Re: US - 28 dead, 363 infected with fungal meningitis in 19 states
Apparently, there has been some kind of mix-up. The CDC has modified today's update and is now not counting a 3rd fatality in VA.
Status: Ongoing Investigation
Infection: Fungal
Facility Type: Outpatient Setting Case Count: 377 States: 19 Deaths: 28* *Virginia is now reporting 2 deaths, instead of 3 deaths.
Last case update:
October 31, 4 p.m.
Re: US - 28 dead, 377 infected with fungal meningitis in 19 states
Today's update from CDC has cleared up the confusion about a possible 3rd fatality in VA. There have been no changes to the Current Situation, or Clinician or Patient Guidance. The CDC has posted results of the laboratory testing done on NECC products. The information can be found on this thread .(a big to Pathfinder for posting it!)
Re: US - 28 dead, 386 infected with fungal meningitis in 19 states
Today's update from CDC includes an additional death in TN. There are no changes to the Current Situation, or to Clinician or Patient Guidance. There are no updates to the FDA website as of 2:30 pm.
The CDC will NOT be updating case counts this weekend.
The head of a pharmacy company blamed for a meningitis outbreak that has killed at least 30 people in the US has been subpoenaed to appear before lawmakers in Congress after refusing to give evidence voluntarily.
Barry Cadden, the co-owner of the New England Compounding Center (NECC) – which is believed to have sent out thousands of contaminated steroid shots from premises in the Boston suburb of Framingham – had been asked to attend a session called by the House's energy and commerce committee along with state and federal regulators.
But the chief pharmacist declined, according to members of the committee.
"With more than 400 people infected and 30 deaths, it is critical that we hear directly from the head of the facility linked to the outbreak," said committee chairman Fred Upton and Ranking Member Henry Waxman in a statement. "Since Mr Cadden has indicated he will not appear voluntarily, we are left with no choice but to issue a subpoena."
On Monday, the committee announced that Dr Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), will be testifying before lawmakers on 14 November.
"The 42-day risk period for contracting fungal meningitis from tainted steroid injections ended on Wednesday, since the drugs were recalled on Sept. 26, but new case reports will probably continue to trickle into the Centers for Disease Control and Prevention for at least a few months, said Dr. Tom Chiller, a fungal disease expert at the CDC
With 18 new cases reported last Friday, and abscesses causing even fungal meningitis survivors to go back to the hospital with new symptoms, sighs of relief could be premature.
snip
A CDC analysis revealed that while preemptive anti-fungal prescriptions reduced patients' risk of death or stroke from meningitis by .1 percent, they increased the risk of other adverse health problems by up to 14 percent, Chiller said.
Chiller said this kind of fungus, exserohilum rostratum, can have a very long incubation period. Although the median incubation period so far has been 20 days, the longest incubation period went beyond 100 days, he said.
snip
Signs that the CDC believes new cases will taper off include the CDC's new, more relaxed online case reporting schedule. Instead of updating case counts by state every day at 2 p.m., as it had for the last month, the CDC will update Monday, Wednesday and Friday only. This Monday's steep new case count of 15 was actually only five new cases per day.
However, 18 new cases were reported between Thursday and Friday of last week, according to CDC reports. Case counts only reached 18 or higher on four days of the whole outbreak.
snip
"The new finding is that patients during treatment or reaching the end of their treatment may actually relapse and come back with new symptoms," said Schaffner, who used to be president of the National Foundation for Infectious Diseases.
[B]
more at above link
Last edited by sharon sanders; November 7th, 2012 at 12:14 PM.
Reason: shortened
Re: US - 31 dead, 424 infected with fungal meningitis in 19 states
FOR IMMEDIATE RELEASE:
November 7, 2012
FURTHER INFORMATION:
Anne Roach (617) 624-5006
STATEMENT OF INTERIM COMMISSIONER DR. LAUREN SMITH ON NECC INVESTIGATION
BOSTON -- Wednesday, November 07, 2012 – The following is a statement from Massachusetts Department of Public Health (DPH) Interim Commissioner Dr. Lauren Smith:
Today I am announcing a development in our ongoing investigation into NECC and administrative changes at the Massachusetts Board of Pharmacy. These personnel actions stem from troubling information that has come to light during our ongoing review of the Board’s oversight of NECC.
