Better oversight of compounding pharmacies won't solve the bigger problem of unnecessary medical procedures
At last count, 32 people are dead and 438 are seriously ill as a result of the fungal meningitis outbreak that has been traced to the New England Compounding Center, the pharmacy based in Framingham. Since the story broke last month, each new report has brought a fresh reason for outrage. More deaths from fungal meningitis linked to the company's contaminated product. More states with stricken patients. More details of how the company failed to maintain equipment and even falsified safety tests.
All this is bad enough, but there's another aspect to this story that is equally shocking. The company's product is unnecessary. The patients who developed meningitis, including those who died, were given a drug combination that had little if any chance of doing them any more good than a safer treatment.
The New England Compounding Center's drug was really two drugs, corticosteroids and an anesthetic, that had been combined, or compounded. Such a mixture is routinely given to patients with back pain, and is often administered by a specialist, who uses CT images to guide placement of the needle. The anesthetic is supposed to relieve the pain temporarily, while the steroids are supposed to reduce swelling and pressure on nerves, giving the back a chance to heal.
That's the theory, anyway. Unfortunately for patients, there's not much evidence to support it. A recent study conducted by members of an international consortium of researchers known as the Cochrane Collaboration looked at four clinical trials comparing low back pain patients who got an injection of anesthetic alone to patients who got a compounded cocktail that included steroids. In all four trials, both sets of patients got pain relief. However, those who got the cocktail of anesthetic plus steroids did no better than patients who got anesthetic alone.
In other words, the addition of the steroid — the part of the New England Compounding Center's drug that transmitted the deadly fungus to patients — almost certainly had no effect on patients' pain. Other studies of steroid injections alone have also failed to show a consistently positive result.
Patients and doctors sometimes think there's no harm in trying a treatment that hasn't been shown to work. The outbreak of fungal meningitis suggests that can be a dangerous assumption. It also hints at the potential harm that is being caused by the widespread use of unnecessary treatments and tests. Anywhere from 10 to 30 percent of every health care dollar spent is wasted on such unnecessary medical interventions as inappropriate elective angioplasties, unwanted hospital admissions, and ineffective antibiotics for viral infections. About a third of CT scans add nothing to the physician's ability to diagnose, but they still expose patients to radiation. Many back surgeries have never been shown to be no more effective at relieving pain than painkillers and physical therapy. The list goes on. How many patients are actually harmed by unneeded medical intervention? Unfortunately, there are no firm estimates — because nobody is keeping track.
The immediate (and correct) regulatory response to the unfolding tragedy caused by the New England Compounding Center is figuring out what went wrong and preventing similar events in the future. That leaves the much larger task of finding ways to protect patients from the widespread and serious problem of unnecessary tests and treatments.
Shannon Brownlee is author of Overtreated: Why Too Much Medicine is Making Us Sicker and Poorer. Dr. Vikas Saini is a clinical cardiologist at Brigham and Women's Hospital and Harvard School of Public Health.