Scared Monkeys Discussion Forum

http://abcnews.go.com/Health/wireStory/dead-rare-meningitis-cases-expected-17393781#.UG2XhK7BnIU
Rare US Meningitis Outbreak Grows; 4 Dead, 22 Sick
October 4, 2012

 An outbreak of a rare form of meningitis is likely to grow after sickening 26 people in five states, including four who died, health officials warned.

All received steroid injections, mostly for back pain, a fairly typical treatment. The drug was made by a specialty pharmacy in Massachusetts that issued a recall last week and has shut down operations.

The type of meningitis involved is not contagious like the more common forms. This type is caused by a fungus often found in leaf mold and which health officials suspect may have been in the steroid.
 ::snipping2::
 More new cases are almost certain to appear in the coming days, said Tennessee Department of Health Commissioner John Dreyzehner. Five new cases were confirmed over the past 24 hours, he said Wednesday, calling the situation a "rapidly evolving outbreak."

But federal health officials weren't clear about whether new infections are occurring. They are looking for — and increasingly finding — illnesses that occurred in the past two or three months.
More...

http://www.medpagetoday.com/Neurology/GeneralNeurology/35125
Steroid 'Prime Suspect' in Meningitis Cases
By Michael Smith, North American Correspondent, MedPage Today
October 4, 2012

http://www.usatoday.com/story/news/nation/2012/10/04/meningitis-outbreak-medicines/1613093/
Meningitis puts spotlight on compound medicines
October 4, 2012

11:17AM EST October 4. 2012 - NASHVILLE -- The fungal meningitis outbreak centered on Nashville has renewed debate over who should regulate specialty pharmacies that compound medicines.

While they fall under the purview of state pharmacy boards, critics contend those state agencies are often too understaffed and underfunded to adequately monitor such facilities. They want the U.S. Food and Drug Administration to take a greater regulatory role.

But the FDA has said it will do that only on a case-by-case basis -- such as the meningitis outbreak that surfaced in Nashville and has since spread to four other states.

Authorities said all of those infected with fungal meningitis received spinal injections of a steroid solution sold by New England Compounding Center, a specialty pharmacy in Framingham, Mass. It and similar facilities combine, mix and/or alter active ingredients to make custom medications, much like early pharmacists.

These modern-day apothecaries now are supplying a greater share of the medicines Americans take, driven by the surge in outpatient procedures, development of bio-engineered drugs and a push for more individualized treatment, experts say.
 ::snipping2::
His group and others have pushed for greater FDA oversight, citing recent outbreaks linked to compounded medications as evidence of the need. Among them:

-- A bacterial infection that killed nine people in two Birmingham, Ala.-area hospitals in early 2011. Another 10 people were sickened by the Serratia marcescens bacteria, which was in an intravenous nutritional supplement prepared by a local compounding pharmacy, the New York Times reported.

-- Bacteria-tainted Avastin injections that caused eye infections in four patients at the Veterans Affairs' Nashville hospital in March 2011. The hospital had compounded the Avastin for eye injections from packaging intended for intravenous use.

-- A fungal endophthalmitis outbreak that struck 33 people in seven states who underwent eye surgery between November 2011 and April 2012, causing vision loss and blindness in some. It was linked to an injectable dye produced by a Florida compounding pharmacy, the FDA said.

The same Florida company, Franck's Lab, also made an injectable supplement that killed 21 polo horses in April 2009, the Associated Press reported. In that case, Franck's won a federal court ruling that said the FDA had no jurisdiction over compounding of veterinary medicines given to non-food animals.

But the agency acted against the company again after the endophthalmitis outbreak earlier this year, saying in a July 9 warning letter that "environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared."

As a result, Franck's stopped selling sterile products -- including methylprednisolone, the drug implicated in the Tennessee outbreak -- in May, well before the current outbreak, according to FDA records.

Despite those and other high-profile cases, advocates have made little progress in gaining greater federal oversight of compounding pharmacies, Vaida said. The Nashville meningitis outbreak could help change that.
More...

http://www.nytimes.com/2012/10/04/health/meningitis-outbreak-grows-with-cases-in-5-states.html?_r=0
In Outbreak, Meningitis Is Reported in 5 States
October 3, 2012

An outbreak of a rare type of meningitis, linked to spinal injections for back pain, is growing and has killed four people and sickened at least 30 others in five states, health officials said on Wednesday. New cases are appearing every day.
 The patients are thought to have been infected by a steroid drug contaminated with a fungus, Aspergillus. The drug may have been shipped to 23 states, a spokesman for the Centers for Disease Control and Prevention said. This type of meningitis does not spread from person to person.

So far, cases have appeared in Tennessee, North Carolina, Florida, Virginia and Maryland. All the patients had received a treatment for back pain called a lumbar epidural steroid injection.

The drug under suspicion is methylprednisolone acetate, and health officials confirmed on Wednesday that all the infected patients had been treated with a brand of it produced by the New England Compounding Center in Framingham, Mass. So far, the incubation period seems to be from a few days to four weeks after the injection.
 ::snipping2::
 The outbreak has also drawn attention to the potential threats posed by compounding pharmacies like the one in New England. These pharmacies prepare drug mixtures and solutions that are not routinely available from major manufacturers, and not subject to the same rigorous safety standards that the government imposes on big drug companies.

On Sept. 26, the New England center voluntarily recalled three lots of the drug after it was told of the problem, according to Erica Jefferson, a spokeswoman for the Food and Drug Administration. She did not know how many doses were in the lots or where they had been shipped, but the center’s Web site said New England Compounding was licensed in all 50 states. One clinic in Tennessee, where most of that state’s patients in the outbreak so far were infected, had received 2,000 vials of the drug.

On Wednesday, North Carolina’s board of pharmacy suspended the company’s permission to do business there. So far the state has had one case, and several clinics received the potentially contaminated drug, a health department spokeswoman said.
 ::snipping2::
 Some hospitalized patients are recovering and walking the halls, but others are severely ill and in intensive care units, said Dr. Robert H. Latham, an infectious diseases specialist at St. Thomas Hospital in Nashville.

Fungal infections are notoriously stubborn and hard to treat, requiring powerful drugs that can have harsh side effects. Dr. Latham predicted that these patients would need six months to a year of treatment to get rid of the infection.

http://abcnews.go.com/Health/wireStory/dead-rare-meningitis-cases-expected-17393781
Rare US Meningitis Outbreak Grows, 5 Dead
October 4, 2012

Another fatality from a growing outbreak of a rare form of meningitis was reported Thursday, raising the death toll to five people, officials said.

In all, 35 people in six states have been sickened from a steroid that was distributed to 23 states, the Centers for Disease Control and Prevention said.

All received steroid injections used mostly for back pain that have been traced back to a specialty pharmacy in Massachusetts. The pharmacy issued a recall last week and has shut down operations.
 ::snipping2::

2 Pgs.  - Video at Link

http://abcnews.go.com/Health/wireStory/dead-rare-meningitis-cases-expected-17393781#.UG3iH67BnIU
FDA: Avoid Drugs From Company Tied to Meningitis
October 4, 2012

http://www.nj.com/politics/index.ssf/2012/10/6_nj_facilities_received_drug.html
6 N.J. facilities received drug tied to meningitis outbreak
October 4, 2012

Six medical facilities in New Jersey received the steroid medication being investigated in a fungal meningitis outbreak that has claimed four lives in other states, health officials said today, as they began investigating whether anyone has been stricken by the illness in the state.

The six facilities that received the potentially tainted steroid are doctor's offices and pain management practices, Health Department Spokeswoman Donna Leusner said. Some patients have received injections from the supply.

There are no meningitis cases reported in New Jersey related to the questionable steroid, Leusner said.

"Patients who may have received an injection from these facilities are being contacted by the facilities," Leusner said. "The Department of Health has told the facilities to stop using the medication" and "the facilities are cooperating. The NJ Department of Health is working with the facilities to ensure that the medication is not used and to identify any illnesses or adverse events associated with the medication."

 ::snipping2::
Meningitis is an inflammation of the lining of the brain and spinal cord. Symptoms include severe and worsening headache, nausea, dizziness and fever. Some of the patients also experienced slurred speech, and difficulty walking and urinating, according to health officials in Tennessee, where the most cases have been reported.

Fungal meningitis, which is not contagious like more common forms, is treated with high-dose antifungal medications, usually given intravenously in a hospital.

http://www.boston.com/news/local/massachusetts/2012/10/05/steroid-related-meningitis-cases-rise/4wg6sgooaYviqrjq9Vc6bO/story.html
Steroid-related meningitis cases rise to 47
October 5, 2012

NEW YORK (AP) — Health officials say the number of people sickened by a deadly meningitis outbreak has risen again. There are now 47 cases in seven states.

The number of deaths — five — has remained the same.

Tennessee, Virginia, Maryland, Florida, North Carolina and Indiana had previously reported cases. On Friday, Michigan joined the list, with four cases.
 ::snipping2::

http://www.nytimes.com/2012/10/06/health/officials-seek-patients-exposed-to-tainted-back-pain-drug.html?_r=0
Officials Seek People Exposed to a Tainted Drug
October 5, 2012

As the case count continued to rise in a multistate outbreak of meningitis linked to a tainted drug, federal health officials emphasized on Friday that it was absolutely essential to find everyone who may have been exposed to the drug, which was used in spinal injections for back pain.

