NEW What Canada is doing about the toxic forever chemicals in drinking water
As the United States sets its first national limits on toxic forever chemicals in drinking water, researchers say Canada is lagging when it comes to regulations.
A panel of U.S. health advisers on Tuesday narrowly backed a closely watched COVID-19 pill from Merck, setting the stage for a likely authorization of the first drug that Americans could take at home to treat the coronavirus.
A Food and Drug Administration panel voted 13-10 that the drug's benefits outweigh its risks, including potential birth defects if used during pregnancy.
The recommendation came after hours of debate about the drug's modest benefits and potential safety issues. Experts backing the treatment stressed that it should not be used by anyone who is pregnant and called on FDA to recommend extra precautions before the drug is prescribed, including pregnancy tests for women of child-bearing age.
The vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including older people and those with conditions like obesity and asthma. Most experts also said the drug shouldn't be used in vaccinated patients, who weren't part of the study and haven't been shown to benefit.
The FDA isn't bound by the panel's recommendation and is expected to make its own decision before year's end. The pill is already authorized in the U.K.
The drug, molnupiravir, could provide a much-needed weapon against the virus as colder weather pushes case counts higher and U.S. officials brace for the arrival of the new omicron variant.
Merck hasn't specifically tested its drug against the new variant but said it should have some potency based on its effectiveness against other strains of coronavirus.
But that uncertainty frustrated many panelists as they grappled with whether to back the treatment for millions of Americans.
“With no data saying it works with new variants I really think we need to be careful about saying that this is the way to go,” said Dr. David Hardy of Charles Drew University School of Medicine and Science, who ultimately voted to back the drug.
The panel's narrow-but-positive recommendation came despite new data from Merck that paint a less compelling picture of the drug's effectiveness than just a few weeks earlier.
Last week, Merck said final study results showed molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, when compared with adults taking a placebo. That effect was significantly less than the 50% reduction it first announced based on incomplete results.
That smaller-than-expected benefit amplified experts' concerns about the drug's toxicity for fetuses.
FDA scientists told the panelists earlier Tuesday that company studies in rats showed the drug caused toxicity and birth defects when given at very high doses. Taken together, FDA staffers concluded the data “suggest that molnupiravir may cause fetal harm when administered to pregnant individuals.”
FDA is weighing a blanket restriction against any use in pregnant women or allowing it in rare cases. Some panelists said the option should be left open for pregnant mothers who have high-risk COVID-19 and may have few other treatment options.
Dr. Janet Cragan, who backed the drug, said that even with tight restrictions some pregnant women would inevitably take the drug.
“I don't think you can ethically tell a woman with COVID-19 that she can't have the drug if she's decided that's what she needs,” a panel member and staffer with the Centers for Disease Control and Prevention. “I think the final decision has to come down to the individual woman and her provider.”
Merck's drug uses a novel approach to fight COVID-19: It inserts tiny errors into the coronavirus' genetic code to stop it from reproducing. That genetic effect has raised concerns that the drug could spur more virulent strains of the virus. But FDA regulators said Tuesday that risk is theoretical and seems unlikely.
While Merck and its partner Ridgeback Biotherapeutics were the first to submit their COVID-19 pill to the FDA, rival drugmaker Pfizer is close behind with its own pill under review.
Pfizer's drug is part of a decades-old family of antiviral pills known as protease inhibitors, a standard treatment for HIV and hepatitis C. They work differently than Merck's pill and haven't been linked to the kind of mutation concerns raised with Merck's drug.
Pfizer said this week that its drug shouldn't be affected by the omicron variant's mutations.
The U.S. government has agreed to purchase 10 million treatment courses of Pfizer's drug, if it's authorized. That's more than three times the government's purchase agreement with Merck for 3.1 million courses of molnupiravir.
Both drugs require patients to take multiple pills, twice a day for five days.
------
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content
As the United States sets its first national limits on toxic forever chemicals in drinking water, researchers say Canada is lagging when it comes to regulations.
Calgary police have arrested a man and a charge is pending in connection with the death of a toddler in 2022.
A Winnipeg woman was sentenced to house arrest after a single date with a man she met online culminated in her harassing him for years, and spurred false allegations which resulted in the innocent man being arrested three times.
Almost 7,000 bars of pure gold were stolen from Pearson International Airport exactly one year ago during an elaborate heist, but so far only a tiny fraction of that stolen loot has been found.
Drivers in Eastern Canada face a big increase in gas prices because of various factors, especially the higher cost of the summer blend, industry analysts say.
Police say one former and one current employee of Air Canada are among the nine suspects that are facing charges in connection with the gold heist at Pearson International Airport last year.
MPs enacted an extraordinary, rarely used parliamentary power on Wednesday, summonsing an ArriveCan contractor to appear before the House of Commons where he was admonished publicly and forced to provide answers to the questions MPs said he'd previously evaded.
Scientists say it's highly unlikely cloud seeding is responsible for the heavy rains that have caused flooding in the United Arab Emirates this month, and that climate change is the more likely culprit.
Ontario Premier Doug Ford is calling on Speaker Ted Arnott to reverse a ban on keffiyehs at Queen's Park, describing the move as “needlessly” divisive.
When Les Robertson was walking home from the gym in North Vancouver's Lower Lonsdale neighbourhood three weeks ago, he did a double take. Standing near a burrow it had dug in a vacant lot near East 1st Street and St. Georges Avenue was a yellow-bellied marmot.
A moulting seal who was relocated after drawing daily crowds of onlookers in Greater Victoria has made a surprise return, after what officials described as an 'astonishing' six-day journey.
Just steps from Parliament Hill is a barber shop that for the last 100 years has catered to everyone from prime ministers to tourists.
A high score on a Foo Fighters pinball machine has Edmonton player Dave Formenti on a high.
A compound used to treat sour gas that's been linked to fertility issues in cattle has been found throughout groundwater in the Prairies, according to a new study.
While many people choose to keep their medical appointments private, four longtime friends decided to undergo vasectomies as a group in B.C.'s Lower Mainland.
A popular highway in Alberta's Banff National Park now has a 'no stopping zone' to help protect two bears.
B.C. resident Robert Conrad spent thousands of hours on Crown land developing an unusual bond with deer.
A Sudbury woman said her husband was bringing the recycling out to the curb Wednesday night when he had to make a 'mad dash' inside after seeing a bear.