They order that more thyroid medicines be taken off the market. People with problems have been reported

Read this article in englishs in the Miami Herald.

After several tests and customer complaints about various medical problems, the company Acella Pharmaceuticals ordered two batches of NP Thyroid thyroid tablets to be recalled.

NP Thyroid was ordered to be regoverned for having underpower, the same reason that earlier this month RLC Labs had picked up Nature-Throid and WP Thyroid. In the notice written by Acella, and posted on its website by the Food and Drug Administration (FDA) it is stated that the tablets “could have 87 percent of the amount of levothyroxine (T4) that appears on the label, which is considered low ”.

In simpler terms, this means that the medicine may be too weak to work. As the notice admits, as of Thursday, “Acella had received four reports of adverse events for the numbers of these that are possibly related to this collection.”

These are lots # M327E19-1 for NP Thyroid 15 tablets, 1/4 grains (15 mg), with an expiration date of October 2020; and Lot # M328F19-3 for NP Thyroid 120 Tablets, 2 Grains (120 mg), with an expiration date of November 2020.

Anyone with pickup questions can email recall@acellaphrama.com or call 888-280-2044, Monday through Friday, 8 am to 5 pm Eastern Standard Time.

Those people who have a medical problem due to this or another medicine, should contact a health professional. You must then report it to the FDA’s MedWatch Adverse Event Reporting Program through the agency’s portal, or through a request that can be obtained by calling 800-332-1088.

Translation of Jorge Posada

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The 943-Dimensional Chess of a Trustworthy Covid-19 Vaccine

Mostly, the protocols are just thick volumes of procedures—the instruction manuals for the trials. How big a dose of vaccine will participants in the experimental group get, and how many? How will they be monitored, and for what symptoms? For how long? What will count as an infection? How will the data be accounted for? Publishing the protocols in advance is all about accountability. These are the rules the companies plan to abide by, available for criticism but also to ensure that nobody does any shenanigans on the other end, cherry-picking data or changing what counts as success.

The details, though, also give some clues as to how the next few months will go. For one thing, both protocols take so much time to put into action that it’s next to impossible that a vaccine will be available before Election Day. Everyone has to get two doses, and the studies must allow enough time to monitor their outcomes.

(I emailed representatives of the other six signatories to the vaccine science pledge asking if they, too, planned to release their research protocols. Spokespeople at Johnson & Johnson, Merck, GlaxoSmithKline, BioNTech, Novavax, and Sanofi all declined to comment.)

Still, even public protocols might not be enough to get the scientific community on board. Hotez hopes the companies will release not only their protocols but also their full Phase III data. He also wonders what an EUA might mean for the other vaccine trials. Ordinarily, ethics would dictate that once a vaccine is available, trials of other candidates should stop. By definition, the risks of those trials now outweigh the potential future rewards. Except here, those other candidates might be better, safer, whatever. EUAs don’t have any guidelines for that, and neither the FDA nor the president have articulated any. They might be forthcoming, but Hotez says he thinks the president is more interested in reelection than vaccines. “He wants a vaccine released under EUA, sort of now, right? He’s never created a national road map or response to Covid-19, this is undermining his candidacy for reelection, and he feels he needs a victory in the area of Covid-19 to be successful,” Hotez says. “But I don’t see a way by which we’d know that vaccines were safe and effective if he tries to release a vaccine in October. So we’re in a bit of a standoff. The scientific community is holding a line.”

It has to; there’s a lot to be suspicious about. Moderna’s leadership has been criticized for questionable stock trades and hyping preliminary results. And in early September, AstraZeneca officials announced that they were pausing their vaccine trial due to an “adverse event”—some kind of medical issue that forced the researchers to stop and determine whether it was a consequence of taking the vaccine. And it wasn’t the first time. A participant got ill in the summer, but they turned out to have a neurological disorder unconnected to the vaccine. This time, an otherwise healthy 37-year-old woman developed a spinal inflammation that looked like a neurological disorder called transverse myelitis, which some scientists think could be an immune issue. That’s disconcerting when it comes to vaccines. But AstraZeneca didn’t release those details on purpose; Stat got them via leaks from a presentation the company made to investors, and CNN obtained an internal report. That’s not transparency. (The trial has since restarted in the UK, and a spokesperson told me they expect it to restart in the US soon.)

