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| Two more deaths as US meningitis outbreak affects more states | Two more deaths as US meningitis outbreak affects more states |
| (6 months later) | |
| An outbreak of meningitis linked to contaminated steroid shots prepared by a Massachusetts pharmacy has now resulted in seven deaths, officials said Saturday as they confirmed that the illness had spread to more states. | An outbreak of meningitis linked to contaminated steroid shots prepared by a Massachusetts pharmacy has now resulted in seven deaths, officials said Saturday as they confirmed that the illness had spread to more states. |
| The total number of cases of the rare form of fungal meningitis is now 64, with Minnesota and Ohio added to the list of states affected. | The total number of cases of the rare form of fungal meningitis is now 64, with Minnesota and Ohio added to the list of states affected. |
| Since the outbreak was traced to products sent out by an unaccredited pharmaceutical compounding company with a history of health violations, medical clinics across the eastern USA have been making contact with patients given the injection. | Since the outbreak was traced to products sent out by an unaccredited pharmaceutical compounding company with a history of health violations, medical clinics across the eastern USA have been making contact with patients given the injection. |
| In the past 24 hours, Centers for Disease Control and Prevention (CDC) has added two people to the number of fatalities. The total number of cases has jumped by 17 from Friday's figure of 47. | In the past 24 hours, Centers for Disease Control and Prevention (CDC) has added two people to the number of fatalities. The total number of cases has jumped by 17 from Friday's figure of 47. |
| The updated figures comes amid growing concern over why clinics from as far away as Florida and Tennessee chose to buy in bulk from a pharmacy that had not applied for accreditation form a professional body and had a checkered health and safety record. | The updated figures comes amid growing concern over why clinics from as far away as Florida and Tennessee chose to buy in bulk from a pharmacy that had not applied for accreditation form a professional body and had a checkered health and safety record. |
| The outbreak has been traced to the New England Compounding Center, which from premises in Framingham, Massachusetts sent out as many as 17,000 doses of contaminated steroid injections. | The outbreak has been traced to the New England Compounding Center, which from premises in Framingham, Massachusetts sent out as many as 17,000 doses of contaminated steroid injections. |
| Investigators from the Food and Drug Administration (FDA) who were sent to the company found a fungal contaminate in a sealed vial of the steroid methylprednisolone acetate. They also found a "foreign material" in another, opened container. Tests are being conducted to determine if the contaminants match the one that has led to recent cases of meningitis. | Investigators from the Food and Drug Administration (FDA) who were sent to the company found a fungal contaminate in a sealed vial of the steroid methylprednisolone acetate. They also found a "foreign material" in another, opened container. Tests are being conducted to determine if the contaminants match the one that has led to recent cases of meningitis. |
| The Guardian has made repeated calls to the homes of the owner of New England Compounding Center and its president. All have gone unanswered. The company's website had been taken down. | The Guardian has made repeated calls to the homes of the owner of New England Compounding Center and its president. All have gone unanswered. The company's website had been taken down. |
| A history of failings at the company has emerged, with complaints having reportedly been made against it as long ago as 2002 and as recently as this year. A 2006 warning letter from the FDA to company owner Barry Cadden cited a string of health and safety violations, including the misbranding of drugs and the copying of FDA-approved, commercially available products. | A history of failings at the company has emerged, with complaints having reportedly been made against it as long ago as 2002 and as recently as this year. A 2006 warning letter from the FDA to company owner Barry Cadden cited a string of health and safety violations, including the misbranding of drugs and the copying of FDA-approved, commercially available products. |
| Investigators expressed special concern over the company's practice of splitting up an injectable drug, Avastin, into multiple doses to be sold on. Such a practice could lead to "potential microbial contamination", the letter stated. | Investigators expressed special concern over the company's practice of splitting up an injectable drug, Avastin, into multiple doses to be sold on. Such a practice could lead to "potential microbial contamination", the letter stated. |
| The FDA also noted that Avastin is approved only for use in treatment of colorectal cancers. New England Compounding Center was marketing the drug to ophthalmologists, despite it having "no approved indications for use in the eye". | The FDA also noted that Avastin is approved only for use in treatment of colorectal cancers. New England Compounding Center was marketing the drug to ophthalmologists, despite it having "no approved indications for use in the eye". |
| "Your firm is distributing an unapproved new drug," Mr Cadden was warned. | "Your firm is distributing an unapproved new drug," Mr Cadden was warned. |
| Compounding pharmacists have long been on the radar of federal regulators. In a 2007 document, the FDA said it was scrutinising the industry "mainly because of instances where compounded drugs have endangered public health". | Compounding pharmacists have long been on the radar of federal regulators. In a 2007 document, the FDA said it was scrutinising the industry "mainly because of instances where compounded drugs have endangered public health". |
| Pharmacists have long mixed or altered ingredients to tailor to the needs of individual patients. | Pharmacists have long mixed or altered ingredients to tailor to the needs of individual patients. |
