By Phil Williams
Chief Investigative Reporter
NASHVILLE, Tenn. -- The deadly meningitis outbreak that started right here in Middle Tennessee has become a nationwide scare.
Now, investigators are raising alarms about the Massachusetts pharmacy that appears to be the source of contaminated drugs.
Among the latest developments:
- Authorities say there are now 35 cases of fungal meningitis in six states and that number is expected to grow.
- A third person has now died here in Middle Tennessee, bringing the total number of deaths nationwide to five.
- Authorities say the recall of that tainted steroid drug includes more than 17,000 vials.
The massive number of doses now in question is raising serious concerns about the pharmacy, located just outside of Boston, that produced the tainted drugs.
For years, the U.S. Food and Drug Administration has been warning about such "compounding pharmacies" that mix up the volume of drugs you would expect from a drug manufacturer -- but without the scrutiny of federal regulators to make sure those drugs are safe.
In this case, the New England Compounding Center in Framingham, Mass., is the focus of intense scrutiny by health investigators from across the country.
While details are still sketchy, whatever they saw inside was serious enough for them to urge doctors across the nation to pull all of the company's products.
"Out of an abundance of caution, FDA is taking the additional step of advising all health care practitioners not to use any product that originated from New England Compounding Center until the investigation of the source of the outbreak is complete," said Ilisa Bernstein, director of compliance for the FDA's Center for Drug Evaluation and Research.
NECC is licensed as a pharmacy, not as a manufacturer.
But the amount of the steroid drug - methylprednisolone acetate - now being recalled in question is staggering: more than 17,000 doses that were shipped to 75 hospitals and clinics in 23 states.
Investigators added that they don't know how many of those 17,000 doses were actually injected into patients, although they did say that substantial amounts of the product have already been returned.
In a conference call, the FDA said they did find foreign material floating inside some of the vials.
"Material from an unopened vial was looked at under the microscope," said FDA consumer safety officer Ian Deveau. "What appeared under the microscope indicated a fungal matter. The additional material is undergoing testing to identify the fungus in question."
As to the pharmacy's history, they are regulated by the Massachusetts Department of Health.
Authorities there said NECC was the subject of complaints back in 2002 and 2003 over the lack of a sterile conditions for mixing drugs. That complaint was finally resolved in 2006 with a consent agreement where the company agreed to improve its practices.
Inspectors went back in 2011 on another complaint, but found nothing.
They are currently investigating a new complaint regarding the potency of a product produced there, although it appears unrelated.
As for where this goes, investigators say that NECC's claim to be licensed to provide products for all 50 states is a concern.
"If they are licensed in 50 states, there is a possibility that it could be elsewhere -- not just this product but other products that they have made," Bernstein said.
NECC was started by a pharmacist and a man who operates a number of recycling businesses in the Boston area.
They also own a second compounding pharmacy called Ameridose. Company officials say those two entities have completely separate mixing facilities and that Ameridose has nothing to do with this scare.
Still, investigators say they are going to be looking into every possibility.
NECC also got in trouble with the FDA back in 2006 over some medications that it was mixing. But the company fought back, filing a lawsuit challenging the agency's right to regulate the company.
On Thursday, the company released a new statement:
"New England Compounding Center (NECC) is working closely with the Massachusetts Board of Pharmacy, the Centers for Disease Control and the U.S. Food and Drug Administration on their investigation into the cause of infection in patients who received injections of methylprednisolone acetate. As part of this process, NECC has initiated a series of recalls encompassing all methylprednisolone acetate products - as well as other injectable medications - distributed from our facility in Framingham, Massachusetts. We also understand the FDA – as a precautionary measure - has suggested to medical professionals that they do not use any NECC products at this time, although there is no indication of any potential issues with other products. As previously announced, we have voluntarily suspended operations while we assist authorities in this investigation. The fatalities and illnesses confirmed today by the CDC and FDA are tragic. The thoughts and prayers of everyone employed by NECC are with those who have been affected."
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