Friday, 7 Aug 2020

Dr Fauci says US should share remdesivir with the world

Dr Fauci says US should share remdesivir with the world after Trump administration cornered world supply in drug used to treat Covid-19

  • Dr Fauci – US’ top disease expert – says the drug should be shared around world 
  • Trump administration has ‘struck an amazing deal’ with remdesivir maker Gilead 
  • For July, Gilead has sold its entire production of the antiviral to the US 
  • Americans will get 90 per cent of the global supply for August and September 
  • Rest of the world will be forced to go without the potentially life-saving drug 
  • Unclear how much US paid but Gilead prices it at $3,200 per treatment course 

America’s top infectious disease expert Dr Anthony Fauci today demanded that Donald Trump share coronavirus wonder drug remdesivir with the world after the US bought up most of the globe’s supply.

Dr Fauci, director of the National Institute of Allergy and Infectious Diseases, says he is in favour of an ‘equitable type of distribution’ of the treatment – one of only two drugs proven to be effective against Covid-19.

Donald Trump was today accused of ‘undermining’ the global coronavirus fight by potentially denying the rest of the world supplies of remdesivir.

Remdesivir is the only drug approved in the US to treat coronavirus. Department of Health and Human Services (HHS) announced the purchase on Monday. It means that any other country will be hard-pressed to get access to the potentially life-saving antiviral medication.

Speaking to BBC Radio 4, Dr Fauci said: ‘I’ve always been as a scientist and a public health official one that feels strongly that whenever you get an intervention, you should have a real careful look at the equity of trying to get some reasonable equitable type of distribution, particularly when you get a product that’s limited’.

The scientist said that if the US produces the best vaccine, it should also share it with the world.

He said: ‘When the United States government is involved in, to a greater or lesser degree, subsidising the development of a number of vaccines, not only ones that were developed in the government auspices, but those in which various candidates at various companies are utilising resources from the government to develop their vaccine – as part of that, we made it clear that we wanted to make sure that enough vaccine was produced.’  

Dr Anthony Fauci, pictured today, demanded that Donald Trump share coronavirus wonder drug remdesivir with the world after the US bought up most of the globe’s supply

The US has bought almost the entire global supply of remdesivir (pictured), one of only two drugs proven to be effective against coronavirus

Britain’s business minister Nadhim Zahawi has criticised the US President’s decision to make the rest of the world compete for the medication, originally designed to treat Ebola but proven to speed up recovery time for coronavirus patients. 

Mr Zahawi told Sky News: ‘It’s much better to work together than to work to undermine each other, so we’ll continue in that spirit.’ 

WHAT IS REMDESIVIR AND DOES IT WORK AGAINST COVID-19? 

Remdesivir was developed by Gilead Sciences to treat Ebola, the deadly hemorrhagic fever that emerged in West Africa in 2014.

Ebola, like Covid-19, is caused by a virus, and scientists have tested remdesivir to treat coronavirus patients.

Trials produced encouraging results earlier this year when it showed promise for both preventing and treating MERS – another coronavirus – in macaque monkeys. 

Studies on humans have produced mixed results.

In a US government-led study, remdesivir shortened recovery time by 31 per cent — 11 days on average versus 15 days for those given just usual care. 

But it had not improved survival according to preliminary results after two weeks of followup. Results after four weeks are expected soon.

The drug appears to help stop the replication of viruses like coronavirus and Ebola alike.

It’s not entirely clear how the drug accomplishes this feat, but it seems to stop the genetic material of the virus, RNA, from being able to copy itself.

That, in turn, stops the virus from being able to proliferate further inside the patient’s body.

He said the UK had ‘rightly’ stockpiled dexamethasone, another accepted treatment for coronavirus, but suggested cooperation rather than competition was the way forward.

Dr Andrew Hill, a senior visiting research fellow from Liverpool University, said: ‘This deal that’s been struck by America means that people with Covid-19 in the UK can’t get access to these treatments that would get them out of hospital quickly and might improve their chances of survival.

UK patients took part in the clinical trials that showed that the drug worked, Dr Hill said. ‘A lot of drugs haven’t worked, so I think the people in Britain deserve something in return from the United States,’ he said.