And all of these political and scientific pressures combine, like separate wildfires cresting the same hill. When they swirl together with general anti-science sentiment and vaccine hesitancy, you get a fire tornado of skepticism. That’s why the trustworthiness of the science will be so important, and so important to communicate—to three disparate groups of people beyond the science community. One is antivaxxers and the vaccine-hesitant. Another is the people who have little information, who may even be outside the health care system altogether. “But the third group is the one that’s the most interesting in this case. They’re worried about the rush. They’re worried about the fact that there’s political pressure. So they’re going to be a little skeptical until they see pretty good evidence that the vaccine being offered is good,” says Christine Grady, chief of the Division of Bioethics at the National Institutes of Health Clinical Center. “Yes, you can message it. It’s not easy to do, but you can. The way the trial was run, ethically and methodologically and rigorously, will matter a lot.” The key is making sure that the trials are run well, and then saying so loudly enough that people believe it.

Updated 9/19/20 1:44 PM PDT to include a link to the AstraZeneca clinical trial protocol.


More Great WIRED Stories

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Experts say food is highly unlikely to be a source of COVID-19 infection

(Cnn in Spanish) – A team of experts in food contamination says that food is highly unlikely to be a source of transmission of COVID-19.

The International Commission on Microbiological Specifications for Foods (ICMSF) examined the evidence that coronavirus could be present in food or its packaging and found very little.

Their finding reflects previous reports from the US Food and Drug Administration (FDA) that there is no real risk of contracting the virus that causes COVID-19 from food or food packaging.

Read also: Bachelet: “It is not true that women are not trained to make decisions”

“To date, there has been no evidence that food, food packaging, or food handling are an important source or route of transmission for SARS-CoV-2 resulting in COVID-19The organization said in a statement.

“There are no foods that should be considered a risk or that justify its consideration as a vector of SARS-CoV-2,” he added.

While it is possible for people to eat something contaminated with the virus and become infected that way, never seen to have happenedthey said.

However, it is still prudent to emphasize good food hygiene practicesthe group said.

Read also: Kylian Mbappé tested positive for COVID-19 and will not play for France in the Nations League

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Learn about all the vaccines in development against COVID-19 and their phases

The pharmaceutical industry and scientific researchers have carried out more than 100 projects for vaccines against the coronavirus COVID-19 of which some are applied in human trials.

In general, developing a vaccine can take several years of research and clinical trials before distribution. On this occasion, pharmaceutical and scientific rush to get the vaccinations are safe and efficient by 2021.

In order for a vaccine to be freely distributed, it must pass several quality filters, of which several factors are measured in the benefits of the body. human without the secondary effects causing severe damage.

Phases:

Scientists test a new vaccine on cells and then administer it to animals such as mice or monkeys to see if it produces an immune response.

Considered safety tests, scientists administer the vaccine to a small number of people to test safety and dosage, as well as to confirm that it stimulates the immune system.

Scientists give the vaccine to hundreds of people divided into groups, such as children and the elderly, to see if the vaccine works differently for them. These trials further test the safety and ability of the vaccine to boost the immune system.

Scientists administer the vaccine to thousands of people and hope to see how many become infected, compared to volunteers who received a placebo. These tests can determine if the vaccine protects against the coronavirus. In June, the FDA He said a coronavirus vaccine would have to protect at least 50% of vaccinated people to be considered effective. Furthermore, the phase 3 trials are large enough to reveal evidence of relatively rare side effects that might be missed in earlier studies.

China and Russia have approved vaccines without waiting for the results of phase 3 trials. Experts say the rushed process carries serious risks.

