Matthew Perrone And Marilynn Marchione, The Associated Press
Published Friday, May 1, 2020 7:25PM EDT
WASHINGTON – U.S. regulators on Friday allowed emergency use of the first drug that appears to help some COVID-19 patients recover faster, a milestone in the global search for effective therapies against the coronavirus.
The Food and Drug Administration said in a statement that Gilead Science’s intravenous drug would be specifically indicated for hospitalized patients with “severe disease,” such as those experiencing breathing problems requiring supplemental oxygen or ventilators.
President Donald Trump announced the news at the White House alongside Gilead CEO Daniel O’Day and Food and Drug Administration Commissioner Stephen Hahn.
“This was lightning speed in terms of getting something approved” said Hahn, calling the drug “an important clinical advance.”
The FDA acted after preliminary results from a government-sponsored study showed that the drug, remdesivir, shortened the time to recovery by 31%, or about four days on average, for hospitalized COVID-19 patients.
The study of 1,063 patients is the largest and most strict test of the drug and included a comparison group that received just usual care so remdesivir‘s effects could be rigorously evaluated.
Those given the drug were able to leave the hospital in 11 days on average vs. 15 days for the comparison group. The drug may also help avert deaths, but the effect is not yet large enough for scientists to know for sure.
Dr. Sameer Khanijo, a critical care specialist, said he wants to see additional studies to clarify the drug’s benefit.
“I don’t think this is a cure yet, but I think it’s starting to point us in the right direction,” said Khanijo of North Shore University Hospital in New York. “As a society it’s nice to have something that will help stem the tide of this disease.”
The FDA said preliminary results for federal researchers warranted Friday’s decision, though regulators acknowledged “there is limited information known about the safety and effectiveness of using remdesivir.”
The drug’s side effects include potential inflammation of the liver and problems related to its infusion, which could lead to nausea, vomiting, sweating and low blood pressure. Information about dosing and potential safety issues will be provided to physicians and patients, the FDA said.
The National Institutes of Health’s Dr. Anthony Fauci said Wednesday the drug would become a new standard of care for severely ill COVID-19 patients. The drug, which blocks an enzyme the virus uses to copy its genetic material, has not been tested on people with milder illness.
The FDA authorized the drug under its emergency powers to quickly speed experimental drugs, tests and other medical products to patients during public health crises.
In normal times the FDA requires “substantial evidence” of a drug’s safety and effectiveness, usually through one or more large, rigorously controlled patient studies. But during public health emergencies the agency can waive those standards and require only that an experimental drug’s potential benefits outweigh its risks.
Gilead has said it would donate its currently available stock of the drug and is ramping up production to make more. It said the U.S. government would co-ordinate distribution of remdesivir to places most in need of it.
No drugs are approved now for treating the coronavirus, and remdesivir will still need formal approval.
The FDA can convert the drug’s status to full approval if Gilead or other researchers provide additional data of remdesivir‘s safety and effectiveness.
“This is a very, very early stage so you wouldn’t expect to have any sort of full approval at this point,” said Cathy Burgess, an attorney specializing in FDA issues. “But obviously they want to get this out to patients as quickly as possible.”
The FDA previously allowed narrow use of a malaria drug, hydroxychloroquine, for hospitalized patients who were unable to take part in ongoing studies of the medication. Trump repeatedly promoted it as a possible COVID-19 treatment, but no large high-quality studies have shown the drug works for that and it has significant safety concerns.
The FDA warned doctors late last month against prescribing the drug outside of hospital or research settings, due to risks of sometimes fatal heart side effects.
Two small studies published Friday add to concerns about the malaria drug. Critically ill COVID-19 patients given hydroxychloroquine were prone to heart rhythm problems, and for many risks mounted when it was combined with an antibiotic, the studies found.
Marchione reported from Milwaukee. AP Medical Writer Lindsey Tanner contributed to this report from Chicago.
B.C. has lost more than 353,000 jobs since pandemic began – CBC.ca
B.C. Finance Minister Carole James said more than 353,000 jobs have been lost provincewide since the pandemic began, with more than 30 per cent of those losses affecting young people.
James said Friday the province’s youth unemployment rates reached roughly 28.7 per cent last month. The minister said young people have been “severely impacted” during the pandemic because they work in the industries hardest hit by the economic slowdown: accommodation, food service, wholesale and retail.
“Those sectors still continue to lead all other industries in job losses, making up 46 per cent of the total jobs lost,” James said Friday.
“We have to remember that those numbers are families. They’re individuals. They’re small businesses who have struggled and continue to struggle as we move into recovery.”
Around 115,000 of the 353,000 positions lost in B.C. in recent months were jobs held by young people.
Statistics Canada said Friday unemployment rate in B.C. rose 1.9 percentage points to 13.4 per cent, up from 11.5 per cent in April.
B.C. did gain 43,300 jobs back in May, James said. The provincial government began easing public health restrictions last month, leading businesses to reopen and more people into the job hunt.
