As the ongoing fungal meningitis outbreak in the U.S. widens, federal officials on Tuesday raided an office of the Massachusetts compounding pharmacy that made steroid injections that have been linked to the infections.
U.S. Food and Drug Administration agents and local police searched the Framingham office of the New England Compounding Center, which made the medicine first implicated in the outbreak -- three lots of preservative-free methylprednisolone acetate. On Oct. 6, NECC recalled all products made at and distributed from the Framingham branch that are currently in circulation.
“I can confirm that this office and our law enforcement partners are investigating allegations concerning the New England Compounding Center,” U.S Attorney Carmen Ortiz said in a statement Tuesday. “I think that it is entirely premature to suggest what the results of the investigation will be.”
NECC's lawyer, Paul Cirel of Collora LLP, said in a statement that the raid was unwarranted.
"It is difficult to understand the purpose of this search, since we have been clear that [NECC] would provide, and has provided, anything requested. We've been clear that warrants weren't needed," Cirel said, according to Reuters.
As of Wednesday, there have been 245 cases of fungal meningitis reported to the U.S. Centers for Disease Control and Prevention, along with two cases of joint infection. Nineteen people have died thus far.
The CDC has confirmed that the fungus exserohilum rostratum was present in at least 10 people stricken with the infection. A Tennessee patient, the first case identified in the outbreak, was infected with a different fungus called aspergillus.
On Monday, the CDC got word of possible meningitis cases stemming from other NECC products besides the methylprednisolone acetate. One patient received an epidural injection of another kind of steroid product called triamcinolone acetonide. Another patient with a fungal infection was the recipient of NECC-made cardioplegic solution, which is used to paralyze the muscles of the heart during open heart surgery.
According to the CDC, people that received the potentially contaminated medication should seek immediate medical attention if they exhibit any of the symptoms of fungal meningitis: worsening headache, fever, sensitivity to light, stiff neck, weakness, numbness or slurred speech. Even a minor headache could be a sign of trouble -- some already documented victims in the outbreak have complained of only slight headaches at first.
NECC has been previously investigated by Massachusetts health regulators and the U.S. Food and Drug Administration, and the FDA sent the company a warning letter in 2006 about alleged violations, including one involving the injectable cancer drug Avastin.
The investigation into NECC may involve matters beyond the immediate meningitis outbreak.
On Tuesday, Congressman Edward Markey (D-Mass.) asked the U.S. Department of Justice to investigate NECC's handling of more than 1,000 controlled substances, including cocaine, morphine and ketamine.
The list of recalled products issued by the NECC seems to include compounds with controlled substances that fall under the purview of the U.S. Drug Enforcement Agency. NECC is not registered with the DEA as a manufacturer and supplier of such compounded drugs, according to Markey.
“This is a matter that I believe requires further investigation by the DEA to ensure that this facility, already believed to have broken Massachusetts state law, has not also skirted federal law related to controlled substances,” Markey said in a letter to the DOJ.
To contact the editor, e-mail: