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Entries in Meningitis (19)

Tuesday
Feb192013

Toddler Injured in Superstorm Sandy Now Battles Deadly Infection

Courtesy of the Halstead family(ATLANTA) -- A Georgia 2-year-old struck by a tree branch during Superstorm Sandy is now battling a potentially life-threatening illness he contracted while in the hospital receiving treatment for his injuries, his family said on Facebook.

Tripp Halstead was playing outside his daycare center in Winder, Ga., on Oct. 29 when Sandy’s winds brought a tree limb down on his head.  He suffered brain damage, underwent emergency surgery and has been in Children’s Health Care of Atlanta ever since.  Last week -- more than three months after the historic storm -- Tripp contracted bacterial meningitis, his mother said on Facebook.

“I have just been staring at that sweet little face.  To think we had come so far, then to get the scare on Thursday that he might have a life- threatening infection and we might lose him,” Stacy Halstead posted on Facebook Saturday.  “Worst day to boot so far.”

The boy’s Facebook page has generated at least 231,831 “likes” since it was set up soon after his injury.  His parents have been asking readers to pray for their son and contribute money for expenses related to his care.

Bacterial meningitis usually affects brain trauma patients in medium- or long-term intensive care, Dr. Bill Schaffner, an infectious disease specialist at the Vanderbilt University Medical Center, told ABC News.  It usually occurs when bacteria gets into the cerebrospinal fluid that bathes the brain, he said.

Even with the cleanest instruments, there’s always a risk bacteria will be introduced into a person’s body when hospital workers use a needle, catheter or other medical tool, he said.

“Every time you breach the body’s protective surface you run the risk of an infection getting from the outside in,” Schaffner said.  “The longer you’re in an intensive care unit, the higher the risk is.”

There are two types of meningitis -- viral and bacterial -- and bacterial meningitis is the more dangerous, Schaffner said.  A vaccine for the viral form, called meningococcal meningitis, is routinely administered to kids starting at age 11, he said.

Tripp got the infection after an emergency surgery was performed Thursday to remove a pump that had been inserted into the fluid surrounding Tripp’s brain to administer medication, his family said.

It appears that doctors noticed the infection early.  Normal treatment would include giving Tripp antibiotics, said Schaffner, who is not involved in Tripp’s treatment.

Tripp’s mother said doctors were able to remove the boy’s breathing tube on Saturday.

“They still think he is doing better.  Still has an infection in his blood so not sure how much longer we will be in ICU,” she said.  “They are doing all that they can to fight it.  He is such a little trooper and hanging in there.”

Copyright 2013 ABC News Radio

Wednesday
Dec122012

New Fungal Meningitis Cases, Spinal Infections Continue to Baffle Doctors

Hemera/Thinkstock(NEW YORK) -- It's been more than a month since the 42-day risk period for contracting fungal meningitis from tainted steroid injections ended on Nov. 7, but new meningitis cases, spinal infections and other complications continue to arise, even for patients who have already been treated and sent home.

"Here's the perplexing issue," said Dr. Tom Chiller, the deputy chief of the Centers for Disease Control and Prevention's mycotic diseases branch.  "Why are we getting people that early on who are presenting with rip-roaring meningitis, but now, they're presenting 100 days later with focal infections only?  Why the difference?  We don't know."

The CDC reported five new meningitis cases, 39 new spinal infections without meningitis, and three new joint infections within the past week.  One more person has died over the same time period, bringing the death toll to 37.

Up to 14,000 people received the tainted injections produced at New England Compounding Center in Framingham, Mass, which recalled all products and shut down on Oct. 6.  It is now being investigated by the Food and Drug Administration, even though its oversight usually falls under its state's pharmacy board's jurisdiction.  

NECC's owner Bill Cadden invoked the Fifth Amendment and declined to answer questions before Congress on Nov. 14.