Regulators in each country review the results of the trial and decide whether or not to approve the vaccine. During a pandemic, a vaccine may receive an emergency use authorization before obtaining formal approval. Once a vaccine is licensed, researchers continue to monitor the people who receive it to make sure it is safe and effective.

Since January 2020, prior to the great impact that the pandemic has left in the world, the effort to find the cure against SARS-CoV-2, known as COVID-19, had its first rehearsals in March.

As you go about finding the formula, some tests have failed and it is normal that they keep failing in the meantime, others may end without a clear result.

Fortunately for some, the results have been successful, according to their own statements these vaccines can be successful in stimulating the immune system to produce effective antibodies against the virus.

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FDA commissioner says he would resign if asked to rush a covid-19 vaccine – CNN

Posted at 12:10 ET (16:10 GMT) Thursday, September 3, 2020

This is how they plan to distribute the coronavirus vaccine





Posted at 10:51 ET (14:51 GMT) Thursday, September 3, 2020







Posted at 10:17 ET (14:17 GMT) Thursday, September 3, 2020

They recommend using a mask during sexual intercourse


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Man fired in the wake of pandemic mows the lawn for free to seniors and veterans





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Cops evict dozens of people in Houston as rent moratorium expires





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She lost her father and husband to coronavirus


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Working from home is working, studies suggest


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Chile gets ready to reopen


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Covid-19 symptoms can last for months


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FDA approves convalescent plasma treatment for coronavirus patients – CNN

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This is the selective isolation that will begin in Colombia


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Doctor talks about doubts in the use of plasma against covid-19


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China says it applied vaccine against covid-19 in July


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To improve the economy, the pandemic must be resolved


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Officially ..FDA approves the emergency license for the remdisiver medicine to treat patients with SK

The US Food and Drug Administration (FDA) has issued a formal authorization for the use of emergency medication to treat “REMDIVIVIR” antiviral drugs for the treatment of suspected or clinically confirmed COVID-19 patients in adults and children in hospitals with severe illness.

The Food and Drug Administration emergency statement for remdesivir, which came two days after the clinical experience of the National Institutes of Health promising results, is an important step forward in the fight against the Corona virus.


FDA approval for the drug Reimserv

Permission to use in emergency situations allows the distribution of remdesivir to treat suspected or confirmed laboratory corona patients in adults and children in hospitals with severe disease, and severe disease is defined as patients with low levels of oxygen in the blood or need oxygen therapy or breathing support More intense like a ventilator.

The text of the FDA statement reads on its official website: “Based on the evaluation of emergency use licensing standards and available scientific evidence, it has been determined that it is reasonable to believe that Remdesivir may be effective in treating COVID-19, and that, as there are no appropriate, approved, or available alternative therapies available, Known and potential benefits of treating this dangerous or life-threatening virus Currently known and potential risks of drug use.

Remsdisver
Ramesdevir

Emphasizing that important information on the use of remdesivir in the treatment of COVID-19 is available to healthcare providers and patients, including dosage instructions, possible side effects and drug interactions. Possible side effects of remedivir include: Increased levels of liver enzymes, which may be a sign of inflammation or damage to liver cells. And leak-related reactions, which may include low blood pressure, nausea, vomiting, sweating and tremors.

The FDA previously allowed study of the investigative drug under clinical trials, as well as extended use for individual patients and through a multi-patient expanded access program coordinated by Gilead Corporation.

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FDA Warns About Drug Poisoning That Trump Promotes

(NEWS NOW) .- The Food and Drug Administration (FDA) warned of poisoning and death from the drugs chloroquine and hydroxychloroquine, which Donald Trump has consistently promoted as a Covid-19 treatment despite there being no evidence in this regard.

PHOTO: Alex Wong / Getty Images

READ: Trump suggests disinfecting the lungs with … chlorox?

These medications are used to treat malaria, but have been used by the public in unsupervised Coronavirus cases or prescription, and out of clinical trials, which has resulted in fatal situations.