“All patients who may have received these medications need to be tracked down immediately,” Dr. Benjamin Park, a medical officer at the Centers for Disease Control and Prevention, said in a statement. “It is possible that if patients with infection are identified soon and put on appropriate antifungal therapy, lives may be saved.”

Health officials said they were concerned that some patients who initially had mild symptoms did not realize they needed medical attention. But this type of meningitis, caused by a fungus, can become very severe, so there is an urgent need for early treatment.

Doctors urged anyone who had a spinal injection for pain in the last few months to contact a doctor if they became ill, particularly with symptoms that include a new or worsening headache, fever, stiff neck, sensitivity to light, nausea, slurred speech or loss of balance. The medical name for the injections is a lumbar epidural steroid injection.

Fungal meningitis does not spread from person to person.
More...

http://www.cdc.gov/hai/outbreaks/meningitis.html
Multistate Meningitis Outbreak Investigation
October 6, 2012
This information will be updated daily at 2pm EST

http://www.cbsnews.com/8301-204_162-57527391/meningitis-outbreak-death-toll-rises-to-7/
Meningitis outbreak death toll rises to 7
October 6, 2012

ATLANTA Health officials say the death toll in a rare fungal meningitis outbreak across several states has risen to seven.

In updated figures posted to its website Saturday, the Centers for Disease Control and Prevention says the outbreak has spread to more than 60 people across nine states. The latest cases have been confirmed in Minnesota and Ohio.
 ::snipping2::

http://www.boston.com/metrodesk/2012/10/07/framingham-pharmacy-recalls-all-its-products-meningitis-cases-double/ZO4bSyK6pTsUwpBfxgbrRP/story.html
Framingham pharmacy recalls all its products as meningitis cases nearly double
October 7, 2012

The number of meningitis cases linked to a Framingham pharmacy has nearly doubled as of the latest count today, and the company has issued a voluntary nationwide recall of all of its products,

The Centers for Disease Control and Prevention reported on its websitetoday that the nationwide outbreak of a rare form of fungal meningitis linked to the steroid produced by the New England Compounding Center has grown to 91 cases, including seven deaths.

The pharmacy issued a statement about the recall yesterday, saying “this action is being taken out of an abundance of caution due to the potential risk of contamination, and in cooperation with an investigation,” by federal and state health agencies.

“While there is no indication at this time of any contamination in other NECC products, this recall is being taken as a precautionary measure.”

The company has posted a 71-page list of the products being recalled.

Products from can be identified by markings that indicate New England Compounding Center by name, its acronym NECC or the company’s logo.

The company’s statement said customers are being notified of the recall by fax.
 ::snipping2::

http://www.reuters.com/article/2012/10/08/us-usa-health-meningitis-idUSBRE8970TQ20121008
Meningitis-linked steroid may have affected 13,000 people in U.S.: CDC
October 8, 2012

(Reuters) - Some 13,000 people in 23 U.S. states may have received steroid injections linked to a rare fungal meningitis outbreak that has killed eight people, but far fewer are likely to contract the disease, the Centers for Disease Control said on Monday.

The CDC for the first time estimated the number of patients potentially affected, after previously saying only that it could be in the thousands.

So far, 105 cases of the rare form of meningitis have been confirmed in nine states. In hardest hit Tennessee another person has died, bringing the national death toll to eight, the CDC and Tennessee state authorities said on Monday.
 ::snipping2::
Fungal meningitis is not contagious, the CDC said. Symptoms include fever, headache, nausea and neurological problems that would be consistent with deep brain stroke.

The steroid was sent to California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia and West Virginia, the CDC said.

A list of facilities that received vials from the infected lots can be found via the website www.cdc.gov .

http://www.guardian.co.uk/world/2012/oct/09/meningitis-death-toll-reaches-11
Meningitis death toll reaches 11 as disease claims three more lives
New Jersey becomes 10th US state to report at least one case of meningitis, health officials say, with 119 people now infected
October 11, 2012

The death toll from a fatal outbreak of meningitis has reached 11, with 119 now sick with the illness, according to health officials.

An update from the Centers for Disease Control and Prevention, issued on Tuesday afternoon, has now included New Jersey to the list of states in which at least one person has contracted meningitis. Some of the patients have had strokes but health agencies have provided no details of the conditions of any patients.
More...

http://www.cnn.com/2012/10/09/health/meningitis-exposure/index.html
Deaths rise to 12, with nearly 120 sickened in rare meningitis outbreak
October 9, 2012

(CNN) -- Florida recorded its first death connected to the outbreak of a rare, noncontagious form of meningitis, raising the toll Tuesday to a total of 12 fatalities nationwide.

Earlier in the day, federal authorities reported 11 deaths and 119 persons becoming ill in the outbreak, the Centers for Disease Control and Prevention announced Tuesday. Those figures were an increase from Monday's count of eight deaths and 105 illnesses.
Florida health officials also reported a total of six cases connected to the outbreak -- all in Marion County.
That figure -- one more than federal officials have so far counted in Florida -- means that a total of 120 persons nationwide have become ill, according to state officials.
More...

http://vitals.nbcnews.com/_news/2012/10/10/14346842-12-deaths-now-linked-to-fungal-meningitis-137-cases?lite
12 deaths now linked to fungal meningitis; 137 cases
October 10, 2012


An outbreak of fungal meningitis linked to steroid shots for back pain has now killed 12 people, with 137 confirmed cases, according to the latest numbers from the Centers for Disease Control and Prevention.
Cases have been identified in 10 states: Florida, Indiana, Maryland, Michigan, Minnesota, New Jersey, North Carolina, Ohio, Tennessee and Virginia. Ten of the people infected have been infected with a black mold called Exserohilum rostratum, CDC officials told doctors in a conference call on Wednesday. While at first the outbreak was linked to another mold called Aspergillus, just one of 11 patients whose tests have come back so far has been infected with that particular fungus.

Exserophilum has never been known to cause meningitis before, Dr. Tom Chiller of the CDC's Division of Foodborne, Waterborne and Environmental Diseases said. This makes it tricky to treat. So the CDC is recommending a strong intravenous cocktail of two antifungal drugs called voriconazole and lipsomal amphotericin B for as long as patients can tolerate it. "We realize these are two antifungal medicines that are toxic," Chiller said. He said CDC is still trying to figure out the best dose and the best length of time to treat patients.
Because the drugs can damage the kidneys and have other toxic side-effects, the CDC doesn't recommend treating anyone who isn't showing symptoms. Most of the patients who have tested positive for signs of fungal meningitis have a headache, neck pain or nausea, Chiller said. A few patients also have reported dizziness or sensitivity to light. Most of the patients who have died had strokes, Chiller said.
More...

http://online.wsj.com/article/SB10000872396390444657804578048873547928866.html?mod=googlenews_wsj
Doctors Are Off Balance as Patients Show Atypical Meningitis Reactions
October 10, 2012

http://www.washingtonpost.com/national/health-science/cdc-cases-of-a-rare-fungal-meningitis-rise-to-170-2-more-death-makes-14/2012/10/11/14bed1a0-13cd-11e2-9a39-1f5a7f6fe945_story.html
CDC: Cases of a rare fungal meningitis rise to 170; 2 more death makes 14
October 11, 2012

An outbreak of fungal meningitis has been linked to steroid shots for back pain. The medication, made by a specialty pharmacy in Massachusetts, has been recalled.

Latest numbers from the Centers for Disease Control and Prevention:
Illnesses: 170

Deaths: 14
 ::snipping2::

http://www.medpagetoday.com/Neurology/GeneralNeurology/35293
Meningitis Cases Still Rising, First Patient Goes Home
October 12, 2012

The number of cases in the outbreak of fungal meningitis continues to rise -- reaching 185, up 15 from Thursday -- but there have been no new fatalities, the CDC said on Friday, and the first patients affected by the nationwide outbreak have begun to go home.

The first patient released – of 33 treated at Nashville's St. Thomas Hospital – is "on intravenous medication and doing very well" at home, according to Robert Latham, MD, the hospital's chief of medicine.

A second patient is ready to go home, he said, but her release has been delayed because of difficulties organizing home care for her IV medication, Latham told reporters in a conference call organized by the Tennessee department of health.

Both patients, he said, were treated early in the course of infection with intravenous antifungal agents "and they responded very quickly." He added the symptoms have almost completely resolved.

On the other hand, Latham said, the hospital has seen two of the six deaths reported in the state and has two patients that are still critically ill. The remaining 28, he added, are making progress in fighting off the infection at different rates.
More...

http://www.miamiherald.com/2012/10/12/3047255/coral-reef-senior-high-student.html

Posted on Friday, 10.12.12

Coral Reef Senior High student dies of meningitis

Health officials and school district administrators are urging Coral Reef parents and students to watch for symptoms. The student’s death is not related to the national outbreak of fungal meningitis.
By Laura Isensee
lisensee@MiamiHerald.com

A senior at Coral Reef Senior High School died Friday at a local hospital of bacterial meningitis.

