This misleading article merely tries push a narrative that the drug company is trying to hide something and is pushing an incorrect narrative. It uses words like "shenanigans" in an attempt to push a twisted view of the situation. Let's outline what both Fauci and Gilead stated - Remdesivir is not a "miracle cure" and should not be viewed as one. The trial (which was not based in China unlike the false assertions in the article) showed that Remdesivir reduced the number of days to recover for hospitalized patients from 14 days to 11 days. Remdesivir did not reduce the fatality rate. Along with the clear notice that more study is needed to determine how effective (if at all) Remdesivir will be in the treatment of COVID-19. Both Fauci and Gilead have been very nuanced in their claims, did not raise false hopes, and made clear that Remdesivir should not be considered a "miracle cure". Remdesivir just received FDA approval for use as emergency treatment for COVID-19 in the past couple of days. Other drugs such as hydroxychloroquine were given emergency FDA approval weeks back with no on-shore study or trial in the U.S. The reality is that Remdesivir has been given more study than other drugs for COVID-19 treatment before receiving FDA emergency approval. The author's claim "the trial was rushed to get quick FDA approval, without getting helpful information on what kinds of patients it helps or hurts the most; and now that the study is over, we’ve forever lost a chance to help doctors treat virus patients better" is laughable. The reality is that there may not be an existing drug that is effective for treatment of COVID-19. However it is worth investigating the best candidates in studies.
since zerohedge is garbage; source opinion piece: https://www.bloomberg.com/opinion/a...a-huge-opportunity?srnd=opinion&sref=ZtdQlmKR Remdesivir Trial Missed a Huge Opportunity Rushing the drug through means we don’t know who it might help, or hurt. The big Covid-19 news this week was a promising result from a new study of remdesivir, an anti-viral produced by Gilead Sciences. But lost in all the discussion of how well the drug works — an earlier study found it wasn’t helpful — was a tragic failure: Gilead missed its one shot at getting vital information on specifically which patients the drug could help. The fact that a drug, any drug, seemed to fight Covid-19 is great news. But doctors also need information on whether older or younger patients were likely to benefit, for example, and how different pre-existing illnesses might tip the risk-benefit ratio. Instead, we got what Memorial Sloan-Kettering Cancer Center physician and epidemiologist Peter Bach calls the bare minimum of information — just enough to get the drug over the hurdles needed for approval. Now there are ethical barriers to the kinds of placebo-controlled studies needed to learn more. There’s a tremendous heterogeneity in patients — in age, health conditions, symptoms, viral load and genetics. More studies of remdesivir would surely have saved lives by revealing whether remdesivir helps only a subset of patients, and whether it might even be toxic to others. To recap: On Wednesday this week, the National Institute for Allergy and Infectious Diseases released results from a placebo-controlled trial of 800 patients, which showed those who got the real drug left the hospital earlier — after 11 days on average as opposed to 15. There was also a modest increase in survival which was not statistically significant. This study comes after Gilead sponsored two other trials — a larger one for the severely ill, which involved 6,000 patients but didn’t use any control cases for comparison. Another, smaller study, for patients with moderate cases of Covid-19, hasn’t been released. That study used a control arm, but no placebo. That means doctors knew which patients got the drug, setting them up for potential bias. There was also an earlier trial of the drug in Wuhan which found no benefit. But this study was discontinued early for lack of patients as the Chinese got their outbreak under control. These earlier trials were not very informative, says Bach. But now that there has been some hint of promise from the NIAID trial, he says, it will become the standard of treatment and make it ethically difficult to do any more placebo-controlled studies. With experts saying emergency-use authorization is imminent, Gilead is gearing up to make millions of doses. But the more ethical thing would have been to design the early trials to get as much insight as possible, says Bach. Now, in terms of data gathering, “We’re going to fall off a cliff.” From a risk-management perspective, it’s optimal for the company’s bottom line, says Bach. Even if the still-unreleased study on moderate illness trial shows no effect, it will likely be trumped by the NIAID one. Doctors are still on a steep learning curve and we’re only at the beginning of this pandemic. We should be trying as hard as we can to get as much insight as possible today. Rushing remdesivir through its early trials is a missed opportunity that might help some patients in the short term, but hurt many more over the months to come.