The agency indicated that they received reports from Covid-19 patients who suffered from “severe heart rate problems” when using malaria medications in combination with azithromycin, an antibiotic known as Z-Pak.

Hydroxychloroquine and chloroquine can cause abnormal heart rates such as QT prolongation interval and dangerously fast heart rate, called ventricular tachycardiaThe FDA wrote in an announcement this Friday, April 24.

The statement also indicated that the agency will continue to investigate the risks associated with the use of these medications in the treatment of Covid-19. He also recommended that doctors not prescribe them to Coronavirus patients outside of a hospital.

READ: Local doctor accused of selling “miracle cure” for COVID-19

A study published in the Journal of the American Medical Association this Friday indicates that researchers had to stop a study on the potential use of chloroquine in patients with Coronavirus, due to concerns for the safety of patients.

In this study, some patients developed irregular heart rates and almost 24 people died after taking doses of chloroquine every day as a Covid-19 treatment.

The FDA clarified that those who are taking these medications to treat diseases such as malaria or autoimmune conditions like lupus, they should continue taking your medicine as prescribed.

Until now there is no proven treatment for Covid-19 and any authority figure who says otherwise and promote medicines without any scientific support is putting people’s lives at risk, especially when the president of the United States says so.

READ: FL receives chloroquine: a drug that is not approved against COVID-19

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How Paul Romer wants to save America’s economy

FThere is only one way for economist Paul Romer to get America’s economy going again as long as no coronavirus vaccine is found and available to everyone: everyone needs to be tested, as soon as possible. The Nobel Memorial Prize for Economics considers 30 million tests a day feasible in terms of production technology. The carriers of the virus would have to be isolated.

Winand von Petersdorff-Campen

Romer sees no alternative to his plan. As long as people were afraid of getting infected, they delayed consumption and investment decisions and returned to work, even if the governors relaxed the requirements. Lifting restrictions without a real exit plan harbors the risk that the virus will return to its path of exponential growth with catastrophic consequences for the economy and new deadly dangers for humans. Fears and insecurity would paralyze people in such a comeback of the pandemic, even if they were allowed unlimited mobility again.

Testing until everyone is vaccinated?

The sheer number of tests that Romer considers necessary seem utopian. Between 150,000 and 175,000 people are currently screened each day in the United States. According to the economist’s analysis, two problems hamper the mass production of the tests: the requirements and the bureaucratic toughness of the FDA, and the lack of financial incentive for the laboratories to carry out the tests. Laboratories could achieve the desired number of tests uninhibited by tight conditions and financially secure. “This nation produces 350 million cans of Cola Fanta and other soft drinks a day. If we can do that, we can also produce 30 million tests a day, ”Romer said in the CNN interview.

Romer with his Nobel Prize in Stockholm in December 2018


The FDA should quickly approve procedures that show the same level of precision as previously approved tests. According to Romer’s rough estimate, the state would have to provide around $ 100 billion a year for universities, hospitals and companies to multiply the American test capacity. He has identified 36 laboratories in America that are eligible for testing based on their experience and capabilities in DNA sequencing. Romer’s goal is to build enough capacity to fully test the 330 million Americans once a week. He would test again and again until everyone was vaccinated. He does not expect this to happen in the next 15 to 18 months.

Treat people with symptoms like sick people

Romer is hoping for new saliva test methods that, according to the latest research from Yale University, show the same or even better diagnostic quality than the smears from the nose that were previously considered the gold standard. They are apparently easier to scale than smear procedures. “The only question is whether Congress is committed to restoring confidence in the health of our citizens and the economy to start the recovery,” Romer writes verbatim.

The former chief economist of the World Bank sees the major problem that the United States not only did far too few tests, but wasted limited resources by testing the wrong people. Romer would not test people with symptoms, but treat them as sick people with proven infection. He would initially reserve the tests for doctors, nurses and nurses who are involved in the fight against the pandemic in order to minimize mutual infection. When mass production started, he would test workers in vital jobs, such as supermarket or police officers. Those who tested positive, their relatives and close employees would have to be isolated.