The sudden death shocked the school community — a mega magnet program with 3,200 students from all over Miami-Dade - and put parents and students on alert for the symptoms of the disease.

The case is not related to the national fungal meningitis outbreak that has killed 14, including two in Florida, according to the Miami-Dade County Health Department.


 ::snipping2::

http://www.nytimes.com/2012/10/14/health/another-death-reported-in-meningitis-outbreak.html
Another Death Reported in Meningitis Outbreak
October 13, 2012

Another person has died from fungal meningitis linked to possibly tainted vials of a steroid medication, bringing the death toll in an outbreak to 15, the Centers for Disease Control and Prevention said Saturday.

The latest victim was in Indiana, which has now reported two deaths from the rare form of meningitis.

The number of people stricken in the outbreak reached 197 on Saturday, up 13 from Friday, the center reported. In addition, there is one case of an infection after an injection in an ankle that has not been confirmed as meningitis.
 ::snipping2::

http://www.boston.com/news/local/new-hampshire/2012/10/14/meningitis-outbreak-toll-cases-deaths/XvD1sPVMlSi1k0aaMBMT7H/story.html
Meningitis outbreak toll: 205 cases, 15 deaths
October 14, 2012

http://health.usnews.com/health-news/news/articles/2012/10/15/meningitis-infections-climb-to-212-cdc-says
Meningitis Infections Climb to 212, CDC Says
Number of deaths linked to tainted steroid injections unchanged at 15
October 15, 2012

MONDAY, Oct. 15 (HealthDay News) -- Seven more cases of fungal meningitis linked to contaminated steroid injections have been reported, bringing the total number to 212, U.S. health officials reported Monday.

The number of deaths held steady at 15, the U.S. Centers for Disease Control and Prevention said.

There also have been two cases of what the CDC calls "peripheral joint infection," meaning an infection in a knee, hip, shoulder or elbow. These peripheral joint infections -- caused by injections of pain-killing steroids -- aren't considered as dangerous as injections near the spine for back pain that have been tied to the potentially fatal meningitis infections.

All of the patients were thought to be injected with methylprednisolone acetate, a steroid drug often used for back and joint pain that investigators suspect was tainted with a common fungus, according to the CDC.
 ::snipping2:

The 14,000 figure includes not only people who got injections for back pain and are most at risk for meningitis, but also others who received injections for pain in their knees and shoulders. Meningitis is inflammation of the lining surrounding the brain and spinal cord.

All of the infected patients are thought to have received the medication from the Massachusetts pharmacy, according to the CDC.
 ::snipping2::

http://abcnews.go.com/Health/Wellness/meningitis-outbreak-drugs-probed/story?id=17484597
Meningitis Outbreak: 2 More Drugs Probed
October 15, 2012

Two other drugs made by the New England Compounding Center (NECC) appear to be involved in the fatal meningitis outbreak that has now claimed the lives of 15 people in as many states, the FDA announced Monday.

The FDA said today it is investigating one case of possible meningitis associated with an epidural injection of triamcinolone acetonide and two reports of fungal infection with Aspergillus fumigatus in two transplant patients who were given cardioplegic solution made by the company.

The solution is used to paralyze the cardiac muscle during open-heart surgery.

The new cases bring the total to 214, an increase of 9 since Sunday, the agency said. Most of the cases are fungal meningitis, but the agency is also reporting that two involve peripheral joint infections.

At this point, an FDA release said, "the sterility of any injectable drugs ... and cardioplegic solutions produced by NECC are of significant concern."

"Patients who received these products should be alerted to the potential risk of infection," the agency said.

So far, there have been no cases of infection linked to any ophthalmic drug made by the company that is either injectable or used in eye surgery, "but FDA believes this class of products could present potentially similar risks of infection," the agency said.
 ::snipping2::
In suspected cases, the CDC is recommending that clinicians collect cerebrospinal fluid for culture and initiate both antibiotic and anti-fungal therapy.

http://transcripts.cnn.com/TRANSCRIPTS/1210/13/hcsg.01.html
SANJAY GUPTA MD

Meningitis Outbreak: Pharmacy Failure; Get Tested, Know Your Status

Aired October 13, 2012 - 16:30   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.


DR. SANJAY GUPTA, HOST: Hey there, and thanks for joining us. I'm back home after spending most of this past week chasing down answers in that meningitis outbreak.

(BEGIN VIDEO CLIP)

GUPTA: Over there, that is the NECC, the compounding facility. Back here, it's a recycling facility, essentially looks like a dump.

(END VIDEO CLIP)

GUPTA: You'll see what else I uncovered in just a moment. It's pretty remarkable stuff.

 ::snipping2::But we begin with the meningitis outbreak, "Under the Microscope".

The plot thickens on the deadly and growing meningitis outbreak that's affecting now so much of the country. At the center of it all, contaminated steroid injections of 14,000 people in 23 states may have received. Now, they were made by NECC. That's a compounding pharmacy in Massachusetts that is licensed to distribute drugs in all 50 states.

Compound pharmacies were established so that the pharmacists could make custom specific doses for specific patients with individual needs. The FDA isn't in charged of regulating them for safety, because technically the pharmacies aren't making new drugs. They're just customizing drugs already on the market.

But I'll tell you what? In recent years, pharmacy compounding has grown into a much larger business. In fact, get this, it accounts for 37 million prescription drugs taken by patients in the United States every year. It's a big business, it has little oversight and it impacts all of us.

(BEGIN VIDEOTAPE) GUPTA: You work here?

UNIDENTIFIED MALE: I'm security for the facility.

GUPTA: OK.

(voice-over): All week, we have been trying to dig up anything to try to understand how a common steroid injection could have become so deadly.

UNIDENTIFIED MALE: Unfortunately, I have to ask you guys to leave the property.

GUPTA: No one here really wants to talk.

AUTOMATED VOICE: Your call has been forwarded to an automatic --

AUTOMATED VOICE: The number you dialed is not in service.

AUTOMATED VOICE: The call has been forwarded to an automatic voice message system.

GUPTA (on camera): All right.

UNIDENTIFIED MALE: Hello?

GUPTA: Hello, I'm trying to get ahold of Barry Cadden?

(voice-over): That one, wrong number.

(on camera): Is there somebody we can actually talk to? We've been living voice messages and --

(voice-over): I even went straight to the home of Barry Cadden. He's the owner of the facility. There was a car parked at the end of the driveway, no visitors allowed. I was told they would call me back, they didn't.

(on camera): We were trying to get information.

We were tipped off about a recycling facility that shares a space with the compounding facility. It's literally in the back yard. It amounted to a garbage dump.

We even saw this health vehicle bringing waste from a nursing home to be disposed of here.

And while there are no laws specifically prohibiting a compounding pharmacy being next to, well, this, the FDA tells us it's all part of the investigation.


But there was something else we noticed. Look closely at the name of this garbage facility connected to the NECC. Conigliaro, well, it turns out this is the maiden name of Barry Cadden's wife, Lisa. She's listed as a pharmacist at the NECC. (on camera): A little bit more digging and we found out that Barry Cadden, Gregory Conigliaro, who is Lisa's brother, are the owners of NECC, that recycling facility, and also this medical facility, called the Ameridose.

(voice-over): They wouldn't even let us on the parking lot here. Now if NECC is big, then Ameridose is the 800 pound guerilla. NECC has 21 employees and generated $8 million in revenue. Ameridose, 400 employees, generated $100 million in a year.

Ameridose does drug manufacturing, which is regulated by the FDA. But they also do add-mixing, that's a form of compounding. And that's regulated by the state pharmacy board.

(on camera): And here's something else, there's a woman named Sophia Pasedis. She's the vice president of compliance here at Ameridoes. But she was also appointed to the state pharmacy board back in 2008. We asked them about that, they say she has recused herself of all matters related to Ameridose and NECC.

(voice-over): Both companies have done business with the United States government. In fact, more than $800,000 worth of drug orders were placed with them by government agencies since 2007.

Together, both these companies produce hundreds of thousands of medication doses. And now, both have shut down their operations.

(END VIDEOTAPE)
GUPTA: And the Massachusetts Department of Health didn't say there was any direct evidence of contamination when it comes to products for Ameridose, but one thing this outbreak exposes is the incredible lack of oversight of compound pharmacies, which can put the public at incredible risk, as we've seen here. We're going to continue to try to push the state health department and the FDA to try to get you some answers.
 ::snipping2::

http://www.reuters.com/article/2012/10/16/us-usa-health-meningitis-idUSBRE8970TQ20121016
Meningitis outbreak "nowhere near the end": health expert
October 16, 2012

(Reuters) - The meningitis outbreak that has so far killed 15 people and sickened more than 200 others is "nowhere near the end," a top medical expert said Tuesday, a day after federal authorities warned more tainted drugs may be linked to the health crisis.

Dr. William Schaffner, an infectious diseases expert at the Vanderbilt University Medical Center in Nashville, said on "CBS This Morning" that he expects a "steady increase" in the number of fungal meningitis infections over the coming weeks.

