Remdesivir’s failure is a warning for Covid-19 vaccines
Skip to main content
  • Home
  • Economy
    • Aviation
    • Bazaar
    • Budget
    • Industry
    • NBR
    • RMG
    • Corporates
  • Stocks
  • Analysis
  • World+Biz
  • Sports
  • Features
    • Book Review
    • Brands
    • Earth
    • Explorer
    • Fact Check
    • Family
    • Food
    • Game Reviews
    • Good Practices
    • Habitat
    • Humour
    • In Focus
    • Luxury
    • Mode
    • Panorama
    • Pursuit
    • Wealth
    • Wellbeing
    • Wheels
  • Epaper
  • More
    • Subscribe
    • Videos
    • Thoughts
    • Splash
    • Bangladesh
    • Supplement
    • Infograph
    • Archive
    • COVID-19
    • Games
    • Long Read
    • Interviews
    • Offbeat
    • Podcast
    • Quiz
    • Tech
    • Trial By Trivia
    • Magazine
  • বাংলা
The Business Standard

Friday
January 27, 2023

Sign In
Subscribe
  • Home
  • Economy
    • Aviation
    • Bazaar
    • Budget
    • Industry
    • NBR
    • RMG
    • Corporates
  • Stocks
  • Analysis
  • World+Biz
  • Sports
  • Features
    • Book Review
    • Brands
    • Earth
    • Explorer
    • Fact Check
    • Family
    • Food
    • Game Reviews
    • Good Practices
    • Habitat
    • Humour
    • In Focus
    • Luxury
    • Mode
    • Panorama
    • Pursuit
    • Wealth
    • Wellbeing
    • Wheels
  • Epaper
  • More
    • Subscribe
    • Videos
    • Thoughts
    • Splash
    • Bangladesh
    • Supplement
    • Infograph
    • Archive
    • COVID-19
    • Games
    • Long Read
    • Interviews
    • Offbeat
    • Podcast
    • Quiz
    • Tech
    • Trial By Trivia
    • Magazine
  • বাংলা
FRIDAY, JANUARY 27, 2023
Remdesivir’s failure is a warning for Covid-19 vaccines

Analysis

Timothy L O'Brien, Bloomberg
22 November, 2020, 05:10 pm
Last modified: 23 November, 2020, 10:36 am

Related News

  • India launches world’s 1st intranasal Covid vaccine
  • US CDC still looking at potential stroke risk from Pfizer bivalent Covid shot
  • China says Covid deaths down by nearly 80 percent
  • Updated Covid vaccines prevented illness from latest variants -CDC
  • Vaccine misinformation spawns 'pure blood' movement

Remdesivir’s failure is a warning for Covid-19 vaccines

The FDA will need to evaluate shots more carefully than it did a pricey Covid-19 treatment

Timothy L O'Brien, Bloomberg
22 November, 2020, 05:10 pm
Last modified: 23 November, 2020, 10:36 am
Hasty drug approval doesn’t always work out. Photographer: OLIVIER DOULIERY/AFP via Getty Images/Bloomberg
Hasty drug approval doesn’t always work out. Photographer: OLIVIER DOULIERY/AFP via Getty Images/Bloomberg

Less than a month ago, the Food and Drug Administration said hospitals could use remdesivir, a drug manufactured by Gilead Sciences Inc., to treat patients with Covid-19. Remdesivir, sold under the brand name Veklury, was said to shorten recovery times and reduce the need for ventilators to facilitate breathing. Yesterday, the World Health Organization hit the brakes: It recommended that doctors avoid using the drug altogether.

"There is currently no evidence that remdesivir improves survival and other outcomes in these patients," the WHO noted, citing detailed studies it sponsored. "The evidence suggested no important effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes."

A group of experts gathered by the WHO concurred, reporting their findings in a well-regarded medical journal. Remdesivir offers "small and uncertain benefits" outweighed by the "possibility of important harms," they wrote. Gilead pushed back, saying it stands by remdesivir and citing other studies supporting its efficacy.

