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Meningitis Deaths Bring Attention to a Poorly Regulated Industry

As the number of cases of people contracting fungal meningitis has risen to 91 in nine states, with 7 deaths, health officials around the country can just hold their breath and hope the disease abates in its slow path of destruction.

The outbreak is linked to people who received steroid injections primarily for back pain, using one of the 17,676 vials of the steroid methylprednisolone acetate that was shipped to 76 facilities in 23 states between July and September by the New England Compounding Center Inc. in Framingham, Massachusetts.

The Centers for Disease Control and Prevention raised the number of cases by 27 yesterday, bringing the total to 91. The state with highest number of cases is Tennessee (32), followed by Michigan (20) and Virginia (18). There are also cases in Indiana (8), Florida (4), Minnesota (3), Maryland (3), North Carolina (2) and Ohio (1).

The CDC describes meningitis as an inflammation of the protective membranes covering the brain and spinal cord, usually caused by an infection with a bacteria or virus, but sometimes less commonly with fungi. The severity of disease and the treatment differ depending on the cause. With fungal meningitis, the fungus spreads through the bloodstream as a result of the fungus being introduced directly into the central nervous system. Fungal meningitis is considered extremely rare.

According to the CDC, the symptoms, which can be very mild at first, include headache, fever, nausea and stiffness of the neck. People with fungal meningitis may also experience confusion, dizziness, and discomfort from bright lights. Patients might just have one or two of these symptoms.

Fungal meningitis is not contagious.

The Massachusetts company where the vials originated, which was previously the subject of complaints, has suspended its operations while an investigation is underway. It has recalled all products compounded and distributed at its Framingham facility.

The outbreak has brought attention to the existence and regulation of compounding pharmacies, which take medications from pharmaceuticals manufacturers and to make them into specific dosages and strengths for use by doctors.

According to Reuters, the U.S. Food and Drug administration has limited authority over the day-to-day operations of compounding pharmacies because they are primarily regulated by state boards that oversee the practices, licensing and certification of pharmacies and pharmacists.

When they are compounded, products don’t even have to get FDA approval before they are sold, and the agency has no jurisdiction over how the products are manufactured or labeled for use. When the FDA tried to exert greater authority over compounded drug products under a section of the Food, Drug and Cosmetic Act that covers new drugs, it resulted in court challenges.

The steroid was sent to California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia and West Virginia, the CDC said.

A list of facilities that received vials from the infected lots can be found via on the CDC website, cdc.gov.

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