The move on Monday by the Food and Drug Administration to widen its investigation into the cause of the fungal meningitis outbreak to other drugs made by a Massachusetts pharmacy, the New England Compounding Center (NECC), is "ominous," Schaffner said.
More...

New England Compounding Center Issues
Voluntary Nationwide Recall of All Products
Product List
 
http://www.fda.gov/Safety/Recalls/ucm322979.htm

http://www.reuters.com/article/2012/10/16/us-usa-health-meningitis-cases-idUSBRE89E19V20121016
CDC says another 19 people diagnosed with meningitis in U.S. outbreak
October 16, 2012

(Reuters) - Another 19 people have been diagnosed with fungal meningitis linked to possibly tainted vials of a steroid medication, the U.S. Centers for Disease Control and Prevention said on Tuesday, bringing the total number of cases to 231.
More...

http://www.cbsnews.com/8301-204_162-57533617/233-now-infected-in-growing-meningitis-outbreak/
233 now infected in growing meningitis outbreak
October 16, 2012

A fungal meningitis outbreak linked to contaminated steroid injections made by a Massachusetts company has infected 233 Americans as of Oct. 16, the Centers for Disease Control and Prevention announced Tuesday.

Two of the cases may be joint infections from steroid shots given in peripheral joints such as the knee, hip, shoulder and elbow.

The outbreak has been linked primarily to methylprednisolone acetate steroid shots used for back pain made by a specialty pharmacy in Framingham, Mass. called the New England Compounding Center. Up to 14,000 patients may have been exposed to those contaminated injections that were sent to 76 facilities in 23 states. The Department of Justice confirmed Tuesday that they are investigating the allegations.
 ::snipping2::

http://www.reuters.com/article/2012/10/17/us-usa-health-meningitis-idUSBRE8970TQ20121017
Feds raid Massachusetts lab tied to meningitis outbreak
October 16, 2012

(Reuters) - Federal agents on Tuesday raided the Massachusetts pharmacy linked to a widespread meningitis outbreak that has killed 16 people and sickened more than 200 others, federal prosecutors said.

Agents from the U.S. Food and Drug Administration searched the New England Compounding Center, or NECC, in the Boston suburb of Framingham, with officers from the local police department providing support, Framingham police said.

The raid took place as calls came for an even wider probe into whether the once obscure pharmacy may have broken federal laws dealing with controlled substances, and as additional meningitis cases were announced.

Carmen Ortiz, U.S. attorney for Massachusetts, said in a statement, "I can confirm that this office and our law enforcement partners are investigating allegations concerning the New England Compounding Center."

Ortiz said it was "entirely premature" to speculate about what might be uncovered.

A lawyer for NECC, said the raid was unnecessary and that "asking would have produced the same result."
 ::snipping2::
The FDA's criminal unit, the Office of Criminal Investigations, is a team of agents with specialized knowledge and training to investigate violations of food and drug laws. It pursues about 1,200 criminal cases each year.

The raid came as a leading U.S. lawmaker called for an investigation of whether the compounding pharmacy violated federal laws covering potentially addictive drugs.

The U.S. meningitis outbreak is widening. A 16th death was announced on Tuesday, a patient from southwest Virginia, that state's Department of Health said in a statement.
 ::snipping2::

Massachusetts Democratic Representative Edward Markey, a senior member of the committee that oversees business, called on the Justice Department to investigate whether NECC violated federal laws designed to stem illegal activity in controlled drugs.

The company already faces multiple investigations by the FDA and several states, but Markey's request could launch an even more serious probe involving the Drug Enforcement Administration, which oversees sales of potentially addictive, or "controlled" drugs.
 ::snipping2::
In compounding, pharmacies prepare specific doses of approved medications, based on guidance from a doctor, to meet an individual patient's need.

A Reuters investigation found that NECC solicited bulk orders from physicians and failed to require proof of individual patient prescriptions as required under state regulations, emails to a customer showed.

State pharmacy regulators have said that NECC violated its license in Massachusetts by not requiring patient prescriptions before shipping products.
More...

http://www.medpagetoday.com/Neurology/GeneralNeurology/35385
Meningitis Outbreak: 4 More Deaths
By David Pittman, Washington Correspondent, MedPage Today
Published: October 17, 2012


The fungal meningitis outbreak has claimed another four lives, and an additional 14 cases have been added to the tally of illnesses traced to a contaminated steroid from the New England Compounding Center (NECC), the CDC announced Wednesday.

The total number of cases nationwide is now 247 in 15 states with 19 deaths, according to the agency's latest update on the nearly 2-week-old outbreak.

Two of the new cases and two of the new deaths were in Tennessee, bringing that hardest-hit state's total to 61 cases and four deaths.

The other two new deaths occurred in Virginia and Florida. Additional cases were also reported in Indiana, Michigan, Minnesota, New Jersey, Ohio, and Virginia.

As reported by U.S. Attorney Carmen Ortiz late Tuesday, federal agents raided the NECC facility in Framingham, Mass., that made the contaminated steroid implicated in the nationwide outbreak.
 ::snipping2::

http://www.bostonherald.com/news/regional/view/20221018more_fungus_at_framingham_pharmacy_linked_to_outbreak/srvc=home&position=recent
More fungus at Framingham pharmacy linked to outbreak
October 18, 2012

Federal authorities say they’ve found meningitis-linked fungus in an unopened vial from the Framingham pharmacy at the center of the nationwide meningitis outbreak, a find that “further links” the now-shuttered facility to the multi-state crisis that has already killed at least 19 people.

The Center for Disease Control and the Food and Drug Administration said in a statement today the fungus, known as Exserohilum rostratum, was detected in one of the three implicated batches of steroid injections the New England Compounding Center shipped to 23 states. They said the new fungus find matches specimens taken from infected patients.
 ::snipping2::

http://www.latimes.com/health/boostershots/la-heb-meningitis-outbreak-20121018,0,4362343.story
Fungal meningitis outbreak claims 20 lives
October 18, 2012

The number of deaths linked to a rare fungal meningitis outbreak rose to 20 on Thursday as health officials announced new evidence tying the illnesses to tainted steroid medication.

According to the Centers for Disease Control and Prevention and the Food and Drug Administration, scientists have confirmed the presence of a fungus known as Exserohilum rostratum in unopened vials of preservative-free methylprednisolone acetate that were packaged by New England Compounding Center in Framingham, Mass.

The vials belonged to one of three lots of medicine that NECC had produced. The company has since been shut down.
 ::snipping2::

http://www.reuters.com/article/2012/10/19/us-usa-health-meningitis-idUSBRE89H1DM20121019
FDA finds fungus in steroid shots, meningitis toll rises
October 18, 2012

(Reuters) - U.S. health officials made their first confirmation of the presence of a deadly fungus in one of three lots of steroids tied to a national meningitis outbreak as the death toll rose to 20 on Thursday.

The U.S. Food and Drug Administration said it was still testing two additional lots of methylprednisolone acetate, the steroid used to treat back pain, for the presence of the rare Exserohilum fungus. It is also testing other injectable drugs that were supplied by the New England Compounding Center, or NECC, in Massachusetts.

"Now we can definitively say that the injections are linked to the infection," Dr. Tom Chiller, an epidemiologist with the U.S. Centers for Disease Control and Prevention, told Reuters in an interview. "To date, CDC has no firm evidence of infection in any patients beyond those exposed to the contaminated lots."

THE CDC said the death toll climbed by one to 20, while nine new cases brought the national total to 254, including the first in New York - the 16th state with confirmed infections.
 ::snipping2::

http://www.chron.com/news/us/article/APNewsBreak-Questions-for-Medicare-in-outbreak-3964532.php
APNewsBreak: Questions for Medicare in outbreak
October 19, 2012

WASHINGTON (AP) — Medicare is coming under scrutiny in the meningitis outbreak that has rekindled doubts about the safety of the nation's drug supply.

The giant health insurance program for seniors long ago flagged compounded drugs produced for the mass market without oversight from the Food and Drug Administration as safety risks. In 2007, Medicare revoked coverage of compounded inhaler drugs for lung disease.

But Medicare doesn't seem to have consistently used its own legal power to deny payment, and critics say that has enabled the compounding business to flourish.

Now program officials are scrambling to find out how many Medicare beneficiaries are among the more than 250 people sickened in 16 states in a still-growing outbreak that has claimed 20 lives.
More...

http://www.reuters.com/article/2012/10/19/us-usa-health-meningitis-idUSBRE89I0UB20121019
Meningitis suit seeks freeze of pharmacy owners' assets
October 19, 2012

 ::snipping2::
Peter McGrath, a former federal prosecutor, said he was spear heading a civil case that alleges Massachusetts-based NECC and company officers Barry and Lisa Cadden and Greg Conigliaro are responsible for the tainted drugs. The lawsuit was filed on behalf of an unnamed plaintiff in Middlesex County Superior Court in suburban Boston, court records show.

"We want to pierce the corporate veil and go after the individuals," McGrath said Friday in a telephone interview. "My clients are in a lot of pain."

