Contaminated Steroids’ Fungal Meningitis Outbreak

This week we learned that 14 people died and over a hundred more people are sick as a result of contaminated injections of the steroid, methylprednisolone acetate, produced by the New England Compounding Center. In May, the NECC  began shipping contaminated steroids to 76 US clinics. People with back and neck pain may have been exposed to fungal meningitis by  injections of steroids to relieve their pain. Meningitis is an inflammation of the membrane covering the brain and spinal cord. 

The FDA was concerned about this drug and had warned the NECC but did not take action to see that distribution stopped, nor did the FDA warn health providers. 

Compounding companies have been around since our earliest pharmacies began, over 4000 years ago. Unlike drugs produced by the big companies for general distribution, compounding prescriptions are produced for specific patients. For example, a patient may need a smaller dose of a particular drug, or the drug may need a liquid added to make it easier to for a child to swallow, or the drug may be put into a topical cream to be absorbed through the skin by a hospice patient. Compounding companies are not allowed to produce a drug that is already commercially available. And, they do not glean enough revenue to fund the research required for FDA approval of new drugs. Their job is to customize existing medication.

 In this case, NECC appears to have been mass producing a preservative free form of this drug without subjecting it to the FDA approval process. The big drug companies like Pfizer and Merck must do extensive research for every drug produced and they spend millions to qualify for FDA approval. Sterile technique is rigorously monitored in their labs. This whole process means that every time a new drug is produced, even if only a molecule is changed in the formula, the big companies charge astronomical prices for each new drug. 

When a compounding company like NECC began producing methyl prednisolone and marketed it at a much lower price because they skipped the FDA approval process, 76 clinics in the US thought it was a good deal. Problem is, with careless oversight, the drug became contaminated with at least two different fungi that cause Fungal Meningitis, a non-contagious form of meningitis.

 Please note: there are many bona fide compounding companies that provide a needed service and play by the rules. No doubt, health practitioners will be carefully checking their supplies but it is up to each of us to double check where any medication we’re given comes from, and to keep a record of what we receive and why.

 Even more important, we need to eat well, exercise well, sleep well, enjoy family and friends, and hopefully be so healthy we won’t need injections!

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