We have discovered a Colorado Board of Pharmacy complaint against NECC, which was forwarded to James D. Coffey, Director of the Massachusetts Board of Pharma cy, on July 26, 2012.
The information shared by Colorado showed that NECC had distributed manufactured drugs to many hospitals in that state between 2010 and 2012 without patient -specific prescriptions, in violation of NECC’s Colorado and Massachusetts l icenses.The Colorado Board of Pharmacy contacted the FDA who confirmed that NECC was not a licensed manufacturer.
As seen in the attached documents, this information was provided in detail by Colorado to Mr. Coffey in July, which he then forwarded to Boa rd attorney Susan Manning and Board inspectors. The director of the Board is responsible for ordering investigations. Mr. Coffey failed to order an investigation or take any other action on the Colorado complaint.
It is incomprehensible that Mr. Coffey and Ms. Manning did not act on the Colorado complaint given NECC’s past, and their responsibility to investigate complaints.
Following the outbreak, staff also failed to disclose the existence of Colorado’s complaint to leadership at DPH.
As a result of these findings, we have terminated James Coffey and placed Susan Manning, a member of a bargaining unit, on administrative leave pending the final conclusions of our investigation. We have identified highly qualified individuals to fill these positions and the important work of the agency will continue with even greater resolve at this critical juncture.
There is no evidence at this time that staff informed Board members about the Colorado issues.
I find the actions of NECC reprehensible. We have the righ t to expect that all companies producing medication for use in delivering health care to comply with laws designed to protect patient safety. But I also expect the staff charged with oversight to perform their duties to the highest standards. That failed to happen here.
Since starting as interim commissioner, I have promised and delivered swift and decisive actions.
This investigation and the Department’s thorough response will not stop until we have a complete understanding of what happened, assign acco untability where it is warranted and can be certain the failures that led to this tragedy never happen again.
### http://www.mass.gov/eohhs/docs/dph/q...uren-smith.pdf
Nearly 150 patients exposed to potentially contaminated steroid injections in Tennessee received medicine more than 7 weeks old, even though industry guidelines say its shelf life should have been no longer than 24 hours.
Almost 1 in 5 of those patients developed a fungal infection — a rate dramatically higher than for those treated with fresher medicine, according to the Tennessee Department of Health.
...Under best-practice guidelines from the U.S. Pharmacopeia Convention, the drug would be considered a "high-risk" product — made from nonsterile ingredients and lacking antimicrobial preservatives. In the absence of a sterility test, storage time should not exceed one day at room temperature or three days at a cold temperature, the guidelines say.
In Tennessee, the compounding center's vials were stored at room temperature, as specified in the package instructions, state health officials said in a paper published Tuesday in the New England Journal of Medicine.
...The preservative-free steroid should never have been produced en masse to begin with, said Loyd V. Allen Jr., editor-in-chief of the International Journal of Pharmaceutical Compounding.
"If it is not preserved — if it is only intended to be used in one patient — then it has to be packaged in a single-use container and its contents have to be used all at one time," Allen said. "If it is going to be used on multiple patients or at multiple times, then it has to have a preservative."
The company shipped 17,676 units of preservative-free methylprednisolone acetate that have been linked to the outbreak. A sterility test should be conducted for any batch larger than 25 units, Allen said.
The state health department's analysis of infection cases in Tennessee found that patients treated with medicine packaged longer than 50 days had a 19% infection rate while those treated with newer vials had only a 3% infection rate.
"We found a strong association between the age of methylprednisolone vials and the rate of infection in one clinic," the physicians wrote. "One possible explanation for this observation is that the level of contamination in the vials may have increased over time with subsequent higher fungal burdens present in older vials."
