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The Club PUBlication  05/25/2020

5/25/2020

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​LAUNCHING A WIDE DRAGNET


Scientists say fighting elusive killer will require multiple paths and drugs.
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By LIZ SZABO • Kaiser Health News

Although scientists have celebrated the approval for emergency use of remdesivir to treat COVID-19, a cure remains a long way off — and might never arrive.
Hundreds of drugs are being studied around the world, but “I don’t see a lot of home runs right now,” said Dr. Carlos del Rio, a professor of infectious diseases at the Emory University Rollins School of Public Health. “I see a lot of strikeouts.”
The coronavirus is an elusive enemy.

Doctors say they’re fighting a war on multiple fronts, battling a virus that batters organs throughout the body, causes killer blood clots and prompts an immune system overreaction. With so many parts of the body under siege , scientists say, improving survival rates will require multiple routes of attack — and more than one drug.

“There are so many pieces of this, and they will all require different therapies,” said Dr. Lewis Kaplan, president of the Society of Critical Care Medicine.

High-tech approaches include using stem cells, virus-specific T cells and synthetic antibodies to neutralize the coronavirus.

Scientists are also taking a fresh look at existing medications that might be repurposed, including antivirals for influenza, arthritis drugs, estrogen patches and even antacids. If repurposed drugs are successful, they could reach patients relatively quickly, because doctors are already familiar with their side effects and safety concerns.

Some doctors are skeptical that drugs for heartburn or hot flashes can treat COVID-19.

Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, said he fears that hype over unproven products could harm patients. Patients who demand antacids or antimalarial drugs being studied in COVID-19 could suffer from side effects, for example. Those who hoard drugs — on the hope of protecting themselves — could deprive other patients of medications they need. “This rush to get every imaginable treatment into a study, it’s not prudent,” Nissen said. “It’s not good medicine. It’s an act of desperation.”

Other experts say scientists should cast a wide net. “I don’t think we want to rule anything out because it sounds out of the ordinary,” said Dr. Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

Antivirals such as remdesivir aim to prevent viruses from replicating, said Dr. Peter Hotez, a professor at Baylor College of Medicine in Houston. But a Chinese study , published in the Lancet, found no benefit to severely ill COVID-19 patients. Remdesivir had failed when tested against Ebola.

Antivirals tend to be most helpful in the early stages of infection, Hotez said.

International researchers also are studying the antiviral favipiravir, developed to fight the flu. The antimalarial drugs chloroquine and hydroxychloroquine — heavily touted by President Donald Trump — also have antiviral effects. Although the Food and Drug Administration approved forms of those drugs for emergency use against COVID-19, it later warned that they could cause dangerous heart rhythm problems.

One of the therapies generating excitement is also one of the oldest: antibody-rich blood from COVID survivors. The immune system produces antibodies in response to invaders , allowing the body to recognize and neutralize them. And donated plasma could potentially shield people exposed to the virus, such as health care workers.

Donated antibodies — and any immunity they might provide — don’t last forever, said Dr. William Schaffner, a professor at the Vanderbilt University Medical Center. The body destroys aging antibodies as part of its routine maintenance, he said. In general, half of donated antibodies are eliminated in about three weeks. The use of convalescent plasma goes back more than a century, but doctors don’t know yet whether it will work for COVID-19.

Researchers are also studying the use of prepackaged plasma, called intravenous immunoglobulin. This product, known as IVIG and already in stock in hospitals, is taken from healthy donors in the general population and has been used to help patients with weakened immune systems fight infections.

In a third form of immune therapy, researchers are trying to identify the antibodies that are most important for neutralizing the coronavirus, then reproduce them as drugs called monoclonal antibodies. Monoclonal antibodies are used to treat a variety of conditions, from cancer to rheumatoid arthritis and migraines.

“When we give people an antibody, they are immediately at least partially immune to that specific virus,” said Dr. James Crowe, director of the Vanderbilt Vaccine Center, who hopes to have antibodies ready for a clinical trial in a few months. “We’re moving the immune system from one person to another.”

Ideally, doctors would develop a very potent monoclonal antibody or a cocktail of antibodies, but manufacturing that can be complicated, expensive and time-consuming. “A cocktail might be preferred,” he said, “but cocktails are harder to move quickly.”

In most cases of COVID-19, patients recover without hospitalization.
But some patients’ immune systems becomes hyperactive, attacking not just the virus but the patient’s cells. A “cytokine storm,” in which the immune system floods the body with inflammatory chemicals, can do more damage than the virus itself.

In an effort to calm the immune system, researchers are testing immune-suppressing drugs, said Dr. Amesh Adalja of Johns Hopkins Center for Health Security.