It's not clear how the fungus got in the steroid vials, but an FDA investigation revealed that a quarter of the steroid vials in an NECC bin contained "greenish black foreign matter," according to an FDA form released on Oct. 26.  The form went on to identify several clean rooms -- where sterile products are produced -- that had either mold or bacterial overgrowths.

The longest fungal infection incubation period the CDC recorded to date was 120 days, Chiller said.  However, the longest incubation period from a previous fungal meningitis outbreak was 152 days.

"We hope that's the exception, not the rule," Chiller said.  "We hope we're nearing the end of this."

In all, 590 people in 19 states have become ill with meningitis or another infection as a result of the tainted steroid injections manufactured by the New England Compounding Company.  Of those, 368 were fungal meningitis and 192 were spinal infections without meningitis.  Other ailment categories included strokes and joint infections.

Perplexingly, the fungal meningitis case tally reached 475 cases on Nov. 19, but some cases have been reclassified as spinal infections, Chiller said.  The CDC started dividing meningitis cases into meningitis cases and spinal infections only on Nov. 26, causing the meningitis count to drop to 360 (including secondary spinal infections) and the spinal infection count to begin at 128 that day.

Copyright 2012 ABC News Radio

Wednesday
Nov142012

Pharmacy Owner Takes Fifth in Meningitis Hearing

Chris Maddaloni/CQ Roll Call(WASHINGTON) -- The owner and co-founder of the New England Compounding Center, the pharmacy at the center of a deadly fungal meningitis outbreak, declined to testify before a congressional hearing Wednesday.

When pressed by members of Congress on his role in ensuring safe and sterile products, Barry Cadden invoked his Fifth Amendment right.

“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 in Washington, D.C.

The House of Representatives had subpoenaed Cadden to the hearing to address the outbreak that has sickened 461 people in 19 states and killed 32. The outbreak has been traced to contaminated vials of methylprednisolone acetate, an injectable steroid used to treat back and joint pain made by Cadden’s pharmacy.

But the Subcommittee on Oversight and Investigations panel became clearly frustrated with the testimony of U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg.

Republican lawmakers noted inspections of NECC going back to 2002 that found sterility issues at the facility, and asked why the FDA had not taken action against the pharmacy.

“You are in charge of the FDA. You are the chief honcho. You’re the great Pooh-Bah of the FDA and I’m asking you, basically, could you have prevented this tragedy? And you are saying you can’t because you didn’t have jurisdiction?” said Rep. Cliff Stearns, R-Fla.

“I think it is very hard to know if any one action that we might have taken could have stopped this terrible tragedy,” Hamburg replied, adding that in her opinion, the FDA did nothing wrong.

The commissioner told the panel that her agency needed stronger authority over “compounding” pharmacies.

“The challenge we have today is that there is a patchwork of legal authorities that oversee the action we can take,” said Hamburg. She said there were “gaps” and “ambiguity” in the FDA’s authority, and described a “crazy quilt” of laws.

Compounding pharmacies traditionally fill special orders placed by doctors for individual patients, turning out a small number of customized formulas each week. NECC, however, acted more like a manufacturer by filling thousands of prescriptions and shipping across state lines causing confusion in the FDA’s jurisdiction.

Republicans were visibly irritated at Hamburg’s lengthy responses to their yes or no questions, at certain points even chastising the FDA commissioner for her responses.

“Can you ever give straight answer to a question?” Rep. Joe Barton, R-Texas, asked, while Stearns reminded Hamburg  that she was under oath.

Joyce Lovelace spoke about her husband Eddie, who died from fungal meningitis in September after receiving a tainted steroid injection, saying she wanted “people to know what kind of person has perished because of their lack of concern.”

“My family is bitter. We are angry. We are heartbroken. We’re devastated and I just come here begging you to do something about the matter,” Lovelace said. “It was a nightmare to see this man who was perfectly healthy one moment and then just so quickly going downhill and everything the doctors were doing for him was to no avail. The medicine, whatever they did, it was not helping him in the least.”

Lovelace begged the committee to “legislate this.”

