Meningitis outbreak widens
Dr. Alfonso Pino, AMA Member
An update from the US Centers for Disease Control and Prevention, indicating the meningitis outbreak has now been reported in six states, spurred extensive media coverage, most of which noted that Federal health authorities are expecting more cases to emerge.
ABC World News (10/4, story 7, 1:30, Sawyer) reported, “A CDC warning about a growing outbreak of meningitis: At least five people have now died; and there 35 cases across six states.” NBC News (10/5, Fox) in its “Vitals” blog reports that the 35 cases “include 25 people in Tennessee, one in North Carolina, two in Florida, three in Virginia, two in Maryland, and in Indiana,” according to the CDC; and “three of the deaths were in Tennessee, one in Virginia and one in Maryland.”
The CBS Evening News (10/4, story 4, 2:20, Pelley) reported, “The suspected source is tainted vials of steroids that were shipped to 23 states.” In a subsequent story, the CBS Evening News (10/4, story 5, 0:40, Pelley) added, “The CDC is investigating how the vials were contaminated.”
The Los Angeles Times (10/5, Muskal) reports that officials from the CDC and the Food and Drug Administration provided the update during a “telephone news conference” Thursday. The FDA’s Center for Drug Evaluation and Research, Office of Compliance Director Dr. Ilisa Bernstein said that all of the reported cases “have been blamed on three product lots from the New England Compounding Center , a specialty pharmacy” in Framingham , Massachusetts . She noted that the lots date is from July, but added that “out of an abundance of caution,” the agency is “advising medical practitioners to discontinue using all of the company’s products.” Dr. Benjamin Park, a CDC medical officer, told the news conference that the “scope of the outbreak is difficult to determine because the medication has been distributed in 23 states to an estimated 75 facilities.” Therefore, Dr. Park added, “We expect to see additional cases soon.”
The Wall Street Journal (10/5, A3, Rockoff, Martin, Subscription Publication) reports that officials at the Massachusetts Department of Public Health said the New England Compounding Center relinquished its state operating license on Oct. 3, after the FDA found the fungi, aspergillus, on the inside of a sealed, steroid-injection vial.
The Washington Post (10/5, Brown, Sun) adds that the Dr. Park said the vials contain “methylprednisolone acetate,” which is “injected around the spinal cord in the lower back to relieve pain caused by ruptured disks or spinal stenosis” and is transported to the brain through cerebrospinal fluid. He said in can take “one to four weeks” for symptoms, which include “fever, headache, nausea and stroke-like weakness” to appear. Park emphasized that if infected patients are identified quickly, and “started on antifungal therapy, some of the unfortunate consequences may be averted.”
According to the AP (10/5, Stobbe), Massachusetts Health Department officials said the compounding center has “recalled three lots consisting of a total of 17,676 single-dose vials of the steroid.” Health regulators said that “several hundred of the vials” have been returned unopened, but many “were used.” Federal health authorities said Thursday that prior to the recall, an “unknown number of those vials reached 75 clinics and other facilities in 23 states between July and September.”
Reuters (10/5, Ghianni) reports that during the conference call, the CDC’s Dr. Park said the 75 clinics that received the compounded steroid vials are in 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, Virginia, Texas and West Virginia.
Meningitis outbreak spurs oversight concerns. In a front-page “news analysis,” the New York Times (10/5, A1, Tavernise, Pollack, Subscription Publication), noting that compounding pharmacies “make their own drug products” and the FDA does not have the authority to approve the drugs, says the big question is why “would pain clinics around the country rely on a pharmacy that mixes its own brand of unapproved drugs, especially for a delicate procedure like an epidural injection?” Some physicians “say compounding pharmacies offer specialty products or dosages not easily found elsewhere, or sometimes simply better prices than big drug companies.” Notably, the Times points out that Pharmacy Compounding Accreditation Board Director Joe Cabaleiro “said that the New England center had never applied for accreditation as meeting the industry’s quality standards.” Moreover, according to James H. Ruble at the University of Utah College of Pharmacy, the FDA does prohibit mass-producing and shipping compounded drugs “across state lines.”
Similarly, the AP (10/5, Marchione) notes that the outbreak has reignited concerns about compound drug regulation. “Two people blinded in Washington , D.C. in 2005. Three dead in Virginia in 2006 and three more in Oregon the following year. Twenty-one dead polo horses in Florida in 2009. Earlier this year, 33 people in seven states with fungal eye infections. And now, at least five people dead and 35 sickened with fungal meningitis that has been linked to steroid shots for back pain.” The AP says, “all these disasters” involved medicines that were “custom-mixed” by specialty compounding pharmacies.