Remdesivir Gilead of Sciences proclaimed our best hope in the fight against the coronavirus pandemic. Unfortunately, the antiviral drug does not really help patients with Covid-19, a disease caused by coronavirus. Although the company’s smart deployment has caused a stir among investors, politicians and the public, the combination of generic drugs, which appears to be more effective in combating coronavirus, has come under the radar.
Despair over a limited supply of remdesivir is so great that Virginia will hold a lottery to determine which of the nearly 1,500 seriously ill patients in the state will be able to receive several hundred donated doses of the drug. In Minnesota, government officials came up with action plan distribute their supply of Covid-19 treatment, which requires the appointment of “sorting officers” who will randomly select among equally suitable patients. And in Alabama, doctors from the coronavirus task force created by the governor will determine which patients are receiving remdesivir.
Some hospitals will receive only one course of treatment. However, Alabama’s health officer, Dr. Scott Harris, recently thanked Gilead, the drug maker, who handed over to the federal government some 940,000 drug vials distributed by state health departments. “Although the total amount of remdesivir is limited, we are grateful that hospitalized patients with severely ill COVID-19 in Alabama can receive this potentially life-saving drug,” Harris said.
It is against the backdrop of these feelings of shortage and debt that Gilead sets the price for its antiviral drugs. It is expected that the company, which has already organized the distribution of remdesivir in 127 countries, will begin selling it for commercial purposes in June. And while a 10-day course of a drug that was developed as a potential treatment for Ebola, at least 79 million dollars According to US government funding, the cost of production is only about 10 US dollars. estimate The Institute of Clinical and Economic Research expects its market price to be several hundred times that amount.
However, price gouging is not something that many scientists are upset about remdesivir. It is the fact that the coronavirus drug that inspired hope and sent Gilead share price (and, according to some analysts, whole stock market) it seems that soaring does not really help patients with coronavirus.
“As far as I can tell, Remdesivir does not work at all or has only a slight effect” said William Hazeltin, a scientist who has been researching viruses for decades and helping US leaders respond to the HIV / AIDS epidemic.
“This is comparable to Tamiflu and perhaps not even so good.” Hazeltin added, citing another antiviral drug that has been available over the counter for 20 years and is expected to be sold over the counter in the coming months.
Hazeltin, who founded the Department of Biochemical Pharmacology and Human Retrovirology at the Harvard University School of Public Health, noted that Gilead does not publish data showing the effects of remdesivir on viral load in people with Covid-19. Meanwhile, the only information available on how the drug affects the amount of coronavirus in patients Learning chinese a drug published in The Lancet showed that the drug does not reduce viral load.
“That’s why I call it a fuzzy drug.” said Hazeltin.
“When the Chinese tried to find an antiviral effect, it was not there.”
Instead, the worry about Remdesivir is largely based on study of Sponsored by the National Institute of Allergy and Infectious Diseases, which showed that people taking the drug recovered faster than those who didn’t take it: an average of 11 days compared to 15 for those taking a placebo. An article published May 22 in the New England Medical Journal showed a slight improvement in hospitalized patients who took remdesivir, although the drug did not seem to help the sickest patients who needed to receive high-flow oxygen through ventilators. or other means. In addition, the drug did not significantly improve the patient’s chances of surviving Covid-19.
However, at a press conference in the Oval Office on April 29 with President Donald Trump, NIAID Director, Dr. Anthony Fauci said the preliminary results of this test proved that “the drug can block this virus.” Since then, remdesivir is positioned as our savior, and Gilead as its benevolent dispenser.
While some patients and their families have spent the past few weeks desperately trying to get remdesivir, it has been proven that another Covid-19 drug is more effective. Although none of the options seems to be such a popular drug for Covid-19, the three-drug regimen suggested a greater reduction in the time needed for patients to recover than remdesivir. People who took the combination of interferon beta-1b, lopinavir-ritonavir and ribavirin recovered within seven days, as opposed to 12 days for those who did not. Critically, the medication has another leg on Gilead’s: it clearly reduced the amount of coronavirus in patients who took it, according to study of Posted in The Lancet May 8th.
However, so far there has not been a stampede of patients requiring a new dosage regimen or lotteries, which may be due, at least in part, to the fact that the treatment was not the subject of a major marketing campaign. It is worth noting that each of the three drugs in the new combination is generic or no longer subject to the patent, which means that no company will receive significant profits from its use.
