Lax oversight played role in meningitis outbreak
That more than a dozen people have died from what is believed to be tainted steroid medications manufactured by a Massachusetts compounding pharmacy is a tragedy.
That federal health officials and members of Congress have known about the potential dangers posed by these large, unregulated businesses for more than a decade and done little about it is an outrage.
On Tuesday, the state Department of Health and Human Services reported the discovery of two more cases of fungal meningitis, part of a national outbreak of a potentially deadly disease linked to medical products manufactured by the New England Compounding Center in Framingham, Mass.
That brings the total number of cases in New Hampshire to six, linked to tainted steroid injections administered as pain medication at Pain Care LLC offices in Merrimack, Newington and Somersworth.
So far, 15 states have reported 214 cases of fungal meningitis – an infection of the membranes covering the brain and spinal cord – including 15 that tragically resulted in deaths. As federal investigations expand to other products manufactured by NECC, the number of cases could grow in the days and weeks to come.
Since the link was discovered, NECC has issued a voluntary recall of more than 2,400 of its products dating back to January, and medical practices have been advised by the Food and Drug Administration to remove all these medications from use. In New Hampshire, Pain Care officials have identified roughly 740 patients who may have been exposed to the tainted steroids, most of whom had been contacted as of late last week.
What are compounding pharmacies?
As far back as the 1700s, they were small operations that made specialized medications for specific patients that otherwise might not be commercially available, such as drugs for an individual who might be allergic to one of its ingredients. As such, they were pretty much exempt from federal regulations that govern large pharmaceutical manufacturers.
Today, however, many have grown into manufacturing operations of their own, shipping more standardized products across state lines. In NECC’s case, as many as 14,000 patients in 23 states may have received one of the contaminated injections, according to the U.S. Centers for Disease Control and Prevention.
Since 2001, more than two-dozen deaths have been tied to contaminated or imprecise doses from compounding pharmacies, according to an extensive review of state and federal records, academic journals and other documents by USA Today. A much larger number suffered serious injuries, in some cases leading to permanent disabilities.
Yet despite pleas from federal health officials at least as far back as 2001, nothing has changed. Congressional bids in 2003 to establish an FDA oversight panel and in 2007 to give the agency some regulatory authority over these pharmacies didn’t go anywhere.
Not surprisingly, both efforts met with strong opposition from the International Academy of Compounding Pharmacists, a trade organization that has spent more than $1.1 million since 2000 lobbying against efforts to impose even minimal regulations on the industry.
Given that “regulation” is a dirty word in Washington these days, we suspect any renewed calls to regulate these large compounding pharmacies would meet a similar fate.
That’s no reason not to try.