The media coverage of the meningitis outbreak continued throughout the weekend as the Centers for Disease Control and Prevention reported that the number of related illness increased from 35 to 91, and the number of deaths increased from five to seven.
Unfortunately, many more patients may be involved; a situation where a simple steroid injection to the spine to relieve pain has turned into death and likely permanent disability. The fungus-tainted vials of steroid have been traced to a compounding pharmacy in Massachusetts, and according to The New York Times, almost 18,000 of the vials have been shipped to clinics across the country.
The Associated Press reported Monday morning that Senator Richard Blumenthal of Connecticut is demanding stronger federal government oversight of compounding pharmacies. Currently, compounding pharmacies are regulated by state boards. Again according to The New York Times, the FDA did have a clear set of rules overseeing compounding pharmacies, but a Supreme Court decision in 2002 struck down these rules; Congress has since never dealt effectively with the compounding pharmacy regulatory issue. Some consumers see compounding pharmacies as providing less expensive alternatives to FDA-approved treatments, and have provided product when pharmaceutical companies have experienced shortages. Unfortunately, drug shortages have become more common, perhaps due to economic realities and profit-loss calculations, leaving the door open to the services of compounding pharmacies.
Of course, this incident has caused some patient safety groups to call for a ban on spinal, or “epidural,” steroid injections. But providers of the injections are just as quick to point out that these injections are safe when performed properly, and remind us that the problem lies with the medicine, and not the medical doctor. As a counterpoint, there are watchdog groups who for many years have been saying that the increasing numbers of epidural steroid injections is not based simply on more back pain in the world, but on the dollars that come as reimbursement for this procedure to the performers of the procedure: A 2010 audit by the Department of Health and Human Services’ Inspector General concluded that a third of the 433 injections it reviewed in 2007 did not fulfill Medicare requirements for being medically necessary.
But while watchdog groups and medical societies argue over the merits and ethics of a steroid injection, let us hope that those patients affected by the tainted steroids will be expeditiously tracked down and treated.