Category Archives: Clinical Research

Researchers stop COVID-19 drug trial after 11 patients die

Posted on by • Posted in Centers for Disease Control & Prevention (CDC), Chloroquine, Clinical Research, Clinical Testing, Coronavirus, Food and Drug Administration (FDA), Hydroxychloroquine, Pandemic, Prescription Drugs, Side Effects • Leave a comment

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.”

 

 

 

Bill Gates says the world is entering ‘uncharted territory’ because it wasn’t prepared for a pandemic like COVID-19

Posted on by • Posted in Centers for Disease Control & Prevention (CDC), Clinical Research, Clinical Research Funding, Clinical Testing, Clinical Trial Recruitment, Coronavirus, Dept of Health and Human Services (HHS), Economic Crisis, Economic Impact, Economic Stimulus, Economy, Failure, Health Policy, Infection Control, Infectious Virus, Intensive Care (ICU), Leadership Cares, Leadership Integrity, Leadership Respect, Leadership Trust, Pandemic, Public Health, Public Safety, Ventilators • Leave a comment

https://www.businessinsider.com/bill-gates-warns-world-is-entering-uncharted-territory-coronavirus-2020-4

5 Books Bill Gates Wants You to Read This Summer | Time

  • Microsoft cofounder Bill Gates said the world was entering into “uncharted territory” because it was not prepared for a pandemic like COVID-19, the disease caused by the novel coronavirus.
  • Speaking to “BBC Breakfast” by video chat on Sunday, Gates said the world should’ve invested more in mitigating a global health crisis.
  • “There is the period where the virus shows up in those first few months,” he said. “Were the tests prepared? Did countries think through getting their ICU and ventilator capacity up?”
  • He added that once the crisis is over “very few countries are going to get an A grade” for their handling of the outbreak.

Microsoft cofounder Bill Gates said the world was entering into “uncharted territory” because it was not prepared for a pandemic like COVID-19, the disease caused by the novel coronavirus.

Gates, who has been warning about the risk of a pandemic disease for years and who has poured millions into fighting the new coronavirus outbreak, told “BBC Breakfast” on Sunday that the world should have invested more into mitigating a global health crisis.

“Well, there was a period when I and other health experts were saying that this was the greatest potential downfall the world faced,” he told the BBC in an interview on Sunday, highlighting his previous warnings against the possibility of a deadly pandemic.

“So we definitely will look back and wish we had invested more,” he said, “so that we could quickly have all the diagnostics, drugs, and vaccines. We underinvested,” he said.

The 67-year-old billionaire warned that in the period before COVID-19 became a public-health crisis, countries could have better prepared their testing capabilities and made sure hospitals were stocked with ventilators and other necessary health supplies.

“There is the period where the virus shows up in those first few months,” he said. “Were the tests prepared? Did countries think through getting their ICU and ventilator capacity up?”

He added that once the crisis is over “very few countries are going to get an A grade” for their handling of the outbreak.

“Now, here we are, we didn’t simulate this, we didn’t practice,” he said. “So both in health policies and economic policies, we find ourselves in uncharted territory.”

Gates has become an outspoken advocate for preparing for a global health crisis like COVID-19.

Speaking to the Financial Times earlier this month, Gates said that COVID-19 was the “biggest event that people will experience in their entire lives” and world leaders and global policymakers have “paid many trillions of dollars more than we might have had to if we’d been properly ready.”

He told FT he was confident that lessons learned from this outbreak would encourage people to better prepare for next time but lamented that the cost this time around was too high.

“It shouldn’t have required a many trillions of dollars loss to get there,” he said. “The science is there. Countries will step forward.”

 

 

 

 

Special Report: Doctors embrace drug touted by Trump for COVID-19, without hard evidence it works

Posted on by • Posted in Centers for Disease Control & Prevention (CDC), Certainty, Clinical Research, Clinical Testing, Coronavirus, Crisis, Crisis Management, Evidence, Expectations, Health Policy, Hope, Hydroxychloroquine, Intensive Care (ICU), Opinion, Pandemic, Physician, Public Health, Public Safety, Side Effects, Uncertainty • Leave a comment

https://www.reuters.com/article/us-health-coronavirus-usa-hydroxychloroq/special-report-doctors-embrace-drug-touted-by-trump-for-covid-19-without-hard-evidence-it-works-idUSKBN21O2VO

Special Report: Doctors embrace drug touted by Trump for COVID-19 ...