“Whoever is responsible, I want them to know their lack of attention to their duties cost my husband his life, cost my family…It may not appear to be anything to you, but you are affecting valuable human lives,” she said. “I cannot beg you enough. Bi-partisan. I don’t care what party, work together and please legislate this so no family has to go through what we have.”

Copyright 2012 ABC News Radio

Wednesday
Nov142012

Meningitis Outbreak: How Two Docs Helped Unravel a Medical Mystery

Jared Wickerham/Getty Images(NEW YORK) -- As she desperately worked to follow the trail of what would turn into a nationwide fungal meningitis outbreak, Dr. Marion Kainer, an epidemiologist at the Tennessee Department of Health, found there was simply no time to sleep. So she camped out at her Nashville office, grabbing a few hours' rest whenever she could.

"I brought in an exercise mat, with a pillow and a blanket and a change of clothes," Kainer told ABC News.

Her efforts and those of Dr. April Pettit at Vanderbilt University were central to uncovering the cause behind the meningitis outbreak, which has been linked to tainted steroids from a compounding pharmacy in Framingham, Mass. The outbreak has killed 32 people and sickened 438 others in 19 states, according to the Centers for Disease Control and Prevention.

The first hint that something was wrong came in mid-September. Pettit, an infectious disease specialist, was puzzled when a patient she had treated for what doctors believed was bacterial meningitis was readmitted to Vanderbilt University Hospital. The patient was agitated, could barely speak, and complained of a headache and low back pain.

As the patient's condition worsened, Pettit went "the extra mile," according to Dr. William Schaffner, head of preventive medicine at Vanderbilt, and ordered another test of the patient's spinal fluid. But this time "she says to the lab, don't just do your routine, also culture for tuberculosis and fungi," Schaffner said.

Those instructions proved critical. The next day, the lab reported an astonishing result: It had found aspergillus, a type of fungus, in the man's spinal fluid.

Aspergillus meningitis is extremely rare, so Pettit sat down with the patient's family to try to figure out how he might have contracted it. She learned that four weeks before he first became sick, he had received an epidural steroid injection to relieve back pain. Worried about a possible connection, Pettit alerted the state health department. It was Tuesday, Sept. 18.

The email from Pettit ultimately ended up in Kainer's inbox. Kainer, who is in charge of health-care related infections for the state of Tennessee, said she became "quite concerned."

Kainer had two years as a CDC epidemic intelligence officer, a so-called disease detective, under her belt before she joined the Tennessee Department of Health. So she wasted no time in launching an investigation.

By Thursday morning, Sept. 20, Kainer confirmed that Pettit's patient had received a steroid epidural at the Saint Thomas Outpatient Clinic in Nashville. She contacted the CDC to see if it knew of other cases. It did not. But they began to turn up. That afternoon, Kainer learned of two more Nashville patients with suspected meningitis who had also had epidural injections.

"So now my interest really peaked up," Krainer told ABC News.

Still, the cause of the meningitis was not known. Was there mold at the clinic where the injections had been given? Were the drugs or the anesthetic tainted? What about the needles? Kainer was like a detective with a host of suspects but no clear guilty party.

 That same afternoon, Kainer received a tantalizing clue. She found out that one of the epidural steroids had come from a compounding pharmacy in Massachusetts.

"We have concerns about compounding pharmacies," said Kainer. "There have been several outbreaks involving [products] from compounding pharmacies."

It was just two days since the first email alert. The New England Compounding Center, which made the steroid, assured the Saint Thomas clinic it knew of no safety problems with the drug. With the cause of the meningitis still a mystery, the clinic voluntarily shut its doors as a precaution. It has still not reopened.

By Friday, Sept. 21, Kainer had heard of two additional possible cases of meningitis. She and the Tennessee Department of Health sent out an urgent alert asking public health officials and hospitals in the state to report any similar cases of possible meningitis that might be associated with an epidural injection. She suspected the steroid was at the root of the outbreak, but had no proof. Still, she told her boss, "I have a really uneasy feeling about this."

By Monday, there was another suspect case, and Tennessee health officials held a conference call with the CDC to brainstorm. They then called heath officials in Massachusetts to find out more about the New England Compounding Center.

The next day, Tuesday Sept. 25, marked one week since Pettit's email, and that's when the FDA got involved. In the meantime, Tennessee health officials were still trying to narrow down the suspects, working until midnight to create a data base of more than 150 patients who had been treated at the Saint Thomas clinic, looking for any threads of proof. For Kainer and her team, "this is still a diagnostic mystery."

 It was still just a hunch that the steroid was at the center of this growing meningitis outbreak, but on Wednesday, Sept. 26, the New England Compounding Center recalled three lots of the drug, some 17,000 vials. The steroid had already been injected into some 1,400 patients.

The CDC put out an emergency health alert to public health departments nationwide, looking for any cases outside Tennessee. The next evening, Sept. 27, a breakthrough came: North Carolina reported a probable case, a patient who had also received a steroid injection from one of the recalled lots.

At the same time, Tennessee's data crunching revealed that patients who'd received more of the steroid were more likely to have gotten sick. For Kainer, it was the first solid evidence that a tainted drug was likely the cause of the meningitis outbreak.

Tennessee's health commissioner wanted every single patient in the state who may have been exposed to the contaminated steroid tracked down, all 1,009 of them. Kainer called the outreach "unprecedented."

Public health nurses knocked on doors around the country, contacted neighbors, tracked down patients in Yellowstone National Park and used Facebook as well as law enforcement to find people. They knew it was critical to locate anyone who may have symptoms and immediately begin anti-fungal medication.

On Oct. 4, the FDA reported it had found what appeared to be fungus in an unopened vial of the steroid. Two weeks later, the agency matched the fungus to the one believed to have triggered the outbreak. Kainer's hunch had been right.

It turned out there had been other cases and at least one death in another state before Dr. April Pettit's patient had became sick. But Vanderbilt's Schaffner said "public health was not notified. It was April who put that all together."And then, said Schaffner, Dr. Marion Kainer jumped in.

"In a shift car with four gears, Marion is always in fifth," he said.

Kainer said it took a herculean effort not only by her but by nearly 200 staff members at the Tennessee Department of Health. They're not done yet, and are still tracking and monitoring those who received the steroid injections.

As for the floor mat, "it is still in my office," Kainer said. But, she added, with hope, "I have not slept on it for a few days now."

Copyright 2012 ABC News Radio

Friday
Nov022012

Meningitis Outbreak: 404 Cases, 29 Deaths

Jared Wickerham/Getty Images(ATLANTA) -- Eighteen more people have been diagnosed with fungal meningitis in an outbreak linked to tainted steroid injections, health officials reported Friday.

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.

For a map of cases by state, click here.


The outbreak has been linked to contaminated vials of methylprednisolone acetate, an injectable steroid used to treat back and joint pain. Sealed vials of the steroid, made by the New England Compounding Center in Framingham, Mass., contained exserohilum rostratum, a fungus found in soil and plants.

For a full list of clinics receiving the recalled lots of spinal steroid injections, click here.


It's not clear how the fungus landed in the pharmacy's ostensibly sterile vials, some of which were shipped to clinics without sterility testing, according to an inspection by the Massachusetts Department of Public Health. Floor mats near sterile drug-mixing areas were "visibly soiled with assorted debris," and a leak from a nearby boiler created an "environment susceptible to contaminant growth," according to the report.

Sealed vials of two other drugs made by the pharmacy contained bacteria, according to the U.S. Food and Drug Administration. The drugs were the steroid betamethasone and a cardioplegic solution that paralyzes the heart during open heart surgery.

The pharmacy has recalled all of its products and shut down operations.

Ameridose, a sister company of the New England Compounding Center, has also recalled all of its drugs citing sterility concerns, according to the FDA. Neither Ameridose nor the FDA have received any complaints or identified any impurities in those drugs.

Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis -- including headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, and redness or swelling at the injection site -- can take more than a month to appear.

The longest duration from the time of injection to the onset of symptoms in the current outbreak is 42 days, according to the CDC. The tainted steroids were recalled 37 days ago.

Fungal meningitis is diagnosed through a spinal tap, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications.

Unlike bacterial meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are thought to be at risk.

Copyright 2012 ABC News Radio

Thursday
Nov012012

Meningitis Outbreak Still Grows: 386 Cases, 28 Deaths

Hemera/Thinkstock(ATLANTA) -- Nine more people have been diagnosed with fungal meningitis in an outbreak linked to tainted steroid injections, health officials reported Thursday.

The U.S. Centers for Disease Control and Prevention has increased the tally of cases to 386 in 19 states: 377 cases of fungal meningitis and nine joint infections. The agency also dropped the death toll for the outbreak from 29 to 28, noting that Virginia is now reporting two deaths instead of three.

For a map of cases by state, click here.

The outbreak has been linked to contaminated vials of methylprednisolone acetate, an injectable steroid used to treat back and joint pain. Sealed vials of the steroid, made by the New England Compounding Center in Framingham, Mass., contained exserohilum rostratum, a fungus found in soil and plants.

For a full list of clinics receiving the recalled lots of spinal steroid injections, click here.

It's not clear how the fungus landed in the pharmacy's ostensibly sterile vials, some of which were shipped to clinics without sterility testing, according to an inspection by the Massachusetts Department of Public Health. Floor mats near sterile drug-mixing areas were "visibly soiled with assorted debris," and a leak from a nearby boiler created an "environment susceptible to contaminant growth," according to the report.

Sealed vials of two other drugs made by the pharmacy contained bacteria, the U.S. Food and Drug Administration reported today. The drugs were the steroid betamethasone and a cardioplegic solution that paralyzes the heart during open heart surgery.

The pharmacy has recalled all of its products and shut down operations.

Ameridose, a sister company of the New England Compounding Center, also recalled all drugs Wednesday, citing sterility concerns, according to the FDA. Neither Ameridose nor the FDA have received any complaints or identified any impurities in those drugs.

Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis -- including headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, and redness or swelling at the injection site -- can take more than a month to appear.

The longest duration from the time of injection to the onset of symptoms in the current outbreak is six weeks, according to the CDC. The tainted steroids were recalled five weeks ago.

Fungal meningitis is diagnosed through a spinal tap, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications.

Unlike bacterial meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are thought to be at risk.

Copyright 2012 ABC News Radio

Friday
Oct262012

Meningitis Outbreak: 331 Cases, 25 Deaths, 7 Joint Infections

Hemera/Thinkstock(ATLANTA) -- Another person has died from fungal meningitis in an outbreak linked to tainted steroid injections, bringing the total to 25 deaths, health officials reported Friday.

The U.S. Centers for Disease Control and Prevention has increased the tally of cases to 338: 331 cases of fungal meningitis and seven cases of joint infections. South Carolina became the 18th state affected by the outbreak on Sunday.

For a map of cases by state, click here.

The outbreak has been linked to contaminated vials of methylprednisolone acetate, an injectable steroid used to treat back and joint pain. Sealed vials of the steroid, made by the New England Compounding Center in Framingham, Mass., contained exserohilum rostratum, a fungus found in soil and plants. It's unclear how the fungus landed in the sealed vials.

The New England Compounding Center has recalled all its products and shut down operations. Calls to the owners were not immediately returned.

As many as 14,000 patients are thought to have received injections of the suspect steroid.

Seventy-six clinics in 23 states that received methylprednisolone acetate from the recalled lots have been instructed to notify all affected patients. The "potentially contaminated injections were given starting May 21, 2012," according to the CDC.

For a full list of clinics receiving the recalled lots of spinal steroid injections, click here.

Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis -- including headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, and redness or swelling at the injection site -- can take more than a month to appear.

