A cheap, readily available steroid drug reduced deaths by a third in patients hospitalized with Covid-19 in a large study, the first time a therapy has been shown to possibly improve the odds of survival with the condition in the sickest patients.
Full data from the study have not been published or subjected to scientific scrutiny. But outside experts on Tuesday immediately embraced the top-line results. The drug, dexamethasone, is widely available and is used to treat conditions including rheumatoid arthritis, asthma, and some cancers.
In a statement, Patrick Vallance, the U.K. governments chief scientific adviser, called the result tremendous news and a ground-breaking development in our fight against the disease. Scott Gottlieb, a former commissioner of the U.S. Food and Drug Administration, called it a very positive finding in an interview on CNBC. I think it needs to be validated, but it certainly suggests that this could be beneficial in this setting.
advertisement
Atul Gawande, the surgeon, writer and public health researcher, urged caution, tweeting, after all the retractions and walk backs, it is unacceptable to tout study results by press release without releasing the paper.
The study randomly assigned 2,104 patients to receive six milligrams of dexamethasone once a day, by mouth or intravenous injection. These were compared to 4,321 patients assigned to receive usual care alone.
advertisement
In patients who needed to be on a ventilator, dexamethasone reduced the death rate by 35%, meaning that doctors would prevent one death by treating eight ventilated patients. In those who needed oxygen but were not ventilated, the death rate was reduced 20%, meaning doctors would need to treat 25 patients to save one life. Both results were statistically significant.
There was no benefit in patients who didnt require any oxygen. The researchers running the study, called RECOVERY, decided to stop enrolling patients on dexamethasone on June 8 because they believed they had enough data to get a clear result.
Dexamethasone is the first drug to be shown to improve survival in COVID-19, Peter Horby, one of the lead investigators of the study and a professor in the Nuffield Department of Medicine at the University of Oxford, said in a statement. He added that the drug should now become the standard treatment for patients with Covid-19 who need oxygen. Dexamethasone is inexpensive, on the shelf, and can be used immediately to save lives worldwide.
A different arm of the same study showed on June 5 that hydroxychloroquine, widely touted as a potential Covid treatment, had no benefit in hospitalized patients. Yesterday, based in part on those results, the Food and Drug Administration revoked an Emergency Use Authorization for using hydroxychloroquine in those patients.
From the start of the pandemic in March, researchers have focused on two different stages of Covid-19, which will likely require very different interventions. Some drugs are designed to directly combat the novel coronavirus, SARS-CoV-2, that causes the disease. The first medicine shown to have a benefit, remdesivir from the biotech firm Gilead Sciences, falls into this category, even though, because it must be given intravenously, it has been tested in hospitalized patients. Remdesivir shortens the course of infection, but has not been shown to save lives.
After patients have become profoundly sick, the problem starts to become not only the virus but their own immune system, which attacks the lungs, a condition called acute respiratory distress syndrome, or ARDS. For these patients, doctors have believed, they would need to dampen patients immune response even as they fought the virus.
Initially, excitement in this area fell on new and expensive drugs, such as Actemra, a rheumatoid arthritis drug from Roche that is used to treat a similar condition caused by some cancer immunotherapies. But a study in patients who needed oxygen showed no benefit from a similar drug, although another arm in sicker patients is continuing. The National Institutes of Health is conducting a study of an Eli Lilly pill targeting rheumatoid arthritis, an extension of the study that showed remdesivir has a benefit.
Dexamethasone, which reached the market 59 years ago, seemed an unlikely candidate to help these patients; it was seen as too crude a way of tamping down the immune system. In guidelines for physicians treating the disease, the NIH doesnt even mention the therapy.
Studies that are testing other medicines may now need to incorporate the use of the drug, which could complicate analyzing the results. A spokesperson for Regeneron, which is testing Covid-19 drugs focused on both attacking the virus and dampening the immune system, said the companys studies are written so that when a new medicine becomes the standard of care, it becomes available to patients in the trial.Some studies have shown a benefit for using dexamethasone in acute respiratory distress syndrome not related to Covid-19, although the benefit was smaller than in RECOVERY.
