Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Smokeless Tobacco Snus can be Marketed as Less Risky Than Cigarettes: FDA
U.S. health groups are slamming the Food and Drug Administration’s decision to permit the General brand of the smokeless tobacco product snus to claim that it poses a “lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis” than cigarettes.
It’s the first time the FDA has allowed product marketing of this type, and means that eight Swedish Match USA Inc. snus products sold under the General brand name will be able to make that claim, CNN reported.
The FDA said it’s decision to allow what’s called a modified risk claim was based on scientific evidence submitted by the company.
“The Lung Association is disappointed with FDA’s announcement today,” said Erika Sward, assistant vice president of national advocacy at the American Lung Association, CNN reported.
“The FDA seems to fundamentally not understand that their consumer and top priority is the public health — not the tobacco industry,” Sward said.
In May, the American Lung Association, American Academy of Pediatrics, American Heart Association, the Campaign for Tobacco-Free Kids and other health advocacy groups urged the FDA to rule against the modified risk claim, CNN reported.
Evidence was lacking on whether the marketing of General snus with a modified risk claim would increase the risk that tobacco non-users, particularly children, would start using tobacco, the groups said.
“Although there are obvious distinctions between e-cigarettes like JUUL and smokeless tobacco products like General snus, the fact that another kind of highly-addictive ‘reduced risk’ product is proving so appealing to young people, in part because it can be used discreetly, should cause FDA to closely scrutinize the potential impact of modified risk claims for General snus on youth initiation,” the groups said in a letter to the FDA, CNN reported.
The groups also expressed concern that adult smokers who try snus wouldn’t quit cigarettes, but would instead use snus in addition to cigarettes.
New Alzheimer’s Drug to be Submitted for FDA Approval
A new drug to treat early Alzheimer’s disease will be submitted to the U.S. Food and Drug Administration for approval, maker Biogen Inc. said Tuesday.
Earlier this year, the company stopped two studies of the drug, called aducanumab, when initial results suggested it would not be effective, so the announcement about seeking approval for the drug is a surprise, according to the Associated Press.
A new analysis of more results suggest that the highest dose of aducanumab — which is meant to help the body clear harmful plaques from the brain — helped slow declines in thinking skills, said Massachusetts-based Biogen, which is developing the drug with Japan-based Eisai Co. Ltd.
The two studies included more than 3,000 patients with mild cognitive impairment or early dementia due to Alzheimer’s disease. In one study, patients who received a high dose of the drug — given as monthly infusions — had 23% less decline on one measure of thinking skills and smaller declines on other measures, the AP reported.
However, Biogen didn’t provide details on what that might mean for patients.
“It’s a tricky question” whether the study results are truly meaningful for patients until more details are known, Dr. Ronald Petersen, a Mayo Clinic dementia specialist who has consulted for Biogen on the studies, told the AP.
“We’re really encouraged by the information that they’ve provided today,” which shows the largest benefit so far for any experimental medicine, Rebecca Edelmayer, a scientist at the Alzheimer’s Association, told the AP.
The group was not involved in the studies.
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