Last year, The Center for Disease Control and Prevention broke the news to the media that there had been numerous deaths from fungal meningitis contracted from tainted vials of a steroid medication often used to treat chronic back pain. At least 16 were killed, while many more became seriously ill. Although that outbreak has been contained, a year later, we still need to rethink back pain treatment.
The outbreak began when The New England Compounding Center, based out of Massachusetts, shipped vials that may have been contaminated to 23 states and 76 medical facilities. At that time, the outbreak spurned multiple investigations and led to a recall of the product and a halt in all further operations by this company.
Companies such as The New England Compounding Center had been contracted by more and more doctors and clinics to produce and sell pharmaceuticals because they are able to sell them at a much cheaper price. These compounding companies concoct their own batches of drugs and are subjected to much less legal oversight and regulation on safety procedures as most large pharmaceutical companies.
Kevin Outterson, an associate professor of law at Boston University said, “The food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts.” This lack of compliancy has caused many, including workers at the compounding companies themselves, to feel uncertain about the safety of their product.
At another company in Massachusetts, Ameridose, which has many of the same share owners as the New England Compounding Center, a pharmacists quit because she believed unqualified people were being used to quickly assemble drugs to be sold to clinics. A salesperson at Ameridose has also admitted that he was asked to perform tasks he was not qualified to perform such as, “packaging and labeling during rush orders,” to assure the product was delivered on time.
Paul Cirel, a lawyer for Ameridose, had said he would not address “what anonymous, maybe disgruntled, ex-employees say… and [what] is not said by the FDA or any other regulator.”
However, the outbreak last year of fungal meningitis eventually led to an increased apprehension for patients considering this option. Also damaging is that the Cochrane Collaboration, an international group of medical specialists, concluded that there was “no strong evidence for or against” the effectiveness of the injection.These injections, known as lumbar epidural injections, are often sought by patients hoping to avoid surgery by obtaining anywhere from a few weeks to a year of relief.
One of the 16 victims who died was a 78 year old Kentucky circuit judge. Eddie C. Loveless sought the lumbar epidural steroid injections to help relieve neck pain he that had been troubling him since he was involved in a car accident. However, the injections, which local health officials believe were contaminated with fungus which caused him to contract meningitis.
“They had sought out a respected neurosurgeon who had been referred by their family doctor, at a respected hospital,” said Tom Carroll, a close friend and lawyer for the Loveless family. “This wasn’t some obscure procedure being done in some obscure hospital. How does this happen?”
Of course many compounding drug products perform remarkably well and can even produce specialized types of a certain drug for distinct needs. Makena, a new version of an older drug used to reduce premature births, provides a much cheaper alternative that most mothers feel they can afford. Also, drug shortages have become more and more complex making the use of compounded drugs an unfortunate, yet sometimes essential, alternative for many patients. The outbreak of fungal meningitis last year makes it clear we need to rethink treatment for back pain.
By: Nick Manai
Source: New York Times