, Wishful Thinking • Leave a comment

https://www.washingtonpost.com/news/powerpost/paloma/the-health-202/2020/05/05/the-health-202-social-distancing-hasn-t-been-as-effective-in-stemming-u-s-coronavirus-deaths-as-policymakers-had-hoped/5eb04b6d88e0fa594778ea5e/

Social distancing isn’t having the effects many had hoped for.

Despite encouraging signs on the nation’s East and West coasts, daily diagnosed cases of the novel coronavirus appear to still be on the rise in about 20 states. A number of rural counties have become unexpected hot spots in recent weeks, including in the Black Belt region of Mississippi and Alabama and in communities throughout Iowa and northern Texas around the Oklahoma panhandle. The country’s overall daily figures of diagnoses and deaths have plateaued, worrying health policymakers as many states move to reopen parts of their economy.

That steep curve of covid-19 cases in March and April isn’t receding the way it rose.

Hot spots are shifting geographically from New York City to areas around the country. For the past month, the figures have hovered around 30,000 diagnosed cases and around 2,000 deaths every day, former Food and Drug Administration commissioner Scott Gottlieb noted in a Wall Street Journal op-ed.

“Everyone thought we’d be in a better place after weeks of sheltering in place and bringing the economy to a near standstill,” he wrote. “Mitigation hasn’t failed; social distancing and other measures have slowed the spread. But the halt hasn’t brought the number of new cases and deaths down as much as expected or stopped the epidemic from expanding.”

President Trump, who last week suggested the novel coronavirus would disappear even without a vaccine, has now upgraded his prediction of fatalities to as many as 100,000 people. Nonetheless, he said in a New York Post interview yesterday that Americans are “starting to to feel good now. The country’s opening again. We saved millions of lives, I think.”

A leaked government report, still in draft version, predicts a spike in cases and deaths beginning on May 14.

The report, which the Centers for Disease Control quickly disavowed as an unfinished projection, suggests new cases could surge to 200,000 per day and daily American deaths could number more than 3,000 by June 1. That’s far more than what other models predict, but the Johns Hopkins epidemiologist who prepared it told my colleagues William Wan, Lenny Bernstein, Laurie McGinley and Josh Dawsey that 100,000 new cases per day by the end of the month isn’t out of the realm of possibility.

Former FDA commissioner Scott Gottlieb:

University of Michigan professor Justin Wolfers:

That’s not the only model showing discouraging figures for the month of May. A model out of the University of Washington, relied upon heavily by the administration, yesterday upgraded its U.S. fatality predictions for the virus’s first wave from 72,433 deaths to 134,475 deaths by Aug. 4.

These aren’t the trends many policymakers had hoped to see, after most Americans spent seven weeks at home under an unprecedented lockdown that has torched the once-booming economy and thrust millions into economic uncertainty. Protests against extended lockdowns are starting to mount around the country, and many governors have assembled and even embarked upon gradual plans to reopen businesses, schools and other public areas.

Nonetheless, a new Washington Post-University of Maryland poll out this morning shows sizable majority of Americans oppose the reopening of restaurants, retail stores and businesses.

Executive producer of 7News WHDH in Boston:

Social distancing did accomplish some important objectives. It undoubtedly saved the health-care system from being crushed by an overwhelming caseload of sick patients all at once.

And the United States is still outranked by half a dozen European countries when it comes to deaths per capita. The U.S. death rate is about 206 deaths per million people. That figure is 538 in Spain, 372 in France, 481 in Italy, 432 in the United Kingdom and 207 in Switzerland, according to a tally by Mother Jones.

But distancing clearly hasn’t been enough — at least the way it’s been carried out — to halt the spread of the highly contagious virus in some places.

New cases and deaths across the whole U.S. are about where they were 20 days ago, my colleague Philip Bump reports. He created a graphic where you can view the three-day averages of cases, deaths and tests performed by state (check it out here).

“The back of the mountain doesn’t look the way the front did,” Philip writes. “We saw a steady, exponential rise in confirmed cases and deaths each day for several weeks. But particularly with daily case totals, the period after the peak nationally has looked more like a plateau than a downward slide.”

Daily cases appear to be rising significantly in Delaware, Illinois, Indiana, Minnesota and Virginia. They’re also trending upward in Arizona, Colorado, D.C., Iowa, Kansas, Maryland, Mississippi, Nebraska, New Hampshire, New Mexico, North Carolina, Tennessee, Texas, Utah and Wisconsin.

Andy Slavitt, former head of the Centers for Medicare and Medicaid Services:

“There are so many emerging areas still throughout the country that our group has been trying to wave our hands about,” Marynia Kolak, a health and spatial data science researcher at the University of Chicago, told me.