The longest duration from the time of injection to the onset of symptoms in the current outbreak is 42 days, according to the CDC's Dr. Benjamin Park.

"But we want to emphasize that we don't know what the longest will be," he added, stressing that patients who received injections of the recalled drug should stay attuned to the subtle symptoms "for months."

Fungal meningitis is diagnosed through a spinal tap, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications.

Unlike bacterial meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are thought to be at risk.

Copyright 2012 ABC News Radio

Monday
Oct222012

Compounding Pharmacists Defend Their Trade After Meningitis Outbreak

Jared Wickerham/Getty Images(SAN JOSE, Calif.) -- Chuck Leiter remembers getting an earful from his father after he helped a young Barry Cadden and his wife set up their booth at a conference for pharmacists in the late 1990s.

"My dad almost killed me," said Leiter, who works with his father at Leiter's Compounding Pharmacy in San Jose, Calif. The Caddens had an unsavory reputation. "I knew they were trouble," he said.

Cadden was the president of the New England Compounding Center, which shut down this month after it was blamed for distributing tainted steroid injections that caused deadly fungal meningitis, killing 23 people to date. Up to 14,000 patients could be at risk, and 294 cases have been reported. Another three people came down with joint infections.

Like many compounding pharmacists nationwide, Leiter wants to make it known that his family-owned business does not operate like NECC, which produced compounded drugs in such high volumes that some groups argue it was a drug manufacturer, not a compounding pharmacy, and should have been under stricter regulation. The Food and Drug Administration raided NECC's Framingham, Mass., facility on Tuesday.

Leiter's grandfather opened his family pharmacy in 1925, he said. Leiter began making compounded drugs for patients since the 1980s, starting with eyedrops for patients allergic to the preservatives in most commercially available drops. He now makes 100 to 300 tailor-made prescriptions a day for everything from allergen-free thyroid medication to injectable erectile dysfunction drugs for prostate cancer survivors on whom Viagra has no effect.

It's not clear how much volume NECC was producing, but the director of the Massachusetts Bureau of Health Care Safety and Quality said that NECC was in violation of state licensing regulations. About 17,000 vials of the tainted steroid were shipped to pain clinics in 23 states.

Leiter actually doesn't produce spinal injections because of the liability, pointing out the fatal meningitis outbreak from 2001 that killed three people who received cortisone injections compounded at Doc's Pharmacy in nearby Walnut Creek, Calif. Its co-owner, Jamey Phillip Sheets, committed suicide by overdosing with painkiller patches a year later.

Unlike drug manufacturers, which are regulated by the FDA, compounding pharmacies usually fall under state pharmacy boards' jurisdiction. The FDA can step in if it has concerns about a compounding pharmacy, such as misbranding or adulteration.

FDA spokeswoman Erica Jefferson said, "FDA's legal authority to regulate compounded drugs is complex and has been challenged vigorously by the compounding industry both in courts and Congress."

Each custom drug has to be tailored to a single patient with a single prescription from a single doctor, Leiter said.

According to a 2006 FDA warning letter, NECC wasn't always doing that. Among other things, the letter said NECC was mass-producing a topical anesthetic cream, and jeopardizing another drug's sterility by repackaging it.

"Further, we have been informed that, although your firm advises physicians that a prescription for an individually identified patient is necessary to receive compounded drugs, your firm has reportedly also told physicians' offices that using a staff member's name on the prescription would suffice," the letter reads, adding the practice is not consistent with FDA policy.

The FDA did not take further action because of its limited jurisdiction over compounding companies.

"These people are all doing it for greed," Lieter said, referring to pharmacists who put their profits ahead of patient safety. "I knew the people at NECC, and I knew Frank's Pharmacy." Frank's Pharmacy is another large compounding pharmacy that had to recall drugs in May because of a fungal contamination.

