WASHINGTON, D.C. (WXYZ) - Congressional hearings were underway Wednesday on the deadly meningitis outbreak.
Michigan has been the state hardest hit by the outbreak, so Action News is in Washington to get answers as to how this tragedy happened, and what can be done to prevent it from ever happening again.
Penny Laperriere lost the love of her life last month. Her husband Lyn died after contracting fungal meningitis from a tainted steroid shot he received for back pain.
“No one should have to suffer the way my husband suffered, and the way his family, and the way I’m suffering not having him here… (it’s) inexcusable. They killed my husband. They murdered him, a slow, painful death,” Penny says.
The shots were made by the New England Compounding Center in Massachusetts, the subject of this week’s hearings. Lyn is one of eight people in Michigan who died after getting a tainted injection. Dozens of others are sick. The CDC’s latest numbers show there have been a total of 128 cases in Michigan, more than any other state.
Unlike drug manufacturers, which are regulated by the US Food & Drug Administration, compounding pharmacies are regulated by state pharmacy boards. For many years, these compounding pharmacies have operated in a legal grey area between state and federal laws.
Michigan Congressman John Dingell is on the committee holding the hearings.
“The problem we have to find out is why Food & Drug [FDA] couldn’t or didn’t have the ability to address this problem. And then what the law change has to be to see to it that this doesn’t happen again,” Congressman Dingell says.
Compounding pharmacies traditionally fill special orders by doctors for individual patients. But some of these pharmacies have grown into much larger businesses.
“They essentially fell themselves into a loophole where they were able to produce enormous amounts of this stuff, thousands of units that they produced,” according to Dingell.
But with the case of this pharmacy, it appears safeguards were not in place. In fact, recently inspectors from the FDA and Massachusetts Department of Health reported unsterile conditions at the pharmacy’s facilities.
An FDA investigation also found that a quarter of the steroid vials in a bin contained “greenish, black foreign matter.”
A report put out prior to the House hearing also shows that the FDA had investigated the New England Compounding Center three times in the last decade, issuing a warning letter in 2006 and that the Massachusetts Board of Pharmacy has an even more extensive history investigating this company. How the company was allowed to continue operating is likely to be discussed at the Congressional hearings.
The Committee has subpoenaed the head of the New England Compounding Center to appear, but it’s possible he could plead the 5th. The head of the FDA is expected to testify, as is the Interim Commissioner with the Massachusetts Department of Public Health.
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