Kolak and her colleagues are tracking covid-19 cases and deaths at the county level. They’ve been increasingly spotting clusters of the disease in rural areas. Kaiser Family Foundation researchers have also found that rural areas are experiencing a faster growth in cases, even as their total numbers remain far below those seen in urban settings.

One example: Five counties in Minnesota with significant meat-processing plants. State officials said about a quarter of cases reported over the weekend came from those counties.

One is Nobles County, home to a JBS USA pork processing plant in Worthington, with a population of around 22,000. It is scheduled to partially reopen this week, under an order by Trump to keep meat plants open.

The outbreaks in counties with meat-processing plants “illustrates how powerfully situations can change at the community level,” said Jan Malcolm, commissioner of Minnesota’s Department of Health.

Malcolm stressed how hard it is to stem the spread of the virus in these types of facilities.

“These are particularly challenging investigations,” Malcolm said. “Many of the workers involved don’t have phones, don’t provide phone numbers, aren’t answering calls. It’s been a very labor-intensive, shoe-leather kind of an approach.”

 

 

Cartoon – Let’s Change “Brink of Chaos” to “Everything is Wonderful”

Posted on by • Posted in 2020 Election Issues, Chaos, Economic Crisis, Economy, Employee Furlough, Employee Hiring Freeze, Employee Layoffs, Employee Pay Cuts, Job, Job Market, Job Search, Job Security, Leadership Intent, Mislead, Misleading, State of the Union, Status Reporting, Uncertainty, Unemployment, Unemployment Insurance, Wishful Thinking, Wonderful • Leave a comment

Cartoon – Status Update | HENRY KOTULA

Trump Moves to Replace Watchdog Who Identified Critical Medical Shortages

Posted on by • Posted in 2020 Election Issues, Accountability, Coronavirus, Credibility, Dept of Health and Human Services (HHS), Health Policy, Leadership Culture, Leadership Intent, Leadership Trust, Leadership Unplanned Departure, Mislead, Misleading, Mistrust, Mortality, Oversight, Pandemic, Personal Protective Equipment (PPE), Supply Chain • Leave a comment

Trump Moves to Replace Watchdog Who Identified Critical Medical ...

The president announced the nomination of an inspector general for the Department of Health and Human Services, who, if confirmed, would replace an acting official whose report embarrassed Mr. Trump.

President Trump moved on Friday night to replace a top official at the Department of Health and Human Services who angered him with a report last month highlighting supply shortages and testing delays at hospitals during the coronavirus pandemic.

The White House waited until after business hours to announce the nomination of a new inspector general for the department who, if confirmed, would take over for Christi A. Grimm, the principal deputy inspector general who was publicly assailed by the president at a news briefing three weeks ago.

The nomination was the latest effort by Mr. Trump against watchdog offices around his administration that have defied him. In recent weeks, he fired an inspector general involved in the inquiry that led to the president’s impeachment, nominated a White House aide to another key inspector general post overseeing virus relief spending and moved to block still another inspector general from taking over as chairman of a pandemic spending oversight panel.

Mr. Trump has sought to assert more authority over his administration and clear out officials deemed insufficiently loyal in the three months since his Senate impeachment trial on charges of abuse of power and obstruction of Congress ended in acquittal largely along party lines. While inspectors general are appointed by the president, they are meant to be semiautonomous watchdogs ferreting out waste, fraud and corruption in executive agencies.

The purge has continued unabated even during the coronavirus pandemic that has claimed about 65,000 lives in the United States. Ms. Grimm’s case in effect merged the conflict over Mr. Trump’s response to the outbreak with his determination to sweep out those he perceives to be speaking out against him.

Her report, released last month and based on extensive interviews with hospitals around the country, identified critical shortages of supplies, revealing that hundreds of medical centers were struggling to obtain test kits, protective gear for staff members and ventilators. Mr. Trump was embarrassed by the report at a time he was already under fire for playing down the threat of the virus and not acting quickly enough to ramp up testing and provide equipment to doctors and nurses.

“It’s just wrong,” the president said when asked about the report on April 6. “Did I hear the word ‘inspector general’? Really? It’s wrong. And they’ll talk to you about it. It’s wrong.” He then sought to find out who wrote the report. “Where did he come from, the inspector general? What’s his name? No, what’s his name? What’s his name?”

When the reporter did not know, Mr. Trump insisted. “Well, find me his name,” the president said. “Let me know.” He expressed no interest in the report’s findings except to categorically reject them sight unseen.

After learning that Ms. Grimm had worked during President Barack Obama’s administration, Mr. Trump asserted that the report was politically biased. In fact, Ms. Grimm is not a political appointee but a career official who began working in the inspector general office late in President Bill Clinton’s administration and served under President George W. Bush as well as Mr. Obama. She took over the office in an acting capacity when the previous inspector general stepped down.

