National news media of all sorts have been reporting about an “epidemic of meningitis” associated with contaminated steroid shots given for back pain. I might as well chime in too. There have been 47 cases identified so far with five deaths, including one Kentuckian. Because hundreds or even thousands of people have received such injections, these numbers will surely increase over the next few weeks. Meningitis is inflammation or infection of the tissues surrounding the spinal cord and brain. The epidural or peri-spinal steroid shots in these cases are injected deeply around the spine and close (if not adjacent) to the meninges. Once the infection breaks through into the spinal fluid or bloodstream, it spreads widely in short order including to the brain.
Generally when people hear about epidemics of meningitis they are concerned about Meningococcal meningitis which is caused by a very specific kind of bacteria. Meningococcal meningitis is contagious and lethal– often very rapidly so. This is the brand of meningitis that causes parents to pull their children out of school or camp. A safe and effective treatment is available, but not all will be saved.
Fungi are bad pathogens to treat.
The meningitis of the current epidemic is very different animal– literally so. It is caused by a fungus, not a bacteria or virus. Fungi are more slow-growing and their cellular structure resembles our own mammalian cells more than those of bacteria. For that reason, medicines that kill fungal cells are also toxic to mammalian cells like ours. The usual antibiotics do not work at all. The implication of this similarity is that treatment is difficult, prolonged, and fraught with toxic side effects. Sometimes fungal infections are virtually untreatable. This type of meningitis is, however, not contagious. The one fungus mentioned so far as the candidate for the current epidemic is Aspergillus– a kind of bread mold. Normally such fungi do not get beyond the body’s defense mechanisms unless there is severe immune deficiency. However, if fungus-contaminated steroid is injected right up next to the spinal cord, the body’s defense systems are bypassed and the contaminant can blossom and spread. To add insult to injury, the steroids simultaneously inhibit the body’s ability to fight off the fungus.
The free market at work.
So, given all the industry complaints about over-zealous FDA supervision of drug companies, how can this kind of thing happen? Well, the fact is that despite everyone’s best intentions, contaminated drugs occasionally will leak through. We read about such instances all the time. However, the steroid suspensions in the current cases were not manufactured by a typical pharmaceutical company and were subject to little-or-no regulatory supervision for safety and effectiveness. (Another demonstration of the power of political contributions and lobbying!) The steroid in question, methylprednisolone acetate, was made and packaged by the New England Compounding Center. Traditionally, some pharmacies would occasionally “compound” or mix up a special preparation of a drug to be used in atypical situations. For example, a pill might be ground up into an ointment. The number of such “compounding pharmacies” has exploded in the last 10 years, presumably because of their immunity from FDA supervision. This is entrepreneurship at work! I predict much bloviating about the situation on cable TV and in the halls of Congress. About all of this, the facts will unfold, and much will be debated.
This is not the first time that outbreaks of fungal infections have occurred following the use of contaminated medications, or even contaminated steroids. Most methylprednisolone acetate preparations are manufactured by traditional drug companies under the usual precautionary supervision. The question has been asked, why would doctors or clinics buy from other than such a company? The question deserves to be answered, but you and I can guess the most likely reasons. I will be writing more about the pain industry later. Another reasonable question about how our “system” works or fails to work is how long it took to figure out what was going on, and if patients who had been exposed were promptly contacted and warned?
Is the risk worth it?
Magnifying the tragedy in my mind is the fact that the huge majority of the shots, if not all of them, would have in my opinion not been medically unnecessary. Doctors (especially in pain clinics) like to give them because as procedures, they pay well. Patients accept them and may even swear by the shots because there is no more powerful placebo than a long needle injected deep into the body. No details have been given yet, but the likelihood is that most of the patients were being treated for routine degenerative disease of the spine, one of the most over-treated conditions of all. The most extensive reviews of clinical research available to me do not confirm a therapeutic benefit from such steroid shots greater than an injection of saltwater. At best, a few studies show only a small benefit that is short-lived. There is no evidence these steroid shots prevent progression of disease or reduce the frequency of later back-surgery (much of which is not medically necessary either.) I never found it appropriate to refer any of my own patients for such shots and I bristle when they are called pain shots.
If you’ve read any of my earlier articles about unnecessary medical treatment, you will understand why most of my hair is prematurely gone. The tragedy of these cases is doubled by the fact that the drug was prepared in less than fully regulated conditions, tripled by the fact that the patients probably paid through the nose for multiple injections, and quadrupled by the fact that not much benefit was to be had anyway. What a waste of time, money, and health! This is American medicine at its typical best. Give me health care reform any day– more and quicker!
Peter Hasselbacher, MD
Emeritus Professor of Medicine, UofL
October 5, 2012