On the contrary, Gilead, a company that had more than $ 22 billion in revenue in 2019 and is going to make money on remdesivir for many yearsThe company carefully organized the deployment of its new method, distributing small, specialized pieces of encouraging press information and emphasizing its compassionate use program.
It is very common for pharmaceutical companies to paint their products in a rainbow light or to take dubious steps to maximize profits. And Gilead, which provided profitable orphan drug status for remdesivir in march to reverse course two days later, he was already faced with widespread criticism, especially in connection with exorbitant prices for his HIV medications Truvada and the drug sofosbuvir for hepatitis C, which is sold for $ 1,000 per pill.
But during a pandemic, noise, politics and greed play an even larger role than usual in determining which drugs are commonly used, while the normal scientific process of evaluating their safety and effectiveness is accelerated and reduced. Trump who excitement aroused about the drug malaria hydroxychloroquine, he has a drug took himself despite the absence of Covid-19, it was the leader.
“You have a president who puts strong pressure on companies, regulators, and others to save his re-election,” said Dr. Michael Carom, director of public health research at Citizen. The consequences warmed by Kar can be fatal.
“I’m really worried that with all the hype and press from the White House, we will deliver something to the market too quickly and harm many people. This is a danger.
It has already been shown that the risk of death is increased in Covid-19 patients who take hydroxychloroquine. According to study of published in Lancet last week, approximately 15,000 people who received hydroxychloroquine or a closely related drug, chloroquine, were about twice as likely to die as those who did not.
The benefits of all drugs must be balanced with their harm. In the case of remdesivir, these hazards include possible damage. kidney and liverWhile the risks and benefits are usually clarified upon further study, NIAID canceled a study of remdesivir, which could provide more information about both drugs so that patients who received a placebo could take the drug.
In addition to possible harm to patients, deciding on coronavirus therapy and vaccines on deception rather than science also carries the risk of premature investment in one product at the expense of another. “It is possible that we are now putting a lot of effort into finding a drug that could lead to fewer studies on something that could be safer or more effective,” Karom said of what he called dubious enthusiasm for regarding Remdesivir. After the drug is received Emergency Permit On May 1, Public Citizen from the Food and Drug Administration for Food and Drug Administration filed a FOIA request for the complete data underlying the decision. The FDA has not provided the group with any documents and usually treats such data as proprietary.
Meanwhile, the excitement surrounding the development of another coronavirus seems to be moving faster than science. Last week, Moderna biotech company also moved markets with an uncertain announcement of preliminary research results. In this case, the company described the initial test results of its potential coronavirus vaccine as “triumphant,” although they were based on eight people from a relatively early stage of the study.
“Most products that have passed this stage will ultimately fail.” said public citizen Karom. Although the company summarized its data, it did not disclose it. “We need to see the details, but we probably won’t.”
The vaccine development process promises to be faster and more vulnerable to conflicts of interest. On May 14, Trump announced the Warp Speed operation, which the administration had undertaken to manufacture and distribute the coronavirus vaccine by the end of the year, despite experts insisting that the process is likely to take years. The operation is headed by the former head of the pharmaceutical company Monsef Slough, who since 2016 has received more than 13.5 million dollars from pharmaceutical and biotechnological firms. Slough also had 155,000 shares of Moderna, whose value rose more than $ 2 million after the good news about her vaccine went live. Under an unusual arrangement, compensation for his work in the government is only $ 1 and is exempted from ordinary federal laws on disclosure and conflict of interest. After Senator Elizabeth Warren attracted attention to his conflict of interest, Sloughy dismissed his shares in Art Nouveau and announced that he would donate money for cancer research, which he earned on their increase after joining Operation Warp Speed.
Although vaccination may be the best hope to put an end to a pandemic as soon as possible, mistakes made due to haste or conflict of interest can have devastating consequences. Since it is planned to vaccinate about 1 billion people worldwide, even infrequent side effects can occur on a massive scale. Wrong vaccines can even spread the disease. “They can give you an unpleasant cold that you can give to unvaccinated people,” Hazeltin said.
The current power of politics and the greed for science make such results more likely.
“I fear that a group of speed distortions will distort our regulatory process and that the administration will make every effort to achieve a result, regardless of the cost of human life,” said Hazeltin.
“People think that deformation means very fast, but deformation also means distortion.”