Mr. Trump was undaunted and attacked her on Twitter. “Why didn’t the I.G., who spent 8 years with the Obama Administration (Did she Report on the failed H1N1 Swine Flu debacle where 17,000 people died?), want to talk to the Admirals, Generals, V.P. & others in charge, before doing her report,” he wrote, mischaracterizing the government’s generally praised response the 2009 epidemic that actually killed about 12,000 in the United States. “Another Fake Dossier!”

To take over as inspector general, Mr. Trump on Friday night named Jason C. Weida, an assistant United States attorney in Boston. The White House said in its announcement that he had “overseen numerous complex investigations in health care and other sectors.” He must be confirmed by the Senate before assuming the position.

Among several other nominations announced on Friday was the president’s choice for a new ambassador to Ukraine, filling a position last occupied by Marie L. Yovanovitch.

Ms. Yovanovitch was ousted a year ago because she was seen as an obstacle by the president’s advisers as they tried to pressure the government in Kyiv to incriminate Mr. Trump’s Democratic rivals. That effort to solicit political benefit from Ukraine, while withholding security aid, led to Mr. Trump’s impeachment largely along party lines in December.

Mr. Trump selected Lt. Gen. Keith W. Dayton, a retired 40-year Army officer now serving as the director of the George C. Marshall European Center for Security Studies in Germany. Mr. Dayton speaks Russian and served as defense attaché in Moscow. More recently, he served as a senior United States defense adviser in Ukraine appointed by Jim Mattis, Mr. Trump’s first defense secretary.

 

 

 

The pandemic didn’t come out of nowhere. The U.S. ignored the warnings.

Posted on by • Posted in 2020 Election Issues, Coronavirus, Crisis, Crisis Management, Denial, Economic Crisis, Emergency Preparedness, Health Policy, Infection Control, Infectious Virus, Leadership Decentralized, Mislead, Misleading, Mortality, National Security, National Security Risk, Pandemic, Partisanship, Public Health, Public Safety, Scientists • Leave a comment

https://www.washingtonpost.com/opinions/global-opinions/the-pandemic-didnt-come-out-of-nowhere-the-us-ignored-the-warnings/2020/04/21/3bf37566-7db3-11ea-a3ee-13e1ae0a3571_story.html?utm_campaign=wp_opinions&utm_medium=email&utm_source=newsletter&wpis

The pandemic didn't come out of nowhere. The U.S. ignored the ...

“CAME OUT of nowhere,” President Trump said March 6 of the coronavirus pandemic. “I just think this is something . . . that you can never really think is going to happen.” A few weeks later, he added, “I would view it as something that just surprised the whole world.” Mr. Trump also said, “Nobody knew there would be a pandemic or epidemic of this proportion.”

Of course, no one can pinpoint the exact moment that lightning will strike. But a global pandemic? Experts have predicted it, warned about the preparedness gaps and urged action. Again and again and again.

Just look at 2019. In January, the U.S. intelligence community issued its annual global threat assessment. It declared, “We assess that the United States and the world will remain vulnerable to the next flu pandemic or large-scale outbreak of a contagious disease that could lead to massive rates of death and disability, severely affect the world economy, strain international resources, and increase calls on the United States for support. . . . The growing proximity of humans and animals has increased the risk of disease transmission. The number of outbreaks has increased in part because pathogens originally found in animals have spread to human populations.”

In September, the Johns Hopkins Center for Health Security issued a report titled “Preparedness for a High-Impact Respiratory Pathogen Pandemic.” The report found that if such a pathogen emerged, “it would likely have significant public health, economic, social, and political consequences. . . . The combined possibilities of short incubation periods and asymptomatic spread can result in very small windows for interrupting transmission, making such an outbreak difficult to contain.” The report pointed to “large national and international readiness gaps.”

In October, the Nuclear Threat Initiative, working with the Johns Hopkins center and the Economist Intelligence Unit, published its latest Global Health Security Index, examining open-source information about the state of health security across 195 nations, and scoring them. The report warned, “No country is fully prepared for epidemics or pandemics, and every country has important gaps to address.” The report found that “Fewer than 5 percent of countries scored in the highest tier for their ability to rapidly respond to and mitigate the spread of an epidemic.”

In November, the Center for Strategic and International Studies published a study by its Commission on Strengthening America’s Health Security. It warned, “The American people are far from safe. To the contrary, the United States remains woefully ill-prepared to respond to global health security threats. This kind of vulnerability should not be acceptable to anyone. At the extreme, it is a matter of life and death. . . . Outbreaks proliferate that can spread swiftly across the globe and become pandemics, disrupting supply chains, trade, transport, and ultimately entire societies and economies.” The report recommended: “Restore health security leadership at the White House National Security Council.”

Came out of nowhere? Not even close. The question that must be addressed in future postmortems is why all this expertise and warning was ignored.