The decades-old drug that President Donald Trump has persistently promoted as a potential weapon against COVID-19 has within a matter of weeks become a standard of care in areas of the United States hit hard by the pandemic — though doctors prescribing it have no idea whether it works.

Doctors and pharmacists from more than half a dozen large healthcare systems in New York, Louisiana, Massachusetts, Ohio, Washington and California told Reuters they are routinely using hydroxychloroquine on patients hospitalized with COVID-19. At the same time, several said they have seen no evidence that the drug, used for years to treat malaria and autoimmune disorders, has any effect on the virus.

Use of hydroxychloroquine has soared as the United States has quickly become the epicenter of the pandemic. More than 355,000 people in the United States have tested positive for the novel coronavirus, and more than 10,000 have died. The federal government estimates that as many as 240,000 people in the country may die from the disease before the outbreak is over.

Facing those numbers, and in the absence of any known effective treatments, doctors on the frontlines said they began using hydroxychloroquine and the related chloroquine on patients who are deteriorating based on a few small studies suggesting a possible benefit. Some said they had come under pressure from patients to use the therapies widely touted by Trump and other supporters.

“I may take it,” Trump said on Saturday, referring to hydroxychloroquine, though he has twice tested negative for coronavirus, according to the White House. “We’re just hearing really positive stories, and we’re continuing to collect the data.”

Potential side effects of hydroxychloroquine include vision loss and heart problems. But doctors interviewed by Reuters say they are comfortable prescribing the drug for a short course of several days for coronavirus patients because the risks are relatively low and the therapies are inexpensive and generally available.

However, protocols directing how these drugs should be used vary from one hospital to another, including when to introduce them and whether to combine them with other drugs. In addition, some studies showing promise involve patients who took the therapies for mild or early-stage illness. Many of those people are likely to recover from the virus on their own.

Patients admitted to the hospital in the United States are generally much sicker than the mildly ill cases cited in such studies when they receive therapy. These factors, doctors said, have made it difficult for them to determine whether the drugs are making a difference. “I have seen hundreds of patients with severe COVID and most of these people are on hydroxychloroquine,” Dr Mangala Narasimhan, regional director of critical care at Northwell Health, a 23-hospital system in New York, said in an email. “In my opinion, although it is very early, I do not see a dramatic improvement from the hydroxychloroquine in these patients.” Dr Daniel McQuillen, an infectious disease specialist at Lahey Hospital & Medical Center in Burlington, Massachusetts, said he has prescribed a course of hydroxychloroquine for about 30 COVID-19 patients so far because the drug has shown “a little bit of antiviral activity.” But he has not seen “marked improvement for patients.”

“Anecdotally, it may have had limited effect in patients with milder disease,” McQuillen said. The therapy “has had no effect in limiting or slowing progression of our patients that have been at or near ICU level when they arrived.”

‘SEE WHAT STICKS’

The experience of David Lat, a legal recruiter and commentator who founded the blog Above the Law, reflects the mixture of hope and uncertainty surrounding the drugs now being pursued as possible coronavirus treatments.

Since early March, the 44-year-old New Yorker has chronicled his near-fatal infection with coronavirus in social media posts followed by thousands of people. Lat’s case has resonated with a U.S. audience that has begun to recognize the risk that coronavirus poses not only to elderly patients with serious medical conditions, but also to generally healthy younger adults.

After more than a week of worsening symptoms, Lat was admitted to NYU Langone Medical Center on March 16 and later placed on a ventilator. On March 28, he shared on Facebook that his doctors had taken him off of the ventilator and had moved him out of intensive care after his condition improved dramatically.

In an exchange of text messages with Reuters, Lat said he was treated with hydroxychloroquine and the antibiotic azithromycin. He also received the experimental therapy clazakizumab, which aims to regulate an overreaction by the body’s immune system thought to trigger the respiratory distress seen in severe COVID-19. After the story was published, Lat clarified that he received a fourth therapy, the antiviral Kaletra, not Kevzara, as he had initially recalled.

“The doctors haven’t concluded what caused my recovery,” Lat said. “The state of coronavirus research is very much ‘throw stuff against a wall and see what sticks’ – but when something does stick, in terms of a good patient outcome, you’re not sure what stuck.” Lat’s doctors were not immediately available to comment on his treatment.