The result, should it hold up to further scrutiny, shows the benefit of the strategy of Horby and Martin Landray, the Oxford researchers who designed the study, leveraging the U.K. health system to start a study of multiple inexpensive potential Covid-19 therapies including hydroxychloroquine, dexamethasone, and also some older HIV medicines. Several months into the Covid-19 pandemic, two of the most important results come from this single study.
Neither of those results, however, have been scrutinized or published.
More here:
Major study finds steroid reduces deaths in patients with severe Covid-19 - STAT
- Yes, But. The Annotated Atlantic. [Last Updated On: November 7th, 2009] [Originally Added On: November 7th, 2009]
- Health Insurance Benefit Costs by Region [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- For an Operator, Please Press... [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Pollyanna With a Pen: Maine Governor Signs 18 New Health Care Bills into Law [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- AMA Sounds the Alarm, Medicare Making Yet Another Attempt to Cut Reimbursement [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Mass Governor Asks Blue Cross to Keep Higher Employer Contribution [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Lifespan and Care New England Plan Monopoly (Again) [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Dirigo Health: Con Artists, Liars, and Thieves? [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- New Orleans: Health Challenges [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- August a Flurry of Activity [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Maine's Dirigo Health Savings One-Third of Original Estimate [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- “Methodolatry”: My new favorite term for one of the shortcomings of evidence-based medicine [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Suzanne Somers’ Knockout: Dangerous misinformation about cancer (part 1) [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- A science-based blog about GMO [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- A Not-So-Split Decision [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Military Medicine in Iraq [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- The effective wordsmithing of Amy Wallace [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- A Science Lesson from a Homeopath and Behavioral Optometrist [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Join CFI in opposing funding mandates for quackery in health care reform [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Mainstreaming Science-Based Medicine: A Novel Approach [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Those who live in glass houses… [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- J.B. Handley of the anti-vaccine group Generation Rescue: Misogynistic attacks on journalists who champion science [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- When homeopaths attack medicine and physics [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- The cancer screening kerfuffle erupts again: “Rethinking” screening for breast and prostate cancer [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- All Medicines Are Poison! [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- When Loud Wins: Will Your Tax Dollars Pay For Prayer? [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- It’s All in Your Head [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- The Skeptical O.B. joins the Science-Based Medicine crew [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- The Tragic Death Toll of Homebirth [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- What’s the right C-section rate? Higher than you think. [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Recombinant Human Antithrombin – Milking Nanny Goats for Big Bucks [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Does C-section increase the rate of neonatal death? [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Man in Coma 23 Years – Is He Really Conscious? [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Why Universal Hepatitis B Vaccination Isn’t Quite Universal [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Ontario naturopathic prescribing proposal is bad medicine [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Naturopaths and the anti-vaccine movement: Hijacking the law in service of pseudoscience [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- The Institute for Science in Medicine enters the health care reform fray [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Neti pots – Ancient Ayurvedic Treatment Validated by Scientific Evidence [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Early Intervention for Autism [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- A temporary reprieve from legislative madness [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- A critique of the leading study of American homebirth [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Lose those holiday pounds [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Endocrine disruptors—the one true cause? [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Evidence in Medicine: Experimental Studies [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Midwives and the assault on scientific evidence [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- The Mammogram Post-Mortem [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- An Influenza Recap: The End of the Second Wave [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- The End of Chiropractic [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Cell phones and cancer again, or: Oh, no! My cell phone’s going to give me cancer! (revisited) [Last Updated On: December 20th, 2009] [Originally Added On: December 20th, 2009]
- Another wrinkle to the USPSTF mammogram guidelines kerfuffle: What about African-American women? [Last Updated On: December 20th, 2009] [Originally Added On: December 20th, 2009]
- Acupuncture, the P-Value Fallacy, and Honesty [Last Updated On: December 20th, 2009] [Originally Added On: December 20th, 2009]
- The One True Cause of All Disease [Last Updated On: December 20th, 2009] [Originally Added On: December 20th, 2009]
- Communicating with the Locked-In [Last Updated On: December 20th, 2009] [Originally Added On: December 20th, 2009]
- Are the benefits of breastfeeding oversold? [Last Updated On: December 20th, 2009] [Originally Added On: December 20th, 2009]
- Measles [Last Updated On: December 20th, 2009] [Originally Added On: December 20th, 2009]
- Radiation from medical imaging and cancer risk [Last Updated On: December 21st, 2009] [Originally Added On: December 21st, 2009]
- Multiple Sclerosis and Irrational Exuberance [Last Updated On: December 21st, 2009] [Originally Added On: December 21st, 2009]
- Medical Fun with Christmas Carols [Last Updated On: December 22nd, 2009] [Originally Added On: December 22nd, 2009]
- Lithium for ALS – Angioplasty for MS [Last Updated On: December 23rd, 2009] [Originally Added On: December 23rd, 2009]
- “Toxins”: the new evil humours [Last Updated On: December 24th, 2009] [Originally Added On: December 24th, 2009]
- 2009’s Top 5 Threats To Science In Medicine [Last Updated On: December 24th, 2009] [Originally Added On: December 24th, 2009]
- Buteyko Breathing Technique – Nothing to Hyperventilate About [Last Updated On: December 26th, 2009] [Originally Added On: December 26th, 2009]
- The Graston Technique – Inducing Microtrauma with Instruments [Last Updated On: December 29th, 2009] [Originally Added On: December 29th, 2009]
- The “pharma shill” gambit [Last Updated On: December 29th, 2009] [Originally Added On: December 29th, 2009]
- Ginkgo biloba – No Effect [Last Updated On: December 30th, 2009] [Originally Added On: December 30th, 2009]
- Oppose “Big Floss”; practice alternative dentistry [Last Updated On: January 1st, 2010] [Originally Added On: January 1st, 2010]
- Causation and Hill’s Criteria [Last Updated On: January 3rd, 2010] [Originally Added On: January 3rd, 2010]
- The life cycle of translational research [Last Updated On: January 10th, 2010] [Originally Added On: January 10th, 2010]
- The anti-vaccine movement strikes back against Dr. Paul Offit [Last Updated On: January 10th, 2010] [Originally Added On: January 10th, 2010]
- Osteoporosis Drugs: Good Medicine or Big Pharma Scam? [Last Updated On: January 10th, 2010] [Originally Added On: January 10th, 2010]
- Acupuncture for Hot Flashes [Last Updated On: January 10th, 2010] [Originally Added On: January 10th, 2010]
- The case for neonatal circumcision [Last Updated On: January 10th, 2010] [Originally Added On: January 10th, 2010]
- A victory for science-based medicine [Last Updated On: January 10th, 2010] [Originally Added On: January 10th, 2010]
- James Ray and testosterone replacement therapy (TRT) [Last Updated On: January 10th, 2010] [Originally Added On: January 10th, 2010]
- The Water Cure: Another Example of Self Deception and the “Lone Genius” [Last Updated On: January 12th, 2010] [Originally Added On: January 12th, 2010]
- Be careful what you wish for, Dr. Dossey, you just might get it [Last Updated On: January 13th, 2010] [Originally Added On: January 13th, 2010]
- You. You. Who are you calling a You You? [Last Updated On: January 15th, 2010] [Originally Added On: January 15th, 2010]
- The War on Salt [Last Updated On: January 16th, 2010] [Originally Added On: January 16th, 2010]
- Is breech vaginal delivery safe? [Last Updated On: January 16th, 2010] [Originally Added On: January 16th, 2010]