by Kevin Cody
Dr. Eric Daar watched President Donald Trump’s press conference at the White House on the eve of the Republican conference last month out of interest, then with apprehension and then with a sense of no, yet.
Daar is a researcher at the Lundquist Institute in Torrance, one of 40 studies institutes across the country in the national CONvalescent plasma project COVID-19 (convalescent plasma is plasma taken from recovering patients).
“I am pleased to make a historic announcement in fact in the war against the Chinese virus that will save countless lives,” the president announced at the August 23 press conference. “The Food and Drug Administration has issued an Emergency Use Authorization (USA). U. S. ) For a remedy known as convalescence plasma. It is a harsh cure that transfuses very strong antibodies from recovered [COVID-19] patients to help treat patients who have recently struggled with the infection.
“You have to reduce [mortality rates] by 35%,” he said.
Health Secretary Alex Azar the president on the podium.
“I don’t need you to overlook that number,” Azar told White House Press Corp. “We dream of 35% relief in drug development mortality. This is a fundamental advance in the treatment of patients. “
Azar followed FDA Commissioner Stephen Hahn.
“In early April, we introduced an expanded access program. Nearly 100,000 and 70,000 remedio won [convalescence plasma] were recruited. It was one of the most important tests in FDA history.
“Those treated with convalescence plasma with the name [antibody concentration] had a 35% improvement in survival,” Hahn said.
President Trump concluded the press convention by saying, “We have damaged the blocking of [the protest] last week by FDA members. My view is that it has nothing to do with politics. It has to do with life or death. We have answers and I’m not going to let them hold on. “
“We don’t know if this is true. Convalescent plasma can be effective and safe. Everything they said beyond that is not backed by the data,” Daar said in a post-White House press conference interview.
Two days after the press conference, Daar’s opinion was validated when FDA commissioner Hahn tweeted an apology.
“I was critical of my comments Sunday night about the benefits of convalescent plasma,” he said. “The complaint is fully justified. “
The Mayo Clinic study cited in 35% mortality relief did not reach this conclusion. This is not a blind study comparing patients who gained convalescent plasma with patients who did not. use that patients may have won.
Following Hahn’s apology, the Los Angeles Times reported, “Some scientists are involved in the FDA’s expanded access [emergency use authorization] to remedy [convalescence plasma] to make it more difficult to conduct comprehensive studies on the effectiveness of the remedy. “
Daar had an explanation as to why express this concern.
(An emergency use authorization for health care professionals to administer untested medications when there are no approved drugs that work. )
In May, Daar began conducting an FDA-funded clinical trial to determine the efficacy of hydroxychloroquine in the remedy of PATIENTS with COVID-19. The rehearsal began at about the same time President Trump said he had taken the drug. for hydroxychloroquine, the FDA issued an emergency use authorization for the drug.
The NIH test hoped to involve another 2,000 people enrolled in more than two dozen clinical laboratories across the country. After 4 months, the trial was cancelled because only 20 patients had been enrolled.
“I’ve been here since the early days of AIDS/HIV studies and I’ve never noticed anything like the reaction we found when we conducted studies on hydroxychloroquine,” Daar said.
“If other people liked Trump, they wouldn’t manifest themselves because they already think hydroxychloroquine is the solution to the world’s problems. If they didn’t like the president, they wouldn’t point out because they think hydroxychloroquine is toxic. “
“We weren’t taking the test so the president would be right or not. We were just looking to answer the question. No one knew if it worked or not. “
“Finishing the exam was heartbreaking because we had devoted a lot of time and power to it and hoped it would help people. But it was simply to continue without the number of enrollees needed to get clinical answers,” Daar said.
“I will give management the advantages of doubt,” Daar said of the president’s press conference on August 23. “But I don’t think they’ve done the world any favors. Actually, this would possibly save us from being”. to answer the question: does convalescence plasma work, a bit like what happened to hydroxychloroquine due to politicization.
The challenge of politicization for convalescent plasma is twofold, Daar said.
One he described as “optical. “
“The president said a blockade in the FDA had prevented convalescing plasma from continuing and that management had damaged the blockade. That’s not how we need the drugs allowed. Approval should be conducted through FDA scientists acting independently. »
According to Daar, a second, more immediate fear is that the possibility of effects on the president’s uncon proven claims on the benefits of convalescent plasma remedy in the FDA-funded trial in which Daar and his team are working.
“We are desperately looking to recruit patients with COVID-19 for a randomized controlled trial to answer the question of whether the convalescent plasma remedy is effective. But we find it difficult to do so because emergency use authorization gives other people a way to extract convalescent plasma This puts others in the position of using it in the hope that it will work, which is the most productive case. At worst, there could possibly be threats involved. Even a small threat is not justified for a remedy that doesn’t work. And we don’t know if it works, ” said Daar.
Daar’s involvement in COVID-19 studies began on March 21, two days after California Gov. Gavin Newsom issued his Shelter At Home order to deter the spread of coronavirus.
“That day,” said the father of 4 young adults from Rancho Palos Verdes, “I got an email from the National Institute of Health. The NIH needed other people with experience conducting large-scale clinical trials and they needed study sites to implement them. ” essays.