Some doctors have been vocal in advocating the drug. Dr Vladimir Zelenko, a general practitioner in upstate New York, has claimed that a three-drug cocktail of hydroxychloroquine, azithromycin and zinc sulfate has helped mitigate the infection in nearly 200 hundred of his patients before they became sick enough to require hospitalization. His recommendations have attracted the attention of Trump’s supporters. Zelenko wasn’t immediately available for comment.

Despite such encouraging reports, hard evidence that any of the therapies now under study will work is weeks and possibly months way.

Early, but mixed, data has emerged from COVID-19 trials of the malaria drugs in China. A research team in Marseilles, France, has published data showing that out of 80 mild COVID-19 patients treated with hydroxychloroquine and azithromycin, 93 percent had no detectable levels of the virus after eight days.

Doctors have questioned the value of the Marseille study and several papers from China as being too small or poorly designed to offer hard evidence of benefit. Most do not compare outcomes of patients who received the malaria therapies with people who did not, considered the most reliable measure of a drug’s effectiveness. Last week, doctors in Paris reported that they tried to replicate the results of the Marseille study and failed. Results from a trial conducted in Wuhan, China, were released that included a control group of patients who did not receive the anti-malarial therapy for comparison. But critics questioned why information on the trial’s main goal — detecting viral load — was not disclosed, and said data was missing for some patients. More rigorous U.S.-led trials are now underway. But most focus on whether the drugs can help prevent illness in people exposed to the coronavirus, such as healthcare workers or relatives of confirmed patients, and not people who are already sick. Randomized, controlled trials of the drugs are being conducted in other countries, including China, Brazil and Norway.

Until the evidence is in, “each institution is setting their own treatment guidelines,” said Dr Otto Yang, an infectious disease specialist at the University of California, Los Angeles Medical Center. “There is simply no data,” he said. “It is a matter of opinion, and opinions differ.”

GAME-CHANGER?

Trump is deeply invested in the idea that the malaria drugs will show a benefit, and personally pressured federal health officials to make them available, Reuters reported on Saturday. The president announced on Twitter last month that hydroxychloroquine, when combined with azithromycin, has the potential to become “one of the biggest game changers in the history of medicine.”

 

 

 

 

TED Danielle Allen: Here’s how we might save both lives and the economy

Posted on by • Posted in Clinical Research, Clinical Testing, Core Values, Coronavirus, Crisis, Crisis Management, Ethics, Health Policy, Infection Control, Infectious Virus, Leadership, Medical Ethics, Pandemic, Plan • Leave a comment

Harvard professors take a lively look at love and politics ...

As the coronavirus pandemic sweeps the globe, it’s hard to know where to turn or what to think. TED Connects is a free, live, daily conversation series featuring experts whose ideas can help us reflect and work through this uncertain time with a sense of responsibility, compassion and wisdom.

Danielle Allen serves as Director of the Edmond J. Safra Center for Ethics at Harvard University. The Center seeks to advance teaching and research on ethical issues in public life. Widespread ethical lapses of leaders in government, business, and other professions prompt demands for more and better moral education. More fundamentally, the increasing complexity of public life – the scale and range of problems and the variety of knowledge required to deal with them – make ethical issues more difficult, even for men and women of good moral character. Not only are the ethical issues we face more complex, but the people we face them with are more diverse, increasing the frequency and intensity of our ethical disagreements.

Given these changes in the United States and in societies around the globe, the Center seeks to help meet the growing need for teachers, scholars, and leaders who address questions of moral choice across many of the professions and in public life more generally, and promotes a perspective on ethics informed by both theory and practice. We explore the connection between the problems that professionals confront and the social and political structures in which they act. More generally, we address the ethical issues that all citizens face as they make the choices that profoundly affect the present and future of their societies in our increasingly interdependent world.

https://scholar.harvard.edu/danielleallen/edmond-j-safra-center-ethics

 

 

 

How Epidemics of the Past Changed the Way Americans Lived

Posted on by • Posted in Clinical Research, Clinical Research Funding, Communication, Epidemic, Health Policy, Pandemic, Public Debate, Public Discourse, Waste Management • Leave a comment

https://www.smithsonianmag.com/history/how-epidemics-past-forced-americans-promote-health-ended-up-improving-life-this-country-180974555/?fbclid=IwAR1_2pHlIidRC01Bjxr7IFOpUBq1ShM8xXXGBkPFT8J6ZK1PtGgtNh9NJ0s

How Epidemics of the Past Changed the Way Americans Lived ...

