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Scientists may be on track to develop a vaccine for the most common strain of meningitis, which has so far resisted an effective vaccine. Meningitis is a serious disease caused by an inflammation of the lining that protects the brain and spinal cord. Vaccines exist for most varieties of the bacteria that cause epidemics of the disease. The disease can be fatal, even when treatment with antibiotics begins quickly. Those who survive can have permanent brain damage. So vaccination is important.
Vaccines against some strains of meningitis have been used for decades, but the method for creating them was not effective in developing a vaccine against the most common variety of the meningitis bacteria, called group B. "For this reason, we had to find different ways. And we have been using genomics to find proteins that could be used as vaccine targets," says Rino Rappuoli of the pharmaceutical company Novartis.
He and his colleagues set out to make a substance - an immunogen - that would prompt the body to produce antibodies to fight all the numerous sub-varieties of group B. Rappuoli and his team developed 54 candidate immunogens and tried them on laboratory mice to see which were most effective. Most of them didn't work very well. "But we found two or three molecules, one of which was very good, which was able to induce immunity against all the variants of the molecule."
Rappuoli's work sets the stage for development of a vaccine against group B meningitis, and the researcher says coming up with a genetically-engineered, custom antigen may lead to development of vaccines against other diseases that have challenged vaccine-makers so far. "I believe that this approach will be used more and more in the future and will help to solve some of those very difficult problems," he says.
Scientists Closer to Developing Meningitis Vaccine | Health | English
A vaccine against one of the most common forms of childhood meningitis could reduce the number of deaths in the UK even further. The current vaccination programme protects against only some of the bacterial types involved. A Chilean study, reported in The Lancet medical journal, found more evidence the new vaccine works against the B form of the disease. This causes about 2,000 cases in the UK each year, mostly in the under-fives. The meningitis vaccine programme here is thought to have saved many hundreds of lives over the past decade. However, meningitis B has been an elusive target for vaccine developers, as it is a group of thousands of subtly-different strains of bacteria, making it difficult to find a single jab that could cover them all. So while four other major strains are included in the vaccine, the danger from meningitis B remains.
Inflammation
The infection, which causes inflammation of membranes surrounding the spinal cord and brain, still causes more than 100 deaths a year, with many more children suffering serious and potentially disabling illness. Scientists produced the "4CMenB" vaccine by analysing the genetic structure of thousands of B strains, looking for shared features which could be targeted. There have already been encouraging results when given to toddlers, and the latest study, carried out by University of Chile scientists, looked at its effectiveness when given to 11 to 17-year-olds. More than 60% of bacterial meningitis cases in Chile involve type B, but two doses of the vaccine appeared to offer almost 100% protection. The researchers said that the vaccine could now be considered for vaccination programmes in countries where the B type was prevalent, including many in Europe, and the United States.
Dr Myron Christodoulides, a senior lecturer in Molecular Microbiology at the University of Southampton, said that the full range of type B strains covered by the vaccine was not yet proven. He said: "Previous studies have shown that 4CMenB has the potential to provide significant protection when administered to infants - this new study shows it could also be highly protective in the adolescent age group. "However, there are still a number of important questions to be answered such as how many strains it will protect against, how long the protection will last and whether it will stop the bacteria from being passed on to others, providing indirect protection to those not vaccinated." Kate Rowland, from Meningitis UK, added: "The UK is a hot spot for meningitis B, with one of the highest incidence rates of the disease in the world. "Scientists have been trying to develop a vaccine against it for years but it has been very challenging as its capsule is similar to the structure of human nerve cells and the bacteria is clever, mutating and adapting."
BBC News - Meningitis jab ?protection hope?
The Tennessee Department of Health is joining forces with the Center for Disease Control to investigate an unusual outbreak of meningitis that has hit 11 Tennesseans so far, killing two of them. The 11 patients who contracted this strain of fungal meningitis in Tennessee received epidural steroid injections at St. Thomas Outpatient Neurosurgery Center between July 30 and Sept. 20. The injections are commonly administered to relieve pain. Another patient was identified in another state who seems to have contracted meningitis after the same procedure.