‘We have to have equality between countries. We have to have the ability of UK health authorities to access these drugs in return for taking part in these studies and people risking their own health.’

Dr Deborah Gleeson, Public Health lecturer from LaTrobe University in Melbourne, Australia, told SBS News: ‘It’s quite outrageous that the US government has bought up almost the entire next three months supply of remdesivir.

‘It’s a very concerning precedent because if we see the vaccine coming from a US company, we’re likely to see the same type of behavior and hoarding by the US and other developed countries.’

‘With a pandemic like Covid-19, the problem won’t be solved until it’s sold for the whole world.’

Many countries fear the US action will leave them short of the drug in the event of a second wave of the virus later this year.  

Italian newspaper La Repubblica said supplies to Europe were at ‘high risk’ while a spokesman for the German Ministry of Health said: ‘The federal government secured remdesivir for the treatment of corona patients at an early stage. 

‘There are still enough reserves at the moment. Approval of Remdesivir for use in the European market is expected later this week. Admission entails the obligation to be able to deliver to a reasonable extent. We expect Gilead to honor that commitment. ”

 María Jesús Lamas, spokeswoman for the Spanish Agency for Medicines and Health Products, said: a ‘strict monitoring’ of the ‘stock’ of remdesivir is being carried out and they have asked the subsidiary of the company in Spain to ‘bring as many treatments as possible.’

She added that if the current situation remains the same there should be enough stock but it is unclear if the country suffers from an outbreak similar to what occurred in the Spring.

 New York University bioethicist Dr Arthur Caplan told DailyMail.com: ‘I suspect there will be enough demand [in the US] – even though remdesivir is not a wonder drug – that it will be used here and won’t go anywhere else for many, many months. 

‘It’s not a huge loss, but it’s a loss. It will mean more suffering. I don’t think it’s going to cost lives.’ 

National Institutes of Health (NIH) tests of remdesivir indicated that patients treated with the drug recovered 31 percent faster than those who got a placebo. 

The US Department of Health and Human Services (HHS) announced the deal with Gilead last night. Pictured, President Donald Trump on Thursday, June 25

‘We deliberately made sure that we had enough stock of dexamethasone, rightly so,’ he said.

‘But we also want to cooperate because the best outcome for the whole world is that we work together.’

Dexamethasone, a cheap steroid that has been around for decades, became the first medicine proven to reduce the death rate among hospitalized patients. 

One leading Oxford University scientist involved in trials of the medicine called for fairer access to the drug, manufactured by California-based pharmaceutical firm Gilead Sciences. 

Professor Peter Horby, chair of the UK government’s advisory panel Nervtag, said Gilead would have been under ‘certain political pressures locally’ as a US company.

The Oxford scientist told BBC Radio 4’s Today program argued that fair pricing and access of any drugs proven to fight the coronavirus were two crucial issues in the pandemic.

Professor Horby said: ‘The trial that gave the result that allowed remdesivir to sell their drug wasn’t just done in the US, there were patients participating through other European countries, in the UK as well, and internationally, Mexico and other places.

‘And I wonder how they would feel knowing now that the drug is going to have restricted availability in their own country and would they have volunteered for that trial if they had known that?’ 

Mr Zahawi went on to highlight deals struck by AstraZeneca to supply a vaccine around the world if the Oxford team’s work is successful.

‘By attempting to compete, I think we ultimately undermine all of our strategies.’ 

Meanwhile, Gilead has donated a supply of the drug to Australia’s national medical stockpile, with the federal health minister, Greg Hunt, saying there will be enough to meet demand in the county.

Despite this Alice Motion,  Associate Professor from University of Sydney’s school of chemistry said the US actions were ‘a real concern’.

She said: ‘Remdesivir is a medicine that helps people to recover faster, but imagine if the same thing happened with a vaccine that emerges. That would be terrible.’

 Associate Professor Barbara Mintzes from the University of Sydney’s Charles Perkins Centre and School of Pharmacy told The Guardian: ‘The US arrangement to buy 500,000 doses of remdesivir from Gilead raises concerns not only about access in other countries but also how to prevent profiteering from the Covid-19 pandemic and ensuring that patients who need treatment are able to access it.’ 

