Anti-Tobacco Critics: FDA’s Menthol Vape Approval ‘Blow To Public Health’
The products, intended as less-harmful alternative to cigarettes, were authorized by the FDA, drawing criticism from pediatricians and anti-tobacco groups. Separately, the Washington Post reports that the tobacco industry is using Black activists to battle menthol tobacco bans.
CNN:
FDA Sign-Off On Menthol E-Cigarettes ‘Flies In The Face Of Public Health,’ Anti-Tobacco Groups Say
Four menthol vaping products were authorized by the US Food and Drug Administration on Friday, the first non-tobacco-flavored e-cigarette products to get the agency’s sign-off. The decision drew harsh criticism from pediatricians and anti-tobacco groups, which called it “a blow to public health” and warned of potential for “disastrous consequences” to children. (Christensen, 6/21)
The Washington Post:
Tobacco Industry Enlists Black Activists To Fight Menthol, Vaping Bans
In 2022, Earl Fowlkes, a Black gay activist, denounced tobacco companies for marketing e-cigarettes to his community as the latest way to hook people on nicotine. A year later he declared that vaping saves Black and LGBTQ+ lives. Fowlkes’s promotion of looser e-cigarette regulations, which came as he developed a relationship with an industry trade group, illustrates how the tobacco industry has expanded alliances with activists representing Black, LGBTQ+ and other disenfranchised groups to defend products public health experts say are harmful. (Nirappil, 6/21)
In other news about the FDA —
Reuters:
US FDA Approves Bristol Myers' Colorectal Cancer Therapy
The U.S. Food and Drug Administration has approved Bristol Myers Squibb's combination therapy for treating colorectal cancer in patients with a specific gene mutation, the health regulator said on Friday. The approval under the agency's accelerated process was based on an early- to mid-stage study, in which 94 previously treated patients were administered the oral drug Krazati, in combination with cetuximab. (Santhosh and L, 6/21)
ScienceAlert:
Parkinson's Discovery Suggests We May Already Have An FDA-Approved Treatment
Researchers have discovered how a cell surface protein called Aplp1 can play a role in spreading material responsible for Parkinson's disease from cell-to-cell in the brain. Promisingly, an FDA-approved cancer drug that targets another protein called Lag3 – which interacts with Aplp1 – blocks the spread in mice, suggesting a potential therapy may already exist. (Dyer, 6/24)
On medical devices —
Stat:
How Kaiser Permanente Hospitals Track Risky Medical Devices
When a new medical device hits the market, there’s typically still some uncertainty about whether it works. Device makers generally do not have to submit as much, or as rigorous, clinical data to the Food and Drug Administration as their biotech counterparts. Once FDA regulators decide a device is safe and effective, companies and researchers then attempt to track how the device performs in the real world. (Lawrence, 6/24)
Reuters:
Doctor's Recommendation Does Not Bar Patient's Lawsuit Over Device - California Top Court
A patient may be able to pursue a claim against a drug or medical device maker for failing to warn of a product's risks even if the warning would not have stopped the patient's doctor from recommending it, California's highest court has ruled. The California Supreme Court, in a unanimous opinion on Thursday by Justice Joshua Groban, revived a lawsuit against Somatics, the maker of an electroshock therapy device, by a woman who said she suffered brain damage after it was used to treat her severe depression. (Pierson, 6/21)