Although the investigation has yet to reveal a definitive culprit behind the fungal meningitis cluster, said TDH Commissioner Dr. John Dreyzehner, the injections have been recalled and evidence suggests more than a dozen other states could be affected. Two other facilities in Tennessee that purchased and received what Dreyzehner called the materials of concern will also contact potentially impacted patients. St. Thomas closed the clinic on Sept. 20, two days after a clinician discovered a case of fungal meningitis.
Fungal meningitis, different from bacterial and viral strains, is not contagious, said Dreyzehner. This type of meningitis is not spread from person to person, he said. About 737 patients who received the same injection at the center during that window have been alerted and examined, he added. Symptoms of fungal meningitis, which could include headaches, fever, numbness or slurring speech, have manifested themselves between seven and 28 days after treatment, he said. The earlier people are identified and treatment begins the better outcome theyre likely to have, he said. Treatments could include anti-fungals and steroids.
This type of meningitis is very rare in those with functioning immune systems, Dreyzehner said. A team of experts is working to determine the best way to treat the surviving patients. Dreyzehner said epidural steroid injections are a common, safe way to alleviate lower-back pain. The infected patients ranged in age between their 40s and 80s. This is a very, very unusual event, Dreyzehner said. This is not a complication that would be expected in the normal course of things.
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Meningitis is a swelling of the protective membranes of the brain and spinal cord. Its usually caused by a bacterial or viral infection and can kill quickly. Symptoms include a high fever, vomiting, headache, stiff neck and back, confusion and a heightened sensitivity to light. Those who survive may suffer from deafness, brain damage and learning difficulties.
Meningitis is really devastating for these countries. Its very unpredictable. It sweeps in unannounced every seven to fourteen years. And when it comes to a country it really causes huge problems. For a start, a lot of people fearing the disease, fearing the death and illness that it brings--they decide to stop gathering and getting together in large groups. So this means children not going to school or adults actually not going to work, said Dan Thomas of the GAVI Alliance, a Geneva-based public-private partnership working on improving health in poor countries.
Africa has a meningitis belt that stretches from Senegal in the west to Ethiopia in the east. The first phase of meningitis immunizations began in Burkina Faso in 2010. About 12 million people were vaccinated. Health officials say since then no cases of the disease have been reported in the country. The countries targeted in the current phase - between October and December - are Benin, Cameroon, Chad, Ghana, Nigeria, Senegal and Sudan. Thomas said that the immunizations target meningitis caused by a virus and will be given to babies, children and young adults. This is a vaccine called MenAfriVac. Its a vaccine against meningitis A, which sweeps through these countries at this time of year before the rainy season, and affects more than 430 million people, who are at risk from illness and death, he said.
He added the vaccine costs only one half U.S. dollar, or 50 cents, per dose. One of the key ideas behind it was that it had to be a vaccine which was affordable. Affordable to GAVI so that we could roll it out for more than 400 million people, but also crucially that these countries take on the cost of the vaccines themselves. The immunization campaign is a partnership involving the GAVI Alliance, the World Health Organization, UNICEF, the Serum Institute of India and the Meningitis Vaccine Project.
New Immunization Effort Launched
The outbreak, with 5 people dead and 30 ill in six states, is thought to have been caused by a steroid drug contaminated by a fungus. The steroid solution was not made by a major drug company, but was concocted by a pharmacy in Framingham, Mass., called the New England Compounding Center. Compounding pharmacies make their own drug products, which are not approved by the Food and Drug Administration. On Monday, federal inspectors at the New England center found a sealed vial of the steroid afloat with so much foreign matter that it could be seen with the naked eye, Food and Drug Administration officials said Thursday. Under the microscope, the particles were a fungus.
The drug has been recalled, the clinics that used it are scrambling to warn patients who might have been exposed and health officials are urging anyone feeling ill after a spinal steroid injection to contact a doctor quickly, especially for symptoms like severe headache, fever, nausea, dizziness, loss of balance or slurred speech. They are also urging doctors and hospitals to stop using any products made by the New England Compounding Center. The pharmacy had shipped 17,676 vials of this potentially contaminated solution to 75 clinics in 23 states, according to Massachusetts and federal health officials.
