Lancet Retracts Study on Safety of Malaria Drugs for Coronavirus 

Several authors of a large study that raised safety concerns about malaria drugs for coronavirus patients have retracted the report, saying independent reviewers were not able to verify information that’s been widely questioned by other scientists. Thursday’s retraction in the journal Lancet involved a May 22 report on hydroxychloroquine and chloroquine, drugs long used for preventing or treating malaria but whose safety and effectiveness for COVID-19 are unknown. The study leaders also retracted an earlier report that used the same company’s database on blood pressure drugs published by the New England Journal of Medicine. That study suggested that widely used blood pressure medicines were safe for coronavirus patients, a conclusion some other studies and heart doctor groups also have reached. Even though the Lancet report was not a rigorous test, the observational study had huge impact because of its size, reportedly involving more than 96,000 patients and 671 hospitals on six continents.  President Donald Trump tells reporters that he is taking zinc and hydroxychloroquine during a meeting with restaurant industry executives about the coronavirus response, in the State Dining Room of the White House, May 18, 2020.Its conclusion that the drugs were tied to a higher risk of death and heart problems in people hospitalized with COVID-19 led the World Health Organization to temporarily stop use of hydroxychloroquine in a study it is leading, and for French officials to stop allowing its use in hospitals there. Earlier this week, WHO said experts who reviewed safety information decided that its study could resume. “Not only is there no benefit, but we saw a very consistent signal of harm,” study leader Dr. Mandeep Mehra of Brigham and Women’s Hospital in Boston told The Associated Press when the work was published. The drugs have been controversial because President Donald Trump repeatedly promoted their use and took hydroxychloroquine himself to try to prevent infection after some White House staffers tested positive for the virus. The drugs are known to have potential side effects, especially heart rhythm problems. Data questionedThe Lancet study relied on a database from a Chicago company, Surgisphere. Its founder, Dr. Sapan Desai, is one of the authors.  Dozens of scientists questioned irregularities and improbable findings in the numbers, and the other authors besides Desai said earlier this week that an independent audit would be done. In the retraction notice, those authors say Surgisphere would not give the reviewers the full data, citing confidentiality and client agreements. “Based on this development, we can no longer vouch for the veracity of the primary data sources” and must retract the report, they wrote.  “I no longer have confidence in the origination and veracity of the data, nor the findings they have led to,” Mehra said in a separate statement Thursday.  The Lancet’s notice said “there are many outstanding questions about Surgisphere and the data that were allegedly included in this study,” and “institutional reviews of Surgisphere’s research collaborations are urgently needed.” Desai and Surgisphere did not immediately respond to requests for comments sent to phone numbers and email address listed on the company’s materials. Good answers neededAll the authors of the study should have had access to the data, said Dr. Steve Nissen of the Cleveland Clinic. “You really don’t know what a study showed unless you have the actual data,” Nissen said. “This is unfortunate. Clearly this is a very important topic and we need good answers.” The retraction shows “the system works,” said Dr. Ashish Jha, director of Harvard’s Global Health Institute. The pace of publishing scientific research has sped up in reaction to the pandemic, Jha said, leading to errors. As long as errors are acknowledged, the pace seems justifiable because waiting a year or two for results to be published “is way too slow for this pandemic.” “Part of the problem is people are so anxious. They want a definite answer yes or no,” Jha said. “We’re moving as fast as we can in science, but we can’t overreact to any single study.” 

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NASA Monitoring ‘Near-Earth’ Asteroid to Pass by Saturday

NASA’s Near-Earth observatory (NEO) is monitoring an asteroid bigger than New York’s Empire State building that is expected to pass by the Earth Saturday.According to the NEO, the asteroid known as 2002 NN4 at its broadest section, has a diameter of 570 meters. The Empire State building is just more than 426 meters tall.  But scientists at the NEO say there is nothing to fear from the asteroid, as “near earth” is a relative term. They measure the distance to deep space objects in astronomical units, with one astronomical unit close to the mean distance between the sun and Earth – approximately 150 million kilometers. Anything that comes within 1.3 astronomical units of the sun, is considered a near-Earth objectAt its closest distance, Asteroid 2002 NN4 is expected to pass about .034 astronomical units – or about 5.09 million kilometers from Earth, about 13 times the distance between the Earth and the moon.  NASA established the Near-Earth Object Observations Program in 1998 to monitor such objects. They say relatively small number of near-Earth objects pass close enough to Earth and are large enough in size to warrant close observation. They say the gravitational tug of the planets could, over time, cause an object’s orbital path to evolve into an Earth-crossing orbit, creating the possibility of a future collision.NASA says it has contingency plans for such an event. But in a recent discussion posted on the space agency’s website. NASA Director of Planetary Science, Dr. Lori Glaze, said the possibility does not keep her up at night.
 