NECC did not respond to requests for comment from ABC News or other news outlets. They said this in a statement: "NECC's intent has always been to operate in compliance with our licenses in the states where we do business, and we have made our best efforts to be in compliance with all governing laws and regulations during 15 years of providing hundreds of thousands of patients with vital medications. We are cooperating with agencies that have a policy of not commenting on pending investigations, and as part of that cooperation we are honoring that policy and not commenting on specific facts."

When large-scale compounding pharmacies began to crop up, health care providers became lax about writing compounded drug prescriptions for individual patients. Leiter said he received prescriptions for patients named "Mickey Mouse," and prescriptions that included extra doses that a single patient couldn't possibly need. Concerned, he called doctors' offices, but they told him their last compounding pharmacist didn't care about such things.

"If they don't want to give me that information, I don't need to fill it. I won't fill it," Leiter said.

Stephen Bernardi, who owns and runs Johnson Compounding and Wellness Center with his wife in Waltham, Mass., not far from NECC headquarters, said one of the misconceptions about his job is that he can just go in a back room and "whip up" whatever customers want.

"It's very, very specific," Bernardi said. "We keep it within the triad of the pharmacist, the specialist and the patient, and it needs to be done for a very specific reason."

He said it takes 24 to 48 hours to process a single prescription, and it goes through many steps and checks from mathematical formula to ready-for-pickup drug. Although he used to be a regular pharmacist who compounded on the side, he realized four years ago that he needed to fully commit to compounding to give himself the work environment that he needed.

Since his pharmacy is so close to NECC and most customers don't know one compounding pharmacy from another, he said he's gotten calls from concerned patients and physicians. When news outlets couldn't get inside NECC but needed stock compounding pharmacy photos, they used his shop and back room for stories about the tainted steroid injections.

"The fallout from this thing is, on one hand, it's obviously a disaster for the victims," Bernardi said. "It's putting a lot of heat on people such as myself and most of my colleagues that I know are doing it the right way. But it's also given us a chance to tell our story."

The state boards of pharmacy want to hear their stories, too. Massachusetts and California both sent pharmacists questionnaires to fill out following the meningitis outbreak.

The Massachusetts form asks for accreditation, manufacturer registration and what kinds of drugs the pharmacies compound. It also has a few yes or no questions, including whether "the Pharmacy only dispenses Compounded Sterile Preparations after receipt of a valid prescription."

Leiter called the letters a "knee-jerk" reaction to the outbreak.

"The forms don't do us squat," he said. "You can lie all the way down the line on those things."

Leiter works with several hospitals and helps with FDA clinical trials, which both require regular audits. He said he sends even more samples out for testing than he has to just to be sure his products are safe. Although California pharmacy inspections are good, he said the Pharmacy Compounding Accreditation Board does the best job.

"California does a really good job, but these people can come in and go through your pharmacy and leave. You can go back and do whatever you want," he said. "PCAB comes through and they're there for two days."

Although sending samples of his drugs for testing is expensive, Leiter said he is considering raising prices to do even more of it.

"I like to sleep at night," he said. "My kids want to do this. My oldest is 18 now, and my grandfather started doing it in 1925. I'm just not interested in taking empty risks."

Copyright 2012 ABC News Radio

Friday
Oct192012

Meningitis Outbreak: 271 Cases, 21 Deaths

Hemera/Thinkstock(ATLANTA) -- One more person has died from fungal meningitis linked to tainted steroid injections, raising the death toll for the outbreak to 21.

The U.S. Centers for Disease Control and Prevention has increased the tally of cases to 271 -- 268 cases of fungal meningitis and three cases of joint infections. The growing outbreak, which spans 16 states, has been linked to contaminated vials of methylprednisolone acetate, an injectable steroid used to treat back and joint pain.

For a map of cases by state, click here.


Sealed vials of the steroid, made by the New England Compounding Center in Framingham, Mass., contained Exserohilum rostratum, a fungus found in soil and plants. It's unclear how the fungus landed in the sealed vials.

The U.S. Centers for Disease Control and Prevention has confirmed 26 cases of Exserohilum meningitis, as well as one case each of Aspergillus and Cladosporium meningitis.