His firm, based in Concord, New Hampshire, is representing several people injured in the meningitis outbreak.
 ::snipping2::

http://online.wsj.com/article/AP87a98d7b62944636b80d596cadf91708.html
Meningitis outbreak toll: 271 cases, 21 deaths
October 19, 2012

http://www.reuters.com/article/2012/10/20/us-usa-health-meningitis-idUSBRE89I0UB20121020
U.S. says death toll rises to 23 in meningitis outbreak
October 20, 2012

(Reuters) - The U.S. death toll from fungal meningitis linked to potentially contaminated steroid injections has risen to 23 with one new death each reported in Tennessee and North Carolina, the Centers for Disease Control and Prevention said on Saturday.

States reported 13 new cases of fungal meningitis, raising the total to 281, the CDC said. There are also three peripheral infections in the outbreak caused by injections into joints.
 ::snipping2::

http://vitals.nbcnews.com/_news/2012/10/20/14579269-fungal-meningitis-victims-face-long-uncertain-recovery?lite&google_editors_picks=true
Fungal meningitis victims face long, uncertain recovery
October 20, 2012

 ::snipping2::
Health officials have noticed that the sickest patients with meningitis are those who either did not catch the symptoms early or who didn't receive appropriate treatment early because doctors didn't know what they were dealing with. The fungi become harder to kill once they have established themselves in a person's body.
"If treatment is given early, it is very effective," said Dr. David Reagan, medical officer for Tennessee, where the outbreak was first detected. "If it is given late, it is not very effective."
Most of the positively identified cases are caused by Exserohilum rostratum (ex-sir-oh-HY-lum ross-TRAH-tum). The fungus is commonly found in the environment, but it has never before been observed as a cause of meningitis.
Because of that, Reagan said, officials have been unable to firmly establish the incubation period and give those who received the tainted injections a date for when they will no longer need to worry about developing meningitis.
"We're saying at least six weeks, or 42 days, but we probably will extend that," he said. "This is new territory. There's no literature to tell us how long."
 ::snipping2::

I hope the death toll from the cases will come to a full stop now,  as victims are identified and receive treatment earlier.  From what I've been reading, those who are in treatment still don't know the extent of the damage and how long they may need to continue treatment and what effect the illness has on their health and prospects for the rest of their lives.   ::MonkeyNoNo::

http://www.philly.com/philly/blogs/phillypharma/CDC-says-meningitis-outbreak-up-to-285-cases-and-23-deaths.html
CDC says meningitis outbreak up to 285 cases and 23 deaths
October 22, 2012

CDC Webiste:
http://www.cdc.gov/HAI/outbreaks/meningitis.html
Multistate Fungal Meningitis Outbreak Investigation

http://www.latimes.com/news/science/sciencenow/la-sci-sn-necc-sued-fungal-meningitis-outbreaks-patient-zero-20121019,0,6093382.story
As NECC is sued, meningitis outbreak's patient zero is autopsied
October 19, 2012

With the toll from the fungal meningitis outbreak up to 21 dead and 247 sickened, and as the compounding facility responsible for fungus-tainted drugs is hit with a lawsuit, researchers have looked back at the first case that alerted them to the disease. Their results were published online Friday in the New England Journal of Medicine.
 ::snipping2::


http://articles.latimes.com/2012/oct/12/science/la-sci-meningitis-q-and-a-20121012
Meningitis outbreak: Some questions and answers
October 12, 2012

http://www.boston.com/whitecoatnotes/2012/10/22/cdc-more-people-infected-with-fungal-meningitis-linked-framingham-pharmacy/1N9Gj73CdQdSyZAgvfZgYI/story.html
CDC: 12 more people infected with fungal meningitis linked to Framingham pharmacy
October 22, 2012

Twelve more people have been infected in an outbreak of fungal meningitis tied to a Framingham pharmacy, bringing the total number of cases to 294. The Centers for Disease Control and Prevention reported no new deaths when it updated its infection report Monday.

Twenty-three people have died after receiving steroid injections made at the New England Compounding Center. Three joint infections have also been tied to the steroids, which are used to treat back and joint pain.
 ::snipping2::

http://www.washingtonpost.com/national/health-science/fda-says-1279-facilities-received-other-necc-products/2012/10/22/687ef4f0-1c7e-11e2-ad90-ba5920e56eb3_story.html
FDA: 1,279 facilities received other products from pharmacy linked to meningitis
October 22, 2012

Federal regulators are asking more than 1,200 hospitals, clinics and doctors nationwide to follow up with patients who may be at risk of infection because they received injectable medications made by the New England Compounding Center, a specialty pharmacy whose tainted steroid shots are linked to the growing fungal-meningitis outbreak.

In the Washington area, about 40 facilities, including several major hospitals and physician groups, are listed as having bought these injectable medications. Some said they were able to warn all affected patients about possible infection.

These medications are separate from the contaminated vials of the steroid drug — methylprednisolone acetate — that have been linked to the outbreak. About 14,000 people received injections of that medication. As of Monday, 294 people have received diagnoses of fungal meningitis linked to that tainted steroid, three others have joint infections, and 23 have died, according to the Centers for Disease Control and Prevention.

Federal officials say they don’t know how many more people may be at risk.

In an update posted Monday on the Web site of the Food and Drug Administration, officials urged health-care providers to follow up with any patient who received an injectable medication from the NECC that was shipped on or after May 21. It gave a list of 1,279 health-care facilities that had purchased products from the NECC, and a 261-page list of those facilities and the products they ordered. The FDA said the lists were based on information provided by the Massachusetts company and may be incomplete or inaccurate.

An FDA spokeswoman said states received the lists last week. As of Monday, the agency had received no reports of cases associated with other NECC products.
More...

http://abcnews.go.com/Health/Wellness/meningitis-outbreak-pharmacy-inspection-reveals-drug-safety-lapses/story?id=17552122
Meningitis Outbreak: Pharmacy Inspection Reveals Drug-Safety Lapses
October 24, 2012

Video at Link

http://abcnews.go.com/Health/Wellness/meningitis-outbreak-308-cases-23-deaths/story?id=17546722
Meningitis Outbreak: 308 Cases, 23 Deaths
October 24, 2012

Ten more people have been diagnosed with fungal meningitis in an outbreak linked to tainted steroid injections, health officials reported today.

The U.S. Centers for Disease Control and Prevention has increased the tally of cases to 308: 304 cases of fungal meningitis and four cases of joint infections. One of the new cases is in Georgia, the 17th state affected by the outbreak that has killed 23 people.
More...

Video at Link

http://www.usatoday.com/story/news/nation/2012/10/25/mold-meningitis-challenge/1658259/
Unprecedented 'black mold' meningitis a challenge
October 25, 2012

Health officials aim to curb the spread of a rare and deadly form of meningitis linked to contaminated steroids.


This meningitis is hard to diagnose
328 cases, 24 deaths reported
Black mold is treatable with a drug


WASHINGTON (AP) — The black mold creeping into the spines of hundreds of people who got tainted shots for back pain marks uncharted medical territory.

Never before has this particular fungus been found to cause meningitis. It's incredibly hard to diagnose, and to kill — requiring at least three months of a treatment that can cause hallucinations. There's no good way to predict survival, or when it's safe to stop treating, or exactly how to monitor those who fear the fungus may be festering silently in their bodies.

"I don't think there is a precedent for this kind of thing," said Dr. Arjun Srinivasan of the Centers for Disease Control and Prevention. Health officials and doctors have tracked down most of the 14,000 people potentially at risk for fungal meningitis, blamed for the deaths of 24 people and sickening more than 300.

"This is definitely new territory for us," he said.
 ::snipping2::

1:00 AM

1,000-plus treated in Maine with products from tainted Mass. pharmacy


 By Leslie Bridgers lbridgers@pressherald.com
Staff Writer


More than 1,000 patients at Maine medical facilities have been treated with products that were recalled by a Massachusetts pharmacy after a steroid injection was linked to a meningitis outbreak that has killed 24 people and sickened hundreds more.
 


Officials from those facilities are stressing that the products they used have not been associated with the meningitis outbreak or any other illnesses, but a spokeswoman from U.S. Food and Drug Administration said Thursday that the agency is not certain the injectable steroid is the only contaminated product from New England Compounding Center.
 
State epidemiologist Dr. Stephen Sears said the tainted steroid injection was not shipped to any facilities in Maine, but 30 facilities in the state have received other products from New England Compounding Center, according to the U.S. Food and Drug Administration.
 
About of half of those facilities said Thursday that no patients have reported concerning symptoms. The other half either did not return phone calls or had no one available to comment.
 
The products from New England Compounding Center used by the Maine facilities include a vein treatment, an asthma test, numbing gels, eye drops and injections for pain, macular degeneration, lipodissolve and early-labor prevention.
 
The FDA has instructed facilities to notify patients who received an injectable product that came from the Framingham, Mass., pharmacy on or after May 21.
 
