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| Meningitis outbreak: director at center of health scandal refuses to testify | Meningitis outbreak: director at center of health scandal refuses to testify |
| (4 months later) | |
| The director of the pharmacy at the centre of a health scandal that has killed 32 people refused to answer questions from a congressional committee on Wednesday. | The director of the pharmacy at the centre of a health scandal that has killed 32 people refused to answer questions from a congressional committee on Wednesday. |
| In answer to repeated questions from representatives investigating the meningitis outbreak which affected more than 400 people given contaminated steroid shots, Barry Cadden, co-founder of the New England Compounding Center, cited his fifth amendment right to silence in order to avoid self-incrimination. | In answer to repeated questions from representatives investigating the meningitis outbreak which affected more than 400 people given contaminated steroid shots, Barry Cadden, co-founder of the New England Compounding Center, cited his fifth amendment right to silence in order to avoid self-incrimination. |
| At one point Cadden was asked by Cliff Stearns, the chairman of the energy and commerce subcommittee for oversight and investigation: "What explanation can you give to the families who have lost their loved ones?" | At one point Cadden was asked by Cliff Stearns, the chairman of the energy and commerce subcommittee for oversight and investigation: "What explanation can you give to the families who have lost their loved ones?" |
| Cadden replied: "Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the fifth amendment." | Cadden replied: "Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the fifth amendment." |
| Cadden's appearance at the committee followed poignant testimony from the widow of a Kentucky circuit judge who was the first to die, following contaminated steroid injections distributed by NECC across the US. | Cadden's appearance at the committee followed poignant testimony from the widow of a Kentucky circuit judge who was the first to die, following contaminated steroid injections distributed by NECC across the US. |
| Joyce Lovelace, from Albany, Kentucky, said she wanted those responsible to know that her family will never recover from their loss. Eddie, her husband of 56 years, was her soulmate and a "rock" to his children and grandchildren, she said. | Joyce Lovelace, from Albany, Kentucky, said she wanted those responsible to know that her family will never recover from their loss. Eddie, her husband of 56 years, was her soulmate and a "rock" to his children and grandchildren, she said. |
| Speaking without notes – in tribute to her husband who never used them – Lovelace said: "It was not an easy death that we witnessed. These are human beings. The FDA, the NECC, whoever is responsible, I want them to know their lack of attention to their duties cost my husband his life, cost my family a loss that they will never recover from." | Speaking without notes – in tribute to her husband who never used them – Lovelace said: "It was not an easy death that we witnessed. These are human beings. The FDA, the NECC, whoever is responsible, I want them to know their lack of attention to their duties cost my husband his life, cost my family a loss that they will never recover from." |
| Her husband, who was 78, walked three miles a day and was planning to go into law practice with one of his granddaughters, she said. In her written testimony, submitted to the committee, she said he was a church and civic leader who devoted his life to public service, loved quoting Shakespeare and the Bible, and was loved by many. | Her husband, who was 78, walked three miles a day and was planning to go into law practice with one of his granddaughters, she said. In her written testimony, submitted to the committee, she said he was a church and civic leader who devoted his life to public service, loved quoting Shakespeare and the Bible, and was loved by many. |
| He died on 17 September after a debilitating stroke caused by the steroid produced by NECC. | He died on 17 September after a debilitating stroke caused by the steroid produced by NECC. |
| "It was a nightmare to see this man who was so healthy one moment so quickly going downhill and to see doctors treat him to no avail," Lovelace said. | "It was a nightmare to see this man who was so healthy one moment so quickly going downhill and to see doctors treat him to no avail," Lovelace said. |
| She told the committee the family thought he had died of a stroke, but later found out, from a local reporter, that he was considered a victim of the meningitis outbreak. | She told the committee the family thought he had died of a stroke, but later found out, from a local reporter, that he was considered a victim of the meningitis outbreak. |
| "My family is bitter. We are angry, we are devastated and I'm begging you to do something about it." | "My family is bitter. We are angry, we are devastated and I'm begging you to do something about it." |