The article does not identify the clinic by name but does note that the clinic had used 1,663 vials of the medicine. The only one of the three clinics in Tennessee that had that much product, according to prior information from the state health department, was St. Thomas Outpatient Neurosurgery Center.
However, Allen said the responsibility for providing guidance on shelf life rests with the drug manufacturer or compounding lab. The best-practice standards do allow compounding labs to recommend usage for up to six months if certain criteria, including a program for sterility testing, are met..."
CDC has recently become aware of reports of spinal epidural abscess and arachnoiditis among a number of patients undergoing treatment for fungal meningitis associated with the outbreak. Both conditions are rare but serious disorders in the general population that require prompt medical attention. Most of these early reports have been about patients in Michigan and Tennessee, but other states have reported patients with these conditions as well. Additional information is found in the Clinician FAQ’s. CDC is working with clinicians and public health officials to obtain more information and refine its clinical guidance as needed.
CDC and public health officials are referring any patients who have symptoms that suggest possible infections to their physicians, who can evaluate them further.
Last edited by Catbird; November 9th, 2012 at 03:02 PM.
Reason: formatting
Re: US - 32 dead, 438 infected with fungal meningitis in 19 states
A really short 4 paragraph article:
Associated Press
11:08 a.m. EST, November 14, 2012
Owner of meningitis-linked pharmacy takes Fifth
...
After repeated questions by House lawmakers, Cadden told the House Energy and Commerce Committee: "Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the Fifth Amendment."
... http://www.wsbt.com/news/wsbt-owner-...,2853554.story
__________________
The salvage of human life ought to be placed above barter and exchange ~ Louis Harris, 1918
Re: US - 32 dead, 438 infected with fungal meningitis in 19 states
[QUOTE=mixin;474521] Owner of meningitis-linked pharmacy takes Fifth
...
After repeated questions by House lawmakers, Cadden told the House Energy and Commerce Committee: "Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the Fifth Amendment."
...
QUOTE]
So this was before a Committee, not a grand jury, or other prelimnary process. But can we still infer that criminal proceedings are likely?
Re: US - 32 dead, 438 infected with fungal meningitis in 19 states
Although we're past the 42 day window of highest risk, the case count is still increasing. The CDC had predicted additional cases but an increase of 23 new cases is significant. Still, without a more detailed breakout, there's no way for us to know if these additional cases are actually new, or were identified in a retrospective analysis. We also don't know how many, if any, are peripheral joint infections, and/or epidural abscesses.
Today's CDC update does not include any changes to the Current Situation, or to the Clinician or Patient Guidance. There are no FDA updates on information about NECC, but the inspection report for its' sister company Ameridose has been posted on a separate FDA page (see thread here).
Re: US - 32 dead, 438 infected with fungal meningitis in 19 states
Quote:
Originally Posted by cartski
So this was before a Committee, not a grand jury, or other prelimnary process. But can we still infer that criminal proceedings are likely?
Here is a good 2 page article discussing the jurisdiction issues, etc:
FDA Seeks More Authority Amid Meningitis Outbreak
By MATTHEW PERRONE AP Health Writer
WASHINGTON November 14, 2012 (AP)
...
Members of the House Energy and Commerce Committee spent most of the first hearing on the outbreak questioning state and federal regulators about why they didn't act sooner against the company.
...
"I 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 very same drug at issue in the current outbreak," said Rep. Fred Upton, R-Mich., who chairs the committee.
..
Federal officials have opened a criminal investigation of Cadden and the NECC.
... http://abcnews.go.com/Business/wireS...9#.UKQwjt2LVNQ
__________________
The salvage of human life ought to be placed above barter and exchange ~ Louis Harris, 1918
As of November 15, 2012, the predominant fungus identified in patients continues to be Exserohilum rostratum, with 84 CDC laboratory-confirmed cases. One patient, the index case, had a laboratory-confirmed Aspergillus fumigatus [JPG - 29 KB] infection. These fungi are common in the environment; fungal infections are not transmitted from person to person.
