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| Meningitis outbreak: pharmacy flagged by FDA as early as 2003, records show | Meningitis outbreak: pharmacy flagged by FDA as early as 2003, records show |
| (7 days later) | |
| The top public health official in Massachusetts has admitted that "troubling questions" remain over why regulators failed eight years ago to severely sanction a pharmacy now linked to a fatal fungal meningitis outbreak which has killed 32 people across the US. | The top public health official in Massachusetts has admitted that "troubling questions" remain over why regulators failed eight years ago to severely sanction a pharmacy now linked to a fatal fungal meningitis outbreak which has killed 32 people across the US. |
| In September 2004, after product safety and sterility problems at the New England Compounding Center – which included meningitis symptoms in two patients linked to methylprednisolone, the injectable steroid implicated in the current outbreak – the state pharmacy board recommended an official reprimand, three years probation and additional sterility training for Brian Cadden, the firm's owner. The company protested, saying it would destroy its business. | In September 2004, after product safety and sterility problems at the New England Compounding Center – which included meningitis symptoms in two patients linked to methylprednisolone, the injectable steroid implicated in the current outbreak – the state pharmacy board recommended an official reprimand, three years probation and additional sterility training for Brian Cadden, the firm's owner. The company protested, saying it would destroy its business. |
| In testimony to be delivered to a congressional inquiry on Wednesday, Dr Lauren Smith said that despite interviews with the state pharmacy board and a review of the "limited records" surrounding safety problems at NECC in 2002-3, she has been unable to determine what influenced the more lenient consent agreement resolution "given NECC's track record". | In testimony to be delivered to a congressional inquiry on Wednesday, Dr Lauren Smith said that despite interviews with the state pharmacy board and a review of the "limited records" surrounding safety problems at NECC in 2002-3, she has been unable to determine what influenced the more lenient consent agreement resolution "given NECC's track record". |
| Instead, the board, responsible for oversight of compounding pharmacies, entered into a "significantly weaker" consent agreement with NECC in 2006. | Instead, the board, responsible for oversight of compounding pharmacies, entered into a "significantly weaker" consent agreement with NECC in 2006. |
| Smith, who was appointed as the public health department's interim commissioner three weeks ago, added: "I will not be satisfied until we know the full story behind this decision." | Smith, who was appointed as the public health department's interim commissioner three weeks ago, added: "I will not be satisfied until we know the full story behind this decision." |
| She concluded that the company linked to the deadly meningitis outbreak that began in September bears the "primary responsibility" for the health scandal. | She concluded that the company linked to the deadly meningitis outbreak that began in September bears the "primary responsibility" for the health scandal. |
| She said: "NECC knowingly disregarded sterility tests, prepared medicine in unsanitary conditions and unlawfully engaged in manufacturing, endangering thousands of lives as a result. NECC bears the primary responsibility for the harm they have caused with these actions." | She said: "NECC knowingly disregarded sterility tests, prepared medicine in unsanitary conditions and unlawfully engaged in manufacturing, endangering thousands of lives as a result. NECC bears the primary responsibility for the harm they have caused with these actions." |
| However, Smith's testimony to the House Energy and Commerce Committee raises more questions than it answers about why, despite repeated complaints, problems and investigations, the company's license was not revoked or other sanctions imposed. | However, Smith's testimony to the House Energy and Commerce Committee raises more questions than it answers about why, despite repeated complaints, problems and investigations, the company's license was not revoked or other sanctions imposed. |
| A memo from committee's oversight and investigations subcommittee states that as far back as 2003, the Food and Drug Administration warned about the "potential for serious public health consequences if NECC's compounding practices, in particular those relating to sterile products, are not improved". | A memo from committee's oversight and investigations subcommittee states that as far back as 2003, the Food and Drug Administration warned about the "potential for serious public health consequences if NECC's compounding practices, in particular those relating to sterile products, are not improved". |
| The memo, released on Monday, shows that after several years of problems, FDA officials in 2003 suggested that the compounding pharmacy be "prohibited from manufacturing" until it improved its operations. But FDA regulators deferred to their counterparts in Massachusetts, who ultimately reached an agreement with the pharmacy to settle concerns about the quality of its prescription injections. | The memo, released on Monday, shows that after several years of problems, FDA officials in 2003 suggested that the compounding pharmacy be "prohibited from manufacturing" until it improved its operations. But FDA regulators deferred to their counterparts in Massachusetts, who ultimately reached an agreement with the pharmacy to settle concerns about the quality of its prescription injections. |
| The health scandal has raised a number of questions over the monitoring and regulation of compounding pharmacies. | The health scandal has raised a number of questions over the monitoring and regulation of compounding pharmacies. |
| In the same memo, published on its website, the subcommittee noted that the FDA said as long as the pharmacy's operations fall within the scope of the practice of pharmacy "the FDA will continue to defer to state authorities for regulatory oversight". | In the same memo, published on its website, the subcommittee noted that the FDA said as long as the pharmacy's operations fall within the scope of the practice of pharmacy "the FDA will continue to defer to state authorities for regulatory oversight". |