Speed is prized in the race to beat back Covid-19 — as it should be. The world is also fortunate to have innovative and dedicated public and private researchers able to produce coronavirus vaccine candidates in record time. But the WHO's thumbs-down on remdesivir is also a reminder that hasty drug development and approval is risky. It highlights why the FDA has to do more than merely rubber-stamp Covid-19 treatments in the face of heavy White House pressure to move quickly.

As my colleague Max Nisen recently observed, it's perplexing that the FDA gave formal approval to remdesivir as a Covid-19 treatment in October. The drug was already available to hospitals and patients under a federal emergency use authorization granted in May. Since then, data supporting its benefits had become murky, and an FDA sign-off was unlikely to significantly expand its use. As I noted in an earlier column, remdesivir is also expensive — perhaps not as costly as other blockbuster drugs the pharmaceutical industry sells, but still expensive.

Two writers for Science magazine, Jon Cohen and Kai Kupferschmidt, offered some answers to these mysteries in a deeply reported piece published late last month. They found that the FDA and the European Union both had approved the use of remdesivir despite some glaring procedural gaps. The FDA didn't consult the outside experts it keeps on tap to analyze approvals for complex antiviral drugs. The EU approved remdesivir's pricing just a week before lackluster results from a major WHO trial of the drug were published — and then seemed clueless about the new data. (Gilead was aware; it had donated drug to the trial and knew the results were poor.)

The Science writers pointed out that the FDA's inaction around remdesivir "stands in sharp contrast to its handling of potential Covid-19 vaccines." For remdesivir, the agency failed to convene an advisory to study the drug. Several prominent medical researchers voiced skepticism about remdesivir in the Science article, including Martin Landry of Oxford University, who said the drug was useless for treating the sickest patients. In any case, most people with Covid-19 recover without medical treatment.

"The argument that the earlier you use it the better is great until you realize what the implications of that are: You won't save many lives, and you'll have to treat a lot of patients," Landry told Science. "It's very inconvenient, and it'll cost you a fortune."

Perhaps it was inevitable that Gilead would receive special treatment. In May, when remdesivir was given its EUA, the company's chief executive officer, Daniel O'Day, was welcomed into the Oval Office for a photo op with President Donald Trump and FDA Commissioner Stephen Hahn. Trump, who was treated with remdesivir after contracting Covid-19 himself, has described it as one of a handful of drugs he received that were like "miracles coming down from God."

Hospitals have been less enthusiastic and have been sharply cutting back their use of remdesivir due to its expense and its value for only the most seriously ill patients — which makes the FDA's enthusiasm for the drug and its manufacturer all the more curious. The FDA approved remdesivir based on three trials, the most weighty of which was conducted by the National Institutes of Health. Both the NIH and the FDA are housed under the Department of Health and Human Services.

Perhaps it was just fine that the FDA relied on what was essentially an in-house trial to approve remdesivir and that Hahn has been unusually amenable to Trump's demands for approving sketchy Covid-19 treatments. And perhaps it's fine that Alex Azar, a former pharmaceutical executive and Big Pharma lobbyist who is a Trump loyalist, runs HHS and supervises Hahn.

In case any of this isn't fine, we should bear it in mind as HHS and the FDA continue to play pivotal roles overseeing the approval, rollout and regulation of more crucial drugs: the Covid-19 vaccines that Pfizer Inc. and Moderna Inc. have put on the table.


Timothy L O'Brien is a senior columnist for Bloomberg Opinion.

Disclaimer: This article first appeared on bloomberg.com, and is published by special syndication arrangement.

Top News

remdesivir / COVID-19 / Vaccine

Comments

While most comments will be posted if they are on-topic and not abusive, moderation decisions are subjective. Published comments are readers’ own views and The Business Standard does not endorse any of the readers’ comments.