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Telehealth Expansion Could Become Permanent Post-Pandemic

The temporary expansion of telehealth during the coronavirus pandemic would become permanent under a bill considered Thursday by a Senate committee.
As passed by the House in March, the bill would allow reimbursement for medication-assisted treatment for substance use disorders conducted via telehealth. But an amendment before the Senate Health and Human Services Committee would also make permanent the provisions of Gov.
Chris Sununu’s emergency order on telehealth, which allowed all health care providers to offer services via phone, video and other remote systems and required insurers to cover them.
Officials representing hospitals, community health centers, dentists and mental health providers all told the committee that telehealth has been a valuable tool during the pandemic and should continue.
Christine Stoddard of the Bistate Primary Care Association said community health centers “were able to turn on a dime” and transition to telehealth. And though in-person visits have resumed, centers still don’t have enough protective gear for staff, making telehealth options essential.
Because of the pandemic, telehealth services have become an important part of the health care system, said Paula Minnehan of the New Hampshire Hospital Association.
“As many experts have predicted, telehealth is here to stay, which is why this legislation is so important to ensure patients are able to get the right care at the right time in the right setting, which ultimately may be in the safety of their own homes,” she said.  
Ken Norton, director of the New Hampshire chapter of the National Alliance on Mental Illness, said telehealth has greatly expanded access to mental health treatment.
“We can’t go back,” he said.
Other coronavirus developments in New Hampshire:The Numbers
As of Wednesday, 4,795 people had tested positive for the virus in New Hampshire, an increase of 47 from the previous day. Nine deaths were announced, for a total of 265.
For most people, the virus causes mild or moderate symptoms, such as fever and cough, that clear up in two to three weeks. For some, especially older adults and the infirm, it can cause more severe illness, including pneumonia, or death.

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ER Visits for Non-Coronavirus Illnesses Plunged in April, CDC Says

A report by the U.S. Centers for Disease Control and Prevention says emergency room visits for non-coronavirus illnesses plummeted in April at the peak of the pandemic.The agency released an analysis Wednesday that the declines were greatest among children 14 years old and younger, women and for people living in the U.S. northeast region.  The CDC noted a steep drop in the number of people seeking emergency care for chest pain, including heart attack, along with declines in children needing help for conditions like asthma.   FILE – A view of medical personnel working in Mt. Sinai Hospital Morningside during the coronavirus pandemic on May 18, 2020 in New York City.The United States has the world’s largest number of confirmed COVID-19 cases with more than 1.8 million infections, with the death toll now topping 107,175.   The New York Times reports the Trump administration has selected five companies as the most likely candidates to produce a coronavirus vaccine.  The companies have been identified as Massachusetts-based Moderna; AstraZeneca, which is partnering with Oxford University; and the pharmaceutical giants Johnson & Johnson, Merck and Pfizer.   The Times quotes a government official as saying the White House will announce the decision in the next few weeks. FILE – Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaks about the new coronavirus in the James Brady Press Briefing Room of the White House, in Washington.Dr. Anthony Fauci, the country’s top infectious disease expert and the head of the National Institute of Allergy and Infectious Diseases, told the Journal of the American Medical Association (JAMA) Tuesday he is “cautiously optimistic” that scientists will come up with an effective vaccine by the start of 2021, saying he hopes to have “hundreds of millions of doses.” But he added, “there’s never a guarantee.”  “It could take months and months and months” before researchers find out if a vaccine works, Fauci said.  Fauci also warned that a new vaccine may not provide long-term immunity against COVID-19, the disease caused by the coronavirus.   “When you look at the history of coronaviruses, the common coronaviruses that cause the common cold … the durability of immunity that’s protective ranges from three to six months to almost always less than a year,” he said. “That’s not a lot of durability and protection.”      FILE – A pharmacy tech pours out pills of hydroxychloroquine at Rock Canyon Pharmacy in Provo, Utah, May 20, 2020.Meanwhile, researchers at the University of Minnesota say hydroxychloroquine, the treatment that President Donald Trump highly touts as an effective COVID-19 treatment, does not keep healthy people exposed to the virus from getting sick.    The report in The New England Journal of Medicine says the drug was no more effective than a placebo in clinical trials.    The scientists carried out their tests on 800 people exposed to someone with the coronavirus.    Hydroxychloroquine is a drug used to treat malaria, which Trump called a “game-changer” in the fight against COVID-19. He claims to have taken the drug himself.    But some doctors say the drug could have serious side effects, including heart rhythm problems or even death.    The World Health Organization has suspended the use of hydroxychloroquine in tests for a coronavirus treatment. France has outlawed its use altogether.  

