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US - CDC reports 63 dead, 749 infected with fungal meningitis in 20 states (Update Aug 5, 2013)

Re: US - 34 dead, 490 infected with fungal meningitis in 19 states

Re: US - 34 dead, 490 infected with fungal meningitis in 19 states

http://www.cnn.com/2012/10/16/opinion/carome-meningitis/index.html
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.
 
Re: US - 34 dead, 490 infected with fungal meningitis in 19 states

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.


Status: Ongoing Investigation
Infection: Fungal
Facility Type: Outpatient Setting
Case Count: 510*
States: 19*
Deaths: 36*
 
Re: US - 36 dead, 510 infected with fungal meningitis in 19 states

Re: US - 36 dead, 510 infected with fungal meningitis in 19 states

Patients say their cases ignored in meningitis outbreak

"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..."
 
Re: US - 36 dead, 510 infected with fungal meningitis in 19 states

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

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.

You can see the latest numbers in the thread "CDC - Multi-State Meningitis Outbreak - Current Case Count (Map)" (with a big :tiphat: to Pathfinder :)).

Status: Ongoing Investigation
Infection: Fungal
Facility Type: Outpatient Setting
Case Count: 541*
States: 19*
Deaths: 36*


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

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.


Status: Ongoing Investigation
Infection: Fungal
Facility Type: Outpatient Setting
Case Count: 590*
States: 19*
Deaths: 37*


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.
 
Re: US - 36 dead, 510 infected with fungal meningitis in 19 states

Re: US - 36 dead, 510 infected with fungal meningitis in 19 states

This weeks update from CDC includes 2 additional deaths; one in TN and one in IN, as well as 30 additional cases being reported.



Status: Ongoing Investigation
Infection: Fungal
Facility Type: Outpatient Setting
Case Count: 620*
States: 19*
Deaths: 39*


ETA: Note from CDC on update schedule:

"* The next update to case counts will be on December 28, then resuming every Monday beginning January 7."
 
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Re: US - 39 dead, 620 infected with fungal meningitis in 19 states

Re: US - 39 dead, 620 infected with fungal meningitis in 19 states

http://www.insurancejournal.com/news/southeast/2012/12/17/274344.htm

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.
 
Re: US - 39 dead, 620 infected with fungal meningitis in 19 states

Re: US - 39 dead, 620 infected with fungal meningitis in 19 states

My apologies for being a bit slow in working on this thread the past couple of weeks. I've been a bit under the weather. :)



This week's update from CDC still shows an increase in reported cases. The good news is that there have not been any further deaths reported during the past 10 days. Information from both media and official state reports seems to indicate that there are few, if any, new cases of fungal meningitis. Almost all the newly reported cases are some form of a localized infection which, according to the CDC's Clinician Guidance, could take any of the following forms: epidual abscess, phlegmo, arachnoiditis, discitis, or vertebral osteomyelitis.

I haven't yet seen any statistical breakdown of how many cases of localized infection are occurring in patients who have also been diagnosed with fungal meningitis, and how many cases consist solely of a localized infection.


Status: Ongoing Investigation
Infection: Fungal
Facility Type: Outpatient Setting
Case Count: 656*
States: 19*
Deaths: 39*

"* The next update to case counts will be on December 28, then resuming every Monday beginning January 7."
 
Re: US - 39 dead, 620 infected with fungal meningitis in 19 states

Re: US - 39 dead, 620 infected with fungal meningitis in 19 states

Reuter's has done an interesting summary article on how the situation is being handled in Michigan. The entire article is worth a read but here are some interesting tidbits:


Fungal meningitis: Michigan hospital leads fight against deadly outbreak



"...St Joseph Mercy - a 537-bed Catholic hospital located in Ypsilanti, on the doorstep of the University of Michigan - has treated 169 of the state's 223 cases of infections that can cause meningitis, including 7 people who died.

At one point it was so overrun that 87 of its 537 beds... were occupied by patients with fungal meningitis and related infections.

...CDC experts initially feared death rates in the 40 to 50 percent range; instead, only about 6 percent of those infected have died, and the CDC credits the creative and dogged efforts of state and local health officials for keeping the death rates so low.

...Dr Anurag Malani, an infectious disease specialist... said the challenge with the outbreak was that there was no medical literature to fall back on.

"No one has ever seen anything of this magnitude related to fungal infections, ever," he said.

Chiller said U.S. doctors had never treated meningitis caused by Exserohilum rostratum, the environmental mold causing most of the infections.

"It's just a rare, rare cause of infection." Seeing that mold in the meninges - membranes covering the brain and spinal cord - is "completely new."