So show one -- just one trial of hydroxychloroquine that was done with a placebo-controlled study. It got FDA emergency use approval weeks back. Trying to push a narrative (like this author) that something is wrong because Gilead only provided the minimal information to get FDA emergency approval is totally off base. Any reasonable drug company would only provide the core information to get approval at this point in a crisis situation uncluttered by unnecessary extra information. Trying to call the limited information Gilead provided unethical is twisting the reality on medical expectations as we battle COVID-19 with accelerated emergency approvals needed.
Trading wise Gild has big sellers when it starts to make fast moves up. I take it as those with inside knowledge are not expecting Remdesivir to have that much of a financial impact on Gilds future earnings.
This is the best way to look at it from a market perspective. Remdesivir appears to have limited capability to help some COVID-19 patients by possibly reducing the number of days they are sick. It is not a "magic cure" - nor will it help Gilead's earnings much when viewed from a big picture perspective of all the drugs they manufacture.
The problem is that the issue of treatment has become political rather than medical... Coronavirus gets a promising drug. MAGA world isn’t buying it. On the heels of positive early signs for remdesivir, several prominent Trump boosters are downplaying the results and continuing to promote hydroxychloroquine. https://www.politico.com/news/2020/05/02/donald-trump-coronavirus-remdesivir-229765 Over three weeks ago, hydroxychloroquine was all the rage in MAGA world, despite flawed and scattered evidence about whether the drug could help cure coronavirus. Now there is another drug, remdesivir, with positive early scientific data. Much of MAGA world wants little to do with it. At first, it may seem like a head-scratching response. President Donald Trump’s base has been quick to trumpet any potential solutions to the coronavirus pandemic — especially those Trump himself promotes — regardless of the red flags from medical experts. But with remdesivir, it’s the Trump-boosting pundits who are raising the red flags, even as the president expresses optimism. Indeed, the same segment of the right that claimed scientists and the media were deliberately downplaying hydroxychloroquine in order to hurt Trump’s standing are now the ones downplaying remdesivir. On Fox News, Laura Ingraham suggested that remdesivir, as a newer drug being produced by the pharmaceutical company Gilead Sciences, could be unsafe and expensive. Those who initially helped raise the profile of hydroxychloroquine raised doubts about the remdesivir studies. The unexpected reaction appears to stem from the differences in how the two drugs came into the public spotlight. Hydroxychloroquine bubbled up through the MAGA grassroots — little-known investors promoted it online, got on Fox News and suddenly the president was talking about it from the White House. Remdesivir’s progress came through a government-funded trial that had the blessing of Dr. Anthony Fauci, the bête noire of Trump hardliners who blame the government’s top infectious disease expert for undermining the president and causing unnecessary economic damage with his social-distancing guidelines. Remdesivir’s connection to a pharmaceutical company also taps into suspicions on the right that corporate executives are trying to rake in huge profits from the coronavirus. Hydroxychloroquine, on the other hand, is already widely available in generic form. These factors were likely enough to turn off people who had been using hydroxychloroquine as a political rallying cry, said David Rapp, a psychology professor at Northwestern University who studies how misinformation shapes beliefs and memory. The hydroxychloroquine boosters, he said, “might find the alternative idea as not being pure, in the sense that it doesn't come from Trump. It's coming from other sources that they might not trust.” The MAGA base’s suspicions about remdesivir began shortly after Fauci on Wednesday announced the results of a government-sponsored clinical trial that showed that the drug shortened recovery time for coronavirus patients, calling it a “clear-cut, positive” development in the fight against the coronavirus. Fauci also made clear that this is a first step; more research needs to be done into this and other potential treatments. That night, Ingraham devoted a segment of her show that night arguing on behalf of hydroxychloroquine. Ingraham first suggested that remdesivir could present dangers, urging restraint until government regulators like the Food and Drug Administration could thoroughly review the treatment. “It hasn’t been approved by the FDA,” she said. “They might do emergency authorization. Hydroxychloroquine was approved decades ago.” The FDA — which Fauci does not run — in fact did move swiftly. On Friday it issued an emergency-use authorization to help patients get quicker access to remdesivir, the first antiviral to show promise against Covid-19 infection. Ingraham added that remdesivir, as a new drug, could be expensive, whereas “hydroxychloroquine is obviously cheap and already readily available.” She then brought out a doctor who defended hydroxychloroquine as “safe” and expressed worries that remdesivir, originally developed to fight Ebola, could be dangerous. The original promoters of hydroxychloroquine also chimed in with their concerns about remdesivir after Fauci’s announcement. James Todaro, a bitcoin investor who cobbled together a Google Doc pitching hydroxychloroquine as a coronavirus treatment that was widely circulated in conservative circles and caught the attention of Fox News, noted that several members on the government panel making treatment recommendations for coronavirus were affiliated with Gilead. The controversial French doctor Didier Raoult, who was behind a disputed and scientifically flawed study about hydroxychloroquine’s benefits for coronavirus patients, was similarly dismissive of the remdesivir results. “Two trials focused on remdesivir delivered their findings: one published in the Lancet, that concluded to an absence of clinical improvement, one another announced by Gilead then by Dr Fauci, that did not have any significative result concerning mortality,” Raoult tweeted. Shiva Ayyudurai, a prominent proponent of the #FireFauci movement who advocates for unproven vitamin therapy to treat the coronavirus, claimed that presenting remdesivir as a “save-all, be-all cure” to coronavirus had the benefit of boosting Gilead’s stock. “On the economic side, you have a situation where this is being moved in a fast track way and it is supporting their stock price,” he said in an interview. “On the health side, this is not about enhancing the immune health of the individual. It is a very, very short term solution.” Officials, including Trump, have been careful to note that remdesivir is not a coronavirus cure-all. Trump on Friday called it “an important treatment for hospitalized coronavirus patients." But the early success has come on the heels of several studies warning that hydroxychloroquine, or the related drug chloroquine, has little provable effect on treating coronavirus patients. One study in Brazil was halted after several patients began experiencing cardiac problems while on the drug, while an analysis of U.S. veterans’ hospitals suggested that patients who received hydroxychloroquine were more likely to die than those who did not. And earlier this week, the FDA published a warning that doctors should not prescribe either hydroxychloroquine or chloroquine to patients outside of a clinical trial. To the remdesivir detractors, these developments were merely a sign that the elites were, once again, at work behind the scenes. “Fauci loves insanely expensive drugs and hates cheap plentiful ones or any hint of preventative supplementation. You see how quickly he praised #remdesivir and has only scorn for #hydroxychroloquine?” tweeted commentator Bill Mitchell, who Trump has been retweeting this week. Mitchell was initially one of the loudest voices on the right dismissing the coronavirus threat and has attacked Fauci in the past. His reasoning? Fauci is “a big pharma puppet.” Fauci has been at the National Institute of Allergy and Infectious Diseases for decades. He receives a government salary and does not profit when a drug company makes money. Rapp said that attacks in this vein have a clear, non-medical goal in mind. “They're using rhetoric that allows them to not just think about which potential solutions might be useful for Covid, but also to push their political agenda,” he said, referencing the disease that develops from the coronavirus. Another factor, he added, was that hydroxychloroquine and chloroquine had entered the conversation first. “From a psychological perspective, thinking about how memory works, the first things that people mention are the ones that people hold on to, and they stick around longest,” he said. The best analogy, he said, could be found in the origins of the anti-vaccine movement, which continues to cite a widely-discredited medical study from the late 1990s. That study was so flawed that the journal that published it later retracted it — but it had lasting influence. “Anti-vaxxers read something about autism being caused by vaccinations, and they won't let that go even though there've been refutations of the original claims,” he said. “That information has been floating out there and either it's become part of their argument, or it's become part of their identity, part of who they are, part of how they make claims.” “Maybe,” he added, “hydroxy has a similar kind of effect on these particular audiences.”
