WASHINGTON — A deadly meningitis outbreak that killed 32 people and sickened
more than 460 others could have been a lot worse if health investigators hadn’t
acted quickly to identify and recall the contaminated medication responsible for
the illness, public health officials said Thursday.
Thirteen of the deaths and 81 of the infections were reported in Tennessee, the first state to see the initial cases of fungal meningitis and sound the alarm that led to a recall of tainted steroid injections just a little more than a week later.
Tennessee alone likely would have recorded at least five more deaths and 59 more infections if a recall of the contaminated shots had been delayed just nine more days, said Dr. Marion Kainer of the Tennessee Department of Health.
"In Tennessee, we still have many patients hospitalized and suffering from complications and others who are exposed and frightened that they may become infected," said Kainer, director of the department’s Healthcare Association Infections and Antimicrobial Resistance Program.
Kainer and other public health officials in Tennessee won special kudos from the U.S. Senate’s Committee on Health, Education, Labor and Pensions for identifying the meningitis outbreak and quickly alerting the U.S. Centers for Disease Control and Prevention, which launched its own investigation.
"Tennessee public officials deserve gold medals," said U.S. Sen. Lamar Alexander, R-Tenn., who sits on the committee. Alexander called the state’s response "a textbook case, a model for the country."
Kainer testified before the Senate committee, which is investigating the government’s oversight of a Massachusetts pharmacy that has been the source of the contaminated injections.
Thursday’s hearing marked the second day in a row that a congressional panel has looked into whether the pharmacy, the New England Compounding Center in Framingham, Mass., had been properly monitored by state officials and the U.S. Food and Drug Administration.
The pharmacy’s owner and director, Barry Cadden, declined the committee’s invitation to testify. On Wednesday, Cadden refused to answer questions before a U.S. House panel and repeatedly invoked his Fifth Amendment right against self-incrimination. The Senate committee decided not to subpoena him, saying there was no need to continue the "charade."
Compounding centers operate under what FDA Commissioner Margaret Hamburg called a "crazy quilt" of state and federal regulations.
Traditional compounding centers, which fill special orders placed by doctors for individual patients, are overseen by state pharmacy boards, but the FDA can step in when problems arise. In recent years, however, larger compounding pharmacies have begun mass-producing thousands of vials of drugs that can be shipped nationwide.
Hamburg said those companies fall into a "gray area" in which it is not clear who has regulatory authority. As a result, she said, the FDA’s ability to inspect such pharmacies and take appropriate enforcement actions has been "limited, unclear and contested" in court.
An estimated 30 to 50 of the compounding pharmacies within the regulatory "gray area" are in Tennessee, Alexander said. It’s those types of companies that should be the focus as Congress looks at tightening federal regulations, he said.
"We don’t need to disturb the local drugstore, and we don’t need to do more about the big manufacturers," Alexander said. "We need to make sure that when a hospital in Tennessee buys a steroid, it either buys it from a manufacturer who’s regulated by the FDA or buys it from a pharmacy that is properly regulated. The latter is what didn’t happen (in Massachusetts)."
Alexander said no one wants to take responsibility for the meningitis outbreak, even though the Massachusetts board of pharmacy investigated at least a dozen complaints against the company that manufactured the injections and the FDA inspected the firm three times for sterility issues.
The Massachusetts board "was obviously incompetent, but they had the authority to regulate," Alexander said. "But the FDA should have been regulating. My experience is when you have two or three or four people who have the same job, nothing gets done."
Alexander said he expects legislation to be filed early next year to clear up the question of who has regulatory authority.
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Thirteen of the deaths and 81 of the infections were reported in Tennessee, the first state to see the initial cases of fungal meningitis and sound the alarm that led to a recall of tainted steroid injections just a little more than a week later.
Tennessee alone likely would have recorded at least five more deaths and 59 more infections if a recall of the contaminated shots had been delayed just nine more days, said Dr. Marion Kainer of the Tennessee Department of Health.
"In Tennessee, we still have many patients hospitalized and suffering from complications and others who are exposed and frightened that they may become infected," said Kainer, director of the department’s Healthcare Association Infections and Antimicrobial Resistance Program.
Kainer and other public health officials in Tennessee won special kudos from the U.S. Senate’s Committee on Health, Education, Labor and Pensions for identifying the meningitis outbreak and quickly alerting the U.S. Centers for Disease Control and Prevention, which launched its own investigation.
"Tennessee public officials deserve gold medals," said U.S. Sen. Lamar Alexander, R-Tenn., who sits on the committee. Alexander called the state’s response "a textbook case, a model for the country."
Kainer testified before the Senate committee, which is investigating the government’s oversight of a Massachusetts pharmacy that has been the source of the contaminated injections.
Thursday’s hearing marked the second day in a row that a congressional panel has looked into whether the pharmacy, the New England Compounding Center in Framingham, Mass., had been properly monitored by state officials and the U.S. Food and Drug Administration.
The pharmacy’s owner and director, Barry Cadden, declined the committee’s invitation to testify. On Wednesday, Cadden refused to answer questions before a U.S. House panel and repeatedly invoked his Fifth Amendment right against self-incrimination. The Senate committee decided not to subpoena him, saying there was no need to continue the "charade."
Compounding centers operate under what FDA Commissioner Margaret Hamburg called a "crazy quilt" of state and federal regulations.
Traditional compounding centers, which fill special orders placed by doctors for individual patients, are overseen by state pharmacy boards, but the FDA can step in when problems arise. In recent years, however, larger compounding pharmacies have begun mass-producing thousands of vials of drugs that can be shipped nationwide.
Hamburg said those companies fall into a "gray area" in which it is not clear who has regulatory authority. As a result, she said, the FDA’s ability to inspect such pharmacies and take appropriate enforcement actions has been "limited, unclear and contested" in court.
An estimated 30 to 50 of the compounding pharmacies within the regulatory "gray area" are in Tennessee, Alexander said. It’s those types of companies that should be the focus as Congress looks at tightening federal regulations, he said.
"We don’t need to disturb the local drugstore, and we don’t need to do more about the big manufacturers," Alexander said. "We need to make sure that when a hospital in Tennessee buys a steroid, it either buys it from a manufacturer who’s regulated by the FDA or buys it from a pharmacy that is properly regulated. The latter is what didn’t happen (in Massachusetts)."
Alexander said no one wants to take responsibility for the meningitis outbreak, even though the Massachusetts board of pharmacy investigated at least a dozen complaints against the company that manufactured the injections and the FDA inspected the firm three times for sterility issues.
The Massachusetts board "was obviously incompetent, but they had the authority to regulate," Alexander said. "But the FDA should have been regulating. My experience is when you have two or three or four people who have the same job, nothing gets done."
Alexander said he expects legislation to be filed early next year to clear up the question of who has regulatory authority.
Source found here
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