This is too dangerous to allow any medications from this facility to be in use, yet alone pick and choose LOT NUMBERS for known cases to be RECALLED. This isn't about protecting the company anymore; it is beyond that.
Elizabeth Cohen from CNN reported today vials were found with visual fungus in them at the facility. This is about gross negligence and it is criminal. It could be the Aspergillus was introduced deliberately which is a heinous crime.
Preservative free has nothing to do with this growing in the vials either. The production of this drug was to take place under sterile conditions. Preservatives extend shelf life, not prevent contamination.
There is something very wrong with this facility. This contamination is unprecedented (no records of this type of organism anywhere in the archives of major research facilities or health organizations causing meningitis). It is too, too dangerous to proceed with any of the medications from this facility. All their products need to be recalled and the doors shut. The facility itself has to be inspected to understand how this fungus ever found its way into a person's body. This is a horrid situation, not simply e. coli from lettuce, okay? This should never, and I mean never, should have happened. There are measures that should have prevented this at all costs.
This is a fatal infection. Patients suffering from this meningitis reach a tipping point where the infection appears intractable. I would say physicians should even consider a 'ICP bolt' with tiny injections of Amphotericine B directly into the meninges or into the CSF in the spinal column. The worst that can happen is a chemical meningitis that may abate with body replacement of CSF in a day or less. The body produces about 500 cc of CSF per day. It may be the only way to stop this fungus and entertain saving failing patients is to inject Amphotericine B directly into the same place the drug was injected. An emergency and experimental procedure could be obtained from the CDC. What else is there? Introducing anti-fungal medications through serum dilutes the delivery of the medication to the meninges.
If serum treatment is working then fine, but, in patients reaching tipping points of intractable disease, extreme measures should be considered. There are potentially more patients in the population receiving this drug. I would expect the maximum effected to reach a crescendo, but, having the products from this facility out there is a foolish notion. It only takes one vial of anything to cause a death. It is unreasonable to consider LIMITING a ? recall ? to lot numbers.
One other thing, patients can be treated by IV infusion of anti-fungal drugs, BUT, the real savior here is for them to be treated as soon as minor symptoms start to show up. A person can be diagnosed accurately in the very early stages of this infection. I would even entertain the thought of CSF examination of suspected patients without symptoms.
This is what CSF looks like. It is crystal clear. Any person can have examination of their CSF at any time. A person does not have to be infected to find out if there is contamination.
The earlier a person is diagnosed the better. IV infusion of anti-fungal drugs at the early stages may very well stop the infection all together. This should not be left up to self-examination of symptoms, but perhaps, a clear instruction to see a physician immediately for diagnosis or not. It could be made mandatory and not simply, "If you have a fever." The fever may be too late to stop the growth of the fungus.
Basically, urgency in my opinion will end this run on danger to those infected.
...While the investigation is ongoing, (click here) according to CDC, all infected patients to date received preservative-free methylprednisolone acetate from among three lots voluntarily recalled by the New England Compounding Center on September 25, 2012. To date, CDC is aware of infections associated only with the three lots that were recalled on September 25, 2012....
Elizabeth Cohen from CNN reported today vials were found with visual fungus in them at the facility. This is about gross negligence and it is criminal. It could be the Aspergillus was introduced deliberately which is a heinous crime.
Preservative free has nothing to do with this growing in the vials either. The production of this drug was to take place under sterile conditions. Preservatives extend shelf life, not prevent contamination.
There is something very wrong with this facility. This contamination is unprecedented (no records of this type of organism anywhere in the archives of major research facilities or health organizations causing meningitis). It is too, too dangerous to proceed with any of the medications from this facility. All their products need to be recalled and the doors shut. The facility itself has to be inspected to understand how this fungus ever found its way into a person's body. This is a horrid situation, not simply e. coli from lettuce, okay? This should never, and I mean never, should have happened. There are measures that should have prevented this at all costs.
This is a fatal infection. Patients suffering from this meningitis reach a tipping point where the infection appears intractable. I would say physicians should even consider a 'ICP bolt' with tiny injections of Amphotericine B directly into the meninges or into the CSF in the spinal column. The worst that can happen is a chemical meningitis that may abate with body replacement of CSF in a day or less. The body produces about 500 cc of CSF per day. It may be the only way to stop this fungus and entertain saving failing patients is to inject Amphotericine B directly into the same place the drug was injected. An emergency and experimental procedure could be obtained from the CDC. What else is there? Introducing anti-fungal medications through serum dilutes the delivery of the medication to the meninges.
If serum treatment is working then fine, but, in patients reaching tipping points of intractable disease, extreme measures should be considered. There are potentially more patients in the population receiving this drug. I would expect the maximum effected to reach a crescendo, but, having the products from this facility out there is a foolish notion. It only takes one vial of anything to cause a death. It is unreasonable to consider LIMITING a ? recall ? to lot numbers.
One other thing, patients can be treated by IV infusion of anti-fungal drugs, BUT, the real savior here is for them to be treated as soon as minor symptoms start to show up. A person can be diagnosed accurately in the very early stages of this infection. I would even entertain the thought of CSF examination of suspected patients without symptoms.
This is what CSF looks like. It is crystal clear. Any person can have examination of their CSF at any time. A person does not have to be infected to find out if there is contamination.
The earlier a person is diagnosed the better. IV infusion of anti-fungal drugs at the early stages may very well stop the infection all together. This should not be left up to self-examination of symptoms, but perhaps, a clear instruction to see a physician immediately for diagnosis or not. It could be made mandatory and not simply, "If you have a fever." The fever may be too late to stop the growth of the fungus.
Basically, urgency in my opinion will end this run on danger to those infected.
...While the investigation is ongoing, (click here) according to CDC, all infected patients to date received preservative-free methylprednisolone acetate from among three lots voluntarily recalled by the New England Compounding Center on September 25, 2012. To date, CDC is aware of infections associated only with the three lots that were recalled on September 25, 2012....