| In the hearing on Wednesday, which will investigate whether the outbreak could have been prevented, legislators will ask FDA commissioner Margaret Hamburg why her agency did not pursue enforcement actions and how Massachusetts officials allowed NECC to keep its license. | In the hearing on Wednesday, which will investigate whether the outbreak could have been prevented, legislators will ask FDA commissioner Margaret Hamburg why her agency did not pursue enforcement actions and how Massachusetts officials allowed NECC to keep its license. |
| Fred Upton, the Republican chairman of the committee, also sent a subpoena to Cadden after he refused to give evidence. | Fred Upton, the Republican chairman of the committee, also sent a subpoena to Cadden after he refused to give evidence. |
| In a statement, the committee said: "Our committee has a long, bipartisan history of conducting drug safety oversight. Since the meningitis outbreak, we have been in close contact with the involved agencies and parties, but many unanswered questions remain. The NECC has a history of problems, some of which were documented in an FDA warning letter in 2006. We want to know what went wrong at this facility, the views and actions of its regulators, and what steps can be taken to ensure such an outbreak never happens again." | In a statement, the committee said: "Our committee has a long, bipartisan history of conducting drug safety oversight. Since the meningitis outbreak, we have been in close contact with the involved agencies and parties, but many unanswered questions remain. The NECC has a history of problems, some of which were documented in an FDA warning letter in 2006. We want to know what went wrong at this facility, the views and actions of its regulators, and what steps can be taken to ensure such an outbreak never happens again." |
| The committee will first hear from Joyce Lovelace, whose husband Eric, a Kentucky judge, died from a stroke linked to the meningitis outbreak on 17 September. He was the first person to die as a result of a contaminated steroid linked to NECC. | The committee will first hear from Joyce Lovelace, whose husband Eric, a Kentucky judge, died from a stroke linked to the meningitis outbreak on 17 September. He was the first person to die as a result of a contaminated steroid linked to NECC. |
| An autopsy earlier this month confirmed his death was connected to tainted steroid shots he received weeks earlier in Tennessee to treat neck and back pain. | An autopsy earlier this month confirmed his death was connected to tainted steroid shots he received weeks earlier in Tennessee to treat neck and back pain. |
| The Senate's health committee plans a hearing on Thursday. | The Senate's health committee plans a hearing on Thursday. |
| In a memorandum, the committee's oversight and investigations subcommittee listed many of the reported incidents concerning "very similar, if not identical underlying misconduct" at NECC. | In a memorandum, the committee's oversight and investigations subcommittee listed many of the reported incidents concerning "very similar, if not identical underlying misconduct" at NECC. |
| "Some of the violations observed by regulators as early as 2002 include the company's failure to maintain adequate standards for sterile injectable products – the very issue at the center of the current meningitis outbreak," it said. | "Some of the violations observed by regulators as early as 2002 include the company's failure to maintain adequate standards for sterile injectable products – the very issue at the center of the current meningitis outbreak," it said. |
| Since the company's formation, in 1998, the Food and Drug Administration has conducted three inspections, each based on a separate set of allegations or events. The Massachusetts Board of Pharmacy, the main regulatory body in charge of NECC, has investigated at least 12 separate complaints concerning NECC or Cadden and issued at least four advisory letters. | Since the company's formation, in 1998, the Food and Drug Administration has conducted three inspections, each based on a separate set of allegations or events. The Massachusetts Board of Pharmacy, the main regulatory body in charge of NECC, has investigated at least 12 separate complaints concerning NECC or Cadden and issued at least four advisory letters. |
| On Monday, the FDA released a 20-page report which listed a string of unsafe practices and unsanitary conditions at Ameridose, a sister drug company of NECC, also owned by Cadden. | On Monday, the FDA released a 20-page report which listed a string of unsafe practices and unsanitary conditions at Ameridose, a sister drug company of NECC, also owned by Cadden. |
| It described the results of a month-long inspection last month. There was rusty and unclean equipment, penetrating leaks, cracked walls covered with what appeared to be adhesive, gloves and gowns that were not sterile, and insects up to 10 feet away from where sterile products were packaged and stored. At least one bird was found flying around the same area, it said. | It described the results of a month-long inspection last month. There was rusty and unclean equipment, penetrating leaks, cracked walls covered with what appeared to be adhesive, gloves and gowns that were not sterile, and insects up to 10 feet away from where sterile products were packaged and stored. At least one bird was found flying around the same area, it said. |
| Inspectors also said Ameridose failed to adequately investigate complaints of serious reactions in patients that might have flagged up drug potency problems. The firm "failed to appropriately classify 'patient response' complaints as adverse events", it said. | Inspectors also said Ameridose failed to adequately investigate complaints of serious reactions in patients that might have flagged up drug potency problems. The firm "failed to appropriately classify 'patient response' complaints as adverse events", it said. |
| Complaints in relation to one drug, Oxytocin, included "fetal distress" and "hyperstimulated uterus", five cases of "maternal haemorrhaging" and "shortness of breath and throat closing", the report said. | Complaints in relation to one drug, Oxytocin, included "fetal distress" and "hyperstimulated uterus", five cases of "maternal haemorrhaging" and "shortness of breath and throat closing", the report said. |
| Problems cited with another drug, Heptarin, included "life-threatening" adverse effects. Patient problems with Fentanyl included those where a patient was "over-sedated, unresponsive" and another in which two patients went into "respiratory distress" after receiving the medication. | Problems cited with another drug, Heptarin, included "life-threatening" adverse effects. Patient problems with Fentanyl included those where a patient was "over-sedated, unresponsive" and another in which two patients went into "respiratory distress" after receiving the medication. |
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