“I think we see some glimmers of hope … when you see the number of jobs that actually were created. It doesn’t touch the loss of jobs, the huge number of loss of jobs over this time period, but I think it does show that you’re starting to see some confidence in the economy,” said James.
“In the coming months, we hope to see more positive results as our economic recovery starts to take shape.
James noted more than 521,000 people have applied for B.C.’s Emergency Benefit for Workers since applications opened on May 1. The benefit provides a one-time payment of $1,000 for residents whose work has been impacted by the pandemic.
Statistics Canada said the national unemployment rate in May rose to 13.7 per cent, the highest level in more than 40 years of comparable data. The previous record of 13.1 per cent was set in December 1982.
The agency said Canada’s economy added 290,000 jobs in May, replacing about 10 per cent of the jobs it lost to COVID-19.
The monthly labour force survey showed that men gained back more jobs than women last month, resulting in a wider gender gap in employment losses as a result of COVID-19, and that the pandemic continued to disproportionately affect lower-wage workers.
OPEC and allies reportedly agree to extend record production cut – CNBC
An OPEC sign hangs outside the OPEC Secretariat in Vienna, Austria, on Nov. 29, 2017.
Akos Stiller | Bloomberg | Getty Images
OPEC and its oil-producing allies reportedly agreed to extend the historic 9.7 million barrels per day production cut that was set to expire at the end of June, according to two sources familiar with the matter.
The cut will be extended through the end of July, and the group is expected to confirm the agreement at its meeting on Saturday, which kicked off a little before 8:30 a.m. ET.
The closely watched meeting was initially scheduled for June 9-10, but was pulled forward after Iraq agreed to comply with its quota.
On Friday West Texas Intermediate jumped 5.72% to settle at $39.55, while international benchmark Brent crude gained 5.78% to settle at $42.30. It was each contract’s sixth straight week of gains, and the highest settle since March 6.
“OPEC+ looks set to formally announce a one-month deal extension at [Saturday’s] ministerial meeting,” said Helima Croft, RBC’s global head of commodities strategy. “Nevertheless, there could be some last minute theatrics at the virtual gathering and we suspect that some individual producer performance will still be less than perfect on a go-forward basis.”
Under the current agreement, which was set during an extraordinary multi-day meeting in April, the 23-member group cut production by 9.7 million bpd beginning May 1 and through the end of June. The cuts would then begin to taper. From July through the end of 2020, 7.7 million bpd would be taken offline, followed by 5.8 million bpd from January 2021 through April 2022.
The cut — the largest in history — came as oil demand fell off a cliff due to the coronavirus pandemic. The International Energy Agency estimates that about one quarter of demand was sapped in April as billions of people around the world stayed home in an effort to slow the spread of Covid-19. The hit to demand came as producers continued to pump oil, which sent WTI tumbling into negative territory for the first time on record, while Brent fell to a 20-year low.
Since then, prices have steadily climbed higher as economies begin to reopen and as producers further rein in output. In the U.S., production has fallen from a record 13.1 million bpd in March to 11.2 million bpd, according to the U.S. Energy Information Administration. WTI is still about 40% below its January high of $65.65, however.
“Although small in scale, this cut is however important in squaring the group’s strategy, which has this year alone swung from price focused cuts, to market-share recapture, to internal price war to finally a record large cut,” Goldman Sachs’ Damien Courvalin wrote in a note to clients Friday.
– CNBC’s Brian Sullivan and Michael Bloom contributed reporting.
Unemployment rate increases in Alberta despite more jobs: StatCan – CTV News
Alberta gained 28,000 jobs in the month of May, according to the latest Labour Force Survey released Friday morning from Statistics Canada.
The increase in employment follows a cumulative decline of 361,000 jobs from February to April.
Alberta’s job increases were entirely driven by the services-producing sector after the province allowed some businesses such as restaurants and non-essential shops to reopen as of May 14.
The unemployment rate in the province increased by 2.1 percentage points to 15.5 per cent, which is now the second highest in the country behind Newfoundland and Labrador at 16.3 per cent.
Nationwide, the average rate of unemployment is now 13.7 per cent, topping the previous high of 13.1 per cent set back in December 1982.
Canada added a total of 290,000 jobs across the country. According to Statistics Canada data, the total number of hours worked is increasing at a faster pace than employment.
Total hours worked across all industries grew by 6.3 per cent in May, compared with an increase of 1.8 per cent (290,000 jobs) in employment.
Alberta Economic Recovery Plan
In response to one of the most dramatic economic downturns in Alberta’s history, the provincial government will start rolling out an economic recovery plan later this month focused on cultivating key industries.
Premier Jason Kenney said last week that Alberta’s strategy will take a “pedal to the metal” approach to diversification after a steep decline in the price of oil.
On Monday, Finance Minister Travis Toews announced that his financial blueprint will be centred on growing sectors such as energy, agriculture, technology and petrochemical manufacturing.
A recent study from the Conference Board of Canada projects Alberta will see its economy shrink by 6.8 per cent this year.
Toews called that report realistic and noted the downturn will be measured in months not weeks.
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