Last edited by Catbird; November 16th, 2012 at 01:39 PM.
Reason: add FDA note
Re: US - 33 dead, 480 infected with fungal meningitis in 19 states
Better late...
Today's CDC update still shows an increased case count and an additional death in Michigan (although it may be counted in Indiana - still checking on this). But having only 10 new cases reported since Friday is almost good news.
Deadly meningitis outbreak was completely avoidable
By Michael Carome, Special to CNN
updated 4:07 PM EDT, Tue October 16, 2012
Editor's note: Dr. Michael Carome is deputy director of the Public Citizen's Health Research Group.
(CNN) --
[snip]
A key player at the federal level deserving a significant amount of blame is the FDA.
Loud alarm bells were sounded on December 4, 2006, when the FDA issued warning letters to the New England Compounding Center and four other compounding pharmacies, directing them to stop producing standardized versions of medications that, according to the agency, were being "marketed for general distribution rather than responding to the unique medical needs of individual patients." the center was cited for violations of FDA regulations in marketing four different drugs, including repackaged doses of the cancer drug Avastin into syringes for treatment of macular degeneration.
News: Injectable drugs from Mass. facility suspect
Clearly, the FDA considered the center and the other compounding pharmacies to be engaged in drug manufacturing. The pharmacies, like any other drug manufacturer, were therefore subject to the safety and effectiveness standards required for approval of new drugs, as well as the rigorous manufacturing standards designed to ensure that drugs are sterile and uncontaminated with such germs as bacteria or fungi before being sold and distributed.
However, following its warning letter, the FDA subsequently dropped the ball and failed to take the actions necessary to ensure the center adhered to these drug standards, which are essential for protecting the health of patients. For whatever reason, whether inattentiveness or lack of compliance and legal resources, by not aggressively enforcing the regulations related to large-scale drug manufacturing and interstate commerce, the FDA allowed the company to shift its wide-scale manufacturing and interstate distribution operation to injectable steroids.
On Thursday, the FDA attempted to deflect criticism for its failures by asserting that it lacked authority to take action earlier. This flies in the face of the agency's long-stated position that it had legal authority over such activities and its prior enforcement activities against the New England center and multiple other compounding pharmacies. While no one wants to be viewed as being responsible for a preventable public health catastrophe, American citizens should express their outrage and demand that all parties responsible for this tragedy -- including the FDA -- be held accountable.
Otherwise history will repeat itself.
__________________ "L’amore ai tempi del caos"
"It is not helpful to hinge the future of the nuclear industry and an important element of the energy supply to a claim that low levels of radiation cause 'negligible' damage or are even helpful." ----Richard Garwin - IBM Emeritus Fellow; Adjunct Prof. of Physics, Columbia University
(My posts are not intended as advice or professional assessments of any kind.)
Re: US - 34 dead, 490 infected with fungal meningitis in 19 states
Today's update from the CDC lists 2 additional deaths in IN and MI. This reflects the case of a MI resident who received contaminated injections in IN but died in MI.
There have been no changes to the Current Situation, or Clinician or Patient Guidance. As of this afternoon, there is no updated information on the FDA website.
"After being treated with drugs from New England Compounding Center, 52-year-old Bret Moody was told he has fungal meningitis. He's infected with Aspergillus, the first contaminant found in a national outbreak of illness tied to tainted medication.
But when health officials count the nearly 500 people sickened by the moldy drugs, they don't include Moody and others like him who fail to match the profile of most victims.
...Some got the spinal steroid, methylprednisolone acetate, blamed for the meningitis outbreak that has killed at least 34 nationwide. Some, like Moody, got other drugs from the Massachusetts firm. But if their symptoms are not already linked to the outbreak, they say, medical professionals aren't taking their illnesses seriously.
Health officials say they are watching closely and haven't yet confirmed any illnesses related to other drugs from New England Compounding or its sister company, Ameridose, both of which recalled all products amid sterility concerns.
