The human body is both a marvel of engineering capable of jamming decades of memories and the programming to run a 100 trillion cell body into a brain the size of a football, and a slipshod jury rig. Ever since Hippocrates (“the father of spine surgery”) prescribed the first treatments for back problems — various combinations of baths, massages, and hanging upside down, all in all not too different from today — humanity has been dealing with chronic back pain. Even apart from classic deformities like kyphosis and scoliosis or a traumatic injury, the human back is just plain prone to problems, from sciatica to compressed discs.
When you add up all the doctors, physical therapists, spine surgeries, and epidural steroid injections, back pain in America is a $30 billion industry, and, as a part of that, over 9 million epidural steroid injections are given every year to treat back pain. It’s an old and simple treatment, dating back to 1952, although the scientific research on it (full text PDF here) remains sparse. There are some non-randomized studies showing that it works to relieve sciatica and low back pain in more than half of patients temporarily, and then there’s a fair amount of anecdotal evidence suggesting it helps in the long term. Part of this problem is likely due to the age of the product: it’s not under patent, so no one will fund the randomized trials to prove or disprove its efficacy.
Patients often opt for the injections because the alternative would be regular use of opioids (or more opioids), either taken orally or through the shockingly dangerous fentanyl patches. What’s the harm?, they ask, and their doctors reply that, of the over 9 million shots a year, only a handful of problems are reported. (They usually don’t mention that those problems can be devastating — including paraplegia, quadriplegia, and cerebral infarction — patients are, after all, receiving an injection directly into their spine.)
Over the past month, the potential harm of epidural steroid shots for back pain became shockingly disproportionate to the benefit, as more than one-hundred people across 23 states developed fungal meningitis from a contaminated steroid solution prepared by New England Compounding Center, a compounding pharmacy in Framingham, Mass. Seven have died. It’s not a disaster on the scale of Thalidomide, which left tens of thousands with birth defects, but it’s comparable to the “Elixir Sulfanilamide” incident from the 1930s, in which an improperly mixed antibacterial solution killed more 100 people.
There’s a lot that can be said about the outbreak’s causes and repercussions, and about reform for the future. USA Today questions whether the steroid shots are too dangerous for treatment of back pain even apart from the meningitis outbreak, and so should be restricted. John Day in Tennessee discusses how “tort reform” has limited the rights available to victims and has exacerbated the disparity in compensation awards for high income versus low income plaintiffs. Brett Emison in Kansas City, Missouri rounds up a number of articles questioning whether the FDA should be given more oversight over compounding pharmacies. There’s also some really interesting product liability questions in there relating to the liability of parties beyond the compounding pharmacy (and the role of strict liability without fault), but we need some more facts to flesh them out. There’s also the lingering question of collectability: it seems that New England Compounding Center has shut down entirely, and who knows what insurance coverage they had available. Medical supply companies aren’t required to carry business liability insurance.
But I want to talk about the contaminated injections in another context: the power of incentives.
Economists and some politicians like to talk about the power of incentives. Greed isn’t good, and it doesn’t explain everything, but corporations are indeed required by law to maximize profits for their shareholders, and so it shouldn’t be surprising that even corporations in the medical field will take shortcuts to improve their bottom line. It’s often called the “race to the bottom.” All things being equal, companies will penny-pinch where they can, going beneath one another in terms of safety, testing, and quality control, each trying to squeeze another nickel out of the process. The race to the bottom is a particular problem in fields where the quality of a service or good isn’t obvious to users; nobody will buy moldy bread, but nobody has a clue if they’re injecting a contaminated medicine into their spinal cord.
One solution to that problem is increased regulation, having the government set some sort of “floor” under which a company may not go. I think that’s a step in the right direction, but regulation obviously has its limits in ensuring companies always put safety first. Consider the pharmaceutical industry: all of the major pharmaceutical companies have paid massive fines, some extending into the billions of dollars, for violating FDA regulations. Right now in Philadelphia the makers of Risperdal are going through a series of jury trials alleging the company covered up data showing the drug could cause gynecomastia (i.e., enlarged mammary glands) in boys and young men. A week ago, Abbott Laboratories was fined $700 million by a federal judge for illegal marketing of Depakote. And we’re only talking about the past week.
Thus, for all the calls that compounding pharmacies be regulated by the FDA (which aren’t new; consider the Makena v. compounded 17-P debacle), whether or not that’s a good idea, it’s certainly not a complete solution. If FDA oversight can’t even ensure the largest drug companies don’t engage in deceptive marketing practices on a national scale, how will they prevent contaminations in thousands of individual compounding pharmacies?
The other solution to the “race to the bottom” problem is to make safe conduct cheaper than unsafe conduct, and we do that by making it expensive to hurt people. We already have a system set up for that, the civil justice system, which has the power to directly move money from the companies that hurt people to the people they hurt. If consistent discipline is the key to raising responsible children, then we should be able to apply that same reasoning to raising responsible corporations that don’t stick their hands in the cookie jar when they should be checking contamination safeguards.