Over the last couple months, we have seen the effects of contaminated steroid medication distributed to a large number of clinics around the country. The New England Compounding Center produced contaminated methylprednisolone that was delivered to 75 pain clinics in approximately 14 states.
Three lots of the medication was found to be contaminated and was injected into over 14,000 individuals. This included epidural injections, facet joint injections, extremity joint injections, and soft tissue injections for pain relief.
So far, due to the contamination there have been almost 80 deaths and over 700 infections as a result of the fungal contamination.
Only a few infections occurred in Florida, as only a small amount of medication from the New England Compounding Center was delivered to the state. What can we learn from this horrible tragedy?
Modern pain management has advanced tremendously over the last decade. However, even a clinic who has a first rate surgical center with Board Certified pain doctors and a stellar reputation can receive medication that is tainted. This is a long way of saying that there are certain things a pain clinic can control, and there are some that are unknown risks. Those risks have nothing at all to do with physician competence.
Another thing that most people following this tragedy have learned is that there is a significant difference between manufacturers who are controlled by the FDA and under those regulations, and compounding pharmacies which are not under the direct purview of the FDA.
In this case, the New England Compounding Center is a compounding pharmacy and not a large manufacturer. Compounding centers do not fall under the FDA’s direct line regulation. Over last few years, the FDA has come under fire for hitting manufacturers with an increasing amount of regulatory warnings that have led to drug shortages from time to time. When a tragedy like this occurs, most reasonable people would look at that and say “I wish the FDA would have the right to oversee all manufacturers and compounding pharmacies of medications such as this.”
In addition to learning about the regulatory limitations of the FDA with compounding pharmacies, this tragedy has also brought up discussions about the effectiveness of epidural steroid injections. The question of risk versus benefit has been placed at the forefront of these discussions.
There’s a reason why epidural steroid injections have been in use for over 60 years. There are significant benefits to these procedures, and they can often allow individuals to avoid surgery and achieve substantial pain relief in a very difficult time. Normally, the risks with steroid medications are under 1%. It is a tragedy like this one that pushes the medical community to take a hard look at the effectiveness of these injections. The vast majority of pain management doctors immediately elucidated the benefits of the procedures and quieted down the naysayers.
One last thing this tragedy has shown us is that fungal infections are very different from bacterial infections. They have a longer incubation period and the medications needed to treat fungal infections can do a lot more harm to the human body than a simple antibiotic typically.
All in all, the fungal meningitis outbreak is something that should have been avoided. It has taught us some interesting facts about how the manufacturing process works and who has the oversight on safety of medications. That may help significantly in the future as the FDA takes a more direct approach with compounding pharmacies, but it will do little at this point to help those who were infected and those unfortunate patients who passed away from fungal meningitis.
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