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– A new mega-study affirms that the drug does not reduce mortality from coronavirus
– He was used to treating President Trump, often praising him
– Only 10 days ago, the EC signed a supply contract for more than one billion euros, the experts demand to be reviewed
A large-scale study by the World Health Organization on remdesivira is destined not only to burn the fragile hope of an effective cure for COVID-19, but also to provoke a serious conflict between the WHO and the United States. And in all this, the EU looks like a victim.
Treatment of coronavirus with remdesivir has “little or no effect” on the survival of critically ill patients, according to a WHO mega clinical study. The bomb was dropped by the Financial Times on Friday. The announced results have not yet been published in a prestigious medical journal and were immediately questioned by the US manufacturer of the drug, “Giliad Science.”
The study
puts a lot
delicately
position and
The European Commission,
that ten days ago it signed a supply contract with the American company worth more than one billion euros.
The WHO Solidarity study examined the effects of remdesivir and three other potential therapies: hydroxychloroquine, interferon, and the combination used in HIV patients: lopinavir and ritonavir. The bottom line is that none of these treatments significantly affect mortality and do not reduce the need to place patients on ventilation. Remdesivirate is also said to have no effect on the hospital stay of patients.
Yet remdesivir was one of the drugs that helped Donald Trump jump the ladder. After the ninth day of the illness, the president of the United States announced that he had left the coronavirus behind and felt perfect. However, in addition to remdesivir, the steroid dexamethasone and experimental antibody therapy were administered. But the US media has long called remdesiviru “the president’s favorite medicine.”
The four COVID-19 therapies were tested in 11,266 adult patients in 500 hospitals in more than 30 WHO countries. However, the researchers said their study was primarily aimed at assessing the effects of drugs on mortality in severe cases. It contradicts an American scientific experiment announced just a week ago at the University of Nebraska, according to which remdesivir
shortens roughly
5 day stay
of patients
at the hospital
and recovery of those who received placebo.
On the same day that the study results were leaked to the media, in Geneva, the head of the WHO, Tedros Gebreyesus, officially presented the partial results and categorically announced that currently the only drug that is effective in treating patients with serious conditions is the corticosteroid. dexamatazone.
Remdesivir, which has another brand name, was developed by the US drug maker Gilead Sciences (Gilead Sciences) initially as a potential drug for Ebola. In early May, the US Food and Drug Administration urgently approved its use for patients with severe complications from COVID-19. However, as early as January, American doctors had started using it under the “humane enforcement” protocol, which generally prescribes experimental drugs to late-stage patients. Hollywood star
Mel Gibson was
one of the first
Famous,
that announced,
that is to say
cured
s remdesivir.
In July, the US Department of Health announced that it was purchasing 500,000 treatment cycles (one patient needed a 5-day course using 6 vials), at a total cost of approximately $ 2,340 per course. Then Trump boasted that the United States had bought 90% of the world’s stocks of the drug.
In early July, remdesivir became the first antiviral drug officially approved in the EU to treat the new infection. EU Health Commissioner Stella Kyriakidis announced that it was an important step in the fight against the disease. It celebrates the EU’s ability to respond rapidly to any new treatment that is available around the world. A month later, the European Commission signed the first contract to supply remdesivir to treat 30,000 of the neediest patients in the EU. The value of the contract was 63 million euros. Kyriakidis also announced that arrangements will be made for additional amounts.
Thus, on October 8, the European Commission signed a new framework agreement with Giliad, this time to
500,000 courses per
treatment price
from 2070 euros
for each. The agreement, signed on behalf of the 27 member states and 10 partner countries, including Great Britain and the Western Balkans, is worth more than € 1 billion this time.
Two weeks ago, the European Medical Agency announced that it was starting to tighten safety monitoring of remdesivira after it was discovered that there were patients with severe kidney problems. However, the European Agency did not change its prescriptions for the use of the preparation.
On Friday, European experts called for a review of the expensive contract between the EC and Giliad, given the new results of the WHO study, Reuters reported. “The European Commission must explain the rush to conclude this treaty and review it in light of the findings of the Solidarity study,” said Janis Nazis, who represents patient organizations on the board of the European Medical Agency. According to the WHO, the American manufacturer knew the results of the study on September 28, when they were sent to it.
The US company told Reuters it received a heavily edited text from the WHO in late September, containing different information from the final document published on Friday.
Brussels’ decision on the new treaty came after several European countries complained of a shortage of remdesivir in their hospitals following the start of the second wave and a sharp increase in cases in Europe. “In times of public health emergency, we invest not only in the development of a vaccine, but also in access to therapy,” said an EC spokesman. However, he added that the European Medical Agency will study the results of the WHO study to “see if changes are needed in the use of the drugs studied.” Reuters also quoted Andrew Hill, a researcher at the Liverpool University Department of Pharmacology, as saying that the EU should reconsider the prices it pays for remdesivi.
“Why not?
pay a billion
euros for
medicine,
that does not affect
about survival? “, question. According to him, there are generics of the drug produced in India, which cost $ 200 per course. The European Commission’s agreement with Giliad does not oblige individual member states to buy the drug, but rather links them to the agreed price. By the way, even before there were doubts about the effectiveness of the drug, several experts from different countries complained that it is very expensive and therefore it is not possible to achieve equality in helping the sick in rich and poor countries.
As soon as the data from the WHO study, which dispute the benefits of remdesivirate, came out, the manufacturer “Giliad” rejected their findings. The company said that
The results
contradict
to others
studies
and noted that the findings have not yet been reviewed.
“Emerging data (from WHO) appear to contradict more reliable evidence from a series of randomized controlled trials (randomization is the distribution of patients into the control group or the randomized treatment group – br), published in peer-reviewed journals confirming the clinical benefit of remdesivir, ”the company said in a statement. “We are concerned that the data from this open global trial has not undergone the rigorous review required for constructive scientific discussion, especially given the limitations of the trial design,” the manufacturers added.
WHO immediately
protection
The methodology
of the study and announced that it would even recommend that regulators in different countries remove remdesiviru from the list of drugs for the treatment of COVID-19. The United States and the WHO have had tense relations since Trump announced he was cutting funding for the organization and accused it of conspiring with China to cover up information about the coronavirus.
Doctors in our country have two opinions
Specialists treating COVID-19 patients in Bulgaria also have two opinions on the use of remdesivir, a 24-hour inspection found.
In some of the major hospitals in the country, it turns out that doctors do not use the drug because they are concerned about the side effects it may have. In other places, it is included in the treatment only of more severe cases, in intensive care.
When not in use, they are based on proven and established combinations of antibiotics that cover the entire bacterial spectrum so that the best possible treatment is delivered.
“Statistics show that remdesivir is an effective drug for the treatment of COVID,” the head of the Cardiology Clinic, Associate Prof. Dobrin Vassilev, told Bulgarian National Radio on Sunday.
According to a large American study, the positive effect of the drug is a fact, so the opinion of the World Health Organization is questioned, “he explained.
There is a third opinion in the medical community, and that is that in a disease for which there is still no cure, every doctor tries to find the best solution and apply the best medicine, so the denial of medicines by the WHO does not is good. example.
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