Developments last week, however, indicate that the scope of the outbreak could be wider than previously believed. The U.S. Food and Drug Administration reported finding a new batch of bacterial and fungal contaminants in drugs from New England Compounding. Meanwhile, the U.S. Centers for Disease Control and Prevention reported a surge in epidural abscesses and bone infections among patients treated with three suspect lots of methylprednisolone acetate. Previously, the dominant infection had been fungal meningitis.
Dr. Diana Zuckerman, president of the patient advocacy organization National Research Center for Women & Families, said she believes more illnesses caused by contaminated drugs may be under the radar.
"This is the tip of the iceberg," Zuckerman said...
...The CDC has received "numerous reports of events following use of other NECC products, said agency spokesman Curtis Allen, but so far has not confirmed infections linked to those drugs.
Confirmation "is complicated and involves gathering clinical and epidemiological evidence of an association," he said..."
"It is not helpful to hinge the future of the nuclear industry and an important element of the energy supply to a claim that low levels of radiation cause 'negligible' damage or are even helpful." ----Richard Garwin - IBM Emeritus Fellow; Adjunct Prof. of Physics, Columbia University
(My posts are not intended as advice or professional assessments of any kind.)
Re: US - 36 dead, 510 infected with fungal meningitis in 19 states
CDC has not posted an update today.
A couple of weeks ago CDC announced that they would be updating on a M - W - F schedule, but I wouldn't be surprised to learn that they're switching to a weekly update.
Re: US - 36 dead, 510 infected with fungal meningitis in 19 states
As noted above, the CDC will only be updating case counts once a week. However, they are now including a breakout of the data to identify the specific type of case by category. So far the types include: meningitis (with or w/out other infection); stroke w/out lumbar puncture only; paraspinal/spinal infection only; peripheral joint infection only; and deaths.
Today's CDC update shows no new deaths but still an increase of 31 cases. There have been no changes to the Current Situation, or to Clinician or Patient Guidance. The various state Health Depts. have significantly decreased the content and frequency of their own updates, and media attention on this topic has dropped off as well. All these factors will make it more difficult to stay informed on what is happening.
One reason this lack of attention may be significant is that the FDA has announced that additional NECC products have tested positive for microbial contamination and the number of identified contaminants has increased. The potential clinical implications of the various contaminants is unknown. (See more at the threads here and here.)
As the article that I posted above the other day mentioned, there are people who received injections with NECC products who are ill but don't fit the original case parameters and so aren't counted among known cases. It's possible that with the new FDA information which identifies additional contaminants in other NECC products, we may soon have a whole new patient set.
Re: US - 36 dead, 510 infected with fungal meningitis in 19 states
This week's update from CDC shows an additional death in Maryland. The MD state Dept. of Health has not yet updated it's website with any info on the fatal case, and I haven't found anything from media sources either. The overall case count has increased by 49 cases.
In spite of the still increasing case count, Virginia has officially announced that it's scaling back surveillance and support (see Virginia thread). Although that is the only official announcement that I've found so far, it's very likely that most other state health departments are doing something similar.
Dozens Sue Pharmacy but Compensation Uncertain, Tenn. Attorney Says
December 17, 2012
[snip]
Complicating efforts to recover damages, attorneys for the patients said, NECC is a small private company that has now recalled all its products and laid off its workers. The company’s pharmacy licenses have been surrendered, and it’s unclear whether NECC had adequate liability insurance...
The medical bills and suffering of survivors are overwhelming and the lives of the caretakers could be changed forever.
__________________ "L’amore ai tempi del caos"
"It is not helpful to hinge the future of the nuclear industry and an important element of the energy supply to a claim that low levels of radiation cause 'negligible' damage or are even helpful." ----Richard Garwin - IBM Emeritus Fellow; Adjunct Prof. of Physics, Columbia University
(My posts are not intended as advice or professional assessments of any kind.)
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Re: US - 28 dead, 363 infected with fungal meningitis in 19 states
to Pathfinder for posting it!)
). 
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