Past public health crises inspired innovations in infrastructure, education, fundraising and civic debate.

At the end of the 19th century, one in seven people around the world had died of tuberculosis, and the disease ranked as the third leading cause of death in the United States. While physicians had begun to accept German physician Robert Koch’s scientific confirmation that TB was caused by bacteria, this understanding was slow to catch on among the general public, and most people gave little attention to the behaviors that contributed to disease transmission. They didn’t understand that things they did could make them sick. In his book, Pulmonary Tuberculosis: Its Modern Prophylaxis and the Treatment in Special Institutions and at Home, S. Adolphus Knopf, an early TB specialist who practiced medicine in New York, wrote that he had once observed several of his patients sipping from the same glass as other passengers on a train, even as “they coughed and expectorated a good deal.” It was common for family members, or even strangers, to share a drinking cup.

With Knopf’s guidance, in the 1890s the New York City Health Department launched a massive campaign to educate the public and reduce transmission. The “War on Tuberculosis” public health campaign discouraged cup-sharing and prompted states to ban spitting inside public buildings and transit and on sidewalks and other outdoor spaces—instead encouraging the use of special spittoons, to be carefully cleaned on a regular basis. Before long, spitting in public spaces came to be considered uncouth, and swigging from shared bottles was frowned upon as well. These changes in public behavior helped successfully reduce the prevalence of tuberculosis.

As we are seeing with the coronavirus today, disease can profoundly impact a community—upending routines and rattling nerves as it spreads from person to person. But the effects of epidemics extend beyond the moments in which they occur. Disease can permanently alter society, and often for the best by creating better practices and habits. Crisis sparks action and response. Many infrastructure improvements and healthy behaviors we consider normal today are the result of past health campaigns that responded to devastating outbreaks.

In the 19th century, city streets in the U.S. overflowed with filth. People tossed their discarded newspapers, food scraps, and other trash out their windows onto the streets below. The plentiful horses pulling streetcars and delivery carts contributed to the squalor, as each one dropped over a quart of urine and pounds of manure every day. When a horse died, it became a different kind of hazard. In “Portrait of an Unhealthy City,” Columbia University professor David Rosner writes that since horses are so heavy, when one died in New York City, “its carcass would be left to rot until it had disintegrated enough for someone to pick up the pieces. Children would play with dead horses lying on the streets.” More than 15,000 horse carcasses were collected and removed from New York streets in 1880. Human waste was a problem, too. Many people emptied chamber pots out their windows. Those in tenement housing did not have their own facilities, but had 25 to 30 people sharing a single outhouse. These privies frequently overflowed until workers known as “night soil men” arrived to haul away the dripping barrels of feces, only to dump them into the nearby harbor.

As civic and health leaders began to understand that the frequent outbreaks of tuberculosis, typhoid and cholera that ravaged their cities were connected to the garbage, cities began setting up organized systems for disposing of human urine and feces. Improvements in technology helped the process along. Officials began introducing sand filtration and chlorination systems to clean up municipal water supplies. Indoor toilets were slow to catch on, due to cost, issues with controlling the stench, and the need for a plumbing system. Following Thomas Crapper’s improved model in 1891, water closets became popular, first among the wealthy, and then among the middle-class. Plumbing and sewage systems, paired with tenement house reform, helped remove excrement from the public streets.

Disease radically improved aspects of American culture, too. As physicians came to believe that good ventilation and fresh air could combat illness, builders started adding porches and windows to houses. Real estate investors used the trend to market migration to the West, prompting Eastern physicians to convince consumptives and their families to move thousands of miles from crowded, muggy Eastern cities to the dry air and sunshine in places like Los Angeles and Colorado Springs. The ploy was so influential that in 1872, approximately one-third of Colorado’s population had tuberculosis, having moved to the territory seeking better health.

Some of this sentiment continues today. While we know that sunshine doesn’t kill bacteria, good ventilation and time spent outside does benefit children and adults by promoting physical activity and improving spirits—and access to outdoor spaces and parks still entices homebuyers. This fresh-air “cure” also eventually incited the study of climate as a formal science, as people began to chart temperature, barometric pressure and other weather patterns in hopes of identifying the “ideal” conditions for treating disease.