Daar is a member of a modern group of AIDS clinical trials.
“The country didn’t have many researchers who read coronaviruses before the pandemic,” he said, “so those of us who reveled in other viral diseases were invited to take on this new challenge. “
His team at the Lundquist Institute, in partnership with studies across the country, is recently running 3 NIH-funded COVID-19 studies.
The convalescent plasma test requires collecting plasma from others who have recovered from COVID-19 and creating a concentrated “cocktail” of their antibodies that has antiviral properties.
“The hope is that the antibody-enriched cocktail will fight the disease so patients don’t have to wait for their own antibodies to develop,” Daar said.
“Not everyone who has recovered from COVID-19 has antibodies. And of those with antibodies, not all antibodies are antiviral,” Daar said.
This is a challenge for COVID-19 patients receiving convalescence plasma as a component of the FDA Emergency Use Authorization Program. The plasma they obtained is detected for antiviral antibodies.
“It’s like giving someone a drug without knowing how many milligrams they are. Possibly it would be 4 or 300. Si there are fewer than 200, it doesn’t work, so let’s hope it’s better. That’s the kind of thing they do, with convalescent plasma remedy [America]. »
The progress of COVID-19 patients in the Daar test who obtain the “cocktail” of antibodies will be with those of COVID-19 patients who get placebos.
The “cocktail” will be given by injection. (The legal remedy throughout the U. S. should be administered intravenously, regularly in a hospital).
“We just have to look for blood donors,” Daar said.
One time dagger and its organization are running are monoclonal antibodies, which are replicas of antibodies produced in the lab through the immune formula in reaction to viruses.
This test started this week. Patients in the early stages of COVID-19 will obtain mass-produced antibodies in tablet or injection form.
“We believe that remedies paint more at the onset of the disease, because the virus is the cause of maximum symptoms. Subsequently, it is the immune formula that causes the symptoms,” Daar said.
Daar stated that there were considerations that many other studios are stretching the studio web too much. Daar’s workday is unusual among professionals in the pandemic. He gets up at home at 3 a. m. for breakfast, then runs, and then heads to the Lundquist Institute where he studies and Harbor UCLA Medical Center, where he provides patient care. He comes home around 7pm, has dinner, checks his emails, and goes to sleep at 10pm. He has had a day off since he received the March 21 email from the National Institute. of health.
“I don’t at all disagree with that view, which is that since 60,000 feet, it would possibly seem that some of the studies are not important or redundant. But other people are dying,” he said. We want to move quickly, we want parallel testing because we don’t have a concept of what will work.
Last Wednesday, the Lundquist Institute held a press conference to announce that it is recruiting volunteers for Phase III trials of a COVID-19 vaccine developed through Oxford University and manufactured through AstraZeneca, a British pharmaceutical company. approved for general use.
Based on the promising effects of phase II trials in July, AstraZeneca has obtained an agreement to supply 400 million doses to the European Commission once it has received regulatory approval.
“Our purpose is to vaccinate 30,000 high-risk volunteers at medical centers across the country over the next two months,” Daar said.
High-risk volunteers are wanted, Daar said, because the more people get sick, the faster a conclusion can be drawn about the effectiveness of the vaccine.
“If a [people’] organization is in poor health, we can compare the organization that won the vaccine with the organization that won a placebo,” he said. “If, for example, only two are in poor health, we cannot make a meaningful comparison. That’s why we want 30,000 high-risk volunteers, so there will be enough people in poor health to make a comparison. “
Daar said the Lundquist Institute hopes to recruit 500 volunteers. Starting Wednesday, volunteers signed up to receive the vaccine. They will receive two injections of the vaccine, one month apart. Your physical condition will be monitored weekly for one year.
“We expect to show that vaccine receptors are at least 50% less likely to receive COVID-19 than those who won the placebo,” Daar said.
“If all goes well,” he said, “we can expect a vaccine to be approved early next year. But it will take months to vaccinate America’s three hundred million. “
“I can’t believe COVID-19 is leaving until next summer,” Daar said.
Meanwhile, he said, “I think other people can go out safely if they wear a mask, distance the the the hand and wash their hands, but not in a crowded theater or at a football game. “
“The challenge is that every time we eliminate draconian measures, such as the Home Shelter order, others don’t take precautions. If we have a peak of COVID-19 in the winter flu season, the effects may be worse than the previous peak this year. »
“We have to get it right. We don’t want to be perfect. We just have to be good,” he said.
The Lundquist Institute is for others most at risk of coVID-19 to volunteer for the AstraZeneca vaccine trial. The Institute is also for others diagnosed with COVID-19 who have not yet required hospitalization to volunteer for the convalescent plasma assay. Trials can be entered by calling the Lundquist Institute at (310) 222-3848 or by visiting helptopcovid. la. ER
by Kevin Cody
Kevin is the editor of Easy Reader and Beach. Share your new tips. 310372-4611 post. 110 or kevin [at] easyreadernews [dot] com
powered through LiveMarket
Our new local LiveMarket allows you to advertise your business on-site 24/7. Click below to launch your first promotion. . . no credit card required, no conditions.