The dangers of compounding pharmacies
Lack of regulation can result in bad outcomes, as Denise Grady, Andrew Pollack, and Sabrine Tavernise report in the NY Times:
Eddie C. Lovelace, a Kentucky judge still on the bench into his late 70s, had a penchant for reciting Shakespeare from memory and telling funny stories in his big, booming voice. But a car accident last spring left him with severe neck pain, and in July and August he sought spinal injections with a steroid medicine for relief.
Instead, Judge Lovelace died in Nashville in September at age 78, one of the first victims in a growing national outbreak of meningitis caused by the very medicine that was supposed to help him. Health officials say they believe it was contaminated with a fungus.
The rising toll — 7 dead, 57 ill and thousands potentially exposed — has cast a harsh light on the loose regulations that legal experts say allowed a company to sell 17,676 vials of an unsafe drug to pain clinics in 23 states. Federal health officials said Friday that all patients injected with the steroid drug made by that company, the New England Compounding Center in Framingham, Mass., which has a troubled history, needed to be tracked down immediately and informed of the danger.
“This wasn’t some obscure procedure being done in some obscure hospital,” said Tom Carroll, a close friend to the Lovelace family, and their lawyer. “They had sought out a respected neurosurgeon who had been referred by their family doctor, at a respected hospital,” he said, referring to the St. Thomas Outpatient Neurosurgery Center. “How does this happen?”
The answer, at least in part, is that some doctors and clinics have turned away from major drug manufacturers and have taken their business to so-called compounding pharmacies, like New England Compounding, which mix up batches of drugs on their own, often for much lower prices than major manufacturers charge — and with little of the federal oversight of drug safety and quality that is routine for the big companies.
“The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts,” said Kevin Outterson, an associate professor of law at Boston University.
The outbreak has also brought new scrutiny to the widely used procedure that Judge Lovelace and millions of Americans undergo each year.
Patients most likely assumed there was strong evidence that the procedure itself works. . . [Well, yes: That's why we have a Food and Drug Administration in the first place. - LG]