Epidemics of the past established an ethos of altruism in the U.S. During the 1793 yellow fever epidemic, Philadelphians selflessly stepped up to save their city. With no formal crisis plan, Mayor Matthew Clarkson turned to volunteers collect clothing, food and monetary donations; to pitch a makeshift hospital; and to build a home for 191 children temporarily or permanently orphaned by the epidemic. Members of the Free African Society, an institution run by and for the city’s black population, were particularly altruistic, providing two-thirds of the hospital staff, transporting and burying the dead and performing numerous other medical tasks.

A 20th-century diphtheria outbreak in a small region in the Alaska Territory inspired a national rally of support—and created the Iditarod, the famous dog sled race. When cases of “the children’s disease” began to mount in Nome, Alaska, in January 1925, the town was in trouble. Diphtheria bacteria produces a toxin, making it especially deadly, unless the antitoxin serum is administered. This serum had been readily available for decades, but Nome’s supply had run short, and the town was inaccessible by road or sea in the winter. Leaping into action, 20 of the area’s finest dogsled teams and mushers carried a supply of the serum all the way from Fairbanks—674 miles—in record time, facing temperatures of more than 60 degrees below zero. Their delivery on February 2nd, plus a second shipment a week later, successfully halted the epidemic, saving Nome’s children from suffocation. Newspapers across the country covered the rescue. It was also memorialized in movies (including the animated Balto), with a Central Park statue—and, most notably, with the annual Iditarod race. The significant challenges of delivery by dogsled also sparked investigation into the possibilities of medical transport by airplane, which takes place all the time in remote areas today but was still in its infancy at the time.

Diseases fueled the growth of fundraising strategies. The polio epidemic of 1952 sickened more than 57,000 people across the United States, causing 21,269 cases of paralysis. The situation became so dire that at one point, the Sister Kenny Institute in Minneapolis, a premier polio treatment facility, temporarily ran out of cribs for babies with the disease. In response, the National Foundation of Infantile Paralysis (NFIP), which had been founded in 1938 by President Franklin D. Roosevelt and later came to be known as the March of Dimes, distributed around $25 million through its local chapters. It provided iron lungs, rocking chairs, beds and other equipment to medical facilities, and assigned physicians, nurses, physical therapists, and medical social workers where they were needed. The March of Dimes success has served as the gold standard in public health education and fundraising since its heyday in the 1940s and 1950s.

Public health emergencies have inspired innovations in education. Starting in 1910, Thomas Edison’s lab, which had invented one of the first motion picture devices in the 1890s, partnered with anti-TB activists to produce short films on tuberculosis prevention and transmission—some of the first educational movies. Screened in public places in rural areas, the TB movies were also the first films—of any type—that viewers had ever seen. The anti-tuberculosis crusade was also a model for later NFIP efforts to combat polio that relentlessly put that disease at the front of public agenda until an effective vaccination was developed and implemented, and set a standard for future public health campaigns.

Past epidemics fueled the growth of civic debate and journalism in the U.S., too. As far back as colonial times, newspapers built their audiences by providing an outlet for debate on controversial issues, including disease. Founders of the New England Courant—the first paper in Colonial America to print the voices and perspectives of the colonists—launched their paper as a vehicle to oppose smallpox inoculation during the 1721 Boston epidemic. As smallpox ravaged the city, a Boston doctor named Zabdiel Boylston began using inoculation, a practice in which people are intentionally infected with a disease, to produce milder cases and reduce mortality risk. Backed by those opposed to the practice, James Franklin started the Courant to serve as a tool to fight it. Inoculation’s success was demonstrated in 1721 and later smallpox epidemics, eventually convincing even staunch opponents of its value—but by inspiring an outlet to air their concerns, the anti-inoculation camp had made an important contribution to public discourse.

Since colonial times, newspapers, pamphlets, and a host of other outlets have continued to thrive and evolve during outbreaks—updating the public on believed transmission and remedies, announcing store closing and quarantine restrictions, advertising outbreak-related job openings (florists, nurses, grave diggers, coffin makers, to name a few), and serving as spaces for public debate. The cycle continues today, as media powers and regular citizens flock to social media to discuss COVID-19—disseminating information, speculating on its origins, expressing fear of its unknowns.