| Members of the committee investigating the deadly outbreak repeatedly challenged the FDA's commissioner to explain why it had not acted sooner against the NECC. They focused on previous problems at NECC and questioned why the FDA or the state regulatory board failed to take effective action. | Members of the committee investigating the deadly outbreak repeatedly challenged the FDA's commissioner to explain why it had not acted sooner against the NECC. They focused on previous problems at NECC and questioned why the FDA or the state regulatory board failed to take effective action. |
| "After a tragedy like this, the first question we all ask is: could this have been prevented?" asked Cliff Stearns, chairman of the subcommittee on oversight and investigations. "After an examination of the documents provided by the Massachusetts board of pharmacy and the FDA — the answer here appears to be: yes." | "After a tragedy like this, the first question we all ask is: could this have been prevented?" asked Cliff Stearns, chairman of the subcommittee on oversight and investigations. "After an examination of the documents provided by the Massachusetts board of pharmacy and the FDA — the answer here appears to be: yes." |
| FDA commissioner Margaret Hamburg told lawmakers that the problems uncovered in inspections were "very serious," but that the agency was obligated to defer to Massachusetts authorities, who have more direct oversight over pharmacies. "The challenge we have today is that there is a patchwork of legal authorities that oversee the action we can take," said Hamburg, who was nominated to head the FDA by President Obama in 2009. | FDA commissioner Margaret Hamburg told lawmakers that the problems uncovered in inspections were "very serious," but that the agency was obligated to defer to Massachusetts authorities, who have more direct oversight over pharmacies. "The challenge we have today is that there is a patchwork of legal authorities that oversee the action we can take," said Hamburg, who was nominated to head the FDA by President Obama in 2009. |
| Hamburg read an opening statement which stretched to 15 pages. | Hamburg read an opening statement which stretched to 15 pages. |
| She said the agency had grown "increasingly concerned" about compounding pharmacies after an increasing number of incidents. She proposed two categories of compounding, "traditional" and "non-traditional", the latter of which are "higher risk" and would be subject to federal standards and urged Congress to strengthen Federal standards for non-traditional compounding. | She said the agency had grown "increasingly concerned" about compounding pharmacies after an increasing number of incidents. She proposed two categories of compounding, "traditional" and "non-traditional", the latter of which are "higher risk" and would be subject to federal standards and urged Congress to strengthen Federal standards for non-traditional compounding. |
| When she finished, Stearns told her: "This was a complete and utter failure on the part of your agency and the [Massachusetts] board of pharmacy … Yet you devoted just once sentence in your statement about this oversight." | When she finished, Stearns told her: "This was a complete and utter failure on the part of your agency and the [Massachusetts] board of pharmacy … Yet you devoted just once sentence in your statement about this oversight." |
| She was repeatedly questioned about the FDA's letter in 2006 to NECC which threatened to shut down the company because of quality problems. | She was repeatedly questioned about the FDA's letter in 2006 to NECC which threatened to shut down the company because of quality problems. |
| Stearns asked her: "Do you think the FDA had the authority to shut down the NECC, yes or no?" | Stearns asked her: "Do you think the FDA had the authority to shut down the NECC, yes or no?" |
| Hamburg told him it was a "very, very complex question" and that "even on smaller regulatory actions the FDA authority to act was contested". | Hamburg told him it was a "very, very complex question" and that "even on smaller regulatory actions the FDA authority to act was contested". |
| Stearns at one point asked her if the letter was an "empty threat" and asked her if she was about "plausible deniability". | Stearns at one point asked her if the letter was an "empty threat" and asked her if she was about "plausible deniability". |
| Her testimony, published on the committee's website, said that the FDA's ability to take action against compounding pharmacies which "exceeds the bounds of traditional compounding pharmacies and poses risks to patients" has been "hampered by gaps and ambiguities in the law". | Her testimony, published on the committee's website, said that the FDA's ability to take action against compounding pharmacies which "exceeds the bounds of traditional compounding pharmacies and poses risks to patients" has been "hampered by gaps and ambiguities in the law". |
| Hamburg said the FDA is now working with Congress to address the gaps in authorities for effective oversight. | Hamburg said the FDA is now working with Congress to address the gaps in authorities for effective oversight. |
