FDA Panel Endorses Stringent Asbestos Testing of Cosmetics and Talcum Powder
Regulations
An expert panel convened by the Food and Drug Administration broke ranks with industry by challenging long-standing industry product-safety assertions and endorsing asbestos testing for cosmetics and talcum powder, as reported by Reuters. Asbestos is a highly carcinogenic mineral often found near talc, the main ingredient in talcum (baby) powder. The panel went further, asserting that all mineral particles small enough to enter the lungs should be viewed as potentially harmful. Because there is no safe level of asbestos exposure, the panel recommended use of the most sensitive asbestos detection methods available.
In October, Johnson and Johnson voluntarily recalled 33,000 bottles of its talcum powder after the FDA found asbestos in a single bottle. The company is currently facing approximately 17,000 lawsuits from plaintiffs alleging that their cancer was caused by the company’s talcum powder.
For the First Time, Corrupt U.S. Opioid Executives Are Going to Jail
Legal Developments
Former billionaire John Kapoor, 76-year-old co-founder of opioid manufacturer Insys Therapeutics, was sentenced Thursday in a federal court to five-and-a-half years in jail. Kapoor and four other Insys executives were convicted in May of a racketeering conspiracy involving physician kickbacks to boost sales of the company’s lucrative prescription drug Subsys (fentanyl), an opioid credited with taking the company’s value to a high of $3.2 billion in 2015, as reported by the Wall Street Journal. Two additional Insys executives pleaded guilty prior to the May trial and testified against the others. The other four convicted executives have already been sentenced to between one and three years in prison, according to Vox.
Arizona-based Insys is shutting down due to the burden of lawsuits from local and state governments.
In 2016, prescription fentanyl claimed the lives of more than 4,000 Americans.
Residing Near Major Roads and Highways Linked to Major Neurological Disorders
Research and Findings
A study published Tuesday in the journal Environmental Health found an increased incidence of Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, and non-Alzheimer’s dementia in individuals living closer than 54 yards from a major road and less than 164 yards from a highway. Researchers from the University of British Columbia analyzed data for metropolitan Vancouver area residents ages 45 to 84 who’d registered with the provincial health insurance plan and remained in Vancouver during the study period, approximately 678,000 individuals out of a population of 2.5 million.
Increased air pollution was linked to a higher incidence of non-Alzheimer’s dementia and Parkinson’s, with women somewhat more impacted than men, but not with multiple sclerosis or Alzheimer’s disease for either gender. Noise pollution was not associated with an increased risk of disease, while living near green spaces, which correlates with less air pollution, was found to have some protective effects for Parkinson’s and non-Alzheimer’s dementia, albeit less for NAD.
Surgical Gown Shortage Delays Surgeries Nationwide
Medical Devices
Cardinal Health voluntarily recalled its Level 3 surgical gowns mid-month due to manufacturing quality concerns, a move the Food and Drug Administration supported in a Jan. 16 statement. According to CNN, more than 9 million gowns were recalled due to concerns they weren’t sterile, including 7.7 million already sent to 2,807 facilities, causing surgical delays around the country. It’s uncertain when the supply issue will be resolved. Surgical gowns are classified into four levels of fluid barrier protection. Level 3 gowns provide moderate protection and are used in emergency rooms, for inserting IVs and arterial blood draws, and in procedures such as heart surgery and knee replacements.