British business minister Nadhim Zahawi accused President Donald Trump’s administration of ‘undermining’ the global fight against coronavirus by making countries compete for medications proven to help

It comes after the German government strongly condemned an alleged US attempt to get exclusive rights to a vaccine being developed by CureVac, a pharmaceutical company based in the southwestern Germany city of Tübingen, in March.

In May, the French government reminded home-grown pharmaceutical giant Sanofi that equal access for everyone to any future vaccine ‘is not negotiable’ after the company’s CEO told US media Washington would be prioritized. 

Sanofi later changed its mind under pressure from the French government.

Justin Trudeau, the Canadian Prime Minister, previously warned: ‘We know it is in both of our interests to work collaboratively and cooperatively to keep our citizens safe.’ 

The drug will likely be unavailable for critically ill patients across Europe until October, raising fears for coronavirus patients in the across the world (Pictured: Gilead Sciences in California)

The drug’s impact on survival odds was minimal. Just over seven percent of those on remdesivir died, compared to 11.9 percent of those on not on the drug. 

But even this potential benefit will be unavailable to other countries for at least the next three months. 

WHAT IS THE OTHER DRUG USED TO TREAT COVID-19? 

Dexamethasone, a cheap steroid that has been around for decades, became the first medicine proven to reduce the death rate among hospitalised patients.

An Oxford University scientist who led a British trial of the drug, Professor Peter Horby, said treating eight people with the drug could save one life and cost just £40 in total.

It could save up to 35 per cent of patients relying on ventilators – the most dangerously ill – and reduce the odds of death by a fifth for all patients needing oxygen at any point. 

Dexamethasone, first created in the 1950s, is usually given to treat ulcerative colitis, arthritis and some types of cancer. 

It is already licensed and proven to be safe, meaning it can be used in human patients immediately, and is a generic drug, meaning it can be manufactured cheaply and en masse by companies all over the world.

Results of the RECOVERY trial, which involved 6,000 Covid-19 patients and was led by Oxford University scientists, suggest the steroid can prevent death in one in eight ventilated coronavirus patients and one in 25 on breathing support. It is the first trial to show a treatment provides significant impact in reducing the risk of death.

But the drug — given as either an injection or once-a-day tablet — had no benefit for people who were hospitalized with the virus but did not require oxygen.

‘The WHO and other groups have said that it’s not good to hoard a drug that you don’t need…people may argue that we should give it to the countries that need it most,’ Dr Caplan said. 

‘But Trump has made it clear that he is going to provide drugs and vaccines – if they become available – to Americans first. He feels it’s the right thing to do and I suspect that there’s a little bit of a political motivation, given that there’s an election coming up, I’m not surprised at all.’ 

Gilead Sciences, which makes remdesivir, has already donated about 120,000 treatment courses of the drug to the US stockpile – a supply set to run out next month. 

Remdesivir is under patent to Gilead, which means no-one else is able to make the drug without permission. 

An option for the British government is the  ‘compulsory license’, which is a legal tool that would allow the Gilead’s patents for the drug to be ignored.

Generic versions of the drug could them be bought from countries such as India which do not recognize the patent.

However, the UK does not like to do this as it would irritate the domestic pharmaceutical industry which claims 20 year copyrights are needed to make back the cash invested in developing new treatments. 

Now the US will have guaranteed access to all 500,000-plus treatment courses the company plans produce in July, and 90 percent of its production for August and September. 

‘President Trump has struck an amazing deal to ensure Americans have access to the first authorized therapeutic for COVID-19,’ said HHS Secretary Alex Azar. 

‘To the extent possible, we want to ensure that any American patient who needs remdesivir can get it. 

‘The Trump Administration is doing everything in our power to learn more about life-saving therapeutics for COVID-19 and secure access to these options for the American people.’ 

 Hospitals will be able to purchase the drug in amounts allocated by the HHS and state health departments.

As this is a hospital drug patients will not pay for it directly – for Medicare and most private insurers the cost is incorporated into payments made by the insurer.

 The HHS has already been allocating 1.5 million doses donated by Gilead earlier in the outbreak after remdesivir first showed its effectiveness against the disease caused by the SARS-CoV-2 coronavirus in clinical trial results announced at the end of April.

According to the HHS it will continue to allocate the drug to states and areas based on Covid-19 hospital burden.