| "In its traditional form, pharmacy compounding is a vital service that helps many people, including those who are allergic to inactive ingredients in FDA-approved medicines, and others who need medications that are not available commercially," Kathleen Anderson, the then-deputy director of the FDA's division of new drugs and labelling compliance, stated in the 2007 public-health information document. | "In its traditional form, pharmacy compounding is a vital service that helps many people, including those who are allergic to inactive ingredients in FDA-approved medicines, and others who need medications that are not available commercially," Kathleen Anderson, the then-deputy director of the FDA's division of new drugs and labelling compliance, stated in the 2007 public-health information document. |
| However, the compounds produced are not FDA-approved and poor practice can lead to contamination. | However, the compounds produced are not FDA-approved and poor practice can lead to contamination. |
| In March 2006, three patients died due to contaminated solutions used to paralyse the heart during open-heart surgery. In 2005, at the Veterans Affairs hospital in Washington DC, two people were blinded by bacteria in a batch of drugs used during cataract operations. Last year, nine patients at hospitals in Alabama died after receiving intravenous nutritional supplements that were infected with a lethal bacteria. The supplements had been prepared by a pharmacy compounder in Birmingham. | In March 2006, three patients died due to contaminated solutions used to paralyse the heart during open-heart surgery. In 2005, at the Veterans Affairs hospital in Washington DC, two people were blinded by bacteria in a batch of drugs used during cataract operations. Last year, nine patients at hospitals in Alabama died after receiving intravenous nutritional supplements that were infected with a lethal bacteria. The supplements had been prepared by a pharmacy compounder in Birmingham. |
| Defenders of the practice have suggested that rogue operators are to blame and that regulators and the clinics affected could also be at fault. | Defenders of the practice have suggested that rogue operators are to blame and that regulators and the clinics affected could also be at fault. |
| David Miller, executive vice president and CEO of the International Academy of Compounding Pharmacists, said the New England Compounding Center was not accredited, and had been guilty of past health violations. He also said that the quantity of doses prepared by the company seemed to put it at odds with the industry at large | David Miller, executive vice president and CEO of the International Academy of Compounding Pharmacists, said the New England Compounding Center was not accredited, and had been guilty of past health violations. He also said that the quantity of doses prepared by the company seemed to put it at odds with the industry at large |
| "There were more than 17,000 doses put together by the pharmacy," he said. "How is it possible they had 17,000 individual doses – it looks like there were working with the drug manufacturers. If that was how it was being done, that is in contrast to traditional compounding." | "There were more than 17,000 doses put together by the pharmacy," he said. "How is it possible they had 17,000 individual doses – it looks like there were working with the drug manufacturers. If that was how it was being done, that is in contrast to traditional compounding." |
| Miller added: "It doesn't make sense, we do not know why there are buying from this pharmacist – was it price? What due-diligence did the clinics do to make sure it was licensed and accredited – which it was not." | Miller added: "It doesn't make sense, we do not know why there are buying from this pharmacist – was it price? What due-diligence did the clinics do to make sure it was licensed and accredited – which it was not." |
| Only one of the clinics affected in the outbreak returned Guardian phone calls made to enquire why they bought drugs from compounders, rather than from bigger pharmaceutical companies. | Only one of the clinics affected in the outbreak returned Guardian phone calls made to enquire why they bought drugs from compounders, rather than from bigger pharmaceutical companies. |
| A representative of Greenspring Surgery Centre in Maryland – which is contacting patients it knows to have been given steroids from the Massacusetts firm – said it bought from compounders "because sometimes there are formulations of medications that are unavailable commercially. This is a commercial product. But whether you buy it from a large or a small company, they all have the same standards that have to be met." | A representative of Greenspring Surgery Centre in Maryland – which is contacting patients it knows to have been given steroids from the Massacusetts firm – said it bought from compounders "because sometimes there are formulations of medications that are unavailable commercially. This is a commercial product. But whether you buy it from a large or a small company, they all have the same standards that have to be met." |
| Asked if there was a cost consideration the spokesman, who declined to be identified, said: "Sometimes there is, sometimes there isn't. In this case there wasn't, it was actually an availability issue and an issue of having the right medication, the right dosage. | Asked if there was a cost consideration the spokesman, who declined to be identified, said: "Sometimes there is, sometimes there isn't. In this case there wasn't, it was actually an availability issue and an issue of having the right medication, the right dosage. |
| "There has a scarcity of multiple medications over the last couple of years and that has created a need to reach out to multiple suppliers." | "There has a scarcity of multiple medications over the last couple of years and that has created a need to reach out to multiple suppliers." |
| The comment seems to contradict the view of International Academy of Compounding Pharmacists, which represents more than 2,700 compounding pharmacists across the US. | The comment seems to contradict the view of International Academy of Compounding Pharmacists, which represents more than 2,700 compounding pharmacists across the US. |
| Miller told the Guardian: "In all the states affected there are compounders who could have provided the drug." | Miller told the Guardian: "In all the states affected there are compounders who could have provided the drug." |
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