Meningitis Scandal Sparks Conversations about Regulation Reform in the Medical Arena

October 10, 2012

The United States has recently seen one of the most distressing and deadly outbreaks of fungal meningitis in years. While not contagious, fungal meningitis is an infection of the membranes covering the brain and spinal cord with symptoms include headache, fever and nausea, and even death. This particular outbreak has gradually morphed into a medical scandal of sorts, with multiple media outlets covering the story after the source of the disease was traced back to one U.S. company that, unfortunately, had a wide-reaching arm. In the wake of the health scandal, the New England Compounding Center (NECC), the Massachusetts-based company responsible for distributing hundreds of contaminated vials of steroids across the country has finally recalled the product.

Unfortunately, despite these corrective measures, according to the U.S. Centers for Disease Control and Prevention (CDC) the number of reported cases has continued to increase at an alarming rate, with approximately 205 incidents reported across 14 states. Of those cases reported, fifteen deaths have ensued, with Tennessee being the hardest-hit state. Even more cases may soon emerge, since an estimated 14,000 people were in receipt of the vials.

For medical malpractice attorneys, the outbreak has brought attention to the possible need for reform in the medical malpractice arena. At the same time, in engaging in conversations about it, many of us are aware that all too often regulation changes do not come until after a large scale incident like this one has already occurred. So where exactly did the problem stem from, and were there warning signs that this might happen?

According to Yahoo! News, the answer to the latter question is a resounding yes, and the problem itself stemmed from a practice called drug/pharmaceutical/niche compounding. Apparently, NECC has come under fire for similar practices before. In both 2002 and 2006, NECC was faced with investigations related to the possible distribution of tainted drugs. ABC News reports that "in 2006, the New England Compounding Center was warned by the FDA for splitting and repackaging the cancer drug Avastin -- a practice that opens the door to contamination." That same year an elderly woman filed a complaint against the company for her husband's meningitis-related death.

What of the compounding process itself? Drug compounding is a personalized process whereby pharmaceuticals are created to fit the unique benefits of each individual client. This can include things like adding a particular flavor to a medication, removing allergens or converting a drug from pill to liquid form. The practice is not approved by the Food and Drug Administration (FDA). In addition, only about 1-3 percent of U.S. dispensed-prescriptions are compounded since compound facilities are not actually manufacturers.

The odd thing about this case is that the compounded medications were shipped to about 75 different medical facilities. This seldom happens with compound facilities because the medications are so unique to each patient. Could this then be an indication that NECC was purposefully misleading regulators and violating its license by acting as a mass manufacturer and shipping large quantities of drugs across the country? If it was, there is a clear and marked call for a change in regulations that would make it easier to spot and curtail compounding companies like NECC that engage in illegal manufacturing practices.

Until this question is resolved, the only option is to wait until the full effects of the outbreak are known. Symptoms of fungal meningitis can take up to a month to manifest. In the meantime, more cases are sure to develop.

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