The question is, Why? Why would pain clinics around the country rely on a pharmacy that mixes its own brand of unapproved drugs, especially for a delicate procedure like an epidural injection that has the potential — realized in these awful cases — to infect a patient’s nervous system? There seems to be no one answer. Some doctors say compounding pharmacies offer specialty products or dosages not easily found elsewhere, or sometimes simply better prices than big drug companies. But other physicians have reservations about using compounded pharmaceuticals.
Dr. Arthur S. Watanabe, an interventional pain specialist in Spokane, Wash., said the steroid for spinal injection was available from mainstream drug companies, and he could not understand why anyone would buy it from a compounding pharmacy. Compounding has been called an ancient art, something practiced long before medicines were premixed and sealed in bubble packs. The practice goes on today, allowed by states and the federal government, but it is supposed to provide custom-made products for individual patients with special needs. It is frequently done in hospital pharmacies, and an estimated 2 to 3 percent of prescriptions in the United States are compounded prescriptions for individual patients, according to the International Academy of Compounding Pharmacists.
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The new tally sent a chill through the U.S. medical community as investigators scrambled to notify hundreds, and possibly thousands, of patients across the country that steroid injections administered to the spinal cord for back pain may have been contaminated with a fungus. Investigators say patients in seven states receiving injections of the drug (methyl-prednisolone acetate) between July and September are believed to be most at risk. Medical detectives have narrowed their search for the source of the contamination to a specialty pharmacy in Massachusetts. The suspect fungus was found this week in at least one sealed vial of the steroid solution at the company's manufacturing facility. More than 17,000 vials were immediately recalled.
Meningitis is an inflammation of the lining of the brain and the spinal cord. Dr. John Jernigan, an epidemiologist at the Centers for Disease Control, says the initial symptoms of fungal meningitis in patients can vary. "The symptoms that they are experiencing are those that we sometimes see in cases of meningitis, such as fever, new or worsening headache, sometimes neck stiffness. We've also seen in a few patients, signs and symptoms of stroke, sudden onset of slurred speech, dizziness, difficulty walking, sudden weakness, etc," said Jernigan, Compounding pharmacies often custom-mix medications into doses and forms that may not be commercially available.
Dr. William Schaffner, chairman of the Department of Preventative Medicine at the Vanderbilt Medical Center, tells VOA the meningitis outbreak shows compounding pharmacies need better regulations. "The Food and Drug Administration seems not to have oversight, regulatory oversight, over these compounding pharmacies. That's got to be changed. There is no reason that in the 21st century patients in the United States should be receiving questionable medications," said Schaffner.
He also warned there could be additional cases of fungal meningitis because of its incubation period. Health officials say so far, the majority of the deaths and illnesses linked to the outbreak have occurred in the state of Tennessee.
Source
In 23 states, hundreds, possibly thousands, of back-pain patients are being warned to watch for symptoms of meningitis because of a custom-mixed steroid solution that may have been contaminated with fungus. Five people have died and more than 40 others have fallen ill.
Doctors who do these injections say they are extremely safe when done correctly with sterile drugs. And many doctors stick to medications approved by the Food and Drug Administration instead of relying on generally less-regulated "compounding pharmacies" like the Massachusetts company implicated in the outbreak. "If I was a patient, I would definitely be concerned," said Dr. Michael Schafer, an orthopedic specialist at Chicago's Northwestern Memorial Hospital.
He said Northwestern gets steroids from federally regulated pharmaceutical companies. And in almost 40 years of experience, he has never had a patient develop an infection from these shots. He and others say patients should ask their doctors if their medications come from compounding pharmacies, which custom-mix and repackage creams, solutions and other drugs. In fact, some doctors who rely on such places are rethinking that.
Dr. Michael Drass of Allegheny Pain Management, a clinic in Altoona, Pa., said he has pulled all drugs that came from the New England Compounding Center off his shelves as the government has urged physicians to do and is re-evaluating whether to rely on compounding pharmacies for the medicines he uses to treat patients. "I've been doing this for 15 years now, and I've done 50,000 injections over that course of time, and I've never seen or heard anything like this. It's a real eye-opener for us in the medical practitioner community," Drass said.