Brian Hicks, Medical Devices Analyst at GlobalData, a leading data and analytics company, said: ‘The US Government’s latest purchase will have wide-ranging implications for its own citizens, as well as for the broader global community. Firstly, as six doses of remdesivir are administered per treatment per patient, less than 100,000 patients in the US will initially be treated with it. According to GlobalData’s COVID-19 Dashboard, there are over 1.7 million active cases currently in the US. Combined with a concerning resurgence of cases in recent weeks, the majority of US patients in the next few months will fail to access the drug.

‘Secondly, with Gilead’s recent remdesivir pricing announcement, some patients, regardless of whether under private insurance or certain government programs, will also struggle to even afford treatment. Many COVID-19 patients who lack health insurance or sufficient funds will view remdesivir treatment as a luxury.

‘Thirdly, it will take almost three months for Gilead to produce the initial 500,000 approximate doses even just for US patients, meaning that the millions of COVID-19 patients outside the US will not have access to the drug until October 2020 at the earliest. Even when additional stocks become available, this is a clear ethical issue as it is possible that rich, developed nations will purchase all available stocks and thus leave poorer, developing nations to continue seeking treatments.

‘As Gilead’s remdesivir production rate is projected to increase in the next few months, GlobalData expects hundreds of thousands of patients to be treated with it before a potential vaccine is developed. The accelerated recovery of these patients’ health will also benefit hospitals, as more beds, ventilators, and other medical devices will become available for other patients. Despite these benefits, Gilead should continue to address the availability and cost challenges, as this pandemic will need to be conquered by all countries cooperating and supporting one another.’ 

The Centers for Disease Control and Prevention (CDC) estimated that there were 98.4 people hospitalized for every 100,000 people in the US. 

Various models have estimated that by mid-July, between 1,000 and 15,000 Americans will be newly hospitalized a day. Many of those projections have shifted upwards in recent weeks, as the number of new cases in states like Texas and Arizona have hit new highs on a daily basis. 

By July 15, the University of Washington’s Institute of Health Metrics (IHME) currently projects that 209,553.86 US hospital beds will be full.   

With 100 percent of Gilead’s supply committed to the US next month, 94,200 patients will be able to receive a full treatment course. 

The US has purchased 100% of next month’s global supply of the antiviral remdesivir to treat American coronavirus patients and 90% of the supply for August and September, meaning there will be very little left for other nations 

Gilead has been criticized for charging $2,340 for a typical remdesivir treatment course for those covered by government health programmes in the US and other developed countries. This is despite remdesivir costing less than $10 to produce.

Gilead Sciences Inc rose 1.8 per cent as a result of its pricing, as Wall Street’s main indexes inched up on following a sharp selloff last week.

HOW MUCH WILL REMDESIVIR COST?

Gilead Sciences announced it would charge governments of developed countries $390 (£320) per vial of remdesivir. 

Most hospitalized patients will need six vials of the Ebola drug — equating to $2,340 for every patient, the California-based firm said.  

Gilead’s chief executive Daniel O’Day revealed the pricing structure in an open letter.  

Mr O’Day wrote the firm had set the price for developed countries ‘to ensure broad and equitable access at a time of urgent global need’.

It did not announce which countries this would apply to — and said the $390 price would apply to Americans covered by government healthcare. 

For US private insurance companies, the cost will be $520 (£420) per vial, or a total of $3,120 (£2,540) per patient.

But Gilead is allowing pharmaceutical firms to make generic supplies of the drug in 127 poor or middle-income countries.  

The price was swiftly criticized with a consumer group called it ‘an outrage’ because of the amount taxpayers invested toward the drug’s development.  

The drug interferes with the virus’s ability to copy its genetic material, stopping the virus from proliferating further inside the body. 

In a US government-led study, remdesivir shortened recovery time by 31 per cent — 11 days on average versus 15 days for those given just usual care. 

But it had not improved survival according to preliminary results after two weeks of followup. Results after four weeks are expected soon.

The Institute for Clinical and Economic Review, a nonprofit group that analyzes drug prices, said it likely costs $9.32 (£7.60) to make a 10-day course of remdesivir.  

‘This is a high price for a drug not shown to reduce mortality,’said Dr Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic.

