Meningitis—a life-threatening inflammation of the membranes surrounding the brain and spinal cord—has seldom been more prominent in the news, and for all the wrong reasons. The contaminated steroid made and distributed by a compounding pharmacy has caused meningitis fatalities and widespread fear, and the story is developing daily.
So a warning letter sent by the FDA is particularly timely. As reported on AboutLawsuits.com, the letter was sent to Avalon Effect Inc., a company in Tennessee, because it has been advertising light emitting diodes (LED) to treat and cure the symptoms of fungal meningitis. In ghoulish exploitation, Avalon has targeted the people suffering from the disease they contracted from the dirty steroid injection.
The FDA letter warned Avalon Effect that the company’s Internet marketing information violates the Federal Food, Drug and Cosmetic Act.
Avalon claims that its Quantum Series Personal Wellness Pack, which promotes light therapy, treats and cures fungal meningitis, methicillin-resistant staphylococcus aureus (MRSA), concussions, Lyme disease and other ailments.
Yes, and it's a good overall pick-me-up nostrum, too. (Not!!!)
The FDA categorized the product as a medical device for treating and curing disease. Because such classification requires FDA approval prior to marketing, and because Avalon does not have that approval, it’s in violation of federal regulations.
Avalon has known for months that the FDA wanted it to clean up its act—the November warning letter is a follow-up to one sent in August, just as the meningitis outbreak was beginning.
The feds are not happy that a purported treatment for fungal meningitis that has not been approved or tested is being promoted purely for profit.
“Consumers should be aware that, especially during disease outbreaks or other public health crises, they may see opportunistic advertisements for products touted as cures or treatments,” said FDA official Steve Silverman in an agency news release. “Bogus medical claims can actually harm consumers by causing them to delay seeking treatments that have been proven to be safe and effective. Consumers should carefully evaluate and discuss the claims with their health care providers.”
Recent developments in the outbreak story include last week’s AP report that in 2002, the FDA advised that the New England Compounding Center (NECC), the outfit responsible for distributing the contaminated medicine, be “prohibited from manufacturing” because its operations were deemed shoddy. The feds deferred to Massachusetts state regulators, who reached an accommodation with the pharmacy to resolve those concerns. Now, you wonder, were they ever resolved? Were they temporarily resolved?
The meningitis outbreak also prompted a Congressional appearance by FDA Commissioner Margaret Hamburg last week. The committee wanted to know why the FDA hammer didn't fall harder on the NECC, and Hamburg said the agency's authority in the matter wasn't clear. The Democrats generally supported boosting FDA authority over compounding pharmacies, but Republicans said the agency has all the power it needs.
The Boston Globe reported that during Congressional hearings last week, Barry Cadden, the owner of the NECC, took the Fifth Amendment and declined to answer questions about the meningitis outbreak.
And, according to The Globe, it turns out that in 2002, Cadden was a member of a state task force charged with writing rules for compounding pharmacies at the same time NECC was being investigated by state and federal regulators. As the old saying goes, who guards the guards?