 

 

 

 

The next outbreak? We’re not ready – Bill Gates 2015

Posted on by • Posted in Centers for Disease Control & Prevention (CDC), Clinical Research, Clinical Research Funding, Coronavirus, Emergency Preparedness, Epidemic, Global Outbreak, Infection Control, Infectious Virus, Pandemic, Public Health, Public Safety, World Health Organization (WHO) • Leave a comment

Image result for bill gates the next outbreak we're not ready

 

To solve the economic crisis, we will have to solve the health-care crisis

Posted on by • Posted in 2020 Election Issues, Clinical Research, Clinical Research Funding, Coronavirus, Crisis, Crisis Management, Demand Shock, Health Policy, Infection Control, Infectious Virus, Leadership, Pandemic, Pharmaceutical Industry, Public Health, Public Safety, Supply Shock, Vaccine • Leave a comment

https://www.washingtonpost.com/opinions/the-coronavirus-pandemic-is-not-an-economic-crisis-its-a-health-care-crisis/2020/03/19/d7bb64a6-6a1a-11ea-abef-020f086a3fab_story.html?fbclid=IwAR1I–vZ_8aqfRe0mIyIdWSWGKHuTnBjS-tqkK3PcyYM7xVKx9LIVn9ddsY&utm_campaign=wp_main&utm_medium=social&utm_source=facebook

Image result for To solve the economic crisis, we will have to solve the health-care crisis

In Washington, the focus has now turned to the economic response to the coronavirus pandemic, with experts and politicians proposing their preferred policy tools — ranging from tax cuts to corporate bailouts to direct payments of cash. Each is worth debating, but the focus is misplaced. This is not an economic crisis; it is a health-care crisis.

The distinction may sound academic. But understanding it is actually vital to designing the policies that should follow.

In an economic crisis, you could imagine a situation in which people lose their jobs and are unable to spend money. That’s called a demand shock, which is what happened during the global financial crisis of 2008. Or producers could raise prices (for various reasons), making it harder to buy their goods. That’s a supply shock, and it describes the oil crises of 1973 and 1979. But what is happening now cannot be addressed primarily by economic responses, because we are witnessing the suspension of economics itself.

Today, even if you have money, increasingly you cannot go into a shop, restaurant, theater, sports arena or mall because those places are closed. If you own a factory that hasn’t already closed for health reasons, you may still have to shut it down because you can’t get key components from suppliers or you can’t find enough stores open to sell your goods.

In these conditions, cash to consumers cannot jump-start consumption. Relief to producers will not jump-start production. This problem is on a level different and far greater than the recession of 2008 or the aftermath of 9/11. If it were to go on for months, it could look worse than the Great Depression.

This is not an argument against any of the economic measures being proposed. People need to be able to eat, buy medicine and pay their bills. New York Times columnist Andrew Ross Sorkin has canvassed experts and concluded that the best approach would be a zero-interest “bridge loan” to all businesses and self-employed people as long as they keep most of their workers on staff. It is probably the right course of action, massively expensive but cheaper than a full-blown Great Depression.

But even that might not work if we do not recognize that first and foremost the United States faces a health crisis. And that crisis is not being solved. China is now reporting no new domestic infections. South Korea, Taiwan and Singapore have also made progress in “flattening the curve” — the phrase of the year — because they have prioritized dealing with the health-care crisis over enacting a grand economic stimulus.

The United States is still dangerously behind the curve. A headline in Thursday’s Wall Street Journal is, “Coronavirus Testing Chaos Across America.” The article details how the country still has “a chaotic patchwork of testing sites,” with testing proceeding “far slower than experts say is necessary, in part due to a slow federal response.” The U.S. testing rate remains shockingly low, well behind the rates of most other rich countries and far behind those of the Asian countries that are handling this crisis best. Across the United States, hospitals are warning of a dire shortage of beds, medical equipment and supplies. And the worst is yet to come. With infections doubling every two to three days, the U.S. health-care system will face what New York Gov. Andrew Cuomo correctly described as a “tsunami.”

The Trump administration is still acting slowly and fitfully. Experts predicted weeks ago that cities would need thousands more hospital beds, and yet the Navy is still performing maintenance on two hospital ships and figuring out staffing. The president says he will invoke “defense production” powers only if necessary. What is he waiting for? He should direct firms to start production of all key medical equipment in short supply. The armed forces should be deployed immediately to set up field testing and hospital sites. Hotels and convention centers should be turned into hospitals. The federal government should announce a Manhattan Project-style public-private partnership to find and produce a vaccine. After decades of attacks on government, federal agencies are understaffed, underfunded and ill-equipped to handle a crisis of this magnitude. They need help, and fast.

