On Oct. 9, New Jersey reported its first case in the fungal-meningitis outbreak that has now spread to 10 states in as many days. There have been no cases reported in Pennsylvania thus far but, according to the Pennsylvania Department of Health, a series of clinics in Allegheny County has already contacted patients because the drugs deemed responsible were used there.
The outbreak is tied to tainted injectable steroids — methylprednisolone acetate —from a compounding pharmacy, the New England Compounding Center, Inc., in Framingham, Mass. The drugs are used for pain management and are injected directly into the patients’ spinal cords in an outpatient procedure known as an epidural injection.
According to the Centers for Disease Control, which has been conducting a multi-state investigation of the rare outbreak, fungal meningitis, also called cryptococcal meningitis, is usually associated with immune disorders, such as HIV/AIDS. It is most common in people with HIV/AIDS in Africa, where it is a major opportunistic infection.
A CDC spokesperson said Oct. 8 that the current outbreak has been traced to two separate molds, aspergillus and exserohilum. The CDC also noted that only in rare instances has aspergillus been linked to meningitis and that exserohilum has not previously been linked to cryptococcal meningitis in people who are otherwise healthy.
As of Oct. 9, 119 people had contracted the disease, which is not communicable, from the steroid treatments. Eleven people have died, several have had strokes and all others remained in critical or guarded condition. Fungal meningitis can cause swelling of the brain as well as stroke. Symptoms, which include fever, severe headache, neck pain and sensitivity to light, can take between one and four weeks to appear.
More than 17,000 people have been injected with the drugs. The Framingham pharmacy has recalled three batches of the drug, which have all shown traces of the molds involved and, on Oct. 7, voluntarily recalled all other drugs compounded at and distributed from NECC, citing a “super abundance of caution.”
Compounding pharmacies like NECC specially mix their medications for patients who cannot, for example, swallow pills and must have liquid forms of drugs, or higher dosages than are usually available, as was the case with the steroid injectables. Fewer than 10 percent of all pharmacies in the United States are specialized compounding pharmacies. Pennsylvania is one of only three states (Georgia and Massachusetts are the other two) that do not require out-of-state drug manufacturers to be licensed to transport drugs. NECC is not licensed, which means that if the pharmacy had not voluntarily ceased to ship the steroid injectables causing the meningitis, Pennsylvania would have no recourse for stopping distribution of the drugs.
People with HIV/AIDS, cancer and other immuno-suppressive diseases are most susceptible to infection.
Robert Winn, medical director for Philadelphia’s Mazzoni Center, told PGN this week that anyone receiving injectable steroids “whether they are HIV-positive or not, should ask their clinician where [the drugs] are coming from.”
Winn added that NECC, regardless of whether it had been operating within established guidelines for compounding pharmacies, had been following clear protocol on batches of drugs and thus the lot numbers were recorded and the tainted drugs were being or had been recalled.
“I would rest assured,” Winn said, “that patients in the area who have been affected by this particular outbreak have been contacted or are being contacted at this time. Whichever procedure [NECC] did not follow, all of those packages have been traced and found.”
While the NECC-related outbreak has received daily national news coverage, a smaller outbreak of invasive meningococcal disease among HIV-positive men who have sex with men in the past few weeks in New York City has fallen under the radar.
On Sept. 27, the New York City Department of Health and Mental Hygiene issued a press release that four men in the city contracted IMD and that one had died. On Oct. 4, the department recommended that all gay and bisexual men who had had sexual contact with other men via digital meeting (phone applications), bars, parties or bathhouses should be vaccinated against the disease.
The CDC states there are only 2,600 cases of meningococcal disease in the United States each year, so the New York outbreak is concerning as the health department reported a total of only 12 cases in the past two years. Unlike fungal meningitis, IMD is highly contagious and can be spread through saliva, kissing or prolonged close contact with an infected person. There is a high mortality rate and among survivors, the CDC noted that permanent brain damage, loss of a limb or loss of hearing are common.
The source of the outbreak is currently unknown, but similar outbreaks among gay and bisexual men in Toronto and Chicago in recent years resulted in double the number of cases and deaths as the New York outbreak has currently reported. These outbreaks were treated prophylactically with mass vaccinations of more than 14,000 men in each city.
Concerns have been raised in New York’s gay community that vaccinations might not be provided in a timely or appropriate manner. A source inside the health department alleged that 10,000 units of the vaccine had been purchased, but a health department spokesperson denied that claim and refused to state how much had been obtained.
Mazzoni’s Winn told PGN, “There are a lot more than 10,000 HIV-positive men in New York,” adding it did not seem like there were enough units of the vaccine if a mass-vaccination program was being instituted.
But Winn also said the logistics for the vaccinations might be difficult and added that the vaccine is pricey. New York’s health department is setting up a series of sites for vaccinations of men in affected communities.
Winn explained why the vaccinations were so important.
“There is no question that someone who is immuno-suppressed is at greater risk for exposure. This is actually the time of year when we see this, these outbreaks.”
Winn said that, typically, cases will be found at colleges, where the close quarters of dorms are an easy breeding ground for communicable diseases, noting that many college students are required to get meningitis vaccinations prior to going into a dorm situation.
The Philadelphia Department of Public Health was scheduled to release a warning Oct. 11 urging local gay and bisexual men planning to travel to New York City to get vaccinated against the illness as a precaution.
Winn urged caution for men in the area.
“If you hear about this and are concerned about it, speak to your clinician,” he said. “If you are someone who goes to New York and hangs out in bathhouses, you should definitely get vaccinated. If you are a college student, or someone who is immuno-suppressed and have concerns, definitely speak with your clinician.”