The economic calculation of this approach is clearly positive: Every month the United States loses $ 500 billion in added value due to the standstill. The $ 100 billion he calculated for building up the mass test capacity was also worthwhile because the corona virus was threatened by even more deadly pandemics. Romer rejects an alternative strategy that relies on antibody tests to measure whether someone has ever developed Covid-19. The procedures are too imprecise, and it is not yet clear whether even the sick could not be infected again.

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Scientists in the United States look for inhibitors of an enzyme that helps the coronavirus



Miami – Based on a discovery by Puerto Rican professor Mariano García Blanco, scientists from universities in Florida and Texas, and from the National Cancer Institute of the United States, are working together in search of a medicine that blocks an enzyme that helps the COVID-19 to multiply in the human body.

Florida International University (FIU) reported Monday that the team’s goal is to discover among the existing and approved drugs in the United States which are the ones that best inhibit the enzyme Topoisomerase III-ß (TOP3B), for which they help with artificial intelligence and molecular models.

García Blanco, a specialist in biochemistry and molecular biophysics trained at Harvard and Yale, and currently a professor at the University of Texas Medical Branch (UTMB) in Galveston, discovered that this enzyme is used by COVID-19 to multiply in the human body, he reported in an article published last month.

Virus factories

With the help of the enzyme TOP3B, COVID-19 replicates (makes copies of itself) within infected human cells, which thus becomes a “virus factory”, as published in the specialist journal BioRxvy.

Following his discovery, García-Blanco enlisted the help of the director of the FIU Institute of Biomolecular Sciences, Yuk-Ching Tse-Dinh, an internationally recognized topoisomerase expert, and deputy director Prem Chapagain.

“We are approaching FIU as the place where the best inhibitors come from,” Garcia-Blanco said in remarks reproduced in the FIU statement.

Tests with medications already approved

Tse-Dinh is testing drugs already approved by the United States Food and Drug Administration (FDA) because what is sought is something that can be tested in patients quickly, to prevent COVID-19 from spreading throughout the world .

We are aiming to stop the TOP3B enzyme from working inside the cell, as the virus will not spread as well as it does, Tse-Dinh said.

In the opinion of the scientific team, if they find a good inhibitor, COVID-19 patients can be applied together with antiviral drugs in order to expand the recovery opportunities of those who are very serious.

Real solutions for the biggest challenge

According to Mike Heithaus, dean of the FIU College of Arts, Sciences and Education, they are looking for real and tangible solutions to the “greatest challenge of our time” and if they succeed, this new approach could be used to treat other viruses and new ones. may arise. Tse-Dinh, Chapagain and two graduate students, Ahmed Seddek and Tumpa Dasgupta, are already identifying drugs using artificial intelligence and molecular models and testing them as potential enzyme inhibitors. When they find one with potential, they are forwarded to García-Blanco and his team, who test them in cell cultures and viruses, including COVID-19. “It is a very simple story. We want to block this enzyme. That’s all. If we can do it and combine it with another antiviral treatment, we may have more opportunities to help people who are very ill,” said García-Blanco. In the midst of the pandemic, research participants are working piecemeal in their labs or some of them from home to achieve the goal. “We feel the urgency, but we have to do things scientifically,” said Tse-Dinh. Something similar in Brazil

In Brazil, a group of researchers found that Atazanavir, a drug used to treat AIDS patients, is effective in inhibiting the viral replication of Sars-Cov-2, the virus that causes COVID-19. Studies by the Oswaldo Cruz Foundation (Fiocruz), the largest medical research center in Latin America and linked to the Brazilian Ministry of Health, found that Atazanavir is capable of slowing down the multiplication of the virus and that it also reduces the inflammatory process in the lungs. of patients who get it. The drug “reduced the production of proteins that are linked to the inflammatory process in the lungs and, therefore, prevented the worsening of the clinical picture generated by the disease,” Fiocruz said in a statement.

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