And here’s another idea: President Trump could forge an international effort to unite the world against this common threat. If the United States, China and the European Union worked together, prospects for success — on a vaccine, for example — would be greater. China in particular produces most of the supplies and medical ingredients the world needs. Trump should remove all of his self-defeating tariffs so that American consumers don’t have to pay more for these goods and China can ramp up production. This is a war, and in a war you try to find allies rather than create enemies.

 

 

Coronavirus Has Mutated into More Aggressive Infection, Say Scientists

Posted on by • Posted in Clinical Research, Clinical Research Funding, Coronavirus, Infection Control, Infectious Virus, Mutation, Vaccine • Leave a comment

https://interestingengineering.com/coronavirus-has-mutated-into-more-aggressive-infection-say-scientists?utm_source=Facebook&utm_medium=Article&utm_campaign=organic&utm_content=Mar06&fbclid=IwAR1uIWQYvlWNvx6BfTbkb7bburGW2-zikXr4KCYhAhoozm2xyx2efPRqQ2s

Coronavirus Has Mutated into More Aggressive Infection, Say Scientists

Coronavirus has undergone mutation into two distinct strains, one of which is far more aggressive and efficient.

Coronavirus has undergone mutation into two distinct strains, and one of them is far more aggressive than the other, according to scientists. This development may slow global attempts to develop a viable vaccine.

Coronavirus: “L” and “S” types

Researchers at Peking University’s School of Life Sciences and the Institut Pasteur of Shanghai witnessed the deadly virus evolve into two major lineages — called “L” and “S” types.

The “S-type” is the older, milder and less infectious type, while the evolved “L-type” spreads more rapidly, and presently accounts for roughly 70% of cases. While the L strain seemed to be more prevalent than the S strain, the S-type of the coronavirus is the ancestral version, reports The Guardian.

Genetic analysis of a man residing in the U.S. who was confirmed infected with coronavirus on Jan. 21 demonstrated to scientists that double-infection is possible.

In other words, anyone can be infected with both types.

Early origin of mutation

The scientists who carried out the genetic analysis used 103 samples of the virus, taken from patients in Wuhan and other cities. This suggests that both the L and S strains emerged early in the early days of the coronavirus, according to The Guardian.

It’s important to note that all viruses mutate over time, and the virus causing COVID-19 is no exception. In other words, while it’s natural to be dismayed, this was and is an expected development.

How widespread it ultimately becomes depends on the evolutionary process of natural selection — the types capable of propagating fastest and most efficiently within the human body achieve the most “success.”

 

 

Is COVID-19 really any worse than normal seasonal flu?

Posted on by • Posted in Centers for Disease Control & Prevention (CDC), Clinical Research, Clinical Research Funding, Coronavirus, Health Policy, Infection Control, Infectious Virus, Public Health, Public Safety, Vaccine • Leave a comment

https://bigthink.com/politics-current-affairs/covid-19-vs-flu

  • Many are suggesting coronavirus is just flu-season business as usual. It’s not.
  • No sensible comparison can be made anyway, for a few reasons.
  • The one that’s less bad — whichever that is — can still kill you.

A lot of people are trying to get a sense of whether COVID-19 is any more dangerous than normal seasonal flu strains. Unfortunately, making meaningful comparisons between them is just not possible yet. From a “what should I do/worry about?” point of view, though, it’s pretty pointless to compare the two.

Whichever one you select as the ultimate Big Bad, they’re both out there: You have a decent chance of contracting either illness, and they both can be fatal for certain demographic segments. Trying to choose which one is worse is like trying to choose whether you’d rather be hit by a bus or a truck.

At this point, the best advice remains the same for both: Start washing those hands well and frequently, and follow the CDC’s recommendations for avoiding infection.

Here’s why we can’t know which is worse

There are some fundamental differences between the statistics available on seasonal flu and COVID-19, and they make a direct comparison impossible.