...It morphed into something bigger when some of its 53 patients with meningitis started returning with infections near the site in their back or neck where the contaminated drug was injected.

..."When it became obvious that the number of patients would be a much higher percentage than anticipated by the CDC, we expanded our clinic and started enlisting the help of several other hospitals," Vandenberg said.

...The decision to screen all patients in the hospital database who might have received tainted injections was not taken at the recommendation of the CDC.

...Excluding patients who had already been screened and those who had injections in areas other than the spine, the hospital targeted about 500 patients for MRI scans.

..."We did over 400 MRIs in about a 4-week period," Vandenberg said. The hospital screened so many patients, in fact, that the state of Michigan sent in an emergency mobile MRI unit to help.

...So far, about 20 percent of the MRIs have shown up as abnormal, meaning that patients have to come back for surgery and treatment.

...Vandenberg nevertheless cautions that the outbreak is still far from over.

"Every single day of this screening program, we're finding one or two cases that are abnormal and need to be admitted," he said.

..."Unfortunately, with fungi, the incubation periods are so long and they can remain indolent. I'm definitely concerned that we're going to continue to see more cases.""
 
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Re: US - 39 dead, 620 infected with fungal meningitis in 19 states

Re: US - 39 dead, 620 infected with fungal meningitis in 19 states

This weeks CDC update includes the additional fatality from MI and shows an increase of only 8 cases since the last update on Dec. 28th.


Status: Ongoing Investigation
Infection: Fungal
Facility Type: Outpatient Setting
Case Count: 664*
States: 19*
Deaths: 40*
Laboratory Results


A comparison of our numbers with the latest CDC count shows a few differences:


IN: FT Count = 68; CDC Count = 70
NC: FT Count = 3; CDC Count = 17
TN: FT Count - 124; CDC Count = 140

None of these 3 states are reporting case counts on their official Dept. of Health websites. Media reporting has dropped to almost nothing, especially for cases of peripheral infections.

From here on, I suspect that the only numbers that we'll be seeing will be coming from the CDC.
 
Re: US - CDC reports 40 dead, 664 infected with fungal meningitis in 19 states

Re: US - CDC reports 40 dead, 664 infected with fungal meningitis in 19 states

This week's update from CDC shows 4 additional deaths. 1 of them is the death reported by mixin (:tiphat:) in Indiana. I will post info on the other fatalities as I find it.

Status: Ongoing Investigation
Infection: Fungal
Facility Type: Outpatient Setting
Case Count: 678*
States: 19*
Deaths: 44*
 
Re: US - CDC reports 44 dead, 678 infected with fungal meningitis in 19 states

Re: US - CDC reports 44 dead, 678 infected with fungal meningitis in 19 states

There's been no weekly update from CDC today, likely due to the federal holiday.

I will be checking for it again tomorrow.
 
Re: US - CDC reports 44 dead, 678 infected with fungal meningitis in 19 states

Re: US - CDC reports 44 dead, 678 infected with fungal meningitis in 19 states

This weeks CDC update includes the latest death in MI, and an additional 15 cases reported.



Status: Ongoing Investigation
Infection: Fungal
Facility Type: Outpatient Setting
Case Count: 693*
States: 19*
Deaths: 45*
 
Re: US - CDC reports 45 dead, 693 infected with fungal meningitis in 19 states

Re: US - CDC reports 45 dead, 693 infected with fungal meningitis in 19 states

This week's CDC update shows no new deaths and an increase of only 3 in the case count. Two of those are in MI.

Status: Ongoing Investigation
Infection: Fungal
Facility Type: Outpatient Setting
Case Count: 696*
States: 20*
Deaths: 45*


ETA: There are now cases in 20 states; the new edition to the list is West Virginia, where 2 cases have been found.
 
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Re: US - CDC reports 45 dead, 693 infected with fungal meningitis in 19 states

Re: US - CDC reports 45 dead, 693 infected with fungal meningitis in 19 states

This week's CDC update includes an additional death and an increase in reported cases of injection site infections.


Status: Ongoing Investigation
Infection: Fungal
Facility Type: Outpatient Setting
Case Count: 704*
States: 20*
Deaths: 46*
 
Re: US - CDC reports 46 dead, 704 infected with fungal meningitis in 19 states

Re: US - CDC reports 46 dead, 704 infected with fungal meningitis in 19 states

This week's CDC update shows an additional death in Indiana and 3 additional cases, which only illustrates the fact that while the outbreak is waning, it is not yet over.

Status: Ongoing Investigation
Infection: Fungal
Facility Type: Outpatient Setting
Case Count: 707*
States: 20*
Deaths: 47*
 
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