The New England Compounding Center has recalled all its products and shut down operations. Calls to the owners were not immediately returned.

As many as 14,000 patients are thought to have received injections of the suspect steroid.

Seventy-six clinics in 23 states that received methylprednisolone acetate from the recalled lots have been instructed to notify all affected patients. The "potentially contaminated injections were given starting May 21, 2012," according to the CDC.

For a full list of clinics receiving the recalled lots of spinal steroid injections, click here.

Meningitis affects the membranous lining of the brain and spinal cord. Early symptoms of fungal meningitis -- including headache, fever, dizziness, nausea, sensitivity to light, stiff neck, weakness or numbness, slurred speech and pain, and redness or swelling at the injection site -- can take more than a month to appear.

The longest duration from the time of injection to the onset of symptoms in the current outbreak is 42 days, according to the CDC's Dr. Benjamin Park.

"But we want to emphasize that we don't know what the longest will be," he added, stressing that patients who received injections of the recalled drug should stay attuned to the subtle symptoms "for months."

Fungal meningitis is diagnosed through a spinal tap, which draws cerebrospinal fluid from the spine that can be inspected for signs of the disease. Once detected, it can be treated with high doses of intravenous antifungal medications.

Unlike bacterial meningitis, fungal meningitis is not transmitted from person to person and only people who received the steroid injections are thought to be at risk.

Copyright 2012 ABC News Radio

Tuesday
Oct162012

Meningitis Scare: Spinal Tap Headaches Can Seem Like Infection

Stockbyte/Thinkstock(NEW YORK) -- Jim McGuire said he was relieved when doctors told him his spinal tap tested negative for fungal meningitis last week, but his feeling of panic returned the next day when a severe headache set in.

Although the headache could have been a result of his spinal tap, McGuire's doctor told him there was a chance he was experiencing the onset of meningitis -- even though he had tested negative the day before.

"It felt like there was a knife sticking in your head," McGuire, 51, said.  "I've had sinus headaches, which are more of a dull ache.  This was a very sharp pain that was constant."

And McGuire is not alone in wondering whether he is having a spinal headache or meningitis.  A spinal tap is the only way to tell if a patient has meningitis, and 40 percent of spinal tap patients get spinal headaches as a result, according to the Mayo Clinic.

More than 14,000 patients nationwide may have been exposed to fungal meningitis if they received contaminated compounded steroid injections manufactured by New England Compounding Co. in Massachusetts.  Of the 212 people who were infected, 15 have died, the Centers for Disease Control and Prevention said on Monday.  Another two patients developed joint infections.

McGuire spent eight hours in the hospital last Monday after he learned that he received a contaminated epidural injection for his back pain in August.  He was among about 300 patients to receive a spinal tap at Saint Thomas Hospital in Nashville, Tenn., because of the fungal meningitis outbreak, said hospital spokeswoman Rebecca Climer.

He then had to miss two and a half days of work, lying down at home with the drapes closed because his head hurt, he said.

If McGuire had a spinal headache, it would mean that spinal fluid leaked from the puncture where doctors performed his spinal tap, offsetting the normal pressure from fluid in the spinal column, said Dr. Joshua Bederson, who chairs neurosurgery at Mount Sinai Hospital in New York.

The brain produces and absorbs four cups of spinal fluid each day, he said.  When there's too little fluid, as in a spinal headache, the brain sags in the skull, pulling on veins that connect the outer surface of the brain to the inner surface of the skull.  That's what causes the intense headache.  It usually clears up on its own without major health complications.

Meningitis headaches, on the other hand, are caused by inflammation of the membranes in the brain and spine.  They can result in permanent neurological damage and death.

But which is which?

If the headache is positional, it's probably a spinal headache, Bederson said.  The patient should get relief from lying down, but feel more pain when he or she stands up.

If the pain is constant and not positional, it may be something else.

Copyright 2012 ABC News Radio







ABC News Radio