 ‘Given the serious nature of the pandemic, I would prefer that the government take over production and distribute the drug for free.’

Peter Maybarduk, an attorney at the consumer group Public Citizen, called the price ‘an outrage.’

‘Remdesivir should be in the public domain’ because it received at least $70million in US public funding toward its development, he said.

‘The price puts to rest any notion that drug companies will “do the right thing” because it is a pandemic,’ Dr Peter Bach, a health policy expert at Memorial Sloan Kettering Cancer Center in New York said. 

‘The price might have been fine if the company had demonstrated that the treatment saved lives. It didn’t.’

Gilead says it will have spent $1billion on developing and making the drug by the end of this year.

The drug has emergency use authorization in the US and Gilead has applied for full approval. 

President Trump and his administration have taken a resolutely ‘America-first’ approach to the coronavirus pandemic 

In 127 poor or middle-income countries, the company is allowing generic makers to supply the drug. Two countries are doing that for around $600 per treatment course. 

‘We’re in uncharted territory with pricing a new medicine, a novel medicine, in a pandemic,’ Gilead’s chief executive, Dan O’Day, said. 

Gilead estimated that with 90 percent of its supply dedicated to the US government for August and September, there will be enough of the drug for 174,900 and 232,800 treatment courses, respectively, each of those months. 

Cases are expected to rise in much of the rest of the world as well. Brazil, for example, is projected to need more than five times as many beds per 100,000 people in its population as the by July 15, according to IHME’s model. 

Saudi Arabia is projected to have 15 times as many full beds. 

By September, the IHME model projects that the number of hospitalizations for coronavirus will be higher in nations in Africa, the Middle East and South America than in the US 

But for those nations, there will be no remdesivir – an antiviral originally developed to treat Ebola, which can shorten recovery times markedly, and may improve survival odds, marginally – available next month, and very little available through August and September.  

The international community never managed to agree upon a way to fairly distribute vaccines and treatments for the 2009 H1N1 swine flu. 

And there are no entities with the authority to enforce such distribution. The WHO can call upon nations to behave in a philanthropic manner, but it has no punitive authority. 

‘Who’s in charge to say where [a drug or vaccine] will go? It’s really just local governments and they tend to respond politically more than ethically or scientifically,’ said Dr Caplan. 

Hoarding remdesivir away from the rest of the world may not have particularly deadly consequences for other countries, but it’s the latest signal of a nationalist posture that could, if and when a vaccine is available, Dr Caplan said.  

‘I think when China has one, it’s likely want to keep its vaccines [for itself], and India for India, and Britain for Britain, and the US for the US, too.

‘We need to have a much more serious discussion about the future distribution for drugs and vaccines.’ 

China has already approved an experimental COVID-19 vaccine for its military members, and the UK currently leads the race among the rest of the world’s nations – so it could even be the US that loses out on the life-saving immunization as a result of the nationalist approach to development being taken by the Trump administration and, seemingly, much of the world. 

HOW HAS REMDESIVIR PERFORMED IN CLINICAL TRIALS? 

Remdesivir, an anti-viral drug first made to try and treat Ebola, has been used experimentally on Covid-19 patients since the outbreak’s early days.

It is approved for use by doctors in the US and UK based on early data suggesting it might be helpful, but scientific evidence has been mixed. 

There are claims of miraculous recovery, improved survival odds and shorter illness, but other studies have found it makes no difference to patients in hospital with Covid-19.

Here is what research has found so far:

‘Highly effective’ in Chinese petri dish experiments (February)

Doctors writing in a study led by the Wuhan Institute of Virology, published in the prestigious scientific journal Nature in February, said: ‘Our findings reveal that remdesivir [is] highly effective in the control of 2019-nCoV infection in vitro.’

They added that, since the drug is proven to be safe in humans, it ‘should be assessed in human patients suffering from the novel coronavirus disease’.

Sudden turnaround in critically-ill US hospital patients  (March) 

George Thompson, an infectious disease specialist at the University of California Davis Medical Center, was part of a team that gave remdesivir to a sickly American woman with Covid-19 in February. 

‘We thought they were going to pass away,’ Thompson told Science magazine. But 36 hours after the woman was admitted to hospital, doctors decided to treat her with remdesivir. Within a day, she saw a drop in the quantity of virus in her body and her condition began to improve.  