More Docs say spine shots for steroids are usually safe - Yahoo! News
The latest two deaths were reported in Michigan, according to the US Centers for Disease Control and Prevention (CDC). Those affected fell ill after receiving steroid injections linked to a pharmaceutical compounding plant in Massachusetts. New cases in Ohio and Minnesota on Saturday brought to nine the number of states affected, officials said. Other states with reported cases of people who fell ill after receiving the injections primarily for back pain are Michigan, Tennessee, Virginia, Florida, Maryland, North Carolina and Indiana. Meningitis is an infection of the membranes covering the brain and spinal cord.
Vials of steroids linked to the outbreak were shipped to 76 facilities in 23 states and could have been used to inject thousands of patients, authorities have said. As in other states where the outbreak has been detected, Minnesota authorities are trying to determine who else may have been infected at six locations known to have used the drugs in question, said Buddy Ferguson, public information officer for the states Department of Health. We have identified a list of approximately 950 people who did receive injectable steroids from the implicated lots, he said.
Tennessee, where the outbreak was first detected, accounts for most of the cases, with 29, state officials said on Friday. Three of the deaths have been in Tennessee, and one each in Virginia and Maryland. The infected patients have shown a variety of symptoms from one to four weeks after their injections, including fever, a new or worsening headache, nausea and neurological problems that would be consistent with a deep brain stroke, the CDC said.
All the cases have been traced to three lots of the steroid prepared at New England Compounding Center in Framingham, Massachusetts. The company said it had suspended its operations while the investigation proceeds. The Massachusetts Health Department said there were 17,676 vials of medication in each of three lots of methylprednisolone acetate sent out from July through to last month and have a shelf life of 180 days.
Death toll from US meningitis outbreak continues to mount - Taipei Times
How could this happen??...
In a Drug Linked to a Deadly Meningitis Outbreak, a Question of Oversight
October 4, 2012 - The nations growing outbreak of meningitis, linked to spinal injections for back pain, was a calamity waiting to happen the result of a lightly regulated type of drug production that had a troubled past colliding with a popular treatment used by millions of Americans a year.
The outbreak, with 5 people dead and 30 ill in six states, is thought to have been caused by a steroid drug contaminated by a fungus. The steroid solution was not made by a major drug company, but was concocted by a pharmacy in Framingham, Mass., called the New England Compounding Center. Compounding pharmacies make their own drug products, which are not approved by the Food and Drug Administration. On Monday, federal inspectors at the New England center found a sealed vial of the steroid afloat with so much foreign matter that it could be seen with the naked eye, Food and Drug Administration officials said Thursday. Under the microscope, the particles were a fungus.
The drug has been recalled, the clinics that used it are scrambling to warn patients who might have been exposed and health officials are urging anyone feeling ill after a spinal steroid injection to contact a doctor quickly, especially for symptoms like severe headache, fever, nausea, dizziness, loss of balance or slurred speech. They are also urging doctors and hospitals to stop using any products made by the New England Compounding Center. The pharmacy had shipped 17,676 vials of this potentially contaminated solution to 75 clinics in 23 states, according to Massachusetts and federal health officials.
The question is, Why? Why would pain clinics around the country rely on a pharmacy that mixes its own brand of unapproved drugs, especially for a delicate procedure like an epidural injection that has the potential realized in these awful cases to infect a patients nervous system? There seems to be no one answer. Some doctors say compounding pharmacies offer specialty products or dosages not easily found elsewhere, or sometimes simply better prices than big drug companies. But other physicians have reservations about using compounded pharmaceuticals.
Dr. Arthur S. Watanabe, an interventional pain specialist in Spokane, Wash., said the steroid for spinal injection was available from mainstream drug companies, and he could not understand why anyone would buy it from a compounding pharmacy. Compounding has been called an ancient art, something practiced long before medicines were premixed and sealed in bubble packs. The practice goes on today, allowed by states and the federal government, but it is supposed to provide custom-made products for individual patients with special needs. It is frequently done in hospital pharmacies, and an estimated 2 to 3 percent of prescriptions in the United States are compounded prescriptions for individual patients, according to the International Academy of Compounding Pharmacists.
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See also:
US Steroid-Related Meningitis Cases Rise to 47
October 05, 2012 - The U.S. Centers for Disease Control says the number of confirmed cases of a rare outbreak of fungal meningitis linked to steroid shots rose on Friday from 34 to 47. The number of confirmed deaths remained at five.
