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Health

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4th death in meningitis outbreak

State probes 51 tainted-steroid cases

– Indiana heath officials say four people have now died from fungal meningitis linked to injections of a recalled back pain medication.

State Department of Health spokesman Ken Severson said Monday Indiana now has 51 cases of the rare disease.

Officials didn’t say where the fourth death occurred. Severson says officials can’t discuss individual cases because of privacy laws.

Elkhart County’s health officer has said three deaths are linked to the northern Indiana county.

The state health agency has said six Indiana clinics received the tainted steroids, including the OSMC Outpatient Surgery Center in Elkhart. The tainted medication also went to clinics in Columbus, Evansville, Fort Wayne, South Bend and Terre Haute.

The tainted steroids have been traced to the New England Compounding Center of Framingham, Mass.

Meanwhile, House lawmakers investigating the nationwide outbreak have summoned the head of the Food and Drug Administration to testify at the first congressional hearing on the issue next week.

The Energy and Commerce Committee said Monday that FDA Commissioner Dr. Margaret Hamburg will appear before the committee Nov. 14. The next day she is scheduled to appear before the Senate health committee, which is also probing the outbreak.

The Centers for Disease Control and Prevention has reported 419 cases of meningitis illness linked to contaminated steroid shots. Thirty people have died as a result of the outbreak, the agency reported Monday.

Committee staffers said they have also invited Barry Cadden, co-founder of the specialty pharmacy linked to the outbreak. Also invited is James Coffey, director of the Massachusetts Board of Registration in Pharmacy. Staffers say they are awaiting replies from Cadden and Coffey.

Compounding pharmacies traditionally fill special orders placed by doctors for individual patients, turning out a small number of customized formulas each week. But some pharmacies like the NECC have grown into much larger businesses in recent years, supplying bulk orders of medicines to thousands of doctors and hospitals across the country.

In recent weeks, inspectors from the FDA and Massachusetts department of health have reported unsterile conditions at the Framingham, Mass., pharmacy’s facilities. The most recent inspection from the FDA uncovered green and yellow residue, water droplets and standing water in or around production rooms that were supposed to be sterile.

House and Senate lawmakers have called for hearings to examine how the outbreak could have been prevented.

Compounding pharmacies have long operated in a legal gray area between state and federal laws. All pharmacies, including compounding pharmacies, have long been regulated by state pharmacy boards.

However, the FDA has attempted to exercise its authority in cases where major problems have arisen. In several instances, federal courts have ruled that the agency overstepped its bounds.

FDA officials said last month that new laws may be needed to clarify the federal government’s role in overseeing compounding pharmacies.

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