Seven facilities reported notifying more than 1,000 patients, from five at MaineGeneral Medical Center in Waterville who received injections for floppy iris procedures to about 600 patients at Central Maine Medical Center in Lewiston, who used a kit to test asthma or received an injection for pain or other conditions, according to officials at those hospitals.
 ::snipping2:: ::snipping2::

http://www.onlinesentinel.com/news/1000-treated-in-maine-with-products-from-tainted-pharmacy_2012-10-25.html

http://www.medpagetoday.com/Neurology/GeneralNeurology/35606
Meningitis: FDA Releases NECC Report, 25 Dead
By David Pittman, Washington Correspondent, MedPage Today
Published: October 26, 2012

The New England Compounding Center (NECC) at the center of the deadly fungal meningitis outbreak found numerous instances of bacteria and mold growing in rooms meant to produce sterile products months before the current outbreak, an inspection report released by the FDA on Friday showed.

Despite those findings by its own workers, the NECC documented no corrective action to prevent contamination of its sterile drug products, the FDA said following its most recent inspection this month.

Instead, the Massachusetts-based NECC continued to produce products in the "clean rooms" before the nationwide outbreak started earlier this month. Sterile products should be produced in sterile rooms to reduce the risk of contamination.

Also on Friday, the CDC reported eight new cases of the fungal meningitis with an additional death in Tennessee, bringing the total number of deaths to 25. There are now 331 fungal meningitis cases in 18 states with seven peripheral joint infections.
More...

http://www.boston.com/whitecoatnotes/2012/10/26/fda-mold-seen-vials-the-steroid-linked-fungal-meningitis-outbreak/TaUeg5iz5PWUaLEedmhdAI/story.html
FDA: Mold seen in 83 vials of the steroid linked to fungal meningitis outbreak
October 26, 2012

The US Food and Drug Administration found visible mold inside the Framingham pharmacy at the center of the national fungal meningitis outbreak, including 83 vials from one lot of the tainted steroid used to treat back pain that contained “greenish black foreign matter.’’

An additional 17 vials in that bin of 321 vials of methylprednisolone acetate had white fibers floating in them during the inspection. FDA investigators visited New England Compounding Center over seven days between Oct. 1 and Oct. 26, which was after the steroid was recalled by the company.

Other vials from this lot had already been sent out to clinics around the country, to be used for back and joint injections, between Aug. 17 and Sept. 25.

The agency Friday afternoon released a form called a 483, which is issued at the end of an inspection when investigators believe that they have observed conditions or practices that may violate the federal law.

New England Compounding did not do proper sterility testing on the steroid, the report said, sending out just one vial from the entire lot for testing -- a vial that passed the test. But when the FDA tested 50 vials, it found contamination in all of them. Experts say a minimum of 20 should be tested under national guidelines.

The FDA also found greenish yellow or other discoloration inside autoclaves, which are used to sterilize vials, stoppers, and compounded drugs.

The company’s own environmental testing showed bacteria and mold in numerous spots in two “clean rooms” -- where sterile drugs are prepared -- at the pharmacy between January and September of this year that were above New England Compounding’s own “action limits.” But there is no evidence that the company investigated further or took corrective measures, the report said.

And, the company did not assess whether products made in the rooms on the days samples were taken could have become contaminated.
More...

http://www.reuters.com/article/2012/10/30/us-usa-health-meningitis-deaths-idUSBRE89T1HX20121030
Three more deaths from meningitis outbreak linked to injections
October 30, 2012

(Reuters) - Three more patients have died after contracting fungal meningitis from potentially tainted steroid injections supplied by a Massachusetts company, the U.S. Centers for Disease Control and Prevention said on Tuesday, bringing the death toll from the outbreak to 28 nationwide.

Two of the new deaths were in Michigan, which now has reported seven fatalities, and one in Tennessee which has confirmed 11 deaths, the CDC said. The two states have been the hardest hit by the outbreak, first discovered in Tennessee late last month.

The number of cases of fungal meningitis reported across the United States rose to 356 on Tuesday, up nine from Monday, the CDC said. Nineteen of 23 states that received shipments of the steroid have reported cases.

There also are seven reported cases of infections after the steroid was injected into a joint such as a knee, hip, shoulder or elbow, bringing the total number of infections to 363.
More...

http://abcnews.go.com/Health/Wellness/meningitis-outbreak-368-cases-29-deaths/story?id=17609742
Meningitis Outbreak: 368 Cases, 29 Deaths
October 31, 2012

Another person has died from a fungal meningitis outbreak tied to tainted steroid injections, bringing the total death toll to 29, health officials reported today.

The U.S. Centers for Disease Control and Prevention has increased the tally of cases to 377. That's 368 cases of fungal meningitis and nine joint infections. Rhode Island became the 18th state affected by the outbreak on Monday.
More...

http://abcnews.go.com/Health/meningitis-outbreak-404-cases-29-deaths/story?id=17629376
Meningitis Outbreak: 404 Cases, 29 Deaths
November 2, 2012

Eighteen more people have been diagnosed with fungal meningitis in an outbreak linked to tainted steroid injections, health officials reported today.

The U.S. Centers for Disease Control and Prevention increased the tally of cases to 404 in 19 states: 395 cases of fungal meningitis and nine joint infections. At least 29 people have died.
More...

Video at Link

http://www.nytimes.com/2012/11/03/health/second-illness-infects-meningitis-sufferers.html
Second Illness Is Infecting Those Struck by Meningitis
November 2, 2012

Just when they might have thought they were in the clear, people recovering from meningitis in an outbreak caused by a contaminated steroid drug have been struck by a second illness.
The new problem, called an epidural abscess, is an infection near the spine at the site where the drug — contaminated by a fungus — was injected to treat back or neck pain. The abscesses are a localized infection, different from meningitis, which affects the membranes covering the brain and spinal cord. But in some cases, an untreated abscess can cause meningitis. The abscesses have formed even while patients were taking powerful antifungal medicines, putting them back in the hospital for more treatment, often with surgery.

The problem has just begun to emerge, so far mostly in Michigan, which has had more people sickened by the drug — 112 out of 404 nationwide — than any other state.
 ::snipping2::

http://abcnews.go.com/Health/meningitis-outbreak-419-cases-30-deaths/story?id=17645227
Meningitis Outbreak: 419 Cases, 30 Deaths
November 5, 2012

Fifteen more people have been diagnosed with fungal meningitis in an outbreak linked to tainted steroid injections, health officials reported today.

The U.S. Centers for Disease Control and Prevention said it now counted 419 cases in 19 states: 409 cases of fungal meningitis and 10 joint infections. At least 30 people have died.
 ::snipping2::

http://www.reuters.com/article/2012/11/05/us-usa-health-meningitis-congress-idUSBRE8A41HR20121105
Congressional panels to hold hearings on meningitis outbreak
November 5, 2012

(Reuters) - Two congressional oversight committees will hold hearings next week on the deadly U.S. meningitis outbreak linked to tainted steroid injections and one panel has invited an official from the compounding pharmacy involved, aides said on Monday.

The House of Representatives Energy and Commerce Committee expects to hear testimony from Food and Drug Administration commissioner Margaret Hamburg on November 14.
 ::snipping2::

http://www.webmd.com/pain-management/news/20121105/spine-infections-fungal-meningitis-survivors
Spine Infections Hit Fungal Meningitis Survivors
Dangerous 2nd Infection in Tainted-Shot Outbreak
November 5, 2012
Nov. 5, 2012 -- As many as a third of people suffering fungal meningitis linked to tainted steroids -- and others who did not get meningitis -- are coming down with dangerous infections in the spine.

Some of these dangerous infections are epidural abscesses: pockets of fungus growing inside the spine. Others are arachnoiditis, a deeper and more serious infection. Both kinds of infection can be crippling or fatal. A few of these infections were seen at the beginning of the outbreak. Now many more cases are popping up.

In some cases, these infections are the first signs of disease in people who received fungus-contaminated spinal steroid injections, says CDC fungal disease expert Tom M. Chiller, MD.

Many of the spine infections are in people who seemed to be recovering from life-threatening fungal meningitis.

"Some of these people were called in, diagnosed with meningitis, and treated. Their meningitis symptoms were improving," Chiller says. But then these patients reported pain in specific parts of the spine. Imaging studies showed they had these pockets of infection.

"We don't have a good handle on why that is," Chiller says. "This is an unprecedented event, injecting fungus into the [inside of the spine], and the disease is manifesting in many ways."
More...

http://online.wsj.com/article/SB10001424127887324073504578105412195419472.html
Head of Massachusetts Pharmacy Board Fired
November 7, 2012

 ::snipping2::
James Coffey, director of the Massachusetts Board of Pharmacy, failed to follow up on a complaint from the Colorado pharmacy board accusing New England Compounding Center of illegally selling medicines without a prescription, the Massachusetts health department said in a statement.

After investigating NECC's sales to hospitals in Colorado, that state's health department last year issued a "cease and desist" order to the pharmacy. In July, a Colorado inspector sent the order as well as other materials to Mr. Coffey, who pledged to follow up, according to his emailed reply.

Steroid injections made by NECC, based in Framingham, Mass., have been linked to an outbreak of an unusual fungal meningitis that has sickened 424 people in the U.S. and killed 31.