Health care giant Roche is conducting large clinical trials of its drug, Actemra, which is designed to lower levels of an inflammatory chemical, interleukin-6, which has been elevated in some patients.

Scientists are also studying similar drugs, anakinra and siltuximab.

Another immune suppressant from Regeneron and Sanofi, called Kevzara, has had disappointing results in clinical trials. The manufacturers plan to continue to see whether it can help certain types of patients.

Until medicines are developed, the best way to prevent coronavirus infections is to maintain social distancing, Adalja said.

“Social distancing is a blunt tool,” he said, “but it’s all that we have.”

“There are so many pieces of this, and they will all require different therapies.” Dr. Lewis Kaplan, president of the Society of Critical Care Medicine




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The Club PUBlication  05/20/2020

5/18/2020

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ACA is linked to fewer cancer deaths


Cancer deaths have dropped more in states that expanded Medicaid coverage under the Affordable Care Act than in states that did not, new research reveals.

The report is the first evidence tying cancer survival to the health care change, which began in 2014, said one study leader, Dr. Anna Lee of Memorial Sloan Kettering Cancer Center in New York.
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“For a policy to have this amount of impact in a short amount of years” is remarkable, because cancer often takes a long time to develop and prove fatal, she said.
The report is the first evidence tying cancer survival to the health care change, which began in 2014, said one study leader, Dr. Anna Lee of Memorial Sloan Kettering Cancer Center in New York.

“For a policy to have this amount of impact in a short amount of years” is remarkable, because cancer often takes a long time to develop and prove fatal, she said.

The law let states expand Medicaid eligibility and offer subsidies to help people buy health insurance. Twenty-seven states and Washington, D.C., did that, and 20 million Americans gained coverage .

Researchers used national health statistics on cancer deaths to track trends before and after the law. They looked only at deaths in people younger than 65, who stood to benefit because those older were already covered by Medicare.

The cancer death rate fell throughout the United States from 1999 to 2017 in that age group, but more in states that expanded Medicaid — 29% versus 25% in states that did not. Researchers specifically compared death rates from 2011 to 2013, before the health care change, to 2015 to 2017, after it. In states that expanded coverage, the change meant 785 fewer cancer deaths in 2017. Another 589 deaths could have been prevented that year if all states had expanded Medicaid, researchers estimated.
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Having health insurance allows quicker treatment after diagnosis and access to more treatment options so patients can get the best care available, which can improve survival odds, Lee said. Insured people also may have more opportunities for screening to detect cancers at a stage when they’re most treatable.

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The Club PUBlication  05/11/2020

5/11/2020

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Feds want stimulus money sent to the dead to be returned

By SARAH SKIDMORE SELL Associated Press

President Donald Trump, Treasury Secretary Steven Mnuchin — and now the IRS — are urging people who received coronavirus relief payments for a deceased taxpayer to return the money to the government.
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But legal experts said there is no law requiring people do that.

Some of the more than 130 million economic impact payments that went out to taxpayers as part of the $2.2 trillion economic relief package were sent to dead people. That happened mainly because of a lag in reporting data on who is deceased.
This is the first time the IRS has asked for the money back from the deceased taxpayers’ survivors. Some law experts said the government may not have the legal authority to require it be returned.
Trump and Mnuchin have both said publicly in recent weeks that money sent to deceased taxpayers should be returned. But the IRS didn’t issue any formal guidance until last week. On Wednesday, it updated its website, stating that if a person died before the payment was issued, the money should be returned. It also provided instructions on how to do so.

The IRS and Treasury did not say what would happen if these payments were not returned or otherwise repaid.
Former Taxpayer Advocate Nina Olson said that there is nothing in the law prohibiting payments from going to the deceased.
Nor is there anything in the law requiring people to return the payments.
“We are starting from these two sound bites and working backward,” Olson, who now runs the nonprofit Center for Taxpayer Rights, said.
The relief payments were made to taxpayers based on the information filed on their 2019 or 2018 taxes. But it is considered a rebate on 2020 taxes. The government used the prior tax forms to help speed along payments to the public to offset some of the economic devastation from the coronavirus pandemic.
The problem is, some people who filed those taxes may no longer be alive. Those payments are sent to an heir or executor of their estate. If the payment is based off a final tax return completed after their death, an economic impact payment check may even denote that the person is deceased next to their name.
It’s confusing at best. But it also would be a legal and logistical mess for the government to try to take back all the money that has been distributed, Olson and others said.
“They don’t have a legal leg to stand on,” Olson said.