The new tally sent a chill through the U.S. medical community as investigators scrambled to notify hundreds, and possibly thousands, of patients across the country that steroid injections administered to the spinal cord for back pain may have been contaminated with a fungus. Investigators say patients in seven states receiving injections of the drug (methyl-prednisolone acetate) between July and September are believed to be most at risk. Medical detectives have narrowed their search for the source of the contamination to a specialty pharmacy in Massachusetts. The suspect fungus was found this week in at least one sealed vial of the steroid solution at the company's manufacturing facility. More than 17,000 vials were immediately recalled.
Meningitis is an inflammation of the lining of the brain and the spinal cord. Dr. John Jernigan, an epidemiologist at the Centers for Disease Control, says the initial symptoms of fungal meningitis in patients can vary. "The symptoms that they are experiencing are those that we sometimes see in cases of meningitis, such as fever, new or worsening headache, sometimes neck stiffness. We've also seen in a few patients, signs and symptoms of stroke, sudden onset of slurred speech, dizziness, difficulty walking, sudden weakness, etc," said Jernigan, Compounding pharmacies often custom-mix medications into doses and forms that may not be commercially available.
Dr. William Schaffner, chairman of the Department of Preventative Medicine at the Vanderbilt Medical Center, tells VOA the meningitis outbreak shows compounding pharmacies need better regulations. "The Food and Drug Administration seems not to have oversight, regulatory oversight, over these compounding pharmacies. That's got to be changed. There is no reason that in the 21st century patients in the United States should be receiving questionable medications," said Schaffner.
He also warned there could be additional cases of fungal meningitis because of its incubation period. Health officials say so far, the majority of the deaths and illnesses linked to the outbreak have occurred in the state of Tennessee.
Source
U.S. health officials on Sunday reported an additional 27 cases in a fungal meningitis outbreak linked to steroid injections that has killed seven people and now infected 91 in nine states. The U.S. Centers for Disease Control and Prevention reported the new total of 91 cases in an update on its website, up from 64 on Saturday. Most of the new cases were reported in Michigan, where the total increased to 20 from eight. Virginia's total increased to 18 from 11.
The widening outbreak has alarmed U.S. health officials and focused attention on regulations of pharmaceutical compounding companies like the one that produced the drugs, the New England Compounding Center Inc in Framingham, Massachusetts. The company shipped 17,676 vials of the steroid methylprednisolone acetate to 76 facilities in 23 states from July through September, the Massachusetts Health Department said.
The steroid is used as a painkiller, usually for the back, and could have been injected in thousands of patients, authorities have said. Meningitis is an infection of the membranes covering the brain and spinal cord, and affected patients started showing a variety of symptoms from one to four weeks after their injections. The company, which was previously the subject of complaints, has suspended its operations while an investigation proceeds and earlier recalled the three lots of the drug. It expanded its recall on Saturday to all products compounded and distributed at its Framingham facility.
According to an announcement on its website, the company issued the broader recall out of "an abundance of caution" because of the "potential risk of contamination." A compounding pharmacy takes medications from pharmaceuticals manufacturers and makes them into specific dosages and strengths for use by doctors. Complaints against the company in 2002 and 2003 about the processing of medication resulted in an agreement with government agencies in 2006 to correct deficiencies, the Massachusetts Health Department said.
LIMITED FDA AUTHORITY
The Centers for Disease Control said Monday that the number of people infected with meningitis related to steroid injections has gone from 91 to 105. The death toll has risen from seven to eight.
Patients in nine states contracted the deadly fungal meningitis after being injected in their spine with a preservative-free steroid called methylprednisolone acetate that was contaminated by a fungus. The steroid is used to treat pain and inflammation.
The New England Compounding Center (NECC), the Massachusetts-based pharmacy that made the contaminated injections, voluntarily recalled three lots of the injected steroid last week.
http://news.blogs.cnn.com/2012/10/08/eighth-death-reported-in-meningitis-outbreak/
The four were admitted to a hospital in the Tuscan port of Livorno Sunday at the end of a cruise by MSC's Orchestra liner, Italy's ANSA news agency reported.
Two crew members were in the hospital's intensive care unit -- a 32-year-old Indonesian, who was critically ill, and a 47-year-old Italian man.