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Silicon Valley Entrepreneurs Reach Out to Help Venezuela

A group of young professionals in California’s Silicon Valley has created a non-profit organization called “Code for Venezuela,” dedicated to bringing together tech innovators to solve the most pressing needs of the South American nation.  The group’s latest initiative aims to help residents in Venezuela find information about COVID-19.   Cristina Caicedo Smit has the story

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Doctors Kept Close Eye on Trump’s Use of Malaria Drug 

The White House medical team kept a close eye on President Donald Trump’s heart rhythms, including at least one electrocardiogram, to watch for potential side effects when he took a two-week course of a malaria drug to try to prevent the coronavirus, his doctor reported Wednesday.”The President completed the regimen safely and without side effects,” Dr. Sean Conley wrote in a report on Trump’s latest physical and his treatment with hydroxychloroquine.A pharmacy tech pours out pills of hydroxychloroquine at Rock Canyon Pharmacy in Provo, Utah, May 20, 2020.Overall, Conley said, Trump showed little change in basic health measurements from 16 months ago. On the negative side, he gained a pound. But on the plus side, his cholesterol level continued to fall.”The data indicates the President remains healthy,” Conley concluded. Trump recently took a two-week course of hydroxychloroquine after two White House staffers tested positive for COVID-19.Conley said it was done in consultation with “appropriate care team members and close monitoring of the electrocardiogram (EKG),” indicating that doctors were looking for changes in his heartbeat because abnormal heart rhythms are one of the dangerous side effects that have been found in studies of the drug.The drug proved ineffective for preventing COVID-19 in the first large, high-quality study to test it in people in close contact with someone with the disease. Results published Wednesday by the New England Journal of Medicine show that hydroxychloroquine was no better than placebo pills at preventing illness from the coronavirus. The drug did not seem to cause serious harm, though — about 40% on it had side effects, mostly mild stomach problems. Trump has frequently cited anecdotal reports and seemed determined to prove the naysayers wrong. Trump’s weight came in a 244 pounds. That gives him a Body Mass Index of 30.5, based on his 6-foot, 3-inch frame. An index rating of 30 is the level at which doctors consider someone to be obese. About 40% of Americans are obese.  Trump was evaluated twice for the physical, first in November 2019 and then in April. He has a resting heart rate of 63 beats per minute. A normal resting heart rate for adults ranges from 60 to 100 beats per minute, and generally, a lower rate implies better cardiovascular fitness.  His blood pressure came in at 121 over 79. The American Heart Association says an elevated blood pressure range is when a reading for the upper number consistently ranges from 120-129 and less than 80 for the lower number. People with elevated blood pressure are likely to develop high blood pressure unless steps are taken to control the condition. Trump has shown marked improvement in his cholesterol levels during his presidency, helped by medication. At his physical in January 2018, his total cholesterol was 223. In early 2019, the reading came in at 196. It now stands at 167. The president takes rosuvastatin to help lower his bad cholesterol, known as LDL, and to raise his good cholesterol, or HDL. Ideally, total cholesterol should be less than 200.  Trump also takes aspirin daily and finasteride, a drug to treat enlargement of the prostate and male pattern hair loss. Aspirin reduces the risk of heart attack and stroke in people at high risk for them. 

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Turkey, Russia Cooperate on Virus Vaccine 

Turkey and Russia have agreed to cooperate in the development of a coronavirus vaccine and plan to carry out joint clinical trials, the Turkish health minister said Wednesday. Health Minister Fahrettin Koca said scientific advisers from the two countries were scheduled to hold a second round of talks later this week. A total of 22 Turkish universities and research centers are working to develop a vaccine, and four of them have advanced to the animal-testing stage, Koca said. The minister also said that Turkey has seen the benefit of the malaria drug hydroxychloroquine and will continue to administer it to COVID-19 patients, despite concerns raised over the drug. Koca said that unlike other countries, Turkey has been using the drug early in COVID-19 threatment.  Turkey recorded 867 confirmed virus cases and 24 deaths between Tuesday and Wednesday, the minister said. The update brought total confirmed cases in the country to 144,422 and the death toll in the pandemic to 4,609.  Foreign Minister Mevlut Cavusoglu said earlier Wednesday that Turkey evacuated more than 75,000 stranded Turkish nationals from 126 countries during the pandemic. At least 562 Turks died abroad, he said Turkish airline companies resumed domestic flights this week as restaurants welcomed sit-down customers and beaches and museums reopened.  

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UK Study Tests Form of Ibuprofen as Coronavirus Treatment

A form of ibuprofen called flarin is being studied in Britain to see if it is effective for treating COVID-19 respiratory symptoms caused by the coronavirus.Also called lipid ibuprofen, flarin has anti-inflammatory effects and is designed to shield the stomach from irritation when taken.The study, LIBERATE Trial in COVID-19, aims to test flarin on 230 people who have been hospitalized due to COVID-19 and have acute respiratory failure. Only patients who are 18 or older are eligible.COVID-19 patients who have shown hypersensitivity to other non-steroidal anti-inflammatory drugs (NSAIDS) do not qualify for the study.Ibuprofen received attention in March, when French Health Minister Olivier Veran tweeted that NSAIDS, which include ibuprofen, could aggravate COVID-19 symptoms.Since then, the World Health Organization, European Medicines Agency and other groups said there was not enough evidence to prove ibuprofen would worsen COVID-19 symptoms.  The sponsor of the LIBERATE study is King’s College London, with the Guy’s and St. Thomas NHS Foundation Trust as the collaborator.The estimated date for initial results is Sept. 25, 2020, and the final estimated study completion date is May 25, 2021. 

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