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The Club PUBlication  05/04/2020

5/4/2020

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​Unlike 2008 crisis, this pandemic has no leader and no global plan

By EDITH M. LEDERER Associated Press
 
MAY 3, 2020 — 11:50AM

UNITED NATIONS — When financial markets collapsed and the world faced its last great crisis in 2008, major powers worked together to restore the global economy, but the COVID-19 pandemic has been striking for the opposite response: no leader, no united action to stop the spread of the new coronavirus, which has killed over 200,000 people.

The financial crisis gave birth to the leaders' summit of the Group of 20, the world's richest countries responsible for 80% of the global economy. But when U.N. Secretary-General Antonio Guterres proposed ahead of their summit in late March that G-20 leaders adopt a "wartime" plan and cooperate on the global response to suppress the virus, there was no response.

In an April 6 letter to the G-20 following the summit, former U.N. Secretary-General Ban Ki-moon and 164 other current and former presidents, prime ministers, scientists and global figures urged the group's leaders to coordinate action "within the next few days" and agree on measures to address the deepening global health and economic crises from COVID-19. Again, no response.


A clearly frustrated Guterres told reporters Thursday that instead of "solid leadership" to fight the pandemic, each country went ahead with a different strategy, increasing the risk that the virus would not disappear, but rather spread and then return.


"It is obvious that there is a lack of leadership," he said. "It is obvious the international community is divided in a moment where it would be more important than ever to be united."


Guterres said what is key is leadership combined with power.


"We see remarkable examples of leadership, but they are usually not associated with power," he said. "And where we see power, we sometimes do not see the necessary leadership. I hope this will be overcome sooner rather than later."


But the 21st century has seen increasing fractures in global unity and cooperation.


In his state of the world speech last September, Guterres warned of the risk of the world dividing between the United States and China at a time of rising populism, increasing xenophobia, spreading terrorism, "exploding" inequality and a lingering climate crisis. He said there is a severe erosion in multilateralism — the foundation on which the United Nations was founded 75 years ago after the devastation of World War II.


The COVID-19 pandemic has put that warning into sharp focus, both in the world's inability to come together in tackling the coronavirus and in the difference in health care, treatment and testing in G-20 nations compared with what exists in developing countries.


The failure has been playing out in the U.N. Security Council, the U.N.'s most powerful body, which has been impotent in addressing the pandemic — a crisis that Germany's U.N. ambassador, Christoph Heusgen, calls "the biggest challenge that civilization has faced since the Second World War."


The council has been unable to adopt a resolution that would endorse the secretary-general's call for pandemic cease-fires in conflicts including Syria, Yemen, Libya and Afghanistan because of a dispute between the United States and China over including a reference to the World Health Organization.


After weeks of praising Chinese President Xi Jinping for his handling of the initial outbreak of the coronavirus, U.S. President Donald Trump is now accusing China of not acting quickly to inform the world of what was happening. He has also suspended U.S. funding to the WHO, accusing the U.N. health agency of parroting Beijing.


Security Council diplomats say China is insisting on a reference to the WHO in any resolution while the U.S. wants no mention of the agency and instead wants the text to demand "transparency" about COVID-19.


When the council discussed the pandemic on April 9, Germany's Heusgen criticized its "deafening silence" and reminded members that during the 2008 financial crisis the G-20 displayed "both the leadership and the power" to deal with it.


"Here we do not have it," Heusgen said. "We do not have leadership and power coming together."


Estonian Ambassador Sven Jürgenson, the council president for May, told reporters Friday, "I think it's a shame that we have not been able to take the leadership."


Since mid-March, Guterres has been speaking out, warning of the global threat posed by the pandemic, especially in the developing world. .He launched a $2 billion appeal to help vulnerable and conflict-torn countries on March 25 which has received about $1 billion.


David Beasley, head of the U.N. World Food Program, has warned of "a hunger pandemic" that could push 265 million people "to the brink of starvation by the end of 2020."


U.N. humanitarian chief Mark Lowcock said most experts agree the pandemic may not peak in the poorest parts of the world for three to six months. He said $90 billion could provide income support, food and a health response for 700 million of the world's poorest and most vulnerable people in 30 to 40 countries — a price tag just 1% of the $8 trillion stimulus package that the G-20 countries put in place for helping the global economy.


Robert Malley, president and CEO of the International Crisis Group think tank, said at a recent briefing, "It's clear that we're facing a crisis of international leadership" and it's unclear who can take over — the G-20 now led by Saudi Arabia, the Group of Seven major industrialized countries led by the United States, the United Nations or anyone else. That's because the powers are all looking inward, and are less interested in being generous when their own citizens are facing crises, he said.


Malley said there shouldn't be nostalgia for the past "when there was virtually a unilateral or Western or U.S. domination" of global power which many countries resented.


"But," he warned, "it's one thing to have a different kind of leadership, it's another thing to have no leadership at all."
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