Friday October 26, 2012

There seems to be no end in sight to the nationwide scare created by tainted medicine that has been traced back to a single company in Framingham, Mass.

To date, more than 300 cases of fungal meningitis have been linked to steroid injections, used primarily to relieve back pain, that were distributed by New England Compounding Center. Most of the cases have been in Michigan, Tennessee, Virginia and Indiana, but there have also been 10 reported cases in New Hampshire. Fortunately, there have been no reported cases in Vermont, and none of the 24 people who died from the infection were from New Hampshire.

The outbreak has been traced back to three batches of the injectible steroid the company began shipping out on May 21. Those three lots were recalled on Sept. 26 and federal officials raided the NECC laboratory earlier this month, finding unsanitary conditions and numerous health and safety violations at the compounding pharmacy. The investigation forced the company to recall all of its products on Oct. 6, and earlier this week the U.S. Food and Drug Administration issued a list of all the medical providers who received any drug from the company between May 21 and Oct. 1. There were more than 3,000 customers from across the country on the list, including 10 medical centers in Vermont and 32 in New Hampshire.

Vermont Department of Health officials began notifying offices on the list Wednesday, and they are trying to keep track of how much of the recalled medicine is in offices across the state. Susan Schoenfeld, deputy state epidemiologist for the DOH, says it’s been "an evolving situation."

Schoenfeld noted that, early in the meningitis outbreak, the focus was on the specific medications that had been linked directly to illness. Since then, officials have been walking a fine line between "being proactive about notification" of patients while also ensuring that health-care providers and patients are receiving accurate, reliable information.

Brattleboro Memorial Hospital is in the process of informing about 200 of its patients that they received some of the recalled products. Other medical providers on the list include West River Family Dental in Townshend, Cheshire Medical Center in Keene, N.H., Franklin Medical Center in Greenfield, Mass., Southwestern Vermont Medical Center in Bennington and Fletcher Allen Health Care in Burlington. Schoenfeld reiterated that there have been no reported illnesses in Vermont connected to the compounding center’s medications. But she said officials are "trying to cast a broad net" because there is no guarantee that any of company’s medications were safe.

"With that question in mind, we’re going to be very cautious," she said.

A wise and prudent approach considering the far-reaching nature of this outbreak.

Meanwhile, accusations of blame are flying, with Public Citizen’s Health Research Group saying the FDA failed to act even though it knew of problems at the Massachusetts company, according to a report from MSN.com. FDA and Massachusetts officials say they lacked the authority to move against the pharmacy and said Congress needs to pass clear legislation giving the FDA authority to regulate these so-called compounding pharmacies.

And you can bet personal injury lawyers across the country are gearing up to file lawsuits against NECC, government agencies or both. To think, this all started from dirty floor mats, a leaky boiler and improper testing procedures at a single compounding pharmacy. In the end it could result in better regulatory oversight of pharmacy and drug manufacturing facilities across the country. It’s unfortunate, however, that so many people had to get sick and die to improve the safety of the medications we receive.