| Fred Upton, chairman of the energy and commerce committee, said the tragedy that befell Lovelace and others was worsened by the fact that it seemed to be preventable. | Fred Upton, chairman of the energy and commerce committee, said the tragedy that befell Lovelace and others was worsened by the fact that it seemed to be preventable. |
| In his opening statement, he pointed to the number of times regulatory bodies had contact with NECC, including the FDA's issuing of a warning letter in 2006, but had taken little action He was "stunned and angered" to learn that an inspection of the NECC by the FDA and the Massachusetts board of pharmacy over 10 years ago identified contamination in the same drug at issue in the current outbreak, he said. | In his opening statement, he pointed to the number of times regulatory bodies had contact with NECC, including the FDA's issuing of a warning letter in 2006, but had taken little action He was "stunned and angered" to learn that an inspection of the NECC by the FDA and the Massachusetts board of pharmacy over 10 years ago identified contamination in the same drug at issue in the current outbreak, he said. |
| In his statement, which is published on the website, Upton said one of his own constituents, a grandmother from Cass County, Michigan, had died in the outbreak. He said: "The loss of innocent lives is tragedy enough, But what makes this tragedy worse is the fact that it seems these deaths and illnesses could have been prevented. | In his statement, which is published on the website, Upton said one of his own constituents, a grandmother from Cass County, Michigan, had died in the outbreak. He said: "The loss of innocent lives is tragedy enough, But what makes this tragedy worse is the fact that it seems these deaths and illnesses could have been prevented. |
| "The NECC was not unknown to its regulators," he said, pointing out that it had been inspected on multiple occasions since opening in 1998 by FDA and Massachusetts regulators. | "The NECC was not unknown to its regulators," he said, pointing out that it had been inspected on multiple occasions since opening in 1998 by FDA and Massachusetts regulators. |
| I was stunned and angered to learn that an inspection of the NECC by the FDA and the Mass board over 10 years ago identified contamination in the very same drug at issue in the current outbreak. The reason for that inspection? Patients had been hospitalized with meningitis-like symptoms. Ten years later, we are in the midst of an unthinkable, worst-case scenario – the body count is growing by the day – and hundreds have fallen ill. This is simply inexcusable. | I was stunned and angered to learn that an inspection of the NECC by the FDA and the Mass board over 10 years ago identified contamination in the very same drug at issue in the current outbreak. The reason for that inspection? Patients had been hospitalized with meningitis-like symptoms. Ten years later, we are in the midst of an unthinkable, worst-case scenario – the body count is growing by the day – and hundreds have fallen ill. This is simply inexcusable. |
| He castigated the FDA for not responding to the committee and told them he wanted a "firm timeline form you today" on when they would produce documents. He said: "The sooner FDA cooperates, the sooner we can determine what went wrong and ensure we never endure a deadly outbreak like this one." | He castigated the FDA for not responding to the committee and told them he wanted a "firm timeline form you today" on when they would produce documents. He said: "The sooner FDA cooperates, the sooner we can determine what went wrong and ensure we never endure a deadly outbreak like this one." |
| In his opening statement, Stearns listed the failures of state and federal agencies to regulate NECC. He said: in 2003 "the FDA made a prophetic statement. The FDA stated that there was 'the potential for serious public health consequences' if NECC's compounding practices, in particular those relating to sterile products, are not improved." | In his opening statement, Stearns listed the failures of state and federal agencies to regulate NECC. He said: in 2003 "the FDA made a prophetic statement. The FDA stated that there was 'the potential for serious public health consequences' if NECC's compounding practices, in particular those relating to sterile products, are not improved." |
| He cited a complaint fin 2011 from the Colorado Board of Pharmacy, which notified the FDA that NECC was again sending its drugs to out-of-state hospitals without first receiving patient prescriptions. | He cited a complaint fin 2011 from the Colorado Board of Pharmacy, which notified the FDA that NECC was again sending its drugs to out-of-state hospitals without first receiving patient prescriptions. |
| "We are left to wonder what would have happened if FDA had investigated, or at least informed the Massachusetts Board of the Colorado complaint. It is possible that this outbreak very well might have been prevented" Stearns said. | "We are left to wonder what would have happened if FDA had investigated, or at least informed the Massachusetts Board of the Colorado complaint. It is possible that this outbreak very well might have been prevented" Stearns said. |
| The hearing continues. | The hearing continues. |
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