Top Stories

  • Infograph: TBS
    State banks spend 80% of their forex for govt imports in H1
  • Manufacturers feel the pinch as consumers tighten belt
    Manufacturers feel the pinch as consumers tighten belt
  • Production remains halted in 8 Ctg power plants
    Production remains halted in 8 Ctg power plants

MOST VIEWED

  • Illustration: TBS
    HC verdict moves the needle on recognising single motherhood
  • Illustration: Jinhwa Jang for Bloomberg Businessweek
    Is a US recession near? Making the call is trickier than ever
  •  Gautam Adani, center.Photographer: Tomohiro Ohsumi/Bloomberg
    The Adani short sale puts investor trust in India in doubt
  • Dominion Energy is seeking to extend the operating license of its North Anna Nuclear Generating Station located in Louisa County, Va., to 80 years. Photographer: Scott Olson/Getty Images North America
    Nuclear power plants are pushed to the limit as demand surges
  • Photo: Bloomberg
    The worst fears for global growth may be subsiding
  • An island unto themselves.Photographer: Sam Yeh/AFP
    US could defend Taiwan from China - at great cost

Related News

  • India launches world’s 1st intranasal Covid vaccine
  • US CDC still looking at potential stroke risk from Pfizer bivalent Covid shot
  • China says Covid deaths down by nearly 80 percent
  • Updated Covid vaccines prevented illness from latest variants -CDC
  • Vaccine misinformation spawns 'pure blood' movement

Features

Sketch:TBS

Why we need consumer education for consumer wellbeing

2h | Thoughts
Dr Ahsan H Mansur, Executive Director, Policy Research Institute. Illustration: TBS

Twin shocks call for stronger domestic policy response

3h | Thoughts
December-er shohor, taxi taken for airport and the Park Street bathed in lights. Photo: Jannatul Naym Pieal

Exploring Kolkata on foot, empowered by Google Maps

4h | Explorer
Island hopping in Bangladesh?

Island hopping in Bangladesh?

5h | Panorama

More Videos from TBS

Kajol’s road paintings bring change in Gafargaon

Kajol’s road paintings bring change in Gafargaon

18h | TBS Stories
Carew & Company witnessed a remarkable growth

Carew & Company witnessed a remarkable growth

19h | TBS Stories
PCB recalls cricketers from BPL ahead of PSL

PCB recalls cricketers from BPL ahead of PSL

21h | TBS SPORTS
Why Misha Sawdagar became villain instead of a Hero?

Why Misha Sawdagar became villain instead of a Hero?

20h | TBS Entertainment

Most Read

1
Picture: Collected
Bangladesh

US Embassy condemns recent incidents of visa fraud

2
Four top bankers arrested in DSA case filed by S Alam group 
Bangladesh

Four top bankers arrested in DSA case filed by S Alam group 

3
Illustration: TBS
Banking

16 banks at risk of capital shortfall if top 3 borrowers default

4
Photo: Collected
Splash

Hansal Mehta responds as Twitter user calls him 'shameless' for making Faraaz

5
A frozen Beyond Burger plant-based patty. Photographer: AKIRA for Bloomberg Businessweek
Bloomberg Special

Fake meat was supposed to save the world. It became just another fad

6
Representational Image
Banking

Cash-strapped Islami, Al-Arafah and National turn to Sonali Bank for costly fund

EMAIL US
[email protected]
FOLLOW US
WHATSAPP
+880 1847416158
The Business Standard
  • About Us
  • Contact us
  • Sitemap
  • Privacy Policy
  • Comment Policy
Copyright © 2023
The Business Standard All rights reserved
Technical Partner: RSI Lab

Contact Us

The Business Standard

Main Office -4/A, Eskaton Garden, Dhaka- 1000

Phone: +8801847 416158 - 59

Send Opinion articles to - [email protected]

For advertisement- [email protected]