Lauren Smith, the Massachusetts health department's interim commissioner, said in a statement that it was "incomprehensible" that Mr. Coffey didn't follow up on Colorado's complaint given previous concerns raised about NECC's and the board's responsibility to investigate complaints.
 ::snipping2::
Susan Manning, a Massachusetts pharmacy board lawyer to whom Mr. Coffey forwarded the Colorado complaint but who also allegedly didn't take any action, was placed on administrative leave pending the conclusion of the state investigation, the state health department said.

I've been watching and changing the subject line on the header of this thread  to adjust the number of cases and the number of dead, and it's getting scary.  I wonder how many may be out there that aren't in the count, like the ones that authorities haven't been able to contact or those that may have died from another injury or illness and the meningitis contributed, but it wasn't known at the time etc.?  What does the future hold for those that have received the injections and even though they aren't showing signs of meningitis at this point?  Could it rear it's ugly head later in life?  And the patients that are being treated for meningitis and other complications from the injections, what of their lives?  Even with treatment, no one really knows.   ::MonkeyNoNo::

http://www.dailymail.co.uk/news/article-2229648/Meningitis-death-toll-rises-31-424-cases-reported-U-S-MORE-expected.html
Meningitis death toll rises to 31 with 424 cases reported in the U.S.
November 8, 2012
Yet another fatality in a fungal meningitis outbreak  linked to tainted steroid injections has been reported, bringing the confirmed death toll to 31 with 424 cases reported in the multistate scourge.

The U.S. Centers for Disease Control and Prevention released new tallies today without identifying the latest death.
 ::snipping2::
The CDC initially said the risk of meningitis was highest in the 42 days following the injection -- a six-week stretch that theoretically ended today, since the suspect steroids were recalled Sept. 26. But new cases will continue to trickle in, according to the agency.

'Forty-two days is not a magic number by any sense of the word,' Dr. Tom Chiller, a fungal disease expert at the CDC, told ABC. 'This is a moving target. The outbreak is evolving'

http://www.cbsnews.com/8301-18563_162-57549404/president-of-firm-linked-to-meningitis-outbreak-to-testify-before-congress/
President of firm linked to meningitis outbreak to testify before Congress
November 13, 2012

(CBS News) WASHINGTON, D.C. -- The president of the New England Compounding Center (NECC) will be called to testify on Capitol Hill Wednesday about the deadly meningitis outbreak linked to contaminated steroid shots distributed by the company.
"I have a right to say there's a debacle here. There's malfeasance. Somebody's culpable," says Rep. Cliff Stearns, R-Fla., who chairs the House Energy and Commerce subcommittee that is investigating the outbreak. "Come to me and explain why 32 Americans have died, 450 are in the hospital. Tell me what happened."

Stearns says he expects NECC president Barry Cadden to remain silent and take the Fifth Amendment.

More than 400 patients in 19 states have been diagnosed with meningitis. Meanwhile, federal investigators found insects, birds and leaky ceilings at a second drug manufacturer that is linked to the NECC.
"There was clear evidence that the quality control was terrible at the New England Compounding Center and he was doing nothing about it," Rep. Stearns says of NECC president Cadden. "So for some reason, he was camouflaging and trying to indicate to the FDA that there was no problem. ... I think obviously he was shading the truth."

Stearns plans to examine an incident in September 2004 when Cadden was asked by an FDA investigator if NECC had "Trypan Blue" -- a product that is not approved by the FDA -- in stock. Cadden said it did not, according to the investigator, who then reported finding 189 vials of it on site.

"So I think the FDA has a lot to explain here, because at this point all of us are just aghast at the number of people that have died, as well as a huge number of people who ended up in hospitals," Stearns says.

Strearns says he plans to question FDA Commissioner Dr. Margaret Hamburg about why the agency dropped investigations into the "Trypan Blue" incident and another incident two years before, when at least two people developed septic shock after being injected with a drug made by NECC.
 ::snipping2::

http://www.wbur.org/2012/12/01/meningitis-grand-jury
Report: Grand Jury Investigating Pharmacy In Meningitis Outbreak
December 1, 2012

Comments

http://www.boston.com/whitecoatnotes/2012/12/06/massachusetts-officials-find-problems-three-more-compounding-pharmacies/oMwdqoKzoFnpyGXl5ot0TK/story.html
Massachusetts officials find problems at three more compounding pharmacies
December 6, 2012

Three compounding pharmacies found to have problems in how they prepared or stored drugs have received cease and desist notices from the state Department of Public Health, as part of its ongoing surprise inspections of pharmacies that prepare sterile drugs used in injections. But none of their products has been recalled.

At the same time, the state announced Thursday the appointment of three new pharmacy board members from a variety of health care backgrounds, and said a commission that plans to make recommendations to Governor Deval Patrick by the end of the month is considering changes in the board’s structure that could ensure more members come from outside the pharmacy industry.

“The issues that were identified did not necessitate a recall; it was more around some of the production approaches,” said Dr. Lauren Smith, interim commissioner of the Department of Public Health. “At this point, the rationale for interrupting or requiring the pharmacies to cease their operations is so the investigation can continue”

The state began unannounced inspections after contaminated steroids produced by New England Compounding Center of Framingham were blamed for the national meningitis outbreak, which has resulted in at least 36 deaths. In October, regulators shut down Infusion Resource, a Waltham compounding pharmacy. That company is still closed and the investigation is ongoing, a spokesman for the state health agency said.

Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, said only a small number of his members do sterile compounding.
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http://www.bostonherald.com/news/regional/view.bg?articleid=1061180031&srvc=rss
Scandal leads to new members for embattled state Pharmacy Board
December 6, 2012

(2 pg. article)
The Bay State’s top public health official today announced the appointment of three new members to the scandal-plagued Massachusetts Board of Pharmacy which oversaw the state’s pharmacy industry during a time when so-called compounding pharmacies grew into industry giants and at least one of those companies, New England Compounding Center, has been blamed for a nationwide outbreak of deadly fungal meningitis.
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http://vitals.nbcnews.com/_news/2012/12/20/16050546-cdc-look-for-hidden-fungal-infections-in-patients-who-got-shots?lite
CDC: Look for hidden fungal infections in patients who got shots
December 20, 2012

Many of the 13,000 or so people who haven’t been sickened by contaminated pain injections from the pharmacy at the center of the fungal meningitis outbreak may have infections they don’t know about, federal health officials warned on Thursday.
Patients who got steroid injections from one of three contaminated batches should check back with their doctors if they have any symptoms at all, officials with the Centers for Disease Control and Prevention said -- and doctors should consider running magnetic resonance imaging (MRI) scans to check for infections.
Researchers in three of the 19 affected states ran an experiment in which they did MRIs on 128 patients who had not been diagnosed with infections before. They all had new or worsening symptoms such as pain at the injection site. More than half of them -- 52 percent -- had MRI evidence of some type of infection, including abscesses, a type of nerve inflammation called arachnoiditis or even infections of the bone in the spine.
“These findings demonstrate that among patients with no previous evidence of infection, and with new or worsening symptoms at or near the site of their injection, more than 50 percent had findings suggestive of a localized spinal or paraspinal infection,” CDC wrote in a health alert sent to doctors.
The outbreak of fungal meningitis has made at least 620 people sick and killed 39 of them, and CDC says to expect more infections. It’s been traced to a single pharmacy, the New England Compounding Center (NECC) in Framingham, Mass. The pharmacy has been closed and all of its products recalled, but the crisis has prompted a Congressional investigation of how regulators allowed NECC to continue operating.
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http://www.medpagetoday.com/Neurology/GeneralNeurology/36546
Meningitis: Outbreak Large, Attack Rate Low
By Michael Smith, North American Correspondent, MedPage Today
Published: December 20, 2012
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

The attack rate in the continuing meningitis outbreak is relatively low, with fewer than five exposed people in 20 having developed the disease, researchers reported.

Despite that and some variation in clinical presentation, it's "one of the largest outbreaks of healthcare–associated fungal meningitis reported to date" in the U.S., according to Rachel Smith, MD, of the CDC in Atlanta, and colleagues.

Smith and colleagues paint a picture of "substantial morbidity and mortality" mitigated by a rapid public health response that alerted physicians and patients to the evolving threat, in a preliminary report on the outbreak appearing online in the New England Journal of Medicine.

Indeed, the NEJM paper is "a snapshot of something that's still happening" and it's too early to make many definitive statements about the outbreak, Smith told MedPage Today.

Nonetheless, one key implication is that "it is imperative that steps are taken" to make sure that compounded medications labeled as sterile actually are sterile, she and colleagues concluded.

That's because the outbreak – with 620 cases and 39 deaths as of Dec. 17 -- has been linked to an injectable steroid, preservative-free methylprednisolone acetate, made by the New England Compounding Center in Framingham, Mass.
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http://abcnews.go.com/Health/year-review-meningitis-outbreak-challenge/story?id=18085624
Year in Review: Meningitis Outbreak Still a Challenge
December 30, 2012

As part of the Year in Review series, MedPage Today reporters are revisiting major news stories and following up with an analysis of the impact of the original report, as well as subsequent news on the topic. Here's what's happened with the fungal meningitis outbreak since we published our first report.

The fungal meningitis outbreak that made headlines in the fall was "unprecedented," in the words of the of the clinicians at the eye of the storm.

