Thursday, November 15, 2012

Meningitis contd. - owner pleads the fifth

No answers from drug executive at hearing on meningitis

Story Highlights

Owner of New England Compounding Center cites Fifth Amendment
The Fifth Amendment protects against self-incrimination
32 people have died from contaminated drugs from the NECC

9:44PM EST November 14. 2012 - WASHINGTON — Barry Cadden, owner of the New England company whose contaminated drugs have sickened patients nationwide, repeatedly cited the Fifth Amendment on Wednesday, declining to answer lawmakers' questions about unsterile conditions at his plant and its culpability in recent meningitis-related deaths.

The House Energy and Commerce Committee's investigations subcommittee held the first in what is likely to be several hearings on the 461 cases of fungal meningitis tied to contaminated steroid drugs from the New England Compounding Center (NECC) in Framingham, Mass.

Thirty-two people have died.

"What explanation can you give to those who have lost their loved ones?" asked subcommittee Chairman Cliff Stearns, R-Fla.

Stearns told Cadden that his plant was guilty of "a massive failure of sterilization." Panel members cited reports about bugs and birds in the plant, and standing water that was breeding areas for bacteria.

Cadden, in citing the Fifth Amendment, said he was doing so on the advice of his attorneys.

Lawmakers also questioned Margaret Hamburg, Food and Drug Administration commissioner, about why the agency did not act against NECC in the mid-2000s, despite reports of dangerous conditions there. The FDA issued a warning letter to NECC in 2005 but went no further.

"This was a complete and utter failure on the part of your agency," Stearns told Hamburg.

Hamburg, who became FDA commissioner in 2009, repeatedly declined to give a yes-or-no answer to questions about whether the FDA could have shut down NECC, frustrating Republican members.

"Unfortunately, we have an unclear, fragmented regulatory framework," she said, adding that Congress needs to clarify the FDA's authority over large-scale, "non-traditional" compounders such as NECC.

Although the FDA has authority over prescription medicine, state agencies usually oversee small-scale compounders such as local druggists.

Rep. Henry Waxman, D-Calif., said he found it ironic that Republicans complain of federal regulators stifling businesses until something like the meningitis outbreak occurs.

"Let's not lose sight of the wrongdoer as we go around blaming the regulators," Waxman said. "The regulators deserve blame, but the primary blame, in my mind, is the company."

Several Republican members, led by Rep. Joe Barton of Texas, told Hamburg the FDA needs to use authority it has rather than asking for new powers.

Joyce Lovelace, widow of Eddie Lovelace, 78, a Kentucky state judge who became the first victim of the outbreak on Sept. 17, said the regulatory failures left her family angry.

"I come here begging you to do something about this," she said. "I don't care what party — work together."

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