  • Seasonal flu is an annual phenomenon (even though strains change). There’s lots of multi-year data on rates of infection and mortality in the hands of numerous national health authorities. COVID-19, on the other hand, has been around for only about two months, and most of the available data comes from just one country, China, where it first emerged.
  • Related to this is that it’s impossible to calculate the spread of COVID-19 from such a limited amount of data, both in terms of time and geography. The disease is now apparently racing around the globe outside China, but how fast will it circulate and what will be its final infection rate? It’s impossible to know.
  • There are remedies and vaccines for seasonal flu strains — neither exist for COVID-19. While existing therapies are being tested for their efficacy against coronavirus, no silver bullet has yet been found and there’s no way to know when/if one will. Hilary Marston, a medical officer and policy advisor at the National Institute of Allergy and Infectious Diseases says of a coronavirus vaccine, “If everything moves as quickly as possible, the soonest that it could possibly be is about one-and-a-half to two years. That still might be very optimistic.” This makes a comparison of the death rates between seasonal flu and COVID-19 unfair: One has a cure, the other doesn’t.

Things people are saying, and what’s real

You’re more likely to get the seasonal flu.

Um, maybe, at the moment. Be aware that COVID-19 is being found in new areas pretty much every day. Harvard epidemiologist Mark Lipstich says, “I think the likely outcome is that it will ultimately not be containable.”

On top of that, we don’t know how fast it will spread in the wild. If it continues to travel at the rate it has in the last two months, hoo boy. However, contagion doesn’t usually remain linear. So it could get better. Or worse. Will seasons affect it? Proper sanitation? Other factors? With only two months of data, we can’t possibly know, but Lipstich predicts 40% to 70% of us will get it.

COVID-19 is 20 times more deadly than seasonal flu.

Sorry. It’s likely a lot worse than that. Last week, COVID-19’s mortality rate was thought to be 2.3%. Now it’s considered to be 3.4%, or .034 of the total number of infections. The CDC estimates the seasonal flu mortality rate this year is .001% — the number of deaths divided by the number of total infections. So, as of March 4, the latest figure for COVID-19’s mortality rate is 34 times greater than seasonal flu, nearly double what you’ve been hearing.

Of course, the lack of effective treatment is a key factor in COVID-19’s mortality rate. When/if one is identified, that rate will go down.

Most people get through COVID-19 just fine.

This is true, However, while in one sense it’s great that the vast majority of people who contract COVID-19 get over it easily, it also means that a lot of people have the coronavirus without realizing it and are continuing to spread the infection. In stark — and tragic — contrast, one of the reasons Ebola eventually stopped infecting people was that most of its victims typically died before they could spread the disease. COVID-19, on the other hand, can travel quite invisibly far and wide before being recognized.

Epidemiologist Jennifer Nuzzo tells The Washington Post that the recent U.S. diagnoses confirm “what we have long suspected — that there is a good chance there already are people infected in this country and that the virus is circulating undetected. It points to the need for expanded surveillance so we know how many more are out there and how to respond. It’s also likely that person-to-person spread will continue to occur, including in the United States.”

So stop comparing and just be safe

Regardless of which disease is worse, they’re both potentially dangerous, so be safe and follow safety guidelines. Take hand-washing seriously: Rub your hands together with soap and water for at least 20 seconds. (Sing the alphabet at a moderate speed and you’ll be about right.)

 

Another new first for CRISPR

Posted on by • Posted in Biotech, Clinical Research, Clinical Research Funding, Gene Editing, Gene Therapy, Genetics, Health Policy, National Institute of Health (NIH) • Leave a comment

https://www.axios.com/newsletters/axios-vitals-38324a12-c0f6-4610-bbc9-675192c94df1.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

Image result for crispr gene editing

For the first time, scientists have used the gene-editing technique CRISPR inside the body of an adult patient, in an effort to cure congenital blindness, Bryan reports.

Why it matters: CRISPR has already been used to edit cells outside a human body, which are then reinfused into the patient.

  • But the new study could open the door to using gene editing to treat incurable conditions that involve cells that can’t be removed from the body, like Huntington’s disease and dementia.

Details: The research was sponsored by biotech companies Editas Medicine of Cambridge, Massachusetts, and Allergan of Dublin, Ireland, and was carried out at Oregon Health and Science University.

  • Scientists led by Eric Pierce of Harvard Medical School injected microscopic droplets carrying a benign virus into the eye of a nearly blind patient suffering from the genetic disorder Leber congenital amaurosis.
  • The virus had been engineered to instruct the cells to create CRISPR machinery. The hope is that CRISPR will edit out the genetic defects that cause blindness, restoring at least some vision.
  • “We literally have the potential to take people who are essentially blind and make them see,” Charles Albright, chief scientific officer at Editas, told AP.

“It gives us hope that we could extend that to lots of other diseases — if it works and if it’s safe,” National Institutes of Health director Francis Collins told NPR.