What's more, "we're not out of the woods yet," said Tom Chiller, MD, deputy director of the CDC's mycotic diseases branch.
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Video at Link

http://www.reuters.com/article/2012/12/30/us-usa-meningitis-michigan-idUSBRE8BT03X20121230
Michigan hospital blazes trail in fight against fungal meningitis
December 30, 2012

http://abcnews.go.com/blogs/health/2013/01/04/meningitis-outbreak-necc-blames-cleaners/
Meningitis Outbreak: NECC Blames Cleaners
January 4, 2013

The pharmacy at the heart of the fungal meningitis outbreak says a cleaning company it hired should share the blame for the tainted steroid injections that caused more than 600 illnesses in 19 states, killing 39 people.

The New England Compounding Pharmacy, which made the fungus-tainted drugs, sent a letter to UniFirst Corp., which provided once-a month cleaning services to the Framingham, Mass., lab, “demanding” it indemnify NECC for the meningitis outbreak, according to a UniFirst filing with the Securities and Exchange Commission.
“Based on its preliminary review of this matter, the company believes that NECC’s claims are without merit,” UniFirst wrote in its quarterly filing.
The New England Compounding Center recalled 17,000 vials of tainted steroid injections on Sept. 26 before recalling all drugs and shutting down on Oct. 6.
The Food and Drug Administration investigated NECC’s lab and found that a quarter of the steroid injections in one bin contained “greenish black foreign matter,” according to the report.  The FDA also identified several cleanrooms that had bacterial or mold overgrowths.
UniFirst’s UniClean business cleaned portions of the NECC cleanrooms to NECC’s specifications and using NECC’s cleansing solutions, UniFirst spokesman Adam Soreoff said in a statement. It provided two technicians once a month for about an hour and a half.
“UniClean was not in any way responsible for NECC’s day-to-day operations, its overall facility cleanliness, or the integrity of the products they produced,” Soreoff said. “Therefore, based on what we know, we believe any NECC claims against UniFirst or UniClean are unfounded and without merit. ”
NECC was not immediately available for comment.
The House of Representatives subpoenaed Barry Cadden, who owns NECC,  to a hearing in Washington, D.C. on Nov. 14. He declined to testify when members of Congress pressed him on his role in ensuring that the drugs his company produced were safe and sterile.
“On advice of counsel, I respectfully decline to answer on the basis of my constitutional rights and privileges including the Fifth Amendment of the Constitution of the United States,” he said at the hearing.
Members of Congress also questioned whether the FDA could have prevented the outbreak.
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http://www.newschannel9.com/template/inews_wire/wires.national/38e81dc5-www.newschannel9.com.shtml
DOJ official wants trustee in Mass. pharmacy case
January 8, 2013

BOSTON (AP) -- A Justice Department official is arguing that an independent trustee must be chosen to oversee the bankruptcy case of a Massachusetts pharmacy linked to a deadly meningitis outbreak.
U.S. Trustee William Harrington says in a filing Tuesday that an accountant chosen by the New England Compounding Center to lead it through Chapter 11 proceedings is "hopelessly conflicted."
He says that's because Keith Lowey was appointed by NECC's board and the board has the power to fire him at any time.
Harrington also argued the company's "gross mismanagement" meant an independent trustee was needed to protect the interests of the NECC's creditors.
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http://www.washingtonpost.com/national/health-science/the-drug-in-fungal-meningitis-cases-is-hard-to-make-and-unusually-dangerous-when-contaminated/2013/02/08/1fb0176e-5a9e-11e2-88d0-c4cf65c3ad15_story.html
The drug in fungal meningitis cases is hard to make and unusually dangerous when contaminated
February 8, 2013

The drug that has caused 696 fungal infections and 45 deaths over the last six months isn’t one you want sloppy amateurs making.

A long-lasting anti-inflammatory, it is difficult to manufacture in sterile form. Injected into joints or around the spine to relieve pain, it stays in the body for months. It has a bad side effect of suppressing defenses — a real problem if it’s contaminated. If the contaminant is a microscopic fungus, the drug feeds it like fertilizer.

n short, methylprednisolone acetate — an “injectable steroid,” in pharmaceutical parlance — is a prescription for disaster if not made right. A few drug companies make it. So do an unknown number of “compounding pharmacies,” a little-known, lightly regulated shadow world of the American pharmaceutical industry.

And that, recent history suggests, is a problem.
One company, New England Compounding Center (NECC) of Framingham, Mass., made tens of thousands of doses of methylprednisolone acetate and two other steroids (betamethasone and triamcinolone) used for similar purposes. It sold them to pain clinics in 23 states, satisfying a demand for preservative-free medicines not available from mainstream drug companies. Last year, samples of all three products — including the deadly lots of methylprednisolone — were found to be contaminated with fungus or bacteria.

The dangers of injectable steroids made by compounding pharmacies have been clear for a while.
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http://www.boston.com/news/local/massachusetts/2013/03/26/mich-seeks-criminal-probe-meningitis-deaths/P7hvoWISE5LAT8ADthToMM/story.html
Mich. AG seeks criminal probe of meningitis deaths
March 26, 2013

LANSING, Mich. (AP) — The state attorney general on Tuesday sought permission to launch a criminal investigation into a Massachusetts pharmaceutical company linked to a deadly outbreak of meningitis, saying Michigan was at the ‘‘epicenter’’ of pain and death in the case.

Bill Schuette filed a request with the Michigan Court of Appeals for a rare, four-county grand jury to conduct a confidential probe into the New England Compounding Center, the company already accused in dozens of civil lawsuits of producing contaminated steroids that killed 51 people nationwide and sickened more than 700.

If the court agrees to an investigation, a jury of citizens in one of the counties would decide if criminal charges should be brought.
More...

http://www.cbsnews.com/news/meningitis-victims-nearing-settlement-with-new-england-compounding-center-for-100m/
Meningitis victims nearing settlement with New England Compounding Center for $100M
December 24, 2013


BOSTON -- Attorneys for creditors of a pharmacy linked to a nationwide meningitis outbreak said Monday they have reached a preliminary settlement that would set up a victim compensation fund worth more than $100 million.

Attorney William Baldiga said the agreement was reached among creditors, bankruptcy trustee Paul D. Moore and the owners and insurers of the New England Compounding Center. The deal needs approval from a bankruptcy judge and likely will be filed in the next few weeks.

The company, based in Framingham, just west of Boston, gave up its license and filed for bankruptcy protection after it was flooded with hundreds of lawsuits from people who received tainted steroid injections.
 ::snipping3::
About 750 people in 20 states have developed fungal meningitis, an inflammation of the lining of the brain and spinal cord, or other infections; 64 have died.

The infections were linked to more than 17,600 doses of methylprednisolone acetate steroid injections used to treat back and joint pain that were shipped by NECC to 23 states. FDA investigators last Oct. found mold and fungal contamination in vials of the drugs, and areas used to prepare sterile drugs at the facility.

Michigan, Tennessee and Indiana were hit the hardest by the infections.

A federal investigation of the company started more than a year ago but hasn't resulted in any criminal charges. The company's owners said in a press release announcing the settlement that they deny any liability or wrongdoing but want to play a major role in establishing a fund for people who died or suffered.
Victims have until Jan. 15 to file claims.

Baldiga said he expects the fund to grow significantly with contributions from others who may have been sued. He said the settlement was reached over the weekend and those involved wanted to announce it as soon as possible so victims who are considering claims know that there is substantial money available.

The initial $100 million will come from cash contributions by the owners of NECC and proceeds from insurance, tax refunds and the sale of a related business.

Baldiga called it "an important step, but a first step only."
 ::snipping3::
Last month, President Barack Obama signed legislation that grants the Food and Drug Administration more regulatory powers over drug compounding pharmacies.

http://www.jrn.com/newschannel5/news/Pharmacy-Owners-Arrested-In-2012-Meningitis-Outbreak-286069131.html?lc=Smart
Pharmacy Owners, Ex-Workers Arrested In 2012 Meningitis Outbreak
December 17, 2014

BOSTON (AP) - Two co-founders and 12 other former employees of a Massachusetts compounding pharmacy blamed for a fungal meningitis outbreak that killed 64 people were arrested early Wednesday, a spokeswoman for the U.S. attorney's office in Boston said.

 Gregory Conigliaro and Barry Cadden, co-founders of the New England Compounding Center in Framingham, were among 14 people arrested at their homes around the state, attorney's office spokeswoman Christina DiIorio-Sterling said.

One of those arrested was Glenn Adam Chin, a former supervisory pharmacist, who had been charged with mail fraud in September.

Tainted steroids manufactured by the pharmacy were blamed for a 2012 outbreak. About 750 people in 20 states developed meningitis or other infections after receiving the contaminated steroids. Michigan, Tennessee and Indiana were the hardest-hit states.
 ::snipping3::
The exact charges are expected to be disclosed at a news conference later Wednesday, and all expected to make an initial court appearance later in the day.

The pharmacy gave up its license and filed for bankruptcy protection after it was flooded with hundreds of lawsuits filed by victims and their families.
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