Corruption seems to be at the heart of so many of our health care problems.
In meningitis scare, charges firm misled U.S. regulators
By Tim Ghianni
Oct 11, 2012
(Reuters)
The deadly meningitis outbreak that has claimed a dozen lives is prompting calls for increased oversight of the nation's custom-made pharmaceutical industry, amid charges that the company at the center of the scare may have misled U.S. regulators.
On Wednesday, Idaho became the 11th state to report a case of the rare illness, which has been linked to tainted steroids produced by a specialty pharmacy in Massachusetts.
The U.S. Food and Drug Administration, whose role in the outbreak has come under criticism, said it was planning an afternoon media briefing on Thursday.
In all, 138 people have contracted meningitis as a result of the now-recalled drugs, according to the latest tally from the U.S. Centers of Disease Control and officials in 11 states where the outbreak has spread. The case in Idaho is the first discovered in the western United States.
Lawmakers have come under pressure to close what critics see as a loophole in oversight that left the New England Compounding Company (NECC), the Massachusetts pharmacy linked to the tainted steroids, largely exempt from federal regulation.
The FDA regulates only the ingredients and their suppliers, not the little-known corner of the drug world known as "compounding," which is subject to a patchwork of state oversight.
State and federal officials are now investigating NECC, which distributed thousands of vials of a contaminated steroid made at a shabby brick complex next to a waste and recycling operation in a western suburb of Boston.
The pharmacies are owned by Gregory Conigliaro, an engineer, and his brother-in-law, Barry Cadden, a pharmacist who was in charge of pharmacy operations at NECC. The waste and recycling facility is another of Conigliaro's business interests.
Compounding pharmacies such as NECC are permitted to make medications based on specific prescriptions for individual patients.
State and federal regulators are investigating why NECC shipped thousands of vials of preservative-free methylprednisolone acetate steroid to healthcare facilities in multiple states.
"It does seem like the agencies, both at the state and the federal level, may have been misled by some of the information we were given," Massachusetts Governor Deval Patrick told reporters on Wednesday.
The number of cases has grown rapidly as health practitioners contacted about 13,000 people who received injections from a potentially tainted supply of steroid medication shipped to 23 states.
In five states - Tennessee, Michigan, Maryland, Virginia, and Florida - the outbreak has claimed lives, with the latest victim a 70-year-old man in Florida.
Thousands of people received the injections to relieve back pain and other complaints and are at risk of infection...
(Writing by James B. Kelleher; Editing By Greg McCune; Desking by Vicki Allen)
Read more: In meningitis scare, charges firm misled U.S. regulators
Showing posts with label fungus. Show all posts
Showing posts with label fungus. Show all posts
Thursday, October 11, 2012
Wednesday, October 10, 2012
Meningitis warning for those who've had spinal injections of steroids since May 21, 2012
Doctors have been having problems recognizing fungal meningitis.
Doctors Are Off Balance as Patients Show Atypical Meningitis Reactions
By JENNIFER CORBETT DOOREN
Wall Street Journal
October 10, 2012
The rare fungal meningitis behind a deadly national outbreak is difficult to diagnose because it can cause strokes and other reactions unlike those typically seen with the more common type of the illness.
Meningitis, a swelling of the protective membranes of the brain and spinal cord, is typically caused by bacteria that can be treated with antibiotics, or by a virus, for which there is no treatment.
Fungal meningitis, on the other hand, needs to be treated with antifungal drugs. The length of treatment isn't known but the federal Centers for Disease Control and Prevention is telling doctors that patients may need treatment for months.
Bacterial meningitis tends to attack quickly with a fever, a headache that grows worse, a stiff neck and eventually a loss of consciousness.
However, some patients who contracted fungal meningitis in the current outbreak have had just a mild headache and no fever, and "for the most part symptoms occur in a more gradual fashion," said William Schaffner, an infectious disease expert and chairman of the department of preventive medicine at Vanderbilt University School of Medicine in Nashville, which has treated four patients with fungal meningitis.
Dr. Schaffner said fungal meningitis is invading blood vessels and causing strokes in some patients affected by the current outbreak. But doctors don't typically test for meningitis when patients go to the emergency room with signs of stroke, such as weakness or loss of movement on one side of their bodies, slurred speech or sudden vision changes.
"Nobody is totally sure what these patients look like," said Trish Perl, senior hospital epidemiologist at the Johns Hopkins Health System in Baltimore, who is advising doctors about patients who might have the disease.
Because the fungal-meningitis symptoms have been so varied among patients, federal health officials have urged doctors to set a low bar in deciding whether to test patients who received a steroid injection in their backs. The test requires a spinal tap, which involves a needle inserted in the spinal column to collect spinal fluid.
The CDC has said as many as 13,000 people in 23 states have been exposed to the potentially contaminated steroid injections made by the New England Compounding Center before the products were recalled Sept. 26. Compounding pharmacies create blends of medicines, including liquid forms of pills.
The agency said patients who have had an epidural steroid injection since May 21, 2012, and are experiencing symptoms such as headache, fever, sensitivity to light, slurred speech or numbness, should contact their doctors as soon as possible.
Officials are most concerned about spinal injections. Those given in other places, such as the knees or hips, are highly unlikely to cause meningitis, though there is the possibility of a local joint infection...
Doctors Are Off Balance as Patients Show Atypical Meningitis Reactions
By JENNIFER CORBETT DOOREN
Wall Street Journal
October 10, 2012
The rare fungal meningitis behind a deadly national outbreak is difficult to diagnose because it can cause strokes and other reactions unlike those typically seen with the more common type of the illness.
Meningitis, a swelling of the protective membranes of the brain and spinal cord, is typically caused by bacteria that can be treated with antibiotics, or by a virus, for which there is no treatment.
Fungal meningitis, on the other hand, needs to be treated with antifungal drugs. The length of treatment isn't known but the federal Centers for Disease Control and Prevention is telling doctors that patients may need treatment for months.
Bacterial meningitis tends to attack quickly with a fever, a headache that grows worse, a stiff neck and eventually a loss of consciousness.
However, some patients who contracted fungal meningitis in the current outbreak have had just a mild headache and no fever, and "for the most part symptoms occur in a more gradual fashion," said William Schaffner, an infectious disease expert and chairman of the department of preventive medicine at Vanderbilt University School of Medicine in Nashville, which has treated four patients with fungal meningitis.
Dr. Schaffner said fungal meningitis is invading blood vessels and causing strokes in some patients affected by the current outbreak. But doctors don't typically test for meningitis when patients go to the emergency room with signs of stroke, such as weakness or loss of movement on one side of their bodies, slurred speech or sudden vision changes.
"Nobody is totally sure what these patients look like," said Trish Perl, senior hospital epidemiologist at the Johns Hopkins Health System in Baltimore, who is advising doctors about patients who might have the disease.
Because the fungal-meningitis symptoms have been so varied among patients, federal health officials have urged doctors to set a low bar in deciding whether to test patients who received a steroid injection in their backs. The test requires a spinal tap, which involves a needle inserted in the spinal column to collect spinal fluid.
The CDC has said as many as 13,000 people in 23 states have been exposed to the potentially contaminated steroid injections made by the New England Compounding Center before the products were recalled Sept. 26. Compounding pharmacies create blends of medicines, including liquid forms of pills.
The agency said patients who have had an epidural steroid injection since May 21, 2012, and are experiencing symptoms such as headache, fever, sensitivity to light, slurred speech or numbness, should contact their doctors as soon as possible.
Officials are most concerned about spinal injections. Those given in other places, such as the knees or hips, are highly unlikely to cause meningitis, though there is the possibility of a local joint infection...
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