Will Gilead price its coronavirus drug for public good or company profit https://www.reuters.com/article/us-...r-public-good-or-company-profit-idUSKBN22I2NM Gilead Sciences Inc (GILD.O) faces a new dilemma in deciding how much it should profit from the only treatment so far proven to help patients infected with the novel coronavirus. The drugmaker earned notoriety less than a decade ago, when it introduced a treatment that essentially cured hepatitis C at a price of $1,000 per pill. Public outrage over the cost of Sovaldi in 2013 - despite that it was a vast improvement over existing equally expensive therapies - ignited a national debate on fair pricing for prescription medicines that the pharmaceutical industry has fought to deflect ever since. That backlash has subsided considerably in the midst of the coronavirus pandemic, during which drugmakers’ efforts to develop vaccines and treatments is considered essential to battling a disease that has infected some 3.7 million people and killed over 258,000 worldwide. Gilead is now in the spotlight again after data showed its antiviral drug remdesivir helped reduce hospital stays for COVID-19 patients, and the U.S. authorized wide emergency use of the therapy. Wall Street analysts say remdesivir could generate $750 million or more in worldwide sales next year, and $1.1 billion in 2022, assuming the pandemic continues. But Gilead, and other drugmakers, will need to avoid the appearance of taking advantage of a global health crisis to rake in profit, according to pharmaceutical industry consultants and former regulators. “This is a tremendous opportunity for drug manufacturers,” to improve the industry’s image, said Ed Schoonveld, a drug pricing expert at consulting firm ZS Associates. “There has been an overwhelmingly negative focus on drug prices.” Gilead Chief Executive Daniel O’Day, in the post just over a year, is proceeding with caution. The company is donating enough remdesivir for at least 140,000 patients for distribution by the U.S. government to hospitals nationally. At a meeting with President Donald Trump in the White House on Friday, O’Day pledged to make the therapy available to those in need. Gilead also aims to increase worldwide manufacturing to supply over a million coronavirus patients by year-end, rising to several million in 2021, if required. The company has not disclosed its pricing plans. “I think this will certainly help the industry’s reputation,” O’Day said on a recent conference call with investors. “I’m not suggesting that there won’t continue to be focus and pressure on drug pricing ... but it’s being done now in a way where we can have an appreciation for the innovation the industry brings.” Gilead on Tuesday said it was talking with chemical and drug manufacturers to produce remdesivir for Europe, Asia and the developing world through at least 2022. The company said it was negotiating voluntary licenses with generic drugmakers in India and Pakistan, who would produce a lower-cost supply of remdesivir for developing countries. FEDERAL MARCH IN? Estimates of a fair price for remdesivir in the United States, where drugmakers generally charge the most for a new therapy, vary widely. The Institute for Clinical and Economic Review (ICER), which assesses effectiveness of drugs to determine appropriate prices, suggested a maximum price of $4,500 per 10-day treatment course based on the preliminary evidence of how much patients benefited in a clinical trial. Consumer advocacy group Public Citizen on Monday said remdesivir should be priced at $1 per day of treatment, since “that is more than the cost of manufacturing at scale with a reasonable profit to Gilead.” Some Wall Street investors expect Gilead to come in at $4,000 per patient or higher to make a profit above remdesivir’s development cost, which Gilead estimates at about $1 billion. Gilead shares have risen about 20% since the beginning of the year, largely on hopes for remdesivir. That compares with a drop of 12% for the broad S&P500 Index. Some experts warn that a much higher U.S. price for remdesivir would put Gilead back in the crosshairs on drug pricing. In a more extreme scenario, the company could risk federal or state government action to march in and invalidate the medicine’s patent protection in the name of public health and issue mandatory manufacturing orders. The U.S. government has never invoked those rights. But it has sued Gilead over patents on two of its widely-used HIV drugs that received federal funding grants while in development. “If there is ever a time when those issues might arise, this would be that time,” said Eric Katz, CEO at consulting firm HealthTech GPS, which advises the industry on pricing. Katz, a former official at the U.S. Food and Drug Administration and the Centers for Medicare and Medicaid Services, said the government could make similar arguments over remdesivir, which was originally developed to treat Ebola with federal funding, and is now being studied in a trial backed by the National Institutes of Health. Democratic lawmaker Lloyd Doggett of Texas, chairman of the House Ways and Means Health Subcommittee, sent Gilead a letter this week demanding the company detail its plans for remdesivir, including supply issues, disclosure of taxpayer investment in the drug’s development, and purchase and pricing arrangements. “American taxpayers have made a big investment in remdesivir, but now in return, those who need treatment may get only a big bill while Gilead gets a big payoff,” Doggett warned.
Gilead needs to be careful about getting too frisky. We are still early in the game and their results are okay, but not much better than just okay. and there are plenty of other drugs/options coming. Since their drug delivery method requires infusion, the patient could, then, just as easily be infused with convalescent plasma. Remdesivir showed some improvement in recovery time - I think about four days or so- compared to a control group which received nothing. Probably patients receiving z-pack and convalescent plasma could do as well or better than that. We shall see before long. I follow remdesivir with interest but see no reason to give the farm away to them just yet. Their results look luke-warm to me and it is very expensive. Of course, time is on their side right now because it is kinda all we got- other than still looking at hydroxy and ramping up plasma transfers. Guess what though. Time does pass. And six months will make a lot of difference. Don't get too frisky Gilead.