WHO Launches Global Solidarity Project To Ramp Up Clinical Trials For Coronavirus Drugs
“Multiple small trials with different methodologies may not give us the clear strong evidence we need about which treatments help to save lives,” said WHO Director-General Tedros Adhanom Ghebreyesus. Scientists around the world have been racing around the clock to come up with treatments, even as a promising drug fails to show results. Meanwhile, President Donald Trump considered an executive order to expand the use of drugs in coronavirus patients, but FDA scientists objected over safety concerns. And health officials push back on rumors the ibuprofen could worsen the symptoms.
Stat:
WHO To Launch Multinational Trial To Jumpstart Search For Coronavirus Drugs
The World Health Organization said Wednesday that it would launch a multiarm, multicountry clinical trial for potential coronavirus therapies, part of an aggressive effort to jumpstart the global search for drugs to treat Covid-19. Four drugs or drug combinations already licensed and used for other illnesses will be tested, said WHO Director-General Tedros Adhanom Ghebreyesus. Ten countries have already indicated they will take part in the trial. (Branswell, 3/18)
The New York Times:
A Promising Treatment For Coronavirus Fails
Antiviral drugs that had held promise as a potential treatment for the coronavirus did not work in one of the first major studies in seriously ill patients, researchers from China reported on Wednesday. “No benefit was observed,” the researchers wrote in The New England Journal of Medicine. The study tested Kaletra, a combination of two antiviral medicines, lopinavir and ritonavir, that are normally used to treat H.I.V. (Grady, 3/18)
The Wall Street Journal:
Trump Sought To Expand Virus Drug Tests Over FDA Objections
The White House considered issuing an executive order greatly expanding the use of investigational drugs against the new coronavirus, but met with objections from Food and Drug Administration scientists who warned it could pose unneeded risks to patients, according to a senior government official. The idea to expand testing of drugs and other medical therapies was strongly opposed by the FDA’s senior scientists this week, the official said, and represented the most notable conflict between the FDA and the White House in recent memory. (Burton, 3/18)
The Hill:
Top Health Official Pushes Back Against Theory That Ibuprofen Worsens Coronavirus
Dr. Anthony Fauci, one of the faces of the Trump administration's coronavirus response, is pushing back against warnings that an anti-inflammatory drug like ibuprofen could worsen the effects of the infection. Fauci, director of the National Institute of Allergy and Infectious Diseases, said Wednesday that the suggestion was a "little bit urban legend" and that there was no "solid evidence" to support the theory after France's health minister urged people to avoid the drug. (Wise, 3/18)
NPR:
Concerns About Ibuprofen And COVID-19 Are Overblown, Most Experts Say
But most infectious disease experts say there's no good scientific evidence at this point to support that claim. The furor was sparked by a tweet by the French health minister, Olivier Véran, over the weekend. He warned people not to take non-steroidal anti-inflammatory drugs, or NSAIDS — a category of pain relievers and fever reducers that includes ibuprofen — because some French COVID-19 patients had experienced serious side effects. The warning was also included in a bulletin from the French health ministry, which counseled that patients should instead use acetaminophen, the generic name for Tylenol. (Godoy, 3/18)
In other pharmaceutical news —
Stat:
Biopharma Groups Push For Industry Exceptions To 'Shelter-In-Place' Orders
As more regional governments consider ordering residents to largely stay inside their homes to try to slow the spread of the coronavirus, drug industry trade groups are pushing to ensure such orders make exceptions to allow the employees of biotech and pharma companies to travel to and from work. The first “shelter-in-place” orders in the U.S. have come over the past few days in the Bay Area and other parts of Northern California. (Robbins and Sheridan, 3/18)
Stat:
Survey: Coronavirus To Have 'Big Impact' On A Third Of U.S. Clinical Trial Sites
Nearly one-third of clinical trial sites expect the novel coronavirus will have a “big or extremely big” impact on their ability to recruit patients for new trials or keep patients already enrolled in existing studies compliant with scheduling, a new survey finds. In addition, 39% of 170 clinical trial sites surveyed in the U.S. believe patients will be much less or somewhat less likely to enroll in new clinical research trials. And 25% of the sites expect patients currently enrolled in a trial to be much less or somewhat less willing to continue their participation. (Silverman, 3/18)