Richard Childs, an assistant surgeon general and lung specialist at the National Institutes of Health, told The Wall Street Journal Friday that 14 American patients from the Diamond Princess cruise ship were treated with remdesivir in Japan. 

‘Many of them were probably going to die in a short amount of time, and two weeks later nobody has died and more than half of them have recovered. It’s just absolutely amazing,’ he remarked. 

‘Encouraging’ results from uncontrolled trial on 53 patients (April)

A study published in the New England Journal of Medicine in April revealed the effects the drug had on a group of 53 Covid-19 patients in the US, Europe, Canada and Japan.  

Thirty-four of them were sick enough to require breathing machines. All were given the drug through an IV for 10 days or as long as they tolerated it.

After 18 days on average, 36 patients, or 68 per cent, needed less oxygen or breathing machine support. Eight others worsened. Four discontinued treatment because of health problems they developed.

Seven patients died, nearly all of them over age 70. That 13 per cent mortality rate appeared lower than seen in some other report, but comparisons were weak.

‘It looks encouraging,’ said Dr Elizabeth Hohmann, an infectious disease specialist at Massachusetts General Hospital. 

Patients discharged after taking remdesivir in ‘hopeful’ Chicago trial (April)

University of Chicago Medicine recruited 125 people with COVID-19 as part of global clinical trials. Of those people, 113 had severe disease, STAT news reported in April.

All the patients were treated with daily infusions of remdesivir. The antiviral medication led to ‘rapid recoveries in fever and respiratory symptoms’, with ‘nearly all patients discharged in less than a week’, the study claimed.

Most of the patients were discharged after their symptoms eased over a week, and only two patients had died at the time of publication.

The paper’s author called the findings ‘hopeful,’ but cautioned it is difficult to interpret the results since they did not include comparison to a control group.

No benefit for patients with Covid-19, major Chinese study finds (April)

Chinese researchers published results from one of the first randomised controlled studies – the gold standard – of remdesivir in April.

Professor Bin Cao, from China-Japan Friendship Hospital and Capital Medical University in China, who led the research, said: ‘Unfortunately our trial found that, while safe and adequately tolerated, remdesivir did not provide significant benefits over placebo.’   

Those on the placebo drug (78 people) had similar outcomes to those given remdesivir (158). It took a shorter time for the remdesivir-treated patients to get better, 21 days compared with 23, but this was not statistically significant.

A randomised controlled trial of remdesivir carried out in China and published in The Lancet produced disappointing results. The drug did not significantly benefit hospitalised patients because it did not speed up recovery or reduce deaths

There was a one per cent difference in mortality rate between the two groups, meaning it didn’t shower a clear benefit in survival rates. 

It was also noted that a larger number stopped their treatment because of adverse events while on remdesivir, such as constipation and anaemia. 

Independent scientists said the trial was too small to write off the drug and that it wasn’t the ‘end of the story’ for remdesivir.

Death rate cut from 12% to 7% among 1,000 patients (May) 

A study published in the New England Journal of Medicine saw remdesivir cut the mortality rate of 1,063 hospital patients around the world.

Patients given remdesivir had a recovery time that was almost a third (31 per cent) faster than those given a placebo – 11 days compared to 14. 

Results also suggested a survival benefit, with a lower mortality rate of 7.1 per cent for the group receiving the drug, compared with 11.9 per cent for the placebo group. But this is not deemed a significant difference. 

Recovery rates improved by 65% (May)

Trial results published by remdesivir’s own manufacturer, Gilead, said it seemed to show improved recovery times for Covid-19 patients. 

The ‘SIMPLE’ trial involved 600 people and evaluated five-day and 10-day courses of remdesivir plus standard care, versus standard care alone. 

Each group in the study included around 200 patients who were hospitalised with moderate Covid-19, meaning they were sick but not in intensive care.

Patients in the five-day remdesivir treatment group were 65 per cent more likely to have clinical improvement at day 11 compared with those in the standard care group. The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard care were also 31 per cent higher.

The statistic is favourable but did not reach statistical significance, Gilead said. 

It was not clear why those given a longer treatment course did not get better as quickly as those in the five-day group.

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