The two other sick crew members were in the hospital's infectious diseases unit. The ship left Livorno to start another cruise late Sunday.
Read more: Meningitis strikes 4 on cruise liner - UPI.com
The New England Compounding Center announced the recall Saturday. The company said in a news release that the move was taken out of an abundance of caution because of the risk of contamination. It says there is no indication that any other products have been contaminated. The Food and Drug Administration had previously told health professionals not to use any products distributed by the center.
The Centers for Disease Control and Prevention posted updated figures to its website Sunday showing there are 91 confirmed cases of the rare form of fungal meningitis. The outbreak spans nine states and has killed at least seven people. The states with reported cases are: Florida, Indiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Tennessee and Virginia.
The steroid linked to the outbreak had already been recalled, and health officials have been scrambling to notify anyone who may have received an injection of it. The Massachusetts pharmacy that made it has said it is cooperating with investigators.
It is not yet known exactly how many people may have been affected, though it could affect hundreds or even thousands of people who received the steroid injections for back pain from July to September. Meningitis is caused by the inflammation of protective membranes covering the brain and spinal cord. Fungal meningitis is not contagious as are its more common viral and bacterial counterparts.
http://news.yahoo.com/pharmacy-linked-outbreak-issues-wide-recall-200818604.html
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: 137
Deaths: 12
States: 10; Florida, Indiana, Maryland, Michigan, Minnesota, New Jersey, North Carolina, Ohio, Tennessee and Virginia.
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Online:
CDC: CDC - Multistate Meningitis Outbreak - HAI
Source
Would be good for college students to get before they go away to school...
Meningitis jab protection hope
18 January 2012 - Meningitis is a major cause of death in children
A vaccine against one of the most common forms of childhood meningitis could reduce the number of deaths in the UK even further. The current vaccination programme protects against only some of the bacterial types involved. A Chilean study, reported in The Lancet medical journal, found more evidence the new vaccine works against the B form of the disease. This causes about 2,000 cases in the UK each year, mostly in the under-fives. The meningitis vaccine programme here is thought to have saved many hundreds of lives over the past decade. However, meningitis B has been an elusive target for vaccine developers, as it is a group of thousands of subtly-different strains of bacteria, making it difficult to find a single jab that could cover them all. So while four other major strains are included in the vaccine, the danger from meningitis B remains.
Inflammation
The infection, which causes inflammation of membranes surrounding the spinal cord and brain, still causes more than 100 deaths a year, with many more children suffering serious and potentially disabling illness. Scientists produced the "4CMenB" vaccine by analysing the genetic structure of thousands of B strains, looking for shared features which could be targeted. There have already been encouraging results when given to toddlers, and the latest study, carried out by University of Chile scientists, looked at its effectiveness when given to 11 to 17-year-olds. More than 60% of bacterial meningitis cases in Chile involve type B, but two doses of the vaccine appeared to offer almost 100% protection. The researchers said that the vaccine could now be considered for vaccination programmes in countries where the B type was prevalent, including many in Europe, and the United States.
Dr Myron Christodoulides, a senior lecturer in Molecular Microbiology at the University of Southampton, said that the full range of type B strains covered by the vaccine was not yet proven. He said: "Previous studies have shown that 4CMenB has the potential to provide significant protection when administered to infants - this new study shows it could also be highly protective in the adolescent age group. "However, there are still a number of important questions to be answered such as how many strains it will protect against, how long the protection will last and whether it will stop the bacteria from being passed on to others, providing indirect protection to those not vaccinated." Kate Rowland, from Meningitis UK, added: "The UK is a hot spot for meningitis B, with one of the highest incidence rates of the disease in the world. "Scientists have been trying to develop a vaccine against it for years but it has been very challenging as its capsule is similar to the structure of human nerve cells and the bacteria is clever, mutating and adapting."
BBC News - Meningitis jab ?protection hope?
In a preliminary report on conditions at the pharmacy, the Food and Drug Administration said Friday that even when the contamination at New England Compounding Center exceeded the company's own safety levels, there is no evidence that staffers investigated or corrected the problem. The FDA uncovered some four dozen reports of potential contamination in company records, stretching back to January this year. The report comes from an FDA inspection of the Framingham, Mass.-based company earlier this month after steroid injections made by the company were tied to an outbreak of fungal meningitis. FDA officials confirmed last week that the black fungus found in the company's vials was the same fungus that has sickened 338 people across the U.S., causing 25 deaths.
