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

[Catbird]

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.

[Catbird]

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!)

Status: Ongoing Investigation
Infection: Fungal
Facility Type: Outpatient Setting
Case Count: 386
States: 19
Deaths: 28


There is also new information from the FDA with further laboratory results and the thread can be found here.

[Catbird]

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.

• Status: Ongoing Investigation
• Infection: Fungal
• Facility Type: Outpatient Setting
• Case Count: 404
• States: 19
• Deaths: 29

NOTICE: Next update will be Monday Nov. 5.

[Catbird]

Re: US - 29 dead, 404 infected with fungal meningitis in 19 states

There are no updates to the Current Situation, or Clinician or Patient Guidance in today's CDC report. There are no updates to the FDA website.

• Status: Ongoing Investigation
• Infection: Fungal
• Facility Type: Outpatient Setting
• Case Count: 419
• States: 19
• Deaths: 30

NOTICE: Next update will be Wednesday, Nov. 7

[Pathfinder]

Re: US - 30 dead, 419 infected with fungal meningitis in 19 states

Congress subpoenas owner of company blamed for meningitis outbreak

Barry Cadden ordered to appear before committee after refusing original invitation to testify about outbreak that has killed 30

Matt Williams in New York
guardian.co.uk, <TIME itemprop="datePublished" datetime="2012-11-07T10:31EST" pubdate="">Wednesday 7 November 2012 10.31 EST</TIME>

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.

More...

http://www.guardian.co.uk/world/2012/nov/07/meningitis-outbreak-congress-subpoenas-owner

[Catbird]

Re: US - 30 dead, 419 infected with fungal meningitis in 19 states

Fungal Meningitis Risk Period Over But Threat Remains

"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

[Catbird]

Re: US - 30 dead, 419 infected with fungal meningitis in 19 states

Today's CDC update notes that further updates will be issued only on Monday, Wednesday and Friday.

• Status: Ongoing Investigation
• Infection: Fungal
• Facility Type: Outpatient Setting
• Case Count: 424*
• States: 19*
• Deaths: 31*
• * Updates occur Mon, Wed & Fri

Both the Clinician and Patient Guidance pages have been reformatted, but, at this time, no significant new information has been posted.

[cartski]

Re: US - 31 dead, 424 infected with fungal meningitis in 19 states

So the deonminator in this situation is 14,000 doses of the 2 primary drugs, making an incidence rate of 424/14,000 = 3.0%?

And the case fatality rate so far is 31 / 424 = 7.3%?

How does these figures compare to other drug induced infections?

J.

[Pathfinder]

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/quality/boards/pharmacy/121107-statement-from-lauren-smith.pdf

[Catbird]

Re: US - 31 dead, 424 infected with fungal meningitis in 19 states

The information in this article is based on the NEJM report published earlier this week.

150 patients got old drugs in meningitis outbreak

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..."

[Catbird]

Re: US - 31 dead, 424 infected with fungal meningitis in 19 states

Today's update from the CDC includes additions to the Current Situation and the Clinician FAQ. There is no change to the Patient Guidance, or to the FDA information.

Status: Ongoing Investigation
Infection: Fungal
Facility Type: Outpatient Setting
Case Count: 438*
States: 19*
Deaths: 32*

[Catbird]

Re: US - 31 dead, 424 infected with fungal meningitis in 19 states

The CDC's Current Situation page has been updated to include the following additional information.

Excerpt from:

Multistate Fungal Meningitis Outbreak Investigation

Current Situation

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.

[Catbird]

Re: US - 32 dead, 438 infected with fungal meningitis in 19 states

There have been no updates to any of the CDC pages today, probably due to the Federal holiday.

[mixin]

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-of-meningitislinked-pharmacy-takes-fifth-20121114,0,2853554.story

[cartski]

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?