The New England Compounding Center's lawyer said Friday the pharmacy "will review this report and will continue our cooperation with the FDA." Compounding pharmacies like NECC traditionally fill special orders placed by doctors for individual patients, turning out a small number of customized formulas each week. They have traditionally been overseen by state pharmacy boards, though the FDA occasionally steps in when major problems arise. Some pharmacies have grown into much larger businesses in the last 20 years, supplying bulk orders of medicines to hospitals that need a steady supply of drugs on hand.
The FDA report provides new details about NECC's conditions, which were first reported by state officials earlier this week. The drug at the center of the investigation is made without preservative, so it's very important that it be made under highly sterile conditions. Compounding pharmacies prepare their medications in clean rooms, which are supposed to be temperature-controlled and air-filtered to maintain sterility. But FDA inspectors noted that workers at the pharmacy turned off the clean room's air conditioning every night. FDA regulators said that could interfere with the conditions needed to prevent bacterial growth.
Inspectors also say they found a host of potential contaminants in or around the pharmacy's clean rooms, including green and yellow residues, water droplets and standing water from a leaking boiler.
Additionally, inspectors found "greenish yellow discoloration" inside an autoclave, a piece of equipment used to sterilize vials and stoppers. In another supposedly sterile room inspectors found a "dark, hair-like discoloration" along the wall. Elsewhere FDA staff said that dust from a nearby recycling facility appeared to be drifting into the pharmacy's rooftop air-conditioning system.
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Lovebears wrote: I think if there was a problem my dr would have called to warn his patients. I hope.
Don't count on it...
... you'll prob'ly have to ask...
... most doctors are advised by their malpractice insurance agents...
... don't volunteer any information unless specifically asked...
... helps keep the malpractice insurance premiums down that way...
... and lessens the chance of being sued.
The fact that the meningitis A vaccine can be removed from the so-called "cold chain" and transported throughout Africa at essentially room temperature means children and young adults who have not been receiving the potentially life-saving vaccine can now get it. The breakthrough was announced by international public health officials at the American Society of Tropical Medicine and Hygiene meeting in Atlanta, Georgia. Godwin Enwere heads the Meningitis Vaccine Project, a joint collaboration between the World Health Organization and the Program for Appropriate Technology in Health, or PATH. Enwere said the discovery that the vaccine could be in transit for up to four days without refrigeration or even coldpacks came after an extensive re-evaluation of stability data by drug regulators in India and Canada.
Prior to the finding, the drug agencies recommended that the meningitis vaccine be transported at temperatures between two and eight degrees centigrade. The ability to transport it safely at ambient temperatures of up to 40 degrees will allow it to reach tens of thousands of children who need it. Enwere recalls that during a meningitis outbreak in Chad last year, there wasnt enough of the drug to go around, and public health officials were only able to immunize youngsters in three districts. That left tens of thousands of children in the rest of the country unprotected. So, this clearly demonstrates not only the effect of the vaccine; that if a system is developed whereby this vaccine can be carried and administered at ambient temperature, then it will increase the coverage," said Enwere. "If we had had this information as of last year, Chad would have introduced this vaccine to a larger population and then perhaps they would not have had this outbreak.
Meningitis A is a serious, potentially fatal bacterial infection common in resource-poor counties. It causes inflammation of the protective linings of the brain and spinal cord, sometimes causing the brain to swell, producing severe fever, headache and confusion. The vaccine is known as MenAfriVac. It originally was created to meet the needs of Africas so-called meningitis belt, which the WHO estimates includes 400 million people who live across a swath of 21 countries that runs from Senegal to Ethiopia.
While the vaccine costs less than 50 cents per dose and is very effective, the biggest obstacle has been keeping it cool enough in the "cold chain" so it doesnt spoil during the final kilometers to its intended destination. Researchers are now investigating whether other cold-chain vaccines can be shipped at room temperature. In particular, they are studying a vaccine against bacterial pneumonia, a disease that kills an estimated half a million children each year.
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